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WO2025072858A1 - Dispositifs, systèmes et procédés d'assistance cardiaque - Google Patents

Dispositifs, systèmes et procédés d'assistance cardiaque Download PDF

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Publication number
WO2025072858A1
WO2025072858A1 PCT/US2024/049109 US2024049109W WO2025072858A1 WO 2025072858 A1 WO2025072858 A1 WO 2025072858A1 US 2024049109 W US2024049109 W US 2024049109W WO 2025072858 A1 WO2025072858 A1 WO 2025072858A1
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WO
WIPO (PCT)
Prior art keywords
blood
pressure
heart
conduit
enclosed chamber
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/049109
Other languages
English (en)
Inventor
Arshad Quadri
Jeremy Brent RATZ
Michael Radford
Christopher William STIVERS
Nicholas LAUDER
Jonah Younghun KO
Adrienne Murphy Jalbert CLARK
Douglas G. Sabin
Kristofer KURTIN
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
inQB8 Medical Technologies LLC
Original Assignee
inQB8 Medical Technologies LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
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Publication of WO2025072858A1 publication Critical patent/WO2025072858A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/104—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body
    • A61M60/117—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body for assisting the heart, e.g. transcutaneous or external ventricular assist devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/247—Positive displacement blood pumps
    • A61M60/253—Positive displacement blood pumps including a displacement member directly acting on the blood
    • A61M60/258—Piston pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/247—Positive displacement blood pumps
    • A61M60/253—Positive displacement blood pumps including a displacement member directly acting on the blood
    • A61M60/268—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
    • A61M60/274—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders the inlet and outlet being the same, e.g. para-aortic counter-pulsation blood pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/247—Positive displacement blood pumps
    • A61M60/253—Positive displacement blood pumps including a displacement member directly acting on the blood
    • A61M60/268—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
    • A61M60/279—Peristaltic pumps, e.g. roller pumps
    • A61M60/284—Linear peristaltic pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40—Details relating to driving
    • A61M60/424—Details relating to driving for positive displacement blood pumps
    • A61M60/427—Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being hydraulic or pneumatic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50—Details relating to control
    • A61M60/508—Electronic control means, e.g. for feedback regulation
    • A61M60/515—Regulation using real-time patient data
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50—Details relating to control
    • A61M60/508—Electronic control means, e.g. for feedback regulation
    • A61M60/515—Regulation using real-time patient data
    • A61M60/531—Regulation using real-time patient data using blood pressure data, e.g. from blood pressure sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/50—Details relating to control
    • A61M60/508—Electronic control means, e.g. for feedback regulation
    • A61M60/562—Electronic control means, e.g. for feedback regulation for making blood flow pulsatile in blood pumps that do not intrinsically create pulsatile flow
    • A61M60/569—Electronic control means, e.g. for feedback regulation for making blood flow pulsatile in blood pumps that do not intrinsically create pulsatile flow synchronous with the native heart beat
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/835—Constructional details other than related to driving of positive displacement blood pumps
    • A61M60/837—Aspects of flexible displacement members, e.g. shapes or materials

Definitions

  • BACKGROUND Field [0002] This application is directed to systems and methods for assisting the function of one or more chambers of a heart of a patient.
  • Description of the Related Art [0003] Patients with impaired heart function are sometimes treated with mechanical circulatory assist or support systems (MCS). Impaired heart function is found in patients with end stage heart failure. For such patients, a ventricular assist device (one form of MCS) may be provided. Such devices usually are implanted to provide support of left ventricle function. Implanting MCS devices requires highly invasive surgery and typically exposes the patient to a risk of infection. The long-term strategy for heart failure patients with MCS devices is to use such devices as a bridge to transplant.
  • MCS mechanical circulatory assist or support systems
  • Impaired heart function also can arise from an acute event such as a heart attack.
  • MCS devices can be provided to stabilize the patient and can be removed when the patient has recovered from the event.
  • Catheter-based MCS devices have been clinically approved for such patients.
  • Impella 2.5, Impella RP, and Protek Duo are examples of commercial catheter-based MCS devices that can used to support ventricle function.
  • Intra- aortic balloon pumps have been used for a long time to move blood within the descending aorta in an attempt to assist heart function.
  • SUMMARY While a number of MCS devices have been demonstrated, improved MCS technologies are needed.
  • VADs ventricular assist devices
  • a continuous flow pumping mechanism which has been shown to cause negative health effects. Therefore, it would be desirable to support the heart with a system that is capable of providing or supporting pulsatile flow to or within the cardiovascular system.
  • existing systems relying on valves, impellers, and other blood-contacting movable parts are subject to wear as well as increased thrombosis and hemolysis risks. Therefore, improved systems are needed in some cases not requiring impellers or valves to move blood through a system.
  • the techniques described herein relate to a method of supporting pumping function of a patient's heart in heart failure, including: advancing a conduit percutaneously into a ventricle to provide a blood flow path from the ventricle to an enclosed chamber located outside of the ventricle; and controllably inflating and deflating a balloon within the enclosed chamber, wherein deflation of the balloon draws blood from the ventricle into the conduit and into the enclosed chamber during diastole, and inflation of the balloon moves blood from the enclosed chamber through the conduit into the ventricle during systole.
  • the method further includes positioning a conduit in a right ventricle.
  • controllably inflating the balloon includes directing a pressurized gas from a pressure chamber to an interior of the balloon.
  • controllably inflating and deflating the balloon includes timing the inflating and deflating based on a point of a heartbeat cycle.
  • controllably inflating and deflating the balloon controls flow in the conduit without requiring any valves in the conduit.
  • the method further includes inflating a coaptation balloon in the heart prior to or when the balloon is controllably inflated within the enclosed chamber to reduce backflow of blood that exits through the conduit into the ventricle.
  • the techniques described herein relate to a system for providing circulatory support to a heart, including: a percutaneous conduit having a proximal end, a distal end, and a blood flow lumen disposed therethrough from the proximal end to the distal end; an extracorporeal pumping device including an enclosed chamber configured to be placed in fluid communication with the blood flow lumen of the conduit and configured to pump blood from outside the patient through the percutaneous conduit; and a controller including a processor, the processor configured to: cause a reduction of pressure in the enclosed chamber (e.g., by deflating a balloon, retracting a moveable member relative to the enclosed chamber, etc.) based on detection of diastole in a heartbeat cycle signal to draw blood through an opening at the distal end of the
  • the system further includes a heartbeat cycle characterizer configured to receive the heartbeat cycle signal, to detect at least one of systole and diastole, and to output a signal to the processor indicating the detected at least one of systole and diastole.
  • the processor is configured to delay increasing pressure in the enclosed chamber when a signal from an ECG sensor indicates the onset of systole but the processor detects unchanged or falling pressure from a signal of a pressure sensor.
  • the conduit includes a wall surrounding the blood flow lumen and the pressure sensor is disposed within the wall peripherally of the blood flow lumen.
  • the system further includes a coaptation balloon disposed around the conduit, the coaptation balloon configured to engage leaflets of an atrioventricular valve to reduce back flow of blood through the atrioventricular valve during systole.
  • the processor is configured to pressurize the coaptation balloon in coordination with causing an increase of pressure in the enclosed chamber.
  • the processor is configured to reduce pressure in the coaptation balloon in coordination with causing a reduction of pressure in the enclosed chamber.
  • the techniques described herein relate to a system for providing circulatory support to a heart, including: a conduit having a proximal end, a distal end, and a blood flow lumen disposed therethrough from the proximal end to the distal end; a pumping device including an enclosed chamber configured to be placed in fluid communication with the blood flow lumen of the conduit; a controller including a processor, the processor configured to: cause a reduction of pressure in the enclosed chamber based on detection of diastole in a heartbeat cycle signal to draw blood through the distal end (e.g., an opening in, at, or near the distal end) of the conduit, the distal end being disposed within a ventricle of the heart or through the ventricle to an artery downstream thereof; and cause an increase of pressure in the enclosed chamber based on detection of systole in the heartbeat cycle signal to move blood from within the enclosed chamber through the distal end (e.g., an opening in, at, or near the distal
  • the system further includes an ECG sensor configured to detect an ECG signal indicative of a phase of the heartbeat cycle.
  • the controller is further configured to controllably cause an increase of pressure in the enclosed chamber when an R-wave peak in the ECG signal is detected.
  • the system further includes a blood pressure sensor configured to detect a blood pressure signal indicative of a phase of the heartbeat cycle, and wherein the controller is further configured to controllably cause an increase of pressure in the enclosed chamber when the R-wave peak in the ECG signal is detected and when the blood pressure signal indicates a rising pressure.
  • the system further includes a blood pressure sensor configured to detect a blood pressure signal indicative of a phase of the heartbeat cycle and wherein the controller is further configured to controllably cause an increase of pressure in the enclosed chamber when the blood pressure signal indicates a rising pressure.
  • the blood pressure sensor includes an optical sensor disposed adjacent to a distal end of the conduit exposed to blood in a chamber of the heart. In some aspects, the optical sensor is exposed to blood in a right atrium of the heart. In some aspects, the optical sensor is exposed to blood in a right ventricle of the heart.
  • the techniques described herein relate to a method of supporting pumping function of a patient's heart in heart failure, including: advancing a conduit percutaneously into a ventricle to provide a blood flow path from the ventricle to an enclosed chamber located outside of the ventricle; and controllably increasing and decreasing pressure in the enclosed chamber, wherein decreasing pressure in the enclosed chamber draws blood from the ventricle into the conduit and into the enclosed chamber during diastole, and increasing pressure in the enclosed chamber moves blood from the enclosed chamber through the conduit into the ventricle during systole, and wherein controllably increasing and decreasing pressure in the enclosed chamber includes timing the increasing and decreasing based on a point of a heartbeat cycle.
  • the method further includes receiving an ECG signal indicative of a phase of the heartbeat cycle and controllably inflating and deflating the balloon based on the ECG signal. In some aspects, the method further includes controllably inflating the balloon when an R-wave peak in the ECG signal is detected. In some aspects, the method further includes receiving a blood pressure signal indicative of a phase of a heartbeat cycle and controllably inflating and deflating the balloon based on the pressure signal and the ECG signal. In some aspects, the method further includes controllably inflating the balloon when an R-wave peak in the ECG signal is detected and when the blood pressure signal indicates a rising pressure.
  • a system for providing circulatory support to a heart of a patient includes a percutaneous conduit, an extracorporeal pumping device, a controller, and a control fluid assembly.
  • the percutaneous conduit has a proximal end, a distal end, and a blood flow lumen disposed therethrough from the proximal end to the distal end.
  • the distal end is configured to be disposed within a ventricle of the heart or through the ventricle to an artery downstream thereof.
  • the extracorporeal pumping device has an enclosed chamber configured to be placed in fluid communication with the blood flow lumen of the conduit and configured to pump blood from outside the patient through the percutaneous conduit.
  • the controller comprises a processor configured to move a moveable member. Movement of the moveable member can be toward a first position to cause a reduction of pressure in the enclosed chamber based on detection of diastole in a heartbeat cycle signal to draw blood through an opening at the distal end of the conduit.
  • a system for providing circulatory support to a heart includes a conduit, a pumping device, and a heartbeat cycle characterizer.
  • the conduit has a proximal end, a distal end, and a blood flow lumen disposed therethrough from the proximal end to the distal end.
  • the distal end is configured to be disposed within a ventricle of the heart or through the ventricle to an artery downstream thereof.
  • the pumping device has an enclosed chamber configured to be placed in fluid communication with the blood flow lumen of the conduit.
  • the controller has a processor configured to cause a reduction in pressure, an increase in pressure and a reduction in pressure in the enclosed chamber following causing the increase of pressure.
  • the reduction of pressure in the enclosed chamber is based on detection of diastole in a heartbeat cycle signal to draw blood through an opening at the distal end of the conduit.
  • the reduction of pressure can be provided by acting against a moveable member biased to a partially decreased pressure state within the chamber to a further decreased pressure state.
  • the reduction of pressure can be provided by removing a load from the moveable member to allow the moveable member to return to the decreased pressure state.
  • the increase of pressure in the enclosed chamber can be driving the moveable member away from the decreased pressure state based on detection of systole in the heartbeat cycle signal to move blood from within the enclosed chamber through the opening at the distal end of the conduit and into the ventricle of the heart or through the ventricle to an artery downstream thereof.
  • the reduction in pressure in the enclosed chamber following the increase of pressure in the enclosed chamber can be caused by allowing the biasing of the moveable member to move the moveable member to the decreased pressure state within the enclosed chamber.
  • the biasing includes storing strain energy in a tension spring coupled to the moveable member.
  • the tension spring is in a free state when the moveable member is in the decreased pressure state.
  • the tension spring is stretched when the moveable member moves away from the decreased pressure state toward an increased pressure state.
  • the stretching stores strain energy in the tension spring.
  • a tension spring can be in the form of a coil where adjacent turns are close together or touching in the free state and are spaced apart or farther apart in the stretched state. Other forms of tension springs are possible as well.
  • the biasing includes storing strain energy in a compression spring coupled to the moveable member.
  • the compression spring is in a free state when the moveable member is in the decreased pressure state.
  • the compression spring is compressed when the moveable member moves away from the decreased pressure state toward an increased pressure state.
  • a compression spring can be in the form of a coil where adjacent turns are spaced apart in the free state and are spaced apart by a lesser amount or touching in the compressed state. Other forms of compression springs are possible as well.
  • the heartbeat cycle characterizer is configured to receive the heartbeat cycle signal, to detect at least one of systole and diastole, and to output a signal to the processor indicating the detected at least one of systole and diastole.
  • a conduit is advanced percutaneously into a ventricle to provide a blood flow path from the ventricle to an enclosed chamber located outside of the ventricle, e.g., outside of the patient.
  • a moveable member is controllably moved within the enclosed chamber from a first position corresponding to a reduced pressure for drawing blood from the ventricle into the conduit and into the enclosed chamber during diastole to a second position corresponding to an elevated pressure for moving blood from the enclosed chamber through the conduit into the ventricle during systole.
  • the moveable member is biased toward the first position when not being controllably moved.
  • a conduit is advanced percutaneously into a ventricle to provide a blood flow path from the ventricle to an enclosed chamber located outside of the ventricle.
  • a source of pressurized control fluid is coupled to a control lumen configured to be placed in pressure communication with a moveable member within the enclosed chamber.
  • Pressure is controllably increased and decreased in the enclosed chamber. Decreasing pressure in the enclosed chamber draws blood from the ventricle into the conduit and into the enclosed chamber during diastole. Increasing pressure in the enclosed chamber moves blood from the enclosed chamber through the conduit into the ventricle during systole.
  • Controllably increasing and decreasing pressure in the enclosed chamber comprises placing the moveable member in pressure communication with the pressurized control fluid through the control lumen while cycling pressure in the pressure fluid to move the moveable member.
  • a system for providing circulatory support to a heart includes a conduit, a pumping device, a controller, and a heartbeat cycle characterizer.
  • the conduit has a proximal end, a distal end, and a blood flow lumen disposed therethrough from the proximal end to the distal end.
  • the distal end is configured to be disposed within a ventricle of the heart or through the ventricle to an artery downstream thereof.
  • the pumping device has an enclosed chamber configured to be placed in communication with the blood flow lumen of the conduit.
  • the controller has a processor configured to cause an increase in pressure and a reduction in pressure in the enclosed chamber following the increase in pressure.
  • the increase of pressure in the enclosed chamber can be driving a moveable member in a first direction based on detection of systole in a heartbeat cycle signal to move blood away from the enclosed chamber through an opening at the distal end of the conduit and into the ventricle of the heart or through the ventricle to an artery downstream thereof.
  • the reduction in pressure in the enclosed chamber draws blood through the opening at the distal end of the conduit by allowing biasing of the moveable member to move the moveable member in a second direction within the enclosed chamber.
  • the heartbeat cycle characterizer is configured to receive the heartbeat cycle signal, to detect at least one of systole and diastole, and to output a signal to the processor indicating the detected at least one of systole and diastole.
  • the enclosed changed is filled using a continuous flow element.
  • a balloon within the enclosed chamber is controllably inflated and deflated. Inflating the balloon moves blood from the enclosed chamber through the conduit into the ventricle during systole.
  • a method of supporting pumping function of a patient’s heart in heart failure is provided.
  • a conduit is advanced percutaneously into a ventricle to provide a blood flow path from the ventricle to an enclosed chamber located outside of the ventricle, e.g., outside of the patient.
  • the enclosed changed is filled using a continuous flow element.
  • a volume of the enclosed chamber varies to move blood from the enclosed chamber through the conduit into the ventricle during systole.
  • a method of supporting pumping function of a patient’s heart in heart failure is provided.
  • a conduit is advanced percutaneously into a ventricle to provide an open/unobstructed blood flow path from the ventricle to an enclosed chamber located outside of the ventricle, e.g., outside of the patient.
  • the enclosed changed is filled using a continuous flow element. Blood is pumped from the enclosed chamber through the open/unobstructed blood flow path of the conduit into the ventricle during systole.
  • a system for providing circulatory support to a heart includes a first conduit, a second conduit, an enclosed chamber, a pumping device, a controller, and a heartbeat cycle characterizer.
  • the first conduit has a first proximal end, a first distal end, and a first blood flow lumen disposed therethrough from the first proximal end to the first distal end.
  • the first distal end is configured to be disposed within a ventricle of the heart or through the ventricle to an artery downstream thereof.
  • the second conduit has a second proximal end, a second distal end, and a second blood flow lumen disposed therethrough from the second proximal end to the second distal end.
  • the second distal end is configured to be disposed within the ventricle or through the ventricle to an artery downstream thereof.
  • the enclosed chamber is configured to be placed in fluid communication with the first blood flow lumen of the first conduit and the second blood flow lumen of the second conduit.
  • the pumping device is coupled to the second conduit.
  • the pumping device is configured to continuously move blood from the ventricle into the enclosed chamber through the second blood flow lumen of the second conduit.
  • the controller has a processor configured to cause an increase of pressure in the enclosed chamber by driving a moveable member away from a decreased pressure state within the enclosed chamber based on detection of systole in a heartbeat cycle signal to move blood from within the enclosed chamber through an opening at the first distal end of the first conduit and into the ventricle of the heart or through the ventricle to an artery downstream thereof.
  • a blood contacting assembly for a cardiac circulatory support system including a blood conduit, an end cap, and a plunger head is provided.
  • the blood conduit has a proximal end, a distal end, and a blood flow lumen disposed therethrough from the proximal end to the distal end.
  • the end cap included a first end, a second end, and a peripheral surface. The first end has a barb configured to connect to the proximal end of the blood conduit.
  • the second end is opposite the first end and has an opening providing access to a concave surface configured to partly enclose a chamber.
  • the peripheral surface is configured to be coupled to a cylinder connector.
  • the plunger head has a first end including a convex surface configured to face the concave surface of the end cap and a second end opposite the first end configured to be coupled to a piston assembly of the cardiac circulatory support system.
  • FIG.1 illustrates a heart support system.
  • FIG.1A-1C illustrate a patient wearing an implementation of a heart assist device
  • FIG.2A illustrates a heart support system applied to a right ventricle
  • FIG.2A’ illustrates a heart support system applied to a right ventricle with a continuous flow system and/or a separate system for independently filling an enclosure
  • FIG. 2A illustrates a spiral-shaped balloon that can be used with a heart support system
  • FIG.2B illustrates a pump element enclosure and a first implementation of a moveable member in the pump enclosure in a first phase of the heart support system of FIG.
  • FIG.2C illustrates the moveable member of FIG.2B in the pump enclosure in a second phase of the heart support system of FIG.2A;
  • FIG. 2D illustrates a heart support system applied to a right ventricle configured to operate on a compressed gas accessible at a source;
  • FIG.2E illustrates a control system configured to connect to a heart support system;
  • FIG.2F illustrates a top view of the control system of FIG.2E with a portion of the housing removed for illustrative purposes;
  • FIG.2G illustrates a side view of a pumping device and stoppage system of the control system of FIG. 2E; [0037] FIG.
  • FIG. 2H illustrates a section view of the pumping device and stoppage system of the control system of FIG.2E along the line 2H-2H in FIG.2F;
  • FIG. 2I illustrates a linear actuator stoppage system that can be used with the control system of FIG. 2E;
  • FIG.2J illustrates a solenoid actuator stoppage system that can be used with the control system of FIG. 2E;
  • FIG.2K illustrates a perspective view of a pumping device that can be used in the heart support system of FIG.1.
  • FIG. 2L illustrates a partial exploded side view of the pumping device of FIG.2K.
  • FIG. 2M illustrates a perspective view of the pumping device of FIG.
  • FIG. 2N illustrates a section view of the pumping device of FIG. 2K along the line 2N-2N in FIG.2K.
  • FIG. 2O illustrates another implementation of an end cap for the pumping device of FIG.2K shown schematically.
  • FIG.3A illustrates an implementation of a pump element enclosure with an implementation of a moveable member in the pump enclosure in a first phase of the heart system of FIG.2A;
  • FIG. 3A’ illustrates an implementation of a pump element enclosure with an implementation of a moveable member in the pump enclosure in a first phase of the heart system of FIG.2D; [0047] FIG.
  • FIG.3F shows an implementation of an enclosure and disposable moveable member
  • FIG. 3G shows an implementation of a disposable moveable member
  • FIG. 3H shows an implementation of a disposable moveable member
  • FIGS. 3I-1 to 3I-5 show a method of using the disposable moveable members of FIGS.3G and 3H
  • FIG. 3J shows a variant of the dual acting piston pump of FIGS. 3E-1 and 3E-2 that eliminates the moveable member by allowing a piston to act directly on blood
  • FIG. 4A is a schematic diagram showing control system components according to one implementation
  • FIGS.7A and 7B illustrate implementations of multiple separate moveable members housed within multiple separate enclosures
  • FIGS. 7C illustrates an implementation of a round movable member in an enclosure
  • FIG. 7D illustrates an implementation of an elongate movable member in an enclosure
  • FIG.7E illustrates an implementation of an asymmetric moveable member and enclosure
  • FIGS. 7F-1 and 7F-2 illustrate views of an implementation of a moveable member fixation element
  • FIG. 7G illustrates a view of an implementation of a moveable member fixation element
  • FIG. 7G illustrates a view of an implementation of a moveable member fixation element
  • FIG. 8 illustrates a modified implementation of the system of FIG. 2A in which the system is configured to position an outlet of the system across the pulmonary valve into the pulmonary artery;
  • FIG. 9 illustrates another modified implementation of the system of FIG. 2A in which a dedicated inflow lumen is provided to intake blood from upstream of the right ventricle, e.g., from the right atrium or the vena cava of the patient’s heart;
  • FIGS.10A-10C illustrate an implementation of closing wires configured to control suction and ejection of blood from different cardiac chambers;
  • FIG.11 illustrates an implementation of a blood flow system;
  • FIG.11A illustrates a close up view of a suction area A shown in FIG.11; [0076] FIGS.
  • FIG. 13B illustrates the timing of operation of bi-ventricular support as shown in FIG.12 relative to the timing of the heartbeat cycle
  • FIG. 13C illustrates additional approaches to controlling the timing of operation of one or more of the heart support systems disclosed herein
  • FIG.14 illustrates an intracardiac heart support system for assisting the left ventricle of a heart
  • FIG. 15 illustrates placement of the system of FIG. 14 in a left atrium of a heart of a patient.
  • FIG.1 illustrates an implementation of a heart support system 10.
  • the heart support system 10 is configured to provide circulatory support to a heart of a patient.
  • the heart support system 10 can include a pumping device 20, a control fluid assembly 30, and/or one or more conduit(s) 50.
  • Various implementations of the heart support system 10 and implementations of its components are described herein. In some implementations, either the pumping device 20 or the control fluid assembly 30 may not be required.
  • FIGS. 2K-2N illustrate an embodiment of the pumping device 20 in the form of a pumping device 800. In some implementations, the pumping device 20 can include an enclosed chamber.
  • the heart support system 10 is applied to the heart and operates in a co- pulsating manner such that the heart support system 10 outputs or expels blood when a chamber that the system 10 is assisting is contracting, e.g., outputting blood when the ventricle is in systole.
  • the heart support system 10 can be configured to output blood when the right ventricle is in systole.
  • the conduit 50 can be a percutaneous conduit having an elongate body extending between a proximal end 52 and a distal end 54, e.g., from the proximal end 52 to the distal end 54.
  • the conduit 50 can have a blood flow lumen disposed therethrough from the proximal end 52 to the distal end 54.
  • the distal end 54 of the conduit 50 can be disposed in the heart of the patient (e.g., the ventricle or through the ventricle to an artery downstream thereof), as shown in at least FIG.2A.
  • the proximal end 52 of the conduit 50 can be placed in fluid or in pressure communication with the pumping device 20 (e.g., the enclosed chamber).
  • the body of the conduit 50 can be implanted in a patient with the body extending from a percutaneous access site to the right ventricle of the patient.
  • the distal end 54 of the conduit 50 can include a tip portion arranged to direct outflow toward or through the pulmonary artery.
  • the distal end 54 of the conduit has a first side configured to bear against or face a wall of the right ventricle and an outlet portion on a second side opposite the first side.
  • the tip portion is configured to orient the outlet portion toward the pulmonary valve when the first side bears against the wall of the right ventricle.
  • the conduit 50 can also have a pre-set bend that can cause blood to flow through an arc to be expelled away from the apex of the heart and toward a valve separating the ventricle from an artery carrying blood away from the heart.
  • the pumping device 20 can be configured to pump blood from outside the patient through the conduit 50.
  • the blood can be pumped into the enclosed chamber (e.g., enclosed chamber 806 of FIG. 2K).
  • the enclosed chamber can enclose a control fluid and can be separated from the blood by a membrane, a balloon, or the like.
  • the pumping device 20 can include a moveable member, which may be disposed within the enclosed chamber.
  • the moveable member can include a balloon as in at least FIGS. 2B and 2C.
  • the moveable member can include a membrane as in at least FIG. 3A.
  • the moveable member can include a plunger and piston as in at least FIGS.2K-2N.
  • moveable members movement of the moveable member within the enclosed chamber can cause fluctuations in pressure in the enclosed chamber, which can cause blood to move into and out of the enclosed chamber and into and out of the heart.
  • a reduction of pressure in the enclosed chamber can draw blood through an opening at the distal end 54 of the conduit 50.
  • an increase in pressure in the enclosed chamber can move blood from within the enclosed chamber through the opening at the distal end 54 of the conduit 50 and into the ventricle of the heart or into an artery downstream thereof.
  • the system 10 can include more than one conduit 50 in fluid communication with the pumping device 20 (see e.g., FIG. 2A’).
  • one conduit can be configured for flow from the pumping device 20 to the heart and the other conduit can be configured for flow from the heart to the pumping device 20.
  • the pumping function of the pumping device 20 can be at least partially pneumatic.
  • the moveable member may be pneumatically actuated to cause at least one of an increase of pressure and a reduction of pressure in the enclosed chamber.
  • the system 20 includes the control fluid assembly 30.
  • FIG. 2A illustrates an embodiment of the control fluid assembly 30 in the form of a control system 112.
  • the control fluid assembly 30 can include a pressure source.
  • the pressure source can be a source of pressurized control fluid (e.g., a compressor, a pressurized tank/chamber, a plumbed gas conduit that is connected to and pressurized by a utility, and/or the like.
  • the control fluid assembly 30 can include a housing 32, which may house the pressure source (see e.g., pressure chamber 526 in FIG.2F). When the pressure source is configured as a compressor or pressurized chamber, the pressure source can be housed within the housing.
  • the control fluid assembly 30 can be connected to an external pressure source (e.g., compressed medical air in a hospital).
  • the control fluid assembly 30 can include an external fluid supply line 36 for connecting to the external pressure source.
  • the control fluid assembly 30 can include one or more valves for controlled distribution of the pressurized fluid into and out of the control fluid assembly 30.
  • the system 10 can include a control system (not shown).
  • the control system can include a power supply and one or more controllers (e.g., processors) for controlling the operations of the system 10.
  • the control system may be housed in the housing 32 of the control fluid assembly 30.
  • the controller can control the one or more valves of the control fluid assembly 30.
  • the control fluid assembly 30 can deliver pressurized fluid to the pumping device 20 to cause the increase and/or reduction of pressure in the enclosed chamber.
  • the system 10 includes a first fluid line 40 and a second fluid line 38 connecting the control fluid assembly 30 to the pumping device 20.
  • only a single fluid line connects the control fluid assembly 30 to the pumping device 20 (see e.g., the heart support system 100 in FIG. 2A).
  • the controller of the system 10 can control the operations of the control fluid assembly 30 and the pumping device 20.
  • the controller may be configured to receive signals to control the operation of the control fluid assembly 30 and the pumping device 20.
  • the controller can be configured to receive pressure signals, signals from one or more heartbeat cycle characterizers, ECG sensors, and/or the like.
  • a heartbeat cycle characterizer can be configured to receive a heartbeat cycle signal, to detect at least one of systole and diastole, and to output a signal to one or more processors of the controller indicating the detected at least one of systole and diastole.
  • pressure signals can be provided to the controller from one or more pressure sensors and can be analyzed by the controller to detect at least one of systole and diastole.
  • the system 10 can include electrical cables 42 for electrically delivering the electrical signals to the controller, e.g., from the heartbeat cycle characterizer.
  • the control fluid assembly 30 includes a display 34.
  • FIGS.1A and 1B illustrate a patient 60 with a wearable heart support system 100.
  • the system 100 can include a modified embodiment of the system 10 or another one of the systems described herein.
  • the heart support system 100 may include a blood flow system 104 (e.g., an implementation of the conduit 50) and a pressurizing element that may include an enclosure 144 configured to house a moveable member 148 (e.g., an implementation of the pumping device 20).
  • the heart support system 100 may include a pressurizing system of a control system 112 connected to a pressurizing fluid line with inflation lumen 142.
  • inflation lumen 142 may extend percutaneously to an implanted enclosure 144 with moveable member 148.
  • enclosure 144 and moveable member 148 are external to the body and connect percutaneously via blood flow system 104 to the heart.
  • FIGS. 2A-C illustrate a heart support system 100 applied to a heart of a patient. The heart support system 100 is shown applied to the right side of the heart, e.g., with an end in the right ventricle RV.
  • the heart support system 100 can access the right ventricle RV by passing through the right atrium RA, as discussed further below.
  • the heart support system 100 preferably is applied to the heart and operates in a co-pulsating manner such that the heart support system 100 outputs or expels blood at when a chamber that the system is assisting is contracting, e.g., outputting blood when the ventricle is in systole.
  • the heart support system 100 would be outputting blood when the right ventricle is in systole.
  • the heart support system 100 includes a blood flow system 104 that, as applied, operates to cause blood to flow therein out the right ventricle RV during diastole as the right ventricle is filling with blood from the right atrium RA in a first phase of operation of the heart support system 100.
  • the blood flow system 104 operates to cause blood to flow therein into the right ventricle RV during systole. Blood exiting the blood flow system 104 flows through the right ventricle outflow tract into the pulmonary artery PA during systole.
  • a modified implementation of the heart support system 100 can optionally include a structure to reduce or eliminate backflow during systole.
  • FIG. 1C illustrates an implementation of the heart support system 100 as applied to the patient 60.
  • the heart support system 100 is configured as a mobile system allowing the patient 60 to be ambulatory.
  • the heart support system 100 includes the blood flow system 104 and the control system 112 that can be carried in a backpack or shoulder strap supported pouch as shown.
  • the control system 112 can be carried along with a source of pressurized gas.
  • the source can be a pressure chamber, a pressure vessel or other canister carrying control fluid at greater than atmospheric pressure.
  • the source is a pressurized air tank.
  • the control system 112 can be carried along with an end of a control fluid assembly (e.g., an implementation of the control fluid assembly 30) that can include a conduit with an inflation lumen or control lumen 142.
  • the lumen 142 can operate to inflate balloon structure or to deflect a moveable member.
  • a plug 151 can be located at a free end of the conduit enclosing the control lumen 142.
  • the plug 151 and the lumen 142 can form parts of the control fluid assembly.
  • the plug 151 is one example of a connector of the conduit of the control fluid assembly that can connect with another connector (e.g., a socket) coupled with the interior of the pressure chamber or other source of pressurized control fluid.
  • control fluid assembly that includes the control lumen 142 can be coupled with a connector, e.g., with a component having a socket.
  • the control system 112 can allow small cannisters (labeled source) to be connected at the plug 151 and when depleted replaced with fully pressurized cannisters.
  • FIG.2A shows more details of the blood flow system 104.
  • the blood flow system 104 includes an elongate catheter body or cannula that can be inserted into the vasculature of the patient and that forms a conduit to be connected to a heart chamber, such as a ventricle to provide a blood flow path from the ventricle to an enclosure for pumping blood.
  • the cannula can include a vascular span 120 that extends from a vascular entry point (e.g., a peripheral access site) through the vasculature (e.g., through a primary blood vessel) to the heart.
  • the vascular span 120 can extend from peripheral venous access site (such as a femoral vein or a subclavian vein) through a portion of the vena cava (such as inferior vena cava by way of the femoral vein or superior vena cava by way of the subclavian vein).
  • a proximal portion of the blood flow system 104 extending from the vascular span 120 can be coupled at a proximal end thereof to an enclosure 144 which can form part of a pressure vessel.
  • the enclosure 144 can be configured to house a moveable member 148.
  • the moveable member 148 can cause fluctuation in pressures in the enclosure 144.
  • the fluctuating pressures can cause flow of blood out of and in some cases away from the ventricle being assisted (the right ventricle RV, as illustrated) in a first phase and toward and into the ventricle in a second phase.
  • the fluctuating pressure can draw blood out of the ventricle through the vascular span 120 in one phase of operation.
  • the fluctuating pressures can cause blood to flow into the ventricle through the vascular span 120 in another phase of operation.
  • the fluctuating pressures are configured to sufficiently move blood into and out of the blood flow system 104, meaning blood flow system 104, including vascular span 120 and ventricular span 128, do not require valves or other control devices.
  • one or more valves may be used to assist timing and control of suction and/or ejection phases.
  • valves or other control devices may be used to direct flow, for example within branches of blood flow system 104.
  • blood is drawn into and ejected from a separate chamber, for example a volume within enclosure 144.
  • the elongate body of the blood flow system 104 can include a ventricular span 128.
  • the ventricular span 128 can extend directly and continuously from the vascular span 120, in some implementations.
  • the ventricular span 128 can be configured to be deployed in the ventricle being assisted, e.g., in the right ventricle RV as illustrated.
  • the proximal end of the ventricular span 128 extends directly from the distal end of the vascular span 120.
  • an atrial span can be provided to allow fluid communication with an atrium in some phases of operation.
  • the ventricular span 128 and the vascular span 120 are not separately formed but rather are portions of the continuous body configured to be inserted into the patient.
  • the ventricular span 128 may be configured to aid in positioning the ventricular span 128 within the chamber in which it is to be deployed, for example in the right ventricle RV as illustrated.
  • the ventricular span 128 may be biased outward to brace against the ventricular wall.
  • ventricular span 128 may be configured to appose or bear against a chamber wall after placement.
  • ventricular span 128 may be anchored, suctioned, or otherwise fixed to a chamber wall.
  • the ventricular span 128 includes a pre-formed bend 132.
  • the pre-formed bend 132 can be shaped to follow the contour of the inner wall shape of the right ventricle RV.
  • the position of the pre-formed bend 132 along the inner wall of the right ventricle RV can help to position a plurality of perforations 136 formed in the ventricular span 128.
  • the perforations 136 can be disposed along the intra-ventricular septum of the heart. In some implementations, at least some perforations 136 may be spaced away from the septum.
  • the perforations 136 can be used to intake blood into a lumen formed in the ventricular span 128 and extending to the proximal end of the blood flow system 104 through the vascular span 120.
  • the pre-formed bend 132 can help to hold at least some of the perforations 136 away from the wall of the right ventricle RV during a first phase or suction phase of the heart support system 100. Such positioning can help assure adequate blood flow into the blood flow system 104 during the suction phase. By positioning at least some of the perforations 136 away from the heart wall, the heart support system 100 is less likely to cause heart tissue to block the perforations 136 in the suction phase.
  • the perforations 136 can be disposed along the ventricular span 128 to provide sufficient redundant inflow openings to prevent suction against the heart chamber wall tissue from blocking flow into the blood flow system 104 during the first phase of operations.
  • the perforations 136 are arranged radially and/or axially around the ventricular span 128. If perforations 136 that are facing the intra-ventricular septum were to be closed off by tissue under section, sufficient flow would be provided through perforations 136 facing away from the intra-ventricular septum that would not be blocked by tissue.
  • the perforations 136 also reduce jetting of blood out of the blood flow system 104 during the second phase of operation by allowing blood to exit the lumen of the ventricular span 128 in many different spaced apart locations.
  • the position of the pre-formed bend 132 along the inner wall of the right ventricle RV can help to position a distal tip 140 of the blood flow system 104.
  • FIG.2A shows that the distal tip 140 can be positioned adjacent to or within the right ventricle outflow tract.
  • the flow of blood out of the perforations 136 may be less than the flow of blood out of an opening at the distal tip 140.
  • the flow out of the opening at the distal tip 140 can be directed toward or along the right ventricle outflow tract such that expelling blood during the second phase of operation of the heart support system 100 appears from the perspective of the lungs to be a greater heart output than would be provided by the patient’s heart prior to the application of the heart support system 100 to assist the pumping function of the heart.
  • the heart support system 100 can also reduce the load on a compromised ventricle. For example, heart support system 100 can assist ventricular function and recovery by offloading the ventricle to allow the heart to recover after damage or injury.
  • the blood flow system 104 causes blood flow into and out of the heart by applying a fluctuating pressure to the blood flow lumen in the blood flow system 104.
  • the fluctuating pressure is applied from within the enclosure 144 adjacent to the proximal end of the blood flow system 104, proximal of the vascular span 120.
  • the enclosure 144 encloses a volume that is configured to intake a volume of blood in a first phase of operation and be emptied of a volume of blood in a second phase of operation.
  • the enclosure 144 preferably has interior surfaces that have no or minimal sharp edges or boundaries to reduce or prevent thrombus formation in use.
  • the interior walls of the enclosure 144 are rounded, spherical, ovoid, ellipsoid, egg-shaped or another shape that comprises curved surfaces.
  • the interior walls of the enclosure 144 can be symmetrical about major and/or minor axes.
  • the interior walls of the enclosure 144 can consist solely of such surfaces in various implementations.
  • the walls of the enclosure 144 can have other shapes and may be coated with heparin or other anti-thrombotic substance to prevent or reduce thrombus formation.
  • the volume of the enclosure 144 can be about 50 cubic centimeters in one implementation.
  • the enclosure 144 can have an internal volume of about 20 to about 80 cubic centimeters, about 30 to about 70 cubic centimeters, about 40 to about 60 cubic centimeters, or an internal volume centered around any of the end points of these ranges.
  • Some or all air in the enclosure 144 can be evacuated through a port 146 formed therein.
  • the enclosure 144 can be rigid or otherwise capable of being pressurized.
  • the enclosure 144 can be non-deformable under pressures sufficient to draw blood out of or pump blood into the heart during a phase of operation of the heart support system 100. By making the enclosure non-deformable under these conditions, the heart support system 100 is more responsive to pressure fluctuations to induce flow toward and/or away from the heart.
  • the port 146 can be accessed to measure pressure during one or more phases of operation of the heart support system 100.
  • the volume can be open or empty other than a moveable member 148 that can be positioned within the enclosure 144.
  • the moveable member 148 preferably has the capability to temporarily reduce the open volume within the enclosure 144.
  • the moveable member 148 preferably can temporarily reduce the open volume within the enclosure 144 that is in fluid communication with the blood flow system 104.
  • the moveable member 148 can include a balloon that is suspended or positioned within the enclosure 144.
  • the balloon can have an open end that is open to a lumen 142 and can have an enclosed end that is spaced away from the open end.
  • the balloon body between the open and closed ends can expand to occupy the space within the enclosure 144, e.g., up to a point where the outside surface of the balloon body touches the inside surface of the enclosure 144. See FIGS.2C and 6A (discussed below).
  • the balloon body between the open and closed ends may be expandable to just short of a point of contact, such that there is no contact, e.g., there is open space, between the outside surface of the expanded balloon and the inside surface of the enclosure 144.
  • the open space may be configured to hold blood.
  • That space can be reduced in the expanded state of the moveable member 148 by 50 percent, 60 percent, 70 percent, 80 percent, 90 percent, 95 percent or is reduced by more than any of the foregoing percentages or is reduced by a range including any of the foregoing percentages as endpoints.
  • the moveable member 148 can be elongate and slender at least when un-expanded, as illustrated. In some variations, an end such as the enclosed end is supported to reduce movement of the moveable member 148 within the enclosure 144 during inflation and deflation.
  • the expanded state of the moveable member 148 corresponds to the second phase or ejection phase of the heart support system 100 as described elsewhere herein. [0105] As shown in FIG.
  • the blood flow system 104 can include a vascular span 120 configured to extend from peripheral vasculature to the heart and a ventricular span 128 configured to be placed in or through a ventricle, e.g., a right ventricle of the heart.
  • the ventricular span 128 can have a pre-formed bend 132 that orients a distal tip 140 in or toward the right ventricle outflow track or through the pulmonary valve into the pulmonary artery.
  • the blood flow system 104 can be applied to a left ventricle, e.g., by advancing a distal portion thereof through an intra-atrial septum into a left atrium.
  • the ventricular span 128 can be advanced through the mitral valve into the left ventricle or through the left ventricle and aortic valve to position the distal tip 140 in the aorta. In addition to an opening at the distal tip 140, the ventricular span 128 can optionally have one or more perforations 136 along a distal length adjacent to the distal tip 140.
  • the enclosure 144 can be carried in a backpack or shoulder pouch in an ambulatory setting or can be on a bedside table for a more critically ill patient.
  • the enclosure 144 can include a moveable member 148A disposed in an enclosed volume or enclosed chamber of the enclosure 144.
  • FIG. 3A’ shows that the moveable member 148A can move to a second position.
  • the second position of the moveable member 148 is as illustrated in FIG. 3A’.
  • the second position is located toward the blood flow system 104 and away from a control lumen 142A.
  • the moveable member 148A can also have a first position shown in dashed lines and labeled 148A’.
  • the first position of the moveable member 148A is located toward the control lumen 142A.
  • the movement of the moveable member 148A from the second position to the first position can be achieved by the spring 149 unloading such that strain energy stored thereby can be exchanged for movement of the moveable member 148A from the illustrated solid line position toward the blood flow system 104 to the dash line position 148A’ located toward the control lumen 142A and return the spring 149 to a compressed state.
  • Examples of springs that can be used as the spring 149 can include tension springs and compression springs.
  • the enclosure 144 can have two areas in which different fluids can be disposed. A first area located between the moveable member 148A and the blood flow system 104 can be configured to cyclically contain blood and have blood expelled therefrom.
  • a second area of the enclosure 144 can be located between the moveable member 148A and the control lumen 142A.
  • the second area can be configured to cyclically house a control fluid.
  • the second area can be cyclically subject to higher and lower pressures of the control fluid.
  • the control fluid can be caused to flow into the second area in a controlled fashion as discussed below.
  • the first and second areas within the enclosure 144 can change in volume as pressure differences are induced in the two areas.
  • An elevated pressure can be provided in the second area by opening the inflation lumen 142 to the source of pressurized control fluid.
  • the spring 149 Upon closing off the inflation lumen 142 to the source of pressurized control fluid, the spring 149 can act against the moveable member 148 to move the moveable member 148 toward the control lumen 142A.
  • FIGS.2E-2H show various views of an implementation of a control system 500.
  • the control system 500 can be used in the heart support systems disclosed herein, such as in the system 10.
  • the control system 500 is similar to the control fluid assembly 30 except as described differently below.
  • the control system 500 pressurizes one side of a moveable wall to cause movement in one direction while a spring can provide movement in the opposite direction.
  • the system 500 can be used with the conduit 50, a conduit of the blood flow system 104, or other conduits disclosed herein to provide circulatory support to a patient’s heart.
  • FIG. 2E shows a perspective view of the control system 500
  • FIG. 2F shows a top view of the internal components of the control system 500.
  • the internal components of the control system 500 can be secured within a housing 502.
  • the control system 500 can include a display 504 that can be used to operate the control system 500.
  • the control system 500 can include a power supply, a pump controller, and/or a controller for controlling operations of the control system 500.
  • the control system 500 can include an AC power entry 512 for connecting to an external power source.
  • the housing 502 can have an internal volume of less than 2000 cubic inches.
  • the control system 500 can include a control fluid assembly 515 and a pumping device 550.
  • the system 500 is similar to the system 10 in that the control fluid assembly 515, like the control fluid assembly 30, uses a control fluid to pressurize a chamber to cause movement of a piston head. The opposite movement of the piston head is provided by a spring whereas the control fluid assembly 30 provide movement in both directions by use of a control fluid.
  • the control fluid assembly 515 could be used in place of the control fluid assembly 30. Or, the control fluid assembly 30 could be used in the control system 500.
  • the control fluid assembly 515 can supply a control fluid to the pumping device 550.
  • the control fluid can be saline, air, helium, carbon dioxide, or other suitable gasses and liquids, that can be used to increase and decrease pressure within the pumping device 550 (e.g., an enclosed chamber 552 to displace a moveable member 560 and draw and eject blood as described herein).
  • the pumping device 550 can apply a fluctuating pressure to the proximal end of the blood flow system 104.
  • the pumping device 550 can be coupled to the proximal end of the blood flow system 104 via the outlet barb 514.
  • the control system 500 can include a controller (not shown) for controlling the operations of the control fluid assembly 515 and the pumping device 550.
  • the controller may be configured to receive signals to control the operation of the control fluid assembly 515 and the pumping device 550.
  • the controller can be configured to receive pressure signals, signals from one or more heartbeat cycle characterizers, and/or the like.
  • a heartbeat cycle characterizer can be configured to receive the heartbeat cycle signal, to detect at least one of systole and diastole, and to output a signal to one or more processors of the controller indicating the detected at least one of systole and diastole.
  • pressure signals can be provided to the controller from one or more pressure sensors and can be analyzed by the controller to detect at least one of systole and diastole.
  • the pumping device 550 can include the enclosed chamber 552 that houses the moveable member 560.
  • the control fluid assembly 515 can supply fluid to the enclosed chamber 552 to cause the moveable member 560 to move within the enclosed chamber 552, causing fluctuating pressures in the enclosed chamber 552.
  • the control fluid assembly 515 can include a pump 520, a pressure chamber 526, a valve 532, and/or an exhaust noise muffler 540.
  • the pump 520 can be fluidly connected via a pump inlet 522 to a priming port 508 that extends through the housing 502.
  • the priming port 508 can be connected to a control fluid source (e.g., a reservoir of compressed air, saline, helium, carbon dioxide, etc.) and can allow for the introduction of the fluid into the pump 520.
  • the priming port 508 may be controlled by a priming valve 510, coupled to the outside of the housing 502.
  • the pump 520 can be a compressor and can be used to compress fluid for supplying the pumping device 550.
  • the pump 520 can include a pump outlet 524 that can be connected to a pressure chamber 526 via a pressure chamber inlet 528.
  • the pressure chamber 526 can serve as a fluid reservoir for the control system 500.
  • the pressure chamber 526 can include a pressure chamber outlet 530 that can be used to direct the stored fluid towards a valve 532 via the valve inlet 534.
  • the valve 532 can regulate the flow of fluid into enclosed chamber 552.
  • the valve 532 can be controlled by the controller of the control system 500.
  • the controller can control the valve 532 based on the signals received from the one or more heartbeat cycle characterizers.
  • the valve 532 can include a valve bidirectional outlet 536 that can be connected to the enclosed chamber 552.
  • the bidirectional outlet 536 can function in two directions to allow compressed fluid to enter and exit the enclosed chamber 552.
  • the bidirectional outlet 536 can direct compressed fluid into the enclosed chamber 552 to cause an increase in pressure in the enclosed chamber 552, causing the moveable member 560 to move in a first direction (e.g., from right to left in FIG.2F).
  • the bidirectional outlet 536 may direct compressed fluid into the enclosed chamber 552 based on a detection of systole in the heartbeat signal.
  • the bidirectional outlet 536 can also be used to cause compressed fluid to exit the enclosed chamber 552, causing a reduction in pressure in the enclosed chamber 552. Fluid exiting the enclosed chamber 552 can be directed to the valve venting outlet 538.
  • the control fluid assembly 515 can include an exhaust noise muffler 540.
  • the valve venting outlet 538 can be connected to the exhaust noise muffler 540 to reduce the noise produced by the venting of the compressed fluid.
  • the pumping device 550 can be mounted to the housing 502.
  • the control system 500 can include a chamber support 556 to retain the pumping device 550 in a fixed location on the housing 502.
  • the chamber support 556 can include a top plate 558 that extends over the pumping device 550 and can be used to support the stoppage system 580, in some implementations.
  • the enclosed chamber 552 can house the moveable member 560.
  • the moveable member 560 can divide the enclosed chamber 552 into a first chamber portion 552A and a second chamber portion 552B.
  • the moveable member 560 can include a seal to prevent fluid exchange between the first chamber portion 552A and a second chamber portion 552B.
  • the first chamber portion 552A can be connected to a chamber outlet 554, which can be connected to the outlet barb 514 for coupling the pumping device 550 to the blood flow system 104.
  • the first chamber portion 552A can be connected to a pressure transducer 576, that can be used to measure the pressure within the first chamber portion 552A and covert the pressure measurement into an electrical signal for the controller.
  • the second chamber portion 552B can be connected to the valve 532 via the bidirectional outlet 536.
  • the bidirectional outlet 536 may extend through the chamber support 556 to connect to the second chamber portion 552B.
  • Compressed fluid entering the second chamber portion 552B causes an increase in pressure in the second chamber portion 552B, driving the moveable member 560 in the first direction, which causes an increase in pressure in the first chamber portion 552A, such that blood flows out of the blood flow system 104 and into the patient’s ventricle.
  • fluid exiting the second chamber portion 552B causes a reduction in pressure in the second chamber portion 552B, allowing the moveable member 560 to move in a second direction (e.g., from left to right in FIG.2F), which causes a reduction in pressure in the first chamber portion 552A, such that blood flows into the blood flow system 104 from the patient’s ventricle.
  • the moveable member 560 can comprise a piston, with a piston head 562 and a piston shaft 564.
  • the piston head 562 separates the first chamber portion 552A from the second chamber portion 552B.
  • the piston shaft 564 can extend through a chamber opening 557 in the enclosed chamber 552, so that a portion of the piston shaft 564 is outside of the enclosed chamber 552.
  • the chamber opening 557 can include one or more seals, such as a seal 557, to prevent fluid exchange between the enclosed chamber 552 and the outside environment through the chamber opening 557.
  • the movement of the moveable member 560 in the second direction can be limited by the stoppage system 580.
  • the length of the piston shaft 564 can impact the range of travel of the moveable member 560, which impacts the volume of blood that enters and exits the blood flow system 104 during a cycle.
  • the length of the piston shaft 564 can be adjustable.
  • the piston shaft 564 can include a first shaft member 564A coupled to the piston head 562 and a second shaft member 564B coupled to the first shaft member 564A.
  • the first and second shaft members 564A, 564B can include external threads and can be coupled using an internally threaded joint 568.
  • the second shaft member 564B can include a shaft head 566 that can be used to rotate the second shaft member 564B relative to the internally threaded joint 568, creating a separation between the first shaft member 564A and the second shaft member 564B, increasing the effective length of the piston shaft 564.
  • the pumping device 550 can include a spring 570.
  • the spring 570 can be used to move the moveable member 560, for example, in the second direction.
  • the spring 570 is a compression spring.
  • the spring 570 can extend over the piston shaft 564 and the internally threaded joint 568 such that the piston shaft 564 can travel through the core of the spring 570.
  • a first end of the spring 570 can be in contact with a spring holder 559, that is coupled to the chamber support 556.
  • a second end of the spring 570 can be in contact with a spring stopper 572 that is supported by the piston shaft 564.
  • the spring stopper 572 can be a washer.
  • the location of the spring stopper 572 on the piston shaft 564 can be fixed using a nut 574 that can be threaded on the second shaft member 564B. Moving the spring stopper 572 closer to the spring holder 559 (e.g., via the nut 574) increases the preload on the spring 570.
  • the preload on the spring 570 can impact the vacuum force applied by the blood flow system 104.
  • changing the preload on the spring 570 can increase the amount of pressure required to displace the moveable member 560.
  • changing the preload on the spring 570 can increase and decrease the maximum and minimum volume of the first chamber portion 552A.
  • changing the preload on the spring 570 can increase and decrease the pressure required to cause the moveable member 560 to move and can increase and decrease the magnitude of pressure applied to the blood flow system 104 by the pumping device 550.
  • the spring 570 is compressed between the spring holder 559 and the spring stopper 572, increasing the spring force in the spring 570.
  • the spring force can cause the moveable member 560 to be driven in the second direction as the spring 570 elongates.
  • the control system 500 can include the stoppage system 580.
  • the stoppage system 580 can be used to limit the movement of the moveable member 560 in the second direction, to control the volume of blood that enters and exits the blood flow system 104.
  • the stoppage system 580 can include a stoppage member 582, a shaft 584, and an external dial 586.
  • the shaft 584 can be coupled to the external dial 586 on a bottom end and can be rotationally supported by the top plate 558 near its second end.
  • the shaft 584 can extend through and be coupled to the stoppage member 582.
  • the external dial 586 can be positioned outside of the housing 502, allowing a user to control the position of the stoppage member 582. As shown in FIG.
  • the stoppage member 582 can have a helical/spiral shape with a cut-out portion 588.
  • the stoppage member 582 can have an increasing radius when moving circumferentially about the center of the stoppage member 582, defined by the shaft 584. As such, rotation of the stoppage member 582 changes a maximum distance between the shaft head 566 of the moveable member 560 and the stoppage member 582.
  • the cut-out portion 588 is aligned with the path of travel of the moveable member 560, the moveable member 560 can travel a maximum distance, and the volume of blood entering and exiting the blood flow system 104 is at a maximum.
  • the control system 500 can include other stoppage systems to limit the travel of the moveable member 560 within the control system 500.
  • FIG. 2I and FIG. 2J illustrate example actuator stoppage systems 580’ and 580” respectively, that can be used in the control system 500.
  • the control system 500 can include a linear actuator system 580’.
  • the linear actuator system 580’ can include a stoppage member 582’, a rod 588’, and a motor 590’.
  • the motor 590’ can be fixed to the housing 502 and can be used to move the rod 588’ linearly within the housing 502.
  • the stoppage member 582’ can be coupled to an end of the rod 588’ and can be used to stop the moveable member 560 and define the maximum distance of travel of the moveable member 560.
  • a user of the control system 500 can control the motor 590’ (e.g., via the controller) to limit the volume of blood entering and exiting the blood flow system 104.
  • FIG.2J illustrates an example solenoid actuator 580” that can be used in the control system 500.
  • the solenoid actuator 580 can include a stoppage member 582”, a rod 588”, a housing 592”, a coil 594”, and/or a spring 596”.
  • the housing 592” can be fixed to the housing 502 and can house the coil 594” and a portion of the rod 588”.
  • the rod 588” can be coupled to the stoppage member 582”.
  • the spring 596” can be coupled to the stoppage member 582” on one end and the housing 592” on the opposite end.
  • the rod 588” can extend through the core of the spring 596”.
  • the rod 588” can be or can contain a magnetic core.
  • the controller of the control system 500 can be used to selectively apply a current to the coil 594”.
  • the controller can be used to vary the amount of current applied to the coil 594”, which varies the distance of travel of the rod 588” and the stoppage member 582” in the first direction. Movement of the stoppage member 582” can also cause the spring 596” to elongate. When the current is reduced or no longer applied to the coil 594”, the spring force can cause the stoppage member 582” to move in the second direction.
  • FIGS. 2K-2N illustrate various views of a pumping device 800.
  • the pumping device can be used in the heart support system 10 in place of the pumping device 20.
  • the pumping device 800 can be in fluid communication with the conduit 50, which may be part of or an embodiment of the blood flow system 104.
  • the pumping device 800 can be configured to apply fluctuating pressures to the conduit 50 to cause blood flow into and out of the heart and/or from the heart to a heart adjacent artery, like the pulmonary artery or aorta.
  • the pumping device 800 can include a first enclosed chamber 806, defined by a blood contacting assembly 802, and a second enclosed chamber 841, defined by a fluid control system 840.
  • the pumping device 800 can include a housing 860 configured to position or secure the blood contacting assembly 802 and the fluid control system 840 relative to each other.
  • the pumping device 800 can include a piston 850.
  • the piston 850 can cause a change in pressure in the first enclosed chamber 806.
  • retracting or moving the piston in a first direction causes a reduction of pressure in the first enclosed chamber 806.
  • advancing or moving the piston in second direction causes an increase of pressure in the first enclosed chamber 806.
  • the reduction of pressure in the first enclosed chamber 806 can move blood through an opening at the distal end 52 of the conduit 50.
  • the blood can travel through the blood flow lumen of the conduit 50 and into the first enclosed chamber 806.
  • Movement in from distal end 52 toward the chamber 806 can be triggered by detection of diastole in a heartbeat cycle signal (e.g., ECG, pressure or both) as discussed further herein.
  • a heartbeat cycle signal e.g., ECG, pressure or both
  • the increase of pressure in the first enclosed chamber 806 can move blood from within the first enclosed chamber 806 and through the opening at the distal end 52 of the conduit 50 into the ventricle of the heart or an artery downstream thereof.
  • Movement in from the chamber 806 toward the distal end 52 can be triggered by detection of systole in a heartbeat cycle signal (e.g., ECG, pressure or both) as discussed further herein.
  • the piston 850 can include a piston shaft 852 having a proximal or first end 856 and a distal or second end 854.
  • the piston 850 can include a piston head 858 disposed between the first end 856 and the second end 854.
  • the piston head 858 is disposed in the second enclosed chamber 841 and divides the second enclosed chamber 841 into a first chamber portion 845 and a second chamber portion 843.
  • the second enclosed chamber 841 can be defined within a body 842 of the fluid control system 840.
  • the second enclosed chamber 841 is configured to be pressurized to cause movement of the piston 850.
  • the first chamber portion 845 can be defined between the distal side of the piston head 858 and a first seal 846 of the fluid control system 840.
  • the second chamber portion 843 can be defined between the proximal side of the piston head 858 and a second seal 844 of the fluid control system 840.
  • the piston shaft 852 can extend through the second enclosed chamber 841 (e.g., through the first seal 846 and the second seal 844).
  • the seals 844, 846 allow the piston 850 to reciprocate within the fluid control system 840 while maintaining the pressurized environment in the second enclosed chamber 841.
  • the first chamber portion 845 and the second chamber portion 843 can be isolated from each other.
  • the piston head 858 can include a seal so that the first chamber portion 845 and the second chamber portion 843 can be pressurized independently, e.g., each portion 843, 845 can have a different pressure or a relative pressure can be established therebetween.
  • Changing the relative pressures between the first chamber portion 845 and the second chamber portion 843 causes the piston 850 to move in the first and second directions because of the pressures acting on the piston head 858.
  • the second enclosed chamber 841 can be connected to the control fluid assembly 30. In some implementations, only one of the first chamber portion 845 and the second chamber portion 843 are connected to the control fluid assembly 30.
  • a biasing mechanism may be used to bias the piston 850 in the first or second direction, similar to the control system 500.
  • Use of a biasing mechanism to bias the piston 850 can provide an advantage of simplifying the system, as fewer fluid lines are required for connecting to a control fluid assembly, such as the control fluid assembly 30.
  • Use of a biasing mechanism to bias the piston 850 can also provide an advantage of eliminating the need for a second enclosed chamber (e.g., the second enclosed chamber 841) as shown in the pumping device 550 of at least FIG. 2H. Both of these differences can result in less seals and pneumatic connections in the system including the pumping device with the biasing mechanism, which can reduce the cost to manufacture such a system and can improve the durability of the system in some implementations.
  • the first chamber portion 845 is connected to the first fluid line 40 and the second chamber portion 843 is connected to the second fluid line 38.
  • the control fluid assembly 30 can include a pressure source (not shown).
  • the fluid lines 38, 40 can connect the second enclosed chamber 841 to the pressure source.
  • the first fluid line 40 can be connected at a first end to the pressure source and at a second end to the first chamber portion 845.
  • the first end of the first fluid line 40 can include a first valve (not shown) for controlling the flow of pressurized gas to the first chamber portion 845.
  • the second fluid line 38 can be connected at a first end to the pressure source and at a second end to the second chamber portion 843.
  • the first end of the second fluid line 38 can include a second valve for controlling the flow of pressurized gas to the second chamber portion 843.
  • the control system of the system 10 can control the first and second valves to selectively deliver pressurized gas and/or vent and/or place one or both of the first chamber portion 845 and the second chamber portion 843 in fluid or pressure communication with a negative pressure.
  • the control system can cause the piston 850 to move in the first and second directions by way of differential pressure in the chamber portions 845, 843. Utilizing a dual-chamber approach, such as in the pumping device 800, can provide an advantage of improved control over the movement of the piston 850 compared to a biased system.
  • the dual-chamber pumping device 800 can allow for more precise control over blood flow into and out of the heart, compared to a spring system, in some implementations.
  • the fluid control system 840 can be secured within the housing 860.
  • the housing 860 can include a first plate member 862 and a second plate member 864.
  • the fluid control system 840 can be positioned between the first plate member 862 and the second plate member 864 and coupled to the plate members 862, 864 via a plurality of spacers 866.
  • the spacers 866 can provide separation between the plate members 862, 864 and the fluid control system 840.
  • the second plate member 864 can be distal to the fluid control system 840.
  • the second plate member 864 can include a connector 868 for connecting the blood contacting assembly 802 to the housing 860.
  • the blood contacting assembly 802 is removably coupled to the housing 860 at least partially by the connector 868.
  • the connector 868 can include an opening 870 (see FIG. 2K). The opening 870 allows the piston 850 to extend through the connector 868 and into the blood contacting assembly 802.
  • the blood contacting assembly 802 can include a cylinder 804, a plunger head 812, and an end cap 820.
  • the cylinder 804 can be a hollow cylinder with an opening defining an internal volume extending from a first end 810 to a second end 808.
  • the internal volume of the cylinder 804 can at least partially define the first enclosed chamber 806.
  • the cylinder 804 can be coupled to the housing 860 at the second end 808.
  • cylinder 804 may be removably coupled to the connector 868 of the second plate member 864.
  • the open second end 808 of the cylinder 804 is aligned with the opening 870 of the connector 868.
  • the connector 868 can have threads on its outer surface and an inner surface of the second end 808 of the cylinder 804 can have internal threads or grooves for receiving the external threads of the connector 868, or vice-versa.
  • the cylinder 804 may be threadedly engaged with the housing 860.
  • a bayonet or other connection type could also be provided.
  • the cylinder is permanently affixed to the second plate member 864.
  • the plunger head 812 is disposed at least partially within the cylinder 804.
  • the plunger head 812 acts as the moveable member for the pumping device 800, with movement of the plunger head 812 causing a change in pressure in the first enclosed chamber 806.
  • the inner volume of the cylinder 804 is at least partially disposed around the plunger head 812. As such, the inner volume of the cylinder 804 is configured to support the reciprocal movement of the plunger head 812 in the cylinder 804.
  • the plunger head 812 includes a first end 816 and a second end 814. The first end 816 can define a proximal end of the first enclosed chamber 806.
  • the first end 816 of the plunger head 812 can have a round or convex surface. Such a configuration can allow the first end 816 of the plunger head 812 to extend at least partially into the end cap 820, as described below.
  • the plunger head 812 can be coupled to the piston 850 at the second end 814.
  • the distal end 854 of the piston shaft 852 can extend into the plunger head 812 via the second end 814.
  • the plunger head 812 is removably coupled to the piston shaft 852.
  • the plunger head 812 can include one or more seals 818 disposed along an outside surface thereof.
  • the plunger head 812 includes a first seal 818a and a second seal 818b (collectively seals 818) spaced apart from each other.
  • the seals 818 can slidingly contact the inner wall of the cylinder 804 that define the inner volume of the cylinder 804.
  • the seals 818 can prevent blood from traveling past the plunger head 812 and into the proximal side of the cylinder 804.
  • the seals 818 can prevent ingress of fluid, such as air, into the first enclosed chamber 806 from the open second end 808 of the cylinder 804. Accordingly, the interaction between the plunger head 812, including the seals 818, and the cylinder 804 partially define an isolated controlled environment for the first enclosed chamber 806.
  • the end cap 820 can be the distal end of the pumping device 800.
  • the end cap 820 can define the distal end of the first enclosed chamber 806.
  • the end cap 820 can also facilitate the connection of the conduit 50 to the first enclosed chamber 806.
  • the end cap 820 includes a first end 823 and an opposite second end 821.
  • the first end 823 includes a barb 822 configured to connect to the proximal end 52 of the conduit 50.
  • the end cap 820 can be coupled at its second end 821 to the cylinder 804.
  • the second end 821 of the end cap 820 includes an opening 825 that aligns with the inner wall that defines the internal volume of the cylinder 804.
  • the pumping device 800 includes a cylinder connector 834 for facilitating a removable coupling between the cylinder 804 and the end cap 820.
  • the cylinder connector 834 can extend around a peripheral outer surface of the first end 810 of the cylinder 804 and a peripheral outer surface of the second end 821 of the end cap 820 when the cylinder 804 and end cap 820 are coupled together.
  • the second end 821 of the end cap 820 can include a recess 830 for receiving a seal 832.
  • the seal 832 seals around the distal portion 810 of the cylinder 804 to create a closed environment for the first enclosed chamber 806.
  • the opening 825 provides access to an inner surface 826 of the end cap 820.
  • the inner surface 826 partially encloses or forms the distal end of the first enclosed chamber 806.
  • the inner surface 826 can have a rounded or concave shape and can be configured to at least partially receive the first end 816 of the plunger head 812, which partially encloses or forms the proximal end of the first enclosed chamber 806.
  • the convex surface 816 of the plunger head 812 faces the concave inner surface 826 of the end cap 820.
  • the piston 850 is advanced in the second direction, the convex surface 816 enters the end cap 820 via the opening 825 and moves towards the concave inner surface 826.
  • Such movement reduces the volume of the first enclosed chamber 806.
  • the chamber 806 is filled with blood, such movement causes an increase in pressure in the chamber 806.
  • Continued advancement of the piston 850 in the second direction can substantially reduce and in some cases eliminate the volume of the first enclosed chamber 806 when the convex surface 816 and the concave inner surface 826 are brought into adjacency, e.g., touching.
  • the convex surface 816 of the plunger head 812 engages or mates with the concave inner surface 826 of the end cap 820.
  • Such a configuration can allow substantially all of the blood in the first enclosed chamber 806 to be evacuated from the first enclosed chamber 806 and into the conduit 50. Removing substantially all of the blood in the first enclosed chamber 806 can provide a benefit of minimizing the risk of thrombosis. Subsequent retraction of the piston 850 in the first direction causes the convex surface 816 of the plunger head 812 to move away from the concave inner surface 826 of the end cap 820. This movement can result in decreasing the pressure in the first enclosed chamber 806 compared to prior to such movement.
  • the end cap 820 includes a lumen 828.
  • the lumen 828 provides a fluid communication channel between the first enclosed chamber 806 and the conduit 50.
  • the lumen 828 extends from a first end disposed adjacent to the barb 822 to a second end disposed on the concave inner surface 826.
  • the end cap 820 can have a conical outer surface.
  • the end cap 820 may include at least one gripping feature 824 disposed on or defined by the outer surface to facilitate assembly and/or disassembly of the end cap 820 from the cylinder 804.
  • the gripping feature 824 can include at least one flat surface that can be gripped by hand or by a tool and can more easily support a torque load than the adjacent curved conical surface.
  • the plunger head 812, the cylinder 804, and the end cap 820 form components of the blood contacting assembly 802 of the pumping device 800 in one embodiment.
  • blood received from the heart at least partially contacts each of these components when the blood flows into the first enclosed chamber 806.
  • the components of the blood contacting assembly 802 can be removable from the pumping device 800 to facilitate a sterilizing process.
  • the plunger head 812 can be removed from the piston 850, and the cylinder 804 can be removed from the housing 860.
  • the blood contacting assembly 802 may be autoclavable (e.g., able to safely undergo autoclaving without damage).
  • the blood contacting assembly 802 may be disposable.
  • the blood contacting assembly 802 may include a membrane (not shown) configured to prevent exposure of at least some of the components of the assembly 802 to the blood in the first enclosed chamber 806.
  • the membrane may be positioned on or between the proximal end 52 of the conduit 50 and the first enclosed chamber 806.
  • the pumping device 800 can include a stoppage system 880.
  • the stoppage system 880 is configured to limit or restrict movement of the piston 850, and the plunger head 812, in the first direction.
  • the stoppage system 880 is also referred to herein as a stroke-length or a chamber volume control system. Accordingly, the stoppage system 880 can control the volume of blood that enters and exits the first enclosed chamber 806.
  • the stoppage system 880 includes a rod 882 configured to move relative to the first plate member 862. Engagement between the rod 882 and the proximal end 856 of the piston shaft 852 defines a maximum retracted position of the piston 850 corresponding to the maximum stroke length of the piston and maximum volume of the first enclosed chamber 806. The maximum retracted position of the piston 850 can be adjusted by moving the rod 882 towards or away from the fluid control system 840. The rod 882 can be threadedly engaged with an opening 872 in the first plate member 862.
  • Rotation of the rod 882 in a first rotational direction relative to the first plate member 862 causes the rod 882 to move in the first direction away from the second enclosed chamber 841, increasing the stroke length of the piston 850 and the maximum volume of the first enclosed chamber 806. Conversely, rotation of the rod 882 in a second rotational direction relative to the first plate member 862 causes the rod 882 to move in the second direction towards the second enclosed chamber 841, decreasing the stroke length of the piston 850 and the maximum operating volume of the first enclosed chamber 806.
  • the cylinder 804 can be sized to accommodate a range of stroke lengths of the plunger head 812.
  • the length of the cylinder 804 can be greater than the depth (proximal distal dimension, e.g., radius) of the first enclosed chamber 806 such that the first end 816 of the plunger head can be retracted past the opening 825.
  • the length of the cylinder 804 can be at least about twice the depth (proximal distal dimension, e.g., radius) of the first enclosed chamber 806 such that the first end 816 of the plunger head can be retracted past the opening 825 by an amount at least about equal to the portion of the stroke length distal to the opening 825.
  • the extent of the stroke length can be based on the patient needs, e.g., volume of the right ventricle, output of the right ventricle, a measure of demand, a heart rate, a blood pressure or other parameters indicative of patient need.
  • the proximal end 856 of the piston shaft 852 can comprise a compressible stoppage member that is configured to repeatedly engage the rod 882.
  • the stoppage system 880 can include a handle 884 for controlling the rotation and movement of the rod 882.
  • other stoppage systems can be used in the pumping device 800.
  • the pumping device 800 may include a stoppage system that is electrically, pneumatically, or magnetically controlled.
  • the system 10 can include two conduits, a first conduit 50a and a second conduit 50b, extending between the heart and the pumping device 800.
  • the first conduit 50a can be configured for one-way flow from the first enclosed chamber 806 to the heart and the second conduit 50b can be configured for one-way flow from the heart to the first enclosed chamber 806.
  • the system can include a first one-way valve 56a for controlling flow in the first conduit 50a and a second one-way valve 56b for controlling flow in the second conduit 50b.
  • valves 56a, 56b in the system can vary, depending on the implementation. Accordingly, the valves 56a, 56b in FIG.2O are shown in dashed lines and in multiple locations.
  • the valves 56a, 56b may be disposed in the end cap 820 e.g., with the first one-way valve 56a in a first barb 822a and the second one-way valve 56b in a second barb 822b.
  • the valves 56a, 56b may be disposed in the conduits 50a, 50b, e.g., with the first one-way valve 56a in the first conduit 50a and the second one-way valve 56b in the second conduit 50b.
  • the first one-way valve 56a can be configured to allow fluid flow from its proximal end 52a to its distal end 54a and prevent fluid flow from the distal end 54a to the proximal end 52a.
  • the second one-way valve 56b can be configured to allow fluid flow from the its distal end 54b to its proximal end 52a and to prevent fluid flow from the second proximal end 52a to the second distal end 54b.
  • the valves 56a, 56b may be located in one or both of the conduits and in the end cap 802. Like the blood flow system 104 of FIG.2A’, both distal ends 54a, 54b of the conduits 50a, 50b can be disposed within the heart. In FIG.
  • neither conduit 50a nor conduit 50b is shown as including a curved distal end 54a, 54b.
  • one or both of the conduits 50a, 50b can include a curved distal end similar to the distal end 54 of conduit 50 shown in FIG. 1.
  • the end cap 820 may include the first barb 822a for connecting to the first conduit 50a and the second barb 822b for connecting to the second conduit 50b.
  • the barbs 822a, 822b can be adjacent to corresponding lumens for facilitating fluid communication between the first enclosed chamber 806 and the conduits 50a, 50b.
  • FIG.3A shows an implementation of the enclosure 144 that can be included in the heart support system 100 in which a moveable member 148A is provided that can include a moveable wall or membrane.
  • the membrane can move away from the proximal end of the blood flow system 104, e.g., proximal of the vascular span 120, to provide an enlarged volume in the enclosure 144 in the first phase of operation and can be moved toward the proximal end of the blood flow system 104 to reduce, minimize or eliminate the volume in the enclosure 144 in the second phase of operation.
  • the structure can comprise a flat sheet that is connected at its periphery to the inside surface of the enclosure 144. A portion of the enclosure 144 disposed away from the connection of the blood flow system 104 to the enclosure 144 can have an aperture in fluid communication with the inflation lumen 142.
  • a fluid can flow into a portion of the enclosure 144 between the membrane and the aperture to move the central span of the membrane toward the connection of the blood flow system 104 to the enclosure 144 in the second phase.
  • the fluid can be removed from the portion of the enclosure 144 between the membrane and the aperture to move the central span of the membrane away from the blood flow system 104 to the enclosure 144 to increase the volume available for blood in the first phase, which is illustrated in FIG.3A.
  • the moveable member 148A may be arranged generally vertically within enclosure 144 as shown in FIG. 3A. In some implementations, moveable member 148A may be arranged generally horizontally. [0134] FIG. 3A also shows an optional spring 149 or another resilient member configured to bias the moveable member 148A.
  • the moveable member 148A can be biased toward pushing out blood, e.g., toward the blood flow system 104 (to the right in FIG. 3A).
  • the moveable member 148A is shown positioned away from the blood flow system 104 (to the left in FIG. 3A). This is as a result of a negative pressure (suction) being applied by a control fluid to the inflation lumen 142.
  • a negative pressure suction
  • the spring 149 stores strain energy.
  • the spring 149 is shown as a coil spring for simple illustration. The coil is stretched in FIG. 3A to illustrate the strain of the spring 149 as it stores energy.
  • the spring 149 can have different configurations.
  • the spring 149 could be placed in the enclosure 144 between the moveable member 148A and the opening into the inflation lumen 142.
  • the spring 149 can be bias the moveable member 148A toward the blood flow system 104 while being positioned in the space between the moveable member 148A and the inflation lumen 142.
  • a suction in the inflation lumen 142 can cause the spring 149 to be compressed in that space.
  • FIG. 3A shows the spring 149 located in the second area, e.g., in the area in fluid communication with the control lumen 142A.
  • the spring 149 can be located in the volume in which control fluid can be disposed.
  • the spring 149 can comprise a coil spring or any other resilient member that can store strain energy when the second area of the enclosure 144 is provided with a relatively high pressure. The strain energy can be released, e.g., the coils of the coil spring can contract. Contraction of the spring 149 can move the moveable member 148 away from the blood flow system 104.
  • the spring 149 can be located in the first area of the enclosure 144. When positioned in the first area, the spring 149 can be exposed to blood. As such, the spring 149 can be coated in heparin or other substance that reduces, minimizes or prevents clotting around the spring 149.
  • the spring 149 can be enclosed in a biocompatible structure, such as a bellows member that can lengthen and shorten and that encloses the spring 149 on one side and that has an opposite side that is biocompatible.
  • a biocompatible structure such as a bellows member that can lengthen and shorten and that encloses the spring 149 on one side and that has an opposite side that is biocompatible.
  • This approach can allow the spring 149 to be on the blood side of the enclosure 144 without contacting the blood.
  • the spring 149 can be configured to be in a free state where the coils are in the first area of the enclosure 144 and the coils are extended such that when the second area is pressurized with control fluid from the control lumen 142A the coils are compressed, storing strain energy.
  • the moveable member 148A can be secured within the enclosure 144 in any suitable manner.
  • the enclosure 144 is roughly egg-shaped or ovoid.
  • the moveable member 148A can be mounted to the enclosure 144 in a generally central position of the internal space of the enclosure.
  • the moveable member 148A can have a generally circular outer periphery that is engaged with an interior portion of the enclosure 144.
  • the enclosure 144 can have an inner groove with which an outer edge of the moveable member 148A can be coupled.
  • a central area of the moveable member 148A can be configured to be coupled with a free end of the spring 149.
  • the moveable member 148A can have a concave structure on the side that is coupled with the spring 149.
  • the moveable member 148A can be flat on the side thereof contacting the spring 149.
  • the moveable member 148A can be configured to remain concave of the side contacting the spring 149 even when the spring is compressed.
  • a connection feature is provided to maintain the spring 149 in a predefined connection configuration with the moveable member 148A whether the spring is compressed or extended.
  • FIG. 2D shows additional structures that control the movement of the control fluid from the source of control fluid to the control lumen 142A.
  • a solenoid 150 or other valve can be positioned in the fluid conduit between the control lumen 142A and the plug 151 (or other connector) and thereby between the source and the control lumen 142A.
  • the solenoid 150 can be operated by a controller 153 that can cyclically open and close the solenoid to control the pressure in the control lumen 142A and thereby in the second area of the enclosure 144.
  • FIG. 2D also shows that the plug 151 can be connected to a socket (or another connector) of a source that is plumbed through the wall or in a tank mounted in or behind the wall.
  • the configuration to engage the wall source is beneficial in that a patient can be provided with the system and the source of pressurizing fluid can come from a readily available wall air source.
  • Pressurized wall air e.g., compressed medical air
  • This enables a clinician to provide support to a patient without the need to locate a pressure vessel and without concern that the pressure vessel might be depleted or low.
  • Using pressurized air accessible from a wall port also potentially allows the system to be a smaller footprint, which can be beneficial in a hospital room or operating room environment that tends to be crowded with other people and equipment.
  • FIG. 3B shows another implementation for alternating pressures in the blood flow system 104, which may be used in the heart support system 10 (e.g., instead of or in addition to the pumping device 20) or another one of the systems described herein.
  • the blood flow system 104 can cause blood to flow toward or away from the heart using a peristaltic mechanism.
  • a roller 200 can be provided to roll along the outside surface of the blood flow system 104 (or a conduit in fluid communication therewith). The roller 200 can roll between a forward position 204 and a retracted position 208. The roller 200 applies a pressure or pinching load to the blood flow system 104.
  • the roller 200 rolls forward from the retracted position 208 to the forward position 204 along a stroke length L the volume of blood along the stroke length L is pushed toward the heart and into the right ventricle RV.
  • blood is drawn in the blood flow system 104 from the heart toward the proximal portion of the blood flow system 104.
  • the roller 200 compresses the tubing and moves in both directions along the tubing length (over the stroke length L) inducing both suction and ejection or injection.
  • FIG.3C illustrates another heart support system in which flow in the blood flow system 104 is provided by syringe pump.
  • the syringe pump can be integrated into the blood flow system 10 as part of the pumping device 20.
  • the syringe pump includes a rigid cylinder 224, a plunger 228 and an actuator 232.
  • a distal end of the rigid cylinder 224 may be connected to the blood flow system 104.
  • a distal end of the rigid cylinder 224 may be connected to an enclosure, for example enclosure 144 discussed above, housing a moveable member, for example the moveable member 148A or balloon variant of member 148 as discussed above.
  • the rigid cylinder 224 may contain a control fluid, such as saline, air, helium, carbon dioxide, or other suitable gasses and liquids, that can be used to increase and decrease pressure within enclosure 144 to displace the moveable member 148 and draw and eject blood as described herein.
  • the rigid cylinder 224 provides an internal volume that linearly scales with the travel length of the plunger 228, which may provide predictable and reliable control over the volume of blood drawn from and ejected into the blood flow system 104.
  • the actuator 232 may be used to move the plunger 228 within the cylinder 224 via a stepper motor.
  • the actuator 232 includes pressure and/or vacuum pumps, solenoid, and/or pneumatics to achieve a desired level of volume control and actuation time.
  • FIG.3D illustrates another heart support system in which flow in the blood flow system 104 is provided by a dual acting piston system.
  • the dual acting piston system can be integrated into the blood flow system 10 as part of the pumping device 20.
  • the dual acting piston system couples an elastic moveable member 148B with the blood flow system 104.
  • the moveable member 148B is disposed in a pressure fluid chamber 244.
  • the enclosure containing the pressure fluid chamber 244 also includes a gas chamber 248 providing a compressible fluid in which a piston 264 moves within forward section 249A and rearward section 249B.
  • the piston 264 includes a forward plate 268 and a rearward plate 272.
  • the forward plate 268 and the rearward plate 272 are coupled by seals 276 disposed between an inside surface of the enclosure and these plates. The seals 276 enable the different fluids to be disposed around the plates and in the pressure fluid chamber 244.
  • a pump 252 can be in fluid communication with forward section 249A of the gas chamber 248 between the forward plate 268 and the rearward plate 272 by action of a forward valve 256.
  • the pump 252 can be in fluid communication with rearward section 249B of the gas chamber 248 between the rearward plate 272 and a rearward surface of the enclosure containing the pressure fluid chamber 244 by action of a rearward valve 260.
  • Valves 256 and 260 can be controlled to move the piston 264 and adjust the moveable member 148B.
  • forward valve 256 and rearward valve 260 can be configured to allow pump 252 to pressurize forward section 249A and vent rearward section 249B.
  • This arrangement draws piston 264 rearward and increases the volume of pressure fluid chamber 244 to draw blood into moveable member 148B.
  • Valves 256 and 260 can then be configured to vent forward section 249A and pressurize rearward section 249B to push piston 264 forward, decreasing the volume of pressure fluid chamber 244 and ejecting blood from moveable member 148B.
  • this arrangement can consolidate an energy source into a single pneumatic pump 252 and can allow for easy and accurate control of blood volume in blood flow system 104.
  • FIGS. 3E-1 and 3E-2 show another heart support system similar to that of FIG.3D where a four-way valve controls timing and pressure within the enclosure containing the pressure fluid.
  • the four-way valve can be integrated into the blood flow system 10 as part of the pumping device 20.
  • a rotatable member 312 can be provided to alternate between the configuration shown in FIG. 3E-1 and a configuration shown in FIG. 3E-2.
  • a forward connection 316 is coupled with forward section 249A occupying a space between the forward plate 268A and the rearward plate 272.
  • a rearward connection 317 is coupled with rearward section 249B occupying a space between the rearward plate 272 and a rearward surface 304 of the enclosure in which the piston 264A moves.
  • rotatable member 312 can provide coordinated connections to connect sections 249A and 249B to the pump 252 and ambient air. As shown in FIG.3E-1, rotatable member 312 can connect forward section 249A to the pump 252 and simultaneously connect rearward section 249B to ambient air.
  • This position allows a heightened pressure to be applied to the forward section 249A
  • pressure in the pressure fluid chamber 244 is decreased and the moveable member 148B expands drawing blood through the blood flow system 104 and out of the heart.
  • the rotatable member 312 is moved such that the rearward section 249B is in fluid communication the pump 252.
  • the forward section 249A is placed in fluid communication with ambient air via forward connection 316. A heightened pressure thus can be applied to rearward section 249B.
  • the pressure differential across the rearward plate 272 moves the piston 264A distally or toward the blood flow system 104.
  • the four-way valve is a rotatable member 312 as discussed above, although other controllable valve structures such as manifolds, multi-action valves, clock valves, and the like may also be appropriate.
  • piston 264A may be identical to piston 264 discussed above.
  • forward plate 268A may be smaller than rearward plate 272. Different sizes of the piston discs or plates 268A and 272 can induce a mechanical advantage and improve the efficiency of pumping blood in the moveable member 148B.
  • a front stop 313 may be provided to limit forward or distal travel distance of the rearward plate 272. This can preserve sufficient space for moveable member 148B and the surrounding saline and/or maintain a minimum volume in pressure fluid chamber 244.
  • front stop 313 is provided by a cylinder or chamber neck as illustrated in FIGS. 3E-1 and 3E-2.
  • front stop 313 may include a ridge, detent, slope, bevel, spring, barrier, or other suitable structure.
  • rearward surface 304 may be moveable. For example, as illustrated in FIGS. 3E1 and 3E2, rearward surface 304 can be moved toward or away from blood flow system 104 with a screw 314.
  • rearward surface 304 This allows for rearward surface 304 to function as an adjustable backstop to control the volume.
  • screw 314 is used to move rearward surface 304 to tune or calibrate the heart support system 100 to an individual patient.
  • the heart support system 100 may be periodically adjusted by moving rearward surface 304, for example to increase the overall volume and volume available to moveable member 148B, and thereby increase the volume of blood moved by blood flow system 104.
  • the pump 252 of the heart support systems illustrated in FIGS. 3D and 3E-1, 3E2 is a pressurizing pump.
  • the pump 252 may be a vacuum pump controlled to appropriately reduce the relative pressure in the forward section 249A and rearward section 249B to achieve the same movement of the pistons 264, 264A.
  • FIGS.3F through 3I-5 illustrate implementations in which at least a portion of the system can be made disposable.
  • a releasable connection allows blood flow system 104 to be separated for disposal while inflation lumen 142 and the pressurizing components can be retained for reuse.
  • a releasable connection can also allow a level of modularity by separating the blood flow system 104 for re-connection to a different inflation lumen 142 of any appropriate system described herein.
  • the enclosure 144 and the moveable member 148 can be coupled to an enclosure of a heighted pressure source, e.g., to the inflation lumen 142 by a coupling 280.
  • a heighted pressure source e.g., to the inflation lumen 142
  • expansion and un-expansion of the moveable member 148 can be by the inflation fluid in the inflation lumen 142.
  • coupling 280 secures enclosure 144 to inflation lumen 142 and provides a seal to prevent blood from leaking out of blood flow system 104 as well as to prevent the pressurized fluid, e.g., saline, from exiting the heart support system 100.
  • the volume 170 between moveable member 148 and enclosure 144 is reduced to increase pressure and eject blood into blood flow system 104.
  • the pressure of the fluid in inflation lumen 142 is decreased, or as pressurized fluid is pumped out of moveable member 148, the volume 170 between moveable member 148 and enclosure 144 is increased, reducing pressure to draw blood into the volume 170, which now acts as a reservoir before ejecting blood on the next cycle.
  • the blood flow system 104 including enclosure 144 containing moveable member 148, can be disconnected from inflation lumen 142 by removing coupling 280.
  • FIGS.3G and 3H each show a variation in which a moveable member 148B is provided.
  • the moveable member 148B is one in which the moveable member 148B is expanded by application of a pressure to the outside surface thereof. The expansion flows blood into the moveable member 148B and pumps the blood out of the moveable member 148B cyclically.
  • enclosure 144 is not separately provided.
  • moveable member 148B may be configured to contain blood, as illustrated in FIGS. 3G and 3H, in contrast other implementations described herein, such as those illustrated in FIGS.
  • the blood flow system 104 can be releasably connected to inflation lumen 142 by coupling 324.
  • inflation lumen 142 may be enclosed by or part of a pressure chamber 320.
  • pressure chamber 320 may be similar to or part of enclosure 144.
  • pressure chamber 320 includes an opening for insertion of moveable member 148B, which is then held in place with coupling 324.
  • moveable member 148B After insertion, the outside of moveable member 148B contacts the pressurizing fluid in inflation lumen 142, and moveable member 148B separates blood in blood flow system 104 from the fluid in inflation lumen 142 and pressure chamber 320. [0153] During operation, when the pressure of the fluid in inflation lumen 142 is increased, the pressure within pressure chamber 320, and therefore a pressure exerted on moveable member 148B, is also increased to reduce the volume within moveable member 148B and eject blood into blood flow system 104.
  • connection can further include a secondary balloon 340, as illustrated in FIG. 3H. Secondary balloon 340 can be permanently affixed to the pressure chamber 320 to receive blood flow system 104, including moveable member 148B.
  • the secondary balloon 340 can provide an additional barrier between the blood in blood flow system 104 and the fluid in pressure chamber 320 and inflation lumen 142. Secondary balloon 340 can also prevent loss of fluid in pressure chamber 320 when blood flow system 104 is disconnected by removing coupling 324. When blood flow system 104 is not attached to pressure chamber 320, the elastic secondary balloon 340 seals the opening at coupling 324.
  • secondary balloon 340 may be an elastic balloon, diaphragm, pouch, flexible bag, membrane, or other barrier.
  • secondary balloon 340 may be configured to assist the drawing or ejecting of blood in blood flow system 104 when blood flow system 104 and moveable member 148B are connected to inflation lumen 142 and pressure chamber 320 at coupling 324.
  • FIGS. 3I-1 through 3I-5 show a method of using the heart support systems of FIG.3G and 3H.
  • moveable member 148B is fully collapsed and separated from pressure chamber 320 with inflation lumen 142.
  • pressure chamber 320 is arranged at the minimum volume (e.g., the internal balloon of FIGS. 2A-C is fully expanded, the roller of FIG. 3B is fully forward, the piston of FIGS. 3C-3E is fully forward, etc.) and the minimum volume is fully primed with saline.
  • moveable member 148B and blood flow system 104 are also primed with saline.
  • moveable member 148B and blood flow system 104 may be primed with blood, anticoagulant, antibiotic, or other appropriate fluid.
  • the collapsed moveable member 148B is pushed into a port of pressure chamber 320.
  • the connection is sealed with coupling 324.
  • coupling 324 includes a tubular port with a mating external collar around the tubing of blood flow system 104, located distal of moveable member 148B.
  • the moveable member 148B After using coupling 324 to connect blood flow system 104 and moveable member 148B to inflation lumen 142 and pressure chamber 320, the moveable member 148B expands and fills with blood as the piston within pressure chamber 320 moves backward and expands the volume of the saline side of the pressure chamber 320 (e.g., as the volume of forward section 249A increases) as shown in FIG. 3I-3. As shown in FIG. 3I-4, the moveable member 148B contracts and ejects blood into blood flow system 104, and eventually the cardiac chamber, as the piston within pressure chamber 320 moves forward and reduces the volume of the saline side of the pressure chamber 320 (e.g., as the volume of forward section 249A decreases).
  • the heart support system 100 cyclically operates between the first suction phase, shown in FIG. 3I-3, and the second ejection phase, shown in FIG.3I-4.
  • the heart support system 100 may be stopped at the end of the ejection phase as shown in FIG.3I-4. Moving the piston to the end of the stroke drains the moveable member 148B and can minimize the volume of blood in the heart support system 100.
  • the coupling 324 can be removed or separated to release moveable member 148B and blood flow system 104 from inflation lumen 142 and pressure chamber 320. In some implementations, such as FIG.
  • removing moveable member 148B may allow some pressurizing fluid to escape from pressure chamber 320.
  • the pressurizing fluid may require refilling or replacement before connecting pressure chamber 320 to another blood flow system 104.
  • use of a secondary balloon 340 or other sealing structure as discussed above with respect to FIG. 3H may avoid this fluid replacement step.
  • the heart support system 100 cyclically operates between the first suction phase (e.g., FIG.3I-3) and the second ejection phase (e.g., FIG.3I-4), and the system is connected and disconnected at the peak ejection phase shown in FIG. 3I-4.
  • the heart support system 100 operates in an operating range with a maximum operating ejection volume that is less than the connection ejection volume.
  • the blood flow system 104 and moveable member 148B may be “fully drained” for connecting and disconnecting, while retaining a residual volume of blood during normal operation.
  • a priming volume of blood may be retained in blood flow system 104 and moveable member 148B during disconnection, for example to maintain a shape for reconnection to another pressure chamber 320 and inflation lumen 142.
  • FIG.3J shows a variation of the dual acting piston systems discussed above (e.g., FIGS.3D and 3E-1, 3E-2) in which expandable members and the pressure fluid chamber are eliminated and a forward plate 268C has a blood contact surface 364 that directly drives and pulls the blood based on action of a pressure pump.
  • the pressurizing system shown in FIG. 3J may be similar or identical to the pressurizing system of FIG.3D or the pressurizing system of FIGS. 3E-1 and 3E-2 in some or all other respects.
  • the pump 252, forward connection 316, rearward connection 317, rotatable member 312, forward section 249A, rearward section 249B, front stop 313, and rearward plate 272 may operate as discussed above.
  • Rearward surface 304 may be fixed or adjustable as discussed above. In some implementations, rearward surface 304 may be adjustable via linkage to customize the stroke length.
  • some or all of the chamber (e.g., cylinder), blood contact surface 364 of forward plate 268C, rearward plate 272, front stop 313, rearward surface 304, and tubing of forward connection 316 and rearward connection 317 may be made of disposable plastic and elastomers.
  • the various sealing interfaces can be shaped and made of materials selected to reduce or eliminate inertia of a metal piston.
  • the pressurizing system of FIG. 3J may be more efficient by eliminating the flow resistance of saline or other pressurizing fluid used in other implementations discussed herein.
  • Blood contact surface 364 may be a suitable material and shape to directly contact blood in blood flow system 104.
  • the structures of the pressurizing system of FIG.3J can be integrated into the blood flow system 10 as part of the pumping device 20.
  • FIG. 2A shows one arrangement for controlling the heart support system 100 to provide the first and second phases of operation discussed above.
  • the inflation lumen 142 is coupled at one end to the moveable member 148 (e.g., to an open end of a balloon) or to the enclosure 144 for moving a moveable membrane.
  • the inflation lumen 142 is coupled at another end to a control system 112 (e.g., an implementation of or in some embodiments integrated into the control fluid assembly 30) including a solenoid 150 configured to selectively connect the lumen to a vacuum or a pressure branch of a pressure system.
  • the vacuum and pressure branches can be formed in a manifold or separately plumbed in the system.
  • the vacuum branch can include a vacuum solenoid 152 configured to selectively connect the inflation lumen 142 to a vacuum pump 154 when the solenoid 150 is configured to put the vacuum branch in fluid communication with the inflation lumen 142.
  • the pressure branch can include a pressure solenoid 156 configured to allow pressure communication between a pressure chamber 157 and the inflation lumen 142. That is when the solenoid 150 is configured to be open to the pressure branch and the pressure solenoid 156 is open, an elevated pressure fluid in the pressure chamber 157 can flow into the inflation lumen 142 and thereby into the moveable member 148 (e.g., the interior of a balloon) causing the moveable member 148 to increase the volume that it occupies in the enclosure 144.
  • the pressure chamber 157 can be pressurized by a compressor pump 159 that is connected to the pressure chamber 157 by a regulator 158.
  • the regulator 158 can prevent the compressor pump 159 from over-pressurizing the pressure chamber 157 and thereby the moveable member 148 (e.g., balloon) which could damage the moveable member 148 (e.g., balloon).
  • Typical operation of the heart support system 100 is as follows.
  • the elongate body of blood flow system 104 is advanced toward the heart, e.g., from a femoral vein (or other peripheral vein) to the heart.
  • the ventricular span 128 is advanced through the tricuspid valve into the right ventricle RV.
  • the perforations 136 are positioned along the intra- ventricular septum such that at least some of the perforations 136 face away from the ventricle wall.
  • the distal tip 140 is positioned in, adjacent to, or facing the right ventricle outflow tract, e.g., pointing toward the pulmonary artery PA.
  • the positioning of the perforations 136 and the distal tip 140 can be by un-straightening the distal portion of the ventricular span 128, e.g., by pulling back on a guidewire to allow the tip to take a pre-formed shape.
  • a portion of the ventricular span 128 proximal of the perforations 136 also can have a stiffness that facilitates positioning the perforations 136 and the distal tip 140, in various implementation.
  • a device for improving coaptation of heart valve leaflets with the blood flow system 104, as discussed below in connection with FIG.6A.
  • the blood flow system 104 can be preconnected at a proximal end (proximal of the vascular span 120) to the enclosure 144 or such connection can be made after the vascular span 120 has been positioned, as described above.
  • the enclosure 144 can be preconnected to the control system 112 or can be connected to the control system 112 after the enclosure 144 is connected to the vascular span 120.
  • the control system 112 can include a source of inflation fluid, e.g., a gas pressurized by the compressor pump 159 and contained in the pressure chamber 157 that can flow into and be pumped out of the inflation lumen 142.
  • FIG. 2A’ illustrates another implementation of the heart support system 100.
  • the heart support system 100 of FIG. 2A’ differs from the heart support system 100 of FIG. 2A in that the control system 112 does not include a vacuum branch (e.g., the vacuum solenoid 152, and the vacuum pump 154) connected to the solenoid 150.
  • control system 112 comprises the pressure branch
  • the solenoid 150 can be configured to open to the pressure branch so that an elevated pressure fluid in the pressure chamber 157 can flow into the inflation lumen 142 and thereby into the moveable member 148 (e.g., the interior of a balloon) causing the moveable member 148 to increase the volume that it occupies in the enclosure 144.
  • FIG. 2A’ illustrates the solenoid 150 connected to the pressure solenoid 156
  • the pressure solenoid 156 may not be required as there may not be a vacuum branch connected to the solenoid 150.
  • the blood can flow through the vascular span 120 in one direction into the ventricle.
  • the control system 112 can include the vacuum branch and blood can flow in two direction through the vascular span 120.
  • the heart support system 100 of FIG. 2A’ can include a second vascular span 120’ and a vacuum pump 154’.
  • the second vascular span 120’ can be connected at a proximal end to the enclosure 144.
  • a distal end 140’ of the second vascular span 120’ can be located within the patient’s heart (e.g., in the right atrium or right ventricle).
  • the vacuum pump 154’ can be coupled to the second vascular span 120’ between the proximal end and the distal end 140’.
  • the vacuum pump 154’ can be used to continuously pump blood out of the heart and into the enclosure 144 via the second vascular span 120’.
  • the second vascular span 120’ and the vacuum pump 154’ can function as a continuous flow system.
  • the vacuum pump 154’ can be a centrifugal pump that can be spun by a motor to generate the continuous flow rate of blood flow from the heart to the enclosure 144.
  • the control system 112 and the moveable member 148 in the enclosure 144 can be activated in a pulsatile manner to direct a flow of blood from the enclosure 144 and into the heart in a similar manner as described above with reference to FIG. 2A.
  • the vascular span 120 and the second vascular span 120’ are illustrated in FIG. 2A’ as being parallel and separate, in some implementations the vascular span 120 and the second vascular span 120’ may be at least partially integrated.
  • the vascular span 120 and the second vascular span 120’ could be two lumens in a multi-lumen vascular span, with second lumen 120’ including the vacuum pump 154’.
  • the second lumen 120’ may include a valve or solenoid to prevent the operation of the pumping system from flowing blow into the second vascular span 120’.
  • the heart support system 100 shown in FIG. 2A’ may provide certain benefit over the heart support system 100 shown in FIG. 2A.
  • the arrangement illustrated in FIG. 2A’ eliminates the need for the control system 112 to both pump blood out of the heart and into the heart, so the control system 112 can be optimized for pumping blood into the heart.
  • the vacuum pump 154’ can be driven by a motor, as opposed to pneumatic, which may reduce the noise produced by the heart support system 100 and/or may result in lower power consumption.
  • the heart support system 100 of FIG. 2A’ may be able to remove more blood from the cardiovascular system by using two vascular spans, 120, 120’ as opposed to one vascular span 120 to both pump blood into and out of the heart. As many heart failure patients have an excess of fluid volume, removing more blood from the patient cardiovascular system will appear to the heart as if the fluid load has been reduced. Further, the pulsatile nature of the pumping system in the heart support system 100 will maintain a more natural biological behavior of the heart and lungs which will be more likely to facilitate recovery.
  • the enclosure 144 can be configured to pump blood from the patient’s heart and into the enclosure 144 through both the vascular span 120 and the second vascular span 120’.
  • the enclosure 144 can include a moveable member 148A.
  • the moveable member 148A When the moveable member 148A is moved towards the inflation lumen 142 (e.g., when pressure is not being applied by the heart support system 100), the movement of the moveable member 148A can induce blood flow out of the heart, through the vascular span 120, and into the enclosure 144.
  • the blood flow from the heart to the enclosure 144 can flow through both the vascular span 120 and the second vascular span 120’, and blood flow from the enclosure 144 to the heart can flow through the vascular span 120.
  • the volume of blood flow from the heart to the enclosure 144 through the vascular span 120 can be less than the volume of blood flow to the enclosure 144 through the second vascular span 120’. In some implementations, the volume of blood flow from the heart to the enclosure 144 through the vascular span 120 can be greater than the volume of blood flow to the enclosure 144 through the second vascular span 120’. In some implementations, the volume of blood flow from the heart to the enclosure 144 can be approximately equally distributed between the vascular span 120 and second vascular span 120’.
  • FIG. 2A illustrates a balloon 154” that can be used in an implementation of the heart support system 100. For example, the balloon 154” can be used as an alternative to the vacuum pump 154’ in the second vascular span 120’.
  • the balloon 154” can be positioned in the second vascular span 120’ and can be configured to pump blood out of the heart and into the enclosure 144 via the second vascular span 120’.
  • the balloon 154” can be shaped as a spiral to enhance the flow of blood from the heart and into the enclosure 144.
  • the balloon 154” can be connected to a fluid source such that the balloon 154” can expand and contract.
  • the spiral-shaped balloon 154” can be expanded in a direction towards the enclosure 144 (e.g., from left to right as shown in FIG. 2A”) to create a positive displacement effect.
  • the spiral-shaped balloon 154” can push the fluid in the second vascular span 120’ from the heart and towards the enclosure 144.
  • Use of the balloon 154” can provide a benefit over other pumping systems because the balloon 154” can be more biocompatible than a pumping system.
  • the balloon 154” lacks blades as would be provided in an impeller based pump, reducing the risk of hemolysis.
  • the balloon 154” can generate less turbulence and provide less sheer stress and on the blood cells in the second vascular span 120’ compared to a pumping system, which could generate significant turbulence and shear forces due to the rapid movement of blades through the blood to induce flow of blood through the pumping system.
  • FIG. 4A provides a schematic illustration of the components of the control system 112 of the heart support system 100.
  • the operation of the heart support system 100 to support the heart is preferably in a co-pulsating manner, meaning that the blood flow out of the blood flow system 104 can be timed to coincide with the systolic phase of the heart. Blood can be expelled by the blood flow system 104 at the same time that the heart is pumping blood out of the right ventricle RV.
  • a heartbeat characterization system or subsystem may be configured to detect systole, diastole, R-wave peak, T-wave, dicrotic notch, or other heartbeat cycle characteristic.
  • a heartbeat cycle characterizer may include an ECG sensor and/or pressure sensor.
  • the control system 112 can have an input signal indicative of the current state of the heartbeat cycle.
  • the control system 112 can have an ECG input signal by which the control system 112 can determine when the heart is approaching, entering, or in systole.
  • a controller is provided to receive and process ECG signals generated by electrodes coupled with the patient. The controller is configured to generate control signals to system components that provide electrical control of certain components.
  • the controller can determine from the ECG input signal when the heart is approaching, entering, or in diastole. At that time, the controller can direct the solenoid 150 to open the inflation lumen 142 to the suction branch and to open the vacuum solenoid 152 to the vacuum pump 154. As a result, decreased or negative pressure can be provided in the inflation lumen 142 to cause the moveable member 148 to occupy less or a minimum amount of the space in the enclosure 144. This corresponds to the first phase of the heart support system 100 in which blood is withdrawn from the right ventricle (or potentially other heart chamber). The controller can determine from the ECG input signal when the heart is approaching, entering, or in systole.
  • the controller can direct the solenoid 150 to open the inflation lumen 142 to the pressure branch and to open the pressure solenoid 156 to the pressure chamber 157.
  • increased pressure can be provided in the inflation lumen 142 to cause the moveable member 148 to occupy more of all of the space inside the enclosure 144.
  • the blood pumped from the blood flow system 104 is added to other blood in the right ventricle and together these volumes flow across the pulmonary valve into the pulmonary artery.
  • the heart support system 100 can include a pressure sensor that can provide an indication of the pressure in the right atrium RA, right ventricle RV or both of these chambers, or of another location in the cardiovascular system (e.g., left atrium LA, left ventricle LV, or aorta).
  • a pressure sensor may include a fiber optic pressure sensor, instrumented pressure lumen, or other sensor arranged to measure pressure in an atrium, a ventricle, the aorta, the superior vena cava, and/or other appropriate location.
  • the pressure signals can be provided to the controller and can be analyzed by the controller to detect the on-set of diastole to cause the solenoid 150 to open to the vacuum branch to reduce or minimize the space occupying effect of the moveable member 148 within the enclosure 144 to withdraw blood from the ventricle.
  • the controller can analyze the pressure signal(s) to detect the on-set of systole to cause the solenoid 150 to open to the pressure branch to increase or maximize the space occupying effect of the moveable member 148 within the enclosure 144 to pump blood into the ventricle and thereby into the pulmonary artery.
  • Other indirect methods could be used to detect timing of diastole, systole or other heartbeat cycle information.
  • auscultation is used to provide a signal to the controller of the control system 112.
  • the control system 112 can operate any other apparatus to selectively create a vacuum or minimal pressure in the inflation lumen 142 to deflate or to move the moveable member 148 to enhance open volume in the enclosure 144 (e.g., to deflate the balloon or move the membrane to enhance the open volume in the enclosure) to cause blood to flow into the perforations 136 and the distal tip 140 and proximal in the vascular span 120 of the blood flow system 104.
  • This can remove a volume, e.g., 50 cc, of blood from the heart during diastole in the first phase of operation and is illustrated in FIG.2B.
  • the control system 112 employ any apparatus to pressurize the inflation lumen 142 causing the moveable member 148 to move to reduce or eliminate open volume in the enclosure 144 forcing blood to flow out of the enclosure 144 through the vascular span 120 and into the patient via the perforations 136 and the distal tip 140 and from there into the right ventricle outflow tract. This is described as the second phase of operation herein and is illustrated in FIG.2C.
  • the volume of the right atrium RA or the right ventricle RV can effectively be increased. This can compensate for stiff heart chamber walls that may prevent normal chamber filling.
  • FIG. 4B shows control components of the heart support system 100 in a schematic manner.
  • the source of control fluid can be placed in communication with the moveable member 148A within the enclosure 144 in a cyclical manner by use of the solenoid 150.
  • the solenoid 150 can be controlled by the controller 153 based on signals being received from one or more heartbeat cycle characterizers.
  • the heartbeat cycle characterizer is configured to receive the heartbeat cycle signal, to detect at least one of systole and diastole, and to output a signal to the processor indicating the detected at least one of systole and diastole.
  • the heartbeat cycle characterizer can include an ECG sensor configured to detect an ECG signal indicative of a phase of the heartbeat cycle.
  • the controller 153 can be further configured to controllably cause an increase of pressure in the enclosed chamber by opening the solenoid 150 when a peak, such as a minimum or maximum, e.g., an R-wave peak, in the ECG signal is detected.
  • the heartbeat cycle characterizer can include a blood pressure sensor configured to detect a blood pressure signal indicative of a phase of the heartbeat cycle.
  • a blood pressure sensor can be configured to detect a blood pressure signal indicative of a phase of the heartbeat cycle and the controller 153 can be further configured to controllably cause an increase of pressure in the enclosed chamber when the blood pressure signal indicates a rising pressure.
  • the controller 153 can be further configured to controllably cause an increase of pressure in the enclosed chamber when the R-wave peak in the ECG signal is detected and when the blood pressure signal indicates a rising pressure detected in the right ventricle.
  • the controller 153 can be further configured to controllably cause an increase of pressure in the enclosed chamber when the R-wave peak in the ECG signal is detected and when the blood pressure signal indicates a rising pressure detected in the right atrium or left atrium.
  • the controller 153 can be further configured to controllably cause an increase of pressure in the enclosed chamber when the R-wave peak in the ECG signal is detected and when the blood pressure signal indicates a rising pressure detected on the right side or left side of the heart.
  • the controller 153 is configured to delay increasing pressure in the enclosed chamber when a signal from an ECG sensor indicates the onset of systole but the processor detects unchanged or falling pressure from a signal of a pressure sensor.
  • the controller 153 is configured to delay increasing pressure in the enclosed chamber when a signal from an ECG sensor indicates the onset of systole but the processor detects unchanged or falling pressure from a signal of a pressure sensor sensing pressure in the right ventricle.
  • the controller 153 is configured to delay increasing pressure in the enclosed chamber when a signal from an ECG sensor indicates the onset of systole but the processor detects unchanged or falling pressure from a signal of a pressure sensor sensing pressure in the right atrium.
  • the controller 153 is configured to delay increasing pressure in the enclosed chamber when a signal from an ECG sensor indicates the onset of systole but the processor detects unchanged or falling pressure from a signal of a pressure sensor sensing pressure on the right side of the heart.
  • the conduit of the blood flow system 104 can comprise a wall surrounding a blood flow lumen therein.
  • a pressure sensor can be disposed within the wall peripherally of the blood flow lumen.
  • the blood pressure sensor can include an optical sensor disposed adjacent to a distal end of the blood flow system exposed to blood in a chamber of the heart.
  • the optical sensor can be exposed to blood in a right atrium of the heart.
  • the optical sensor can be exposed to blood in a right ventricle of the heart.
  • the foregoing can help patients with heart failure with reduced left and/or right side ejection fraction. In such patients the heart is suffering from systolic failure, for example, where the left ventricle or right ventricle has lost or is losing its ability to contract normally.
  • FIGS. 2A-2D illustrate a system in which the enclosure 144 is located outside the heart.
  • the enclosure 144 can be located outside the patient in an acute application.
  • the enclosure 144 can be supported at a bedside of the patient is not ambulatory.
  • the enclosure 144 can be configured to be carried by the patient in an ambulatory configuration.
  • the enclosure 144 can be configured to be implanted in a subcutaneous pocket, e.g., superficially near the clavicle where the access to the vasculature is via a subclavian or jugular vein in a longer term ambulatory application. In one approach, the enclosure 144 can be configured to be placed in a manner similar to placement of a pacemaker.
  • FIG. 5 shows how the heart support system 100 operates in relation to the heartbeat cycle for a right heart support configuration. While reference is provided with respect to a balloon moveable member, any other implementation of the heart support system 10 can be used in a similar manner, including such implementations that do not include balloons.
  • the top line shows an ECG signal from the heartbeat cycle. This trace reveals the timing of the operation of the heart valves.
  • the end of the T-wave corresponds to the opening of the mitral valve and left ventricular filling. Due to very short right-sided isovolumic relaxation time, the tricuspid valve opens slightly earlier than the mitral valve. Thus, right ventricle filling in diastole is slightly earlier than left ventricular filling in diastole.
  • the movement of the moveable member 148 to a low profile state (e.g., if the moveable member 148 is a balloon to a deflated state) in the first phase of operation will be timed to commence slightly before the end of the T wave.
  • the beginning of the first phase can start at about 95 percent of the width of the T wave, or about 90 percent of the width of the T wave, or about 85 percent of the width of the T wave, or about 80 percent of the width of the T wave, or about 75 percent of the width of the T wave, or about 70 percent of the width of the T wave, or after about 50 percent of the width of the T wave has occurred, or after a maximum magnitude of the T wave has been detected.
  • the moveable member 148 can remain low profile or in the first phase until the atrioventricular valves close, e.g., at the peak of the QRS complex. At the peak of the QRS complex (or other ECG feature corresponding to the onset of systole), the moveable member 148 can be actuated to a high profile state (e.g., if the moveable member 148 is a balloon, inflated), that is to the second phase.
  • FIG. 5 illustrates an ECG trace, as noted above the timing of the heart could be based on other signals such as pressure waves detected in or around the heart or even heart sounds (auscultation).
  • FIGS.6A-6C show another implementation of a heart support system 100A that is similar to the heart support system 100 except as described differently below.
  • the heart support system 100A includes a blood flow system 104A that comprises a catheter assembly.
  • the blood flow system 104A includes a vascular span 120 and a ventricular span 128 similar to those described above.
  • the blood flow system 104A is connected to the enclosure 144 proximal of the vascular span 120.
  • the blood flow system 104A is configured to withdraw from and deliver blood to a heart chamber, e.g., to the right ventricle as shown.
  • the blood flow system 104A includes a balloon catheter 108 that operates in a coordinated manner with the blood flow system 104 to reduce or eliminate backflow from the right ventricle RV to the right atrium RA during systole.
  • the vascular span 120 can extend partly through the balloon catheter 108 as discussed further below.
  • the balloon catheter 108 can assist in reducing or eliminating backflow of blood from within the blood flow system 104 into the right ventricle RV and into the right atrium RA during systole.
  • the actuation of the blood flow system 104 and the balloon catheter 108 as well as the coordination of these components can be provided by a control system 112A coupled with one or both of the blood flow system 104 and the balloon catheter 108.
  • the balloon catheter 108 can be provided to enhance the support capability of the blood flow system 104.
  • the balloon catheter 108 can include a catheter body 160 that can be delivered into the heart along the same access path as the vascular span 120 and the ventricular span 128 of the blood flow system 104.
  • a vascular portion of the catheter body 160 can be arranged coaxially with the vascular span 120 of the blood flow system 104.
  • An intra- cardiac portion of the catheter body 160 can disposed within the heart, e.g., spanning between the right atrium RA and the right ventricle RV.
  • the intra-cardiac portion can include a balloon, for example coaptation balloon 164.
  • the coaptation balloon 164 can include a distal portion that extends from a waist portion the coaptation balloon 164 toward a ventricular span of the catheter body 160 configured to reside in the right ventricle RV.
  • the waist portion can be a widest portion and/or a longitudinally central portion and the distal portion as described in that sentence can be the tapered outside surface against which FIGS.
  • the distal portion can taper distally from the waist portion to the ventricular span to position a sealing surface of the coaptation balloon 164 adjacent to native leaflets NL of the tricuspid (or, generally, an atrioventricular) valve.
  • the distal portion can allow for sealing of the native leaflet NL of the tricuspid valve to sealing surface of the coaptation balloon 164.
  • the coaptation balloon 164 can be shaped to enhance conforming of the leaflets to the distal portion, e.g., by having a shape that mirrors the line (or lines) of coaptation of a normal atrioventricular valve in a healthy heart.
  • the shape of the balloon can be based on the configuration of the valve.
  • the coaptation balloon 164 can be oval, round, dome-shaped, symmetrical, or asymmetrical.
  • the coaptation balloon 164 can be steerable in certain implementation, e.g., by providing one or more pull wires attached at distal ends adjacent to the coaptation balloon 164 and at proximal ends to one or more knobs accessible to the cardiologist at the proximal end of the catheter body 160. [0183] In the heart support system 100 of FIGS.
  • the leaflets of the tricuspid valve may simply coapt against the cannula, e.g., between the pre- formed bend 132 of the ventricular span 128 and the vascular span 120.
  • a non-inflatable structure such as a static widening can be provided that can occupy space between the cannula of the blood flow system 104 and the edges of the leaflets of the tricuspid, mitral valve or other heart valve, to reduce the incidence of backflow of blood proximally along the outside surface of the cannula.
  • coaptation balloon 164 or other occluding or semi-occluding feature may be configured for placement in or near a valve or ostium to reduce or prevent regurgitation.
  • the coaptation balloon 164 can be inflated by an inflation medium that can be delivered by a separate inflation source than is used to flow fluid into the enclosure 144.
  • control system 112A can include more than one pressure branches, e.g., one for actuating the moveable member 148 and one for inflating the coaptation balloon 164.
  • a separate inflation source is provided for inflating the coaptation balloon 164, the source can be a syringe pump, for example.
  • the coaptation balloon 164 can be in fluid communication with the blood flow lumen in the blood flow system 104 such that some of the blood delivered by the moveable member 148 can inflate the coaptation balloon 164.
  • the timing of inflating the balloon can be synchronized with the delivery of blood through the blood flow system 104, e.g., one to a few milliseconds prior to blood flowing out of the perforations 136 and the distal tip 140.
  • the coaptation balloon 164 can be inflated just prior to systole in some examples.
  • the coaptation balloon 164 can be expanded just prior to systole and can be deflated during at least a portion of diastole.
  • the coaptation balloon 164 can be moved cyclically to provide sealing function during systole and reduce or eliminate obstruction during diastole.
  • the coaptation balloon 164 could be moved distally just prior to systole to be in a position where the surfaces of the distal portion of the balloon engage the native leaflet NL to seal against or reduce backflow into the right atrium RA during systole.
  • the coaptation balloon 164 could be moved proximally just prior to or during diastole to be in a position where the balloon moved proximally relative to the valve annulus to allow enhanced flow between the native leaflet NL and the distal portion of the catheter body 160.
  • the balloon catheter 108 can be delivered in a same or similar manner as the blood flow system 104, e.g., from a femoral vein (or other peripheral vein) to the heart to span across the tricuspid valve.
  • the blood flow system 104 and the balloon catheter 108 can be delivered together as a unit in some techniques.
  • the balloon catheter 108 can be delivered over the blood flow system 104 in some techniques.
  • the blood flow system 104 can be advanced through the balloon catheter 108 after the balloon catheter 108 has been positioned in some techniques.
  • a lumen in the catheter body 160 can be coupled with a source of pressurized fluid.
  • the pressurized fluid source can be blood expelled from the enclosure 144 or can be an inflation media delivered by a syringe pump or other pump.
  • the heart support system 100A is then operated in a manner that does not impede filling of the right ventricle RV during diastole.
  • the native leaflets NL move away from the outside surface of the coaptation balloon 164 in diastole such that spaces are provided between the leaflets and the balloon.
  • the size of the spaces can be enhanced by cyclically deflating or reducing the pressure in the coaptation balloon 164.
  • the pressure of the inflation medium in the coaptation balloon 164 can be reduced.
  • the coaptation balloon 164 can be completely deflated at in some implementations by operating a vacuum branch, as discussed in connection with the moveable member 148 of the heart support system 100.
  • the coaptation balloon 164 can be moved proximally relative to the valve annulus to position a narrower part of the balloon or the ventricular span of the balloon catheter 108 in the valve annulus.
  • a combination of deflating and proximally moving can be used to present a slenderer structure in the vicinity of the native leaflets NL.
  • catheter body 160 may be used to for blood flow and coaptation balloon 164 may be controlled via dedicated balloon catheter 108 as discussed above.
  • a multi-lumen catheter may be used for providing blood flow, controlling a valve sealing member, and/or collecting pressure measurement(s).
  • a multi-lumen catheter 600 can be used to provide blood flow through blood lumen 616 terminated at a distal end 618.
  • Blood lumen 616 may be similar to catheter body 160 in some or all respects, and may include features such as aperture 400, flap 404, valve 408, porous section 412, ball 416, and/or backstop 420 as discussed herein.
  • multi-lumen catheter 600 may include a side lumen, for example balloon lumen 604, which can be used to control inflation of a coaptation balloon 164 as discussed above. Additional lumens, such as atrial pressure lumen 612 may be used to collect pressure measurements from an atrium, for example a right atrium as shown in FIG. 6D. Similarly, a ventricular pressure lumen 608 may be used to collect pressure measurements from a ventricle, for example a right ventricle as shown in FIG.6D. In some implementations, one or more side lumens may be located in a sidewall of a primary or central lumen, for example blood lumen 616.
  • Atrial pressure lumen 612 may be located on an outside of multi-lumen catheter 600 and may terminate in a distal end 614 at a location along the multi-lumen catheter 600 that is proximal to the coaptation balloon 164, and therefore proximal to the native leaflet NL in the atrium.
  • a ventricular pressure lumen 608 may be located on an outside of multi-lumen catheter 600 and may terminate in a distal end 610 at a location along the multi-lumen catheter 600 that is distal to the coaptation balloon 164, and therefore distal to the native leaflet NL in the ventricle.
  • distal end 610 of ventricular pressure lumen 608 and distal end 614 of atrial pressure lumen 612 may be located at or near distal end 618 of the multi-lumen catheter 600.
  • distal end 614 and distal end 618 are located as close as possible to coaptation balloon 164, which may minimize turbulence or motion related noise in a collected pressure measurement.
  • FIGS. 6E-1, 6E-2, and 6E-3 each illustrate a cross-section at line 6E-6E of various implementations of multi-lumen catheter 600. As shown in FIG.
  • a multi-lumen catheter 600A may include a blood lumen 616 and a balloon lumen 604, as well as ventricular pressure lumen 608 and atrial pressure lumen 612, similar to multi-lumen catheter 600 shown in FIG. 6D. Pressure lumens 608 and 612 may each include pressure sensors be used as instrumented pressure lumens, as discussed above.
  • a multi-lumen catheter 600B may include a blood lumen 616, a balloon lumen 604, and ventricular pressure lumen 608, as shown in FIG. 6E-2.
  • a multi-lumen catheter 600C may include a blood lumen 616, a balloon lumen 604, and atrial pressure lumen 612 as shown in FIG. 6E-3.
  • the balloon lumen 604, ventricular pressure lumen 608, and atrial pressure lumen 612 may be grouped on one side of blood lumen 616.
  • lumens 604, 608, 612 are distributed around blood lumen 616.
  • ventricular pressure lumen 608 and atrial pressure lumen 612 may be grouped together and kept separate from balloon lumen 604.
  • additional lumen may be used for steering mechanisms such as steering, puller, torque, or shape memory wires.
  • one or more side ports along multi-lumen catheter 600 may be used to collect pressure measurements, flow measurements, or other data at various locations along the multi-lumen catheter 600.
  • enclosure 144 and moveable member 148 can be configured one or more moveable members 148 within one or more enclosures 144.
  • a single enclosure 144 contains a single moveable member 148, which operates as discussed above with respect to FIGS. 2B and 2C.
  • multiple separate moveable members 148 can be housed within multiple enclosures 144. These arrangements can be used, for example, to provide controllability and/or redundancy.
  • multiple moveable members 148 may be selectively operated to provide a controllable volume of blood moved within the heart support system 100. For example, a first moveable member 148 may be activated just after installation of heart support system 100. If a patient’s cardiac output continues to decline over time, additional moveable member(s) 148 may be activated to increase the volume of blood moved by heart support system 100. Similarly, multiple moveable members 148 may be activated just after installation of heart support system 100.
  • one or more individual moveable members 148 may be deactivated to decrease the volume of blood moved by heart support system 100, gradually increasing the load on the heart.
  • a second moveable member 148 may be activated in place of a first movable member 148, for example in case of failure, leak, malfunction, etc., after a predetermined runtime or effective life of the first moveable member 148, and/or to alter the volume of blood moved by heart support system 100.
  • multiple moveable members may be used to increase safety by allowing each active moveable member to fully inflate and deflate, thereby improving washout and decreasing a risk of dead space, pooling, and/or thrombosis.
  • Multiple moveable members may also allow a large volume of blood to be moved at a lower overall velocity, which may reduce shear stress applied to the blood.
  • multiple moveable members 148 may be activated together if they are activated during the same suction and ejection phases. In some implementations, moveable members 148 are activated together by all activating essentially in parallel at the same time. In some implementations, moveable members 148 are activated together serially or in a coordinated order, for example from a most proximal moveable member 148 to a most distal moveable member 148. [0193] Each moveable member 148 may be activated and/or deactivated by valves, clamps, ligatures, cuffs, and the like.
  • a first moveable member 148 is deactivated at the same time a second moveable member 148 is activated.
  • paired valves or a diverter may be used to switch flow from a first moveable member 148 to a second moveable member 148.
  • an inactive moveable member 148 may be removed from the flow path of inflation lumen 142 as well as the flow path of blood flow system 104 to minimize backflow, dead space, and/or pressure changes in the conduits into and out of the inactive moveable member 148.
  • the multiple moveable members 148 may be generally identical and the multiple enclosures 144 may have similar conduit lengths to the inflation lumen 142 and blood flow system 104.
  • the multiple moveable members 148 may be generally identical and the multiple enclosures 144 may have varying conduit lengths to the inflation lumen 142 and blood flow system 104. As shown, this arrangement can be used to stagger the locations of the enclosures 144, and may create parallel nested enclosures 144. The arrangement may allow for a lower profile, which may be longer but shorter and thinner than a single enclosure 144.
  • a single moveable member 148 may be housed in a single enclosure 144 with a large round shape.
  • appropriate shapes for moveable member 148 and enclosure 144 can include spheres, ovals, eggs, and discs.
  • a single moveable member 148 may be housed in a single enclosure 144 with an elongate shape. This arrangement may also provide a lower profile with a shorter and thinner shape, while using a longer moveable member 148 to provide sufficient volume.
  • an intra-aortic balloon pump (IABP) balloon or similar device may be used or modified to provide appropriate connections to blood flow system 104 and inflation lumen 142.
  • the multiple movable members 148 may be separately housed in multiple enclosures 144.
  • multiple moveable members 148 may be housed in a single enclosure 144, which may optionally include inner walls or baffles to separate the moveable members 148.
  • the multiple moveable members 148 may be controlled by a single inflation lumen 142 and/or may feed a single blood flow system 104.
  • the single inflation lumen 142 and single blood flow system 104 may include valves, manifolds, or other structures to allow appropriate distribution of the pressurizing control fluid and blood. This arrangement can simplify tubing management for the patient and clinician.
  • the multiple moveable members 148 may be controlled by multiple individual inflation lumens 142 and/or may feed multiple branches of blood flow system 104. This arrangement can provide greater control of inflation of individual moveable members 148 and/or location of blood suction and ejection.
  • the blood flow passage may be disposed on a first lateral side of an enclosed chamber and the balloon may be configured to expand toward an interior surface of a second lateral side of the enclosed chamber opposite to the first lateral side prior to expanding toward the first lateral side of the enclosed chamber.
  • This arrangement may be useful for filling a proximal portion of the enclosure 144, away from the inlet, before filling a distal portion of the enclosure 144, thereby reducing obstruction of the inlet during filling.
  • moveable member 148 may arranged in enclosure 144 along an axis 700.
  • Inflation lumen 142 may also be arranged along axis 700, while blood flow system 104 may be arranged at an angle 704 as illustrated in FIG. 7E.
  • moveable member 148 may be configured for preferential flow.
  • moveable member 148 may have an asymmetric shape, port location, fixation location, material, thickness, compressibility, stiffness, or other property to direct blood flow.
  • moveable member 148 is configured to provide blood ejection and suction at a uniform rate of flow.
  • moveable member 148 is configured to provide complete blood ejection.
  • a distal end of moveable member 148 is free within enclosure 144, for example as illustrated in FIGS. 3D, 3E-1, 3E-2, etc.
  • a distal end 712 of moveable member 148 is fixed, as illustrated in FIG.7E, for example with a balloon support. Fixing a distal end 712, or other portion, of moveable member 148 to the enclosure 144 with a balloon support may help prevent moveable member 148 from touching the inner sidewall of enclosure 144, which may decrease thrombosis and improve blood flow 708 within enclosure 144. As illustrated in FIG.
  • a distal end 712A of a moveable member 148C may be fixed to enclosure 144C with a balloon support, for example with a grate 750.
  • grate 750 may include one or more openings 758 separated by one or more spokes 754.
  • a center hub or nose 762 may anchor spokes 754 and secure distal end 712A of moveable member 148C.
  • grate 750 allows blood flow 708A to pass through openings 758 and symmetrically around moveable member 148C that remains centered within enclosure 144C.
  • a grate 750A may be similar to grate 750 in some or all respects, and may include one or more spokes 754, one or more openings 758, and center nose 762 fixing both an inner end of each spoke 754 and a distal end 712A of moveable member 148.
  • Outer rim 766 may fix an outer end of each spoke 754 and enclosure 144 at a proximal end of blood flow system 104.
  • grate 750, 750A may include atraumatic shapes and materials.
  • spokes 754 may include bevels and/or tapers to improve blood flow during suction and ejection
  • center nose 762 may be shaped to direct blood flow 708A evenly toward the openings 758.
  • FIG. 8 illustrates a blood flow system 104A that is a variant of the blood flow system 104 for use in any of the heart support systems described herein (e.g., the heart support system 10, the heart support system 100).
  • the blood flow system 104A has a ventricular span 128 and also has a distal portion 130 that extends farther than the distal tip 140 in the blood flow system 104.
  • the distal portion 130 extends from the right ventricle RV into the pulmonary artery PA such that a distal tip 140A of the blood flow system 104A is on the opposite side of the pulmonary valve than is the pre-formed bend 132A.
  • the pre- formed bend 132A is shaped to hold the distal portion 130 and the distal tip 140A within the pulmonary valve throughout all heart cycles.
  • the blood flow system 104A would have an inflow aperture 139 to draw blood out of the heart in diastole, e.g., out of the right ventricle RV.
  • the inflow aperture 139 is disposed in the right atrium RA to draw blood from the right atrium during diastole.
  • the inflow aperture 139 is disposed in the vena cava to draw blood from the venous vasculature upstream of the heart during diastole.
  • more than one aperture can be provided in the blood flow system 104A to draw blood from within the right ventricle RV and from another point upstream thereof or from multiple points upstream of the right ventricle RV in diastole.
  • FIG. 8 shows the operation of the blood flow system 104A in systole where heart valves are open and blood flow is provided around the blood flow system 104A and through the lumen therein.
  • the blood flow system 104A has one or more anchor members (e.g., a balloon or expandable member, such as a stent body) in the pulmonary artery PA to work together with the pre-formed bend 132A to hold the distal portion 130 in the pulmonary artery PA during systole.
  • anchor members e.g., a balloon or expandable member, such as a stent body
  • FIG. 9 shows another implementation of a blood flow system 104B that is similar to the blood flow system 104A and the blood flow system 104 except as described differently below.
  • the blood flow system 104B includes a valve 139B that opens and closes access to an inflow aperture 139.
  • the inflow aperture 139 can be disposed in a short lumen branching off of the catheter body of the blood flow system 104B.
  • the short lumen can position and orient the inflow aperture 139 away from the tricuspid leaflets.
  • the valve 139B can have at least the two positions shown in FIG. 9.
  • a first position is one that covers the short lumen that branches off from the catheter body to prevent blood flow in this short lumen.
  • This position of the valve 139B is configured to direct blood flow from the enclosure 144 through the ventricular span 128 and the distal portion 130 and out of the distal tip 140A in the pulmonary artery PA.
  • a second position is across the main lumen in the blood flow system 104B such that suction generated by the deflation or movement of the moveable member 148 draws blood from the right atrium RA through the inflow aperture 139 and toward the enclosure 144 through the vascular span 120.
  • the valve 139B enables a higher percentage of the blood drawn from the heart to be sourced from an opening that is not in the pulmonary artery PA, e.g., not at the distal tip 140A.
  • a blood flow system 104C may additionally or alternatively include closing wires 139C and 139D.
  • blood flow system 104C may include branches disposed in or directed to the right atrium (RA) and pulmonary artery (PA).
  • the closing wires may be located at or near these branches of the blood flow system 104.
  • RA right atrium
  • PA pulmonary artery
  • a first closing wire 139C can be placed around a branch of the blood flow system 104 directed to or disposed in the right atrium.
  • a second closing wire 139D can be placed around a branch of the blood flow system 104 directed to or placed in the pulmonary artery.
  • the first closing wire 139C can be pulled to cinch or constrict the RA branch, as shown in FIG. 10B.
  • the RA branch of the blood flow system 104 closes to reduce or prevent ejection of blood into the RA and direct the blood into the PA branch.
  • blood in the PA branch may be delivered through the pulmonary valve or may be directed into or toward the right ventricular outflow tract.
  • second closing wire 139D can be pulled or cinched to constrict the PA branch, and the first closing wire 139C is released to open the RA branch. This arrangement, illustrated in FIG.
  • closing wires 139C and 139D have been discussed here as wires, other suitable materials may be used, for example sutures and threads of metal, polymer, or other biocompatible materials and/or coatings.
  • closing wires 139C and 139D can include a cuff, clamp, annular balloon or other constricting structure configured to controllably open and close around a branch of blood flow system 104.
  • FIG.11 illustrates a blood flow system 104D, which is similar to blood flow systems 104, 104A, 104B, and 104C described above.
  • FIGS. 11A, 11A-1 and 11A-2 illustrate details of area A in FIG. 11.
  • a proximal section of blood flow system 104D includes one or more distributed apertures 400, which may be similar to inflow aperture 139.
  • a leaf valve or flap 404 may be located inside the lumen of blood flow system 104D at each aperture 400.
  • FIG. 11A-1 shows operation of the flap 404 during diastole or the suction phase of heart support system 100.
  • FIG. 11A-2 illustrates operation of the flap 404 during systole or the ejection phase of heart support system 100. During this phase, pressure inside the lumen of blood flow system 104D increases past the pressure within the RA, pushing flap 404 outward and closing aperture 400. Closing all the apertures 400 with flaps 404 allows blood to travel past the RA and into the distal portions of blood flow system 104D (see FIG. 11). [0204] FIGS.
  • FIG. 11B-1 through 11B-4 illustrate features of the distal end 140D of blood flow system 104D shown within circle B of FIG.11. Distal end 140D may be similar to distal tip 140 in many respects, except as described below.
  • distal end 140D of blood flow system 104D may include a valve 408.
  • the valve 408 As shown in FIG. 11B-1, during systole or the ejection phase of heart support system 100, the valve 408 is open to allow blood to exit distal end 140D.
  • FIG. 11B-2 during diastole or the suction phase of heart support system 100, the valve 408 may be closed to prevent suction of blood from the PA.
  • valve 408 is a tilting disc valve configured to rotate on an axis through the diameter of a tubing of blood flow system 104D. Under high pressure, valve 408 rotates to align a disc with the direction of flow, opening valve 408 to allow ejection of blood (see FIG. 11B-1). When pressure in the lumen of blood flow system 104D is reduced during the suction phase, the disc rotates to occlude the lumen of blood flow system 104D (see FIG.11B-2). As illustrated in FIGS. 11B- 3 and 11B-4, in some implementations, valve 408 may be one or more leaflets, for example leaflets 408A and 408B.
  • valve 408A and 408B can be configured to open during the ejection phase (FIG. 11B-3) and close during the suction phase (FIG. 11B-4).
  • valve 408 may include three, four, or more leaflets configured to cooperate to open and close the lumen of blood flow system 104D.
  • FIGS. 11B-5 and 11B-6 illustrate additional optional features of a valve in a distal end 140E of blood flow system 104D, which may be similar to distal tip 140 and/or tip 140D in many respects.
  • distal end 140E may include a ball valve, including a ball 416, porous section 412, and backstop 420. As illustrated in FIG.
  • a ball 416 can be configured to move forward or distal during systole or the ejection phase, due to increased pressure and the resulting ejected blood flow.
  • the ball 416 moves distally past porous section 412, which allows blood to exit through porous section 412.
  • distal tip 140E may include a taper or stop to prevent ball 416 from exiting blood flow system 104D.
  • ball 416 can be configured to move backward or proximally during diastole or the suction phase, due to decreased pressure and the resulting suction.
  • FIG.12 shows that the heart support system 100 can be used to support both sides of the heart.
  • the heart support system 100 can be configured for right side support, and hence is labeled “RVAD” in the figure.
  • the heart support system 100 can be configured for left side support, and hence is labeled “LVAD” in the figure.
  • At least the vascular span 120 of blood flow system 104 is installed percutaneously.
  • the RVAD is shown in the illustrated approach as being delivered from the inferior vena cava, e.g., inserted at a femoral vein.
  • the RVAD may be installed via superior vena cava access, e.g., inserted at a jugular vein.
  • the LVAD is shown as being delivered through the right subclavian vein and superior vena cava.
  • the LVAD can be advanced through the intra-atrial septum so that the ventricular span 128 is disposed in the left ventricle while the vascular span 120 is disposed in the vena cava as shown.
  • a left portion of a biventricular assist device may be implanted trans-septally to the left side of the heart, e.g., transfemoral access through the inferior vena cava, then across the septum to the left atrium and left ventricle.
  • the depiction of the heart support system 100 as the RVAD is schematic. In actual practice the distal tip 140 would be adjacent to, aligned with or would extend across the pulmonary valve.
  • the heart support system 100 configured as the LVAD would be positioned within the left ventricle such that the distal tip 140 is in the left ventricular outflow tract or across the aortic valve.
  • FIG. 13A shows how the heart support system 100 operates in relation to the heartbeat cycle for a left heart support configuration.
  • the top line shows an ECG signal from the heartbeat cycle.
  • This trace reveals the timing of the operation of the heart valves.
  • the end of the T-wave corresponds to the opening of the mitral valve and left ventricular filling. Accordingly, the movement of the moveable member 148 to a low profile state (e.g., if the moveable member 148 is a balloon to a deflated state) in the first phase of operation will be timed to commence at the end of the T wave.
  • the end of the T wave can be calculated in any suitable manner.
  • the moveable member 148 can remain low profile or in the first phase until the mitral valve closes, e.g., at the peak of the QRS complex. At the peak of the QRS complex (or other ECG feature corresponding to the onset of systole), the moveable member 148 can be actuated to a high profile state (e.g., if the moveable member 148 is a balloon, inflated), that is to the second phase of operation.
  • FIG. 13B shows how the heart support system 100 operates in relation to the heartbeat cycle for a bi-ventricular heart support configuration. As in FIG. 13A, the top line shows an ECG signal from the heartbeat cycle. This trace reveals the timing of the operation of the heart valves.
  • FIGS.13A and 13B illustrates an ECG trace
  • the timing of the heart could be based on other signals such as pressure waves detected in or around the heart or even heart sounds (auscultation).
  • the left side timing is similar to or the same as in FIG. 5. That is, due to very short right-sided isovolumic relaxation time, the tricuspid valve opens slightly earlier than the mitral valve. Thus, right ventricle filling in diastole is slightly earlier than left ventricular filling in diastole.
  • the movement of the moveable member 148 of the right side heart support system 100 to a low profile state (e.g., if the moveable member 148 is a balloon to a deflated state) in the first phase of operation will be timed to commence slightly before the end of the T wave.
  • the beginning of the first phase can start at about 95 percent of the width of the T wave, or about 90 percent of the width of the T wave, or about 85 percent of the width of the T wave, or about 80 percent of the width of the T wave, or about 75 percent of the width of the T wave, or about 70 percent of the width of the T wave, or fatter about 50 percent of the width of the T wave has occurred, or after a maximum magnitude of the T wave has been detected.
  • the moveable member 148 of the right side heart support system 100 can remain low profile or in the first phase until the atrioventricular valves close, e.g., at the peak of the QRS complex.
  • the moveable member 148 of the right side heart support system 100 can be actuated to a high profile state (e.g., if the moveable member 148 is a balloon, inflated), that is to the second phase.
  • the left side heart support system 100 has timing similar to FIG. 13A.
  • the end of the T-wave corresponds to the opening of the mitral valve and left ventricular filling.
  • the end of the T-wave corresponds to the opening of the mitral valve and left ventricular filling. Accordingly, the movement of the moveable member 148 of the left side heart support system 100 to a low profile state (e.g., if the moveable member 148 is a balloon to a deflated state) in the first phase of operation will be timed to commence at the end of the T wave.
  • the end of the T wave can be calculated in any suitable manner.
  • the moveable member 148 of the left side heart support system 100 can remain low profile or in the first phase until the mitral valve closes, e.g., at the peak of the QRS complex.
  • FIG. 13B shows that a bi-ventricular support configuration employing a heart support system 100 for each side will result in slightly asynchronous operation of the moveable members 148 in the two system. This could be arranged by the controller of FIG.
  • FIG.13C illustrates four additional scenarios for controlling a heart support system 100.
  • the heart support system 100 can optionally assist opening the native valves.
  • FIG. 13C illustrates these four scenarios for a heart support system 100 such as the system illustrated in FIG.2A, configured to draw blood from the right ventricle during the first suction phase and to eject blood into the right ventricle during the second ejection phase.
  • Appropriate timing can be used to assist opening of one or both valves, as described below. Assisting valve closure may aid recovery of the heart.
  • pressure measurements and/or electrocardiogram (ECG) data may be used to control the timing.
  • a time derivative may be used. For example, a slope, slope change, or inflection point may be identified in the pressure, ECG, or both.
  • both pressure and ECG are used.
  • ECG data may be analyzed to identify the R- wave, and a positive slope of pressure may be used to verify cardiac action. If the R-wave is found with RV pressure rising, the heart support system 100 can be activated to eject blood.
  • the heart support system 100 may refrain from activation, or may not be fully activated. This confirmation helps avoid ejecting blood into a ventricle that is already full, or further stressing a contracting ventricle.
  • past time average cycle data may be used with ECG and/or pressure data to further refine timing of system activation.
  • the ejection phase of heart support system 100 configured to provide both suction from and ejection into a right ventricle, can be initiated, for example by inflating the moveable member 148, after the tricuspid valve has closed and immediately after the pulmonary valve opens, shown as point 1304 in FIG. 13C.
  • ejection can be initiated immediately after the tricuspid valve closes, shown as point 1304A.
  • the pressure differential created by the ejection phase may be sufficient to cause the pulmonary valve to open if the native valve has not opened naturally, or continue to open if in the process of opening.
  • the suction phase of heart support system 100 can be initiated, for example by deflating moveable member 148, after the pulmonary valve closes and immediately after the tricuspid valve opens, shown as point 1308 in FIG.13C.
  • the suction phase can be initiated when the pulmonary valve has closed but before the tricuspid valve has opened, shown as point 1308A.
  • the heart support system 100 can be configured to begin the ejection phase and the suction phase as appropriate. For example, in some implementations, ejection can begin after the tricuspid valve closes and after the PA valve opens at point 1304, and suction can begin after the pulmonary valve closes and the tricuspid valve opens at point 1308, with both phases waiting for the natural behavior of the native valves.
  • ejection can similarly begin after the tricuspid valve closes and after the PA valve opens at point 1304, and suction can begin earlier, after the pulmonary valve has closed but before the tricuspid valve has opened at point 1308A. Still alternatively, ejection can begin earlier, immediately after the tricuspid valve closes and before the pulmonary valve opens at point 1304A, and suction can be initiated after the pulmonary valve closes and the tricuspid valve opens at point 1308. Finally, ejection can begin immediately after the tricuspid valve closes and before the pulmonary valve opens at point 1304A, and suction can begin after the pulmonary valve has closed but before the tricuspid valve has opened at point 1308A.
  • heart support system 100 can be configured provide no valve assist, or assisted opening of the tricuspid valve, the pulmonary valve, or both.
  • the timing of the first suction phase and second ejection phase may be further adjusted, depending on which chamber is used for each phase.
  • the timing of the suction and ejection phases may be tuned to correctly cooperate with the heart’s natural contractions, with natural valve opening or closing times, and/or to provide valve assistance as discussed above.
  • the LV begins contraction slightly earlier than RV contraction.
  • the dicrotic notch may be identified for determining the timing as described above.
  • a right ventricle pressure measurement may not sufficiently detect a similar notch, because in many patients a right side notch may be small or non-existent.
  • the heart support system 100 is configured to eject blood into the right side of the heart while the pulmonary valve is open.
  • the heart support system 100 is configured to eject blood into the left side of the heart while the aortic valve is closed.
  • FIGS. 14-15 illustrates another approach in which an enclosure enclosing a moveable member (e.g., balloon) is located inside the heart.
  • the system is configured to place the enclosure in an atrium and to direct flow from the atrium to a ventricle.
  • the system of FIGS. 14-15 is configured for placement in the left atrium LA.
  • the system includes an enclosed made up of two portions – labeled half 1 and half 2. Although the two portions are labeled as a half, they the proportion of the assembly in the two portions can be other than one-half.
  • the first half is coupled with a patent foramen ovale (PFO) anchor.
  • the second half is coupled with a left atrial appendage (LAA) anchor.
  • PFO patent foramen ovale
  • LAA left atrial appendage
  • An outlet can be disposed at the joining location of the first half and the second half.
  • the outlet can direct blood toward or through the mitral valve.
  • the system can be operated though a cannula (e.g., of size 24 French) coupled with the right atrium side of the PFO anchor.
  • An inflation lumen can extend through the PFO anchor to be in fluid communication with an expandable member (e.g., an inflatable balloon or deflectable membrane) located within the first half, the second half, or both the first and second halves. Pressurizing the inflation lumen can cause the space in the two half enclosure to be reduced or eliminated forcing blood out of the outlet. Reducing the pressure or creating a vacuum in the inflation lumen can cause blood to flow into the two half enclosure.
  • the heart support system 100 and variants thereof preferably operate in a pulsatile manner.
  • One pulsatile operational mode is illustrated in FIG. 4A.
  • the foregoing can help patients with heart failure with reduced ejection fraction (HFrEf).
  • the heart is suffering from systolic failure.
  • the left ventricle has lost or is losing its ability to contract normally.
  • the system increases the fraction and the volume of blood delivered downstream.
  • HFpEF preserved ejection fraction
  • the heart is too stiff to fill properly.
  • a method of supporting pumping function of a heart in heart failure comprising: advancing a conduit percutaneously into a ventricle to provide a blood flow path from a chamber of the heart or a vascular segment upstream of a ventricular outflow tract to an enclosed chamber located outside of the ventricle; controllably inflating and deflating a balloon within the enclosed chamber, wherein deflation of the balloon draws blood from the chamber or vascular segment into the conduit and into the enclosed chamber during diastole, and inflation of the balloon moves blood from the enclosed chamber through the conduit toward or through the ventricular outflow tract during systole.
  • Clause 2 The method of Clause 1, wherein the conduit is positioned through an atrioventricular valve and comprises a distal end positioned in the ventricle. [0219] Clause 3. The method of Clause 1, wherein the conduit is located in a left ventricle. [0220] Clause 4. The method of Clause 1, wherein the conduit is located in a right ventricle. [0221] Clause 5. The method of Clause 1, wherein the enclosed chamber is implanted subcutaneously within a patient. [0222] Clause 6. The method of Clause 1, wherein the enclosed chamber is positioned outside of a patient. [0223] Clause 7.
  • Clause 9 further comprising analyzing a signal from an ECG sensor indicating the timing of one or more of diastole and systole.
  • Clause 11 The method of Clause 9, further comprising analyzing a signal from a pressure sensor in pressure communication with the chamber or vascular segment.
  • Clause 12 The method of Clause 9, wherein controllably inflating the balloon comprises inflating the balloon at or just prior to the onset of systole.
  • Clause 13 Clause 13.
  • the method of Clause 9, wherein controllably deflating the balloon comprises deflating the balloon at or just prior to the onset of diastole.
  • Clause 14 The method of Clause 9, wherein controllably deflating the balloon comprises deflating the balloon at or just prior to the onset of diastole.
  • a method of supporting pumping function of a heart comprising: directing blood from a chamber of the heart into a separate chamber in fluid communication with the chamber of the heart; controllably inflating and deflating a balloon within the separate chamber, wherein deflation of the balloon is timed to draw blood into the separate chamber from the chamber of the heart and inflation of the balloon is timed to eject blood from the separate chamber into back into a chamber of the heart or downstream.
  • Clause 15 The method of Clause 14, wherein the chamber is positioned outside of the heart and the blood is directed into the chamber via a conduit extending from chamber of the heart to the separate chamber.
  • Clause 15 wherein the conduit comprises a single lumen for drawing blood from the chamber of the heart into the separate chamber and for ejecting blood into the chamber of the heart or downstream.
  • Clause 17 The method of Clause 16, wherein the single lumen is contained within a cannula comprising solid wall structure perforated only by unobstructed openings both during drawing and ejecting.
  • Clause 18 The method of Clause 14, further comprising implanting the separate chamber within an atrium of the heart.
  • Clause 14 further comprising anchoring a first half of the chamber in a PFO, anchoring a second half of the chamber in a LAA, and coupling the first half to the second half prior to directing blood or controllably inflating and deflating.
  • An apparatus for supporting heart function comprising: a blood flow system comprising an elongate cannula having a proximal portion, a distal portion, and a blood flow lumen extending from a proximal end to a distal end, the distal portion comprising a ventricular span configured to be deployed in a ventricle and to position a distal tip in, adjacent to, or directed toward a ventricular outflow tract; an enclosure having a rigid interior wall enclosing a controllable volume configured to be in fluid communication with the blood flow lumen, the enclosed controllable volume having a first phase in which the volume is increased to induce a vacuum in the blood flow lumen and a second phase in which the volume is decreased to induce pressure in the blood flow lumen; and a control system configured to initiate the first phase at or just prior to the onset of diastole and to initiate the second phase at or just prior to the onset of systole.
  • Clause 21 The apparatus of Clause 20, further comprising a balloon catheter comprising a catheter body and a balloon configured to be placed in an atrioventricular valve, an external surface of the balloon configured to coapt with one or more native leaflets of the atrioventricular valve to reduce or prevent backflow through the atrioventricular valve when ventricle pressure of the ventricle in which the distal tip of the blood flow system is positioned exceeds atrial pressure on the opposite side of the atrioventricular valve.
  • Clause 22 The apparatus of Clause 21, wherein the blood flow system is configured to be slidably disposed within the balloon catheter.
  • Clause 21 The apparatus of Clause 21 or Clause 22, wherein the balloon catheter is coupled with the distal portion of the blood flow system.
  • Clause 24 The apparatus of any of Clause 21 – Clause 23, wherein the balloon is in fluid communication with a source of inflation media fluidly isolated from the blood flow lumen.
  • Clause 25 The apparatus of any of Clause 21 – Clause 23, wherein the balloon is in fluid communication with the blood flow lumen.
  • Clause 26 Clause 26.
  • a method of supporting pumping function of a patient's heart in heart failure comprising: advancing a conduit percutaneously into a ventricle to provide a blood flow path from the ventricle to an enclosed chamber located outside of the ventricle; and controllably inflating and deflating a balloon within the enclosed chamber, wherein deflation of the balloon draws blood from the ventricle into the conduit and into the enclosed chamber during diastole, and inflation of the balloon moves blood from the enclosed chamber through the conduit into the ventricle during systole.
  • Clause 27 The method of Clause 26, wherein the conduit is positioned through an atrio-ventricular valve and comprises a distal end positioned in the ventricle.
  • Clause 26 The method of Clause 26, wherein the conduit is positioned in a left ventricle.
  • Clause 29 The method of Clause 26, wherein the conduit is positioned in a right ventricle.
  • Clause 30 The method of Clause 26, wherein the enclosed chamber is implanted subcutaneously within a patient.
  • Clause 31 The method of Clause 26, wherein the enclosed chamber is positioned outside of a patient.
  • Clause 32 The method of Clause 26, wherein controllably inflating and deflating the balloon increases ventricular diastolic volume, increases ventricular ejection fraction, and/or reduces pulmonary capillary wedge pressure (PWCP).
  • PWCP pulmonary capillary wedge pressure
  • Clause 26 wherein the conduit comprises a single aperture through which blood is drawn into the conduit and through which blood is moved into the ventricle.
  • Clause 34 The method of Clause 26, wherein the conduit comprises an aperture disposed at a distal end of the conduit through which blood is drawn into the conduit and through which blood is moved into the ventricle.
  • Clause 35 The method of Clause 34, wherein the aperture disposed at the distal end of the conduit comprises a single aperture of the conduit at the distal end.
  • Clause 36 The method of Clause 34, wherein controllably inflating and deflating the balloon controls flow in the conduit without requiring any valves in the conduit.
  • Clause 37 Clause 37.
  • controllably inflating the balloon comprises directing a pressurized gas from a pressure chamber to an interior of the balloon.
  • controllably deflating the balloon comprises providing fluid communication between a vacuum source and an interior of the balloon.
  • Clause 39. The method of Clause 26, further comprising evacuating air from a portion of an interior of the enclosed chamber in fluid communication with the conduit.
  • Clause 40. The method of Clause 26, further comprising inserting the balloon into the enclosed chamber and detachably coupling the enclosed chamber with a source of pressurized fluid.
  • Clause 26 further comprising receiving an ECG signal indicative of a phase of a heartbeat cycle and controllably inflating and deflating the balloon based on the ECG signal.
  • Clause 42 The method of Clause 41, further comprising controllably inflating the balloon when an R-wave peak in the ECG signal is detected.
  • Clause 43 The method of Clause 41, further comprising receiving a blood pressure signal indicative of a phase of a heartbeat cycle and controllably inflating and deflating the balloon based on the pressure signal and the ECG signal.
  • Clause 44 Clause 44.
  • Clause 43 further comprising controllably inflating the balloon when an R-wave peak in the ECG signal is detected and when the blood pressure signal indicates a rising pressure.
  • Clause 45 The method of Clause 43, further comprising refraining from controllably inflating the balloon when an R-wave peak in the ECG signal is detected but the blood pressure signal indicates a constant or falling pressure.
  • Clause 46 The method of Clause 26, further comprising receiving a blood pressure signal indicative of a phase of a heartbeat cycle and controllably inflating and deflating the balloon based on the pressure signal.
  • Clause 47 The method of Clause 46, further comprising controllably inflating the balloon when the blood pressure signal indicates a rising pressure.
  • Clause 48 The method of Clause 46, further comprising refraining from controllably inflating the balloon when the blood pressure signal indicates a constant or falling pressure.
  • Clause 49 The method of Clause 46, wherein the blood pressure signal corresponds to central venous pressure.
  • Clause 50 The method of Clause 46, wherein receiving the blood pressure signal comprises detecting fluctuations in pressure in a column of fluid extending from a sensor located outside the cardiovascular system to a chamber of the heart.
  • Clause 51 The method of Clause 50, wherein the column of fluid extends through a peripheral lumen of the conduit that extends from the sensor located outside the cardiovascular system to an opening disposed in a right atrium of the heart.
  • Clause 52 Clause 52.
  • Clause 50 wherein the column of fluid extends through a peripheral lumen of the conduit that extends from the sensor located outside the cardiovascular system to an opening disposed in a right ventricle of the heart.
  • receiving the blood pressure signal comprises receiving a pressure signal from an optical sensor disposed adjacent to a distal end of the conduit exposed to blood in a chamber of the heart.
  • Clause 54 The method of Clause 53, wherein the optical sensor is exposed to blood in a right atrium of the heart.
  • Clause 55 The method of Clause 53, wherein the optical sensor is exposed to blood in a right ventricle of the heart.
  • Clause 26 further comprising inflating a coaptation balloon in the heart prior to or when the balloon is controllably inflated within the enclosed chamber to reduce backflow of blood that exits through the conduit into the ventricle.
  • Clause 57 The method of Clause 56, further comprising deflating the coaptation balloon in the heart prior to or when the balloon is controllably deflated within the enclosed chamber to reduce obstruction of flow from the atrium into the ventricle during diastole.
  • Clause 58 The method of Clause 26, further comprising activating a first balloon of a plurality of balloons prior to controllably inflating and deflating the balloon, each balloon of the plurality of balloons disposed in a corresponding enclosed chamber.
  • Clause 59 The method of Clause 58, further comprising activating a second balloon of the plurality of balloons after activating the first balloon and controllably inflating and deflating the second balloon within a second enclosed chamber.
  • Clause 60 The method of Clause 59, wherein activating the second balloon occurs while the first balloon continues to be controllably inflated and deflated such that a level of support provided to the patient is increased by combined flow caused the first balloon and the second balloon.
  • Clause 61 The method of Clause 59, further comprising deactivating the first balloon when the second balloon is activated.
  • Clause 62 The method of Clause 59, further comprising deactivating the first balloon when the second balloon is activated.
  • Clause 61 The method of Clause 61 wherein a level of support provided by the first balloon is thereafter provided by the second balloon.
  • Clause 63 The method of Clause 61 wherein a level of support provided by the first balloon is thereafter increased by the second balloon.
  • Clause 64 The method of Clause 61 wherein a level of support provided by the first balloon is thereafter decreased by the second balloon.
  • Clause 65 The method of Clause 26, wherein controllably inflating the balloon comprises causing blood to be expelled from interior portions of the enclosed chamber fluidly remote from the conduit prior to inflation of the balloon against an interior of the enclosure adjacent to the conduit or while preventing inflation of the balloon against an interior of the enclosure adjacent to the conduit.
  • Clause 66 The method of Clause 26 wherein controllably inflating the balloon comprises causing blood to be expelled from interior portions of the enclosed chamber fluidly remote from the conduit prior to inflation of the balloon against an interior of the enclosure adjacent to the conduit or while preventing inflation of the balloon against an interior of the enclosure adjacent to the conduit.
  • Clause 26 further compromising restraining an end of the balloon adjacent to the conduit to prevent expansion of the balloon from occluding flow into or out of the enclosed chamber.
  • Clause 67 The method of Clause 26, wherein controllably inflating the balloon comprises inflating the balloon after an antrio-ventricular valve adjacent to the ventricle closes and after a ventricular outflow valve adjacent to the ventricle opens.
  • Clause 68 The method of Clause 26, wherein controllably inflating the balloon comprises inflating the balloon after an antrio-ventricular valve adjacent to the ventricle closes and before a ventricular outflow valve adjacent to the ventricle opens.
  • Clause 69 Clause 69.
  • controllably deflating the balloon comprises deflating the balloon before an antrio-ventricular valve adjacent to the ventricle opens and after a ventricular outflow valve adjacent to the ventricle closes.
  • controllably deflating the balloon comprises deflating the balloon after an antrio-ventricular valve adjacent to the ventricle closes and after a ventricular outflow valve adjacent to the ventricle closes.
  • a method of supporting pumping function of a heart in heart failure comprising: directing blood from a chamber of the heart into a separate chamber in fluid communication with the chamber of the heart; and controllably inflating and deflating a balloon within the separate chamber, wherein deflation of the balloon is timed to draw blood into the separate chamber from the chamber of the heart and inflation of the balloon is timed to eject blood from the separate chamber back into the chamber of the heart or downstream of the chamber of the heart.
  • Clause 72 The method of Clause 71, further comprising advancing a conduit percutaneously through a blood vessel into the chamber of the heart while the separate chamber is located outside the heart.
  • a method of supporting pumping function of a heart in heart failure comprising: directing blood from a chamber of the heart into a separate chamber in fluid communication with the chamber of the heart; and controllably increasing and decreasing pressure within the separate chamber, wherein decreasing pressure is timed to draw blood into the separate chamber from the chamber of the heart and increasing pressure within the separate chamber is timed to eject blood from the separate chamber back into the chamber of the heart or downstream of the chamber of the heart.
  • Clause 74 The method of Clause 73, further comprising advancing a conduit percutaneously through a blood vessel into the chamber of the heart while the separate chamber is located outside the heart.
  • Clause 73 further comprising biasing a membrane within the separate chamber to an increased pressure position and actuating the membrane from the increased pressure position to a decreased pressure position.
  • Clause 76 The method of Clause 73, further comprising biasing a membrane within the separate chamber to a decreased pressure position and actuating the membrane from the decreased pressure position to an increased pressure position.
  • Clause 77 The method of Clause 73, wherein controllably increasing and decreasing pressure comprises rolling a roller downstream toward the heart and upstream away from the heart respectively.
  • Clause 78 Clause 78.
  • controllably increasing and decreasing pressure comprises advancing a piston of a syringe pump and retracting the piston of the syringe pump respectively.
  • controllably increasing and decreasing pressure comprises advancing a piston of a syringe pump and retracting the piston of the syringe pump respectively.
  • Clause 79. The method of Clause 74, wherein the separate chamber comprises an expandable member in fluid communication with the conduit on a first side and exposed to external pressure on a second side, and wherein controllably increasing and decreasing pressure comprises controllably increasing and decreasing pressure on the second side of the expandable member.
  • controllably increasing and decreasing pressure on the second side of the expandable member comprises moving a piston enclosing a fluid in fluid communication with the second side of the expandable member.
  • Clause 81 The method of Clause 79, further comprising inserting the expandable member into a pressure vessel containing a fluid applying the external pressure to the second side of the expandable member and, after a treatment is complete, removing the expandable member from the pressure vessel.
  • Clause 82 The method of Clause 81, wherein the pressure vessel comprises a flexible wall enclosing the fluid, the flexible wall providing a pressure communicating barrier between the fluid and the expandable member to contain the fluid when the expandable member is not disposed in the pressure vessel.
  • Clause 73 wherein the separate chamber is enclosed by a moveable wall and controllably increasing and decreasing pressure comprises moving the wall toward the heart to increase pressure and moving the wall away from the heart to decrease pressure.
  • Clause 84 The method of Clause 74, further comprising advancing the conduit into the right ventricle and through the pulmonary valve into the pulmonary artery and controllably increasing pressure within the separate chamber to eject blood from the separate chamber into the pulmonary artery.
  • the conduit comprises a first aperture in fluid communication with venous blood upstream of the right ventricle, a second aperture at an end of the conduit disposed in the pulmonary artery, and a valve configured to selectively place the first or the second aperture in fluid communication with the separate chamber, and the method further comprising: actuating the valve to put the first aperture in fluid communication with the separate chamber when controllably decreasing pressure to draw blood into the separate chamber from the right atrium and actuating the valve to put the second aperture in fluid communication with the separate chamber when controllably increasing pressure within the separate chamber to eject blood from the separate chamber back into the pulmonary artery.
  • actuating the valve comprises exposing a flap to a suction pressure within the conduit causing the flap to move away from a sealing position around the first aperture and exposing the flap to an enhanced pressure causing the flap to move toward a sealing position around the first aperture.
  • Clause 87 The method of Clause 85, wherein actuating the valve comprises cinching an exterior of a leg of the conduit extending to the first aperture or cinching an exterior of a leg of the conduit extending to the second aperture.
  • actuating the valve comprises, under enhanced pressure, pushing leaflets of a valve at the second aperture to an open position, the leaflets returning to a closed position when the enhanced pressure is removed.
  • Clause 89 The method of Clause 85, wherein actuating the valve comprises, under enhanced pressure, rolling a ball seal to an open position, the ball seal returning to a closed position when the enhanced pressure is removed.
  • Clause 90 The method of Clause 74, wherein the conduit is a single conduit.
  • Clause 91 The method of Clause 73, further comprising positioning the separate chamber within a chamber of the heart.
  • Clause 92 Clause 92.
  • Clause 91 wherein the separate chamber is positioned in an atrium of the heart.
  • Clause 93 The method of Clause 91, further comprising: anchoring a first half of the separate chamber in an opening in the intra-atrial septum, anchoring a second half of the chamber in a left atrial appendage, and coupling the first half to the second half prior to directing blood or controllably increasing or decreasing.
  • Clause 94 Clause 94.
  • a system for providing circulatory support of a heart comprising: a percutaneous conduit having a proximal end, a distal end, and a blood flow lumen disposed therethrough from the proximal end to the distal end; a pumping device comprising an enclosed chamber configured to be placed in fluid communication with the lumen of the conduit; and a controller comprising a processor, the processor configured to: cause a reduction of pressure in the enclosed chamber based on detection of diastole in a heartbeat cycle signal to draw blood through an opening at the distal end of the conduit, the distal end being disposed within a ventricle of the heart or through the ventricle to an artery downstream thereof; and cause an increase of pressure in the enclosed chamber based on detection of systole in the heartbeat cycle signal to move blood from within the enclosed chamber through the opening at the distal end of the conduit and into the ventricle of the heart or through the ventricle to an artery downstream thereof.
  • Clause 95 The system of Clause 94, wherein the pumping device further comprises a balloon disposed in the enclosed chamber, an interior of the balloon in fluid communication with a balloon lumen configured to be fluidly coupled with a fluctuating pressure source.
  • Clause 96 The system of any of Clause 94 or Clause 95, further comprising a heartbeat cycle characterizer configured to receive the heartbeat cycle signal, to detect at least one of systole and diastole, and to output a signal to the processor indicating the detected at least one of systole and diastole.
  • Clause 97 The system of Clause 96, wherein the heartbeat cycle characterizer comprises an ECG sensor.
  • Clause 98 The system of Clause 97, wherein the heartbeat cycle characterizer is configured to detect systole by detecting an R-wave peak in an ECG signal generated by the ECG sensor.
  • Clause 99 The system of any of Clauses 96-98, wherein the heartbeat cycle characterizer comprises a pressure sensor configured to detect pressure in an atrium upstream of the opening in the distal end of the conduit.
  • Clause 100 The system of Clause 99, wherein the heartbeat cycle characterizer is configured to confirm the detection of diastole by detecting a rising pressure from the pressure sensor before causing the increase of pressure in the enclosed chamber.
  • Clause 99 wherein the processor is configured to delay increasing pressure in the enclosed chamber when a signal from the ECG sensor indicates the onset of systole but the processor detects unchanged or falling pressure from a signal of the pressure sensor.
  • Clause 102 The system of any of Clauses 96-98, wherein the heartbeat cycle characterizer comprises a pressure sensor configured to detect pressure upstream of the ventricle in which the distal end of the conduit is disposed in use.
  • Clause 103 The system of Clause 102, wherein the pressure sensor is configured to detect central venous pressure.
  • Clause 102 wherein the pressure sensor is configured to detect pressure adjacent to an atrioventricular valve in an atrium on a same side of the heart as the ventricle through which the conduit is disposed in use.
  • Clause 105 The system of Clause 102, wherein the heartbeat cycle characterizer is configured to detect at least one of diastole or systole from a signal generated by the pressure sensor.
  • Clause 106 The system of any of Clauses 102-105, wherein the conduit comprises a wall surrounding the blood flow lumen and the pressure sensor is disposed within the wall peripherally of the blood flow lumen.
  • Clause 110 The system of any of Clauses 102-106, wherein the pressure sensor comprises a pressure lumen providing a column of fluid to a sensor disposed outside vasculature.
  • Clause 108 The system of any of Clauses 102-106, wherein the pressure sensor comprises an optical sensor and an optical fiber disposed within a wall peripherally of the blood flow lumen.
  • Clause 109 The system of any of Clauses 94-108, further comprising a coaptation balloon disposed around the conduit, the coaptation balloon configured to engage leaflets of an atrioventricular valve to reduce back flow of blood through the atrioventricular valve during systole.
  • Clause 110 Clause 110.
  • Clause 109 wherein the processor is configured to pressurize the coaptation balloon in coordination with causing an increase of pressure in the enclosed chamber in fluid communication with the blood flow lumen.
  • Clause 111 The system of any of Clauses 109-110, wherein the processor is configured to reduce pressure in the coaptation balloon in coordination with causing a reduction of pressure in the enclosed chamber in fluid communication with the blood flow lumen.
  • Clause 112. The system of any of Clauses 94-111, wherein the enclosed chamber comprises a first enclosed chamber and wherein the pumping device comprises a second enclosed chamber, the processor configured to selectively activate flow in the second enclosed chamber.
  • Clause 113 Clause 113.
  • Clause 112 wherein the processor is configured to activate flow in the second enclosed chamber upon a decline in performance of the first enclosed chamber.
  • Clause 114 The system of Clause 112, wherein the processor is configured to activate flow in the second enclosed chamber upon a patient need for a greater amount of support than can be provided by the first enclosed chamber.
  • Clause 115 The system of any of Clauses 94-114, wherein the processor is configured to cause an increase of pressure in the enclosed chamber after an antrio-ventricular valve opens and after a ventricular outflow valve adjacent to the ventricle opens, wherein the opening in the conduit is configured to be placed downstream of the antrio-ventricular valve and upstream of the ventricular outflow valve.
  • Clause 116 Clause 116.
  • Clause 117 The system of any of Clauses 94-114, wherein the processor is configured to cause a reduction in pressure in the enclosed chamber after an antrio-ventricular valve closes and before a ventricular outflow valve adjacent to the ventricle opens, wherein the opening in the conduit is configured to be placed downstream of the antrio-ventricular valve and upstream of the ventricular outflow valve.
  • Clause 118 The system of any of Clauses 94-114, wherein the processor is configured to cause a reduction in pressure in the enclosed chamber after an antrio-ventricular valve closes and after a ventricular outflow valve adjacent to the ventricle opens, wherein the opening in the conduit is configured to be placed downstream of the antrio-ventricular valve and upstream of the ventricular outflow valve.
  • Clause 119 The system of any of Clause 94 or Clauses 96-119, wherein the pumping device comprises a balloon disposed in the enclosed chamber, the balloon being configured to be fluidly coupled to at least one of a pressure chamber and a vacuum chamber.
  • Clause 119 wherein the enclosed chamber comprises a blood flow passage in fluid communication with the blood flow lumen of the conduit, the balloon being configured to inflate in a first phase of inflation toward and against a portion of an interior surface of the enclosed chamber away from the blood flow passage to reduce blocking of the blood flow passage during the first phase of inflation.
  • Clause 121 The system of Clause 120, wherein the blood flow passage is disposed in an upper portion of the enclosed chamber and the balloon is configured to expand toward an interior surface of a lower portion of the enclosed chamber prior to expanding toward the upper portion of the enclosed chamber and the blood flow passage.
  • the system of Clause 120 wherein the blood flow passage is disposed on a first lateral side of the enclosed chamber and the balloon is configured to expand toward an interior surface of a second lateral side of the enclosed chamber opposite to the first lateral side prior to expanding toward the first lateral side of the enclosed chamber.
  • Clause 123 The system of Clause 119, further comprising a balloon support disposed in the enclosed chamber comprising a central hub coupled with a free end of the balloon and at least one strut extending from the central hub to an interior wall of the enclosed chamber a blood flow passage defined between the interior wall of the enclosed chamber, the strut, and the hub.
  • Clause 125 The system of any of Clause 94 or Clauses 96-118, wherein the pumping device further comprises a membrane disposed in the enclosed chamber, the membrane being biased toward an increased pressure configuration, the processor configured to cause a reduction in pressure in the enclosed chamber by causing an action against the increased pressure bias and configured to cause an increase in pressure in the enclosed chamber by reducing the action against the increased pressure bias.
  • Clause 128 The system of Clause 127, wherein causing the increase and the decrease in pressure on the second side of the expandable member comprises moving a piston enclosing a fluid in fluid communication with the second side of the expandable member.
  • Clause 130 The system of Clause 129, wherein the pressure vessel further comprises a flexible wall enclosing the fluid, the flexible wall providing a pressure communicating barrier between the fluid and the second side of the expandable member to contain the fluid when the expandable member is not disposed through the opening.
  • Clause 131 Clause 131.
  • Clause 134 The system of Clause 94, wherein the enclosed chamber is enclosed by a moveable wall, the processor configured to cause a reduction of pressure in the enclosed chamber by moving the moveable wall toward the heart, the processor configured to cause an increase in pressure in the enclosed chamber by moving the wall away from the heart.
  • Clause 132 The system of any of Clauses 94-131, wherein the conduit is configured such that the opening at the distal end of the conduit can be advanced into a right atrium from a peripheral vascular location.
  • Clause 133 The system of any of Clauses 94-131, wherein the conduit is configured such that the opening at the distal end of the conduit can be advanced into a pulmonary artery from a peripheral vascular location.
  • Clause 135. The system of any of Clause 94 or Clauses 96-118, wherein the opening in the conduit comprises a first opening at an end of the conduit configured to be disposed in the pulmonary artery and further comprising a second opening configured to be disposed in fluid communication with venous blood upstream of the right ventricle and a valve configured to selectively place the first opening in fluid communication with the separate chamber to eject blood from the separate chamber into the pulmonary artery or to selectively place the second opening in fluid communication with the separate chamber to draw blood into the separate chamber from upstream of the right atrium.
  • Clause 136 Clause 136.
  • valve configured to be actuated by exposing a flap to a suction pressure within blood flow lumen of the conduit causing the flap to move away from a sealing position around the first aperture and to be actuated by exposing the flap to an enhanced pressure causing the flap to move toward a sealing position around the first aperture.
  • valve is configured to be actuated by cinching an exterior of a leg of the conduit extending to the first aperture or cinching an exterior of a leg of the conduit extending to the second aperture.
  • valve configured to be actuated under enhanced pressure by pushing leaflets of a valve at the first opening to an open position, the leaflets configured to return to a closed position when the enhanced pressure is removed.
  • valve is configured to be actuated under enhanced pressure by rolling a ball seal to an open position, the ball seal returning to a closed position when the enhanced pressure is removed.
  • a system for providing circulatory support to a heart comprising: a percutaneous conduit having a proximal end, a distal end, and a blood flow lumen disposed therethrough from the proximal end to the distal end; a pumping device comprising an enclosed chamber configured to be placed in fluid communication with the lumen of the conduit; a heartbeat cycle characterizer configured to detect a heartbeat cycle signal indicating an onset of at least one of systole in a heartbeat cycle and diastole in the heartbeat cycle; and a controller comprising a processor, the processor configured to: receive the heartbeat cycle signal; identify the onset of diastole; following the identification of the onset of diastole, cause a reduction of pressure in the enclosed chamber in fluid communication with the blood flow lumen to draw blood from an opening at the distal end of the conduit, the distal end being disposed within a ventricle of the heart; identify the onset of systole; and following the identification of the onset of s
  • Clause 141 The system of Clause 140, wherein the pumping device further comprises a balloon disposed in the enclosed chamber, an interior of the balloon in fluid communication with a balloon lumen configured to be fluidly coupled with a vacuum source and a pressure chamber, the controller operably coupled with the vacuum source and the pressure chamber to selectively couple the balloon lumen with the vacuum source and the pressure chamber.
  • Clause 142 The system of Clause 140, wherein the heartbeat cycle characterizer comprises an ECG sensor.
  • Clause 143 The system of Clause 142, wherein the processor is configured to identify the onset of systole by detecting an R-wave peak in an ECG signal generated by the ECG sensor.
  • the heartbeat cycle characterizer comprises a pressure sensor configured to detect pressure in an atrium on the same side of the heart as the ventricle.
  • Clause 145 The system of Clause 144, wherein the processor is configured to confirm the onset of diastole by detecting a rising pressure from the pressure sensor before causing the increase of pressure in the enclosed chamber.
  • Clause 146 The system of Clause 144, wherein the processor is configured to delay increasing pressure in the enclosed chamber when a signal from the ECG sensor indicates the onset of systole but the processor detects unchanged or falling pressure from a signal of the pressure sensor.
  • Clause 147 Clause 147.
  • the heartbeat cycle characterizer comprises a pressure sensor configured to detect pressure upstream of the ventricle in which the distal end of the conduit is disposed in use.
  • Clause 148 The system of Clause 147, wherein the pressure sensor is configured to detect central venous pressure.
  • Clause 149 The system of Clause 147, wherein the pressure sensor configured to detect pressure in an atrium on a same side of the heart as the ventricle within which the distal end is disposed in use.
  • Clause 147 wherein the processor is configured to at least one of identify the onset of diastole and identify the onset of systole from a signal generated by the pressure sensor.
  • Clause 151 The system of any of Clauses 144-150, wherein the conduit comprises a wall surrounding the blood flow lumen and the pressure sensor is disposed through the wall peripherally of the blood flow lumen.
  • Clause 152 The system of any of Clauses 140-150, wherein the pressure sensor comprises a pressure lumen providing a column of fluid to a pressure sensor disposed outside vasculature.
  • Clause 153 Clause 153.
  • Clause 154 The system of any of Clauses 140-153, further comprising a coaptation balloon disposed around the conduit, the coaptation balloon configured to engage leaflets of a heart valve between the ventricle and an atrium on the same side of the heart as the ventricle in which the distal end is disposed to reduce back flow of blood through the heart valve during systole.
  • Clause 155 Clause 155.
  • Clause 154 wherein the processor is configured to pressurize the coaptation balloon in coordination with causing an increase of pressure in the enclosed chamber in fluid communication with the blood flow lumen
  • Clause 156 The system of Clause 155, wherein the processor is configured to reduce pressure in the coaptation balloon in coordination with causing a reduction of pressure in the enclosed chamber in fluid communication with the blood flow lumen
  • Clause 157 The system of any of Clauses 140-156, wherein the enclosed chamber comprises a first enclosed chamber and wherein the pumping device comprises a second enclosed chamber, the processor configured to selectively activate flow in the second enclosed chamber.
  • Clause 157 The system of Clause 157, wherein the processor is configured to activate flow in the second enclosed chamber upon a decline in performance of the first enclosed chamber.
  • Clause 159 The system of Clause 157, wherein the processor is configured to activate flow in the second enclosed chamber upon a patient need for a greater amount of support than can be provided by the first enclosed chamber.
  • Clause 160 The system of any of Clauses 140-159, wherein the processor is configured to cause an increase of pressure in the enclosed chamber after an antrio- ventricular valve adjacent to the ventricle closes and after a ventricular outflow valve adjacent to the ventricle opens. [0377] Clause 161.
  • Clause 162 The system of any of Clauses 140-159, wherein the processor is configured to cause a reduction of pressure in the enclosed chamber before an antrio- ventricular valve adjacent to the ventricle closes and after a ventricular outflow valve adjacent to the ventricle opens.
  • Clause 164 The system of any of Clause 140 or Clauses 142-163, wherein the pumping device comprises a balloon disposed in the enclosed chamber, the balloon being configured to be fluidly coupled to at least one of a pressure chamber and a vacuum chamber.
  • Clause 164 wherein the enclosed chamber comprises a blood flow passage in fluid communication with the blood flow lumen of the conduit, the balloon being configured to inflate in a first phase of inflation toward and against a portion of an interior surface of the enclosed chamber away from the blood flow passage to reduce blocking of the blood flow passage during the first phase of inflation.
  • Clause 166 The system of Clause 165, wherein the blood flow passage is disposed in an upper half of the enclosed chamber and the balloon is configured to expand toward an interior surface of a lower half of the enclosed chamber prior to expanding toward the upper hand of the enclosed chamber and the blood flow passage.
  • Clause 167 Clause 167.
  • the system of Clause 165 wherein the blood flow passage is disposed on a first lateral side of the enclosed chamber and the balloon is configured to expand toward an interior surface of a second lateral side of the enclosed chamber opposite to the first lateral side prior to expanding toward the first lateral side of the enclosed chamber.
  • Clause 168 The system of Clause 164, further comprising a balloon support disposed in the enclosed chamber comprising a central hub coupled with a free end of the balloon and at least one strut extending from the central hub to an interior wall of the enclosed chamber a blood flow passage being defined between the interior wall of the enclosed chamber, the strut and the hub.
  • Clause 170 The system of any of Clause 140 or Clauses 142-163, wherein the pumping device further comprises a membrane disposed in the enclosed chamber, the membrane being biased toward an increased pressure configuration, the processor configured to cause a reduction in pressure in the enclosed chamber by acting against the increased pressure bias and configured to cause an increase in pressure in the enclosed chamber by reducing the action against the increased pressure bias.
  • Clause 173 The system of Clause 172, wherein increasing and decreasing pressure on the second side of the expandable member comprises moving a piston enclosing a fluid in fluid communication with the second side of the expandable member.
  • the system of Clause 172 further comprising a pressure vessel containing a fluid and an opening through which the expandable member can be inserted to expose the second side to external pressure.
  • Clause 175. The system of Clause 174, wherein the pressure vessel further comprises a flexible wall enclosing the fluid, the flexible wall providing a pressure communicating barrier between the fluid and the second side of the expandable member to contain the fluid when the expandable member is not disposed through the opening.
  • Clauses 140-175 wherein the enclosed chamber is enclosed by a moveable wall, the processor configured to cause a reduction of pressure in the enclosed chamber by moving the moveable wall toward the heart, the processor configured to cause an increase in pressure in the enclosed chamber by moving the wall away from the heart.
  • Clause 177 The system of any of Clauses 140-176, wherein the conduit is configured such that the opening at the distal end of the conduit can be to be advanced into a right atrium from a peripheral vascular location.
  • Clause 178 The system of any of Clauses 140-176, wherein the conduit is configured such that the opening at the distal end of the conduit can be to be advanced into a pulmonary artery from a peripheral vascular location.
  • Clause 179 The system of any of Clauses 140-178, wherein the conduit is a single conduit
  • Clause 180 The system of any of Clauses 140-179, wherein the opening in the conduit comprises a first opening at an end of the conduit configured to be disposed in the pulmonary artery and a second opening configured to be disposed in fluid communication with venous blood upstream of the right ventricle, and a valve configured to selectively place the first opening in fluid communication with the separate chamber to eject blood from the separate chamber back into the pulmonary artery or to selectively place the second opening in fluid communication with the separate chamber to draw blood into the separate chamber from upstream of the right atrium.
  • valve configured to be actuated by exposing a flap to a suction pressure within the conduit causing the flap to move away from a sealing position around the first aperture and to be actuated by exposing the flap to an enhanced pressure causing the flap to move toward a sealing position around the first aperture.
  • valve is configured to be actuated by cinching an exterior of a leg of the conduit extending to the first aperture or cinching an exterior of a leg of the conduit extending to the second aperture.
  • valve configured to be actuated by, under enhanced pressure, pushing leaflets of a valve at the second opening to an open position, the leaflets configured to return to a closed position when the enhanced pressure is removed.
  • valve is configured to be actuated by, under enhanced pressure, rolling a ball seal to an open position, the ball seal returning to a closed position when the enhanced pressure is removed.
  • pumping device further comprises a roller and the processor is configured to advance the toward the heart to cause and away from the heart respectively.
  • Clause 187 The system of Clause 140, wherein the pumping device further comprises a syringe pump and the reduction of pressure is caused by retracting a piston of the syringe pump and the increase of pressure is caused by advancing the piston of the syringe pump.
  • Clause 187 The system of Clause 140, wherein the enclosed chamber is configured for placement within a chamber of the heart.
  • Clause 188 The system of clause 187, wherein the enclosed chamber is configured for placement in an atrium of the heart.
  • Clause 189 Clause 189.
  • Clause 190 The system of Clause 187, wherein the enclosed chamber comprises a first half configured to be anchored in an opening in the intra-atrial septum and a second half configured to be anchored in a left atrial appendage, wherein the first half is configured to be coupled to the second half prior to the controller causing a reduction or increase of pressure.
  • a method of supporting pumping function of a patient's heart in heart failure comprising: advancing a conduit percutaneously into a ventricle to provide a blood flow path from the ventricle to an enclosed chamber located outside of the ventricle; and controllably moving a moveable member within the enclosed chamber from a first position corresponding to a reduced pressure for drawing blood from the ventricle into the conduit and into the enclosed chamber during diastole to a second position corresponding to an elevated pressure for moving blood from the enclosed chamber through the conduit into the ventricle during systole; wherein the moveable member is biased toward the first position when not being controllably moved.
  • Clause 190 wherein advancing the conduit comprises positioning the conduit in a right ventricle.
  • Clause 192 The method of Clause 190, wherein the conduit comprises a single aperture through which blood is drawn into the conduit and through which blood is moved into the ventricle.
  • Clause 193 The method of Clause 190, wherein the enclosed chamber is positioned outside of the patient.
  • Clause 194 The method of Clause 190, wherein controllably moving the moveable member comprises directing a pressurized gas from a pressure chamber to a side of the moveable member opposite a blood containing volume of the enclosed chamber.
  • controllably moving the moveable member comprises admitting pressurized gas into the enclosed chamber on a side of the moveable member fluidly isolated from the conduit.
  • Clause 196 The method of Clause 190, further comprising connecting a plug of a control fluid assembly to a source of pressurized gas.
  • Clause 197 The method of Clause 196, wherein connecting the plug comprises inserting the plug into a socket of a wall source of gas.
  • Clause 198. The method of Clause 196, wherein connecting the plug comprises inserting the plug into a socket of a portable pressure chamber configured to be carried by the patient.
  • a system for providing circulatory support to a heart of a patient comprising: a percutaneous conduit having a proximal end, a distal end, and a blood flow lumen disposed therethrough from the proximal end to the distal end, the distal end configured to be disposed within a ventricle of the heart or through the ventricle to an artery downstream thereof; an extracorporeal pumping device comprising an enclosed chamber configured to be placed in fluid communication with the blood flow lumen of the conduit and configured to pump blood from outside the patient through the percutaneous conduit; a controller comprising a processor, the processor configured to: move a moveable member toward a first position to cause a reduction of pressure in the enclosed chamber based on detection of diastole in a heartbeat cycle signal to draw blood through an opening at the distal end of the conduit; and move the moveable member toward a second position to cause an increase of pressure in the enclosed chamber based on detection of systole in the heartbeat cycle signal to move blood from within the enclosed chamber through the opening
  • Clause 200 The system of Clause 199, further comprising a heartbeat cycle characterizer configured to receive the heartbeat cycle signal, to detect at least one of systole and diastole, and to output a signal to the processor indicating the detected at least one of systole and diastole.
  • Clause 201 The system of Clause 199 or 200, wherein the processor is configured to delay increasing pressure in the enclosed chamber when a signal from an ECG sensor indicates the onset of systole but the processor detects unchanged or falling pressure from a signal of a pressure sensor.
  • Clause 202 Clause 202.
  • Clause 201 wherein the conduit comprises a wall surrounding the blood flow lumen and the pressure sensor is disposed within the wall peripherally of the blood flow lumen.
  • Clause 203 The system of any of Clauses 199-202, further comprising a wall source of gas compromising a socket configured to engage the plug.
  • Clause 204 The system of any of Clauses 199-202, further comprising a portable pressure chamber configured to be carried by the patient having a socket configured to engage the plug.
  • Clause 205 Clause 205.
  • a system for providing circulatory support to a heart comprising: a conduit having a proximal end, a distal end, and a blood flow lumen disposed therethrough from the proximal end to the distal end, the distal end configured to be disposed within a ventricle of the heart or through the ventricle to an artery downstream thereof; a pumping device comprising an enclosed chamber configured to be placed in fluid communication with the blood flow lumen of the conduit; a controller comprising a processor, the processor configured to: cause a reduction of pressure in the enclosed chamber based on detection of diastole in a heartbeat cycle signal to draw blood through an opening at the distal end of the conduit; cause an increase of pressure in the enclosed chamber by driving the moveable member away from the decreased pressure state based on detection of systole in the heartbeat cycle signal to move blood from within the enclosed chamber through the opening at the distal end of the conduit and into the ventricle of the heart or through the ventricle to an artery downstream thereof; and cause a reduction
  • Clause 206 The system of Clause 205, wherein the heartbeat cycle characterizer comprises an ECG sensor configured to detect an ECG signal indicative of a phase of the heartbeat cycle.
  • Clause 207 The system of Clause 206, wherein the controller is further configured to cause an increase of pressure in the enclosed chamber when or after an R-wave peak in the ECG signal is detected.
  • Clause 208 The system of Clause 205-207, further comprising a blood pressure sensor configured to detect a blood pressure signal indicative of a phase of the heartbeat cycle, and wherein the controller is further configured to cause an increase of pressure in the enclosed chamber when or after an R-wave peak is detected and when the blood pressure signal indicates a rising pressure.
  • Clause 209 The system of Clause 205-207, further comprising a blood pressure sensor configured to detect a blood pressure signal indicative of a phase of the heartbeat cycle, and wherein the controller is further configured to cause an increase of pressure in the enclosed chamber when or after an R-wave peak is detected and when the blood pressure signal indicates a rising pressure.
  • the heartbeat cycle characterizer comprises a blood pressure sensor configured to detect a blood pressure signal indicative of a phase of the heartbeat cycle and wherein the controller is further configured to cause an increase of pressure in the enclosed chamber when the blood pressure signal indicates a rising pressure.
  • the blood pressure sensor comprises an optical sensor disposed adjacent to a distal end of the conduit exposed to blood in a chamber of the heart.
  • Clause 211 The system of Clause 209 or 210, wherein the pressure sensor is configured to be exposed to blood in a right atrium of the heart.
  • Clause 212 Clause 212.
  • Clause 21 The system of Clause 209 or 210, wherein the pressure sensor is configured to be exposed to blood in a right ventricle of the heart.
  • Clause 213. The system of any of Clauses 205-212, further comprising a control fluid assembly comprising a first connector and a wall source of gas comprising a second connector configured to engage the first connector.
  • Clause 214. The system of any of Clauses 205-212, further comprising a control fluid assembly comprising a first connector and a portable pressure chamber comprising a second connector configured to engage the first connector.
  • a method of supporting pumping function of a patient's heart in heart failure comprising: advancing a conduit percutaneously into a ventricle to provide a blood flow path from the ventricle to an enclosed chamber located outside of the ventricle; and coupling a source of pressurized control fluid to a control lumen configured to be placed in pressure communication with a moveable member within the enclosed chamber; controllably increasing and decreasing pressure in the enclosed chamber, wherein decreasing pressure in the enclosed chamber draws blood from the ventricle into the conduit and into the enclosed chamber during diastole, and increasing pressure in the enclosed chamber moves blood from the enclosed chamber through the conduit into the ventricle during systole, and wherein controllably increasing and decreasing pressure in the enclosed chamber comprises placing the moveable member in pressure communication with the pressurized control fluid through the control lumen while cycling pressure in the pressure fluid to move the moveable member, moving the moveable member causing storing of strain energy in a biasing member coupled with the moveable member.
  • Clause 216 The method of Clause 215, further comprising receiving an ECG signal indicative of a phase of a heartbeat cycle and controllably increasing and decreasing pressure in the enclosed chamber based on the ECG signal.
  • Clause 217 The method of Clause 216, further comprising controllably increasing pressure in the enclosed chamber when an R-wave peak in the ECG signal is detected.
  • Clause 218 The method of Clause 217, further comprising receiving a blood pressure signal indicative of a phase of a heartbeat cycle and controllably increasing and decreasing pressure in the enclosed chamber based on the pressure signal and the ECG signal.
  • Clause 218 further comprising controllably increasing the pressure when an R-wave peak in the ECG signal is detected and when the blood pressure signal indicates a rising pressure.
  • Clause 220 The method of Clause 218, further comprising refraining from controllably increasing the pressure when an R-wave peak in the ECG signal is detected but the blood pressure signal indicates a constant or falling pressure.
  • Clause 221. The method of Clause 215, further comprising receiving a blood pressure signal indicative of a phase of the heartbeat cycle and controllably increasing and decreasing pressure in the enclosed chamber based on the pressure signal.
  • Clause 222 Clause 222.
  • coupling the source of pressurized control fluid to the control lumen comprises connecting a first connector coupled with the control lumen with a second connector of a wall source of gas.
  • coupling the source of pressurized control fluid to the control lumen comprises connecting a first connector coupled with the control lumen with a second connector of a portable pressure chamber configured to be carried by the patient.
  • Clause 224 comprises connecting a first connector coupled with the control lumen with a second connector of a portable pressure chamber configured to be carried by the patient.
  • a system for providing circulatory support to a heart comprising: a conduit having a proximal end, a distal end, and a blood flow lumen disposed therethrough from the proximal end to the distal end, the distal end configured to be disposed within a ventricle of the heart or through the ventricle to an artery downstream thereof; a pumping device comprising an enclosed chamber configured to be placed in communication with the blood flow lumen of the conduit; a controller comprising a processor, the processor configured to: cause an increase of pressure in the enclosed chamber by driving a moveable member in a first direction based on detection of systole in a heartbeat cycle signal to move blood away from the enclosed chamber through an opening at the distal end of the conduit and into the ventricle of the heart or through the ventricle to an artery downstream thereof; and cause a reduction in pressure in the enclosed chamber following causing the increase of pressure in the enclosed chamber to draw blood through the opening at the distal end of the conduit by allowing biasing of the moveable member to
  • Clause 225 The system of Clause 224, wherein the moveable member comprises a piston head coupled to a piston shaft, the piston head positioned within the enclosed chamber and dividing the enclosed chamber into a first chamber and a second chamber, the piston shaft extending through the enclosed chamber.
  • Clause 226 The system of Clause 225, further comprising a control fluid assembly comprising a pressure chamber and a first valve, the pressure chamber connected to the second chamber via the first valve, wherein the pressure chamber is configured to deliver a pressurized gas to the second chamber, wherein delivery of the pressurized gas causes the moveable member to move in the first direction.
  • Clause 227 Clause 227.
  • Clause 226 or Clause 227 wherein the first chamber is configured to receive blood from the blood flow lumen.
  • Clause 228 The system of Clause 226 or Clause 227, further comprising a membrane positioned between the proximal end of the conduit and the enclosed chamber, the first chamber storing a control fluid.
  • Clause 229. The system of any of Clauses 226-228, wherein the first valve is configured to selectively vent the second chamber.
  • Clause 230 The system of any of Clauses 224-229, further comprising a stoppage system configured to limit movement of the moveable member in the second direction. [0447] Clause 231.
  • Clause 230 wherein the stoppage system is rotatable, wherein rotation of the stoppage system changes a maximum distance between the moveable member and the stoppage system and a maximum volume of the first chamber.
  • Clause 232 The system of Clause 230, wherein the stoppage system comprises a linear actuator comprising a stoppage member and a motor, wherein the motor is configured to move the stoppage member to change a maximum distance between the moveable member and the stoppage member and a maximum volume of the first chamber.
  • the stoppage system comprises a solenoid actuator comprising a stoppage member, a magnetic rod, and a coil
  • the controller is configured to apply a current to the coil to move the magnetic rod and the stoppage member in the first direction to reduce a maximum distance between the moveable member and the stoppage member and a maximum volume of the first chamber.
  • the piston shaft comprises a first shaft member and a second shaft member, wherein the first shaft member is coupled to the second shaft member via an internally threaded joint, wherein a length of the piston shaft can be adjusted by moving the second shaft member relative to the internally threaded joint.
  • Clause 236 The system of Clause 235, wherein the spring is positioned between the enclosed chamber and a spring stopper coupled to the piston shaft.
  • Clause 237 The system of Clause 236, wherein the spring stopper is moveable along a length of the piston shaft, the spring stopper's position on the piston shaft changing a preload on the spring.
  • a method of supporting pumping function of a patient's heart in heart failure comprising: advancing a conduit percutaneously into a ventricle to provide a blood flow path from the ventricle to an enclosed chamber located outside of the ventricle; filling the enclosed chamber using a continuous flow element; and controllably inflating and deflating a balloon within the enclosed chamber, wherein inflating the balloon moves blood from the enclosed chamber through the conduit into the ventricle during systole.
  • a method of supporting pumping function of a patient's heart in heart failure comprising: advancing a conduit percutaneously into a ventricle to provide a blood flow path from the ventricle to an enclosed chamber located outside of the ventricle; filling the enclosed chamber using a continuous flow element; and varying a volume of the enclosed chamber to move blood from the enclosed chamber through the conduit into the ventricle during systole.
  • a method of supporting pumping function of a patient's heart in heart failure comprising: advancing a conduit percutaneously into a ventricle to provide an open/unobstructed blood flow path from the ventricle to an enclosed chamber located outside of the ventricle; filling the enclosed chamber using a continuous flow element; and pumping blood from the enclosed chamber through the open/unobstructed blood flow path of the conduit into the ventricle during systole.
  • Clause 242 The method of Clause 241, wherein blood flows from the ventricle to the enclosed chamber through both the conduit and the second conduit, wherein blood flows from the enclosed chamber to the ventricle only through the conduit.
  • Clause 243 The method of Clause 241 or Clause 242, wherein the conduit comprises a first lumen of a dual lumen catheter and the second conduit comprises a second lumen of the dual lumen catheter.
  • Clause 244 The method of any of Clauses 241 to 243, wherein the proximal end of the second conduit comprises a valve, the valve configured to allow blood to flow from the second conduit into the enclosed chamber, the valve configured to restrict blow flow from the enclosed chamber into the second conduit. [0461] Clause 245.
  • a system for providing circulatory support to a heart comprising: a first conduit having a first proximal end, a first distal end, and a first blood flow lumen disposed therethrough from the first proximal end to the first distal end, the first distal end configured to be disposed within a ventricle of the heart or through the ventricle to an artery downstream thereof; a second conduit having a second proximal end, a second distal end, and a second blood flow lumen disposed therethrough from the second proximal end to the second distal end, the second distal end configured to be disposed within the ventricle or through the ventricle to an artery downstream thereof; an enclosed chamber configured to be placed in fluid communication with the first blood flow lumen of the first conduit and the second blood flow lumen of the second conduit; a pumping device coupled to the second conduit, the pumping device configured to continuously move blood from the ventricle into the enclosed chamber through the second blood flow lumen of the second conduit; and a controller comprising a processor,
  • Clause 246 The system of Clause 245, wherein the moveable member is biased to the decreased pressure state.
  • Clause 247 The system of Clause 245 or Clause 246, wherein the processor is further configured to: cause a reduction in pressure in the enclosed chamber following causing the increase of pressure in the enclosed chamber by allowing the biasing of the moveable member to move the moveable member to the decreased pressure state within the enclosed chamber.
  • Clause 248 Clause 248.
  • a system for providing circulatory support to a heart of a patient comprising: a percutaneous conduit having a proximal end, a distal end, and a blood flow lumen disposed therethrough from the proximal end to the distal end; an extracorporeal pumping device comprising an enclosed chamber configured to be placed in fluid communication with the blood flow lumen of the percutaneous conduit and configured to pump blood from outside the patient through the percutaneous conduit; and a controller comprising a processor, the processor configured to: cause a reduction of pressure in the enclosed chamber based on detection of diastole in a heartbeat cycle signal to draw blood through an opening at the distal end of the percutaneous conduit, the distal end configured to be disposed within a ventricle of the heart or through the ventricle to an artery downstream thereof; and cause an increase of pressure in the enclosed chamber based on detection of systole in the heartbeat cycle signal to move blood from within the enclosed chamber through the opening at the distal end of the percutaneous conduit and into the ventricle of the
  • Clause 252 The system of clause 251, further comprising a heartbeat cycle characterizer configured to receive the heartbeat cycle signal, to detect at least one of systole and diastole, and to output a signal to the processor indicating the detected at least one of systole and diastole.
  • Clause 253 The system of clause 251 or clause 252, wherein the processor is configured to delay increasing pressure in the enclosed chamber when a signal from an ECG sensor indicates the onset of systole but the processor detects unchanged or falling pressure from a signal of a pressure sensor.
  • Clause 255 The system of any of clauses 251 to 254, wherein the enclosed chamber comprises a first enclosed chamber and wherein the extracorporeal pumping device further comprises a second enclosed chamber.
  • Clause 256 The system of any of clauses 251 to 255, wherein the extracorporeal pumping device further comprises a syringe pump and the reduction of pressure is caused by retracting a piston of the syringe pump and the increase of pressure is caused by advancing the piston of the syringe pump.
  • a system for providing circulatory support to a heart comprising: a conduit having a proximal end, a distal end, and a blood flow lumen disposed therethrough from the proximal end to the distal end; a pumping device comprising an enclosed chamber configured to be placed in fluid communication with the blood flow lumen of the conduit; a controller comprising a processor, the processor configured to: cause a reduction of pressure in the enclosed chamber based on detection of diastole in a heartbeat cycle signal to draw blood through the distal end of the conduit, the distal end being disposed within a ventricle of the heart or through the ventricle to an artery downstream thereof; and cause an increase of pressure in the enclosed chamber based on detection of systole in the heartbeat cycle signal to move blood from within the enclosed chamber through the distal end of the conduit and into the ventricle of the heart or through the ventricle to an artery downstream thereof; and a heartbeat cycle characterizer configured to receive the heartbeat cycle signal, to detect at least one of
  • Clause 258 The system of clause 257, wherein the pumping device further comprises a piston, wherein the reduction of pressure is caused by retracting the piston in a first direction and the increase in pressure is caused by advancing the piston in a second direction.
  • Clause 259. The system of clause 258, further comprising a biasing member configured to bias the piston in the first direction or the second direction.
  • Clause 260. The system of clause 259, wherein the biasing member comprises a spring.
  • Clause 261. The system of clause 258, wherein the pumping device further comprises a second enclosed chamber, the second enclosed chamber configured to be pressurized to cause movement of the piston. [0478] Clause 262.
  • a control fluid assembly comprising: a pressure source; a first fluid line connected at a first end to the pressure source via a first valve and at a second end to the first chamber portion; and a second fluid line connected at a first end to the pressure source via a second valve and at a second end to the second chamber portion, wherein the pressure source is configured to deliver a pressurized gas to the second enclosed chamber, wherein delivery of the pressurized gas to the first chamber portion causes the piston to move in the first direction and delivery of the pressurized gas to the second chamber portion causes the piston to move in the second direction.
  • a control fluid assembly comprising: a pressure source; and a fluid line connected at a first end to the pressure source and at a second end to the first chamber portion, wherein the pressure source is configured to deliver a pressurized gas to the second enclosed chamber, wherein delivery of the pressurized gas to the first chamber portion causes the piston to move in the second direction.
  • a control fluid assembly comprising: a pressure source; and a fluid line connected at a first end to the pressure source and at a second end to the first chamber portion, wherein the pressure source is configured to deliver a pressurized gas to the second enclosed chamber, wherein delivery of the pressurized gas to the first chamber portion causes the piston to move in the second direction.
  • Clause 257 to 262 further comprising a control fluid assembly comprising a first connector and a portable pressure chamber comprising a second connector configured to engage the first connector.
  • Clause 268 The system of any of clauses 257 to 267, further comprising a membrane positioned between the proximal end of the conduit and the enclosed chamber, the enclosed chamber enclosing a control fluid.
  • Clause 269. The system of any of clauses 262 to 268, further comprising a stoppage system configured to limit movement of the piston in the first direction, wherein engagement between a first end of the piston shaft and the stoppage system defines a maximum retracted position of the piston.
  • Clause 270 Clause 270.
  • the stoppage system comprises a rod threadedly engaged with a housing of the pumping device, wherein rotation of the rod in a first rotational direction causes the rod to move in the first direction away from the second enclosed chamber, and rotation of the rod in a second rotational direction causes the rod to move in the second direction towards the second enclosed chamber.
  • the enclosed chamber further comprises a cylinder and an end cap, the end cap disposed on a distal end of the cylinder, the end cap comprising at barb configured to connect to the proximal end of the conduit.
  • Clause 278 The system of clause 277, wherein a maximum retracted position of the plunger head along the length of the cylinder is adjustable, wherein the maximum retracted position of the plunger head defines a stroke length and corresponding stroke volume of the pumping device. [0495] Clause 279. The system of clause 278, wherein a distal end of the plunger head is adjacent a distal end of the cylinder when the piston is at a first maximum retracted position. [0496] Clause 280.
  • conduit further comprises a pre-formed bend proximal the distal end and a distal tip, the distal tip comprising an opening, the pre-formed bend shaped to hold the distal tip on an opposite side of the pulmonary valve than the pre-formed bend.
  • pre-formed bend is shaped to hold the distal tip within the pulmonary valve and/or the pulmonary artery throughout all heart cycles.
  • Clause 283 The system of clause 280 or clause 281, wherein the conduit further comprises an inflow aperture located proximal the distal tip, the inflow aperture configured to be positioned within the right atrium, the vena cava, or the right vertical, the inflow aperture configured draw blood into the conduit during diastole.
  • Clause 283 The system of clause 282, wherein the conduit further comprises a valve configured to open and close access to the inflow aperture.
  • Clause 284 The system of any of clauses 257 to 283, further comprising one or more anchor members located within the pulmonary artery and configured to hold the distal end of the conduit in the pulmonary artery during at least one of systole and diastole.
  • Clause 286 The system of any of clauses 257 to 285, wherein the conduit further comprises a tip valve configured to open and close access to an opening at the distal end of the conduit.
  • Clause 287 The system of any of clauses 271 to 286, wherein the end cap comprises a second barb for connecting to a second proximal end of a second conduit.
  • Clause 288 The system of any of clauses 257 to 287, further comprising an ECG sensor configured to detect an ECG signal indicative of a phase of the heartbeat cycle.
  • Clause 292 wherein the optical sensor is configured to be exposed to blood in a right ventricle of the heart.
  • Clause 295. The system of any of clauses 251 to 256 or clauses 257 or 294, further comprising a coaptation balloon disposed around the conduit, the coaptation balloon configured to engage leaflets of an atrioventricular valve to reduce back flow of blood through the atrioventricular valve during systole.
  • Clause 296 The system of clause 295, wherein the processor is configured to pressurize the coaptation balloon in coordination with causing the increase of pressure in the enclosed chamber.
  • Clause 298 A method of supporting pumping function of a patient's heart in heart failure, comprising: advancing a conduit percutaneously into a ventricle to provide a blood flow path from the ventricle to an enclosed chamber located outside of the ventricle; and controllably increasing and decreasing pressure in the enclosed chamber, wherein decreasing pressure in the enclosed chamber draws blood from the ventricle into the conduit and into the enclosed chamber during diastole, and increasing pressure in the enclosed chamber moves blood from the enclosed chamber through the conduit into the ventricle during systole, and wherein controllably increasing and decreasing pressure in the enclosed chamber comprises timing the increasing and decreasing based on a point of a heartbeat cycle.
  • Clause 299. The method of clause 298, further comprising receiving an ECG signal indicative of a phase of the heartbeat cycle and controllably increasing and decreasing pressure in the enclosed chamber based on the ECG signal.
  • Clause 300. The method of clause 299, further comprising controllably increasing pressure in the enclosed chamber when an R-wave peak in the ECG signal is detected.
  • Clause 301. The method of clause 300, further comprising receiving a blood pressure signal indicative of a phase of a heartbeat cycle and controllably increasing and decreasing pressure in the enclosed chamber based on the blood pressure signal and the ECG signal.
  • Clause 301 further comprising controllably increasing the pressure when the R-wave peak in the ECG signal is detected and when the blood pressure signal indicates a rising pressure.
  • Clause 303 The method of clause 301, further comprising refraining from controllably increasing the pressure when the R-wave peak in the ECG signal is detected but the blood pressure signal indicates a constant or falling pressure.
  • Clause 304 The method of clause 298, further comprising receiving a blood pressure signal indicative of a phase of the heartbeat cycle and controllably increasing and decreasing pressure in the enclosed chamber based on the blood pressure signal.
  • Clause 305 Clause 305.
  • a blood contacting assembly for a cardiac circulatory support system comprising: a blood conduit having a proximal end, a distal end, and a blood flow lumen disposed therethrough from the proximal end to the distal end; an end cap comprising a first end having a barb configured to connect to the proximal end of the blood conduit, a second end opposite the first end having an opening providing access to a concave surface configured to partly enclose a chamber, and a peripheral surface configured to be coupled to a cylinder connector; and a plunger head having a first end comprising a convex surface configured to face the concave surface and a second end opposite the first end configured to be coupled to a piston assembly of the cardiac circulatory support system.
  • the blood conduit comprises an elongate body configured to extend from a percutaneous access site to a right ventricle of a patient and a tip portion disposed at the distal end of the elongate body, the tip portion having a first side configured to bear against a wall of the right ventricle and an outlet portion on a second side opposite the first side, the tip portion configured to orient the outlet portion toward a pulmonary valve when the first side bears against the wall of the right ventricle.
  • the term “and/or” in reference to a list of two or more items covers all of the following interpretations of the word: any one of the items in the list, all of the items in the list, and any combination of the items in the list.
  • the term “each,” as used herein, in addition to having its ordinary meaning, can mean any subset of a set of elements to which the term “each” is applied.
  • the terms “approximately”, “about”, “generally,” and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount.
  • the terms “generally parallel” and “substantially parallel” refer to a value, amount, or characteristic that departs from exactly parallel by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degree.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Anesthesiology (AREA)
  • Mechanical Engineering (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Informatics (AREA)
  • External Artificial Organs (AREA)

Abstract

L'invention concerne des systèmes et des procédés d'aide à la fonction d'une ou de plusieurs chambres du cœur d'un patient. Le système peut comprendre un dispositif de pompage comprenant une chambre fermée configurée pour être placée en communication fluidique avec une lumière d'écoulement sanguin d'un conduit et configurée pour pomper le sang à travers le conduit. Provoquer une réduction de la pression dans la chambre fermée aspire le sang à travers une extrémité distale du conduit, l'extrémité distale étant configurée pour être disposée à l'intérieur d'un ventricule du cœur ou à travers le ventricule vers une artère en aval de celui-ci. Provoquer une augmentation de la pression dans la chambre fermée déplace le sang depuis l'intérieur de la chambre fermée à travers l'extrémité distale du conduit et dans le ventricule du cœur ou à travers le ventricule vers une artère en aval de celui-ci.
PCT/US2024/049109 2023-09-28 2024-09-27 Dispositifs, systèmes et procédés d'assistance cardiaque Pending WO2025072858A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202363586320P 2023-09-28 2023-09-28
US63/586,320 2023-09-28
US202463648288P 2024-05-16 2024-05-16
US63/648,288 2024-05-16

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WO2025072858A1 true WO2025072858A1 (fr) 2025-04-03

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3421497A (en) * 1964-02-26 1969-01-14 United Aircraft Corp Heart pump system
US5820542A (en) * 1996-10-31 1998-10-13 Momentum Medical, Inc. Modified circulatory assist device
US20020169413A1 (en) * 1999-01-11 2002-11-14 Libra Medical Systems, Inc. Apparatus and methods for treating congestive heart disease
US20060252977A1 (en) * 2004-01-08 2006-11-09 Sullivan Paul J Nondestructive fluid transfer device
US20220280768A1 (en) * 2019-08-30 2022-09-08 Reco2Very Therapies Gmbh Cannula for Endovascular Blood Circuit Support, Corresponding Assembly, Method and Cannula System

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3421497A (en) * 1964-02-26 1969-01-14 United Aircraft Corp Heart pump system
US5820542A (en) * 1996-10-31 1998-10-13 Momentum Medical, Inc. Modified circulatory assist device
US20020169413A1 (en) * 1999-01-11 2002-11-14 Libra Medical Systems, Inc. Apparatus and methods for treating congestive heart disease
US20060252977A1 (en) * 2004-01-08 2006-11-09 Sullivan Paul J Nondestructive fluid transfer device
US20220280768A1 (en) * 2019-08-30 2022-09-08 Reco2Very Therapies Gmbh Cannula for Endovascular Blood Circuit Support, Corresponding Assembly, Method and Cannula System

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