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WO2024156589A1 - Cathéter d'imagerie intraluminale avec structure extensible pour la stabilisation d'élément d'imagerie - Google Patents

Cathéter d'imagerie intraluminale avec structure extensible pour la stabilisation d'élément d'imagerie Download PDF

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Publication number
WO2024156589A1
WO2024156589A1 PCT/EP2024/051158 EP2024051158W WO2024156589A1 WO 2024156589 A1 WO2024156589 A1 WO 2024156589A1 EP 2024051158 W EP2024051158 W EP 2024051158W WO 2024156589 A1 WO2024156589 A1 WO 2024156589A1
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WIPO (PCT)
Prior art keywords
catheter
ice
movement
expandable structure
heart
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PCT/EP2024/051158
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English (en)
Inventor
Nathan C. FRANCIS
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Koninklijke Philips NV
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Koninklijke Philips NV
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Publication of WO2024156589A1 publication Critical patent/WO2024156589A1/fr
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • A61B8/445—Details of catheter construction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Clinical applications
    • A61B8/0883—Clinical applications for diagnosis of the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/52—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/5269—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving detection or reduction of artifacts
    • A61B8/5276—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving detection or reduction of artifacts due to motion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00273—Anchoring means for temporary attachment of a device to tissue
    • A61B2018/00279—Anchoring means for temporary attachment of a device to tissue deployable
    • A61B2018/00285—Balloons
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple balloon catheters

Definitions

  • the present disclosure relates generally to intraluminal imaging devices and, in particular, to imaging assemblies that include expandable stabilizing structures.
  • IVUS intravascular ultrasound
  • ICE intra-cardiac echocardiography
  • IVUS catheters are typically used in the large and small blood vessels (arteries or veins) of the body, and are almost always delivered over a guidewire having a flexible tip.
  • ICE catheters are usually used to image chambers of the heart and surrounding structures, for example, to guide and facilitate medical procedures, such as transseptal lumen punctures, left atrial appendage closures, atrial fibrillation ablation, and valve repairs.
  • Commercially-available ICE catheters are not designed to be delivered over a guidewire, but instead have distal ends which can be articulated by a steering mechanism located in a handle at the proximal end of the catheter.
  • an ICE catheter may be inserted through the femoral or jugular vein when accessing the anatomy, and steered in the heart to acquire images necessary to the safety of the medical procedures.
  • TEE transesophageal echocardiography
  • the ultrasound probe is placed down the patient’s esophagus to image the heart.
  • the tight fit between the probe and the esophagus lumen keeps the imaging sensor, and therefore the projected image, very stable, allowing the echocardiographer to let go of the probe handle and not continuously adjust the imaging plane.
  • TEE can require general anesthesia, which significantly increases hospital resources and patient stay.
  • ICE has seen increasing use in structural heart interventions over trans-esophageal echocardiography (TEE) due to its improved imaging of right-side structures and the feasibility of conscious sedation for the patient.
  • TEE trans-esophageal echocardiography
  • ICE uses a much smaller catheter than TEE to image the heart via transvenous access.
  • ICE allows physicians to use conscious sedation on patients during the procedure, which may reduce the need for an anesthesiologist and also reduce post-operative times, thus significantly reducing hospital resources required to perform cardiac imaging procedures.
  • ICE catheters are typically 9Fr in diameter and placed in the heart via femoral venous access up through the inferior vena cava (IVC).
  • IVC inferior vena cava
  • the ICE catheter has a steerable mechanism to position the imaging sensor in the direction of interest. Since the ICE catheter is floating within the large chambers of the heart, rather than being confined by a tight lumen like the TEE, the cardiographer may need to keep their hands on the catheter and continually adjust the probe head to keep the imaging plane on the anatomy of interest.
  • the present disclosure provides devices, systems, and related methods for stabilizing an ICE catheter during intracardiac imaging.
  • the disclosure includes a stabilizing method to keep the ICE probe head in the same location during an intracardiac imaging procedure, via a balloon or other expandable structure. This allows for stabilization of the ICE imaging probe head within the cardiac anatomy, thus freeing up the interventionist’ s hands to perform other parts of the procedure.
  • the main elements are an expandable structure either built into the imaging catheter or built into a guide catheter, and an expansion mechanism.
  • the imaging catheter with stabilizing structures, disclosed herein, has particular, but not exclusive, utility for intracardiac imaging.
  • One general aspect includes a system, which includes an intracardiac echocardiography (ICE) catheter including an ultrasound transducer array configured to obtain ultrasound imaging data of a heart of a subject; and an expandable structure operably associated with the ICE catheter, where the expandable structure is configured to be positioned within a body lumen associated with the heart and transitioned between an expanded state and an unexpanded state, where, in the unexpanded state, the ICE catheter is configured for movement relative to the body lumen, and where, in the expanded state, the expandable structure is configured to restrict the movement of the ICE catheter relative to the body lumen such that the ultrasound transducer array is stabilized to obtain the ultrasound imaging data of the heart.
  • ICE intracardiac echocardiography
  • Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.
  • the movement includes at least one of longitudinal movement, rotational movement, lateral movement, and/or bending movement.
  • the expandable structure is disposed on the ICE catheter distal of the ultrasound transducer to, in the expanded state, restrict the longitudinal movement, the rotational movement, the lateral movement, and the bending movement of the ICE catheter relative to the body lumen.
  • the expandable structure is disposed on the ICE catheter proximal of the ultrasound transducer to, in the expanded state, restrict the longitudinal movement, the rotational movement, and the lateral movement of the ICE catheter relative to the body lumen.
  • the expandable structure is disposed on the ICE catheter proximal of the ultrasound transducer, and a second expandable structure is disposed on the ICE catheter distal of the ultrasound transducer, such that the expandable structure and the second expandable structure, in the expanded state, restrict the longitudinal movement, the rotational movement, the lateral movement, and the bending movement of the ICE catheter relative to the body lumen.
  • the expandable structure is disposed on a guide catheter through which the ICE catheter is extended to, in the expanded state, restrict the lateral movement of the ICE catheter relative to the body lumen.
  • the guide catheter includes an aperture or acoustically transparent window through which the ultrasound transducer can obtain the ultrasound imaging data of the heart of the subject.
  • the ICE catheter includes a guidewire lumen through which a guidewire extends, and where the expandable structure is disposed at a distal end of the guidewire to, in the expanded state, dampen the lateral movement and the bending movement of the ICE catheter relative to the body lumen.
  • the ICE catheter extends through a guide catheter, where the guide catheter includes a guidewire lumen through which a guidewire extends, and where the expandable structure is disposed at a distal end of the guidewire to, in the expanded state, dampen the lateral movement and the bending movement of the ICE catheter relative to the body lumen.
  • the guide catheter includes an aperture or acoustically transparent window through which the ultrasound transducer can obtain the ultrasound imaging data of the heart of the subject.
  • the ICE catheter includes at least one pull wire extending through at least one pull wire lumen, and where the at least one pull wire is configured to deflect a distal portion of the ICE catheter.
  • the at least one pull wire is configured to deflect the distal portion of the ICE catheter in at least two planes.
  • the expandable structure and the ultrasound transducer array are configured to be positioned in different anatomy from one another while the ultrasound transducer array obtains the ultrasound imaging data of the heart.
  • the body lumen includes different anatomy than the heart such that the different anatomy is different than anatomy depicted in the ultrasound imaging data. In some embodiments, the body lumen includes a great vessel. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer- accessible medium. [0009] One general aspect includes a method.
  • the method includes moving an intracardiac echocardiography (ICE) catheter with an ultrasound transducer array longitudinally relative to a body lumen associated with a heart of a subject while an expandable structure operably associated with the ICE catheter is an unexpanded state; transitioning the expandable structure to an expanded state such that movement of the ICE catheter relative to the body lumen is restricted, and obtaining ultrasound imaging data of the heart with the ultrasound transducer array while the ultrasound transducer array is stabilized by the expandable structure in the expanded state.
  • ICE intracardiac echocardiography
  • Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.
  • the system includes an intracardiac echocardiography (ICE) catheter including an ultrasound transducer array configured to obtain ultrasound imaging data representative of a heart of a subject; and a balloon operably associated with the ICE catheter and configured to be transitioned between an expanded state and an unexpanded state, where the balloon is configured to be positioned within at least one of the superior vena cava or the inferior vena cava and the ultrasound transducer array is configured to be positioned within a right atrium such that the balloon and the ultrasound transducer array are positioned within different anatomy, where, in the unexpanded state, the ICE catheter is configured for movement relative to at least one of the superior vena cava or the inferior vena cava, and where, in the expanded state, the balloon is configured to restrict the movement of the ICE catheter relative to at least one of the superior vena cava or the inferior vena cava such that ultrasound transducer array is stabilized within the right atrium to obtain the ultrasound imaging data of the heart
  • ICE intracardiac echocardiography
  • Figure 1 is a schematic diagram of an intraluminal imaging system according to embodiments of the present disclosure.
  • Figure 2 is a schematic diagram of a portion of an intraluminal device according to embodiments of the present disclosure.
  • Figure 3 is a schematic diagram of a tip assembly according to embodiments of the present disclosure.
  • Figure 4 is a schematic, diagrammatic side view of at least a portion of the ICE device under deflection according to embodiments of the present disclosure.
  • Figure 5 is a schematic diagram illustrating deflections planes of the ICE device according to embodiments of the present disclosure.
  • Figure 6 is an end cross-sectional view of a multi-lumen catheter shaft, according to embodiments of the present disclosure.
  • Figure 7A is a cross-sectional front view of a human heart, according to aspects of the present disclosure.
  • Figure 7B is a cross-sectional front view of a human heart, according to aspects of the present disclosure.
  • Figure 8 is a schematic, diagrammatic side view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • Figure 9 is a schematic, diagrammatic side view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • Figure 10 is a schematic, diagrammatic side view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • Figure 11 is a schematic, diagrammatic side cross-sectional view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • Figure 12 is a schematic, diagrammatic side cross-sectional view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • Figure 13 is a schematic, diagrammatic end cross-sectional view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • Figure 14 is a schematic, diagrammatic end cross-sectional view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • Figure 15 is a schematic, diagrammatic end cross-sectional view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • Figure 16 is a schematic, diagrammatic end cross-sectional view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • Figure 17 is a schematic, diagrammatic side view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • Figure 18 is a schematic, diagrammatic side view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • Figure 19 is a schematic, diagrammatic side view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • Figure 20 is a schematic, diagrammatic side view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • Figure 21 is a schematic, diagrammatic side view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • Figure 22 is a schematic, diagrammatic side cross-sectional view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • Figure 23 is a schematic, diagrammatic end cross-sectional view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • Figure 24 is a schematic, diagrammatic end cross-sectional view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • Figure 25 is a schematic, diagrammatic side view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • Figure 26 is a schematic, diagrammatic side cross-sectional view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • Figure 27 is a schematic, diagrammatic end cross-sectional view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • Figure 28 is a schematic, diagrammatic side view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • Figure 29 is a schematic, diagrammatic side cross-sectional view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • Figure 30 is a schematic, diagrammatic end cross-sectional view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • Figure 31 is a schematic diagram of a processor circuit 3150, according to embodiments of the present disclosure.
  • Figure 32 is a flow diagram of an example intracardiac echography imaging method, according to embodiments of the present disclosure.
  • An imaging catheter with stabilizing structures which includes a balloon-based stabilizing method to keep the ICE probe head in the same location during an intracardiac imaging procedure.
  • An ICE catheter typically includes an ultrasound imaging component that generates and receives acoustic energy.
  • the imaging component may include an array of transducer elements or transducer elements arranged in any suitable configuration.
  • the imaging component is encased in a tip assembly located at a furthest distal tip of the catheter.
  • the tip assembly is covered with acoustic adhesive materials.
  • An electrical cable is connected to the imaging component and extends through the core of the body of the catheter.
  • the electrical cable may carry control signals and echo signals to facilitate imaging of the heart anatomy.
  • the device may provide rotational, 2-way, or 4-way steering mechanisms such that anterior, posterior, left, and/or right views of the heart anatomy may be imaged.
  • An ICE catheter typically includes an ultrasound imaging element that generates and receives acoustic energy.
  • the imaging element may include a linear array of transducer elements or transducer elements arranged in any suitable configuration.
  • the imaging element may for example be part of a tip assembly located at a furthest distal tip of the catheter.
  • the present disclosure allows for stabilization of the ICE imaging probe head within the cardiac anatomy, thus freeing up the interventionist’s hands to perform other parts of the procedure.
  • the main elements are an insufflating member (e.g., a balloon) either built into the imaging catheter or built into a guide catheter; an inflation mechanism, such as a syringe; and an inflation lumen that allows passage of fluid from the inflation mechanism to the insufflation member.
  • an insufflating member e.g., a balloon
  • an inflation mechanism such as a syringe
  • an inflation lumen that allows passage of fluid from the inflation mechanism to the insufflation member.
  • One embodiment includes a compliant or semi-compliant balloon built into the distal tip of an ICE catheter.
  • the balloon could be either distal or proximal of the imaging sensor to stabilize the probe head in either SVC, IVC, pulmonary artery, etc. Stabilization proximal to the probe head provides benefit that the tip deflection mechanisms on the handle can still be used. Distal stabilization would hinder tip deflection and rely on electronic steering only.
  • An inflation lumen could for example be extruded into the imaging catheter, from the location of balloon inflation exit port all the way to the handle, with a side port that connects with an inflation mechanism such as a syringe or electronically actuated syringe.
  • the stabilizing balloon could also be built into a guide catheter with a lumen sized to fit the imaging catheter.
  • the guide catheter could have a window cut into it, either distal or proximal to the stabilizing balloon, depending on the needs of the procedure, so the imaging catheter can view cardiac anatomy without interference from guide catheter.
  • the balloon can cover the full circumference of the imaging catheter, like standard valvuloplasty or PTCA balloons, but most likely will require an open area somewhere in the circumference so as to not block all blood flow in the deployed region of the anatomy.
  • Possible methods for providing such channels include but are not limited to: 1) fusing one section of the balloon to the catheter body so as to create a single flow lumen past balloon, and 2) having two or more smaller balloons that deploy from either side of catheter, rather than around the catheter, such that flow areas are created between the deployed balloons.
  • the present disclosure aids substantially in intracardiac imaging procedures, by improving the stability of the ultrasound imaging element within the moving chambers of the heart.
  • the imaging catheter with stabilizing structures, disclosed herein provides practical improvements in the ability of a cardiologist or surgeon to image moving tissues within the human body.
  • This improved imaging capability transforms a complex manual procedure into one where the imaging element can be placed and stabilized while the clinician performs other required tasks, all without the normally routine need to place the patient under full sedation.
  • This unconventional approach improves the functioning of the intracardiac imaging system, by improving image quality and decreasing the time and resources required to perform an imaging procedure.
  • the imaging catheter with stabilizing structures may be controlled at least in part by a computer program viewable on a display, and operated by a control process executing on a processor that accepts user inputs from a keyboard, mouse, or touchscreen interface, and that is in communication with one or more sensors and/or actuators.
  • the control process performs certain specific operations in response to different inputs or selections made at different times.
  • Certain structures, functions, and operations of the processor, display, sensors, and user input systems are known in the art, while others are recited herein to enable novel features or aspects of the present disclosure with particularity.
  • These descriptions are provided for exemplary purposes only, and should not be considered to limit the scope of the imaging catheter with stabilizing structures. Certain features may be added, removed, or modified without departing from the spirit of the claimed subject matter.
  • FIG. 1 is a schematic, diagrammatic view of an intraluminal imaging system 100 according to embodiments of the present disclosure.
  • the system 100 may include an intraluminal device 110, a connector 124, a control and processing system 130, such as a console and/or a computer, and a monitor 132.
  • the intraluminal device 110 includes a tip assembly 102, a flexible elongate member 108 (e.g., a catheter or guidewire), and a handle 120.
  • the flexible elongate member 108 includes a distal portion 104 and a proximal portion 106. The distal end of the distal portion 104 is attached to the tip assembly 102.
  • the proximal end of the proximal portion 106 is attached to the handle 120 for example, by a resilient strain reliever 112, for manipulation of the intraluminal device 110 and manual control of the intraluminal device 110.
  • the tip assembly 102 can include an imaging component with ultrasound transducer elements and associated circuitry.
  • the handle 120 can include actuators 116, a clutch 114, and other steering control components for steering the intraluminal device 110.
  • the intraluminal device 110 is an ICE device.
  • the handle 120 is connected to the connector 124 via another strain reliever 118 and an electrical cable 122.
  • the connector 124 may be configured in any suitable configurations to interconnect with the processing system 130 and the monitor 132 for processing, storing, analyzing, manipulating, and displaying data obtained from signals generated by the imaging component at the tip assembly 102.
  • the processing system 130 can include one or more processors, memory, one or more input devices, such as keyboards and any suitable command control interface device.
  • the processing system 130 can be operable to facilitate the features of the intraluminal imaging system 100 described herein.
  • the processor can execute computer readable instructions stored on a non-transitory tangible computer readable medium.
  • the monitor 132 can be any suitable display device, such as liquid-crystal display (LCD) panel , light-emitting diode (LED) panel, or the like.
  • a physician or a clinician advances the flexible elongate member 108 into a vessel within the heart anatomy.
  • the physician or clinician can steer the flexible elongate member 108 to a position near the area of interest (e.g., the area to be imaged) by controlling the actuators 116 and the clutch 114 on the handle 120.
  • one actuator 116 may deflect the tip assembly 102 and the distal portion 104 in a left-right plane and the other actuator 116 may deflect the tip assembly 102 and the distal portion 104 in an anterior-posterior plane.
  • the clutch 114 provides a locking mechanism to lock the positions of the actuators 116 and in turn the deflection of the flexible elongate member 108 while imaging the area of interest.
  • the imaging process may include activating the ultrasound transducer elements on the tip assembly 102 to produce ultrasonic energy. A portion of the ultrasonic energy is reflected by the area of interest and the surrounding anatomy, and the ultrasound echo signals are received by the ultrasound transducer elements.
  • the connector 124 transfers the received echo signals to the processing system 130 where the ultrasound image is reconstructed and displayed on the monitor 132.
  • the processing system 130 can control the activation of the ultrasound transducer elements and the reception of the echo signals.
  • the processing system 130 and the monitor 132 may be part of the same system.
  • the system 100 may be utilized in a variety of applications such as transseptal punctures, left atrial appendage closures, atrial fibrillation ablation, and valve repairs and can be used to image vessels and structures within a living body.
  • the tip assembly 102 may include any suitable physiological sensor or component for diagnostic, treatment, and/or therapy.
  • the tip assembly can include an imaging component, an ablation component, a cutting component, a morcellation component, a pressure-sensing component, a flow-sensing component, a temperature-sensing component, and/or combinations thereof.
  • FIG. 2 is a schematic, diagrammatic side view of at least a portion of the intraluminal device 110 according to embodiments of the present disclosure.
  • the tip assembly 102 and the flexible elongate member 108 are shaped and sized for insertion into vessels of a patient body.
  • the flexible elongate member 108 can be composed of any suitable material, such as Pebax® polyether block amides.
  • the distal portion 104 and the proximal portion 106 are tubular in shape and may include one or more lumens extending along a length of the flexible elongate member 108. In some embodiments, one lumen (e.g., a primary lumen) may be sized and shaped to accommodate an electrical cable 340 (shown in Fig.
  • the lumen may be shaped and sized to accommodate other components for diagnostic and/or therapy procedures.
  • one or more lumens may be sized and shaped to accommodate pull wires or steering wires, for example, extending from the distal portion 104 to the handle 120.
  • the steering wires may be coupled to the actuators 116 and the clutch 114 such that the flexible elongate member 108 and the tip assembly 102 are deflectable based on actuations of the actuators 116 and the clutch 114.
  • Dimensions of the flexible elongate member 108 can vary in different embodiments.
  • the flexible elongate member 108 can be a catheter having an outer diameter between about 8 and about 12 French (Fr) and can have a total length 206 between about 80 centimeters (cm) to about 120 cm, where the proximal portion 106 can have a length 204 between about 70 cm to about 118 cm and the distal portion 104 can have a length 202 between about 2 cm to about 10 cm.
  • Fr French
  • the proximal portion 106 can have a length 204 between about 70 cm to about 118 cm
  • the distal portion 104 can have a length 202 between about 2 cm to about 10 cm.
  • FIG 3 is a schematic, diagrammatic perspective view of the tip assembly 102 of an example intraluminal device 110, according to embodiments of the present disclosure.
  • Figure 3 provides a more detailed view of the tip assembly 102.
  • the tip assembly 102 includes a tip member 310, an imaging component 320, and an interposer 330.
  • the tip member 310 has a tubular body sized and shaped for insertion into a patient body.
  • the tip member 310 can be composed of a thermoplastic elastomer material or any suitable biocompatible material that has acoustic impedance matching to blood within a vessel of a patient body when in use.
  • the tip member 310 can be composed of Pebax® polyether block amides.
  • the tip member 310 can vary in different embodiments and may depend on the size of the catheter or the flexible elongate member 108.
  • the tip member 310 can include a length 302 between about 15 millimeter (mm) to about 30 mm and a width 304 between about 2 mm to about 4 mm.
  • the interposer 330 interconnects the imaging component 320 to an electrical cable 340.
  • the imaging component 320 emits ultrasound energy and receives ultrasound echo signals reflected by surrounding tissues and vasculatures.
  • the electrical cable 340 carries the ultrasound echo signals to the processing system 130 for image generation and analysis.
  • the electrical cable 340 can carry control signals for controlling the imaging component 320.
  • the electrical cable 340 can carry power for powering the imaging component 320.
  • the electrical cable 340 may for example extend along a length of the flexible elongate member 108.
  • the interposer 330 functions as an interconnect to distribute or transfer signals between the imaging component 320 and the electrical cable 340.
  • the interposer 330 can be composed of any suitable substrate material, such as ceramic, glass, quartz, alumina, sapphire, and silicon, that may provide high-density signal routing in a small form factor.
  • the interposer 330 may leverage semiconductor processes, but may not include active components such as transistors as in typical semiconductor devices.
  • Figure 4 is a schematic, diagrammatic side view of at least a portion of the ICE device 110 under deflection according to embodiments of the present disclosure.
  • the flexible elongate member 108 shown in Figure 2 is referred to as a neutral position.
  • the tip assembly 102 and the distal portion 104 of the flexible elongate member 108 are deflected from the neutral position.
  • the distal portion 104 may be deflected up to a bend radius 305 of about 27 millimeters (mm) to about 28 mm.
  • One type of ICE catheter has a distal articulation in a single plane (both directions), operated by a single wheel that rotates about the lengthwise axis of the handle.
  • the wheel may be turned to a specific position for the desired catheter shape, staying in place due to the inherent friction on the wheel mechanism and/or by friction applied by the clutch mechanism 114 (see Figure 1).
  • the catheter is torqueable, and can be rotated with the handle to facilitate steering in a second plane. The motions required to simultaneously rotate the catheter while operating the control wheels often require two-handed operation.
  • ICE catheters commonly provide steering through pull wires secured to the distal portions of the catheters near the tip assemblies.
  • the pull wires are also referred to as steering lines.
  • the pull wires extend through the bodies of the catheters and are coupled to control wheels at handles of the catheters located at the proximal end of catheters. For example, a pair of pull wires may provide steering in a leftright plane and another pair of pull wires may provide steering in an anterior-posterior plane.
  • an intraluminal catheter e.g., an ICE catheter
  • ICE catheter may for example be found in pre-grant publications US20190274658A1, with a priority date of September 29, 2016, US20190307420A1, with a priority date of September 29, 2016, US20210275136A1, with a priority date of September 29, 2016, and US20210298718A1, with a priority date of September 30, 2016.
  • Figure 5 is a schematic diagram illustrating deflections planes of the ICE device 110 according to embodiments of the present disclosure.
  • the tip assembly 102 and the distal portion 104 can be deflected along a first plane as shown by the solid arrows and a second plane as shown by the dotted arrows.
  • the first plane is represented by an x-y plane and the second plane is represented by an x-z plane.
  • the x-y plane may correspond to a left-right plane and the x-z plane may correspond to an anterior-posterior plane for imaging the heart anatomy.
  • Figure 6 is an end cross-sectional view of a multi-lumen catheter shaft 600 (e.g., a shaft of a flexible elongate member 108, as shown in Figure 1), according to embodiments of the present disclosure.
  • the catheter shaft 600 can be employed by the ICE device 110 as the flexible elongate member 108.
  • the catheter shaft 600 is tubular in shape with a tubular wall 602 and a primary lumen 608.
  • the primary lumen 608 may for example extend between the distal end and the proximal end of the catheter shaft 600, for example, along a central longitudinal axis of the catheter shaft 600.
  • the steerability of the catheter shaft 600, the amount of force to bend the catheter shaft 600, and the locality of the bend force and/or actuations may depend on the durometer of the catheter shaft 600.
  • the catheter shaft 600 further includes a plurality of secondary lumens 606 extending longitudinally through a length of the tubular wall 602.
  • the primary lumen has a cross-shaped cross-sectional profile. This profile may be rounded (as shown in Figure 6) or rectangular, for example.
  • the secondary lumens 606 are shaped and sized to accommodate pull wires 607 for steering or deforming the catheter shaft 600 as described above.
  • the secondary lumens 606 may also be referred to as pull wire lumens.
  • the secondary lumens 606 may for example be positioned within the tubular wall 602 radially spaced apart by an angle 680 of about 90 degrees.
  • the arms 610 of the cross-shaped cross section form recesses that can anchor the angular positions of the secondary lumens 606.
  • the secondary lumens 606 may be positioned between adjacent arms 610 during manufacturing as described in greater detail herein.
  • the primary lumen 608 and the secondary lumens 606 can be lined with a lubricious lining material 609 such as a polytetrafluoroethylene (PTFE) material.
  • PTFE polytetrafluoroethylene
  • the lining material 609 creates frictionless surfaces for threading, delivery, and actuations of pull wires 607 or any other suitable diagnostic sensor assembly.
  • the lining material 609 can function as a support structure to prevent the primary lumen 608 and the secondary lumens 606 from collapsing.
  • the lining material 609 can function as a barrier to protect abrasion caused by the frequent shifting or actuations of the pull wires and/or threading of the other diagnostic sensor assembly.
  • the catheter shaft 600 may further include a braided layer 604 embedded within the tubular wall 602.
  • the braided layer 604 can be composed of any suitable material and geometry.
  • the braided layer 604 may include stainless steel flat wires, which may provide optimal usage of radial space and additional strength.
  • the braided layer 604 can have braids with pitches that vary along a length of the tubular wall 602.
  • the braids can include any suitable braid pattern. The braid pattern may be selected to improve torque transmission, pushability, and/or kink resistance.
  • Dimensions of the catheter shaft 600 can vary in different embodiments. In some embodiments, the catheter shaft 600 may be a 9 Fr catheter.
  • the catheter shaft 600 can have an outer diameter 682 of about 3 mm.
  • the dimensions of the cross-shaped primary lumen 608 can be sized to allow components (e.g., a printed circuit board (PCB) and/or a coaxial cable) to be thread through the lumen 608 during assembly instead of using the coaxial cable as an anchor as in some configurations, and thus may improve handling responsiveness during operation.
  • the material used in in the tubular wall 602 and the braided layer 604 allows the catheter shaft 600 to deflect up to a bend radius (e.g., the bend radius 305 of Figure 4) of between about 13 mm to about 14 mm.
  • FIG. 7A is a cross-sectional front view of a human heart 700, according to aspects of the present disclosure.
  • an intraluminal imaging device 110 has been inserted through a blood vessel 721 proximate to the heart 700, such as the inferior vena cava 790.
  • the ultrasound imaging component 320 has a viewing region 730 that encompasses portions of the heart 700.
  • the flexible elongate member 108 and imaging component 320 are stabilized within the blood vessel 721 by an expandable balloon 702 located proximal of the imaging component 320 on the flexible elongate member 108.
  • the balloon 702 can be positioned, for example, in any suitable body lumen or body cavity, including within the heart 700 and/or within a blood vessel 721 in fluid communication with the heart.
  • a blood vessel 721 may be an artery or vein, and may include one or more great vessels (e.g., the aorta 702, superior vena cava 760, inferior vena cava 790, pulmonary artery 770 (which takes oxygen-poor blood from the heart, through the pulmonary valve (not shown) to the lungs where it is oxygenated), or pulmonary veins 780 (which bring oxygen-rich blood from the lungs to the heart)).
  • great vessels e.g., the aorta 702, superior vena cava 760, inferior vena cava 790, pulmonary artery 770 (which takes oxygen-poor blood from the heart, through the pulmonary valve (not shown) to the lungs where it is oxygenated), or pulmonary veins 780 (which bring oxygen-rich blood from the lungs to the heart
  • oxygen-poor blood enters the human heart 700 in the right atrium 712 and travels to the right ventricle 714 through the tricuspid valve 716.
  • the oxygen-poor blood leaves the right ventricle 714 and travels to the lungs.
  • Also visible are a left atrium 718 and a left ventricle 720.
  • oxygen-rich blood is received from the lungs in the left atrium 718 and travels to the left ventricle 720 through the mitral valve 722.
  • the oxygen-rich blood leaves the left ventricle 720 and goes out to the body through the aorta 702 via an aortic valve 724.
  • This configuration allows the flexible elongate member 108 to be deflected (as described for example in Figures 4 and 5) distal of the balloon 702, thus reorienting the imaging component 320 and pointing the viewing region 730 at different portions of the patient’s anatomy (e.g., different portions of the heart 700).
  • balloon is used herein for exemplary purposes only, and that a balloon is merely one example of an expandable structure serving the described function.
  • Alternative expandable structure could include, for example., a plurality of arms distributed circumferentially around the flexible elongate member, or otherwise.
  • Figure 7B is a cross-sectional front view of a human heart 700, according to aspects of the present disclosure. Visible are the aorta 702, superior vena cava 760, inferior vena cava 790, pulmonary artery 770, pulmonary veins 780, right atrium 712, right ventricle 714, tricuspid valve 716, left atrium 718, left ventricle 720, mitral valve 722, and aortic valve 724.
  • an intraluminal imaging device 110 has been inserted through a blood vessel 721 proximate to the heart 700, such as the superior vena cava 760.
  • the ultrasound imaging component 320 has a viewing region 730 that encompasses portions of the heart 700.
  • the flexible elongate member 108 and imaging component 320 are stabilized within the right atrium 712 by an expandable balloon 702 located within the superior vena cava 760, distal of the imaging component 320.
  • This configuration may permit the imaging component 320 to be rotated around the longitudinal axis of the flexible elongate member 108, but may reduce opportunities to reorient the imaging component 320 by bending or deflecting the flexible elongate member 108 (e.g., with steering cables or pull wires).
  • FIG 8 is a schematic, diagrammatic side view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • the intraluminal imaging device 110 includes a handle 120, a flexible elongate member or catheter body 108 with a proximal end 810 and a distal end 820.
  • the intraluminal imaging device 110 also includes a stabilizing balloon 702 and a transducer array or imaging component 320.
  • the stabilizing balloon 702 is located proximal of the transducer array or imaging component 320, and is spaced from the transducer array or imaging component 320 by a separation distance LI.
  • Stabilization proximal to the imaging component 320 provides benefit that the tip deflection mechanisms on the handle 120 can still be used, thus allowing the stabilized imaging component 320 to be reoriented in a variety of different directions.
  • the balloon 702 When the balloon 702 is fully inflated, it can arrest axial movement, rotational movement, lateral movement, and deflection or bending of the catheter body 108.
  • FIG. 9 is a schematic, diagrammatic side view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure. Visible are the handle 120, flexible elongate member or catheter body 108, proximal end 810, distal end 820, stabilizing balloon 702, and transducer array or imaging component 320.
  • the stabilizing balloon 702 is located distal of the transducer array or imaging component 320, and is spaced from the transducer array or imaging component 320 by a separation distance L2, and from the distal end 820 of the flexible elongate member 108 by a distance L3. It is noted that the distance L3 could be zero, e.g., the balloon 702 could be located at the distal end 820 of the flexible elongate member 108.
  • Stabilization distal of the imaging component 320 may hinder the tip deflection mechanisms in the handle 120, though without affecting the ability of the ultrasound beam to be steered electronically (e.g., through beam steering).
  • Figure 10 is a schematic, diagrammatic side view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure. Visible are the handle 120, flexible elongate member or catheter body 108, proximal end 810, distal end 820, two stabilizing balloons 702, and transducer array or imaging component 320.
  • a first stabilizing balloon 702 is located proximal of the transducer array or imaging component 320
  • a second stabilizing balloon 702 is located distal of the transducer array or imaging component 320, at the distal end 820 of the flexible elongate member 108.
  • FIG 11 is a schematic, diagrammatic side cross-sectional view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure. Visible are the handle 120, flexible elongate member or catheter body 108, proximal end 810, distal end 820, stabilizing balloon 702, and transducer array or imaging component 320.
  • the handle 120 includes at least one actuator 116, which operates at least one pull wire 607 within a pull wire lumen 606 within the flexible elongate member 108.
  • the pull wire 607 may for example be anchored to the tip assembly 102.
  • the flexible elongate member 108 also includes a plurality of electrical wires 1110 within the electrical wire lumen 1105, that place the imaging component or transducer array 320 in electrical communication with the processing system 130.
  • the electrical wires 1110 run from the tip assembly 102 through the entire length of the flexible elongate member 108, through the handle 120, through the cable 122 and connector 124 (see Figure 1) to connect with the processing system 130.
  • the flexible elongate member 108 also includes an inflation port 1120 located at or near the proximal end 810 of the flexible elongate member.
  • the inflation port 1120 is in fluid communication with an inflation opening 1140 that is in fluid communication with the interior of the balloon 702, such that fluid pumped into the inflation port 1120 by an inflation source 1150 can expand the balloon 702, and such that fluid pumped out of the inflation port 1120 by the inflation source 1150 can deflate the balloon 702.
  • the inflation source 1150 may be manually operable (e.g., a syringe) or automatically operable (e.g., an electrically operated syringe or pump in electrical communication with the processing system 130).
  • Embodiments with two or more balloons 702 may share an inflation port 1120, inflation lumen 1130, and inflation opening 1140 between the two balloons 702.
  • two or more balloons 720 may share an inflation port 1120 and inflation lumen 1130, but each balloon 702 may have its own inflation opening 1140 leading to the inflation lumen 1130.
  • each balloon 702 may have its own inflation port 1120, inflation lumen 1130, and inflation opening 1140.
  • the inflation lumen 1130 may be or include a pull wire lumen, push rod lumen, rotary wire lumen, or other appropriate structure as would be understood by a person of ordinary skill in the art.
  • Figure 12 is a schematic, diagrammatic side cross-sectional view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure. Visible are the handle 120, flexible elongate member or catheter body 108, actuator 116, pull wire 607, pull wire lumen 606, electrical wires 1110, electrical wire lumen 1105, inflation lumen 1130, and inflation port 1120.
  • the inflation port 1120 is located within a surface of the handle 120, and a portion of the inflation lumen 1130 extends through the handle 120.
  • the inflation lumen 1130 may extend outside of both the flexible elongate member 108 and the handle 120 (e.g., through a Y connector), or may extend alongside the cable 122 (see Figure 1), or be situated on other components of the intraluminal imaging system 100.
  • Figure 13 is a schematic, diagrammatic end cross-sectional view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure. Visible are the flexible elongate member or catheter body 108, pull wires 607, pull wire lumens 606, electrical wires 1110, electrical wire lumen 1105, and inflation lumen 1130. Also visible is inflation fluid 1310 disposed within the inflation lumen 1130. Depending on the implementation, the inflation fluid may be a gas (e.g., air, nitrogen, etc.), a liquid (e.g., water, saline), or a gel (e.g., saline gel).
  • a gas e.g., air, nitrogen, etc.
  • a liquid e.g., water, saline
  • gel e.g., saline gel
  • Figure 14 is a schematic, diagrammatic end cross-sectional view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure. Visible are the flexible elongate member or catheter body 108, pull wires 607, pull wire lumens 606, electrical wires 1110, electrical wire lumen 1105, inflation lumen 1130, inflation opening 1140, balloon 702, and inflation fluid 1310 disposed within the inflation lumen 1130 and balloon 702. Inflation fluid 1310 passes from the inflation lumen 1130 into the balloon 702 through the inflation opening 1140 in order to expand the balloon 702, and passes from the balloon 702 into the inflation lumen 1130 through the inflation opening 1140 in order to deflate the balloon 702.
  • Figure 15 is a schematic, diagrammatic end cross-sectional view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure. Visible are the flexible elongate member or catheter body 108, and balloon 702, within a blood vessel 721. It is understood that a balloon 702 that completely filled a blood vessel 721 could potentially block blood flow. In the example shown in Figure 15, the balloon 702 is kidney- shaped, which leaves a blood flow channel 1510 through the blood vessel 721.
  • Figure 16 is a schematic, diagrammatic end cross-sectional view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • the flexible elongate member or catheter body 108 and two balloons 702, within a blood vessel 721.
  • the two balloons 702 are oval- shaped and positioned on opposite sides of the flexible elongate member 108, which leaves two blood flow channels 1510 through the blood vessel 721.
  • FIG 17 is a schematic, diagrammatic side view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • the intraluminal imaging device 110 includes a handle 120, a flexible elongate member or catheter body 108 with a proximal end 810 and a distal end 820, and an imaging component or transducer array 320.
  • the flexible elongate member or catheter body 108 is surrounded by a guide catheter or accessory sheath 1710 (e.g., a second flexible elongate member), from which a stabilizing balloon 1702 extends, such that the stabilizing balloon is aligned with the distal end 1720 of the guide catheter or accessory sheath 1710.
  • a guide catheter or accessory sheath 1710 e.g., a second flexible elongate member
  • the flexible elongate member or catheter body 108 extends past the distal and of the guide catheter or accessory sheath 1710, such that the imaging element or transducer array 320 is exposed, to facilitate imaging.
  • the balloon 1702 When the balloon 1702 is fully inflated within a body lumen, it can arrest axial movement, rotational movement, and lateral movement of the guide catheter or accessory sheath 1710, while permitting axial movement, rotational movement, and deflection or bending of the catheter body 108, such that the imaging component or transducer array 320 can be fully retracted within the guide catheter or accessory sheath 1710, fully extended outside of the guide catheter or accessory sheath 1710, deflected outside the guide catheter or accessory sheath 1710, or rotated to various clock angles around the longitudinal axis to facilitate imaging of anatomical structures.
  • the deflectable portion of the portion of the catheter body 108 extends beyond the distal end of the guide catheter or accessory sheath 1710, it can be deflected regardless of whether the balloon 1702 is inflated. If the deflectable portion of the portion of the catheter body 108 does not extend beyond the distal end of the guide catheter or accessory sheath 1710, it will be restricted from deflecting by the walls of the guide catheter or accessory sheath, regardless of whether the balloon 1702 is inflated.
  • the flexible elongate member or catheter body 108 fits fairly snugly inside the guide catheter or accessory sheath 1710, such that the elongate member or catheter body 108 can be stabilized by the balloon 1702, in order to facilitate imaging by the imaging element or transducer array 320.
  • the fit also needs to be loose enough that the flexible elongate member or catheter body 108 and the guide catheter or accessory sheath 1710 can be translated and/or rotated relative to one another.
  • an inner diameter of the guide catheter or accessory sheath 1710 is larger than an outer diameter of the flexible elongate member or catheter body 108 by no less than 10 microns and no more than 50 microns.
  • FIG 18 is a schematic, diagrammatic side view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • the intraluminal imaging device 110 includes a handle 120, a flexible elongate member or catheter body 108 with a proximal end 810 and a distal end 820, and an imaging component or transducer array 320.
  • the flexible elongate member or catheter body 108 is surrounded by a guide catheter or accessory sheath 1710 (e.g., a second flexible elongate member), from which the stabilizing balloon 1702 extends.
  • the balloon 720 is positioned proximal of the distal end 1720 of the guide catheter or accessory sheath 1710.
  • the flexible elongate member or catheter body 108 fits within the guide catheter or accessory sheath 1710, such that the distal end 820 of the flexible elongate member 108 is proximal of the distal end 1720 of the guide catheter or accessory sheath 1710.
  • the imaging element or transducer array 320 is longitudinally and rotationally aligned with an opening 1810 in the guide catheter or accessory sheath 1710, distal of the balloon 1702, such that the imaging element 320 is exposed to facilitate imaging.
  • FIG 19 is a schematic, diagrammatic side view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • the intraluminal imaging device 110 includes a handle 120, a flexible elongate member or catheter body 108 with a proximal end 810 and a distal end 820, and an imaging component or transducer array 320.
  • the flexible elongate member or catheter body 108 is surrounded by a guide catheter or accessory sheath 1710 (e.g., a second flexible elongate member), from which the stabilizing balloon 1702 extends.
  • a guide catheter or accessory sheath 1710 e.g., a second flexible elongate member
  • the flexible elongate member or catheter body 108 fits within the guide catheter or accessory sheath 1710, such that the distal end 820 of the flexible elongate member 108 is proximal of the distal end 1720 of the guide catheter or accessory sheath 1710.
  • the imaging element or transducer array 320 is longitudinally and/or rotationally aligned with an acoustically transparent window 1910 in the guide catheter or accessory sheath 1710, distal of the balloon 720, such that the imaging element 320 is exposed to facilitate imaging.
  • the acoustically transparent window 1910 may for example be formed from an acoustically transparent material forming at least a portion of the body of the guide catheter or accessory sheath 1710.
  • the entire guide catheter or accessory sheath 1710 may be formed from acoustically transparent material, which may in some cases obviate the need for a window 1910 or opening 1810 in the body of the guide catheter or accessory sheath 1710.
  • FIG 20 is a schematic, diagrammatic side view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • the intraluminal imaging device 110 includes a handle 120, a flexible elongate member or catheter body 108 with a proximal end 810 and a distal end 820, and an imaging component or transducer array 320.
  • the flexible elongate member or catheter body 108 is surrounded by a guide catheter or accessory sheath 1710 (e.g., a second flexible elongate member), from which the stabilizing balloon 1702 extends.
  • the balloon 720 is positioned at the distal end 1720 of the guide catheter or accessory sheath 1710.
  • the flexible elongate member or catheter body 108 fits within the guide catheter or accessory sheath 1710, such that the distal end 820 of the flexible elongate member 108 is proximal of the distal end 1720 of the guide catheter or accessory sheath 1710.
  • the imaging element or transducer array 320 is longitudinally and rotationally aligned with an opening 1810 in the guide catheter or accessory sheath 1710, proximal of the balloon 1702, such that the imaging element 320 is exposed to facilitate imaging.
  • FIG. 21 is a schematic, diagrammatic side view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • the intraluminal imaging device 110 includes a handle 120, a flexible elongate member or catheter body 108 with a proximal end 810 and a distal end 820, and an imaging component or transducer array 320.
  • the flexible elongate member or catheter body 108 is surrounded by a guide catheter or accessory sheath 1710 (e.g., a second flexible elongate member), from which two stabilizing balloons 1702 extend.
  • a guide catheter or accessory sheath 1710 e.g., a second flexible elongate member
  • the flexible elongate member or catheter body 108 fits within the guide catheter or accessory sheath 1710, such that the distal end 820 of the flexible elongate member 108 is proximal of the distal end 1720 of the guide catheter or accessory sheath 1710.
  • the imaging element or transducer array 320 is longitudinally and rotationally aligned with an opening 1810 in the guide catheter or accessory sheath 1710, proximal of the balloon 1702, such that the imaging element 320 is exposed to facilitate imaging.
  • the first balloon 1702 is positioned proximal of the opening 1810.
  • the second balloon 720 is positioned distal of the opening 1810, near the distal end 1720 of the guide catheter or accessory sheath 1710, and spaced from the distal end 1720 by a distance L4. It is noted that the distance L4 could be zero, e.g., the second balloon 1702 may be located at the distal end 1720 of the guide catheter or accessory sheath 1710.
  • FIG 22 is a schematic, diagrammatic side cross-sectional view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure. Visible are the handle 120, flexible elongate member or catheter body 108, proximal end 810, distal end 820, and transducer array or imaging component 320.
  • the handle 120 includes at least one actuator 116, which operates at least one pull wire 607 within a pull wire lumen 606 within the flexible elongate member 108.
  • the pull wire 607 may for example be anchored to the tip assembly 102.
  • the flexible elongate member 108 also includes a plurality of electrical wires 1110 that place the imaging component or transducer array 320 in electrical communication with the processing system 130.
  • the electrical wires 1110 run through the electrical wire lumen 1105 from the tip assembly 102 through the entire length of the flexible elongate member 108, through the handle 120, through the cable 122 and connector 124 (see Figure 1) to connect with the processing system 130.
  • the flexible elongate member 108 does not include a stabilizing balloon, inflation port, inflation lumen, or inflation opening.
  • the flexible elongate member is circumferentially surrounded by a guide catheter or accessory sheath 1710.
  • the guide catheter or accessory sheath includes a stabilizing balloon 1702, as well as an inflation port 2220, inflation lumen 2230, and inflation opening 1140 that are in fluid communication with the interior of the balloon 1702, such that fluid pumped into the inflation port 2220 by an inflation source 1150 can expand the balloon 1702, and such that fluid pumped out of the inflation port 2220 by the inflation source 1150 can deflate the balloonl702.
  • the configuration shown in Figure 22 thus includes many similarities to the configuration shown in Figure 11, except that it is possible to remove the accessory sheath 1710 (including the stabilizing balloon 1702, inflation port 2220, inflation lumen 2230, and inflation opening 2240) from the patient without removing the flexible elongate member 108, and/or to remove the flexible elongate member 108 without removing the guide catheter 1710.
  • the accessory sheath 1710 including the stabilizing balloon 1702, inflation port 2220, inflation lumen 2230, and inflation opening 2240
  • the guide catheter 1710 also includes an acoustically transparent window 1910 (e.g., made from an acoustically transparent material forming portion of the body or wall of the guide catheter 1710), such that when the flexible elongate member 108 is advanced within the guide catheter 1710 until the imaging element 320 is aligned with the acoustically transparent window 1910, ultrasound energy can pass back and forth through the acoustically transparent window 1910, thus enabling the imaging element 320 to image anatomy within the patient.
  • an acoustically transparent window 1910 e.g., made from an acoustically transparent material forming portion of the body or wall of the guide catheter 1710
  • the inner diameter of the accessory sheath or guide catheter 1710 is slightly larger than the outer diameter of the ICE catheter body or flexible elongate member 108, but not substantially larger, so that the flexible elongate member 108 can be translated and/or rotated within the accessory sheath or guide catheter 1710, yet held stable by the stabilizing balloon 1702 during imaging.
  • an inner diameter of the guide catheter or accessory sheath 1710 is larger than an outer diameter of the flexible elongate member or catheter body 108 by no less than 10 microns and no more than 50 microns.
  • Figure 23 is a schematic, diagrammatic end cross-sectional view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure. Visible are the flexible elongate member or catheter body 108, pull wires 607, pull wire lumens 606, electrical wires 1110, electrical wire lumen 1105, accessory sheath or guide catheter 1710, and inflation lumen 2230. The flexible elongate member 108 fits within a lumen 2310 of the accessory sheath or guide catheter 1710. Also visible is inflation fluid 1310 disposed within the inflation lumen 2230. Depending on the implementation, the inflation fluid may be a gas (e.g., air, nitrogen, etc.), a liquid (e.g., water, saline), or a gel (e.g., saline gel).
  • a gas e.g., air, nitrogen, etc.
  • a liquid e.g., water, saline
  • a gel e.g., saline gel
  • Figure 24 is a schematic, diagrammatic end cross-sectional view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure. Visible are the flexible elongate member or catheter body 108, pull wires 607, pull wire lumens 606, electrical wires 1110, electrical wire lumen 1105, accessory sheath or guide catheter 1710, inflation lumen 2230, inflation opening 2240, balloon 1702, and inflation fluid 1310 disposed within the inflation lumen 1130 and balloon 1702.
  • the flexible elongate member 108 fits within a lumen 2310 of the accessory sheath or guide catheter 1710.
  • FIG. 25 is a schematic, diagrammatic side view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • the intraluminal imaging device 110 includes a handle 120, a flexible elongate member or catheter body 108 with a proximal end 810 and a distal end 820, and an imaging component or transducer array 320.
  • the flexible elongate member or catheter body 108 includes a guide wire lumen 2510 through which a guide wire 2520 extends.
  • the guide wire (which may be considered a second flexible elongate member) enters the guidewire lumen at a guidewire entry port 2530 and exits at a guidewire exit port 2540, which may for example be at the distal and 820 of the flexible elongate member 108.
  • the balloon 2502 When the balloon 2502 is fully inflated within a body lumen, it can arrest axial movement, rotational movement, and lateral movement of the guidewire 2520, while permitting axial and rotational movement of the catheter body 108, such that the imaging component or transducer array 320 can be translated longitudinally or rotated to various clock angles around the longitudinal axis to facilitate imaging of anatomical structures.
  • the guidewire When the balloon 2502 is fully inflated, the guidewire will dampen but not altogether prevent lateral movement and/or deflection of the flexible elongate member 108.
  • a stabilizing balloon 2502 which can be expanded or deflated via an inflation lumen located within the guidewire 2520
  • the guidewire 2520 fits fairly snugly inside the flexible elongate member or catheter body 108, such that the elongate member or catheter body 108 can be stabilized by the balloon 702, in order to facilitate imaging by the imaging element or transducer array 320.
  • the fit also needs to be loose enough that the flexible elongate member or catheter body 108 and the guide catheter or accessory sheath 1710 can be translated and/or rotated relative to one another.
  • an inner diameter of the flexible elongate member or catheter body 108 is larger than an outer diameter of the guidewire 2520 by no less than 10 microns and no more than 50 microns.
  • Figure 26 is a schematic, diagrammatic side cross-sectional view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure. Visible are the handle 120, flexible elongate member or catheter body 108, proximal end 810, distal end 820, and transducer array or imaging component 320.
  • the handle 120 includes at least one actuator 116, which operates at least one pull wire 607 within a pull wire lumen 606 within the flexible elongate member 108.
  • the pull wire 607 may for example be anchored to the tip assembly 102.
  • the flexible elongate member 108 also includes a plurality of electrical wires 1110 within the electrical wire lumen 1105, that place the imaging component or transducer array 320 in electrical communication with the processing system 130.
  • the electrical wires 1110 run through an electrical wire lumen 1105 from the tip assembly 102 through the entire length of the flexible elongate member 108, through the handle 120, through the cable 122 and connector 124 (see Figure 1) to connect with the processing system 130.
  • the flexible elongate member 108 also includes a guidewire lumen 2510 through which a guidewire 2520 extends.
  • the guidewire includes an inflation port 2620 and inflation lumen 2630 in fluid communication with an inflation opening 2640 that is in fluid communication with the interior of a stabilizing balloon 2602, such that fluid pumped into the inflation port 2620 by an inflation source 1150 can expand the balloon 2602, and such that fluid pumped out of the inflation port 2620 by the inflation source 1150 can deflate the balloon 2602.
  • the inflation source 1150 may be manually operable (e.g., a syringe) or automatically operable (e.g., an electrically operated syringe or pump in electrical communication with the processing system 130).
  • Figure 27 is a schematic, diagrammatic end cross-sectional view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure. Visible are the flexible elongate member or catheter body 108, pull wires 607, pull wire lumens 606, electrical wires 1110, electrical wire lumen 1105, guidewire lumen 2510, guidewire 2520, inflation lumen 2630, and inflation fluid 1310 disposed within the inflation lumen 2630.
  • an inner diameter of the flexible elongate member or catheter body 108 is larger than an outer diameter of the guidewire 2520 by no less than 10 microns and no more than 50 microns.
  • FIG. 28 is a schematic, diagrammatic side view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure.
  • the intraluminal imaging device 110 includes a handle 120, a flexible elongate member or catheter body 108 with a proximal end 810 and a distal end 820, and an imaging component or transducer array 320.
  • the flexible elongate member or catheter body 108 is surrounded by a guide catheter or accessory sheath 2810 (e.g., a second flexible elongate member), which includes a guidewire lumen 2820 through which extends a guidewire 2520 (e.g., a third flexible elongate member) that has a stabilizing balloon 2502 at its distal end.
  • the flexible elongate member or catheter body 108 extends to the distal and of the guide catheter or accessory sheath 2810, such that the imaging element or transducer array 320 is aligned with an acoustically transparent window 2250, to facilitate imaging.
  • Figure 29 is a schematic, diagrammatic side cross-sectional view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure. Visible are the handle 120, flexible elongate member or catheter body 108, proximal end 810, distal end 820, and transducer array or imaging component 320.
  • the handle 120 includes at least one actuator 116, which operates at least one pull wire 607 within a pull wire lumen 606 within the flexible elongate member 108.
  • the pull wire 607 may for example be anchored to the tip assembly 102.
  • the flexible elongate member 108 also includes a plurality of electrical wires 1110 within the electrical wire lumen 1105, that place the imaging component or transducer array 320 in electrical communication with the processing system 130.
  • the electrical wires 1110 run from the tip assembly 102 through the entire length of the flexible elongate member 108, through the handle 120, through the cable 122 and connector 124 (see Figure 1) to connect with the processing system 130.
  • the flexible elongate member 108 is surrounded by an accessory sheath or guide catheter 2810, which includes a guidewire lumen 2510 and an acoustically transparent window 2250.
  • a guidewire 2520 may be inserted through the guidewire lumen 2510 until its distal end projects past the distal end 820 of the flexible elongate member 108 and also the distal end of the accessory sheath or guide catheter, such that a stabilizing balloon 2602 positioned at or near the distal and of the guidewire 2520 can be expanded.
  • the guidewire 2520 includes an inflation port 2620, inflation lumen 2630, and inflation opening 2640, through which fluid can be moved in order to expand or deflate the balloon 2602.
  • Figure 30 is a schematic, diagrammatic end cross-sectional view of at least a portion of an example intraluminal imaging device 110, according to embodiments of the present disclosure. Visible are the flexible elongate member or catheter body 108, pull wires 607, pull wire lumens 606, and electrical wires 1110 within the electrical wire lumen 1105. Also visible is an accessory sheath or guide catheter 2810 surrounding the flexible elongate member 108 in a catheter lumen 3010. The accessory sheath or guide catheter 2810 also includes a guidewire lumen 2510, through which a guidewire 2520 can be inserted. The guidewire 2520 includes an inflation lumen 2630 through which inflation fluid 1310 can flow.
  • an inner diameter of the catheter lumen 3010 is larger than an outer diameter of the flexible elongate member by no less than 10 microns and no more than 50 microns
  • an inner diameter of the guidewire lumen 2510 is larger than an outer diameter of the guide wire 2520 by no less than 10 microns and no more than 50 microns.
  • FIG 31 is a schematic diagram of a processor circuit 3150, according to embodiments of the present disclosure.
  • the processor circuit 3150 may be implemented in the intraluminal imaging system 100, or other devices or workstations (e.g., third-party workstations, network routers, etc.), or on a cloud processor or other remote processing unit, as necessary to implement the method.
  • the processor circuit 3150 may include a processor 3160, a memory 3164, and a communication module 3168. These elements may be in direct or indirect communication with each other, for example via one or more buses.
  • the processor 3160 may include a central processing unit (CPU), a digital signal processor (DSP), an ASIC, a controller, or any combination of general -purpose computing devices, reduced instruction set computing (RISC) devices, application-specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or other related logic devices, including mechanical and quantum computers.
  • the processor 3160 may also comprise another hardware device, a firmware device, or any combination thereof configured to perform the operations described herein.
  • the processor 3160 may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.
  • the memory 3164 may include a cache memory (e.g., a cache memory of the processor 3160), random access memory (RAM), magnetoresistive RAM (MRAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read only memory (EPROM), electrically erasable programmable read only memory (EEPROM), flash memory, solid state memory device, hard disk drives, other forms of volatile and non-volatile memory, or a combination of different types of memory.
  • the memory 3164 includes a non-transitory computer-readable medium.
  • the memory 3164 may store instructions 3166.
  • the instructions 3166 may include instructions that, when executed by the processor 3160, cause the processor 3160 to perform the operations described herein.
  • Instructions 3166 may also be referred to as code.
  • the terms “instructions” and “code” should be interpreted broadly to include any type of computer-readable statement(s).
  • the terms “instructions” and “code” may refer to one or more programs, routines, sub-routines, functions, procedures, etc.
  • “Instructions” and “code” may include a single computer-readable statement or many computer-readable statements.
  • the communication module 3168 can include any electronic circuitry and/or logic circuitry to facilitate direct or indirect communication of data between the processor circuit 3150, and other processors or devices.
  • the communication module 3168 can be an input/output (I/O) device.
  • the communication module 3168 facilitates direct or indirect communication between various elements of the processor circuit 3150 and/or the intraluminal imaging system 100.
  • the communication module 3168 may communicate within the processor circuit 3150 through numerous methods or protocols.
  • Serial communication protocols may include but are not limited to United States Serial Protocol Interface (US SPI), Inter-Integrated Circuit (I 2 C), Recommended Standard 232 (RS-232), RS-485, Controller Area Network (CAN), Ethernet, Aeronautical Radio, Incorporated 429 (ARINC 429), MODBUS, Military Standard 1553 (MIL-STD-1553), or any other suitable method or protocol.
  • Parallel protocols include but are not limited to Industry Standard Architecture (ISA), Advanced Technology Attachment (ATA), Small Computer System Interface (SCSI), Peripheral Component Interconnect (PCI), Institute of Electrical and Electronics Engineers 488 (IEEE-488), IEEE- 1284, and other suitable protocols. Where appropriate, serial and parallel communications may be bridged by a Universal Asynchronous Receiver Transmitter (UART), Universal Synchronous Receiver Transmitter (USART), or other appropriate subsystem.
  • UART Universal Asynchronous Receiver Transmitter
  • USBART Universal Synchronous Receiver Transmitter
  • External communication may be accomplished using any suitable wireless or wired communication technology, such as a cable interface such as a universal serial bus (USB), micro USB, Lightning, or FireWire interface, Bluetooth, Wi-Fi, ZigBee, Li-Fi, or cellular data connections such as 2G/GSM (global system for mobiles) , 3G/UMTS (universal mobile telecommunications system), 4G, long term evolution (LTE), WiMax, or 5G.
  • a Bluetooth Low Energy (BLE) radio can be used to establish connectivity with a cloud service, for transmission of data, and for receipt of software patches.
  • BLE Bluetooth Low Energy
  • the controller may be configured to communicate with a remote server, or a local device such as a laptop, tablet, or handheld device, or may include a display capable of showing status variables and other information. Information may also be transferred on physical media such as a USB flash drive or memory stick.
  • Figure 32 is a flow diagram of an example intracardiac echography imaging method 3200, according to embodiments of the present disclosure.
  • step 3210 the method includes advancing an ICE catheter into a patient’s heart.
  • step 3220 the method includes positioning an expandable structure of the ICE catheter into a suitable body lumen.
  • step 3230 the method includes transitioning the expandable structure into an expanded state, such that the ICE catheter is stabilized by the expandable structure and the body lumen.
  • step 3240 the method includes obtaining ICE images via the stabilized ICE catheter.
  • step 3250 the method includes transitioning the expandable structure to its unexpanded state and withdrawing the ICE catheter.
  • the imaging catheter with stabilizing structures advantageously provides devices, systems, and methods for imaging structures within the heart chambers (or other body lumens) while stabilizing imaging sensors against unwanted motion during the imaging process.
  • connection references e.g., attached, coupled, connected, joined, or “in communication with” are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise indicated. As such, connection references do not necessarily imply that two elements are directly connected and in fixed relation to each other.
  • the term “or” shall be interpreted to mean “and/or” rather than “exclusive or.”
  • the word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. Unless otherwise noted in the claims, stated values shall be interpreted as illustrative only and shall not be taken to be limiting.

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  • Molecular Biology (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Abstract

L'invention concerne un système qui comprend un cathéter d'échocardiographie intracardiaque (ICE) avec un réseau de transducteurs ultrasonores configuré pour obtenir des données d'imagerie échographique du cœur d'un sujet ; et une structure extensible fonctionnellement associée au cathéter ICE. La structure extensible est conçue pour être positionnée à l'intérieur d'une lumière corporelle associée au cœur et passer d'un état déployé à un état non déployé. Dans l'état non déployé, le cathéter ICE est conçu pour se déplacer par rapport à la lumière corporelle. Dans l'état déployé, la structure extensible est configurée pour limiter le mouvement du cathéter ICE par rapport à la lumière corporelle de telle sorte que le réseau de transducteurs ultrasonores soit stabilisé pour obtenir les données d'imagerie échographique du cœur.
PCT/EP2024/051158 2023-01-26 2024-01-18 Cathéter d'imagerie intraluminale avec structure extensible pour la stabilisation d'élément d'imagerie Ceased WO2024156589A1 (fr)

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US202363441243P 2023-01-26 2023-01-26
US63/441,243 2023-01-26

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140180126A1 (en) * 2012-12-20 2014-06-26 Volcano Corporation Catheter with balloon and imaging
US20150238729A1 (en) * 2014-02-24 2015-08-27 Mark Lynn Jenson Cardiac Access Catheter, System, and Method
US20190274658A1 (en) 2016-09-29 2019-09-12 Koninklijke Philips N.V. Intracardiac echocardiography (ice) catheter tip assembly
US20190307420A1 (en) 2016-09-29 2019-10-10 Koninklijke Philips N.V. Pullwire crown and crown sleeve for catheter assembly
US20190321176A1 (en) * 2015-09-29 2019-10-24 Millipede, Inc. Methods for delivery of heart valve devices using intravascular ultrasound imaging
US20210275136A1 (en) 2016-09-29 2021-09-09 Koninklijke Philips N.V. Lined variable braided differential durometer multi-lumen shaft with a cross-shaped inner profile
US20210298718A1 (en) 2016-09-30 2021-09-30 Koninklijke Philips N.V. Control handle for steerable medical devices
WO2022224071A1 (fr) * 2021-04-22 2022-10-27 Edwards Lifesciences Innovation (Israel) Ltd. Dispositifs de stabilisation de cathéter

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140180126A1 (en) * 2012-12-20 2014-06-26 Volcano Corporation Catheter with balloon and imaging
US20150238729A1 (en) * 2014-02-24 2015-08-27 Mark Lynn Jenson Cardiac Access Catheter, System, and Method
US20190321176A1 (en) * 2015-09-29 2019-10-24 Millipede, Inc. Methods for delivery of heart valve devices using intravascular ultrasound imaging
US20190274658A1 (en) 2016-09-29 2019-09-12 Koninklijke Philips N.V. Intracardiac echocardiography (ice) catheter tip assembly
US20190307420A1 (en) 2016-09-29 2019-10-10 Koninklijke Philips N.V. Pullwire crown and crown sleeve for catheter assembly
US20210275136A1 (en) 2016-09-29 2021-09-09 Koninklijke Philips N.V. Lined variable braided differential durometer multi-lumen shaft with a cross-shaped inner profile
US20210298718A1 (en) 2016-09-30 2021-09-30 Koninklijke Philips N.V. Control handle for steerable medical devices
WO2022224071A1 (fr) * 2021-04-22 2022-10-27 Edwards Lifesciences Innovation (Israel) Ltd. Dispositifs de stabilisation de cathéter

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