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WO2025144761A1 - Systèmes de pose pour valvules cardiaques prothétiques et systèmes d'imagerie - Google Patents

Systèmes de pose pour valvules cardiaques prothétiques et systèmes d'imagerie Download PDF

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Publication number
WO2025144761A1
WO2025144761A1 PCT/US2024/061564 US2024061564W WO2025144761A1 WO 2025144761 A1 WO2025144761 A1 WO 2025144761A1 US 2024061564 W US2024061564 W US 2024061564W WO 2025144761 A1 WO2025144761 A1 WO 2025144761A1
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WO
WIPO (PCT)
Prior art keywords
catheter
delivery system
delivery
proximal
distal
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/US2024/061564
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English (en)
Inventor
Eric Robert DIXON
Zachary Charles VANEVERY
Paul Warren JULIAN
ASH (FORMERLY HOYE), Shannon, Nicole
David Robert LANDON
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.)
Edwards Lifesciences Corp
Original Assignee
Edwards Lifesciences Corp
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
Application filed by Edwards Lifesciences Corp filed Critical Edwards Lifesciences Corp
Publication of WO2025144761A1 publication Critical patent/WO2025144761A1/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
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0133—Tip steering devices
    • A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M25/04—Holding devices, e.g. on the body in the body, e.g. expansible
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/2436—Deployment by retracting a sheath

Definitions

  • Human heart valves which include the aortic, pulmonary, mitral, and tricuspid valves, function essentially as one-way valves operating in synchronization with the pumping heart.
  • the valves allow blood to flow downstream, but block blood from flowing upstream.
  • Diseased heart valves exhibit impairments such as narrowing of the valve or regurgitation, which inhibit the valves’ ability to control blood flow.
  • Such impairments reduce the heart’s blood-pumping efficiency and can be a debilitating and life-threatening condition.
  • valve deficiencies can lead to conditions such as heart hypertrophy and dilation of the ventricle.
  • efforts have been made to develop methods and apparatuses to repair or replace impaired heart valves.
  • Delivering devices to native valves can be extremely challenging. Obtaining access to perform procedures in the heart or in other anatomical locations may require delivery of devices percutaneously through tortuous vasculature. To compound the difficulty, delivery systems have a practical maximum diameter to enable passage through the vasculature, which limits the number and type of delivery tools that can fit within the delivery sheath. A need exists for more advanced transcatheter delivery systems.
  • the delivery system includes a rail catheter or rail.
  • the rail or rail catheter can include a steerable distal end portion.
  • the rail catheter is one of the one or more catheters of the delivery system.
  • the rail or rail catheter can include an anchor coupled to a distal end of the steerable distal end portion.
  • the anchor is useable for anchoring the steerable distal end portion to a heart wall, e.g., a wall within a ventricle of the heart.
  • the rail or rail catheter can include an intermediate portion coupled to a proximal end of the steerable distal end portion.
  • the intermediate portion is adapted to extend axially through an atrioventricular heart valve from an atrium to the ventricle of the heart.
  • the intermediate portion adapted to form a bend portion on an atrial side of the atrioventricular' heart valve.
  • FIG. 21 illustrates a rail catheter 12 extended through the right atrium 144 and the right ventricle 142.
  • the anchor 98 has been deployed.
  • the deflection sections 18, 20 can be flexed as desired to provide a desired alignment of the rail catheter 12 with the native valve or tricuspid valve 150 for deployment.
  • a user may steer the deflection sections 18, 20 to form a desired bend in the ventricle.
  • the linear portion or column portion of the intermediate portion 30 is preferably placed in desired axial alignment with the native valve. Imaging can be utilized to determine the alignment of the rail catheter 12 as desired.
  • Dual control or flexure points useable with the system 10 can provide a variety of benefits.
  • the anchor 98 can support the distal end of the rail catheter 12 such that flexure of the distal end of the rail catheter 12 is stabilized within the ventricle. As such, a stable anchoring point for the rail catheter 12 is provided. Flexure of the deflection sections 18, 20 of the rail catheter 12 can be provided with stable positioning of the anchor 98. A solid pivot point in the ventricle near the apex is provided. The offset of the distal end portion of the rail catheter 12 can be controlled. Further, the bend catheter 16 can provide a proximal flexure point that provides stable alignment of the intermediate portion 30 of the rail catheter 12 through the native valve annulus. Imaging can be utilized to determine a desired alignment of the intermediate portion 30 of the rail catheter 12.
  • an optional nose body and/or guidewire can be utilized for further stability of the delivery system 10.
  • the implementations of FIGS. 27-43 can be utilized with the system 10 or can be utilized with other forms of delivery systems as desired.
  • FIG. 26 illustrates use of a nose body 170 or nose cone, which can include a lumen 172 for passage of a guidewire 174 therethrough (i.e., a guidewire lumen).
  • the guidewire 174 can extend through the lumen 172 and slide within the lumen 172 during an insertion procedure.
  • a nose body and/or guidewire can be adapted to produce improved anchoring at desired portion within the vasculature of the subject (c.g., living subject, simulation, etc.).
  • the anchoring can be utilized as an anchor in the system 10 or can be utilized for anchoring in other forms of delivery systems (e.g., any other form of delivery system disclosed herein).
  • FIGS. 27-43 illustrate implementations of a nose body being positioned at a distal end portion of an elongate shaft, which can comprise any shaft as disclosed herein (including a rail catheter 12 or other delivery catheters as disclosed herein).
  • an optional fixation feature is coupled to the nose body and is adapted to fix the nose body in position against a heart wall (e.g., of a ventricle, etc.) to support the elongate shaft during deployment of a prosthetic heart valve to a heart valve (e.g., an atrioventricular heart valve).
  • a heart wall e.g., of a ventricle, etc.
  • a prosthetic heart valve e.g., an atrioventricular heart valve
  • FIGS. 27-29 illustrate an implementation in which a nose body 180 includes a fixation feature in the form of a sock or sleeve 182 extending from a distal end of the nose body 180.
  • the sock or sleeve 182 can include an interior lumen 184 for passage of the guidewire 174 therethrough.
  • the sock or sleeve 182 can have a textured outer surface (e.g., ribs or pleats) in some implementations, which can increase friction with an anchoring site.
  • FIG. 28 illustrates an exemplary textured outer surface 186 that can be utilized. Ridges or ribbing of the textured outer surface 186 can grip at an anchoring site to produce friction and increase anchoring with the sock or sleeve 182. Other forms of textured outer surfaces 186 can be utilized in some implementations.
  • FIG. 29 illustrates an exemplary use, in which the guidewire 174 passes into the sock or sleeve 182 that is textured.
  • the sock or sleeve 182 contacts the interior surface of the heart (e.g., an interior surface of the ventricle) to provide the desired friction for anchoring.
  • FIGS. 30-34 illustrate a variation in which the nose body 190 includes a fixation feature in the form of a friction surface 192.
  • the friction surface 192 is configured to be smooth or relatively low friction unless force is applied to the nose body 190 or the nose body 190 is otherwise deflected.
  • FIG. 31 A illustrates the friction surface 192 having a relatively smooth surface upon a lack of deflection
  • FIG. 3 IB illustrates the increased roughness of the surface 192 (with raised portions 194) produced by a force or a deflection.
  • the friction surface 192 for example, can comprise a cut pattern of cloth or fabric that is smooth until deflected, similar to a cut pattern 191 as shown in FIG. 32.
  • the friction surface 192 can comprise a rubberized surface with pits 193 and ridges that increase in relative height upon a force or deflection upon the surface 192 as represented in FIG. 33.
  • FIG. 34 illustrates an implementation in which the nose body 190 contacts against the interior surface of the heart wall to deflect the friction surface 192. As such, friction is increased upon deflection and the nose body 190 anchors in position.
  • a friction surface 192 can be utilized with a guidewire as desired.
  • a distal end portion of the guidewire can include any form of fixation feature disclosed herein.
  • FIGS. 35-37 illustrate a variation in which a nose body 200 includes a fixation feature in the form of an inflatable body 202.
  • Inflation lumens 204 extend to inflate the inflatable body 202.
  • the inflatable body 202 can comprise a balloon and can include a grip surface or texture surface on an outer surface to increase grip and anchoring.
  • FIG. 36 illustrates advancement of the nose body 200 to a treatment site (e.g., an apex of a ventricle).
  • the inflatable body 202 is in a deflated state.
  • FIG. 37 illustrates the inflatable body 202 inflated to contour to the shape of the apex and anchor in position.
  • the textured outer surface of the inflatable body 202 engages the interior surface of the ventricle to secure in position.
  • an inflatable body can be positioned on a guidewire and can be utilized in a similar manner.
  • FIGS. 38 and 39 illustrate a variation in which a nose body 210 includes a fixation feature in the form of barbs or prongs 212 for gripping tissue.
  • the barbs or prongs 212 can be expandable in some implementations or can be non-expandable in some implementations.
  • FIG. 39 illustrates an implementation in which the barbs or prongs 212 penetrate the heart wall tissue for anchoring.
  • a guidewire can include similar features.
  • An external magnet 234 (marked in FIG. 43) or magnetic responsive material can be utilized to provide the force against the magnets 232 on the nose body 230. A magnetic coupling with an external magnetic responsive material or magnet may result.
  • the external magnet 234 can be positioned external of the ventricle and/or external of the subject’s body if desired.
  • the external magnet 234 can comprise an electromagnet to control the strength of the magnetic field or can comprise a permanent magnet in some implementations.
  • a guidewire can include similar features for clamping with the external magnet 234.
  • FIGS. 27-43 can be utilized with the delivery system 10 or can be utilized with any other form of system as desired (including other delivery systems as disclosed herein).
  • the features of the implementations of FIGS. 27-43 can be utilized solely or in combination with any other implementation disclosed herein.
  • FIGS. 44 and 45 illustrate implementations of delivery systems 240, 250 including respective elongate delivery shafts or catheters 242, 252 and actuator assemblies or handles 244, 254.
  • the elongate delivery shafts 242, 252 can each include a plurality of shafts or sheaths that can be utilized to deploy an implant and/or navigate the delivery shafts 242, 252 to a desired treatment site.
  • the delivery systems 240, 250 e.g., shafts 242,252 thereof
  • the delivery systems 240, 250 can include respective control mechanisms or actuators 245, 255 for controlling deflection of the respective elongate delivery shafts 242, 252 or release of the prosthetic heart valve from the delivery shafts 242, 252.
  • the delivery systems 240, 250 can include multiple catheters, shafts, or sheaths along the elongate delivery shafts/catheters 242, 252.
  • the multiple catheters/shafts/sheaths may be utilized for a variety of purposes including deflection of the respective elongate delivery shafts/catheters 242, 252 and/or release of the prosthetic heart valve and/or variation of a depth or height of an elongate delivery shaft 242, 252.
  • a delivery catheter is adapted to retain a device (e.g., replacement device, prosthetic heart valve, repair device, treatment device, implant, etc.) and advance to a native heart valve.
  • a device e.g., replacement device, prosthetic heart valve, repair device, treatment device, implant, etc.
  • the delivery catheter is adapted or configured to retain an expandable device (e.g., replacement device, prosthetic heart valve, repair device, treatment device, implant, etc.) in a radially collapsed configuration and advance to a native heart valve.
  • the delivery catheter is adapted or configured for deployment or implantation of the device or expandable device at the native heart valve.
  • the delivery catheter includes a first shaft and a second shaft for sliding axially relative to the first shaft.
  • friction e.g., stiction
  • Such friction can be undesirable as the shafts (or sheaths) can be stuck together and otherwise difficult to move.
  • the friction can particularly be reduced at any bend portion or deflection portion of an elongate shaft at which the delivery catheter bends. Implementations disclosed herein can reduce such friction or stiction.
  • FIGS. 46-48 illustrate mechanisms to reduce friction or stiction between shafts or sheaths of a delivery system.
  • a variety of forms of mechanisms can be utilized.
  • Vibration mechanisms can be utilized in some implementations.
  • a vibration mechanism can produce vibration of a first shaft 262 relative to a second shaft 264 to reduce friction between the first shaft 262 and the second shaft 264.
  • FIG. 46 illustrates a configuration in which a vibration mechanism comprising a vibrating body 260 (such as an oscillating offset weight, a magnetically vibrating body (e.g., an ultrasonic vibration), or a piezoelectric vibrating transducer) can be applied to one of the shafts 262.
  • the vibration can carry along the shaft 262 to reduce friction (stiction) with other of the shafts 264.
  • the vibrating body 260 can be electrically controlled with a controller 266 in some implementations.
  • the vibrating body 260 can be positioned at a proximal end portion of a delivery shaft 242, 252 (as shown in FIGS. 44 and 45), which can comprise a handle in some implementations.
  • the vibrating body 260 can vibrate continuously during a procedure or at selected times at which a user provides such input (a user input) to the controller 266.
  • the position of the vibrating body 260 can vary in some implementations.
  • FIG. 47 illustrates a configuration in which the vibrating body 260 is positioned at the distal end portion of the delivery shaft 242, 252 (as shown in FIGS. 44 and 45). Electrical conduits can extend to the controller 266 to control actuation of the vibrating body 260.
  • the distal end portion may be a portion at the deployment or delivery site and may include a capsule or other form of implant retention area for retaining the implant therein (e.g., the prosthetic heart valve).
  • the frequency of the vibrations can be tuned to induce micromovements.
  • Example 22 The method of any example herein, in particular example 21, further comprising steering the steerable distal end portion to form a bend of the steerable distal end portion in the ventricle.
  • Example 68 The delivery system of any example herein, in particular example 67, wherein the magnetically vibrating body is configured to produce ultrasonic vibration.
  • Example 74 The delivery system of any example herein, in particular- examples 61-
  • the expandable device is at least one of an expandable prosthetic mitral heart valve or an expandable prosthetic tricuspid heart valve.
  • Example 76 A method comprising: deploying a device at a native heart valve utilizing a delivery system, the delivery system including: a delivery catheter adapted to retain the device therein and approach the native heart valve for deployment of the device at the native heart valve, the delivery catheter including a first shaft and a second shaft for sliding axially relative to the first shaft, and/or a vibration mechanism for producing vibration of the first shaft relative to the second shaft to reduce friction between the first shaft and the second shaft.
  • Example 80 The method of any example herein, in particular examples 76-79, wherein the device is at least one of an expandable prosthetic mitral heart valve or an expandable prosthetic tricuspid heart valve.
  • Example 81 A delivery system, comprising: a treatment device; a delivery catheter adapted to retain the treatment device and approach a native heart valve for deployment of the treatment device at the native heart valve; a sensor system for sensing movement of at least a portion of the delivery catheter; and/or a data logger for storing data of the movements of at least the portion of the delivery catheter sensed by the sensor system.
  • Example 82 The delivery system of any example herein, in particular example 81, wherein the sensor system includes one or more of a rotary encoder or a linear encoder.
  • Example 86 The delivery system of any example herein, in particular example 85, wherein the remote electronic device includes a display screen for displaying movements of one or more actuators of the delivery catheter or movements of one or more shafts of the delivery catheter.
  • Example 87 The delivery system of any example herein, in particular example 86, wherein the remote electronic device is configured to display in real time a position of one or more actuators of the delivery catheter during a deployment procedure.
  • Example 89 The delivery system of any example herein, in particular- examples 81-
  • the device is at least one of an expandable prosthetic mitral heart valve or an expandable prosthetic tricuspid heart valve.
  • Example 91 A method comprising: deploying a device to a native heart valve utilizing a delivery system, the delivery system including: a delivery catheter adapted to retain the device and approach the native heart valve for deployment of the expandable device at the native heart valve, a sensor system for sensing movement of at least a portion of the delivery catheter, and/or a data logger for storing data of the movements of at least the portion of the delivery catheter sensed by the sensor system.
  • Example 92 The method of any example herein, in particular example 91, wherein the sensor system includes one or more of a rotary encoder or a linear encoder.
  • Example 93 The method of any example herein, in particular example 92, wherein the delivery catheter includes one or more control knobs for actuating a portion of the delivery catheter, and the rotary encoder is configured to track a rotational movement of the one or more control knobs.
  • Example 94 The method of any example herein, in particular examples 91-93, wherein the data logger includes an electronic device that is configured to display in real time a position of one or more actuators of the delivery catheter during a deployment procedure.
  • Example 95 The method of any example herein, in particular examples 91-94, wherein the device is at least one of an expandable prosthetic mitral heart valve or an expandable prosthetic tricuspid heart valve.
  • Example 96 A delivery system, comprising: a treatment device; an elongate imaging catheter (e.g., an intracardiac echocardiography catheter, etc.) adapted to image a treatment site for the treatment device; and/or a delivery catheter adapted to retain the treatment device and approach a native heart valve for deployment of the treatment device at the native heart valve, the delivery catheter including a coupler for coupling the elongate imaging catheter to the delivery catheter.
  • an elongate imaging catheter e.g., an intracardiac echocardiography catheter, etc.
  • Example 97 The delivery system of any example herein, in particular example 96, wherein the coupler comprises a channel extending along a length of the delivery catheter.
  • Example 98 The delivery system of any example herein, in particular example 97, wherein the channel is an expandable channel configured to expand upon insertion of the elongate imaging catheter therethrough.
  • Example 100 The delivery system of any example herein, in particular examples 97-
  • the delivery catheter includes an elongate shaft and a sheath extending over the elongate shaft, the sheath being adapted to rotate about the elongate shaft and including the channel.
  • Example 101 The delivery system of any example herein, in particular examples 96-
  • Example 102 The delivery system of any example herein, in particular example 101 , wherein the delivery catheter includes a proximal end portion and/or a distal end portion, and the clip is positioned at the distal end portion of the delivery catheter.
  • Example 103 The delivery system of any example herein, in particular examples 96- 102, wherein the coupler comprises one or more snares for snaring the elongate imaging catheter in vivo and retaining the elongate imaging catheter to the delivery catheter.
  • Example 104 The delivery system of any example herein, in particular example 103, further comprising a pulley positioned on the delivery catheter, the one or more snares being routed through the pulley.
  • Example 105 The delivery system of any example herein, in particular example 103 or example 104, wherein the delivery catheter includes an outer surface, and the one or more snares protrude from the outer surface of the delivery catheter.
  • Example 106 The delivery system of any example herein, in particular examples 96-
  • the coupler comprises a magnetic coupler
  • Example 107 The delivery system of any example herein, in particular examples 96-
  • the coupler comprises a wire for the elongate imaging catheter to slide along.
  • Example 108 The delivery system of any example herein, in particular examples 96-
  • the coupler comprises a rail for the elongate imaging catheter to slide along.
  • Example 109 The delivery system of any example herein, in particular examples 96-
  • the delivery catheter includes a capsule for retaining the device.
  • Example 110 The delivery system of any example herein, in particular examples 96-
  • the device is at least one of an expandable prosthetic mitral heart valve or an expandable prosthetic tricuspid heart valve.
  • Example 111 A method comprising: deploying an expandable device at a native heart valve utilizing a delivery system, the delivery system including: an elongate imaging catheter (e.g., an intracardiac echocardiography catheter, etc.) adapted to image a treatment site for the expandable device, and/or a delivery catheter adapted to retain the expandable device in a radially collapsed configuration and approach the native heart valve for deployment of the expandable device to the native heart valve, the delivery catheter including a coupler for coupling the elongate imaging catheter to the delivery catheter.
  • Example 1 12 The method of any example herein, in particular example 111 , further comprising coupling the elongate imaging catheter to the delivery catheter in vivo.
  • Example 113 The method of any example herein, in particular example 111 or example 112, further comprising coupling the elongate imaging catheter to the delivery catheter ex vivo.
  • Example 114 The method of any example herein, in particular examples 111-113, further comprising imaging the native heart valve with the elongate imaging catheter, with the elongate imaging catheter coupled to the delivery catheter.
  • Example 115 The method of any example herein, in particular examples 111-114, wherein the expandable device is at least one of an expandable prosthetic mitral heart valve or an expandable prosthetic tricuspid heart valve.
  • Example 116 A delivery system, comprising: a rail catheter for producing a bend for orienting a device in vivo, the rail catheter including: a tube portion configured to deflect to produce the bend of the rail catheter, the tube portion including an interior lumen positioned between a distal body and a proximal body, the proximal body having a channel extending therethrough, a pull wire extending through the channel of the proximal body and through the interior lumen, the pull wire having a distal end portion coupled to the distal body, the pull wire adapted to be retracted to deflect the tube portion in a direction, and/or a force resisting member positioned upon the pull wire between the distal body and the proximal body, the force resisting member configured to abut the proximal body and the distal body to resist a deflection of the tube portion.
  • Example 117 The delivery system of any example herein, in particular example 116, wherein the force resisting member is configured to abut the distal body at a connection point between the pull wire and the distal body.
  • Example 118 The delivery system of any example herein, in particular example 116 or example 117, wherein the force resisting member is configured to resist a compression of the force resisting member applied by the proximal body and the distal body.
  • Example 119 The delivery system of any example herein, in particular examples 116— 118, wherein the force resisting member is configured to be compressed to a length that is less than a length between the distal body and the proximal body with the tube portion straightened.
  • Example 120 The delivery system of any example herein, in particular examples 116-
  • the force resisting member has a length that is less than a length between the distal body and the proximal body with the tube portion straightened.
  • Example 121 The delivery system of any example herein, in particular examples 116—
  • the tube portion includes a plurality of cuts configured to allow the tube portion to deflect in the direction.
  • Example 122 The delivery system of any example herein, in particular examples 116—
  • the tube portion is a first tube portion
  • the rail catheter includes a second tube portion positioned proximal of the first tube portion, the second tube portion configured to deflect in a direction that is different than the direction that the first tube portion is configured to be deflected in.
  • Example 123 The delivery system of any example herein, in particular examples 116—
  • the force resisting member comprises one or more of a coil or a tube positioned upon the pull wire.
  • Example 124 The delivery system of any example herein, in particular example 123, wherein the coil includes wraps that abut each other with the tube portion straightened, or includes wraps that are spaced from each other with the tube portion straightened.
  • Example 125 The delivery system of any example herein, in particular examples 116- 124, wherein the force resisting member includes a plurality of bodies configured to slide along the pull wire.
  • Example 127 The delivery system of any example herein, in particular examples 116- 126, further comprising an outer shaft extending over the rail catheter.
  • Example 128 The delivery system of any example herein, in particular example 127, wherein the outer shaft includes a capsule for retaining the device.
  • Example 129 The delivery system of any example herein, in particular example 127 or example 128, wherein the outer shaft is configured to slide relative to the rail catheter.
  • Example 130 The delivery system of any example herein, in particular examples 116- 129, wherein the device is at least one of an expandable prosthetic mitral heart valve or an expandable prosthetic tricuspid heart valve.
  • Example 131 A method comprising: deploying an device at a native heart valve utilizing a delivery system, the delivery system including: a rail catheter for producing a bend for orienting the device in vivo, the rail catheter including: a tube portion configured to deflect to produce the bend of the rail catheter, the tube portion including an interior lumen positioned between a distal body and a proximal body, the proximal body having a channel extending therethrough, a pull wire extending through the channel of the proximal body and through the interior lumen, the pull wire having a distal end portion coupled to the distal body, the pull wire adapted to be retracted to deflect the tube portion in a direction, and/or a force resisting member positioned upon the pull wire between the distal body and the proximal body, the force resisting member configured to abut the proximal body and the distal body to resist a deflection of the tube portion.
  • a rail catheter for producing a bend for orienting the device in viv
  • Example 132 The method of any example herein, in particular example 131, wherein the force resisting member is configured to resist the deflection of the tube portion beyond a defined angle.
  • Example 133 The method of any example herein, in particular example 131 or example 132, wherein the force resisting member is configured to be compressed to a length that is less than a length between the distal body and the proximal body with the tube portion straightened.
  • Example 134 The method of any example herein, in particular examples 131-133, wherein the force resisting member includes a plurality of bodies configured to slide along the pull wire.
  • Example 135 The method of any example herein, in particular examples 131-134, wherein the device is at least one of an expandable prosthetic mitral heart valve or an expandable prosthetic tricuspid heart valve.
  • any of the features of any of the examples, including but not limited to any of the first through 135 examples referred to above, is applicable to all other aspects and examples identified herein, including but not limited to any examples of any of the first through 135 examples referred to above.
  • any of the features of an example of the various examples, including but not limited to any examples of any of the first through 135 examples referred to above, is independently combinable, partly or wholly with other examples described herein in any way, e.g., one, two, or three or more examples may be combinable in whole or in part.
  • any of the features of the various examples, including but not limited to any examples of any of the first through 135 examples referred to above may be made optional to other examples.
  • Any example of a method can be performed by a system or apparatus of another example, and any aspect or example of a system or apparatus can be configured to perform a method of another aspect or example, including but not limited to any examples of any of the first through 135 examples referred to above.
  • the body parts e.g., heart, tissue, valve, etc.
  • the body parts can be assumed to be simulated or can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, simulated valve, etc.) and can optionally comprise computerized and/or physical representations of body parts, tissue, etc.
  • simulated e.g., simulated heart, simulated tissue, simulated valve, etc.
  • the term “simulation” covers use on a cadaver, computer simulator, imaginary person (e.g., if they are just demonstrating in the air on an imaginary heart), etc.
  • any of the various systems, assemblies, devices, components, apparatuses, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise (or additional methods comprise or consist of) sterilization of the associated system, device, component, apparatus, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Cardiology (AREA)
  • Veterinary Medicine (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Pulmonology (AREA)
  • Mechanical Engineering (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne des systèmes d'administration transcathéter ayant un certain nombre d'améliorations pour faciliter l'avancement à l'intérieur du corps. Un système d'administration peut comprendre un ou plusieurs éléments parmi un cathéter à rail, un cathéter à courbure conçu pour courber une partie de courbure d'une partie intermédiaire du cathéter à rail sur un côté auriculaire d'une valvule cardiaque atrioventriculaire, et un cathéter d'administration conçu pour coulisser axialement le long du cathéter à rail. Des éléments de fixation peuvent être prévus pour des corps de nez ou fils-guides. Certains cathéters d'administration comprennent un coupleur pour coupler un cathéter d'imagerie de forme allongée au cathéter d'administration.
PCT/US2024/061564 2023-12-29 2024-12-20 Systèmes de pose pour valvules cardiaques prothétiques et systèmes d'imagerie Pending WO2025144761A1 (fr)

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US202363616321P 2023-12-29 2023-12-29
US63/616,321 2023-12-29

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140277405A1 (en) * 2013-03-15 2014-09-18 Cardiosolutions, Inc. Mitral valve spacer and system and method for implanting the same
CA3100052A1 (fr) * 2018-06-05 2019-12-12 Edwards Lifesciences Corporation Reparation de valve et interventions associees
WO2021080782A1 (fr) 2019-10-23 2021-04-29 Edwards Lifesciences Corporation Systèmes et procédés pour le traitement de la valve tricuspide
US20210161661A1 (en) * 2018-02-22 2021-06-03 Medtronic Vascular, Inc. Prosthetic heart valve delivery systems and methods
WO2022174057A1 (fr) 2021-02-11 2022-08-18 Edwards Lifesciences Corporation Systèmes de pose pour valvules cardiaques de remplacement
US20230270552A1 (en) * 2020-11-04 2023-08-31 Edwards Lifesciences Corporation Systems, tools, and methods for delivering implants and catheters for a prosthetic valve

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140277405A1 (en) * 2013-03-15 2014-09-18 Cardiosolutions, Inc. Mitral valve spacer and system and method for implanting the same
US20210161661A1 (en) * 2018-02-22 2021-06-03 Medtronic Vascular, Inc. Prosthetic heart valve delivery systems and methods
CA3100052A1 (fr) * 2018-06-05 2019-12-12 Edwards Lifesciences Corporation Reparation de valve et interventions associees
WO2021080782A1 (fr) 2019-10-23 2021-04-29 Edwards Lifesciences Corporation Systèmes et procédés pour le traitement de la valve tricuspide
US20230270552A1 (en) * 2020-11-04 2023-08-31 Edwards Lifesciences Corporation Systems, tools, and methods for delivering implants and catheters for a prosthetic valve
WO2022174057A1 (fr) 2021-02-11 2022-08-18 Edwards Lifesciences Corporation Systèmes de pose pour valvules cardiaques de remplacement

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