EP-4736819-A2 - TRANSCATHETER PROSTHETIC HEART VALVE DELIVERY DEVICE WITH STABILITY TUBE

EP4736819A2EP 4736819 A2EP4736819 A2EP 4736819A2EP-4736819-A2

Abstract

A device for percutaneous delivery of a stented prosthetic heart valve. The device includes a sheath, a handle, and an outer stability tube. The sheath includes a distal capsule and a proximal shaft. The handle has a housing maintaining an actuator mechanism that is coupled to the shaft. The actuator mechanism is configured to selectively move the shaft, and thus the capsule, relative to the housing. The stability tube is coupled to the housing and is coaxially received over the shaft such that the shaft is slidable relative to the stability tube. In a delivery state, the capsule encompasses the prosthetic valve. In a deployed state, the capsule is withdrawn from the prosthetic valve. The shaft slides relative to the stability tube in transitioning from the loaded state to the deployed state. When used with an introducer device, the stability tube frictionally isolates the sheath.

Inventors

TABOR, CHARLES, P.

Assignees

Medtronic Inc.

Dates

Publication Date: 20260506
Application Date: 20110330

Claims (11)

A system for restoring a defective heart valve of a patient, the system comprising: a delivery device including: an outer stability tube defining a distal end, a delivery sheath assembly defining a lumen and including a distal capsule and a proximal shaft, the shaft slidably received within the outer stability tube, a handle including: a housing defining a distal side and coupled to the outer stability tube such that the outer stability tube extends distal the distal side, an actuator mechanism maintained by the housing and coupled to the shaft such that the delivery sheath assembly extends distal the distal side and is selectively moveable relative to the outer stability tube with operation of the actuator mechanism; and a prosthetic heart valve having a stent frame and a valve structure attached to the frame and forming at least two valve leaflets, the prosthetic heart valve being self-expandable from a compressed arrangement to a natural arrangement; wherein the system is configured to be transitionable from a loaded condition in which the prosthetic heart valve is retained within the capsule and deployed condition in which the capsule is withdrawn from the prosthetic heart valve to permit the prosthetic heart valve to self-expand to the natural arrangement and release from the delivery device, the actuator mechanism being configured to effectuate transitioning from the loaded condition to the deployed condition by sliding the delivery sheath assembly relative to the prosthetic heart valve and the stability tube; and an introducer device, wherein with transitioning of the delivery device (40) from the loaded condition to the deployed condition via sliding of the delivery sheath assembly (42), the delivery sheath assembly (42) does not bear against or otherwise frictionally interface with the introducer device (400).
The system of claim 1, further comprising: a retention member disposed within the lumen and configured to support the prosthetic heart valve within the capsule in the loaded condition.
The system of claim 2, wherein the retention member is coupled to the housing such that the capsule slides relative to the retention member in transitioning from the loaded condition to the deployed condition.
The system of any preceding claim, further comprising: a flush port construction maintained by the housing and including tubing fluidly connected to a region between an outer diameter of the delivery sheath assembly and an inner diameter of the outer stability tube.
The system of any preceding claim, wherein an outer diameter of the capsule is greater than an outer diameter of the shaft, the shaft being affixed to the capsule at a connection point, and further wherein in the loaded condition, the connection point is distal the distal end of the stability tube by a distance of 3 - 13 cm.
The system of any preceding claim, wherein an outer diameter of the capsule is greater than an outer diameter of the shaft, the capsule being affixed to the shaft at a connection point, and further wherein in the deployed condition, the connection point is distal the distal end of the stability tube.
The system of any preceding claim, wherein the shaft is a braided tube and the capsule has a construction differing from that of the shaft.
The system of any preceding claim, wherein the stability tube includes: a tubular body; and reinforcing members circumferentially supporting the tubular body; wherein the stability tube is moveable relative to the delivery sheath assembly for performing a re-capture operation.
The system of any preceding claim, wherein the capsule (50) includes a polymer tube embedded with a metal braiding.
The system of any preceding claim, wherein the capsule (50) is formed of a transparent material.
The system of any preceding claim, wherein the delivery device further includes a cap (130) for rigidly connecting the outer stability tube (52) to the handle (48), the cap being a hub-like body forming a head (150) and a base (152), wherein the outer stability tube (52) is fixed with the head 150 by means of an adhesive or a weld.

Description

Background The present disclosure relates to systems and methods for percutaneous implantation of a prosthetic heart valve. More particularly, it relates to systems and methods for transcatheter implantation of a stented prosthetic heart valve. Diseased or otherwise deficient heart valves can be repaired or replaced with an implanted prosthetic heart valve. As used throughout this specification, the terms "repair," "replace," and "restore" are used interchangeably, and reference to "restoring" a defective heart valve is inclusive implanting a prosthetic heart valve that renders the native leaflets non-functional, or that leaves the native leaflets intact and functional. Conventionally, heart valve replacement surgery is an open-heart procedure conducted under general anesthesia, during which the heart is stopped and blood flow is controlled by a heart-lung bypass machine. Traditional open surgery inflects significant patient trauma and discomfort, and exposes the patient to a number of potential risks, such as an infection, stroke, renal failure, and adverse affects associated with the use of the heart-lung machine, for example. Due to the drawbacks of open-heart surgical procedures, there has been an increased interest in minimally invasive and percutaneous replacement of cardiac valves. With percutaneous transcatheter (or transluminal) techniques, a valve prosthesis is compacted for delivery in a catheter and then advanced, for example, through an opening in the femoral artery and through the descending aorta to the heart, where the prosthesis is then deployed in the annulus of the valve to be repaired (e.g., the aortic valve annulus). Although transcatheter techniques have attained widespread acceptance with respect to delivery of conventional stents to restore vessel patency, only mixed results have been realized with respect to percutaneous delivery of the more complex prosthetic heart valve. Various types and configurations of prosthetic heart valves are available for percutaneous valve replacement procedures, and continue to be refined. The actual shape and configuration of any particular prosthetic heart valve is dependent to some extent upon the native shape and size of the valve being replaced or repaired (i.e., mitral valve, tricuspid valve, aortic valve, or pulmonary valve). In general, prosthetic heart valve designs attempt to replicate the function of the valve being replaced and thus will include valve leaflet-like structures. With a bioprostheses construction, the replacement valve may include a valved vein segment that is mounted in some manner within an expandable stent frame to make a valved stent (or "stented prosthetic heart valve"). For many percutaneous delivery and implantation devices, the stent frame of the valved stent can be made of a self-expanding material and construction. With these devices, the valved stent is crimped down to a desired size and held in that compressed state within an outer delivery sheath, for example. Retracting the sheath from the valved stent allows the stent to self-expand to a larger diameter, such as when the valved stent is in a desired position within a patient. In other percutaneous implantation systems the valved stent can be initially provided in an expanded or uncrimped condition, then crimped or compressed on a balloon portion of a catheter until it is as close to the diameter of the catheter as possible. Once delivered to the implantation site, the balloon is inflated to deploy the prosthesis. With either of these types of percutaneous stented prosthetic valve delivery devices, conventional sewing of the prosthetic heart valve to the patient's native tissue is typically not necessary. In addition to the delivery device itself, typical transcatheter heart valve implantation techniques entail the use of a separate introducer device to establish a portal to the patient's vasculature (e.g., femoral artery) and through which the prosthetic valve-loaded delivery device is inserted. The introducer device generally includes a relatively short sheath and a valve structure. By inserting the prosthetic heart valve-loaded sheath through the introducer valve and sheath, a low friction hemostasis seal is created around the outer surface of the delivery sheath. While highly desirable, friction between the introducer device and the delivery sheath can be problematic, leading to unexpected movement of the prosthesis prior to release from the delivery device. In particular, with a self-expanding stented prosthetic heart valve, the outer delivery catheter or sheath is retracted from over the prosthesis, thereby permitting the stented valve to self-expand and release the prostheses from the delivery device. Friction between the introducer device and the delivery sheath has a tendency to resist necessary proximal movement of the delivery sheath. Because the retraction force is initiated at a handle of the delivery device, this resistance is transferred to the handl