US-12616573-B2 - Prosthetic valve delivery system and method

US12616573B2US 12616573 B2US12616573 B2US 12616573B2US-12616573-B2

Abstract

A valve delivery system and valve delivery method are disclosed. The valve delivery system includes an inner shaft extending along a longitudinal axis and an elongated tension member to continuously circumferentially coil around a prosthetic valve disposed on the inner shaft to form a sheath portion to releasably contain the prosthetic valve on the inner shaft in a compressed state, the elongated tension member extending from the sheath portion along the longitudinal axis of the inner shaft.

Inventors

Marc Anderson
Niall Crosbie
James Keogh

Assignees

MEDTRONIC VASCULAR, INC.

Dates

Publication Date: 20260505
Application Date: 20231026

Claims (11)

1 . A prosthetic valve delivery method, comprising: advancing a valve delivery assembly through a vascular pathway of a patient, the valve delivery assembly including: an inner shaft, and an elongated tension member including a first end attached to a distal portion of the inner shaft proximal of the prosthetic valve, a sheath portion continuously circumferentially coiled around a prosthetic valve to releasably maintain the prosthetic valve in a radially compressed state, wherein sheath portion extends distally from the first end of the elongated tension member, and a proximal portion extending proximally from a distal end of the sheath portion over the coiled portion; positioning the prosthetic valve at a target site along the vascular pathway; and pulling the proximal portion of the elongated tension member proximally to uncoil the sheath portion of the elongated tension member from around the prosthetic valve, thereby releasing the prosthetic valve from the sheath portion of the elongated tension member and enabling the prosthetic valve to self-expand to a radially expanded state at the target site.
2 . The method of claim 1 further comprising releasing a releasable coupling of the elongated tension member.
3 . The method of claim 1 , wherein the valve delivery assembly further comprises: an outer shaft disposed around the inner shaft, wherein a distal end of the outer shaft is proximal to the prosthetic valve along the inner shaft, and a collar disposed around the inner shaft, the collar longitudinally disposed between the prosthetic valve and the outer shaft, the collar including a port, wherein the proximal portion of the elongated tension member extends proximally from the coiled portion through the port in the collar and proximally between the outer shaft and the inner shaft.
4 . A method of assembling a valve delivery assembly comprising: locating a prosthetic valve over a distal portion of an inner shaft of a delivery system; attaching a first end of an elongated tension member to the inner shaft adjacent to and proximal of the prosthetic valve; coiling a distal portion of the elongated tension member around the prosthetic valve from the first end of the elongated tension member distally around the prosthetic valve to releasably restrain the prosthetic valve in a radially compressed state over the distal portion of the inner shaft; and longitudinally extending a proximal portion of the elongated tension member proximally from a distal end of the coiled distal portion over coils of the coiled distal portion to a proximal portion of the delivery system.
5 . The method of claim 4 , further comprising: assembling an outer shaft around the inner shaft, wherein a distal end of the outer shaft is proximal to the prosthetic valve along the inner shaft, and assembling a collar around the inner shaft and longitudinally between the prosthetic valve and the outer shaft, the collar including a port, wherein longitudinally extending the elongated tension member proximally comprises longitudinally extending the elongated tension member proximally through the port in the collar and proximally between the outer shaft and the inner shaft.
6 . The method of claim 4 , further comprising: assembling a tip coupled to a distal end of the inner shaft, the tip including a port, wherein longitudinally extending the elongated tension member proximally comprises longitudinally extending the elongated tension member through the port of the tip, into a lumen of the inner shaft, and proximally within the lumen of the inner shaft.
7 . A prosthetic valve delivery method, comprising: advancing a valve delivery assembly through a vascular pathway of a patient, the valve delivery assembly including: an inner shaft, and an elongated tension member including a first end attached to a distal portion of the inner shaft distal of a prosthetic valve, a sheath portion continuously circumferentially coiled around the prosthetic valve to releasably maintain the prosthetic valve in a radially compressed state, the sheath portion of the elongated tension member extends proximally from the first end of the elongated tension member, and a proximal portion extending proximally from a proximal end of the sheath portion, wherein the proximal portion of the elongated tension member first extends distally from a proximal end of the sheath portion over the sheath portion and then proximally from a distal end of the sheath portion through a lumen in the inner shaft; positioning the prosthetic valve at a target site along the vascular pathway; and pulling the proximal portion of the elongated tension member proximally to uncoil the sheath portion of the elongated tension member from around the prosthetic valve, thereby releasing the prosthetic valve from the sheath portion of the elongated tension member and enabling the prosthetic valve to self-expand to a radially expanded state at the target site.
8 . The method of claim 7 , wherein the valve delivery assembly further comprises: a tip coupled to a distal end of the inner shaft, the tip including a port, wherein the proximal portion of the elongated tension member extends from over the sheath portion through the port of the tip, into the lumen of the inner shaft, and proximally within the lumen of the inner shaft.
9 . The method of claim 7 , further comprising releasing a releasable coupling of the elongated tension member.
10 . A method of assembling a valve delivery assembly comprising: locating a prosthetic valve over a distal portion of an inner shaft of a delivery system; attaching a first end of an elongated tension member to the inner shaft adjacent to and distal of the prosthetic valve; coiling a distal portion of the elongated tension member from the first end of the elongated tension member proximally around the prosthetic valve to releasably restrain the prosthetic valve in a radially compressed state over the distal portion of the inner shaft; and longitudinally extending a proximal portion of the elongated tension member first distally from a proximal end of the coiled distal portion and then proximally from a distal end of the coiled distal portion to a proximal portion of the delivery system.
11 . The method of claim 10 , wherein first longitudinally extending the proximal portion distally comprises longitudinally extending the proximal portion distally over coils of the coiled distal portion.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application is a Division of U.S. application Ser. No. 16/950,215, filed Nov. 17, 2020, which is a Division of U.S. application Ser. No. 15/589,183, filed May 8, 2017, now U.S. Pat. No. 10,856,980, the entire teachings of both of which are incorporated herein by reference. BACKGROUND The present disclosure relates to systems and methods for delivering a medical device such as a heart valve. More particularly, it relates to minimally invasive, transcatheter-based systems and methods for delivering a medical device, such as a prosthetic mitral valve. Many prosthetic valves include stents and stent-grafts that are “self-expanding”, i.e., inserted into the vascular system in a compressed or contracted state, and permitted to expand upon removal of a restraint to an expanded or natural state. Self-expanding stents and stent-grafts typically employ a wire or tube configured (e.g., bent or cut) to provide an outward radial force and employ a suitable elastic material such as stainless steel or nitinol (nickel-titanium). Nitinol may additionally employ shape memory properties. The self-expanding stent, or self-expanding stent-graft, is typically configured in a tubular shape, sized to have a slightly greater diameter than the diameter of the blood vessel in which the stent or stent-graft is intended to be used. In general, rather than inserting it in a traumatic and invasive manner using open surgery, stents and stent-grafts are typically deployed through a less invasive intraluminal delivery, i.e., cutting through the skin to access a lumen or vasculature or percutaneously via successive dilatation, at a convenient (and less traumatic) entry point, and routing the compressed stent or stent-graft in a delivery system through the lumen to the site where the prosthesis is to be deployed. Intraluminal deployment, in one example, is effected using a delivery catheter with a coaxial inner tube, sometimes called an inner tube, and an outer tube, sometimes called the sheath, arranged for relative axial movement. The prosthetic valve is compressed and typically disposed within the distal end of the sheath in front of the inner tube. The catheter is then maneuvered, typically routed through a vessel (e.g., lumen), until the end of the catheter containing the prosthetic valve is positioned in the vicinity of the intended treatment site. The inner tube is then held stationary while the sheath of the delivery catheter is withdrawn proximally. The inner tube prevents the prosthetic valve from moving back as the sheath is withdrawn. As the sheath is withdrawn, the prosthetic valve is gradually exposed from its distal end to its proximal end. The exposed portion of the prosthetic valve radially expands so that at least a portion of the expanded portion is in substantially conforming surface contact with a portion of the interior of the blood vessel wall until it is fully deployed. In order to fully deploy, the sheath must be withdrawn fully from the prosthetic, and in this manner, the deployment site typically requires a length that is equivalent to the length of the prosthetic valve plus the length of the capsule. In order to deliver the prosthetic valve to the target state, the valve delivery system must often be maneuvered through a tortuous vascular pathway and has limited deployment area. It is desirable to deliver the prosthetic valve with an economical valve delivery system that minimizes the cross-sectional area and length of the delivery system and has a high degree of lateral flexibility to allow passage of through a patient's vascular system. SUMMARY One aspect of the present disclosure relates to a valve delivery system including an inner shaft extending along a longitudinal axis and an elongated tension member configured to continuously circumferentially coil around a prosthetic valve disposed on the inner shaft to form a sheath portion to releasably contain the prosthetic valve on the inner shaft in a compressed state. The elongated tension member extends from the sheath portion along the longitudinal axis of the inner shaft. Another aspect of the present disclosure relates to a valve delivery system including an inner shaft and an elongated tension member. The elongated tension member is extendable along the inner shaft. The elongated tension member is transitional between a first state and a second state. In the first state, a distal portion is continuously coiled successively around a prosthetic valve in a compressed state. The coils of the distal portion extend from a first end to an opposing second end of the prosthetic valve. The prosthetic valve is releasably fixed in the compressed state along the inner shaft in the first state. The distal portion is uncoiled from around the prosthetic valve and the prosthetic valve is expandable from the compressed state in the second state. Another aspect of the present disclosure relates to a prosthetic valve delivery method. T