Delivery system having retractable wires as a coupling mechanism and a deployment mechanism for a self-expanding prosthesis

Patent metadata

Field	Value
Publication number	US-11413144-B2
Application number	US-201916675414-A
Country	US
Kind code	B2
Filing date	Nov 6, 2019
Priority date	Dec 14, 2015
Publication date	Aug 16, 2022
Grant date	Aug 16, 2022

Abstract

A delivery system for transcatheter implantation of a heart valve prosthesis. The delivery system includes an outer sheath component defining a lumen therethrough, an elongate tube having at least two flat wires longitudinally extending from a distal end thereof, and self-expanding first and second frames disposed in series within a distal portion of the outer sheath component and held in a compressed delivery configuration therein. The elongate tube and the at least two flat wires are slidably disposed within the lumen of the outer sheath component. In the compressed delivery configuration the at least two flat wires longitudinally extend along exterior portions of the first and second frames and are woven through adjacent ends of the first and second frames to releasably couple them to each other. Proximal retraction of the at least two flat wires from the first and second frames releases at least the first frame from the delivery system.

First claim

What is claimed is:

1. A method of implanting a valve prosthesis within a native valve, the method comprising the steps of:
percutaneously advancing a delivery system to the native valve, wherein the delivery system includes an outer sheath component defining a lumen therethrough, an elongate tube defining a lumen and having at least two wires longitudinally extending from a distal end thereof, and the elongate tube and the at least two wires being slidably disposed within the lumen of the outer sheath component, and wherein the delivery system further includes a valve prosthesis having a self-expanding valve frame with a prosthetic valve component secured therein and a self-expanding docking frame, the docking frame being disposed distal of the valve prosthesis and each frame being held in a compressed delivery configuration within a distal portion of the outer sheath component, and wherein the at least two wires longitudinally extend along exterior portions of the valve frame and the docking frame and are woven through adjacent distal and proximal ends of the valve frame and the docking frame, respectively, to releasably couple them to each other;
proximally retracting the outer sheath component to uncover the docking frame and thereby deploy the docking frame to an expanded configuration within the native valve;
further proximally retracting the outer sheath component to uncover the valve frame and thereby deploy the valve frame to an expanded configuration;
proximally retracting the at least two wires from the deployed docking frame to uncouple the deployed docking frame from the deployed valve frame;
recapturing the deployed valve frame into the outer sheath component;
repositioning the recaptured valve frame within the deployed docking frame; and
proximally retracting the outer sheath component to uncover the recaptured valve frame and thereby deploy the valve frame to an expanded configuration within the deployed docking frame.

2. The method of claim 1 , wherein the delivery system further includes an inner shaft slidably disposed within the lumen of the elongate tube and wherein the valve frame is releasably coupled to a distal end of the inner shaft to be slidable therewith relative to the elongate tube.

3. The method of claim 1 , wherein when in the compressed delivery configuration a distal segment of the valve frame is nested within a proximal segment of the docking frame to provide a circumferential overlap therebetween and in the circumferential overlap each of the at least two wires is woven through a respective distalmost crown of the valve frame to releasably couple the docking frame and the valve frame to each other.

4. The method of claim 1 , wherein when the outer sheath component is proximally retracted to uncover the docking frame the at least two wires slow the self-expansion of the docking frame.

5. The method of claim 1 , wherein when the outer sheath component is further proximally retracted to uncover the valve frame the at least two wires slow the self-expansion of the valve frame to control deployment of the valve prosthesis.

6. The method of claim 1 , further comprising the step of distally advancing the outer sheath component over the at least two wires in order to recapture the docking frame when the docking frame is at least partially expanded distal of the outer sheath component while remaining coupled to the valve frame by the at least two wires.

7. The method of claim 1 , wherein the at least two wires are flat and proximal retraction of the at least two flat wires from the deployed docking frame releases the deployed docking frame from the delivery system.

8. A method of implanting a first frame and a second frame at a treatment site in situ, the method comprising the steps of:
percutaneously advancing a delivery system to the treatment site, wherein the delivery system includes an outer sheath component defining a lumen therethrough and an elongate tube defining a lumen and having at least two wires longitudinally extending from a distal end thereof, the elongate tube and the at least two wires being slidably disposed within the lumen of the outer sheath component, and wherein the delivery system further includes a first frame that is self-expanding and a second frame that is self-expanding, each frame being held in a compressed delivery configuration within a distal portion of the outer sheath component and the first frame being disposed distal of the second frame, and wherein the at least two wires longitudinally extend along exterior portions of each of the first frame and the second frame and are woven through adjacent ends of each of the first frame and the second frame to releasably couple them to each other;
proximally retracting the outer sheath component to uncover the first frame and thereby deploy the first frame to an expanded configuration at the treatment site;
further proximally retracting the outer sheath component to uncover the second frame and thereby deploy the second frame to an expanded configuration;
proximally retracting the at least two wires from the deployed first frame to uncouple the deployed first frame from the deployed second frame;
recapturing the deployed second frame into the outer sheath component;
repositioning the recaptured second frame within the deployed first frame; and
proximally retracting the outer sheath component to uncover the recaptured second frame and thereby deploy the second frame to an expanded configuration within the deployed first frame.

9. The method of claim 8 , wherein the delivery system further includes an inner shaft slidably disposed within the lumen of the elongate tube and the second frame is releasably coupled to a distal end of the inner shaft to be slidable therewith relative to the elongate tube.

10. The method of claim 8 , wherein when the outer sheath component is proximally retracted to uncover the first frame the at least two wires slow the self-expansion of the first frame and wherein when the outer sheath component is further proximally retracted to uncover the second frame the at least two wires slow the self-expansion of the second frame.

11. The method of claim 8 , further comprising the step of distally advancing the outer sheath component over the at least two wires in order to recapture the first frame when the first frame is at least partially expanded distal of the outer sheath component while remaining coupled to the second frame by the at least two wires.

12. The method of claim 8 , wherein the at least two wires are flat and proximal retraction of the at least two flat wires from the deployed first frame releases the deployed first frame from the delivery system.

13. The method of claim 8 , wherein when in the compressed delivery configuration a distal segment of the second frame is radially disposed within a proximal segment of the first frame to provide a circumferential overlap region therebetween and the at least two wires are woven through overlapping openings of the first and second frames along the circumferential overlap region of the first and second frames to releasably couple them to each other.

Assignees

• Medtronic Inc

Inventors

• Rothstein Paul
• Keogh James R

Classifications

• A61F2/966

  with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod · CPC title

• A61F2002/9665

  with additional retaining means · CPC title

• A61F2/2469

  with resilient valve members, e.g. conical spiral · CPC title

• A61F2/2436

  Deployment by retracting a sheath · CPC title

• A61F2230/0069

  cylindrical · CPC title