DELIVERY SYSTEM HAVING RETRACTABLE WIRES AS A COUPLING MECHANISM AND A DEPLOYMENT MECHANISM FOR A SELF-EXPANDING PROSTHESIS

• US 20170165065A1
• Filed: 12/14/2015
• Published: 06/15/2017
• Est. Priority Date: 12/14/2015
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Rothstein, Paul, Keogh, James R.
• Granted Patent: US 10,500,046 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/2469 with resilient valve members, e.g. conical spiral
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/006 modular

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.

Claims

1. A delivery system for transcatheter implantation of a heart valve prosthesis comprising:

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, the elongate tube and the at least two wires being slidably disposed within the lumen of the outer sheath component;

a valve prosthesis having a self-expanding valve frame with a prosthetic valve component secured therein;

a self-expanding docking frame, wherein the docking frame is disposed distal of the valve prosthesis when each is held in a compressed delivery configuration within a distal portion of the outer sheath component and

wherein in the compressed delivery configuration 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.

2. The delivery system of claim 1, wherein the docking frame is configured to be released from and implanted by the delivery system at an implantation site and thereafter the valve prosthesis is configured to be released from and implanted by the delivery system within the docking frame.

3. The delivery system 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 to control deployment thereof.

4. The delivery system of claim 3, 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 prosthesis.

5. The delivery system of claim 1, further comprising an inner shaft slidably disposed within the lumen of the elongate tube, wherein the valve frame is releasably coupled to a distal end of the inner shaft.

6. A delivery system for transcatheter implantation of a heart valve prosthesis comprising:

an outer sheath component defining a lumen therethrough;

an elongate tube 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

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,

wherein in the compressed delivery configuration the at least two 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.

7. The delivery system of claim 6, wherein the first frame is distal of the second frame and 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 to control deployment thereof

8. The delivery system of claim 7, 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.

9. The delivery system of claim 8, wherein when each of the first and second frames is at least partially expanded distal of the outer sheath component while remaining coupled to each other by the at least two wires, the first and second frames are recapturable by the outer sheath component being distally advanced over the at least two wires.

10. The delivery system of claim 8, wherein the at least two wires are flat and 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.

11. The delivery system of claim 6, further comprising:

a prosthetic valve component disposed within and secured to the second frame, and wherein the first frame is a docking frame that is configured to receive the second frame with the prosthetic valve component.

12. The delivery system of claim 11, wherein the docking frame is configured to be released from and implanted by the delivery system at an implantation site and thereafter the second frame with the prosthetic valve component is configured to be released from and implanted by the delivery system within the docking frame.

13. The delivery system of claim 6, further comprising an inner shaft slidably disposed within the lumen of the elongate tube, wherein the second frame is releasably coupled to a distal end of the inner shaft.

14. 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.

15. The method of claim 14, wherein the delivery system further includes an inner shaft slidably disposed within the lumen of the elongate tube and the valve frame is releasably coupled to a distal end of the inner shaft.

16. The method of claim 14, wherein when in the compressed delivery configuration a distal segment of the delivery frame is nested within a proximal segment of the valve 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 delivery frame to releasably couple the delivery frame and the valve frame to each other.

17. The method of claim 14, 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.

18. The method of claim 14, 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.

19. The method of claim 14, 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.

20. The method of claim 14, 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 prosthesis from the delivery system.