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

• US 10,500,046 B2
• Filed: 12/14/2015
• Issued: 12/10/2019
• 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.
• Primary Examiner(s): Tyson, Melanie R
• Application Number:
  US14/968,135
• Publication Number:
  US 20170165065A1
• Time in Patent Office: 1,457 Days
• Field of Search: 623 211
• 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 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;

an inner shaft slidably disposed within the lumen of the elongate tube;

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

a docking frame that is self-expanding, 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,

wherein in the compressed delivery configuration the valve frame is releasably coupled to a distal end of the inner shaft to be slidable therewith relative to the elongate tube and 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 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 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 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 system of claim 1, wherein a proximal end of the valve frame is releasably coupled to a distal hub disposed at the distal end of the inner shaft.

6. The system of claim 1, wherein a distal segment of the valve frame is radially disposed within a proximal segment of the docking frame to provide a circumferential overlap region therebetween.

7. The system of claim 6, wherein the at least two wires are woven through overlapping openings of the docking and valve frames along the circumferential overlap region of the docking and valve frames to releasably couple them to each other.

8. The system of claim 7, wherein each of the at least two wires is woven through a first set of overlapping openings of the docking and valve frames within the circumferential overlap region of the docking and valve frames and through a second set of overlapping openings of the docking and valve frames within the circumferential overlap region of the docking and valve frames.

9. A 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;

an inner shaft slidably disposed within the lumen of the elongate tube; and

a first frame that is self-expanding and a second frame that is self-expanding, the first frame and the second frame being disposed in series within a distal portion of the outer sheath component and held in a compressed delivery configuration therein, wherein the first frame is distal of the second frame,

wherein in the compressed delivery configuration the second frame is releasably coupled to a distal end of the inner shaft to be slidable therewith relative to the elongate tube and 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.

10. The system of claim 9, 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.

11. The system of claim 10, 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.

12. The system of claim 11, wherein when each of the first frame and the second frame 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 frame and the second frame are recapturable by the outer sheath component being distally advanced over the at least two wires.

13. The system of claim 11, wherein the at least two wires are flat and proximal retraction of the at least two flat wires from the first frame and the second frame releases at least the first frame from the delivery system.

14. The system of claim 9, 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.

15. The system of claim 14, 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.

16. The system of claim 9, wherein a proximal end of the second frame is releasably coupled to a distal hub disposed at the distal end of the inner shaft.

17. The system of claim 9, wherein 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.

18. The system of claim 17, wherein 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.

19. The system of claim 18, wherein each of the at least two wires is woven through a first set of overlapping openings of the first and second frames within the circumferential overlap region of the first and second frames and through a second set of overlapping openings of the first and second frames within the circumferential overlap region of the first and second frames.

20. A 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;

an inner shaft slidably disposed within the lumen of the elongate tube;

a valve prosthesis having a valve frame that is self-expanding with a prosthetic valve component secured therein, wherein a proximal end of the valve frame includes a plurality of paddles proximally extending therefrom; and

a docking frame that is self-expanding, 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,

wherein in the compressed delivery configuration a proximal end of the valve frame is releasably coupled to a distal hub disposed at a distal end of the inner shaft to be slidable therewith relative to the elongate tube, the distal hub including a plurality of recesses and the plurality of paddles of the valve frame are configured to be received within the plurality of recesses of the distal hub to releasably couple the valve frame to the inner shaft, and 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.