Modular valve prosthesis, delivery system, and method of delivering and deploying a modular valve prosthesis

• US 10,588,745 B2
• Filed: 06/20/2016
• Issued: 03/17/2020
• Est. Priority Date: 06/20/2016
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Bell, Rodney, Costello, Declan, Duffy, Niall, Harewood, Frank
• Primary Examiner(s): Simpson, Sarah A
• Application Number:
  US15/186,593
• Publication Number:
  US 20170360561A1
• Time in Patent Office: 1,366 Days
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/852 Two or more distinct overlapping stents
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/006 modular

Abstract

A modular valve prosthesis includes an inflow stent, a valve component including a valve stent and a prosthetic valve, and an outflow stent. In a radially compressed delivery configuration, an inflow end of the valve stent is separated from an outflow end of the inflow stent and an outflow end of the valve stent is separated from an inflow end of the outflow stent. In a radially expanded deployed configuration, the inflow end of the valve stent is in contact with the outflow end of the inflow stent and the outflow end of the valve stent is in contact with the inflow end of the outflow stent. A delivery system includes a capsule including first, second and third sections and flexible first and second bands between respective sections. The modules of the modular valve prosthesis are aligned with the sections and gaps between the modules are aligned with the bands.

Claims

1. A delivery system for delivering a modular valve prosthesis, the delivery system comprising:

an inner shaft;

an outer sheath surrounding the inner shaft, the outer sheath including a capsule at a distal portion thereof, the capsule including a first section, a second section, and a first band disposed between the first section and the second section, wherein the first and second sections comprise a first material and the first band comprising a second material different than the first material, wherein the second material is more flexible than the first material; and

a modular valve prosthesis disposed within the capsule in a radially compressed delivery configuration for delivery to a treatment site, wherein the modular valve prosthesis includes a first module and a second module separated by a first gap such that the first and second modules do not contact each other in the radially compressed delivery configuration, wherein the modular valve prosthesis is disposed within the capsule such that the first module is aligned with the first section of the capsule, the second module is aligned with the second section of the capsule, and the first gap is aligned with the first band of the capsule.

2. The delivery system of claim 1,

wherein the capsule further includes a third section,

wherein the modular valve prosthesis further includes a third module and a second gap disposed between the second module and the third module, wherein the third module is not in contact with the second module in the radially compressed delivery configuration and wherein the third module of the modular valve prosthesis is aligned with the third section of the capsule.

3. The delivery system of claim 2,

wherein the capsule includes a second band between the second section and the third section, wherein the second section comprises the first material and the second band comprises the second material,

wherein the second band is aligned with the first second gap.

4. The delivery system of claim 3, further comprising a plurality of sutures coupled to each of the first, second, and third modules of the modular valve prosthesis in the radially compressed delivery configuration, wherein the plurality of sutures are configured to be tightened during deployment of the modular valve prosthesis to bring the first, second and third modules closer together.

5. The delivery system of claim 4, further comprising a hub disposed within the outer sheath between the capsule and a proximal end of the delivery system, wherein the plurality of sutures are attached to the hub.

6. The delivery system of claim 5, further comprising a suture detaching mechanism, wherein the suture detaching mechanism is configured to cut or detach a portion of each of the plurality of sutures from the hub upon retraction of the capsule.

7. The delivery system of claim 6, wherein the suture detaching mechanism comprises a circumferential bump extending from an inner surface of the outer sheath towards a central longitudinal axis of the outer sheath, wherein the circumferential bump is configured to cut or detach the portion of each of the plurality of sutures.

8. The delivery system of claim 7, wherein the circumferential bump interacts with the hub to cut or detach the portion of each of the plurality of sutures.

9. The delivery system of claim 1, further comprising a plurality of sutures coupled to each of the first and second modules of the modular valve prosthesis in the radially compressed delivery configuration, wherein the plurality of sutures are configured to be tightened during deployment of the modular valve prosthesis to bring the first and second modules closer together.

10. The delivery system of claim 9, further comprising a hub disposed within the outer sheath between the capsule and a proximal end of the delivery system, wherein the plurality of sutures are attached to the hub.

11. The delivery system of claim 10, wherein each of the plurality of sutures comprises a loop extending from a first end attached to the hub distally through the first and second modules, and looping back proximally to a second end attached to the hub.

12. The delivery system of claim 11, further comprising a suture detaching mechanism, wherein the suture detaching mechanism is configured to cut or detach a portion of each of the plurality of sutures from the hub upon retraction of the capsule, such that one of the first or second ends of each suture remains attached to the hub, thereby enabling the sutures to remain with the delivery system upon removal of the delivery system.

13. The delivery system of claim 12, wherein the suture detaching mechanism comprises a circumferential bump extending from an inner surface of the outer sheath towards a central longitudinal axis of the outer sheath, wherein the circumferential bump is configured to cut or detach the portion of each suture loop.

14. The delivery system of claim 13, wherein the circumferential bump interacts with the hub to cut or detach the portion of each suture loop.

15. A delivery system for delivering a modular valve prosthesis, the delivery system comprising:

an inner shaft;

an outer sheath surrounding the inner shaft, the outer sheath including a capsule at a distal portion thereof, the capsule including a first section, a second section, and a first band disposed between the first section and the second section, wherein the first band is more flexible than the first and second sections;

a modular valve prosthesis disposed within the capsule in a radially compressed delivery configuration for delivery to a treatment site, wherein the modular valve prosthesis includes a first module and a second module separated by a first gap such that the first and second modules do not contact each other in the radially compressed delivery configuration, wherein the modular valve prosthesis is disposed within the capsule such that the first module is aligned with the first section of the capsule, the second module is aligned with the second section of the capsule, and the first gap is aligned with the first band of the capsule; and

a plurality of sutures coupled to each of the first and second modules of the modular valve prosthesis in the radially compressed delivery configuration, wherein the plurality of sutures are configured to be tightened during deployment of the modular valve prosthesis to bring the first and second modules closer together.

16. The delivery system of claim 15, further comprising a hub disposed within the outer sheath between the capsule and a proximal end of the delivery system, wherein the plurality of sutures are attached to the hub.

17. The delivery system of claim 16, wherein each of the plurality of sutures comprises a loop extending from a first end attached to the hub distally through the first and second modules, and looping back proximally to a second end attached to the hub.

18. The delivery system of claim 17, further comprising a suture detaching mechanism, wherein the suture detaching mechanism is configured to cut or detach a portion of each of the plurality of sutures from the hub upon retraction of the capsule, such that one of the first or second ends of each suture remains attached to the hub, thereby enabling the sutures to remain with the delivery system upon removal of the delivery system.

19. The delivery system of claim 18, wherein the suture detaching mechanism comprises a circumferential bump extending from an inner surface of the outer sheath towards a central longitudinal axis of the outer sheath, wherein the circumferential bump is configured to cut or detach the portion of each suture loop.

20. The delivery system of claim 19, wherein the circumferential bump interacts with the hub to cut or detach the portion of each suture loop.