Transcatheter heart valves

• US 9,962,258 B2
• Filed: 02/11/2014
• Issued: 05/08/2018
• Est. Priority Date: 11/17/1999
• Status: Expired due to Fees

• Current Assignee: Medtronic CV Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic CV Luxembourg SARL (Medtronic Plc)
• Inventors: Seguin, Jacques, Bortlein, Georg
• Primary Examiner(s): SCHILLINGER, ANN M
• Application Number:
  US14/177,811
• Publication Number:
  US 20140194979A1
• Time in Patent Office: 1,547 Days
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/93 circumferentially expandable by using ratcheting locks
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/91591 Locking connectors, e.g. using male-female connections
• CPC Class Codes: A61F 2210/0023 operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 : conical
• CPC Class Codes: A61F 2230/0078 : hyperboloidal
• CPC Class Codes: A61F 2250/0003 : having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61F 2250/0039 : differing in diameter
• CPC Class Codes: A61F 2250/0048 : differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61F 2250/0069 : Sealing means

Abstract

A prosthetic heart valve comprises a collapsible and expandable support frame comprising a longitudinal axis. The frame comprises a first circumferential undulating structure defining an outflow end of the frame, and a second circumferential undulating structure spaced apart from the first circumferential undulating structure. The frame also comprises a plurality of struts longitudinally aligned with the longitudinal axis of the frame, and connecting the first circumferential undulating structure to the second circumferential undulating structure. Each strut of the plurality of struts comprises a first end terminating at a trough of the first circumferential undulating structure, and a second end terminating at a peak of the second circumferential undulating structure. The prosthetic heat valve also comprises a biological tissue valve coupled to the frame. The prosthetic heart valve is configured to be collapsed for introduction into a patient using a catheter and to be expanded for deployment at an implantation site.

Claims

1. A prosthetic heart valve comprising:

a collapsible and expandable support frame comprising a longitudinal axis, the frame comprising;

a first circumferential undulating structure defining an outflow end of the frame;

a second circumferential undulating structure spaced apart from the first circumferential undulating structure toward an inflow end of the frame; and

a plurality of struts longitudinally aligned with the longitudinal axis of the frame, and connecting the first circumferential undulating structure to the second circumferential undulating structure, each strut of the plurality of struts comprising;

a first end terminating at a trough of the first circumferential undulating structure, wherein the trough is defined between adjacent struts of a plurality of struts that form the first circumferential undulating structure and opens toward the inflow end of the frame; and

a second end terminating at a peak of the second circumferential undulating structure, wherein the peak is an apex of the second circumferential undulating structure disposed toward the outflow end of the frame,

wherein a segment of the support frame that extends between the first and second circumferential undulating structures includes a portion that consists of the plurality of longitudinally aligned struts; and

a biological tissue valve coupled to the frame,

wherein the prosthetic heart valve is configured to be collapsed for introduction into a patient using a catheter and to be expanded for deployment at an implantation site.

2. The prosthetic heart valve of claim 1, further comprising a third circumferential undulating structure that is located axially between the first circumferential undulating structure and the second circumferential undulating structure and that is connected to the plurality of longitudinally aligned struts.

3. The prosthetic heart valve of claim 2, wherein the third circumferential undulating structure is connected to intermediate portions of struts of the plurality of longitudinally aligned struts.

4. The prosthetic heart valve of claim 1, wherein the frame is configured to be balloon expandable.

5. The prosthetic heart valve of claim 1, wherein the frame comprises a shape memory material.

6. The prosthetic heart valve of claim 5, wherein the shape memory material comprises a nickel-titanium alloy.

7. The prosthetic heart valve of claim 1, wherein a portion of the prosthetic heart valve is configured to be positioned at a native cardiac ring upon implantation.

8. The prosthetic heart valve of claim 1, wherein the biological tissue valve is coupled to the frame using sutures.

9. The prosthetic heart valve of claim 1, wherein the frame is tubular.

10. The prosthetic heart valve of claim 1, further comprising a sealing layer coupled to the frame and configured to conform to any surface irregularities at or near an existing cardiac ring.

11. A prosthetic heart valve comprising:

a collapsible and expandable support frame comprising a longitudinal axis, the frame comprising;

a first circumferential undulating structure defining an outflow end of the frame;

a plurality of struts longitudinally aligned with the longitudinal axis of the frame, each strut of the plurality of struts comprising a first end connected to a respective trough of the first circumferential undulating structure and a second end, wherein the respective trough is defined between adjacent struts of a plurality of struts that form the first circumferential undulating structure and opens toward an inflow end of the frame, and wherein troughs of the first circumferential undulating structure connected to respective first ends of struts of the plurality of struts are spaced from each other by at least one trough unconnected to a strut of the plurality of struts; and

a second circumferential undulating structure spaced apart from the first circumferential undulating structure toward the inflow end of the frame, and comprising a plurality of peaks, wherein a respective second end of each strut of the plurality of struts is connected to a respective peak of the plurality of peaks, wherein the respective peak is an apex of the second circumferential undulating structure disposed toward the outflow end of the frame,

wherein a segment of the support frame that extends between the first and second circumferential undulating structures includes a portion that consists of the plurality of longitudinally aligned struts; and

a biological tissue valve coupled to the frame,

wherein the prosthetic heart valve is configured to be collapsed for introduction into a patient using a catheter and to be expanded for deployment at an implantation site.

12. The prosthetic heart valve of claim 11, further comprising a third circumferential undulating structure between the first circumferential undulating structure and the second circumferential undulating structure, and connected to the plurality of longitudinally aligned struts.

13. The prosthetic heart valve of claim 12, wherein the third circumferential undulating structure is connected to intermediate portions of struts of the plurality of longitudinally aligned struts.

14. The prosthetic heart valve of claim 11, wherein the frame is configured to be balloon expandable.

15. The prosthetic heart valve of claim 11, wherein the frame comprises a shape memory material.

16. The prosthetic heart valve of claim 15, wherein the shape memory material comprises a nickel-titanium alloy.

17. The prosthetic heart valve of claim 11, wherein a portion of the prosthetic heart valve is configured to be positioned at a native cardiac ring upon deployment.

18. The prosthetic heart valve of claim 11, wherein the biological tissue valve is coupled to the frame using sutures.

19. The prosthetic heart valve of claim 11, wherein the frame is tubular.

20. The prosthetic heart valve of claim 11, further comprising a sealing layer coupled to the frame and configured to seal the prosthetic heart valve.