LOW PROFILE TRANSCATHETER HEART VALVE

• US 20190091018A1
• Filed: 11/28/2018
• Published: 03/28/2019
• Est. Priority Date: 06/06/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Hariton, Ilia, Benichou, Netanel, Nitzan, Yaacov, Felsen, Bella, Nguyen-Thien-Nhon, Diana, Khanna, Rajesh A., Nguyen, Son V., Levi, Tamir S., Pelled, Itai
• Granted Patent: US 10,426,611 B2
• Time in Patent Office: 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 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/005 using adhesives
• 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 2230/0054 V-shaped
• CPC Class Codes: B05B 1/185 characterised by their outlet element; Mounting arrangements therefor
• CPC Class Codes: E03C 1/025 Water supply lines as such, e.g. shower hoses
• CPC Class Codes: E03C 1/066 allowing height adjustment of shower head
• CPC Class Codes: Y10T 29/49863 with prestressing of part

Abstract

A method of crimping an implantable prosthetic valve can include placing protective material over at least a portion of the implantable prosthetic valve. The protective material can be configured to occupy space between open cells of a frame of the implantable prosthetic valve to prevent damage to a leaflet structure of the implantable prosthetic valve. The method can also include crimping the implantable prosthetic valve with the protective material on the implantable prosthetic valve, and removing the protective material from between the frame and the leaflet structure of the implantable prosthetic valve.

Claims

1. An assembly comprising:

a delivery catheter comprising a balloon; and

an implantable prosthetic heart valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, the prosthetic heart valve comprising;

a radially expandable annular frame having an inflow end portion defining an inflow end of the frame that is configured to receive antegrade blood flow into the prosthetic heart valve when implanted within a patient'"'"'s body in the expanded configuration, and the frame also having an outflow end portion defining an outflow end of the frame opposite the inflow end of the frame;

wherein the frame comprises at least first and second circumferentially extending rows of angled struts arranged end-to-end in a zig-zag pattern and a plurality of axially extending struts interconnecting the first and second rows of angled struts; and

wherein each of the axially extending struts joins to a U-shaped crown structure joining adjacent ends of struts of the first row of angled struts and joins to a U-shaped crown structure joining adjacent ends of struts of the second row of angled struts, wherein the first and second rows of angled struts and axially extending struts form a circumferentially extending row of six-sided cells of the frame;

wherein the prosthetic valve can be radially crimped to the collapsed configuration around the balloon for delivery into a patient'"'"'s body and radially expanded to the expanded configuration with the balloon inside the patient'"'"'s body.

2. The assembly of claim 1, wherein the axially extending struts are thinner than the U-shaped crown structures of the first and second rows in a circumferential direction of the frame.

3. The assembly of claim 1, wherein the row of six-sided cells is at the inflow end of the frame.

4. The assembly of claim 1, wherein each U-shaped crown structure comprises two vertical portions and a lateral portion extending between the two vertical portions, wherein the vertical portions are parallel to a central longitudinal axis of the prosthetic heart valve, wherein the lateral portion extends between and interconnects ends of the vertical portions, and wherein the vertical portions are spaced apart from each other to define a gap between the ends of a corresponding pair of adjacent struts.

5. The assembly of claim 1, wherein the first row of angled struts defines an inflow end of the frame.

6. The assembly of claim 5, wherein each strut of the first row has upper and lower opposing ends, the lower end being connected by a respective U-shaped crown structure to an adjacent lower end of an adjacent strut in the first row and the upper end being connected by a respective U-shaped crown structure to an adjacent upper end of an adjacent strut in the first row.

7. The assembly of claim 6, wherein the U-shaped crown structures connecting the lower ends of the struts in the first row and the U-shaped crown structures connecting the upper ends of the struts in the first row point in opposite directions.

8. The assembly of claim 7, wherein each axially extending strut has a lower end that is connected to one of the U-shaped crown structures connecting the upper ends of the struts in the first row.

9. The assembly of claim 5, wherein the frame further comprises a third circumferentially extending row of angled struts arranged end-to-end in a zig-zag pattern, wherein each strut of the third row has upper and lower opposing ends, the upper end being connected by a respective U-shaped crown structure to an adjacent upper end of an adjacent strut in the third row, wherein the U-shaped crown structures connecting the upper ends of struts of the third row define an outlet end of the frame.

10. The assembly of claim 9, wherein the frame further comprises a fourth circumferentially extending row of angled struts arranged end-to-end in a zig-zag pattern, the fourth row being located axially between the third row and the second row along a length of the frame, wherein each strut of the fourth row has upper and lower opposing ends, the lower end being connected by a respective U-shaped crown structure to an adjacent lower end of an adjacent strut in the fourth row.

11. The assembly of claim 10, wherein the frame further comprises additional axially extending struts, each of which joins to a U-shaped crown structure of the second row and joins to a location along the fourth row.

12. The assembly of claim 11, wherein the second and fourth rows of angled struts and additional axially extending struts form another circumferentially extending row of six-sided cells of the frame.

13. An assembly comprising:

a delivery catheter comprising a balloon; and

an implantable prosthetic heart valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, the prosthetic heart valve comprising;

a radially collapsible and expandable annular frame, the frame having three commissure attachment portions and at least three rows of circumferentially extending rows of angled struts including a first row of angled struts defining an inflow end of the frame, a second row of angled struts, and a third row of angled struts defining an outflow end of the frame, the second row of struts being positioned axially between the first and third rows of angled struts along a length of the frame, the frame further comprising a plurality of axially extending struts interconnecting the first and second rows of angled struts;

a leaflet structure comprising three leaflets defining three commissures, each commissure being attached to one of the commissure attachment portions; and

wherein each of the axially extending struts joins to a U-shaped crown structure joining adjacent ends of struts of the first row of angled struts and joins to a U-shaped crown structure joining adjacent ends of struts of the second row of angled struts;

wherein the prosthetic valve can be radially crimped to the collapsed configuration around the balloon for delivery into a patient'"'"'s body and radially expanded to the expanded configuration with the balloon inside the patient'"'"'s body.

14. The assembly of claim 13, wherein the first and second rows of angled struts and axially extending struts form a circumferentially extending row of six-sided cells of the frame.

15. The assembly of claim 13, wherein the axially extending struts are thinner than the U-shaped crown structures of the first and second rows in a circumferential direction of the frame.

16. The assembly of claim 15, wherein the row of six-sided cells is at the inflow end of the frame.

17. The assembly of claim 13, wherein each U-shaped crown structure comprises two vertical portions and a lateral portion extending between the two vertical portions, wherein the vertical portions are parallel to a central longitudinal axis of the prosthetic heart valve, wherein the lateral portion extends between and interconnects ends of the vertical portions, and wherein the vertical portions are spaced apart from each other to define a gap between the ends of a corresponding pair of adjacent struts.

18. An assembly comprising:

a delivery catheter comprising a balloon; and

an implantable prosthetic heart valve that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration, the prosthetic heart valve comprising;

a radially collapsible and expandable annular frame, the frame having three commissure attachment portions and at least three rows of circumferentially extending rows of angled struts including a first row of angled struts defining an inflow end of the frame, a second row of angled struts, and a third row of angled struts defining an outflow end of the frame, the second row of struts being positioned axially between the first and third rows of angled struts along a length of the frame; and

a leaflet structure comprising three leaflets defining three commissures, each commissure being attached to one of the commissure attachment portions;

wherein each strut of the first row has upper and lower opposing ends, the lower end being connected by a respective U-shaped crown structure to an adjacent lower end of an adjacent strut in the first row;

wherein each strut of the second row has upper and lower opposing ends, the lower end being connected by a respective U-shaped crown structure to an adjacent lower end of an adjacent strut in the second row;

wherein each strut of the third row has upper and lower opposing ends, the upper end being connected by a respective U-shaped crown structure to an adjacent upper end of an adjacent strut in the third row;

wherein the second and third rows of angled struts form an upper row of closed cells of the frame defining openings in the frame and the U-shaped crown structures of the third row and the U-shaped crown structures of the second row point in opposite directions;

wherein the prosthetic valve can be radially crimped to the collapsed configuration around the balloon for delivery into a patient'"'"'s body and radially expanded to the expanded configuration with the balloon inside the patient'"'"'s body.

19. The assembly of claim 18, wherein the upper end of each strut of the first row is connected by a respective U-shaped crown structure to an adjacent upper end of an adjacent strut in the first row and the frame further comprises a plurality of axially extending struts having lower ends connected to the U-shaped crown structures connecting the upper ends of the struts in the first row.

20. The assembly of claim 18, wherein the commissure attachment portions are positioned axially along the frame entirely within the upper row of cells.