Low profile transcatheter heart valve

• US 9,662,204 B2
• Filed: 09/11/2014
• Issued: 05/30/2017
• Est. Priority Date: 06/06/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Hariton, Ilia, Levi, Tamir S., Nitzan, Yaacov, Benichou, Netanel, Khanna, Rajesh A., Nguyen, Son V., Felsen, Bella, Pelled, Itai, Nguyen-Thien-Nhon, Diana
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US14/483,862
• Publication Number:
  US 20150134052A1
• Time in Patent Office: 992 Days
• Field of Search: 623 211- 219
• 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

An implantable prosthetic valve, according to one embodiment, comprises a frame, a leaflet structure, and a skirt member. The frame can have a plurality of axial struts interconnected by a plurality of circumferential struts. The leaflet structure comprises a plurality of leaflets (e.g., three leaflets arrange to form a tricuspid valve). The leaflet structure has a scalloped lower edge portion secured to the frame. The skirt member can be disposed between the leaflet structure and the frame.

Claims

1. A system comprising:

an implantable prosthetic valve having a radially collapsible and expandable annular frame and tissue leaflets mounted inside of the frame;

a crimping apparatus having a plurality of crimping jaws arranged to form an aperture sized to receive the implantable prosthetic valve and to radially collapse the implantable prosthetic valve from a first, expanded state to a second, radially collapsed state; and

a layer of deformable material configured to be positioned as an intermediate protective layer between the plurality of crimping jaws of the crimping apparatus and the frame of the implantable prosthetic valve,

wherein the layer of deformable material comprises an annular sleeve configured to be placed around the implantable prosthetic valve, and

wherein the layer of deformable material can be removed from the implantable prosthetic valve prior to implanting the implantable prosthetic valve.

2. The system of claim 1, further comprising a balloon catheter, wherein the implantable prosthetic valve is configured to be crimped onto the balloon catheter in the radially collapsed state by the crimping apparatus.

3. The system of claim 1, wherein the layer of deformable material is configured to fully cover the frame of the implantable prosthetic valve.

4. The system of claim 1, wherein the annular sleeve comprises a sponge material.

5. The system of claim 1, wherein the annular sleeve comprises a foamed polymeric material.

6. The system of claim 1, wherein the layer of deformable material comprises at least one deformable packet filled with a flowable and deformable material.

7. The system of claim 1, further comprising a fabric configured to be positioned between the frame of the implantable prosthetic valve and the layer of deformable material.

8. The system of claim 1, wherein the frame comprises a plurality of struts defining multiple openings in the frame, the layer of deformable material being configured to protrude into the openings in the frame as a result of the plurality of crimping jaws pressing the layer of deformable material against the frame.

9. The system of claim 1, wherein the layer of deformable material prevents the crimping jaws from directly contacting the frame.

10. The system of claim 1, wherein the layer of deformable material comprises an elastomer, a sponge, or a foamed material.

19. The system of claim 1, wherein the annular sleeve comprises a polyethylene terephthalate fabric material.

20. The system of claim 1, wherein portions of the annular sleeve extend radially inwardly through open cells of the frame and prevent the leaflets of the implantable prosthetic valve from entering the open cells when the implantable prosthetic valve is collapsed to its collapsed state by the crimping jaws.

21. The system of claim 20, wherein the portions of the annular sleeve that extend through the open cells of the frame press the leaflets radially inwardly relative to the frame when the implantable prosthetic valve is collapsed by the crimping jaws.

22. The system of claim 1, wherein the annular sleeve is configured to be placed around the implantable prosthetic valve when the implantable prosthetic valve is in the expanded state.

11. A system comprising:

an implantable prosthetic valve having a radially collapsible and expandable annular frame and tissue leaflets mounted inside of the frame;

a crimping apparatus having a plurality of crimping jaws arranged to form an aperture sized to receive the implantable prosthetic valve and to radially collapse the implantable prosthetic valve from a first, expanded state to a second, radially collapsed state; and

a layer of deformable material configured to be positioned as an intermediate protective layer between the plurality of crimping jaws of the crimping apparatus and the frame of the implantable prosthetic valve, wherein the layer of deformable material comprises an annular sleeve configured to be placed around the implantable prosthetic valve in its expanded state.

12. The system of claim 11, wherein the annular sleeve comprises a sponge material.

13. The system of claim 11, wherein the annular sleeve comprises a foamed polymeric material.

14. The system of claim 11, wherein the annular sleeve comprises a fabric material.

15. The system of claim 14, wherein the fabric material of the annular sleeve comprises polyethylene terephthalate.

16. The system of claim 15, wherein the implantable prosthetic valve further comprises a skirt coupled to the frame, and the skirt comprises polyethylene terephthalate fabric material.

17. The system of claim 11, wherein portions of the annular sleeve extend radially inwardly beyond an inner diameter of the frame and press the leaflets of the implantable prosthetic valve radially inwardly when the implantable prosthetic valve is collapsed to its collapsed state by the crimping jaws.

18. A system comprising:

an implantable prosthetic valve having a radially collapsible and expandable annular frame and tissue leaflets mounted inside of the frame;

a crimping apparatus having a plurality of crimping jaws arranged to form an aperture sized to receive the implantable prosthetic valve and to radially collapse the implantable prosthetic valve from a first, expanded state to a second, radially collapsed state; and

a layer of deformable material configured to be positioned as an intermediate protective layer between the plurality of crimping jaws of the crimping apparatus and the frame of the implantable prosthetic valve,

wherein the layer of deformable material comprises a plurality of slices of the deformable material mounted on inner surfaces of the jaws, and

wherein the layer of deformable material can be removed from the implantable prosthetic valve prior to implanting the implantable prosthetic valve.