METHOD AND DEVICE FOR CRIMPING AND LOADING HEART VALVE

• US 20170100243A1
• Filed: 10/08/2015
• Published: 04/13/2017
• Est. Priority Date: 10/08/2015
• Status: Active Grant

• Current Assignee: Shlomo Gabbay
• Original Assignee: Shlomo Gabbay
• Inventors: Gabbay, Shlomo
• Granted Patent: US 9,980,817 B2
• Time in Patent Office: Days
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 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 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2310/00011 Metals or alloys

Abstract

A method of crimping and loading prosthetic heart valves comprises folding a crimping sheet to form a spiral wrapped around a heart valve; manually rolling and tightening the spiral to compress the valve inside the spiral; inserting the tightened spiral wrapped around the valve into a cannula; and displacing the valve out of the tightened spiral and into the cannula. A kit for crimping and loading the valve into a delivery device comprises a crimping sheet foldable to form a spiral wrapped around the valve, the spiral manually rollable and tightenable to compress the valve wrapped inside the spiral, so that the tightened spiral is slidably insertable into a lumen of a cannula for delivering the valve; and a plunger sized for insertion into the tightened spiral to displace the heart valve out of the spiral and into the lumen of the cannula.

Claims

1. A method of crimping and loading a prosthetic heart valve, comprising:

folding a crimping sheet to form a spiral wrapped around the heart valve;

manually rolling and tightening said spiral to compress said heart valve wrapped inside said spiral;

inserting an end of the tightened spiral wrapped around the heart valve into a cannula; and

displacing the heart valve out of said end of said tightened spiral and into said cannula.

2. The method of claim 1, further comprising cooling said heart valve and said crimping sheet before said folding.

3. The method of claim 1, comprising placing a restriction ring around said tightened spiral to prevent loosening of said tightened spiral before said tightened spiral is inserted into said cannula.

4. The method of claim 1, wherein said crimping sheet comprises a metal or a plastic.

5. The method of claim 1, wherein said crimping sheet has a thickness of less than 1 mm.

6. The method of claim 1, wherein said cannula is in a trocar.

7. The method of claim 1, wherein said lumen of said cannula has a diameter of 1 mm to 40 mm.

8. The method of claim 1, wherein said heart valve is a sutureless mitral, aortic, tricuspid, or pulmonic valve.

9. The method of claim 1, wherein said heart valve is a stented valve.

10. The method of claim 1, comprising sizing the heart valve by annuloplasty suturing.

20. The kit of claim 1, wherein the heart valve is a stented sutureless mitral, aortic, tricuspid, or pulmonic valve.

11. A kit for crimping and loading a prosthetic heart valve into a delivery device, comprising:

a crimping sheet foldable to form a spiral wrapped around the heart valve, said spiral manually rollable and tightenable to compress the heart valve wrapped inside said spiral, so that the tightened spiral is slidably insertable into a lumen of a cannula for delivering the heart valve; and

a plunger sized for insertion into said tightened spiral to displace the heart valve out of the spiral and into said lumen of said cannula.

12. The kit of claim 11, further comprising said cannula, wherein said lumen of said cannula is sized to house the compressed heart valve.

13. The kit of claim 11, further comprising a restriction ring sized to slide over said tightened spiral to prevent loosening of said tightened spiral.

14. The kit of claim 11, wherein said crimping sheet comprises a metal or a plastic.

15. The kit of claim 11, wherein said crimping sheet has a thickness of less than 1 mm.

16. The kit of claim 11, wherein said cannula is in a trocar.

17. The kit of claim 11, wherein said lumen of said cannula has a diameter from 1 mm to 40 mm.

18. The kit of claim 11 comprising a plurality of cannulas having different lumen diameters.

19. The kit of claim 18, wherein the lumen diameters are selected from 18, 21, 23, 24, 25, 27, 29, 31, 33, and 35 mm.