Methods of heart valve repair

• US 5,716,399 A
• Filed: 10/06/1995
• Issued: 02/10/1998
• Est. Priority Date: 10/06/1995
• Status: Expired due to Term

• Current Assignee: Cardiomend LLC
• Original Assignee: Cardiomend LLC
• Inventors: Love, Jack W.
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/539,971
• Time in Patent Office: 858 Days
• Field of Search: 623/2, 623/900, 623/901
• US Class Current: 128/898
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers

Abstract

A method for repairing a heart valve comprising steps of sizing an annulus of a heart; harvesting tissue; cutting a trefoil pattern matched to the size of the annulus from the harvested tissue; forming a valve having at least one leaflet from said trefoil pattern, where the valve has a base with an edge portion of tissue extending around an outer periphery thereof; and suturing the edge portion to the exposed annulus; also disclosed is a method of repairing a heart valve comprising steps of: sizing an annulus of a heart at a repair site; harvesting tissue; cutting a trefoil pattern from the harvested tissue specific to the size of the annulus; providing first and second formers which are specific to the size of the annulus of the valve, forming a tri-leaflet valve from said trefoil pattern by engaging blades of said first former to corresponding blades of said second former with said trefoil pattern sandwiched therebetween; exposing an edge portion of tissue extending around an outer periphery of a base of the valve; moving the formers with the trefoil pattern sandwiched therebetween to a position which is proximate to the repair site; suturing the exposed edge portion to the annulus; and withdrawing the formers from the repair site.

Claims

1. A method for repairing a heart valve comprising:

(a) sizing an annulus of a heart;

(b) harvesting tissue;

(c) cutting a trefoil pattern matched to the size of the annulus from the harvested tissue;

(d) forming a valve having at least one leaflet from said trefoil pattern, the valve having a base with an edge portion of tissue extending around an outer periphery thereof; and

(e) suturing the edge portion to the exposed annulus.

2. The method of claim 1 wherein said harvesting step comprises harvesting autologous tissue.

3. The method of claim 2 wherein said harvesting step comprises harvesting pericardium.

4. The method of claim 2 further comprising the step of immersing said harvested tissue in a glutaraldehyde solution.

5. The method of claim 1 wherein said forming step comprises molding the pattern into the valve using a pair of engageable formers.

6. The method of claim 5 wherein the formers are molded in a three-dimensional shape representative of a partially closed tri-leaflet valve.

7. The method of claim 5 wherein the formers are planar.

8. The method of claim 5 wherein said forming step further comprises exposing said edge portion of tissue.

9. The method of claim 1 wherein said cutting step comprises cutting the pattern from the harvested tissue using a size specific tissue cutting die.

10. The method of claim 1 further comprising the step of reinforcing the edge portion of tissue with a pledget made from a bio-compatible material.

11. The method of claim 5 further comprising providing a pre-fabricated kit in which is contained said pair of formers.

12. The method of claim 1 wherein the pattern is a trefoil pattern, and the valve is a tri-leaflet valve.

13. The method of claim 1 wherein the pattern has less than three lobes, and the valve has less than three leaflets.

14. A method of repairing a heart valve comprising the steps of:

(a) sizing an annulus of a heart at a repair site;

(b) harvesting tissue;

(c) cutting a trefoil pattern from the harvested tissue specific to the size of the annulus;

(d) providing first and second formers which are specific to the size of the annulus of the valve,

(e) forming a tri-leaflet valve from said trefoil pattern by engaging blades of said first former to corresponding blades of said second former with said trefoil pattern sandwiched therebetween;

(f) exposing an edge portion of tissue extending around an outer periphery of a base of the valve;

(g) moving the formers with the trefoil pattern sandwiched therebetween to a position which is proximate to the repair site;

(h) suturing the exposed edge portion to the annulus; and

(i) withdrawing the formers from the repair site.

15. The method of claim 14 wherein said harvesting step comprises harvesting autologous tissue.

16. The method of claim 15 wherein said step of harvesting tissue comprises harvesting pericardium.

17. The method of claim 15 further comprising the step of immersing said harvested tissue in a glutaraldehyde solution.

18. The method of claim 14 wherein said cutting step comprises cutting said trefoil pattern out of said harvested tissue using a size specific tissue cutting die.

19. The method of claim 14 further comprising reinforcing the exposed strip of tissue with a pledget made of a bio-compatible material.

20. The method of claim 14 further comprising providing a size specific pre-fabricated kit in which said formers are contained.

21. The method of claim 18 further comprising providing a pre-fabricated kit in which is contained said size specific tissue cutting die.

22. A method of repairing a heart valve comprising the steps of:

(a) sizing an annulus of a heart at a repair site;

(b) harvesting autologous tissue;

(c) cutting a unitary trefoil pattern from the harvested tissue, the trefoil pattern having three lobes arranged in substantial radial symmetry about a central coaption point within a central aperture, the central aperture having coaptive edges which meet at the central coaption point when the valve is in a closed position;

(d) providing a pre-fabricated kit containing size specific first and second formers;

(e) engaging blades of the first former with corresponding blades of the second former with the trefoil pattern sandwiched therebetween to form a tri-leaflet valve;

(f) exposing an edge portion of tissue extending around an outer periphery of a base of the valve;

(g) moving the formers with the trefoil pattern sandwiched therebetween to a position which is proximate to the repair site;

(h) suturing the edge portion to the annulus; and

(i) withdrawing the formers from the valve repair site.

23. The method of claim 22 wherein said harvesting step comprises harvesting pericardium.

24. The method of claim 22 wherein said cutting step comprises cutting said trefoil pattern from said harvested tissue using a size specific tissue cutting die.

25. The method of claim 24 further comprising containing said size specific tissue cutting die in said pre-fabricated kit.

26. The method of claim 22 further comprising retracting the blades of said lower former.

27. The method of claim 22 wherein said cutting step further comprises cutting said trefoil pattern such that the lobes meet adjacent lobes at commissure areas, and are configured with extra coaptive surfaces such that the central coaption point lies above a plane defined by the commissure areas.