Stentless heart valve

• US 5,509,930 A
• Filed: 12/17/1993
• Issued: 04/23/1996
• Est. Priority Date: 12/17/1993
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Autogenics Co.
• Inventors: Love, Jack W.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Fossum, Laura
• Application Number:
  US08/170,002
• Time in Patent Office: 858 Days
• Field of Search: 623/2, 623/66, 623/900
• US Class Current: 623/2.1
• 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 2/2415 Manufacturing methods
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

A stentless heart valve assembled from autologous tissue is provided. The tissue is cut into a rectangular shape, folded, and stapled at several locations to form the cusps of the valve. The outer walls of the valve are pinched at the midpoint of each cusp to prevent the cusps from adhering to the valve walls. The ends of the rectangle are then stapled to form the annular valve itself.

Claims

1. A stentless prosthetic heart valve formed from tissue removed from a patient during open heart surgery, said heart valve comprising:

a single piece of autologous tissue substantially entirely forming said heart valve, inner and outer layers of said tissue having a common fold, said layers secured to each other along two lines extending distally from said fold to form three segments of tissue, said folded tissue having opposing ends, said opposing ends being parallel to said two distally extending lines, said opposing ends being joined together to form an annular, self-supporting heart valve in which the three segments of inner tissue form three coapting valve cusps.

2. A stentless prosthetic heart valve formed from tissue removed from a patient during open heart surgery, said heart valve comprising:

a single piece of autologous tissue substantially entirely forming said heart valve, inner and outer layers of said tissue having a common fold, said layers secured to each other along two lines extending distally from said fold to form three segments of tissue, each segment having opposing corners at said fold, said inner and outer layers secured together along an arc formed in each segment, said arc sealing the corners of said segments of tissue from bloodflow through said valve to prevent stagnation of blood in said valve during the operation thereof, said folded tissue having opposing ends, said opposing ends being parallel to said two distally extending lines, said opposing ends being joined together to form an annular, self-supporting heart valve in which the three segments of inner tissue form three coapting valve cusps.

3. A stentless prosthetic heart valve formed from tissue removed from a patient during open heart surgery, said heart valve comprising:

a single piece of autologous tissue substantially entirely forming said heart valve, inner and outer layers of said tissue having a common fold, the upper end of said inner layer having a straight edge, said layers secured to each other along two lines extending distally from said fold to form three segments of tissue, said folded tissue having opposing ends, said opposing ends being parallel to said two distally extending lines, said opposing ends being joined together to form an annular, self-supporting heart valve in which the three segments of inner tissue form three coapting valve cusps.

4. A stentless prosthetic heart valve formed from tissue removed from a patient during open heart surgery, said heart valve comprising:

a single piece of autologous tissue substantially entirely forming said heart valve, inner and outer layers of said tissue having a common fold, a distal end of said tissue being cut into a scalloped shape, said inner layer including an upper edge having said distal end scalloped shape and an outer layer of tissue, said layers secured to each other along two lines extending distally from said fold to form three segments of tissue, said folded tissue having opposing ends, said opposing ends being parallel to said two distally extending lines, said opposing ends being joined together to form an annular, self-supporting heart valve in which the three segments of inner tissue form three coapting valve cusps, whereby said scalloped shape of said upper edge of the inner layer provides greater coaptive surface area for said valve cusps.

5. A stentless prosthetic heart valve formed from tissue removed from a patient during open heart surgery, said heart valve comprising:

a single piece of autologous tissue substantially entirely forming said heart valve, inner and outer layers of said tissue having a common fold, said layers secured to each other along two lines extending distally from said fold to form three segments of tissue, said folded tissue having opposing ends, said opposing ends being parallel to said two distally extending lines, said opposing ends being joined together to form an annular, self-supporting heart valve in which the three segments of inner tissue form three coapting valve cusps, said outer layer of tissue pinched at three locations opposite the distal end of said inner layer of tissue at a midpoint of each segment of tissue to prevent said valve cusps from adhering to said outer layer of tissue during operation of said valve.

6. The prosthetic heart valve of claim 5 wherein said outer layer of tissue is pinched by emplacement of a single staple at the midpoint of each segment of tissue opposite the distal end of said inner layer of tissue.

7. A stentless prosthetic heart valve formed from tissue removed from a patient during open heart surgery, said heart valve comprising:

a single piece of autologous tissue substantially entirely forming said heart valve, inner and outer layers of said tissue having a common fold, said layers secured to each other along two lines extending distally from said fold to form three segments of tissue, said folded tissue having opposing ends, said opposing ends being parallel to said two distally extending lines, said opposing ends being joined together to form an annular, self-supporting heart valve in which the three segments of inner tissue form three coapting valve cusps, said prosthetic heart valve including a prosthetic cloth or cloth-covered girdle placed around and constricting the midsection of said valve, said girdle preventing said cusps from adhering to said outer layer of tissue during operation of said valve.

8. A stentless prosthetic heart valve formed from tissue removed from a patient during open heart surgery, said heart valve comprising:

a single piece of autologous tissue substantially entirely forming said heart valve, inner and outer layers of said tissue having a common fold, said layers secured to each other along two lines extending distally from said fold to form three segments of tissue, said outer layer of tissue extending distally from the distal end of said inner layer to form an outflow tract, said outflow tract selectively cut to match said patient'"'"'s vascular anatomy, said folded tissue having opposing ends, said opposing ends being parallel to said two distally extending lines, said opposing ends being joined together form an annular, self-supporting heart valve in which the three segments of inner tissue form three coapting valve cusps.

9. A stentless prosthetic heart valve formed from removed from a patient during open heart surgery, said heart valve comprising:

a single piece of autologous tissue substantially entirely forming said heart valve, said tissue briefly immersed in a solution containing at least 0.6% glutaraldehyde, inner and outer layers of said tissue having a common fold, said layers secured to each other along two lines extending distally from said fold to form three segments of tissue, said folded tissue having opposing ends, said opposing ends being parallel to said two distally extending lines, said opposing ends being joined together to form an annular, self-supporting heart valve in which the three segments of inner tissue form three coapting valve cusps.

10. A cardiac valve, comprising:

a self-supporting annular body formed substantially entirely from a single piece of autologous pericardium tissue, said tissue having distal and proximal ends, said distal end of said tissue cut into a plurality of scalloped portions, said tissue folded at a fold to form inner and outer layers of tissue, said inner and outer layers of tissue stapled together at a first set of staples along a plurality of lines extending distally from said fold, said inner and outer layers stapled at a second set of staples in a plurality of arcs at said fold, said inner layer of tissue forming a plurality of valve cusps coapting with one another, said second set of staples preventing areas of bloodflow stagnation from forming during operation of said valve, and said scalloped portions providing improved coaption between said valve leaflets.

11. A cardiac valve, comprising:

a single piece of autologous tissue substantially entirely forming said valve, a self-supporting annular body of said tissue having distal and proximal ends, said tissue folded at a fold location to form a plurality of layers of tissue, said layers of tissue secured together along a plurality of lines extending distally from said fold location of said valve.

12. The cardiac valve of claim 11, wherein said layers are secured together by staples.

13. The cardiac valve of claim 11, wherein said layers are secured together by sutures.

14. The cardiac valve of claim 11, wherein said layers are secured together along a plurality of arcs at said fold location of said valve.

15. The cardiac valve of claim 11, wherein said proximal end of said tissue is cut into a plurality of scalloped portions.

16. The cardiac valve of claim 11, wherein a layer of said tissue is tucked at a plurality of locations around said annular body of tissue to prevent said layers from adhering to each other during operation of said valve.

17. The cardiac valve of claim 16, wherein a layer of said tissue is tucked midway between each of said lines securing said tissue opposite the distal end of the innermost of said layers.

18. The cardiac valve of claim 16, wherein a layer of said tissue is tucked by emplacement of a suture in said outer layer opposite the distal end of the innermost of said layers.

19. The cardiac valve of claim 16, wherein a layer of said tissue is tucked by emplacement of a staple in said outer layer opposite the distal end of the innermost of said layers.

20. The cardiac valve of claim 11, wherein said proximal end of said tissue has a straight edge.

21. The cardiac valve of claim 11, further comprising:

a girdle placed around the outside of the middle section of said valve, said girdle constricting the middle section of said valve to form a sinus, said girdle thereby preventing said layers of said tissue from adhering during operation of said valve.

22. The cardiac valve of claim 11 wherein said tissue is immersed in a solution containing glutaraldehyde.

23. The cardiac valve of claim 11 wherein said tissue is autologous pericardium.

24. The cardiac valve of claim 11 wherein said tissue is autologous fascia lata.

25. A cardiac valve, comprising:

a self-supporting annular body consisting of substantially a single piece of autologous tissue, said tissue having a distal end and a proximal end, said distal end cut along a plurality of scalloped sections, said tissue folded at a location distally from said proximal end to form inner and outer layers, said inner and outer layers of tissue secured along a plurality of lines extending distally from said folded location of said valve to the top of said inner layer, said inner and outer layers of tissue secured at the fold forming said inner and outer layers along a plurality of arcs, each of said arcs tangent at its midpoint to said fold, said outer layer pinched at a plurality of locations opposite the distal end of said inner layer to prevent said inner and said outer layers from adhering to each other during the operation of said valve.

26. A stentless prosthetic heart valve formed from tissue removed from a patient during open heart surgery, said valve comprising a single piece of autologous tissue substantially entirely forming said valve, said valve having an annular configuration in which said tissue has been folded into two layers and said layers have been secured to one another into three outer and inner segments, the inner segments of said annular configuration comprising three coapting valve cusps.

29. The heart valve of claim 26 wherein said tissue is autologous pericardium.

30. The heart valve of claim 26, wherein said tissue is autologous fascia lata.

27. A stentless prosthetic heart valve, comprising:

a self-supporting annular body consisting substantially of a single piece of autologous pericardial tissue, said tissue having inner and outer layers, said tissue having a common fold, said layers secured to each other along two lines extending distally from said fold to form three segments of tissue, said folded tissue having opposing ends, said opposing ends being parallel to said two distally extending lines, said opposing ends being joined together to form the annular body of the heart valve in which the three segments of inner tissue form three coapting valve cusps.

28. A stentless prosthetic heart valve, comprising:

a self-supporting annular body consisting substantially of a single piece of autologous pericardial tissue, said tissue having inner and outer layers, said tissue having a common fold, said inner and outer layers of tissue stapled together along a plurality of lines extending distally from said fold to form three segments of tissue, said folded tissue having opposing ends, said opposing ends being parallel to said plurality of distally extending lines, said opposing ends being joined together to form the annular body of the heart valve in which the three segments of inner tissue form three coapting valve cusps.