Implantable patch prosthesis having one or more cusps for improved competency and method for using same

• US 20020072794A1
• Filed: 12/11/2000
• Published: 06/13/2002
• Est. Priority Date: 12/11/2000
• Status: Active Grant

• Current Assignee: Shlomo Gabbay
• Original Assignee: Shlomo Gabbay
• Inventors: Gabbay, Shlomo
• Granted Patent: US 6,517,576 B2
• Time in Patent Office: Days
• US Class Current: 623/2.12
• 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: 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
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: Y10S 623/912 Method or apparatus for measuring or testing prosthetic

Abstract

A patch prosthesis includes at least one cusp extending from a length of an associated valve wall. An elongated sheet of biocompatible material is attached to the valve wall, such that a portion of the elongated sheet extends beyond an inflow end of the cusp. A measurement system may be employed to measure the size of a patient'"'"'s native cusp(s), which measurement may be utilized to select a patch prosthesis having an appropriately sized cusp.

Claims

1. A cardiac patch prosthesis, comprising:

at least one cusp extending from a length of an associated valve wall; and

an elongated sheet of biocompatible material, the valve wall being attached to the elongated sheet, such that a portion of the elongated sheet extends beyond an inflow end of the cusp.

2. The prosthesis of claim 1, wherein the at least one cusp further comprises two cusps extending from the associated valve wall.

3. The prosthesis of claim 1, wherein the valve wall is part of a valve wall of an animal pulmonic heart valve and the at least one cusp is a cusp of the pulmonic heart valve.

4. The prosthesis of claim 1, wherein the valve wall is part of a valve wall of an animal aortic heart valve and the at least one cusp is a cusp of the aortic heart valve.

5. The prosthesis of claim 1, further comprising sutures located near inflow and outflow ends of the at least one cusp to attach the valve wall relative to the elongated sheet.

6. The prosthesis of claim 5, wherein the sutures located near the outflow end of the at least one cusp extend through the elongated sheet and partially through valve wall.

7. The prosthesis of claim 1, wherein an outflow end portion of the valve wall extends a length beyond an outflow end of the elongated sheet.

8. The prosthesis of claim 1 in combination with a plurality of measurement tools, at least one of the measurement tools having a generally spherical end portion insertable into adapted to measure size of the at least one cusp and another of the measurement tools having a generally spherical end portion insertable into adapted to measure size of at least one native cusp of an intended recipient of the prosthesis.

9. A repair system, comprising:

a patch prosthesis including an elongated sheet of a biocompatible flexible material and at least one cusp extending outwardly from and moveable relative to the elongated sheet; and

a measurement system including at least two sizing tools, each of the sizing tools having a generally spherical end portion insertable into and adapted to measure size of a cusp, the end portions of the sizing tools being configured to engage each other and provide a generally cylindrical structure having a generally circular cross-section having a predetermined diameter.

10. The system of claim 9, wherein the prosthesis further comprises a length of a valve wall from which the at least one cusp extends outwardly, the valve wall being attached to the elongated sheet.

11. The system of claim 10, wherein the at least one cusp further comprises two cusps extending from the length of valve wall.

12. The system of claim 10, wherein the prosthesis further comprises sutures located near inflow and outflow ends of the at least one cusp to attach the valve wall relative to the elongated sheet.

13. The system of claim 12, wherein the sutures located near the outflow end of the at least one cusp extend completely through the elongated sheet and partially through valve wall.

14. The system of claim 10, wherein an outflow end portion of the valve wall extends a length beyond an outflow end of the elongated sheet.

15. The system of claim 9, wherein the at least two sizing tools further comprises three sizing tools, each of the sizing tools having an end portion dimensioned and configured to engage the other two sizing tools as a sectional part of the cylindrical structure.

16. The system of claim 15, wherein each of the sizing tools further comprises a handle extending from the end portion thereof.

19. The system of claim 18, wherein the at least two sizing tools further comprises three sizing tools, each of the sizing tools having an end portion dimensioned and configured to engage the other two sizing tools as a sectional part of the cylindrical structure.

17. A cardiac patch prosthesis, comprising:

an elongated sheet of a flexible, biocompatible material;

flexible cup-shaped means attached to and extending from an associated valve wall for moving between open and closed conditions relative to the valve wall; and

means for connecting the cup-shaped means and valve wall relative to the elongated sheet.

18. A measurement system to facilitate repair of a heart valve, comprising:

at least two sizing tools, each of the sizing tools having a generally spherical end portion and a handle extending therefrom, each end portion being insertable into and dimensioned to measure size of a cusp, the end portions of the sizing tools being configured to engage each other and form a generally cylindrical structure having a generally circular cross-section having a predetermined diameter.

20. A method to facilitate repair of a heart valve comprising:

inserting at a first sizing tool into a native cusp of the heart valve to measure the size of the native cusp;

inserting at least a second sizing tool into a cusp of a patch prosthesis to measure the size of the cusp of the patch relative to the size of the native cusp, the first and second sizing tools having end portions configured to engage each other and form a generally cylindrical structure having a generally circular cross-section having a predetermined diameter approximating a cross-sectional diameter of the heart valve.

21. The method of claim 20, wherein prior to inserting the sizing tool into the cusp of the patch, the method further comprises inserting a third sizing tool into a second native cusp of the patient, each of the three sizing tools having an end portion dimensioned and configured to engage the other sizing tools as a sectional part of the cylindrical structure.

22. The method of claim 20, further comprising temporarily mounting the patch over the native cusp, such that commissures of the native cusp align with commissures of the cusp of the patch and applying fluid at an outflow end of the cusps to test competency of a resulting heart valve.

23. The method of claim 20, wherein the cusp of the patch prosthesis further comprises two cusps that extend from an associated valve wall.

24. The method of claim 23, further comprising inserting a third sizing tool into a second cusp of the patch prosthesis to measure the size of the second cusp of the patch relative to the native cusp, each of the three sizing tools having an end portion dimensioned and configured to engage the other sizing tools as a sectional part of the cylindrical structure.

26. The method of claim 25, wherein the assembly includes two cusps extending from the associated valve wall.

25. A method of forming a patch prosthesis, comprising:

excising a heart valve from an animal, the heart valve having at least two cusps extending from an interior of a valve wall;

fixing the valve in a fixation solution;

opening the valve by cutting axially through the valve wall thereof;

removing a section of the valve wall from the opened valve, which section includes at least one cusp, to form an assembly that includes least one cusp and a length of associated valve wall;

attaching the valve wall of the assembly to an elongated sheet of a biocompatible material, a portion of the elongated sheet extending beyond an inflow end of the cusp.