Method and apparatus for preparing a contoured biological tissue

• US 9,615,922 B2
• Filed: 09/12/2014
• Issued: 04/11/2017
• Est. Priority Date: 09/30/2013
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Munnelly, Amy E., Dove, Jeffrey S., Lee, Minsey
• Primary Examiner(s): Marmor, II, Charles A
• Assistant Examiner(s): Dorna, Carrie R
• Application Number:
  US14/485,576
• Publication Number:
  US 20150091219A1
• Time in Patent Office: 942 Days
• 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 2240/004 Using a positive or negative model, e.g. moulds

Abstract

An assembly and methods for providing a contoured biological tissue are described. The assembly comprises a first plate and a second plate. The first plate is configured to receive a biological tissue. The second plate is configured to apply a compressive force on the biological tissue that is disposed on the first plate. One or both of the first and second plates comprise a defined shape and a contoured area within the defined shape. The contoured area comprises at least first and second elevations and a continuous transition between the first and second transitions. One or more energy sources is associated with one or both of the first and second plates. The one or more energy sources delivers energy while the second plate applies the compressive force on the biological tissue disposed on the first plate.

Claims

1. An assembly for providing a contoured biological tissue, the assembly comprising:

a first plate configured to receive a biological tissue;

a second plate having a surface and being configured to apply a compressive force on the biological tissue disposed on the first plate;

wherein one or both of the first and second plates comprise a defined shape and a contoured area within the defined shape, the contoured area comprising at least first and second elevations and a continuous transition between the first and second elevations; and

one or more energy sources associated with one or both of the first and second plates, the one or more energy sources delivering energy when the the biological tissue is compressed between the first and second plates;

wherein the defined shape includes a peripheral edge region and a central region within the peripheral edge region, and

wherein a first distance between the first and second plates along at least a portion of the peripheral edge region is greater than a second distance between the first and second plates along at least a portion of the central region.

2. The assembly of claim 1, wherein the one or both of the first and second plates are porous.

3. The assembly of claim 1, wherein the defined shape is one or a plurality of heart valve leaflets and wherein the heart valve leaflets each has a substantially straight free edge and an arcuate cusp edge.

4. The assembly of claim 3, wherein the first elevation is defined along the arcuate cusp edge and the second elevation is located between the arcuate cusp edge.

5. The assembly of claim 4, wherein the first elevation is higher relative to the second elevation.

6. The assembly of claim 4, wherein the second elevation is higher relative to the first elevation.

7. The assembly of claim 1, further comprising a spacer disposed between the first and second plates, the spacer controlling a thickness of the compressed biological tissue.

8. The assembly of claim 1, further comprising a blade corresponding substantially to the defined shape on the first plate.

9. The assembly of claim 1, wherein the energy delivered by the one or more energy sources is one or a combination selected from the group consisting of:

thermal, ultrasound, electromagnetic, vibrational, hydraulic, piezoelectric, pneumatic, and acoustic or sound.

10. The assembly of claim 9, wherein the energy is thermal energy and wherein the one or more energy sources is one or a combination selected from the group consisting of:

thermal coils disposed within the first plate, thermal coils disposed within the second plate, and a liquid bath.

11. The assembly of claim 9, wherein the energy is ultrasound energy and wherein the one or more energy sources is an ultrasound transducer associated with one or both of the first and second plates or with a liquid bath.

12. The assembly of claim 9, wherein the energy is electromagnetic energy and wherein the energy source is a RF or microwave antenna embedded in a non-conducting plate or a printed circuit antenna insulated from the tissue.

13. The assembly of claim 9, wherein the energy is vibrational energy and wherein the one or more energy sources is a clamp coupled to one or both of the first and second plates, a platform in contact with one or both of the first and second plates, an actuator coupled to one or both of the first and second plates.

14. The assembly of claim 1, wherein the first plate comprises the defined shape and contoured area and the second plate comprises a substantially flat surface.

15. The assembly of claim 1, wherein the first and second plates each comprise the defined shape and the contoured area within the defined shape.

16. The assembly of claim 1, wherein the first distance is from about 250 to about 700 microns and the second distance is from about 100 to about 250 microns.

17. A method for preparing a contoured biological tissue comprising:

compressing a layer of biological tissue between first and second plates to reduce a thickness of at least a portion of the tissue; and

delivering energy from an energy source to one or both of the first and second plates during the compressing;

wherein the tissue following the compressing has at least two areas of different thicknesses and a continuous transition within a defined shape.

18. The method of claim 17, further comprising treating the tissue with a first fixative to at least partially fix the tissue.

19. The method of claim 18, further comprising treating the tissue with a second fixative before, during or before and during the compressing.

20. The method of claim 19, wherein the second fixative is one or a combination selected from the group consisting of:

polyvinyl alcohols, polyetheramines, polyethyleneimine, di- or poly-amines, polyurethanes, polyepoxies, polysiloxanes, polyacrylates, polyesters, poly block isobutylene-co-maleic acid, collagen, elastin, fibrin, hyaluronic acid, dextrin, genapin, di- or poly-alkynes, di- or poly-azides, and tannins.

21. The method of claim 17, further comprising soaking the tissue with a fixative, wherein the fixative is a 0.1% polyetheramine solution having an average molecular weight of about 600 and a pH of about 6 to 9.

22. The method of claim 17, wherein a first thickness is from about 250 to about 700 microns and a second thickness is from about 100 to about 250 microns.

23. The method of claim 17, wherein the step of treating the tissue with a first fixative to at least partially fix the tissue occurs before the compressing step.

24. The method of claim 17, wherein the step of treating the tissue with a first fixative to at least partially fix the tissue occurs during the compressing step.

25. The method of claim 17, wherein the step of treating the tissue with a first fixative to at least partially fix the tissue occurs after the compressing step.