Bioprosthetic components for an implant, in particular partly crosslinked biological heart valves
Bioprosthetic components based on, or comprising, biological materials for implants, preferably biological heart valves, in particular biological heart valve leaflets, which have only been chemically or thermally stabilized (partly crosslinked) at mechanically stressed points and therefore have zones having different mechanical properties, and to a method for the production thereof.
1. A bioprosthetic component for a circulatory system implant comprising a surface of a biological material with one or more zones having increased mechanical stability compared to a remaining zone, wherein the increased mechanical stability is from shaping and by a short-term thermal treatment, further wherein the one or more zones having increased mechanical stability account for a proportion of at least 2% and up to 40% of the surface.
2. The biosprosthetic component of claim 1 , wherein the biological material is punched with simultaneous heating at edges.
3. The biosprosthetic component of claim 1 , wherein the biological material is punched then heated.
4. The biosprosthetic component of claim 1 , wherein the biological material is laser cut.
5. The biosprosthetic component of claim 1 , wherein the bioprosthetic component is a heart valve leaflet.
6. The biosprosthetic component of claim 1 , wherein the biological material is decellularized.
7. The biosprosthetic component of claim 1 , wherein the one or more zones having increased mechanical stability have a suture retention strength (SRS) from 30 to 450 N/mm 2 .
8. The biosprosthetic component of claim 1 , wherein at least 10% of the surface has the increased mechanical stability.
9. The biosprosthetic component of claim 8 , wherein 10% to 20% of the surface has the increased mechanical stability.
10. The bioprosthetic component of claim 1 , wherein the biological material is modified by treatment with a 0.3 to 1.0% by weight glutaraldehyde solution based on a phosphate-buffered isotonic sodium chloride solution having a pH of from 7.2 to 7.5.
11. The biosprosthetic component of claim 1 , wherein the implant is selected from the group consisting of a mitral heart valve, an aortic heart valve, a pulmonary heart valve, and a venous valve.
12. A bioprosthetic component for a circulatory system implant comprising a surface of a biological material with one or more zones having increased mechanical stability compared to a remaining zone, wherein the increased mechanical stability is from shaping and by a short-term thermal treatment, further wherein the one or more zones having increased mechanical stability account for a proportion up to 40% of the surface, further wherein the one or more zones having increased mechanical stability have a suture retention strength (SRS) from 30 to 450 N/mm 2 .
13. The biosprosthetic component of claim 12 , wherein the bioprosthetic component is a heart valve leaflet.
14. The biosprosthetic component of claim 12 , wherein the implant is selected from the group consisting of a mitral heart valve, an aortic heart valve, a pulmonary heart valve, and a venous valve.
15. The biosprosthetic component of claim 12 , wherein at least 10% of the surface has the increased mechanical stability.
16. The biosprosthetic component of claim 12 , wherein the biological material is punched with simultaneous heating at edges.
17. The biosprosthetic component of claim 12 , wherein the biological material is punched then heated.
18. The biosprosthetic component of claim 12 , wherein the biological material is laser cut.
19. The biosprosthetic component of claim 12 , wherein the biological material is decellularized.
20. The bioprosthetic component of claim 12 , wherein the biological material is modified by treatment with a 0.3 to 1.0% by weight glutaraldehyde solution based on a phosphate-buffered isotonic sodium chloride solution having a pH of from 7.2 to 7.5.