阅读说明：本技术 包含宏观纹理化的软假体植入物及其制造方法 (Soft prosthetic implant including macro texturing and method of making same ) 是由 弗雷泽·哈维 于 2018-03-22 设计创作，主要内容包括：植入物,其包含植入物主体,其中所述植入物主体包含在所述植入物主体表面上的一个或更多个宏观纹理化区域。描述了制造在植入物主体表面上包含一个或更多个宏观纹理化区域的植入物的多种方法,所述方法是(i)制造植入物,其包括在芯模上形成壳并用芯材料填充所述壳,其中将所述芯模成形为在所述壳中形成宏观纹理化区域；(ii)制造植入物,其包括将包含硅酮聚合物的支架固定至植入物主体的表面或(iii)制造植入物,其包括将会形成宏观纹理化区域的材料挤出到植入物主体上或(iv)制造植入物,其包括对植入物主体上的表面进行激光刻蚀以形成宏观纹理化区域。(An implant comprising an implant body, wherein the implant body comprises one or more macro textured regions on a surface of the implant body. Various methods of manufacturing an implant comprising one or more macro textured regions on the surface of the implant body are described, the methods being (i) manufacturing an implant comprising forming a shell on a core mold and filling the shell with a core material, wherein the core mold is shaped to form macro textured regions in the shell; (ii) (ii) fabricating an implant comprising securing a scaffold comprising a silicone polymer to a surface of an implant body or (iii) fabricating an implant comprising extruding material that will form a macro textured region onto an implant body or (iv) fabricating an implant comprising laser etching a surface on an implant body to form a macro textured region.)

1. An implant comprising an implant body, wherein the implant body comprises one or more macro textured regions on a surface of the implant body.

2. The implant of claim 1, wherein the implant body is smooth and/or comprises micro textured areas.

3. The implant of claim 1 or claim 2, wherein the macro textured region has a cross section of 0.1cm to 10 cm.

4. The implant of any preceding claim, wherein the macro textured region has a depth of 0.1cm to 1.5 cm.

5. The implant of any preceding claim, wherein the macro textured region provides a fixed surface on the implant.

6. The implant of any preceding claim, wherein the macro texturing is provided by a scaffold secured to a surface of the implant body.

7. The implant of claim 6, wherein the scaffold comprises a mesh formed directly on a surface of the implant.

8. The implant of any one of claims 1 to 5, wherein the macro textured region is integral with a surface of the implant body.

9. The implant of any preceding claim, wherein the macro textured region has a configuration selected from: a ring configuration comprising a single ring or a plurality of concentric rings, a randomized configuration comprising a plurality of macro textured regions, a ribbon configuration, or a combination thereof.

10. The implant of any preceding claim, wherein the implant is an implant selected from the group consisting of: hip, breast, chest, calf, abdomen and arm implants.

11. The implant of claim 10, wherein the implant is a breast implant.

12. The implant of claim 11, wherein the implant is a breast implant and the macro textured region has a tape-like configuration comprising one or more tapes positioned at points in the implant that will be located in a sub-mammary fold.

13. The implant of any preceding claim, wherein the macro textured region functions as an implant orientation marker.

14. The implant of any preceding claim, wherein the macro textured region and/or the implant body comprises a bioactive material.

15. The implant of claim 14, wherein the macro textured region and/or the implant body is coated and/or impregnated with a bioactive material.

16. The implant of claim 14 or claim 15, wherein the bioactive material comprises an antibiotic, an antimicrobial, a biocide, an anti-inflammatory, a steroid, isolated adipocytes, or a combination thereof.

17. The implant of any preceding claim, wherein one or more of the macro textured regions comprises a polymer selected from the group consisting of: silicone, polyurethane, polyester, polypropylene, polycarbonate, polyethylene, polybutylene, polymethylmethacrylate, polyvinyl chloride, polytetrafluoroethylene, polyethylene glycol, polyethylene oxide, or a combination thereof.

18. The implant of claim 17, wherein one or more of the macro-textured regions comprises a polymer selected from silicone polymers.

19. The implant of claim 18, wherein the silicone polymer is selected from the group consisting of: polydimethylsiloxanes, polysiloxanes, polyfluorosiloxanes, phenylsiloxanes, and combinations thereof.

20. The implant of any one of claims 6, 7, and 10-19, wherein the scaffold is at least partially absorbable.

21. The implant of claim 20, wherein the scaffold comprises a polymer selected from the group consisting of: polylactic acid, polyglycolic acid, polycaprolactone, polytrimethylene carbonate, polyhydroxybutyrate, polyhydroxyvalerate, or a combination thereof.

22. The implant of any one of claims 6, 7, and 10-20, wherein the scaffold comprises a foam, a felt, a nonwoven, a braided material, a mesh, a woven fabric, a 3D printed material, a fiber spun material, a laminate, or a combination thereof.

23. The implant of claim 22, wherein the scaffold comprises foam.

24. The implant of any one of claims 6, 7, and 10 to 23, wherein the scaffold is porous.

25. A method of making an implant comprising forming a shell on a core mold and filling the shell with a core material, wherein the core mold is shaped to form a macro-textured region in the shell.

26. The method of claim 25, further comprising curing the core material.

27. A method of manufacturing an implant comprising securing a scaffold comprising a silicone polymer to a surface of an implant body.

28. The method of claim 27, wherein securing the scaffold to the implant body comprises one or more steps selected from the group consisting of: applying the scaffold to an outer layer of an uncured implant body, followed by curing; applying an uncured layer of implant body material to the scaffold, applying the scaffold to an outer layer of the cured implant body, and curing the uncured material; adhering the scaffold to the implant body.

29. The method of claim 28, wherein adhering comprises using a glue selected from the group consisting of: room temperature vulcanizing silicone adhesive, UV curing isocyanate adhesive and/or moisture curing isocyanate adhesive.

30. A method of manufacturing an implant includes extruding a material that forms a macro textured region onto an implant body.

31. The method of claim 30, further comprising curing the material.

32. A method of manufacturing an implant, the method comprising laser etching a surface of an implant body to form a macro-textured region.

33. The method of manufacturing an implant according to claim 32, wherein the step of laser etching is preceded by the steps of forming a shell on a core mold and filling the shell with a core material, wherein the core mold is shaped to form a macro textured region in the shell.

34. A method of tissue augmentation or reconstruction comprising surgically inserting an implant as claimed in any one of claims 1 to 24 into a tissue cavity of a human or animal.