Bioabsorbable breast implant

• US 6,214,045 B1
• Filed: 10/09/1998
• Issued: 04/10/2001
• Est. Priority Date: 10/10/1997
• Status: Expired due to Term

• Current Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Original Assignee: Whitewater Investments Incorporated
• Inventors: Leonetti, Lori A., Corbitt, John D. Jr.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US09/169,351
• Time in Patent Office: 914 Days
• Field of Search: 623/7, 623/8, 623/23.75, 628/8, 606/77, 424/426
• US Class Current: 623/8
• CPC Class Codes: A61F 2/0059 Cosmetic or alloplastic implants A61F2/10 - A61F2/16, A61F2/28 take precedence
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence

Abstract

A breast implant has at least an outer shell which is composed of a resorbable material. The implant, which can be formed entirely of bioresorbable material, is sized and shaped to replace excised tissue. The implant supports surrounding tissue upon implantation, while allowing for in-growth of fibrous tissue to replace the implant. According to various alternative embodiments, the implant is elastically compressible, or can be formed from self-expanding foam or sponges, and can be implanted through a cannula or by injection, as well as by open procedures. The implant also is capable of carrying therapeutic and diagnostic substances.

Claims

1. An implant for implantation in a human body comprising an outer shell of resorbable material and a resorbable inner fluid core, the implant being formed to fit the shape and size of a cavity in the human body, the implant being configured to be installed for supporting tissue surrounding the cavity and allowing in-growth of fibrous tissue into and replacing the outer shell.

2. The implant of claim 1, wherein the outer shell further comprises a non-resorbable material.

3. The implant of claim 1, wherein the outer shell is elastically compressible.

4. The implant of claim 1, wherein the core is surrounded completely by the outer shell.

5. The implant of claim 4, wherein the core includes autologous material.

6. The implant of claim 1, further comprising at least one of radiation material, antibiotics, chemotherapies, cancer therapies, hemostatic material, hormone therapies, and radiographic markers.

7. The implant of claim 1, further comprising at least one medicinal, therapeutic or diagnostic substance.

8. The implant of claim 7, wherein the at least one substance is selected from the group consisting of radiation material, antibiotics, chemotherapies, cancer therapies, hemostatic material, hormone therapies, and radiographic markers. and the step of implanting is performed by injection of the self-expanding foam.

12. The implant of claim 1, wherein the core includes a saline solution.

13. The implant of claim 1, further comprising a resorbable inner shell surrounding the inner core, and a supply of fluid disposed between the inner shell and the outer shell.

21. The implant of claim 1, wherein the outer shell is adjacent the inner core.

9. A method for replacing excised human breast tissue with an implant comprising the steps of:

forming a cavity having surrounding tissue within a breast;

forming the implant entirely of resorbable material and sizing the implant to occupy the cavity; and

implanting the implant in the cavity, the implant supporting the surrounding tissue and allowing for in-growth of fibrous tissue into and replacing the resorbable material wherein the resorbable material is elastically compressible, and the step of implanting includes the step of compressing the resorbable material.

10. The method of claim 9, further comprising the step of introducing into the implant at least one of a medicinal, therapeutic or diagnostic substance.

11. The method of claim 9, wherein the at least one substance is selected from the group consisting of radiation material, antibiotics, chemotherapies, cancer therapies, hemostatic material, hormone therapies, and radiographic markers.

16. The method of claim 9, wherein the step of implanting the implant in the cavity comprises expanding the implant within the cavity.

14. An implant for implantation in a human body comprising an outer shell of a resorbable material, the implant being formed to fit the shape and size of a cavity in the human body, the implant supporting tissue surrounding the cavity upon implantation and allowing for in-growth of fibrous tissue into and replacing the outer shell, and a resorbable core provided inside and surrounded by the outer shell and containing autologous material.

15. The implant of claim 14, wherein the core is partially enclosed by a nonabsorbable material.

17. A breast implant comprising a self-expanding matrix of biocompatible material, the expanded matrix having a porous structure for supporting surrounding tissue of a breast and configured to provide a framework for the in-growth of fibrous tissue into the matrix.

18. The breast implant of claim 17, wherein the biocompatible material is resorbable.

19. The breast implant of claim 17, wherein the self-expanding matrix comprises a foam.

20. The breast implant of claim 17, wherein the self-expanding matrix comprises a resilient framework for implantation by compressing the matrix into a smaller volume, the matrix expanding resiliently within the breast.

22. A method for replacing excised human breast tissue with an implant comprising the steps of:

forming a cavity having surrounding tissue within a breast;

forming the implant entirely of resorbable material and sizing the implant to occupy the cavity; and

implanting the implant in the cavity, the implant supporting the surrounding tissue and allowing for in-growth of fibrous tissue into and replacing the resorbable material, wherein the resorbable material is formed from a self-expanding foam and the step of implanting is performed by injection of the self-expanding foam.

23. The method of claim 22, further comprising the step of introducing into the implant at least one of a medicinal, therapeutic or diagnostic substance.

24. The method of claim 23, wherein the at least one substance is selected from the group consisting of radiation material, antibiotics, chemotherapies, cancer therapies, hemostatic material, hormone therapies, and radiographic markers.