Tissue marking implant

• US 20050187624A1
• Filed: 04/19/2005
• Published: 08/25/2005
• Est. Priority Date: 10/10/1997
• Status: Active Grant

• Current Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Original Assignee: Whitewater Investments Incorporated
• Inventors: Corbitt, John D. Jr.
• Granted Patent: US 7,637,948 B2
• Time in Patent Office: Days
• US Class Current: 623/8
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• 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 tissue marking implant includes a matrix material and a dye marker. The implant, which can be formed entirely of bioresorbable material such as a collagen foam, 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 can carry therapeutic and diagnostic substances. The dye marker leaches from the implant such that a surgeon, upon subsequent surgical intervention, visibly recognizes the tissue marked by the dye marker.

Claims

1. An implant for marking an area within a living body comprising a matrix material and a marking material, the implant being formed to fit the shape and size of a cavity in the human body, the implant being installed for supporting tissue surrounding the cavity and allowing in-growth of fibrous tissue into and replacing at least a portion of the matrix material.

2. The implant of claim 1, wherein the marking material is a dye.

3. The implant of claim 2, wherein the dye is one of indigo carmine and methylene blue.

4. The implant of claim 1, wherein the matrix material is elastically compressible.

5. The implant of claim 1, wherein the matrix material is formed from one of a self-expanding foam, a compressible foam or sponge, and a non-compressible foam or sponge.

6. The implant of claim 1, wherein the matrix material is formed of a foamed bioabsorbable protein.

7. The implant of claim 1, wherein the matrix material is formed of a foamed collagen.

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

9. The implant of claim 8, wherein the at least one substance is selected from the group consisting of radiation materials, antibiotics, chemotherapies, cancer therapeutics, hemostatic materials, hormone therapeutics, and radiographic markers.

10. The implant of claim 1, wherein the matrix material is at least partially resorbable.

11. The implant of claim 1, further comprising a shell containing the matrix material.

12. The implant of claim 11, wherein the shell comprises compressed matrix material.

13. The implant of claim 11, wherein the shell completely surrounds the matrix material.

14. A tissue marking implant comprising a matrix of collagen material, the 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;

and

a dye marker supported by the matrix for dispersion into the tissue.

15. The tissue implant of claim 14, wherein the matrix comprises a foam.

16. The tissue implant of claim 14, wherein the matrix comprises a resilient framework for implantation by compressing the matrix into a smaller volume, the matrix expanding resiliently within the breast.

17. The breast implant of claim 14, wherein the matrix is self-expanding.

18. A method for marking tissue surrounding excised human tissue with an implant comprising the steps of:

forming a cavity having surrounding tissue;

forming the implant of a matrix material and sizing the implant to occupy the cavity, the matrix material supporting a dye marker; and

implanting the implant in the cavity, the implant supporting the surrounding tissue and allowing for in-growth of fibrous tissue and replacing the matrix material, wherein the matrix material is elastically compressible, and the step of implanting includes the step of compressing the matrix material, whereby the surrounding tissue is visibly marked by the dye marker as the result of the dye marker leaching from the implant into the surrounding tissue.

19. The method of claim 18, further comprising the step of introducing into the implant at least one of a medicinal, therapeutic or diagnostic substance.

20. The method of claim 19, wherein the at least one substance is selected from the group consisting of radiation material, antibiotics, chemotherapies, cancer therapies, hemostatic material, hormone therapies, stem cells, cellular precursors, and radiographic markers.

21. The method of claim 19, wherein the step of implanting the implant in the cavity comprises expanding the implant within the cavity.

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

forming a cavity having surrounding tissue within a breast;

forming an implant entirely of resorbable material and sizing the implant to occupy the cavity, the implant including a dye marker; 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, the dye marker leaching into the breast tissue to mark the tissue surrounding the cavity.

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, stem cells, cellular precursors, and radiographic markers.