Tissue marking implant

• US 7,637,948 B2
• Filed: 04/19/2005
• Issued: 12/29/2009
• Est. Priority Date: 10/10/1997
• Status: Expired due to Term

• Current Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Original Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Inventors: Corbitt, John D. Jr.
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US11/108,785
• Publication Number:
  US 20050187624A1
• Time in Patent Office: 1,715 Days
• Field of Search: 623 7- 8, 623/23.75, 424/400
• 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 system for filling a cavity formed by removal of soft tissue from a site within a patient'"'"'s breast comprising:

an elongated delivery cannula having a proximal and a distal end and an inner lumen extending therein;

a compressed resilient implant disposed within the inner lumen of the delivery catheter and formed of foamed or sponge matrix material which is at least in part bioabsorbable and which has a marking material, the implant being formed to fit the cavity in the patient'"'"'s breast, and configured to support tissue surrounding the cavity when delivered thereto and expanded therein and to allow in-growth of fibrous tissue into and replacing at least a portion of the foamed or sponge matrix material.

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

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

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

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

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

7. The implant system of claim 1, wherein the matrix contains at least one medicinal, therapeutic, or diagnostic substance.

8. The implant system of claim 7, 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.

9. The implant system of claim 1, wherein the implant has a shell containing the matrix material.

10. The implant system of claim 9, wherein the shell comprises compressed matrix material.

11. The implant system of claim 9, wherein the shell completely surrounds the matrix material.

12. The implant system of claim 1 wherein the marker material is a radiographic element.

13. The implant system of claim 12 wherein the radiographic element is formed of a metallic material.

14. A tissue marking implant system for filling a cavity formed by removal of soft tissue from a site within a patient'"'"'s breast comprising:

an elongated delivery cannula having a proximal and a distal end and an inner lumen extending therein;

an expandable matrix of collagen material compressed within the inner lumen of the delivery cannula, the matrix having a porous structure configured for supporting tissue surrounding the cavity formed in the patient'"'"'s breast and configured to provide a framework for the in-growth of fibrous tissue into the matrix when deployed from the distal end of the delivery cannula and disposed within the cavity formed in the patient'"'"'s breast; and

a dye marker supported by the matrix for dispersion within the cavity.

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

16. The tissue implant of claim 14, wherein the porous structure of the matrix comprises a resilient framework which expands resiliently within the cavity in the patient'"'"'s breast to support tissue surrounding the cavity.

17. The tissue implant of claim 14, wherein the porous structure of the matrix is self-expanding within the patient'"'"'s breast.