Breast tissue engineering

• US 5,716,404 A
• Filed: 12/16/1994
• Issued: 02/10/1998
• Est. Priority Date: 12/16/1994
• Status: Expired due to Fees

• Current Assignee: Children's Medical Center Corporation, Massachusetts Institute of Technology
• Original Assignee: Massachusetts Institute of Technology
• Inventors: Langer, Robert S., Vacanti, Joseph P., Atala, Anthony, Mooney, David J.
• Primary Examiner(s): ISABELLA, DAVID J
• Application Number:
  US08/358,189
• Time in Patent Office: 1,152 Days
• Field of Search: 623/8, 623/11, 623/12, 623/66, 435/178, 435/173, 435/240, 435/241, 435/32, 424/240.1, 424/240.23, 128/898
• US Class Current: 623/8
• CPC Class Codes: A61F 2/12 Mammary prostheses and implants
• CPC Class Codes: A61F 2002/0086 for preferentially controlling or promoting the growth of specific types of cells or tissues
• CPC Class Codes: A61F 2250/0003 having an inflatable pocket filled with fluid, e.g. liquid or gas
• CPC Class Codes: A61L 2430/04 for mammary reconstruction
• CPC Class Codes: A61L 27/3804 characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
• CPC Class Codes: A61L 27/3839 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60

Abstract

Methods and compositions are described herein for reconstruction or augmentation of breast tissue. Dissociated cells, preferably muscle cells, are implanted in combination with a suitable biodegradable, polymeric matrix to form new tissue. There are two forms of matrices which can be used: a polymeric hydrogel formed of a material such as alginate having cells suspended therein, and a fibrous matrix having an interstitial spacing between about 100 and 300 microns. Preferred polymeric materials are those degrading over about one to two months, such as polylactic acid-glycolic acid copolymers. The matrices can be seeded prior to implantation or implanted, allowed to vascularize, then seeded with cells. In a preferred embodiment, the cell-matrix structures are implanted in combination with tissue expander devices. As cell-matrix is implanted, or cells proliferate and form new tissue, the expander size is decreased, until it can be removed and the desired reconstruction or augmentation is obtained. The preferred cell types are muscle cells, although other types of mesenchymal cells, fibroblasts, chondrocytes, and adipocytes can be used. Cells obtained from tissue such as the labia can be used for specialized applications such as formation of a nipple type tissue. Other materials, such as bioactive molecules that enhance vascularization of the implanted tissue and/or which inhibit ingrowth of fibrotic tissue, can be implanted with the matrix to enhance development of more normal tissue.

Claims

1. A method for augmentation or reconstruction of breast tissue comprising implanting into the breast area of a patient in need of treatment thereof an effective amount of dissociated human cells selected from the group consisting of mesenchymal cells, myocytes, chondrocytes, adipocytes, fibromyoblasts, and ectodermal cells, in combination with a polymeric matrix shaped to form breast tissue, wherein the cells proliferate to form or augment tissue with the texture, feel and general appearance similar to that of normal breast.

2. The method of claim 1 wherein the cells are smooth or skeletal muscle cells.

3. The method of claim 1 further comprising implanting the cells at the same time as the matrix.

4. The method of claim 1 wherein the matrix is a biocompatible, biodegradable hydrogel.

5. The method of claim 1 wherein the matrix is implanted, allowed to vascularize, then seeded with cells.

6. The method of claim 1 wherein the matrix is a fibrous, polymeric matrix.

7. The method of claim 1 wherein the matrix is formed of a biodegradable polymer.

8. The method of claim 1 further comprising implanting struts into the patient at the site where the matrix is to be implanted to support the surrounding tissue and prevent the tissue from deforming the matrix.

9. The method of claim 1 further comprising implanting bioactive molecules selected from the group of molecules enhancing vascularization, cell survival, proliferation or differentiation, inhibiting ingrowth of fibrotic tissue, inhibiting growth of cancerous cells, and inhibiting inflammation.

10. The method of claim 1 further comprising implanting a tissue expander into the patient at the site where the matrix and cells are to be implanted, wherein the expander is implanted prior to implanting the cells or matrix.

11. The method of claim 1 further comprising seeding the matrix with nerve cells.