Use of pouch for implantation of living cells

• US 5,916,554 A
• Filed: 06/05/1995
• Issued: 06/29/1999
• Est. Priority Date: 07/29/1992
• Status: Expired due to Fees

• Current Assignee: Washington University In St Louis
• Original Assignee: Washington University In St Louis
• Inventors: Dionne, Keith E., Scharp, David W.
• Primary Examiner(s): Stanton, Brian R.
• Assistant Examiner(s): PRIEBE, SCOTT DAVID
• Application Number:
  US08/465,195
• Time in Patent Office: 1,485 Days
• Field of Search: 435/240.2, 435/240.21, 435/423, 435/424, 435/425, 435/426, 435/325, 604/891.1, 424/93.1, 424/93.2, 424/93.21, 424/422-424
• US Class Current: 424/93.21
• CPC Class Codes: A61F 2/022 Artificial gland structures using bioreactors hemodialysis A61M1/16; hemofiltration A61M1/34; other extracorporeal blood treatment A61M1/36
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L

Abstract

A biocompatable and biostable flexible pouch for use e.g., in implanting cell bodies producing therapeutic agents, featuring, in various aspects, either encapsulated or unencapsulated cell bodies contained within the pouch; and a means for attaching the opening of the pouch to a vascularized tissue pedicle.

Claims

1. A method for implanting into an individual a plurality of cell bodies secreting an agent, the method comprising the steps of:

(a) placing or forming a biocompatible and biostable pouch over a vascularized tissue pedicle pendant from and projecting into a cavity of an individual'"'"'s body so that at least part of the pedicle is encased by the pouch, the part projecting into the opening of the pouch,

(b) attaching the pouch to the pedicle, and

(c) dispersing the cell bodies into the pouch or the pedicle.

2. The method of claim 1 in which the cell bodies are contained in microcapsules.

3. The method of claim 1 in which the forming step is performed by molding biocompatible cross-linked alginate onto the surface of the pedicle and permitting the alginate to set in the form of a continuous pouch conforming to the shape of the pedicle.

4. The method of claim 1 in which the attaching step is performed by suturing.

5. The method of claim 1 in which the attaching step is performed by tightening the perimeter of the opening of the pouch around the pedicle.

6. The method of claim 5 which the perimeter of the pouch opening is elastic and attaches by expansion to fit over the pedicle followed by contraction into a compression fit.

7. The method of claim 1 in which the pedicle is naturally occurring.

8. The method of claim 1 in which, prior to step (a), a vascularized tissue mass is detached from the individual'"'"'s body and connected to a vascular source at a selected site on the wall of the cavity within the individual to revascularize the tissue mass, thereby forming the vascularized tissue pedicle of step (a).

9. The method of claim 1 further comprising:

(d) surgically removing the pouch, attached pedicle, and contained cell bodies as a unit from the individual'"'"'s body.

10. The method of claim 1 further comprising:

(d) dislodging the plurality of cell bodies from the pedicle and collecting them in the pouch, and

(e) surgically removing the pouch and contained dislodged cell bodies from the individual'"'"'s body leaving the pedicle in place.

11. The method of claim 1 in which the cell bodies are dispersed by injection from a conduit through the pouch into different sites on the pedicle.

12. The method of claim 1 in which the cell bodies are dispersed into the pedicle through a cannula into an artery feeding the pedicle.

13. The method of claim 1 further comprising placing polytetrafluoroethylene fibers around the pedicle as a substrate for the cell bodies.

14. The method of claim 1 wherein the cell bodies are selected from the group consisting of naturally occurring cells and genetically engineered cells.

15. The method of claim 1 wherein the cell bodies are dispersed into multiple locations of the pouch.

16. The method of claim 1 wherein at least some of the cell bodies are dispersed onto the pedicle.

17. The method of claim 1 wherein at least some of the cell bodies are dispersed into the pedicle.

18. The method of claim 1 in which cell bodies are dispersed on and adhered to the inner wall of the pouch.

19. The method of claim 1 wherein the pouch is flexible.

20. The method of claim 1 wherein the cell bodies are islet cell bodies, the agent is insulin, and a therapeutically effective number of islet cell bodies are dispersed into the pouch.

21. The method of claim 20 wherein the islet cell bodies produce insulin in response to glucose levels.

22. A method for implanting into an individual a plurality of cell bodies producing an agent, the method comprising the steps of:

(a) placing a biocompatible and biostable pouch over a vascularized tissue pedicle pendant from and projecting into a cavity of an individual'"'"'s body so that at least part of the pedicle is encased by the pouch, the part projecting into the opening of the pouch, the pouch containing cell bodies dispersed on and adhered to the inner wall of the pouch, and

(b) attaching the pouch to the pedicle.

23. The method of claim 22 in which the cell bodies are contained in microcapsules.

24. The method of claim 22 wherein the cell bodies are cells present in a tissue.

25. The method of claim 22 wherein the cell bodies are in cell clusters.

26. The method of claim 22 wherein the cell bodies are individually isolated cells.

27. The method of claim 22 further comprising:

(d) surgically removing the pouch, attached pedicle, and cell bodies as a unit from the individual'"'"'s body.

28. The method of claim 22 further comprising:

(d) dislodging most of the cell bodies from the pedicle and collecting them in the pouch, and

(e) removing the pouch and contained dislodged cell or cell cluster bodies from the individual'"'"'s body leaving the pedicle in place.

29. The method of claim 22 wherein the cell bodies are islet cell bodies, the agent is insulin, and a therapeutically effective number of islet cell bodies are dispersed on and adhered to the inner wall of the pouch.

30. The method of claim 29 wherein the islet cell bodies produce insulin in response to glucose levels.