Method and apparatus for sealing implantable, membrane encapsulation devices

• US 5,713,887 A
• Filed: 06/06/1995
• Issued: 02/03/1998
• Est. Priority Date: 06/23/1993
• Status: Expired due to Term

• Current Assignee: Neurotech S.A. (LivaNova Plc)
• Original Assignee: Brown University
• Inventors: Dionne, Keith E., Warner, Nicholas F., Doherty, Edward J., Rein, David H., Hazlett, Tyrone F., Cain, Brian M., Mills, John F.
• Primary Examiner(s): Bockelman, Mark
• Assistant Examiner(s): Nguyen, At
• Application Number:
  US08/488,560
• Time in Patent Office: 973 Days
• Field of Search: 604/93, 604/8-10, 604/175, 604/185, 604/890.1, 604/891.1, 604/132, 604/57, 604/110, 604/133, 128/749-755, 128/762, 128/632, 128/634, 128/748, 435/179, 435/180, 435/182, 435/188, 435/240.22, 264/4, 425/382.2, 424/424, 607/35
• US Class Current: 604/890.1
• 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 sealed, implantable, encapsulation device (20) for diffusing a biologically active product or function to an individual which includes a substantially non-porous fitting (32) including an inner surface (33) defining an access port (34). A permselective, porous, membrane (21), having an interior surface (22), cooperates with the fitting inner surface (33) to form a storage cavity (23) therebetween. The membrane interior surface (22) is in substantially cell-tight dry sealing engagement with fitting (32) to seal cavity (23). Living cells (24) are disposed in the cavity (23) which are capable of secreting the biologically active product to an individual. The membrane (21) is of a material capable of permitting the passage of substances between the individual and cells required to provide the biological product or function. A plug member (35) is positioned in the access port (34) and seated in cell-tight sealing engagement with the fitting inner surface (33). A method for sealing the implantable encapsulation device (20) is also provided.

Claims

1. A sealed, implantable, encapsulation device for providing a biologically active product or function to an individual, said encapsulation device comprising:

a permselective, porous membrane shaped so as to form a cell-impervious encapsulating enclosure including an exterior surface, an interior surface and an opening, said interior surface substantially defining a storage cavity and said opening providing open communication between said storage cavity and the exterior of said enclosure;

a fitting disposed within or about said opening so as to form a substantially cell-tight dry seal between said fitting and said membrane, said fitting being made of a resilient, self-sealable material capable of permitting a syringe needle to penetrate therethrough to form an access port extending through said fitting, said material further being sufficiently resilient to cell-tight seal said access port upon withdrawal of said needle therefrom; and

living cells disposed in said storage cavity and capable of secreting a biologically active product or of providing a selected biological function to an individual, said membrane permitting passage therethrough of substances secreted by said cells and required to provide said biological product or function.

2. The encapsulation device according to claim 1, wherein the resilient, self-sealable material is silicone.

3. The encapsulation device according to claim 1, wherein an adhesive is disposed between said fitting and said membrane.

4. The encapsulation device according to claim 3, wherein said adhesive is selected from the group consisting of light-curable acrylate polymer adhesives, two-part polyurethane adhesives, epoxies, and silicones.

5. The encapsulation device according to claim 3, wherein said adhesive is a two-part polyurethane adhesives.

6. An implantable encapsulation device comprising:

a tubular permselective hollow membrane having an exterior surface and an interior surface and having a closed end and an open end, the interior surface of said tubular permselective hollow membrane generally defining a storage cavity;

a fitting disposed in or about said open end so as to form a cell-tight, dry seal between said fitting and the open end of said tubular permselective hollow membrane, said tubular permselective hollow membrane and said fitting together making said storage cavity a cell-tight enclosure;

wherein said fitting is of a resilient, self-sealable material capable of permitting a syringe needle to penetrate therethrough to form an access port extending through said fitting, said material further being sufficiently resilient to cell-tight seal said access port upon withdrawal of said needle therefrom.

7. The encapsulation device according to claim 6, wherein the resilient, self-sealable material is silicone.

8. The encapsulation device according to claim 6, wherein an adhesive is disposed between said firing and the open end of said tubular permselective hollow membrane.

9. The encapsulation device according to claim 8, wherein said adhesive is selected from the group consisting of light-curable acrylate polymer adhesives, two-part polyurethane adhesives, epoxies, and silicones.

10. The encapsulation device according to claim 8, wherein said adhesive is a two-part polyurethane adhesives.

11. The encapsulation device according to claim 8, further comprising a solution of living cells disposed within said storage cavity.

12. The encapsulation device according to claim 6, further comprising a solution of living cells disposed within said storage cavity.