Method and apparatus for sealing implantable, membrane encapsulation devices

• US 5,738,673 A
• Filed: 06/07/1995
• Issued: 04/14/1998
• 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): Buiz, Michael Powell
• Assistant Examiner(s): NGUYEN, ANH TUAN TUONG
• Application Number:
  US08/476,498
• Time in Patent Office: 1,042 Days
• Field of Search: 604/93, 604/870, 604/175, 604/185, 604/890.1, 604/891.1, 604/132, 604/57, 128/749-755, 128/762, 435/179, 435/180, 435/182, 435/288, 435/240.22, 264/4, 425/382.2, 424/424
• US Class Current: 604/891.1
• 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 defining a storage cavity and said opening providing open communication between said storage cavity and the exterior of said enclosure;

a non-permeable, non-porous fitting disposed within or about said opening so as to make a substantially cell-tight dry seal between said fitting and said enclosure, said fitting further including an access bore therethrough, dimensioned so as to permit introduction of living cells into said storage cavity;

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

a non-permeable, non-porous plug member disposed within or about the access bore of said fitting to form a cell-tight sealing engagement therewith to seal said access bore; and

a tether member coupled to said fitting.

2. The encapsulation device as defined in claim 1, wherein said plug member includes a connector portion extending outwardly from said fitting, and said tether member includes a tether bore formed and dimensioned for sliding receipt of said connector portion therein.

3. The encapsulation device as defined in claim 2, wherein one end of said plug member is frictionally engaged with said fitting within said access bore, and the connector portion of said plug member is frictionally engaged with said tether within said tether bore.

4. The encapsulation device as defined in claim 3, wherein said connector portion includes at least one annular ring portion adapted for fictional engagement with said tether within said tether bore.

5. The encapsulation device as defined in claim 1, wherein said plug member is composed of a radio-opaque material.

6. The encapsulation device as defined in claim 5, wherein said radio-opaque material is titanium.

7. The encapsulation device as defined in claim 4, wherein said connector portion includes a plurality of spaced-apart annular ring portions adapted for frictional engagement with said tether within said tether bore.

8. The encapsulation device as defined in claim 7, wherein said fitting and said tether are juxtaposed to form a juncture therebetween, and wherein a biocompatible adhesive is disposed within or about said juncture between said fitting and said tether.

9. The encapsulation device as defined in claim 8, wherein said connector portion includes a recess region aligned with said juncture and formed for receipt of said adhesive therein.

10. The encapsulation device as defined in claim 9, wherein said recess region is annular.