Implantation assembly

• US 5,964,261 A
• Filed: 05/28/1997
• Issued: 10/12/1999
• Est. Priority Date: 05/29/1996
• Status: Expired due to Term

• Current Assignee: Baxalta GmbH (Shire plc), Baxalta Incorporated (Shire plc)
• Original Assignee: Baxter International Inc.
• Inventors: Jones, Mark, Shors, Stephanie, Daugird, Joanne, Fredericksen, Scott, Maryanov, David, Loudovaris, Thomas, Brauker, James, Neuenfeldt, Steven, Geller, Robin Lee
• Primary Examiner(s): JACYNA, J CASIMER
• Application Number:
  US08/864,209
• Time in Patent Office: 867 Days
• Field of Search: 141/2, 141/9, 141/10, 141/18, 141/100, 141/313, 141/325-327, 141/329, 424/424, 206/438, 206/439
• US Class Current: 141/327
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• 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
• CPC Class Codes: A61L 27/36 containing ingredients of undetermined constitution or reaction products thereof , e.g. transplant tissue, natural bone, extracellular matrix isolated natural compounds, e.g. collagen A61L27/24
• CPC Class Codes: A61L 27/38 containing added animal cells organs or tissue containing native cells A61L27/36

Abstract

An implant assembly and methods for loading implant devices which avoids the accidental deposition of transplanted material or other contaminates on the exterior of the device during transportation, storage, and handling are disclosed. The implant assembly of the invention may be used with a large variety of implant devices for implanting a variety of materials such as cells, tissue or other materials into a host. The implant assembly includes an implant device having an elongated port and a first chamber for holding material for implantation and a container with a second chamber for holding the implant device. The container functions to maintain the sterility and protect the physical integrity of the implant device during loading, storage, cryopreservation and transportation and is removed immediately prior to implantation of the device. The container may optionally include liquid media for cellular growth, maintenance, cryostorage, or transportation purposes.

Claims

1. An implant assembly comprising:

(a) an implant device comprising porous walls defining a first chamber and having an elongated port means providing access to the first chamber; and

(b) a removable container defining a second chamber for holding the implant device, the container having a means for admitting liquids into the second chamber, wherein the elongated port means extends from the first chamber through the container and the exterior of the port means forms a seal with the container.

2. The assembly according to claim 1 wherein the elongated port means is in communication with multiple access means for providing multiple access to the elongated port means.

3. The assembly according to claim 2 wherein the second chamber contains liquid and the means for admitting liquid and the elongated port means are closed.

4. The assembly according to claim 2 wherein the first chamber contains materials to be implanted and, the second chamber contains liquid and the interior of the elongated port is sealed.

5. The assembly according to claim 4 wherein the first chamber contains cells or tissue to be implanted.

6. The assembly according to claims 1,2,3,4 or 5 wherein the implantation assembly is sealed in a sterile pouch.

7. The assembly according to claim 2 wherein the multiple access means includes first and second access means for accessing the multiple access means, the first access means is fitted with a device for delivering materials to the first chamber of the implant device through the elongated port and the second access means is fitted with a device containing a sealant for delivering sealant to plug the elongated port after material is delivered to the first chamber.

8. The assembly according to claim 7, wherein the sealant contains a colorant.

9. An implant assembly comprising:

(a) an implant device comprising porous walls defining a first chamber and having an elongated port means providing access to the first chamber;

(b) a removable container defining a second chamber for holding the implant device, the container having a means for admitting liquids into the second chamber, wherein the elongated port means extends from the first chamber through the container and the exterior of the port means forms a seal with the container; and

(c) a liquid contained in the second chamber.

10. The assembly according to claim 9 wherein the elongated port means is in communication with multiple access means.

11. The assembly according to claim 10 wherein the means for admitting liquid and the multiple access means are closed.

12. The assembly according to claim 10 wherein the first chamber contains materials to be implanted and the interior of the elongated port is sealed.

13. The assembly according to claim 12 wherein the first chamber contains cells or tissue to be implanted.

14. The assembly according to claims 9, 10, 11, 12 or 13 wherein the implantation assembly is sealed in a sterile pouch.

15. The assembly according to claim 10 wherein the multiple access means includes first and second access means for accessing the multiple access means, the first access means is fitted with a device for delivering materials to the first chamber of the implant device through the elongated port and the second access means is fitted with a device containing a sealant for delivering sealant to plug the elongated port after material is delivered to the first chamber.

16. The assembly according to claim 15, wherein the sealant contains a colorant.

17. An implant assembly comprising:

(a) an implant device comprising porous walls defining a first chamber and having an elongated port means providing access to the first chamber;

(b) cells or tissue contained in the first chamber;

(c) a removable container defining a second chamber for holding the implant device, the container having a means for admitting liquids into the second chamber, wherein the elongated port means extends from the first chamber through the container and the exterior of the port means forms a seal with the container; and

(d) a liquid contained in the second chamber for maintaining the cells or tissue.

18. The assembly according to claim 17 wherein the elongated port means is in communication with multiple access means for providing multiple access to the elongated port means.

19. The assembly according to claim 18 wherein the first chamber contains liquid and the means for admitting liquid and the elongated port means are closed.

20. The assembly according to claim 18 wherein the first chamber contains materials to be implanted and, the second chamber contains liquid and the interior of the elongated port is sealed.

21. The assembly according to claim 20 wherein the first chamber contains cells or tissue to be implanted.

22. The assembly according to claim 17 wherein the liquid is a cryopreservation medium.

23. The assembly according to claims 17, 18, 19, 20, 21, or 22 wherein the implantation assembly is sealed in a sterile pouch.

24. The assembly according to claim 18 wherein the multiple access means includes first and second access means for accessing the multiple access means, the first access means is fitted with a device for delivering materials to the first chamber of the implant device through the elongated port and the second access means is fitted with a device containing a sealant for delivering sealant to plug the elongated port after material is delivered to the first chamber.

25. The assembly according to claim 24, wherein the sealant contains a colorant.