Implantable containment apparatus for a therapeutical device and method for loading and reloading the device therein

• US 5,843,069 A
• Filed: 07/10/1997
• Issued: 12/01/1998
• Est. Priority Date: 06/07/1995
• Status: Expired due to Term

• Current Assignee: W. L. Gore & Associates (W.L. Gore & Associates)
• Original Assignee: Gore Hybrid Technologies, Inc.
• Inventors: Davidson, Daniel F., Mish, Stanley L., Butler, Mark D., Moore, James W. III
• Primary Examiner(s): Stright, Jr., Ronald
• Assistant Examiner(s): NGUYEN, ANH TUAN TUONG
• Application Number:
  US08/891,119
• Time in Patent Office: 509 Days
• Field of Search: 604/890.1, 604/891.1, 604/892.1, 604/93, 424/422, 424/423, 424/424, 623/1, 623/11, 623/12
• US Class Current: 604/891.1
• CPC Class Codes: A61F 2/0004 Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
• 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 31/048 obtained by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61N 5/1007 Arrangements or means for the introduction of sources into the body
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: C08L 29/04 Polyvinyl alcohol; Partially hydrolysed homopolymers or copolymers of esters of unsaturated alcohols with saturated carboxylic acids
• CPC Class Codes: C08L 33/14 of esters containing halogen, nitrogen, sulfur, or oxygen atoms in addition to the carboxy oxygen
• CPC Class Codes: C08L 33/22 Homopolymers or copolymers of nitriles containing four or more carbon atoms
• CPC Class Codes: C08L 39/06 Homopolymers or copolymers of N-vinyl-pyrrolidones
• CPC Class Codes: C08L 5/00 Compositions of polysaccharides or of their derivatives not provided for in groups C08L1/00 or C08L3/00
• CPC Class Codes: C08L 5/04 Alginic acid; Derivatives thereof
• CPC Class Codes: C08L 89/06 derived from leather or skin , e.g. gelatin

Abstract

This invention relates generally to an implantable containment apparatus made of selectively permeable material. In particular, the implantable containment apparatus is used to contain a therapeutical device, such as a drug delivery device, a cell encapsulation device, or a gene therapy device. A therapeutical device can be easily placed and replaced in an apparatus of the present invention without damaging tissues associated with the selectively permeable material of the apparatus.

Claims

1. An implantable containment apparatus comprising:

a material in the form of a chamber;

wherein the chamber comprises an exterior surface, an interior surface that defines a luminal space, and at least one access means through which at least one therapeutical device is insertable into the luminal space of the chamber;

the material comprising a laminate, the laminate comprising a first layer attached to a second layer, the first layer comprising a porous stretched polytetrafluoroethylene material that is impervious to cellular ingrowth across the interior surface of the chamber, the second layer comprising a porous stretched polytetrafluoroethylene material that is sufficiently porous to permit growth of vascular tissue from a recipient within the pores of the porous stretched polytetrafluoroethylene material up to, but not through, the first layer;

wherein the chamber is adapted to retain at least one therapeutical device in the luminal space of the chamber;

wherein therapeutical substances can diffuse across the thickness of the chamber between a therapeutical device contained therein and tissues of a recipient surrounding the apparatus; and

wherein the therapeutical device is removable from the chamber though the access means of the chamber.

2. The implantable containment apparatus of claim 1 wherein the chamber is substantially in the form of a tube and wherein the tube has an access means at each end of the tube.

3. The implantable containment apparatus of claim 2 wherein a therapeutical device is inserted and removed from the luminal space of the tube with a fluid stream.

4. The implantable containment apparatus of claim 2 wherein both access means of the tube are positioned and maintained sufficiently close to one another with a holding means that the tube is implantable and accessible for filling and refilling with a therapeutical device at a single surgical site in a recipient.

5. The implantable containment apparatus of claim 2 wherein at least a portion of the tube is attached to a planar material.

6. The implantable containment apparatus of claim 1 wherein the implantable containment apparatus, in conjunction with a cell encapsulation device, serves as an implantable medical device.

7. The implantable containment apparatus of claim 6 wherein the implantable medical device is an artificial organ.

8. The implantable containment apparatus of claim 7 wherein the artificial organ is an artificial pancreas.

9. The implantable containment apparatus of claim 1 wherein the implantable containment apparatus, in conjunction with a drug delivery device, serves as an implantable medical device.

10. The implantable containment apparatus of claim 1 wherein the implantable containment apparatus, in conjunction with a gene therapy device, serves as an implantable medical device.

11. The implantable containment apparatus of claim 1 having a plurality of generally cylindrically shaped chambers attached to a planar material in a radial array with the access means of each chamber directed toward the center of the radial array.

12. The implantable containment apparatus of claim 1 having a plurality of generally cylindrically shaped chambers attached to a planar material oriented generally in parallel with respect to each other.

13. The implantable containment apparatus of claim 1 wherein the chamber is refillable with at least one therapeutical device through an access means of the chamber.

14. The implantable containment apparatus of claim 1 wherein the luminal space is of substantially uniform diameter.

15. The implantable containment apparatus of claim 1 further comprising at least one therapeutical device retained in the luminial space of the chamber, wherein the therapeutical device has a length.

16. The implantable containment apparatus of claim 15 wherein the therapeutical device is retained in direct contact with the interior surface of the chamber along substantially the entire length of the therapeutical device.

17. The implantable containment apparatus of claim 15 wherein the therapeutical device contains therapeutical substances that diffuse through the material between the therapeutical device and tissues of a recipient when the containment apparatus is implanted in the recipient.

18. The implantable containment apparatus of claim 15 wherein the therapeutical device contains cells that excrete therapeutical substances that diffuse through the material between the therapeutical device and tissues of a recipient when the containment apparatus is implanted in the recipient.

19. An implantable containment apparatus comprising:

a material in the form of a chamber;

wherein the chamber comprises an exterior surface, an interior surface that defines a luminal space, and at least one access means through which at least one therapeutical device is insertable into the luminal space of the chamber;

wherein the material is impervious to cellular ingrowth across the interior surface of the chamber;

wherein the chamber is adapted to retain at least one therapeutical device in the luminal space of the chamber;

wherein therapeutical substances can diffuse across the thickness of the chamber between a therapeutical device contained therein and tissues of a recipient surrounding the apparatus;

wherein the therapeutical device is removable from the chamber though the access means of the chamber; and

wherein the implantable containment apparatus, in conjunction with a gene therapy device, serves as an implantable medical device.

20. An implantable containment apparatus comprising:

a porous material in the form of a chamber;

wherein the chamber comprises an exterior surface, an interior surface that defines a luminal space, and at least one access means through which at least one therapeutical device is insertable into the luminal space of the chamber;

the porous material comprising a hydrogel material that renders the material impervious to cellular ingrowth across the interior surface of the chamber;

wherein the porous material is sufficiently porous to permit growth of vascular tissue from a recipient within the pores of the material up to, but not through, the hydrogel material;

wherein the chamber is adapted to retain at least one therapeutical device in the luminal space of the chamber;

wherein therapeutical substances can diffuse across the thickness of the chamber between a therapeutical device contained therein and tissues of a recipient surrounding the apparatus; and

wherein the therapeutical device is removable from the chamber though the access means of the chamber.

21. The implantable containment apparatus of claim 20 wherein the hydrogel is selected from at least one member of a group consisting of partially hydrolyzed polyacrylonitrile, non-fibrogenic alginate, agarose, alginic acid, carrageenan, collagen, gelatin, polyvinyl alcohol, poly(2-hydroxyethyl methacrylate, poly(N-vinyl-2-pyrrolidone), or gellan gum, either alone or in combination.

22. The implantable containment apparatus of claim 20 wherein the implantable containment apparatus, in conjunction with a cell encapsulation device, serves as an implantable medical device.

23. The implantable containment apparatus of claim 22 wherein the implantable medical device is an artificial organ.

24. The implantable containment apparatus of claim 23 wherein the artificial organ is an artificial pancreas.

25. The implantable containment apparatus of claim 20 wherein the hydrogel material is impregnated within the material adjacent to and continuous with the interior surface of the chamber.

26. The implantable containment apparatus of claim 20 wherein the implantable containment apparatus, in conjunction with a gene therapy device, serves as an implantable medical device.

27. The implantable containment apparatus of claim 20 wherein the porous material is selected from at least one member of a group consisting of stretched polytetrafluoroethylene, stretched polypropylene, stretched polyethylene, or porous polyvinylidene fluoride, either alone or in combination.

28. The implantable containment apparatus of claim 20 wherein the porous material is stretched polytetrafluoroethylene.

29. The implantable containment apparatus of claim 20 wherein the implantable containment apparatus, in conjunction with a drug delivery device, serves as an implantable medical device.

30. An implantable containment apparatus comprising:

a material in the form of a chamber;

wherein the chamber comprises an exterior surface, an interior surface that defines a luminal space, at least one access means through which at least one therapeutical device is insertable into the luminal space of the chamber, and a stent;

wherein the material is impervious to cellular ingrowth across the interior surface of the chamber;

wherein the chamber is adapted to retain at least one therapeutical device in the luminal space of the chamber;

wherein therapeutical substances can diffuse across the thickness of the chamber between a therapeutical device contained therein and tissues of a recipient surrounding the apparatus; and

wherein the therapeutical device is removable from the chamber though the access means of the chamber.

31. The implantable containment apparatus of claim 30 wherein the implantable containment apparatus, in conjunction with a cell encapsulation device, serves as an implantable medical device.

32. The implantable containment apparatus of claim 30 wherein the implantable containment apparatus, in conjunction with a drug delivery device, serves as an implantable medical device.

33. The implantable containment apparatus of claim 30 wherein the implantable containment apparatus, in conjunction with a gene therapy device, serves as an implantable medical device.

34. An implantable containment apparatus for a therapeutical device comprising:

a material in the form of a chamber;

wherein the chamber comprises an exterior surface, an interior surface that defines a luminal space, and at least one access means through which at least one therapeutical device is insertable into the luminal space of the chamber;

wherein the material comprises a laminate comprising a first layer that prevents cells from penetrating the interior surface of the material, wherein the first layer is comprised of a stretched polytetrafluoroethylene material having essentially no nodes, a thickness of about 1 micron to about 25.4 microns, and an average pore size of about 0.05 to about 0.4 micron, as measured by porometry, attached to a second layer comprised of a stretched polytetrafluoroethylene material comprised of nodes and fibrils, the second layer having a thickness of about 10 microns to about 1000 microns and an average pore size greater than about 3 microns, as measured by fibril length;

wherein the chamber is adapted to retain a therapeutical device in the luminal space of the chamber;

wherein therapeutic substances can diffuse across the thickness of the chamber between a therapeutical device contained therein and tissues of a recipient surrounding the apparatus; and

wherein the therapeutical device is removable from the chamber through the access means of the chamber.

35. An implantable containment apparatus for a therapeutical device comprising:

a material in the form of a chamber;

wherein the chamber comprises an exterior surface, an interior surface that defines a luminal space, and at least one access means through which at least one therapeutical device is insertable into the luminal space of the chamber;

wherein the material comprises a laminate comprising a first layer that prevents cells from penetrating the interior surface of the material, wherein the first layer is comprised of a stretched polytetrafluoroethylene material having essentially no nodes, a thickness of about 1 micron to about 25.4 microns, and an average pore size of about 0.05 to about 0.4 micron, as measured by porometry, attached to a second layer comprised of a stretched polytetrafluoroethylene material comprised of nodes and fibrils, the second layer having a thickness of about 10 microns to about 1000 microns and an average pore size greater than about 3 microns, as measured by fibril length;

wherein the second layer is sufficiently porous to permit growth of vascular tissue from a recipient within the pores of the stretched polytetrafluoroethylene material, up to, but not through, the first layer;

wherein the chamber is adapted to retain a therapeutical device in the luminal space of the chamber;

wherein therapeutic substances can diffuse across the thickness of the chamber between a therapeutical device contained therein and tissues of a recipient surrounding the apparatus; and

wherein the therapeutical device is removable from the chamber through the access means of the chamber.

36. An implantable containment apparatus for a therapeutical device comprising:

a material in the form of a chamber;

wherein the chamber comprises an exterior surface, an interior surface that defines a luminal space, and at least one access means through which at least one therapeutical device is insertable into the luminal space of the chamber;

wherein the material comprises a laminate comprising a first layer that prevents cells from penetrating the interior surface of the material, wherein the first layer is comprised of a stretched polytetrafluoroethylene material having essentially no nodes, a thickness of about 1 micron to about 25.4 microns, and an average pore size of about 0.05 to about 0.4 micron, as measured by porometry, attached to a second layer comprised of a stretched polytetrafluoroethylene material comprised of nodes and fibrils, the second layer having a thickness of about 10 microns to about 1000 microns and an average pore size greater than about 3 microns, as measured by fibril length;

wherein the second layer is sufficiently porous to permit growth of vascular tissue from a recipient within the pores of the stretched polytetrafluoroethylene material, up to, but not through, the first layer;

wherein the chamber is adapted to retain a therapeutical device in the luminal space of the chamber;

wherein therapeutic substances can diffuse across the thickness of the chamber between a therapeutical device contained therein and tissues of a recipient surrounding the apparatus;

wherein the therapeutical device is removable from the chamber through the access means of the chamber; and

wherein the implantable containment apparatus, in conjunction with a cell encapsulation device, serves as an implantable medical device.

37. An implantable containment apparatus for a therapeutical device comprising:

a material in the form of a chamber;

wherein the chamber comprises an exterior surface, an interior surface that defines a luminal space, and at least one access means through which at least one therapeutical device is insertable into the luminal space of the chamber;

wherein the material comprises a laminate comprising a first layer that prevents cells from penetrating the interior surface of the material, wherein the first layer is comprised of a stretched polytetrafluoroethylene material having essentially no nodes, a thickness of about 1 micron to about 25.4 microns, and an average pore size of about 0.05 to about 0.4 micron, as measured by porometry, attached to a second layer comprised of a stretched polytetrafluoroethylene material comprised of nodes and fibrils, the second layer having a thickness of about 10 microns to about 1000 microns and an average pore size greater than about 3 microns, as measured by fibril length;

wherein the second layer is sufficiently porous to permit growth of vascular tissue from a recipient within the pores of the stretched polytetrafluoroethylene material, up to, but not through, the first layer;

wherein the chamber is adapted to retain a therapeutical device in the luminal space of the chamber;

wherein therapeutic substances can diffuse across the thickness of the chamber between a therapeutical device contained therein and tissues of a recipient surrounding the apparatus;

wherein the therapeutical device is removable from the chamber through the access means of the chamber;

wherein the implantable containment apparatus, in conjunction with a cell encapsulation device, serves as an implantable medical device; and

wherein the implantable medical device is an artificial organ.

38. An implantable containment apparatus for a therapeutical device comprising:

a material in the form of a chamber;

wherein the chamber comprises an exterior surface, an interior surface that defines a luminal space, and at least one access means through which at least one therapeutical device is insertable into the luminal space of the chamber;

wherein the material comprises a laminate comprising a first layer that prevents cells from penetrating the interior surface of the material, wherein the first layer is comprised of a stretched polytetrafluoroethylene material having essentially no nodes, a thickness of about 1 micron to about 25.4 microns, and an average pore size of about 0.05 to about 0.4 micron, as measured by porometry, attached to a second layer comprised of a stretched polytetrafluoroethylene material comprised of nodes and fibrils, the second layer having a thickness of about 10 microns to about 1000 microns and an average pore size greater than about 3 microns, as measured by fibril length;

wherein the second layer is sufficiently porous to permit growth of vascular tissue from a recipient within the pores of the stretched polytetrafluoroethylene material, up to, but not through, the first layer;

wherein the chamber is adapted to retain a therapeutical device in the luminal space of the chamber;

wherein therapeutic substances can diffuse across the thickness of the chamber between a therapeutical device contained therein and tissues of a recipient surrounding the apparatus;

wherein the therapeutical device is removable from the chamber through the access means of the chamber;

wherein the implantable containment apparatus, in conjunction with a cell encapsulation device, serves as an implantable medical device;

wherein the implantable medical device is an artificial organ; and

wherein the artificial organ is an artificial pancreas.