Artificial pancreatic perfusion device

• US 5,741,334 A
• Filed: 10/16/1996
• Issued: 04/21/1998
• Est. Priority Date: 06/07/1995
• Status: Expired due to Fees

• Current Assignee: CB Biomedical, Inc. (Arbios Systems, Inc.)
• Original Assignee: CB Biomedical, Inc. (Arbios Systems, Inc.)
• Inventors: Mullon, Claudy Jean Paul, Dunleavy, Karen E.
• Primary Examiner(s): Weiss, John G.
• Assistant Examiner(s): CUDDIHY, FRANCIS KEVIN
• Application Number:
  US08/732,146
• Time in Patent Office: 552 Days
• Field of Search: 623/1, 623/11, 623/12, 604/4, 210/192, 210/321.78, 210/321.87, 424/424, 424/423, 424/422, 435/283.1, 435/284.1
• US Class Current: 623/23.64
• 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: A61L 27/3804 characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
• CPC Class Codes: A61L 27/3839 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60

Abstract

An artifical pancreatic perfusion device comprising a hollow fiber having a porosity ranging from about 25 Kd to about 200 Kd. The hollow fiber has one end connected to a blood vessel for receiving blood and a second end connected to a blood vessel for returning said blood. Islets of Langerhans surround the hollow fiber. The hollow fiber and islets are surrounded by a housing comprising a semipermeable membrane having a pore size small enough to offer protection to the islets and host from immune reactive substances. Further disclosed is a method for providing and regulating insulin to insulin deficient individuals.

Claims

1. An artifical pancreatic perfusion device, comprising:

a. a hollow fiber having a porosity ranging from about 25 Kd to about 200 Kd;

said hollow fiber having a first end adapted to be connected to a blood vessel for receiving blood and a second end adapted to be connected to a blood vessel for returning blood;

b. islets of Langerhans surrounding said hollow fiber, wherein the fiber provides for a directly continuous blood flow between said receiving blood vessel and said returning blood vessel; and

c. a housing for said hollow fiber and islets, comprised in whole or in part by a semipermeable membrane;

said housing having a pore size small enough to offer protection to the islets and host from immune reactive substances.

2. The artificial pancreatic perfusion device of claim 1, wherein the semipermeable membrane has a molecular weight cut off from about 25 Kd to about 200 Kd.

3. The artificial pancreatic perfusion device of claim 1, wherein the semipermeable membrane comprises part of the housing.

4. The artificial pancreatic perfusion device of claim 1, wherein the semipermeable membrane comprises all of the housing.

5. The artificial pancreatic perfusion device of claim 1, wherein said islets of Langerhans are suspended in a matrix consisting of acrylic polycarbonate, polysulphone, or polyurethane.

6. The artificial pancreatic perfusion device of claim 1, wherein an inner surface area of the hollow fiber is from about 50 cm squared to about 100 cm squared.

7. The artificial pancreatic perfusion device of claim 5, comprising from about 30K to about 1×

10⁹ K islet of Langerhans.

8. The artificial pancreatic perfusion device of claim 1, wherein the housing is cylindrical.

9. The artificial pancreatic perfusion device of claim 1, wherein the housing is annular.

10. A method for providing and regulating insulin to insulin deficient individuals, comprising the steps of:

a. seeding a device as described in claim 1, with islets of Langerhans;

b. attaching one end of said device to a blood vessel for receiving blood and attaching the other end to a blood vessel for returning blood to the patient;

c. circulating blood through said device.

11. A method for providing and regulating insulin to an insulin deficient individual, comprising the steps of:

a. seeding a device as described in claim 1, with islets of Langerhans;

b. attaching an inlet end of said device to a blood vessel for receiving blood and attaching an outlet end of said device to a blood vessel for returning blood to an individual;

c. implanting said device into an individual and circulating blood through said device so that blood circulates through said hollow fiber, and body fluid perfuses through said housing so that insulin is secreted through said hollow fiber as well as through said housing.

12. The articial pancreatic perfusion device described in claim 9, wherein the device is adapted to be attached to a blood vessel for receiving blood and a blood vessel for returning blood via a vascular graft.

13. The articial pancreatic perfusion device described in claim 9, wherein the islets of Langerhans are seeded in a suspension or a gel matrix.

14. The articial pancreatic perfusion device described in claim 12, wherein from about 100,000 to about 2,000,000 islets are seeded.

15. The articial pancreatic perfusion device described in claim 9, wherein the semipermeable membrane has a pore size from about 25 Kd to about 200 Kd.

16. The articial pancreatic perfusion device described in claim 14, wherein the semipermeable membrane comprises part of the housing.

17. The articial pancreatic perfusion device described in claim 14, wherein the semipermeable membrane comprises all of the housing.

18. The method described in claim 14, wherein the housing is cylindrical.

19. The articial pancreatic perfusion device described in claim 14, wherein the housing is annular.

20. The artifical pancreatic perfusion device described in claim 1, wherein the islets of Langerhans are suspended in a liquid, gel, or bead matrix.

21. The artifical pancreatic perfusion device described in claim 20, wherein the islets of Langerhans are suspended in an agar, alginate, or agarose bead matrix.