Intravasular artificial organ

• US 4,911,717 A
• Filed: 06/18/1987
• Issued: 03/27/1990
• Est. Priority Date: 06/18/1987
• Status: Expired due to Term

• Current Assignee: Harold V. Gaskill III
• Original Assignee: Harold V. Gaskill III
• Inventors: Gaskill, Harold V. III
• Primary Examiner(s): Apley, Richard J.
• Assistant Examiner(s): Isabella, David J.
• Application Number:
  US07/063,313
• Time in Patent Office: 1,013 Days
• Field of Search: 604/53, 604/175, 604/891.1, 623/10, 623/11, 623/12, 623/1, 623/66, 128/1 R
• US Class Current: 604/891.1
• 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: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61M 2039/0211 with multiple chambers in a single site
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 39/0208 Subcutaneous access sites for injecting or removing fluids transcutaneous access sites A61M39/0247; implantable infusion devices A61M5/14276

Abstract

The intravascular artificial organ is comprised of a flexible, hollow, semipermeable catheter containing living cells or tissue. The catheter is constructed of material with a pore size resulting in a molecular weight cutoff of approximately 50,000 Daltons. This pore size permits oxygen, glucose, and hormones to diffuse freely into and out of the organ. By contrast, cells of the host immune system cannot gain access to the cells or tissues within the organ and destroy them. Thus, it is possible to load the intravascular artificial organ with cells and tissues of immunologically foreign individuals, animals, bacteria or plants. The preferred embodiment consists of a double lumen catheter connected to two percutaneous access ports permitting flushing and reloading of the organ without removing it from the body.

Claims

1. A method of delivering a biosynthetic substance to a patient comprising (a) inserting into a blood vessel of a patient a catheter closed at one end and having a cell culture chamber, said chamber being adapted to receive and maintain functional cells or tissues which produce a desired biosynthetic substance, said chamber having a wall, at least a portion of said wall being permeable to said substance and to nutrients provided by the blood which are necessary to maintain the cells or tissues in a functional state, said wall being impermeable to immunocytes and immunoglobulins;

and (b) tethering said catheter in place in the blood vessel by tethering means, whereby the wall of the cell culture chamber is constantly bathed by blood flowing in said blood vessel, said tethering means further providing conduit means whereby cells or liquids may be introduced into or withdrawn from said chamber;

said desired biosynthetic substance being produced by said cells and delivered through said wall directly into the bloodstream of the patient.

2. The method of claim 1 in which the cells are introduced into the chamber before the catheter is inserted into the blood vessel.

3. The method of claim 1 in which the cells are introduced into the chamber after the catheter is inserted into the blood vessel.

4. The method of claim 1 in which the blood vessel is a vein.

5. The method of claim 4 in which the vessel has a diameter of at least 5 mm.

6. The method of claim 4 in which the vein is the subclavian vein.

7. The method of claim 1 in which the substance is insulin.

8. The method of claim 7 in which the tissue is pancreatic islet tissue.

9. The method of claim 1 in which the chamber wall is formed of a semipermeable membrane having a molecular weight cut-off of about 50,000 Daltons whereby entry of immunoglobulins is prevented.

10. The method of claim 1 in which cells or tissue are no longer functional are removed from the culture chamber through said conduit means.

11. The method of claim 1 in which a therapeutic agent is introduced through said conduit into said chamber and thence into the bloodstream.

12. The method of claim 11 in which the agent is an antibiotic.

13. The method of claim 1 in which, after insertion, the composition of the cells within the chamber is modified without removing the catheter from the patient.

14. The method of claim 1 in which the conduit means is a double lumen conduit means, and cells or liquid are introduced through one lumen and withdrawn through the other lumen.

15. The method of claim 1, said conduit means comprising subcutaneous port means at the end distal to said cell culture chamber, and wherein said catheter is implanted so that said port means assumes a subcutaneous position.

16. The method of claim 15 wherein said port means comprises a septum pierceable by a hypodermic needle.

17. The method of claim 16 wherein cells or substances are introduced into or withdrawn from said culture chamber by piercing said septum with a hypodermic needle and getting cells or substances from or drawing them into said needle.

18. The method of claim 1 wherein the tethering means is sufficiently rigid to hold the chamber in position within a blood vessel.

19. The method of claim 1 wherein the portion of the exterior surface of the catheter which is intended to come into prolonged contact with blood is treated with an agent to reduce the incidence of blood clotting thereon.