Polyumenal implantable organ

• US 5,370,681 A
• Filed: 03/12/1993
• Issued: 12/06/1994
• Est. Priority Date: 09/16/1991
• Status: Expired due to Fees

• Current Assignee: Atrium Medical Corporation (Getinge AB)
• Original Assignee: Atrium Medical Corporation (Getinge AB)
• Inventors: Martakos, Paul, Karwoski, Theodore, Herweck, Steve A.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): Nguyen, Dinh X.
• Application Number:
  US08/029,990
• Time in Patent Office: 634 Days
• Field of Search: 623/1, 623/11, 623/12, 606/190, 606/191, 606/192, 606/193, 606/194, 606/195, 606/196, 606/197, 606/198, 606/199, 606/200, 600/36
• US Class Current: 623/1.27
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene

Abstract

A polylumenal implantable device comprises a body defining a plurality of capillary lumina. The prosthetic device is suitable for implantation in a patient as an arterial or venous bypass graft or shunt, or intra-organ implant as well as other purposes. The improved prosthetic device has increased surface area and preferably a three-dimensional porosity for encouraging the harboring of, for example, endothelial cells, as well as for receiving organized deposition of material such as genetically enhanced cell types. A method for providing a bioactive material to a patient includes the steps of providing a polyluminal implantable organ comprising an implantable body defining a plurality of capillary lumina, treating the interior surfaces of the lumina with a bioactive material or plasma polymerization, and implanting the prosthetic device in the patient so that bodily fluids of the patient come into contact with the treated interior surfaces.

Claims

1. An implantable prosthetic device for connection to a fluid flow pathway of a patient, the device comprising an implantable body made of a single biocompatible material and extruded as a single body with microporous interior walls, said extruded single body having a shape to attach to said fluid flow pathway, said single body further having a multiplicity of capillary lumina therein defined by said microporous interior walls and extending substantially parallel to each other along a longitudinal axis of the body for accommodating fluid flow along said axis when attached to said fluid flow pathway.

2. A device as set forth in claim 1 wherein said microporous walls are sufficiently permeable to allow transluminal communication of cells and extra-cellular fluid.

3. A device as set forth in claim 1 wherein said implantable body is of a first diameter and said lumina are of a second diameter, said first diameter being approximately six times greater than said second diameter.

4. A device as set forth in claim 1 wherein all of said multiplicity of capillary lumina are of substantially equal diameter.

5. A device as set forth in claim 1 wherein each of said lumina is defined by an interior surface, said interior surfaces being treated with a bioactive material selected from the group consisting of protein, glycoprotein, and growth factors.

6. A device as set forth in claim 1 wherein said body has a D-shaped cross-section.

7. A device as set forth in claim 1 wherein said implantable body consists of polytetrafluoroethlene.

8. A device as set forth in claim 7 wherein said polytetrafluoroethylene is selected from the group consisting of expanded polytetrafluoroethylene, stretched polytetrafluoroethylene, and expanded and stretched polytetrafluoroethylene.

9. A device as set forth in claim 1 wherein said implantable body consists of a material including copolymers.

10. A device as set forth in claim 1 wherein selected capillary lumina are filled with a bioactive material.

11. A device as set forth in claim 10 wherein said bioactive material is a therapeutic agent.

12. A device as set forth in claim 10 wherein said bioactive material is a diagnostic agent.

13. An implantable prosthetic device for sustained release of a bioactive material into a patient'"'"'s blood stream, the device comprising an implantable tubular body formed of a single porous biocompatible material and adapted for attachment to a blood vessel of the patient, said implantable body including a body portion extruded as a single segment with a plurality of interior walls defining a multiplicity of capillary lumina extending substantially parallel to a longitudinal axis of the body portion and of a size for accommodating blood flow therethrough, said single segment being porous such that said interior walls are permeable to allow transluminal permeation of a bioactive material.

14. A device as set forth in claim 13 wherein said implantable body is of a first diameter and said lumina are of a second diameter, said first diameter being approximately six times greater than said second diameter.

15. A device as set forth in claim 13 wherein all of said multiplicity of capillary lumina are of substantially equal diameter.

16. A device as set forth in claim 13 wherein each of said lumina is defined by an interior surface, said interior surfaces being treated with a bioactive material selected from the group consisting of protein, glycoprotein, and growth factors.

17. A device as set forth in claim 13 wherein said outer wall is D-shaped.

18. A device as set forth in claim 13 wherein said implantable body consists of polytetrafluoroethylene.

19. A device as set forth in claim 18 wherein said polytetrafluoroethylene is selected from the group consisting of expanded polytetrafluoroethylene, stretched polytetrafluoroethylene, and expanded and stretched polytetrafluoroethylene.

20. A device as set forth in claim 13 wherein selected capillary lumina are filled with said bioactive material.

21. A device as set forth in claim 20 wherein said bioactive material is a therapeutic agent.

22. A device as set forth in claim 20 wherein said bioactive material is a diagnostic agent.

23. A method for providing a bioactive material to a fluid flow pathway of a patient, the method comprising the steps of

providing an implantable body formed of a single porous biocompatible material and adapted for attachment to said fluid flow pathway and for accomodating fluid flow therethrough, said implantable body being extruded as a single body with a plurality of interior walls defining a multiplicity of capillary lumina extending substantially parallel to a longitudinal axis of the single body, said lumina being separated by walls sufficiently permeable to allow transluminal permeation of a bioactive material,

introducing said bioactive material to selected capillary lumina, and

surgically grafting said prosthetic device to the fluid flow pathway in the patient to establish fluid flow along said longitudinal axis through others of said capillary lumina through said implantable body.

24. A method as set forth in claim 23 wherein said introducing step is carried out by prefilling said selected capillary lumina with the bioactive material.

25. A method as set forth in claim 23 wherein said introducing step is carried out by coating the interior surfaces of said selected capillary lumina with the bioactive material.

26. A method as set forth in claim 23 wherein said implanting step is carried out by placing implantable body in fluid communication with the patient'"'"'s vascular system.

27. A method as set forth in claim 23 wherein said implanting step is carried out by placing the implantable body in fluid communication with an internal organ of the patient.

28. A method as set forth in claim 23 further comprising the step of

seeding said selected capillary lumina prior to said introducing step with material to promote both naturally occurring and genetically derived and cultured cell attachment and growth.

29. A method for providing a bioactive material to a patient'"'"'s blood stream, the method comprising the steps of forming from a mass of porous polytetrafluoroethylene by applying heat and pressure, a single body, said body being extended and having plural interior walls and adapted for attachment to a blood vessel of the patient, said plural interior walls of the single body defining a multiplicity of capillary lumina extending substantially parallel to a longitudinal axis of the body and adapted for accommodating blood flow therethrough, said interior walls formed of said porous polytetrafluoroethylene being permeable to allow transluminal permeation of a bioactive material,

introducing said bioactive material to selected ones of said capillary lumina, and

surgically grafting said prosthetic device to the blood vessel to establish blood flow through at least some of said capillary lumina.

30. A method as set forth in claim 29 wherein said introducing step is carried out by prefilling said selected capillary lumina with the bioactive material.

31. A method as set forth in claim 29 wherein said introducing step is carried out by coating the interior surfaces of said capillary lumina with the bioactive material.

32. A method as set forth in claim 29 wherein said implanting step is carried out by placing implantable body in fluid communication with the patient'"'"'s vascular system.