Intravascular blood conditioning device and use thereof

• US 20020090389A1
• Filed: 11/30/2001
• Published: 07/11/2002
• Est. Priority Date: 12/01/2000
• Status: Abandoned Application

• Current Assignee: Nephros Therapeutics, Inc. (Renamed Biologics, Inc.)
• Original Assignee: Nephros Therapeutics, Inc. (Renamed Biologics, Inc.)
• Inventors: Humes, H. David, Tziampazis, Evangelos, Andrews, Richard A.
• Application Number:
  US09/999,211
• Publication Number:
  US 20020090389A1
• Time in Patent Office: Days
• US Class Current: 424/422
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61M 1/1678 intracorporal peritoneal dialysis A61M1/28

Abstract

Disclosed is an implantable, intravascular device for treating a medical disorder associated with the presence of a particular molecule in the systemic circulation of a mammal. When implanted, the device removes or reduces the concentration of the molecule in the blood stream thereby conditioning the blood. The device includes an anchor component immobilizable to an inner wall of an intact blood vessel and a cartridge component that is retained in place within the blood vessel by the immobilized anchor. The cartridge contains a converting agent, for example, viable cells or enzyme preparations, that catabolize or convert the molecule of interest into one or more other molecules that are not associated with the disorder. The invention also provides a minimally or non-invasive method for introducing into and, optionally, removing from the blood vessel the device of the invention.

Claims

1. An implantable, intravascular device for treating a disorder associated with the presence of a pre-selected molecule in the blood stream of an animal, the device comprising:

(a) an anchor immobilizable to an inner wall of an intact blood vessel which, when immobilized in the vessel, permits blood in the vessel to pass therethrough; and

(b) a cartridge containing a converting agent, wherein the cartridge when introduced into the blood vessel is retained by the anchor and permits blood in the vessel to pass therethrough, and the converting agent converts or modifies the pre-selected molecule that enters the cartridge from the blood stream so as to remove the pre-selected molecule from the blood stream.

2. The device of claim 1, wherein the anchor comprises at least one element biased in a radially outward direction when immobilized in the blood vessel.

3. The device of claim 1, wherein the anchor is a stent.

4. The device of claim 1, wherein the anchor comprises an outwardly extending barb.

5. The device of claim 4, wherein the anchor comprises a head and a plurality of barbed filaments attached by one end to the head.

6. The device of claim 4, wherein the anchor is an embolism anti-migration filter.

7. The device of claim 1, wherein the anchor comprises a receptacle for receiving the cartridge.

8. The device of claim 7, wherein the anchor further comprises an interlocking mechanism that engages a reciprocal interlocking mechanism of the cartridge for locking the anchor to the cartridge.

9. The device of claim 1, wherein the cartridge comprises at least one hollow fiber.

10. The device of claim 9, wherein the hollow fiber is defined at least in part by a semi-permeable membrane.

11. The device of claim 10, wherein the semi-permeable membrane defines pores of a size sufficient to permit passage of the pre-selected molecule therethrough.

12. The device of claim 11, wherein the pores permit passage therethrough of a pre-selected molecule smaller than 150 kD.

13. The device of claim 10, wherein the semi-permeable membrane comprises a material selected from the group consisting of polyvinylchloride, polyvinylidene fluoride, polyurethane isocyanate, alginate, cellulose, cellulose acetate, cellulose diacetate, cellulose triacetate, cellulose nitrate, polyarylate, polycarbonate, polysulfone, polystyrene, polyurethane, polyvinyl alcohol, polyacrylonitrile, polyamide, polyimide, polyacrylonitrite, polymethylmethacrylate, polyethylene oxide, polytetrafluorthylene, and mixtures thereof

14. The device of claim 1, wherein the converting agent is a biocatalyst.

15. The device of claim 14, wherein the biocatalyst is a viable cell or an enzyme.

16. The device of claim 15, wherein the viable cell is a eukaryotic cell.

17. The device of claim 16, wherein the eukaryotic cell is a mammalian cell.

18. The device of claim 14, wherein the biocatalyst catabolizes the pre-selected molecule.

19. The device of claim 15, wherein the enzyme is a purified enzyme preparation.

20. The device of claim 15, wherein the enzyme is immobilized on a solid support.

21. The device of claim 1, wherein the pre-selected molecule is harmful to the animal.

22. The device of claim 21, wherein the pre-selected molecule is selected from the group consisting of β

₂-microglobulin, lipoprotein, and bilirubin.

24. The cartridge of claim 23, further comprising an interlocking mechanism that engages a reciprocal interlocking mechanism of an anchor immobilizable to an inner wall of the blood vessel for locking the cartridge to the anchor.

25. The cartridge of claim 23, wherein the cartridge comprises a plurality of hollow fibers.

26. The cartridge of claim 23, wherein the pores are dimensioned to permit passage of the pre-selected molecule therethrough but insufficient to permit passage of the converting agent therethrough.

27. The cartridge of claim 23, further comprising an internal diameter of less than about 1000 μ

m.

28. The cartridge of claim 27, further comprising an internal diameter of less than about 500 μ

m.

29. The cartridge of claim 23, wherein the converting agent comprises a viable cell or an enzyme.

30. The cartridge of claim 29, wherein the viable cell is a mammalian cell.

31. The cartridge of claim 29, wherein the enzyme is a purified enzyme preparation.

32. The cartridge of claim 29, wherein the enzyme is immobilized on a solid support.

23. A cartridge for implantation into a lumen of a blood vessel for treating a disorder associated with the presence of pre-selected molecule in the blood stream of an animal, the cartridge comprising:

a wall defining an inner volume and defining a plurality of pores passing therethrough dimensioned to permit entry of the pre-selected molecule into the inner volume; and

a converting agent disposed within the inner volume capable of converting or modifying the pre-selected molecule,

wherein the cartridge, when introduced into a blood vessel, permits blood to pass through the vessel and removes the pre-selected molecule from the blood stream.

33. A method of treating a disorder associated with the presence of a pre-selected molecule in the blood stream of an animal, the method comprising the steps of:

(a) introducing into a lumen of a blood vessel in the animal a cartridge containing a converting agent capable of catabolizing the pre-selected molecule; and

(b) anchoring the cartridge within the blood vessel.

34. The method of claim 33, comprising the additional step of, prior to step (a), immobilizing an anchor to an inner wall of the blood vessel, wherein the anchor, when immobilized to the inner wall of the blood vessel, permits blood in the vessel to pass therethrough and engages the cartridge.

35. The method of claim 34, further comprising the additional step of locking the cartridge to the anchor.

36. The method of claim 33, wherein the cartridge is introduced into the vessel by a catheter.

37. The method of claim 34 or 36, wherein the anchor is introduced into the vessel by a catheter.

38. The method of claim 33 or 34, comprising the additional step of prior to step (a) introducing the converting agent into the cartridge.

39. The method of claim 33 or 34, comprising the additional step of after step (b) introducing the converting agent into the cartridge.

40. The method of claim 33, wherein the blood vessel is a vein, venule, artery or arteriole.