Intravascular drug delivery device and use therefor

• US 20020090388A1
• Filed: 11/30/2001
• Published: 07/11/2002
• Est. Priority Date: 12/01/2000
• Status: Abandoned Application

• Current Assignee: Renamed Biologics, Inc.
• Original Assignee: Renamed Biologics, Inc.
• Inventors: Humes, H. David, Tziampazis, Evangelos
• Application Number:
  US09/999,210
• Publication Number:
  US 20020090388A1
• Time in Patent Office: Days
• US Class Current: 424/422
• CPC Class Codes: A61K 9/0004 Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
• CPC Class Codes: A61K 9/0019 Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner non-active ingredients are additionally classified in A61K47/00
• 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: A61P 7/02 Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: A61P 7/04 Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
• CPC Class Codes: A61P 7/06 Antianaemics
• CPC Class Codes: A61P 9/02 Non-specific cardiovascular stimulants, e.g. drugs for syncope, antihypotensives
• CPC Class Codes: A61P 9/04 Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
• CPC Class Codes: A61P 9/06 Antiarrhythmics
• CPC Class Codes: A61P 9/08 Vasodilators for multiple indications
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
• CPC Class Codes: A61P 9/12 Antihypertensives

Abstract

Disclosed is an implantable drug delivery device for delivering a pre-selected drug directly into the systemic circulation of an animal. The device comprises an anchor immobilizable to an inner wall of an intact blood vessel. The device also comprises a drug containing reservoir that is retained in place within the blood vessel by the immobilized anchor. The reservoir may include, for example, a drug containing osmotic pump or a drug permeable capsule having disposed therein drug containing particles, which release the drug directly into blood passing the reservoir. The invention also provides a minimally invasive method for introducing into a blood vessel and, optionally, removing from the blood vessel the drug delivery device of the invention.

Claims

1. An intravascular drug delivery device for delivering a pre-selected drug into systemic circulation of an animal, the device comprising:

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

(b) a cell-free reservoir containing pre-selected drug, which when introduced into the blood vessel is retained by the anchor and releases the pre-selected drug into blood passing the reservoir.

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 1, wherein the anchor comprises a head and a plurality of barbed filaments attached by one end to the head.

6. The device of claim 5, wherein the anchor is an embolism anti-migration filter.

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

8. The device of claim 7, wherein the receptacle further comprises an interlocking mechanism for locking the reservoir to the anchor.

9. The device of claim 8, wherein the reservoir further comprises an interlocking mechanism that engages the interlocking mechanism of the anchor for locking the reservoir to the anchor.

10. The device of claim 1, wherein the reservoir comprises a wall at least partially defining an inner volume for retaining the pre-selected drug.

11. The device of claim 1, wherein the reservoir is a pump.

12. The device of claim 11, wherein the pump is an osmotic pump.

13. The device of claim 1, wherein the reservoir is a drug permeable capsule.

14. The device of claim 13, wherein the capsule has disposed therein particles containing the pre-selected drug for release therefrom.

15. The device of claim 10, wherein the wall is a semi-permeable membrane.

16. The device of claim 15, wherein the semi-permeable membrane defines pores of a size sufficient to permit diffusion of the pre-selected drug therethrough.

17. The device of claim 16, 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, polyacrylate, polycarbonate, polysulfone, polystyrene, polyurethane, polyvinyl alcohol, polyacrylonitrile, polyamide, polyimide, polymethylmethacrylate, polyethylene oxide, polytetrafluorethylene, and mixtures thereof.

18. The device of claim 1, wherein the pre-selected drug is a fatty acid, a cardiovascular drug or a coagulation factor.

19. The device of claim 1, wherein the reservoir comprises a plurality of pre-selected drugs which are released into blood passing the reservoir.

20. The device of claim 1, wherein the reservoir releases the pre-selected drug over a pre-selected period of time.

21. A method of introducing into a blood vessel a drug delivery device for delivering a pre-selected drug directly into systemic circulation of an animal, the method comprising the steps of:

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

(b) introducing into the blood vessel a cell-free reservoir containing pre-selected drug, such that when introduced into the blood vessel the reservoir releases the pre-selected drug into blood passing the reservoir; and

(c) permitting the reservoir to be retained in the blood vessel by the anchor.

22. The method of claim 21, comprising the additional step of, prior to step (a), introducing the anchor into the blood vessel via a catheter.

23. The method of claim 21 or 22, wherein the reservoir is introduced into the blood vessel by a catheter.

24. The method of claim 21, comprising the additional step of locking the reservoir to the anchor.

25. The method of claim 24, wherein the reservoir is locked to the anchor after the anchor is immobilized in the blood vessel.

27. The anchor of claim 26, wherein the first element is located proximal to the second element.

28. The anchor of claim 26, wherein the first element is a stent.

29. The anchor of claim 26, wherein the first element comprises at least one outwardly extending barb.30. The anchor of claim 26, further comprising a third element interposed between the first and second elements for connecting the first and second elements.

31. The anchor of claim 30, wherein the third element comprises a filament.

32. The anchor of claim 26, wherein the second element further comprises an interlocking mechanism for engaging an interlocking mechanism on the reservoir to lock the reservoir to the anchor.

33. The anchor of claim 32, wherein the interlocking mechanism comprises an annular member having an inner wall that defines a bore running therethrough, wherein the inner wall further defines a groove perpendicular to the bore for engaging the interlocking mechanism on the reservoir.

35. The reservoir of claim 34, wherein the first element comprises an annular member having an outer wall, wherein a first portion of the outer wall has a first radial dimension, and a second portion of the outer wall has a second, different radial dimension, wherein the second radial dimension is greater than the first radial dimension.

36. The reservoir of claim 34, wherein the second element is a pump.

37. The reservoir of claim 34, wherein the pump is an osmotic pump.

38. The reservoir of claim 34, wherein the second element is a drug permeable capsule.

39. The reservoir of claim 38, wherein the capsule has disposed therein particles containing the pre-selected drug for release therefrom.

40. The reservoir of claim 34, wherein the wall is a semi-permeable membrane.

41. The reservoir of claim 40, wherein the semi-permeable membrane defines pores of a size sufficient to permit diffusion of the pre-selected drug therethough.

42. The reservoir of claim 34, wherein the drug is a fatty acid, a cardiovascular drug, or a coagulation factor.

43. The reservoir of claim 34, further comprising a plurality of pre-selected drugs for release therefrom.

26. An anchor for implantation into an intact blood vessel of an animal, the anchor comprising:

a first element adapted for immobilization to an inner wall of the blood vessel, wherein the first element comprises at least one member biased in a radially outward direction when immobilized in the blood vessel; and

attached thereto

a second element forming a receptacle for receiving a drug delivery reservoir member of a predetermined configuration.

34. A drug delivery reservoir for implantation into an intact blood vessel of an animal, the reservoir comprising:

a first element forming an interlocking mechanism for engaging a receptacle of an anchor immobilizable to an inner wall of an intact blood vessel; and

attached thereto

a second element having a wall at least partially defining an inner volume for retaining the drug and defining at least one pore dimensioned to permit the drug retained therein to pass therethrough.

44. An implantable, intravascular drug delivery device, the device comprising:

(a) an anchor comprising a first element adapted for immobilization to an inner wall of a blood vessel, wherein the first element comprises at least one member biased in a radially outward direction when immobilized in the blood vessel and, in connection therewith, a second element comprising a first interlocking mechanism; and

(b) a reservoir comprising a first element comprising a second interlocking mechanism and in connection therewith a second element having a wall at least partially defining an inner volume for retaining the drug and defining at least one pore dimensioned to permit the drug retained therein to pass therethrough,

wherein the first interlocking mechanism is capable of engaging the second interlocking mechanism to the lock the reservoir to the anchor.