Method of treating coronary arteries with perivascular delivery of therapeutic agents

• US 7,998,105 B2
• Filed: 09/24/2003
• Issued: 08/16/2011
• Est. Priority Date: 03/13/1997
• Status: Expired due to Fees

• Current Assignee: BioCardia, Inc
• Original Assignee: BioCardia, Inc
• Inventors: Altman, Peter A.
• Primary Examiner(s): Chen; Tse
• Assistant Examiner(s): Cheng; Jacqueline
• Application Number:
  US10/671,270
• Publication Number:
  US 20040102759A1
• Time in Patent Office: 2,883 Days
• Field of Search: 600/407, 623/1.11, 623/1.42, 604/19, 604/48, 604/500, 606/194, 128/898
• US Class Current: 604/19
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 2018/1435 Spiral
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61K 9/127 Liposomes
• CPC Class Codes: A61K 9/1676 having a drug-free core with discrete complete coating layer containing drug adsorbates of liquid drug formulations on inert powders without simultaneous granulation step A61K9/141; with further drug-free outer coating A61K9/5078; drug conjugated to non-active particles A61K47/6921
• CPC Class Codes: A61K 9/50 Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals A61K9/2081 takes precedence; particles with a single coating comprising drug A61K9/167
• CPC Class Codes: A61K 9/5084 Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs tablets containing such a mixture A61K9/2077
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61N 1/0575 with drug delivery
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/06 Antiarrhythmics
• CPC Class Codes: A61P 9/08 Vasodilators for multiple indications

Abstract

A method of treating the intraluminal disease in a coronary artery by injecting therapeutic agents perivascularly into the myocardium near the site of disease.

Claims

1. A method of treating a stenosis or restenosis in a coronary blood vessel characterized by a proximal end nearest the origination of blood flow from the heart and a distal end, said method comprising the steps of:

implanting a stent at a first location within the coronary blood vessel; and

injecting a therapeutic agent comprising an anti-restenosis agent into the myocardium proximate the coronary blood vessel at a second location, where the second location is distal, in relation to the coronary blood vessel, to the first location.

2. The method of claim 1 further comprising the steps of:

injecting the therapeutic agent into the myocardium from an endocardial space of the heart.

3. The method of claim 1 further comprising the steps of:

injecting the therapeutic agent peri-adventitially through the blood vessel wall.

4. The method of claim 1 further comprising the step of:

injecting the therapeutic agent peri-adventitially through a coronary vein or coronary sinus.

5. The method of claim 1, 2, 3 or 4 further comprising the steps of:

selecting the anti-restenosis agent from the group comprising anti-oxidant drugs, anti-inflammatory drugs, anti-neoplastic agents, anti-angiogenic agents and gene therapy agents.

6. The method of claim 1, 2, 3 or 4 further comprising the step of:

providing the therapeutic agent in a time release formulation.

7. The method of claim 1, 2, 3 or 4 further comprising the step of:

providing the therapeutic agent in a microsphere formulation.

8. The method of claim 1, 2, 3 or 4 further comprising the step of:

providing the therapeutic agent in a formulation in which the therapeutic agent is encapsulated in micelles.

9. The method of claim 1, 2, 3 or 4 further comprising the step of:

providing the therapeutic agent in a formulation in which the therapeutic agent is encapsulated in liposomes.

10. A method of treating a stenosis or restenosis in a coronary blood vessel characterized by a proximal end nearest the origination of blood flow from the heart and a distal end, said method comprising the steps of:

performing an angioplasty procedure at a first location within the coronary blood vessel; and

injecting a therapeutic agent comprising an anti-restenosis agent into the myocardium proximate the coronary blood vessel at a second location, where the second location is distal, in relation to the coronary blood vessel, to the first location.

11. The method of claim 10 further comprising the steps of:

injecting the therapeutic agent into the myocardium from an endocardial space of the heart.

12. The method of claim 10 further comprising the steps of:

injecting the therapeutic agent peri-adventitially through the blood vessel wall.

13. The method of claim 10 further comprising the step of:

injecting the therapeutic agent peri-adventitially through a coronary vein or coronary sinus.

14. The method of claim 10, 11, 12 or 13 further comprising the steps of:

selecting the anti-restenosis agent from the group comprising anti-oxidant drugs, anti-inflammatory drugs, anti-neoplastic agents, anti-angiogenic agents and gene therapy agents.

15. The method of claim 10, 11, 12 or 13 further comprising the step of:

providing the therapeutic agent in a time release formulation.

16. The method of claim 10, 11, 12 or 13 further comprising the step of:

providing the therapeutic agent in a microsphere formulation.

17. The method of claim 10, 11, 12 or 13 further comprising the step of:

providing the therapeutic agent in a formulation in which the therapeutic agent is encapsulated in micelles.

18. The method of claim 10, 11, 12 or 13 further comprising the step of:

providing the therapeutic agent in a formulation in which the therapeutic agent is encapsulated in liposomes.

19. A method of treating a segment of a coronary blood vessel, the segment characterized by a proximal end nearest the origination of blood flow from the heart and a distal end, said method comprising the steps of:

injecting a therapeutic agent comprising an anti-restenosis agent into the myocardium proximate the coronary blood vessel at a site distal, to the segment to be treated.

20. The method of claim 19 further comprising the steps of:

injecting the therapeutic agent into the myocardium from an endocardial space of the heart.

21. The method of claim 19 further comprising the steps of:

injecting the therapeutic agent peri-adventitially through the blood vessel wall.

22. The method of claim 19 further comprising the step of:

injecting the therapeutic agent peri-adventitially through a coronary vein or coronary sinus.

23. The method of claim 19, 20, 21 or 22 further comprising the steps of:

selecting the anti-restenosis agent from the group comprising anti-oxidant drugs, anti-inflammatory drugs, anti-neoplastic agents, anti-angiogenic agents and gene therapy agents.

24. The method of claim 19, 20, 21 or 22 further comprising the step of:

providing the therapeutic agent in a time release formulation.

25. The method of claim 19, 20, 21 or 22 further comprising the step of:

providing the therapeutic agent in a microsphere formulation.

26. The method of claim 19, 20, 21 or 22 further comprising the step of:

providing the therapeutic agent in a formulation in which the therapeutic agent is encapsulated in micelles.

27. The method of claim 19, 20, 21 or 22 further comprising the step of:

providing the therapeutic agent in a formulation in which the therapeutic agent is encapsulated in liposomes.

28. A method of treating a segment of a coronary blood vessel characterized by an intraluminal disease, the segment further characterized by a proximal end nearest the origination of blood flow from the heart and a distal end, said method comprising the steps of:

injecting a therapeutic agent into the myocardium proximate the coronary blood vessel at a site distal, to the segment to be treated.

29. The method of claim 28 further comprising the steps of:

injecting the therapeutic agent into the myocardium from an endocardial space of the heart.

30. The method of claim 28 further comprising the steps of:

injecting the therapeutic agent peri-adventitially through the blood vessel wall.

31. The method of claim 28 further comprising the step of:

injecting the therapeutic agent peri-adventitially through a coronary vein or coronary sinus.

32. The method of claim 28, 29, 30 or 31 further comprising the steps of:

selecting the therapeutic agent from the group comprising anti-oxidant drugs, anti-inflammatory drugs, anti-neoplastic agents, anti-angiogenic agents and gene therapy agents.

33. The method of claim 28, 29, 30 or 31 further comprising the step of:

providing the therapeutic agent in a time release formulation.

34. The method of claim 28, 29, 30 or 31 further comprising the step of:

providing the therapeutic agent in a microsphere formulation.

35. The method of claim 28, 29, 30 or 31 further comprising the step of:

providing the therapeutic agent in a formulation in which the therapeutic agent is encapsulated in micelles.

36. The method of claim 28, 29, 30 or 31 further comprising the step of:

providing the therapeutic agent in a formulation in which the therapeutic agent is encapsulated in liposomes.

37. A kit for delivering a therapeutic agent to a patient suffering from vascular disease characterized by a diseased treatment region in a coronary blood vessel, the diseased treatment region characterized by a proximal end nearest the origination of blood flow from the heart and a distal end, said kit comprising:

a catheter having means for introducing a therapeutic agent into in a perivascular space surrounding the blood vessel; and

a dose of therapeutic agent suitable for introduction into the perivascular space surrounding the blood vessel through the catheter;

instructions for use of the catheter according to the following method;

positioning the means for introducing into the perivascular space; and

delivering a dose of the therapeutic agent into the perivascular space near the diseased treatment region at a site distal, to the diseased treatment region.