Methods for enhancing fluid flow through an obstructed vascular site, and systems and kits for use in practicing the same

• US 20070173784A1
• Filed: 10/12/2006
• Published: 07/26/2007
• Est. Priority Date: 10/22/1999
• Status: Abandoned Application

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Delaney, David, Johansson, Peter, Constantz, Brent
• Application Number:
  US11/581,222
• Publication Number:
  US 20070173784A1
• Time in Patent Office: Days
• US Class Current: 604/507
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0175 having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61M 2025/1015 having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• 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

Abstract

Methods of enhancing fluid flow through a vascular site occupied by a vascular occlusion, as well as systems and kits for use in practicing the same, are provided. In practicing the subject methods, the vascular site is flushed simultaneously with a first dissolution fluid (e.g., an organic matter dissolution fluid and/or an inorganic matter dissolution fluid), and a second dissolution fluid attenuating fluid, where flushing is carried out in a manner such that only a surface of the vascular occlusion is contacted with the non-attenuated dissolution fluid. Examples of dissolution fluid/dissolution fluid attenuating fluid pairs include: (1) oxidizing agent fluid and fluid comprising oxidizable neutralizing agent; (2) surfactant fluid and phosphate buffered saline; (3) acidic solution and phosphate buffered saline; etc. Flushing is carried out in this manner for a period of time sufficient for fluid flow through the vascular site to be enhanced, e.g. increased or established. The subject methods, systems and kits for practicing the same find use in the treatment of a variety of different vascular diseases characterized by the presence of vascular occlusions, including both partial and total occlusions.

Claims

1. A method of enhancing fluid flow through a vascular site occupied by a vascular occlusion, said method comprising:

simultaneously flushing said vascular site with;

(i) a dissolution fluid; and

(ii) a dissolution fluid attenuating fluid;

for a period of time sufficient for fluid flow to be enhanced through said vascular site;

with the proviso that said simultaneous flushing occurs in a manner such that only a surface of said vascular occlusion is contacted with non-attenuated dissolution fluid and the remainder of said vascular site is not contacted with non-attenuated dissolution fluid;

whereby fluid flow is enhanced through said vascular site.

2. The method according to claim 1, wherein said vascular occlusion at least comprises organic matter.

3. The method according to claim 1, wherein said vascular occlusion at least comprises inorganic matter.

4. The method according to claim 1, wherein said vascular occlusion comprises both organic and inorganic matter.

5. The method according to claim 1, wherein said dissolution fluid is an organic matter dissolution fluid.

6. The method according to claim 1, wherein said organic matter dissolution fluid comprises an active agent selected from the group consisting of enzymes, surfactants, oxidizing agents and thrombolytic agents.

7. The method according to claim 1, wherein said dissolution fluid is an inorganic matter dissolution fluid.

8. The method according to claim 7, wherein said inorganic matter dissolution fluid is an acidic dissolution fluid.

9. The method according to claim 1, wherein said occlusion is a total occlusion.

10. The method according to claim 1, wherein said occlusion is a partial occlusion.

11. The method according to claim 1, wherein a catheter device is used to flush said surface of said vascular occlusion.

12. The method according to claim 11, wherein said catheter device comprises at least three different lumens.

13. The method according to claim 11, wherein said catheter device comprises at least four different lumens.

41. A kit for use in enhancing fluid flow through a vascular site occupied by a vascular occlusion, said kit comprising:

a means for flushing said vascular site with a dissolution fluid and a dissolution fluid attenuating fluid; and

instructions for practicing the method of claim 1.

42. The kit according to claim 41, wherein said kit further comprises a dissolution fluid or a precursor(s) thereof.

43. The kit according to claim 41, wherein said kit further comprises a dissolution fluid attenuating fluid or precursors thereof.

44. The kit according to claim 41, wherein said kit further comprises a guidewire.

14. A method of enhancing fluid flow through a vascular site occupied by an organic matter comprising vascular occlusion, said method comprising:

simultaneously flushing said vascular site with;

(i) an organic matter dissolution fluid; and

(ii) an organic matter dissolution fluid attenuating fluid;

for a period of time sufficient for fluid flow to be enhanced through said vascular site;

with the proviso that said simultaneous flushing occurs in a manner such that only a surface of said organic matter comprising vascular occlusion is contacted with non-attenuated organic matter dissolution fluid and the remainder of said vascular site is not contacted with non-attenuated organic matter dissolution fluid;

whereby fluid flow is enhanced through said vascular site.

15. The method according to claim 14, wherein said organic matter dissolution fluid comprises an active agent selected from the group consisting of enzymes, surfactants, oxidizing and thrombolytic agents.

16. The method according to claim 14, wherein said organic matter dissolution fluid attenuating agent is an aqueous fluid.

17. The method according to claim 14, wherein said organic matter dissolution fluid comprises an oxidizing agent.

18. The method according to claim 17, wherein said organic matter dissolution fluid attenuating agent comprises an aqueous buffer solution.

19. The method according to claim 18, wherein said wherein said organic matter dissolution fluid comprises surfactant.

20. The method according to claim 14, wherein said vascular occlusion is a total occlusion.

21. The method according to claim 14, wherein said vascular occlusion is a partial occlusion.

22. A method of enhancing fluid flow through a vascular site occupied by an inorganic matter comprising vascular occlusion, said method comprising:

simultaneously flushing said vascular site with;

(i) an inorganic matter dissolution fluid; and

(ii) an inorganic matter dissolution fluid attenuating fluid;

for a period of time sufficient for fluid flow to be enhanced through said vascular site;

with the proviso that said simultaneous flushing occurs in a manner such that only a surface of said inorganic matter comprising vascular occlusion is contacted with non-attenuated inorganic matter dissolution fluid and the remainder of said vascular site is not contacted with non-attenuated inorganic matter dissolution fluid;

whereby fluid flow is enhanced through said vascular site.

23. The method according to claim 22, wherein said inorganic matter is a calcium phosphate mineral.

24. The method according to claim 22, wherein said inorganic matter dissolution fluid is an acidic solution.

25. The method according to claim 24, wherein said inorganic matter dissolution fluid attenuating fluid is a buffer solution.

26. The method according to claim 22, wherein said vascular occlusion is a total occlusion.

27. The method according to claim 22, wherein said vascular occlusion is a partial occlusion.

28. A method of enhancing fluid flow through a vascular site occupied by vascular occlusion, said method comprising:

simultaneously flushing said vascular site with;

(i) a dissolution fluid that dissolves both organic and inorganic matter;

and

(ii) a dissolution fluid attenuating fluid;

for a period of time sufficient for fluid flow to be enhanced through said vascular site;

with the proviso that said simultaneous flushing occurs in a manner such that only a surface of said inorganic matter comprising vascular occlusion is contacted with non-attenuated dissolution fluid and the remainder of said vascular site is not contacted with non-attenuated dissolution fluid;

whereby fluid flow is enhanced through said vascular site.

29. The method according to claim 28, wherein said dissolution fluid comprises an acid.

30. The method according to claim 28, wherein said dissolution fluid comprises a surfactant.

31. The method according to claim 28, wherein said dissolution fluid attenuating fluid is a buffer solution.

32. The method according to claim 28, wherein said vascular occlusion is a total occlusion.

33. The method according to claim 28, wherein said vascular occlusion is a partial occlusion.

34. A system for use in enhancing fluid flow through a vascular site occupied by an vascular occlusion, said system comprising:

a means for simultaneously flushing said vascular site with a dissolution fluid and a dissolution fluid attenuating fluid;

a dissolution fluid; and

an dissolution fluid attenuating fluid.

35. The system according to claim 34, wherein said means for simultaneously flushing said vascular site with a dissolution fluid and a dissolution attenuating fluid comprises two different fluid introducing means and a fluid aspiration means.

36. The system according to claim 34, wherein said flushing means is a catheter means.

37. The system according to claim 34, wherein said system further comprises:

(a) a manifold;

(b) a dissolution fluid reservoir;

(d) a dissolution fluid attenuating; and

(e) a source of negative pressure.

38. The system according to claim 34, wherein said system further includes a balloon inflation means.

39. The system according to claim 38, wherein said balloon inflation means is a syringe.

40. The system according to claim 34, wherein said system further comprises a guidewire.

45. A lesion dissolution fluid comprising:

an acid; and

a surfactant.

46. The fluid according to claim 45, wherein said fluid further comprises a salt.

47. The fluid according to claim 45, wherein said acid is an inorganic acid.

48. The fluid according to claim 45, wherein said inorganic acid is hydrogen chloride.

49. The fluid according to claim 45, wherein said surfactant is selected from the group consisting of cationic surfactants, anionic surfactants, zwitterionic surfactants and nonionic surfactants.

50. The fluid according to claim 49, wherein said surfactant is a cationic surfactant.

51. The fluid according to claim 50, wherein said cationic surfactant is sodium dodecyl sulfate.