Proton generating catheters and methods for their use in enhancing fluid flow through a vascular site occupied by a calcified vascular occlusion

• US 6,540,733 B2
• Filed: 12/29/2000
• Issued: 04/01/2003
• Est. Priority Date: 12/29/2000
• Status: Active Grant

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Corazon Technologies, Inc. (Cardinal Health, Inc.)
• Inventors: Ross, John, Constantz, Brent R.
• Primary Examiner(s): Yuen, Henry C.
• Assistant Examiner(s): FRISTOE JR, JOHN K
• Application Number:
  US09/753,023
• Publication Number:
  US 20020087112A1
• Time in Patent Office: 823 Days
• Field of Search: 604/20, 604/21, 604/22, 604/501, 604/93.01, 604/96.01, 604/104, 604/264, 604/523, 604/532, 604/607, 606/191, 606/192, 606/194
• 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 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• 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 2017/22082 after introduction of a substance
• CPC Class Codes: A61N 1/306 Arrangements where at least part of the apparatus is introduced into the body

Abstract

Catheter devices and methods are provided for enhancing fluid flow through a vascular site occupied by a calcified lesion. The catheter devices of the subject invention at least include, at their distal end, a proton generating means, and in many embodiments also include a flushing means. In using the subject devices, the distal end of the catheter is placed proximal to the vascular occlusion and protons are generated, e.g., via proton generation from water, in a manner sufficient to reduce the pH of the vascular site in the region proximal to the occlusion. The subphysiologic pH is maintained for a period of time sufficient for fluid flow through the vascular site to be enhanced. Also provided are kits comprising the subject catheter devices for use in the subject methods.

Claims

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

(a) positioning a proton generating electrode at said vascular site;

(b) generating protons from water in said vascular site using said proton generating element in a manner sufficient to provide for a subphysiological pH in said vascular site; and

(c) maintaining said subphysiological pH in said vascular site for a period of time sufficient for fluid flow to be enhanced through said vascular site so that fluid flow is enhanced through said vascular site.

2. The method according to claim 1, wherein said method further comprises flushing said vascular site with an aqueous solution.

3. The method according to claim 2, wherein said aqueous solution is an electrolyte solution.

4. The method according to claim 2, wherein said protons are generated by electrolyzing water in said vascular site.

5. The method according to claim 1, wherein said vascular occlusion comprises calcium.

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

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

8. The method according to claim 1, wherein said proton generating means is an electrode.

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

(a) positioning an electrode at said vascular site;

(b) generating protons from water in said vascular site using said electrode in a manner sufficient to provide for a subphysiological pH in said vascular site; and

(c) maintaining said subphysiological pH in said vascular site for a period of time sufficient for fluid flow to be enhanced through said vascular site so that fluid flow is enhanced through said vascular site.

10. The method according to claim 9, wherein said method further comprises flushing said vascular site with an aqueous solution.

11. The method according to claim 10, wherein said aqueous solution is an electrolyte solution.

12. The method according to claim 9, wherein said protons are generated by electrolyzing water in said vascular site.

13. The method according to claim 9, wherein said vascular occlusion comprises calcium.

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

15. The method according to claim 9, wherein said occlusion is a partial occlusion.

16. The method according to claim 9, wherein said electrode is present at a distal end of a catheter device.

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

(a) positioning a distal end of a catheter device comprising an electrode at said vascular site;

(b) generating protons from water in said vascular site using said electrode in a manner sufficient to provide for a subphysiological pH in said vascular site; and

(c) maintaining said subphysiological pH in said vascular site for a period of time sufficient for fluid flow to be enhanced through said vascular site so that fluid flow is enhanced through said vascular site.

18. The method according to claim 17, wherein said method further comprises flushing said vascular site with an aqueous solution.

19. The method according to claim 18, wherein said aqueous solution is an electrolyte solution.

20. The method according to claim 17, wherein said protons are generated by electrolyzing water in said vascular site.

21. The method according to claim 17, wherein said vascular occlusion comprises calcium.

22. The method according to claim 17, wherein said occlusion is a total occlusion.

23. The method according to claim 17, wherein said occlusion is a partial occlusion.

24. The method according to claim 17, wherein said electrode is present at a distal end of a catheter device.