Method and apparatus for treatment of cardiovascular tissue mineralization

• US 6,394,096 B1
• Filed: 07/15/1998
• Issued: 05/28/2002
• Est. Priority Date: 07/15/1998
• Status: Expired due to Term

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Corazon Technologies, Inc. (Cardinal Health, Inc.)
• Inventors: Constantz, Brent R.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): BARRETT, THOMAS C
• Application Number:
  US09/118,193
• Time in Patent Office: 1,413 Days
• Field of Search: 128/898 604/27,28,96.01,101.01,101.05,103.07,916,507
• US Class Current: 128/898
• 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 2017/22098 Decalcification of valves

Abstract

A method and several assemblies for the reducing of mineralization of cardiovascular tissue in vivo is provided. The method involves contacting cardiovascular tissue, such as a valve or a vessel, with an acidic treatment solution. One apparatus is a balloon catheter assembly for the infusion of an acidic treatment solution into a define area of a cardiovascular tissue. A second apparatus is a flexible cup which forms a defined area with the wall of a vessel for the introduction of an acidic treatment solution for the reduction of mineralization of a vessel. A third apparatus is an assembly for the introduction of an acidic treatment solution on one side of a valve, and the removal of the acidic treatment solution from the opposite side of the valve. Each apparatus can take the form of an elongated catheter for use in minimally invasive procedures or as hand held devices for use in an open surgical field.

Claims

1. A method for reducing mineralization of a cardiovascular tissue, comprising contacting the cardiovascular tissue with an acidic treatment solution having a pH of less than about 4 for a period of time sufficient to reduce mineralization.

2. The method of claim 1, further comprising applying ultrasonic vibration to the cardiovascular tissue.

3. The method of claim 1, further comprising rinsing said cardiovascular tissue with a rinsing solution.

4. The method of claim 1, wherein said acidic treatment solution comprises an inorganic acid.

5. The method of claim 1, wherein said acid comprises a Tris acid.

6. The method of claim 1, wherein said acidic treatment solution has a pH of about 5.5 to about 1.0.

7. The method of claim 1, wherein said contacting is performed at a temperature from about the freezing temperature of the acidic treatment solution to about 37°

C.

8. The method of claim 7, wherein said contacting is performed at a temperature from about 0°

C. to about 10°

C.

9. The method of claim 1, wherein said cardiovascular tissue is a vessel.

10. The method of claim 9, wherein said vessel is a graft.

11. The method of claim 1, wherein said cardiovascular tissue is a heart valve.

12. The method of claim 11, wherein said heart valve is a prosthetic heart valve.

13. The method of claim 12, wherein said prosthetic heart valve is a bioprosthetic heart valve.

14. The method of claim 1, wherein said contacting is in vivo.

15. A method for infusing a demineralization solution into a cardiovascular tissue of a subject, comprising:

inserting a catheter into the cardiovascular tissue so that the catheter defines a blood flow passage,

occluding a region within said cardiovascular tissue by inflating a first and a second balloon, wherein said first balloon defines the proximal end of said region and said second balloon defines the distal end of said region,

infusing an acidic treatment solution having a pH of less than about 4 for a period of time sufficient to reduce mineralization.

16. The method of claim 15, wherein said acid is an inorganic acid .

17. The method of claim 15, wherein said acidic treatment solution has a pH of about 5.5 to about 1.0.

18. The method of claim 15, wherein said cardiovascular tissue is a vessel.

19. The method of claim 18, wherein said vessel is a graft.

20. The method of claim 15, wherein said cardiovascular tissue is a heart valve.

21. The method of claim 20, wherein said heart valve is a prosthetic heart valve.

22. The method of claim 21, wherein said prosthetic heart valve is a bioprosthetic heart valve.