Methods and devices for reducing the mineral content of vascular calcified lesions

• US 6,387,071 B1
• Filed: 11/18/1998
• Issued: 05/14/2002
• 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:
  US09/195,291
• Time in Patent Office: 1,273 Days
• Field of Search: 128/898, 604/27, 604/28, 604/96.01, 604/101.01, 604/43
• US Class Current: 604/43
• 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

Methods and devices are provided for at least reducing the mineral content of a vascular calcified lesion, i.e. a calcified lesion present on the vascular tissue of a host. In the subject methods, the local environment of the lesion is maintained at a subphysiologic pH for a period of time sufficient for the mineral content of the lesion to be reduced, e.g. by flushing the lesion with a fluid capable of locally increasing the proton concentration in the region of the lesion. Also provided are catheters for use in performing the subject methods, where the catheters at least include a first lumen capable of delivering fluid to a vascular site and a second lumen capable of removing fluid from a vascular site. The subject methods and devices find particular use in the treatment of vascular diseases associated with the presence of calcified lesions on vascular tissue.

Claims

1. A catheter comprising:

a dissolution fluid introduction lumen comprising an acidic dissolution fluid having a pH of less than about 2, wherein introduction lumen is capable of delivering a dissolution fluid to a vascular tissue site and

a fluid removal lumen capable of removing fluid from said vascular tissue site having dimensions sufficient to allow passage of lesion debris.

2. The catheter according to claim 1, wherein said catheter further comprises a means for substantially isolating said vascular tissue site.

3. The catheter according to claim 2, wherein said means for substantially isolating said vascular tissue site is a double balloon system.

4. A system for flushing a vascular tissue site with a dissolution fluid, said system comprising:

(a) a catheter comprising a dissolution fluid introduction lumen capable of delivering fluid to said vascular tissue site and a fluid removal lumen capable of removing fluid and lesion debris from said vascular tissue site;

(b) a first pumping means operatively linked to said fluid introduction lumen in a manner sufficient such that said first pumping means forces fluid out of the distal end of said fluid introduction lumen;

(c) a second pumping means operatively linked to said fluid removal lumen in a manner sufficient such that said second pumping means sucks fluid into the distal end of said fluid removal lumen; and

(d) a dissolution fluid having a pH of less than about 2.

5. A kit for at least reducing the mineral content of a vascular calcified lesion, said kit comprising:

a fluid capable of locally increasing the proton concentration in the region of said calcified lesion, said fluid having a pH of less than about 2; and

a catheter fluid introduction means.

6. The kit according to claim 5, wherein said kit further comprises instructions for practicing a method of reducing or eliminating the mineral content of a vascular calcified lesion using a solution having a pH of less than about 2.