Catheter devices and methods for their use in the treatment of calcified vascular occlusions

• US 6,290,689 B1
• Filed: 10/22/1999
• Issued: 09/18/2001
• Est. Priority Date: 10/22/1999
• 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., Johansson, Peter, Delaney, Dave
• Primary Examiner(s): Dawson, Glenn K.
• Assistant Examiner(s): MAYNARD, JENNIFER J
• Application Number:
  US09/425,826
• Time in Patent Office: 697 Days
• Field of Search: 604/101-1-1, 604/102.01, 604/102.03, 604/96.01, 604/507-509, 604/264, 604/183, 604/912, 606/192-194, 606/198, 606/159
• 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: 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
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

Catheter devices and methods for their use in enhancing fluid flow through a vascular site occupied by a vascular occlusion are provided. The subject catheter devices include at least a first, second and third lumen, where: (a) the first lumen is used for delivery of an acidic dissolution solution to the vascular site; (b) the second lumen is used for delivery of a buffer solution to the vascular site; and (c) the third lumen is used for removal of fluid from the vascular site. In many preferred embodiments, the first, second and third lumens are coaxial. In practicing the subject methods, the vascular site is flushed simultaneously with an acidic dissolution fluid and a buffer solution, where flushing is carried out in a manner such that only a surface of the vascular occlusion is contacted with the acidic dissolution fluid and the remainder of the vascular site is not contacted with fluid having a pH that is lower than about 4. 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 catheter devices and methods find use in the treatment of a variety of different vascular diseases characterized by the presence of calcified vascular occlusions, including peripheral and coronary vascular diseases.

Claims

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

simultaneously, yet separately flushing said vascular site with;

(i) an acidic dissolution fluid; and

(ii) a buffer solution distinct from said acidic dissolution fluid;

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

wherein said simultaneous flushing occurs in a manner such that only a surface of said vascular occlusion is contacted with said acidic dissolution fluid and the remainder of said vascular site is not contacted with solution having a pH of less than about 4;

whereby fluid flow is enhanced through said vascular site.

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

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

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

5. A method according to claim 1, wherein a catheter device comprising first, second and third lumens, wherein at least one of said lumens is fabricated from a material sufficient for delivery of an acidic dissolution solution;

and a first vascular occlusion means;

is used to flush said surface of said vascular occlusion.

6. A system for enhancing fluid flow through a vascular site occupied by a vascular occlusion, said system comprising:

(a) a catheter device comprising first, second and third lumens, wherein at least one said lumens is fabricated from a material sufficient for delivery of an acidic dissolution fluid; and

a first vascular occlusion means;

(b) a manifold;

(c) an acidic dissolution fluid reservoir in fluid communication said first lumen;

(d) a buffer solution reservoir in fluid communication with said second lumen; and

(e) a source of negative pressure in fluid communication with said third lumen.

7. The system according to claim 6, wherein said system further includes a balloon inflation means.

8. The system according to claim 6, wherein said balloon inflation means is a syringe.

9. The system according to claim 6, wherein said system further comprises a guidewire.