Kits for use in the treatment of vascular calcified lesions

• US 6,562,020 B1
• Filed: 01/14/2000
• Issued: 05/13/2003
• 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., Johansson, Peter
• Primary Examiner(s): Casler, Brian L.
• Assistant Examiner(s): Thissell, Jeremy
• Application Number:
  US09/483,634
• Time in Patent Office: 1,215 Days
• Field of Search: 604/523, 604/93.01, 604/27, 604/43, 604/48, 604/264, 604/171
• US Class Current: 604/523
• 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: 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 2025/1052 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

Kits for use in the treatment of vascular calcified lesions are provided. The subject kits include at least one of: (a) a fluid delivery means for conveying fluid to and from a vascular site; and (b) a dissolution fluid for at least partially dissolving the target lesion. In many embodiments, the kits include both of these components. The subject kits further include instructions for treating vascular calcified lesions with the contents of the kit, where the instructions are typically recorded on a recording medium, e.g. printed on a substrate, such as paper.

Claims

1. A kit for use in the treatment of vascular calcified lesions, said kit comprising:

(a) at least one of;

(i) an acidic dissolution fluid having a pH of less than about 3.0 or a component(s) thereof; and

(ii) a localized fluid delivery means capable of conveying fluid to a vascular site; and

(b) a recording medium having recorded thereon instructions for using said fluid delivery means and acidic dissolution fluid to treat a vascular calcified lesion.

2. The kit according to claim 1, wherein said fluid delivery means is capable of flushing said vascular site with said dissolution fluid.

3. The kit according to claim 1, wherein said fluid delivery means comprises at least one catheter.

4. The kit according to claim 2, wherein said fluid delivery means comprises at least two catheters capable of assuming a coaxial configuration.

5. The kit according to claim 1, wherein said acidic dissolution fluid is a hydrochloric acid solution.

6. The kit according to claim 1, wherein said kit comprises both of said fluid delivery means and said dissolution fluid or components thereof.

7. The kit according to claim 1, wherein said instructions are printed onto a substrate.

8. The kit according to claim 1, wherein said kit further comprises a buffer solution or a component(s) thereof.

9. A kit for use in the treatment of vascular calcified lesions, said kit comprising:

(a) an acidic dissolution fluid having a pH of less than about 3.0;

(b) a catheter fluid delivery system capable of localized flushing a vascular site with said dissolution fluid; and

(c) instructions for using said fluid delivery means and dissolution fluid to treat a vascular calcified lesion, wherein said instructions are printed onto a substrate.

10. The kit according to claim 9, wherein said catheter fluid delivery system comprises at least two catheters capable of assuming a coaxial configuration.

11. The kit according to claim 9, wherein said catheter fluid delivery system comprises at least three catheters, at least two of which are capable of assuming a coaxial configuration.

12. The kit according to claim 9, wherein said acidic dissolution fluid is a hydrochloric acid solution.

13. The kit according to claim 12, wherein said hydrochloric acid solution comprises a salt.

14. The kit according to claim 13, wherein said salt is NaCl.

15. The kit according to claim 9, wherein said kit further comprises a guidewire.

16. The kit according to claim 9, wherein said kit further comprises a buffer solution.

17. A kit for use in the treatment of vascular calcified lesions, said kit comprising:

(a) a hydrochloric acid dissolution solution having a pH ranging of less than about 3.0; and

(b) a catheter fluid delivery system capable of localized flushing a vascular site with said hydrochloric acid dissolution solution, wherein said catheter fluid delivery system comprises at least two catheters capable of assuming a coaxial configuration.

18. The kit according to claim 17, wherein said kit further comprises instructions for using said fluid delivery means and dissolution fluid to treat a vascular calcified lesion, wherein said instructions are printed onto a substrate.

19. The kit according to claim 17, wherein said catheter fluid delivery system comprises at least three catheters, two of which are capable of assuming a coaxial configuration.

20. The kit according to claim 17, wherein said hydrochloric acid solution comprises a salt.

21. The kit according to claim 20, wherein said salt is NaCl.

22. The kit according to claim 17, wherein said kit further comprises a guidewire.

23. The kit according to claim 17, wherein said kit further comprises a buffer solution.