Drug treatment of diseased sites deep within the body

• US 5,588,962 A
• Filed: 03/29/1994
• Issued: 12/31/1996
• Est. Priority Date: 03/29/1994
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Corporation
• Inventors: Barry, James J., Sahatjian, Ronald A., Nicholas, Peter M.
• Primary Examiner(s): McDermott, Corrine M.
• Assistant Examiner(s): SMITH, CHALIN A
• Application Number:
  US08/219,108
• Time in Patent Office: 1,008 Days
• Field of Search: 604/20, 604/53, 604/96, 604/99, 604/265-266, 604/890.1, 604/892.1, 604/52, 604/21, 604/22, 606/192, 606/194, 128/898, 424/443, 424/445, 424/423-426
• US Class Current: 604/507
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04

Abstract

A diseased site, such as vascular dilatation site, is treated by first locally delivering to the site an agent that is effective to localize a desired drug and then systematically administering the drug.

Claims

1. A method for treating a diseased site in a vascular lumen deep within the body of a patient, comprising:

(a) providing a drug-localizing agent for a drug that is effective to treat said diseased site,

(b) providing a medical device capable of being placed into said vascular lumen at said diseased site and capable of delivering said localizing agent locally at said site,

(c) preparing said medical device for delivering said agent at said site,

(d) placing said medical device at said site,

(e) locally delivering said agent to said site in a manner that said agent is retained at said site,

(f) removing said medical device from said vascular lumen,

(g) providing said drug effective to treat said diseased site in a form suitable for systemic administration, and

(h) systematically administering said drug so that said drug is transported through the body of said patient and localized at said diseased site by the presence of said drug-localizing agent retained at said site.

2. The method of claim 1 wherein said agent includes an adhesive polymer that adheres to said site, said polymer incorporating a specie that forms a complex with said drug.

3. The method of claim 1 comprising:

delivering said agent to said site under pressure.

4. The method of claim 1 comprising:

delivering said agent to said site with the aid of heat.

5. The method of claim 1, comprising:

monitoring said patient for symptoms of restenosis after removing the medical device from the vascular lumen, and

providing and administering said drug after observation of said symptoms.

6. The method of claim 1 comprising:

locally delivering a sufficient amount of said agent to localize an effective amount of said drug from multiple sequential systemic administrations, and

systematically administering a sufficient quantity of said drug to effectively treat said site in a sequential fashion as needed.

7. The method of claim 1 comprising:

after systemically delivering a desired drug, delivering additional drug-localizing agent locally to said diseased site and, thereafter

systemically delivering additional desired drug.

8. The method of claim 1 comprising:

delivering a mixture of drug-localizing agents effective to concentrate different drugs and

systemically administering said drugs as desired.

9. The method of claim 1 wherein said medical device is a dilatation catheter having an expandable portion.

10. The method of claim 1 comprising:

providing a medical device in the form of a dilation catheter having an expandable portion,

expanding said expandable portion to dilate said diseased site, and

delivering said agent simultaneously with the dilation of said diseased site.

11. The method of claim 10 comprising:

locally administering the same drug that is to be administered systemically.

12. The method of any one of claims 1, 10, or 11 wherein said expandable portion includes a polymer capable of releasing said agent.

13. The method of claim 12 when said polymer is a compressible hydrogel capable of releasing said agent when compressed.

14. The method of claim 12 wherein said expandable portion includes openings or pores or channels through which said agent may pass to deliver said agent to said site.

15. The method of claim 1 said drug forms a chemical complex with said drug-localizing agent.

16. The method of claim 15 wherein said drug is an anionic species and said agent is a cationic species in the body lumen environment of said site.

17. The method of claim 15 wherein said agent is cimetidine and said drug is lidocaine.

18. The method of claim 15 wherein said drug is heparin.

19. The method of claim 18 wherein said agent is an ammonium cation.

20. The method of claim 19 wherein said agent is benzalkonium cation.

21. A method for treating a diseased site in a vascular lumen deep within the body of a patient, comprising:

(a) providing a drug-localizing agent for a drug that is effective to treat said diseased site,

(b) providing a medical device capable of being placed into said vascular lumen at said diseased site and capable of delivering said localizing agent locally at said site,

(c) preparing said medical device for delivering said agent at said site,

(d) placing said medical device at said site,

(e) locally delivering said agent to said site in a manner that said agent is retained at said site,

(f) removing said medical device from said vascular lumen,

(g) monitoring said patient for symptoms of restenosis after removing the medical device from the vascular lumen, and

(h) systemically administering said drug to said patient having symptoms of restenosis.

22. A method for treating a diseased site deep within the body, comprising:

locally delivering to said diseased site a drug-localizing agent using a medical device capable of carrying said agent to and releasing said agent at said site in a manner that the agent is retained at the site,

removing the medical device from the body, and

systemically delivering drug, said drug being localized at said site by the presence of said localizing agent.

23. A kit for delivering a drug-localizing agent to a diseased site in a vascular lumen deep within the body of a patient, comprising:

a drug-localizing agent, in a form suitable for local administration that is retained at said site and is effective for localizing a systemically-administered drug to said site, said agent lacking said drug in a form suitable for local administration, and

a medical catheter device sized and constructed for placement into said vascular lumen at said diseased site and for delivering said localizing agent locally at said site in a manner that said agent is retained at said site.

25. The method of claim 23 or 24 wherein said medical device is a dilation catheter having an expandable portion.

26. The method of claim 25 wherein said expandable portion includes a polymer membrane capable of releasing said agent.

27. The method of claim 26 when said polymer is a compressible hydrogel capable of releasing said agent when compressed.

24. A kit for treating a diseased site in a vascular lumen deep within the body of a patient, comprising:

a drug-localizing agent in a form suitable for local administration that is retained at said site and is effective for localizing a systemically-administered drug, said agent lacking said drug in a form suitable for local administration,

a drug, in a form suitable for systemic administration, that is effective to treat said diseased site and is localized at said site by prior administration of said localizing agent, and

a medical catheter device sized and constructed for placement into said vascular lumen at said diseased site and for delivering said localizing agent locally at said site in a manner that said agent is retained at said site.