System for administering a combination of therapies to a body lumen

• US 6,918,869 B2
• Filed: 12/02/2002
• Issued: 07/19/2005
• Est. Priority Date: 12/02/2002
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Shaw, William J., Palasis, Maria, Barry, James, Goll, Paul J.
• Primary Examiner(s): Hindenburg, Max F.
• Assistant Examiner(s): Veniaminov, Nikita R.
• Application Number:
  US10/307,917
• Publication Number:
  US 20040106841A1
• Time in Patent Office: 960 Days
• Field of Search: 600 2- 4, 600/8, 600/7, 600/685, 600/20, 623/1.13, 623/1.39, 623/1.42, 623/1.49, 623/901, 623/1.28, 623/1, 623/12, 623/1.16, 623/1.43, 606/194, 606/192, 606/195, 606/198, 606/20, 427/2.3, 427/2.28, 427/393.5, 427/430.1, 427/493, 427/5, 604/265, 604/103.02, 604/913, 604/508, 604/101.02, 604/103.05, 604/96.01, 604/103.11, 604/103.12, 604/500, 295/92, 376/158, 376/195, 376/201
• US Class Current: 600/3
• CPC Class Codes: A61B 2017/22051 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation A61B2017/22048, A61B2017/3486 take precedence
• CPC Class Codes: A61B 2018/0022 Balloons
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/0262 using a circulating cryogenic fluid
• CPC Class Codes: A61B 2018/046 in liquid form
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61K 9/0024 Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue compositions for intravenous administration, normal injectable solutions or dispersions for, e.g. subcutaneous administration A61K9/0019; brain implants A61K9/0085; (coated) prostheses, catheters or stents A61L
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy

Abstract

The invention provides a system which comprises a medical device that delivers a combination of therapies. These therapies include the administration of radiation, biologically active materials, cryotherapy, and thermotherapy. The present invention is also directed to a method of treating body lumen surfaces using the system of the invention. A system is provided for delivering a biologically active material to a surface of a body lumen being exposed to a radioactive source. In one aspect, the system comprises an implantable medical device which has two opposing ends, each having a surface, and a middle portion. The two opposing ends comprise a biologically active material and the middle portion of the medical device is substantially free of any biologically active material. In another aspect, the system delivers a genetic material to a surface of a body lumen which is exposed to a radioactive source. Another system is provided for treating a surface of a body lumen in which the system comprises an implantable medical device which comprises a biologically active material and a device for applying a therapy source to the parts of the body lumen surface that are in contact with the opposing ends of the medical device. The therapy source may be a cryotherapy source or a thermotherapy source.

Claims

1. A system for delivering a biologically active material to a surface of a body lumen exposed to a radioactive source comprising:

(a) an implantable medical device having two opposing ends, a middle portion and a surface; and

(b) at least one biologically active material applied to the ends of the medical device,

wherein the middle portion is substantially free of any biologically active material; and

wherein the biologically active material comprises a non-genetic therapeutic agent, a genetic material, a cell or a charged therapeutic agent, and is in a particulate form having an average particle size of about 1 to about 100 microns.

4. The system of claim 1 further comprising a radioactive source for delivering radiation to the surface of the body lumen.

2. A system for delivering a biologically active material to a surface of a body lumen exposed to a radioactive source comprising:

(a) an implantable medical device having two opposing ends, a middle portion and a surface;

(b) a biologically active material incorporated into a first coating composition; and

(c) a second coating composition comprising a second biologically active material, wherein the first and the second coating composition are disposed upon at least one end of the medical device; and

the middle portion is substantially free of a biologically active material.

3. The system of claim 2 further comprising a radioactive source for delivering radiation to the surface of the body lumen.

5. A system for delivering a biologically active material to a surface of a body lumen exposed to a radioactive source comprising:

(a) an implantable medical device having two opposing ends, a middle portion and a surface;

wherein the medical device comprises a catheter, a guide wire, a balloon, a filter, a stent, a stent graft, or a vascular graft; and

(b) at least one biologically active material applied to the ends of the medical device;

wherein the biologically active material is released upon application of the radioactive source, and wherein the middle portion is substantially free of any biologically active material.

6. The system of claim 5 wherein the device is a stent.

7. The system of claim 6 wherein the stent comprises a radioactive material.

8. The system of claim 5 further comprising a catheter for applying the radioactive source.

9. The system of claim 5 wherein the biologically active material is incorporated into a first coating composition and wherein the first coating composition is applied to at least one end of the medical device.

10. The system of claim 5 wherein the biologically active material comprises a non-genetic therapeutic agent, a genetic material, a cell or a charged therapeutic agent.

11. The system of claim 10 wherein the biologically active material comprises a glucocorticoid, heparin, hirudin, angiopeptin, aspirin, an ACE inhibitor, a growth factor, an oligonucleotide, an antiplatelet agent, an anti-hypertensive, an anti-coagulant agent, an antimitotic agent, an antioxidant, an antimetabolite agent, an anti-inflammatory agent or an antibiotic.

12. The system of claim 10 wherein the biologically active material comprises paclitaxel.

13. The system of claim 5 wherein the lengths of the two opposing ends of the medical device are each about 1-25% of the full length of the medical device.

14. The system of claim 13 wherein the lengths of the two opposing ends of the medical device are each about 5-15% of the full length of the medical device.

15. The system of claim 5 further comprising a radioactive source for delivering radiation to the surface of the body lumen.