Catheter having an expandable radioactive source

• US 5,879,282 A
• Filed: 01/21/1997
• Issued: 03/09/1999
• Est. Priority Date: 01/21/1997
• Status: Expired due to Term

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Cordis A Johnson and Johnson Company
• Inventors: Fischell, David R., Fischell, Robert E., Fischell, Tim A.
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US08/786,677
• Time in Patent Office: 777 Days
• Field of Search: 600/1-8
• US Class Current: 600/3
• CPC Class Codes: A61N 2005/1004 having expandable radiation sources
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy

Abstract

A balloon catheter for irradiation with or without dilatation of an arterial stenosis has an inflatable balloon and a generally cylindrical, thin-walled, elastic radioactive source both located coaxially at a distal section of the balloon catheter. The elastic radioactive source is moved radially outward as a result of injection of an inflation fluid into the inflatable balloon thus placing the radioactive source in close proximity to the wall of a vessel of the human body into which the balloon catheter has been inserted.

Claims

1. A balloon catheter system comprising a balloon catheter, an inflation liquid and a flexible guide wire, the balloon catheter having a distal section and also having an inflatable balloon and a generally cylindrical, thin-walled, elastic radioactive source both located coaxially at the distal section of the balloon catheter, the inflatable balloon being adapted to be inflated by injection into the balloon of the inflation liquid, the elastic radioactive source having a proximal end and a distal end and being adapted to move radially outward as a result of the injection of the inflation liquid into the inflatable balloon thus placing the radioactive source in close proximity to the wall of a vessel of the human body into which the balloon catheter has been inserted.

2. The balloon catheter system of claim 1 wherein the radioactive source is predominantly a beta particle emitter.

3. The balloon catheter system of claim 2 wherein the beta particle emitter is phosphorous-32.

4. The balloon catheter system of claim 2 wherein the beta particle emitter is yttrium-90.

5. The balloon catheter system of claim 1 wherein the inflatable balloon is an angioplasty balloon.

6. The balloon catheter system of claim 1 wherein the inflatable balloon is an elastic balloon.

7. The balloon catheter system of claim 1 wherein a first radiopaque marker band is used to indicate the proximal end of the elastic radioactive source and a second radiopaque marker band is used to indicate the distal end of the elastic radioactive source.

8. The balloon catheter system of claim 1 wherein the balloon catheter includes a guide wire lumen and the guide wire is an oxygenation guide wire that is adapted to perfuse tissue located distally to the inflatable balloon.

9. The balloon catheter system of claim 1 wherein the balloon catheter includes a guide wire lumen and the guide wire is placed through the guide wire lumen, the guide wire having a high density metal, highly radiopaque distal portion for indicating the longitudinal position of a dilated stenosis which is to be irradiated by the elastic radioactive source.

10. The balloon catheter system of claim 1 wherein the inflation liquid is a highly concentrated contrast medium having a concentration of at least 55% of an iodine based radiopaque liquid in normal saline solution.

11. The balloon catheter system of claim 10 wherein the inflation liquid includes a material having an atomic number greater than 53.

12. The balloon catheter system of claim 1 wherein the elastic radioactive source is made from silicone rubber into which a radioisotope has been placed.

13. The balloon catheter system of claim 12 wherein the radioisotope is a compound of phosphorous 32.

14. The balloon catheter system of claim 13 wherein the compound containing phosphorous 32 is adenosine triphosphate.

15. The balloon catheter system of claim 13 wherein the compound containing phosphorous 32 is orthophosphate.

16. The balloon catheter system of claim 1 wherein the balloon catheter has both an angioplasty balloon and an elastic balloon placed coaxially at the distal section of the balloon catheter.

17. The balloon catheter system of claim 16 wherein the elastic balloon is positionally located inside the angioplasty balloon.

18. The balloon catheter system of claim 16 wherein the elastic balloon is positionally located outside the angioplasty balloon.

19. The balloon catheter system of claim 16 wherein the elastic radioactive source is fixedly attached to the elastic balloon.

20. The balloon catheter system of claim 1 wherein the inflatable balloon of the balloon catheter is an angioplasty balloon and the elastic radioactive source is in the form of a cylinder that surrounds the angioplasty balloon.

21. The balloon catheter system of claim 20 wherein the elastic radioactive source is tapered at both its proximal end and its distal end.

22. A balloon angioplasty catheter having a distal section;

an angioplasty balloon formed from a plastic material located at the distal section of the balloon angioplasty catheter, the angioplasty balloon having a radioactive material incorporated into the plastic material from which the angioplasty balloon is formed.

23. The balloon angioplasty catheter of claim 22 wherein the radioactive source is predominantly a beta particle emitter.

24. The balloon angioplasty catheter of claim 22 wherein the beta particle emitter is phosphorous-32.

25. An elastic balloon catheter having a distal section;

an elastic balloon formed from an elastomer located at the distal section of the elastic balloon catheter and a radioactive material incorporated into the elastomer from which the elastic balloon is formed.

26. The elastic balloon catheter of claim 25 wherein the radioactive material is predominantly a beta particle emitter.

27. The elastic balloon catheter of claim 25 wherein the beta particle emitter is phosphous-32.

28. The elastic balloon catheter of claim 25 wherein the beta particle emitter is yttrium-90.

29. A system for dilating and irradiating an arterial stenosis the system comprising:

a balloon angioplasty catheter having a distal section and having an angioplasty balloon located at the distal section of the balloon angioplasty catheter; and

a sheath situated coaxially around the balloon angioplasty catheter and adapted to move slideably over the balloon angioplasty catheter, the sheath having a distal section where a radioactive source in the form of an elastic cylinder is located.

30. A system for irradiating a dilated arterial stenosis without unduly irradiating health care workers, the system being adapted for placement into an artery of a human body;

the system comprising;

a balloon catheter having a proximal section and a distal section and having an inflatable balloon and an expandable radioactive source both located at the distal section of the balloon catheter; and

a radiation shield being coaxially situated at the proximal section of the balloon catheter, the entire radiation shield remaining exterior to the human body while the balloon catheter is advanced through the radiation shield and into a vessel of the human body so as to place the radioactive source at the site of the dilated arterial stenosis.