Delivery catheter for a radioisotope stent

• US 6,146,323 A
• Filed: 05/14/1999
• Issued: 11/14/2000
• Est. Priority Date: 05/14/1999
• Status: Expired due to Fees

• Current Assignee: Isostent, Inc. (Cardinal Health, Inc.)
• Original Assignee: Isostent, Inc. (Cardinal Health, Inc.)
• Inventors: Fischell, Robert E.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US09/311,876
• Time in Patent Office: 550 Days
• Field of Search: 600/1-8
• US Class Current: 600/3
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0095 radioactive
• CPC Class Codes: A61N 2005/1004 having expandable radiation sources
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy

Abstract

Disclosed is a stent delivery catheter system for placing a radioactive stent within a blockage in a vessel of a human body. The stent delivery catheter system consists of a radioactive stent that is placed onto an angioplasty balloon that is located at the distal portion of a stent delivery catheter. Just proximal and just distal to the stent there is a proximal radioactive band and a distal radioactive band, respectively, each of which are generally thin walled and cylindrical. The radioactive stent located on the balloon at the distal portion of the stent delivery catheter is advanced over a flexible guide wire until the non-deployed radioactive stent is placed at the site of a vessel blockage such as an arterial stenosis. The balloon is inflated and the radioactive stent and the distal and proximal radioactive bands are pushed radially outward in apposition to the wall of the artery, resulting in dilatation of the stenosis. The balloon remains expanded for several minutes, which maintains the proximal radioactive band and the distal radioactive band against the artery wall at positions that are just proximal and just distal to the edges of the stent. By this means, the regions of the vessel wall that are just proximal and just distal to the edges of the stent experience a sufficient dose of radiation so that the cells in that region become incapable of producing growth factor.

Claims

1. A stent delivery catheter system for placing a radioactive stent within a stenosis of a vessel in a human body, the system comprising:

a flexible guide wire;

a stent delivery catheter;

the stent delivery catheter having a distal portion;

the stent delivery catheter having an angioplasty balloon adapted for inflation by injectable inflation fluid, the balloon being located at the distal portion of the stent delivery catheter and having a proximal and a distal end;

the stent delivery catheter having a radioactive stent mounted co-axially around the angioplasty balloon;

the radioactive stent having a proximal end and a distal end;

the stent delivery catheter also having a proximal radioactive band and a distal radioactive band;

the proximal and distal radioactive bands being generally thin walled and cylindrical;

the proximal radioactive band having a distal end located in proximity to the proximal end of the radioactive stent;

the distal radioactive band having a proximal end located in proximity to the distal end of the radioactive stent;

the proximal and distal radioactive bands adapted to be moved in apposition to the vessel wall.

2. The system of claim 1 wherein the proximal and distal radioactive bands include a beta particle emitting radioisotope.

3. The system of claim 2 wherein the beta particle emitting isotope is phosphorous-32.

4. The system of claim 2 wherein the beta particle emitting isotope is yttrium-90.

5. The system of claim 1 wherein the proximal and distal radioactive bands include a gamma ray emitting radioisotope.

6. The system of claim 1 wherein the proximal and distal radioactive bands include an x-ray emitting radioisotope.

7. The system of claim 1 wherein the proximal and distal radioactive bands each have a radioactive activity level that lies between 1 and 100 milliCuries.

8. The system of claim 1 wherein the balloon angioplasty catheter has an inner shaft for the passage of the flexible guide wire;

and located in the distal portion of the balloon angioplasty catheter a radiopaque marker band is located co-axially over the inner shaft and co-axially under the radioactive stent and is centered between the proximal and distal ends of the radioactive stent.

9. The system of claim 1 wherein the proximal and distal radioactive bands are radiopaque.

10. The system of claim 1 wherein the proximal radioactive band is adhesively joined to the proximal section of the angioplasty balloon along a narrow longitudinal line and the distal radioactive band is adhesively joined to the distal section of the angioplasty balloon along a narrow longitudinal line.

11. The system of claim 1 wherein the stent delivery catheter includes a guide wire lumen and an oxygenation guide wire is placed through the guide wire lumen to perfuse the tissue located distally to the angioplasty balloon.