Irradiation catheter and method of use

• US 5,540,659 A
• Filed: 08/30/1994
• Issued: 07/30/1996
• Est. Priority Date: 07/15/1993
• Status: Expired due to Term

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Dr. Paul Teirstein
• Inventors: Teirstein, Paul S.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): STRIGHT, RONALD K
• Application Number:
  US08/298,053
• Time in Patent Office: 700 Days
• Field of Search: 604/52-53, 604/96-105, 606/192, 606/194, 606/2, 606/7, 606/13, 606/14, 606/27, 606/32-34, 600/3, 600/7
• US Class Current: 604/104
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 25/0023 by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/0032 characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61N 2005/1003 having means for centering a radioactive source within the lumen, e.g. balloons
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy

Abstract

A catheter for use with a radioactive source within the catheter to irradiate a selected area of a blood vessel in combination with angioplasty procedures, to prevent restenosis of that area of the blood vessel. The catheter has a guidewire channel formed near its distal end to facilitate use of the catheter as a rapid exchange catheter, allowing insertion of the catheter over a guidewire also used in performance of an angioplasty procedure. The catheter can also have a guidewire channel formed near its proximal end to provide an O-ring sealing surface and to facilitate free guidewire movement. The catheter also has a closed end to retain the radioactive source within the catheter. The catheter can also be provided with a centering balloon or a set of centering wire loops to center the radioactive source radially within the blood vessel.

Claims

1. An irradiation catheter assembly for disposing a nuclear irradiation source at a selected position in a blood vessel, comprising:

a flexible tubular catheter body having an inner lumen;

an elongated irradiation ribbon disposed within said lumen;

at least one radioactive element mounted on said ribbon;

a guidewire channel formed on said catheter body; and

a guidewire disposed within said guidewire channel for guiding said catheter body to a selected site within the blood vessel.

2. An irradiation catheter assembly as claimed in claim 1, further comprising an expandable wire structure mounted on said catheter body, for radially positioning said radioactive element.

3. An irradiation catheter assembly as claimed in claim 2, wherein said expandable wire structure comprises:

a plurality of flexible wire loops, each of said wire loops having a first end attached to said catheter body;

flexing means attached to a second end of each of said wire loops, said flexing means being selectively movable by a user to move said second ends of said wire loops toward said first ends to flex said wire loops radially outwardly, thereby positioning said radioactive element as desired relative to the walls of the blood vessel.

4. An irradiation catheter assembly as claimed in claim 1, wherein a portion of said guidewire channel is formed near a distal end of said catheter body to enable use of said catheter body as a rapid exchange catheter, and further comprising a second guidewire channel portion formed near a proximal end of said catheter body to provide a sealing surface around the perimeter of said body for encircling said guidewire.

5. An irradiation catheter assembly as claimed in claim 1, further comprising:

at least one balloon mounted on said catheter body, said balloon being inflatable to radially extend at least one extremity of said balloon from said catheter body to position said radioactive element as desired relative to the walls of the blood vessel; and

an inflation lumen formed on said catheter body, said inflation lumen being connected in flow communication with said balloon for providing inflation pressure to said balloon.

6. An irradiation catheter assembly for disposing a nuclear irradiation source at a selected position in a blood vessel, comprising:

a flexible tubular catheter body having an inner lumen;

an elongated irradiation ribbon disposed within said lumen;

at least one radioactive element disposed near a distal end of said ribbon;

a guidewire channel formed adjacent a distal end of said catheter body;

a guidewire disposed within said guidewire channel for guiding said catheter body to a selected site within the blood vessel;

a closed distal end formed on said inner lumen to retain said radioactive element within said lumen; and

an expandable centering means mounted on said catheter body adjacent said radioactive element, for selectively centering said catheter body radially within the blood vessel.

7. An irradiation catheter assembly as claimed in claim 6, wherein said centering means comprises an expandable wire structure.

8. An irradiation catheter assembly as claimed in claim 7, wherein said expandable wire structure comprises:

a plurality of flexible wire loops, each of said wire loops having a first end attached to said catheter body;

flexing means attached to a second end of each of said wire loops, said flexing means being selectively movable by a user to move said second ends of said wire loops toward said first ends to flex said wire loops radially outwardly, thereby centering said body relative to the walls of the blood vessel.

9. An irradiation catheter assembly as claimed in claim 6, wherein said centering means comprises:

at least one balloon mounted on said catheter body, said balloon being selectively inflatable to radially extend at least one extremity of said balloon from said catheter body to radially center said catheter body relative to the walls of the blood vessel; and

an inflation lumen formed on said catheter body, said inflation lumen being connected in flow communication with said balloon for providing inflation pressure to said balloon.

10. A catheter for disposing a nuclear irradiation source at a selected position in a blood vessel over a guidewire, said catheter comprising:

a flexible tubular body having an inner lumen for receiving the irradiation source;

a guidewire channel formed on said body for receiving the guidewire;

a positioning means mounted on said body adjacent the intended position of the irradiation source, for positioning said body radially as desired within the blood vessel; and

a closed distal end formed on said inner lumen to retain the irradiation source within said lumen;

wherein said positioning means comprises;

at least one balloon mounted on said body, said balloon being inflatable to radially extend at least one extremity of said balloon from said body to position said body as desired relative to the walls of the blood vessel; and

an inflation lumen formed on said body, said inflation lumen being connected in flow communication with said balloon for providing inflation pressure to said balloon;

wherein said at least one balloon comprises an inflatable coil surrounding said body.

11. A catheter as claimed in claim 10, wherein said inflatable coil comprises a plurality of loops having a substantially constant diameter.

12. A catheter for disposing a nuclear irradiation source at a selected position in a blood vessel over a guidewire, said catheter comprising;

a flexible tubular body having an inner lumen for receiving the irradiation source;

a guidewire channel formed on said body for receiving the guidewire;

a positioning means mounted on said body adjacent the intended position of the irradiation source, for positioning said body radially as desired within the blood vessel; and

a closed distal end formed on said inner lumen to retain the irradiation source within said lumen;

wherein said positioning means comprises;

at least one balloon mounted on said body, said balloon being inflatable to radially extend at least one extremity of said balloon from said body to position said body as desired relative to the walls of the blood vessel; and

an inflation lumen formed on said body, said inflation lumen being connected in flow communication with said balloon for providing inflation pressure to said balloon;

wherein said at least one balloon comprises at least one substantially annular balloon surrounding said body.

13. A catheter as claimed in claim 12, further comprising a plurality of substantially annular balloons surrounding said body, said plurality of substantially annular balloons having extremities extending radially from said body by substantially equal distances.

14. A catheter as claimed in claim 13, wherein each of said substantially annular balloons comprises a plurality of lobes extending substantially equidistantly from said body.

15. A method for irradiating a stenotic segment of a blood vessel, said blood vessel having a guidewire disposed therein, said method comprising the steps of:

providing an irradiation catheter having a closed distal end and having a guidewire channel formed adjacent said distal end;

providing an irradiation ribbon having a radioactive source adjacent its distal end;

inserting a proximal end of said guidewire through said guidewire channel;

inserting said irradiation catheter into said blood vessel over said guidewire, until said distal end of said irradiation catheter is located within said stenotic segment;

inserting said irradiation ribbon into said irradiation catheter, until said radioactive source is located within said stenotic segment.

16. A method as claimed in claim 15, further comprising the step of selectively positioning said distal end of said irradiation catheter at a desired radial position relative to the wall of said blood vessel.

17. A method as claimed in claim 16, wherein said step of selectively positioning said distal end of said irradiation catheter comprises the steps of:

providing an expandable positioning means on said irradiation catheter, near said distal end of said catheter; and

selectively expanding said positioning means to radially position said irradiation catheter as desired.

18. A method as claimed in claim 17, wherein:

said expandable positioning means comprises a wire structure; and

said step of expanding said positioning means comprises the step of expanding said wire structure.

19. A method as claimed in claim 17, wherein:

said expandable positioning means comprises an inflatable structure; and

said step of expanding said positioning means comprises the step of inflating said inflatable structure.

20. A method as claimed in claim 16, wherein said step of selectively positioning said distal end of said irradiation catheter comprises the steps of:

introducing a bend into said guidewire near a distal end of said guidewire;

rotating said guidewire to orient said bend toward a direction of desired deflection of said irradiation catheter; and

partially withdrawing said guidewire from said guidewire channel while holding said irradiation catheter in place longitudinally, until said bend exerts sufficient force on said guidewire channel to cause said irradiation catheter to deflect in said desired direction by a desired amount.