Radiation delivery catheter

• US 6,048,299 A
• Filed: 11/07/1997
• Issued: 04/11/2000
• Est. Priority Date: 11/07/1997
• Status: Expired due to Term

• Current Assignee: Endologix
• Original Assignee: Radiance Medical Systems, Inc.
• Inventors: Hoffmann, Gerard von
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US08/965,900
• Time in Patent Office: 886 Days
• Field of Search: 600/1-8, 604/19, 604/280, 604/281, 604/282
• 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

Disclosed is a delivery catheter adapted for delivery of a dose of radiation to a vessel wall. A radiation source is enlargeable from a first, reduced cross-sectional profile to a second, enlarged cross-sectional profile by unwinding around a central core. Following delivery of a radiation dose to the vessel wall, the source is reduced in profile by wrapping around the core and removed from the treatment site.

Claims

1. A radiation delivery catheter for temporarily placing a radioactive source adjacent a vessel wall, comprising:

an elongate, flexible tubular body, having a proximal end and a distal end;

an axially moveable core, having proximal and distal ends, extending through the tubular body; and

at least one radioactive source in the form of a flexible radioactive sheet on the distal end of the core;

wherein the radioactive sheet is moveable between a first position within the tubular body and a second position outside of the tubular body.

2. A catheter as in claim 1, wherein the radioactive sheet is rolled into a tube having a reduced diameter when in the first position, and the tube self expands by at least partially unrolling into a larger diameter adjacent the vessel wall when the sheet is in the second position.

3. A catheter as in claim 1, wherein the core further comprises a guidewire lumen extending therethrough.

4. A catheter as in claim 1, further comprising a guidewire lumen extending along at least a distal portion of the tubular body.

5. A catheter as in claim 1, further comprising an axially extending slot in the tubular body at the distal end thereof, for receiving the radioactive sheet.

6. A radiation delivery catheter as in claim 1, wherein the radioactive source has a thickness of no more than about 0.001 inches.

7. A radiation delivery catheter as in claim 1, wherein the radioactive source has a thickness of no more than about 0.0005 inches.

8. A radiation delivery catheter as in claim 1, wherein the radiation source comprises a beta emitter.

9. A radiation delivery catheter, comprising:

a first elongate element, having a proximal end and a distal end;

a second elongate element moveable with respect to the first element; and

a radiation source attached to the second element, said radiation source having first and second ends;

wherein rotation of the first end of the radiation source with respect to the second end causes the source to change from a reduced cross-sectional area to an enlarged cross-sectional area.

10. A radiation deliver catheter as in claim 9, wherein the radiation source comprises a flexible metal sheet.

11. A radiation delivery catheter as in claim 10, wherein the sheet is rolled into a first, reduced diameter tubular configuration for positioning at a treatment site in a vessel, and biased toward a second, larger diameter tubular configuration for expanding against the wall of the vessel.

12. A radiation delivery catheter as in claim 9, wherein the radiation source self expands from a reduced cross sectional profile to a larger cross sectional profile in response to axial movement of the second element with respect to the first element.

13. A radiation delivery catheter as in claim 9, wherein the radiation source is reducible from a relatively larger cross sectional area to a relatively smaller cross sectional area in response to rotation of the second element with respect to the first element.

14. A radiation delivery catheter as in claim 9, wherein the radiation source comprises a plurality of circumferentially extending elements.

15. A radiation delivery catheter, comprising:

an elongate, flexible tubular body, having a proximal end and a distal end; and

a self expandable circumferentially rolled radiation delivery source on the distal end of the delivery catheter.

16. A method of delivering a dose of radiation to a site in a vessel, comprising the steps of:

providing a radiation delivery catheter having a self expandable radiation source on a distal end thereof,

positioning the radiation source at the site; and

permitting the radiation source to self expand at the site;

radially reducing the radiation source, and withdrawing the radiation source from the site;

wherein the permitting the radiation source to expand step comprises permitting at least one rolled flexible metal element to partially unroll from a reduced cross sectional area for positioning at the site to an enlarged cross sectional area for treating the site.

17. A method as in claim 16, wherein the radially reducing step comprises rolling the radiation source around a rotatable core wire.

18. A method of delivering a dose of radiation to a site in a vessel as in claim 16, wherein the positioning the radiation source step is accomplished following dilatation of the vessel wall at the site.

19. A method of delivering a dose of radiation to a site in a vessel as in claim 16, wherein the positioning the radiation source comprises positioning the source within a previously implanted stent.

20. A method of delivering a dose of radiation to a site in a vessel as in claim 16, wherein said permitting the radiation source to self-expand comprises permitting a plurality of adjacent elements to self-expand from a reduced profile rolled configuration to an enlarged tubular configuration to conform to the vessel wall throughout the axial length of the radiation source.

21. A method of delivering a dose of radiation to a site as in claim 16, further comprising the step of permitting the radiation source to deliver a dose of radiation to the vessel wall while in contact with the vessel wall prior to said radially reducing step.

22. A method as in claim 16, further comprising the step of permitting perfusion through the radiation source during a treatment period when the radiation source is in the enlarged cross sectional area configuration.

23. A method of delivering a dose of radiation to a site in a vessel, comprising the steps of:

providing a radiation delivery catheter having a thin sheet radiation source on a distal end thereof,

positioning the radiation source at the site;

expanding the radiation source at the site;

radially reducing the radiation source, and withdrawing the radiation source from the site;

wherein the expanding the radiation source step comprises at least partially unrolling at least one rolled flexible sheet from a reduced cross sectional area for positioning at the site to an enlarged cross sectional area for treating the site.

24. A method as in claim 23, wherein the radially reducing step comprises rolling the radiation source around a rotatable core wire.

25. A method of delivering a dose of radiation to a site in a vessel as in claim 23, wherein the positioning the radiation source step is accomplished following dilatation of the vessel wall at the site.

26. A method of delivering a dose of radiation to a site in a vessel as in claim 23, wherein the positioning the radiation source comprises positioning the source within a previously implanted stent.

27. A method of delivering a dose of radiation to a site in a vessel as in claim 23, wherein said expanding step comprises permitting a plurality of adjacent elements to self-expand from a reduced profile rolled configuration to an enlarged tubular configuration to conform to the vessel wall throughout the axial length of the radiation source.

28. A method as in claim 23, further comprising the step of permitting perfusion through the radiation source during a treatment period when the radiation source is in the enlarged cross sectional area configuration.

29. A method of delivering radiation to a site in a vessel, comprising the steps of:

providing a radiation delivery source in the form of a thin sheet having a radioactive isotope thereon;

positioning the radiation delivery source at the site; and

expanding the radiation delivery source at the site to bring the sheet into contact with the vessel wall;

wherein the expanding the radiation delivery source step comprises at least partially unrolling the sheet from a tubular roll having a reduced cross sectional area for positioning at the site to an enlarged cross sectional area for treating the site.

30. A method of delivering radiation to a site in a vessel as in claim 29, wherein said isotope is a beta emitter.

31. A method of delivering radiation to a site as in claim 29, wherein the thin sheet has a thickness of no more than about 0.001 inches.

32. A method of delivering radiation to a site as in claim 29, wherein the sheet has a thickness of no more than about 0.0005 inches.

33. A method of delivering radiation to a site as in claim 29, wherein said positioning step is accomplished following dilatation of the vessel at the site.

34. A method of delivering radiation to a site as in claim 29, wherein the positioning step comprises positioning the radiation delivery source within a previously implanted stent.