Radiation delivery balloon catheter

• US 6,699,170 B1
• Filed: 10/16/2000
• Issued: 03/02/2004
• Est. Priority Date: 01/31/1997
• Status: Expired due to Fees

• Current Assignee: Endologix
• Original Assignee: Endologix
• Inventors: Kick, George F., Crocker, Michael, Siminuk, Mark A.
• Primary Examiner(s): Gilbert, Samuel G.
• Application Number:
  US09/688,396
• Time in Patent Office: 1,233 Days
• Field of Search: 600/1-9
• US Class Current: 600/3
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61N 2005/1004 having expandable radiation sources
• CPC Class Codes: A61N 2005/1005 with asymmetrical radiation pattern
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy

Abstract

Disclosed is a balloon catheter having an inflatable balloon having a radiation carrier such as a radiation delivery layer thereon. In one embodiment, the radiation delivery layer comprises one or more layers of metal foil, such as gold. The foil is irradiated, and the balloon is thereafter positioned at a treatment site in a vessel and expanded to bring the metal foil layer into close proximity with the vessel wall. In another embodiment, the radiation carrier is in the form of a dopant in the balloon material. Methods of using the balloon include radiation dosing a site following a balloon dilatation or other procedure, and simultaneously performing balloon angioplasty and radiation dosing.

Claims

1. A radiation delivery balloon catheter, comprising:

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

an inflatable balloon on the tubular body having a proximal end, a distal end and a working length therebetween, said balloon in fluid communication with an inflation lumen extending axially through the tubular body;

a substantially inelastic radiation source secured to the balloon; and

an outer tubular sleeve surrounding the radiation source, wherein the sleeve is necked down to the tubular body proximally and distally beyond the working length of the balloon.

2. A radiation delivery balloon catheter as in claim 1, wherein the radiation source is no more than about 0.001 inches thick.

3. A radiation delivery balloon catheter as in claim 1, wherein the radiation source is within the range of from about 0.0001 inch to about 0.009 inch thick.

4. A radiation delivery balloon catheter as in claim 1, further comprising a guide wire lumen extending axially throughout at least a portion of the catheter.

5. A radiation delivery balloon catheter as in claim 4, further comprising a proximal guide wire access port on the tubular body, positioned distally of the proximal end of the tubular body.

6. A radiation delivery balloon catheter as in claim 1, further comprising a perfusion conduit extending through the tubular body from a proximal side of the inflatable balloon to a distal side of the inflatable balloon, at least a first perfusion port on the tubular body on the proximal side of the balloon and at least a second perfusion port on the tubular body on the distal side of the balloon.

7. A radiation delivery balloon catheter as in claim 1, further comprising an implantable stent mounted on the balloon.

8. A radiation delivery balloon catheter as in claim 1, wherein the balloon comprises a central section having a larger inflated diameter than a proximal section and a distal section.

9. A radiation delivery balloon catheter as in claim 1, wherein the radiation delivery source comprises a metal.

10. A radiation delivery balloon catheter as in claim 1, wherein the radiation delivery source is selected from the group consisting of Pt, P-32, Y-90, Au-198, Ir-192, Mo-99, and combinations thereof.

11. A radiation delivery balloon catheter as in claim 1, wherein the radiation delivery source is doped into the material of the balloon.

12. A radiation delivery balloon catheter as in claim 1, wherein the radiation delivery source comprises a non metal.

13. A radiation delivery balloon catheter as in claim 1, wherein the radiation delivery source is tubular.

14. A radiation delivery balloon catheter as in claim 1, wherein the radiation delivery source is annular.

15. A radiation delivery balloon catheter as in claim 1, wherein the radiation delivery source has a proximal end, a distal end, and a length therebetween, and the source is continuous along the length.

16. A radiation delivery device, comprising:

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

a substantially inelastic radially expandable support member on the tubular body;

a radiation source carried by the support member; and

an outer tubular sleeve surrounding the radiation source, wherein the sleeve is necked down to the tubular body proximally and distally of the source, and wherein the support member is expanded by means non-removably attached thereto.

17. A radiation delivery device as in claim 16, wherein the support member is an inflatable balloon.

18. A radiation delivery device as in claim 17, wherein the balloon is provided with a central section having a larger inflated diameter than a proximal section and a distal section.

19. A radiation delivery device as in claim 16, further comprising a guide wire lumen extending axially throughout at least a portion of the device.

20. A radiation delivery device as in claim 19, further comprising a proximal guide wire access port on the tubular body, positioned distally of the proximal end of the tubular body.

21. A radiation delivery device as in claim 16, further comprising a perfusion conduit extending from a proximal side of the support member to a distal side of the support member.

22. A radiation delivery device as in claim 16, wherein the radiation source comprises a beta-emitting isotope.

23. A radiation delivery device as in claim 16, wherein the radiation source is annular.

24. A radiation delivery device as in claim 16, wherein the radiation source is tubular.

25. A radiation delivery device as in claim 16, wherein the radiation delivery source has a proximal end, a distal end, and a length therebetween, and the source is continuous along the length.

26. A radiation delivery device as in claim 16, wherein the radiation source is integral with the support.

27. A radiation delivery device as in claim 16, wherein the radiation source is layered upon the support.

28. A method of treating a site within a vessel, comprising the steps of:

identifying a site in a vessel to be treated;

providing a radiation delivery catheter including an elongate flexible tubular body having radiation source carried by a substantially inelastic radially expandable support and an outer sleeve surrounding the radiation source, wherein the outer sleeve is necked down to the tubular body proximally and distally of the radiation source, and wherein the support member is expanded by means non-removably attached thereto;

positioning the radiation source within the treatment site;

expanding the expandable support to position the radiation source against the vessel wall;

delivering a circumferentially substantially uniform dose of radiation from the radiation source to the vessel wall; and

thereafter contracting the expandable support and removing said support from the treatment site.

29. A method as in claim 28, wherein the expanding step comprises inflating an inflatable balloon.

30. A method as in claim 29, wherein the expanding step comprises expanding a central section of the balloon having a larger inflated diameter than a proximal section and a distal section of the balloon.

31. A method as in claim 28, further comprising the step of perfusing blood from a proximal side of the expandable support to a distal side of the expandable support.

32. A method as in claim 28, wherein the catheter further comprises a proximal guide wire access port on the tubular body, positioned distally of the proximal end of the tubular body.

33. A method as in claim 28, wherein the radiation source comprises a beta-emitting isotope.

34. A method as in claim 28, wherein the radiation source is annular.

35. A method as in claim 28, wherein the radiation source is tubular.

36. A method as in claim 28, wherein the radiation source has a proximal end, a distal end, and a length therebetween, and the source is continuous along the length.

37. A method as in claim 28, wherein the positioning step comprises positioning the source within a stent.

38. A method as in claim 28, wherein the radiation source is integral with the support.

39. A method as in claim 28, wherein the radiation source is layered upon the support.

40. A radiation delivery catheter, comprising:

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

a substantially inelastic radially expandable support on the tubular body, wherein the support is expanded by means non-removably attached thereto;

a radiation source carried by the support; and

a cover surrounding the radiation source extending from the body proximally of the source to the body distally of the source.

41. A radiation delivery catheter as in claim 40, wherein the support is an inflatable balloon.

42. A radiation delivery catheter as in claim 41, wherein the balloon is provided with a central section having a larger inflated diameter than a proximal section and a distal section.

43. A radiation delivery catheter as in claim 40, further comprising a guide wire lumen extending axially throughout at least a portion of the catheter.

44. A radiation delivery catheter as in claim 40, further comprising a proximal guide wire access port on the tubular body, positioned distally of the proximal end of the tubular body.

45. A radiation delivery catheter as in claim 40, further comprising a perfusion conduit extending from a proximal side of the support to a distal side of the support.

46. A radiation delivery catheter as in claim 40, wherein the radiation source comprises a beta-emitting isotope.

47. A radiation delivery catheter as in claim 40, wherein the radiation source is annular.

48. A radiation delivery device as in claim 40, wherein the radiation source is tubular.

49. A radiation delivery device as in claim 40, wherein the radiation source has a proximal end, a distal end, and a length therebetween, and the source is continuous along the length.

50. A radiation delivery device as in claim 40, wherein the radiation source is integral with the support.

51. A radiation delivery device as in claim 40, wherein the radiation source is layered upon the support.

52. A method of treating a site within a lumen, comprising the steps of:

identifying a site in a lumen to be treated;

providing a radiation delivery catheter including an elongate flexible tubular body having a radiation source carried by a substantially inelastic radially expandable support and a cover surrounding the radiation source extending from the body proximally of the source to the body distally of the source;

positioning the radiation source within the treatment site;

radially expanding the expandable support using means fixedly attached to the support to position the radiation source against the wall of the lumen;

delivering a circumferentially substantially uniform dose of radiation from the radiation source to the wall; and

radially contracting the expandable support and removing the catheter from the treatment site.

53. A method as in claim 52, wherein the expanding step comprises inflating an inflatable balloon.

54. A method as in claim 53, wherein the expanding step comprises expanding a central section of the balloon having a larger inflated diameter than a proximal section and a distal section of the balloon.

55. A method as in claim 52, further comprising the step of perfusing blood from a proximal side of the expandable support a distal side of the expandable support.

56. A method as in claim 52, wherein the catheter further comprises a proximal guide wire access port on the tubular body, positioned distally of the proximal end of the tubular body.

57. A method as in claim 52, wherein the radiation source comprises a beta-emitting isotope.

58. A method as in claim 52, wherein the radiation source is annular.

59. A method as in claim 52, wherein the radiation source is tubular.

60. A method as in claim 52, wherein the radiation source has a proximal end, a distal end, and a length therebetween, and the source is continuous along the length.

61. A method as in claim 52, wherein the radiation source is integral with the support.

62. A method as in claim 52, wherein the radiation source is layered upon the support.

63. A method as in claim 52, wherein the positioning step comprises positioning the radiation source within a stent.

64. A method as in claim 52, wherein the lumen is selected from the group consisting of large and small arteries, large and small veins, hollow organs, surgically created pathways, esophagus, trachea, urethra, ureters, fallopian tubes, intestines and colon.