Intravascular radiation therapy device and method of use

• US 6,338,709 B1
• Filed: 02/19/1998
• Issued: 01/15/2002
• Est. Priority Date: 02/19/1998
• Status: Expired due to Fees

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: Medtronic PercuSurge, Inc. (Medtronic Plc)
• Inventors: Omaleki, Samuel L., Geoffrion, Richard P., Zadno-Azizi, Gholam Reza
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US09/026,103
• Time in Patent Office: 1,426 Days
• Field of Search: 600/1-8
• US Class Current: 600/3
• CPC Class Codes: A61N 2005/1003 having means for centering a radioactive source within the lumen, e.g. balloons
• CPC Class Codes: A61N 2005/1005 with asymmetrical radiation pattern
• CPC Class Codes: A61N 2005/1021 Radioactive fluid
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy

Abstract

A radiation delivering catheter is positioned away from the walls of the vessel to be treated, e.g. at a stenosis site, so that the radiation flux impacting the walls is more uniform. In one embodiment, one or more balloons are used, and in another, one or more expandable structures. In other embodiments, a radiation source residing within a balloon is shielded from the vessel walls when the balloon is not inflated, but exposes the vessel walls to radiation when the balloon is inflated.

Claims

1. A device for treating a segment of a vessel in a patient, comprising:

a catheter for delivering radiation;

an elongate inner guidewire sized to fit within said radiation catheter, said radiation catheter sliding on said inner guidewire such that said inner guidewire guides said radiation catheter to said segment of the vessel;

at least one expandable structure at a distal end portion of said inner guidewire, said inner guidewire and said expandable structure configured such that said expandable structure can be positioned distal to said segment; and

a radioactive source for treating the vascular segment, said radioactive source at a distal end portion of said radiation catheter,

wherein said expandable structure supports both said distal end portion of said inner guidewire and said distal end portion of said radiation catheter to generally center said distal end portion of said radiation catheter within the vessel.

2. The device of claim 1, in which said at least one expandable structure is one expandable structure.

3. The device of claim 1, wherein said guidewire is hollow.

9. The device of claim 1, wherein said guidewire comprises Nitinol.

10. The device of claim 1, wherein said expandable structure comprises a balloon.

11. The device of claim 10, wherein said balloon is inflated with fluid that passes through said inner guidewire.

12. The device of claim 10, wherein said balloon is compliant.

13. The device of claim 1, further comprising a sheath for shielding the vessel from radiation when said segment is not being treated.

4. A method of treating a segment in a vessel, comprising:

inserting an elongate inner member into the vessel;

expanding at least one expandable structure at a distal end portion of the inner member to support the distal end portion of the inner member in the vessel, such that the expanded structure is in contact with the vessel but distal to the segment to be treated;

providing a catheter having radiation material;

guiding the catheter over the inner member so that the radiation material is within said segment of the vessel; and

treating the vascular segment by exposing it to radiation.

5. The method of claim 4, further comprising:

contracting the expandable structure after treatment; and

removing the expandable structure and the catheter from the vessel.

14. The method of claim 4, said treating the vascular segment comprising retracting a sheath to expose said segment to radiation.

15. The method of claim 4, comprising positioning the expandable structure distal to and within about 4 cm of said segment during treatment.

16. The method of claim 4, wherein the expandable structure comprises a balloon.

17. The method of claim 16, said expanding comprising inflating the balloon with fluid.

18. The method of claim 4, wherein the inner member comprises a guidewire.

19. The method of claim 18, wherein the guidewire is hollow.

20. The method of claim 18, wherein the guidewire comprises Nitinol.

6. A radiation device for treating a segment of a vessel in a patient, comprising:

a catheter;

a guidewire within said catheter for directing said catheter through the vessel, said guidewire comprising a centering device for generally centering said guidewire within the vessel; and

a radioactive source fastened directly onto said catheter.

7. The device of claim 6, further comprising a retractable shield that surrounds said radioactive source when the vascular segment is not being treated.

8. The device of claim 6, in which said radioactive source is bonded onto said catheter.

21. A device for treating a segment of a vessel in a patient, comprising:

a non-inflatable catheter for delivering radiation;

an elongate inner member sized to fit within said radiation catheter, said radiation catheter sliding on said inner member such that said inner member guides said radiation catheter to said segment of the vessel;

at least one expandable structure at a distal end portion of said inner member for securing said inner member within the vessel; and

a radioactive source for treating the vascular segment, said radioactive source at a distal end portion of said radiation catheter,

wherein said expandable structure supports said distal end portion of said inner member to generally center said distal end portion of said radiation catheter within the vessel.

26. The device of claim 21, wherein said elongate member is hollow.

27. The device of claim 21, wherein said elongate member comprises Nitinol.

28. The device of claim 21, wherein said expandable structure comprises a balloon.

29. The device of claim 28, wherein said balloon is inflated with fluid that passes through said elongate member.

30. The device of claim 28, wherein said balloon is compliant.

31. The device of claim 21, further comprising a sheath for shielding the vessel from radiation when said segment is not being treated.

22. A device for treating a segment of a vessel in a patient, comprising:

a catheter for delivering radiation;

an elongate inner member sized to fit within said radiation catheter, said radiation catheter sliding on said inner member such that said inner member guides said radiation catheter to said segment of the vessel;

at least one expandable structure at a distal end portion of said inner member for securing said inner member within the vessel; and

a radioactive source for treating the vascular segment, said radioactive source at a distal end portion of said radiation catheter,

wherein said expandable structure supports said distal end portion of said inner member to generally center said distal end portion of said radiation catheter within the vessel and to position said radioactive source at the center of the vessel.

32. The device of claim 22, wherein said elongate member is hollow.

33. The device of claim 22, wherein said elongate member comprises Nitinol.

34. The device of claim 22, wherein said expandable structure comprises a balloon.

35. The device of claim 34, wherein said balloon is inflated with fluid that passes through said elongate member.

36. The device of claim 34, wherein said balloon is compliant.

37. The device of claim 22, further comprising a sheath for shielding the vessel from radiation when said segment is not being treated.

23. A device for treating a segment of a vessel in a patient, comprising:

a catheter for delivering radiation;

an elongate member that slides relative to said radiation catheter;

an expandable structure at a distal end portion of said member for securing said member within the vessel; and

a radioactive source for treating the vascular segment, said radioactive source at a distal end portion of said radiation catheter,

wherein said expandable structure supports said distal end portion of said member to generally center said distal end portion of said radiation catheter within the vessel when one of said expandable structure and said source is distal to and spaced apart from the other of said expandable structure and said source.

38. The device of claim 23, wherein said elongate member is hollow.

39. The device of claim 23, wherein said elongate member comprises Nitinol.

40. The device of claim 23, wherein said expandable structure comprises a balloon.

41. The device of claim 40, wherein said balloon is inflated with fluid that passes through said elongate member.

42. The device of claim 40, wherein said balloon is compliant.

43. The device of claim 23, further comprising a sheath for shielding the vessel from radiation when said segment is not being treated.

24. A method of treating a segment in a vessel, comprising:

inserting an elongate inner member into the vessel;

expanding at least one expandable structure at a distal end portion of the inner member to support the distal end portion of the inner member in the vessel;

providing a non-inflatable catheter having radiation material;

guiding the catheter over the inner member so that the radiation material is within said segment of the vessel; and

treating the vascular segment by exposing it to radiation.

44. The method of claim 24, further comprising:

contracting the expandable structure after treatment; and

removing the expandable structure and the catheter from the vessel.

45. The method of claim 24, said treating the vascular segment comprising retracting a sheath to expose said segment to radiation.

46. The method of claim 24, comprising positioning the expandable structure distal to and within about 4 cm of said segment during treatment.

47. The method of claim 24, wherein the expandable structure comprises a balloon.

48. The method of claim 24, wherein the inner member comprises a guidewire.

49. The method of claim 48, wherein the guidewire is hollow.

50. The method of claim 48, wherein the guidewire comprises Nitinol.

25. A method of treating a segment in a vessel, comprising:

inserting an elongate inner member into the vessel;

expanding at least one expandable structure at a distal end portion of the inner member to support the distal end portion of the inner member in the vessel;

providing a catheter having radiation material;

guiding the catheter over the inner member so that the radiation material is within said segment of the vessel and positioned at the center of the vessel; and

treating the vascular segment by exposing it to radiation.

51. The method of claim 25, further comprising:

contracting the expandable structure after treatment; and

removing the expandable structure and the catheter from the vessel.

52. The method of claim 25, said treating the vascular segment comprising retracting a sheath to expose said segment to radiation.

53. The method of claim 25, comprising positioning the expandable structure distal to and within about 4 cm of said segment during treatment.

54. The method of claim 25, wherein the expandable structure comprises a balloon.

55. The method of claim 25, wherein the inner member comprises a guidewire.

56. The method of claim 55, wherein the guidewire is hollow.

57. The method of claim 55, wherein the guidewire comprises Nitinol.