Radiation centering catheters

• US 6,224,535 B1
• Filed: 02/17/1998
• Issued: 05/01/2001
• Est. Priority Date: 02/17/1998
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated
• Original Assignee: Advanced Cardiovascular Systems Incorporated
• Inventors: Chiu, Jessica G., Peterson, Eric D.
• Primary Examiner(s): GILBERT, SAMUEL G
• Application Number:
  US09/024,666
• Time in Patent Office: 1,169 Days
• Field of Search: 600/1-8, 604/93, 604/171, 604/264, 604/280
• US Class Current: 600/3
• 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: 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

The invention is directed to a radiation delivery catheter assembly for maintaining patency of a body lumen for a period of time sufficient to allow delivery of a radiation source to the body lumen. The catheter utilizes an inflatable region which maintains and centers the catheter in the body lumen. The catheter may include a perfusion lumen for supplying oxygenated blood to tissue located downstream from the catheter when the inflatable region is expanded in the body lumen. The inflatable region can be made up of a plurality of balloon segments which help center the radiation source, even if placed on a curved section of the body lumen. Embodiments of the invention include a catheter design which utilizes “rapid exchange” features and a dual therapeutic catheter which is capable of dilating a stenosed region of the body lumen prior to the administration of the radiation treatment. A two-piece protective sheath is used to protect the radiation source from bodily fluids.

Claims

1. A radiation centering catheter assembly for maintaining the patency of a body lumen for a period of time sufficient to permit delivery of a radiation dose to the body lumen while permitting blood perfusion, comprising:

an elongated catheter body having a proximal end and a distal end;

an inflation lumen extending within the elongated catheter body to a location within a distal portion of the elongated body;

an inflatable region located near the distal end of the elongated catheter body having an interior in fluid communication with the inflation lumen, the inflatable region adapted to be expandable to contact a portion of the body lumen;

a perfusion lumen extending through a portion of the elongated catheter body for permitting perfusion of blood through the inflatable region when the inflatable region is expanded within the body lumen;

a guide wire lumen extending through at least a portion of the elongated catheter body for receiving a guide wire;

a radiation source wire; and

a protective sheath adapted to encase the radiation source wire, the protective sheath and the radiation source wire being insertable within the guide wire lumen to provide a radiation source to the body lumen.

2. The catheter of claim 1, wherein the inflatable region is made from a plurality of inflatable balloon segments extending axially along the elongated catheter body.

3. The catheter as defined in claim 1, wherein said perfusion lumen is formed from a portion of the guide wire lumen.

4. The catheter as defined in claim 3, wherein a plurality of perfusion ports located distal and proximal to the inflatable region which are in fluid communication with the guide wire lumen form the perfusion lumen of the catheter body.

5. The catheter as defined in claim 1, wherein the inflatable region is configured to center tie radiation source wire within the body lumen so that substantially equal amounts of radiation are directed to the body lumen.

6. The catheter as defined in claim 1, wherein the elongated catheter body has multiple inner lumens extending therethrough and includes an inner lumen for receiving the protective sheath and the radiation source wire.

7. A radiation centering catheter assembly for maintaining the patency of a body lumen for a period of time sufficient to permit delivery of a radiation dose to the body lumen while permitting blood perfusion, comprising:

an elongated catheter body having a proximal end and a distal end;

an inflation lumen extending within the elongated catheter body to a location within a distal portion of the elongated body;

an inflatable region located near the distal end of the elongated catheter body having an interior in fluid communication with the inflation lumen, the inflatable region adapted to be expandable to contact a portion of the body lumen;

a guide wire lumen extending through at least a portion of the elongated catheter body for receiving a guide wire;

a first guide wire port in the distal end of the catheter body in communication with the guide wire lumen and a second guide wire port in the catheter body and spaced a short distance from the distal end of the catheter body and a substantial distance from the proximal end of the catheter body and which is in communication with the guide wire lumen;

an inner lumen extending through the elongated catheter body from the proximal end to about the second guide wire port;

a radiation source wire; and

a protective sheath adapted to encase the radiation source wire, the protective sheath and the radiation source wire being insertable within the inner lumen and guide wire lumen to provide a radiation source to the body lumen.

8. The catheter as defined in claim 7, further including a perfusion lumen extending through a portion of the elongated catheter body for permitting perfusion of blood through the inflatable region when the inflatable region is expanded within the body lumen.

9. The catheter of claim 7, wherein the inflatable region is made from a plurality of inflatable balloon segments extending axially along the elongated catheter body.

10. The catheter as defined in claim 8, wherein said perfusion lumen is formed from a portion of the guide wire lumen.

11. The catheter as defined in claim 10, wherein a plurality of perfusion ports located distal and proximal to the inflatable region which are in fluid communication with the guide wire lumen form the perfusion lumen of the catheter body.

12. The catheter as defined in claim 7, wherein the inflatable region is configured to center the radiation source wire within the body lumen so that substantially equal amounts of radiation are directed to the body lumen.

13. The catheter as defined in claim 7, wherein the elongated catheter body has multiple inner lumens extending therethrough and includes an inner lumen for receiving the protective sheath and radiation source wire.

14. A dual therapeutic dilatation catheter assembly for dilating a stenosed region in a body lumen and for maintaining the patency of the body lumen for a period of time sufficient to permit delivery of a radiation dose to the body lumen, comprising:

an elongated catheter body having a proximal end and a distal end;

an inflation lumen extending within the elongated catheter body to a location within a distal portion of the elongated body;

an inflatable region located near the distal end of the elongated catheter body having an interior in fluid communication with the inflation lumen, the inflatable region adapted to be expandable to dilate the stenosed region of the body lumen and to contact a portion of the body lumen;

a guide wire lumen extending through at least a portion of the elongated catheter body for receiving a guide wire;

a radiation source wire; and

a protective sheath adapted to encase the radiation source wire, the protective sheath and the radiation source wire being insertable within the guide wire lumen to provide a radiation source to the body lumen.

15. The catheter as defined in claim 14 further including a perfusion lumen extending through a portion of the elongated catheter body for permitting perfusion of blood through the inflatable region when the inflatable region is expanded within the body lumen.

16. The catheter of claim 14, wherein the inflatable region is made from a plurality of inflatable balloon segments extending axially along the elongated catheter body.

17. The catheter as defined in claim 15, wherein said perfusion lumen is formed from a portion of the guide wire lumen.

18. The catheter as defined in claim 17, wherein a plurality of perfusion ports located distal and proximal to the inflatable region which are in fluid communication with the guide wire lumen form of the perfusion lumen of the catheter body.

19. The catheter as defined in claim 14, wherein the inflatable region is configured to center the radiation source wire within the body lumen so that substantially equal amounts of radiation are directed to the body lumen.

20. The catheter as defined in claim 14, wherein the elongated catheter body has multiple inner lumens extending therethrough and includes an inner lumen for receiving the protective sheath and the radiation source wire.

21. A method for maintaining the patency of a body lumen for a period of time sufficient to permit delivery of a radiation dose to the body lumen while permitting blood perfusion, comprising the steps of:

a) providing a catheter having;

an elongated catheter body having a proximal end and a distal end;

an inflation lumen extending within the elongated catheter body to a location within a distal portion of the elongated body;

an inflatable region located near the distal end of the elongated catheter body having an interior in fluid communication with the inflation lumen, the inflatable region adapted to be expandable to contact a portion of the body lumen;

a perfusion lumen extending through a portion of the elongated catheter body for permitting perfusion of blood through the inflatable region when the inflatable region is expanded within the body lumen;

a guide wire lumen extending through at least a portion of the elongated catheter body for receiving a guide wire;

a radiation source wire; and

a protective sheath adapted to encase the radiation source wire, the protective sheath and the radiation source wire being insertable within the guide wire lumen to provide a radiation source to the body lumen;

b) positioning a guide wire in the body lumen;

c) advancing the catheter over the guide wire;

d) advancing the elongated catheter body over the guide wire until the inflatable region is in proper position in the body lumen;

e) inflating the inflatable region to contact the body lumen to center the guide wire lumen within the body lumen;

f) perfusing blood flow through the inflatable region;

g) removing the guide wire from the guide wire lumen;

h) inserting the protective sheath into the guide wire lumen;

i) inserting a radiation source wire into the protective sheath and advancing the protective sheath and the radiation source wire to the desired area in the body lumen and administering a radiation dose;

j) deflating the inflatable region; and

k) withdrawing the catheter and the protective sheath and the radiation source wire from the body lumen.

22. A method for dilating a stenosed region in a body lumen and maintaining the patency of the body lumen for a period of time sufficient to permit delivery of a radiation dose to the body lumen, comprising the steps of:

a) providing a catheter having;

an elongated catheter body having a proximal end and a distal end;

an inflation lumen extending within the elongated catheter body to a location within a distal portion of the elongated body;

an inflatable region located near the distal end of the elongated catheter body having an interior in fluid communication with the inflation lumen, the inflatable region adapted to be expandable to dilate the stenosed region of the body lumen and to contact a portion of the body lumen;

a guide wire lumen extending through at least a portion of the elongated catheter body for receiving a guide wire;

a radiation source wire; and

a protective sheath adapted to encase the radiation source wire, the protective sheath and the radiation source wire being insertable within the guide wire lumen to provide a radiation source to the body lumen;

b) positioning a guide wire in the body lumen;

c) advancing the catheter over the guide wire;

d) advancing the elongated catheter body over the guide wire until the inflatable region is in proper position in the body lumen;

e) inflating the inflatable region to dilate the stenosed region in the body lumen;

f) removing the guide wire from the guide wire lumen;

g) inserting the protective sheath into the guide wire lumen;

h) inserting a radiation source wire into the protective sheath and advancing the protective sheath and radiation source wire to the desired area in the body lumen and administering a radiation dose;

i) deflating the inflatable region; and

j) withdrawing the catheter and the protective sheath and radiation source wire from the body lumen.

23. The method of claim 22, wherein the catheter further includes a perfusion lumen extending through a portion of the elongated catheter body for permitting perfusion of blood through the inflatable region when the inflatable region is expanded within the body lumen, and further includes, after step (e), the step of perfusing blood flow through the inflatable region.

24. A method for maintaining the patency of a body lumen for a period of time sufficient to permit delivery of a radiation dose to the body lumen while permitting blood perfusion, comprising the steps of:

a) providing a catheter having;

an elongated catheter body having a proximal end and a distal end;

an inflation lumen extending within the elongated catheter body to a location within a distal portion of the elongated body;

an inflatable region located near the distal end of the elongated catheter body having an interior in fluid communication with the inflation lumen, the inflatable region adapted to be expandable to contact a portion of the body lumen;

a guide wire lumen extending through at least a portion of the elongated catheter body for receiving a guide wire;

a first guide wire port in the distal end of the catheter body in communication with the guide wire lumen and a second guide wire port in the distal end of the catheter body which is spaced a short distance from the distal end of the catheter body and a substantial distance from the proximal end of the catheter body and which is in communication with the guide wire lumen;

an inner lumen extending through the elongated catheter body from the proximal end to about the second guide wire port;

a radiation source wire; and

a protective sheath adapted to encase the radiation source wire, the protective sheath and the radiation source wire being insertable within the inner lumen and guide wire lumen to provide a radiation source to the body lumen;

b) preloading the protective sheath within the inner lumen of the elongated catheter using a support mandrel;

c) positioning a guide wire in the body lumen;

d) advancing the catheter over the guide wire;

e) advancing the elongated catheter body over the guide wire until the inflatable region is in proper position in the body lumen;

f) inflating the inflatable region to contact the body lumen to center the guide wire lumen within the body lumen;

g) removing the guide wire from the guide wire lumen;

h) advancing the protective sheath into the guide wire lumen;

i) removing the support mandrel from the protective sheath;

j) inserting a radiation source wire into the protective sheath and advancing the radiation source wire to the desired area in the body lumen and administering a radiation dose;

k) deflating the inflatable region; and

l) withdrawing the catheter and the protective sheath and radiation source wire from the body lumen.

25. The method of claim 24, wherein the catheter further includes a perfusion lumen extending through a portion of the elongated catheter body for permitting perfusion of blood through the inflatable region when the inflatable region is expanded within the body lumen, and further includes, after step (f), the step of perfusing blood flow through the inflatable region.

26. A radiation centering catheter assembly for maintaining the patency of a body lumen for a period of time sufficient to permit delivery of a radiation dose to the body lumen while permitting blood perfusion, comprising:

an elongated catheter body having a proximal end and a distal end;

an inflation lumen extending within the elongated catheter body to a location within a distal portion of the elongated body;

an inflatable region located near the distal end of the elongated catheter body having an interior in fluid communication with the inflation lumen, the inflatable region adapted to be expandable to contact a portion of the body lumen;

a perfusion lumen extending through a portion of the elongated catheter body for permitting perfusion of blood through the inflatable region when the inflatable region is expanded within the body lumen;

a guide wire lumen extending through at least a portion of the elongated catheter body for receiving a guide wire; and

a protective sheath adapted to encase a radiation source wire, the protective sheath being insertable within the guide wire lumen to provide a barrier between a radiation source wire and body fluids.

27. The catheter of claim 26, wherein the inflatable region is made from a plurality of inflatable balloon segments extending axially along the elongated catheter body.

28. The catheter as defined in claim 26, wherein said perfusion lumen is formed from a portion of the guide wire lumen.

29. The catheter as defined in claim 28, wherein a plurality of perfusion ports located distal and proximal to the inflatable region which are in fluid communication with the guide wire lumen form the perfusion lumen of the catheter body.

30. The catheter as defined in claim 26, wherein the inflatable region is configured to center the protective sheath within the body lumen so that substantially equal amounts of radiation are directed to the body lumen when a radiation source wire is inserted into the protective sheath.

31. The catheter as defined in claim 26, wherein the elongated catheter body has multiple inner lumens extending therethrough and includes an inner lumen for receiving the protective sheath.

32. A radiation centering catheter assembly for maintaining the patency of a body lumen for a period of time sufficient to permit delivery of a radiation dose to the body lumen while permitting blood perfusion, comprising:

an elongated catheter body having a proximal end and a distal end;

an inflation lumen extending within the elongated catheter body to a location within a distal portion of the elongated body;

an inflatable region located near the distal end of the elongated catheter body having an interior in fluid communication with the inflation lumen, the inflatable region adapted to be expandable to contact a portion of the body lumen;

a guide wire lumen extending through at least a portion of the elongated catheter body for receiving a guide wire;

a first guide wire port in the distal end of the catheter body in communication with the guide wire lumen and a second guide wire port in the catheter body and spaced a short distance from the distal end of the catheter body and a substantial distance from the proximal end of the catheter body and which is in communication with the guide wire lumen;

an inner lumen extending through the elongated catheter body from the proximal end to about the second guide wire port; and

a protective sheath adapted to encase a radiation source wire, the protective sheath being insertable within the inner lumen and guide wire lumen to provide a barrier between a radiation source wire and body fluids.

33. The catheter as defined in claim 32, further including a perfusion lumen extending through a portion of the elongated catheter body for permitting perfusion of blood through the inflatable region when the inflatable region is expanded within the body lumen.

34. The catheter of claim 32, wherein the inflatable region is made from a plurality of inflatable balloon segments extending axially along the elongated catheter body.

35. The catheter as defined in claim 33, wherein said perfusion lumen is formed from a portion of the guide wire lumen.

36. The catheter as defined in claim 35, wherein a plurality of perfusion ports located distal and proximal to the inflatable region which are in fluid communication with the guide wire lumen form the perfusion lumen of the catheter body.

37. The catheter as defined in claim 32, wherein the inflatable region is configured to center the protective sheath within the body lumen so that substantially equal amounts of radiation are directed to the body lumen when a radiation source wire is inserted into the protective sheath.

38. The catheter as defined in claim 32, wherein the elongated catheter body has multiple inner lumens extending therethrough and includes an inner lumen for receiving the protective sheath.

39. A dual therapeutic dilatation catheter assembly for dilating a stenosed region in a body lumen and for maintaining the patency of the body lumen for a period of time sufficient to permit delivery of a radiation dose to the body lumen, comprising:

an elongated catheter body having a proximal end and a distal end;

an inflation lumen extending within the elongated catheter body to a location within a distal portion of the elongated body;

an inflatable region located near the distal end of the elongated catheter body having an interior in fluid communication with the inflation lumen, the inflatable region adapted to be expandable to dilate the stenosed region of the body lumen and to contact a portion of the body lumen;

a guide wire lumen extending through at least a portion of the elongated catheter body for receiving a guide wire; and

a protective sheath adapted to encase a radiation source wire, the protective sheath being insertable within the guide wire lumen to provide a barrier between a radiation source wire and body fluids.

40. The catheter as defined in claim 39 further including a perfusion lumen extending through a portion of the elongated catheter body for permitting perfusion of blood through the inflatable region when the inflatable region is expanded within the body lumen.

41. The catheter of claim 39, wherein the inflatable region is made from a plurality of inflatable balloon segments extending axially along the elongated catheter body.

42. The catheter as defined in claim 40, wherein said perfusion lumen is formed from a portion of the guide wire lumen.

43. The catheter as defined in claim 42, wherein a plurality of perfusion ports located distal and proximal to the inflatable region which are in fluid communication with the guide wire lumen form of the perfusion lumen to the catheter body.

44. The catheter as defined in claim 39, wherein the inflatable region is configured to center the protective sheath within the body lumen so that substantially equal amounts of radiation are directed to the body lumen when a radiation source wire is inserted into the protective sheath.

45. The catheter as defined in claim 39, wherein the elongated catheter body has multiple inner lumens extending therethrough and includes an inner lumen for receiving the protective sheath.

46. A method for maintaining the patency of a body lumen for a period of time sufficient to permit delivery of a radiation dose to the body lumen while permitting blood perfusion, comprising the steps of:

d) providing a catheter having;

an elongated catheter body having a proximal end and a distal end;

an inflation lumen extending within the elongated catheter body to a location within a distal portion of the elongated body;

an inflatable region located near the distal end of the elongated catheter body having an interior in fluid communication with the inflation lumen, the inflatable region adapted to be expandable to contact a portion of the body lumen;

a perfusion lumen extending through a portion of the elongated catheter body for permitting perfusion of blood through the inflatable region when the inflatable region is expanded within the body lumen;

a guide wire lumen extending through at least a portion of the elongated catheter body for receiving a guide wire; and

a protective sheath adapted to encase a radiation source wire, the protective sheath being insertable within the guide wire lumen to provide a barrier between a radiation source wire and body fluids;

e) positioning a guide wire in the body lumen;

f) advancing the catheter over the guide wire;

d) advancing the elongated catheter body over the guide wire until the inflatable region is in proper position in the body lumen;

e) inflating the inflatable region to contact the body lumen to center the guide wire lumen within the body lumen;

f) perfusing blood flow through the inflatable region;

i) removing the guide wire from the guide wire lumen;

j) inserting the protective sheath into the guide wire lumen;

i) inserting a radiation source wire into the protective sheath and advancing the protective sheath and radiation source wire to the desired area in the body lumen and administering a radiation dose;

j) deflating the inflatable region; and

k) withdrawing the catheter and the protective sheath and radiation source wire from the body lumen.

47. A method for dilating a stenosed region in a body lumen and maintaining the patency of the body lumen for a period of time sufficient to permit delivery of a radiation dose to the body lumen, comprising the steps of:

b) providing a catheter having;

an elongated catheter body having a proximal end and a distal end;

an inflation lumen extending within the elongated catheter body to a location within a distal portion of the elongated body;

an inflatable region located near the distal end of the elongated catheter body having an interior in fluid communication with the inflation lumen, the inflatable region adapted to be expandable to dilate the stenosed region of the body lumen and to contact a portion of the body lumen;

a guide wire lumen extending through at least a portion of the elongated catheter body for receiving a guide wire; and

a protective sheath adapted to encase a radiation source wire, the protective sheath being insertable within the guide wire lumen to provide a barrier between a radiation source wire and body fluids;

b) positioning a guide wire in the body lumen;

c) advancing the catheter over the guide wire;

d) advancing the elongated catheter body over the guide wire until the inflatable region is in proper position in the body lumen;

e) inflating the inflatable region to dilate the stenosed region in the body lumen;

f) removing the guide wire from the guide wire lumen;

h) inserting the protective sheath into the guide wire lumen;

h) inserting a radiation source wire into the protective sheath and advancing the protective sheath and radiation source wire to the desired area in the body lumen and administering a radiation dose;

i) deflating the inflatable region; and

j) withdrawing the catheter and the protective sheath and radiation source wire from the body lumen.

48. The method of claim 47, wherein the catheter further includes a perfusion lumen extending through a portion of the elongated catheter body for permitting perfusion of blood through the inflatable region when the inflatable region is expanded within the body lumen, and further includes, after step (e) the step of perfusing blood flow through the inflatable region.

49. A method for maintaining the patency of a body lumen for a period of time sufficient to permit delivery of a radiation dose to the body lumen while permitting blood perfusion, comprising the steps of:

b) providing a catheter having;

an elongated catheter body having a proximal end and a distal end;

an inflation lumen extending within the elongated catheter body to a location within a distal portion of the elongated body;

an inflatable region located near the distal end of the elongated catheter body having an interior in fluid communication with the inflation lumen, the inflatable region adapted to be expandable to contact a portion of the body lumen;

a guide wire lumen extending through at least a portion of the elongated catheter body for receiving a guide wire;

a first guide wire port in the distal end of the catheter body in communication with the guide wire lumen and a second guide wire port in the distal end of the catheter body which is spaced a short distance from the distal end of the catheter body and a substantial distance from the proximal end of the catheter body and which is in communication with the guide wire lumen;

an inner lumen extending through the elongated catheter body from the proximal end to about the second guide wire port; and

a protective sheath adapted to encase a radiation source wire, the protective sheath being insertable within the inner lumen and guide wire lumen to provide a barrier between a radiation source wire and body fluids;

b) preloading the protective sheath within the inner lumen of the elongated catheter using a support mandrel;

c) positioning a guide wire in the body lumen;

d) advancing the catheter over the guide wire;

e) advancing the elongated catheter body over the guide wire until the inflatable region is in proper position in the body lumen;

f) inflating the inflatable region to contact the body lumen to center the guide wire lumen within the body lumen;

j) removing the guide wire from the guide wire lumen;

k) advancing the protective sheath into the guide wire lumen;

l) removing the support mandrel from the protective sheath;

j) inserting a radiation source wire into the protective sheath and advancing the radiation source wire to the desired area in the body lumen and administering a radiation dose;

k) deflating the inflatable region; and

l) withdrawing the catheter and the protective sheath and radiation source wire from the body lumen.

50. The method of claim 49, wherein the catheter further includes a perfusion lumen extending through a portion of the elongated catheter body for permitting perfusion of blood through the inflatable region when the inflatable region is expanded within the body lumen, and further includes, after step (f), the step of perfusing blood flow through the inflatable region.