Apparatus and method to treat a disease process in a luminal structure

• US 6,652,441 B2
• Filed: 04/17/2001
• Issued: 11/25/2003
• Est. Priority Date: 01/21/1994
• Status: Expired due to Fees

• Current Assignee: Trustees Of Columbia University In The City Of New York (Columbia University)
• Original Assignee: Trustees Of Columbia University In The City Of New York (Columbia University)
• Inventors: Amols, Howard I., Weinberger, Judah Z.
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US09/837,440
• Publication Number:
  US 20010037046A1
• Time in Patent Office: 952 Days
• Field of Search: 600/1-8
• US Class Current: 600/3
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61N 2005/1008 Apparatus for temporary insertion of sources, e.g. afterloaders
• CPC Class Codes: A61N 2005/1021 Radioactive fluid
• CPC Class Codes: A61N 2005/1094 Shielding, protecting against radiation
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy
• CPC Class Codes: A61N 5/1007 Arrangements or means for the introduction of sources into the body

Abstract

An apparatus and a method to treat a disease process in a luminal structure. A dual-balloon catheter for treating a disease process in a luminal structure of a patient comprises an inner balloon, an outer balloon substantially concentric with and substantially surrounding the inner balloon, an inner balloon fluid delivery lumen in fluid connection with the inner balloon, and an outer balloon fluid delivery lumen in fluid connection with the outer balloon.

Claims

1. An apparatus guided by a guidewire within a patient'"'"'s artery for reducing restenosis after arterial intervention in the patient'"'"'s artery comprising:

a radiation dose delivery wire with a radiation source encapsulated within its distal end; and

a catheter with a blind lumen sealed at its distal end and a guidewire lumen extending therethrough to accept said guidewire;

said blind lumen being adapted to accept said radiation dose delivery wire into its proximal end.

2. The apparatus of claim 1, further comprising means for providing a liquid-tight seal between the radiation dose delivery wire and the proximal end of the blind lumen.

3. An apparatus to be inserted into a catheter for reducing restenosis after arterial intervention in a patient'"'"'s artery comprising:

a radiation dose delivery wire with a radiation source encapsulated within its distal end; and

a blind lumen open at its proximal end and sealed at its distal end;

said blind lumen being adapted to accept said radiation dose delivery wire into its proximal end and to be inserted into said catheter.

4. The apparatus of claim 3, further comprising means for providing a liquid-tight seal between the radiation dose delivery wire and the proximal end of the blind lumen.

5. An apparatus guided by a guidewire within a luminal structure of a patient for treating a disease process comprising:

a radiation dose delivery wire with a radiation source attached to its distal end;

a balloon catheter with a blind lumen sealed at its distal end and a guidewire lumen extending therethrough to accept said radiation delivery wire into its proximal end; and

means for moving the distal end of said radiation dose delivery wire to a predetermined position within said blind lumen for a predetermined period of time.

6. The apparatus of claim 5, wherein said means for moving is a computer controlled afterloader.

7. The apparatus of claim 6, wherein said computer controlled afterloader calculates said predetermined position and said predetermined time.

8. The apparatus of claim 7, wherein said computer controlled afterloader calculates said predetermined position and said predetermined time based upon plurality of input variables including a half-life of the radiation source, an activity level of the radiation source, a diameter of said luminal structure, and a desired radiation dosage to be delivered to the luminal structure at the predetermined position.

9. The apparatus of claim 8, wherein a user inputs a plurality of values each representing respective ones of the plurality of input variables to the computer controlled afterloader.

10. The apparatus of claim 9, wherein the computer controlled afterloader oscillates said distal end of said radiation dose delivery wire back and forth in the area of the predetermined position for a predetermined period of time.

13. The apparatus of claim 10, wherein said radiation blocking shield is lead.

11. An apparatus guided by a guidewire within a luminal structure of a patient for treating a disease process comprising:

a radiation dose delivery wire with a radiation source attached to its distal end;

a balloon catheter with a blind lumen sealed at its distal end and a guidewire lumen extending therethrough to accept said guidewire;

said blind lumen being adapted to accept said radiation dose delivery wire into its proximal end; and

a radiation blocking shield movable between the radiation source within the patient'"'"'s luminal structure and a user of the apparatus.

12. The apparatus of claim 11, wherein said radiation blocking shield is concrete.

14. An apparatus inserted into a sheath in a luminal structure of a patient and guided by a guidewire within the patient'"'"'s luminal structure for treating a disease process comprising:

a radiation dose delivery wire with a radiation source attached to its distal end;

a balloon catheter with a blind lumen sealed at its distal end and a guidewire lumen extending therethrough to accept said guidewire.

15. The apparatus of claim 14, further comprising means for maintaining an extended coaxial relationship between a proximal end of said sheath and the proximal end of said blind lumen.

16. An apparatus guided by a guidewire within a luminal structure of a patient for treating a disease process comprising:

a radiation dose delivery wire with a radiation source attached to its distal end; and

a balloon catheter with a blind lumen sealed at its distal end and a guidewire lumen extending partially through said balloon catheter;

said blind lumen being adapted to accept said radiation dose delivery wire into its proximal end;

said guidewire lumen having an entry port located at a distal end of said balloon catheter and an exit port located upon a circumferential surface of said balloon catheter.

17. An apparatus guided by a guidewire within a luminal structure of a patient for treating a disease process comprising:

a radiation dose delivery wire with a radiation source attached to its distal end; and

a catheter with a blind lumen sealed at its distal end and a guidewire lumen extending therethrough to accept said guidewire;

said blind lumen being adapted to accept said radiation dose delivery wire into its proximal end.

18. The apparatus of claim 17, further comprising means for providing a liquid-tight seal between the radiation dose delivery wire and the proximal end of the blind lumen.

19. An apparatus with a catheter to be inserted into a luminal structure of a patient for treating a disease process comprising:

a radiation dose delivery wire with a radiation source attached to its distal end; and

a blind lumen open at its proximal end and sealed at its distal end;

said blind lumen being adapted to accept said radiation dose delivery wire into it proximal end and to be inserted into said catheter.

20. The apparatus of claim 19, further comprising means for providing a liquid-tight seal between the radiation dose delivery wire and the proximal end of the blind lumen.

21. A method for treating a disease process in a luminal structure of a patient comprising:

inserting a balloon catheter with a fluid delivery port connected thereto into the patient'"'"'s luminal structure; and

inserting a radioactive fluid into the balloon catheter through the fluid delivery port, wherein said radioactive fluid is selected from the group consisting of fluids containing Cu-61, Se-73, Co-55, Sc-44, Sr-75, Kr-77, Ga-68, In-110, Br-76, Ga-66, Ga-72, Sb-122, Na24, Si-31, Ge-77;

Ho-166, Re-188, Bi-212, Y-90, K-42, Tr-192, I-125, Pd-103, Sr-90, and radioactive sodium-chloride.

22. An apparatus guided by a guidewire within a luminal structure of a patient for receiving a radiation dose delivery wire with a radiation source attached to its distal end and for treating a disease process comprising:

a balloon catheter with a blind lumen sealed at its distal end and a guidewire lumen extending therethrough to accept said guidewire;

said blind lumen being adapted to accept said radiation delivery wire into its proximal end; and

means for moving the distal end of said radiation dose delivery wire to a predetermined position within said blind lumen for a predetermined period of time.

24. The apparatus of claim 22, wherein said means for moving is a computer controlled afterloader.

25. The apparatus of claim 24, wherein said computer controlled afterloader calculates said predetermined position and said predetermined time.

26. The apparatus of claim 24, wherein said computer controlled afterloader calculates said predetermined position and said predetermined time based upon a plurality of input variables including a half-life of the radiation source, an activity level of the radiation source, a diameter of said luminal structure, and a desired radiation dosage to be delivered to the luminal structure at the predetermined position.

27. The apparatus of claim 26, wherein a user inputs a plurality of values each representing respective one of the plurality of input variables to the computer controlled afterloader.

28. The apparatus of claim 27, wherein the computer controlled afterloader moves said distal end of said radiation dose delivery wire back and forth in the area of the predetermined position for a predetermined period of time.

23. An apparatus guided by a guidewire within a luminal structure of a patient for receiving a radiation dose delivery wire with a radiation source attached to its distal end and for treating a disease process comprising:

a balloon catheter with a blind lumen sealed at its distal end and a guidewire lumen extending therethrough to accept said guidewire;

said blind lumen being adapted to accept said radiation delivery wire into its proximal end;

means for providing a liquid-tight seal between the radiation dose delivery wire and the proximal end of the blind lumen, wherein liquid-tight seal comprises a liquid-tight radiation delivery wire port connected to the proximal end of the blind lumen, whereby a liquid-tight seal is effectuated between the proximal end of the blind lumen and the radiation dose delivery wire.

29. An apparatus for use with a sheath and a guidewire inserted into a luminal structure of a patient for treating a disease process comprising:

a radiation dose delivery wire with a radiation source attached to its distal end; and

a balloon catheter with a blind lumen sealed at its distal end and a guidewire lumen extending therethrough adapted to accept a guidewire for guiding the balloon catheter in the patient'"'"'s luminal structure;

said blind lumen being adapted to accept said radiation dose delivery wire into its proximal end;

said balloon catheter being adapted to be inserted into a sheath in the patient'"'"'s luminal structure surrounding said guidewire.

30. The apparatus of claim 29, further comprising means for providing a liquid-tight seal between the radiation dose delivery wire and the proximal end of the blind lumen.