Balloon catheter having adjustable centering capabilities and methods thereof

• US 6,508,784 B1
• Filed: 05/19/2000
• Issued: 01/21/2003
• Est. Priority Date: 05/19/2000
• Status: Expired due to Fees

• Current Assignee: Polymerex Medical Corp.
• Original Assignee: Polymerex Medical Corp.
• Inventors: Shu, Yan-Ho
• Primary Examiner(s): Walberg, Teresa
• Assistant Examiner(s): DAHBOUR, HENRY
• Application Number:
  US09/575,869
• Time in Patent Office: 977 Days
• Field of Search: 604/96.01, 604/104, 604/101.01, 604/264, 604/500, 604/508, 604/509, 604/20, 604/22, 600/3, 606/159, 606/198
• US Class Current: 604/96.01
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• 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 5/1002 Intraluminal radiation therapy

Abstract

A radiation treatment system comprising a balloon catheter and a treatment apparatus. A method for delivering radioactive dose adequately to treat eccentric atheroma comprises positioning a radiation source on the treatment apparatus to the eccentric atheroma for a predetermined treatment period, wherein the positioning of the radiation source over a balloon catheter is radially and/or axially adjustable. The balloon catheter has adjustable centering capability and comprises a tubular centering structure disposed at the distal end of the balloon catheter, wherein the centering structure comprises a plurality of balloon members that are independently radially expandable and adjustable in inflation size. The treatment apparatus is slidably positioned inside the lumen of the balloon catheter, wherein the treatment apparatus comprises a radiation source.

Claims

1. A method for delivering radioactive dose adequately to treat eccentric atheroma comprising positioning a radiation source close to said eccentric atheroma for a predetermined treatment period, wherein said positioning of the radiation source is adjustable, and wherein said method of positioning said radiation source comprises a plurality of balloons disposed at a distal section of a balloon catheter, said plurality of balloons being independently adjustable in inflation size.

2. A radiation treatment system comprising:

a balloon catheter having adjustable centering capability, said balloon catheter comprising an elongated catheter shaft having a shaft distal end, a shaft proximal end, a shaft distal section, and a plurality of lumens between the shaft distal end and the shaft proximal end;

a tubular centering structure disposed at the shaft distal end, wherein said centering structure comprises a plurality of balloon members that are radially expandable, wherein each of said plurality of balloon members is independently adjustable in inflation size;

each of said plurality of balloon members being connected to and communicated to one of said plurality of lumens for balloon inflation and deflation; and

a treatment apparatus slidably positioned inside one of said plurality of lumens of the balloon catheter, wherein said treatment apparatus comprises a radiation source.

3. A radiation treatment system according to claim 2, wherein said centering structure of the balloon catheter has an outer diameter essentially equivalent to an outer diameter of said catheter shaft and one of said plurality of lumens of the balloon catheter is a lumen for passing a guide wire.

4. A radiation treatment system according to claim 2 further comprising a distal element that is distal to said tubular centering structure, wherein said distal element comprises a lumen.

5. A radiation treatment system according to claim 2, wherein said centering structure of the balloon catheter is made of material selected from the group consisting of polyurethane, silicone, copolymer of polyurethane and silicone, natural rubber, synthetic rubber, elastomers, nylon, latex, polyethylene, polyethylene terephthalate, polyethylene terephthalate glycol, polyisoprene, polyisobutylene, and their mixture.

6. A radiation treatment system according to claim 2, wherein said elongated catheter shaft of the balloon catheter is made of material selected from the group consisting of polyethylene, polyimide, polypropylene, nylon, polyvinyl chloride, and their mixture.

7. A radiation treatment system according to claim 2, wherein said radiation source of the treatment apparatus is selected from the group consisting of beta radiation, gamma radiation, and combination of beta and gamma radiation.

8. A radiation treatment system according to claim 2, wherein at least two of said plurality of balloon members of said tubular centering structure are positioned at different locations axially from one another.

9. A radiation treatment system according to claim 2, wherein said centering structure of the balloon catheter is imprinted with radiopaque ink for tracking exact location of the balloon catheter inside a patient.

10. A radiation treatment system according to claim 2, wherein at least one radiopaque marker is disposed on the balloon catheter for tracking exact location of the balloon catheter inside a patient.

11. A radiation treatment system according to claim 2, wherein said balloon catheter further comprises a distal element that is distal to the tubular centering structure, wherein the distal element comprises a lumen for guide wire insertion.

14. A method for treating restenosis according to claim 2, wherein said centering structure is made of material selected from the group consisting of polyurethane, silicone, copolymer of polyurethane and silicone, natural rubber, synthetic rubber, nylon, and latex.

15. A method for treating restenosis according to claim 2, wherein said centering structure is imprinted with radiopaque ink or incorporated with at least one radiopaque marker for tracking exact location of the balloon catheter inside a patient.

12. A method for treating restenosis of a lesion region of a patient comprising the steps of:

(g) inserting a balloon catheter through a body conduit to said lesion region of the patient, wherein said balloon catheter comprises a tubular centering structure disposed at a distal section of the balloon catheter, wherein said centering structure comprises a plurality of balloon members that are radially expandable;

(h) inflating each of said plurality of balloon members independently and adjustably in inflation size to stabilize the distal section of the balloon catheter with respect to said lesion region;

(i) inserting a treatment apparatus inside a lumen of the balloon catheter, wherein said treatment apparatus comprises a radiation source;

(j) positioning the radiation source at about the lesion region;

(k) holding the radiation source for a predetermined treatment period for treating restenosis; and

(l) withdrawing the treatment apparatus.

13. A method for treating restenosis according to claim 12, wherein said radiation source is selected from the group consisting of beta radiation, gamma radiation, and combination of beta and gamma radiation.