System and method for intravascular ionizing tandem radiation therapy

• US 6,416,457 B1
• Filed: 03/09/2000
• Issued: 07/09/2002
• Est. Priority Date: 03/09/2000
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation), Innovative Hearth Products, LLC (Harbert Management Corp.)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Verin, Vitali E., Popowski, Youri G., Urick, Michael J.
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US09/522,122
• Time in Patent Office: 852 Days
• Field of Search: 600/1-8
• US Class Current: 600/3
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy

Abstract

A system for intravascular ionizing radiation therapy including a radiation device and a guide wire having radiopaque markers to facilitate precise repositioning of the radiation source along the length of the treatment site. The radiopaque markers are separated by a distance L, which corresponds to the distance between the 50% dose points in the dose fall-off regions. This produces partial dose overlap when the radioactive source is positioned in tandem adjacent each radiopaque marker. Preferably, only the dose fall-off regions overlap thereby providing more uniform and complete radiation exposure along the length of the treatment site.

Claims

1. A medical system for intravascular ionizing radiation therapy, comprising:

an elongate radiation device having a radiopaque marker and a radioactive source disposed adjacent a distal end thereof, the radioactive source having a length and a dose distribution, the dose distribution having a nominal dose, a proximal dose fall-off, a distal dose fall-off, a proximal point in the proximal dose fall-off corresponding to 50% of the nominal dose, a distal point in the distal dose fall-off corresponding to 50% of the nominal dose, wherein the proximal 50% point is separated from the distal 50% point by a distance L; and

an elongate guide wire having a plurality of radiopaque markers disposed adjacent a distal region thereof, the radiopaque markers separated by the distance L such that dose fall-off overlap is created when the radioactive source is positioned adjacent each radiopaque marker.

2. A medical system as in claim 1, wherein the distance L is less than the length of the radioactive source.

3. A medical system as in claim 1, wherein the radioactive source is a line source.

4. A medical system as in claim 1, wherein the elongate radiation device includes a delivery catheter and a source wire insertable therein, the radioactive source disposed adjacent a distal end of the source wire.

5. A medical system as in claim 4, wherein the delivery catheter includes a guide wire lumen, and wherein the guide wire is disposed in the guide wire lumen.

6. A medical system as in claim 5, wherein the delivery catheter includes a centering means disposed adjacent a distal end thereof.

7. A medical system as in claim 6, wherein the delivery catheter includes a radiopaque marker disposed adjacent the centering means.

8. A medical system as in claim 7, wherein the centering means has a proximal end, a distal end and a midpoint therebetween, and wherein the radiopaque marker is disposed adjacent the midpoint of the centering means.

9. A medical system as in claim 7, wherein the centering means has a proximal end, a distal end and a midpoint therebetween, and wherein the radiopaque marker is disposed adjacent the proximal end of the centering means.

10. A medical system as in claim 7, wherein the centering means has a proximal end, a distal end and a midpoint therebetween, and wherein the radiopaque marker is disposed adjacent the distal end of the centering means.

11. A medical system as in claim 10, wherein the delivery catheter includes a first and second radiopaque marker, the first radiopaque marker disposed adjacent the proximal end of the centering means and the second radiopaque marker disposed adjacent the distal end of the centering means.

12. A medical system as in claim 10, wherein the source wire includes a radiopaque marker disposed adjacent the radioactive source.

13. A guide wire for use in combination with an elongate radiation device for intravascular ionizing radiation therapy, wherein the elongate radiation device includes a radioactive source disposed adjacent a distal end thereof, the radioactive source having a length and a dose distribution, the dose distribution having a nominal dose, a proximal dose fall-off, a distal dose fall-off, a proximal point in the proximal dose fall-off corresponding to 50% of the nominal dose, a distal point in the distal dose fall-off corresponding to 50% of the nominal dose, wherein the proximal 50% point is separated from the distal 50% point by a distance L, the guide wire comprising:

an elongate shaft having a distal region; and

two or more radiopaque markers disposed adjacent the distal region of the shaft, the radiopaque markers separated by the distance L such that dose fall-off overlap is created when the radioactive source is positioned adjacent each radiopaque marker.

14. A guide wire as in claim 13, wherein the distance L is less than the length of the radioactive source.

15. A method of administering ionizing radiation at a treatment site within a patient'"'"'s vasculature, comprising the steps of:

providing an elongate radiation device having a radiopaque marker and a radioactive source disposed adjacent a distal end thereof, the radioactive source having a length and a dose distribution, the dose distribution having a nominal dose, a proximal dose fall-off, a distal dose fall-off, a proximal point in the proximal dose fall-off corresponding to 50% of the nominal dose, a distal point in the distal dose fall-off corresponding to 50% of the nominal dose, wherein the proximal 50% point is separated from the distal 50% point by a distance L;

providing an elongate guide wire having a proximal and a distal radiopaque marker disposed adjacent a distal region thereof, the radiopaque markers separated by the distance L;

inserting the guide wire into the vasculature of the patient;

advancing the guide wire through the vasculature until the radiopaque markers are disposed adjacent the treatment site;

inserting the radiation device into the vasculature of the patient;

positioning the radioactive source adjacent one of the radiopaque markers; and

repositioning the radioactive source adjacent the other of the radiopaque markers such that dose fall-off overlap is created.

16. A method as in claim 15, wherein the radiation device is inserted into the vasculature over the guide wire.

17. A method as in claim 15, wherein the distance L is less than the length of the radioactive source.