Device and method for radiation therapy

• US 6,302,839 B1
• Filed: 08/06/1999
• Issued: 10/16/2001
• Est. Priority Date: 01/14/1998
• Status: Expired due to Term

• Current Assignee: Calmedica LLC
• Original Assignee: Calmedica LLC
• Inventors: Jackson, Jerome, Schmidlen, Robert L., Chernomorsky, Ary S.
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US09/370,387
• Time in Patent Office: 802 Days
• Field of Search: 600/1-8
• US Class Current: 600/4
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/10184 Means for controlling or monitoring inflation or deflation
• CPC Class Codes: A61M 25/104 used for angioplasty
• 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 5/1007 Arrangements or means for the introduction of sources into the body

Abstract

There is provided a device and a method for irradiating vascular tissues. The device generally includes a transfer device having a first chamber and a second chamber and a piston slidably disposed between the chambers. A ballon catheter is provided for positioning witin the vascular system and is connected to the transfer device such that an inflation lumen of the balloon catheter is in fluid communication with the second chamber. A proximal end of the balloon catheter is affixed to a mounting block which is configured to receive the transfer device. An inflation device is provided to force fluid into the first chamber such that the piston is driven to force a radioactive fluid contained in the second chamber into the balloon.

Claims

1. A system for radiation therapy of a vessel comprising:

a transfer device defining a first chamber at a first end thereof and a second chamber at a second end thereof the transfer device including a piston movably disposed therein and separating the first and second chambers;

a catheter engageable with the transfer device, the catheter including an expandable portion and defining a lumen in communication with the expandable portion;

mounting structure operably associated with the catheter, wherein an interior of the mounting structure is in communication with the lumen and the transfer device; and

a radioactive substance located in one of the first and second chambers of the transfer device and movable between the transfer device and the catheter in response to movement by the piston.

2. A system as recited in claim 1, further comprising a n inflation device removably engageable with the transfer device.

3. A system as recited in claim 1, further comprising an inflation device for providing a first fluid to the first chamber, the inflation device being removably engageable with the first end of the transfer device.

4. A system as recited in claim 1, wherein the expandable portion includes an inflatable balloon.

5. A system as recited in claim 4, wherein the lumen extends from the balloon to a location adjacent a proximal end of the catheter.

6. A system as recited in claim 1, wherein the mounting structure includes a fluid chamber in fluid communication with the lumen.

7. A system as recited in claim 1, wherein the radioactive substance is located in the second chamber and movable between the second chamber and the expandable portion in response to movement of the piston.

8. A system as recited in claim 1, wherein the first chamber of the transfer device has a first predetermined cross-sectional area and the second chamber of the transfer device has a second predetermined cross-sectional area different from the first predetermined cross-sectional area.

9. A system as recited in claim 1, wherein the piston includes a first piston head movably mounted within the first chamber and a second piston head movably mounted within the second chamber.

10. A system as recited in claim 1, wherein the transfer device includes an injection needle extending from the second chamber.

11. A system as recited in claim 10, wherein the injection needle is surrounded by an elastomeric boot.

12. A system as recited in claim 10, wherein the transfer device has a needle shield extending from the second chamber to the second end of the transfer device.

13. A system as recited in claim 12, wherein the needle shield includes a bayonet mount engageable with a corresponding bayonet mount structure on the mounting structure.

14. A system as recited in claim 10, wherein the mounting structure is a mounting block having a self-sealing septum, the septum configured to seal about the injection needle.

15. A system as recited in claim 14, wherein the mounting block includes a chamber in fluid communication with the lumen of the catheter.

16. A system as recited in claim 15, wherein the mounting block has an injection port in fluid communication with the chamber, the septum of the mounting block being mounted on the injection port.

17. A system as recited in claim 14, wherein the mounting block is connected to the second chamber of the transfer device with a proprietary interlock that is electronically coded with respect to the catheter size and function.

18. A system as recited in claim 2, further comprising an over pressure relief valve mounted on the inflation device.

19. A system as recited in claim 1, wherein the radioactive substance includes a beta or gamma emitting radio isotope in liquid or gas form.

20. A system as recited in claim 1, wherein the catheter includes a guide wire lumen extending from a first guide wire port at a distal end of the catheter to a proximal guide wire port located proximal to the expandable portion.

21. A system as recited in claim 20, wherein the proximal guide wire port is adjacent a proximal end of the catheter.

22. A system as recited in claim 3, wherein the first fluid is saline.

23. A method of irradiating vascular tissue comprising the steps of:

providing a balloon catheter, an inflation device and a transfer device, the transfer device having a first chamber and a second chamber and a piston or membrane therein for separating the first and second chambers;

drawing a radioactive substance into the second chamber of the transfer device;

inserting the balloon catheter into a vascular system such that a balloon associated with the balloon catheter is positioned at a stenotic site;

attaching the balloon catheter to the transfer device such that an inflation lumen of the catheter is in fluid communication with the second chamber of the transfer device;

connecting the inflation device to the transfer device such that the inflation device is in fluid communication with the first chamber of the transfer device;

injecting fluid from the inflation device into the first chamber of the transfer device to move the piston or membrane of the transfer device to force the radioactive substance out of the second chamber and into the inflation lumen to inflate the balloon.

24. The method as recited in claim 23, wherein the step of drawing a radioactive substance includes the steps of:

connecting the first chamber of the transfer device to the inflation device;

bringing a source of the radioactive substance into fluid communication with the second chamber of the transfer device; and

actuating the inflation device to apply negative pressure in the first chamber thereby drawing the piston to create a negative pressure in the second chamber to draw the radioactive substance out of the source of the radioactive substance and into the second chamber.

25. The method as recited in claim 24, further comprising the step of disconnecting the transfer device from the inflation device and the source of the radioactive substance.

26. The method as recited in claim 23, further comprising the step of creating a vacuum in the balloon catheter and the inflation lumen prior to the step of inserting the balloon catheter into the vascular system.

27. The method as recited in claim 23, wherein the step of attaching includes affixing a proximal end of the balloon catheter to a mounting block and affixing the transfer device to the mounting block such that of the transfer device is in fluid communication with the inflation lumen of the balloon catheter through the mounting block.

28. The method as recited in claim 23, further comprising the step of providing adequate shielding for an operator and a patient, such shielding being incorporated into at least the balloon catheter.

29. A device for radiation therapy of a vascular system comprising:

a transfer device defining a first chamber at a first end thereof and a second chamber adjacent the first chamber, the transfer device including a piston or membrane movably disposed therein to separate the first and second chambers;

an inflation device containing a first fluid transferable to the first chamber of the transfer device;

a catheter having an inflatable balloon adjacent a distal end of the catheter and defining an inflation lumen extending from the balloon to a location adjacent a proximal end of the catheter; and

a radioactive substance located in the second chamber of the transfer device and movable between the second chamber and the balloon in response to movement of the piston or membrane by actuation of the inflation device.

30. The device as recited in claim 29, wherein the inflation device is removably engageable with the first end of the transfer device.

31. The device as recited in claim 29, further comprising mounting structure removably associated with the balloon catheter and having a fluid chamber in fluid communication with the inflation lumen, the mounting structure being removably engageable with a second end of the transfer device such that the fluid chamber of the mounting structure is in fluid communication with the second chamber of the transfer device.

32. A device for radiation therapy of tissue comprising:

a transfer device defining a first chamber and a second chamber adjacent the first chamber, the transfer device including a partition disposed therein to separate the first and second chambers, the partition being movable within the transfer device in response to a force exerted within the first chamber;

a catheter having an inflatable balloon adjacent a distal end of the catheter and defining an inflation lumen extending from the balloon to a location adjacent a proximal end of the catheter; and

a radioactive substance located in the second chamber of the transfer device and movable between the second chamber and the balloon in response to movement of the partition.

33. A device as recited in claim 32 further comprising a forcing device for providing the force to move the partition of the transfer device.

34. A device as recited in claim 33, wherein the forcing device is configured to provide substance to the first chamber of the transfer device.

35. A device as recited in claim 34, wherein the substance is fluid.

36. A method of irradiating tissue comprising the steps of:

providing a transfer device and a balloon catheter connected to the transfer device, the transfer device having a first chamber and a second chamber and a movable partition therein for separating the first and second chambers, an inflation lumen of the catheter being in fluid communication with the second chamber of the transfer device;

providing a radioactive substance in the second chamber of the transfer device;

inserting the balloon catheter into a body such that a balloon associated with the balloon catheter is positioned at a treatment site; and

forcing a substance in the first chamber of the transfer device to move the partition of the transfer device to thereby force the radioactive substance out of the second chamber and into the inflation lumen to inflate the balloon.

37. A method as recited in claim 36, wherein the step of forcing is exerted by an inflation device connected to the transfer device.

38. A method as recited in claim 36, wherein the step of forcing is performed by forcing fluid in the first chamber of the transfer device.