Implantable radiotherapy/brachytherapy radiation detecting apparatus and methods

• US 20050101824A1
• Filed: 11/07/2003
• Published: 05/12/2005
• Est. Priority Date: 11/07/2003
• Status: Active Grant

• Current Assignee: Cytyc Corporation (Hologic Incorporated)
• Original Assignee: Proxima Therapeutics, Inc.
• Inventors: Stubbs, James B.
• Granted Patent: US 7,354,391 B2
• Time in Patent Office: Days
• US Class Current: 600/3
• CPC Class Codes: A61N 5/1015 Treatment of resected cavities created by surgery, e.g. lumpectomy
• CPC Class Codes: A61N 5/1048 Monitoring, verifying, controlling systems and methods
• CPC Class Codes: A61N 5/1071 for verifying the dose delivered by the treatment plan

Abstract

An interstitial brachytherapy apparatus and method for delivering and monitoring radioactive emissions delivered to tissue surrounding a resected tissue cavity. The brachytherapy device including a catheter body member having a proximal end, a distal end, and an outer spatial volume disposed proximate to the distal end of the body member. A radiation source is disposed in the outer spatial volume and a treatment feedback sensor is provided on the device. In use, the treatment feedback sensor can measure the radiation dose delivered from the radiation source.

Claims

1. A brachytherapy apparatus for delivering and monitoring radioactive emissions to an internal body location, comprising:

a catheter body member having a proximal end, a distal end, and an outer spatial volume disposed proximate to the distal end of the body member;

a radiation source disposed in the outer spatial volume; and

a radiation sensor provided on the device;

wherein the radiation sensor measures the radiation delivered from the radiation source.

2. The apparatus of claim 1, wherein the radiation sensor is positioned within the catheter body member.

3. The apparatus of claim 2, wherein the radiation sensor is positioned in the center of the outer spatial volume.

4. The apparatus of claim 1, wherein the radiation sensor is positioned within the outer spatial volume

5. The apparatus of claim 1, wherein the outer spatial volume is defined by an expandable surface member and the radiation sensor is mated with the expandable surface.

6. The apparatus of claim 1, wherein an additional radiation sensor is positioned outside the brachytherapy device.

7. The apparatus of claim 1, wherein the outer spatial volume is defined by an expandable surface member.

8. The apparatus of claim 7, wherein the radiation source generates a three-dimensional isodose profile that is substantially similar in shape to the expandable surface member.

9. The apparatus of claim 8, wherein output from the sensor is used to verify that a three-dimensional isodose profile substantially similar in shape to the expandable surface member is delivered to adjacent tissue.

10. The apparatus of claim 8, wherein the radiation sensor is mated with the expandable surface member.

11. The apparatus of claim 1, wherein the brachytherapy device generates an asymmetric isodose radiation profile.

12. The apparatus of claim 1, wherein an inner spatial volume is disposed within the outer spatial volume.

13. The apparatus of claim 12, wherein the radiation source is disposed within the inner spatial volume.

14. The apparatus of claim 13, wherein the inner and outer spatial volumes are defined by inner and outer balloons.

15. The apparatus of claim 14, wherein at least one radiation sensor is positioned on the inner and the outer balloon.

16. The apparatus of claim 1, wherein the radiation source is a solid radiation source.

17. The apparatus of claim 16, wherein the radiation sensor is positioned on the catheter body member at a position in the longitudinal direction where it is desired to position the radiation source.

18. The apparatus of claim 1, wherein the brachytherapy apparatus is an interstitial brachytherapy apparatus.

19. The apparatus of claim 1, wherein more than one radiation sensor is provided.

20. The apparatus of claim 19, wherein a radiation sensor is positioned in tissue adjacent to the device.

21. The apparatus of claim 19, wherein a radiation sensor is positioned on the wall of the resected tissue cavity.

22. The apparatus of claim 1, wherein the radiation delivered from the radiation source is altered if the radiation dose is outside a prescribed range.

23. A radiation therapy apparatus for delivering and monitoring radioactive emissions to a resected tumor cavity, comprising:

a catheter body member having a proximal end, a distal end, and an expandable surface member disposed proximate to the distal end of the catheter body member;

an external radiation source positionable outside the resected tissue cavity; and

a radiation sensor;

wherein expandable surface member can be positioned within a resected tissue cavity and expanded to position the surrounding tissue such that the delivery of a radiation beam from the external radiation source is accurately delivered and measured by the radiation sensor positioned within the tissue cavity.

24. The apparatus for claim 23, wherein the radiation sensor is positioned within the catheter body member.

25. The apparatus of claim 23, wherein the radiation sensor is positioned on the expandable surface member.

26. A method for delivering and monitoring radioactive emissions to an internal body location, comprising:

inserting a brachytherapy device into a resected cavity, the brachytherapy device including a catheter body member with proximal and distal ends, an expandable surface member disposed proximate to the distal end of the catheter body member, and a radiation source disposed within the expandable surface member;

inserting a radiation sensor into the resected cavity;

delivering a minimum prescribed absorbed radiation dose for therapeutic effects to a target tissue, the target tissue being defined between the expandable surface member and a minimum distance outward from the expandable surface member; and

sensing the radiation dose;

whereby output from the sensor confirms that the brachytherapy device delivers the minimum prescribed dose.

27. The method of claim 26, wherein the brachytherapy device provides a controlled dose at the expandable surface member to reduce or prevent necrosis in healthy tissue proximate to the expandable surface.

28. The method of claim 26, wherein the radiation sensor is positioned on the brachytherapy device.

29. The method of claim 28, wherein the radiation sensor is positioned on the expandable surface member.

30. The method of claim 28, wherein the radiation sensor is positioned within the catheter body member.

31. The method of claim 26, wherein more than one sensor is used with the device.

32. The method of claim 31, wherein one sensor is positioned on the wall of the resected cavity.

33. The method of claim 31, wherein one sensor is positioned in tissue adjacent to the device.

34. The method of claim 26, wherein data collected from sensing the radiation dose is used to confirm that the delivered radiation dose is within a prescribed dose range.

35. The method of claim 26, wherein a user is alerted if the radiation dose is outside the prescribed dose range.

36. The method of claim 35, wherein the radiation dose is altered if the sensed radiation dose is outside the prescribed dose range.

37. The method of claim 26, wherein the brachytherapy device delivers an asymmetrical dose of radiation such that radiation sensitive tissue adjacent to the device is shielded and a radiation sensor is positioned between the brachytherapy device and the radiation sensitive tissue.

38. A brachytherapy apparatus for delivering radioactive emissions to an internal body location, comprising:

a catheter body member having a proximal end, a distal end, and an outer spatial volume disposed proximate to the distal end of the body member;

a radiation source disposed in the outer spatial volume; and

a treatment feedback sensor provided on the device;

wherein the treatment feedback sensor can be used to evaluate the treatment of proliferative tissue disorders.

39. The apparatus of claim 38, wherein the treatment feedback sensor measures the radiation delivered from the radiation source.

40. The apparatus of claim 39, wherein an additional treatment feedback sensor is positioned outside the brachytherapy device.

41. The apparatus of claim 38, wherein the treatment feedback sensor detects the delivery of a supplemental treatment.

42. The apparatus of claim 41, wherein the treatment feedback sensor monitors the delivery of a treatment agent to the surrounding tissue.

43. The apparatus of claim 38, wherein the treatment feedback sensor measures one of the characteristics selected from the group consisting of, tissue temperature, oxygenation, pH, treatment agent concentration, and cytokine concentration.

44. The apparatus of claim 43, wherein the outer spatial volume is defined by a permeable balloon and the treatment feedback sensor detects a treatment agent which is capable of permeating through the wall of the permeable balloon.

45. The apparatus of claim 38, wherein the outer spatial volume is defined by an expandable surface member and the treatment feedback sensor is mated with the expandable surface.

46. The apparatus of claim 38, wherein the treatment feedback sensor is positioned within the catheter body member.

47. A method for delivering radioactive emissions to an internal body location, comprising:

inserting a brachytherapy device into a resected cavity, the brachytherapy device including a catheter body member with proximal and distal ends, an expandable surface member disposed proximate to the distal end of the catheter body member, and a radiation source disposed within the expandable surface member;

inserting a treatment feedback sensor into the resected cavity;

delivering a minimum prescribed absorbed radiation dose for therapeutic effects to a target tissue, the target tissue being defined between the expandable surface member and a minimum distance outward from the expandable surface member; and

sensing the adjacent tissue;

whereby output from the sensor is used to monitor the effectiveness of the therapeutic radiation dose.

48. The method of claim 47, wherein the brachytherapy device provides a controlled dose of radiation at the expandable surface member to reduce or prevent necrosis in healthy tissue proximate to the expandable surface.

49. The method of claim 47, wherein the treatment feedback sensor is positioned on the brachytherapy device.

50. The method of claim 47, wherein the treatment feedback sensor is positioned on the expandable surface member.

51. The method of claim 47, wherein the treatment feedback sensor is positioned on the wall of the resected cavity.

52. The method of claim 47, wherein treatment feedback sensor is positioned in tissue adjacent to the device.

53. The method of claim 47, wherein a user is alerted if the radiation dose is outside the prescribed dose range.

54. The method of claim 53, wherein the radiation dose is altered if the sensed radiation dose is outside the prescribed dose range.

55. The method of claim 47, wherein the treatment feedback sensor measures one of the characteristics selected from the group consisting of, tissue temperature, oxygenation, pH, treatment agent concentration, and cytokine concentration.

56. The method of claim 47, wherein a treatment agent is delivered to tissue surrounding the device.

57. The method of claim 56, wherein the treatment feedback sensor monitors the delivery of the treatment agent.