Guiding a tool for medical treatment by detecting a source of radioactivity

• US 8,239,002 B2
• Filed: 08/10/2006
• Issued: 08/07/2012
• Est. Priority Date: 08/12/2004
• Status: Expired due to Fees

• Current Assignee: Novate Medical Limited (Boston Scientific Corporation)
• Original Assignee: Novate Medical Limited (Boston Scientific Corporation)
• Inventors: Kornblau, Giora, Neustadter, David Maier
• Primary Examiner(s): Cheng, Jacqueline
• Application Number:
  US11/463,664
• Publication Number:
  US 20070055144A1
• Time in Patent Office: 2,189 Days
• Field of Search: 600/424, 600/431, 600/436, 250302-303
• US Class Current: 600/424
• CPC Class Codes: A61B 2034/2068 using pointers, e.g. pointers having reference marks for determining coordinates of body points
• CPC Class Codes: A61B 2090/101 for stereotaxic radiosurgery
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/392 Radioactive markers
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/1127 using markers
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61N 2005/1051 using an active marker markers in general A61B90/39
• CPC Class Codes: A61N 5/1049 for verifying the position of the patient with respect to the radiation beam
• CPC Class Codes: A61N 5/1067 in real time, i.e. during treatment
• CPC Class Codes: A61N 5/1069 Target adjustment, e.g. moving the patient support

Abstract

Systems and methods disclosed provide for guiding a tool using a source of radioactivity. The method includes implanting a source of radioactivity at a position having a geometric relationship to a target tissue, determining at least an indication of a location of the source using at least one radioactivity detecting position sensor, and positioning a tool at a desired relative location with respect to the target tissue based on the determined location.

Claims

1. A method of guiding a tool, the method comprising:

implanting a source of radioactivity at a position having a geometric relationship to a target tissue;

acquiring at least three sets of first and second output signals, respectively, from at least three sets of first and second radiation detectors, each set of first and second radiation detectors configured to respond to ionizing radiation from said source of radioactivity;

determining at least three different planes in which said source of radioactivity resides using the at least three sets of first and second output signals, each plane corresponding to one set of the at least three sets of first and second output signals;

determining at least an indication of a location of said source by calculating an intersection of the at least three different planes; and

positioning a tool at a desired relative location with respect to said target tissue based on said determined location.

2. The method of claim 1, wherein said geometric relationship is known prior to said implanting.

3. The method of claim 1, wherein said geometric relationship is determined after said implanting using imaging.

4. The method of claim 1 comprising:

causing at least a portion of said tool to enter the patient and approach said target tissue.

5. The method of claim 1, wherein positioning comprises maintaining said relative location while at least one of said target and said tool move.

6. The method of claim 1, wherein determining at least three different planes comprises determining a direction.

7. The method of claim 1,

wherein a radioactivity detecting position sensor comprises at least one set of the at least three sets of first and second radiation detectors, and

wherein said radioactivity detecting position sensor generates a direction signal using the respective set of first and second output signals.

8. The method of claim 1, wherein the positioning includes positioning directed by a positioning mechanism.

9. The method of claim 1, wherein the positioning includes manual positioning.

10. The method of claim 1 comprising:

tracking a position of said tool.

11. The method of claim 10, wherein said tracking utilizes a non-ionizing position sensing method.

12. The method of claim 1 comprising:

determining an orientation of said tool.

13. The method of claim 1 comprising:

determining a relative position of said tool and said at least three sets of first and second radiation detectors.

14. The method of claim 1, wherein the determined location is defined as a relative location with respect to the target tissue.

15. The method of claim 1, wherein the source is characterized by an activity which does not cause clinically significant cytotoxicity in a period of 7 days.

16. The method of claim 1, wherein the source is selected from one of:

a source attached to a fixation element and a source integrally formed with a fixation element.

17. The method of claim 1, wherein the source includes a biocompatible outer surface adapted to maintain said source in said geometrical relationship.

18. The method of claim 1, wherein the determined location is determined with an error not exceeding 2 mm.

19. The method of claim 1, wherein the determined location is determined with an error not exceeding 1 mm.

20. The method of claim 1, wherein determining at least an indication of a location comprises determining a series of indications of locations as affected by a physiological motion cycle.

21. The method of claim 20, wherein said physiological motion cycle comprises breathing.

22. The method of claim 20, wherein causing at least a portion of said tool to enter the patient is timed with respect to the physiological motion cycle.

23. The method of claim 1, wherein determining an indication of a location comprises providing a series of temporally defined locations which define a trajectory.

24. The method of claim 1, comprising:

registering a first position coordinate system with a second position coordinate system,

wherein the first position coordinate system is employed by the at least three sets of first and second radiation detectors and the second position coordinate system is employed by the tool.

25. The method of claim 1 comprising:

removing at least a portion of said target tissue with said tool.

26. The method of claim 25 comprising:

repositioning the tool at least one time and removing at least one additional portion of said target tissue.

27. The method of claim 1 comprising:

delivering a therapeutic agent to said target tissue with said tool.

28. The method of claim 1, wherein the positioning includes moving said tool to a desired position.

29. The method of claim 1, wherein the positioning includes subjecting said tool to an angular adjustment.

30. The method of claim 1 comprising:

supporting said patient by a frame mechanically coupled to a radioactivity detecting position sensor,

wherein said radioactivity, detecting position sensor comprises at least one set of the at least three sets of first and second radiation detectors.

31. The method of claim 1 comprising:

attaching a tool control unit to a frame mechanically coupled to a radioactivity detecting position sensor,

wherein said radioactivity detecting position sensor comprises at least one set of the at least three sets of first and second radiation detectors.

32. The method of claim 1 comprising:

providing a radioactivity detecting position sensor within a piece of furniture adapted to hold a patient during therapy,

wherein said radioactivity detecting position sensor comprises at least one set of the at least three sets of first and second radiation detectors.

33. The method of claim 1, wherein said tool provides a light beam.

34. A therapy system, the system comprising:

a position sensing module comprising at least three sets of first and second radiation detectors, wherein each first and second radiation detector of the at least three sets of first and second radiation detectors is

configured to receive ionizing radiation from an implantable radioactive source, and wherein the at least three sets of first and second radiation detectors are configured to generate, respectively, at least three associated sets of first and second output signals;

a processor configured to receive and use the at least three associated sets of first and second output signals from the at least three sets of first and second radiation detectors to determine at least three different planes in which the implantable radioactive source resides, each plane of the at least three different planes corresponding to one set of the at least three associated sets of first and second output signals, the processor further configured to determine an intersection of the at least three different planes and output a position output signal;

control circuitry; and

an output module;

wherein the control circuitry is configured to receive the position output signal, calculate a target location based upon the position output signal, and provide at least an indication of target coordinates to the output module; and

wherein the output module is configured to receive the indication of target coordinates and assist in positioning a tool at the target location.

35. The therapy system of claim 34, wherein said output module comprises:

a tool positioning mechanism configured to position said tool with respect to said target location according to said position output signal.

36. The therapy system of claim 35, wherein said control circuitry is configured to generate said indication of target coordinates based on a desired safety effect.

37. The therapy system of claim 35,

wherein said control circuitry is configured for registering a first position coordinate system with a second position coordinate system, and

wherein the first position coordinate system is associated with the position sensing module and the second position coordinate system is associated with the tool positioning mechanism.

38. The therapy system of claim 35, wherein said tool positioning mechanism is configured to move said tool to a desired position.

39. The therapy system of claim 35, wherein said tool positioning mechanism is configured to subject said tool to an angular adjustment.

40. The therapy system of claim 34, wherein said output module comprises a visual display.

41. The therapy system of claim 34, wherein said control circuitry is configured to generate said indication of target coordinates based on a desired therapeutic procedure.

42. The therapy system of claim 34, wherein the position sensing module is capable of determining a position in less than 1 second and an accuracy of better than 5 mm, and wherein the implantable radioactive source is a source characterized by an activity which does not cause clinically significant cytotoxicity in a period of 7 days.

43. The therapy system of claim 42, wherein the activity is in the range of 1 μ

Ci to 300 μ

Ci.

44. The therapy system of claim 42, wherein the activity is in the range of 1 μ

Ci to 100 μ

Ci.

45. The therapy system of claim 34, wherein at least one set of the at least three sets of first and second radiation detectors comprises at least one radiation shield.

46. The therapy system of claim 45, wherein the at least one set of the at least three sets of first and second radiation detectors comprises a collimator.

47. The therapy system of claim 45, wherein the at least one set of the at least three sets of first and second radiation detectors comprises a differential radiation detector.

48. The therapy system of claim 45, wherein the at least one set of the at least three sets of first and second radiation detectors comprises a rotating radiation sensor with angular sensitivity.

49. The therapy system of claim 34, wherein the indication of target coordinates are provided with an error not exceeding 2 mm.

50. The therapy system of claim 34, wherein the indication of target coordinates are provided with an error not exceeding 1 mm.

51. The therapy system of claim 34, wherein the position output signal comprises data associated with a series of temporally defined sets of coordinates which define a trajectory.

52. The therapy system of claim 34, wherein one of the at least three sets of first and second radiation detectors is installed within a patient support adapted to hold a patient during therapy.

53. Therapy system of claim 52, wherein at least a portion of said position sensing module is positionable within said support.

54. The therapy system of claim 53, wherein at least one set of the at least three sets of first and second radiation detectors is adapted to move independently of at least one other set of the at least three sets of first and second radiation detectors.