System and method for directing and monitoring radiation

• US 6,431,175 B1
• Filed: 05/06/1999
• Issued: 08/13/2002
• Est. Priority Date: 12/30/1997
• Status: Expired due to Term

• Current Assignee: Remon Medical Technologies Ltd. (Boston Scientific Corporation)
• Original Assignee: Remon Medical Technologies Ltd. (Boston Scientific Corporation)
• Inventors: Penner, Avi, Porat, Yariv, Doron, Eyal
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US09/305,442
• Time in Patent Office: 1,195 Days
• Field of Search: 600/1-3, 128/897-99, 128/903
• US Class Current: 128/899
• CPC Class Codes: A61B 2562/028 Microscale sensors, e.g. electromechanical sensors [MEMS]
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/413 Monitoring transplanted tissue or organ, e.g. for possible rejection reactions after a transplant
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 2005/1072 taking into account movement of the target
• 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
• CPC Class Codes: H04R 17/00 Piezoelectric transducers; Electrostrictive transducers piezoelectric or electrostrictive elements in general H10N30/00; details of piezoelectric or electrostrictive motors, generators or positioners H10N30/00
• CPC Class Codes: H10N 30/302 Sensors

Abstract

A system for monitoring, directing and controlling the dose of radiation in a medical procedure for irradiating a specific region of a patient'"'"'s body. In its generic form, the system includes at least one sensor being implantable within, or in proximity to, the specific region of the patient'"'"'s body, the at least one sensor being for sensing at least one parameter associated with the radiation. The system further includes a relaying device which is in communication with the sensor(s). The relaying device serves for relaying the information outside of the patient'"'"'s body.

Claims

1. A system for use in a medical procedure, said medical procedure utilizes radiation for irradiating a specific region of a patient'"'"'s body, the system comprising:

(a) at least one sensor adapted to be implanted within, or in proximity to, the specific region of the patient'"'"'s body, said at least one sensor adapted for sensing at least one parameter associated with the radiation; and

(b) a relaying device being in communication with said at least one sensor, said relaying device including a transducer unit designed for transducing an interrogating signal generated outside the body into a first electrical signal for powering said at least one sensor and for receiving a second electrical signal pertaining to said at least one parameter from said at least one sensor and transducing said second electrical signal into a signal transmitted outside the body thereby relaying information pertaining to said at least one parameter and therefore to said radiation outside of the patient'"'"'s body.

2. The system of claim 1 wherein said relaying device further includes a processor communicating with said at least one sensor.

3. The system of claim 1, wherein each of said at least one sensor has an identification code associated therewith.

4. The system of claim 2, wherein said processor is adapted for intrabody use.

5. The system of claim 2, wherein said processor is adapted for extracorporeal use.

6. The system of claim 1, wherein said relaying device is adapted for intrabody implantation.

7. The system of claim 6, further comprising an extracorporeal monitoring unit telemetrically communicating with said at least one sensor via said implantable telemetry device.

8. The system of claim 1, wherein said transducer unit is an acoustic transducer unit, said interrogating signal is an acoustic interrogating signal, and said signal which can be received outside the body is an acoustic signal.

9. The system of claim 8, wherein said acoustic transducer unit includes:

(i) a cell member having a cavity;

(ii) a substantially flexible piezoelectric layer attached to said cell member, said piezoelectric layer having an external surface and an internal surface, said piezoelectric layer featuring such dimensions so as to enable fluctuations thereof at its resonance frequency upon impinging of an external acoustic; and

(iii) a first electrode attached to said external surface and a second electrode attached to said internal surface.

10. The system of claim 1, wherein said transducer unit is a radio transducer unit, said interrogating signal is a radio interrogating signal, and said signal which can be received outside the body is a radio signal.

11. The system of claim 10, wherein said at least one sensor and said radio transducer unit are intrabodily wired so as to enable transplanting said radio transducer unit close to the skin, while at the same time transplanting said at least one sensor deeper within the body of the patient.

12. The system of claim 1, further comprising an extracorporeal monitoring unit telemetrically bidirectionally communicating with said transducer unit via said interrogating signal and said signal transmitted outside the body.

13. The system of claim 1, wherein said at least one sensor is adapted for sensing at least one parameter associated with a radiation selected from the group consisting of an ultrasonic radiation and electromagnetic radiation.

14. The system of claim 13, wherein said electromagnetic radiation is selected from the group consisting of alpha radiation, beta radiation, gamma radiation, X-ray radiation and neutron radiation.

15. The system of claim 13, wherein said electromagnetic radiation is selected from the group consisting of microwave radiation, visible light radiation, ultraviolet radiation and infrared radiation.

16. The system of claim 1, wherein said at least one sensor is adapted for sensing at least one parameter associated with a radiation used for treating a medical disorder characterized by abnormal cell proliferation.

17. The system of claim 16, wherein said radiation is used for treating a medical disorder selected from the group consisting of a tumor, a cancer, a thrombus and restenosis.

18. The system of claim 1, wherein said at least one sensor is selected from the group consisting of a temperature sensor, an electromagnetic radiation sensor, an acoustic radiation sensor, a light sensor, and an electromagnetic field sensor.

19. The system of claim 1, wherein said at least one parameter is directly associated with said radiation, thereby said at least one sensor directly senses said radiation.

20. The system of claim 1, wherein said at least one parameter is indirectly associated with said radiation, thereby said at least one sensor indirectly senses an interaction of said radiation with the body.

21. The system of claim 1, wherein said at least one sensor is selected from the group consisting of a scintillation crystal sensor and a solid state semi-conductor sensor.

22. In a medical procedure utilizing radiation for irradiating a specific region of a patient'"'"'s body, a method of monitoring the radiation comprising the steps of:

(a) implanting at least one sensor within, or in proximity to, the specific region of the patient'"'"'s body, said at least one sensor being for sensing at least one parameter associated with the radiation; and

(b) relaying outside the patient'"'"'s body, during the course of the procedure, information pertaining to said at least one parameter.

23. The method of claim 22, further comprising the step of processing said information prior to or following step (b).

24. The method of claim 22, further comprising identifying each of said at least one sensor prior to, concomitant with or following step (b).

25. The method of claim 22, wherein the step of relaying outside the patient'"'"'s body, during the course of the procedure, said information pertaining to said at least one parameter is effected by acoustic or radio transmission.

26. The method of claim 25, wherein step (b) is effected by transducing an interrogating signal generated outside the body into a first electrical signal for powering said at least one sensor and receiving a second electrical signal from said at least one sensor, transducing said second signal into a signal relayed outside the body, said signal including said information pertaining to said at least one parameter.

27. The method of claim 26, wherein said transducing said interrogating signal and said second electrical signal is effected by at least one acoustic transducer unit.

28. The method of claim 27, wherein said at least one acoustic transducer unit includes:

(i) a cell member having a cavity;

(ii) a substantially flexible piezoelectric layer attached to said cell member, said piezoelectric layer having an external surface and an internal surface, said piezoelectric layer featuring such dimensions so as to enable fluctuations thereof at its resonance frequency upon impinging of an external acoustic wave; and

(iii) a first electrode attached to said external surface and a second electrode attached to said internal surface.

29. The method of claim 26, wherein said at least one transducer unit is a radio transducer unit, said interrogating signal is a radio interrogating signal, and said signal receivable outside the body is a radio signal.

30. The method of claim 22, wherein said at least one sensor is selected from the group consisting of a temperature sensor, an electromagnetic radiation sensor, an acoustic radiation sensor, a light sensor, and an electromagnetic field sensor.

31. The method of claim 22, wherein said at least one parameter is directly associated with said radiation, thereby said at least one sensor directly senses said radiation.

32. The method of claim 22, wherein said at least one parameter is indirectly associated with said radiation, thereby said at least one sensor indirectly senses an interaction of said radiation with the body.

33. The method of claim 22, wherein said at least one sensor is battery powered and further wherein said step of relaying outside the patient'"'"'s body, during the course of the procedure, said information pertaining to said at least one parameter is effected by a transmitter.

34. In a medical procedure utilizing radiation for irradiating a specific region of a patient'"'"'s body, a method of directing the radiation relative to the specific region of the patient'"'"'s body, the method comprising the steps of:

(a) implanting at least one sensor within, or in proximity to, the specific region of the patient'"'"'s body, said at least one sensor being adapted for sensing at least one parameter associated with the radiation; and

(b) providing outside the body a radiation control feedback element communicating with a source of said radiation and with said at least one sensor, said radiation control feedback element serves for directing said radiation in a desired direction relative to the specific region of the patient'"'"'s body; and

(c) relaying, during the course of the procedure, information pertaining to said at least one parameter from said at least one sensor to said radiation control feedback element for effecting said step of directing said radiation in a desired direction relative to the specific region of the patient'"'"'s body.

35. The method of claim 34, further comprising the step of processing said information prior to or following step (c).

36. The method of claim 34, further comprising identifying each of said at least one sensor prior to, concomitant with or following step (c).

37. The method of claim 34, further comprising the step of processing said information prior to or following step (c).

38. The method of claim 34, wherein step (c) is effected by transducing an interrogating signal generated outside the body into a first electrical signal for powering said at least one sensor and receiving a second electrical signal from said at least one sensor, transducing said second signal into a signal relayed outside the body, said signal including said information pertaining to said at least one parameter.

39. The method of claim 38, wherein said transducing said interrogating signal and said second electrical signal is effected by at least one acoustic transducer unit.

40. The method of claim 39, wherein said at least one acoustic transducer unit includes:

(i) a cell member having a cavity;

(ii) a substantially flexible piezoelectric layer attached to said cell member, said piezoelectric layer having an external surface and an internal surface, said piezoelectric layer featuring such dimensions so as to enable fluctuations thereof at its resonance frequency upon impinging of an external acoustic wave; and

(iii) a first electrode attached to said external surface and a second electrode attached to said internal surface.

41. The method of claim 38, wherein said at least one transducer unit is a radio transducer unit, said interrogating signal is a radio interrogating signal, and said signal receivable outside the body is a radio signal.

42. The method of claim 34, wherein said at least one sensor is selected from the group consisting of a temperature sensor, an electromagnetic radiation sensor, an acoustic radiation sensor, a light sensor, and an electromagnetic field sensor.

43. The method of claim 34, wherein said at least one parameter is directly associated with said radiation, thereby said at least one sensor directly senses said radiation.

44. The method of claim 34, wherein said at least one parameter is indirectly associated with said radiation, thereby said at least one sensor indirectly senses an interaction of said radiation with the body.

45. The method of claim 34, wherein said at least one sensor is selected from the group consisting of a scintillation crystal sensor and a solid state semi-conductor sensor.

46. The method of claim 34, wherein said at least one sensor is battery powered and further wherein said step of relaying, during the course of the procedure, said information pertaining to said at least one parameter from said at least one sensor to said radiation control feedback element is effected by a transmitter.

47. In a medical procedure utilizing radiation for irradiating a specific region of a patient'"'"'s body, a method of controlling a dose of radiation applied to the specific region of the patient'"'"'s body, the method comprising the steps of:

(a) implanting at least one sensor within, or in proximity to, the specific region of the patient'"'"'s body, said at least one sensor being adapted for sensing at least one parameter associated with the radiation; and

(b) providing outside the body a radiation control feedback element communicating with a source of said radiation and with said at least one sensor, said radiation control feedback element serves for controlling the dose of radiation being applied to the specific region of the patient'"'"'s body; and

(c) relaying, during the course of the procedure, information pertaining to said at least one parameter from said at least one sensor to said radiation control feedback element for effecting said step of controlling the dose of radiation being applied to the specific region of the patient'"'"'s body.

48. The method of claim 47, further comprising the step of processing said information prior to or following step (c).

49. The method of claim 47, further comprising identifying each of said at least one sensor prior to, concomitant with or following step (c).

50. The method of claim 47, wherein step (c) is effected by transducing an interrogating signal generated outside the body into a first electrical signal for powering said at least one sensor and receiving a second electrical signal from said at least one sensor, transducing said second signal into a signal relayed outside the body, said signal including said information pertaining to said at least one parameter.

51. The method of claim 50, wherein said transducing said interrogating signal and said second electrical signal is effected by at least one acoustic transducer unit.

52. The method of claim 51, wherein said at least one acoustic transducer unit includes:

(i) a cell member having a cavity;

(ii) a substantially flexible piezoelectric layer attached to said cell member, said piezoelectric layer having an external surface and an internal surface, said piezoelectric layer featuring such dimensions so as to enable fluctuations thereof at its resonance frequency upon impinging of an external acoustic wave; and

(iii) a first electrode attached to said external surface and a second electrode attached to said internal surface.

53. The method of claim 51, wherein said at least one transducer unit is a radio transducer unit, said interrogating signal is a radio interrogating signal, and said signal receivable outside the body is a radio signal.

54. The method of claim 47, wherein said at least one sensor is selected from the group consisting of a temperature sensor, an electromagnetic radiation sensor, an acoustic radiation sensor, a light sensor, and an electromagnetic field sensor.

55. The method of claim 47, wherein said at least one parameter is directly associated with said radiation, thereby said at least one sensor directly senses said radiation.

56. The method of claim 47, wherein said at least one parameter is indirectly associated with said radiation, thereby said at least one sensor indirectly senses an interaction of said radiation with the body.

57. The method of claim 47, wherein said at least one sensor is selected from the group consisting of a scintillation crystal sensor and a solid state semi-conductor sensor.

58. The method of claim 47, wherein said at least one sensor is battery powered and further wherein said step of relaying, during the course of the procedure, said information pertaining to said at least one parameter from said at least one sensor to said radiation control feedback element is effected by a transmitter.

59. A system for use in a medical procedure, said medical procedure utilizes radiation for irradiating a specific region of a patient'"'"'s body, the system comprising:

(a) at least one sensor being implantable within, or in proximity to, the specific region of the patient'"'"'s body, said at least one sensor being for sensing at least one parameter associated with the radiation, said at least one sensor having an identification code associated therewith; and

(b) a relaying device being in communication with said at least one sensor, said relaying device being for relaying information pertaining to said at least one parameter and therefore to said radiation outside of the patient'"'"'s body.

60. A system for use in a medical procedure, said medical procedure utilizes radiation for irradiating a specific region of a patient'"'"'s body, the system comprising:

(a) at least one sensor being implantable within, or in proximity to, the specific region of the patient'"'"'s body, said at least one sensor being for sensing at least one physiological parameter associated with the radiation; and

(b) a relaying device being in communication with said at least one sensor, said relaying device being for relaying information pertaining to said at least one parameter and therefore to said radiation outside of the patient'"'"'s body.

61. A system for use in a medical procedure, said medical procedure utilizes radiation for irradiating a specific region of a patient'"'"'s body, the system comprising:

(a) at least one sensor being implantable within, or in proximity to, the specific region of the patient'"'"'s body, said. at least one sensor being for sensing at least one parameter associated with the radiation;

(b) a power source for powering said at least one sensor to thereby enable sensing said at least one parameter associated with the radiation; and

(c) a relaying device being in communication with said at least one sensor, said relaying device being for relaying information pertaining to said at least one parameter and therefore to said radiation outside of the patient'"'"'s body.

62. A system for use in a medical procedure, said medical procedure utilizes radiation for irradiating a specific region of a patient'"'"'s body, the system comprising:

(a) at least one sensor being implantable within, or in proximity to, the specific region of the patient'"'"'s body, said at least one sensor being for sensing at least one parameter associated with the radiation; and

(b) a relaying device being in communication with said at least one sensor, said relaying device being for relaying information pertaining to said at least one parameter and therefore to said radiation outside of the patient'"'"'s body; and

(c) an extracorporeal monitoring unit communicating with said relaying device, said extracorporeal monitoring unit serves for receiving information pertaining to said at least one parameter, said extracorporeal monitoring unit including a radiation control feedback element, said radiation control feedback element communicating with a source of the radiation and being for directing the radiation in a desired direction relative to said at least one sensor and/or for controlling a radiation dose applied to the specific region of the patient'"'"'s body.

63. A implant for use in a medical procedure, the medical procedure utilizing radiation for irradiating a specific region of a patient'"'"'s body, the implant comprising:

(a) an implant body being adapted for intrabody implantation;

(b) at least one sensor being attached to, or forming a part of said implant body, said at least one sensor being for sensing at least one parameter associated with the radiation; and

(c) a relaying device being in communication with said at least one sensor, said relaying device being for relaying information pertaining to said at least one parameter and therefore to said radiation outside of the patient'"'"'s body.

64. A system for use in a medical procedure, said medical procedure utilizes radiation for irradiating a specific region of a patient'"'"'s body, the system comprising:

(a) at least one sensor adapted to be implanted within, or in proximity to, the specific region of the patient'"'"'s body, said at least one sensor adapted for sensing at least one parameter associated with the radiation; and

(b) a relaying device being in communication with said at least one sensor, said relaying device including at least one first transducer unit designed for transducing an interrogating signal generated outside the body into a first electrical signal for powering said at least one sensor and at least one second transducer unit for receiving a second electrical signal pertaining to said at least one parameter from said at least one sensor and transducing said second electrical signal into a signal transmitted outside the body thereby relaying information pertaining to said at least one parameter and therefore to said radiation outside of the patient'"'"'s body.

65. The system of claim 64, wherein said at least one first transducer unit and said at least one second transducer unit are each independently selected from the group consisting of an acoustic transducer unit and an RF transducer unit.