Single-use external dosimeters for use in radiation therapies

• US 7,557,353 B2
• Filed: 11/25/2002
• Issued: 07/07/2009
• Est. Priority Date: 11/30/2001
• Status: Active Grant

• Current Assignee: SNC Holdings Corp.
• Original Assignee: Sicel Technologies, Inc.
• Inventors: Widener, Steven R., Mann, Gregory Glenwood, Lehman, Phillip M., Black, Robert D.
• Primary Examiner(s): Porta; David P
• Assistant Examiner(s): Taningco; Marcus H
• Application Number:
  US10/303,591
• Publication Number:
  US 20030125616A1
• Time in Patent Office: 2,416 Days
• Field of Search: 250/370.07
• US Class Current: 250/370.07
• 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: G01T 1/026 Semiconductor dose-rate meters

Abstract

Methods, systems, devices, and computer program products include positioning disposable single-use radiation sensor patches that have adhesive means onto the skin of a patient to evaluate the radiation dose delivered during a treatment session. The sensor patches are configured to be minimally obtrusive and operate without the use of externally extending power chords or lead wires.

Claims

1. A method for monitoring radiation doses administered to patients undergoing radiation treatments, comprising the steps of:

releasably securing at least one single-use dosimeter sensor patch comprising an electronic memory held thereon, the patch secured to be in intimate contact with the skin of the patient such that during operation, the patch is self-contained and devoid of wires extending therefrom;

administering radiation to the patient in a first treatment session after the securing step;

contacting the self-contained sensor patch with a dose-reader device after the administering step to obtain data associated with a change in an operational parameter in the dosimeter sensor patch and to obtain data from the electronic memory; and

determining the radiation dose received by the patient during the administering step based on the change in the operational parameter.

2. A method according to claim 1, wherein an underside of the patch comprises an adhesive, and wherein the releasably securing step is carried out by pressing the patch onto the skin so that it adheres thereto.

3. A method according to claim 1, wherein the releasably securing step is carried Out using an adhesive coverlay disposed over the sensor patch such that at least a portion of the adhesive coverlay contacts the skin and adheres the sensor patch thereto.

4. A method according to claim 1, further comprising at least one of calibrating and/or pre-dosing the at least one single-use dosimeter sensor patch before releasably securing the sensor patch onto the skin of the patient.

5. A method according to claim 4, wherein the calibrating step and/or pre-dosing step further comprises calibrating and/or pre-dosing a plurality of sensor patches simultaneously, wherein the plurality of sensor patches are disposed on a unitary sheet of sensor patches that are electrically coupled.

6. A method according to claim 1, further comprising storing the patient'"'"'s determined radiation-dose data in the memory of the sensor patch.

7. A method according to claim 6, further comprising downloading the stored data to a remote computer and/or reader.

8. A method according to claim 1, further comprising sterilizing the single-use dosimeter sensor patch and applying an adhesive to a selected primary surface.

9. A method according to claim 8, further comprising packaging the single-use dosimeter patch in a sterile package suitable for human medical use.

10. A method according to claim 1, wherein the at least one single-use dosimeter patch is a plurality of low-profile discrete flexible single use patches, and wherein the step of releasably securing comprises positioning each patch in a different location about the targeted radiation zone on the patient.

11. A method according to claim 10, further comprising positioning at least one of the patches proximate to a region where radiation is not desired or in radiation sensitive region to detect whether radiation is received in the regions.

12. A method according to claim 10, further comprising:

positioning a second plurality of self-contained dosimeter sensor patches different from the first dosimeter patches to be in intimate contact with the skin of the patient during a second treatment session, the patches of the second plurality of patches comprising an electronic memory held thereon;

administering a second radiation therapy to the patient at a second treatment session;

contacting each of the second plurality of sensor patches with a dose-reader device after the administering step to obtain data associated with a change in an operational parameter in each respective dosimeter sensor patch and to obtain data from the electronic memory thereof; and

determining the radiation dose received by the patient during the administering step based on the change in the operational parameter of the dosimeter sensor patches.

13. A method according to claim 12, further comprising:

disposing of the first plurality of dosimeter sensor patches after the first treatment session; and

disposing of the second plurality of dosimeter patches after the second treatment session.

14. A method according to claim 12, further comprising:

storing the determined radiation dose of the first plurality of dosimeter sensor patches in the electronic memory of the respective patches after the first treatment session to form a patient record of radiation dose; and

storing the determined radiation dose of the second plurality of dosimeter patches in the electronic memory of the respective patches after the second treatment session to form a patient record of radiation dose.

15. A method according to claim 12, wherein the patches are placed in substantially the same locations for the first and second treatments.

16. A method according to claim 10, wherein the determining step includes serially individually physically contacting the sensor patches with the dose-reader device to determine the radiation dose amount for each of the sensor patches.

17. A method according to claim 16, further comprising:

positioning a second plurality of self-contained dosimeter sensor patches onto the patient during a second treatment session subsequent to the first treatment session, the patches having an associated electronic memory thereon;

administering a second radiation therapy to the patient at a second treatment session; and

electronically considering whether there is a different determined value at one or more patch locations between the first and second treatments to identify whether the radiation is properly focused.

18. A method according to claim 10, wherein the patient undergoing treatment has a targeted tumor treatment site, wherein the dosimeter patches are disposed about the tumor site on the front and back of the body, and wherein the dose amount delivered to the tumor site is estimated based on the determined values.

19. A method according to claim 10, further comprising electronically mapping a dose gradient by correlating the determined radiation dose values at each sensor patch to the anatomical location on the subject of each patch.

20. A method according to claim 10, wherein the determining step is carried out to calculate an average or weighted average of the dose amount based on the doses associated with the plurality of patches.

21. A method according to claim 1, wherein contacting the sensor patch with a dose-reader device comprises positioning the sensor patch in a sensor port of the dose-reader device such that there is an electrical coupling between the sensor patch and the dose-reader device.

22. A method according to claim 21, wherein the sensor patch has been adapted to be inserted into the dose-reader device and wherein the dose-reader device has been adapted to receive the sensor patch.

23. A method according to claim 1, wherein contacting the sensor patch with a dose-reader device comprises positioning the dose-reader device such that an electrical coupling is established between the sensor patch and the dose-reader device, wherein the sensor patch includes at least one electrical sensor contact to facilitate the electrical coupling.

24. A method according to claim 1, wherein the dosimeter patch sensor comprises a MOSFET device with an associated threshold voltage which changes when exposed to radiation, and wherein the determining step further includes the step of analyzing the change in the threshold voltage.

25. A method according to claim 24, wherein the method further comprises the step of determining a pre-radiation threshold voltage value stored in the electronic memory of the patch prior to the administering radiation step.

26. A method according to claim 25, further comprising delivering a first set-up verification non-therapeutic radiation dose and obtaining a first radiation dose value for at least one sensor patch after the at least one sensor patch is secured to the patient to confirm that a plurality of beam set-up parameters are correct and/or suitable.

27. A method according to claim 26, wherein the plurality of set-up beam parameters comprise at least one of beam energy, field size, surface to surface distance, electrons and photons.

28. A method according to claim 24, wherein the determining step comprises automatically reducing the value of the post-radiation threshold voltage by the pre-radiation threshold voltage value and electronically comparing to a dose curve to determine the radiation dose.

29. A method according to claim 1, wherein the step of contacting is carried out to obtain measurement methodology from the electronic memory.

30. A method according to claim 1, wherein the at least one patch is a plurality of patches, the method further comprising discarding a sensor patch radiation value or alerting a clinician of potential data corruption if a large variation in dose amount is determined between patches.

31. A method for monitoring radiation doses administered to patients undergoing radiation treatments, comprising the steps of:

releasably securing at least one single-use dosimeter sensor patch onto the skin of the patient such that the patch is self-contained and devoid of wires extending therefrom;

providing an overlay material over the surface of the sensor patch to simulate a subsurface placement of the sensor patch corresponding to a desired distance beneath the skin of the patient;

administering radiation to the patient in a first treatment session;

contacting the sensor patch with a dose-reader device after the administering step to obtain data associated with a change in an operational parameter in the dosimeter sensor patch; and

determining the radiation dose received by the patient during the administering step based on the change in the operational parameter

32. A method according to claim 31, wherein the overlay material is configured to be integrated with the sensor patch.

33. A method according to claim 31, wherein the overlay material comprises a resilient, flexible, skin-like material.

34. A method according to claim 31, wherein forming the overlay material comprises forming the overlay material having a thickness of from about 0.5 to about 3 cm.

35. A method according to claim 34, wherein forming the overlay material comprises forming the overlay material having a thickness of from about 1 to about 1.5 cm.

36. A system for monitoring radiation administered to a patient during a therapeutic treatment, the system comprises:

at least one single-use self-contained dosimeter patch, the patch comprising a body configured to be in intimate contact with skin of a patient, the patch holding a circuit with at least one MOSFET and an external reader contact region thereon, the at least one MOSFET having an associated threshold voltage that changes when exposed to radiation, the body comprising opposing upper and lower primary surfaces; and

an external portable dose-reader being configured to make electrical contact with the patch by physically engaging with the contact region on the patch to obtain voltage threshold data corresponding to the dose amount of radiation exposure it is exposed to in use,

wherein the patch has a perimeter that is devoid of outwardly extending loose lead wires.

37. A system according to claim 36, wherein the at least one patch comprises a tab portion that is configured to be inserted in the external portable dose reader and to make electrical contact therewith.

38. A system according to claim 37, wherein the external portable dose-reader comprises a sensor port, the senor port being configured to receive the tab portion of the patch and make electrical contact therewith to obtain the threshold voltage value associated with the patch.

39. A system according to claim 36, wherein the at least one dosimeter patch is a plurality of discrete sensor patches. each having a substantially conformable resilient body that adhesively attaches to the skin of the patient.

40. A system according to claim 36, wherein the at least one dosimeter patch is a plurality of discrete sensor patches having a substantially conformable resilient body, and wherein the patches are configured to be used concurrently at multiple different positions on the patient.

41. A system according to claim 40, wherein the reader is configured to electronically consider whether there is a different determined value at one or more patch locations to identify whether the radiation is properly focused.

42. A system according to claim 36, wherein the reader has a probe end portion that is configured to penetrate or pierce the body of the patch to make direct electrical contact with the circuit at the reader contact region.

43. A system according to claim 36, wherein the reader further comprises a display for outputting the calculated dose amount, and wherein the reader is configured to serially contact with each respective sensor patch to obtain the threshold voltage value associated therewith before and after use in active radiation therapy.

44. A system according to claim 36, wherein the reader comprises data transfer means to transmit the calculated dose amount to a local or remote controller for electronic storage into a patient'"'"'s records.

45. A system according to claim 36, wherein the patch further comprises an electronic memory storage device that is electrically coupled to the at least one MOSFET, the memory storage device including patient information.

46. A system according to claim 45, wherein the memory storage device comprises an EEPROM.

47. A system according to claim 45, wherein the memory storage device comprises data corresponding to an electronic bias parameter for radiation quantification.

48. A system according to claim 45, wherein the at least one patch is at least one of pre-dosed and/or calibrated prior to placing the at least one patch on the patient and wherein the pre-dosing and/or calibration data is stored in the memory storage device of the patch.

49. A system according to claim 48, wherein a plurality of patches are provided on a unitary sheet, the sheet of patches being at least one of pre-dosed and/or calibrated simultaneously, and wherein the pre-dosing and/or calibration data is stored in the memory storage device of the respective patches.

50. A system according to claim 36, wherein the at least one patch is a plurality of patches, and wherein the dose reader is configured to determine a radiation value for each patch and a delivered dose for each treatment session, the patch being configured to measure between about 1.8-2 Gray per session.

51. A system according to claim 50, wherein the at least one patch is a plurality of patches, and wherein the dose reader is configured to evaluate the individual radiation dose amounts for each patch during each session to generate confirmation of delivered cumulative doses in the range of between 35-80 Gray.

52. A system according to claim 36, wherein the lower primary surface of the patch comprises a medical grade adhesive thereon.

53. A system according to claim 36, wherein the patch comprises a coverlay that includes a medical grade adhesive that is configured to overlie the circuit substrate and hold the sensor patch in position on the patient.

54. A system according to claim 36, wherein the at least one patch is a plurality of patches, and wherein the dose reader is configured to calculate an average or weighted average of the dose amount based on the doses associated with the plurality of patches.

55. A system according to claim 36, wherein the at least one patch is a plurality of patches sealed in at least one sterile package.

56. A system according to claim 36, wherein the at least one patch further comprises an electronic memory storage device configured to electronically store a patients radiation dose data to provide a patient radiation dose record.

57. A system according to claim 36, wherein the at least one patch further comprises an electronic memory storage device configured to electronically store calibration data and measurement methodology of a respective patch readable by the external reader.

58. A system according to claim 36, wherein the reader is configured to evaluate whether the sensor is in a targeted zone of a radiation path to determine if a radiation value departs from a predicted value or statistical norm.

59. A system for monitoring radiation administered to a patient during a therapeutic treatment, the system comprises:

at least one single-use dosimeter patch, the patch comprising a body holding a circuit with at least one MOSFET and an external reader contact region thereon, the at least one MOSFET having an associated threshold voltage that changes when exposed to radiation, the body comprising opposing upper and lower primary surfaces; and

an external portable dose-reader being configured to make electrical contact with the patch by physically engaging with the contact region on the patch to obtain voltage threshold data corresponding to the dose amount of radiation exposure it is exposed to in use,

wherein the patch has a perimeter that is devoid of outwardly extending loose lead wires, and

wherein the at least one MOSFET includes a MOSFET pair, wherein the MOSFET pair are differentially biased during irradiation to create different voltage offsets.

60. A system for monitoring radiation administered to a patient during a therapeutic treatment, the system comprises:

at least one single-use dosimeter patch, the patch comprising a body holding a circuit with at least one MOSFET and an external reader contact region thereon, the at least one MOSFET having an associated threshold voltage that changes when exposed to radiation, the body comprising opposing upper and lower primary surfaces; and

an external portable dose-reader being configured to make electrical contact with the patch by physically engaging with the contact region on the patch to obtain voltage threshold data corresponding to the dose amount of radiation exposure it is exposed to in use,

wherein the patch has a perimeter that is devoid of outwardly extending loose lead wires, and

wherein the at least one MOSFET includes a MOSFET pair, wherein one of the MOSFETs in the pair is selectively implanted with dopant ions to shift the threshold voltage with respect to the other MOSFET and/or to increase the radiation sensitivity of the implanted MOSFET relative to the other MOSFET.

61. A system for monitoring radiation administered to a patient during a therapeutic treatment, the system comprises:

at least one single-use dosimeter patch, the patch comprising a body holding a circuit with at least one MOSFET and an external reader contact region thereon, the at least one MOSFET having an associated threshold voltage that changes when exposed to radiation, the body comprising opposing upper and lower primary surfaces;

an overlay material over the surface of the at least one sensor patch to simulate a subsurface placement of the at least one sensor patch corresponding to a desired distance beneath the skin of the patient; and

an external portable dose-reader being configured to make electrical contact with the patch by physically engaging with the contact region on the patch to obtain voltage threshold data corresponding to the dose amount of radiation exposure it is exposed to in use,

wherein the patch has a perimeter that is devoid of outwardly extending loose lead wires.

62. A system according to claim 61, wherein the overlay material is configured to be integrated with the sensor patch.

63. A system according to claim 61, wherein the overlay material comprises a flexible, resilient, skin-like material.

64. A system according to claim 61, wherein the overlay material has a thickness of from about 0.5 to about 3 cm.

65. A system according to claim 61, wherein the overlay material has a thickness of from about 1 to about 1.5 cm.

66. An oncology single-use external use radiation dosimeter patch, the patch comprising a substantially conformable resilient substrate holding a circuit comprising at least one FET that changes a parameter in a detectable predictable manner when exposed to radiation, and wherein the patch comprises electronic memory that is configured to communicate with an external reader that electronically determines a radiation dose amount based on data from the patch and stores the radiation dose amount in the electronic memory, the body comprising opposing upper and lower primary surfaces, wherein the dosimeter patch, in use and position on a patient, is devoid of externally extending lead wires, and wherein the patch is a single-use self-contained dosimeter patch that is adhesively secured to skin of an oncology patient.

67. A dosimeter patch according to claim 66, wherein the lower primary surface comprises an adhesive thereon.

68. A dosimeter patch according to claim 66, wherein the patch comprises a coverlay that includes a medical grade adhesive that is configured to overlie the circuit substrate and hold the sensor patch in position on the patient.

69. A dosimeter patch according to claim 66, wherein the electronic memory is configured to store a date and time stamp of when the circuit FET threshold voltage was read by the external reader.

70. A dosimeter patch according to claim 69, wherein the electronic memory comprises an EEPROM.

71. A dosimeter patch according to claim 69, wherein the patch is at least one of pre-dosed and/or calibrated and pre-dosing and/or calibration data is stored in the memory storage device.

72. A dosimeter patch according to claim 66, wherein the dosimeter patch is adapted to be inserted into a reader device and electrically couple the reader device to the patch circuit.

73. A dosimeter patch according to claim 66, wherein the circuit at least one FET is at least one MOSFET, wherein the circuit is adapted to engage with an external reader, and wherein the detectable operational parameter that changes is the at least one MOSFET threshold voltage.

74. A dosimeter patch according to claim 73, wherein the at least one MOSFET is configured to electrically short the gate to drain connection.

75. A dosimeter patch according to claim 66, wherein the circuit comprises at least two MOSFETS, a respective one positioned over another on opposing sides of the substrate in face-to-face alignment to inhibit orientation influence of the substrate.

76. A dosimeter patch according to claim 66, wherein the disposable patch is configured to communicate with a reader device wirelessly to obtain measured radiation data.

77. An oncologic external single-use radiation dosimeter patch, the patch comprising a substantially conformable resilient substrate holding a circuit with an operational electronic component that changes a parameter in a detectable predictable manner when exposed to radiation, the body comprising opposing upper and lower primary surfaces, wherein the dosimeter patch, in use, is devoid of externally extending lead wires and wherein the patch is a single-use dosimeter patch that is adhesively secured to the skin of a patient,

wherein the at least one MOSFET is a pair of MOSFETs, wherein one of the MOSFETs in the pair is selectively implanted with dopant ions so as to shift its threshold voltage relative to that of the other MOSFET and/or to increase the sensitivity of the implanted MOSEET relative to the other MOSFET to thereby allow a differential voltage measurement to be obtained to measure radiation.

78. An oncology medical set-of single-use radiation dosimeter patches comprising:

a plurality of discrete single-use self-contained dosimeter patches, each patch comprising a substantially conformable resilient substrate holding a circuit with an operational electronic component that changes a parameter in a detectable predictable manner when exposed to radiation, wherein the patches comprise an electronic memory that engages an external reader to provide calibration data associated with the circuit components and that accepts and stores a calculated radiation dose associated with the patch, the body comprising opposing upper and lower primary surfaces, and wherein the dosimeter patch, in use, is devoid of externally hanging lead wires, and wherein the patches are configured to detect radiation doses in the range of at least from about 10 to about 200 cGy.

79. A set of patches according to claim 78, wherein the lower primary surfaces comprise an adhesive thereon, wherein the patches are substantially planar when viewed from the side, wherein the patches are held in a sterile package prior to use, and wherein at least some of the plurality of patches are used concurrently on a single patient.

80. A set of patches according to claim 78, wherein each patch in the set of patches comprises a coverlay that includes a medical grade adhesive that is configured to overlie the circuit substrate and hold the sensor patch in position on the patient.

81. A set of patches according to claim 78, wherein the sensor patches are configured with identifying indicia thereon, and wherein the electronic memory of the patches is configured to store a date and time stamp associated with when the external reader communicates with a respective patch.

82. A set of patches according to claim 81, wherein the operational electronic component is at least one MOSFET, and wherein the detectable operational parameter that changes is the at least one MOSFET threshold voltage.

83. A set of patches according to claim 78, wherein the calibration data comprises zero dose characterizing data of threshold voltage for the respective patch.

84. A set of patches according to claim 83, wherein the electronic memory is connected to a circuit that allows an external reader to communicate therewith to obtain a patient history record of radiation dose received by a patient during a radiation treatment session.

85. A set of patches according to claim 78, wherein the electronic memory is configured to store patient identification data transmitted by an external reader.

86. A set of patches according to claim 85 wherein each of the sensor patches are configured to detect radiation doses in the range of at least from about 40 to about 70 cGy, and wherein the sensor patches are stored in sterile packaging before use.

87. A set of patches according to claim 78, wherein the sensor patches are configured with a low profile when viewed from the side.

88. A set of patches according to 87, wherein the sensor patches are substantially planar when viewed from the side, and wherein the sensor patches are adhesively releasably attachable to the skin of the patient.

89. A set of patches according to claim 78, wherein the sensor patches are conformable to the skin and substantially planar.

90. A set of patches according to claim 78, wherein the sensor patches are adapted be at least partially inserted into a reader device and electrically connect the reader device to the circuit.

91. A set of patches according to claim 78, wherein the set of patches are disposed on a common sheet and wherein the sheet of patches is at least one of pre-dosed and/or calibrated before the set of patches are exposed to active therapeutic radiation.

92. A set of patches according to claim 91, wherein the set of patches are electrically coupled to each other during calibration and/or pre-dosing.