Single-use external dosimeters for use in radiation therapies and related methods and systems

• US 7,495,224 B2
• Filed: 06/10/2004
• Issued: 02/24/2009
• Est. Priority Date: 11/30/2001
• Status: Active Grant

• Current Assignee: SNC Holdings Corp.
• Original Assignee: Sicel Technologies, Inc.
• Inventors: Widener, Steven R., Carroll, John
• Primary Examiner(s): Porta; David P
• Assistant Examiner(s): Taningco; Marcus H
• Application Number:
  US10/865,615
• Publication Number:
  US 20040236207A1
• Time in Patent Office: 1,720 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 administered to patients undergoing radiation, comprising the steps of:

releasably securing at least one single-use dosimeter sensor patch comprising electronic memory to be in intimate contact with the skin of the patient such that, during irridation, the patch is self-contained;

obtaining data associated with a change in an operational parameter in the at least one patch electronic memory using a dose reader, the patch electronic memory being configured with data including instructions that direct how the dose reader communicates with the at least one patch and/or obtains data stored in the patch electronic memory; and

determining a radiation dose received by the patient based on the obtained data of the change in the operational parameter.

2. The method of claim 1 wherein obtaining data from the electronic memory comprises wirelessly obtaining data from the patch electronic memory on the at least one patch using the dose reader.

3. The method of claim 1 wherein an underside of the at least one patch comprises an adhesive, and wherein the releasably securing step is carried out by pressing the patch onto the skin so that it conformably adheres thereto.

4. The method of claim 1 wherein releasably securing the sensor patch onto the skin of the patient is preceded by:

at least one of calibrating and/or pre-dosing the at least one patch; and

storing patch specific calibration data in the patch electronic memory of each respective at least one patch.

5. The method of claim 1 further comprising storing radiation-dose data, patient data, time and date of radiation reading, and/or calibration data in the patch electronic memory of the at least one patch.

6. The method of claim 1 wherein the at least one patch comprises a MOSFET device with an associated threshold voltage which changes when exposed to radiation, wherein the threshold voltage is the operational parameter, wherein a post-radiation threshold voltage value of the MOSFET device and a pre-radiation threshold voltage value of the MOSFET device are stored in the patch electronic memory and wherein the determining step further includes analyzing the change in the threshold voltage based on the stored post-radiation threshold voltage value and the stored pre-radiation threshold voltage value of the MOSFET device.

7. The method of claim 6 wherein releasably securing the at least one patch is followed by administering therapeutic radiation to the patient.

8. The method of claim 6 wherein determining a radiation dose further comprises automatically reducing the post-radiation threshold voltage value by the pre-radiation threshold voltage value and automatically comparing to a dose curve to automatically determine the radiation dose.

9. The method of claim 8 wherein determining a radiation dose further comprises automatically prompting a user of the dose reader for predetermined data;

then automatically determining the radiation dose using the predetermined data.

10. The method of claim 9 wherein the predetermined data comprises a correction factor related to the at least one patch.

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

releasably securing at least one single-use dosimeter sensor patch comprising electronic memory to be in intimate contact with the skin of the patient such that, during irradiation, the patch is self-contained;

obtaining data associated with a change in an operational parameter in the at least one patch electronic memory using a dose reader, the patch electronic memory being configured with data including instructions that direct how the dose reader communicates with the at least one patch and/or obtains data stored in the patch electronic memory;

determining a radiation dose received by the patient based on the obtained data of the change in the operational parameter; and

providing a buildup cap on the surface of the at least one patch to simulate a subsurface placement of the at least one patch corresponding to a depth Dmax at which an absorbed dose reaches a maximum for a given energy.

12. The method of claim 11 wherein Dmax corresponds to a distance of from about 1 to about 3 cm beneath the skin of the patient.

13. The method of claim 11 wherein the buildup cap is configured to attach onto the at least one sensor patch, and wherein the lower primary surface of the buildup cap comprises a medical grade adhesive thereon.

14. The method of claim 11 wherein the buildup cap comprises molded polystyrene and a layer of copper on the molded polystyrene.

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

releasably securing at least one single-use dosimeter sensor patch comprising electronic memory to be in intimate contact with the skin of the patient such that, during irradiation, the patch is self-contained;

obtaining data associated with a change in an operational parameter in the at least one patch electronic memory using a dose reader, the patch electronic memory being configured with data including instructions that direct how the dose reader communicates with the at least one patch and/or obtains data stored in the patch electronic memory;

determining a radiation dose received by the patient based on the obtained data of the change in the operational parameter, wherein the at least one patch comprises a MOSFET device;

measuring a zero temperature coefficient of the MOSFET prior to securing the patch on the patient; and

storing the zero temperature coefficient of the MOSFET in the patch electronic memory.

16. The method of claim 15 further comprising:

measuring the pre-radiation threshold voltage value of the MOSFET device;

biasing the MOSFET using the stored zero temperature coefficient after the administering of therapeutic radiation to the patient;

measuring the post-radiation threshold voltage value of the MOSFET device; and

automatically calculating the radiation dose based on the change in threshold voltage of the MOSFET based on the pre-radiation threshold voltage value and the post-radiation threshold voltage value.

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

releasably securing at least one single-use dosimeter sensor patch comprising electronic memory to be in intimate contact with the skin of the patient such that, during irradiation, the patch is self-contained;

administering therapeutic radiation to the patient;

obtaining data associated with a change in an operational parameter in the at least one patch electronic memory using a dose reader, the patch electronic memory being configured with data including instructions that direct how the dose reader communicates with the at least one patch and/or obtains data stored in the patch electronic memory; and

determining a radiation dose received by the patient based on the obtained data of the change in the operational parameter;

wherein the at least one patch comprises a MOSFET device and wherein the MOSFET is not biased during the administration of therapeutic radiation to the patient.

18. An external use radiation dosimeter patch, the patch comprising:

a conformable substrate having opposing upper and lower primary surfaces and holding a circuit with a MOSFET that changes an operational parameter in a detectable predictable manner when exposed to radiation and a patch electronic memory configured with instructions on how to obtain data stored in the patch electronic memory, wherein the patch, in use, is devoid of externally extending lead wires and wherein the patch is a single-use dosimeter patch that is adhesively securable to the skin of a patient.

19. The patch of claim 18 wherein the lower primary surface comprises a medical grade adhesive thereon.

20. The patch of claim 18 further comprising a single MOSFET and wherein the patch electronic memory comprises an electrically erasable programmable read only memory (EEPROM).

21. The patch of claim 20 wherein the patch is at least one of pre-dosed and/or calibrated and associated pre-dosing and/or calibration data is stored in the patch electronic memory.

22. The patch of claim 18 wherein the patch electronic memory further comprises radiation-dose data, patient data, and/or time and date of radiation reading.

23. The patch of claim 18 wherein the circuit is adapted to engage with a reader, wherein the MOSFET is configured to withstand therapeutic doses of radiation, wherein the operational parameter that changes comprises a threshold voltage of the MOSFET which changes when exposed to radiation and wherein the patch electronic memory is further configured to communicate with the reader to automatically determine and store data associated with administering therapeutic radiation to the patient.

24. The patch of claim 23 wherein a post-radiation threshold voltage value of the MOSFET and a pre-radiation threshold voltage value of the MOSFET are stored in the patch electronic memory.

25. The patch of claim 24 wherein the patch electronic memory further comprises a zero temperature coefficient of the MOSFET prior to administering therapeutic radiation to the patient.

26. The patch of claim 18 wherein the patch is configured to make electrical contact with the reader device to obtain data associated with the administrating of therapeutic radiation to the patient.

27. The patch of claim 26 wherein the patch is adapted to be received by the reader device to make electrical contact with the reader device.

28. The patch of claim 18 wherein the disposable patch is configured to wirelessly communicate with a reader device to obtain data associated with the administrating of therapeutic radiation to the patient.

29. An external use radiation dosimeter patch, the patch comprising:

a conformable substrate having opposing upper and lower primary surfaces and holding a circuit with a MOSFET that changes an operational parameter in a detectable predictable manner when exposed to radiation and a patch electronic memory configured with instructions on how to obtain data stored in the patch electronic memory, wherein the patch, in use, is devoid of externally extending lead wires and wherein the patch is a single-use dosimeter patch that is adhesively securable to the skin of a patient, the patch further comprising a buildup cap on the upper primary surface of the patch to simulate a subsurface placement of the patch corresponding to a depth Dmax at which an absorbed dose reaches a maximum for a given energy.

30. The patch of claim 29 wherein Dmax corresponds to a distance of from about 1 to about 3 cm beneath the skin of the patient.

31. The patch of claim 29 wherein the buildup cap is configured to attach onto the upper primary surface of the patch and wherein the lower primary surface of the buildup cap comprises a medical grade adhesive thereon.

32. The patch of claim 29 wherein the buildup cap comprises a layer of molded polystyrene and a layer of copper on the layer of molded polystyrene.

33. An external use radiation dosimeter patch, the patch comprising:

a conformable substrate having opposing upper and lower primary surfaces and holding a circuit with a MOSFET that changes an operational parameter in a detectable predictable manner when exposed to radiation and a patch electronic memory configured with instructions on how to obtain data stored in the patch electronic memory, wherein the patch, in use, is devoid of externally extending lead wires and wherein the patch is a single-use dosimeter patch that is adhesively securable to the skin of a patient, wherein the patch electronic memory further comprises a zero temperature coefficient of the MOSFET prior to administering therapeutic radiation to the patient and wherein the MOSFET is configured to be biased using the stored zero temperature coefficient after the administering of therapeutic radiation to the patient.

34. An external use radiation dosimeter patch, the patch comprising:

a conformable substrate having opposing upper and lower primary surfaces and holding a circuit with a MOSFET that changes an operational parameter in a detectable predictable manner when exposed to radiation and a patch electronic memory configured with instructions on how to obtain data stored in the patch electronic memory, wherein the patch, in use, is devoid of externally extending lead wires and wherein the patch is a single-use dosimeter patch that is adhesively securable to the skin of a patient, wherein the MOSFET is unbiased during administration of therapeutic radiation to the patient.

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

at least one single-use dosimeter patch, the patch comprising a generally conformable body configured to, in position, be in intimate contact with skin of a patient, the patch holding a circuit with a MOSFET, the MOSFET having an associated threshold voltage that changes when exposed to radiation, the body comprising opposing upper and lower primary surfaces and a patch electronic memory configured to include a unique patch identifier; and

a portable dose-reader configured to communicate with the at least one patch to obtain data corresponding to a dose amount of radiation exposure the at least one patch is exposed to in use.

36. The system of claim 35 wherein the at least one dosimeter patch is a plurality of discrete sensor patches having a conformable body, wherein ones of the plurality of discrete sensor patches include a single MOSFET used to detect radiation exposure and wherein the reader is configured to communicate with each respective sensor patch to obtain a pre-radiation threshold voltage value associated with the single MOSFET prior to administering therapeutic radiation therapy to the patient.

37. The system of claim 35 wherein the at least one dosimeter patch is a plurality of discrete sensor patches having a conformable resilient body, and wherein the reader is configured to wirelessly communicate with each respective sensor patch to obtain a post-radiation threshold voltage value associated therewith after use administering therapeutic radiation therapy to the patient.

38. The system of claim 37 wherein the patch electronic memory further comprises detected and/or calculated radiation doses, date and/or time stamps, and/or a clinician entered patient identifier and/or record number.

39. The system of claim 37 wherein the at least one patch is configured with 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 patch electronic memory of the patch.

40. The system of claim 35 wherein the at least one dosimeter patch is a plurality of discrete sensor patches having a conformable resilient body, and wherein the reader is configured to electrically contact each respective sensor patch to obtain a post-radiation threshold voltage value associated therewith after use administering therapeutic radiation therapy to the patient.

41. The system according to claim 35 wherein the patch further comprises a single MOSFET used to detect radiation exposure, wherein the patch electronic memory is electrically coupled to the single MOSFET, wherein the patch electronic memory is configured to further include the obtained threshold voltage measurement data, time and date of radiation measurement and patient data and wherein the reader is further configured to wirelessly communicate with the patch electronic memory to obtain the unique patch identifier, the obtained threshold voltage measurement data, the time and the date of radiation measurement and/or the patient data.

42. The system of claim 41 wherein the patch electronic memory comprises an electrically erasable programmable read only memory (EEPROM) and is configured to store measurement methodology that can instruct the dose reader how to obtain the radiation measurement.

43. The system of claim 42 wherein the patch electronic memory further comprises a post-radiation threshold voltage value of the single MOSFET and a pre-radiation threshold voltage value of the single MOSFET.

44. The system of claim 35 wherein the lower primary surface of the at least one patch comprises a medical grade adhesive thereon.

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

at least one single-use dosimeter patch, the patch comprising a generally conformable body configured to, in position, be in intimate contact with skin of a patient, the patch holding a circuit with a MOSFET, the MOSFET having an associated threshold voltage that changes when exposed to radiation, the body comprising opposing upper and lower primary surfaces and a patch electronic memory configured to include a unique patch identifier; and

a portable dose-reader configured to communicate with the at least one patch to obtain data corresponding to a dose amount of radiation exposure the at least one patch is exposed to in use, wherein the patch electronic memory further comprises a zero temperature coefficient of the MOSFET.

46. The system of claim 45 wherein the MOSFET is configured to be biased using the zero temperature coefficient and wherein the reader is configured to automatically reduce the post-radiation threshold voltage value by the pre-radiation threshold voltage value and automatically compare a result to a dose curve to automatically determine the radiation dose.

47. The system of claim 46 wherein the single MOSFET is unbiased during the administration of therapeutic radiation to the patient.

48. The system of claim 46 wherein the reader is further configured to automatically prompt a user of the reader for predetermined data before determining the radiation dose and to automatically determine the radiation dose using the predetermined data, the voltage data and/or the temperature data.

49. The system of claim 48 wherein the predetermined data comprises a correction factor related to the at least one sensor patch.

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

at least one single-use dosimeter patch, the patch comprising a generally conformable body configured to, in position, be in intimate contact with skin of a patient, the patch holding a circuit with a MOSFET, the MOSFET having an associated threshold voltage that changes when exposed to radiation, the body comprising opposing upper and lower primary surfaces and a patch electronic memory configured to include a unique patch identifier;

a portable dose-reader configured to communicate with the at least one patch to obtain data corresponding to a dose amount of radiation exposure the at least one patch is exposed to in use; and

a buildup cap on a surface of the at least one sensor patch to simulate a subsurface placement of the at least one sensor patch corresponding to a depth Dmax at which an absorbed dose reaches a maximum for a given energy.

51. The system of claim 50 wherein Dmax corresponds to a distance of from about 1 to about 3 cm beneath the skin of the patient.

52. The system of claim 50 wherein the buildup cap comprises a hemispherical shape and is configured to attach to the at least one sensor patch and wherein the lower primary surface of the buildup cap comprises a medical grade adhesive thereon.

53. The system of claim 50 wherein the buildup cap comprises a layer of molded polystyrene and a layer of copper on the layer of molded polystyrene.

54. The system of claim 53 wherein the copper layer has a thickness of from about 0.5 to about 1 mm.

55. The system of claim 53 wherein the polystyrene has a diameter of from about 6 to about 7 mm.