Equipment and method for calibration and quality assurance of an ultrasonic bone anaylsis apparatus

• US 5,755,228 A
• Filed: 09/26/1995
• Issued: 05/26/1998
• Est. Priority Date: 06/07/1995
• Status: Expired due to Fees

• Current Assignee: Hologic Incorporated
• Original Assignee: Hologic Incorporated
• Inventors: O'Brien, John P., Stein, Jay A., Wilson, Kevin E., Barry, Donald, Lamser, Dennis G.
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US08/534,131
• Time in Patent Office: 973 Days
• Field of Search: 128/660.01, 128/660.02, 128/660.06, 128/661.03, 73/599, 73/602
• US Class Current: 600/459
• CPC Class Codes: A61B 5/1074 Foot measuring devices
• CPC Class Codes: A61B 8/0875 for diagnosis of bone A61B5/4504 takes precedence
• CPC Class Codes: A61B 8/587 Calibration phantoms models for medical purposes G09B23/28

Abstract

An improvement to calibration and quality assurance of an ultrasonic bone analysis apparatus is achieved by using phantoms. A received ultrasound signal that passed through a first phantom is used as a baseline for calculating BUA. The first phantom has an attenuation-versus-frequency profile that is substantially flat in a frequency range of 200 to 1000 kHz and a sound impedance that approximates that of soft human tissue. A propagation time of the signal is used to calibrate a zero point of the apparatus. A second phantom has an attenuation in a frequency range of 200-1000 kHz which approximates that of a human foot, including an attenuation-versus-frequency profile that is substantially linear in the frequency range of 200-600 kHz and is approximately 1 dB/MHz per mm. A received ultrasound signal that passed through the second phantom is used to calibrate the apparatus for a BUA calculation, and can also be used for at least one of determining and correcting a drift of the apparatus. A third phantom has a predetermined SOS that is substantially independent of temperature. A received ultrasound signal that passed through the third phantom is used to calibrate the apparatus for a SOS calculation, and can also be used for at least one of determining and correcting instrument drift. An ultrasonic signal is transmitted through mutually touching transducer pads. The received signal is used as a baseline for calculating BUA. A measurement of the propagation time of the received signal is compared with a temporally-proximate measurement of an ultrasonic signal that passed through a patient'"'"'s heel to determine a time of propagation through the heel.

Claims

1. A phantom for an ultrasound bone analysis apparatus having a foot well and a plurality of transducer pads, comprising:

a plug cast having a plurality of indentations located on a respective plurality of opposite sides thereof, the plurality of indentations having a respective plurality of shapes complementary to a respective plurality of shapes of the respective plurality of transducer pads, the plug also having an attenuation-versus-frequency profile that is substantially flat in a frequency range of between about 200 kHz and about 1000 kHz and a sound impedance that approximates that of soft human tissue.

2. The phantom according to claim 1, wherein a speed of sound through the plug is predetermined.

3. The phantom according to claim 1, wherein the plug is made of an elastomeric material.

4. The phantom according to claim 1, wherein the plug is made of an elastomeric castable polyurethane having a durometer between 10 and 50 Shore A.

5. The phantom according to claim 1, further comprising a housing, the plug being cast inside the housing, wherein when the phantom is placed in the foot well of the ultrasonic bone analysis apparatus, the housing positions the plug properly in relation to the plurality of transducer pads.

6. The phantom according to claim 1, wherein the complementary shapes of the plurality of transducer pads and the respective plurality of indentations facilitate coupling of the plurality of transducer pads to the plug.

7. The phantom according to claim 1, wherein the phantom has a width of a typical female heel, and an ultrasound signal passing through the phantom spreads out in a pattern approximating that of an ultrasound signal passing through a human heel.

8. The phantom according to claim 1, wherein an ultrasound signal received through one of the plurality of transducer pads which passed through the phantom is used to calibrate the ultrasound bone analysis apparatus.

9. The phantom according to claim 1, wherein a propagation time of an ultrasound signal received through one of the plurality of transducer pads which passed through the phantom is used to calibrate a zero point of the ultrasound bone analysis apparatus.

10. The phantom according to claim 1, wherein an ultrasound signal received through one of the plurality of transducer pads which passed through the phantom is used as a baseline for calculating BUA.

11. The phantom according to claim 1, wherein an ultrasound signal received through one of the plurality of transducer pads which passed through the phantom is used for at least one of determining and correcting a drift of the ultrasound bone analysis apparatus.

12. The phantom according to claim 1, further comprising:

a heater for maintaining the phantom at a predetermined temperature; and

a temperature sensor for measuring the temperature of the phantom.

13. A phantom for an ultrasound bone analysis apparatus having a foot well and a plurality of transducer pads, comprising:

a block of material having a plurality of indentations located on a respective plurality of opposite sides thereof, the plurality of indentations having a respective plurality of shapes complementary to the respective plurality of transducer pads, and the block having an attenuation in a frequency range of between about 200 kHz and about 1000 kHz which approximates that of a human foot.

14. The phantom according to claim 13, wherein the block is made of a castable polyurethane.

15. The phantom according to claim 13, wherein the phantom has an attenuation-versus-frequency profile that is substantially linear in a frequency range of 200-600 kHz and is approximately 1 dB/MHz per mm.

16. The phantom according to claim 13, wherein the complementary shapes of the respective plurality of transducer pads and the respective plurality of indentations facilitate coupling of the plurality of transducer pads to the phantom.

17. The phantom according to claim 13, wherein the phantom has a width of a typical female heel.

18. The phantom according to claim 13, wherein the block is shaped such that when the phantom is placed in the foot well of the ultrasonic bone analysis apparatus, the phantom is positioned properly in relation to the plurality of transducer pads of the ultrasonic bone analysis apparatus.

19. The phantom according to claim 13, wherein an ultrasound signal received through one of the plurality of transducer pads which passed through the phantom is used to calibrate the apparatus for a BUA calculation.

20. The phantom according to claim 13, wherein an ultrasound signal received through one of the plurality of transducer pads which passed through the phantom is used for at least one of determining and correcting a drift of the ultrasound bone analysis apparatus.

21. The phantom according to claim 13, further comprising:

a heater for maintaining the phantom at substantially a predetermined temperature; and

a temperature sensor for monitoring the temperature of the phantom.

22. A phantom for an ultrasound bone analysis apparatus having a foot well and a plurality of transducer pads, comprising:

a housing having a plurality of inner walls and a plurality of indentations located on a respective plurality of opposite sides of the housing, the plurality of indentations having a respective plurality of bottoms parallel to respective adjacent ones of the plurality of inner walls of the housing; and

a mixture of ethyl alcohol and water which is contained by an air-tight receptacle formed from the plurality of inner walls of the housing, the mixture having a predetermined ratio of alcohol and water and a predetermined SOS that is substantially temperature-independent, and air-tight receptacle preventing a change in alcohol concentration by evaporation of the alcohol or absorption of water by the mixture.

23. The phantom according to claim 22, wherein the mixture is substantially 17% ethyl alcohol by weight.

24. The phantom according to claim 22, wherein the housing is made from a polymer which has a predetermined SOS.

25. The phantom according to claim 22, wherein the housing is made from a polyurethane which has a predetermined SOS.

26. The phantom according to claim 22, wherein the ones of the plurality of inner walls which are adjacent to the respective plurality of indentations are relatively thin compared to the distance between the ones of the plurality of inner walls which are adjacent to the respective plurality of indentations.

27. The phantom according to claim 22, wherein the phantom has a width of a typical female heel.

28. The phantom according to claim 22, wherein the housing is shaped to position the phantom properly in relation to the plurality of transducer pads.

29. The phantom according to claim 22, wherein an ultrasound signal received through one of the plurality of transducer pads which passed through the phantom is used to calibrate the apparatus for a SOS calculation.

30. The phantom according to claim 22, wherein an ultrasound signal received through one of the plurality of transducer pads which passed through the phantom is used for quality assurance including at least one of determining and correcting instrument drift by calculating a SOS based on the received signal and comparing the calculated SOS with the predetermined SOS.

31. The phantom according to claim 22, wherein the mixture is pure water.

32. A method of calibrating an ultrasound bone analysis apparatus having a foot well and a plurality of transducer assemblies with a respective plurality of transducer pads, comprising the steps of:

placing in the foot well a first phantom having an attenuation-versus-frequency profile that is substantially flat in a frequency range of between about 200 kHz and about 1000 kHz and a sound impedance that approximates that of soft human tissue;

adjusting the plurality of transducer assemblies;

transmitting through the first phantom via one of the plurality of transducer pads an ultrasound signal;

receiving via another one of the plurality of transducer pads a signal that passed through the first phantom; and

using the received signal that passed through the first phantom as a baseline for calculating a BUA.

33. The method according to claim 32, further comprising the steps of:

measuring a propagation time of the received signal that passed through the first phantom; and

using the propagation time to calibrate a zero point of the apparatus.

34. The method according to claim 33, further comprising the steps of:

measuring a temperature of the first phantom; and

adjusting the zero point according to the measured temperature of the first phantom.

35. The method according to claim 32, further comprising the step of using the received signal that passed through the first phantom for at least one of determining and correcting a drift of the apparatus.

36. The method according to claim 32, further comprising the steps of:

removing the first phantom from the foot well;

placing in the foot well a second phantom having an attenuation in a frequency range of 200-1000 kHz which approximates that of a human foot, including an attenuation-versus-frequency profile that is substantially linear in a frequency range of 200-600 kHz and is approximately 1 dB/MHz per mm;

adjusting the plurality of transducer assemblies;

transmitting through the second phantom via the one of the plurality of transducer pads a second ultrasound signal;

receiving via the another one of the plurality of transducer pads a second signal that passed through the second phantom; and

using the second received signal that passed through the second phantom to calibrate the apparatus for a BUA monitoring.

37. The method according to claim 36, wherein the received signal that passed through the first phantom is also used for quality assurance of the apparatus for a BUA measurement.

38. A method of calibrating an ultrasound bone analysis apparatus having a foot well and a plurality of transducer assemblies with a respective plurality of transducer pads, comprising the steps of:

placing in the foot well a phantom having an attenuation in a frequency range of between about 200 kHz and about 1000 kHz which approximates that of a human foot, including an attenuation-versus-frequency profile that is substantially linear in a frequency range of between about 200 kHz and about 600 kHz and is approximately 1 dB/MHz per mm;

adjusting the plurality of transducer assemblies;

transmitting through the phantom via one of the plurality of transducer pads an ultrasound signal;

receiving via another one of the plurality of transducer pads a signal that passed through the phantom; and

using the received signal that passed through the phantom to calibrate the apparatus for a BUA calculation.

39. The method according to claim 38, further comprising the step of using the received signal that passed through the phantom for at least one of determining and correcting a drift of the apparatus.

40. A method of calibrating an ultrasound bone analysis apparatus having a foot well and a plurality of transducer assemblies with a respective plurality of transducer pads, comprising the steps of:

placing in the foot well a phantom having a predetermined SOS that is substantially temperature-independent;

adjusting the plurality of transducer assemblies;

transmitting through the phantom via one of the plurality of transducer pads an ultrasound signal;

receiving via another one of the plurality of transducer pads a signal that passed through the phantom; and

using the received signal that passed through the phantom for at least one of determining and correcting a drift of the apparatus.

41. The method according to claim 40, further comprising the step of using the received signal that passed through the phantom to calibrate the apparatus for a SOS calculation.

42. The method according to claim 40, wherein the drift of the apparatus is determined by calculating a SOS based on the received signal that passed through the phantom and comparing the calculated SOS with the predetermined SOS.

43. A method of calibrating an ultrasound bone analysis apparatus having a plurality of transducer assemblies with a respective plurality of transducers and a respective plurality of transducer pads, comprising the steps of:

adjusting the plurality of transducer assemblies until the plurality of transducer pads are mutually in contact;

transmitting an ultrasound signal through one of the plurality of transducers; and

receiving a signal corresponding to the transmitted signal through another one of the plurality of transducers.

44. The method according to claim 43 further comprising the step of using the received signal as a baseline for calculating BUA.

45. The method according to claim 43 further comprising the steps of:

measuring a propagation time of the received signal; and

using the propagation time as a reference time of propagation through the plurality of transducer pads.

46. The method according to claim 45 further comprising the step of comparing the reference time of propagation through the plurality of transducer pads with a temporally-proximate measurement of an ultrasonic signal that passed through a patient'"'"'s heel to determine a time of propagation through the heel.

47. The method according to claim 43 further comprising the steps of:

comparing a time of arrival of the received signal with a predetermined time of arrival of an ultrasonic signal measured at a predetermined temperature to calculate an effective temperature of the plurality of pads; and

using the calculated effective temperature to adjust temperature-dependent coefficients of a BUA of a temporally-proximate measurement of an ultrasonic signal that passed through a patient'"'"'s heel.

48. The method according to claim 43 further comprising the steps of:

measuring a reflected signal from a reflection by at least one of an interface between the plurality of transducer pads, a reflecting object placed in the plurality of transducer pads, and a face of one of the plurality of transducers which was not transmitting; and

using the measured reflected signal to determine a time of propagation through at least one of the plurality of transducers and the plurality of transducer pads.

49. An apparatus for performing ultrasonic bone analysis comprising:

a foot well assembly having a foot well for resting a patient'"'"'s foot;

a transducer drive mechanism including a plurality of transducer assemblies having a plurality of respective transducers and a plurality of respective coupling pads, at least one of the plurality of transducers supplying ultrasonic signals and at least another one of the plurality of transducers receiving ultrasonic signals corresponding to the transmitted signals, and the plurality of transducer assemblies being adjustable to respective positions such that the plurality of respective coupling pads are in mutual contact; and

a controller for controlling the positioning of the plurality of transducer assemblies to achieve ultrasonic coupling, controlling the ultrasonic signals transmitted by at least the one of the plurality of transducers, performing calibration including calibrating a zero point of the apparatus, and performing quality assurance including at least one of determining and correcting a drift of the apparatus.

50. The apparatus according to claim 49, further comprising a phantom having an attenuation-versus-frequency profile that is substantially flat in a frequency range of 200 to 1000 kHz and a sound impedance that approximates that of soft human tissue, wherein the controller uses a received signal as a baseline for calculating BUA, the received signal being an ultrasonic signal received by the another one of the plurality of transducers which was transmitted by the one of the plurality of transducers and passed through the phantom.

51. The apparatus according to claim 49, further comprising a phantom having an attenuation-versus-frequency profile that is substantially flat in a frequency range of 200 to 1000 kHz and a sound impedance that approximates that of soft human tissue, wherein the controller measures a propagation time of an ultrasonic signal received by the another one of the plurality of transducers which was transmitted by the one of the plurality of transducers and passed through the phantom, and uses the measured propagation time to calibrate the zero point of the apparatus.

52. The apparatus according to claim 49, further comprising a phantom having an attenuation-versus-frequency profile that is substantially flat in a frequency range of 200 to 1000 kHz and a sound impedance that approximates that of soft human tissue, wherein the controller uses a received signal for at least one of determining and correcting the drift of the apparatus, the received being an ultrasonic signal received by the another one of the plurality of transducers which was transmitted by the one of the plurality of transducers and passed through the phantom.

53. The apparatus according to claim 49, further comprising a phantom having an attenuation in a frequency range of 200-1000 kHz which approximates that of a human foot, wherein the controller uses a received signal to calibrate the apparatus for a BUA calculation, the received signal being an ultrasonic signal received by the another one of the plurality of transducers which was transmitted by the one of the plurality of transducers and passed through the phantom.

54. The apparatus according to claim 49, further comprising a phantom having an attenuation in a frequency range of 200-1000 kHz which approximates that of a human foot, wherein the controller uses a received signal for at least one of determining and correcting the drift of the apparatus, the received signal being an ultrasonic signal received by the another one of the plurality of transducers which was transmitted by the one of the plurality of transducers and passed through the phantom.

55. The apparatus according to claim 49, further comprising a phantom having a predetermined SOS that is substantially temperature-independent, wherein the controller uses a received signal for calibrating the apparatus for a SOS calculation, the received signal being an ultrasonic signal received by the another one of the plurality of transducers which was transmitted by the one of the plurality of transducers and passed through the phantom.

56. The apparatus according to claim 49, further comprising a phantom having a predetermined SOS that is substantially temperature-independent, wherein the controller uses a received signal for at least one of determining and correcting the drift of the apparatus, the received signal being an ultrasonic signal received by the another one of the plurality of transducers which was transmitted by the one of the plurality of transducers and passed through the phantom.

57. The apparatus according to claim 49, wherein the controller adjusts the positioning of the plurality of transducer assemblies until the plurality of transducer pads are mutually in contact, and uses a received signal as a baseline for calculating BUA, the received signal being an ultrasound signal received by the another one of the plurality of transducers which was transmitted by the one of the plurality of transducers and passed through the plurality of mutually contacting transducer pads.

58. The apparatus according to claim 49, wherein the controller adjusts the positioning of the plurality of transducer assemblies until the plurality of transducer pads are mutually in contact, determines a propagation time of an ultrasound signal received by the another one of the plurality of transducers which was transmitted by the one of the plurality of transducers and passed through the plurality of mutually contacting transducer pads, and uses the propagation time to calibrate the zero point of the apparatus.

59. The apparatus according to claim 49, wherein the controller adjusts the positioning of the plurality of transducer assemblies until the plurality of transducer pads are mutually in contact, and uses for at least one of determining and correcting the drift of the apparatus, the received signal being an ultrasound signal received by the another one of the plurality of transducers which was transmitted by the one of the plurality of transducers and passed through the plurality of mutually contacting transducer pads.

60. The apparatus according to claim 49, the plurality of transducer pads having:

a plurality of heaters for maintaining the plurality of respective transducer pads at substantially a predetermined temperature; and

a plurality of temperature sensors for measuring the temperature of the plurality of respective transducer pads, wherein the controller monitors the measured temperature of the transducer pads which is supplied by the plurality of temperature sensors and controls the plurality of respective heaters accordingly to maintain the plurality of respective transducer pads at the predetermined temperature.

61. A phantom for an ultrasound bone analysis apparatus having a foot well and a plurality of transducer pads, comprising:

a block of material having a predetermined SOS that is substantially temperature-independent and a sound impedance that approximates that of soft human tissue, and the block having at least one of an attenuation-versus-frequency profile that is substantially flat in a frequency range of between about 200 kHz and about 1000 kHz and an attenuation in a frequency range of between about 200 kHz and about 1000 kHz which approximates that of a human foot.