Ultrasound therapeutic device

• US 20040082857A1
• Filed: 10/25/2002
• Published: 04/29/2004
• Est. Priority Date: 10/25/2002
• Status: Active Grant

• Current Assignee: DJO Global Switzerland SARL (Enovis Corp.)
• Original Assignee: Compex Medical S.A. (Enovis Corp.)
• Inventors: Buhlmann, Felix, Rigaux, Pierre, Schonenberger, Klaus, Muller, Pierre-Yves
• Granted Patent: US 6,860,852 B2
• Time in Patent Office: Days
• US Class Current: 600/439
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• CPC Class Codes: A61B 8/4438 Means for identifying the diagnostic device, e.g. barcodes
• CPC Class Codes: A61N 2007/0008 Destruction of fat cells
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092

Abstract

The ultrasound therapeutic system of the present invention generally includes a generator unit, at least one transducer treatment head, and a programmable controller. The generator is in operable communication with the at least one transducer treatment head such that electric power outputted from the generator to the head is converted into acoustic power by the head. Re-programmable software at the controller generally controls all features and functions for the system. In particular, the controller calculates an initial optimal treatment dose, maintains effective acoustic power transmitted to the patient through the at least one treatment head, performs calibration procedures for the at least one treatment head, controls outputting for each supported treatment mode, and provides for various other features and functions.

Claims

1. An ultrasound system for physical therapy comprising:

a generator for generating an ultrasound output signal;

at least one ultrasonic transducer capable of receiving the ultrasound output signal to generate an acoustic treatment wave;

an input device for receiving histological tissue data from a user including target treatment tissue type, and intermediate tissue structure; and

a controller including treatment software wherein the inputted histological tissue data is processed through at least a treatment simulation to calculate an ultrasound dosage including an acoustic intensity value and a treatment duration value, wherein the target tissue type and the acoustic treatment wave effects of the inputted intermediate tissue structure are processed to generate the acoustic intensity value and the treatment duration value.

2. The system of claim 1, wherein the controller, at the thermal simulation, processes at least two output frequency values to determine the correct treatment duration and acoustic intensity values for the ultrasound dosage.

3. The system of claim 1, wherein the at least two output frequency values processed at the simulation stage are a first frequency of approximately 1 MHz and a second frequency of approximately 3 MHz for calculating the ultrasound dosage, the controller analyzing use of each first and second frequencies to select the preferred output frequency resulting in the smallest ultrasound dosage that can be employed based on the inputted histological tissue data.

4. The system of claim 3, wherein the treatment software links the treatment duration value and the acoustic intensity value such that a change in one results in a proportional change in the other to maintain a constant ultrasound dosage.

5. The system of claim 1, wherein the input device is further capable of receiving a treatment mode selection.

6. The system of claim 5, wherein the treatment mode selections are from a group consisting of:

thermal, biological, and phonophoresis modes.

7. The system of claim 1, wherein the controller processes the inputted histological tissue data to compute a treatment intensity coefficient that represents the acoustic energy losses caused by the intermediate tissue structure, with the treatment intensity coefficient being used in the thermal simulation.

8. The system of claim 7, wherein the controller calculates the acoustic energy losses to account for the change in acoustic impedance caused by the reflection of the treatment wave at tissue interfaces.

9. The system of claim 7, wherein the controller calculates the acoustic energy losses to account for the absorption of energy in the tissue from heat generated therein.

10. The system of claim 1, further including at least one cable adapted to communicate the output signal from the generator to the transducer, the cable having an interchangeable head connector end capable of selectively receiving a plurality of treatment heads.

11. The system of claim 10, wherein the interchangeable head connector end of the at least one cable is capable of receiving treatment heads having different acoustic treatment wave capabilities.

12. The system of claim 3, wherein the controller further processes the selected ultrasound dosage following the thermal simulation to ensure that the treatment intensity value and the treatment duration value are within acceptable limits.

13. An ultrasound system for physical therapy comprising:

generating means for generating an ultrasound output signal;

delivery means for receiving the ultrasound output signal to deliver an acoustic treatment wave;

inputting means for receiving histological tissue data from a user including target treatment tissue type, and intermediate tissue structure; and

control means for running treatment software, wherein the inputted histological tissue data is processed through at least a treatment simulation to calculate an ultrasound dosage including an acoustic intensity value and a treatment duration value, wherein the target tissue type and the acoustic treatment wave effects of the inputted intermediate tissue structure are processed to generate the acoustic intensity value and the treatment duration value.

14. The system of claim 13, wherein the treatment software links the treatment duration value and the acoustic intensity value such that a change in one results in a proportional change in the other to maintain a constant ultrasound dosage.

15. An ultrasound system for physical therapy comprising:

a generator unit for generating an output signal;

at least one ultrasonic transducer capable of receiving the output signal to generate acoustic output;

an input device for receiving a treatment mode selection and histological tissue data from a user, the treatment mode being selectable from biological, thermal, and phonophoresis modes; and

a controller programmed to calculate an ultrasound dosage after processing the inputted mode selection and histological tissue data, wherein the ultrasound dosage includes a treatment duration value and an acoustic intensity value.

16. The system of claim 15, wherein the phonophoresis treatment mode selection causes the controller to automatically select predefined treatment duration and acoustic intensity values.

17. The system of claim 16, wherein the predefined treatment intensity value is approximately 1.5 W/cm².

18. The system of claim 16, wherein the predefined treatment duration value is approximately 8 minutes.

19. The system of claim 15, wherein the selection of the phonophoresis treatment mode causes the controller to automatically select a predefined output frequency of approximately 3 MHz.

20. The system of claim 15, wherein the selection of the thermal treatment mode causes the controller to process the ultrasound dosage through at least program thermal simulation stage.

21. The system of claim 20, wherein the controller, at the thermal simulation stage, processes at least two output frequency values to determine the correct treatment duration and acoustic intensity values for the ultrasound dosage.

22. The system of claim 21, wherein the at least two output frequency values processed at the simulation stage are a first frequency of approximately 1 MHz and a second frequency of approximately 3 MHz, with the controller analyzing use of each first and second frequencies to determine the preferred output frequency resulting in the smallest ultrasound dosage that can be employed based on the inputted histological tissue data.

23. An ultrasound system for physical therapy comprising:

generating means for generating an ultrasound output;

delivery means for receiving the ultrasound output to generate acoustic output;

inputting means for receiving a treatment mode selection and histological tissue data, the treatment mode being selectable from biological, thermal, and phonophoresis modes; and

control means for running treatment software, including calculating an ultrasound dosage after analyzing the inputted mode selection and the histological tissue data.

24. A method of therapy with an ultrasound system having a transducer treatment head for applying acoustic waves to a user, comprising the steps of:

determining tissue depth data for a user;

inputting into the ultrasound system histological tissue data, including

inputting target tissue data;

inputting tissue type data, and tissue depth data for tissue intermediate the treatment head and the target tissue; and

processing the histological tissue data at a controller of the ultrasound system wherein the controller includes a simulation algorithm to process the inputted histological tissue data to calculate a treatment dose including a treatment duration value, and an acoustic intensity value.

25. The method of claim 24, wherein two output frequency values are processed during the simulation algorithm to determine the correct treatment duration and acoustic intensity values for the treatment dose.

26. The method of claim 25, wherein the two output frequency values processed are a first frequency value of approximately 1 MHz and a second frequency value of approximately 3 MHz.

27. The method of claim 26, wherein each of the first and second frequency values are individually processed through the simulation algorithm to determine the smallest treatment dose that can be employed in light of the known histological tissue data.

28. The method of claim 24, wherein the product of the treatment duration value and the acoustic intensity value equals the treatment dose, with the two values of the treatment dose being linked such that a change in one provides a proportional change in the other to maintain a constant treatment dose.

29. A method of calibration for an ultrasound therapeutic treatment head, comprising the steps of:

determining the presence of a treatment head in an ultrasound system;

obtaining identification information for the treatment head;

performing a frequency scan around a theoretical resonant frequency using stepped intervals to determine a maximum unloaded conductance value of the treatment head and a corresponding resonant frequency;

storing the maximum unloaded conductance value and the resonant frequency value;

calculating a maximum series conductance under load of the treatment head;

calculating a real-time acoustic coupling efficiency of the treatment head from the maximum unloaded conductance value and the maximum series conductance under load; and

compensating for real and complex changes in the electrical characteristics of the treatment head according to the calculated real-time acoustic coupling efficiency.

30. The method of claim 29, wherein the step of obtaining identification information for a treatment head further comprises retrieving stored identification information from the controller.

31. The method of claim 29, wherein the step of determining the presence of a treatment head further comprises introducing a new treatment head to the ultrasound system.

32. The method of claim 29, wherein the step of determining the presence of a treatment head further comprises reintroducing a previously calibrated treatment head to the ultrasound system.

33. The method of claim 29, wherein the step of obtaining identification information further comprises reading data stored electronically for the treatment head by a controller in operable communication with the treatment head.

34. An automatic calibration system for use in an ultrasound system for physical therapy comprising:

a generator for generating an ultrasound output signal;

at least one ultrasonic transducer capable of receiving the ultrasound output signal to generate an acoustic output;

an input device for receiving histological tissue data from a user including target treatment tissue type; and

a controller running treatment software and calibration software, wherein the inputted histological tissue data is processed to generate an acoustic intensity value and a treatment duration value.

35. The system of claim 34, wherein the calibration software operably calculates an acoustic coupling efficiency from an actual loaded conductance and an unloaded series conductance to compensate for changes in the electrical characteristics of the ultrasonic transducer.

36. The system of claim 34, wherein the calibration software operably considers both impedance amplitude and phase to account for complex changes in the ultrasonic transducer and the ultrasound system.

37. The system of claim 34, wherein the at least one ultrasonic transducer is new to the ultrasound system.

38. The system of claim 34, wherein the at least one ultrasonic transducer is an ultrasonic transducer that has been previously calibrated by the ultrasound system.

39. An automatic calibration system for use in an ultrasound system for physical therapy comprising:

means for generating an ultrasound output signal;

at least one ultrasonic transducer capable of receiving the ultrasound output signal to generate an acoustic treatment output;

an input device for receiving histological tissue data from a user including target treatment tissue type, and intermediate tissue structure;

means for running treatment software, wherein the inputted histological tissue data is processed to calculate an ultrasound dosage including an acoustic intensity value and a treatment duration value; and

means for making a calibration adjustment to the ultrasound system that considers impedance amplitude and phase and accounts for complex changes in the electrical characteristics of the ultrasonic transducer.

40. A method of monitoring and controlling the acoustic power delivered to a treatment head of a therapeutic treatment system using a feedback loop, comprising the steps of:

applying electric power from a generator to a treatment head to generate an acoustic power output;

measuring, at a controller in operable communication with the generator, treatment head voltage values at stepped intervals;

calculating at the controller a coupling efficiency of the treatment head and an applied electric power from the measured treatment head voltage values at stepped intervals;

calculating at the controller an effective transmitted acoustic power; and

adjusting the electric power from the generator in response to the calculated coupling efficiency in order to maintain a constant level of effective acoustic power transmitted.

41. The method of claim 40, wherein the step of calculating at the controller a coupling efficiency of the treatment head further comprises:

measuring a vector voltage output of a multiplier in the feedback loop; and

calculating the coupling efficiency of the treatment head and the applied electric power using the vector voltage output.

42. The method of claim 40, wherein the step of adjusting the electric power includes performing the adjustment every 20 milliseconds.

43. The method of claim 40, further comprising the step of notifying a user of the therapeutic treatment system if a feedback loop failure occurs.

44. The method of claim 43, further comprising:

suspending the transmission of electric power from the generator;

commencing a resonance search and output calculation mode;

monitoring the output for a minimum tolerance; and

restarting the feedback loop and resuming normal operation when the output surpasses the minimum tolerance.

45. A feedback loop for monitoring and controlling the acoustic power delivered to a treatment head of a therapeutic treatment system comprising:

at least one ultrasonic transducer capable of receiving an ultrasound output signal to generate an acoustic treatment output;

a generator unit in operable communication with the ultrasonic transducer for generating the ultrasound output signal;

a voltage converter in operable communication with the generator unit to supply a voltage control signal;

a controller running treatment software, wherein inputted histological tissue data is processed to calculate an ultrasound dosage including an acoustic intensity value and a treatment duration value, and wherein the controller is in operable communication with the voltage converter;

an analog multiplier in operable communication with the generator to receive measured voltage and current signals and the controller adapted to supply a vector output signal;

a quadrature signal generator in operable communication with the analog multiplier to provide reference signals; and

a digital sine-wave generator in operable communication with the controller, the generator unit to provide a reference wave, and the quadrature signal generator to provide a reference wave.

46. The feedback loop of claim 45, wherein a coupling efficiency is calculated in the controller and the voltage control signal supplied to the generator unit is adjusted to operably maintain a constant level of effective acoustic power transmitted from the ultrasonic transducer to a user.

47. The feedback loop of claim 46, wherein the constant level of acoustic power transmitted to the user is maintained by adjusting an electric power in response to the coupling efficiency calculated by the controller.

48. The feedback loop of claim 47, wherein the electric power is adjusted every 20 milliseconds.

49. The feedback loop of claim 46, wherein the controller scans a maximum conductance value of the ultrasonic transducer to detect a shift in a resonant frequency and readjust the electric power in response.

50. A method of ultrasound therapy with a system having a generator, a treatment head, and a programmable controller in operable communication with the generator and the treatment head, comprising the steps of:

inputting histological tissue data by a user, the histological tissue data representing at least tissue type and tissue depth data;

inputting a treatment mode from a selection of thermal, biological, and phonophoresis;

automatically configuring treatment dosage parameters at the controller based on the inputted histological tissue data and treatment mode;

monitoring the operation of the system during treatment of a user; and

maintaining a constant acoustic power transmitted to the user during online use according to values received at the controller from the treatment head.

51. The method of claim 50, wherein the step of monitoring the operation of the system during treatment of a user further comprises:

monitoring a feedback loop within the system for failure;

monitoring a resonant frequency search and centering;

monitoring a presence of the treatment head; and

monitoring a temperature of the treatment head.

52. The method of claim 50, wherein the step of maintaining a constant acoustic power further comprises the steps of:

applying electric power from a generator to the treatment head to generate an acoustic power output;

measuring, at a controller in operable communication with the generator, treatment head voltage values at stepped intervals;

calculating at the controller a coupling efficiency of the treatment head; and

adjusting the electric power from the generator in response to the calculated coupling efficiency in order to maintain a constant level of effective acoustic power transmitted.

53. The method of claim 52, wherein the step of calculating at the controller a coupling efficiency of the treatment head further comprises:

measuring a maximum conductance of the treatment head in an unloaded state;

measuring a maximum conductance of the treatment head in a loaded state; and

calculating the coupling efficiency of the treatment head using the measured maximum conductance of the treatment head in an unloaded state and the measured maximum conductance of the treatment head in a loaded state.

54. The method of claim 52, wherein the step of adjusting the electric power is performed every 20 milliseconds

55. The method of claim 52, further comprising the step of notifying an operator of the system if a feedback loop failure occurs.

56. The method of claim 55, further comprising the steps of:

suspending the transmission of electric power from the generator;

commencing a resonance search and an output calculation mode;

monitoring the output for a minimum tolerance; and

restarting the feedback loop and resuming normal operation when the output surpasses the minimum tolerance.

57. An ultrasound therapeutic treatment system, comprising:

an ultrasound treatment device having

a generator capable of generating an ultrasound output;

an input device adapted to receive histological tissue data from a user including treatment tissue type and tissue depth;

a controller running treatment software to calculate an ultrasound dosage including a treatment duration value, an acoustic intensity value, and an output frequency value;

a plurality of ultrasonic transducer heads capable of receiving the ultrasound output from the generator to generate acoustic output; and

a cable having

a first end connector adapted to attach to the ultrasound treatment device; and

a second end connector adapted to selectively attach to each of the plurality of ultrasonic transducer heads.

58. The system of claim 57, wherein each of the plurality of ultrasonic transducer heads includes at least one memory device capable of operable communication with the controller.

59. The system of claim 58, wherein the at least one memory device is adapted to operably communicate with the controller to communicate stored data to the controller for each of the plurality of ultrasonic transducer heads.

60. The system of claim 59, wherein the data stored at the at least one memory device is selectable from a group consisting of:

temperature data, transducer head serial number, and calibration data.

61. The system of claim 57, wherein the attachment of the second end connector of the cable to each of the plurality of ultrasonic transducer heads results in a substantially watertight attachment.

62. The system of claim 57, wherein each of the plurality of ultrasonic transducer heads are configured to have different acoustic output capabilities.

63. An ultrasound therapeutic treatment system, comprising:

an ultrasound treatment device having

generator means for generating an ultrasound output;

input means for receiving histological tissue data from a user including treatment tissue type and tissue depth;

control means for running treatment software to calculate an ultrasound dosage including a treatment duration value, and an acoustic intensity value;

a plurality of delivery means for receiving the generated ultrasound output from the generator means to deliver acoustic output; and

means for communicating the generated ultrasound output to the delivery means, having

first connector means for attachment to the ultrasound treatment device; and

second connector means for selective attachment to each of the plurality of delivery means.

64. The system of claim 63, wherein each of the plurality of delivery means includes storage means for storing data at the delivery means for communication with the control means.

65. The system of claim 63, wherein the plurality of delivery means are substantially watertight when attached to the second connector means.

66. The system of claim 63, wherein each of the plurality of delivery means are capable of having different acoustic output capabilities.

67. A method of interchangeably connecting a plurality of transducer treatment heads for use with an ultrasound therapeutic treatment device, the method comprising the steps of:

connecting a first transducer treatment head to a head connector at one end of a cable in operable communication with a generator of the ultrasound therapeutic treatment device;

disconnecting the first transducer treatment head from the head connector; and

connecting a second transducer treatment head to the head connector.

68. The method of claim 67, further including the step of reading, at a controller in operable communication with the cable, data stored at a memory device of the first transducer treatment head.

69. The method of claim 67, further including the step of reading, at a controller in operable communication with the cable, data stored at a memory device of the second transducer treatment head.

70. The method of claim 67, wherein the connecting of the second transducer head includes connecting the second transducer head having a different acoustic output capability than the first transducer treatment head.

71. A method of ultrasonic therapeutic treatment comprising the steps of:

selecting at an ultrasonic therapy device a treatment mode from options of biological, thermal, and phonophoresis mode;

inputting into the input device histological tissue data for a user; and

processing at a controller the inputted treatment mode selection and the histological tissue data to calculate an output treatment dosage including a treatment duration value and an acoustic intensity value for communication to a transducer treatment head.

72. The method of claim 71, wherein the output treatment dosage processed at the controller includes a fixed treatment duration value and a fixed treatment intensity value when a user selects phonophoresis as the treatment mode option.

73. The method of claim 72, wherein the fixed treatment intensity value is approximately 1.5 W/cm².

74. The method of claim 72, wherein the fixed treatment duration value is approximately 8 minutes.

75. The method of claim 71, wherein input selection of the phonophoresis treatment mode causes the controller to automatically select a fixed output frequency of approximately 3 MHz.

76. The method of claim 71, wherein inputting the histological tissue data after selecting the thermal treatment mode option includes inputting target tissue data and inputting tissue structure data for tissue intermediate the target tissue and the transducer head.

77. The method of claim 76, wherein selecting the thermal treatment mode selection further causes the controller to perform at least a thermal simulation to calculate the output treatment dosage.

78. The method of claim 77, wherein, at the thermal simulation, the controller performs the steps of processing at least two output frequency values to determine the correct treatment duration and acoustic intensity values for the output treatment dosage.

79. The method of claim 78, wherein the step of processing at least two output frequency values includes processing a first frequency of approximately 1 MHz and a second frequency of approximately 3 MHz, with the controller analyzing use of each first and second frequencies to determine the preferred output frequency resulting in the smallest output treatment dosage that can be employed based on the inputted histological tissue data.

80. A feedback loop for monitoring and controlling the acoustic power delivered at a treatment head of a therapeutic treatment system comprising:

at least one ultrasonic transducer capable of receiving an ultrasound output signal to generate an acoustic treatment output;

means for generating the ultrasound output signal in operable communication with the ultrasonic transducer;

means to supply a voltage control signal in operable communication with the means for generating the ultrasound output signal;

control means for running treatment software, wherein inputted histological tissue data is processed to calculate an ultrasound dosage including an acoustic intensity value and a treatment duration value, and wherein the controller is in operable communication with the means to supply a voltage control signal;

means to receive measured voltage and current signals and to supply a vector output signal in operable communication with the means for generating the ultrasound output signal and the control means;

means to provide reference signals in operable communication with the means to receive measured voltage and current signals and to supply a vector output signal; and

means to provide a reference wave in operable communication with the control means, with the means for generating the ultrasound electric output signal to provide a reference wave, and with the means to provide reference signals.