Ultrasonic bone-therapy apparatus and method

• US 5,752,924 A
• Filed: 08/02/1996
• Issued: 05/19/1998
• Est. Priority Date: 10/25/1994
• Status: Expired due to Term

• Current Assignee: DJO LLC (Enovis Corp.)
• Original Assignee: OrthoLogic Corporation
• Inventors: Chiabrera, Alessandro E., Kaufman, Jonathan J.
• Primary Examiner(s): JAWORSKI, FRANCIS J
• Application Number:
  US08/691,619
• Time in Patent Office: 655 Days
• Field of Search: 601/2, 128/660.03, 607/50, 607/51, 600/439, 600/449
• US Class Current: 601/2
• CPC Class Codes: A61B 2017/0015 applied simultaneously
• CPC Class Codes: A61B 2017/00172 Pulse trains, bursts, intermittent continuous operation
• CPC Class Codes: A61F 2002/2864 by ultrasonic or acoustic vibrations
• 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

A method of ultrasonic bone-therapy subjects a bone to an ultrasonic excitation pulse signal of finite duration, supplied to a transducer next to the bone, and involving a sinusoidal signal in the ultrasonic region to approximately 2 MHz peculiarly modulated by a sinusoidal signal with frequency between about 0 Hz and about 25 kHz; the excitation signal is repeated in the range of 1 to 5000 Hz. The exposure time for therapy is chosen to be in the range of 5 minutes to 1 hour, for 1 to 3 times a day, for a period of days as necessary for healing or for promoting bone growth and ingrowth. An apparatus for implementing the above method for ultrasonic bone therapy is disclosed comprising a transducer having a transmitting and a receiving element, a special waveform signal generator, and a computer for performing the necessary operations defining a preferred treatment regime.

Claims

1. A method of non-invasively therapeutically treating a bone tissue in vivo using ultrasonic signals, comprising the steps of:

producing a preselected periodic therapeutic sine modulated ultrasonic sine signal;

exposing said bone tissue to said therapeutic ultrasonic signal transmitted through soft tissue overlying said bone tissue;

transmitting an interrogating acoustic ultrasonic pulse to said bone tissue through said soft tissue overlying said bone tissue;

receiving a portion of said interrogating signal reflected from said bone tissue;

determining the thickness of said soft tissue using said reflected portion; and

adjusting the amplitude of said therapeutic ultrasonic signal as to ensure that spatial-average time-average power intensity thereof reaching said bone tissue corresponds to a predetermined value.

9. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 1, wherein said thickness of said soft tissue is calculated as

10. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 1, wherein said initial interrogating acoustic ultrasonic pulse is an exponentially damped sinusoidal signal at 1.1 MHz, with a duration of about 2 μ

s.

2. A method of non-invasively therapeutically treating a bone tissue in vivo using ultrasonic signals, comprising the steps of:

producing a preselected periodic therapeutic sine modulated ultrasonic sine signal; and

exposing said bone tissue to said therapeutic ultrasonic signal transmitted through soft tissue overlying said bone tissue

wherein said sine modulated ultrasonic sine signal is amplitude modulated and includes

a carrier frequency being selected in a range between about 25 kHz and about 2 MHZ,

a modulating frequency being selected in a range up to about 25 kHz,

a modulation index being up to 1000,

a pulse width being between about 0.1 ms and about 1.0 s,

a cycle duration being between about 0.2 ms and about 1.0 s,

an intensity (I_SATA) being in the range of 20-100 mW/cm², and

a duration of exposure being between about 5 minutes and about 1 hour for 1 to 3 times a day.

3. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 2, wherein said sine modulated ultrasonic sine signal is the amplitude modulated signal having

the carrier frequency being 1.1 MHz,

the modulating frequency being 20 kHz,

the modulation index being 0.3,

the pulse width being 0.5 ms,

the cycle duration being 5 ms, and

the intensity being 45 mW/cm².

4. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 2, wherein said sine modulated ultrasonic sine signal is the amplitude modulated signal having

the carrier frequency being 1.1 MHz,

the modulating frequency being 20 kHz.

5. A method of non-invasively therapeutically treating a bone tissue in vivo using ultrasonic signals, comprising the steps of:

producing a preselected periodic therapeutic sine modulated ultrasonic sine signal; and

exposing said bone tissue to said therapeutic ultrasonic signal transmitted through soft tissue overlying said bone tissue

wherein said preselected periodic therapeutic sine modulated ultrasonic sine signal is the amplitude modulated signal with

a carrier frequency being selected in a range between about 25 kHz and about 2 MHZ,

a modulating frequency being selected in a range up to about 25 kHz,

a modulation index being up to 1000,

a pulse width being between about 0.1 ms and about 1.0 s,

a duration of a pulse and a pause for one repetition being between about 0.1 ms and about 1.0 s,

a number of pulse repetitions within a cycle being up to 5000,

a cycle duration being between about 0.2 ms and about 1.0 s,

an intensity being in the range of 20-100 mW/cm², and

a duration of exposure being between about 5 minutes and about 1 hour for 1 to 3 times a day.

6. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 5, wherein said preselected periodic therapeutic sine modulated ultrasonic sine signal is the amplitude modulated signal having

the carrier frequency being 1.1 MHZ,

the modulating frequency being 5 kHz,

the modulation index being 0.3,

the pulse width being 4 ms,

the duration of a pulse and a pause for one repetition being 8 ms,

the number of pulse repetitions within a cycle being 25,

the cycle duration being 1 s, and

the intensity being 45 mW/cm².

7. A method of non-invasively therapeutically treating a bone tissue in vivo using ultrasonic signals, comprising the steps of:

producing a preselected periodic therapeutic sine modulated ultrasonic sine signal; and

exposing said bone tissue to said therapeutic ultrasonic signal transmitted through soft tissue overlying said bone tissue

wherein said preselected periodic therapeutic sine modulated ultrasonic sine signal is a frequency and amplitude modulated signal with a carrier frequency having a selected value in the range between about 25 kHz and about 2 MHZ, and having a sweep range between the selected value and about 2 MHZ;

a modulating frequency having a selected value in the range up to about 25 kHz, and having a sweep range between the selected value and about 25 kHz;

a modulation index being up to 1000;

a pulse width being between about 0.1 ms and about 1.0 s;

a duration of a pulse and a pause for one repetition being between about 0.01 ms and about 1.0 s;

a number of pulse repetitions within a cycle being up to 5000;

a cycle duration being between about 0.2 ms and about 1.0 s;

an intensity being in the range of 20-100 mW/cm² ; and

a duration of exposure being between about 5 minutes and about 1 hour for 1 to 3 times a day.

8. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 7, wherein said preselected periodic therapeutic sine modulated ultrasonic sine signal is the frequency and amplitude modulated signal with:

the carrier frequency being 1.1 MHZ,

the modulating frequency being 500 Hz, said modulating frequency having a sweeping range between 500 Hz and 2000 Hz;

the modulation index being 1,

the pulse width being 4 ms,

the duration of a pulse and a pause for one repetition being 8 ms,

the number of pulse repetitions within a cycle being 25,

the cycle duration being 1 s, and

the intensity being 45 mW/cm².

11. A method of non-invasively therapeutically treating a bone tissue in vivo using ultrasonic signals, comprising the steps of:

(A) generating a preselected periodic therapeutic ultrasonic signal;

(B) selecting a power intensity of said therapeutic signal by virtue of

(Ba) generating an interrogating ultrasonic pulse,

(Bb) transmitting said interrogating ultrasonic pulse to said bone tissue through said soft tissue overlying said bone tissue,

(Bc) receiving a portion of said interrogating pulse reflected from said bone tissue,

(Bd) determining the thickness of said soft tissue using said reflected portion, and

(Be) adjusting the amplitude of said therapeutic ultrasonic signal as to ensure that a spatial-average time-average power intensity thereof reaching said bone tissue corresponds to a predetermined value; and

(C) exposing said bone tissue to said therapeutic ultrasonic signal transmitted through soft tissue overlying said bone tissue.

12. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 11, wherein said preselected periodic therapeutic ultrasonic signal is amplitude modulated and has

a carrier frequency being between about 25 kHz and about 2 MHz,

a modulating frequency being up to about 25 kHz,

a modulation index being up to 1000,

a effective duty cycle being between about 0.0001 and about 1,

an intensity being in the range of 20-100 mW/cm², and

a duration of exposure being between about 5 minutes and about 1 hour for 1 to 3 times a day.

13. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 12, wherein said amplitude modulated signal has

the carrier frequency of 1.1 MHz,

the modulating frequency of 20 kHz,

the modulation index of 0.3,

the pulse width of 0.5 ms,

the cycle duration of 5 ms, and

the intensity of 45 mW/cm².

14. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 12, wherein said amplitude modulated signal has

the carrier frequency of 1.1 MHz,

the modulating frequency of 20 kHz,

the modulation index of 0.3,

the pulse width of 0.1 ms,

the cycle duration of 0.5 ms, and

the intensity of 45 mW/cm².

15. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 12, wherein said amplitude modulated signal has:

a pulse width of between about 0.1 ms and about 1.0 s,

a duration of a pulse and a pause for one repetition of between about 0.1 ms and about 1.0 s,

a number of pulse repetitions within a cycle of up to 5000, and

a cycle duration of between about 0.2 ms and about 1.0 s.

16. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 15, wherein said amplitude modulated signal has

the carrier frequency of 1.1 MHz,

the modulating frequency of 5 kHz,

the modulation index of 0.3,

the pulse width of 4 ms,

the duration of a pulse and a pause for one repetition of 8 ms,

the number of pulse repetitions within a cycle of 25,

the cycle duration of 1 s, and

the intensity of 45 mW/cm².

17. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 11, wherein said preselected periodic therapeutic ultrasonic signal is a frequency and amplitude modulated signal with

a carrier frequency having a selected value in the range between about 25 kHz and about 2 MHz, and having a sweep range between the selected value and about 2 MHz;

a modulating frequency having a selected value in the range up to about 25 kHz, and having a sweep range between the selected value and about 25 kHz;

a modulation index being up to 1000,

a pulse width being between about 0.1 ms and about 1.0 s,

duration of a pulse and a pause for one repetition being between about 0.1 ms and about 1.0 s,

a number of pulse repetitions within a cycle being up to 5000,

a cycle duration being between about 0.2 ms and about 1.0 s,

an intensity being in the range of 20-100 mW/cm², and

a duration of exposure being between about 5 minutes and about 1 hour for 1 to 3 times a day.

18. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 17, wherein said frequency and amplitude modulated signal has

the carrier frequency of 1.1 MHZ,

the modulating frequency of 500 Hz, said modulating frequency sweeping range of between 500 Hz and 2000 Hz;

the modulation index of 1,

the pulse width of being 4 ms,

the duration of a pulse and a pause for one repetition of 8 ms,

the number of pulse repetitions within a cycle of 25,

the cycle duration of 1 s, and

the intensity of 45 mW/cm².

19. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 11, wherein said thickness of said soft tissue is calculated as

20. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 11, wherein said initial interrogating acoustic ultrasonic pulse is an exponentially damped sinusoidal, signal at 1.1 MHz, with a duration of about 2 μ

s.

21. An apparatus for non-invasively therapeutically treating bone tissue in vivo comprising:

a waveform synthesizer for producing

an initial interrogating acoustic ultrasonic signal to determine the thickness of a soft tissue overlying said bone tissue, and

an excitation signal to be applied to said bone tissue, said excitation signal being a finite duration sine wave carrier signal with a frequency selected in the ultrasonic region to approximately 1.1 MHz, modulated by a modulating sine signal with a frequency selected between about 0 Hz and about 25 kHz, said excitation signal being repeated substantially in the range 1 to 5000 Hz;

an ultrasonic transducer having

a transmitting element being connected to said waveform synthesizer and adapted for acoustic coupling to nearby skin and for conveying said interrogating and said excitation signals along an ascertained path to said bone tissue,

a receiving element for receiving a reflected portion of said interrogating signal reflected from said bone tissue; and

a computer coupled to said transducer and said receiving element, for adjusting said excitation signal responsive to said received reflected signal.