Ultrasonic bone-therapy apparatus and method

• US 5,547,459 A
• Filed: 10/25/1994
• Issued: 08/20/1996
• Est. Priority Date: 10/25/1994
• Status: Expired due to Term

• Current Assignee: DJO LLC (Enovis Corp.)
• Original Assignee: OrthoLogic Corporation
• Inventors: Kaufman, Jonathan J., Chiabrera, Alessandro E.
• Primary Examiner(s): JAWORSKI, FRANCIS J
• Application Number:
  US08/329,015
• Time in Patent Office: 665 Days
• Field of Search: 128/660.01, 128/660.03, 128/661.03, 607/51-52, 601/2
• 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 an ultrasonic signal, comprising the steps of:

(A) producing a periodic therapeutic sine-wave modulated ultrasonic sine-wave signal described by ##EQU15## ##EQU16## where N is the number of pulse repetitions within each cycle and 1<

N<

10,000, f_m is the modulating frequency which is selected within the range of 0<

f_m <

25 kHz;

f_o is the carrier frequency which is selected within the range of 25 kHz<

f_o <

2 MHz;

T is the cycle duration which is 0.2 ms<

T<

1.0 s;

T_s is the pulse width which is 0.1 ms<

T_s <

1.0 s;

T_s '"'"' is the duration of a pulse and a pause for one repetition (N=1) which is 0.1 ms<

T_s '"'"'<

1.0 s;

a is the modulation index which is 0<

a<

1000;

K is a constant defining intensity (I_SATA) of said ultrasonic signal; and

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

to thereby induce bone growth and bone healing.

2. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 1, further comprising the step of:

(C) preselecting said intensity of said therapeutic signal.

3. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 2, wherein said step (C) comprises the substeps of:

generating an interrogating ultrasonic pulse;

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

receiving a portion of said interrogating pulse 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 to ensure that spatial-average time-average intensity thereof reaching said bone tissue is in a predetermined range of 20-100 mW/cm².

4. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 3, wherein said thickness of said soft tissue is calculated as

d_s =v_s τ

/2

where d_s is the desired thickness;

v_s is the velocity of ultrasound in soft tissue; and

τ

is a round-trip transit time for said acoustic pulse to travel from a source thereof through the soft tissue, to the bone tissue, and back through the soft tissue.

5. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 3, wherein said initial interrogating ultrasonic pulse is an exponentially damped sinusoidal signal at 1.1 MHz, with a duration of about 2 μ

s.

6. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 1, wherein said p_s (t) has the form of ##EQU17## with the number N of pulse repetitions within each cycle being 1, the carrier frequency f_o being 1.1 MHz,

the modulating frequency f_m being 20 kHz,

the modulation index a being 0.3,

the pulse width T_s being 0.5 ms,

the cycle duration T being 5 ms, and

the intensity I_SATA being 45 mW/cm².

7. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 1, wherein said p_s (t) has the form of ##EQU18## with the number N of pulse repetitions within each cycle being 1, the carrier frequency f_o being 1.1 MHz,

the modulating frequency f_m being 20 kHz,

the modulation index a being 0.3,

the pulse width T_s being 0.1 ms,

the cycle duration T being 0.5 ms, and

the intensity I_SATA being 45 mW/cm².

8. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 1, wherein said periodic therapeutic sine-wave modulated ultrasonic sine-wave signal has the form of

p(t)=p_s (t)=K{1+a sin(2π

f_m t)}sin(2π

f_o t), 0<

t<

T_s,

with the number N of pulse repetitions within each cycle being 1, and

an intensity I_SATA being in the range of 20-100 mW/cm².

9. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 1, wherein said periodic therapeutic sine-wave modulated ultrasonic sine-wave signal is described by ##EQU19## with p_s (t) given by the equation:

##EQU20## having the carrier frequency f_o of 1.1 MHz, the modulating frequency f_m of 5 kHz,

the modulation index a of 0.3,

the pulse width T_s of 4 ms,

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

the number N of pulse repetitions within a cycle being 25,

the cycle duration T of 1 s, and

the intensity I_SATA of 45 mW/cm².

10. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 1, wherein said intensity of said ultrasonic signal is selected in the range of 20 mW/cm² ≦

I_SATA <

100 mW/cm₂.

11. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 1, further comprising the step of

(D) maintaining said exposing between about 5 minutes and about 1 hour.

12. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 11, further comprising the step of

(E) repeating said exposing for about 1 to 3 times a day.

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

(A) generating a periodic therapeutic frequency modulated sine wave amplitude modulated frequency modulated sine wave 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 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;

to thereby induce bone growth and healing.

14. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 13, wherein a duration of exposure being between about 5 minutes and about 1 hour for 1 to 3 times a day and said periodic therapeutic ultrasonic signal is amplitude modulated and has

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

a modulating frequency of up to about 25 kHz,

a modulation index being selected in a range between 0 and 1000, and

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

15. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 14, 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.

16. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 14, 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.

17. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 14, 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.

18. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 14, 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.

19. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 13, wherein a duration of exposure being between about 5 minutes and about 1 hour for 1 to 3 times a day and said periodic therapeutic ultrasonic signal has

a carrier frequency with a selected value in the range between about 25 kHz and about 2 MHz and with a sweeping range between the selected value and about 2 MHz;

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

a modulation index selected in a range between 0 and 1000,

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

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

a number of pulse repetitions within a cycle up to 10,000,

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

an intensity in the range of 20-100 mW/cm².

20. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 19, wherein said periodic therapeutic ultrasonic 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 between 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.

21. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 13, wherein said thickness of said soft tissue is calculated as

d_s =v_s τ

/2

where d_s is the desired thickness;

v_s is the velocity of ultrasound in soft tissue; and

τ

is a round-trip transit time for said acoustic pulse to travel from a source thereof through the soft tissue, to the bone tissue, and back through the soft tissue.

22. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 13, wherein said initial interrogating ultrasonic pulse is an exponentially damped sinusoidal signal at 1.1 MHz, with a duration of about 2 μ

s.

23. 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 frequency modulated sine wave carrier signal with a frequency selected in the ultrasonic region within the range of between about 25 kHz and about 2 MHz and having a sweeping range between a selected value and an upper limit value of about 2 MHz, amplitude modulated by a frequency modulated sine wave signal with a modulating frequency selected between about 0 Hz and about 25 kHz and having a sweeping range between a selected value and an upper limit value of 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.

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

(A) producing a periodic therapeutic ultrasonic signal described by ##EQU21## repeating every T seconds (1/T Hz), with p_s (t) given by the equation;

space="preserve" listing-type="equation">p.sub.s (t)=K{1+a sin[2π

(f.sub.m +(f.sub.m *-f.sub.m)t/T.sub.s)t]sin [2π

(f.sub.o +f.sub.o *-f.sub.o)t/T.sub.s)t}, 0≦

t≦

T.sub.s,

where

f_m is a modulating frequency selected within the range of 0<

f_m ≦

25 kHz and having a sweeping range between a selected value f_m and an upper limit value f_m * of about 25 kHz;

f_o is a carrier frequency selected within the range of 25 kHz<

f_o ≦

2 MHz and having a sweeping range between a selected value f_o and an upper limit value f_o * of about 2 MHz;

T is the cycle duration which is 0.2 ms≦

T≦

1.0 s;

T_s is the pulse width which is 0.1 ms≦

T_s ≦

1.0 s;

T_s '"'"' is the duration of a pulse and a pause for one repetition (N=1) which is 0.1 ms<

T_s '"'"'≦

1.0 s;

a number N of pulse repetitions within a cycle being up to 10,000;

a is the modulation index which is 0≦

a≦

1000;

K is a constant defining intensity (I_SATA) of said ultrasonic signal which is adjusted so that 20 mW/cm² ≦

I_SATA ≦

100 mW/cm² ; and

(B) exposing said bone tissue to said therapeutic ultrasonic signal transmitted through a soft tissue overlying said bone tissue;

to thereby induce bone growth and healing.

25. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 24, wherein said periodic therapeutic ultrasonic signal is described by the equation ##EQU22## where ##EQU23## with the carrier frequency f_o being 1.1 MHz;

the modulating frequency fm being 500 Hz;

the frequency f_m * being 2000 Hz;

the modulation index a being 1;

the pulse width T_s being 4 ms;

the duration T_s '"'"' of a pulse and a pause for one repetition being 8 ms;

the number N of pulse repetitions within a cycle being 25;

the cycle duration T being 1 s; and

the constant K being adjusted so that the intensity I_SATA is 45 mW/cm².

26. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 24, further comprising the step of

(C) maintaining said exposing between about 5 minutes and about 1 hour.

27. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 26, further comprising the step of

(D) repeating said exposing for about 1 to 3 times a day.

28. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 24, further comprising the step of

(E) preselecting an intensity of said periodic therapeutical ultrasonic signal.

29. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 28, wherein said step (E) comprises the substeps of:

(Ea) generating an interrogating ultrasonic pulse;

(Eb) transmitting said interrogating ultrasonic pulse to said bone tissue through said soft tissue overlying said bone tissue;

(Ec) receiving a portion of said interrogating ultrasonic pulse reflected from said bone tissue;

(Ed) determining a thickness of said soft tissue using said reflected portion; and

(Ee) adjusting an amplitude of said therapeutic ultrasonic signal to ensure that said intensity thereof reaching said bone tissue is in a predetermined range of 20-100 mW/cm².

30. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 29, wherein said thickness of said soft tissue is calculated as

d_s =v_s τ

/2

where d_s is the desired thickness;

v_s is the velocity of ultrasound in soft tissue; and

τ

is a round-trip transit time for said acoustic pulse to travel from a source thereof through the soft tissue, to the bone tissue, and back through the soft tissue.

31. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 29, wherein said interrogating ultrasonic pulse is an exponentially damped sinusoidal signal at 1.1 MHz, with a duration of about 2 μ

s.

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

(A) generating a therapeutic ultrasonic signal;

(B) selecting an 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 to ensure that a spatial-average time-average 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;

to thereby induce bone growth and healing.

33. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 32, wherein said interrogating ultrasonic pulse is an exponentially damped sinusoidal signal at 1.1 MHz, with a duration of about 2 μ

s.

34. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 32, wherein said thickness of said soft tissue is calculated as

d_s =v_s τ

/2

where d_s is the desired thickness;

v_s is the velocity of ultrasound in soft tissue; and

τ

is a round-trip transit time for said acoustic pulse to travel from a source thereof through the soft tissue, to the bone tissue, and back through the soft tissue.

35. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 32, further comprising the step of

(D) maintaining said exposing between about 5 minutes and about 1 hour.

36. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 35, further comprising the step of

(E) repeating said exposing for about 1 to 3 times a day.

37. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 32, wherein said therapeutic ultrasonic signal is a periodic frequency-modulated-sine-wave-amplitude-modulated-by-a -frequency-modulated-sine-wave signal having

a carrier frequency fo with a selected value in a range between about 25 kHz and about 2 MHz, and swept up to the value f_o * of about 2 MHz;

a modulating frequency fm with a selected value in a range up to about 25 kHz, and swept up to the value f_m * of about 25 kHz;

a modulation index a in a range between 0 and 1000,

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

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

a number N of pulse repetitions within a cycle of up to 10,000,

a cycle duration T of between about 0.2 ms and about 1.0 s, and

an intensity I_SATA in a range of 20 mW/cm² -100 mW/cm².

38. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 37, wherein

the carrier frequency f_o is 1.1 MHz;

the modulating frequency f_m is 500 Hz, swept up to

the f_m * value of 2000 Hz;

the modulation index a is 1;

the pulse width T_s is 4 ms;

the duration T_s '"'"' of a pulse and a pause for one repetition is 8 ms;

the number N of pulse repetitions within a cycle is 25;

the cycle duration T is 1 s; and

the intensity I_SATA is 45 mW/cm².

39. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 32, wherein said therapeutic ultrasonic signal is an amplitude modulated periodic signal having

a carrier frequency f_o of between about 25 kHz and about 2 MHz,

a modulating frequency f_m of up to about 25 kHz,

a modulation index a in a range between 0 and 1000,

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

a cycle duration T of between about 0.2 ms and about 1.0 s, and

an intensity I_SATA in a range of 20-100 mW/cm².

40. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 39, wherein

the carrier frequency f_o is 1.1 MHz,

the modulating frequency f_m is 20 kHz,

the modulation index a is 0.3,

the pulse width T_s is 0.5 ms,

the cycle duration T is 5 ms, and

the intensity I_SATA is 45 mW/cm².

41. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 39, wherein

the carrier frequency f_o is 1.1 MHz,

the modulating frequency f_m is 20 kHz,

the modulation index a is 0.3,

the pulse width T_s is 0.1 ms,

the cycle duration T is 0.5 ms, and

the intensity I_SATA is 45 mW/cm².

42. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 39, wherein

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

a number N of pulse repetitions within a cycle is up to 10,000.

43. The method of non-invasively therapeutically treating a bone tissue in vivo according to claim 39, wherein

the carrier frequency f_o is 1.1 MHz,

the modulating frequency f_m is 5 kHz,

the modulation index a is 0.3,

the pulse width T_s is 4 ms,

the duration T_s '"'"' of a pulse and a pause for one repetition is 8 ms,

the number N of pulse repetitions within a cycle is 25,

the cycle duration T is 1 s, and

the intensity I_SATA is 45 mW/cm².