CA2456734A1 - Method and means for controlling acoustic modes in tissue healing applications - Google Patents

Method and means for controlling acoustic modes in tissue healing applications Download PDF

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Publication number
CA2456734A1
CA2456734A1 CA002456734A CA2456734A CA2456734A1 CA 2456734 A1 CA2456734 A1 CA 2456734A1 CA 002456734 A CA002456734 A CA 002456734A CA 2456734 A CA2456734 A CA 2456734A CA 2456734 A1 CA2456734 A1 CA 2456734A1
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Prior art keywords
further characterized
modal converter
transducer
interface
tissue
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CA002456734A
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French (fr)
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CA2456734C (en
Inventor
Alan A. Winder
Roger J. Talish
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Exogen Inc
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Exogen, Inc.
Alan A. Winder
Roger J. Talish
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Publication of CA2456734A1 publication Critical patent/CA2456734A1/en
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Publication of CA2456734C publication Critical patent/CA2456734C/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy
    • A61N2007/0078—Ultrasound therapy with multiple treatment transducers

Abstract

A modal converter having at least one ultrasonic transducer or at least one array of such transducers positioned on the modal converter at various angle s relative to a tissue surface and bone tissue surface, such that some combination of one or more of the following occur: longitudinal waves are produced perpendicular to the bone surface, longitudinal waves propagate alo ng the surface of the skin after incidence at the skin tissue surface, and both longitudinal and shear waves propagate along the surface of the bone after incidence at the bone tissue surface. Illuminating an open tissue wound and bone fracture site with these acoustic modes enhances and promotes angiogenesis and the biological endostial or periostial healing phases, or both, of the bone fracture healing process. The spatial and temporal distribution of acoustic waves directed to the treatment area via the ultrasonic transducers and the modal converter may be controlled.

Claims (67)

1. A method of noninvasively applying an ultrasonic excitation signal from at least one transducer to human tissue in vivo for therapeutic applications, characterized by:
acoustically coupling a modal converter (16) to a tissue surface, wherein the modal converter (16) comprises a top surface (26), a bottom surface (34), and a plurality of side surfaces (28) positioned at angles relative to the bottom surface (34) such that the at least one transducer (20, 22) is acoustically coupled to one of the plurality of side surfaces (28) and can emit an acoustic wave that reflects at an interface and, after reflection, travels parallel to and along the interface; and emitting an acoustic wave from the at least one transducer (20, 22) acoustically coupled to the modal converter (16) at an angle relative to the bottom surface (34) of the modal converter (16), such that the acoustic wave emitted from the at least one transducer (20, 22) reflects upon striking the interface and after reflection travels parallel to and along the interface.
2. The method of claim 1, further characterized by generating an excitation signal and transmitting the excitation signal to the at least one transducer (20, 22).
3. The method of claim 1, further characterized by controlling the spatial and temporal distribution of acoustic energy from the at least one transducer (20, 22) using a system controller (54).
4. The method of claim 3, further characterized by using the system controller (54) comprises using a programmable microprocessor.
5. The method of claim 1, further characterized by generating longitudinal waves that propagate substantially normal to the tissue surface, the waves being generated from at least one transducer (20, 22) positioned on the top surface (26) of the modal converter (16).
6. The method of claim 1, further characterized by emitting an acoustic wave toward the interface comprises emitting the acoustic wave toward an interface between a skin tissue surface (36) and the modal converter (16).
7. The method of claim 6, further characterized by emitting the acoustic wave toward an interface between a skin tissue surface and the modal converter (16) comprises emitting the acoustic wave at a first critical angle (30, 31) relative to the bottom surface (34) of the modal converter (16) such that the acoustic wave converts partially into a longitudinal wave traveling parallel to and along the skin tissue surface, and converts partially into a shear wave traveling at a refraction angle, .theta.sv, after incidence at the interface between the skin tissue surface and the modal converter (16), wherein .theta.sv = sin-1 {(1-2v)/2(1-v)} 1/2, wherein v represents Poisson's ratio for soft tissue and sv refers to the vertical component of the shear wave (44).
8. The method of claim 1, further characterized by emitting the acoustic wave toward the interface comprises emitting the acoustic wave toward an interface between bone tissue and surrounding soft tissue.
9. The method of claim 8, further characterized by emitting the acoustic wave toward an interface between bone tissue and surrounding soft tissue comprises emitting the acoustic wave at a first critical angle relative to the bottom surface (34) of the modal converter (16) such that the acoustic wave converts partially into a longitudinal wave traveling parallel to and along the interface between the surrounding soft tissue and the bone tissue, and converts partially into a shear wave traveling at a refraction angle, .theta.sv, after incidence at the interface between the surrounding soft tissue and the bone tissue, wherein .theta.sv = sin-1 {(1-2v)/2(1-v)}1/2, wherein v represents Poisson's ratio for bone tissue and sv refers to the vertical component of the shear wave.
10. The method of claim 9, further characterized by emitting an acoustic wave from the at least one transducer (20, 22) at a second critical angle relative to the bottom surface (34) of the modal converter (16) such that the acoustic wave reflects and travels as an acoustic shear wave parallel to and along the interface between the surrounding soft tissue and bone tissue after incidence at the interface between the surrounding soft tissue and bone tissue.
11. The method of claim 10, further characterized by emitting an acoustic wave from the at least one transducer (20, 22) at the second critical angle that converts totally into an acoustic shear wave traveling parallel to and along the bone tissue surface.
12. The method of claim 1, further characterized by acoustically coupling a modal converter (16) to a tissue surface comprises acoustically coupling a modal converter (16) comprising a material having an acoustic impedance comparable to an acoustic impedance for human soft tissue.
13. The method of claim 1, further characterized by acoustically coupling a modal converter (16) to a tissue surface comprises acoustically coupling a modal converter (16) comprising a material having a longitudinal velocity less than a longitudinal velocity for human soft tissue.
14. The method of claim 1, further characterized by acoustically coupling a modal converter (16) to a tissue surface comprises acoustically coupling a modal converter (16) comprising a material having a longitudinal velocity less than a longitudinal velocity for bone tissue.
15. The method of claim 1, further characterized by acoustically coupling a modal converter (16) to a tissue surface comprises acoustically coupling a modal converter (16) comprising thermoplastics, thermosets, elastomers or combinations thereof.
16. The method of claim 15, further characterized by acoustically coupling a modal converter (16) to a tissue surface comprises acoustically coupling a modal converter (16) comprising ethyl vinyl acetate, ecothane, polyurethane, silicone or combinations thereof.
17. The method of claim 1, further characterized by acoustically coupling a modal converter (16) to a tissue surface comprises acoustically coupling a modal converter (16) comprising a coupling material having an acoustic impedance comparable to an acoustic impedance for human soft tissue.
18. The method of claim 1, further characterized by the emitting of acoustic waves from the at least one transducer (20, 22) comprises emitting occurs multiple times during a time period comprising a dosage period, wherein the dosage period is between about 1 and about 60 minutes.
19. The method of claim 2, further characterized by generating an excitation signal comprises generating an excitation signal that is a modulated pulsed sine wave.
20. The method of claim 19, further characterized by generating an excitation signal comprises generating an excitation signal that is amplitude modulated.
21. The method of claim 19, further characterized by generating an excitation signal comprises generating an excitation signal that is phase modulated.
22. The method of claim 21, further characterized by generating an excitation signal comprises generating an excitation signal that is within the range from a delayed linear (CW) to a logarithmic (hyperbolic FM) variation with time, based on a power series representation of a frequency versus time curve as defined by f(t) = .alpha.o + .alpha.1t + .alpha.2t2 + .alpha.3t3 + ..., wherein the set of constants, .alpha., characterize a particular modulation system.
23. The method of claim 19, further characterized by generating an excitation signal comprises generating an excitation signal comprising a carrier frequency, a pulsewidth, a pulse repetition frequency, and a spatial-average temporal-average intensity.
24. The method of claim 23, further characterized by generating an excitation signal comprises generating an excitation signal comprising a carrier frequency that is within the range of 10 kHz to 10 MHz for the at least one transducer (20, 22).
25. The method of claim 23, further characterized by generating an excitation signal comprises generating an excitation signal comprising a pulsewidth that is within the range of 100 microseconds to 100 milliseconds for the at least one transducer (20, 22).
26. The method of claim 23, further characterized by generating an excitation signal comprises generating an excitation signal comprising a pulse repetition frequency that is within the range of 1 Hz to 10,000 Hz for the at least one transducer (20, 22).
27. The method of claim 23, further characterized by generating an excitation signal comprises generating an excitation signal comprising a spatial-average temporal-average intensity that is within the range of 5 mW/cm2 to 500 mW/cm2 for the at least one transducer (20, 22).
28. An apparatus for noninvasively applying an ultrasound excitation signal from at least one transducer (20, 22) to human tissue in vivo for therapeutic applications, characterized in that:
a modal converter (16) including a top surface (26), a plurality of side surfaces (28), a bottom surface (34), and at least one transducer (20, 22), wherein the plurality of side surfaces (28) are positioned at angles relative to the bottom surface (34) and wherein the at least one transducer (20, 22) is acoustically coupled with one of the plurality of sides of the modal converter (16) and positioned at an angle relative to the bottom surface (34) such that an acoustic wave emitted from the at least one transducer (20, 22) reflects upon striking an interface and travels parallel to and along the interface.
29. The apparatus of claim 28, further characterized in that a system controller (54) for controlling the spatial and temporal distribution of the acoustic wave from the at least one transducer (20, 22).
30. The apparatus of claim 28, further characterized in that a system generator for generating and transmitting an excitation signal to the at least one transducer (20, 22).
31. The method of claim 29, further characterized in that the system controller (54) is a programmable microprocessor.
32. The apparatus of claim 28, further characterized in that said modal converter (16) comprises at least one transducer (18) positioned on the top surface (26) of the modal converter (16) for generating longitudinal waves normal to the skin tissue surface.
33. The apparatus of claim 28, further characterized in that the interface comprises an interface positioned between a skin tissue surface and the modal converter (16).
34. The apparatus of claim 33, characterized in that the at least one transducer (20, 22) is positioned at a first critical angle relative to the bottom surface (34) of the modal converter (16) so that the at least one transducer (20, 22) may emit an acoustic wave that converts partially into a longitudinal wave traveling parallel to and along the skin tissue surface and converts partially into a shear wave traveling at a refraction angle, .theta.sv, after incidence at the interface between the skin tissue surface and the modal converter, wherein .theta.sv = sin-1 {(1-2v)/2(1-v)} 1/2, wherein v represents Poisson's ratio for human soft tissue and sv refers to the vertical component of the shear wave.
35. The apparatus of claim 28, further characterized in that the interface is comprises an interface positioned between surrounding soft tissue and bone tissue.
36. The apparatus of claim 34, further characterized in that the at least one transducer (20, 22) is positioned at a first critical angle relative to the bottom surface (34) of the modal converter (16) so that the at least one transducer (20, 22) may emit an acoustic wave that converts partially into a longitudinal wave traveling parallel to and along the interface between surrounding soft tissue and bone tissue and converts partially into a shear wave traveling at a refraction angle, .theta.sv, after incidence at the interface between surrounding soft tissue and bone tissue, wherein .theta.sv = sin-1 {(1-2v)/2(1-v)}1/2, wherein v represents Poisson's ratio for human soft tissue and sv refers to the vertical component of the shear wave.
37. The apparatus of claim 28, further characterized in that the at least one transducer (22) is positioned at a second critical angle relative to the bottom surface (34) of the modal converter (16) such that the at least one transducer (22) can emit an acoustic wave that reflects at the interface between the surrounding soft tissue and the bone tissue, and after incidence travels as an acoustic shear wave parallel to and along the interface between the surrounding soft tissue and the bone tissue.
38. The apparatus of claim 37, further characterized in that the acoustic wave emitted from the at least one transducer (22) at the second critical angle converts totally into an acoustic shear wave traveling parallel to and along the interface between the surrounding soft tissue and the bone tissue.
39. The apparatus of claim 28, further characterized in that said modal converter (16) comprises a material having an acoustic impedance comparable to an acoustic impedance for human soft tissue.
40. The apparatus of claim 28, further characterized in that said modal converter (16) comprises a material having a longitudinal velocity less than a longitudinal velocity for soft tissue.
41. The apparatus of claim 28, further characterized in that said modal converter (16) comprises a material having a longitudinal velocity less than a longitudinal velocity for bone tissue.
42. The apparatus of claim 28, further characterized in that said modal converter (16) comprises thermoplastics, elastomers or combinations thereof.
43. The apparatus of claim 42, further characterized in that said modal converter (16) further comprises ethyl vinyl acetate, ecothane, polyurethane, silicone or combinations thereof.
44. A modal converter (16), characterized in that:
a top surface (26);
a substantially flat bottom surface (34);
a plurality of side surfaces (28) capable of receiving at least one transducer (20, 22) and positioned at critical angles relative to the bottom surface (34) such that an acoustic wave emitted from at least one transducer (20, 22) acoustically coupled to at least one side surface (28) reflects upon striking an interface and travels parallel to and along the interface.
45. The modal converter (16) of claim 44, further characterized in that said modal converter (16) further comprises a trapezoidal cross-section.
46. The modal converter (16) of claim 44, further characterized in that said top surface (26) is substantially parallel to the bottom surface (34).
47. The modal converter (16) of claim 44, further characterized in that at least one side surface (28) is positioned at a first critical angle relative to the bottom surface (34) of the modal converter (16) so that at least one transducer (20, 22) acoustically coupled to the at least one side surface (28) can emit an acoustic wave that converts partially into a longitudinal wave traveling parallel to and along a skin tissue surface and converts partially into a shear wave (44) traveling at a refraction angle, 0sv, after incidence at an interface between the skin tissue surface (36) and the modal converter (16), wherein .theta.sv = sin-1 {(1-2v)/2(1-v)} 1/2, wherein v represents Poisson's ratio for human soft tissue and sv refers to the vertical component of the shear wave.
48. The modal converter (16) of claim 44, further characterized in that at least one side surface (28) is positioned at a first critical angle relative to the bottom surface (34) of the modal converter (16) so that at least one transducer (20, 22) acoustically coupled to the at least one side surface (28) can emit an acoustic wave that converts partially into a longitudinal wave traveling parallel to and along an interface between surrounding soft tissue and bone tissue and converts partially into a shear wave traveling at a refraction angle, .theta.sv, after incidence at the interface between surrounding soft tissue and bone tissue, wherein .theta.sv = sin-1 {(1-2v)/2(1-v)} 1/2, wherein v represents Poisson's ratio for human soft tissue and sv refers to the vertical component of the shear wave.
49. The modal converter (16) of claim 48, further characterized in that at least one side surface (28) is positioned at a second critical angle relative to the bottom surface (34) of the modal converter (16) such that at least one transducer (20, 22) acoustically coupled to the at least one side surface (28) can emit an acoustic wave that reflects at the interface between the surrounding soft tissue and the bone tissue, and after incidence travels as an acoustic shear wave parallel to and along the interface between the surrounding soft tissue and the bone tissue.
50. The modal converter (16) of claim 49, further characterized in that the at least one side surface (28) is positioned at the second critical angle relative to the bottom surface (34) of the modal converter (16) such that an acoustic wave emitted from the at least one transducer (20, 22) acoustically coupled to the at least one side surface (28) converts totally into an acoustic shear wave traveling parallel to and along the interface between the surrounding soft tissue and the bone tissue.
51. The modal converter (16) of claim 44, further characterized in that said modal converter (16) comprises a material having an acoustic impedance comparable to an acoustic impedance for human soft tissue.
52. The modal converter (16) of claim 44, further characterized in that said modal converter (16) comprises a material having a longitudinal velocity less than a longitudinal velocity for soft tissue.
53. The modal converter (16) of claim 44, further characterized in that said modal converter (16) comprises a material having a longitudinal velocity less than a longitudinal velocity for bone tissue.
54. The modal converter (16) of claim 44, further characterized in that said modal converter (16) comprises thermoplastics, elastomers or combinations thereof.
55. The modal converter (16) of claim 54, further characterized in that said modal converter (16) further comprises ethyl vinyl acetate, ecothane, polyurethane, silicone or combinations thereof.
56. The modal converter (16), of claim 44, further characterized in that:
at least one side surface (28) contains at least one cavity capable of receiving at least one transducer (20, 22) and wherein said at least one cavity comprises at least one flat surface capable being acoustically coupled to at least one transducer (20, 22) and positioned at a critical angle relative to the bottom surface (34) such that an acoustic wave emitted from at least one transducer (20, 22) acoustically coupled to the at least one flat surface reflects upon striking an interface and travels parallel to and along the interface.
57. The modal converter (16) of claim 56, further characterized in that at least one flat surface is positioned at a first critical angle (30, 31) relative to the bottom surface (34) of the modal converter (16) so that at least one transducer (20, 22) acoustically coupled to the at least flat side surface (28) can emit an acoustic wave that converts partially into a longitudinal wave traveling parallel to and along a skin tissue surface and converts partially into a shear wave traveling at a refraction angle, .theta.sv, after incidence at an interface between the skin tissue surface and the modal converter (16), wherein .theta.sv = sin-1 {(1-2v)/2(1-v)1/2, wherein v represents Poisson's ratio for human soft tissue and sv refers to the vertical component of the shear wave.
58. The modal converter (16) of claim 56, further characterized in that at least one flat surface is positioned at a first critical angle relative to the bottom surface (34) of the modal converter (16) so that at least one transducer (20, 22) acoustically coupled to the at least one flat surface can emit an acoustic wave that converts partially into a longitudinal wave traveling parallel to and along an interface between surrounding soft tissue and bone tissue and converts partially into a shear wave traveling at a refraction angle, .theta.sv, after incidence at the interface between surrounding soft tissue and bone tissue, wherein .theta.sv = sin-1 {(1-2v)/2(1-v)} 1/2, wherein v represents Poisson's ratio for human soft tissue and sv refers to the vertical component of the shear wave.
59. The modal converter (16) of claim 58, further characterized in that at least one flat surface is positioned at a second critical angle relative to the bottom surface (34) of the modal converter (16) such that at least one transducer (20, 22) acoustically coupled to the at least one flat surface can emit an acoustic wave that reflects at the interface between the surrounding soft tissue and the bone tissue, and after incidence travels as an acoustic shear wave parallel to and along the interface between the surrounding soft tissue and the bone tissue.
60. The modal converter (16) of claim 59, further characterized in that the at least one flat surface is positioned at the second critical angle relative to the bottom surface (34) of the modal converter (16) such that an acoustic wave emitted from the at least one transducer (20, 22) acoustically coupled to the at least one flat surface converts totally into an acoustic shear wave traveling parallel to and along the interface between the surrounding soft tissue and the bone tissue.
61. The modal converter (16) of claim 56, further characterized in that said modal converter (16) comprises a material having an acoustic impedance comparable to an acoustic impedance for human soft tissue.
62. The modal converter (16) of claim 56, further characterized in that said modal converter (16) comprises a material having a longitudinal velocity less than a longitudinal velocity for soft tissue.
63. The modal converter (16) of claim 56, further characterized in that said modal converter (16) comprises a material having a longitudinal velocity less than a longitudinal velocity for bone tissue.
64. The modal converter (16) of claim 56, further characterized in that said modal converter (16) comprises thermoplastics, elastomers or combinations thereof.
65. The modal converter (16) of claim 64, further characterized in that said modal converter (16) further comprises ethyl vinyl acetate, ecothane, polyurethane, silicone or combinations thereof.
66. The apparatus of claim 28, which is adapted for systemically administering therapeutic ultrasound to a patient, further characterized in that:
a system controller (54) for controlling the spatial and temporal distribution of acoustic energy from at least one transducer (20, 22) is coupled to the modal converter, which is in the form of a wedge.
67. The apparatus of claim 66, further characterized in that the system controller (54) is a programmable microprocessor.
CA2456734A 2001-08-09 2002-08-01 Method and means for controlling acoustic modes in tissue healing applications Expired - Fee Related CA2456734C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/925,193 US7429248B1 (en) 2001-08-09 2001-08-09 Method and apparatus for controlling acoustic modes in tissue healing applications
US09/925,193 2001-08-09
PCT/US2002/024389 WO2003013654A1 (en) 2001-08-09 2002-08-01 Method and means for controlling acoustic modes in tissue healing applications

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CA2456734A1 true CA2456734A1 (en) 2003-02-20
CA2456734C CA2456734C (en) 2010-06-01

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US (1) US7429248B1 (en)
EP (1) EP1414521B1 (en)
JP (1) JP4299128B2 (en)
KR (1) KR100904812B1 (en)
AT (1) ATE306969T1 (en)
AU (1) AU2002329676B2 (en)
CA (1) CA2456734C (en)
DE (1) DE60206773T2 (en)
DK (1) DK1414521T3 (en)
ES (1) ES2249617T3 (en)
WO (1) WO2003013654A1 (en)

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