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Title:
APPARATUSES AND SYSTEMS FOR GENERATING HIGH-FREQUENCY SHOCKWAVES, AND METHODS OF USE
Document Type and Number:
WIPO Patent Application WO/2011/091020
Kind Code:
A2
Abstract:
Apparatuses and methods for generating therapeutic shock waves. Some embodiments comprise: an acoustic-wave generator configured to emit acoustic waves having at least one frequency between 1 MHz and 1000 MHz; a shock wave housing coupled to the acoustic-wave generator; and a shock wave medium disposed in the shock wave housing; where the apparatus is configured such that if the acoustic-wave generator emits acoustic waves then at least some portion of the acoustic waves will travel through the shock wave medium and form one or more shock waves.

Inventors:
CAPELLI CHRISTOPHER C (US)
Application Number:
PCT/US2011/021692
Publication Date:
July 28, 2011
Filing Date:
January 19, 2011
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
UNIV TEXAS (US)
CAPELLI CHRISTOPHER C (US)
International Classes:
A61B17/225; A61B18/00; A61N1/06; A61N7/00
Foreign References:
US20080194967A12008-08-14
US20080146971A12008-06-19
US20070049829A12007-03-01
US20080269608A12008-10-30
Other References:
None
See also references of EP 2525727A4
Attorney, Agent or Firm:
ROBINSON, Eagle, H. (600 Congress Ave.Suite 240, Austin TX, US)
Download PDF:
Claims:
CLAIMS

1. An apparatus for generating therapeutic shock waves, comprising:

an acoustic-wave generator configured to emit acoustic waves having at least one frequency between 1 MHz and 1000 MHz;

a Shockwave housing coupled to the acoustic-wave generator; and

a Shockwave medium disposed in the Shockwave housing;

where the apparatus is configured such that if the acoustic- wave generator emits acoustic waves then at least some portion of the acoustic waves will travel through the Shockwave medium and form one or more shock waves.

2. The apparatus of claim 1, where the Shockwave medium is unitary with the Shockwave housing.

3. The apparatus of claim 2, where the Shockwave housing and Shockwave medium comprise silicone.

4. The apparatus of any of claims 2-3, where the Shockwave medium comprises one or more bubbles.

5. The apparatus of claim 1, where the Shockwave housing defines a chamber, and where the Shockwave medium is disposed in the chamber.

6. The apparatus of claim 5, where the Shockwave medium comprises a fluid.

7. The apparatus of claim 6, where the Shockwave medium comprises a gel.

8. The apparatus of claim 7, where the Shockwave medium comprises a liquid.

9. The apparatus of any of claims 5-8, where the Shockwave medium is configured such that in the presence of acoustic waves from the acoustic-wave generator the Shockwave medium will exhibit nonlinear properties.

10. The apparatus of any of claims 5-9, where the Shockwave medium comprises one or more of: bubbles, solid particles, or a combination of bubbles and solid particles.

90340728.1

11. The apparatus of any of claims 5-10, where the Shockwave medium comprises one or more of: water, glycerin, poly(ethylene glycol) (PEG), propylene glycol, silicone oil, alcohol, or a combination of two or more of these.

12. The apparatus of any of claims 1, and 5-11, where the Shockwave housing defines a chamber having an inlet end coupled to the acoustic-wave generator and an outlet end extending from the acoustic-wave generator, and where the Shockwave housing includes an end cap covering the outlet end of the chamber.

13. The apparatus of claim 12, where the chamber has a circular cross-sectional shape.

14. The apparatus of claim 12, where the chamber has a rectangular cross-sectional shape.

15. The apparatus of claim 14, where the chamber has a square cross-sectional shape.

16. The apparatus of claim 12, where the chamber has a ovular cross-sectional shape.

17. The apparatus of claim 12, where the chamber has a triangular cross-sectional shape.

18. The apparatus of any of claims 12-17, where the end cap is configured to permit Shockwaves to exit the outlet end of the Shockwave chamber.

19. The apparatus of claim 18, where the end cap is configured such that attenuation of a Shockwave exiting the end cap will be less than twenty percent.

20. The apparatus of claim 19, where the end cap comprises at least one of: polymer, hydrogel, plastic, or silicone.

21. The apparatus of any of claims 12-20, where the inlet end of the chamber has a transverse internal dimension at least as large as a corresponding transverse external dimension of the acoustic-wave generator.

22. The apparatus of claim 21, where the chamber has a substantially constant cross- section between the inlet end and the outlet end.

90340728.1

23. The apparatus of claim 21, where the chamber has a varying cross-section between the inlet end and the outlet end.

24. The apparatus of any of claims 21-23, where the Shockwave housing is configured such that if acoustic waves are incident on the Shockwave housing from within the Shockwave chamber, then the Shockwave housing will reflect at least some portion of the incident acoustic waves back into the Shockwave chamber.

25. The apparatus of any of claims 12-23, where the distance from the acoustic-wave generator to the outlet end of the chamber is between 100 and 1000 percent of at least one internal transverse dimension of the chamber. 26. The apparatus of claim 25, where the distance from the acoustic-wave generator to the outlet end of the chamber is between 100 and 1000 percent of the minimum internal transverse dimension of the chamber.

27. The apparatus of claim 25, where the distance from the acoustic-wave generator to the outlet end of the chamber is between 300 and 900 percent of at least one internal transverse dimension of the chamber.

28. The apparatus of claim 27, where the distance from the acoustic-wave generator to the outlet end of the chamber is between 400 and 800 percent of at least one internal transverse dimension of the chamber.

29. The apparatus of any of claims 12-23, where the distance from the acoustic-wave generator to the outlet end of the chamber is greater than or equal to: τ ~~ i!f!L «~

"" T K . :.ΐ...·.·.·Λ·"ί..Γ....". where€ = nonlinear parameter of Shockwave medium; ω = frequency of acoustic wave; po = density of the Shockwave medium; λ = wavelength of acoustic wave; Co = velocity of sound in the Shockwave medium; PQ = pressure amplitude in Shockwave medium; and ΜΩ = acoustic mach number = PQ ÷ (CQ2 po).

90340728.1

30. The apparatus of any of claims 1-29, where the acoustic-wave generator comprises an ultrasound head.

31. The apparatus of any of claims 1-29, where the acoustic-wave generator comprises ceramic. 32. The apparatus of any of claims 1-7, where the acoustic-wave generator comprises a piezoelectric acoustic element.

33. The apparatus of any of claims 1-29, further comprising:

a controller coupled to the acoustic-wave generator and configured to actuate the

acoustic-wave generator to emit acoustic waves. 34. The apparatus of claim 33, where the controller is configured to adjust the acoustic- wave generator to vary at least one of the amplitude and frequency of acoustic waves emitted from the acoustic-wave generator.

35. The apparatus of any of claims 33-34, where the controller is configured to actuate the acoustic-wave generator to continuously emit acoustic waves for a period of time. 36. The apparatus of any of claims 33-34, where the controller is configured to actuate the acoustic-wave generator to emit acoustic waves in an intermittent on-off sequence.

37. The apparatus of any of claims 33-36, where the controller is configured to actuate the acoustic-wave generator to emit acoustic waves in a periodic on-off sequence.

38. The apparatus of any of claims 33-37, where the acoustic-wave generator is a first acoustic-wave generator, and where the apparatus further comprises:

a second acoustic-wave generator configured to emit acoustic waves having at least one frequency between 1 MHz and 1000 MHz;

where the Shockwave housing is also coupled to the second acoustic-wave generator; where the apparatus is configured such that if the second acoustic-wave generator emits acoustic waves then at least some portion of the acoustic waves will travel through the Shockwave medium and form one or more shock waves; and

90340728.1 where the controller is also coupled to the second acoustic-wave generator and configured to actuate second the acoustic-wave generator to emit acoustic waves.

39. The apparatus of claim 38, where the controller is configured to actuate the first and second acoustic-wave generators such that the acoustic waves that are emitted from the second acoustic-wave generator are out-of-phase from the waves that are emitted from the first acoustic-wave generator.

40. The apparatus of any of claims 1-34, where the apparatus is configured to generate shock waves having an intensity between 50 and 1000 Watts per square centimeter (W/cm2). 41. The apparatus of claim 40, where the apparatus is configured to generate shock waves having an intensity between 100 and 500 W/cm2.

42. The apparatus of any of claims 1-41, where the apparatus is configured to generate 100 or more Shockwaves per minute.

43. The apparatus of claim 42, where the apparatus is configured to generate 500 or more shock waves per minute.

44. The apparatus of claim 43, where the apparatus is configured to generate 1000 or more shock waves per minute.

45. The apparatus of any of claims 1-44, where the apparatus is configured to fit within a box having a length of 3 feet, a width of 2 feet, and a height of 2 feet. 46. The apparatus of claim 45, where the apparatus is configured to fit within a box having a length of 3 feet, a width of 1 foot, and a height of 1 foot.

47. The apparatus of claim 46, where the apparatus is configured to fit within a box having a length of 2 feet, a width of 1 foot, and a height of 1 foot.

48. The apparatus of claim 47, where the apparatus is configured to fit within a box having a length of 1 foot, a width of 8 inches, and a height of 8 inches.

90340728.1

49. A method of generating therapeutic shock waves, comprising:

providing an apparatus of any of claims 1-48; and

actuating the apparatus to generate one or more shock waves.

50. The method of claim 49, further comprising:

disposing the apparatus adjacent tissue of a patient such that at least one shock wave enters the tissue.

51. The method of claim 50, where the tissue comprises skin tissue on the face of the patient.

52. A method of generating therapeutic shock waves, comprising:

actuating an acoustic-wave generator to emit acoustic waves having at least one frequency between 1 MHz and 1000 MHz, such that at least some portion of the acoustic waves travel through a Shockwave medium that is disposed in a Shockwave housing to form one or more shock waves.

90340728.1

Description:
DESCRIPTION

APPARATUSES AND SYSTEMS FOR GENERATING HIGH-FREQUENCY

SHOCKWAVES, AND METHODS OF USE

RELATED APPLICATION

[0001] This application claims priority to U.S. Provisional Application No.

61/296,376, filed January 19, 2010, which is incorporated here in its entirety.

BACKGROUND

1. Field of the Invention

[0002] The present invention relates generally to therapeutic uses for shock waves.

More particularly, but not by way of limitation, the present invention relates to an apparatus for generating therapeutic shock waves (shock waves with therapeutic uses).

2. Background Information

[0003] Shockwaves may be used in certain medical and aesthetic therapies. Since the early 1980s, Shockwaves have been used in the form of extracorporeal lithotripsy, in which pulses may be used to form shock fronts for fragmentation of renal calculi. The Shockwave source in lithotripsy is typically generated by the discharge of electric energy between test electrodes.

[0004] More recently, Shockwaves have been described for use in medical therapy in which the Shockwaves may not originate from the discharge of electric energy between test electrodes. For example, U.S. Patent No. 6,325,769, by Peter J. Klopotek, describes a method and apparatus for reducing skin wrinkles, comprising applying a focused ultrasound beam to a region of human skin to generate a Shockwave to mechanically disrupt a dermis layer in the region of the skin so as to cause a change in the dermis layer of the skin that results in a change in a smoothness of the epidermis layer of the skin. Klopotek discloses that the acoustic pulses used to treat the skin have pressure amplitudes that are sufficiently high to introduce nonlinearity. The result of this nonlinearity is distortion of the waveform of the pulses as they travel through the skin. These waveforms convert from a typical Gaussian amplitude (pressure) profile to a waveform having a much sharper leading face. Klopotek claims that the waveform was "essentially a 'shock-wave' in the target region below the surface of the skin." Klopotek further states that in a normal wave propagation mode, there is essentially no movement of dermal material. However, when acoustic waves exhibit

90340728.1 nonlinearity, the dermal tissue moves, creating a negative pressure, or vacuum effect, in the tissue in the wake of the pulse - which can induce tissue damage, tearing tissue structures apart, heating the region and, thereby, triggering the synthesis of new connected tissue.

[0005] A problem with the generation of Shockwaves as described by Klopotek is that it is not predictable. As described by Klopotek, the Shockwaves form as they travel through the skin because of the nonlinear nature of the skin tissue. The formation of a Shockwave is dependent on the frequency and amplitude of the acoustic waves. Additionally, the formation of a Shockwave is dependent on the medium in which the wave is traveling. Depending on the frequency, amplitude and media, the distance at which a Shockwave forms from the transducer head is relatively large and can vary drastically depending on the type of tissue. As a result, up to now, due to variations in the nonlinearity of the tissue that is being treated, creating consistent high-frequency Shockwaves suitable for therapy is difficult.

SUMMARY

[0006] The present disclosure includes embodiments of apparatuses and methods for generating therapeutic shock waves.

[0007] Some embodiments of the present apparatuses for generating therapeutic shock waves, comprise: an acoustic-wave generator configured to emit acoustic waves having at least one frequency between 1 MHz and 1000 MHz; a Shockwave housing coupled to the acoustic-wave generator; and a Shockwave medium disposed in the Shockwave housing; where the apparatus is configured such that if the acoustic-wave generator emits acoustic waves then at least some portion of the acoustic waves will travel through the Shockwave medium and form one or more shock waves. In some embodiments, the Shockwave medium is unitary with the Shockwave housing. In some embodiments, the Shockwave housing and Shockwave medium comprise silicone. In some embodiments, the Shockwave medium comprises one or more bubbles. In some embodiments, the Shockwave housing defines a chamber, and where the Shockwave medium is disposed in the chamber. In some embodiments, the Shockwave medium comprises a fluid. In some embodiments, the Shockwave medium comprises a gel. In some embodiments, the Shockwave medium comprises a liquid.

[0008] In some embodiments, the Shockwave medium is configured such that in the presence of acoustic waves from the acoustic-wave generator the Shockwave medium will exhibit nonlinear properties. In some embodiments, the Shockwave medium comprises one or more of: bubbles, solid particles, or a combination of bubbles and solid particles. In some

90340728.1 embodiments, the Shockwave medium comprises one or more of: water, glycerin, poly(ethylene glycol) (PEG), propylene glycol, silicone oil, alcohol, or a combination of two or more of these.

[0009] In some embodiments, the Shockwave housing defines a chamber having an inlet end coupled to the acoustic-wave generator and an outlet end extending from the acoustic-wave generator, and where the Shockwave housing includes an end cap covering the outlet end of the chamber. In some embodiments, the chamber has a circular cross-sectional shape. In some embodiments, the chamber has a rectangular cross-sectional shape. In some embodiments, the chamber has a square cross-sectional shape. In some embodiments, the chamber has a ovular cross-sectional shape. In some embodiments, the chamber has a triangular cross-sectional shape. In some embodiments, the end cap is configured to permit Shockwaves to exit the outlet end of the Shockwave chamber. In some embodiments, the end cap is configured such that attenuation of a Shockwave exiting the end cap will be less than twenty percent. In some embodiments, the end cap comprises at least one of: polymer, hydrogel, plastic, or silicone. In some embodiments, the inlet end of the chamber has a transverse internal dimension at least as large as a corresponding transverse external dimension of the acoustic-wave generator. In some embodiments, the chamber has a substantially constant cross-section between the inlet end and the outlet end. In some embodiments, the chamber has a varying cross-section between the inlet end and the outlet end.

[0010] In some embodiments, the Shockwave housing is configured such that if acoustic waves are incident on the Shockwave housing from within the Shockwave chamber, then the Shockwave housing will reflect at least some portion of the incident acoustic waves back into the Shockwave chamber. In some embodiments, the distance from the acoustic- wave generator to the outlet end of the chamber is between 100 and 1000 percent of at least one internal transverse dimension of the chamber. In some embodiments, the distance from the acoustic-wave generator to the outlet end of the chamber is between 100 and 1000 percent of the minimum internal transverse dimension of the chamber. In some embodiments, the distance from the acoustic-wave generator to the outlet end of the chamber is between 300 and 900 percent of at least one internal transverse dimension of the chamber. In some embodiments, the distance from the acoustic-wave generator to the outlet end of the chamber is between 400 and 800 percent of at least one internal transverse dimension of the chamber.

[0011] In some embodiments, the distance from the acoustic-wave generator to the outlet end of the chamber is greater than or equal to:

90340728.1 where€ = nonlinear parameter of Shockwave medium; ω = frequency of acoustic wave; po = density of the Shockwave medium; λ = wavelength of acoustic wave; Co = velocity of sound in the Shockwave medium; PQ = pressure amplitude in Shockwave medium; and Μ Ω = acoustic mach number = PQ ÷ (<¾ 2 p )-

[0012] In some embodiments, the acoustic-wave generator comprises an ultrasound head. In some embodiments, the acoustic-wave generator comprises ceramic. In some embodiments, the acoustic-wave generator comprises a piezoelectric acoustic element.

[0013] Some embodiments further comprise: a controller coupled to the acoustic-wave generator and configured to actuate the acoustic-wave generator to emit acoustic waves. In some embodiments, the controller is configured to adjust the acoustic-wave generator to vary at least one of the amplitude and frequency of acoustic waves emitted from the acoustic-wave generator. In some embodiments, the controller is configured to actuate the acoustic-wave generator to continuously emit acoustic waves for a period of time. In some embodiments, the controller is configured to actuate the acoustic-wave generator to emit acoustic waves in an intermittent on-off sequence. In some embodiments, the controller is configured to actuate the acoustic-wave generator to emit acoustic waves in a periodic on-off sequence.

[0014] In some embodiments, the acoustic-wave generator is a first acoustic-wave generator, and the apparatus further comprises: a second acoustic-wave generator configured to emit acoustic waves having at least one frequency between 1 MHz and 1000 MHz; where the Shockwave housing is also coupled to the second acoustic-wave generator; where the apparatus is configured such that if the second acoustic-wave generator emits acoustic waves then at least some portion of the acoustic waves will travel through the Shockwave medium and form one or more shock waves; and where the controller is also coupled to the second acoustic-wave generator and configured to actuate second the acoustic-wave generator to emit acoustic waves. In some embodiments, the controller is configured to actuate the first and second acoustic-wave generators such that the acoustic waves that are emitted from the second acoustic-wave generator are out-of-phase from the waves that are emitted from the first acoustic- wave generator.

[0015] In some embodiments, the apparatus is configured to generate shock waves having an intensity between 50 and 1000 Watts per square centimeter (W/cm ). In some embodiments, the apparatus is configured to generate shock waves having an intensity

90340728.1 2

between 100 and 500 W/cm". In some embodiments, the apparatus is configured to generate 100 or more Shockwaves per minute. In some embodiments, the apparatus is configured to generate 500 or more shock waves per minute. In some embodiments, the apparatus is configured to generate 1000 or more shock waves per minute.

[0016] In some embodiments, the apparatus is configured to fit within a box having a length of 3 feet, a width of 2 feet, and a height of 2 feet. In some embodiments, the apparatus is configured to fit within a box having a length of 3 feet, a width of 1 foot, and a height of 1 foot. In some embodiments, the apparatus is configured to fit within a box having a length of 2 feet, a width of 1 foot, and a height of 1 foot. In some embodiments, the apparatus is configured to fit within a box having a length of 1 foot, a width of 8 inches, and a height of 8 inches.

[0017] Some embodiments of the present methods of generating therapeutic shock waves, comprise: providing any of the present apparatuses; and actuating the apparatus to generate one or more shock waves. Some embodiments, further comprise: disposing the apparatus adjacent tissue of a patient such that at least one shock wave enters the tissue. In some embodiments, the tissue comprises skin tissue on the face of the patient.

[0018] Some embodiments of the present methods of generating therapeutic shock waves, comprise: actuating an acoustic-wave generator to emit acoustic waves having at least one frequency between 1 MHz and 1000 MHz, such that at least some portion of the acoustic waves travel through a Shockwave medium that is disposed in a Shockwave housing to form one or more shock waves.

[0019] Any embodiment of any of the present systems and/or methods can consist of or consist essentially of - rather than comprise/include/contain/have - any of the described steps, elements, and/or features. Thus, in any of the claims, the term "consisting of or "consisting essentially of can be substituted for any of the open-ended linking verbs recited above, in order to change the scope of a given claim from what it would otherwise be using the open-ended linking verb.

[0020] Details associated with the embodiments described above and others are presented below. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The following drawings illustrate by way of example and not limitation. For the sake of brevity and clarity, every feature of a given structure is not always labeled in every figure in which that structure appears. Identical reference numbers do not necessarily indicate

90340728.1 an identical structure. Rather, the same reference number may be used to indicate a similar feature or a feature with similar functionality, as may non-identical reference numbers.

[0022] FIG. 1 depicts one embodiments of the present apparatuses for generating therapeutic shock waves. DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

[0023] The term "coupled" is defined as connected, although not necessarily directly, and not necessarily mechanically; two items that are "coupled" may be integral with each other. The terms "a" and "an" are defined as one or more unless this disclosure explicitly requires otherwise. The terms "substantially," "approximately," and "about" are defined as largely but not necessarily wholly what is specified, as understood by a person of ordinary skill in the art.

[0024] The terms "comprise" (and any form of comprise, such as "comprises" and

"comprising"), "have" (and any form of have, such as "has" and "having"), "include" (and any form of include, such as "includes" and "including") and "contain" (and any form of contain, such as "contains" and "containing") are open-ended linking verbs. As a result, a method that "comprises," "has," "includes" or "contains" one or more steps possesses those one or more steps, but is not limited to possessing only those one or more steps. Likewise, a lid that "comprises," "has," "includes" or "contains" one or more elements possesses those one or more elements, but is not limited to possessing only those elements. For example, in a lid that comprises a body and an inner member, the lid includes the specified elements but is not limited to having only those elements. For example, such a lid could also include a cover member.

[0025] Further, a device or structure that is configured in a certain way is configured in at least that way, but it can also be configured in other ways than those specifically described.

[0026] There are a number of considerations for generating therapeutic shock waves from acoustic waves. For example, a classical effect of nonlinear acoustics is that a plain sinusoidal acoustic wave propagating in a nonlinear medium typically transforms to a sawtooth wave with one shock per cycle. In the past, it has been demonstrated that exposure of cells to high-power ultrasonic radiation under conditions excluding thermal cavitation- induced degradation, was accompanied by structural modification of macromolecules, nuclei, and intracellular submicroscopic complexes (Burov, 2002). Upon exposure to a Shockwave, acceleration of structures within a cell due to the impact front may be very large. At the same

90340728.1 time, elasticity of biological structures exposed to such large gradients of pressure is often significantly reduced. Under these conditions, cellular structures may behave as low- compliance materials. As a result, even a seemingly insignificant deformation may cause cell destruction. In addition, rapidly changing mechanical loads applied to structures periodically at a high frequency can lead to fatigue failure (Burov, 2002).

[0027] Tissues may be modified with ultrasound waves by modification of macromolecules, membranes, nuclei and intracellular submicroscopic complexes. Progressive nonlinear distortion of the waveform can result in the formation of pressure impact fronts, or shock waves, that cause deformation and failure of cells and subcellular structures. More specifically, progressive nonlinear distortion of the wavelength can result in formation of impact fronts that periodically follow each other with the frequency f. It was described in (Burov, 2002) that the duration of the front may be much shorter than the period 1/ as shown in Equation (1):

where b is the effective viscosity; C is the nonlinear factor; and p and C are the medium density and speed of sound, respectively. As a result of this shock wave with its short duration, acceleration of higher-density particles within the cellular structure exposed to the impact front is typically very large. At the same time, elasticity of lower-density biological structures making up the cell structure exposed to such a large gradient of pressure is significantly reduced, and generally act as low-compliance material. The mismatch between biological structures within the cell, and cells' ability to experience deformation when exposed to the impact front, leads to cellular destruction (Burov, 2002).

[0028] While a cell may oscillate as an integral unit when impacted by these pressure fronts, sharp gradients of mechanical stress can be generated inside the cell as a result of spatial heterogeneity parameters (i.e., density and shear elasticity modulus). (Burov, 2002) illustrated this by modeling the biological structure as two linked balls with masses and m 2 and the density ( p 0 ) of the liquid oscillating around the balls with the speed μ 0 (ί) differ insignificantly from the densities of the balls (by \ and 2 respectively). If only the resistance to potential flow is taken into account, the force applied to the link is calculated as shown in Equation (2):

90340728.1 For example, if the ball radius (R) is about 10 μιη and the difference between the densities of

2 9 2

the balls is 0.1 po, and results in a stress force, F/(nR )m of 10 dyne/cm . This according to Burov was substantially greater than the cell membrane breaking point.

[0029] Referring now to the drawings, and more particularly to FIG. 1, shown therein and designated by the reference numeral 10 is one embodiment of the present apparatuses for generating therapeutic shock waves (e.g., high-frequency shock waves), such as, for example, that can be delivered to tissue of a patient (e.g., a human patient). In the embodiment shown, apparatus 10 comprises: an acoustic-wave generator 14, a Shockwave housing 18 coupled to acoustic-wave generator 14, and a Shockwave medium 22 disposed in Shockwave housing 18. In the embodiment shown, acoustic-wave generator 14 is configured to emit acoustic waves having at least one frequency between 1 megahertz (MHz) and 1000 MHz (e.g., 1 MHz, 2 MHz, etc.) (and/or at least one wavelength corresponding to at least one frequency between 1 MHz and 1000 MHz, such as, for example, in the Shockwave medium 22, or in a reference medium such as, for example, atmospheric air). In the embodiment shown, acoustic-wave generator 14 comprises an ultrasound head (e.g., a commercially available ultrasound head). In some embodiments, acoustic-wave generator 14 comprises ceramic and/or a piezoelectric acoustic element. Apparatus 10 is configured such that if acoustic-wave generator 14 emits acoustic waves then at least some portion of the acoustic waves will travel through Shockwave medium 22 and form one or more shock waves (e.g., in or near Shockwave housing 18). For example, Shockwave housing 18 (and Shockwave medium 22) can have a length large enough to allow the transformation of the acoustic waves into shock waves; and/or acoustic-wave generator 14 can be actuated to emit acoustic waves at sufficient amplitude and frequency to induce Shockwave (or shockwave-type) formations in the shock chamber. By way of another example, the progressive nonlinear distortion of the wavelength of the acoustic waves in the Shockwave medium 22 can result in the formation of pressure impact fronts, or shock waves, that can cause deformation and/or failure of cells (e.g., when the shock waves are applied at an intensity and for a period of time sufficient to affect tissue). In some embodiments, acoustic-wave generator 14 is configured to emit acoustic waves with beam radian power of between about, or substantially equal to 5 and 1000 Watts per square centimeter (W/cm )

2 2

(e.g., 100 to 500 W/cm 100 to 400 W/cn ). In some embodiments, apparatus 10 is configured to generate 100 or more Shockwaves per minute (e.g., 200, 300, 400, 500, 1000, 2000, 5000, or more shock waves per minute).

90340728.1 [0030] Apparatus 10, for example, can be operated to predictably and/or consistently generate shock waves that can be delivered to tissue in proximity of apparatus 10, for example, to cause cellular damage to the tissue (e.g., for medical and/or aesthetic therapeutic uses. Some embodiments of apparatus 10 can be configured to provide or generate shock waves at an energy level sufficient to cause membrane-degradation damage of cells. For example, when targeted tissue is exposed to high-frequency Shockwaves, sharp gradients of mechanical stress can be generated inside the cell as a result of spatial heterogeneity parameters (i.e., density and shear elasticity modulus).

[0031] In the embodiment shown, Shockwave housing 18 defines a chamber 26, and Shockwave medium (or media) 22 is disposed in chamber 26. Housing 18 can comprise, for example, polymer, plastic, silicone, metal, and/or any other suitable material. Shockwave medium 22 can comprise a material that exhibits or is able to experience nonlinearities in the presence of acoustic waves generated or emitted from acoustic-wave generator 14. These nonlinearities can be induced from the diffraction of the ultrasound waves from the wall of Shockwave housing 18. Additionally or alternatively, nonlinearities may result from inhomogeneities induced by ultrasound waves traveling through Shockwave medium (or media) 22. Furthermore, nonlinearities can result from inclusion of particles or bubbles in the media (i.e. gas bubbles, nanoparticles, etc.). In some embodiments, Shockwave medium 22 comprises a fluid. In some embodiments, Shockwave medium 22 comprises a gel. In some embodiments, Shockwave medium 22 comprises a liquid. In some embodiments, Shockwave medium 22 is configured such that in the presence of acoustic waves from acoustic-wave generator 14, Shockwave medium 22 will exhibit nonlinear properties. In some embodiments, Shockwave medium 22 comprises one or more of: water, glycerin, poly(ethylene glycol) (PEG), propylene glycol, silicone oil, alcohol, or a combination of two or more of these. In some embodiments, Shockwave medium 22 comprises one or more of: bubbles (e.g., gas bubbles), solid particles, or a combination of bubbles and solid particles. Gas bubbles can be introduced into medium 22, for example, by the addition of a gas such as carbon dioxide, and/or can be introduced in the form of stabilized gas bubbles found in ultrasound contrast media or as part of nanoparticles.

[0032] Additionally, in the embodiment shown, Shockwave housing 18 defines chamber 26 having an inlet end 30 coupled to acoustic-wave generator 14, and an outlet end 34 extending from acoustic-wave generator 14. Some embodiments of Shockwave housing 18 can also include an end cap 38 covering outlet end 34 of chamber 26. In the embodiment shown, chamber 26 has a circular cross-sectional shape. In other embodiments, chamber 26

90340728.1 has a rectangular, square, ovular, triangular, octagonal, and/or any other suitable cross- sectional shape. In some embodiments, Shockwave housing 18 is configured such that distance 42 from acoustic-wave generator 14 (e.g., at inlet end 30 of chamber 26) to outlet end 38 of chamber 26 is between 100 and 1000 percent of at least one (e.g., the minimum) internal transverse dimension (e.g., diameter 42) of chamber 26. In some embodiments, distance 46 from acoustic-wave generator 14 (e.g., at inlet end 30 of chamber 26) to outlet end 34 of chamber 26 is between 300 and 900 percent (and/or between 400 and 800 percent) of at least one (e.g., the minimum) internal transverse dimension (e.g., diameter 42) of the chamber.

[0033] In some embodiments, inlet end 30 of chamber 26 has a transverse internal dimension (e.g., diameter 42) at least as large as a corresponding transverse external dimension of acoustic-wave generator 14 (e.g., at output end 50). For example, in the embodiment shown, diameter 42 of chamber 26 is at least as large as (e.g., just larger than) the outer diameter of a corresponding portion (e.g., output end 50) of acoustic-wave generator 14. In other diameters, diameter 42 can be larger (e.g., and/or a gasket or coupler can be used to couple housing 18 to output end 50 of acoustic-wave generator). In the embodiment shown, chamber 26 has a substantially constant cross-section between inlet end 30 and outlet end 34. In other embodiments, chamber 26 has a varying cross-section between inlet end 30 and outlet end 34.

[0034] In some embodiments, a suitable length 46 of Shockwave chamber 26 is a function of a nonlinear parameter, pressure amplitude, frequency of the ultrasound wave, the density of medium 22, and the speed of sound in medium 22. For example, distance 46 from acoustic-wave generator 14 (e.g., at inlet end 30 of chamber 26) to outlet end 34 of chamber 26 may be greater than or equal to that given by Equation (3): I fo L _ where€ = nonlinear parameter of Shockwave medium; ω = frequency of acoustic wave; po = density of the Shockwave medium; λ = wavelength of acoustic wave; Co = velocity of sound in the Shockwave medium; P 0 = pressure amplitude in Shockwave medium; and Μ ω = acoustic mach number = Po ÷ (c 0 2 po). In general, the higher the frequency and/or the higher the intensity, the shorter length 46 of chamber 26 must be to permit shock wave formation at or before outlet end 34 (and/or before end cap 38) of chamber 26.

90340728.1 [0035] Additionally, in the embodiment shown, Shockwave housing 18 is configured such that if acoustic waves are incident on Shockwave housing 18 from within Shockwave chamber 26, then Shockwave housing 18 will reflect at least some portion of the incident acoustic waves back into Shockwave chamber 26.

[0036] In the embodiment shown, end cap 38 is configured enclose outlet end 34 of chamber 26 such that medium 22 is substantially prevented from exiting chamber 26, and to permit Shockwaves to exit outlet end 34 of Shockwave chamber 26. In some embodiments, end cap 38 is configured to have a low Shockwave attenuation (e.g., such that attenuation of a Shockwave exiting end cap 38 will be less than twenty percent) and/or low Shockwave reflection. In some embodiments, end cap 38 comprises at least one of: polymer, hydrogel, membrane, plastic, or silicone.

[0037] In other embodiments, Shockwave medium 22 is unitary with Shockwave housing 18 (e.g. comprise the same piece of material. In some embodiments, Shockwave housing 18 and Shockwave medium 22 comprise silicone. In other embodiments, Shockwave medium 22 comprises one or more bubbles (e.g., gas bubbles or the like).

[0038] In the embodiment shown, apparatus 10 further comprises: a controller 54 coupled to acoustic-wave generator 14 and configured to actuate acoustic-wave generator 14 to emit acoustic waves. Controller 54 can comprise any suitably programmed hardware, such as, for example, a processor with memory, a programmable logic controller (PLC), and a personal digital assistant (PDA), and/or the like. Although illustrated as a separate component, controller 54 can be integrated into (e.g., share a common housing with) acoustic- wave generator 14. In some embodiments, controller 54 is configured to adjust acoustic-wave generator 14 to vary at least one of the amplitude and frequency of acoustic waves emitted from acoustic-wave generator 14. In some embodiments, controller 54 is configured to actuate acoustic-wave generator 14 to continuously emit acoustic waves for a period of time (e.g., when acoustic-wave generator is actuated to be On'). In some embodiments, controller 54 is configured to actuate acoustic-wave generator 14 to emit acoustic waves in a periodic on-off sequence (e.g., a sequence with regular, periodic intervals). In some embodiments, controller 54 is configured to actuate acoustic-wave generator 14 to emit acoustic waves in an intermittent on-off sequence (e.g., a non-periodic sequence without regular, periodic intervals). Actuation of acoustic-wave generator 14 in an on-off sequence can, for example, reduce heat buildup in tissue. In some embodiments, controller 54 is configured to actuate acoustic-wave generator 14 to emit acoustic waves in an on-off sequence, and to adjust the duration of "on" and/or "off portions of the on-off sequence based on or responsive to

90340728.1 measured and/or predicted temperature. For example, temperature can be measured with a thermometer (e.g., infrared thermometer) coupled to controller 54, and/or controller 54 can be configured to predict tissue temperature based, at least in-part, on intensity and/or other properties of acoustic waves emitted from acoustic-wave generator 14 and/or shock waves generated in housing 18 or delivered to tissue.

[0039] In some embodiments, acoustic-wave generator 14 is a first acoustic-wave generator, and apparatus 10 further comprises: a second acoustic-wave generator (not shown) configured to emit acoustic waves having at least one frequency between 1 MHz and 1000 MHz; where Shockwave housing 18 is also coupled to the second acoustic-wave generator. In such embodiments apparatus 10 is configured such that if the second acoustic- wave generator emits acoustic waves then at least some portion of the acoustic waves will travel through Shockwave medium or media 22 and form one or more shock waves. Some of these embodiments further comprise a controller 54 coupled to the second acoustic-wave generator and configured to actuate second the acoustic-wave generator to emit acoustic waves. In some embodiments, controller 54 is configured to actuate first acoustic-wave generator 14 and the second acoustic-wave generator (not shown) such that the acoustic waves that are emitted from the second acoustic-wave generator are out-of-phase from the waves that are emitted from first acoustic-wave generator 14.

[0040] In some embodiments, apparatus 10 is configured to fit within a box having a length of 3 feet, a width of 2 feet, and a height of 2 feet. In some embodiments, apparatus 10 is configured to fit within a box having a length of 3 feet, a width of 1 foot, and a height of 1 foot. In some embodiments, apparatus 10 is configured to fit within a box having a length of 2 feet, a width of 1 foot, and a height of 1 foot. In some embodiments, apparatus 10 is configured to fit within a box having a length of 1 feet, a width of 8 inches, and a height of 8 inches.

[0041] Embodiments of the present apparatuses (e.g., apparatus 10) can be used for wrinkle reduction. For example, some embodiments of the present methods of generating therapeutic shock waves, comprise: providing any of the present apparatuses (e.g., apparatus 10); and actuating the apparatus to generate one or more shock waves. Some embodiments further comprise: disposing the apparatus (e.g., outlet end 34 of housing 18) adjacent tissue of a patient such that at least one shock wave enters the tissue. In some embodiments, the tissue comprises skin tissue on the face of the patient.

[0042] Some embodiment of the present methods of generating therapeutic shock waves, comprise: actuating an acoustic-wave generator (e.g., 14) to emit acoustic waves

90340728.1 having at least one frequency between 1 MHz and 1000 MHz, such that at least some portion of the acoustic waves travel through a Shockwave medium (e.g., 22) that is disposed in a Shockwave housing (e.g., 18) to form one or more shock waves.

[0043] The various illustrative embodiments of devices, systems, and methods described herein are not intended to be limited to the particular forms disclosed. Rather, they include all modifications and alternatives falling within the scope of the claims. For example, the present watering systems can include any number of basins in any of the shapes that are described and/or depicted.

[0044] The claims are not intended to include, and should not be interpreted to include, means-plus- or step-plus-function limitations, unless such a limitation is explicitly recited in a given claim using the phrase(s) "means for" or "step for," respectively.

90340728.1 References

The following reference, to the extent that it provides exemplary procedural or other details supplementary to those set forth herein, are specifically incorporated herein by reference.

[1] Burov, V. A., Nonlinear ultrasound: breakdown of microscopic biological structures and nonthermal impact on malignant tumor. Doklady Biochemistry and Biophysics Vol JSJ, pp. 101-104 (2002).

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