KR20080028352A - Non-thermal acoustic tissue modification - Google Patents

Abstract

A methodology and system for modifying tissue including an acoustic transducer assembly (10) having a phased array (14) of piezoelectric elements (15) that directs the acoustic beam for a predetermined time duration at a multiplicity of target volumes (12), which target volumes contain tissue, thereby to modify the tissue in the target volumes while the acoustic beam has a pressure at target volume which lies below a cavitation threshold and the predetermined time duration is shorter than a time duration over which the acoustic beam produces thermal modification of tissue in the target volume, further including pressure sensors (29), a skin temperature sensor (34), and an electronic circuit (24) coupled to a control subsystem (42). ® KIPO & WIPO 2008

Description

NON-THERMAL ACOUSTIC TISSUE MODIFICATION}

The present invention relates generally to tissue modification, and more particularly to non-heated acoustic tissue modification.

The following United States patents and prior art are believed to represent the current state of the art:

US Patent No. 3,637,437; 4,043,946; 4,049,580; 4,110,257; 4,116,804; 4,126,934; 4,169,025; 4,450,056; 4,605,009; 4,826,799; 4,886,491; 4,986,275; 4,938,216; 5,005,579; 5,079,952; 5,080,101; 5,080,102; 5,111,822; 5,143,063; 5,143,073; 5,209,221; 5,219,401; 5,301,660; 5,419,761; 5,431,621; 5,507,790; 5,512,327; 5,526,815; 5,601,526; 5,640,371; 5,884,631; 5,618,275; 5,827,204; 5,938,608; 5,948,011; 5,993,979; 6,039,048; 6,071,239; 6,086,535; 6,113,558; 6,113,559; 6,206,873; 6,309,355; 6,384,516; 6,436,061; 6,573,213; 6,607,498; 6,652,463 B2; 6,685,657 B2; 6,747,180

PCT International Publication Number. WO 2004/014488 Al;

British patent number. GB 2 303 552;

Rod J. Rohrich, et al., "Comparative Lipoplasty Analysis of in Vivo-Treated Adipose Tissue", Plastic and Reconstruction Journal, 105: 2152-2158, 2000;

T. G. Muir, et al., "Prediction of Nonlinear Acoustic Effects at Biomedical Frequencies and Intensities", Ultrasound in Med. & Biol., Vol. 6, pp. 345-357, Pergamon Press Ltd., 1980;

Jahangir Tavakkoli, et al., "A Piezocomposite Shock Wave Generator with Electronic Focusing Capability: Application for Producing Cavitation-Induced Lesions in Rabbit Liver", Ultrasound in Med. & Biol., Vol. 23, No. 1, pp. 107-115, 1997;

N. I. Vykhodtseva, et al., "Histologic Effects of high Intensity Pulsed Ultrasound Exposure with Subharmonic Emission in rabbit Brain In Vivo", Ultrasound in Med. & Biol, Vol. 21, No. 7, pp. 969-979, 1995;

Gail R. Ter Haar, et al., "Evidence for Acoustic Cavitation In Vivo: Thresholds for Bubble Formation with 0.75-MHz Continuous Wave and Pulsed Beams", IEEE Transactions on Ultrasonics, Ferroelectronics, and Frequency Control, Vol. Uffc-33, No. 2, pp. 162-162, March 1986;

D. R. Bacon et al, "Comparison of Two Theoretical Models for Predicting Non-Linear Propagation in Medical Ultrasound Fields", Phys. Med. Biol. 1989 Nov; 34 (11): 1633-43;

E. L. Carstensen et al, "Demonstration of Nonlinear Acoustical Effects at Biomedical Frequencies and Intensities", Ultrasound in Med. & Biol., Vol. 6, pp 359-368, 1980.

The present invention seeks to provide an improved apparatus and method for acoustically non-heated tissue deformation.

Thus, according to a preferred embodiment of the present invention,

Providing an acoustic beam; And

The acoustic beam is directed to the target volume to deform the tissue by the target volume for a predetermined time shorter than the time it takes for the acoustic beam to cause thermal deformation of the tissue in the target volume to the site containing the tissue of the body. Aiming, wherein the acoustic beam applies pressure to the tissue by a target volume that is below a cavitation threshold in the tissue.

In addition, according to a preferred embodiment of the present invention,

Generating an acoustic beam generally deforming the tissue at a source external to the body; And

From the source outside the body to the target volume to deform the tissue by the target volume for a predetermined time shorter than the time it takes for the acoustic beam to cause thermal deformation of the tissue in the target volume. Aimating the acoustic beam is provided, wherein the acoustic beam pressurizes the tissue by a target volume below the cavitation threshold in the tissue.

In addition, according to a preferred embodiment of the present invention,

Defining a portion of the body at least partially by sensing spatial indications on the body; And

Aiming the acoustic beam to a plurality of target volumes within the site to deform tissue at a target volume, the target volume comprising tissue, the acoustic beam being a target volume that is below the cavitation threshold in the tissue. Pressure is applied to the tissue, wherein the predetermined time is shorter than the time taken for the acoustic beam to cause thermal deformation of the tissue in the target volume.

In addition, according to a preferred embodiment of the present invention,

Aim the acoustic beam at a plurality of target volumes within the site, the target volume comprising tissue, the acoustic beam exerting pressure on the tissue by a target volume below the cavitation threshold in the tissue, The time is shorter than the time it took for the acoustic beam to cause thermal deformation of the tissue in the target volume, thereby deforming the tissue in the target volumes; And

A method of tissue deformation is provided that includes computerized tracking of the plurality of target volumes despite movement of the body.

In addition, according to a preferred embodiment of the present invention,

The predetermined time is shorter than the time it takes for the acoustic beam to cause thermal deformation of the tissue in the target volume, and pressures the tissue by the target volume below the cavitation threshold in the tissue at the target volume on the body part containing the tissue. Aimator for aiming the acoustic beam for applying a; And

A tissue modifying device is provided that includes a modulator that cooperates with the acoustic beam collimator to produce the acoustic beam to modify the tissue in the target volume.

In addition, according to a preferred embodiment of the present invention,

The predetermined time is shorter than the time it takes for the acoustic beam to thermally deform the tissue in the target volume and generates an acoustic beam that exerts pressure on the tissue by the target volume below the cavitation threshold in the tissue outside the body. Source;

Tissue deforming devices are provided that include an acoustic beam collimator that employs an acoustic beam that will generally deform tissue at a target volume of a body containing tissue.

In addition, according to a preferred embodiment of the present invention,

A region definer for defining a portion of the body at least partially by sensing spatial indicia on the body; And

Aim the acoustic beam into a plurality of target volumes within the site, the target volume including tissue, thereby including an aimer to deform the tissue in the target volumes, wherein the acoustic beam includes a cavitation threshold in the tissue. There is provided a tissue deforming device comprising an aimer, wherein the predetermined amount of pressure is applied to the tissue below the target volume, the predetermined time being shorter than the time taken for the acoustic beam to cause thermal deformation of the tissue in the target volume.

In addition, according to a preferred embodiment of the present invention,

Aim the acoustic beam at a plurality of target volumes within the site, the target volume comprising tissue, thereby deforming the tissue in the target volumes, the acoustic beam being below the cavitation threshold in the tissue. Pressure is applied to the tissue in the target volume, the predetermined time being shorter than the time taken for the acoustic beam to cause thermal deformation of the tissue in the target volume; And

Tissue deforming devices are provided that include computerized tracking functionality that provides for computerized tracking of the plurality of target volumes despite movement of the body.

Preferably, aiming the acoustic beam generally prevents deformation of tissue outside of the target volumes.

According to a preferred embodiment of the present invention, the method also includes at least partially acoustic imaging of the site simultaneously with aiming the acoustic beam at the target volume.

Preferably, aiming includes positioning at least one acoustic transducer relative to the body to direct the acoustic beam to the target volume.

The aiming may also include varying the focus of at least one acoustic transducer to direct the acoustic beam to the target volume. The change in focus may change the volume of the target volume and / or change the distance of the target volume from the at least one acoustic transducer.

The aiming may also include positioning at least one acoustic transducer relative to the body to direct the acoustic beam to the target volume.

The method preferably also includes sensing of the acoustic beam that couples to the outer surface of the body adjacent to the target volume.

Preferably, the aiming step occurs from an acoustic transducer located outside of the body.

According to a preferred embodiment of the invention, the acoustic beam has an initial frequency in the range of 50 KHz-1000 KHz, more preferably in the range of 75 KHz-500 KHz, most preferably in the range of 100 KHz-300 KHz Is in.

According to a preferred embodiment of the invention, the acoustic beam is at least 1 dB lost by harmonic generation at the beginning of the treatment site.

According to a preferred embodiment of the present invention, the wave form occurring at the treatment site has a "toothed" shape causing local extreme pressure gradients to form shock waves.

The shock waves cause tissue modification by causing at least one of the following: apoptosis, necrosis, changes in the chemical and / or physical properties of proteins, changes in the chemical and / or physical properties of lipids, sugars Changes in chemical and / or physical properties and / or changes in chemical and / or physical properties of glycoproteins.

Preferably, the duty cycle is between 1: 2 and 1: 250, more preferably between 1: 5 and 1:30, and most preferably between 1:10 and 1:20 by initial adjustment. ).

In accordance with a preferred embodiment of the present invention, the adjustment is such that sequential shock waves between 1 and 1000, more preferably propagating nonlinear mechanical thresholds, are amplitudes above the propagating non linear mechanical threshold at the treatment site. Provides sequential shock waves between 1 and 100 with excess amplitude, most preferably between 1 and 10 with amplitudes sufficient for treatment.

Advantageously, said adjusting comprises adjusting the amplitude of said acoustic beam over time.

According to a preferred embodiment of the present invention, the total sum in the target volumes of shock waves with amplitudes above the propagation nonlinear mechanical threshold is between 1000 and 100,000, more preferably between 10,000 and 50,000.

According to a preferred embodiment of the invention, the acoustic beam has an initial shock wave shape at a total time of 1 to 10 microseconds.

Preferably, the initial adjustment provides a duty cycle between 1: 2 and 1: 250, more preferably between 1: 5 and 1:30, and most preferably between 1:10 and 1:20. .

According to a preferred embodiment of the present invention, the control is performed at the treatment site with sequential shock waves between 1 and 1000 with an amplitude exceeding the propagation nonlinear mechanical threshold, more preferably 1 to 100 with an amplitude exceeding the propagation nonlinear mechanical threshold. Sequential shockwaves in between provide sequential shockwaves between 1 and 10, most preferably at an amplitude that exceeds the propagation nonlinear mechanical limit.

According to a preferred embodiment of the present invention, the total sum in the target volumes of shock waves with amplitudes above the propagation nonlinear mechanical threshold is between 1000 and 100,000, more preferably between 10,000 and 50,000.

Preferably, aiming comprises aiming the acoustic beam at a plurality of target volumes in time order.

In accordance with a preferred embodiment of the present invention, aiming includes aiming the acoustic beam at a plurality of target volumes that at least partially overlap at various times.

Preferably, at least some of the plurality of target volumes are at least partially overlapping in space.

According to a preferred embodiment of the present invention, the method comprises the step of defining a site by marking at least one surface of the body. The method may also include defining a site by selecting at least one depth to the body and / or sensing tissue of the body and / or sensing unmodified tissue.

Preferably, aiming also includes defining target volumes in unit volumes of unmodified tissue within the site.

According to a preferred embodiment of the present invention, adjusting the acoustic beam to deform the tissue in the plurality of target volumes proceeds sequentially over time so that the selective adjustment of the tissue at each target volume is not deformed therein. It only occurs after detection of unorganized tissue.

Advantageously, the method also includes performing computerized tracking of said plurality of target volumes in the presence of body movement.

Advantageously, the computerized tracking comprises sensing a change in the position of the markings on the body and tracking the positions of the target volumes of the body and employing the sensed change.

Preferably, an acoustic conducting layer is located between the acoustic beam collimator and the body contacting surface. The acoustic conducting layer is typically located between the upper part and the contact surface of the body and the contact surface of the contact surface, the fluid containing the fluid to enhance cooling during operation of the power source and regulator in a position adjacent to the acoustic beam sight and similar to that of the contact surface. And a lower portion having an acoustic impedance.

According to another preferred embodiment, a power source and regulator operative to generate an acoustic beam capable of modifying a target volume of tissue at a site comprising tissue of the body, an acoustic beam aimer and an acoustic beam to direct the acoustic beam to the target volume. A tissue deforming device is provided, comprising an acoustic conducting interface located between the aimer and the body contacting surface. The acoustic conduction interface includes an upper portion adjacent the acoustic beam collimator and a lower portion located between the upper portion and the contact surface of the body. The upper portion preferably contains an acoustic coupling fluid that also enhances cooling while the power supply and regulator are in operation. The lower portion has an acoustic impedance similar to that of the contact surface. The body contact surface is preferably coated with an acoustic coupling medium.

According to another preferred embodiment of the invention, the tissue deforming device also comprises an acoustic binding medium applicator for supplying an acoustic binding medium between the acoustic beam aimer and the body.

According to another preferred embodiment of the present invention, the tissue deforming device further comprises a plurality of sensors operative to measure the degree of acoustic coupling between the acoustic beam and the body.

Furthermore, according to a preferred embodiment of the present invention, the tissue modifying apparatus also includes an electronic circuit associated with the acoustic beam collimator for storing the parameters related to the acoustic beam collimator.

Advantageously, said electronic circuit stores parameters related to operating characteristics of said acoustic beam aimer.

According to another preferred embodiment of the present invention, the tissue modifying device also includes an interlock circuit that receives the predetermined parameters from the electronic circuit and operates to condition the operation of the device.

According to another preferred embodiment of the present invention, at least some predetermined parameters are stored on an acoustic beam aimer identification storage medium, which is supplied to the interlock circuitry upon reading to provide the interlock circuitry with the interlock circuitry. It serves to verify the identification of the acoustic beam aimer.

In accordance with another preferred embodiment of the present invention, a power source and a regulator for actuating an acoustic beam capable of modifying a target volume of tissue at a site containing tissue of the body, an acoustic beam for directing the acoustic beam to the target volume. A tissue deforming device is provided that includes an aiming and acoustic coupling applicator for supplying an acoustic binding medium between the aiming instrument and the acoustic beam aimer.

According to another preferred embodiment of the present invention, a power source and a regulator that operates to generate an acoustic beam capable of modifying a target volume of tissue at a site containing tissue of the body, and an acoustic beam collimator for directing the acoustic beam to the target volume. And a plurality of sensors operative to measure the degree of acoustic coupling between the acoustic beam aimer and the body.

According to another preferred embodiment of the present invention, a power source and a regulator which acts to generate an acoustic beam capable of modifying a target volume of tissue in a region containing tissue of the body, an acoustic beam that directs the acoustic beam to the target volume. An apparatus is provided for modifying a deformation of a tissue comprising an aimer and an electronic circuit associated with an acoustic beam aimer storing parameters associated therewith.

According to another preferred embodiment of the present invention, the electronic circuit stores parameters related to operating characteristics of the acoustic beam aimer.

According to another preferred embodiment of the present invention, the tissue modifying device also includes an interlock circuit that receives the predetermined parameters from the electronic circuitry and operates to coordinate the operation of the device.

Further, according to a preferred embodiment of the present invention, at least some predetermined parameters are stored on an acoustic beam collimator identification storage medium, which is supplied to the interlock circuit in readout so that the acoustic beam aimer in the interlock circuit is read. Serves to verify the identification of

The invention will be more fully understood from the detailed description taken in conjunction with the following drawings:

1 is a simplified illustration of the overall structure and operation of a non-invasive acoustic non-heated tissue deforming device constructed and operated in accordance with a preferred embodiment of the present invention;

2 is a simplified block diagram illustrating a preferred pattern of change in acoustic pressure over time from a sound source to a target volume, in accordance with a preferred embodiment of the present invention;

3A and 3B briefly illustrate aspects of an operator interface in normal operation and in abnormal operation, respectively;

4A and 4B are front and partial cutaway side views of a patient, respectively, showing a non-uniform distribution of target volumes at the patient's treatment site;

5 is a simplified block diagram of a non-invasive acoustic non-heated tissue deforming device constructed and operated in accordance with a preferred embodiment of the present invention; And

6A, 6B and 6C are all simplified flow charts showing operator steps for performing tissue modifications in accordance with a preferred embodiment of the present invention.

Reference is made to FIG. 1 which briefly illustrates the overall structure and operation of a non-invasive acoustic non-heated tissue deforming device constructed and operated in accordance with a preferred embodiment of the present invention. As shown in FIG. 1, an acoustic beam generator and aimer, such as an acoustic transducer assembly 10, located outside the body, locates the transducer assembly 10 in a proper position relative to the body and thus provides a target volume 12 within the body. Aim at and generate an acoustic beam that acts to deform the tissue there.

A preferred embodiment of the acoustic beam generator and aimer useful in the present invention comprises a acoustical resilient comprising a phased array 14 of piezoelectric elements 15 having a conductive coating 16 on their opposite sides. ) Transducer 13. The individual piezoelectric elements 15 are separated by insulative elements 17. The piezoelectric elements 15 may be of any suitable configuration, shape and distribution.

Typically, an acoustic coupling interface comprising first and second layers is provided between the piezoelectric elements 15 and the body. The first layer, designated by reference numeral 18, is preferably a fluid, such as an oil, and preferably serves both as a heat sink and an acoustic conductor. The second layer, designated by reference numeral (19), is preferably formed of a material such as polyurethane having an acoustic impedance similar to that of soft mammalian tissue, and is usually a suitable coupling oil coating the contact surface of the body. An acoustic coupling medium such as oil defines a contact surface 20 for engagement with the body.

The contact surface 20 can be planar, but need not be. Fluid layer 18 enhances acoustic contact between piezoelectric elements 15 and polyurethane layer 19. Fluid layer 18 may be circulated to improve cooling during treatment.

Properly regulated AC power is supplied to the conductive coatings 16 by the conductors 22 to cause the piezoelectric elements 15 to provide the desired acoustic beam output.

According to a preferred embodiment of the invention, the electronic circuit 24, which typically comprises ROM and RAM memories, is preferably mounted in the converter assembly 10. The electronic circuit 24 is coupled to the control subsystem 42 described below, preferably via a connecting cable 25. The ROM preferably stores characteristic parameters such as operational frequency, impedance and peak stability life of the transducer assembly 10. Preferably these parameters are also stored in a smart card 26.

The RAM preferably stores operating parameters such as the number of propagating acoustic pulses and the cumulative duration of treatments of the transducer assembly 10. The information stored in the electronic circuit 24 is utilized by the interlock circuit included in the subsystem 42 in confirming that the transducer assembly 10 is suitable for operation.

According to a preferred embodiment of the invention an acoustic coupling medium 21, such as castor oil, is applied on the contact surface 20 and the body of the transducer 10, typically through the canister 27. The duct 27 is connected to a suitable acoustic coupling medium storage assembly that supplies the duct connection medium 21 to the contact surface 20.

According to a preferred embodiment of the present invention, the plurality of pressure sensors 29 are distributed around the circumference of the transducer assembly 10 to sense the engagement between the transducer assembly 10 and the body. In addition, the pressure sensors 29 can be removed and the degree of acoustic engagement between the transducer and the body can be measured by analyzing the acoustic signals received by the transducer from the body. According to a preferred embodiment of the present invention, the imaging acoustic transducer assembly 23 comprises a piezoelectric element 24 having conductive surfaces 28 contained within the transducer 10 and typically associated with opposite surfaces thereof. Properly regulated alternating current power is supplied to the conducting surfaces 28 by the conductors 32 to provide the piezoelectric element 24 with an acoustic beam output. Leads 32, coupled to surfaces 28, also provide an imaging output from imaging acoustic transducer subassembly 23.

It will be appreciated that any suitable acoustic transducer assembly available on the market may be used and alternatively the imaging acoustic transducer subassembly 23 may be removed.

It will also be appreciated that various types of acoustic transducer assemblies 10 may be used. For example, such transducers may include piezoelectric elements of various shapes and sizes arranged in multiple piezoelectric elements, multilayer piezoelectric elements and face arrays.

In a preferred embodiment of the invention as seen in FIG. 1, the acoustic beam generator and aimer are combined in the transducer assembly 10. In addition, the functions of generating and directing an acoustic beam may be provided in separate devices.

According to an embodiment of the invention, a skin temperature sensor 34, such as an infrared sensor, may be mounted side by side with the imaging acoustic transducer subassembly 23. According to another preferred embodiment of the present invention, a transducer temperature sensor 36, such as a thermocouple, may also be mounted side by side with the imaging acoustic transducer subassembly 23.

The acoustic transducer assembly 10 preferably receives a properly regulated power supply from the regulator assembly 40 and the power supply that forms part of the control subsystem 42. Appropriate parameters of the transducer assembly 10 are supplied via a smart card 26 which is preferably read by a suitable card reader 43 to the interlock circuit forming part of the control subsystem 42. The interlock circuit preferably operates to receive the predetermined parameters from the electronic circuit to adjust the operation of the acoustic transducer assembly 10. Therefore, by connecting the incompatible transducer assembly 10 or the transducer assembly 10 whose stable life has expired, unsafe operation can be prevented.

The control subsystem 42 also typically includes a tissue deformation control computer 44 having an associated camera 46, such as a video camera, and a display 48. The acoustic transducer assembly 10 is preferably positioned automatically or semi-automatically, such as by an X-Y-Z positioning assembly. In addition, the acoustic transducer assembly 10 may be positioned at a desired position manually by the operator.

According to a preferred embodiment of the present invention, the camera 46 serves to image the part of the body where tissue deformation proceeds. A picture of the part of the patient's body as viewed by the camera is preferably displayed on the display 48 in real time.

The operator may specify to modify the contour of the site 49 containing tissue. According to one embodiment of the present invention, the designation of such a portion 49 is such that the operator designates the patient's skin by marking it with a contour 50, which is imaged with the camera 46 and the display 48. The tissue deformation control computer 44 is then used to control the application of the acoustic beam to locations indicated by and also within the site. Reproduction of computer-generated contours can also be displayed superimposed on the display 48 as indicated by reference numeral 52. In addition, the operator can make virtual markings on the skin, such as using a digitizer (not shown), which can also provide a computer calculated contour representation 52 on the display 48. have.

In addition to the contour reproduction 52, the functional means of the system of the present invention is preferably also located outside the region 49, which also includes the tissue to be deformed, but also the region 49 designated by the contour 50. Employ a plurality of markers 54 that can be located inside of. Markers 54 are apparently detectable markers, which are clearly visible and captured by camera 46 and displayed by display 48. Markers 54 may be natural anatomical markers, such as individual parts of the body, or may be artificial markers, such as colored stickers. Such markers are preferably employed to assist the system in dealing with the deformation of a site whose contour 50 is nominally defined due to movement and rearrangement of the body during tissue deformation. Preferably, transducer assembly 10 also bears a visible marker that is captured by camera 46 and displayed on display 48.

Markers 54, 56 may be displayed on display 48 with marker representations 58, 60, typically processed by computer 44 and calculated on display 48, respectively.

Shockwaves modify tissue by causing at least one of the following: apoptosis, necrosis, changes in the chemical and / or physical properties of proteins, changes in the chemical and / or physical properties of lipids, chemicals and / or sugars Or changes in physical properties, changes in chemical and / or physical properties of glycoproteins.

In accordance with a preferred embodiment of the present invention, a simplified block diagram illustrates portions of the transducer 10 and the preferred power and regulator assembly 40, showing a pattern of acoustic wave change over time in a target volume. See 2. As shown in FIG. 2, the power and regulator assembly 40 is preferably adjusted to have a series of relatively high amplitude portions that are typically separated in time by a series of relatively low amplitude portions 104. And a signal generator 100 providing a time varying signal. Each relatively high amplitude portion 102 preferably corresponds to a shock wave at the target volume.

The time duration relationship between the (102) and (104) portions is preferably between 1: 2 and 1: 250, more preferably between 1: 5 and 1:30, most preferably between 1:10 and 1 Provide a duty cycle of between: 20.

The maximum energy distribution generated at the output of the signal generator 100 is preferably in the frequency range of 50 KHz to 1000 KHz, more preferably 100 KHz to 500 KHz, most preferably 150 KHz to 300 KHz.

The output of the signal generator 100 is preferably provided to a suitable power amplifier 106, which becomes the input of the acoustic transducer 10 (FIG. 1) through the impedance matching circuit 108 and receives there. One electrical signal is converted into the corresponding acoustic beam output. As shown in FIG. 2, the acoustic beam output is a series of relatively high amplitude portions corresponding to (104) portions, typically corresponding to (102) portions separated in time by a series of relatively low amplitude portions (114). It includes a time change signal adjusted accordingly to the output of the signal generator 100 to have a.

Each of the relatively high amplitude portions 112 changes its waveform during propagation due to the non-uniform nature of the medium, resulting in a 1 dB reduction in harmonic generation at the target volume. Harmonic wave generation causes the corresponding waveform to the target volume, denoted by reference numeral 116, to take the form of a " sawtooth " causing locally extreme pressure gradients to form shock waves.

The relatively low amplitude portions 114 have an amplitude below the treatment threshold and do not cause shock waves to the target volume 12.

According to a preferred embodiment of the present invention, the output of the signal generator 100 produces sequential shock waves between 1 and 1000, more preferably propagating nonlinear mechanical, with an amplitude exceeding a propagating non linear mechanical threshold. Generate an ultrasound beam comprising sequential shock waves between 1 and 100 with amplitudes above the threshold, most preferably between 1 and 10 with sequential shock waves with amplitudes above the propagation nonlinear mechanical threshold.

According to a preferred embodiment of the invention, the total number of saw tooth waveforms applied to the target volume during the course of treatment is between 1000 and 100,000, more preferably between 10,000 and 50,000.

Reference is made to FIGS. 3A and 3B, which briefly illustrate aspects of an operator interface in normal operation and in abnormal operation, respectively. As shown in FIG. 3A, during normal operation, the display 48 typically displays a plurality of target volumes 12 () within the calculated target area 200 in which the contour reproduction 52 (FIG. 1) is delimited. 1). In addition, display 48 preferably provides one or more pre-programmed execution messages 202 and status messages 203.

It will be appreciated that various target volumes 12 with different degrees of shading are shown to indicate treatment status. For example, the unshaded target volumes indicated here by reference numeral 204 have already undergone tissue deformation. The target volume, shown in black at 205, is the target volume that will be tissue modified next time. Partially shaded target volume 206 represents a target volume that has received insufficient treatment to achieve complete tissue deformation, typically due to insufficient treatment duration.

Due to the presence of insufficient tissue there or for other reasons, other types of target volumes, such as untreated target volume, may be indicated by appropriate colors or other indicator means, where reference numeral 208 and (210).

Typical action messages 202 may include the phrases “shock wave treatment in progress” and “tissue deformed at this volume”. Typical status messages 203 include the power level, operating frequency, number of target volumes 12 within the calculated target region 200, and number of target volumes 12 that are under tissue deformation. can do.

Display 48 also preferably includes a graphical cross-sectional representation 212 derived from the acoustic image provided by imaging acoustic transducer subassembly 23 (FIG. 1). The indication 212 preferably shows in cross section various tissues in the body and shows the target volumes 12 associated therewith.

3B, the display 48 provides a preprogrammed warning message 214 in abnormal operation.

Typical warning messages include an indication that no shock waves are generated due to "poor connection", "temperature too high". The message " temperature too high " relates to skin tissue, although in other ways it may additionally be related to other tissues in or out of the target volume or in the transducer 10 (FIG. 1).

Reference is made to FIGS. 4A and 4B, which are front and partial cutaway side views of the patient, respectively, showing a non-uniform distribution of target volumes 12 at the treatment site 200 of the patient. In FIGS. 4A and 4B it is seen that the density of the target volumes can vary at the target site as a function of position relative to the body surface and depth below the body surface.

Reference is made to FIG. 5, which illustrates an acoustic tissue modification system constructed and operative in accordance with a preferred embodiment of the present invention. As described above with reference to FIG. 1 and as seen in FIG. 5, the acoustic tissue deformation system includes a tissue deformation control computer 44 that delivers the output to the display 48. Tissue deformation control computer 44 preferably includes inputs from video camera 46 (FIG. 1) and inputs from skin temperature sensor 34 (FIG. 1) and transducer temperature sensor 36 (FIG. 1). As well as receiving inputs from the temperature measuring unit 300 which receives the temperature limit settings. The temperature measuring unit 300 preferably compares the outputs of both sensors of (34) and (36) with appropriate threshold settings to display an indication informing the tissue deformation control computer 44 of which limit has been exceeded. to provide. It is to be noted that the temperature limit settings should be chosen at temperatures that do not fall below those required to reach thermal cell destruction functionality, as opposed to the non-heated tissue deformation functional means of the present invention. It is characteristic. Typical threshold settings are approximately 38 ° C. for skin temperature sensor 34 and approximately 40 ° C. for transducer temperature sensor 36.

The operator changes the focus of the acoustic beam produced at each piezoelectric element of the paced array 14 to direct the acoustic beam towards the target volume 12 in the treatment area 200. Changing the focus of the acoustic beam emitted from each acoustic element 15 causes the distance of the target volume 12 from each acoustic element 15 to change as described above with respect to FIGS. 3A and 3B.

The tissue deformation control computer 44 also preferably receives an input from the acoustic contact monitoring unit 302 which in turn receives an input from the transducer electrical property measurement unit 304. The transducer electrical property measurement unit 304 preferably monitors the output of the power supply and regulator assembly 40 (FIG. 1) entering the acoustically curable transducer assembly 13.

The transducer electrical property measurement unit 304 preferably compares the power supply and the output of the regulator 40 with appropriate threshold settings and determines whether the threshold settings in the tissue deformation control computer 44 exceed the power level threshold set. Provide an informative indication. It is a feature of the present invention that power source threshold settings are selected to define a power level threshold that is below the power level characterized by cavitation cell destruction in the target volume. It is to be understood that the power level characteristic of cavitation cell destruction is substantially higher than the power level employed by the mechanical non-cavified tissue modification function of the present invention.

According to a preferred embodiment of the present invention, the power level threshold is significantly lower than the power level required for cavitation to occur in the tissue. For example, the power level is 160 Watts at an operating frequency of 250 kHz, while the power level limit found in laboratory experiments for in water cavitation thresholds is at least 600 Watts. It is assumed that the threshold for cavitation cell destruction at the target volume is typically at a higher power level than the threshold required for cavitation in water.

Alternatively or additionally, the acoustic contact monitoring unit 302 receives an input from the acoustic reflection analysis function means 314.

The output of transducer electrical property measurement unit 304 is preferably also supplied to power meter 306 to provide an output to tissue deformation control computer 44 and a feedback output to power and regulator assembly 40.

The tissue deformation control computer 44 also preferably receives inputs from the tissue layer identification function means 310 and the modified tissue identification function means 312, both functional means reflecting and modifying function means 314. Receive input from The acoustic reflection and deformation function means 314 receives acoustic imaging inputs from the acoustic imaging subsystem 316 that operates the imaging acoustic transducer subassembly 23 (FIG. 1).

The tissue deformation control computer 44 outputs the outputs to the power and regulator assembly 40 to operate the acoustical transducer 13 and to the acoustic imaging subsystem 316 to operate the imaging acoustic transducer subassembly 23. Provide them. Positioning control unit 318 also includes an XYZ positioning assembly 49 for positioning the transducer 10 including the acoustically healable transducer 13 and the imaging acoustic transducer subassembly 23 in the correct position. Receive the output from the tissue deformation control computer 44 needed to operate (Figure 1).

Reference is now made to FIGS. 6A, 6B, and 6C, which are simplified flowcharts showing operator steps for performing tissue transformation in accordance with a preferred embodiment of the present invention. As shown in FIG. 6A, initially the operator preferably draws a contour 50 (FIG. 1) on the patient's body. Preferably, the operator also attaches stereotactic markers 54 to the patient's body and positions the transducer 10 and bearing marker 56 in the desired position within the contour 50.

Camera 46 (FIG. 1) captures outline 50 and markers 54, 56. Preferably the outline 50 and the markers 54, 56 are displayed on the display 48 in real time. The output of camera 46 is also preferably supplied to a memory associated with tissue deformation control computer 44 (FIG. 1).

The computerized tracking function means preferably embodied in the tissue deformation control computer 44 preferably outputs the camera 46 to calculate a contour representation 52 that can be displayed on the display 48 for the operator. Use The computerized tracking function means also preferably calculates the distributions and densities of the target volumes for tissue deformation treatment. The distribution of target volumes can be non-uniform with respect to both the body surface and the depth below the body surface, as is evident in FIGS. 4A and 4B. The computerized tracking function means preferably also calculates the coordinates of the target volumes and also calculates the total volume to be handled during the treatment.

Preferably, the operator identifies the positions of the markers 54, 56 on the display and the computerized tracking function means calculates corresponding marker representations 58, 60.

According to a preferred embodiment of the present invention, the computerized tracking function means is used to maintain a continuous registration of the contour 50 with respect to the contour reproduction 52 and such as the patient entering or leaving the breathing or treatment position. Markers 54 and marker representations 58 are used to keep a record of the target volumes 12 relative to the patient's body during movement of the patient's body during treatment, such as due to other movements.

The computerized tracking function means selects the initial target volume to be treated and the position control unit 318 (FIG. 5) calculates the necessary repositioning of the transducer assembly 10. The X-Y-Z position assembly 49 repositions the transducer assembly 10 so that it overlies the selected target volume.

Referring also to FIG. 6B, after repositioning the transducer assembly 10, the tissue deformation control computer 44 knows that the correct position of the transducer assembly 10 is ascertained with respect to the selected target volume. The acoustic imaging subsystem 316 (FIG. 5) activates the imaging acoustic transducer subassembly 23, causing it to provide the acoustic reflection and conditioning function means 314 with the output supplied from the subsystem 316. FIG.

Acoustic reflection and conditioning function means 314 analyzes the received data. Based on the output from the acoustic reflection and conditioning function means 314, the tissue position identification function means 310 identifies the tissue to be deformed and the tissue deformation control computer 44 applies the target volume and tissue overlap. . The operator can confirm the selection of the target volume and activate the power supply and regulator assembly 40 (FIG. 1).

Also returning to FIG. 6C, it is found that the following functional means are provided:

The transducer electrical property measurement unit 304 preferably provides an output to the acoustic contact monitoring unit 302 which analyzes the current and voltage in the healable transducer 13 to determine whether or not the acoustic contact with the patient is sufficiently in contact. do. The output of the monitoring unit 302 is applied to the tissue deformation control computer 44.

The transducer electrical property measurement unit 304 provides an output to a power meter 306 that calculates the average power received by the curable transducer 13. If the average power received by the curable transducer 13 exceeds a predetermined power level threshold, the operation of the power supply and regulator assembly 40 may be terminated automatically. As mentioned above in connection with FIG. 5, a power level threshold is selected to prevent cavitation to the target volume. The output of power and regulator assembly 40 is applied to tissue deformation control computer 44.

The skin temperature sensor 34 measures the current temperature of the skin in the transducer subassembly 23 and supplies it to the temperature measuring unit 300 so as to compare the skin temperature with a corresponding threshold temperature. In a similar manner, the transducer temperature sensor 36 measures the current temperature in the transducer subassembly 23 and supplies it to the temperature measuring unit 300 to compare the transducer subassembly 23 temperature with its corresponding threshold temperature. do. The outputs of the temperature measuring unit 300 are supplied to the tissue deformation control computer 44.

If any one of the following four conditions occurs, the power supply and regulator assembly 40 automatically terminates operation of the curable transducer 13. If any of the following conditions do not occur, automatic operation of the power and regulator assembly 40 continues:

1. The average power received by the curable transducer 13 exceeds a predetermined limit;

2. Acoustic contact is insufficient;

3. The skin temperature exceeds the threshold temperature; And

4. The transducer 13 temperature exceeds the threshold temperature.

Returning to FIG. 6B, while the power and regulator assembly 40 is operating automatically, the video camera 46 preferably stops the transducer 10 while recording the target site and treating the selected target volume 12 as a whole. You will notice that you are observing whether or not you remain intact. If so, and none of the four conditions mentioned above occur, the tissue deformation control computer 44 confirms that the selected target volume has been treated. The computerized tracking function of the tissue deformation control computer 44 then suggests that the target volume 12 be further treated.

However, if transducer 10 does not remain stationary for a sufficient period of time, the selected target volume will cause tissue deformation control computer 44 to designate that the treatment is not sufficient.

Using multiple transducers, it will be appreciated that the plurality of target volumes can be treated sequentially or at least partially in overlapping times.

It will also be appreciated that the plurality of target volumes may at least partially overlap.

It will be understood by those skilled in the art that the present invention is not particularly limited by what has been shown and described above. Rather, the scope of the present invention includes all combinations and subcombinations of the various features described above as well as changes and modifications that may occur to those skilled in the art upon reading the specification.

Claims (118)

Providing an acoustic beam; And The acoustic beam is directed to the target volume to deform the tissue by the target volume for a predetermined time shorter than the time it takes for the acoustic beam to cause thermal deformation of the tissue in the target volume to the site containing the tissue of the body. And aiming, wherein the acoustic beam applies pressure to the tissue by a target volume that is below a cavitation threshold in the tissue. The method of claim 1, Providing an acoustic conducting layer located between an acoustic beam collimator and a contact surface of the body. The method of claim 2, An acoustic conducting layer is located adjacent to the acoustic beam collimator and is located between the upper and the upper and the surface of the body and containing the fluid to improve cooling during operation of the power source and regulator. And a lower portion having an acoustic impedance similar to the acoustic impedance of the surface. The method according to any one of the preceding claims, Aiming the acoustic beam generally prevents deformation of the tissue outside of the target volume. The method according to any one of the preceding claims, The aiming of the acoustic beam is performed on a plurality of target volumes distributed at a non-uniform depth with respect to the surface of the body. The method according to any one of the preceding claims, Aiming the acoustic beam generally prevents deformation of the tissue outside of the target volume. The method according to any one of the preceding claims, And acoustically imaging the region at least spatially while simultaneously aiming the acoustic beam at the target volume. The method according to any one of the preceding claims, And said aiming comprises positioning at least one acoustic transducer with respect to the body to aim the acoustic beam at the target volume. The method according to any one of the preceding claims, And said aiming comprises changing the focus of at least one acoustic transducer to aim said acoustic beam at said target volume. The method of claim 9, Changing the focal point changes the volume of the target volume. The method of claim 9, Varying the focus changes the distance of the target volume from the at least one acoustic transducer. The method according to any one of the preceding claims, And detecting the acoustic beam that couples to an outer surface of the body adjacent the target volume. The method according to any one of the preceding claims, The aiming is from an acoustic transducer located external to the body. The method according to any one of the preceding claims, The maximum value of the energy distribution is in a frequency range between 50 KHz and 1000 KHz. The method according to any one of the preceding claims, And the maximum value of the energy distribution is in a frequency range between 100 KHz and 500 KHz. The method according to any one of the preceding claims, And the maximum value of the energy distribution is in a frequency range between 150 KHz and 300 KHz. The method according to any one of the preceding claims, The acoustic beam has a duty cycle between 1: 2 and 1: 250. The method according to any one of the preceding claims, The acoustic beam has a duty cycle between 1: 5 and 1:30. The method according to any one of the preceding claims, The acoustic beam has a duty cycle between 1:10 and 1:20. The method according to any one of the preceding claims, And the acoustic beam has sequential shock waves between 1 and 1000 at a pressure amplitude above the propagation nonlinear mechanical threshold at the treatment site. The method according to any one of the preceding claims, And the acoustic beam has sequential shock waves between 1 and 100 at a pressure amplitude above the propagation nonlinear mechanical threshold at the treatment site. The method according to any one of the preceding claims, And the acoustic beam has sequential shock waves between 1 and 10 with a pressure amplitude above the propagation nonlinear nonlinear threshold in the treatment site. The method according to any one of the preceding claims, The cumulative number of shock waves in the one target volume is between 1000 and 100,000. The method according to any one of the preceding claims, The cumulative number of shock waves in the one target volume is between 10,000 and 50,000. The method according to any one of the preceding claims, And the acoustic beam has an acoustic signal at the target volume that is reduced by 1 dB in a first harmonic wave due to harmonic generation. The method according to any one of the preceding claims, And wherein said acoustic signal at said target volume has a "tooth" shape. The method of claim 26, Wherein the " toothed " shape causes locally extreme pressure gradients to form shock waves. The method according to any one of the preceding claims, Tissue transformation leads to apoptosis. The method according to any one of the preceding claims, Tissue deformation leads to cell necrosis. The method according to any one of the preceding claims, The method of claim, characterized by the fact that tissue modification leads to changes in protein structure. The method according to any one of the preceding claims, Tissue transformation leads to changes in protein function. The method according to any one of the preceding claims, Tissue deformation leads to a change in the sugar structure. The method according to any one of the preceding claims, Tissue transformation leads to a change in saccharide function. The method according to any one of the preceding claims, Tissue transformation leads to changes in lipid structure. The method according to any one of the preceding claims, Tissue transformation leads to a change in lipid function. The method according to any one of the preceding claims, Tissue modifications lead to changes in glycoprotein structure. The method according to any one of the preceding claims, Tissue transformation leads to a change in glycoprotein function. Defining a portion of the body at least partially by sensing spatial indications on the body; And Within the site, target volumes comprise tissue, and aiming the acoustic beam into a plurality of target volumes, thereby deforming the tissue at the target volumes. The method of claim 38, And said plurality of target volumes are distributed unevenly with respect to the surface of said body. The method of claim 38 or 39, wherein And said plurality of target volumes are distributed at a non-uniform depth with respect to the surface of said body. 41. The method of any of claims 38-40. And said aiming comprises aiming at a sound in a plurality of target volumes in chronological order. 41. The method of any of claims 38-40. And said aiming comprises aiming an acoustic beam at said plurality of target volumes that at least partially overlap at various times. 43. The method of any of claims 38-42, Wherein at least some of the plurality of target volumes overlap at least partially in space. The method of any one of claims 38 to 43, And defining said site by marking at least one surface of said body. The method of any one of claims 38 to 43, Selecting at least one depth in the body to define the site. The method according to any one of claims 38 to 45, And defining the site by sensing tissue in the body. 47. The method of claim 46 wherein And defining the site by detecting tissue that has not been modified. 47. The method of claim 46 wherein And the aiming step further comprises defining the target volumes as unit volumes of unmodified tissue in the site. The method of claim 48, Proceeding sequentially over time and further comprising adjusting the acoustic signal energy to modify the tissue in the plurality of target volumes, wherein selective adjustment of the tissue at each target volume is not deformed therein. Tissue transformation method characterized in that it occurs only after detection of non-tissue. The method according to any one of claims 38 to 49, And performing the computed tracking of the plurality of target volumes in the movement of the body. 51. The method of claim 50, Wherein the computerized tracking comprises detecting a change in the position of the markings on the body, and tracking the positions of the target volumes of the body and employing the sensed change. Within the site, target volumes contain tissue, and aiming the acoustic beam at a plurality of target volumes to deform the tissue at the target volumes; And And performing computerized tracking of the plurality of target volumes in movement of the body. The method of claim 52, wherein Wherein the computerized tracking comprises detecting a change in the position of the markings on the body, and tracking the positions of the target volumes of the body and employing the sensed change. A power source and a regulator operative to generate an acoustic beam capable of deforming the tissue at a target volume of the area containing tissue of the body; And An acoustic beam collimator that aims the acoustic beam at the target volume, the acoustic beam pressurizing the tissue of the target volume below the cavitation threshold in the tissue and acting on the volume for a predetermined time And said predetermined time is shorter than the time taken for said acoustic beam to cause thermal deformation of said tissue in said target volume. The method of claim 54, And a sound conducting layer located between the sound beam collimator and the body contact surface. The method of claim 55, An acoustic conducting layer is located adjacent the acoustic beam collimator and is located between the upper and upper portions of the body and the surface of the body and the acoustic impedance of the contact surface, the fluid containing the fluid to enhance cooling during operation of the power source and regulator. And a lower portion having a similar acoustic impedance. 57. The method of any one of claims 54 to 56, And the aiming device is operable to aim the acoustic beam into a plurality of target volumes distributed unevenly with respect to the surface of the body. The method of any one of claims 54-57, And the aiming device is operable to aim the acoustic beam into a plurality of target volumes distributed at non-uniform depths with respect to the surface of the body. The method of any one of claims 54-58, And the aiming device prevents deformation of tissue that is generally outside of the target volume. 60. The method of any one of claims 54 to 59, And an acoustic imager that at least partially provides acoustic imaging of the site while aiming the acoustic beam at the target volume. 61. The method of any one of claims 54 to 60, The aiming device includes a positioner for positioning at least one acoustic transducer relative to the volume to aim the acoustic beam at the target volume. 63. The method of any one of claims 54 to 61, And the aiming device changes the focus of at least one acoustic transducer to aim the acoustic beam at the target volume. 63. The method of claim 62, The changing focal point changes the volume of the target volume. 63. The method of claim 62, Varying focus changes the distance from the target volume to the at least one acoustic transducer. 55. The method of claim 54, And said aimer places at least one acoustic transducer relative to said body to direct said acoustic beam to said target volume. 55. The method of claim 54, And the aiming device changes the focus of at least one acoustic transducer to direct the acoustic beam to the target volume. The method of any one of claims 54-66, And a sensor for sensing an acoustic beam connected to the outer surface of the body adjacent the target volume. The method of any one of claims 54-66, And the aiming device comprises an acoustic transducer located outside of the body. The method of any one of claims 54-68, Wherein the maximum energy distribution is in a frequency range between 50 kHz and 1000 kHz. The method of any one of claims 54-68, And wherein the maximum energy distribution is in a frequency range between 100 kHz and 500 kHz. The method of any one of claims 54-68, Wherein the maximum energy distribution is in a frequency range between 150 kHz and 300 kHz. The method of any one of claims 54-71, Wherein said regulator provides a duty cycle between 1: 2 and 1: 250. The method of any one of claims 54-71, Wherein said regulator provides a duty cycle between 1: 5 and 1:30. The method of any one of claims 54-71, Wherein said regulator provides a duty cycle between 1:10 and 1:20. The method of any one of claims 54-74, wherein The regulator providing sequential shock waves between 1 and 1000 at a therapeutic amplitude at the target volume. The method of any one of claims 54-74, wherein The regulator providing sequential shock waves between 1 and 100 at a therapeutic amplitude at the target volume. The method of any one of claims 54-74, wherein The regulator providing sequential shock waves between 1 and 10 at a therapeutic amplitude at the target volume. 78. The method of any one of claims 54 to 77, And the number of cumulative shock waves in the one target volume is between 1000 and 100,000. 78. The method of any one of claims 54 to 77, And the number of cumulative shock waves in the one target volume is between 10,000 and 50,000. 78. The method of any one of claims 54 to 77, And a regulator for adjusting the amplitude of the acoustic signal over time. 81. The method of any of claims 54-80, And an adjuster for generating a harmonic wave to decrease the amplitude of the acoustic signal formed in the target volume by 1 dB in the first harmonic wave. 82. The method of any of claims 54-81, And a regulator for adjusting the amplitude of the acoustic signal to form a “sawtooth” shaped waveform at the target volume. 83. The method of claim 82, Wherein the " toothed " formation causes a local extreme pressure gradient that causes shock waves to form. 84. The method of any one of claims 54 to 83, A device characterized in that the tissue transformation leads to apoptosis. 84. The method of any one of claims 54 to 83, A device characterized in that tissue deformation leads to cell necrosis. 84. The method of any one of claims 54 to 83, A device characterized in that the tissue modification leads to a change in protein structure. 84. The method of any one of claims 54 to 83, A device characterized in that tissue transformation leads to changes in protein function. 84. The method of any one of claims 54 to 83, A device characterized in that the tissue deformation leads to a change in the sugar structure. 84. The method of any one of claims 54 to 83, A device characterized in that the tissue transformation leads to a change in sugar function. 84. The method of any one of claims 54 to 83, A device characterized in that the tissue deformation leads to a change in the lipid structure. 84. The method of any one of claims 54 to 83, A device characterized in that the tissue transformation leads to a change in lipid function. 84. The method of any one of claims 54 to 83, A device characterized in that the tissue modification leads to a change in the glycoprotein structure. 84. The method of any one of claims 54 to 83, A device characterized in that the tissue transformation leads to a change in glycoprotein function. 84. The method of any one of claims 54 to 83, And a regulator for adjusting the amplitude of the acoustic signal in view of the non-uniformity of the medium causing the formation of a waveform having a " tooth " shape in the target volume, creating a local extreme pressure gradient that causes shock waves to form. Device. 95. The method of any one of claims 54 to 94, And a region definer defining at least partially a portion of the body by sensing spatial indicia on the body. 97. The method of claim 95, And the definer employs marking on at least one surface of the body. 97. The method of claim 95, The deflector further employs a selection of at least one depth in the body. 97. The method of claim 95, And the definer detects tissue of the body. 97. The method of claim 95, And the definer defines the site at least partially by sensing undeformed tissue. The method of any one of claims 54 to 99, And the aiming device also defines the target volumes as unit volumes of tissue that are not deformed within the site. 101. The method of claim 100, The aiming device proceeds sequentially over time so that selective regulation of tissue at each target volume occurs only after detection of undeformed tissue therein. 101. The method of claim 100, And the aiming device also defines the target volumes as unit volumes of tissue in the site. 101. The method of claim 100, The aiming device proceeds sequentially over time so that selective regulation of tissue at each target volume occurs only after detection of undeformed tissue therein. 103. The method of any of claims 100-103, And the computerized tracking function means for providing computerized tracking of the plurality of target volumes despite movement of the body. 105. The method of claim 104, Said computerized tracking function means for detecting a change in the position of the markings on the body, tracking the positions of the target volumes of the body and employing the sensed change. 105. The method of any of claims 54-105, And an acoustic coupling medium applicator for supplying an acoustic coupling medium between the acoustic beam aimer and the body. 107. The method of any one of claims 54 to 106, And a plurality of sensors operative to measure the degree of acoustic coupling between the acoustic beam aimer and the body. 108. The method of any of claims 54 to 107, And electronic circuitry associated with said acoustic beam aimer for storing related parameters. 109. The method of claim 108, And said electronic circuit stores parameters relating to operating characteristics of said acoustic beam collimator. 109. The method of any one of claims 108 and 109, And interlock circuitry operative to receive predetermined parameters from the electronic circuitry to adjust operation of the device. 112. The method of claim 110, At least some of the predetermined parameters are stored on an acoustic beam aimer identification storage medium, wherein the medium is supplied to the interlock circuit upon reading to verify the identification of the acoustic beam aimer on the interlock circuit. Tissue deforming device. A power source and a regulator operative to generate an acoustic beam capable of deforming a target volume of tissue at a site comprising tissue of the body; An acoustic beam aimer for aiming the acoustic beam at the target volume; An acoustic conducting layer located between the acoustic beam aimer and the contact surface of the body; The acoustic conductive layer including an upper portion adjacent the acoustic beam collimator and a lower portion located between the upper portion and the contact surface of the body; The upper portion containing a fluid to enhance cooling while the power source and the regulator are in operation; And And the lower portion having an acoustic impedance similar to that of the contact surface. A power source and a regulator operative to generate an acoustic beam capable of deforming a target volume of tissue at a site comprising tissue of the body; An acoustic beam aimer aiming an acoustic beam at the target volume; And And an acoustic coupling medium applicator for supplying an acoustic coupling medium between the acoustic beam aimer and the body. A power source and a regulator operative to generate an acoustic beam capable of deforming a target volume of tissue at a site comprising tissue of the body; An acoustic beam collimator directing an acoustic beam to the target volume; And And a plurality of sensors operative to measure the degree of acoustic coupling between the acoustic beam aimer and the body. A power source and a regulator operative to generate an acoustic beam capable of deforming a target volume of tissue at a site comprising tissue of the body; An acoustic beam aimer aiming an acoustic beam at the target volume; And And an electronic circuit associated with the acoustic beam collimator for storing associated parameters. 116. The method of claim 115, And said electronic circuit stores parameters relating to operating characteristics of said acoustic beam collimator. 116. The method of any one of claims 115 and 116, And an interlock circuit operable to receive certain parameters from the electronic circuitry to coordinate operation of the device. 118. The method of claim 117 wherein At least some of the predetermined parameters are stored on an acoustic beam aimer identification storage medium, wherein the medium is supplied to the interlock circuit upon reading to verify the identification of the acoustic beam aimer on the interlock circuit. Tissue deforming device.

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