MXPA97004906A - Acoustic system for therapy of fracture of hu - Google Patents

Abstract

The present invention relates to a method for surgically using non-invasive low frequency acoustic energy to accelerate the repair of a bone fracture, wherein the fracture includes a space between the confronting surface portions of the fracture; the method comprises the step of transcutaneously and non-invasively delivering ultra high frequency acoustic carrier frequency energy to a body tissue and / or adjacent fluids in at least a portion of the fracture and at a wavelength to establish a standing wave vibration condition in space, where the space is at least an extension of a quarter of

Description

ACOUSTIC SYSTEM FOR BONE FRACTURE THERAPY DESCRIPTION OF THE INVENTION The invention relates to the use of ultrasonic radiation at relatively low levels in living tissue for the treatment of surgically non-invasive healing of bone fractures. Patent Duarte No. 4,530,360 describes a technique for the treatment of bone defects, such as bone fractures, pseudoarthrosis and the like, using a pulsed ultrasonic radiofrequency signal by means of a transducer to the patient's skin and directing sound waves to the bone defect that is going to be healed. Duarte's teaching is to proceed from the fact that bone is piezoelectric in nature; instead of inducing a current, which promotes. Bone growth with an external electromagnetic field or generation of such a current directly, Duarte's mechanical ultrasound energy is converted to an electrical current in the bone, by which time and then it provides healing. Talish et al. Patents 5,003,965 and 5,186,162 advances the Duarte technique providing characteristics which favor the safety in the periodic use of the patient of the ultra high frequency supply, in pulses to an affected region of the patient's body, by electrically separating a power supply and a module that generates pulses from a low power, local radio frequency generator. The local radio frequency generator complete with the battery, is contained in a miniaturized housing, which also mounts a piezoelectric transducer means for the patient-operated application to a special mounting fixture, which is stabilized by the plaster fixation for the limb. damaged of the patient; and pulse-modulation of the high local frequency output to the transducer is by means of a fiber optic link between the power supply / module that generates the pulse and the miniaturized housing (and its transducer). The osteogenic properties of the ultra high pulsed frequency of Duarte's acoustic therapy has been confirmed by others, but it may be that most of these others are not specified in the recommendations for how and where to apply such acoustic therapy with respect to the location of known fracture. At least two technicians (H.-G. Knoch and W. Klug, "Stimulation of Fracture Healing with Ultrasound, Springer-Verlag, Berlin, Heidelberg 1990 (translation)), are specific in their recommendation that the directional axis of the acoustic signal must be normal to the bone and a displacement of longitudinal distance of approximately 5.8 an of the fracture, being noted that The energy level as the Knoch / Klug names are can cause tissue damage if it is directed to the fracture site. The present invention proceeds from the awareness that a relatively low frequency (for example 5Hz to 10kHz) and low intensity (for example less than 100 milliwatts / cm2) the acoustic signal probably has the highest value and effectiveness for oeteogépico therapy, but Conventional knowledge must concede that such a signal, supplied non-invasively to the body, has little characteristic of being delivered therapeutically to a fractured site. And even if the fractured bone is the tibia, fractured in the skin, and therefore as closed as possible for non-invasive access, there is no assurance that the region of the opposing separation of bone fragments will receive the excitement of lowering. frequency, which is believed to be necessary for the initial generation of collagen and callus formation, to close the space or spaces between the bone fragments, which are confronted, through each other, through a space or gap of separation . It is an object of the invention to provide an improved technique and apparatus for the non-invasive use of ultra high frequency acoustic energy in accelerating the repair of bone fracture.

It is a specific object to use non-invasive surgery that confronts the surfaces of separated bone fragments in the local detection of a radiofrequency signal of osteogenic value, in and within the site of a bone fracture. A general object is to achieve the above objects with the equipment which is safe and simple to use by the patient and which involves only a minimal change of existing equipment. In its currently preferred mode. The invention achieves these objects by providing an ultra-high frequency carrier signal for low power excitation of an acoustic transducer that is acoustically connected to a member or other part of the living body, for non-invasive surgery of transcutaneous delivery of acoustic energy to the tissue body and / or fluid adjacent to at least a portion of a bone fracture, wherein the fracture is at least partly characterized by a separation between confronting surfaces of the fracture. The carrier frequency is sufficiently high to establish a condition, a wait-wave in one or more spaces between the confronting surfaces of a bone fracture, while the space that is dimensionally characterized by at least a quarter of a wavelength in frequency carrier so it allows the demodulation of the carrier at the site of the fracture. Generally speaking, the lower limit of the separation of the confronting fragment in a bone fracture is in the order of 0.04 or 0.05 mm and a lower separation bone disorder is usually indicated as a tension fracture. Preferably, a low frequency signal that is present as a modulation on the carrier is the product of such demodulation and thus is available directly for its therapeutic value, where most need, in and around the space within the fracture. Within a matter of days, healing proceeds at an accelerated pace in the environment of such demodulation with resultant collagen and callus and cartilage developed in the reduction of space, to the point of dimensional insufficiency for the development of wait-wave; but the pattern of the propagation of the carrier wave in the body tissue and / or fluid surrounding the central axis of acoustic propagation is rich in therapeutically beneficial tension waves of the acoustic energy that floods a region, which surrounds fracture. Fracture healing therapy may continue with fracture healing or with adequately modified acoustic propagation in and around the fracture site. The various specific modalities are described for bone repair treatment of the indicated character, suitably for one or more of treatments per day of approximately 20 minutes, individual. BRIEF DESCRIPTION OF THE DRAWINGS The invention will be described in detail, in conjunction with the accompanying drawings, in which: Figure 1 is a perspective, simple view of the remote control and the applicator units to the body of the invention, er. the context of the fixed orientation, the body's applicator unit for the accelerated repair of a fractured tibia, which is fixed to the cast; Figure 2 is an enlarged view in a first perspective of the applicator unit of the body of Figure 1 and in a second perspective of the reverse image of an insert interspersed to intersperse in the plaster of Figure 1, in which the accessory is adapted to be detachably mounted at the reception of the bone-apiicator unit; Figure 3 is a simplified block diagram of remote control system components of Figures 1 and 2; Figure 4 is a perspective view for showing a modified application of an interleaved accessory as in Figure 2, but adapted for the application of a mail or fixed end in any other way, for example fixed by external fixator (not shown); ); Figure 5 is a schematic diagram for illustrating a conical mode of acoustic scanning of the fracture region of a bone; Figure 5A is a diagram as in Figure 5 to illustrate a cylindrical acoustic scan mode; Figure 6 is another diagram as in Figure 5 to illustrate an alternating linear mode of acoustic scanning, - Figure 7 is a schematic diagram to show the coordinated use of two transducers in the treatment of a bone fracture; Figure 8 is a diagram as in Figure 7 to illustrate the coordinated use of a larger plurality of transducers, - Figure 9 is a diagram to illustrate the use of a plurality of transducers in a linear arrangement; Figure 10 is a view as in Figure 9 to illustrate the use of a plurality of transducers in a concentric arrangement. Figure 11 is a simplified diagram to illustrate the use of a modal converter as part of a phase of fracture repair with the invention; and Figure 12 is a block diagram for illustrating certain selectively available features pertaining to the use of the invention.

With reference initially to Figures 1 and 2, the invention is shown illustratively for using the basic components that resemble those described in the Patent 5,186,162 whose patent is incorporated herein by reference. It is sufficient here to identify in these drawings an applicator-body unit 10, shown mounted to an orthopedic plaster 11 for the treatment of a bone fracture, such as a fractured tibia in the human leg 12. A flexible cable 13, comprising lines of fiber optic 14, 15 lined, separately, connect the applicator-body unit 10 to a remote control unit 16, which can be relatively compact and portable, as suggested by a carrying handle 17; and detachable connectors of the optical transmission lines 14, 15 the plug on the front panel of the control unit 16. The electrical contents, inside the housing 20 of the applicator unit 10 to the body, can generally be described in detail in the Patent No 5,003,965 but with important differences to be indicated in the following. It suffices to establish that the housing contains storage batteries and a circuit of driving / oscillating components (sometimes referred to as the ultrasonic generator), with a flexible connection cable to a thin, flat 24 transducer element. Element 24 is a coeaerially available piezoelectric disk , suitable as of the cable-zirconium-titanate material known as PZT-4; and the element 24 will be understood to include a separate thin-sheet electrode, joined between each of its front and rear surfaces, to allow the fluctuation of the thicknesses in response to impulse excitation. The transducer 24 is coated with an outer impedance coupling layer 25 of epoxy and on any other side is the part of a seal component 26, which is secured to the outer end of. straps 22 of the silphon type of docile elastomeric material molded gently. The base end 28 of the straps 27 is fastened to the front panel of the housing 20, around an opening (not shown) for the connection of the transducer-cable to the output of a circuitry of electrical components within the housing. Figure 2 also shows a mounting accessory which can be used for the removable assembly of the treatment head 10. As shown, this accessory 30 corz. renders a generally rectangular, lightweight outer frame having a peripheral projection 31 which, in the case of an orthopedic plaster 11, will be understood to be interleaved in the hardened material of the plaster. Within the confines of the projection 31, the vertical body structure 32 has a central opening, which provides rotational support for a ring member 33 having a pair of arcuate groove formations 34, d? At? Etro. ".?tea opposite ones which are adapted for retention recessibly coupled to the treatment head, by means of mounting brackets 35, which extend from the front panel of the treatment head 10. The ends of the head 'of the posts 35 will be understood to be able to be made to enter the enlarged exoskeys of the groove 34 formation and the head of the treatment. that to be frictionally secured c.srr.raii in cua.rui rr ra form to the mounting accessory 30, by rotation similar to a bayonet, partial of the head 10 with respect to the ring 33. As subsequently it will become Of course, it is a feature of the invention that, with the cavity 11 or treated in this way secured to the part or spreader of the attachment 30, a central axis 36 of the rotation of the adjustable treatment head is defined by the mounted head 10, but the front panel of the eye 21 places the transaxle shaft 36 of the r :: a:? or.aI adjustment of the mounted treatment head. Therefore, e. A-us e girattric of the treatment head about the axis 37 will dictate an eccentrically rotated orbital displacement of the longitudinally central response axis 37 of the transducer 25 about the rotational adjustment axis 36. In Figure 2, the limits of that displacement of the ee 37 -z ~ l tr¿_- »u-tor are shown er. i '7'. 37".

It has been indicated generally in the above, that it is important for the invention that the ultra high frequency signal with which the transducer 24 is driven, should be as high as is able to establish a wait-wave condition in the body tissue and / or fluids in the space between the fragments of broken bone. Such space will be at least C.G4 rpm. for e .. case of a bone fracture; Any smaller than usual C04 mm, will usually indicate a tension fracture and large space between the bone fragments, will usually indicate the physical breakdown of the bone structure. For a standby-wave condition, the space must be sufficient up to the extent of the inertia of the wavelength in the frequency of the excitation signal, for example, in body tissues and / or fluids and for a space of 0.04 mm or 0.05 mm, the ultra-high frequency should be at least ten egahertz tlO MHz) to establish a skewness condition between adjacent surfaces of the adjacent bone fragments. However, larger spaces between the confronting surfaces of the bone fracture can be much larger than 0.04 mm. Therefore, the preferred range of signals ultra high to the transducer, will be in the range of up to at least 10 MHz, frequency in which ur-a lons t "z? E a quart of wave for a condition of rest / cao ae * • a * C K.

In the simplified block diagram of Figure 3, the applicator-body unit 10 is fully self-contained in the sense that it includes its own power source, a battery 40 and a power supply means 41 for the operation of a generator 42 of ultra high frequency and for the operation of a signal generator from oa to frequency, which is suitably and preferably a pulse eater having low-frequency pulse-pulse velccle. A modulator 44 connected to the generators 42, 43 supplies ultra-high pulse-frequency signals modulated to the transducer 24, which through the interposition of a coupling gel, transmits pulse-modulated acoustic signals to the region? E ur. fractured bone; Illustratively, the gel of aooplar.ier.to may be the filling of a pillow or a flexible plastic wrap which is transparent to the acoustic transmission. It will be understood that all necessary adjustments within the descritc = components of the applicator-body unit can serve all therapeutic needs, only with an on / off switch as the externally operated control unit. However, for security purposes and for greater opportunity to change and monitor certain variables, such tasks are in Figure 3 relegated to the remote control unit with surrounds of the 14: c lines of fiber optics for controlling and monitoring the applicator unit 10. Alternatively, in the case of a battery-operated remote unit 16, the electric wire cable control of an applicator unit 10 of the body is advantageous. In Figure 3 the remote control unit 16 has a power supply 50, which is based on a domestic-current connection 41 and which drives the power laser 52 which is coupled to the optical fiber 14, is subjected to to digital coding at 53 according to the instructions of command module 54, which includes a surface of a microcomputing. At the receiving end of the optical fiber 14, a decoder 55 classifies various instructions for the components of the apiicator-body unit. The applicator-body unit is further shown with its own battery-operated laser means 56, and a plurality of arrows to an encoder 57, it will be understood that it indicates that a plurality of individual "rer ~ rt * back" connections not shown. tarr.cn are projected to monitor the purposes for the modular operating components of the applicator-body 10. All the monitoring data reported to and coded in 57 becomes digitally transmitted by the laser means 56 and transmitted by the other optical fiber 15, back to the remote control unit 16 where it is decoded at 58 for the * a? ic? c? ír. at 55.

Figure 4 is a simplified perspective view to illustrate that the mounting accessory 30 of Figure 2 can also be adjustably mounted to a portion of the human body, by means of fastener straps, retained by hook and loop fastener means, it being understood that protective gauze or flannel (not shown) between the body part and the individual straps is recommended to avoid irritating the skin. An arrangement as in Figure 4, which will be observed to serve a patient who relies on external fixation (not shown) between the bone screws (ta-little shown) which do not need any present interference with the mounting mounted on the strap, shown. Figure 5 is a schematic diagram to show that the modulated ultra high frequency acoustic signal transmits by a transducer (64) and the coupled body by means of a suitable gel can be moved mechanically in a movement of exp. pray. . of conical orbit, according to the slow pulse by * 1 motor means 65. As shown, the transducer 64 is mounted to a disk 66, which is driven by the motor about an axis 67, and the transducer 64 is oscillated mounted to the disk 66, such that its central axis 68 of acoustic propagation is at a right angle with respect to the axis of rotation 67. The rotation per engine means € 5. with the driving connection of edge to disk 66, thus produces a conical scan rotated eccentrically from the fracture site, as suggested in 69. In the layout of Figure 5A, the corresponding parts identified in Figure 5 ee give them the same reference numbers , with the premium annotation. The only difference in Figure 5A is that the transducer 64 'is mounted to the disk 66' in such a way that its central axis 68 'of acoustic propagation is parallel to but radially displaced from the rotating shaft 67' of the disk 66 *. The result is that the transducer is propagated on a cylindrically rotated course, with a circular acoustic scan resulting in the diameter D, for the central axis? E the propagation? Ei transducer. In the arrangement of Figure 6, a transducer 64"is mounted to a plate 66" which is slidably guided for the straight-line displacement of the central axis of the acoustic propagation between the rectilinear scanning limits that are separated to the extent of retraction. S. A monitor 65"drives a crankshaft and link connection to plate 66" to account for the recycled displacement The schematic diagram of Figure 7 in relation to a bone 70 that is fractured at 71 along a rail. .sc-rso, which has atbos of the * - components cross-sectional and longitudinal, illustrates that in certain cases, it may be advantageous and therapeutically more effective to mount the transducers 72, 73 according to the technique described in relation to Figure 4, in each of the locations, namely, diametrically opposed sides in Substantial fracture shape and longitudinal displacement of the locations, which generally overlaps the respective ends of the fracture course. Er. such case, the switching means 74 is understood to be switched to the ultra high carrier frequency in alternation with the respective transducers 72, 73, via the lines 72 ', 73'. An additional connection 75 to means 74 should be understood suggesting the selective control of the rate of alternation, ie variation, on ur. side of a low frequency pulse modulation (on line 72 ') to the next (on line 73'), - or to a pulse modulation download on line 72 'and to a similar but successive download of pulse modulations in line "3", or in addition to a remote control manually from which the transducer is to be driven, only in alternation with the other transducer The arrangement illustrated schematically in Figure 8 illustrates a plurality of three transducers 80, 81, 82 similar, mounted as by the application of straps to angularly spaced locations around the site of the fracture of a bone 84, and excited in the ceramics zone. by the means 85 interposed between the source of modulated-carrier signals and the separated lines of the switched supply to the respective transducers. Again, as in Figure 7, the stipulation is made 75"in Figure 8 and the selective remote control, in a manner described by the means 75 of Figure 7. It is a feature of the invention that once a space or spaces between the bone fragment surfaces have been closed to the point of an inability to sustain a standby-wave condition on the carrier frequency, the same carrier frequency modulation can be supplied in more than one widely diffused volume of propagation in the The region of the fracture, on opposite longitudinal sides of the fracture, can be achieved by various techniques, which will be discussed in connection with Figures 9, 10 and 11. In Figure 9, a primary transducer 90 is supplied (by means of the switching means 91) with the modulated carrier for a phase of initial-closing space of the fracture repair, from a period of several days or approximately one week. the operation of the remote control at 92 can redirect the supply of the modulated carrier to two external transducers 93, 94, to the exclusion of transducers 90 which cause the continuous acoustic propagation of the drivers 53. 94 they reach to extend more and therefore they are rich in cutting waves. In this way, greater volumetric supply of the carrier-pulse acoustic propagation is favored. As shown, transducers 93, 90, 94 are in longitudinal position, i.e. distributed along the longitudinal direction along a bone (not shown) toward which there is no invasive propagation. In Figure 10, successive transducers 95, 96 are in a concentric arrangement and the central transducer 95 can be based on the development of wait-wave and demodulation of the low frequency signal in the initial phase of bone repair. fractured. Therefore, with the means 51 of Figure 5, the switching means SI 'of Figure 1C can be operated to supply modulated carrier signals for the concentric, outer annular transducer 96 for the exclusion of the central transducer 95, which results in greater dispersion of cutting wave development in the volume of the body tissue and / or fluids between the transducer and the fractured bone region. In the schematic representation of Figure 11, it is indicated that the so-called modal converter 97, inter-positioned between an acoustic transducer 98 and suitably coupled to bone tissue and / or fluids, can be based to develop a greater dispersion of the energy of wave of acoustic cut, if it is interposed between the transducer 98 and the tissue of the attached body and / or fluids. The resulting dispersion, preferably only in the second phase of the fracture repair - is suggested schematically by the extension of the solid angle d in Figure 11. The schematic diagram of Figure 12 is a fragment of circuitry taken from Figure 3 to show certain adjustable and adjustable characteristics of the apparatus that serves one or more of the phases of bone fracture repair. In this way, the carrier-modulated signal supplied to the transducer 24 operates from the output of the modulator 44 'using the low-frequency signal or the stetogenic signal of the generator 43' and the signal-carrier output UHF of the generator 42 '. For certain purposes, it is advantageous to vary the frequency of the carrier and such variation is provided schematically by suitable means 99, shown with various illustrative options and control adjustment characteristics. For example, er. the fas * one of the generation of ultra high carrier frequency, in the megahertz range, suitably in the range of 5 to 10 MHz, the manual adjustment of the medium 99 is sufficient for the selection of such carrier frequency and for the subsequent manual change to a smaller range, for example in the range of 500 kHz to 5 MHz, after the closing of the spaces of the fract_r * and for the subsequent repair phase er. the CU...... the spread wave propagation of the modulated carrier is desired. Furthermore, in relation to the frequency variation means 99 of FIG. 12, it is considered advantageous in certain cases to progressively and / or cyclically sweep the carrier frequency between upper and lower limits, such as MHz to 10 MHz in one phase, followed by reduced limits (for example 500 kHz to 5 MHz) in the subsequent healing phase of the fracture. The selective availability of such limiting settings, including sweep speed, is indicated by the legends in the appropriate controls suggested by marked arrows. To conclude the present description, it is well to summarize the significant features of the invention, namely: (a) an appreciation of the fact that the repair of the bone fracture can and should be directed by sep. Radc for each of the two phases, a sar * r, a first phase of separation or closing space within the fracture and a following second phase of providing a volumetric environment rich in primary shear waves, in the expanded external envelope of the fracture site. (b) The use of an ultra high frequency acoustic carrier, high enough, modulated with a known frequency slit signal of known value, er. the one that the carrier frequency has a quarter-wave dimension in the body tissue and / or fluids related to a minimum dimensional space attributable to the fracture, which thus allows the modulated acoustic waves of the carrier to enter a guides waves between the boundaries of the fracture separated from one or more spaces within the fracture, where such spaces are large enough to allow a wave-wait phenomenon within the separated fracture-space, so that the carrier and thus secondarily and locally to establish the region of low frequency cutting waves of known osteogenic value, where most urgently need in the first phase of repair of the fracture, namely in and within the fracture site. (c) A closure of the space or spaces within the fracture, other techniques are available for the second phase of repair of the fracture, by which the surrounding volumetric environment of the fracture site is further enriched, without necessarily classifying the continuous flood with the original low frequency modulation of the same ultra high frequency carrier. The nature of bone fractures in a living body is widely variable and therefore I ?? acoustic bone fracture repair techniques, and Parameter preferences will be subjected to a range of values best determined by professional experience, with numbers of fracture cases. Subject to this circumstance and the fact that the experience to date has its limitations, however it is helpful for a list of currently recommended parameter values and ranges of parameter values, as follows: 1. The frequency of the acoustic supply not surgically invasive in the body, it must be of at least one approach to and in the low megahertz range (eg 250 kKz and above), calculated by the expected-wave development within the fracture site for propagation in body tissue and / or fluids. For an assumed minimum available fracture, the space of at least 0.04 mm attributable to the fracture, the carrier frequency must be at least 10 MHz. 2. The low frequency signal to be used for the first phase of separation-closure of the fracture repair should be selected for the known osteogenic value. In the present, this leads to the recommended selection of pulsed modulation of the carrier, in which the pulse repetition rate is in the range 5 Hz to 10 kHz, preferably of approximately one kilohertz; and with a work cycle in the range d * 5 per cent to - 2 percent. 3. The acoustic intensity at the fracture site is advantageously less than 100 milliwatts / cm2 and the acoustic intensity in the transducer is recommended in the range of 5 mW / cm2 to 75 m / cm2, preferably being approximately 30 mW / cm2. . 4. The frequency of the carrier must be adjustable in a separable manner, with the provision for sweeping the frequency between the limits a; sta?: s. For example, currently available transducers should be selected with at least one response frequency range of one to two octaves. 5. The frequency of pulse modulation should be: r a; oetable er. Select the .. with the provision for the collection of rec-enc a between limits to - ^ = tadcs. 6. The configuration of the transducer must consist of one or more elements, in which the axes of the elements can be of arbitrary relations to each other, : n the provision for multiple elements d exci aric. "e. -r.a predetermined synchronization and a for-a that varies c: r. time, repeatable. Although the mechanism involved in accelerating the healing of bone fractures through ultrasound stimulation as it currently occurs is not fully understood, it is believed that: 1. The wait-wave condition in the tissue-body and / or fluids-will stimulate the exposed nerve terminals of the periosteum within the fracture site. 2. The "space" that characterizes the fracture site is understood to be with or without body fluid, with or without tissue debris. 3. The multitransductor configurations described herein are intended to control the spatial, temporal and frequency distribution of the acoustic energy in the region containing the complex fracture. 4. There are at least five unique characteristics that characterize this invention, namely: (a) the nominal value of the carrier frequency is sufficient to establish a wait-wave condition in the space that characterizes the state of the fracture, as well as also to stimulate the exposed nerve terminals of the periosteum. b A wave-wait condition within the fracture space is demodulated as a cut wave at the pulse repetition frequency. (c) The acoustic intensity at the site of the fracture. fracture exceeds the biological threshold to elicit biological regulatory feedback mechanisms. (d) The period of repetition of the pulse is less than the relaxation times of the significant regulatory healing mechanisms. (e) Multiple element arrangement configurations, pulse modulation and carrier frequency control and temporal control, allowing the coupling of spatial frequency and temporal distribution of acoustic energy to the complex structure of a particular fracture, so that the healing process is optimized. The acoustic intensity at the fracture site refers to the Temporary Average-Spatial Averaging intensity (SATA) defined by the AIITM-N? MA standard of 1981.

Claims (45)

1. CLAIMS 1. The method of using low frequency acoustic energy, surgically non-invasive, to accelerate the repair of a bone fracture, in which the fracture is at least in part characterized by a space between the confronting surface portions of the bone. fracture; the method comprises the step of the transcutaneous and non-invasive delivery of ultra high frequency acoustic carrier frequency energy to body tissue and / or adjacent fluids in at least a portion of the fracture and a wavelength, such that the space it is at least of the extension of a quarter of wave, reason why it establishes a condition of vibration in rest-wave in the space.
2. 2. The method of compliance with the claim 1, characterized in that it includes the additional step of modulating the ultra high frequency with a low frequency signal of osteogenic value, by which it uses the wait-wave condition for the local demodulation for the low frequency signal and thus establishing a Therapeutic condition of osteogenic value for the bone tissue inside and on both sides of the space.
3. 3. The method of compliance with the claim 2, characterized in that the modulation is with a cycle of work and pulse amplitude that reflects an increase in osteogenic temperature in the bone.
4. 4. The method of compliance with the claim 3, characterized in that the predetermined temperature increase is at least 0.01 ° C. 5. The method of compliance with the claim 4, characterized in that the use of the temperature is less than 2eC. 6. The method of using low frequency acoustic energy, surgically non-invasive, to accelerate the repair of a bone fracture, in which the method is characterized in that it comprises the steps of: (a) selecting an electroacustic tranceuct to direct the application of ultra-high frequency energy to the skin; (b) placing and maintaining the transducer in a region of transcutaneous, acoustic coupling with body tissue and / or fluids adjacent to the fracture site; (c) excite the transducer with an ultra high modulated frequency low frequency carrier, in which the carrier frequency is in the range of up to 10 MHz and in which the modulation frequency is in the range of 5 Hz to 10 kHz, so for a space between the adjacent portions of the fractured bone and in which the space is at least a quarter of a wavelength at carrier frequency, a wait-wave condition will be established within the fracture, which results in an acoustic cut wave signal, of low demodulated frequency of known local osteogenic value and within the fracture; and (d) maintaining such excitation of the transducer at an intensity to couple the acoustic energy to the body tissue and / or fluids, so that the intensity is less than 100 milliwatts / c 2 at the fracture site, the maintenance of such excitation that is during a predetermined period of time per day. The method according to claim 6, characterized in that the predetermined period is at least five minutes per day. 5. The method according to claim 6, characterized in that the predetermined period is less than 4 hours per day. The method according to claim 6, characterized in that step d is for a period of about 20 minutes at least once per time. 10. The method of compliance with the claim 6, characterized in that step (d) is for a period of about 20 minutes to at least twice per day. 11. The method according to claim 6, characterized in that the modulation frequency is varied between the limits within the ra.a: modulac: - - fr ci-o ua. 12. The method in accordance with the claim 11, characterized in that the variation of the modulation frequency is a continuous variation. The method according to claim 12, characterized in that the variation or modulation is a variation of recycle, in which each cycle of variation has a period of about one minute. 14. The method of compliance with the claim 12, characterized in that the variation of the modulation is a variation of recycle, which has a period of at least one minute. 15. The method according to claim 6, characterized in that the positioning and fastening of the stage (b) includes the angular displacement of the orientation of the transducer with respect to the transcutaneous, acoustic coupling region, the angular displacement that is A recycle displacement of at least one half of a degree per second 16. The method according to claim 15, characterized in that the recycle displacement is between predetermined limits and with a recurring periodicity of approximately one minute. according to claim 6, characterized in that the modulation of step (c) is a Pulse modulation that has a duty cycle in the range of 5 percent to 90 percent. 18. The method according to claim 6, characterized in that the delivery of step (a) is by means of a selected first transducer, transcutaneously coupled to the body tissue and / or fluids on one side of the bone fracture and also it is by means of a second selected transducer, transcutaneously coupled to the body tissue and / or fluid on the other side of the bone fracture. 19. The method according to claim 18, characterized in that each of the supplies is by means of modulations similar to a pulse in relation of time / interlacing. 20. The method of compliance with the claim 6, characterized in that the delivery of step (a) is by means of a selected first transducer, transcutaneously coupled to the body tissue and / or fluids in a lateral aspect of the bone fracture and in which the first transducer is one of a plurality of transducers similarly coupled in spaced relation to each other and in oriented aspects, which are directed to the fracture site. 21. The method according to claim 20, characterized in that the plurality of transducers is arranged in a longitudinally spaced relation, generally parallel to the axis of the fractured bone. 22. The method according to claim 21, characterized in that »the individual transducers of the plurality of transducers are sequentially driven according to step (c). 23. The method according to claim 20, characterized in that the plurality of transducers is arranged in a generally circumferential shape in a spaced relation around the fracture site. 24. The method according to claim 23, characterized in that the individual transducers of the plurality of transducers are sequentially driven according to step (c). 25. The apparatus for the use of low frequency sound accelerates the repair of a bone fracture, the apparatus is characterized in that it comprises an electroacoustic transducer having an input front surface on a longitudinal axis of directional propagation, the transducer is adapted for externally direct, non-invasive coupling to the skin and for subcutaneous attachment to body tissue and / or fluids adjacent to a fracture site, in which the fracture has confronting walls separated from the fracture, and a generating medium to excite the transducers with an electrical output signal which meets the following criteria: (i) an ultra-high carrier frequency in the range of 20 kHz to 10 MHz, the carrier frequency that is elevated in this form in the context of the area frontal / surface such as to establish, for acoustic propagation in body tissue and / or fluids, a primary, relatively narrow directional response lobe, centered above and mainly in the longitudinal direction of the axis and (b) in a surrounding and outer volume of the lobe, a relatively broad region that is rich in primary shear waves; (ii) a modulation of low frequency bone therapy of the carrier frequency in the range of 5 Hz to 1C kKz; and (iii) a lower acoustic intensity than 100 milliwatts / cm2 at the fracture site; whereby (a) it allows the directional supply of acoustic carrier / modulated energy by means of the directional response lobe to at least a portion of the fracture site and (b) to use the separated walls of the fracture as a waveguide to establish a wait-wave condition of the carrier frequency within at least a portion of the fracture, such that the wait-wave condition can provide local demodulation of the modulated carrier at the wait-wave action site , with the development of the secondary shear wave of the therapy acoustic signal-of local low-frequency bone and within the fracture; and (c) to flood primary body tissue and / or the region of external body fluid with primary shear waves. fracture. 26. The apparatus according to claim 25, characterized in that the low frequency modulation is a pulse modulation. 27. The apparatus according to claim 26, characterized in that the pulse modulation has a duty cycle in the range of 5 percent to 90 percent. 28. The apparatus according to claim 25, characterized in that the acoustic intensity in the transducer is in the range of 5 mW / cm2 to 75 pf / cm2. 29. The apparatus in accordance with the claim 28, characterized in that the acoustic intensity in the transducer is approximately 30 mW / cm2. 30. The apparatus according to claim 25, characterized in that the frequency of the carrier is at least one megahertz. 31. The apparatus according to claim 25, characterized in that the modulation frequency of the carrier is periodically swept between the predetermined upper and lower limiting frequencies within the range of 5 Hz to 10 kHz. 32. The apparatus according to claim 25, characterized in that the frequency of the carrier frequency is swept between predetermined upper and lower limit frequencies with the range. 33. The apparatus in accordance with the claim 32, characterized in that the range is between 2.
5. 5 MHz and 10 MHz. The apparatus according to claim 25, characterized in that the transducer is of a plurality of such transducers, all of which are adapted for similar coupling, but of separate direct coupling to the tissue of the body and / or fluids and with their respective longitudinal direct spreading axes to one more c portions of the fracture site. 35. The apparatus in accordance with the claim 25, characterized in that the mounting structure for the transducer is adaptable for mounting to the affected body part of a patient. 36. The apparatus according to claim 35, characterized in that the mounting structure includes means for movingly adjusting the placement of the transducer with respect to the body part. 37. The apparatus according to claim 36, characterized in that the mounting structure includes means for the selective assembly of a plurality of similar transducers in direct coupling similar, but separated from the body tissue and / or fluids and with their respective longitudinal axes of propagation directed to one or more portions of the fracture site. 38. The apparatus' in accordance with the claim 34, characterized in that the generating means has separate output connections to at least two of the transducers and er. that the low frequency modulation is a pulse modulation, with the pulse modulation supplied to one of the translators in time interleaving with the-pulse modulation supplied to one second of the transducers. 39. The apparatus according to claim 34, characterized in that the generating means has separate output connections for a plurality of transducers, and wherein the low frequency modulation is a pulse modulation, with the pulse modulation supplied to each transducer er. time interleaved with the pulse modulation supplied to another transducer of the plurality. 40. The apparatus in accordance with the claim 25, characterized in that the electroacoustic transducer is a component of the transducer means, which additionally includes means for modal conversion of the transducer output. 41. The apparatus according to claim 40, characterized in that the transducer means includes means for the selective application of modal conversion means at the output of the transducer. 42. The apparatus in accordance with the claim 25, characterized in that the transducer includes a first component of the transducer having a front surface area and in which the transducer further includes a second transducer component having a front surface area such as to provide enhanced enrichment of the wave propagation of primary cut, when the second transducer component is energized. 43. The apparatus according to claim 42, characterized in that the front-surface pax'te of the first transducer component is circular, and in which the front surface of the second transducer component is at least one ring, which surrounds the first drag component. 44. The apparatus according to claim 42, characterized in that the second transducer component comprises one or more separate front surface areas, adjacent to the first transducer component. 45. The apparatus according to claim 42, characterized in that the front surface of the second transducer includes two or more areas of transducer. separate front surfaces, adjacent to the first transducer component and positioned symmetrically on the laterally opposite sides of the first transducer component.