Abstract:
The present invention relates to an apparatus for therapeutically treating bone structure using ultrasound, and more particularly, the present invention relates to an apparatus with an attachment structure for treating bone injuries or a variety of musculoskeletal injuries and/or problems.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present invention claims priority to US provisional application No.  61 / 109824  entitled “Apparatus and methods for ultrasonic spine treatment” filed on 30 Oct. 2008, which is herein incorporated in its entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates to an apparatus for therapeutically treating bone structure using ultrasound, and more particularly, the present invention relates to an apparatus with an attachment structure for treating bone injuries or a variety of musculoskeletal injuries and/or problems. 
       BACKGROUND OF THE INVENTION 
       [0003]    The use of ultrasound to therapeutically treat and evaluate bone injuries is known. Impinging ultrasonic pulses having appropriate parameters, e.g., frequency, pulse repetition, and amplitude, for suitable periods of time and at a proper external location adjacent to a bone injury has been determined to accelerate the natural healing of, for example, bone breaks and fractures. For patients with reduced healing capacity, such as elderly persons with osteoporosis, ultrasonic therapy may promote healing of bone injuries that would otherwise require prosthetic replacement or leave the patient permanently disabled. 
         [0004]    U.S. Pat. No. 4,530,360 to Duarte describes a basic non-invasive therapeutic technique and apparatus for applying ultrasonic pulses from an operative surface placed on the skin at a location adjacent a bone injury. The applicator described in the &#39;360 patent has a plastic tube which serves as a grip for the operator, an RF plug attached to the plastic tube for connection to an RF source, and internal cabling connected to an ultrasonic transducer. To apply the ultrasound pulses during treatment an operator must manually hold the applicator in place until the treatment is complete. As a result, the patient is, in effect, immobilized during treatment. The longer the treatment period, the more the patient and/or the assistant is inconvenienced, and certain parts of the body, such as the back, cannot be reached by the patient with such a device, thus requiring the help of an assistant. The &#39;360 patent also describes a range of RF signals for creating the ultrasound, ultrasound power density levels, a range of duration for each ultrasonic pulse, and a range of ultrasonic pulse frequencies. 
         [0005]    U.S. Pat. No. 5,003,965 to Talish et al. relates to an ultrasonic body treatment system having a body-applicator unit connected to a remote control unit by sheathed fiber optic lines. The signals controlling the duration of ultrasonic pulses and the pulse repetition frequency are generated apart from the body-applicator unit. Talish et al. also describes a mounting fixture that is adapted for use with a cast for attaching the body-applicator unit to a patient so that the operative surface is adjacent the skin location. 
         [0006]    U.S. Pat. No. 5,211,160 to Talish et al. relates to an ultrasonic treatment system with a mounting fixture that attaches to a patient&#39;s limb using straps and a hook and loop attachment. The body application unit interfaces with the mounting fixture so that the operative surface is adjacent to the skin location. 
         [0007]    While the systems described in these patents relate to therapeutic methods and apparatus for ultrasonically treating injured bone, and describe basic mounting fixtures for use with a cast or limb for attaching the body applicator unit to the patient, they do not disclose signal generators and transducers, and attachments therefore, that permit placement of the body-applicator unit adjacent to various parts of the body that are either hard-to-reach or, because of the topology of the external skin location, make it difficult to manually position and maintain a transducer adjacent thereto. Nor do these systems permit patient mobility during treatment. 
         [0008]    Spinal fusion, also known as spondylodesis or spondylosyndesis, is a surgical technique used to combine two or more vertebrae. Supplementary bone tissue (either autograft or allograft) is used in conjunction with the body&#39;s natural osteoblastic processes. This procedure is used primarily to eliminate the pain caused by abnormal motion of the vertebrae by immobilizing the vertebrae themselves. Spinal fusion is done most commonly in the lumbar region of the spine, but it is also used to treat cervical and thoracic problems. People rarely have problems with the thoracic spine because there is little normal motion in the thoracic spine. Patients requiring spinal fusion have either neurological deficits or severe pain which has not responded to conservative treatment. 
         [0009]    There are two main types of lumbar spinal fusion, which may be used in conjunction with each other: Posterolateral fusion and Interbody fusion. Posterolateral fusion places the bone graft between the transverse processes in the back of the spine. These vertebrae are then fixed in place with screws and/or wire through the pedicles of each vertebra attaching to a metal rod on each side of the vertebrae. 
         [0010]    Interbody fusion places the bone graft between the vertebra in the area usually occupied by the intervertebral disc. In preparation for the spinal fusion, the disc is removed entirely. A device may be placed between the vertebra to maintain spine alignment and disc height. The intervertebral device may be made from either plastic or titanium. The fusion then occurs between the endplates of the vertebrae. Two primary types of interbody fusion are: Anterior lumbar interbody fusion (ALIF) and Posterior lumbar interbody fusion (PLIF). In ALIF, an anterior abdominal incision is used to reach the lumbar spine, and in PLIF a posterior incision is used to reach the lumbar spine. Another type of fusion is Transforaminal Lumbar Interbody Fusion (TLIF). TLIF fuses the anterior (front) and posterior (back) columns of the spine through a single posterior approach. 
         [0011]    In most cases, the fusion is augmented by a process called fixation, meaning the placement of metallic screws (pedicle screws often made from titanium), rods or plates, or cages to stabilize the vertebra to facilitate bone fusion. The fusion process typically takes 6-12 months after surgery. During in this time external bracing (orthotics) may be required. External factors such as smoking, osteoporosis, certain medications, and heavy activity can prolong or even prevent the fusion process. If fusion does not occur, patients may require re-operation. 
         [0012]    Therefore, a need exists for apparatus which optimize healing while maintaining patient mobility. In particular, a need exists for an apparatus which permits placement of the body-applicator unit adjacent to various parts of the body that are hard-to-reach or otherwise hard to manually position a transducer adjacent thereto, such as the spine, hip, or pelvis region. 
       SUMMARY OF THE INVENTION 
       [0013]    According to a first aspect of the invention there is provided an ultrasound delivery system for use in accelerating bone formation in a subject, the system comprising a subject attachment structure having a subject-facing surface which is configured to substantially contour to a region of the subject to which ultrasound is to be delivered, the subject attachment structure comprising;
       a pair of ultrasound transducer holders located on the subject-facing surface, each holder capable of receiving an ultrasound transducer,   a belt attachment region.       
 
         [0016]    In embodiments of the invention the subject attachment structure is provided with a mechanism for altering at least one of the superior/inferior, the medial/lateral, or the anterior/posterior position of at least one transducer holder of the pair relative to the region of the subject to which the subject attachment structure is applied. 
         [0017]    In embodiments of the invention the transducer holders are removably locatable on the subject attachment structure 
         [0018]    In embodiments of the invention the subject attachment structure is provided with an array of transducer holder positioning holes to which the transducer holders are securable. 
         [0019]    In embodiments of the invention at least one transducer holder of the pair is carried on a transducer holder carrying member and wherein the transducer holder carrying member is associated with and moveable along a track which extends at least partially across the subject-facing surface. 
         [0020]    In embodiments of the invention each of the transducer holders of the pair is carried on the transducer holder carrying member. 
         [0021]    In embodiments of the invention each transducer holder extends from the transducer holder carrying member in an opposing direction. 
         [0022]    In embodiments of the invention the transducer holder carrying member extends between two substantially parallel tracks. 
         [0023]    In embodiments of the invention each of the transducer holders of the pair is carried on a separate transducer holder carrying member, and wherein each transducer holder carrying member is associated with and moveable along a track. 
         [0024]    In embodiments of the invention the transducer holder carrying members are movable along the same track. 
         [0025]    In embodiments of the invention the transducer holder carrying members are independently moveable along the track. 
         [0026]    In embodiments of the invention each transducer holder carrying member is associated with a separate track. 
         [0027]    In embodiments of the invention the separate tracks are substantially parallel. 
         [0028]    In embodiments of the invention the separate tracks are substantially perpendicular. 
         [0029]    In embodiments of the invention the transducer holder carrying member is slidably attachable to the track. 
         [0030]    In embodiments of the invention the subject attachment structure is provided with a peripheral frame and wherein the track extends between opposing edges of the frame. 
         [0031]    In embodiments of the invention the track forms opposing edges of the frame. 
         [0032]    In embodiments of the invention the track is a rail which extends outwardly from the subject-facing surface. 
         [0033]    In embodiments of the invention the transducer holder or at least one transducer holder of a pair is moveable on the transducer holder carrying member. 
         [0034]    In embodiments of the invention the transducer holder is slidably moveable on the transducer holder carrying member. 
         [0035]    In embodiments of the invention the transducer holders are capable of being adjusted in an anterior/posterior direction relative to the subject when the subject attachment structure is in situ. 
         [0036]    In embodiments of the invention at least one of the transducer holder or the transducer holder carrying member is provided with a mechanism to enable at least of one of the angular or rotational adjustment of the transducer holder. 
         [0037]    In embodiments of the invention wherein a locking mechanism is provided to lock the transducer holder in a specific orientation. 
         [0038]    In embodiments of the invention the angle of the transducer holder can be adjusted to be from about 1° to about 50° relative to the subject-facing surface. 
         [0039]    In embodiments of the invention the angle is from about 1° to about 35° relative to the subject-facing surface. 
         [0040]    In embodiments of the invention the transducer holder comprises a dish or cup portion adapted to receive a transducer. 
         [0041]    In embodiments of the invention a gel retaining cup is associated with the transducer holder. 
         [0042]    In embodiments of the invention the subject attachment structure comprises at least two pairs of transducer holders. 
         [0043]    In embodiments of the invention the subject attachment structure comprises an alignment feature for use in aligning the subject attachment structure with an anatomical structure and/or a marking on the subject. 
         [0044]    In embodiments of the invention the anatomical structure is a vertebrae. 
         [0045]    In embodiments of the invention the marking on the subject is an incision mark, a line of sutures or a scar. 
         [0046]    In embodiments of the invention the subject attachment structure is provided with at least one window. 
         [0047]    In embodiments of the invention measurement markings are provided adjacent to the track. 
         [0048]    In embodiments of the invention the subject attachment structure is configured to substantially contour to the torso. 
         [0049]    In embodiments of the invention at least an area of the subject attachment portion is made of a flexible material to enable the subject attachment structure to conform to the body. 
         [0050]    In embodiments of the invention the area of the subject attachment structure, which in use aligns with the vertebral column, is made of a substantially flexible material. 
         [0051]    In embodiments of the invention the area of the subject attachment structure which aligns with the vertebral column acts as a hinge. 
         [0052]    In embodiments of the invention a belt attachment region is provided on at least two opposing sides of the subject attachment structure. 
         [0053]    In embodiments of the invention the belt attachment region comprises a slot through which a portion of a belt is passable. 
         [0054]    According to a further aspect of the invention there is provided a method of accelerating bone formation in a subject, the method comprising the steps of;
       (i) providing an ultrasound delivery system comprising a subject attachment structure having a subject-facing surface which is configured to substantially contour to a region of the subject to which ultrasound is to be delivered, the subject attachment structure comprising;
           a pair of ultrasound transducer holders located on the subject-facing surface, each holder capable of receiving an ultrasound transducer,   a belt attachment region;   
           (ii) introducing a ultrasound transducer into each transducer holder;   (iii) placing the subject-facing surface of the subject attachment structure against the treatment site;   (iv) adjusting the position of at least one of the transducer holders in at least one of the medial/lateral, or the inferior/superior or the anterior/posterior position relative to the treatment site;   (v) introducing a belt into the belt attachment region and securing the subject attachment structure at the treatment site.       
 
         [0062]    In embodiments of the invention the angular position of at least one transducer holder can be altered relative to the treatment site. 
         [0063]    In embodiments of the invention the method is used for accelerating bone formation in spinal indications. 
         [0064]    In embodiments of the invention the method is used to obtain partial or complete vertebral fusion. The method is used in spondylodesis or spondylosyndesis. 
         [0065]    In embodiments of the invention the pair of transducer holders are positioned such that a transducer holder is located on either side of a vertebrae. 
         [0066]    In embodiments of the invention the subject attachment structure is placed at the iliac crest. 
         [0067]    In embodiments of the invention ultrasound is applied to the treatment site on a daily basis. 
         [0068]    In embodiments of the invention the ultrasound is applied for a period of from about 10 to about 30 minutes 
         [0069]    In embodiments of the invention the subject is a mammal. 
         [0070]    In embodiments of the invention the mammal is a human. 
         [0071]    In embodiments of the invention mammal is a non-human mammal. 
         [0072]    According to a further aspect of the invention, there is provided an apparatus for accelerating spinal fusion. The apparatus comprises a treatment head module housing and a belt. The treatment head module housing has a frame with adjustment rails, at least two yoke attached to the adjustment rails, a plunger movably attached to each of the yoke, and a transducer holder attached to each plunger. The belt may be connected to the treatment head module housing. 
         [0073]    According to a further aspect of the invention, there is provided a method of medical treatment. The method comprises performing spinal fusion on a patient&#39;s spine; fitting a treatment head module housing to the patient; adjusting a position of at least one of the transducer holders; and treating a spine fusion area with ultrasound on a regular basis for a period of time. 
         [0074]    According to a further aspect of the invention there is provided an ultrasound delivery system or a method as substantially herein described with reference to the accompanying Figures. 
         [0075]    Further areas of applicability of the invention will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating the particular embodiment of the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0076]    The accompanying drawings, which are incorporated in and form a part of the specification, illustrate the embodiments of the present invention and together with the written description serve to explain the principles, characteristics, and features of the invention. In the drawings: 
           [0077]      FIG. 1  is a front view of a treatment head module housing in a first embodiment. 
           [0078]      FIG. 2  is a back view of the embodiment shown in  FIG. 1 . 
           [0079]      FIG. 3  is a front perspective view of a treatment head module housing in a second embodiment. 
           [0080]      FIG. 4  is a front perspective view of the second embodiment illustrated with a belt attached. 
           [0081]      FIG. 5  is a front view of a transducer holder in a first embodiment. 
           [0082]      FIG. 6  is a back view of the embodiment shown in  FIG. 5 . 
           [0083]      FIG. 7  illustrates variations of the transducer holder shown in  FIG. 5 . 
           [0084]      FIG. 8  is a top perspective view of a transducer holder in a second embodiment. 
           [0085]      FIG. 9  is a top perspective view of a transducer holder in a third embodiment. 
           [0086]      FIG. 10  is a top perspective view of a transducer holder in a fourth embodiment. 
           [0087]      FIG. 11  is a back perspective view of a treatment head module housing in a third embodiment. 
           [0088]      FIG. 12  is a front perspective view of the embodiment shown in  FIG. 11 . 
           [0089]      FIG. 13  is a detailed perspective view of a yoke in a first embodiment. 
           [0090]      FIG. 14  is an exploded view of the embodiment shown in  FIG. 13 . 
           [0091]      FIG. 15  is a rear perspective view of the embodiment shown in  FIG. 14 . 
           [0092]      FIG. 16  is a back perspective view of a treatment head module housing in a fourth embodiment. 
           [0093]      FIG. 17  is a perspective side view of a transducer holder in a fifth embodiment. 
           [0094]      FIG. 18  is a side view of the embodiment shown in  FIG. 17 . 
           [0095]      FIG. 19  is a perspective side view of a plunger in an alternative embodiment. 
           [0096]      FIG. 20  is a back perspective view of a treatment head module housing in a fifth embodiment. 
           [0097]      FIG. 21  is a back perspective view of a treatment head module housing in a sixth embodiment. 
           [0098]      FIG. 22  is a back perspective view of a treatment head module housing in a seventh embodiment. 
           [0099]      FIG. 23  is a back perspective view of a treatment head module housing in an eighth embodiment. 
           [0100]      FIG. 24  is a detailed perspective view of a yoke in a second embodiment. 
           [0101]      FIG. 25  is a back perspective view of a treatment head module housing in a ninth embodiment. 
           [0102]      FIG. 26  is a detailed perspective view of a yoke in a third embodiment. 
           [0103]      FIG. 27  is a back perspective view of a treatment head module housing in a tenth embodiment. 
           [0104]      FIG. 28  is a detailed perspective view of a yoke in a fourth embodiment. 
           [0105]      FIG. 29  is a back perspective view of a treatment head module housing in an eleventh embodiment. 
           [0106]      FIG. 30  is a detailed perspective view of a yoke in a fifth embodiment. 
           [0107]      FIG. 31  is a back perspective view of a treatment head module housing in a twelfth embodiment. 
           [0108]      FIG. 32  is a back perspective view of a treatment head module housing in a thirteenth embodiment. 
           [0109]      FIG. 33  is a back perspective view of a treatment head module housing in a fourteenth embodiment. 
           [0110]      FIG. 34  is a back perspective view of a treatment head module housing in a fifteenth embodiment. 
           [0111]      FIG. 35  is a back perspective view of a frame of the embodiment shown in  FIG. 34 . 
           [0112]      FIG. 36  is a perspective back view of a transducer holder in a sixth embodiment. 
           [0113]      FIG. 37  is a perspective front view of a transducer holder in a seventh embodiment. 
           [0114]      FIG. 38  is perspective back view of the embodiment shown in  FIG. 37 . 
           [0115]      FIG. 39  is a perspective front view of a transducer holder in an eighth embodiment. 
           [0116]      FIG. 40  is a back perspective view of a treatment head module housing in a sixteenth embodiment. 
           [0117]      FIG. 41  is a back perspective view of a treatment head module housing in a seventeenth embodiment. 
           [0118]      FIG. 42  is a back perspective view of a treatment head module housing in an eighteenth embodiment. 
           [0119]      FIG. 43  is a back perspective view of a treatment head module housing in a nineteenth embodiment. 
           [0120]      FIG. 44  is a detailed perspective view a transducer holder in a ninth embodiment. 
           [0121]      FIG. 45  is a rear perspective view of the embodiment shown in  FIG. 44 . 
           [0122]      FIG. 46  is a back perspective view of a treatment head module housing in a twentieth embodiment. 
           [0123]      FIG. 47  is a detailed perspective view a transducer holder in a tenth embodiment. 
           [0124]      FIG. 48  is a back view of a treatment head module housing in a twenty-first embodiment. 
           [0125]      FIG. 49  is a perspective view of the embodiment shown in  FIG. 48 . 
           [0126]      FIG. 50  illustrates variations of the transducer holder shown in  FIG. 49   
           [0127]      FIG. 51  is a sectional view of a yoke in a sixth embodiment. 
           [0128]      FIG. 52  is a sectional view of a yoke in a seventh embodiment. 
           [0129]      FIG. 53  is a sectional view of a yoke in an eighth embodiment. 
           [0130]      FIG. 54  is a sectional view of a yoke in a ninth embodiment. 
           [0131]      FIG. 55  is a sectional view of a yoke in a tenth embodiment. 
           [0132]      FIG. 56  is a sectional view of a yoke in an eleventh embodiment. 
           [0133]      FIG. 57  is a sectional view of a yoke in a twelfth embodiment. 
           [0134]      FIG. 58  is a sectional view of a yoke in a thirteenth embodiment. 
           [0135]      FIG. 59  is a sectional view of a yoke in a fourteenth embodiment. 
           [0136]      FIG. 60  is a back view of a treatment head module housing in a twenty-second embodiment. 
           [0137]      FIG. 61  is a detailed front perspective view of the embodiment shown in  FIG. 60 . 
           [0138]      FIG. 62  is a detailed rear perspective view of the embodiment shown in  FIG. 60 . 
           [0139]      FIG. 63  is a back view of a treatment head module housing in a twenty-third embodiment. 
           [0140]      FIG. 64  is a front perspective view of the embodiment shown in  FIG. 63 . 
           [0141]      FIG. 65  is a partially exploded, rear perspective view of the embodiment shown in  FIG. 63 . 
           [0142]      FIG. 66  is a detailed perspective view of a treatment head module housing in a twenty-fourth embodiment. 
           [0143]      FIG. 67  is a detailed perspective view a transducer holder in an eleventh embodiment. 
           [0144]      FIG. 68  is a detailed top perspective view a transducer holder in a twelfth embodiment. 
           [0145]      FIG. 69  is a detailed bottom perspective view of the embodiment shown in  FIG. 68 . 
           [0146]      FIG. 70  is a front perspective view of a transducer holder in a thirteenth embodiment. 
           [0147]      FIG. 71  is a front perspective view of the transducer holder shown in  FIG. 70  with the cover removed. 
           [0148]      FIG. 72  is a detailed perspective view of a yoke in a fifteenth embodiment. 
           [0149]      FIG. 73  is a first belt configuration. 
           [0150]      FIG. 74  is a second belt configuration. 
           [0151]      FIG. 75  is third belt configuration. 
           [0152]      FIG. 76  is a fourth belt configuration. 
           [0153]      FIG. 77  is a fifth belt configuration. 
           [0154]      FIG. 78  illustrates transducer signals of the prior art. 
           [0155]      FIG. 79  illustrates transducer signals of one particular embodiment. 
           [0156]      FIG. 80  illustrates a system for applying transducer signals. 
           [0157]      FIG. 81  is a block diagram of the controller shown in  FIG. 80 . 
           [0158]      FIG. 82  is a flowchart illustrating a method of ultrasound application. 
           [0159]      FIG. 83  is an instrument for selecting transducer placement. 
       
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
       [0160]    The following description of the depicted embodiment(s) is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses. 
         [0161]      FIGS. 1 and 2  illustrate a treatment head module housing  10 . The treatment head module housing  10  includes a pair of transducer holders  12  and a pair of belt insert openings  14 . Each transducer holder  12  is adapted to hold a transducer (not shown) and includes a wire opening  16  to receive a wire (not shown) attached to the transducer. A belt (not shown) may be attached to one or both of the belt insert openings  14 . 
         [0162]      FIGS. 3 and 4  illustrate a second embodiment of the treatment head module housing  50 . The treatment head module housing  50  includes positioning holes  52 , belt attachment members  54 , and an alignment portion  56 . A belt  58  is attached to the treatment head module housing  50  at the belt attachment members  54 . Transducer holders  62  may be selectively positioned in the positioning holes  52 . In the depicted embodiment, the positioning holes are arranged in a grid-like fashion. In some embodiments, the treatment head module housing  50  includes an incision window  60 . In some embodiments, the treatment head module housing  50  may include a flex portion  55 . The flex portion  55  is more flexible than the belt attachment members  54  and allows the treatment head module housing  50  to conform to a patient&#39;s back. 
         [0163]      FIGS. 5-7  illustrate the transducer holder  62 . The transducer holder  62  includes a dished portion or cup  66 . The cup  66  is adapted to receive a transducer (not shown). One or more fasteners  64  may be used to attach the transducer holder  62  to the treatment head module housing  50 . As best seen in  FIG. 7 , the transducer holder  62  may be shaped to transmit ultrasound signals from the transducer towards a patient&#39;s spine. The transducer holder  62  may be angled relative to the treatment head module housing  50 . As illustrated in  FIG. 7 , the angle may range from about 1 degree to about 50 degrees, and more particularly from about 1 degree to about 35 degrees. 
         [0164]      FIG. 8  is a top perspective view of a transducer holder in a second embodiment. The transducer holder  70  has a backing layer  72 , a base  74 , and an adhesive layer  76 . The backing layer  72  is removed to reveal the adhesive layer  76 . A transducer  78  may be attached to the base  74  via the adhesive layer  76 . 
         [0165]      FIG. 9  is a top perspective view of a transducer holder in a third embodiment. The transducer holder  80  includes a first layer  82  and a second layer  84 . The second layer  84  may include a dish portion or cup  86  adapted to receive a transducer. 
         [0166]      FIG. 10  is a top perspective view of a transducer holder in a fourth embodiment. The transducer holder  90  includes a lower portion  92 , an upper portion  94 , and a fastener  96  to connect the upper and lower portions  92 ,  94 . The upper portion  94  includes a dish portion or cup  95  adapted to receive the transducer. The upper and lower portions  92 ,  94  have a complementary shape and complementary teeth  98 . The upper portion  94  may be rotated relative to the lower portion  92  to achieve a desired angle of the transducer. 
         [0167]      FIGS. 11-15  illustrate a treatment head module housing  100 . The treatment head module housing  100  includes a frame  110  and adjustment rails  112 . In some embodiments, the treatment head module housing  100  includes an alignment feature  114 . A pair of yoke  116  is removably attached to the frame  110 . In some embodiments, one or more of the yokes may be permanently affixed to the frame  110 . A horizontal adjustment knob  118  is used to adjust the yoke  116  in a medial/lateral direction. As best seen in  FIG. 14 , the horizontal adjustment knob  118  may include a first fastener  124 . The first fastener  124  may be connected to a second fastener  142 , such as a nut, to lock the horizontal adjustment knob. A transducer holder  120  is connected to the yoke  116  through the use of a plunger  119 . In the depicted embodiment the plunger is D-shaped. In other embodiments, the plunger  119  may be cylindrical. Those having ordinary skill in the art would understand that other shapes, such as triangular or square, may be used. 
         [0168]    The transducer holder  120  receives a transducer  140 . In some embodiments, the transducer holder  120  includes a slot  121  to receive a wire  146  of the transducer  140 . A gel retaining cup  122  may be placed in-between the transducer  140  and the transducer holder  120 . In the depicted embodiment, the gel-retaining cup is generally frusto-conical. The gel retaining cup  122  may be used to retain a gel. In some embodiments, gel is placed in the retaining cup  122 , the cup is placed against the patient&#39;s skin, and the cone opens up upon placement against the patient&#39;s skin. The gel retaining cup  122  reduces the possibility of gel spillage. 
         [0169]    In some embodiments, the transducer holder  120  may be angled relative to the yoke  116 . This angle may be in the range from about zero degrees to about fifty degrees. In the depicted embodiment, the transducer holder  120  is at an angle of about five degrees. 
         [0170]    The frame  110  includes a pair of belt attachment members  138 . The belt attachment members  138  are used to attach a belt (not shown) to the frame  110 . The belt attachment members  138  may be integral with the frame  110 , but in the depicted embodiment the pair of belt attachment members  138  are removably attached to main section of the frame  110 . 
         [0171]    As best seen in  FIG. 14 , an alignment member  126  is placed in-between the yoke  116  and the rail  112 . The rail  112  may include one or more grooves or channels  113 . The alignment member  126  may include one or more rail boss  136 . The rail boss  136  is complementary to the channel  113  and is adapted to locate the alignment member  126  in a proximal/distal direction. Of course, those skilled in the art would understand that the channel  113  and the rail boss  136  may reversed in position. In some embodiments, the alignment member  126  includes one or more flanges  127  to prevent rotation of the yoke  116 . In some embodiments, the rail  112  includes a rail opening  132 , and the alignment member  126  includes a corresponding alignment guide  134 . The alignment guide  134  extends within the rail opening  132  to locate the alignment member  126  in a medial/lateral direction. The alignment guide  134  may have certain geometric features, such as generally parallel sides, that complement the rail opening  132  to substantially prevent rotation of the alignment member  126 . While the rail opening  132  is illustrated as one continuous slot, those of ordinary skill in the art would understand that the rail opening  132  could equally be a series of holes. In some embodiments, the frame  110  has a generally arcuate shape from top-to-bottom. In some embodiments, the frame  110  has a generally arcuate shape from side-to-side. In yet another embodiment, the frame  110  has a generally arcuate shape from top-to-bottom and from side-to-side. 
         [0172]      FIGS. 13-15  illustrate one particular embodiment of the yoke  116 . In the depicted embodiment, the yoke  116  includes gear teeth  130 , and the horizontal adjustment knob includes a corresponding gear member  128 . The teeth of the gear member  128  are adapted to mesh with the gear teeth  130  such that as the gear member  128  is rotated, the yoke  116  is moved in a medial/lateral direction. In the depicted embodiment, the yokes  116  may be placed a minimum of about 45 mm apart or a maximum of about 120 mm apart. 
         [0173]      FIG. 16  is an alternative version of the treatment head module housing  100 . In the embodiment depicted in  FIG. 16 , the treatment head module housing  100  includes the frame  110  and adjustment rails  112 . In the embodiment depicted in  FIG. 16 , the rails do not include grooves or channels but do include one or more rail openings  132 . In some embodiments, the treatment head module housing  100  includes the alignment feature  114 . The pair of yoke  116  is removably attached to the frame  110 . In some embodiments, one or more of the yokes may be permanently affixed to the frame  110 . The horizontal adjustment knob  118  is used to adjust the yoke  116  in a medial/lateral direction. The transducer holder  120  is connected to the yoke  116 . The transducer holder  120  receives the transducer  140 . The gel retaining cup  122  may be placed in-between the transducer  140  and the transducer holder  120 . In some embodiments, the transducer holder  120  may be angled relative to the yoke  116 . This angle may be in the range from about zero degrees to about fifty degrees. In the depicted embodiment, the transducer holder  120  is at an angle of about five degrees. In some embodiments, the frame  110  has a generally arcuate shape from top-to-bottom. In some embodiments, the frame  110  has a generally arcuate shape from side-to-side. In yet another embodiment, the frame  110  has a generally arcuate shape from top-to-bottom and from side-to-side. 
         [0174]    The frame  110  includes the pair of belt attachment members  138 . The belt attachment members  138  are used to attach a belt (not shown) to the frame  110 . The belt attachment members  138  may be integral with the frame  110 , but in the depicted embodiment the pair of belt attachment members  138  are removably attached to main section of the frame  110 . 
         [0175]      FIGS. 17-18  illustrate a transducer holder in a fifth embodiment. The transducer holder  123  has a generally hemispherical shape and a central pocket that holds the transducer  140 . 
         [0176]      FIG. 19  is a perspective side view of a plunger in an alternative embodiment. The plunger  120  includes a cam  148 . The cam  148  allows for two-position operation, similar to a ball point pen. 
         [0177]      FIG. 20  is a back perspective view of a treatment head module housing in a fifth embodiment. The treatment head module housing  200  includes a frame  210 , adjustment rails  212 , and belt attachment members  216 . In some embodiments, the treatment head module housing  200  also includes an alignment feature  214 . In some embodiments, a belt (not shown) may be permanently or removably attached to the belt attachment members  216 . 
         [0178]      FIG. 21  is a back perspective view of a treatment head module housing in a sixth embodiment. The treatment head module housing  300  includes a frame  310  and adjustment rails  312 . In some embodiments, the treatment head module housing  300  also includes an alignment feature  314 . In the depicted embodiment, the frame  310  has a generally arcuate shape from top-to-bottom. In some embodiments, the frame  310  has a generally arcuate shape from side-to-side. In yet another embodiment, the frame  310  has a generally arcuate shape from top-to-bottom and from side-to-side. 
         [0179]      FIG. 22  is a back perspective view of a treatment head module housing in a seventh embodiment. The treatment head module housing  220  includes a frame  222  and may include one or more yokes  226  attached to the frame  222 . The frame  222  includes one or more rails  224 . A transducer holder  228  may be connected to each yoke  226 . In the depicted embodiment, the transducer holder  228  is pivotable relative to the yoke  226 . The transducer holder  228  may be angularly adjusted and temporarily locked into place. 
         [0180]      FIG. 23  is a back perspective view of a treatment head module housing in an eighth embodiment. In the depicted embodiment, the yoke  226  further includes a gel retaining cup  230 , a transducer (not shown), and a wire or cable  232  extending from the transducer. 
         [0181]      FIG. 24  is a detailed perspective view of a yoke in a second embodiment. The yoke  226  includes the transducer holder  228 . In the depicted embodiment, a transducer  234  is placed within the transducer holder  228  and a wire or cable  232  extends from the transducer  234 . The yoke  226  and the transducer holder  228  have holes  236 . A fastener (not shown), such as a removable pin, may be placed in the aligned holes  236  to retain a selected angle adjustment. 
         [0182]      FIG. 25  is a back perspective view of a treatment head module housing in a ninth embodiment. The treatment head module housing  240  includes a frame  242  and one or more yokes  246 . The frame  242  includes one or more rails  244 . A transducer holder  248  may be connected to the yoke  246 . In the depicted embodiment, a plunger  250  connects the transducer holder  248  to the yoke  246  and movement of the plunger  250  changes the anterior/posterior position of the transducer holder  248 . A gel retaining cup  252  may be associated with the transducer holder  248 . The plunger  250  may be spring biased to make it more likely that the gel retaining cup  252  contacts the patient&#39;s skin. 
         [0183]      FIG. 26  is a detailed perspective view of a yoke in a third embodiment. In the depicted embodiment, the yoke  246  includes the transducer holder  248 , the plunger  250 , and the gel retaining cup  252 . 
         [0184]      FIG. 27  is a back perspective view of a treatment head module housing in a tenth embodiment. The treatment head module housing  260  includes a frame  262  and one or more yokes  266 . The frame  262  includes one or more rails  264 . In the depicted embodiment, the yoke  266  is recessed or has an offset portion for longer travel depth adjustment. A transducer holder  268  may be connected to the yoke  266 . In the depicted embodiment, a plunger  270  connects the transducer holder  268  to the yoke  266  and movement of the plunger  270  changes the anterior/posterior position of the transducer holder  268 . A gel retaining cup  272  may be associated with the transducer holder  268 . The plunger  270  may be spring biased to make it more likely that the gel retaining cup  272  contacts the patient&#39;s skin. 
         [0185]      FIG. 28  is a detailed perspective view of a yoke in a fourth embodiment. The yoke  316  has a captured gear  322 . The yoke  316  includes a track  324 , and the captured gear  322  is located in the track  324 . A plunger  320  may be attached to the yoke  316 . The plunger  320  may include holes  326 . The holes  326  may be used with a transducer holder and/or a transducer cup (not shown) to achieve a selected angular adjustment of the transducer. In the depicted embodiment, the yoke  316  is recessed or has an offset portion for longer travel depth adjustment. The captured gear  322  may be rotated to move the yoke in a medial/lateral direction. 
         [0186]      FIG. 29  is a back perspective view of a treatment head module housing in an eleventh embodiment. The treatment head module housing  280  includes a frame  282  and one or more yokes  286 . The frame  282  includes one or more rails  284 . In the depicted embodiment, the yoke  286  is recessed or has an offset portion for longer travel depth adjustment and also has a thicker portion to provide stability for the yoke. A transducer holder  288  may be connected to the yoke  286 . In the depicted embodiment, a plunger  290  connects the transducer holder  288  to the yoke  286  and movement of the plunger  290  changes the anterior/posterior position of the transducer holder  288 . A gel retaining cup  292  may be associated with the transducer holder  288 . The plunger  290  may be spring biased to make it more likely that the gel retaining cup  292  contacts the patient&#39;s skin. 
         [0187]      FIG. 30  is a detailed perspective view of a yoke in a fifth embodiment. The yoke  318  includes one or more windows  332  to reduce weight. Although windows  332  are illustrated as circular, other geometric shapes may be used. A plunger  330  may be attached to the yoke  318 . 
         [0188]      FIG. 31  is a back perspective view of a treatment head module housing in a twelfth embodiment. The treatment head module housing  380  includes a frame  382 . The frame  382  may include a wing-shaped belt attachment structure  384 . The wing-shaped belt attachment structure  384  may extend the whole length from top-to-bottom or cover only a portion thereof. 
         [0189]      FIG. 32  is a back perspective view of a treatment head module housing in a thirteenth embodiment. The treatment head module housing  390  includes a frame  392 . The frame  392  may include a cutout  394  proximate to or adjacent to a belt attachment structure  396  for the reduction of weight. The cutout  394  may extend the whole length from top-to-bottom or cover only a portion thereof. 
         [0190]      FIG. 33  is a back perspective view of a treatment head module housing in a fourteenth embodiment. The treatment head module housing  400  includes a frame  410  and a rail  412 . In the depicted embodiment, the rail  412  is offset from a generally planar face of the frame  410  but the rail  412  could equally be substantially co-planar. The rail  412  may include one or more openings  414 . A wrench  416  is removably attached to the rail  412 . In some embodiments, a clip  418  is used to hold the wrench in place relative to the rail  412 . The clip  418  snaps into the openings  414 . The wrench  416  may be adjusted proximally or distally and held at the selected location via the clip  418 . The wrench  416  may have one or more transducer holders  420 . The wrench may be shaped to angle the transducer holder relative to the frame  410  or relative to one another. In the depicted embodiment, the wrench  416  includes two transducer holders  420  which are separated a fixed equal distance from the rail  412 . However, those of ordinary skill in the art would understand that the transducer holders  420  may be separated a fixed unequal distance from the rail  412 . 
         [0191]      FIGS. 34-36  illustrate a treatment head module housing in a fifteenth embodiment. The treatment head module housing  500  includes a frame  510  and rails  512 . In some embodiments, the frame  510  includes an alignment feature  511 . The rail  512  may include one or more openings  514 . A wrench  516  is removably attached to the rails  512 . The wrench  516  may be adjusted proximally or distally and held at the selected location via the openings  514 . The wrench  516  may have one or more transducer holders  520 . The wrench may be shaped to angle the transducer holder relative to the frame  510 . In the depicted embodiment, the wrench  516  includes two transducer holders  520  which are equally spaced relative to the rails  512 . However, those of ordinary skill in the art would understand that the transducer holders  520  may be unequally spaced from the rails  512 . In some embodiments, the wrench includes one or more alignment features  518 . The alignment feature  518  may be aligned with anatomy or scar tissue.  FIG. 35  is a back perspective view of a frame of the embodiment shown in  FIG. 34 . In the embodiment depicted in  FIG. 36 , the wrench  516  includes a pin  522  for connection to the opening  514 . The pin  522  may be removably attached or an integral component. 
         [0192]      FIGS. 37-38  illustrate a transducer holder in a seventh embodiment. The transducer holder is in the form of a wrench  530 . The wrench  530  includes one or more transducer cups  532 , each of which are adapted to hold a transducer  534 . The wrench may include one or more slots  536 . In some embodiments, the wrench  530  includes an alignment feature  538 . 
         [0193]      FIG. 39  is a perspective front view of a transducer holder in an eighth embodiment. The transducer holder is in the form of a wrench  650 . The wrench  650  has a first portion  652  and a second portion  654 . Each portion  652 ,  654  has a transducer cup  622 . The first portion  652  has a channel  656  that receives a tab  658  of the second portion  654 . Each portion  652 ,  654  may include one or more holes to connect the wrench  650  to a frame (not shown). 
         [0194]      FIG. 40  is a back perspective view of a treatment head module housing in a sixteenth embodiment. The treatment head module housing  450  includes a frame  452  and a rail  454 . In the depicted embodiment, the rail  454  is substantially planar with a generally planar face of the frame  452  but the rail  454  could equally be offset. A wrench  458  is removably attached to the rail  454 . The rail  454  may include one or more slots  455  and markings  456 . As examples, the markings  456  may be detents or protrusions to aid in measuring position of the wrench  458 . The wrench  458  may include tabs (not shown) that extend into the slots  455 . The wrench  458  may be adjusted proximally or distally and held at the selected location via friction between the tabs and the rail  454 . The wrench  458  may have one or more transducer holders  464 . The wrench  458  may be shaped to angle the transducer holder relative to the frame  452 . In the depicted embodiment, the wrench  458  includes two transducer holders  464  which are separated a fixed equal distance from the rail  454 . However, those of ordinary skill in the art would understand that the transducer holders  464  may be separated a fixed unequal distance from the rail  454 . In some embodiments, the wrench  458  includes a screw mechanism or a worm mechanism  462  to adjust the transducer holders  464  toward or away from the rail  454 . The screw mechanism  462  is similar in operation as to that of a screw and band-type hose clamp. In some embodiments, the wrench  458  or the transducer holder  464  may include a locking mechanism  466  such that the transducer holder  464  is held at a fixed angle after adjustment. 
         [0195]      FIG. 41  is a back perspective view of a treatment head module housing in a seventeenth embodiment. The treatment head module housing  600  includes a frame  610  and a rail  612 . In the depicted embodiment, the rail  612  is generally co-planar with a generally planar face of the frame  610  but the rail  612  could equally be offset. The rail  612  may include one or more openings  613  with horizontal slots  615 . A rack-and-pinion  614  is removably attached to the rail  612 . The rack-and-pinion  614  may include a first rack  616 , a second rack  618 , and a knob assembly  624 . Each rack  616 ,  618  may include teeth  620 . The knob assembly  624  includes an outer dial  626  and an inner dial  628 . The outer dial  626  includes teeth (not shown) to engage the teeth  620 . The outer dial  626  may be rotated to move racks  616 ,  618  toward or away from the rail  612 . The inner dial  628  may include a fastener portion (not shown) adapted to engage a friction plate (not shown). The friction plate may engage the horizontal slots  615 . The rack-and-pinion  614  may be adjusted proximally or distally and held at the selected location via the inner dial  628  and the friction plate. The rack-and-pinion  614  may have one or more transducer holders  622 . The rack-and-pinion  614  may be shaped to angle the transducer holder relative to the frame  610 . In the depicted embodiment, the rack-and-pinion  614  includes two transducer holders  622  which are separated a fixed equal distance from the rail  612 . However, those of ordinary skill in the art would understand that the transducer holders  622  may be separated a fixed unequal distance from the rail  612 . 
         [0196]      FIG. 42  is a back perspective view of a treatment head module housing in an eighteenth embodiment. 
         [0197]      FIG. 43  is a back perspective view of a treatment head module housing in a nineteenth embodiment. The treatment head module housing  700  includes a frame  710 , an opening  712 , a first rail  714 , a second rail  716 , and a third rail  718 . Transducer holders  720  are slidably attached to the third rail  718 . In some embodiments, the rails  714 ,  716 ,  718  may include tick marks  722 . The transducer holder  720  or the third rail  718  may include a locking mechanism  726 . The third rail  718  may be adjusted in a proximal/distal direction and locked in place. Further, the transducer holders  720  may be adjusted in a medial/lateral direction. 
         [0198]      FIGS. 44-45  illustrate a transducer holder in a ninth embodiment. The transducer holder  720  may include a shaft  724 , and the shaft  724  may be threaded. In some embodiments, the transducer holder  720  includes a transducer mount  728 . The transducer mount  728  may be pivotally attached through the use of a hinge  730 . A transducer  732  may be connected to the transducer mount  728 . Alternatively, the transducer  732  may be directly mounted on the transducer holder  720 . In the embodiment depicted in  FIG. 45 , the shaft  724  is rotated to push against the transducer mount  728 , the transducer mount  728  pivots to adjust the angle of the transducer  732 . 
         [0199]      FIG. 46  is a back perspective view of a treatment head module housing in a twentieth embodiment. The treatment head module housing  150  includes a frame  152  and an opening  154 . The frame  152  may include a first rail  158  and a second rail  160 . The treatment head module housing  150  may include one or more yokes  162 . Each yoke  162  may include gear teeth  163 . The treatment head module housing  150  may include one or more alignment features  156 . The alignment features  156  may be aligned with a patient&#39;s incision or scar  190 . Each rail  158 ,  160  may include one or more slots  157 . Each slot  157  may include one or more medial/lateral grooves, channels, or slots  159 . A knob assembly  164  may connect each yoke  162  to each rail portion  158 ,  160 . Each knob  164  may include an outer dial  166  and an inner dial  168 . A swivable transducer holder  170  may be mounted to each yoke  162 . The outer dial  166  includes teeth (not shown) to engage the teeth  163 . The outer dial  166  may be rotated to move yokes  162  toward or away from the rails  158 ,  160 . The inner dial  168  may include a fastener portion (not shown) adapted to engage a friction plate (not shown). The friction plate may engage the horizontal slots  159 . The yoke  162  may be adjusted proximally or distally and held at the selected location via the inner dial  168  and the friction plate. 
         [0200]      FIG. 47  is a detailed perspective view a transducer holder in a tenth embodiment. The transducer holder  342  is connected to a swivel yoke  340  through the use of a pin  344 . The swivel yoke has multiple pin hole locations such that an angle of the transducer holder  342  may be selected and locked in place via the pin  344 . 
         [0201]      FIGS. 48-50  illustrate a treatment head module housing in a twenty-first embodiment. The treatment head module housing  800  includes a frame  810 . A belt  812  may be attached to the frame  810 . The frame  810  may include an opening  814 . The frame  810  may include one or more rails  815 . A transducer holder  816  may be connected to each rail  815 . The transducer holder  816  may include a cup  830 . The cup  830  is adapted to receive a transducer  832 . As best seen in  FIG. 49 , a clip  818  may be used to connect the transducer holder  816  to the rail  815 . The rail  815  may include one or more holes  820  and channel  821 . The holes  820  may be marked with markings  822 . The transducer holder  816  may include a tab  826  with holes  828 . The tab  826  may be inserted into the channel  821  and the holes  820 ,  828  aligned such that the clip  818  may be inserted there through. As best seen in  FIG. 50 , the cup  830  may be angled relative to the tab  826 . In this manner, a transducer holder  816  may be selected for the desired angle of the transducer  832  relative to the frame  810 . 
         [0202]      FIG. 51  is a sectional view of a yoke in a sixth embodiment. The yoke  350  includes a cup  358 . Gel or gel pack  352  and transducer  354  are connected to or rest upon the yoke  350 . For example, the transducer  354  may sit within or be attached to the cup  358 . In the embodiment depicted in  FIG. 51 , the cup  358  has a ramp portion  351 . A sliding bar  356  engages the ramp portion  351  to affect the angle of the transducer  354 . In other words, the sliding bar  356  may be moved in a medial/lateral direction to adjust the angle of the transducer  354 . 
         [0203]      FIG. 52  is a sectional view of a yoke in a seventh embodiment. The yoke  350  includes a cup  358 . Gel or gel pack  352  and transducer  354  are connected to or rest upon the yoke  350 . For example, the transducer  354  may sit within or be attached to the cup  358 . In the embodiment depicted in  FIG. 52 , the yoke  350  includes a hinged shroud  370 . 
         [0204]      FIG. 53  is a sectional view of a yoke in an eighth embodiment. The yoke  350  includes a cup  358 . Gel or gel pack  352  and transducer  354  are connected to or rest upon the yoke  350 . For example, the transducer  354  may sit within or be attached to the cup  358 . In the embodiment depicted in  FIG. 53 , the cup  358  forms a rotatable knob having a handle  360  and external threads. The yoke  350  includes threads  362 , and the cup  358  is rotated in or out to vary the transducer  354  position. 
         [0205]      FIG. 54  is a sectional view of a yoke in a ninth embodiment. The yoke  350  includes a cup  372 . A transducer  354  and gel or a gel pack  352  are arranged in the cup  372 . The cup  372  may be flexible and may be adapted to contain the gel  352 . 
         [0206]      FIG. 55  is a sectional view of a yoke in a tenth embodiment. The yoke  350  includes a cup  358 . Gel or gel pack  352  and transducer  354  are connected to or rest upon the yoke  350 . For example, the transducer  354  may sit within or be attached to the cup  358 . In the embodiment depicted in  FIG. 55 , the cup  358  is mounted on springs  364 . A shroud  366  may used to contain the springs. 
         [0207]      FIG. 56  is a sectional view of a yoke in an eleventh embodiment. The yoke  350  includes a stepped cup  374 . A transducer  354  and gel or a gel pack  352  are arranged in the stepped cup  374 . The stepped cup  372  may be flexible and may be adapted to contain the gel  352 . 
         [0208]      FIG. 57  is a sectional view of a yoke in a twelfth embodiment. The yoke  350  includes a cup  358 . Gel or gel pack  352  and transducer  354  are connected to or rest upon the yoke  350 . For example, the transducer  354  may sit within or be attached to the cup  358 . In the embodiment depicted in  FIG. 57 , a shroud  366  is mounted on springs  364 . 
         [0209]      FIG. 58  is a sectional view of a yoke in a thirteenth embodiment. The yoke  350  includes a cup  358 . Gel or gel pack  352  and transducer  354  are connected to or rest upon the yoke  350 . For example, the transducer  354  may sit within or be attached to the cup  358 . In the embodiment depicted in  FIG. 58 , flexible bristles  376  are attached to the cup  358 . 
         [0210]      FIG. 59  is a sectional view of a yoke in a fourteenth embodiment. The yoke  350  includes a cup  358 . Gel or gel pack  352  and transducer  354  are connected to or rest upon the yoke  350 . For example, the transducer  354  may sit within or be attached to the cup  358 . In the embodiment depicted in  FIG. 59 , a shroud  368  surrounds the cup  358  and the gel  352 . 
         [0211]      FIGS. 60-62  illustrate a treatment head module housing in a twenty-second embodiment. The treatment head module housing  470  includes a frame  472  and rails  474 . A transducer holder  476  may be connected to the frame  472 . In the depicted embodiment, the frame  472  is adapted to move in a proximal/distal direction and the transducer holder  476  is adapted to move in a medial/lateral direction. The treatment head module  470  may include one or more locking mechanism to hold the frame or transducer holder in place after adjustment. The transducer holder may include a hinge  478  to allow for angular adjustment of a transducer  480 . The transducer holder  476  may include an adjustment screw  479  to adjust the angle of the transducer  480 . The transducer holder  476  may include markings to indicate the angle of adjustment. 
         [0212]      FIGS. 63-65  illustrate a treatment head module housing in a twenty-third embodiment. The treatment head module housing  490  includes a frame  492  and rails  494 . A transducer holder  496  may be connected to the frame  492 . In the depicted embodiment, the frame  492  is adapted to move in a proximal/distal direction and the transducer holder  496  is adapted to move in a medial/lateral direction. The treatment head module  490  may include one or more locking mechanism to hold the frame or transducer holder in place after adjustment. In some embodiments, a rod  498  may be attached to each rail  494  to provide structure for attaching a belt. 
         [0213]      FIG. 66  is a detailed perspective view of a treatment head module housing in a twenty-fourth embodiment. The treatment head module housing  660  includes a first sliding member  662  and a second sliding member  664 . Each sliding member  662 ,  664  includes a transducer holder  666  and a stepped edge  667 . Each sliding member  662 ,  664  may include a belt attachment  668  for attaching a belt. The treatment head module housing  660  may be placed across a patient&#39;s back and adjusted in width by sliding the sliding members  662 ,  664  relative to one another. The treatment head module housing  660  may include markings to indicate a distance between transducer holders  666 . 
         [0214]      FIG. 67  is a detailed perspective view a transducer holder in an eleventh embodiment. The transducer holder  670  has an angular adjustment and a rotational adjustment. After adjustment, it can be locked in place. This is similar to the embodiment shown in  FIG. 10 . 
         [0215]      FIGS. 68-69  illustrate a transducer holder in a twelfth embodiment. The transducer holder  680  includes a cam  682  and a slider  683 . The slider  683  moves along the cam  682  to move the transducer in or out. In the embodiment depicted in  FIG. 69 , the transducer holder  690  includes a cam  692  and a slider  693 . The slider  693  moves along the cam  692  to move the transducer in or out. 
         [0216]      FIGS. 70-71  illustrate a transducer holder in a thirteenth embodiment. The transducer holder  180  includes a lid  182 , a body  184 , a handle  186 , and a spring loaded cup  188 . The cup  188  is biased against the spring and held in place through the use of the handle  186 . The handle  186  may be moved to release the cup  188 . 
         [0217]      FIG. 72  is a detailed perspective view of a yoke in a sixteenth embodiment. The yoke  694  includes a first sliding member  696  and a second sliding member  698 . Each sliding member  696 ,  698  includes a transducer holder  699 . The yoke  694  may be placed across a patient&#39;s back and adjusted in width by sliding the sliding members  696 ,  698  relative to one another. The yoke  694  may include markings to indicate a distance between transducer holders  699 . 
         [0218]      FIG. 73  is a first belt configuration. In the depicted embodiment, there is an assembly  900  having a frame  910  and a belt  912 , and the belt  912  is substantially centered with respect to the frame  910 . 
         [0219]      FIG. 74  is a second belt configuration. In the depicted embodiment, there is an assembly  920  having a frame  922  and a belt  924 , and the belt  924  is attached to a lower portion of the frame  922  in proximal/distal direction but does not extend below the frame  922 . In some embodiments, the frame  924  is extended proximally or distally to accommodate a wider range of patients. In the depicted embodiment, an upper portion of the frame  924  is extended in a proximal direction by about 63.5 millimeters. 
         [0220]      FIG. 75  is third belt configuration. In the depicted embodiment, there is an assembly  930  having a frame  932  and a belt  934 . The frame  932  has three or more slots  936  on each side. The belt  934  attaches to the upper two slots  936  for low fractures. Alternatively, the belt  934  attaches to the lower two slots  936  for high fractures, as is shown in  FIG. 76 . In the depicted embodiment, the belt  934  is asymmetric. In some embodiments, the belt  934  may be worn upside down or downside up to reach a lower part or an upper part of the lumbar spine. 
         [0221]      FIG. 77  is a fifth belt configuration. In the depicted embodiment, there is an assembly  950  having a frame  952  and a belt  954 , and the belt  954  is attached to a lower portion of the frame  952  in proximal/distal direction but does not extend below the frame  952 . The belt  954  may be worn right-side up for low fractures or upside-down for high fractures. 
         [0222]    In some embodiments, suspenders (not shown) are attached to the belt  912 ,  924 ,  934 ,  954  to secure the frame  910 ,  922 ,  932 ,  952  at the appropriate height in relation to a fracture site. Further, in some embodiments, the frame  910 ,  922 ,  932 ,  952  is telescoping in a proximal/distal direction and may temporarily lock in place once the frame height is adjusted. Finally, the frame  910 ,  922 ,  932 ,  952  may be modular such that the height is adjusted during manufacturing based upon a selection of components. 
         [0223]      FIG. 78  illustrates transducer signals of the prior art. In the depicted embodiment, an independent controller with two transducers results in one controller signal overlaying with the other controller signal. Referring to U.S. Pat. No. 5,762,616, which is incorporated by reference herein, the disclosed apparatus envisions a plurality of ultrasonic transducers that may all be activated at once for musculoskeletal injuries on the torso. In the prior art devices, there is a possibility that using independent controllers will cause the treatment signals to become asynchronous resulting in the possibility of treatment signal overlay, causing either destructive or constructive inference which has unknown effects. 
         [0224]      FIG. 79  illustrates transducer signals of one particular embodiment. In the depicted embodiment, a single controller with two transducers synchronizes two or more signals without overlay. 
         [0225]      FIG. 80  illustrates a system for applying transducer signals to a spine  1090  without overlay. The system  1000  includes a frame  1010 , a controller  1014 , and at least two transducers  1016 ,  1018 . The system  1000  may also include a belt  1012  to secure the frame  1010  to the patient. The use of a single controller  1014  ensures that the signals delivered stays synchronous. Further, a single controller  1014  with two or more transducers has a treatment time significantly less than a controller with one transducer. 
         [0226]      FIG. 81  is a block diagram of the controller  1014 . In the depicted embodiment, the controller  1014  includes a battery  1020 , a first converter  1022 , a second converter  1024 , a first voltage adjust circuitry  1026 , a microcontroller  1028 , a second voltage adjust circuitry  1030 , a first transducer drive circuitry  1032 , a first gel sense circuit  1034 , a second gel sense circuit  1036 , and a second transducer drive circuitry  1038 . 
         [0227]    The components described herein may be made from a metal, polymer, or composite. The components may be made from a medical grade plastic. The components may be hypoallergenic. A cushioning material may be applied to some areas of the treatment head module housing to make it more comfortable for the user. 
         [0228]    The apparatus described above may be used in conjunction with a method of treatment. The method of treatment may be used to significantly reduce the time to obtain partial or complete bone fusion. In the method, spinal fusion is performed on the patient by a health care provider. After a period of time, such as 1-4 weeks, the patient returns to the health care provider for fitting of a treatment head module housing to the patient. The health care provider may use x-ray images, palpitation, and/or measuring devices to locate the area of the spinal fusion and placement of the treatment head module housing. In some embodiments of the method, the treatment head module housing is placed with respect to the iliac crest such that it may be applied in a repeatable manner. After placement of the treatment head module housing, the position of the transducers may be adjusted relative to the housing and relative to the spine fusion area. In some embodiments, radiographic markers may be used to place the treatment head module housing and/or the transducers. Thereafter, the spine fusion area is treated with ultrasound on a regular basis for a period of time. For example, the spine fusion area may be treated daily with ultrasound for a period of 10-30 minutes. One particular example, the spine fusion area is treated for a period of 20 minutes per day. 
         [0229]      FIG. 82  illustrates a flowchart for a method of ultrasound application. The method starts in step  1200 . In optional step  1210 , spinal fusion is performed on a patient. In step  1212 , there is provided an ultrasound treatment device, which may include the treatment head module housing. In step  1214 , the ultrasound treatment device is applied to the patient. This step may include fitting the treatment head module housing to the patient and/or locating the treatment head module housing with respect to the iliac crest. The controller is engaged or powered up in step  1216 . The controller may include a microprocessor. In step  1218 , the microprocessor calls a first subroutine. In step  1220 , the microprocessor turns on a first microprocessor port which engages a signal for a first transducer drive circuitry. In step  1222 , there is a decision whether the microprocessor port has been engaged for a sufficient period of time. As an example, sufficient time may be as little as about 200 microseconds or about 300 cycles. If so, in step  1224  the microprocessor calls a second subroutine. Otherwise, the microprocessor continues to send a signal to the first transducer driver circuitry. In step  1226 , the microprocessor turns on a second microprocessor port which engages a signal for a second transducer drive circuitry. In step  1228 , there is a decision whether the microprocessor port has been engaged for a sufficient period of time. As an example, sufficient time may be as little as about 200 microseconds or about 300 cycles. If so, in step  1230  the microprocessor proceeds to monitor status of various functions, which may include such things as gel status, battery status, etc. Otherwise, the microprocessor continues to send a signal to the second transducer driver circuitry. In some embodiments, the process loops back to step  1218 . Various steps in the method may be looped or repeated to obtain an acceptable period of application. The process ends in step  1232 . As an example, the process may automatically end after a period of time, such as twenty minutes. 
         [0230]      FIG. 83  is an instrument for selecting transducer placement. A spine goniometer  1100  may be used in conjunction with a CT-image or MRI scan to set an angle for each transducer. The spine goniometer  1100  has two pivotable arms  1110 ,  1112 , a stationary arm  1114 , and a slideable arm  1116 . The spine goniometer  1100  is placed over the image and adjusted to match the bony anatomy and the fixation components. Thereafter, the angle is read and used to select the angle of the transducers. 
         [0231]    As various modifications could be made to the exemplary embodiments, as described above with reference to the corresponding illustrations, without departing from the scope of the invention, it is intended that all matter contained in the foregoing description and shown in the accompanying drawings shall be interpreted as illustrative rather than limiting. Features of the various embodiments may be combined in any desirable manner. Thus, the breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims appended hereto and their equivalents.