Patent Abstract:
Embodiments of the present invention provide a system and method for delivering a plurality of modalities for the treatment of Carpal Tunnel Syndrome. Light therapy is applied to the carpal tunnel region of the hand during alternating periods of automated carpal bone structure extensions, whereby said light therapy penetrates beyond the bone structures to the carpal (volar and transverse) ligament structures, median nerve, and muscles. The light therapy is applied both above and below these structures. Simultaneously applied electrical stimulation may occurs between electrodes located both above and below various positions about the carpal tunnel region. Both light therapy and electrical stimulation are positioned optimally to affect the carpal tunnel via automated structures that provide continuous feedback to a control system. The automated structures also stimulate the flow of blood and movement of fluids associated with pressure inducing edema through the carpal tunnel region.

Full Description:
RELATED APPLICATION  
       [0001]     This application claims the benefit of U.S. Provisional Application No. 60/812,661, filed Jun. 9, 2006, which is incorporated herein by reference in its entirety. 
     
    
     BACKGROUND OF THE INVENTION  
       [0002]     Embodiments of the present invention generally relate to the treatment of carpal tunnel syndrome, and more particularly to a system and method for simultaneously applying a plurality of therapeutic modalities to treat carpal tunnel syndrome.  
         [0003]     Carpal Tunnel Syndrome affects a wide demographic of the population. Occupational hazards such as typing in offices, performing mechanical operations repetitively, and carrying of heavy loads create repetitive stress injuries in the joint structures of the wrist and hand. These stresses irritate and inflame the carpal ligaments (both volar and transverse), as well as tendons and tissues between the ulna and radius bones of the forearm and the metacarpals. This inflammation leads to edema and swelling, which puts pressure on neural pathways (median nerve and to a lesser extent the ulnar nerve), as well as blood flow structures (radial artery and to a lesser extent the ulnar artery). The condition is painful, causes inflamed regions and pockets of fluid that decrease mobility, and diminishes nerve signal conduction resulting in a loss of control of the hand and finger structures. Carpal Tunnel Syndrome is progressive. As irritation, edema, and inflammation increase, numbness, pain, tingling sensations in the hand and digits and general swelling increase. The condition can progress such that neural scarring occurs, further decreasing nerve conduction.  
         [0004]     Once the condition has produced sufficient neural scarring, invasive procedures are utilized to treat the patient. These procedures include releasing (severing) the transverse and possibly volar carpal ligaments, and additionally in some cases scraping away scar tissue.  
         [0005]     Patients who seek intervention prior to the need for invasive procedures may receive manually applied physical therapy. These therapies are designed to non-invasively increase the mobility of the nerve structures of the carpal tunnel region. They are also designed to move fluids through the region, decreasing edema and pressure. Light therapy, including light sources such as lamps, light emitting diodes (LEDs), and “cold” lasers, may be applied to specific points for definite periods of time in an effort to increase local healing functions and reduce inflammation. In some cases, a carpal strap is applied about the carpal tunnel region between the metacarpals and the ulna and radius bones of the forearm. This strap is tightened such that pressures applied perpendicular to the flat of the hand press the carpal bones (including the harnate, capitate, trapeziod, trapezium, scaphoid, and lunate). This action deepens the carpal tunnel in an effort to increase the carpal tunnel space and relieve pressure on the median nerve. This action also decreases the stress on the transverse and volar ligaments. Patients are typically instructed to wear a wrist splint, which immobilizes the wrist, reducing further irritation through movement of the structures during periods throughout the day. A patient&#39;s daily activities may be assessed for causes of the irritation. More ergonomic methods may be suggested for activities which incite and irritate the carpal tunnel region. Finally, TENS units may be applied and additionally issued to patients for the reduction of pain and ability to increase cellular functions related to healing.  
         [0006]     Exercises, both those with and without the assistance of a healthcare provider, are dependent upon technique and may vary from application to application. As well, exercises assisted by a healthcare provider require one-on-one time which is increasingly difficult to schedule as the number of patients exhibiting symptoms of carpal tunnel Syndrome increases.  
         [0007]     Light therapy via cold laser therapy requires knowledgeable application by a healthcare professional and is point dependent—again placement of the laser can vary from application to application. Cold laser therapy covers only a small region of the carpal tunnel, resulting in the need for repeated applications. Additionally the wavelength of the laser is finite by the nature of the technology—it has been demonstrated that wavelengths between 790 nm and 870 nm are preferable for the treatment of inflammation and increased cellular function. Cold laser instruments are also expensive and require safety goggles to protect patient and healthcare provider vision. Light Therapy from lamps and LEDs can be applied about the carpal region. Flexible light pads containing lamps and LEDs provide heat and general light. In both cold laser and non-laser illumination, the carpal bones absorb and reflect a significant amount of light. As the bones block the underside of the carpal tunnel, light is typically directed around and about these structures—these methods limit the exposure of affected structures to the benefits of light therapy. As before, the one-on-one time required between patient and physician is increasingly difficult to schedule, and often a compromise between manual manipulation for mobility and some form of light therapy is required.  
         [0008]     Carpal straps and wrist splints are affective for short periods of time and are dependent upon application. Often these devices are applied by unskilled patients, thereby limiting the effectiveness of the device.  
       SUMMARY OF THE INVENTION  
       [0009]     Certain embodiments of the present invention provide a combination of effective modalities (Light Therapy and Electrical Stimulation) simultaneously to achieve a higher degree of effectiveness relative to the time spent in the healthcare provider&#39;s facility. Further, a device that may apply these modalities in an automatic fashion, requiring limited setup by a healthcare provider, increases the number of patients who may be successfully treated. A device that automates these modalities may also manipulate the carpal tunnel region simultaneously to circulate fluids and open the carpal spaces. The automated manipulation can be designed such that the bone structures of the carpal tunnel are separated, allowing the application of light therapy to penetrate deeper beyond and around the bones that would otherwise block their delivery.  
         [0010]     Such a device would expedite the healing process of the patient and provide an opportunity for healthcare providers to treat more patients. The majority of a healthcare provider&#39;s time could be spent performing and instructing on stretches and exercises designed to increase mobility and move edema through the affected regions, counseling the patient on the use of passive immobilization devices outside of the healthcare provider&#39;s office, and assessing and counseling patients on more ergonomic methods of utilizing the hands and wrist.  
         [0011]     Certain embodiments of the present invention include a system for capturing and positioning the wrist and hand of a patient for the application of a plurality of therapeutic modalities. The system includes a conforming, ergonomic portion above and below the hand and wrist that positions the structures for optimal delivery of therapeutic modalities. The lower portion may remain stationary while the upper portion is automatically lowered upon the hand and wrist. Tension measuring device(s) detect pressures exerted upon the hand and wrist so as to optimize capture of the structures while limiting the possibility of cutting off circulation and placing excessive pressures on the carpal tunnel space. The hand may be placed into this structure flat, parallel to the ground.  
         [0012]     Certain embodiments of the present invention provide a system and method of placement of therapy devices containing both light therapy and electrical stimulation components. The placement of the therapy devices are optimized such that light therapy is fixedly directed to the entirety of the carpal tunnel region extending from the ends of the ulna and radius forearm bones to just above the beginning of the metacarpals. Electrical stimulation is fixedly placed such that bipolar interferential (two pad) electrical stimulation is applied above, about, and below the carpal tunnel region. Additionally, switching mechanisms allow for electrical pad designations that convert the pain blocking bipolar interferential therapies to change to a crosswise pattern that allows quadripolar interferential therapy. The electrodes are positioned such that the epicenter of the interference pattern is located central to the carpal tunnel. This switching mechanism allows for on-the-fly adjustments for optimal therapeutic benefit.  
         [0013]     Certain embodiments of the present invention include an automated rotation of the hand and wrist once placed and secured between the upper and lower portions of the capturing device previously described. The hand and wrist are rotated 90° outward, palm facing towards the body, perpendicular to the floor. This action places the muscles and tendons in a natural state more suited to stimulation and the application of decompressive tensile forces. The hand and wrist capturing devices and light therapy and electrical stimulation apparatus is further automated to apply decompressive tensile forces inline with the forearm, wrist and hand. These forces extend and decompress the carpal bones, allowing light therapy to penetrate from all sides of the wrist into the carpal tunnel. Decompressive tensile forces are applied logarithmically and are alternated between upper and lower tensile force plateaus. The alternation of the forces produces a pumping motion that stimulates movement of fluids through the carpal tunnel. Fluids influenced include blood supply, nourishing the wrist and hand, as well as those associated with edema, moving them through and away from the carpal tunnel.  
         [0014]     Embodiments of the invention described above are useful in the treatment of Carpal Tunnel Syndrome (CTS) as it may arise again after invasive procedures have occurred. The system is also capable of routine application as a preventative measure for those patients who have undergone invasive procedures.  
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0015]      FIG. 1  illustrates the wrist and hand bone structure.  
         [0016]      FIG. 2  illustrates the ligament, nerve, and artery structures of the wrist and hand associated with Carpal Tunnel Syndrome.  
         [0017]      FIG. 3  illustrates a lower portion of a therapy housing used to contain the wrist and hand according to one embodiment of the present invention.  
         [0018]      FIG. 4  illustrates a therapeutic system for automatically compressing a wrist and hand between the upper portion and the lower portion of the form structure according to one embodiment of the present invention.  
         [0019]      FIG. 5  illustrates a proximal therapeutic device that is used to supply light therapy and electrical stimulation simultaneously to the hand and wrist according to one embodiment of the present invention.  
         [0020]      FIG. 6  illustrates a distal therapeutic device that is used to supply light therapy and electrical stimulation simultaneously to the hand and wrist according to one embodiment of the present invention.  
         [0021]      FIG. 7  illustrates a system for aligning the light and electrical stimulation of a proximal and distal therapeutic device within the lower portion of a therapy housing according to one embodiment of the present invention.  
         [0022]      FIG. 8  illustrates a wrist and hand positioned in the lower portion of a therapy housing according to one embodiment of the present invention.  
         [0023]      FIG. 9  illustrates a wrist and hand compressed between the upper and lower portions of a therapy housing according to one embodiment of the present invention.  
         [0024]      FIG. 10  illustrates a rotated and compressed wrist and hand and a secured upper arm during use of a therapeutic system in accordance with one embodiment of the present invention.  
         [0025]      FIG. 11  is a top plan view of a wrist and hand positioned between the proximal and distal therapeutic devices as they may be positioned within the therapy housing (not shown) according to one embodiment of the present invention.  
         [0026]      FIG. 12  is a top plan view of a wrist and hand undergoing Quadripolar Interferential stimulation while positioned between proximal and distal therapeutic devices according to one embodiment of the present invention.  
         [0027]      FIG. 13  is a top plan view of an upper and lower proximal and distal therapeutic devices positioned about a patient&#39;s wrist and hand that is undergoing Medium Frequency or Bipolar Interferential stimulation of the carpal tunnel region according to one embodiment of the present invention. 
     
    
       [0028]     The foregoing summary, as well as the following detailed description of certain embodiments of the present invention, will be better understood when read in conjunction with the appended drawings. For the purpose of illustrating the invention, there is shown in the drawings, certain embodiments. It should be understood, however, that the present invention is not limited to the arrangements and instrumentalities shown in the attached drawings.  
       DETAILED DESCRIPTION OF THE INVENTION  
       [0029]      FIG. 1  illustrates the wrist and hand bone structure  100 . The distal heads of the ulna forearm bone  105  and radius forearm bone  110  are shown crossing into the carpal tunnel region  155  of treatment. Although the focus of the light therapy and electrical stimulation of the present invention may be the carpal tunnel region  155 , in some embodiments of the present invention the light therapy and electrical simulation may also cover areas distal and/or proximal to the carpal tunnel region  155 . Distal to the carpal tunnel region  155  are the metacarpal bones  115 . The proximal metacarpal bones  115  are shown included in the carpal tunnel region  155 . The various bones of the wrist are all contained within the carpal tunnel region  155 , and include the lunate  120 , triquetral  125 , capitate  130 , harnate  135 , scaphoid  140 , trapezoid  145 , and trapezium  150 . The wrist bones may form the bottom and partial sides of the carpal tunnel region  155  itself. The decompressive tensile forces of the present invention seek to extend the spaces between these bones such that light therapy from a plurality of sources and types, including, but not limited to, laser, LED, and lamp, may penetrate between and into the bottom of the carpal tunnel region  155 .  
         [0030]      FIG. 2  illustrates the ligament, nerve, and artery structures of the wrist and hand associated with Carpal Tunnel Syndrome (CTS). The two major carpal tunnel ligaments  270  associated with CTS are the volar carpal ligament  210  and the transverse carpal ligament  220 . The volar carpal ligament  210  and the transverse carpal ligament  220  may be relieved by the compressive forces of a carpal strap by exerting pressures on either side of the carpal tunnel region. Where a patient&#39;s condition indicates the need, the volar and transverse carpal ligaments  210 ,  220  may be cut or “released” via invasive surgeries.  
         [0031]     Extending through and about the carpal tunnel region  155  are the nerves, such as the median nerve  230  and the ulnar nerve  250 , along with arteries, such as the radial artery  240  and the ulnar artery  260 , that may be associated with CTS. The median nerve  230  may run directly through the center of the carpal tunnel region and may be affected by irritation and edema associated with CTS. With the infliction of CTS, the median nerve  230  conduction velocity may be gradually diminished, which eventually may lead to neural scarring that may require invasive scraping and removal. The radial artery  240  also may run through and about the carpal tunnel region. Through irritation and edema within the carpal tunnel region, the radial artery  240  may become compressed, thereby becoming less able to deliver blood to the structures of the wrist and hand.  
         [0032]     Secondary structures affected by CTS may include the ulnar nerve  250  and ulnar artery  260 . Both the ulnar nerve  250  and ulnar artery  260  run through and about the carpal tunnel region. As discussed below, embodiments of the present invention may be configured to relieve irritation and edema related pressure on the median nerve  230 , radial artery  240 , ulnar nerve  250  and ulnar artery  260  by directing light therapy, electrical stimulation, and decompressive tensile force simultaneously at and about the carpal tunnel region.  
         [0033]      FIG. 3  illustrates a lower portion  300  of a therapy housing used to contain the wrist and hand according to one embodiment of the present invention. The therapy housing may include both a lower portion  300 , as shown in  FIG. 3 , and an upper portion (not shown). The upper portion may or may not have a configuration similar or at least generally identical to that of the lower portion  300 . Further, the lower portion  300  and the upper portion may be configured so that, when properly oriented and used in conjunction with each other, at least a portion of a patient&#39;s hand and/or wrist is enclosed by the therapy housing. Additionally, the therapy housing may be configured so as to accommodate a variety of different wrist and hand morphologies. When the upper portion and lower portion  300  of the therapy housing are in position for the therapeutic treatment of CTS, the therapy housing may also allow decompressive tensile forces to be comfortably applied to the hand and/or wrist.  
         [0034]     In one embodiment of the present invention, the lower portion  300  of the therapy housing may be constructed with conforming foam that is built upon a rigid platform. The conforming foam may assist in attempting to evenly and comfortably distribute pressures that may be exerted on the hand and wrist when the hand and wrist are at least partially enclosed by upper portion and lower portion  300  of the therapy housing. In use, a patient&#39;s wrist may be laid into a wrist channel  310  on the lower portion  300  of the therapy housing. Wrist supports  350  may be located at either side of the wrist channel  310  so as to assist in properly positioning the hand and wrist of a patient at the desired location. The wrist supports  350  may also be configured to allow for the repeated placement of different patients&#39; wrists in the same general location in the therapy housing. In one embodiment, the sizing and placement of the wrist supports  350  may also allow the lower portion  300  to “grab” the hand distal and at the heads of the ulna and radius forearm bones.  
         [0035]     In one embodiment of the present invention, the wrist supports  350  may be extruded foam blocks. By constructing the wrist channel  310  primarily of conforming foam, the wrist channel  310  may be able to expand to accommodate larger wrist structures, which may thereby assist in allowing the placement of wrist and hand of many different patients in the same general location within the therapy housing.  
         [0036]     In accordance with one embodiment of the current invention, the wrist supports  350  may extend several inches back from the heads of the ulna and radius forearm bones  105 ,  110 , which may accommodate and seat the wrist sufficiently for therapy.  
         [0037]     The lower portion  300  of the therapy housing may also include a carpal tunnel area  360 . The carpal tunnel area  360  may be designed to exert as little compressive force from the therapy housing as possible. Therefore, according to one embodiment of the present invention, the tunnel area may be a recessed surface that is configured so as to prevent any further irritation of the patient&#39;s CTS.  
         [0038]     The lower portion  300  of the therapy housing may also extend beyond the wrist supports  350  sufficiently far so as to seat the patient&#39;s hand. The patient&#39;s hand may lie on a hand support region  320  that may be a relatively flat area or an at least partially contoured area. The hand region  320  may include foam that may assist in at least partially distributing compressive forces exerted upon the hand by the upper portion and/or lower portion of the therapy housing as evenly and comfortably as possible.  
         [0039]      FIG. 4  illustrates a therapeutic system  400  for automatically compressing a wrist and hand between the upper portion  410  and the lower portion  300  of the therapy housing  900  according to one embodiment of the present invention. The therapeutic system  400  may include a controller  485  which receives commands from a computer that allows healthcare providers to set individual parameters for the treatment of different patients. The controller  485  may automate the lowering of the upper portion  410  of the therapy housing  900  upon the patient&#39;s hand. For example, the upper portion  410  may be lowered via a mechanical scissors apparatus  415  secured to the top of a fixed mechanical framework  405  and to the bottom of the upper portion  410  of the therapy housing  900 . The mechanical scissors apparatus  415  may be extended and contracted, exacting a lowering and raising of the upper portion  410 , by a rotational motor, for example a stepper motor  420 . Further, the stepper motor  420  may be operated by a controller  485 . In such an embodiment, the stepper motor  420  may include a threaded motor shaft screw that is rotated, thereby causing the centers of the mechanical scissors apparatus  415  to be forced outward, which results in the upper portion  410  of the therapy housing  900  to be extended downwards toward the lower portion  300  of the therapy housing  900 . The upper portion  410  of the therapy housing  900  may ride along rails  425 , which may smoothly deliver the upper portion  410  of the therapy housing  900  upward and downward, relative to the mechanical framework  405 .  
         [0040]     In accordance with the embodiment of the present invention illustrated in  FIG. 4 , in operation, a patient&#39;s wrist and hand may be seated on or against the lower portion  300  of the therapy housing  900  while the upper portion  410  may be at least partially retracted. Once the patient&#39;s wrist and hand are seated in the lower portion  300 , the upper portion  410  of the therapy housing  900  may be lowered onto at least a portion of the patient&#39;s hand and/or wrist by the rotation of the stepper motor  420  threaded shaft screw and resulting extension of the mechanical scissors apparatus  415 , as described above. A tension measuring device  435 , for example a load cell or load button, may be located underneath the lower portion  300  of the therapy housing  900 , and may provide compressive force feedback to the controller  485 . Based on feedback from the tension measuring device  435 , the controller  485  may continuously adjust the compression exerted on the wrist and hand by controlling the position of the upper portion  410  of the therapy housing  900  through the activation of the stepper motor  420 .  
         [0041]     In one embodiment of the present invention, once the wrist and hand are compressed between the upper and lower portions  410 ,  300  of the therapy housing  900 , the therapy housing  900  (and the hand inserted therein) may be rotated, for example by rotation assembly that may rotate the therapy housing approximately 90 degrees outward. Rotational adjustment of the location of hand and wrist may allow for the wrist and hand of the patient to be placed at an optimal position for treatment. Any number of mechanical devices and connections may be utilized by the rotation assembly to rotate the therapy housing. For example, the rotation assembly may be comprised of chains and sprockets, belts and pulleys, or the direct coupling of a motor to the therapy housing, among others. In the embodiment illustrated in  FIG. 4 , this rotational adjustment may be achieved by rigidly securing the mechanical framework  405  to a large gear  440 . The large gear  440  is rotationally fixed to one side of a roller bearing, which is rigidly fixed to an intermediate frame  445 . The large gear  440  may be rotated in either direction by a smaller gear  450 , which may be connected to the output shaft of a gearbox  455 . The large gear  440 , small gear  450 , and gearbox  455  may provide sufficient mechanical advantage such that a small rotation motor  460  may be capable of smoothly rotating and holding in place the mechanical framework  405  of the wrist and hand capturing therapy housing  900 . Suitable rotational motors  460  include, but are not limited to, a servo motor, which may receive commands from a servo amplifier located within the controller  485 .  
         [0042]     The large gear  440  may also be connected to a device that accurately records position, such as, but not limited to, a potentiometer, resolver, encoder, or absolute position sensor. The rotational sensing device may also be an absolute position sensor, which, upon device power up, relays feedback to the controller  485  of the exact position of the large gear  440  without the need to find a homing sensor and/or limit sensors. Limit sensors and mechanical stops may be positioned such that the rotation cannot exceed 90 degrees in either direction. Additionally, if the device is to only treat either the left or right wrist and hand, limit sensors and mechanical stops can be positioned to limit rotation to 90 degrees in a specific direction.  
         [0043]     The frame  455  of the present embodiment supporting the rotation and compression devices described above may be secured to two hardened steel shafts  465  via pillow blocks located beneath it  455  figure. This may allow the frame  455  to slide linearly. Additionally a threaded mechanical screw  470  running between the steel shafts  465  may be held suspended between two lower support blocks  472 . The threaded mechanical screw  470  may be free to rotate, via bearings within the support blocks  472 . These support blocks  472  may also rigidly hold the steel shafting  465 .  
         [0044]     In the embodiment illustrated in  FIG. 4 , a small rotational motor  480  is coupled to a gearbox  475 , which is coupled to the threaded mechanical screw  470 . The small rotational motor  480  is operated by the controller  485 . The small rotational motor  480  may be a servo motor, and may be controlled via a servo amplifier located within the controller  485 . The threaded mechanical shaft  470  may be coupled to the frame  455  via an external linear nut that is rigidly fixed underneath the frame  455 . As the small rotational motor  480  rotates the threaded mechanical shaft  470 , the frame  455  is moved linearly forwards and backwards.  
         [0045]     In one embodiment of the present invention in  FIG. 4 , the upper arm of the patient may be held in a fixed position at the level of the side of the body by an upper arm restraint, such as that shown in  FIG. 10 . The captured and rotated wrist and hand are moved linearly away from and back towards the elbow by the actions of the small rotational motor. As this cyclic action occurs, the bone structures of the wrist and hand are extended and retracted, affecting a cyclic unloading of said bone structions. This action decompresses the bone structures of the hand and wrist. The decompressive tensile forces described above are measured by a tension measuring device that may located within an upper arm restraining device that retains the position of the upper arm. The tensile force feedback of the upper arm restraining device may be fed back to the controller  485 , which may adjust and keep safe decompressive tensile force levels.  
         [0046]     Dual light therapy and electrical stimulation devices may be located within the upper portion  410  and/or the lower portion  300  of the therapy housing  900 , which may apply simultaneous therapy to the hand and wrist. During periods of decompressive tensile force application, the controller  485  may power the light therapy devices such that light therapy is applied from above and/or below the wrist and hand. The controller  485  may also control the continuous application of electrical stimulation therapy. The decompressive tensile force may also be configured to cause a pumping action on the hand and/or wrist as it is cycled logarithmically between periods of maximum and minimum tension, thereby assisting in the movement of fluid through and about the wrist, reducing edema. Decompressive tensile forces may also promote the improvement of mobility of structures located within the carpal tunnel.  
         [0047]      FIG. 5  illustrates a proximal therapeutic device  500  that is used to supply light therapy and electrical stimulation simultaneously to the hand and wrist according to one embodiment of the present invention. The proximal therapeutic device  500  shown may be housed in a single structure  540 . Further, the proximal therapeutic device  500  may be made of a solid, optically transparent material, for example ABS plastic, that is biologically safe for application to the skin. The proximal therapeutic device  500  may include a plurality of light therapy sources  520 , such as, but are not limited to, lasers, LEDs and lamps, or a combination thereof. The light therapy sources  520  may be arranged such that illumination is permitted to extend upward or downward and into the patient&#39;s carpal tunnel region. In one embodiment of the present invention, at least a portion of the light therapy sources may be positioned within the therapy housing. In such an embodiment, the light therapy sources  520  may be located nearer to the wrist, such as about and beyond the proximal heads of the metacarpals of the hand.  
         [0048]     The proximal therapeutic device  500  shown in  FIG. 5  may also include at least one electrode  510 . The electrode  510  may be made of a biologically safe material, including, but not limited to, medical-grade metals, such as stainless steel, and silicon-rubber doped with such agents as carbon-black, silver, and gold, among others. Further, in one embodiment, the electrode  510  may extend upon smooth lines above the clear housing  540 . The electrode  510  conducts electrical current into the hand and/or wrist and may communicate this current between any of the other wrist or hand electrodes of the present invention. In one embodiment of the present invention, the light therapy sources  520  and electrode  510  may be held rigidly in place within the clear housing  540 . Further, the light therapy sources  520  and electrode  510  may be connected internally to a printed circuit board  530 , which may deliver and route power to the light therapy sources  520  and electrode  510 . Further, the printed circuit board  530  may be electrically connected to a controller  485 .  
         [0049]      FIG. 6  illustrates a distal therapeutic device  600  that is used to supply light therapy and electrical stimulation simultaneously to the hand and/or wrist according to one embodiment of the present invention. The distal therapeutic device  600  may include a housing  640 . The housing  640  may be constructed form a number of different materials, including, but not limited to, a solid, optically transparent material, such as ABS plastic, that is biologically safe for application to the skin. The housing  640  may be operably connected to a plurality of light sources  620 , for example lasers, LEDs and/or lamps, arranged such that illumination is permitted to extend upward or downward and into the patient&#39;s carpal tunnel region. For example, the housing may be configured so that the light therapy is directed principally at the carpal tunnel region and secondarily to the wrist at and below the ulna and radius forearm bones. When positioned within the therapy housing, the light sources  620  may be located nearer to the wrist, about and beyond the distal heads of the ulna and radius bones of the forearm. An electrode  610  made of a biologically safe material may extend upon smooth lines above the housing  640 . The electrode  610  conducts electrical current into the wrist and may communicate this current between any of the other wrist or hand electrodes of the present invention. The light sources  620  and electrode  610  may be held rigidly in place within the housing  640 , and may be connected internally to a printed circuit board  630 , which may deliver and route power to the light sources  620  and electrode  610 . The printed circuit board  630  may be electrically connected to the controller  485 .  
         [0050]      FIG. 7  illustrates a system for aligning the light therapy and electrical stimulation of proximal and distal therapeutic devices  500 ,  600  within the lower portion  300  of a therapy housing according to one embodiment of the present invention. The system of the present invention may be configured to allow the use or inclusion of any number of different therapeutic devices. In use, the wrist may be placed within the wrist channel  310  and the hand upon the hand support region  320  of the lower portion  300  of the therapy housing such that the distal heads of the ulna and radius forearm bones  105 ,  110  are contained within the wrist supports  350 . The hand support region  320  of the lower portion  300  of the therapy housing may extend sufficiently to accommodate various hand and finger lengths. As shown, the carpal tunnel area  360  may extend from just before the end of the wrist supports  350  about the light therapy sources  520  of the proximal therapeutic device  500 . The proximal therapeutic device  500  may direct current into the wrist through a biologically safe conductive electrode  510 . As previously mentioned, light therapy may radiate into the wrist and carpal tunnel region via a plurality of light sources  520 . Further, the proximal therapeutic device  500  may direct current into the hand through a biologically safe conductive electrode  770 .  
         [0051]     Light therapy may also radiate into the hand and carpal tunnel region via the distal therapeutic device  600 , which may include a plurality of light sources  620  and an electrode  610 . The plurality of light sources  620  and electrode  610  may be positioned within the therapy housing such that light and electrical stimulation is optimally delivered to a variety of wrist and hand morphologies. Further, the upper portion of the therapy housing may also include the same or similar therapeutic devices as those described above so that light and electrical stimulation therapy may be applied from both above and below the carpal tunnel region.  
         [0052]      FIG. 8  illustrates a wrist  820  and hand  830  positioned in the lower portion  300  of a therapy housing according to one embodiment of the present invention. At least a portion of the wrist  820  may be placed within the wrist channel  310  and between the wrist supports  350 . The hand  830  may extend beyond the wrist supports  350  and lie on the hand support region  320  of the lower portion  300  of the therapy housing. The carpal tunnel area  360  is shown as extending from approximately just above the distal heads of the ulna and radius forearm bones in the wrist  820  to approximately just below the proximal heads of the metacarpal bones of the hand  830 . The proximal and distal therapeutic devices  500 ,  600  are located correspondingly below the wrist  820  and hand  830 .  
         [0053]      FIG. 9  illustrates a wrist  930  and hand  940  compressed between the upper and lower portions  410 ,  300  of a therapy housing  900  according to one embodiment of the present invention. The therapy housing  900  may capture the wrist  930  and hand  940  in compression. The wrist supports  350  may be positioned and configured so as to assist in preventing the patient&#39;s wrist  930  and hand  940  from slipping out of the therapy housing  900 . As the upper and lower portions  410 ,  300  of the therapy housing  900  are compressed about the wrist  930  and hand  940 , a space may exist only about the patient&#39;s carpal tunnel region such that minimal compression is exerted in this region.  
         [0054]      FIG. 10  illustrates a rotated and compressed wrist  930  and hand  940  and a secured upper arm  1010  during use of a therapeutic system  1000  in accordance with one embodiment of the present invention. As shown, the therapeutic system  1000  may hold a patient&#39;s upper arm  1010  inline with his or her standing or seated body via an upper arm restraining device  1020 . The upper arm restraining device  1020 , which may prevent the patient&#39;s arm from moving forward, may contain a conforming foam and/or a pneumatic inflation bladder to cushion the upper arm  1010  during periods of decompressive tensile force application  1095 . The upper arm restraining device  1020  may include a tension measuring device, such as, but not limited to, a load cell or load button that may feed information regarding the decompressive tensile force  1095  exerted at the wrist  1050  and hand  1060  locations back to the controller  485 . Below the upper arm restraining device  1020 , the elbow  1030  may be bent to or near 90 degrees, and extends the forearm  1040  towards the wrist  930  and hand  940 . The wrist  1050  and hand  1060  are shown captured between the upper and lower portions  410 ,  300  of the therapy housing  900  and rotated outward 90 degrees. In one embodiment, the patient&#39;s hand  940  may be positioned so that the palm is facing the patient&#39;s body. As previously mentioned, the wrist supports  350  of the therapy housing  900  may keep the wrist  930  and hand  940  from slipping out from between the therapy housing  900  during periods of decompressive tensile force application  1095 .  
         [0055]      FIG. 11  is a top plan view of a wrist  930  and hand  940  positioned between the proximal and distal therapeutic devices  500   a ,  500   b ,  600   a ,  600   b  as they may be positioned within the therapy housing (not shown) according to one embodiment of the present invention. The lower proximal therapeutic device  600   a  is shown being positioned such that the plurality of light sources  620   a  are near the distal heads of the ulna and radius forearm bones and illuminate  1160  (shown as line arcs) the wrist  930  and carpal tunnel region  155 . The distal therapeutic device  600   b  along the upper portion  410  may be positioned such that its plurality of light sources  620   b  are near the distal heads of the ulna and radius forearm bones  105 ,  110  and illuminate  1160  the wrist  930  and carpal tunnel region  155 . The lower proximal therapeutic device  500   a  may be positioned such that its light therapy sources  520   a  are near the proximal heads of the metacarpal bones and illuminate  1160  the hand  940  and carpal tunnel region  155 . The upper proximal therapeutic device  500   b  may be positioned such that its light therapy sources  520   b  are near the proximal heads of the metacarpal bones and illuminate  1160  the hand  940  and carpal tunnel region  155 .  
         [0056]     During periods of illumination by the proximal and distal therapeutic devices  500   a ,  500   b ,  600   a ,  600   b , which may be applied during decompressive tensile force cycles, light therapy from all of the therapeutic devices  500   a ,  500   b ,  600   a ,  600   b  may substantially illuminate  1160  the carpal tunnel region  155 .  
         [0057]      FIG. 12  is a top plan view of a wrist  930  and hand  940  undergoing Quadripolar Interferential stimulation while positioned between proximal and distal therapeutic devices  500   a ,  500   b,    600   a ,  600   b  according to one embodiment of the present invention. The lower distal therapeutic device  600   a  may be positioned such that its electrode  610   a  is near the distal heads of the ulna and radius forearm bones. This electrode  610   a  may transmit a high frequency sine wave  1255   a  through the wrist  930  and carpal tunnel region  155  to the electrode  510   b  in the upper proximal therapeutic device  500   b.  The upper distal therapeutic device  600   b  may be positioned such that its electrode  610   b  is near the distal heads of the ulna and radius forearm bones. This electrode  610   b  may transmit a high frequency sine wave  1255   b  through the wrist  930  and carpal tunnel region  155  to the hand electrode  510   a  of the lower proximal therapeutic device  500   a . The lower proximal therapeutic device  500   a  may be positioned such that its electrode  510   a  is near the proximal heads of the metacarpal bones. This electrode  510   a  may transmit a high frequency sine wave  1255   b  through the wrist  930  and carpal tunnel region  155  to the electrode  610   b  of the upper distal therapeutic device  600   b . The upper proximal therapeutic device  500   b  may be positioned such that its electrode  510   b  is near the proximal heads of the metacarpal bones. This electrode  510   b  may transmit a high frequency sine wave  1255   a  through the wrist  930  and carpal tunnel region  155  to the electrode  610   b  of the lower distal therapeutic device  600   a.    
         [0058]     The two high frequency sine waves  1255   a ,  1255   b  transmitted through the carpal tunnel region  155  may be of different frequencies (e.g. 4000 Hz and 4250 Hz). Wherever the two waveforms  1255   a ,  1225   b  are present, for example at a crossing  1265  at the center of the carpal tunnel region in  FIG. 12 , interference may occur. Interference results in a waveform with low-frequency characteristics (a “beat frequency”)  1260 ,  1270 , which radiates through and about the carpal tunnel region.  155 .  
         [0059]      FIG. 13  is a top plan view of upper and lower proximal and distal therapeutic devices  500   a ,  500   b ,  600   a ,  600   b  positioned about a patient&#39;s wrist  930  and hand  940  that is undergoing Medium Frequency or Bipolar Interferential stimulation of the carpal tunnel region  155  according to one embodiment of the present invention. The lower distal therapeutic device  600   a  may be positioned such that its electrode  610   a  is near the distal heads of the ulna and radius forearm bones. The electrode  610   a  of the lower distal therapeutic device  600   a  may transmit a high frequency sine wave  1360  through the wrist  930  and carpal tunnel region  155  to the upper distal therapeutic device  600   b . The upper distal therapeutic device  600   b  may be positioned such that its electrode  610   b  is near the distal heads of the ulna and radius forearm bones. The electrode  610   b  of the upper distal therapeutic device  600   b  may transmit a high frequency sine wave  1360  through the wrist  930  and carpal tunnel region  155  to the electrode  610   a  of the lower distal therapeutic device  600   a . The lower proximal therapeutic device  500   a  may be positioned such that its electrode  510   a  is near the proximal heads of the metacarpal bones. The electrode  510  of the lower proximal therapeutic device  500   a  may transmit a high frequency sine wave  1360  through the wrist  930  and carpal tunnel region  155  to the upper proximal therapeutic device  500   b . The upper proximal therapeutic device  500   b  may be positioned such that its electrode  510   b  is near the proximal heads of the metacarpal bones. The electrode  510   b  of the upper proximal therapeutic device  500   b  may transmit a high frequency sine wave  1360  through the wrist  930  and carpal tunnel region  155  to the lower proximal therapeutic device  500   a.    
         [0060]     While the invention has been described with reference to certain embodiments, it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from its scope. Therefore, it is intended that the invention not be limited to the particular embodiments disclosed, but that the invention will include all embodiments falling within the scope of the appended claims.

Technology Classification (CPC): 0