Patent Document

FIELD OF THE INVENTION 
   The herein disclosed invention finds applicability in the field of therapeutic devices used to free-up stiff muscles and stiff joints. In particular, the invention is directed to relieving the effects of carpal tunnel syndrome. 
   BACKGROUND OF THE INVENTION 
   A moderately active individual makes thousands of different hand movements in a single day. Such activity may lead to repetitive strain injuries, such as carpal tunnel syndrome (CTS), in which the tendons and ligaments in the carpal tunnel swell and compress nerves, resulting in hand numbness. 
   The increase of computer keyboards in offices and homes has created a dramatic increase in the number of repetitive strain injuries such as carpal tunnel syndrome. Carpal tunnel syndrome (CTS) is believed to be caused by compression of the median nerve resulting from a swelling of tendons and sheaths. Swelling of the tendons in the carpal tunnel reduces circulation to the hands causing numbness and pain. It is well known that a person who performs repetitive motions with his hands might develop a repetitive stress injury such as carpal tunnel syndrome. 
   Individuals who spend extended periods of time with their wrist in a flexed condition may develop CTS. A major cause of CTS is the continuous flexing of the wrist which is particularly common amongst individuals who spend long periods of time at keyboards, whether such keyboards be associated with computers per se, or with cash registers or other such devices. Such flexing is generally accompanied by pronation of the hand, i.e., holding the palm in a downward facing position, which further strains the connective tissue and nerves running through the carpal tunnel. Musicians are also subject to CTS, CTS itself is caused by compression of the median nerve, which runs through the wrist and branches into the palm, thumb and first three fingers. The median nerve runs through a bony structure which is identified as the carpal tunnel. The flexor tendons and the carpal ligament in the carpal tunnel may swell due to repetitive hand movements, pinching the medial nerve and producing the condition known as CTS. CTS generally results in an inability effectively to grip with the hands, and is usually accompanied by a tingling and numbness in the fingers. 
   The herein disclosed invention is designed to provide a therapy device for relieving the effect of carpal tunnel syndrome; and to bring flexibility to the hand and wrist as soon as possible. 
   BRIEF SUMMARY OF THE INVENTION 
   The Dynasplint™ carpal tunnel therapy device of this invention is a mechanical device for applying pressure at three points by means of a graded tensioning mechanism to create an “opening” or spread of the carpal tunnel, thereby, relieving stress and compression of the median nerve. Pressure is applied for relatively prolonged periods of time with a graded increase of pressure to allow for the relief of pressure on the median nerve which is being impinged, producing symptoms associated with carpal tunnel syndrome. The carpal tunnel therapy device is unique in being able to adjust for the degree of tension to be applied to the hand to relieve pressure on the nerve. 
   The Dynasplint Carpal Tunnel Syndrome (CTS) System is designed to treat, a disorder marked by compression of the carpal tunnel region in the wrist. CTS is a disabling wrist/hand condition usually involving tightening of the transverse carpal ligament causing compression of the median nerve, artery and vein. Signs and symptoms of numbness, tingling, burning and muscle weakness can occur. 
   CTS can be very disabling often resulting in partial loss of the use of the hand. Treatment frequently consists of surgical release of the transverse carpal ligament with weeks of recovery needed. Often times physical therapy is employed both pre- and post operatively. 
   The success rate for treatment of CTS has varied greatly. Even with surgery, many patients are left with continued weakness and/or paresthesias. Occupations involving hand use, ranging anywhere from secretarial duties such as typing and writing to the carpenter&#39;s need to use a screwdriver can cause CTS and be difficult for the patient to resume normal activity once this disabling condition develops. CTS has an etiology associated with repetitive trauma syndrome (RTS), which occurs when relatively minor traumas occur many times over a period of weeks or months. The cumulative stress then causes the tissue around the carpal tunnel to shrink and tighten (forming a contracture) which in turn compresses the enveloped tissues (median nerve, vein and artery). This compression then “cuts off” the vitally important nerve conductivity and blood flow which in turn results in the disabling muscle weakness of the thumb, index and middle fingers and causes paresthesias of the same digits plus the radial side of the 4 th  digit. 
   The purpose of the Dynasplint CTS system is to restore the normal length of the transverse carpal ligament and other associated surrounding tissues so that the median nerve, vein and artery have less compression which then allows freer blood flow and improved nerve conductivity. This compressive relief can then lead to abatement of paresthesias, improved muscle strength and overall improved hand function thereby allowing return to work and other activities. 
   The CTS System is designed to be used for 30-60-minute sessions, 1-3 times per day with low tension progressing as tolerated to higher levels of tension. Total duration of wear may be up to three months or longer but frequently less time of wear will be curative. 
   Prior Art Patents 
   Taylor (U.S. Pat. No. 6,010,431) teaches an exercise device for relieving carpal tunnel syndrome by pushing down of the hand to urge apart opposite sides of the palm to thereby relieve compression on the blood vessels and nerves. 
   Anliker (U.S. Pat. No. 5,613,923) teaches a device for treating repetitive strain injury which employs a glove, a resilient member and an anchor mechanism, wherein the user&#39;s fingers and thumb are extended. In actual use the user&#39;s fingers and wrist are extended; and the user&#39;s fingers and thumb are abducted. The user encounters resistance, exercising the extensor muscles of the fingers, hand, wrist and elbow, thereby relieving carpal tunnel syndrome. 
   Washburn (U.S. Pat. No. 5,551,933) teaches a hand-held device with a bead on a series of loops serving as a track for the bead. The bead is moved along the track by wrist-motion. This wrist motion exercises the wrist, thereby relieving carpal tunnel syndrome. 
   Gibney (U.S. Pat. No. 5,492,525) and (U.S. Pat. No. 5,366,436) teaches an exercise device to treating symptoms related to carpal tunnel syndrome. The thumb fingers are inserted into the device; and the thumb and fingers are stretched away from each other. This exercise is designed to relieve carpal tunnel syndrome. 
   Charles (U.S. Pat. No. 5,514,052) teaches a finger exerciser to relieve carpal tunnel syndrome. The device can retain the fingers and can apply tension to the fingers by means of tension stays which apply tension to elastic cords. By stretching the fingers and strengthening extensor muscles of the wrist, hand and fingers, the ill-effects of carpal tunnel syndrome are alleviated. 
   None of the prior art cited shows a graded tensioning mechanical device such as described by this invention for treating carpal tunnel syndrome. 
   OBJECTS OF THE INVENTION 
   A main object of the invention is to efficiently treat carpal tunnel syndrome. 
   A further object of this invention is to produce a therapy device which will allow for rapid rehabilitation of stiff fingers and hand. 
   Another object of this invention is to produce a device with a tension mechanism which is adjustable to produce greater or lesser tension-pressure or force on the hand as required. 
   Other objects of the present invention will become apparent from a reading of the following specification taken in conjunction with the enclosed drawings. 
   These and other objects of the present invention will become apparent from a reading of the following specification taken in conjunction with the enclosed drawings. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
       FIG. 1  is a perspective view of the carpal tunnel syndrome therapy device. 
       FIG. 2  is a front plan view thereof. 
       FIG. 3  is a left side elevational view thereof. 
       FIG. 4  is a front plan view of the drive assembly for the carpal tunnel syndrome therapy device. 
       FIG. 5  is a cross-section taken along  5 — 5  of FIG.  4 . 
       FIG. 6  is top plan view of the drive assembly for the carpal tunnel syndrome therapy device. 
       FIG. 7  is a cross-section thereof taken along  7 — 7  of FIG.  6 . 
       FIG. 8  is a view of the chisel tip and indicator gauge assembly of the tensioning mechanism used in the carpal tunnel syndrome therapy device. 
       FIG. 9  is a view of indicator gauge assembly of the device shown in  FIG. 8  turned 90°. 
       FIG. 10  is a perspective view of the housing head, tube and yoke sub-assembly of the therapy device. 
       FIG. 11  is a perspective view of a stem rod yoke to rod and joint sub-assembly of the therapy device. 
       FIG. 12  is a sectional view of the counterforce taken along  12 — 12  of FIG.  2 . 
       FIG. 13  is an exploded view showing the plunger release assembly. 
       FIG. 14  is a front plan view of the left side foot yoke and bracket. 
       FIG. 15  is a sectional view of the foot yoke taken along  15 — 15  of FIG.  14 . 
       FIGS. 16-21  are views illustrating the components of the foot yoke and the order for assembling and placement on the bracket. 
       FIGS. 22 and 23  are a side plan view and an end view of the torsion spring used in the foot yoke assembly. 
       FIG. 24  is a front plan view of the spread connector attached to the brackets of the carpal tunnel therapy device. 
       FIG. 25  is a sectional view thereof taken along  25 — 25  of FIG.  24 . 
       FIGS. 26-30  illustrate the components of the spread connector and the order for assembly of the spread connector. 
       FIGS. 31A-31E  are a sequence for using the carpal tunnel therapy device. 
   

   DESCRIPTION 
   With reference to  FIGS. 1  to  3  a carpal tunnel syndrome therapy device  10  is provided with carpal pads  12  and a counter force pad  14 . The carpal pads  12  are supported on a pair of carpal foots  16  which in turn are attached to a pair of carpal foot yokes  18 . The counter force pad is attached to a counter force foot  20  which in turn is attached to a pair of counter force brackets  22 . The counter force brackets  22  are joined at the top by a bracket bar  23  and joined at the bottom by a counter force foot  20 . 
   The carpal tunnel therapy device is provided with a drive assembly  24  (shown in detail in  FIGS. 4-11 ) which is attached to a pair of carpal tunnel brackets  26 , by way of housing tube yoke  28  and stem rod yoke  30  (FIGS.  1  and  2 ). As best shown in  FIGS. 4-12 , there is a drive assembly having a stem rod  36  attached to a main joint  34  which is inserted into a housing tube head  35  attached to a housing tube  38  and at the end of the housing tube there is disposed a loading screw knob  40  attached to loading screw  42 . 
     FIGS. 4-7  are views of the drive assembly  24 . The tension mechanism is contained in a housing tube  38  and has a loading screw knob  40  and loading screw  42  which presses an indicator bar  52  and spring spacer  60  as best shown in  FIGS. 8 and 9 . With particular reference to  FIGS. 8 and 9 , the compression spring  44  fits over the spring spacer  60  onto bottom support  64  of the spring spacer  60  and chisel tip  50  fits inside and over the compression spring  44 . In turn, the chisel tip  50  abuts the keeper  37  of the main joint  34  joined to stem rod  36 . Main joint  34  assembly is housed in housing head  35 . 
   With special reference to  FIGS. 6-7 , there is shown a sectional view, taken along lines  7 — 7  of  FIG. 6 , of the drive assembly  24  contained in the housing tube  38 , and main joint  34 , housing tube head  35  with stem rod  36  attached to joint  34  which abuts chisel tip  50 . Chisel tip  50  applies pressure to the joint  34  through compression spring  44  which in turn has pressure put on it through loading screw  42  and loading screw knob  40 . As the loading screw knob  40  and loading screw  42  are tightened, more and more pressure can be applied to the compression spring  44  which in turn exerts more pressure on the stem rod  36 . The force on stem rod  36  attached to stem rod yoke  30  produces a counter force on pad  14  to apply pressure to the top of the hand  41  shown in dashed lines in FIG.  1 . The amount of pressure is indicated by indicator screw head  54  and indicator marker  56  (best shown in FIG.  4 ). Note that the scale is 0-9 with 9 indicating maximum pressure for that setting. 
   In use the palm of the affected hand would be placed on pads  12 . The counter force pad  14  would be placed over the top of the hand using the variable height sub-assembly  69  best shown in  FIGS. 12 and 13 . Once the counter force pad  14  is in place over the top of the hand, added pressure can be applied to the hand incrementally using loading screw knob  40 . A more detailed method of use and protocol are set forth below. 
   With particular reference to  FIGS. 8 and 9 , an exploded view of the compression assembly  58  within the housing tube  38  is made up of two indicator bars  52  and a compression spring spacer  60 , compression spring  44  and chisel tip unit  62  composed of a chisel tip  50  and boss  63 . In operation the compression spring  44  is given tension by the loading screw  42  pressing against the bottom support  64  and the chisel tip  50  pressing against the main joint  34  in housing head  35 . The indicator bar  52  rises as the loading screw  42  presses on the bottom support  64  of spring spacer  60  of the compression assembly  58 . The compression mechanism is similar to that shown in U.S. Pat. No. 5,558,624. 
   With special reference to  FIGS. 1 ,  2  and  4 , there is shown as part of the housing tube  38  a viewing slot  68  showing indicator screw  54 . In  FIG. 4 , the viewing slot  68  is accompanied by a scale  56 . The higher the number of the scale  56 , the higher will be the compression or tension on the stem rod  36  and the greater the pressure on the hand during therapy. 
   With particular reference to  FIGS. 12 through 30 , various sub-assemblies of the carpal tunnel syndrome therapy device are described. 
   Counter Force Variable Height Adjustment Sub-assembly 
   With reference to  FIGS. 1 ,  2 ,  12  and  13 , there is provided a variable height adjustment sub-assembly  69  for the counter force  70  consisting principally of the head  35  for the housing tube  38  the head being integrally capped  71  on a first end with a collar  72  which receives a spring plunger spring  73  and over which is placed a tapped spring plunger  75  which in turn receives a threaded spring plunger button  77  into the tapped end of the spring plunger  75 . The second end of the housing tube head  35  is provided with a removable plate cap  79  with collar  78  which receives a spring plunger spring  73 , a spring plunger  75  and a spring plunger button  77 . Housing tube head  35  and main joint  34  are joined and held in place by screw  76 . In use the variable height adjustment sub-assembly is mounted between two counter force brackets  22  which are provided with a contiguous series of scalloped detent openings  80  to receive the spring plunger  75  of the counter force sub-assembly. Note that spring plungers  75  have a collar  74  and the housing head  35  has a collar  72  and the plate cap  79  has a collar  78  in which each of the spring plunger springs  73  are retained. 
   To adjust the height of the counter force sub-assembly  70 , spring plunger buttons  77  on either side of the counter force sub-assembly are squeezed inward. This squeezing causes the spring plunger  75  and the spring plunger spring  73  to depress allowing narrower threaded portion  81  of spring plunger button  77  to line up with scalloped openings  80  allowing free movement up or down of counter force pad  14  held on counter force brackets  22 . Once the proper height is attained, the spring plunger buttons  77  can be released and the spring plunger spring  73  expands to cause the spring plunger  75  to re-engage the scalloped openings  80  in the counter force brackets  22 . 
   Foot Yoke Sub-assembly 
   With reference to  FIGS. 1 ,  2  and  14 - 23 , the pads  12  of the carpal tunnel syndrome therapy device  10  are attached to bracket  26  through foot yoke  18 . There are two symmetrical foot yoke sub-assemblies  84 . Each sub-assembly  84  is composed of a foot yoke  18 , a foot yoke pivot pin  86 , foot yoke torsion spring  88 , a lateral adjustment screw  90  and lateral adjustment screw housing  91 . 
   To assemble the foot yoke sub-assembly  84  to bracket  26 , foot yoke pin  86  is partially inserted into opening  85  of yoke as shown in  FIGS. 16 and 17 . Bracket  26  with opening  95  (best shown in  FIG. 24 ) is inserted into slot  83  and pin  86  is further inserted through opening  95  of bracket  26 . Spring  88  is then inserted into yoke  18  ( FIG. 18 ) and slot  87  of pin  86  is lined up with diametric fold  89  of spring  88  as best shown in cross-sectional view of FIG.  15 . Pin  86  is inserted further to protrude through opening  81  on the opposite side of yoke  18 . As shown in  FIGS. 19 and 20 , lateral adjusting screw  90  is inserted through opening  59  into tapped hole  92  of the foot yoke pin  86 . The tangential tail  82  of spring  88  buts against the inner wall  53  of the foot yoke  18  to provide spring tension to the foot yoke. Once the yoke  18  is on the bracket  26 , the lateral adjusting screw housing can be attached with a fixed screw  98  or other securing means. 
   Adjusting lateral screw  90  provided in each yoke sub-assembly adjusts the pads  12  to accommodate the width of the palm of the hand. 
   Spring  88  serves to spring-load the yoke in an outward direction left and right, respectively and functions to counteract outward spreading that takes place when downward force is applied. 
   Spread Connector Sub-assembly 
   With reference to  FIGS. 24-30 , the carpal tunnel syndrome therapy device is provided with spread connector  93  attached to brackets  26  to adjust the spread of the brackets and accordingly the pair of yokes  18  and pads  12  attached thereto. The main components of the spread connector assembly  93  are the spread connector outer tube  94 , spread connector spring  96  and spread connector inner tube  97 . 
   As shown in  FIGS. 24-30 , the spread connector assembly  93  is made by inserting spring  86  over inner tube  97  ( FIGS. 26-28 ) and inserting both completely into outer tube  94  (FIGS.  29  and  30 ). The spread connector assembly is placed on bracket  26  through slots  65  and  67  and are held in place by a fixed screw  98 , of course other fasteners known in the art could be used. 
   The spread connector serves to adjust the spread or spacing of the brackets  26  and to spread or close to accommodate the spread of the carpal pads  12 . The spread connector also by virtue of the spring  96  holds the brackets inward and accordingly accomplishes presenting the carpal pads at the correct angularity at the initial fitting. 
   The stem rod  36  and housing tube  38  are attached to bracket  26  with stem rod yoke  30  held in place by a pivot pin  99 . Pivot pins  99  are also employed to position the spread connector assembly  93  on brackets  26 . While pivot pins have been used herein, other holding means such as rivets or bolts could be used. 
   With reference to  FIGS. 31A-31E , there is shown the use of the carpal tunnel syndrome therapy device. As noted, at the start of therapy, the scale  56  is set at zero. The palm of the hand is placed on carpal pads  12  and the counter force pads  14  are placed over the top of the hand by using the variable height adjusting mechanism  69  (described in FIGS.  12 - 13 ). Once the hand is set between the carpal pad  12  and counter force pad  14 , pressure can be applied by using loading screw knob  40  (FIGS.  31 B and  31 C). On an on-going basis pressure is increased using loading screw knob  40  and the amount of pressure can be viewed in scale  56 . The amount of pressure indicated is graduated as see scale of 0-9, with 9 being the greater pressure. This pressure action is designed to further spread the carpal tunnel area. 
   The carpal tunnel therapy device is primarily intended to be a passive therapy device in that it is to be worn for extended periods of time to thereby relieve carpal tunnel area and thereby prevent invasive surgery. 
   In  FIGS. 31A-31E , the vertical arrows show the height adjustment for the counter force pads  14  and the horizontal arrows show the direction of spread of the spread connector. 
   The therapy device of this invention is designed to be used 1-3 times a day for 30-60 minutes in each session. The treatment programs begin with lower pressure or tension on the device and progressing to higher pressure as tolerated to relieve the pain, stress, numbness brought about by the carpal tunnel syndrome. 
   Obviously, many modifications may be made without departing from the basic spirit of the present invention. Accordingly, it will be appreciated by those skilled in the art that within the scope of the appended claims, the invention may be practiced other than has been specifically described herein.

Technology Category: 1