# Patent

## Title
Device for treating carpal tunnel syndrome

## Abstract

A therapeutic device for applying graded compression to the hand to remedy the symptoms of carpal tunnel syndrome. The device is a passive therapy device which receives the palm of the hand and applies graduated pressure to the top of the hand to relieve carpal tunnel region of the hand by spreading the area of the carpal tunnel. There are also disclosed a centralizing means which allows for accurate placement of the means for apply pressure to the top of the hand and also a means for further spreading and fixing the spread in the carpal tunnel region.

## Background
RELATED APPLICATIONS
This application is a continuation-in-part of our Ser. No. 10/159,614, filed May 30, 2002.


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 DynasplintTM carpal tunnel therapy device of this invention is an improved 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 carpal tunnel therapy device of the herein disclosed invention also describes improvements made to the carpal tunnel therapy device of our Ser. No. 10/159,614 filed May 30, 2002. The improved device has a centralizing mechanism as well as a spread connector cam and handle sub-assembly which in use spreads the carpal pads to produce its therapeutic effect. Functions of these components will be described in greater detail as this specification is read.
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'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 4th 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's fingers and thumb are extended. In actual use the user's fingers and wrist are extended; and the user'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.
Sucher (U.S. Pat. No. 5,468,220) teaches a device for the treatment or prevention of carpal tunnel syndrome having two arms having pads attached, a c-shaped member having a pad attached at the central portion thereof and a pair of pads attached to the arms of the c-shaped member. The Sucher device is distinct from the therapy device of the disclosed invention in that in Sucher the pads flex towards each other when the device is applied. On the other hand, in the device of the herein disclosed invention the pads flex away from each other.
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.
An important object of this invention is to provide an improved carpal tunnel therapy device with a means for centralizing the counter-force bracket and an improved means for spreading the carpal pads.
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 counter force 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.
FIGS. 32-44 describe the improved carpal tunnel therapy device.
FIG. 32 is a perspective view of the improved carpal tunnel syndrome therapy device showing the centralizing mechanism and spread connector cam.
FIG. 33 is a front plan view thereof.
FIG. 34 is a backside plan view thereof.
FIG. 35 is a left side elevational view thereof.
FIG. 36 is a right side elevational thereof.
FIG. 37 is a plan view of the centralizing mechanism with the top of the gear housing removed.
FIG. 38A is a plan view of a joined centralizing rod end and gear rack.
FIG. 38B is a perspective view of the centralizing gear rack.
FIG. 39 is a cross-section view of the improved carpal tunnel syndrome therapy device taken along lines 39—39 of FIG. 34.
FIG. 40 is a front plan view of the cam and handle sub-assembly in the open position.
FIG. 41 is a front plan view of the cam and handle sub-assembly in the closed position.
FIGS. 42 and 43 are views of the centralizing gear housing.
FIGS. 44A-44G illustrate a sequence of steps for applying the carpal tunnel syndrome therapy device to the hand to treat carpal tunnel syndrome.



DESCRIPTION
With reference to FIG. 1, a previously disclosed 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 pad 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 pads 12 and counter force pad 14, pressure can be applied by using loading screw knob 40 (FIGS. 31B and 31C). 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.
Improved Device for Treating Carpal Tunnel Syndrom
The inventors have continued to improve their device for treating carpal tunnel syndrom as described with reference to FIGS. 32-44.
In drawings 32 through 44 where the part of the old device and that of the new improved device are the same, the same number has been retained; where new components appear, the new components have been given new numbers.
With reference to FIGS. 32-44 improvements to the carpal tunnel therapy device 100 are described. The inventors have added a centralizing mechanism means 102 which functions to centralize the counter-force bracket 22 and the counter force foot 20 over the carpal pads 104. They have also added a spread connector cam and handle sub-assembly 106 which facilitates the spreading of the carpal pads. Also added are easily replaceable carpal pads 104. All new features will be described in detail hereinafter.
With reference to FIGS. 32-34 and 37-41, the centralizing mechanism 102 has a centralizing gear housing 108 having a gear housing bottom 110 and a gear housing top 112. Contained in the centralizing gear housing 108 is a centralizing spur gear 114 and meshing with the spur gear 114 is a centralizing gear rack 116 having a threaded end 118 and a serrated end 120. The threaded end 118 of the gear rack 116 is threaded into the tapped end of rod end 122 which in turn attaches to bracket 26. Note also, as best shown in FIGS. 32, 42 and 43, that the centralizing gear housing 108 has on either side of its longitudinal dimension a cutout 124 in which rides upright 22 to provide centralizing stability to the device. The centralizing mechanism 102 serves to keep the counter force foot 20 and counter force brackets 22 over the carpal pads 104 during the entire time force is being applied to the hand.
FIGS. 37, 38A and 38B, 42 and 43 describe the components of the centralizing mechanism 102. The centralizing mechanism has a centralizing gear housing 108 which has a bottom 110 and a top 112 joined by screws, although other joining means could be used. Contained in the housing 108 is spur gear 114 meshing with two gear racks 116. As best shown in FIG. 38B, the gear rack 116 has a threaded end 118 and a serrated end 120. The serrated end 120 of the gear rack 116 meshes with spur gear 114. The gear rack 116 during operation rides in channels 123. With reference to FIGS. 37 and 43, the spur gear rides on shaft 140. The threaded end 118 of the gear rack 116 threads into the tapped end of the rod end 122. Referring to FIG. 37, the centralizing mechanism 102 attaches to brackets 26. Note that the centralizing mechanism 102 attaches to brackets 26 with long pins 125 joining to rod ends 122 to stem rod yoke 30 and housing tube yoke 28.
With reference to FIGS. 42A-D and 43A-D detailed views of the top and bottom portions of the centralizing gear housing 108 have a gear shaft 140 for retaining spur gear 114 (shown in FIG. 37) and in top FIGS. 42A and 42B there is recess 141 for receiving gear shaft 140. Gear rack 116 (FIGS. 37 and 38A) slide in channel 123 of the centralizing gear housing 108.
Referring to FIGS. 37 and 44, the function of the spur gear 114 and gear rack 116 in the centralizing mechanism 102 is to allow main joint 34 to be flexible and at the same time keep the counter-force pad 14 over the carpal pad 104 and also to stay in place over the palm of the hand as pressure is applied by loading screw 42 to the drive assembly 24. At the start of therapy, the force is set at zero and main joint 34 is at a high point over the centralizing mechanism. As force is applied with the loading screw 42 using knob 146 the main joint descends and gear rack 116 extends out of the centralizing mechanism as shown by FIGS. 44A to 44G.
Referring to FIGS. 32, 33, 40, 41 and 44, there is a cam sub-assembly 106 which is made of a cam 132 joined to a cam handle 134. The purpose of the cam sub-assembly is to further spread apart the carpal pads 104 once the palm of the hand is securely placed on the carpal pads.
FIGS. 40 and 41 describe the cam and handle sub-assembly 106 which is attached to the bottom of bracket 26 through long screw 138. FIG. 40 shows the cam sub-assembly 106 in an unengaged position and FIG. 41 shows the cam sub-assembly in an engaged position. In FIG. 40 arrow 144 shows the brackets 26 upon which foot yokes 18 are attached (FIG. 33) in the relaxed position. Engaging the cam sub-assembly spreads apart left and right brackets 26 and the foot yokes 18 attached thereto and thus, further spreads the palm of the hand relieving carpal tunnel syndrome by spreading the contracted tissue around carpal tunnel to free-up and relieve the median nerve, vein and artery which are being impinged.
Referring to FIGS. 33, 40 and 41, the operation of the cam and handle sub-assembly 106 is described as follows: With the palm of the hand placed on carpal pads and the counter-force pad snugly placed in contact with the top of the hand and the cam handle 134 is moved in a clockwise direction to cause cam 132 to butt against and engage the right hand end 136 of connector outer tube 94. The right hand end 136 of connector outer tube 94 is shown in detail in FIGS. 29, 30, 40 and 41. Engaging of the cam 132 with the right hand end 136 of the connector outer tube 94 causes brackets 26 to which the connector outer tube is attached to extend apart thereby causing carpal pads 104 attached to carpal foot yokes 18 to spread apart and thereby spread the palm of the hand to relieve pressure on the carpal nerve.
As best shown in FIGS. 3, 16-21 and 32, the foot yokes 18 having carpal pads thereon can be independently laterally adjusted by the use of lateral adjusting screw 90. Adjustment is made using a phillips head or other type screw-driver 148 shown in FIG. 32 turned in the head of lateral adjusting screw 90 which is set in the lateral adjusting screw housing 91. With particular attention to FIGS. 19, 32 and 33 note that the lateral adjusting screw housing 91 has a recess 142 (shown in dashed lines in FIG. 32) for retaining the position of the head of the lateral adjusting screw 90. Turning the head of the screw 90 with a driver causes the foot yoke 18 having disposed thereon foot pad 104 to be laterally displaced. This lateral adjustment of the foot yokes 18 and attached carpal pads allows for accurate placement of the pads relative to the palm of the hand to produce maximum spread effectiveness for relieving carpal tunnel syndrome.
Referring to FIGS. 32 and 33, the carpal foot yokes 18 have disposed thereon new carpal pads 104 set within a framed recess 128. The carpal pad 104 over the carpal foot yokes 18 are made of a clean room tacky material called “Dura-2TM”. This material since it is tacky, will cause the palm to cling and allow for a more secure placement of the palm of the hand on the carpal pads 104, and accordingly a more efficient spreading of the palm of the hand is achieved. Note also that carpal pads 104 are improved in that they are easily removable. This easy removal allows for efficient replacement when the pads become worn or when the same device is to be used for a different patient.
Note also that the loading screw knob 146 has been modified to allow for a more comfortable, and efficient application of force.
In summary, the improved inventive device can be described as being an improved therapeutic device to be used to treat carpal tunnel syndrome comprising:

    
    
        a) a paired means for receiving the palm of the hand spreadable relative to each member of the paired means,
        b) a compression means placed over the paired means for receiving the palm of the hand, and
        c) a centralizing means positioned over said compression means to enable the compression means to be steadily positioned over the paired means for receiving the palm of the hand, such that by applying pressure to the palm of the hand, the palm is spread freeing-up contracted tissue around the carpal tunnel to relieve the median nerve, vein and artery being impinged, to thereby relieve carpal tunnel syndrome. The device can be further supplied with a means for laterally adjusting the spaced distance of each member of the paired means for receiving the palm of the hand. There is also supplied a cam means which will spread and fix the spread of the paired means for receiving the palm of the hand and thereby produce greater spread of the carpal tunnel. Note that the compression means for receiving the palm of the hand can be graded compression means and may comprise a chisel tip applying pressure to a main joint. The means for receiving the palm of the hand can be described as a pair of carpal pads which can be spread apart relative to each other and are flexibly placed relative to the counter force compression means such that the graded counter force compression means when applied to the hand will spread the palm of the hand and remedy the effect of the carpal tunnel syndrome.
    
    


The preferred device for treating carpal tunnel syndrome is one having a (1) centralizing mechanism, (2) cam adjustment and (3) lateral adjustment for the yokes. Each one of the features identified as 1, 2, 3 individually provide a patentable subspecies of the invention.
Protocol of Use
With reference to FIGS. 44A-44G, a method for employing the device for treating carpal tunnel syndrome is described. For convenience of application, the device is applied to the palm of the hand with the cam side up. This allows for the convenient application of the cam and the convenient adjustment of the lateral adjusting screws.
Application of the Device

    
    
        1) Referring to FIG. 44A: With the cam 123 facing up, set tension gauge at zero using the loading screw knob 146.
        2) FIG. 44B: Place the hand in the device so that the back of the hand is placed on the counter force pad 14 and the foot yoke pads 104 are placed over the palm of the hand.
        3) FIG. 44C: Once the hand is in place, the counter force bracket 22 is adjusted to make a snug fit of the hand between the counter force pad 14 and the foot yoke pads 104.
        4) FIG. 44D: With the attainment of the snug fit of the hand between the counter force pad and foot yoke pads, the loading screw knob 146 is turned causing the counter force pad 14 to exert pressure on the palm of the hand.
        5) FIG. 44E: With pressure applied using the counter force, more spreading is applied by setting the cam 132.
        6) FIG. 44F: More pressure can be applied by further adjusting the counter force by the use of the loading screw knob 146.
        7) FIG. 44G: After this adjustment using the loading screw knob 146, the foot yokes 18 are further spread using the lateral adjusting screws 190 to give further spread to the palm of the hand to relieve carpal tunnel syndrome.
    
    


The therapy device of this invention is designed to be used 1-3 times a day for 15-30 minutes in each session. The treatment programs begin with lower pressure or tension on the device, 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.

## Claims

1. An improved therapeutic device to be used to treat carpal tunnel syndrome comprising:
a) a paired means for receiving the palm of the hand spreadable relative to each member of the paired means, 
b) a compression means placed over the paired means for receiving the palm of the hand, and 
c) a centralizing means positioned over said compression means to enable the compression means to be steadily positioned over the paired means for receiving the palm of the hand, such that by applying pressure to the palm of the hand, the palm is spread freeing-up contracted tissue around the carpal tunnel to relieve the median nerve, vein and artery being impinged, to thereby relieve carpal tunnel syndrome.

2. The improved therapeutic device of claim 1 wherein there is supplied a means for laterally adjusting the spaced distance of each member of the paired means for receiving the palm of the hand.

3. The improved therapeutic device of claim 1 wherein the paired means for receiving the palm of the hand can be further spread apart by a cam means which will spread and fix the spread of the paired means for receiving the palm of the hand and thereby produce greater spread of the carpal tunnel to relieve carpal tunnel syndrome.

4. The improved therapeutic device of claim 1 wherein the compression means for receiving the palm of the hand is a graded compression means.

5. The improved therapeutic device of claim 1 wherein the paired means for receiving the palm of the hand have an adhesive surface which will fix the palm of the hand to the adhesive surface and thereby accurately position the palm of the hand on the paired means for receiving the palm of the hand.

6. The improved therapeutic device of claim 1 wherein the compression means placed over the paired means for receiving the palm of the hand is attached to a vertical adjusting means.

7. A therapeutic device to be used to treat carpal tunnel syndrome comprising a means for receiving the palm of the hand in combination with a graded counter force compression means and being further supplied with a centralizing means positioned over the means for receiving the palm of the hand, wherein the means for receiving the palm of the hand are a pair of carpal pads which can be spread apart relative to each other and are flexibly placed relative to the counter force compression means such that the graded counter force compression means when applied to the hand will spread the palm of the hand and remedy the effect of the carpal tunnel syndrome.

8. The therapeutic device for relieving carpal tunnel syndrome of claim 7 further comprising carpal pads for receiving the palm of the hand and a counter force pad applied to the top of the hand wherein the counter force pad is attached to a means for adjusting height to snugly place the counter force pad over the top of the hand and a means for applying graded pressure to the hand thereby relieving the effects of carpal tunnel syndrome.

9. The device of claim 8 wherein the carpal pads and counter force pad are all supported by a pair of brackets.

10. A therapeutic device to be used to treat carpal tunnel syndrome comprising, 1) a pair of carpal pads spreadable relative to each other for receiving the palm of the hand and being flexibly positioned under a means disposed to contact the top of the hand for applying pressure to the hand, 2) the means for applying pressure to the top of the hand being attached to a vertical adjusting means, attached to a centralizing means and 3) the vertical adjusting means retaining thereon a means creating pressure to apply to the hand.

11. The therapeutic device of claim 10 wherein said pair of carpal pads for receiving the hand comprises a pair of carpal pads mounted on a pair of carpal foot yokes.

12. The therapeutic device of claim 10 wherein the means for applying pressure to the hand comprises a chisel tip applying pressure to a main joint.

13. The therapeutic device of claim 12 wherein the means for applying pressure to the hand has a means for graduating the pressure.

14. The therapeutic device of claim 11 wherein the carpal foot yokes and pad supported thereon can be laterally displaced by using a spread connector to which the yokes are attached.

15. A therapeutic device to be used to treat carpal tunnel syndrome comprising, 1) a pair of carpal pads spreadable relative to each other for receiving the palm of the hand and being flexibly positioned under a means disposed to contact the top of the hand for applying pressure to the hand, 2) the means for applying pressure to the top of the hand being attached to a vertical adjusting means, 3) the vertical adjusting means retaining thereon a means creating pressure to apply to the hand and 4) the device being further supplied with a cam means for further spreading and fixing the carpal pads.

16. An improved therapeutic device to be used to treat carpal tunnel syndrome comprising,
a) a paired means for receiving the palm of the hand spreadable relative to each member of the paired means, 
b) a compression means placed over the paired means for receiving the palm of the hand, 
c) a centralizing means positioned over said compression means to enable the compression means to be steadily positioned over the paired means for receiving the palm of the hand, 
d) a cam means to spread and fix the spread of the paired means for receiving the palm of the hand, and 
e) a means for laterally adjusting the spaced distance of each member of the paired means for receiving the palm of the hand, such that by the use of the improved therapeutic device, the palm of the hand is spread freeing-up contracted tissue around the carpal tunnel to relieve the median nerve, vein and artery being impinged, to thereby relieve carpal tunnel syndrome.

17. A method for treating carpal tunnel syndrome comprising, 1) placing the palm of the hand onto a pair of carpal pads spreadable relative to each other supported on a pair of yokes, 2) lowering a counter force pad attached to a counter force bracket to which is attached a centralizing means and compression assembly having a means for graduating the pressure on the counter force pad onto the top of the hand and 3) applying graduated pressure to the palm of the hand thereby spreading the palm of the hand to relieve carpal tunnel syndrome.