WO2001017467A1 - Attelle dynamique pour traitement du syndrome du canal carpien - Google Patents

Attelle dynamique pour traitement du syndrome du canal carpien Download PDF

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Publication number
WO2001017467A1
WO2001017467A1 PCT/US2000/024791 US0024791W WO0117467A1 WO 2001017467 A1 WO2001017467 A1 WO 2001017467A1 US 0024791 W US0024791 W US 0024791W WO 0117467 A1 WO0117467 A1 WO 0117467A1
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WO
WIPO (PCT)
Prior art keywords
forearm
ulnar
carpal
dorsal
hand
Prior art date
Application number
PCT/US2000/024791
Other languages
English (en)
Inventor
George Roger Williams
Original Assignee
Theraid Manufacturing, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Theraid Manufacturing, Inc. filed Critical Theraid Manufacturing, Inc.
Priority to AU73650/00A priority Critical patent/AU7365000A/en
Priority to CA002384683A priority patent/CA2384683A1/fr
Priority to EP00961736A priority patent/EP1233733A4/fr
Publication of WO2001017467A1 publication Critical patent/WO2001017467A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/01—Orthopaedic devices, e.g. splints, casts or braces
    • A61F5/0102—Orthopaedic devices, e.g. splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations
    • A61F5/0104—Orthopaedic devices, e.g. splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations without articulation
    • A61F5/0118—Orthopaedic devices, e.g. splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations without articulation for the arms, hands or fingers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/01—Orthopaedic devices, e.g. splints, casts or braces
    • A61F5/0102—Orthopaedic devices, e.g. splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations
    • A61F5/013—Orthopaedic devices, e.g. splints, casts or braces specially adapted for correcting deformities of the limbs or for supporting them; Ortheses, e.g. with articulations for the arms, hands or fingers

Definitions

  • This invention relates generally to medical therapeutic devices for treating and curing functional disorders of the carpal area of the arm. More particularly, the present invention provides a splint for providing dynamic pressure .to the transverse carpal, volar carpal, and intra carpal ligaments, tending to relieve contractures of the ligaments and thus relieving the pain and correcting altered kinematics associated with carpal tunnel syndrome (CTS) by increasing the carpal volume, while providing free movement of the patient's wrist with minimal impediment during activities of daily living. Additionally, the device provides optional adjustable resistance in either direction for selective , preventative , and therapeutic impetus in reestablishing normal cocontraction for a more permanent , lasting solution .
  • CTS carpal tunnel syndrome
  • Carpal tunnel syndrome is a painful condition caused by compression of the median nerve of the forearm as it passes through the wrist canal, or carpal tunnel .
  • the median nerve and the flexor tendons pass from the forearm to the hand through the carpal tunnel ; compression can result from either a reduction in carpal tunnel volume, swelling of tissues passing through the canal , or both .
  • Prolonged exertion at a keyboard or manual labor are common, but by no means the only, associations of the syndrome .
  • CTS is believed to be caused by a biomechanical ligament imbalance in the volar carpal ligaments , namely, a thickening of the palmer transverse carpal ligament (PTCL, also known as the retinacular ligament) , a thickening of the volar intracarpal ligaments , and contraction of an assortment of volar carpal ligaments .
  • PTCL palmer transverse carpal ligament
  • volar shall be interpreted as " in the direction of the palm of the hand” and " dorsal” shall be interpreted as the opposite of “volar” , that is , in a direction away from the palm of the hand or directed outwardly from trie back of the hand .
  • volar shall be interpreted as " in the direction of the palm of the hand” and " dorsal” shall be interpreted as the opposite of “volar” , that is , in a direction away from the palm of the hand or directed outwardly from trie back of the hand .
  • all descriptions and observations shall be made from the standpoint of an individual ' s right hand and forearm for consistency and ease of description . The discussion whi ch follows applies equally well to either hand or forearm.
  • the flexor muscle tendons of the forearm acting o the wrist, fingers and thumb exert a collective static force power many times greater, volarly, than the extensor muscle tendons acting to stabilize the same members of the wrist and hand dorsally .
  • This interaction between the flexor muscles ( antagonist ) and the extensor muscles (agonist) which tends to hold the j oint in a fixed and stable position is termed " cocontraction.”
  • Trie ratio of these opposing forces is normally four to one flexor to extensor .
  • work demands often increas e this ratio through hypertrophy of the flexor muscle tendon units by intensity and duration of tasks requiring do inantly finger, thumb, and wrist function .
  • volar flexor forces acting upon the PTCL as a pulley, attenuate the PTCL and apply force s anteriorly and medially . This places traction forces to the ligament ends of the carpus .
  • volar intracarpal segments restore their normal position grossly; however, some minute anterio edial deformity remains , and slack of the
  • PTCL is concurrently taken up by contractile forces of this and the other ligament (s ) .
  • Numerous cycles of force followed by rest develop an established deforming characteristic which is manifested by narrowing the horseshoe ends of the carpal tunnel , which are held in position by a thickening PTCL and other volar carpal ligaments , resulting in a transverse deformity .
  • the PTCL acting as a pulley concentrate s the load of the finger and thumb function so that a volar glide is initiated, where volar glide is defined as movement of the carpal metacarpal complex as a unit in a volar direction .
  • This volar glide of the carpal metacarpal complex attenuates the predisposed thin dorsal carpal ligaments (DCL) originating from the distal radia l ulna ( DRU) . Since the volar carpal ligaments collectively become less stressed, they begin to contract, thus encouraging the anteriomedial collapse of the intercarpal spaces simultaneous to a longitudinal deformity .
  • the long moment arm of the carpal muscle tendon units are only capable of stabilization of the carpus when the muscle tone is within normal limits , i . e .
  • a variation of one or more serves to simplify convergence towards a direct line to this point of origin and shorten the distance therebetween . This force results in a decreasing biomechanical advantage which is manifested fc>y a volar shift of the axis of the proximal carpal row.
  • the resistance of the PTCL and related volar ligaments are encountered when returning the carpal metacarpal complex to a neutral position, i . e . dorsal glide , should be indicative of the severity of the condition of carpal tunnel syndrome or the propensity of the subj ect to incur the condition .
  • C Standard Treatment of Carpal Tunnel Syndrome
  • CTS has been treated with wri st rests, anti-inflammatory medications , cortisone inj ections, surgery, or static wrist splints . Alone or combined, these treatments have met with varying degrees of minimal succession s . Symptom relief is short lived and compounded by surgical complications . Even after these treatments are applied, the patient' s biomechanical configuration remains unchanged or complicated . Reduced grasp strength has been well documented .
  • the obvious solution, i . e . removing the cause of the injury by refraining from the manual labor believed to cause the problem, is not always practical since the cause of the injury is frequently t ie means by which the patient obtains his or her livelihooci .
  • the next best choice prevention through proper intervention, can be achieved by enlarging the carpal canal to maintain adequate space for the median nerve and thus avoid compression .
  • the mechanism for correcting this condition long term does not exist .
  • the carpal canal can be enlarged by osteopathic manipulation and stretching maneuvers , thereby alleviating compression on the median nerve and resolving CTS . While severe cases may require other treatment, manipulation is effective in the maj ority of cases and has the advantage of being prophylactic, i . e . a preventative . Optimum resolution of the symptoms requires frequent stretching and the assistance of another person, a physician or therapist to perform the manipulation . There is a need for an appliance which a patient can use to augment treatment by the physician o r therapist . It is known from studies of rehabilitated knee j oints and elbow j oints that the longest period of low force stretching produces the greatest amount of permanent elongation of connective tissue .
  • the stretching would be accomplished by means of an appliance which is adjusted by the physician or therapist to provide the appropriate force for stretching, preferably continuously.
  • an appliance which is adjusted by the physician or therapist to provide the appropriate force for stretching, preferably continuously.
  • there are a number of difficulties in the use of such appliances First, simply prescribing the use of an appliance does not mean that the patient will use it properly. If a patient is expected to put on and remove an appliance, a properly adjusted appliance must not be able to be put on incorrectly or to inflict eithe r too much or too little stretching . Proper use also refers to the compliance or self-discipline of the patient and how easy it is to use the appliance . In general , an appliance that is mechanically simple , easy to use, and comfortable to wear will more likely be used as directed .
  • the skin is sensitive to long term pressure, which can cause a localized loss of circulation and lead to ulceration. Obviously, a patient will not be comfortable if an appliance causes such irritation. O n the other hand, sufficient pressure must be applie d in order to be effective. Such an appliance must be comfortable to wear and not cause undue irritation or pressure on the skin.
  • an appliance must not interfere with the normal activities of living. It must be comfortable in the sense that it does not interfere with the function of the arm, wrist, and hand. Otherwise, a patient is unlikely to wear the appliance long enough to be fully effective, preferably overnight, or when performing routine tasks which may irritate the median nerve or promote the deformities. An appliance duplicating the manipulation by a physician or therapist would obviously interfere with the patient's use of the hand. W hat is d esired is an appliance which duplicates as much of the physician's treatment as possible without interfering with the use of the arm, wrist, or han d .
  • the ⁇ 645 patent provides a splint with an elongated, flexible member having a palmar portion configured to extend from the middle of the forearm, across the volar carpal area, and across the palm to bias the palm in a dorsal direction. It also functions as a reminder of the proper positioning to relieve pressure on the median nerve associated with CTS. It is designed to allow use of the fingers and thumb and to permit near normal hand function.
  • the appliance must duplicate the stretching maneuver performed by a trained therapist to stretch the PTCL and collective volar carpal ligaments over time ; 2 .
  • the appliance must be easily worn and removed by a patient with minimal or no training required for its use ;
  • the appliance must not present pre s sure point s to the patient or unduly irritate the skin;
  • the appliance must be easily worn during routine daily life with little or no interference with motion during supination and pronation or during manipulation o f the ' fingers ;
  • the appliance must both promote re storation o ff the carpal ligaments to their proper configuration as well as restore the proper cocontraction of the stabilizing flexor and extensor muscle groups against the carpal j oint ; and,
  • the appliance must be able to accommodate individuals having different forearm and wrist measurements .
  • obj ect of the present invention to provide a splint appliance for treating or preventing carpal tunnel syndrome .
  • Another obj ect of the invention is to provide a splint appliance which is comfortable and can be worn during the normal activities of daily living without unduly interfering with hand movement .
  • I t is a further obj ect of the invention to provide a means to relieve pressure on the median nerve by applying low intensity, extended volar pressure to the hand and thus stretch the palmer transverse carpal ligament .
  • the invention described herein to satis fy these obj ects consists of a dynamic orthotic appliance designed to provide low level pressure on the PTCL over extended periods of time while at the same time allowing the use r to execute the standard activities of daily living, as well as general activities particular to the user' s occupation, without interference from the orthotic . It consists of three components — a biasing component, a forearm component , and a palmar component .
  • the biasing component models the movement of the carpal /metacarpal and distal forearm/carpal j oints by employing a unique and innovative tensioning arrangement . It provides continuous , low pressure force which opposes movement off the wrist in a volar direction .
  • the forearm component provides a platform for a biasing component and maintain s the biasing component in particular relationship and alignment with the ulnar aspect of the forearm and carpu s during all normal movements .
  • the palmar component is positioned on the ulnar side of the hand and is designed to allow unobstructed flexion of the fingers and opposition of the thumb with the fingers ; it also couple s the biasing component to the hand .
  • the three component s are articulated in a novel manner which allows supination and pronation of the forearm without binding of the appliance or obstructing free movement .
  • FIG . 1 shows a elevation view of the ulnar aspect o f an embodiment of the dynamic splint as it relates to the right arm in accordance with the present invention with its maj or topological features , with the hand shown in a position where the spring is not applying tension agains t the hand .
  • FIG . 2 shows the same elevation view of the dynamic splint as in FIG . 1 , but with the spring applying dorsal tension against a volar movement of the hand .
  • FIG . 3 shows a plan view of the forearm component of the one embodiment of the dynamic splint illustrated in FIG . 1 . with its maj or topological features .
  • FIG . 4 shows an elevation view of the radial aspect of the dynamic splint as it relates to the right arm in accordance with the present invention .
  • FIG . 5 shows a sectional view of the splint and forearm, illustrating the stabilizing mechanism used for positioning the spring along the ulnar side of the forearm.
  • FIG . 6 shows a dorsal view of the hand with the palmar component attached the ulnar side of the hand and the positioning of the springs with relationship to the carpus .
  • FIG . 7 shows the volar view of the hand with the palmar component attached to the ulnar side of the hand .
  • FIGS 8 , 9 , and 10 show three views of the connecti on block used for attaching the spring to the palmar component of the dynamic splint .
  • FIG . 11 shows the method of securing the end of the spring to the palmar component of the dynamic splint using the connection block .
  • FIG . 12 shows a plan view of the radial side of the forearm component of the preferred embodiment of the dynamic splint with its maj or topological features .
  • FIG . 13 shows a plan view of the ulnar side of the forearm component of the preferred embodiment of the dynamic splint with its major topological features .
  • FIG . 14 shows a plan view of the forearm component of the preferred embodiment of the dynamic splint illustrated in FIGS . 12 and 13 with its maj or topological features .
  • FIG . 15 shows a sectional view of the splint and forearm taken from FIG. 12 , illustrating how the dorsal block is employed in the preferred embodiment .
  • volar and dorsal indicate directions of movement or location, where a volar movement is in the direction of the palm of the hand and dorsal movement is in the direction of the back of the hand .
  • the terms can indicate pos ition, where , for example, a volar carpal ligament would be a ligament located in the carpal complex on the palmar side of the hand .
  • proximal and distal relate to the position of the described obj ect with relationship to the trunk of the body .
  • the radius and ulna each has a proximal end (the elbow area) and a distal end (the wri s t end) .
  • the carpus is composed of a proximal carpal row of five bones and a distal carpal row of five bones , where the proximal carpal row adj oins the distal end of the radius and ulna .
  • Supination is defined as a rotational movement of the radius and ulna which result s in a palm up position of the hand, whereas " pronation” i s defined as a similar rotational movement resulting in a palm down position of the hand.
  • Dorsif lexion' is defined as a movement of the hand which forms an arc by extending the wrist dorsally .
  • Cocontraction is define d as the interaction between the flexor muscle tendons of the volar forearm acting on the wrist, fingers and thumb , with the dorsal extensor muscle tendons of the forearm, to stabilize the same members of the wrist and hand, thus tending to hold the carpal j oint in a fixed and stable position .
  • Glide is a term used to describe an involuntary movement of the carpal metacarpal complex, whereby the proximal carpal row is said to glide in a shear manner which maintains a parallel relationship with the distal forearm.
  • a volar glide is observed when, with the fingers extended, the palmar plane has moved in a volar direction with relationship to the distal forearm carpa l j oint , such movement consisting of a shear movement in a volar direction of the proximal carpal row .
  • the magnitude of volar glide is indicative of the severity o f CTS .
  • a dorsal glide is observed when the dorsal plane of the hand is moved dorsally through a shear movement of the distal forearm carpal j oint, an opposite movement of volar glide .
  • Ulnar deviation is defined as a movement of the hand in an ulnar direction without either dorsal or volar movement ; the plane of ulnar movement is perpendicular to that of dorsal-volar movement .
  • Radial deviation is defined as a movement o f the hand in a radial direction opposite to that of ulnar deviation . It has been observed in practice that there is a change is distance between the metacarpals and the dista l ulna-radius during flexion and extension of the hand. This change of distance results in an elliptical path being followed by the hand during its range of motion from flexion to extension .
  • I t is desirable in any dynamic splint design to mirror the s e kinematics so that a proper dorsal force can be applied by the splint appliance to resist volar glide .
  • FIG . 1 illustrates an embodiment for a dynamic splint appliance for use in the treatment and prevention of CTS in accordance with the present invention, generally designated by the numeral 10 .
  • the splint appliance 10 consists of a forearm component 20 , a palma r component 30, and a biasing component 40 and is shown configured in FIG . 1 to the right forearm 50 and right hand 60 of a user with carpal tunnel syndrome . While subsequent descriptions will for consistency and clarity be directed towards use of the appliance 10 with the right forearm of a user, the same appliance can be used on the left forearm and hand of a user, with all element s of the appliance being mirror images of thos e elements for the right forearm and hand .
  • the forearm component 20 is shown more generally in the plans of FIGS . 1 , 2 , and 4 .
  • the forearm component 20 is configured as a generally semicircular splint body 100 shown contoured around the dorsal side of the forearm 50 in FIG . 1 and in a flattened plan in FIG . 3 .
  • the splint body 100 is oriented on the forearm 50 with its distal edge 120 generally covering the distal radius and ulna , its proximal edge 130 in the direction of the elbow, and its ulnar edge 110 oriented so that it is generally parallel to the ulna (not shown) of forearm 50 .
  • the proximal strap support 140 and the transverse strap fulcrum 160 are wrapped over the dorsum of the forearm 50 so that both extend to points generally adj acent to the radius bone of the forearm 50, so as to capture only the dorsum of the forearm 50 .
  • Cutout 150 on the dorsum of splint body 100 is provided to solve the binding problem. It is generally centered on the dorsum of the forearm 50 and functions to prevent binding of the appliance during supination and pronation . Allowing the distal and proximal ends of splint 100 to move relatively independently of each other while being connected only along the ulnar edge 110 provide s a two point stabilization of the ulnar edge 110 during supination and pronation and maintains alignment of the ulnar edge 110 along the ulnar side of the forearm.
  • Trie proximal edge 130 of splint body 100 is convexly contoured on forearm 50 along the dorsum towards the distal radial end and away from the proximal radial end so that the extensor muscle group of the forearm is le t uncovered and ergonomically accommodated without binding .
  • Splint body 100 consists of a thin metal core material cut to the shape seen in FIG .
  • a covering material composed of a neoprene external nyl on or other anti-perspiration material, such material as i s in common use and knowledge among physical therapists , so that the splint body 100 can be molded and customized t o individual forearms and trimmed to accommodate individual differences in forearm length and circumference .
  • the exterior of the covering material should is sensitive t o attachment by the hook component of an industry standard hook-and-loop system of the type sold under the tradema rk "VELCRO" , so that transverse strap 190 can be removably attached to appropriate areas of the splint body 100, a s described below .
  • Splint body 100 is secured to the forearm 50 by distal forearm strap 170 , proximal forearm st rap 180, and transverse strap 190 .
  • Distal forearm strap 170 is secured to the splint body 100 by one or more rivets 172 , of whi ch a single representation is shown .
  • the rivet 172 as shown also serves to prevent the biasing component 40 from signi ficant movement either distally or proximally along the ulnar side of the forearm.
  • Distal forearm strap 170 is of sufficient length to allow end 174 having an attached hook and loop fastener strip 177 to be brought around the ulnar side of the forearm, across the distal end of the volar forearm, and over the radial forearm, where end 174 passes through distal buckle 175 and back onto distal forearm strap 170, where a cooperating hook and loop fastener strip (not shown) is fixed so that end 174 is removably secured to distal forearm strap 170.
  • Proximal forearm strap 180 is secured to the proximal strap support 140 by one or more rivets 182.
  • Proximal forearm strap 180 is of sufficient length to allow end 184 having an attached hook and loop fastener strip 185 to be passed around the radial side of the forearm, across the proximal end of the volar forearm, and over the ulnar forearm, where end 184 passes through proximal buckle 188 and back onto proximal forearm strap 180 , where a cooperating hook and loop fastener strip (not shown) is fixed so that end 184 is removably secure d to proximal forearm strap 180 . As shown in thi s
  • proximal buckle 188 is fixedly attached to the fixed end 186 of transverse strap 190 which is fastened to the splint body 100 by rivet 189 .
  • transverse strap 190 is secured to the splint body
  • transverse strap 190 follows a line from the proximal ulnar edge o f the splint body, across the volar forearm, and over the transverse strap fulcrum 160 , where end 192 having a hoo k and loop fastener strip 193 is removably secured to the distal strap 170 at an arbitrary point, either by using a cooperating hook and loop fastening strip (not shown) or preferably by attachment directly to the material comprising the distal strap 170 which is sensitive to attachment by the hook component of a standard hook-and- loop fastening means .
  • Transverse strap 190 moves to a limited extent across the transverse strap fulcrum 160, a portion of splint body 100 which provides a platform for transverse strap 190 against the forearm and prevents it from rubbing or binding during supination and pronation .
  • the transverse strap 190 tends to stabilize the splint body 100 by translating this
  • the bias ing component 40 is constructed of a formed wire 200 having a supporting end 202 and a torquing end 204 .
  • the formed wire 200 is preferably made from a length of 24 gauge 304 stainless steel with a B2 finish, as is commonly known to physical therapists in the construction of orthopedic appliances .
  • a plurality of spring loops 206 are formed near the torquing end 204 with each comprised of one or more turns of wire as needed to produce a suitable tensioning force at the torquing end 204 of approximately 8 pounds .
  • Formed wire 202 is enclosed in the covering material 208 along the ulnar edge 110 of splint body 10O , wherein the proximal end of supporting end 202 is allowed to rotate freely within the sheath formed by the covering material as the forearm moves in supination and pronation .
  • rivets may be placed at the proximal end of the splint body 100 at the ulnar edge 110 , wherein the proximal end of the supporting end
  • An ulnar saddle 210 is formed in the formed wire 200 and positioned over the distal ulna 52 to rotationally stabilize the formed wire 200 during pronation and supination of the forearm.
  • Rivet 172 around which the ulnar saddle 210 is positioned, serves to stabilize the formed wire 200 from s ignificant proximal or distal movement . As seen more particularly in FIG .
  • the ulnar saddle 210 curves from the ulnar side of the forearm 50 up to a point on the dorsum of the forearm and then back to the plane of the ulnar edge 110 of splint body 100 .
  • the spring loops 206 are formed and positioned along formed wire 200 so that they are located laterally on the ulnar side of the ulnar-radial/metacarpal j oint and the intra-metacarpal j oint and are not covered by distal strap 170 . It is believed that each spring loop 206 models the action of the corresponding j oint .
  • This double loop spring arrangement has been found to provide sufficient proximal-distal tolerance to accommodate changing distance between the metacarpals and the distal ulna-radius during flexion and extension of the hand, and it thus prevents binding of the palmar component 30 when connected to the torquing end 204 .
  • the torquing end 204 of formed wire 200 is shaped so that , when connected with the palmar component 30 and attached to a hand, the hand at substantially 20 ° of dorsiflexion does not encounter resistance from the biasing component 40 .
  • the general loop configuration s the preferred embodiment
  • other tensioning shapes may be us ed to provide resistance to movement of the torquing end o f the biasing component and still remain within the spirit of the invention, namely, to apply a low force load opposing volar glide over long intervals of t ime .
  • an arrangement was formulated (not shown) consisting of slotted bars comprising the support end and torquing end o f the biasing component, with a coiled spring wound around a spool , similar to that found in clocks , fixedly connect ed to the support end .
  • the torquing end rotated about the axis of the coiled spring as the end of the coiled spring applied pressure opposing dorsiflexion .
  • the range of deviation for a hand is approximately 35 ° m a radial direction and 45 ° in an ulnar direction, but much less range is required to achieve the activities of daily living .
  • the biasing component in the form of a shaped wire 200 allows 20 ° ulnar deviation, but less restricti on on radial deviation, thus permitting a more natural movement of the hand .
  • the palmar component 30 is illustrated as having a rigid ulnar gutter 300 enclosing the ulnar side of the hand and serving as a platform for the fixed attachment of connection block 310 .
  • Ulnar gutter 300 is preferably comprised of a plastic material of any suitable composition to enable it to be custom fitted and shaped to the individual hand.
  • Connection block 310 is permanently affixed to ulnar gutter 300 by any suitable means known to the art, including rivets , screws , glue , or capture in a molded channel in ulnar gutter 300 .
  • Palm strap 320 i s permanently affixed to the volar end 302 of the ulnar gutter 300 by means of a rivet 322 , although any suitabl e means known to the art can be employed .
  • the volar end 302 of ulnar gutter 300 and the volar end 324 of palm strap 320 are shaped so that they are substantially confined between the thenar crease 62 and the MCP joint crease 64 of a typical hand 60 so as to permit unimpeded use of the hand during normal activities of daily living . Palm strap 320 narrows as it passes over the thenar web 66 in order to prevent interference with normal activities . This contouring of palm strap 320 allows unobstructed flexion of the fingers and opposition movement of thumb with that of fingers .
  • the dorsal end 326 of palm strap 320 is removably secured to the dorsa l end 304 of the ulnar gutter 300 by cooperating hook and loop attachment strips 328 attached to the palm strap 320 and ulnar gutter 300 by any suitable means .
  • An alternate embodiment (not shown) for palm strap 320 would be to employ the buckling arrangement as described for distal forearm strap 170, while contouring the shape of the strap to accommodate the thenar crease, the MCP j oint crease , and the thenar web as described above .
  • connection block 310 is formed o f a rectangular block of material, preferably of metal composition, having a top side 319 as shown in FIG . 10, a receiving end 317 as shown in FIG . 9 , and a clamping end 318 as shown in FIG . 10.
  • Receiving end 317 has a centrally located horizontal bore 311 which is colinear with the longitudinal axis of connection block 310.
  • An inclined bore 312 in the same axial plane as the horizontal bore 311 is slantingly positioned so that at receiving end 317 inclined bore 312 does not intersect horizontal bore 311 .
  • Incline bore 312 is slantingly disposed towards the clamping end 318 and horizontal bore 311. Inclined bore 312 gradually approaches horizontal bore 311 so that it intersects horizontal bore 311 forming notch 313, which gradually becomes wider as inclined bore 312 fully intersects and terminates before exiting horizontal bore 311 on its opposite side.
  • Vertical bore 314 intersecting two opposing faces of connection block 310 is perpendicular to the axis of both inclined bore 312 and horizontal bore 311 and is located at the widest point of notch 313.
  • Vertical bore 314 is threaded to receive set screw 315.
  • a dado is formed between the inclined bore 312 and the top side 319 of connection block 310. Top side 319 is fixedly joined to ulnar gutter 300 with its receiving end 317 oriented proximally and its clamping end 318 oriented dorsally as described previously.
  • the torquing end 204 of formed wire 200 is inserted into the horizontal bore 311 on the receiving end 317 and made to protrude from the clamping end 318.
  • the ulnar gutter 300 is positioned and strapped to the ulnar side of the hand.
  • Set screw 315 is then tightened against formed wire 200 to force formed wire 200 into notch 313 which clamps the connection block 310 to the formed wire 200, so that connection block 310,and consequently the ulnar gutter 300 and the entire palmar component 30, is constrained from rotational movement about formed wire 200 and from longitudinal motion along formed wire 200 by the clamping action of notch 313 on formed wire 200 .
  • This embodiment of the invention has been described to illustrate one way in which the theory of the invention is implemented in a dynamic orthot ic .
  • This embodiment while effective in treating CTS , has not proven to be conducive to mass manufacture , but it has been presented to show how the problems of preventing binding during supination and pronation and of providing a biasing component with the proper characteristics can be solved without departing from the basic concept of the invention .
  • FIGS . 12 through 15 The preferred embodiment of the invention is shown in FIGS . 12 through 15 .
  • This embodiment has been found to be more manufacturable than the previous embodiment and illustrates how the implementation of bias ing component and the solution to prevent binding of the biasing component can differ from the first embodiment and still be within the concept of the invention .
  • FIGS . 13 and 14 which illustrate in perspective the ulnar and radial aspect of the orthotic as it is worn on the right forearm 50
  • FIG 15 which shows the pattern of the forearm component
  • the preferred embodiment of the invention consi sts of orthotic 400 which is also composed of a palmar component 410 , a biasing component 420, and a forearm component
  • the palmar component 410 is essentially the same as palmar component 30 described previously .
  • the body 431 of the preferred embodiment cons ists of two pieces of a substantial external nylon or other anti- perspiration material, such material as is in common us e and knowledge among physical therapists , cut to the shaoe seen in FIG . 14 and enclosing a core pad of neoprene. Also enclosed within the two layers of covering material are several metal portions which shall be described presently .
  • the covering material should be sensitive to attachment by the hook component of an industry standard hook-and-loop system of the type sold under the trademar k "VELCRO" , so that distal buckle 175 and proximal buckle 188 of the previous embodiment can be eliminated and transverse strap 440 and distal carpal strap 460 can be removably attached to appropriate areas of splint body 431 , as described below .
  • the ulnar support plate 470, radial support plate 480 , and block plate 490 are sandwiched between the two layers of material composing the splint body 431 .
  • Each plate defines a reinforced area on the orthotic to assi st strap attachment to body 431 and to position and orient bias ing component 420 to the forearm.
  • Ulnar support plate 470 is positioned on the ulnar portion 432 of body 431 and radial support plate 480 is positioned on the radial portion 433 of body 431 and in opposing relation to ulnar support plate 470 . Both are composed of plastic, dead soft aluminum ( a term familia r to persons knowledgeable in the art ) , or some other suitable material which is relatively rigid . Dorsal gap
  • a first end of dorsal strap 450 is attached to ulnar support plate 470 by means of rivet 500 inserted through washer 501 , the outer fabric covering of body 431 , ulnar support plate 470, the inner fabric covering of body 431, anothe r washer (not shown) , and secured in place in the manner o f rivets .
  • a second end of dorsal strap 450 is attached to radial support plate 480 in the same manner as the first end and secured by rivet 502 and washer 503 .
  • Dorsal strap 450 is positioned on the dorsum of forearm 50 (FI G .
  • transverse strap 440 i s fixedly attached to radial support plate 480 by means of rivet 504 and washer 505 in the same manner as des cribed previously .
  • transverse strap 440 has a hook portion 441 sewn thereto and on one side so that i t can be wrapped about the volar forearm and attached to the surface of the ulnar distal portion of body 431.
  • Transverse strap 440 corresponds to transverse strap 190 of the first embodiment ( FIG . 3 ) , but passes from the radial proximal side of the forearm to the distal ulnar side , rather than from the ulnar proximal side of the forearm to the distal radial side as shown in FIG . 3.
  • transverse strap 440 stabilizes body 431 by translating differential rotation motion observed in supination and pronation to the radia l portion 433 to maintain alignment of radial portion 433 with the radius of forearm 50 . In both cases , transve rse strap 190 , 440 loads the supporting end of the biasing component 40 , 420 .
  • block plate 490 is located on the distal edge 435 of splint body 431 and sandwiched between the two layers of material composing the splint body 431 . It may be composed of a rigid material which may be appropriately formed, such as plastic, dead soft aluminum, and the like . It s function is to provide support for distal carpal strap 460 and to provide a platform for the biasing component 420 . Bloc k plate 490 is comprised of the following three portions : curved portion 491, horizontal portion 492 , and vertical portion 493 . These portions are shown more clearly in the cross-sectional view shown in FIG . 15 .
  • Vertical portion 493 forms a ninety degree angle with horizontal portion 492 at bend 497; curved portion 491 begins its curvature at bend 496 and continues around the carpus for an arbitrary distance .
  • Construction of block plate 490 out of dead soft aluminum permits curved portion 491 to be easily molded to each individual carpus .
  • Horizontal portion 492 is parallel to the plane 55 defined by the centers of the ulna and radius of forearm 50 . It has been found by experimentation and measurement that the ninety degree orientation between portions 493 and 492 remains invariant over the range of supination and pronation .
  • Along the angled proximal edge 498 of block plate 490 are two tabs 494 and 495 to accommodate the biasing component which shall be presently described.
  • Tabs 494 , 495 are bent back over portion 492 to capture a section of the biasing component 420 therebetween for rotational movement of biasing component 420 .
  • the first end of distal carpal strap 460 is fixedly attached to block plate 490 by means of rivet 506 and washer 507 in the same manner as previously described for the first end of the dorsal strap .
  • the second end of distal carpal strap 460 has a hook portion 461 sewn thereto and on one side so that it can be wrapped about the carpus and attached to the surface of the distal portion of body 431 to hold body 431 in close contact and orientation with the forearm.
  • biasing component 420 is illustrated in FIG . 14 . It is comprised spring wire and divided into a torquing end 423, a middle segment 422, and a support end 421 , with middle segment
  • Torquing end 423 extends from the within body 431 to attach to the palmar component 410 in the same manner as described previously .
  • spring loops 424 positioned along the wire so that they are located laterally on the ulnar side o f the distal forearm/carpal j oint and the carpal /metacarpal j oint and slightly dorsal to the axis of the carpus .
  • the two spring loops 424 may optionally be enclosed in a pouch (not shown ) composed of the same material comprising the splint body 431 in order to prevent chafing of the ulnar side of the hand and to provide a comfortable pad .
  • Middle segment 422 is loos ely captured by tabs 494 , 495 on block plate 491 so that torquing end
  • Support end 421 extends along the radial side of forearm 50 so that its end is captured between radial support plate 480 and the outer layer of fabric comprising body 431 . Support end 421 may be bent slightly from the plane formed by
  • an ulnar arm 425 formed of spring wire is loosely attached to the wire at the apex of the angle formed by the torqueing end 423 and middle segment 422 by means of a simple loop in its end.
  • the opposite end of ulnar arm 425 is captured between ulnar support plate 470 and the outer layer o f fabric comprising body 431 .
  • the preferred specifications for the bias ing component are as follows .
  • the distance between the proximal spring loop 424 and the bend between middle segment 422 and the torqueing end 423 has been found to be 0 . 65 inches .
  • the obtuse angle between the middle segment 422 and torquing end 423 should be between 125 ° and 130 ° , and the angled proximal edge 498 of block plate
  • the obtuse angle between the middle segment 422 and support end 421 should be between 125 ° and 135 ° .
  • the invention is designed to realistically mirror the movement of the hand without interfering with the normal activities of daily living .
  • the biasing component is positioned by the palmar component and the forearm component to reside laterally on the ulnar side of the distal forearm/carpal j oint and the carpal/metacarpal j oint , and slightly dorsal to the axis of the carpus . This positioning allows the appliance to correctly track: the elliptical path that the hand follows during extension and flexion . It is adj usted by the therapist or at the factory so that force applied by the biasing component is neutral when the palm is at approximately 20 ° dorsiflexion .
  • the biasing component tends to force the palm back to the neutral position at 20 ° dorsiflexion .
  • Thi s force is resisted by the extensor muscles of forearm 50 which further tends to strengthen the extensors and restore a normal four to one flexor to extensor ratio, which tends to stabilize the carpal-metacarpal j oint . 2 t the same time the dorsal attitude of the palm tends to apply a long-term low force against the PTCL and over time will lengthen the ligament and relieve the symptoms of carpal tunnel syndrome .
  • the support end of the biasing component sets the tension of the dual springs at the carpus by tightening or loosening the transverse strap, which loads the springs to the desired tension. This permits the tension on the biasing component to be easily adjusted .
  • the design of the biasing component in the preferred embodiment enables the orthotic to fit more individuals because it will accommodate varying sizes of forearm and wri st . Measurable improvement in the patient ' s condition should be observed in about three to four weeks of continuous use . While only two embodiments have been illustrated and described, they serve to illustrate obvious modifications which are contemplated within the scope of this invention and the following claims . Accordingly, the scope of the invention should be determined not by the embodiments illustrated but by the appended claims and their legal equivalents .

Abstract

Cette invention concerne une méthode et un dispositif relatif à une attelle permettant d'appliquer une pression dynamique sur les ligaments carpiens transversaux, médiocarpiens et intracarpiens. Cette attelle, qui tend à atténuer les contractures des ligaments, soulage par là même la douleur et corrige une cinématique modifiée par suite d'un syndrome du canal carpien, ce qui a pour effet d'augmenter le volume carpien tout en laissant au patient la liberté de son poignet pour une gêne minimale lors des activités de la vie courante, tant à la maison qu'au travail. Ce dispositif comprend un élément d'avant-bras (431) constituant le corps de l'attelle qui est conçu pour maintenir en alignement et soutenir un élément de contrainte (420) disposé sur le côté cubital de l'avant-bras (50). Cet élément de contrainte (420) comprend un ressort (424) situé approximativement sur le côté cubital du carpe et est relié à un élément palmaire (410) fixé au côté cubital de la main. L'élément de contrainte (420) exerce une force résistive au glissement palmaire d'une façon qui reproduit avec précision la cinématique du carpe et de l'avant-bras.
PCT/US2000/024791 1999-09-08 2000-09-08 Attelle dynamique pour traitement du syndrome du canal carpien WO2001017467A1 (fr)

Priority Applications (3)

Application Number Priority Date Filing Date Title
AU73650/00A AU7365000A (en) 1999-09-08 2000-09-08 Dynamic splint for carpal tunnel syndrome treatment
CA002384683A CA2384683A1 (fr) 1999-09-08 2000-09-08 Attelle dynamique pour traitement du syndrome du canal carpien
EP00961736A EP1233733A4 (fr) 1999-09-08 2000-09-08 Attelle dynamique pour traitement du syndrome du canal carpien

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US39157799A 1999-09-08 1999-09-08
US09/391,577 1999-09-08
US22722500P 2000-08-23 2000-08-23
US60/227,225 2000-08-23

Publications (1)

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WO2001017467A1 true WO2001017467A1 (fr) 2001-03-15

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PCT/US2000/024791 WO2001017467A1 (fr) 1999-09-08 2000-09-08 Attelle dynamique pour traitement du syndrome du canal carpien

Country Status (4)

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EP (1) EP1233733A4 (fr)
AU (1) AU7365000A (fr)
CA (1) CA2384683A1 (fr)
WO (1) WO2001017467A1 (fr)

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Publication number Priority date Publication date Assignee Title
DE102020112003A1 (de) 2020-05-04 2021-11-04 Christian-Albrechts-Universität Zu Kiel Gelenk-Schutz-Schiene sowie Verwendung dieser
WO2023249977A1 (fr) * 2022-06-21 2023-12-28 Dimension Orthotics, LLC Fabrication soustractive en 3d de plâtres, d'attelles, d'éclisses et autres orthèses

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US4862877A (en) * 1987-11-18 1989-09-05 Lmb Hand Rehab Products, Inc. Hand splint for wrist support with optional support of MP joints and thumb and IP finger assists
US4966137A (en) 1989-09-19 1990-10-30 Davini Mark A Splint system
US5385527A (en) 1990-07-26 1995-01-31 Du Pont-Mitsui Polychemicals Co., Ltd. Method for the preparation of cylindrical members for paper containers
US5417645A (en) 1993-11-29 1995-05-23 Lemmen; Roger D. Flexible wrist splint for carpal tunnel syndrome treatment
US5468220A (en) 1995-02-27 1995-11-21 Sucher; Benjamin M. Carpal tunnel bracelet
US5695453A (en) * 1995-12-22 1997-12-09 Deroyal Industries, Inc. Limb immobilizer having reinforcing wire members embedded therin

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US4677971A (en) * 1985-12-26 1987-07-07 Rolyan Manufacturing Co. Inc Adjustable wrist splint
US5002044A (en) * 1989-10-10 1991-03-26 Carter Peter R Derotation wrist brace
US5653680A (en) * 1995-08-10 1997-08-05 Cruz; Mark K. Active wrist brace

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US4657000A (en) * 1981-07-23 1987-04-14 Dynasplints Systems, Inc. Adjustable splint and securing means therefor
US4862877A (en) * 1987-11-18 1989-09-05 Lmb Hand Rehab Products, Inc. Hand splint for wrist support with optional support of MP joints and thumb and IP finger assists
US4966137A (en) 1989-09-19 1990-10-30 Davini Mark A Splint system
US5385527A (en) 1990-07-26 1995-01-31 Du Pont-Mitsui Polychemicals Co., Ltd. Method for the preparation of cylindrical members for paper containers
US5417645A (en) 1993-11-29 1995-05-23 Lemmen; Roger D. Flexible wrist splint for carpal tunnel syndrome treatment
US5468220A (en) 1995-02-27 1995-11-21 Sucher; Benjamin M. Carpal tunnel bracelet
US5695453A (en) * 1995-12-22 1997-12-09 Deroyal Industries, Inc. Limb immobilizer having reinforcing wire members embedded therin

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102020112003A1 (de) 2020-05-04 2021-11-04 Christian-Albrechts-Universität Zu Kiel Gelenk-Schutz-Schiene sowie Verwendung dieser
WO2021223803A1 (fr) 2020-05-04 2021-11-11 Christian-Albrechts-Universität Zu Kiel Attelle de protection d'articulation et son utilisation
WO2023249977A1 (fr) * 2022-06-21 2023-12-28 Dimension Orthotics, LLC Fabrication soustractive en 3d de plâtres, d'attelles, d'éclisses et autres orthèses

Also Published As

Publication number Publication date
AU7365000A (en) 2001-04-10
CA2384683A1 (fr) 2001-03-15
EP1233733A4 (fr) 2004-05-12
EP1233733A1 (fr) 2002-08-28

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