CA2285662A1 - Orthotic device for treating contractures due to immobility - Google Patents

Abstract

An orthotic device is disclosed which is useful for extending the range of angular movement between adjacent first and second body parts which are and have been drawn to and involuntarily held in an immobile angular position relative to one another by contraction of muscles and connective tissue due to immobility. The orthotic device ( 140) comprises first (174) and second (176) orthotic device portions which are interconnected for permitting pivotal angular motion therebetween. A spring (160, 162) is connected between the first and second orthotic device portions for urging the first orthotic device portion to return to its initial angular position relative to the second orthotic device portion. The orthotic device may be configured for use with an arm, leg, ankle, head, back, and other skeletal body parts.

Description

'WO 98/43560 PCT/US98/05985 ORTHOTIC DEVICE FOR TREATING CONTRACTURES
- DUE TO IMMOBILITY
BACKGROUND OF THE INVENTION:
Field of the Invention:
The present invention relates generally to the field of orthotic devices and appliances; more particularly to orthotic devices and appliances useful for restoring movement to a connective joint of a mammalian body; and still more particularly to orthotic devices and appli-ances used to reverse contractures due to immobility and neurological dysfunction.
Background Discussion:
Webster's New Collegiate Dictionary defines "orthotics" as "a branch of mechanical and medical sci-ence that deals with the support and bracing of weak or ineffective joints or muscles."
Orthotic devices and appliances, commonly referred to just as "orthotics" (in spite of the broader diction ary definition of orthotics) have been utilized for many years by physical therapists, occupational therapists, and certified orthotic fitters to assist in the rehabili tation of loss of range of motion (LROM) of patients' joints and associated limbs or adjacent skeletal parts of the patients' body.
Orthotics, as well as splints, have been designed both to maintain and to restore the range of bodily mo-tion due to LROM. Such loss of range of motion may, for example, be caused by traumatic injury, rehabilitation following joint or limb surgery, and contracture due to immobilization caused by neuromuscular disorders (e. g., ' stoke and closed head injury) and other disease processes that significantly limit a patients ability to use a joint for normal activities of daily living (ADL).
SUBSTITUTE SHEET ( rule 26 ) Two fundamentally different types of contractures exist which clinically should have two different treat-ment protocols. The difference in these two types of con-tractures is the basis for the clinical techniques and design of the orthotics of the present invention which will be described below.
A first one of these two fundamentally different types of contracture may be defined as a fixed, high re-sistance of muscle to passive stretch resulting from fi-brosis of the muscles and joints, or from disorders of the muscle fiber resulting in LROM, for example, of a pa tient's arm or leg. In this regard, Webster's Dictionary defines "contracture" as "a permanent shortening (as of muscle, tendon and scar tissue) producing deformity or distortion."
This first type of contracture is usually due to trauma, injury, or surgical intervention affecting the joint, as may be typical of sports injuries and the treatment thereof. As the injured tissue heals, edema, post trauma or surgically affected tissue regeneration and other natural healing processes result in fusing to-gether of what were, prior to the trauma, separate, pris-tine connective tissues, that is, the collagen fiber ma-trix (depicted diagrammatically in FIG. lA hereof), capa-ble of easily gliding over one another, as is needed for normal joint movement and related muscle elongation.
However, post-trauma, this collagen fiber matrix be-comes random and irregular (depicted diagrammatically in FIG. 1B hereof), and neither elongates nor stretches com pared to non-traumatized collagen fibers. This fusing together or adhesion of connective tissue structures (e.g., ligaments, tendons, synovial membrane, fascia and fibrous joint capsules) is the result of the tissues be-ing invaded by developing undifferentiated scar between adjacent tissue, thereby diminishing or preventing the mut=ual gliding after early healing of the trauma or post-surgical trauma has been accomplished.
SUBSTITUTE SHEET ( rule 26 ) 'WO 98/43560 PCT/US98/05985 Such fu sing together of connective tissue is a lead-- ing cause of lags (a non-specific indictment of the motor system's failure to move the affected joint through the a full available passive range) relating to tendon gliding, depending on their strategic placement in reference to structures crossing the joint. With limited mobility and associated extensor muscle atrophy, combined witty the formation of adhesions and scar. tissue in the forrn of a significantly increased number of joined fiber matrix junctions, the muscle fibers become shortened.
The restoration of full range of motion where fibro-sis of the muscle fiber with scar tissue and adhesions are present, requires that the adhesions and scar tissue or fused fiber matrix junc:ti.ons tie "worked through" or broken to restore normal functional elongation or stretch. The term "no pain, no gain" (of increased ROM) is associated with the process of breaking through joined or fused fiber matrix junctions t.~ resCore full el~nga-tion of the connective tissue, tendon:: and muscles asso-ciated with the trauma-affected joint..
Heretofore known orthotics are primarily designed t:c~
treat this first type of contracture, but have also been used to treat contr.3ctures caused by immobility and rreu-rological dysfunction (described I~elow). However, suc.-.h orthotic devices are not, as far as is known by the pres-ent inventor, best suited for such additional purpose.
The second and very different type of contracture results from joint immobility--not joint-related trauma or surgical repair of a joint. Contracture resulting from immobility is simply a shortening and thickening of the connective tissue, tendons and muscles (depicted in FIG. 1C hereof) that restrict the ROM of a joint. In such situations, the muscle fibers still retain their original uniform shape and t: he re are no adhesions or scar tissue or significantly increased joined fiber matrix junctions to break through in order to restc~r.e full range of mo-tion.
SUBSTITUTE SHEET ( rule 26 ) 'WO 98/43560 PCT/US98/05985 In contrast to trauma-caused contractures, contrac-tures due to immobility do not need a "no pain. no gain"
approach to restoring the normal range of motion, and, in fact, such an approach can actually do more harm than good. As mentioned above, the collagen fibers of a con-tracture due to immobility are simply shorter and thicker, and will respond to appropriate stretching tech-niques and motion of the joint to restore LROM. The stretching technique usually used f.or contractures caused by immobility is Range Of Motion (ROM) Therapy and the use of Low-Load Protracted Stretch/Stress (LLPS) or "extended stretch" static or dynamic orthotic devices.
According to authors Kenneth R. Flowers and Susan L.
Michlovitz in their article titled 'ASSESSMENT AND
MANAGEMENT OF hOSS OF MOTION IN ORTHOPEDIC DYSFUNCTION"
(published in Postgraduate Advances in PHYSICAL THERAPY, American Physical Therapy Association, 1988 II-VIII), To-tal End Range Time (TERT) in conjunction with LLPS is the key to restoring full. ROM.
All contractures, whether caused by injury, surgery, or immobility, limit range of motion of the affected joint and make simple activities of. daily living, sue:h as eating and sell-dressing, more difficult, if not impossi-ble. Moderate to severe contractures can be debilitating, and can leave afflicted individuals bed-bound and unable to care for themselves in the most basic daily living tasks. Even mild contractures due to immobility can prog ress to severe contractures if proper intervention is not prescribed and implemented so long as the immobility con tinues.
SUBSTITUTE SHEET ( rule 26 ) 'WO 98/43560 PCT/LJS98/05985 Electrotherapy has been used extensively in the rehabilitation of joint and muscle related injury, pain, - and LROM. Electrotherapy also has demonstrated other valuable healing properties. Many forms of electrotherapy exist, and are characterized by the wave form of the electrical current. The wave form "rate" or frequency refers to the number of pulses delivered per second. Pulse rate is the number of pulses in each energy wave. Pulse width is the length of time each energy burst stays on (for example, double pulse width to double the energy in that pulse). Pulse amplitude or height of the pulse increases as the amplitude setting is increased. The total energy per pulse is determined by the amplitude and pulse width. Many variations of electrotherapy wave forms exist that are utilized therapeutically for joint rehabilitation, pain management, and the healing properties provided by electrical stimulation.
The use of transcultaneous electric neuromuscular stimulation or TENS has been used extensively to treat muscle injury and related pain. TENS is characterized by biphasic electric current and selected parameters.
TENS has clinically demonstrated the ability to increase blood flow, reduce swelling and edema, and provide both acute and chronic pain relief. TENS is commonly used to treat back and cervical muscular and disc syndromes, arthritis, shoulder syndromes, neuropathies and many other conditions. Neuromuscular electrical stimulation or NMES also provides many therapeutic benefits. NMES
is characterized by a low volt stimulation targeted at motor nerves to cause a muscle contraction.
Electrically controlled contraction/relaxation of muscles has been found to effectively treat a variety of musculoskeletal and vascular conditions. It is used to maintain or increase range of motion, prevent or retard SUBSTITUTE SHEET ( rule 26 ) disuse atrophy, muscle re-education, relaxation of muscle spasm, increase circulation, and for deep vein thrombosis prevention.
Microcurrent therapy is characterized by a subsensory current that acts on the body's naturally occurring electrical impulses to decrease pain and facilitate the healing process. Such form of electrotherapy provides symptomatic pain relief for both post surgical and post traumatic acute pain.
Interferntial therapy or IF is characterized by the crossing of two medium, independent frequencies which work together to effectively stimulate large impulse fibers. These frequencies interfere with the transmission of pain message at the spinal chord level.
Because of these frequencies, the IF wave meets low impedance when crossing the skin to underlying tissue.
This deep tissue penetration can be adjusted to stimulate parasympathetic nerve fibers for increased blood flow and edema reduction. High Voltage Galvanic Therapy is characterized by high volt, pulsed galvanic stimulation, and used primarily for local edema reduction through muscle pumping and through "polarity effect". This type of electrotherapy is used to increase or maintain range of motion, to treat disuse atrophy, for muscle re-education, to increase circulation, and to treat degenerative joint disease.
Different electrotherapy wave forms, for example, as described above, have been identified for the treatment of varying conditions. Some of the benefits are perceptible to the user ( felt during therapy) and others are below the perception level. The specific electric pulse width and pulse rate can be controlled and varied, and as a result can have a wide range of clinical benefits. Electrotherapy can elicit very significant muscle contraction of specific muscles to SUBSTITUTE SHEET ( rule 26 ) entire muscle groups. On the opposite end of the spectrum, electrotherapy can be used to inhibit muscle - contraction and even provide total nerve block therapy simply by directing the correct electrical wave form to S the appropriate site to have the desired clinical effect. Electrotherapy has also been used to keep neurotransmitters in the muscles functioning normally until new neuropathways can be developed to reconnect the muscle groups to the brain post stroke, spinal cord injury, closed head injury, etc.
Electrotherapy has also been used to provide soft tissue therapy, and has been used extensively for the repair of nerves, tendons and ligaments as well as muscles. IF and electro-therapeutic applications have been used to treat contractures, re-connect damaged neuro-pathways, teal chronic wounds, and to treat incontinence. The U.S. Public Health Department in it's pamphlet on The Treatment of Pressure Sores cited electrotherapy has having the greatest clinical promise of providing possible treatment breakthroughs in the treatment of chronic wounds.
Electrotherapy is applied primarily through the use of an electrotherapy unit (device emitting a controlled electrical wave form and amplitude) through electrical connections to strategically placed electrodes placed on the body to provide electrical current to the desired site.
A principal objective of my c:.urrent invention is ar.-cordingly to provide more clinically effective orthotics that are an alternative to the known types of orthotics - currently used to treat: contractures caused by immobility and the ROM stretr.hing technique. The main function of - my new and more effective orthotic devices is to treat contracture due to i.mmobility--not trauma related to sur fiery or injury.
SUBSTITUTE SHEET ( rule 26 ) The present inventor considers that TART with Activ ity Stimulus strategy (i.e., flexing)-not LLPS-is the key to predisposing tissue to elongation and restoring range of motion, where LROM i.s due to immobility or neurologi.
cal dysfunction.
The clinical importance and value of my invention are significant in that contractures and other hazards of immobility are one of the ten current highest health care costs in America that are totally preventable. This puts the health risks associated with immobility in the same category as cigarette smoking, alcohol and drug abuse, and automobile accidents in financial impact on American health care costs.
The new orthotic devices of the present invention provide more effective clinical treatment for LROM due to immobility by increasing the "stimulus of activity" of the affected tissue (connective and muscle fiber) rather than just holding the issue in moderately lengthened po sition (LLPS or "gradual extension" therapy). According to Brand (1984), "It is better not to use the word stretch for what should be long-term growth. If we want to restore normal length to a tissue that has shortened after disease (or disuse), we need to reverse the process and apply the stimulus of activity. or better, the stimu-lus of holding the tissue in the moderately lengthened position for a significant time." According to Brand, it will then "grow" or lengthen. Flowers and Michovitz in the before-mentioned article theorize that the joint somehow senses or computes the total stress applied to it in any given direction over a period of time. It then stimulates a proportionate amount of biological activity, leading to a proportionate mount of remodeling of the stressed tissue. The total stress is a product of its intensity, frequency and duration. The crucial elements in this conceptual model are frequency and duration. To-tal stress equals intensity times frequency times dura-tion (intensity x frequency x durati.on).
SUBSTITUTE SHEET ( ruie 26 ) ~VVO 98/43560 PCT/US98105985 The present: orthotic devices increase the stimulus - of activity relative to current orthotic devices which simply hold the limb and joint in an extended position for extended periods. Conceptual.iy, patient outcomes should be more positive based upon an increased stimulus of activity as well as providing moderate stretch for a prolonged period with the new devices. The cycling or repeated extension and contraction of the joint by the new devices provides the additional benefits of motion (activity), increased lubrication of the tissues (production of synovial fluid) facilitating movement, and muscle re-education and diminished spasticity where neu-rological dysfunction is present (stroke, closed head in-jury, MS, etc.). The level of activity is higher with the new devices when high tone, spasticity, or moderate to high contraction reflexes are present in the affected limb and joint. 'thus the new dr'vices are uniquely appro-priate for contractures due to immobility where neuro-logical dysfunction is present in the affected limb.
SUMMARY OF THE INVENTION:
In accordance with the present invention, there are provided orthotic devices, for example, in combination with electrotherapy, useful for extending the range of angular movement between adjacent first and second skeletal body parts which have been drawn to and involuntarily held in a shortened or restricted angular position (limited to a narrow range of motion) relative to one another by contraction of muscles and connective tissue due to immobility. Each such orthotic device comprises a first orthotic device portion, a second orthotic device portion, and means interconnecting the first and second orthotic device portions for permitting relative angular motion therebetween. Included are means for establishing an initial angle between the first and second orthotic device portions.
Further comprising the orthotic device are means for operatively applying or connecting the first orthotic de vice portion to the first body part; and the second or --, , SUBSTITUTE SHEET ( rule 26 ) thotic device portion to the second body part after the first body part has been pivote~J, by an externally-applied force, to an increased angular position relative to the second body part:, the first and second orthotic 5 device portions being then set by the establishing means at the initial angular position relative to one another which corresponds to Che increased .~nyular position of the first body part relative to the second body part.
Spring means are connected between the first and 10 second orthotic device portions for urging the first or thotic device portion to return to its initial angular position relative to the second orthotic device portion when the first ortholic device portion i.s pulled by the applied first body part through muscular contraction and/or the elastic properties oC the muscles and connec-tive tissue from the increased angular position Coward the first angular position of I:he first body part rela-i.ive to the seconcJ I~c~dy part, thereby pulling the f i rsl body part back toward the increased angular position relative to the sPCOnd body part.
The spring means are configured so that pivotal movement of the first orthotic device portion relative to the second orthotic device portion away from the in-creased angular position causes a restoring loading of the spring means. This restoring loading of the spring means and the muscular contraction and/or the elastic properties of the muscles and connective tissue of the first body part act. against one anot~.her and cause the first body part to cycle angularly toward and away Cram the flrst an~g.ular position and the increased angular. po-silion without further external intervention, thereby c~msing a gradual angular loosening of the first t_~ody part relative to the second body part and ultimately po-sitioning the first body part at t:he increased angular position without the yoplication oC alher forces.
The spring means are further configured for providing substantially no or a low load spring force between the first and second orthotic device portions when the first orthotic SUBSTITUTE SHEET { rule 26 ) device portion is at the initial angular position rela-tive to the second orthotic device portion.
In one embodiment of the invention, the first body part comprises the individual's upper limb part and wherein the second body part comprises the individual's lower limb part, the limb being the indi.vidual's arm or.
leg.
In such case, the first orthotic device portion in-cludes a first cuff and the second orthotic device por-tion includes a second cuff. The applying means releasa-bly attaches the first cuff to the lower limb part and releasably attaches the second cuff to the individual's upper limb part.
The interconnecting means comprise at least one stiff member having a first end region fixed to the first cuff and a second end region fixed to the second cuff and including a hinge intermediate the first and second end regions for enabling relative anpul.ar movement thereL~e t:ween in a plane ~Js~lined key Che longitudinal axis of the limb upper and lower parts.
Means are included for releasably locking the hinge at any selected angular position of the first end region relative to the second end region. The hinge may also or alternatively include a ratchet for enabling the opening of the first end region relative to the second end region from one angle therebetween to a larger angle therebe-tween.
Preferably, the spring means comprise relative out wardly bowing and twisting of the first and second end regions of the member when the first end region of the bar is pivoted from the initial angular position relative to the second end region to a smaller angle therebetween.
In a variation orthotic device, the orthotic device of the present invention comprises a thermal setting, flexible member having first and second regions defined by a bend line between the first and second member re gions, a bend at the bend line being set by heating, bending and cooling the member at the bend line, the bend SUBSTITUTE SHEET ( ruie 26 ) line permitting angular movement and enabling the setting of ,a selected angle between ttie f i r. st and second member regions.
Means are included applying or attaching the first member region to the first body part and the second or thotic device portion t:o the seconcJ body part after the first body part has been moved against rontracture forces away from the LROM position to an initial extended range of motion (ROM) angular position relative to the second body part, the first and second member regions being then set at the initial extended range of motion position relative to one another.
Also includes are spring means associated with the first and second member regions for urging the first mem ber region to return to the extended ROM position in re sponse to the f i r st: member reg ion bc~i ng pulled by the ap-plied or attache~J first body part through muscle fiber contraction and/or tl~e elastic properties of the muscle fibers and connective tissue away from the extended ttOM
position and toward said LROM positi~,n, thereby causing a cycling movement: of the first bogy part between sai~j ex-tended ROM and LROM angular po~iti.ons and a gradual loos-ening of the first body part rel.al.ive to the second body pert and an nlt:im~ite nxtendin~~ of the ROM of the first 2~ body part re.i.ati.vE~ Co the second body part at the ex-tended ROM position without additional external interven-tion.
The spring means are configured for providing substantially no or a low load spring force between the first and second orthotic device portions when the first orthotic device portion is at the initial extended ROM angular position relative to the second member region.
In one version, the first body part comprises the individual's forearm at the wrist and the second body 35 part comprises said individual's hand. In another ver-sion, the first. body part comprises the individual's lower leg at the ankle and the second body part comprises said individual's foot.
SUBSTITUTE SHEET ( rules 2,6~~j ~~j 'WO 98/43560 PCT/US98/05985 In another version, the first body part comprises the individual's back at the neck and the second body part comprises the individual's head. In another ver-sion, the first body part comprises an upper region the individual's back and the second body part comprises a lower region of the individual's back.
In still another version, the first body part com-prises an individual's upper thigh after lower regions of the leg have been amputated and the second body part com-prises a lower region of the individua.l's torso at the hip.
In yet another version, the body part comprises the individual's forearm at the wrist and the second body part comprises said individual's hand.
In the orthotic device for each of the pairs of body parts it is preferred that the spring means are provided by flexibility of ttte elastic member.
SUBSTITUTE SHEET ( rule 26 ) In a particularly useful embodiment, the present invention is directed systems comprising orthotic devices, for example, such as those described herein, and electrode components positioned to be effective to conduct an electrical current to at least one body part of a patient being treated. The orthotic device preferably is adapted to extend the range of angular movement between adjacent first and second skeletal body parts which have been drawn to and involuntarily held in a limited angular range of motion position relative to one another by contraction of muscle fibers and connective tissue due to immobility of one or both of said skeletal body parts. The electrode components preferably include a plurality of individual electrically conductive elements or electrodes strategically placed relative to the orthotic device, for example, in or on the orthotic device, to combine orthotic treatment and electrotherapy. A power source, for example, an electrotherapy unit, such as those of conventional design, disposable units and the like, is used to provide electrical power or enerQV to rhP
electrode component so that electrical current can be provided to the desired body part or parts. Although the orthotic device may be worn by the patient for several hours, the electrotherapy may be actually used for either all or a portion of the time the orthotic is worn.
The combination of electrotherapy and an orthotic device has many advantages over the separate use of each modality. The electrotherapy can be activated through the strategic placement of a plurality of conductive elements or electrodes, for example, in or on the orthotic device to provide numerous therapeutic benefits. Electrotherapy can elicit partial to total muscle inhibition to allow the orthotic device to SUBSTITUTE SHEET ( rule 26 ) provide superior muscle stretch and to eliminate the pain and discomfort sometimes experienced by the wearing of an orthotic device. Muscle strengthening and re-education, muscle contraction inhibition, increased 5 blood flow, nerve stimulation and neuro-pathway reconstruction, and other benefits can also be provided while the patient wears the orthotic device. By combining the application and therapeutic benefits of both modalities in one device, therapeutic patient 10 outcomes as well as patient compliance are often significantly increased. The electrotherapy/orthotic therapy combination preferably reduces the treatment time required relative to the treatment time required if each therapy is provided separately.
15 Many advantages are evident in the combination of the two modalities. A few of the benefits include:
(1) inhibiting contraction of the contracted muscles, tendons. and connective tissue to allow the orthotic device to provide "long effects" or permanent stretch therapy for a greater period relative to using only one of the modalities:
(2) muscle strengthening and re-education of the "antagonist" muscles to provide longer lasting permanent stretch and joint range of motion. By strengthening the antagonist muscle group opposing the "shortened" or contracted muscle group, the "effect" of the contracted muscles is diminished and the muscles are maintained in a stretched permanent position;
(3) by enhancing the development of new neuro-pathways to the brain so that muscle groups non-responsive to brain function can be significantly improved, providing greater post stroke or other neurological disorder rehabilitation, resulting in an improved use of the effected side;
SUBSTITUTE SHEET ( ruie 26 ) (4) increasing blood flow, reducing swelling, and enhancing the production of synovial fluid will enhanced joint movement.

(5) providing muscle contraction inhibition and/or nerve block electrotherapy with the ability of the orthotic device to provide Low Load Prolonged Stretch (LLPS) conveniently allows maintaining an optimal setting of the orthotic device. The orthotic device setting is effectively self adjusted, for example, by a ratchet-like hinge, to the gains made via the electrotherapy portion of combined therapy device. Thus, numerous device checks or modifications become unnecessary; and (6) The combination of electrotherapy with orthotic stretch requires significantly less therapy or caregiver intervention to enhance therapy.
There are other potential benefits to having an electrotherapy component built into the orthotic device.
The list of benefits cited is not meant to be exhaustive, only to provide insight as to the benefit of the present invention to the field of contracture management. The soft goods and/or hard goods of the present orthotic device can be configured appropriately to provide the desired therapeutic result.
SUBSTITUTE SHEET ( rule 26 ) BRIEF DESCRIPTION OF THE DRAWINGS:
The present invention may be more readily understood when taken in conjunction with the accompanying drawings in which:
FIG. 1 is a pictorial diagram depicting, in diagram-matic form, the condition of typical muscle and connec-tive tissue across a joint: FIG. lA depicting the normal condition of a typical bundle or matrix of normal muscle and connective tissue fibers; FIG. 1B depicting the same bundle of matrix of muscle and associated connective tis-sue in a tangled condition associated with post-trauma conditions and showing adhesion «f t:h a muscle and connec-tive tissue fibers; and FIG. 1C depicting the same bundle of muscle and connective tissue fibers similar to normal muscle and connective tissue, but having become shortened as a result of immobility:
FIG. 2 is a pictorial drawing of an upper region of an individual, showing in solid lines, by way of illus-SUBSTITUTE SHEET ( rule 26 ) trative example, the individual's arm involuntarily held in a bent position with the forearm at a high LROM angle, ao, with respect to the upper arm, and further showing, in phantom lines, the forearm extended at increasing an-y gles al through a4 relative to the upper arm by applica-tion of the present orthotics invention;
FIG. 3 is a illustrative graph in which forearm an-gles ao through a4 of FIG. 2 are plotted against repre-sentative intervals of treatment time, depicting several exercise cycles of the individual's arm by use of the present orthotic invention to increase the bend or ROM
angle between the forearm and the upper arm from ao to al in time interval t~ to tl, from as to az in time interval tl to t2, from a2 to a3 in time interval t2 to t3, and from a3 to a4 in time interval t3 to t4:
FIG. 4 is a partially exploded, perspective drawing of a representative elbow orthotic device of the present invention which is constructed for providing gradual ex-tension of a human arm about an elbow joint from an ini-tial, involuntary tight angle ao to an extended angle a4 which enables the individual to restore full or partial ROM of his or her arm;
FIG. 5 is a side view of the representative elbow orthotic device of FIG. 4, showing the device operation-ally installed onto the individual's arm in a manner bridging the individual's elbow, with the upper and lower arm held at an initial stretched ROM angle al (referring to FIGS. 2 and 3);
FIG. 6 is a longitudinal cross sectional view taken along line 6-6 of FIG. 5, showing upper and lower arm cuffs of the elbow orthotic device, and showing construc-tion of an associated pair of interconnecting hinged ele-ments which also function as orthotic device return springs:
SUBSTITUTE SHEET ( rule 26 ) 'WO 98/43560 PCT/US98/05985 FIG. 7 is a side view of the elbow orthotic device of FIG. 4 showing the device operationally installed onto the individual's arm with the upper and lower arm re-turned to initial ROM angle ao (referring to FIGS. 2 and 3) showing flexure of the hinged interconnecting ele-ments:
FIG. 8 is a longitudinal cross sectional view taken line 8-8 of FIG. S, showing the pair of hinged intercon-necting elements flexed and twisted outwardly at the hinge point in a manner providing a torsion spring force to urge the return of the orthotic device and the wearer's arm to the initial open position of angle al:
FIG. 9 is a transverse cross sectional drawing taken along line 9-9 of FIG. 5, showing the manner in which an upper end region of the orthotic device is releasably at-tached to the individual's upper arm;
FIG. 10 is perspective drawing of a representative one of the hinged interconnecting members, showing the first and second end portions disassembled at the hinge and showing the manner in which the hinge holds the two end portions in a fixed relative position;
FIG. 11 is a perspective drawing of an alternative lockable hinge connection between first and second device portions of a hinged interconnecting member, showing a ratchet configuration of the hinge connection which per-mits easier and more rapid extension between the two por-tions:
FIG. 12 is a perspective drawing of a leg- or knee-type orthotic device according to the present invention, showing features of the device and showing the device op-eratively installed on an individual's knee:
SUBSTITUTE SHEET ( rule 26 ) CVO 98/43560 Z p PCT/US98/05985 FIG. 13 is a perspective drawing of a hip abductor-type orthotic device in accordance with the present in-vention showing useful in treating hip contracture which limits the range of motion of one leg of an individual relative to the other leg of the individual, that is, when the leg is maintained by contracture crossed over the other leg;
FIG. 14 is a perspective drawing of an orthotic de-vice in accordance with the present invention for the therapeutic treatment of contracture of a representative portion (stump) of an upper leg after the amputation of the remaining, lower portion of the leg, showing a sub-stantially flat thermal-setting, plastic member having a first portion to be weighted down by the individual's buttocks and a second portion for detachable attachment to the stump;
FIG. 15 is a longitudinal cross sectional drawing taken along line 15-15 of FIG. 14 showing the manner in which the second portion of the device is manually bent (by heating of the device) in steps from an initial treatment ROM angle al to an extended ROM angle a4:
FIG. 16 is a perspective drawing of a foot-type or thotic device in accordance with the present invention for treating contracture of a foot with the toe pointing inwardly and showing construction of the device, includ ing boot and bar portions and showing the boot attached to an individual's foot:
FIG. 17 is a perspective drawing of a first neck/head positioning-type orthotic device in accordance with the present invention for treating contracture of the cervical region of the spine (neck)with the head in a forward and downward direction by contracture of neck muscle fibers and connective tissue showing an elongated neck plate having attached to upper regions thereof a SUBSTITUTE SHEET ( rule 26 ) headband for detachably attaching to an individual's head and further showing an upper torso encircling member. for retaining lower regions of the neck plate:
FIG. 18 is a perspective drawing of a back-type or-thotic device in accordance with the present invention for treating a non-functional functional. (forward; back-ward, S-shaped curvature of an individual's spine and showing a back plate and upper and lower regions of an upper torso harness for detachably attaching correspond-ing upper and lower regions of the device to an individ-ual;
FIG. 19 is a perspective drawing of an upper torso-type orthotic device in accordance with the present in-vention for treating contracture of an individual's upper body in which the upper body is bent forward or to one side and showing construction of the device and showing means for detachable attaching the device to an individ ual's upper body:
FIG. 20 is a perspective drawing of an ankle-type orthotic device in accordance with the present invention for treating contracture of an individuals foot relative to his or her ankle in which the toe portion of the foot is held by contracture substantially straight down with respect to the ankle and showing construction of a boot shaped assemble and means for holding a sole of the boot against the toe portion of the foot;
FIG. 21 is a perspective drawing of a wrist-hand-finger-type orthoti.c device in accordance with the pres-ent invention showing the manner in which the device is constructed and detachably attached to an individual's wrist for treating contracture of an individual's hand relative to his or her wrist, and showing how the device may be used for treatment of contracture of the individ-ual's fingers relative to his or her hand.
f~. . ' . .. ~:5.~
SUBSTITUTE SHEET ( rule 26 ) CVO 98!43560 PCT/US98/05985 FIG. 22 is a perspective drawing of the wrist-habd-finger-type orthotic device depicted in FIG. 19, showing the manner in which the device is used for treating con-s tracture of the indivi.dual's hand relative to his or her wrist and also showing how the device may be used for treatment of contracture of the individual's fingers relative to his or her hand, and further showing the man-ner in which graduated small-to-large finger rolls can be attached to the orthotic device for treatment of contrac-ture of the fingers:;
FIG. 23 is a side view of a head back type of or-thotic device in accordance with the present invention for treating contracture of an individual's neck in a backwardly bent LROM angular contracture position, show-ing an upwardly-extending back member, means for detacha-bly attaching lower regions of the back plate to an indi-vidual's upper body and a elastomeric neck cylinder dis-posed between upper regions of the back plate and the back of the individual's neck just below the individual's head:
FIG. 24 is a perspective drawing showing a series of neck cylinders of graduated diameter useful in the head backward orthotic device of FIG. 23 (and which are repre-sentative of the finger rolls used in the hand-type or-thotic device of FIG. 22);
FIG. 25 is a perspective drawing of a shoulder-type orthotic device further in accordance with the present invention for treating a contracture of an individual's arm relative to the individual's upper body in which the upper arm has a LROM relative to the upper body, showing construction of the device having a pocket for receiving and holding various sizes of elastomeric blocks for caus-ing progressively-increasing ROM of the arm; and SUBSTITUTE SHEET ( rule ~6 ~ °-~

FIG. 26 is a perspective drawing of the shoulder-type orthotic device of FIG. 75 showing the manner in which the device i.~ detachably ottached to the indi.vid-ual's upper arm.
FIG. 27 is a perspective drawing of an elbow-type orthotic device in combination with an electrode component and an electrotherapy unit.
In the various FIGS. identical elements and features are given the same reference number, and similar or cor responding elements and features are or may be given the same reference numbers followed by an a, b, c, and so on, as appropriate and as will be evicJent, for purposes of describing the various orthotic c)evlces of the present orthotic device invention.
DESCRIPTION OF TItE fREFF.:ItRED EM130DIMI:NT:
The present inventor suggests Lhat a better a nder-standing of the presanl, s~rthotis dpvic:r, invention may be had by a more detailed conslcJerW.ic~n «f FIGS. 1-3 wt,irh depict the operative ssperts of the I,rc~sent invent. inn. tt:
is thus believed that a brief consicier.~tion of how and why the orthotic cJevices of t:he preseW invention work will lead to an rrnciersl:.~n~3ing «f t.t,e urthotic devices which are describAd t,e)c~w, As briefly mentioned above, FIt~. l depicts--by way ~5 oC an illustrative example for descrilcl.ive purposes, with no limitation hciny I,hereby int~ncteH c, r- implied--a sim plified diagram of a representative bundle c,r matrix of muscle fibers and ~onne~;t.ive tissue which may control ROM
of typical jo.inl., for example, an ell.c~w of a human t,~
ing.
FIG. lA depir:ls ar represent.at.iv~ bundle or mW .rix 100 of muscle and ~:onnective tissue in ., normal stare c,r condition. FIG.111 cte)ric-.ls a simit.~n, rr't~resentativc~ han-dle 102 of mu s~:le f.it,ers ancJ cc,nnee;l ive tissue in twisted and distorte~.i, post-trauma state or condition. In turn, FIG 1C depie:t.. a similar., reC,resentative bundle lflA
of muscle fibers anrl connectJVe tissue in a shortened, but non-distorted sl. ~I.e or ~ondit ic,n a , .i result oC immo-bility.
SUBSTITUTE SHEET ( rule 26 ) The present invention, as described below, is de-signed and constructed to provide treatment for muscles and connective tissue on various parts of the human body skeletal system which are in the condition of bundle of muscle fibers and connective tissue depicted in FIG. 1C
as a result of immobility.
An individual's arm and elbow will be hereinafter be considered for the express purposes of describing the present orthotic device invention. It is, however, to be understood that what is described for the arm, and par-ticularly for the elbow, applies in principle to such other skeletal parts of the body as the leg, hip, ankle, wrist, hand, neck and back, which may also suffer limited ROM as a result of immobility, and to orthotic devices therefor in accordance with the present invention.
There is depicted in FIG. 2, for such illustrative purposes, and with no limitation .intended or implied, an individual 110 (only the upper torso of which is shown), is depicted having a right arm or limb 112 which com-prises an upper arm or upper limb portion 114 and a fore-arm or lower limb portion 116. Forearm i16 is shown in solid lines in an involuntary, slightly extended ROM an-gular position, ao, relative to upper arm 114, by con-tracted muscle and/or interconnecting tissue of the con-figuration depicted in FIG. 1C and caused by immobility for a protracted period of time due to one or more of the above-mentioned causes. Consequently, the afflicted in-dividual 110 is unable by himself or herself to extend forearm 116 from this a~ position without significant re-sistance and potential further iniury to the afflicted joint(i.e., elbow).
Depicted in phantom lines in FIG. 2, is a sequence of increasingly greater angular ROM positions of forearm 116 relative to upper arm 114, these positions being identified for descriptive purposes by ROM angles al, az, a3 and a4. As will become evident from the following de-scription, these increasing ROM angles al, a2, a3 and a4 represent increasingly greater angular ROMs of forearm SUBSTITUTE SHEET ( rule 26 ) 25 , 116 relative to upper arm 119 which result from the ap-plication to arm 112 of an elbow-type orthotic device in accordance with the present invention.
FIG. 3 depicts in a simplified representation the manner in which the increasing angular ROM of arm 112 as depicted in FIG. 2 may be achieved by use of the present orthotic device invention. As such, FIG. 3 plots angular ROMs of forearm 116 ao, al, a2, a3 and a4 against repre sentative periods of time, in which initial time to cor responds to ROM angle ao, time tl corresponds to in-creased ROM angle al, time t2 corresponds to further in-creased ROM angle a2, time t3 corresponds to still fur-ther increases angle a3, and time t4 corresponds to full extension ROM angle a4.
It is to be clearly understood that although the se-quential time periods or intervals to to ti, tl to t2, t2 to t3 and t3 to t4 are depicted in FIG. 3 for illustrative purposes only, as being equal, in practice, the actual time intervals will usually be different, and, in fact, may be significantly or greatly different.
The objective of FIG. 3 is to depict the general situation in which the increased ROM of the individual's forearm 116 relative to upper arm 114 from ao to al, over some time interval to to tl, is gradually achieved through a series of forearm arm extension and contraction cycles, identified by the reference number 120. Initial extension of forearm 116 to ROM angular position aI de-picted by initial portion 120a of cycles 120, is caused by manual massage and slow extension of the forearm 116 to the point of resistance to passive stetch.
When angular position al of forearm 116 is reached through such manual manipulation, the elbow orthotic de-vice (described below) of the present invention is ap-plied to arm 112 and the forearm is released. Thereafter the angular cycling of forearm 116 relative to upper arm 119 is caused by the counter action of contracture of the individual's muscle and/or. connecting tissue across the elbow, which tend to pull the forearm back toward its SUBSTITUTE SHEET ( rule 26 ) initial shortened involuntary ROM angle ao relative to the upper arm, and the restoring spring force of the pre sent orthotic device, which operates to pull or extend the forearm back to the extended ROM angle al relative to upper arm 114.
At time tl, depicted in FIG. 3, and after a number of retraction and extension cycles as described above, the angular ROM of forearm 116 relative to upper arm lI4 has been increased to ROM angle al such that individual 120 will be able to move his or her arm 112 to this ex-tended ROM angular position without mechanical or other assistance. It is, however, to be appreciated that some reinforcement treatment may from time to time be required to maintain this increased angular ROM.
It is again emphasized that the extension-retraction cycles in sequence 120, although shown regular in nature for illustrative and descriptive purposes, will, in practice, likely vary in number, length of time and magnitude, depending upon such factors as condition of the associated muscular and connective tissue (hypertonicity, spasticity, contraction reflexes, etc.) length of the immobility time, and age and general health of the patient At time ti, when the angular ROM of the individual's forearm 116 has been increased to al, the orthotic device is loosened or removed from arm 112 and the forearm is manually massaged and slowly stretched to an increased ROM angle a2. The orthotic device of the present inven tion is retightened or reapplied to arm and is reset to angle az. Forearm 11.6 is released and cycles through a sequence 122 of angular contraction and extension move-ment in the manner just described for increasing the an-gular ROM of the forearm to al until the angular ROM of forearm 116 is increased to angle az.
This procedure is repeated through a sequence of contraction and extension cycles 129 to increase the an-gular ROM of forearm 116 relative to upper arm 114 from az to angle a3, and finally through a sequence 126 of SUBSTITUTE SHEET ( rule 26 ) contraction and extension cycles of forearm movement un-til a full ROM of the forearm, depicted by angle a4 has been achieved.
It is, of course, to be understand that more or less that the four angular extension steps depicted in FIG. 3 may be required in actual practice and may vary consid erably from individual to individual. In addition, the sequence of steps achieving ROM increase from its initial LROM angle ao to the full range of motion associated with a4 may require hours, days, weei;s or even months, ac cording to the length of time forearm 116 has been con tracted and the condition (hypertonicity, tone, spasicity, contraction reflexes, etc,) of the muscles and connective tissue and fibers associated with movement of the forearm.
Elbow- or Arm-Type Orthotic Device of FIGS 4 11-By way of continuing the illustrative example started above, FIG. 4 shows in exploded form a elbow- or arm-type orthotic device 140 in accordance with the pres ent invention. Elbow-type orthotic device 140 will be described in detail as an introduction to other types of similarly functioning orthotic devices included in the present invention and which will be described hereinbe low.
Elbow-type orthotic device 140 is specifically con-figured for treating contracture of arm 112 relative to elbow 142 and thereby to achieve the extended angular ROM
depicted in FIGS. 2 and 3.
As shown in FIG. 4, elbow-type orthotic device 140 comprises generally a stiff U-shaped first orthotic de-vice upper arm portion or member 194 and a similar, stiff U-shaped second orthotic device lower arm portion or mem-ber 146. First and second device portions 149 and 196 are connected together in a manner enabling relative an-gular motion therebetween and are, in fact, hinged to-SUBSTITUTE SHEET ( rule 26 ) 'WO 98/43560 2 8 PCT/US98/05985 gether by connecting means 148, as more particularly de-scribed below.
Further included in elbow-type orthotic device 140 are a first, upper arm padded cuf.C 150 and a similar, second, lower arm padded cuff 152. Means for detachahly attaching device 140 to arm 112 comprise an adjustable upper strap 154 that is attached to device upper member 144 and an adjustable lower strap 156 that is attached to device lower member 146.
The means 148 for interconnecting upper and lower portions 144 and 146 comprise elongate first, right side and second, left side mirror-image connecting assemblies 160 and 162, respectively. As shown in FIGS. 4, 6, 8 and 10, right side connecting assembly 160 comprises similar upper and lower elements 166 and 168, respectively.
Adjacent ends of elements 166 and 168 are connected for relative angular. movement therebet:ween by a lockahle hinge 170. In the same manner, left side connecting as-sembly 162 comprises corresponding upper and lower el.e-ments 174 and 176, respectively, a~jjacent ends of which are connected for relative angular movement therebetween by a lockable hinge I78.
As shown in disassembled condition in FIG. 10, right-hand lockable hinge 170 includes mating first and second toothed end regions 180 and 182 of respective ele ments 166 and 168. When assembled and tightened to-gether a bolt 184 and nut 186, end regions 180 and 182 intermesh to Wick upper and lower elements 166 and 168 a.n any selected relative angular position. A left lockable hinge 178, is constructed in the same way, not specifi-cally shown.
In the alternative connection configuration depicted in FIG. 11, a corresponding right-hand hinge 170a between respective upper and lower elements 166a and 168a has first and second mating regions 180a and 182a having SUBSTITUTE SHEET ( rule 26 ) 'WO 98/43560 PCT/US98/05985 teeth shaped for enabling a ramping or ratcheting action for easy opening of the upper and lower elements to greater angles therebetween, while inhibiting the closing of the elements . Upper and lower elements 166a and 168a are fastened together by a bolt 184 and nut 168. A
spring-type washer, for example, a Belleville washer, 188 is installed on bolt 184 so that lower element 168 can be ratcheted to a greater angle position relative to upper element 166 without completely withdrawing bolt 189 from l0 nut 186.
As depicted in FIG. 7 for right side connection as-sembly 160 (typical also for left side connection assem-bly 162) the upper end region of upper element 166 is non-pivotally attached to a right-hand side region of de-vice upper member 194, for example, by two rivets, screws or the like 190. A lower end region of lower element 168 is pivotally attached to a right-hand side region of de-vice lower member 146 by a single pivot pin or screw 192.
Upper and lower left hand elements 174 and 176 of 24 connection assembly 162 are attached to generally oppo site sides of respective upper and lower device members 144 and 146 in the manner described for connection assem bly 160.
As shown in FIG. 9, upper elements 166 and 179 are attached to opposite side regions of upper portion 144 in off-center positions. Assuming arrow A points to a 12 o'clock position of upper member 144, elements 166 and 174 are attached to the upper member at about 4 0' clock and about 8 o'clock positions, respectively. The attach ment of lower elements 168 and 176 are attached to lower member 196 in a similarly offset manner. Such offset at-tachments enable appropriate spring action of connecting assemblies 160 and 162, as described below.
Upper and lower elements 166 and 168 of right con-necting assembly 160 are constructed, as shown in FIG. 6, SUBSTITUTE SHEET ( rule 26 ) which represents orthotic device 140 in the unloaded or initially set angular position al of device 140, as being slightly bowed outwardly in the region of hinge 170 from a central longitudinal axis 200. In a similar manner, 5 elements 174 and 176 of left connecting assembly 162 are constructed for being slightly bowed outwardly from axis 200 in the region of hinge 178.
Right and left connecting assemblies 160 and 162 are thus bowed outwardly from longitudinal axis 200 in oppo 10 site directions along a transverse axis 202. This con figuration, as well as the offset mounting described above causes hinge regions of connecting assemblies 160 and 162 to be twisted outwardly in the direction of Ar-rows "H" (FIG. 8) to create a restoring force whenever 15 hinges 170 and 178 are locked and device 140 is con tracted in an angular direction of Arrow "C", FIG. 7.
In operation, referring to FIG. 2, forearm 116 of arm 112 is gradually moved by a manual massaging action from its LROM angular position depicted at angle a~, to 20 initial extended ROM angle al which is selected to be as far as forearm 116 can be extended without inflicting damage to muscles and connective tissue between the fore-arm and upper arm 114.
Referring to FIGS. 9-6 and 9, with forearm 116 held 25 in this extended position of al, bolts 184 of hinges 170 and 178 of orthotic device 190 are loosened so that upper device member 144 can be fit onto upper arm 116 and at-tached thereto by first strap 154, cuff 150 being used to pad the upper portion and protect the upper arm. In a 30 like manner, lower member 148 is fit onto and attached to forearm 116 by second strap 156. Hinges 170 and 178 are then locked into position by tightening bolts 189 so that device 140 conforms to the ROM angle (i.e., ROM angle al) between individual's forearm 114 and upper arm 116.
SUBSTITUTE SHEET ( rule 26 ) 'WO 98/43560 PCTNS98/05985 At this point, connecting assemblies 160 and 162 are un-stressed and provide no force whatsoever on arm 112 as long as the arm is held at ROM angle al.
With orthotic device 140 attached to arm 112 as de-scribed above at arm ROM angle al and with the arm held (by other than the orthotic device) and as depicted in FIGS. 5 and 6, the arm is then released and forearm lI6 is pulled back (in the direction of Arrow "C", FIG. 7) toward LROM angle ao by the previously stretched muscles and connective tissue across elbow 142.
Connecting assemblies 160 and 162 thus function as torsion springs which, as they are increasingly twisted outwardly by contracture of arm 112, store increasing amounts of energy as forearm 116 increasingly contracts back toward upper. arm 114. At some angular return posi-tion between al and a~, the restoring spring energy in connection assemblies 160 and 162 and the contracture force attempting to return forearm to its LROM angle ao equalize and the return contracture movement of forearm 116 ceases. Thereafter, the muscle fibers and connecting tissue across elbow 142 start relaxing or weakening, and the stored torsional energy in connecting assemblies take over and start to pull forearm back toward ROM angle al.
At some time before or as forearm 115 reaches back to an-gle al, the contractile forces on arm 112 take and once again start pulling the forearm back towards LROM angle ao relative to upper arm 119. The cycling of forearm 116 back and forth between LROM angle an and extended angle al, is repeated, as indicated in the time interval t~ to tl depicted in FIG. 3, until the muscle fibers and con-nective tissue across elbow 192 are stretched to the point that they no longer provide any contracting force at ROM angle ai.
SUBSTITUTE SHEET ( rule 26 ) With device 140 remaining attached to arm 112, de-vice hinges 170 and 172 are then loosened and forearm 116 is massaged against contracture forces until the forearm is stretched as far as possible without injury to muscle fibers and connective tissue to a new ROM angle a2.
Hinges 170 and 172 are retightened and forearm 116 is then released. Alternatively, when ROM angle al has been attained, device 140 may be removed from arm 112 and may be reinstalled after hinges 170 and 172 have been re set to ROM angle az.
The cycling of forearm 116 between ROM angle a2 and ROM al then starts upon release of forearm 116 and con-tinues in the above-described manner until the arm can stay at ROM a2 on its own.
The above-described process is repeated through ROM
angle a3 until a full ROM angle of arm 112 is attained, for example, ROM angle a4 at time t4 as depicted in FIG.
3.
The alternative use of ratcheting type of hinges 170a and 172a depicted in FIG. 11 make the above-described steps of increasing the angle of connecting as-semblies 160a and 162a easier. The ratcheting action of hinges 170a and 172a depicted in FIG. 11 also allow pro-gression from al to aZ to occur without the need to manu-ally adjust the hinge setting as the limb "relaxes" or "fatigues" allowing additional extension during the "relaxed" phase of contraction and extension cycling.
Device connecting assemblies 160 and 162, as well as 160a and 162a, are preferably constructed of a stiff elastomeric plastic material, such as polyurethane or. fi berglass. As with entire device 140, dimensions of con-necting assemblies 160 and 162 are necessarily varied in dimensions, as can be determined by one skilled in the relevant art, according to the age, size and muscular and SUBSTITUTE SHEET ( rule 2G ) 'WO 98/43560 PCT/US98/05985 interconnecting tissue characteristics of the individual to be fitted with the device and further according to the extent of LROM of the individuals arm and the duration and type of immobility which has caused contracture of arm 112.
It will be appreciated that the same principle of operation described above for device 190 is used with the below-described other types of orthotic devices which are within the scope of the present invention. By other 30 types it is meant types of orthotic devices that are spe-cifically designed for other skeletal parts of the body-such as knee, wrist, ankle and so forth. The main dif-ferences in the various types of orthotic devices dis-closed herein are the means for attaching the devices to . 15 the body or for causing one or both of the main parts of the device to bear operatively against an associated part of the body. Consequently, description of the de-vices will be concentrated on the principal differences between the device being described and device 140 which 20 is described above in detail.
Knee- or LeQ-Ty a Orthotic Device of FIG 12:
Fig 12 depicts a knee- or leg-type orthotic device 200 in accordance with another embodiment of the present 25 invention. Because of the similarity between elbow 192 and a knee 202 it will be readily understood that knee-type device 200 is virtually identical with above-described elbew-type device 140 except for a shaped knee retainer 204 that is detachably attached to connection 30 assemblies 160a and 166a (which correspond directly to connection assemblies 160 and 166 of device 140) so as to keep knee 202 from slipping through the device.
Connection assemblies 160b and 166b are attached to respective upper device member or portion 144a and lower 35 member or portion 146a in the same offset manner de SUBSTITUTE SHEET ( rule 26 ) i~VO 98143560 PCT/US98/05985 scribed above for corresponding upper and lower members 144 and 146 of device 140. tipper and lower members 154a and 156a respectively are detachab.ly installed on leg 21.0 in the same way upper and lower members 154 and 156 are attached to arm 212, that is, the upper and lower members are attached to respective upper l.eg or thigh 212 and lower leg 214 by respective straps 154a and 156a, and a.re covered with padded cuffs 150a and la2a to protect lec_t 210.
In FIG. 12, leg 210 is shown in solid lines at ROM
angle al and in phantom lines at LROM angle ao.
The operation of knee-type orthotic device 200 is identical to the operation of. arm-type orthotic device 190 described above and does not, therefore, require any description.
Hip Abduction-TVpe Orthotic Device of F1G 13:
In some contracture conditions, including hip abduc-tion, knee abduction and scissoring of the lower limbs, and as depicted in FIG. 13, an ankle region of one leg 220 of an individual is held in the LROM position against (as indicated in phantom lines) or. ~:rossed over the ankle region of other leg 222. This condition can understanda-bly prevent the individual from walking or engaging in any activity requiring the use of an individual's legs.
In such a condition, the therapeutic objective is to restore normal ROM ~f legs 220 and 222 relative to one another by use of a hip abduction-type orthotic device (or knee abduction device) 224 which comprises a connec-tion member 160c isimilar to above-described connection member 160) which is connected between ankle regions of respective right and left ankle boots 226 and 228.
SUBSTITUTE SHEET ( rule 26 ) 'WO 98/43560 3 5 PCT/US98/05985 In this regard, a distal end of right portion 166c of connection member 160c is attached to an rear, ankle region of right boot 226 by a pivot pin 230 and a distal end of left portion 166c of member 160c is attached to a rear, ankle region of left boot 228 by a pivot pin 232.
Proximal ends of member portions 160c and 168c are inter-connected by a hinge assembly 170c.
Each connection member portion :166c and 168c is shown in phantom lines in FIG. 13 at a LROM angle al relative to a vertical. axis or plane 234. Shown in solid lines in FIG. 13, connection member portions 166c and 168c are at post-treatment ROM angles a4 relative to ver-tical plane or axis 234.
Step-wise operation of hip-type device 224 is ex actly as described above for elbow-device 140 and knee device 200, with connection member J60c functioning as a spring pulling legs 220 and 221 apart in response to con tracted muscle fibers and connective tissue at the hip joint pulling the legs together.
Amputated Lea-Type Orthotic Device of FIGS 14 and 15:
A number of regions of the body can be afflicted by contractures but which are not configured in such a man-ner that the orthotic devices of the present invention cannot be configured in the manner of elbow-type and knee-type orthotic devices 140 and 200 described above.
Nevertheless, the principle of the above-described opera-tion to overcome contractures of these other parts of the body is essentially identical to that described for or-thotic devices 140, 200 and 224.
FIGS. 14 and 15 depict a hip or pelvic control or-thotic device 250 in according to the present invention that is useful for the treatment of contracture of a re-maining stump portion 252 of an individual's leg after SUBSTITUTE SHEET ( rule 2fi ) 'WO 98143560 3 6 PCT/US98105985 the remaining lower portion of the leg has been ampu-tated.
In the case being considered herein, contracture of.
stump 252 has caused the stump to point upwardly or out.-wardly at some LROM angle. FIG. 15 shows stump 252 pointing upwardly or outwardly at a LROM angle ao rela-tive to the individual's lower. body. Not only is such a contracture of stump 252 unsightly and embarrassing to the individual, but in a practical sense makes many sit-ting or sleeping positions impossible or uncomfortable.
makes dressing of the individual very difficult and pre-vents the use of an orthopedic or artificial leg impossi-ble.
The intent of amputated leg-type orthotic device 250 is to restore, in the manner described above relative to elbow-type orthotic device 140 and knee-type device 200, the full angular ROM of stump 252 relative to the indi-vidual's trunk 254. Such restoration will enable the in-dividual to move stump 252, without external assistance, to and from a normal leg position relative to trunk 254 to thereby enable the individual to lead a more normal life.
As shown in FIG. 14, the orthotic device 250 of the present invention comprises a plate or plate portion 256 and a detachable stump attachment element or adjustable strap 258. Plate portion 256 is formed from a flat sheet of thermal-setting plastic, such as KYDEX4~ or LEXAN~?, and is generally rectangular in shape and about one-eighth of an inch in thickness. Plate or plate portion 256 is formed having a split 260 in the thigh region along a longitudinal axis 262, the split defining side-by-side first and second thigh regions 7.64 and 266, re-spectively.
A transverse bend line 268 (which can be considered as a hinge line)is defined between thigh regions 264 and SUBSTITUTE SHEET ( ruie 26 ) 266 at the distal end of split 260, and essentially di-vides the thigh regions from a seat portion 270.
Depending on which leg has been amputated, attach ment element 258 is installed through slots 272 in either first or second thigh regions 264 or. 266 adjacent a proximal edge 280. As depicted in FIG. 14, attachment.
element is installed through slots 272 in first thigh re-gion 264 for use with stump 252 of the individual's right leg. A padded sleeve 282 (FIG. 15) is preferably i.n-stalled over plate 256 to provide comfort to the individ-ual being treated.
With the individual lying on a firm surface 280.
such as a massage table, stump 252 is massaged by another individual, who may be a physical therapist, from its contracture LROM angular.position as to an initial ex-tended ROM angular position al (FIG. 15), which corre-sponds to the initial ROM angular position described above for devices 140 and 200.
The individual' s extended ROM angle al of stump 252 is measured by a goniometer, in a well known manner. he-vice plate 256 is heated along bend line 268 and first thigh region 264 is bent along the bend line to angle al (FIG. 15) and is then allowed to cool to "lock" the bend at such angle.
With the individual's stump 252 held at ROM angle al, he or she is lifted and device 250 is slid under the individual so that potion 270 is beneath the patient's buttocks and so that stump 252 is resting on first thigh region 264. Attachment element 258 is installed around stump 252 and is tightened to securely hold the stump against region 264 of device 250, plate region 270 being held down by the individual's weight.
When stump 75'?. is then released, the stretched hip muscle fibers and connective tissue contract and pull the SUBSTITUTE SHEET ( ruie 26 ) stump and flex first thigh region 264 back toward LItOM
angle ao. As a result, thigh region 262 of device plate 256 becomes temporarily flexed or elastically bent into a curve in the same manner that a limb of_ an archery bow .is flexed and bent when the bow is drawn t:o shoot an arrow.
As stump 252 is thus pulled back against the bending of thigh region 262 and approaches LROM angle aa, the associ-ated hip muscles and connecting tissue relax to an extent that energy stored in the flexed thigh region 252 of plate 256, pulls stump 252 back toward ROM angular posi-tion al against the restoring forces of the hip muscle fibers and connecting tissue.
After a number of such cycles (as depicted in FIG.
3), the angular ROM of stump 252 is extended to angle al.
At this point, device 250 is removed from the individual and the stump is massaged to a further extended ROM angle az and is held there while plate 256 is heated along line 268 and is bent to new ROM angle a~. Device 250 is reap-plied to the individual as described above and the iust-described cycling procedure is repeated until the angular ROM of stump 252 has increased to angle a2. This proce-dure is repeated until the full angular ROM (for example, angle a4) is achieved.
From the foregoing description, it can be seen that device 250 is exactly analogous to devices 140 and 200 which have been described above. In the case of device 250, the material of plate portion 256 adjacent bend line 268 deforms in operation, for example, like hinges 170 and 178 described initially in connection with device 190.
Foot-Type Orthotic Device of FIG. 16:
There is depicted in FIG. 16 a foot-type orthotic device 300 in accordance with the present invention for.
SUBSTITUTE SHEET ( rule 26 ) therapeutic treatment of inversion of the foot, and f~x-ternal rotation of. the hip. Hy way of example, FIG. 16 depicts in phantom lines a foot 302 that as a result of contracture is turned inwardly(inversi.on).
Comprising device 300 are a boot portion 304, to n rearward region of which is attached a plastic bar 30a.
Bar 30B may be constructed of the same plastic material as plate 256 of stump-device 250 described above and )nas a bend line 310.
With partial boot 304 installed on an individual's foot 302 and the individual resting on a surface, such as a bench, the floor or a bed(designated by reference num-ber 314), an end region 312 of bar 306 bears against the floor, bench or bed.
Through a sequence of therapeutic foot extension steps in which bar 306 is heated and bent at angles a~
through a, at bend line 310, associated with a like se-quence of increasing foot ROM angular. positions from uon-tracture LROM angle a~ to fully extended ROM angle a4, a full ROM of the foot is achieved in precisely the same manner described above for stump-type device 250. Accord-ingly, no further description of foot-type orthotic de-vice 300 is considered necessary.
Cervical Extension Orthotic Device of FIG. 17:
A forward cervical extension orthotic device 350 de-picted in FIG. 17 is similar in general construction and operation to stump-type device 250 and foot-type device 300 described above. Comprising cerv.i~:al extension or-thotic device 350 is a cervical extension flexible bar or.
stem 352, which i.s preferably constructed of the same flexible plastic material as plate 256. A head-restraining member or headpiece 354 is attached to an up-per end of stem 352. A lower region of stem 352 is re-tained inside a vest-like retainer 360 that is detachably SUBSTITUTE SHEET ( rule 26 ) attached (as by hook and loop fasteners) around an upper body portion 362 of the individual being therapeutically treated by device 350.
With the individual's head 364 initially bent 5 sharply forwardly and downwardly at a LROM angular posi tion ao, due to contracture of neck muscle fibers and connecting tissue, the head is massaged upwardly and backwardly to ROM angular position al and is held in that position.
10 After the head angle al has been measured (for exam-ple, by a goniometer) , device stem 352 is heated along a transverse bend line 366 to a matching angle. A lower end region of stem 352 is then inserted downwardly into an upper region 368 of retainer 362. Headpiece 354 is 15 detachably attached by a strap 370 around head 364 and the head is released.
As described below, for example, relative to stump-type device 250 (FIGS. 14 and 15), head 364 is released and is pulled by contracted muscle fibers and connective 20 tissue back toward LROM angle ao, thereby flexing stem 352, which then pulls the head back towards angle al__all in the manner described above. This cycle is repeated un-til the head's ROM has been extended to ROM angle al.
Headpiece 354 is then detached from head 369 and de 25 vice 350 is detached from the individual. Head 369 is then massaged to angular position a? and is held there while stem 362°is repeated and rebent at bend line 366 to a matching angle, at which time device 350 is reinstalled on the individual as depicted in FIG. 17. When head ROM
30 position a2 has been established in the manner for ROM
angular position al p, the operation is repeated as many times as is required to fully extend the ROM of head 364, for example, at ROM angle a4.
SUBSTITUTE SHEET ( rule 26 ) .WO 98/43560 PCT/US98/05985 Back-Type Orthotic Device of FIG 18:
There is shown in FIG. 18 a back-type orthotic de vice 400 according to the present invention which is use s ful for extending the ROM of an individual's back which is involuntarily restricted by contracture of back muscle fibers and connective tissue to an LROM which misshapes the individual's back, for example, into a general S-shape.
Comprising orthotic device 400 are a generally I-shaped flexible plate 402 (which is preferably con-structed of the same material as plate 256 of stump-type orthotic device 250) and a harness assembly 409 which is worn around the upper torso 906 for detachably attaching the back plate to the individual's back in the region of contracture. A transverse bend line 908, which functions as a lockable hinge, separates plate 402 into respective upper and lower portions 410 and 912.
Back plate 400 functions and is operated in conjunc tion with the individual's back in the same manner that stump device plate 256 and device stem 352 of cervical extension orthotic device 350 as the ROM of the individ ual's back is increased from an initial LROM angle a~ to a fully extended (that is, straightened) ROM angle, for example angle a4. In the above-described manner, for ex-ample, for orthotic device 350. During such procedure, back plate 902 is heated and bent along bend line 408 at each increased ROM angle of the individual's back (for example, at ROM angles al, a2. a3 and a4. In each case, the flexing of plate 402 about bend line 908 working against contracture forces of the individual's back causing a cy-cling between angles a~ and al, between al and a2 and so forth in the manner described above until the full ROM of the back I attained.
SUBSTITUTE SHEET ( rule 26 ) Upper Torso-Type Orthotic Device of FIG. 19:
There is shown in FIG. 19 an upper torso-type or thotic device 950 in accordance with the present i.nven tion for treating sideways or forward contracture of an individual's upper torso relative to the individual's lower torso, and for restoring the full side-to-side and forward-to-straight ROM of the upper torso.
Comprising device 450 are a member 452, which is preferably constructed of the same flexible plastic mate rial as, for example, plate 256 described above, and strap means 459 for detachably attaching the member to an individual's upper torso and thighs, as depicted in FIG.
19 and as described below.
Member 452 is formed in one piece of right and left side L-shaped side portions 456 and 458, respectively, which fit vert9.cally along the .individual's right and left sides and horizontally along the seated individual's respective right and left thighs 460 and 462. Fu.rt.her comprising member 452 is an arcuate portion 464 which in-terconnects upper end regions of side portions 456 and 458, and which fits around forward regions of the indi-vidual's upper torso. Member 452 is preferably padded to provide comfort to the individual.
Vertical sections or regions of side portions 456 and 458 function in the manner of stem 352 of orthotic device 350, as described above in connection with FIG.
17. In that regard, each of the vertical sections of side portions 456 and 458 have transverse bend lines 470 and 472, respectively, which divide the vertical sections into upper and lower regions and which function in the manner of lockable hinges interconnecting such upper and lower regions.
In the manner described above, for example, in con-junction with stump-type orthotic device 250 (FIGS. 14 SUBSTITUTE SHEET ( rule 26 ) and 15)and cervical extension orthotic device 350 (F1G.
17), the individual's upper torso is worked from an ini-tial LROM angular position ao caused by contracture, through increasing greater ROM angular positions a,, cx~
and a3 until the full ROM angular position a, is reached (it is, of course to be understood that more or fewer than the four ROM angular positions a,, a?, a3 and ae may, in practice, be required).
Further in the manner described above relative to orthotic devices 250, 300, 350 and 900, these ROM angular positions al, a2, a3 and a, of the individual' s torso are provided by sequentially bending vertical sections of side portions 456 and 458 about respective bend lines 470 and 972 at angles ac, az, a~ and a,, the side sections be-ing elastically bent at each ROM angular position by con-tractive forces of the forso pulling the torso back to-ward the previous ROM angular position.
Ankle-Type Orthotic Device of FIG. 20:
There is depicted in FIG. 20 an ankle-type orthotic device 500 further in accordance with the present inven-tion, that is configured for treating contracture of an individual's foot 502 relative to the individual's lower leg 504, about the ankle 506. The particular type of contracture depicted is such that foot 502 is straight-ened out or is in a "foot-dropped" condition, with its LROM angular position at ao. Other types of contracture of foot 502 are possible and are therapeutically treated in a manner similar to that described hereinbelow for the dropped-foot condition.
Device 500 comprises a single piece slipper-shaped flexible plastic member 508 which has sole and ankle re-SUBSTITUTE SHEET ( rule 26 ) 49 , gions 510 and 512, respectively. Preferably, a cutout 514 is provided in member 508 at heel 506 to eliminate pressure on the heel. A transverse bend line is located along a transverse axis 516 through cutout 514. n soft inner padding 518 is provided which wraps about foot in a protective manner. Included in orthotic device 500 is a detachable strap 520 for holding the device 500 onto foot 502.
Right and left side adjustable side straps 522 and 524, respectively, are connected to an upper end of ankle region 512 by a back-strap 526 and extend under sole re gion 510 for enabling alignment of foot 502 as may be necessary.
Member 508, which is constructed from a flexible, thermal-setting plastic, is successively bent around bend axis 516 at angles aj, az, a3 and a4 to extend the angular ROM of foot 502 from its LROM position of al to its full.
ROM of a, in the same manner described above for orthok is devices 250, 300, 350, 400 and 450. Consequently, a fur ther detailed description of orthotic device 500 is not considered to be necessary, except to note that single piece member 598 may alternatively he constructed of two separate sections corresponding to sections 510 and 512 which are interconnected with interconnection members similar to above-described members 160 and 162 of or-thotic device 140(FIGS. 5-8).
Wrist-Type Orthotic Device of FIGS 21 and_2_2:
There is shown in FIGS. 21 and 22 a wrist-type or thotic device 550 in accordance with the present inven tion for treating one or more types of contractu re af flicting an individual's hand 552 relative to forearm 554 about a wrist 556. Shown comprising orthotic device 550 are an elongate, flexible plastic member 558 which is fashioned to fit the inner surface shape of an individ-SUBSTITUTE SHEET ( ruie 26 ) 'WO 98/43560 4 5 PCT/US98/05985 ual's lower forearm 554, wrist 556 and palm of his or. her hand 552. Included in device 550 are adjustable straps:
forearm strap 560, wrist strap 562 and hand strap 564.
It can be understood that a healthy individual c:an rotate his o.r her hand 552 through a complete c.irc:le relative to forearm 559 about wrist connection or joint 556. For orthotic device 550, member 558 is shaped and bent at any appropriate bend or torsion line, for exam ple, transverse bend line 568( FIG. 21), to treat ditfer ent various contractures affecting hand 552 with respect to forearm 559.
Consequently, applied to preqent orthotic device 500 for treating contractures of hand 502 is the same method described above with respect t:o orthotic devices 250, 300, 350, 400 and 450, including bending the associated flexible plastic members 256, 310, 352, 402, 452 in in-cremental, progressive angular steps to increase the ROM
of an affected body part from its LROM ~f ao, through in-termediate ROM angles a,, aZ and a3, t:o the fully extended ROM angle a~.
Shown also in FIGS. 21 and 22 with respect to or-thotic device 500 are means 570 for treating contracture of fingers 570, 572, 574 and 576 by means of a flexible cylinder 580, as more particularly described with respect to the following head-type orthotic device.
Head Hyperextension-Type Orthotic Device of FIGS. 23 and 24:
Shown in FIGS. 23 and 24 i.s a hyperextension-type orthotic device 600, in still further accordance with the present invention, for treating a contracture of neck muscular fibers and connecting tissue which causes an in-dividual's head 602 to be involuntarily held in an ex-treme head-back LROM angular position a~ (FIG. 23).
SUBSTITUTE SHEET ( ruie 26 ) 'WO 98/43560 PCT/US98/05985 Comprising orthotic device 600 is a slightly curved stiff bar 604, a lower end region of which is retained in a block 606 that .is detachably held to the individual' s back by adjustable straps 608 and 610. Further compris-ing orthotic device 600 is a series of elastic cylinders or neck bolsters 620, 622, 629 and 626 (FIG. 24 and shown in phantom line in FIG. 23). These bolsters 620, 622, 624 and 626 have respective diameters which correspond to progressively greater ROM angles al, az. a3 and aa~ and when are sequentially installed between bar 604 and a back region 630 of the individual's head cause the head to be moved to corresponding ROM angular positions a,, a2, a3 and a4 from contr_acture hROM position ao, to ROM an-gular positions al, az, a3 and a4 in the same manner that would occur if bar 504 were to be progressively bent to such ROM angles (i.n the manner. described above for. or-thotic devices 7.50, z00, 350, 400, 450. 500 and 550).
This principle o.f using cylinders or. bolsters of in-creasing diameters is used as well t:o treat contracture of an individuals fingers 570, 572, 574 and 576 for or thotic device 550 (FIGS. 21 and 22).
Shoulder- and Arm-Type Orthotic Device of FIGS. 25 and 26:
There is shown in FIGS. 25 and 26 a shoulder-and arm-type orthotic device 650, in accordance with the pre-sent invention, whish is used to treat contracture of an individual's arm 652 relative to the individual's shoul-der 654 (FIG. 26). Shown comprising orthotic device 650 are a flexible pillow body 656 having an internal recess or pocket 658 for receiving one of graduated flexible plastic elements 660, 662, 664 and 666 which are sized and or otherwise constructed (for example, of increas-ingly denser or stiffer materials) to correspond to pro-SUBSTITUTE SHEET ( rule 26 ) 'WO 98/43560 4 ~ PCT/US98/05985 gressively greater ROM angles al, a,, a3 and a4 of arm 652 relative to shoulder 654.
In operation, after arm 652 has been extended from LROM angle ao relative to shoulder 654, by manual massage and slow extension, to ROM angular position al, and the arm is held in that angular position, elastic element 660 (which corresponds to ROM angle al) is inserted into pocket 658. Thereafter, body 656 (which is constructed of a pliable material, such as nylon fabric) of orthotic device 650 is detachably attached to under regions of arm 652, in the individual's armpit, by adjustable straps 666, 668 and 670, with a body flap 672 abutting the individual's body (FIG. 26). In this case, the in-tersection line 674 between body 656 and flap 672 func-lions as a hinge and element 660 functions as a hinge lock.
In such attachment of orthotic device 650, elastic element 660 functions as a spring wh.i.ch is unloaded at ROM angle al. When the individual's ~~rm 652 is then re-leased, the contracture of muscle fibers and connecting tissue in the armpit region pulls the arm back toward LROM angular position ao, thereby compressing element 660.
This compression of element 660 counteracts the con-tracture and, when the muscle fibers and connective tis-sue relax or fatigue, pushes arm 652 back away from Lhe individual's body toward ROM angular position a~. After several or a number of such contraction and extension cy-cles, arm 652 achieves the extended ROM of al.
The foregoing procedure is repeated, using elastic elements 662, 664 and 666 (through intermediate ROM angular positions az and a3) »ntil arm 652 reaches its fully extended ROM angular position a4.
SUBSTITUTE SHEET { rule 26 ) From the foregoing description, it will be appreci-ated that orthotic device 650 functions in the same man-ner, for example, o.s el.bow-t:ypc, c~rt.hoti.c device I4O
(Ref. FIGS. S-11) and knee-type orthotic device 200 (Ref. FIG. 12) described above, with elastic elements 660, 662, 664 and 6G4 t:ak.ing Lf~e place of spr.inc~-type connecting members 1.E,0 and IG2 (for device 140) and 160b and 162b (for. device 200?. In fact, orthotic device 650 can be modi f. i ec3 Ln an obv i o«.; manner to serve orthotic devices for t:reat:ing con t.r,c:t.ure of the elt~c~w and contracture of. the knee.
SUBSTITUTE SHEET ( rule 26 ) 'WO 98/43560 PCT/US98/05985 Fig. 27 illustrates one embodiment combining orthotic therapy and electrotherapy. Individual electrodes 701 are located on upper arm member 149 and lower arm member 196 of elbow-type orthotic device 190.
The electrodes 701 are of any suitable structure and are made of electrically conductive material. For example, electrodes 701 may be made of electro-mesh material which is sewn to the soft parts of orthotic device 190. Alternately, electrodes 701 may be conventional peel and stick electrodes, for example, peel and stick gel adhesive electrodes, which are stuck onto the soft parts of orthotic device 140. The electrodes 701 are positioned to be in close proximity, to, preferably direci:ly adjacent, the body parts being treated. Each of the electrodes 701 is adapted to be detachably connected to vne of the electric wires 703, for example, using any suitable connector many of which are conventional and well known in the art. Many electrode connection appliances are available, for example, wire plug connections, snap on wires, electrical signal transmitter to receptor electrode connections, and others. Also, the number of electrodes can vary widely, for example, in a range of about 2 to about 4 or about 8 or about 16 or more per orthotic device.
Electrodes 701 in proximity to the extensor muscles of the arm in Fig. 27 are connected by electric wires 703 to electrotherapy unit 705, which may be of conventional design. Electrodes 701 in proximity to the flexor muscles of the arm are not connected to the electrotherapy unit 705. ~Iowever, if desired, the wires 703 can be disconnected from the "extensor muscle"
electrodes 701 and connected to the "flexor muscle"
electrodes. Other combinations of electrodes 701 can be connected to unit 705 to achieve a desired treatment.
SUBSTITUTE SHEET ( rule 26 ) SO
For example, if it is desired to pass electric current through the elbow joint, preferably the polarity of the power being passed through the electric wires 703 to the electrodes 701 on upper arm 'member 144 is reversed relative to the polarity of the power being passed to the electrodes 701 on lower arm member 196. This approach provides an "X" pattern of electric current through the elbow which is particularly therapeutically effective.
The electrotherapy unit 705 can be either attached to the orthotic device 140 or simply connected to the orthotic via electrode connections. The electrotherapy unit 705 may be portable, for example, suitable for being carried on the body of the patient being treated.
Also, the unit 705 may be powered by line voltage, suitably transformed down to an acceptably reduced voltage, or may be powered using one or more storage batteries, for example, of conventional design.
The electrodes 701, wires 703 and electrotherapy unit 705 are used to conduct electrical current to the elbow and related muscles, tendons. and connective tissue on or near which device 140 is located.
Soft tissue electrotherapy, microcurrent electrotherapy, nerve stimulation or high volt therapy could be provided as needed to treat joint related problems. Enhanced muscle and tendon stretch can be achieved by placing electrodes (connected to an electrotherapy unit) at the location of the contracted muscles. Antagonist muscle groups can be stimulated to provide muscle strengthening and re-education on a different or same setting of the electrotherapy unit.
SUBSTITUTE SHEET ( rule 26 ) It is to be understood that: although for de-scriptive purposes, extension of a skeletal body part:, such as a forearm, foot, J.ower leg, head, hand, and t:he like has been described in terms of extension to a ex-tended range of motion (FROM) from ~~n initial limited range of motion (LROM) angle ao to an extended angle cza through intermediate ROM angular. positions a,, az and a3, it is to be understood that no limitation is intended or implied thereby. In actual practice, a greater ar lesser number of intermediate ROM angles may be required.
Moreover, the number. of degrees between each adjacent pair of ROM angular positions will usually not be equal.
It is also to be understood that although several different configurations of orthotic devices have been described, all function according to the same pr.inu.i ple--that of the contracture forces lording a spring to thereby cause a return to an extended ROM.
Although there has been desct-ibed and illustrated various types of orthotic devices utilizing the same principle for treating contractures oC various parts of a human body in accordance with the present invention for purposes of illustrating frhe manner in which the inven-tion may be used to advantage, it is to be appreciated that the invention is not limited thereto. Therefore. any and all variations and modifications that may occur to those skilled in the .applicable art are to be considered as being within the scope and spirit oC the claims as ap-pended hereto.
SUBSTITUTE SHEET ( ruie 26 )

Claims (36)

CLAIMS:

What is claimed is:
1. Claim 1. An orthotic device useful for extending the range of angular movement between adjacent first and second skeletal body parts which are have been drawn to and involuntarily held in an limited angular range of motion (LROM) position relative to one another by contraction of muscle fibers and connective tissue due to immobility of one or both of said skeletal body parts, said orthotic device comprising:
   a. a first orthotic device portion;
   b. a second orthotic device portion;
   c. means interconnecting said first and second orthotic device portions for permitting angular movement and for enabling the setting of a selected angle therebetween:
   d. means for applying or attaching said first orthotic device portion to the first body part and said second orthotic device portion to the second body part after the first body part has been moved against contracture forces away from said LROM position to an extended range of motion (EROM) position relative to the second body part, said first and second orthotic device portions being then set at said EROM position relative to one another; and e. spring means associated with the first and second orthotic device portions for urging the first orthotic device portion to return to said EROM position in response to the first orthotic device portion being pulled by the applied or attached first body part through muscular contraction and/or the elastic properties of the muscles and connective tissue away from said EROM position and toward said LROM position, thereby causing a cycling movement of the first body part between said EROM
   and LROM angular positions and a gradual loosening of said first body part relative to said second body part and an ultimate extending of the ROM of the first body part relative to the second body part at said EROM
   position without additional external intervention.
2. Claim 2. The orthotic device as claimed in Claim 1, wherein said spring means are configured for providing substantially no or a low load spring force between said first and second orthotic device portions when the first orthotic device portion is at said initial angular position relative to the second orthotic device portion.
3. Claim 3. The orthotic device as claimed in Claim 1, wherein said first body part comprises the individual's upper limb part and wherein said second body part comprises said individual's lower limb part, and wherein said first orthotic device portion includes a first cuff and said second orthotic device portion includes a second cuff, said applying means including means for releasably attaching said first cuff to said lower limb part and for releasably attaching said second cuff to the individual's upper limb part.
4. Claim 4. The orthotic device as claimed in Claim 3, wherein said interconnecting means comprise at least one bar having a first end region fired to said first cuff and a second end region fixed to said second cuff and including a hinge intermediate said first and second end regions for enabling the relative angular movement therebetween in a plane defined by the longitudinal axis of said limb upper and lower parts.
5. Claim 5. The orthotic device as claimed in Claim 4, including means for releasably locking said hinge at any selected angular position of said first end region relative to said second end region.
6. Claim 6. The orthotic device as claimed in Claim 9, wherein said hinge includes a ratchet for enabling the opening of said first end region relative to said second end region from one angle therebetween to a larger angle therebetween.
7. Claim 7. The orthotic device as claimed in Claim 4 wherein said spring means comprise the outwardly bowing and twisting of said first end region of said bar relative to said second end region of the bar when the first end region of the bar is pivoted from the initial angular position relative to said second end region to a smaller angle therebetween.
8. Claim 8. An orthotic device useful for extending the range of angular movement between adjacent first and second skeletal body parts which are have been drawn to and involuntarily held in an limited angular range of motion (LROM) position relative to one another by contraction of muscle fibers and connective tissue due to immobility of one or both of said skeletal body parts, said orthotic device comprising:
   a. a thermal setting, flexible member having first and second regions;
   b. a bend line between said first and second member regions, a bend at said bend line being set by heating, bending and cooling said member at said bend line, said bend line permitting angular movement and enabling the setting of a selected angle between said first and second member regions:
   c. means for applying or attaching said first member region to the first body part and said second orthotic device portion to the second body part after the first body part has been moved against contracture forces away from said LROM position to an initial extended range of motion (ROM) angular position relative to the second body part, said first and second member regions being then set at said initial extended range of motion position relative to one another: and d. spring means associated with the first and second member regions for urging the first member region to return to said extended ROM position in response to the first member region being pulled by the applied or attached first body part through muscle fiber contraction and/or the elastic properties of tile muscle fibers and connective tissue away from said extended ROM position and toward said LROM position, thereby causing a cycling movement of the first body part between said extended ROM
   and LROM angular positions and a gradual loosening of said first body part relative to said second body part and an ultimate extending of the ROM of the first body part relative to the second body part at said extended ROM position without additional external intervention.
9. Claim 9. The orthotic device as claimed in Claim 8, wherein said spring means are configured for providing substantially no or a low load spring force between said first and second orthotic device portions when the first orthotic device portion is at said initial extended ROM
   angular position relative to the second member region.
10. Claim 10. The orthotic device as claimed in Claim 8, wherein said first body part comprises the individual's forearm at the wrist and wherein said second body part comprises said individual's hand.
11. Claim 11. The orthotic device as claimed in Claim 8, wherein said first body part comprises the individual's lower leg at the ankle and wherein said second body part comprises said individual's foot.
12. Claim 12. The orthotic device as claimed in Claim 8, wherein said first body part comprises the individual's back at the neck and wherein said second body part comprises the individual's head.
13. Claim 13. The orthotic device as claimed in Claim 8, wherein said first body part comprises an upper region the individual's back and wherein said second body part comprises a lower region of the individual's back.
14. Claim 14. The orthotic device as claimed in Claim 8, wherein said first body part comprises an individual's upper thigh after lower regions of the leg have been amputated and wherein said second body part comprise s a lower region of the individual's torso at the hip.
15. Claim 15. The orthotic device as claimed in Claim 8. wherein said spring means is provided by flexibility of said member.
16. Claim 16. The orthotic device as claimed in Claim 8, wherein said first body part comprises the individual's forearm at the wrist and wherein said second body part comprises said individual's hand.
17. Claim 17. A therapeutic system comprising:
    a. an orthotic device adapted to extend the range of angular movement between adjacent first and second skeletal body parts which have been drawn to and involuntarily held in a limited angular range of motion position relative to one another by contraction of muscle fibers and connective tissue due to immobility of one or both of said skeletal body parts; and b. an electrode component positioned to be effective to conduct an electrical current to at least one of said body parts.
18. Claim 18. The system as claimed in Claim 17, which further comprises an electrotherapy unit in electrical communication with said electrode component.
19. Claim 19. The system as claimed in Claim 17, wherein said electrode component is secured to said orthotic device.
20. Claim 20. The system as claimed in Claim 17, wherein said electrode component comprises a plurality of individual electrodes.
21. Claim 21. The system as claimed in Claim 17, wherein said electrode component includes peel and stick gel adhesive electrodes.
22. Claim 22. The system as claimed in Claim 17, wherein said electrode component comprises an electrically conductive material.
23. Claim 23. The system as claimed in Claim 17, wherein said electrode component comprises electro-mesh material.
24. Claim 24. An orthotic device useful for extending the range of angular movement between adjacent first and second skeletal body parts which have been drawn to and involuntarily held in a limited angular range of motion (LROM) position relative to one another by contraction of muscle fibers and connective tissue due to immobility of one or both of said skeletal body parts, said orthotic device comprising:
    a. a first orthotic device portion;
    b. a second orthotic device portion:
    c. means interconnecting said first and second orthotic device portions for permitting angular movement and for enabling the setting of a selected angle therebetween;
    
    d. means for applying or attaching said first orthotic device portion to the first body part and said second orthotic device portion to the second body part after the first body part has been moved against contracture forces away from said LROM position to an extended range of motion (EROM) position relative to the second body part, said first and second orthotic device portions being then set at said EROM position relative to one another;
    e. spring means associated with the first and second orthotic device portions for urging the first orthotic device portion to return to said EROM position in response to the first orthotic device portion being pulled by the applied or attached first body part through muscular contraction and/or the elastic properties of the muscles and connective tissue away from said EROM position and toward said LROM position, thereby causing a cycling movement of said first body part between said EROM and LROM angular positions and a gradual loosening of said first body part relative to said second body part and an ultimate extending of the range of angular motion of said first body part relative to said second body part at said EROM position without additional external intervention; and f. an electrode component positioned to be effective to conduct an electrical current to at least one of said body parts.
25. Claim 25. The orthotic device as claimed in Claim 24, which further comprises an electrotherapy unit in electrical communication with said electrode component.
26. Claim 26. The orthotic device as claimed in Claim 24, wherein at least a first portion of said electrode component is in close relation to said first orthotic device portion and at least a second portion of said electrode component is in close relation to said second orthotic device portion.
27. Claim 27. The orthotic device as claimed in Claim 24, wherein said electrode component comprises a plurality of individual electrodes.
28. Claim 28. The orthotic device as claimed in Claim 24, wherein said electrode component includes peel and stick gel adhesive electrodes.
29. Claim 29. The orthotic device as claimed in Claim 24, wherein said electrode component comprises electrically conductive material.
30. Claim 30. The orthotic device as claimed in Claim 24, wherein said electrode component comprises electro-mesh material.
31. Claim 31. An orthotic device useful for extending the range of angular movement between adjacent first and second skeletal body parts which have been drawn to and involuntarily held in a limited angular range of motion (LROM) position relative to one another by contraction of muscle fibers and connective tissue due to immobility of one or both of said skeletal body parts, said orthotic device comprising:
    a. a thermal setting, flexible member having first and second regions;
    b. a bend line between said first and second member regions, a bend at said bend line being set by heating, bending and cooling said member at said bend line, said bend line permitting angular movement and enabling the setting of a selected angle between said first and second member regions;
    c. means for applying or attaching said first member region to said first body part and said second orthotic device portion to said second body part after the first body part has been moved against contracture forces away from said LROM position to an initial extended range of motion (EROM) angular position relative to said second body part, said first and second member regions being then set at said initial extended range of motion position relative to one another;
    d. spring means associated with said first and second member regions for urging said first member region to return to said EROM position in response to the first member region being pulled by the applied or attached first body part through muscle fiber contraction and/or the elastic properties of the muscle fibers and connective tissue away from said EROM
    position and toward said LROM position, thereby causing a cycling movement of said first body part between said EROM and said LROM angular positions and a gradual loosening of said first body part relative to said second body part and an ultimate extending of the range of angular motion of said first body part relative to said second body part at said EROM position without additional external intervention; and e. an electrode component positioned to be effective to conduct an electrical current to at least one of said body parts.
32. Claim 32. The orthotic device as claimed in Claim 31, which further comprises an electrotherapy unit in electrical communication with said electrode component.
33. Claim 33. The orthotic device as claimed in Claim 31 wherein said electrode component comprises a plurality of individual electrodes.
34. Claim 34. The orthotic device as claimed in Claim 31 wherein said electrode component includes peel and stick gel adhesive electrodes.
35. Claim 35. The orthotic device as claimed in Claim 31 wherein said electrode component comprises electrically conductive material.
36. Claim 36. The orthotic device as claimed in Claim 31 wherein said electrode component comprises electro-mesh material.