Patent Publication Number: US-10779984-B2

Title: Shoulder orthosis including flexion/extension device

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 14/077,398, now issued as U.S. Pat. No. 9,572,702, filed Nov. 12, 2013, which is a continuation of U.S. patent application Ser. No. 12/910,682, now issued as U.S. Pat. No. 8,591,441, filed Oct. 22, 2010, each of which is incorporated herein by reference in its entirety. 
    
    
     FIELD OF THE DISCLOSURE 
     The present disclosure relates generally to a shoulder orthosis, and more particularly, to a shoulder orthosis which includes a flexion/extension device. 
     BACKGROUND OF THE DISCLOSURE 
     In general, a range-of-motion of a joint in the human body is the distance (e.g., linear or rotational) the joint can move in a certain direction. For example, movements of the shoulder joint (i.e., the glenohumeral joint) include flexion, extension, abduction, adduction, and internal and external rotation. Flexion of the shoulder joint involves rotational movement of the upper arm anteriorly, and extension involves rotational movement of the upper arm posteriorly. Abduction of the shoulder joint involves rotational movement of the upper arm laterally away from the midline of the body (e.g., upward), and adduction involves rotational movement of the upper arm medially toward the midline (e.g., downward). Internal (e.g., medial) rotation of the shoulder joint involves rotation of the upper arm about its longitudinal axis, toward the midline of the body, and external (e.g., lateral) rotation of the shoulder joint involves rotation of the upper arm about its longitudinal axis away from the midline. Internal (e.g., medial) rotation may involve inferior (e.g., downward) rotation of the forearm when the upper arm is abducted and the elbow is flexed 90 degrees, and external (e.g., lateral) rotation may involve superior (e.g., upward) rotation of the forearm when the upper arm is abducted and the elbow is flexed 90 degrees. Combinations of these shoulder joint movements are also possible, including transverse (e.g., horizontal) adduction (e.g., combining flexion and adduction), transverse (e.g., horizontal) abduction (e.g., combining extension and abduction), and circumduction (e.g., combining all directions of movement). 
     When a joint is injured, either by trauma or by surgery, scar tissue can form or tissue can contract and consequently limit the range-of-motion of the joint. For example, adhesions can form between tissues and the muscle can contract itself with permanent muscle contracture or tissue hypertrophy such as capsular tissue or skin tissue. Lost or limited range-of-motion may also result from trauma, such as excessive temperature (e.g., thermal or chemical burns), or surgical trauma, so that tissue planes which normally glide across each other may become adhered together, markedly restricting motion. The adhered tissues may result from chemical bonds, tissue hypertrophy, proteins such as Actin or Myosin in the tissue, or simply from bleeding and immobilization. It is often possible to mediate, and possibly even correct this condition by use of a range-of-motion (ROM) orthosis, but the longer the period of stiffness or loss of motion the greater the time interval and the force required to regain lost range-of-motion. Therefore, it is beneficial to treat the tissue or joint as early as possible. For example, a ROM orthosis may be applied immediately after surgery or as soon as the stiffness problem is diagnosed. ROM orthoses may also be used for tissue transport, bone lengthening, stretching of skin or other tissue, tissue fascia, and the like. 
     SUMMARY 
     In an aspect, a shoulder orthosis generally comprises a shoulder therapy device adapted to provide treatment to a shoulder joint of a person, and a flexion/extension device. The flexion/extension device is configured to position the shoulder joint in at least one of greater than 0 degrees of flexion and greater than 0 degrees of extension concurrently with the shoulder therapy device providing the treatment to the shoulder joint. 
     In another aspect, a method of treating a shoulder joint of a person using a shoulder orthosis that includes a flexion/extension device and a shoulder therapy device is provided. The method generally comprises operatively securing at least a portion of an arm associated with shoulder joint to the shoulder orthosis. The shoulder joint is positioned using the flexion/extension device in one of greater than 0 degrees of flexion and greater than 0 degrees of extension. The shoulder therapy device is operated to facilitate movement of the shoulder joint after positioning the shoulder joint using the flexion/extension device. 
     In another aspect, a shoulder orthosis generally comprises a torso securing device configured for removable securement to a torso of a person. An internal/external rotation device is adapted to facilitate at least one of internal rotation and external rotation of a shoulder joint of the person. A flexion/extension device operatively connects the internal/external rotation device to the torso securing device. The flexion/extension device is configured to position the shoulder joint in greater than 0 degrees of flexion when the torso securing device is secured to the torso and as the internal/external rotation device is facilitating at least one of internal rotation and external rotation of the shoulder joint. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1A  is a rear perspective of a shoulder orthosis secured to a torso and an arm of a person; 
         FIG. 1B  is a top plan of  FIG. 1A ; 
         FIG. 2  is front elevation of the shoulder orthosis; 
         FIG. 3  is a rear elevation of the shoulder orthosis; 
         FIG. 4  is an exploded view of the shoulder orthosis illustrating a torso securing device, a flexion/extension device, an abduction/adduction device, and an internal/external rotation device of the orthosis, with straps on the torso securing device being removed for illustrative purposes; 
         FIG. 5  is an exploded view of the shoulder orthosis similar to  FIG. 4 , except taken from a different viewpoint for illustrative purposes; 
         FIG. 6  is an enlarged top plan view of the torso securing device and the flexion/extension device exploded therefrom; 
         FIG. 7A  is an enlarged exploded perspective of the flexion/extension device and the abduction/adduction device, with the flexion/extension device also being exploded into separate component; 
         FIG. 7B  is a fragmentary perspective of the shoulder orthosis including a second embodiment of the flexion/extension device; 
         FIG. 7C  is an enlarged perspective of the flexion/extension device of  FIG. 7B ; 
         FIG. 7D  is a top plan view of the flexion/extension device of  FIG. 7C ; 
         FIG. 7E  is an exploded perspective of the flexion/extension device of  FIG. 7C ; 
         FIG. 7F  is an exploded perspective of the flexion/extension device similar to  FIG. 7C , except taken from a different viewpoint for illustrative purposes; 
         FIG. 8  is an enlarged front elevation of the abduction/adduction device; 
         FIG. 9  is a front perspective of the abduction/adduction device of  FIG. 8 ; 
         FIG. 10  is a rear perspective of the abduction/adduction device of  FIG. 8 ; 
         FIG. 11  is an enlarged perspective of a rotation control device of the abduction/adduction device; and 
         FIG. 12  is an exploded perspective of the rotation control device of  FIG. 11 ; 
         FIG. 13  is an enlarged fragmentary perspective of another embodiment of the abduction/adduction device; 
         FIG. 14  is an enlarged perspective of the internal/external rotation device; 
         FIG. 15  is an exploded, bottom plan view of the internal/external rotation device of  FIG. 14 ; 
         FIG. 16  is a bottom perspective of a gearbox of the internal/external rotation device of  FIG. 14  including a drive mechanism; 
         FIG. 17  is similar to  FIG. 16 , except that the gearbox is removed. 
     
    
    
     Corresponding reference characters indicate corresponding parts throughout the drawings. 
     DETAILED DESCRIPTION OF THE DRAWINGS 
     Referring now to the drawings, and in particular to  FIGS. 1A and 1B , a shoulder orthosis for use in treating a shoulder joint (i.e., glenohumeral joint) of a person is generally indicated at  10 . In general, the illustrated shoulder orthosis  10  provides passive range-of-motion (ROM) exercise of the shoulder, although it is understood that the shoulder orthosis may be configured to facilitate active assisted range-of-motion exercise or the orthosis may be configured to apply static support and/or substantially immobilize the shoulder joint. The illustrated shoulder orthosis  10  is configured for treating a right shoulder of a person, however, the principles disclosed herein apply equally to a shoulder orthosis configured for treating a left shoulder of the user. 
     Referring to  FIG. 1A  through  FIG. 5 , the shoulder orthosis  10  comprises a torso securing device, generally indicated at  12 , for removably securing the shoulder orthosis  10  to a torso of a person. The shoulder orthosis  10  also includes a flexion/extension device, generally indicated at  14 , for selectively facilitating flexion and/or extension of the shoulder joint; an abduction/adduction device, generally indicated at  16 , for selectively facilitating abduction and/or adduction of the shoulder joint; and an internal/external rotation device, generally indicated at  18 , for selectively facilitating internal rotation and/or external rotation of the shoulder joint. In the illustrated embodiment, the internal/external rotation device  18  is operatively secured to the abduction/adduction device  16 , and the flexion/extension device  14  operatively connects the abduction/adduction device, and in turn the internal/external rotation device, to the torso securing device  12 . Other configurations are possible and may be within the scope of the present disclosure. 
     Broadly, the abduction/adduction device and the internal/external rotation device are “shoulder therapy devices”, meaning that for the devices facilitate moving and/or positioning the shoulder joint in one or more of internal rotation, external rotation, abduction, and adduction. As explained below, the illustrated abduction/adduction device positions the shoulder joint in a selected degree of abduction, and the illustrated internal/external device positions the shoulder joint in a selected degree of each of internal and external rotation. It is understood that the orthosis may include one or more different therapy devices, in combination with or in place of the abduction/adduction device and the internal/external rotation device, for combining the movements of the abduction/adduction device and the internal/external rotation device. The orthosis  10  may also include therapy devices for treating other joints in addition to the shoulder joint, such as the elbow joint, the wrist joint, and the radioulnar joint. 
     Torso Securing Device 
     Referring to  FIGS. 1A  through  FIG. 6 , the torso securing device  12  of the shoulder orthosis  10  includes a thoracic support  20 , a waist support  22 , and adjustable straps  24   a ,  24   b ,  24   c  for securing the thoracic and waist supports to the person. As seen best in  FIG. 1A , the thoracic support  20  is configured to engage the right rib cage (i.e., right lateral thorax) of the person and extend anteriorly and posteriorly so as to at least partially wrap around the right rib cage. The thoracic support  20  has an armpit recess  25  for receiving the armpit (i.e., axially) of the person and a scapular portion  26  (a superior and posterior portion of the thoracic support) for engaging the scapula. The waist support  22  is configured to engage the right portion of the waist region of the person and extend anteriorly and posteriorly so as to at least partially wrap around the right waist region. The waist support  22  may engage a lower portion of the right rib cage and the right hip. The thoracic and waist supports  20 ,  22 , respectively, may each include a semi-rigid outer shell (as illustrated) that provides some resilient flexibility for fitting the supports on torsos of various sizes. A soft and compressible inner liner (not shown) may be secured to the interior of the outer shell to provide comfort to the person. In the illustrated embodiment, the thoracic and waist supports  20 ,  22 , respectively, are formed as separate components and secured to one another by the flexion/extension device  14 , as explained below. In another embodiment, the supports  20 ,  22  may be integrally formed as a one-piece component. 
     As seen best in  FIG. 1A  through  FIG. 3 , in the illustrated embodiment, the adjustable straps designated at  24   a ,  24   b  are secured to the thoracic support  20 , and the adjustable strap  24   c  is secured to the waist support  22 . In general, the adjustable straps  24   a ,  24   b ,  24   c  are adjustable in functioning length and configured to substantially hold the thoracic and waist supports  20 ,  22  against movement relative to the torso of the person during use of the orthosis  10 . The straps designated  24   b ,  24   c  are transverse straps that are configured to extend transversely around the rib cage and the waist, respectively, and the strap designated  24   a  is a shoulder strap that is configured to extend around the clavicle of the right shoulder. The torso securing device  12  may be removably securable to the torso of the person in other ways. 
     In the illustrated embodiment, the transverse straps  24   b ,  24   c  have fixed ends secured to posterior sides of the respective thoracic and waist supports  20 ,  22  and free end margins that are insertable into and releasably securable around D-rings  29  ( FIG. 2 ) on anterior sides of the respective thoracic and waist supports. The transverse straps  24   b ,  24   c  may include hook and loop fasteners (e.g., hook and loop fasteners) for securing the straps to the D-rings  29 , or the straps may be releasably fastenable to the D-rings in other ways. The straps  24   b ,  24   c  also includes a relatively semi-rigid, padded segment  30  that engages the posterior region (i.e., the back) of the person and provides a level of comfort to the person. The segments  30  also hold the straps  24   b ,  24   c  in a position that the patient can readily and easily reach. The straps  24   a ,  24   b ,  24   c  may include additional padding or other soft and/or compressible material to provide comfort. The straps  24   b ,  24   c  may be of other configurations without departing from the scope of the present disclosure. 
     The shoulder strap  24   a  has a fixed end secured to an anterior side of the thoracic support  20  and a free end margins that are insertable into and releasably securable around a D-ring  32  ( FIG. 3 ) on an posterior side of the thoracic support. The shoulder strap  24   a  may include hook and loop fasteners (e.g., hook and loop fasteners) for securing the straps to the D-ring  32 , or the strap may be releasably fastenable to the D-ring in other ways. The shoulder strap  24   a  may include padding or other soft and/or compressible material to provide comfort. The strap  24   a  is also configured in such way that allows the patient to readily reach the strap even after it is fed through the D-ring  32 . The strap  24   a  may be of other configurations without departing from the scope of the present disclosure. 
     It is understood that the torso securing device  12  may be of other configurations without departing from the scope of the present disclosure. For example, the torso securing device may not include the thoracic support  20  or the waist support  22  or any other torso support. In such an embodiment, the torso securing device may include straps that are secured directly to one or more of shoulder therapy devices, such as the abduction/adduction device and the internal/external rotation device, or to the flexion/extension device. Other configurations do not depart from the scope of the present disclosure. 
     Moreover, the orthosis  10  may be configured for mounting on a stand, such as disclosed in U.S. Patent Application Publication No. 2009/0264799, filed Oct. 22, 2009, the teachings of which relating to the mounting of an orthosis on a stand are herein incorporated by reference. In such an embodiment, the torso securing device  12  of the illustrated embodiment disclosed herein may be omitted or replaced with another type of securing device, without departing from the scope of the present disclosure. 
     Flexion/Extension Device 
     As used herein, the term “flexion/extension device” is a device that is configured to move and/or position the shoulder joint in at least one of a selected degree of flexion (which may include transverse adduction when the shoulder joint is in abduction) and a selected degree of extension (which may include transverse abduction when the shoulder joint is in abduction), or only one of a selected degree of flexion and a selected degree of extension. Moreover, the flexion/extension device may be non-adjustable, such that the degree of flexion/extension of the shoulder is fixed ( FIGS. 4-6 and 7A ), or the flexion/extension device may be selectively adjustable, to allow for selective adjustment of the degree of flexion and/or extension of the shoulder joint ( FIGS. 7B through 7F ). 
     In the illustrated embodiment of  FIGS. 4-6 and 7A , the flexion/extension device  14  includes a first load-bearing plate  40  (broadly, a first load-bearing member) fixedly secured to lateral portions of the thoracic and waist supports  20 ,  22 , respectively, and positioned generally immediately below the armpit recess. When the torso securing device  12  is secured to the torso, the load-bearing plate  40  is configured to lie substantially in a sagittal plane S (i.e. any longitudinal plane that passes from the anterior to the posterior of the body, divides the body into right and left portions, and is parallel to the median plane) and intersect the mid-coronal plane C (i.e. any longitudinal plane that is at a right angle of the sagittal plane, which divides the body into anterior and posterior portions) of the person&#39;s body, as seen in  FIG. 6 , for example. The load-bearing plate  40  includes an angular positioning member  42 , which may be a separate component or formed integrally with the load-bearing plate. In the illustrated embodiment, a second load-bearing plate  44  (broadly, a load-bearing member) is secured to the angular positioning member  42 , such as by threaded fasteners, so that the angular positioning member  42  angular offsets the second-load bearing plate  44  relative to a sagittal plane of the person&#39;s body. 
     As explained in more detail below, the abduction/adduction device  16  is secured to a mounting surface  46  ( FIGS. 6 and 7 ) of the second load-bearing plate  44  such that the flexion/extension device  14  operatively connects the abduction/adduction device and the internal/external rotation device  18  to the torso securing device  12 , although it is understood that the flexion/extension device may not operatively connect the abduction/adduction device and the internal/external rotation device  18  to the torso securing device  12  without departing from the scope of the present disclosure. Broadly, the illustrated flexion/extension device functions as a shim, positioned between the torso-securing device  12  and the abduction/adduction device  16 , and in turn, the internal/external rotation device, to provide a desired angular offset between the torso-securing device and the respective devices. As explained below, the abduction/adduction device  16  defines an abduction/adduction plane through which the upper arm moves under load of the abduction/adduction device. The illustrated flexion/extension device  14  angularly offsets this abduction/adduction plane relative to a sagittal plane of the person&#39;s body to provide flexion of the shoulder when the user&#39;s arm is secured to the orthosis. 
     As seen in  FIGS. 1A and 1B , the flexion/extension device  14  of this illustrated embodiment is configured to position the shoulder joint at about 30 degrees of flexion. It is believed that about 30 degrees of flexion of the shoulder joint will generally locate the upper arm, and more specifically, the abduction plane of the shoulder, in a plane that is substantially coplanar with and/or parallel to a scapular plane defined by the scapula. It is also believed that positioning the shoulder joint in flexion coplanar with (e.g., parallel to) the scapular plane when treating the shoulder joint, such as by adduction or abduction and/or internal or external rotation, has certain therapeutic benefits. It is contemplated that in other embodiments, the flexion/extension device  14  may be configured to place the shoulder joint from about 5 degrees to about 90 degrees of flexion, more specifically, about 10 degrees to about 60 degrees flexion, or about 15 degrees to about 45 degrees flexion, or about 20 degrees to about 40 degrees, or about 25 degrees to about 35 degrees. Moreover, the flexion/extension device  14  may be configured to facilitate positioning of the shoulder joint at a selected degree of extension, such as from about 1 degree of extension to about 10 degrees of extension. Broadly, the flexion/extension device  14  is configured to position the shoulder joint at at least one of greater than 0 degrees of flexion and greater than 0 degrees of extension. It is understood that the flexion/extension device  14  may have other configurations without departing from the scope of the present disclosure. For example, the flexion/extension device  14  may not include the first load-bearing plate  40  or the second load-bearing plate  44 , as illustrated, and may include a component other than the angular positioning member  42  for facilitating flexion and/or extension of the shoulder. 
     In another embodiment, as seen in the illustrated embodiment of  FIGS. 7B through 7F , the flexion/extension device  14 ′ is selectively adjustable to allow for selective adjustment of the degree of flexion and/or extension of the shoulder joint. Selective adjustability of the degree of flexion and/or extension of the shoulder joint provides for greater range-of-motion treatment to the shoulder joint. Moreover, the adjustable flexion/extension device may be used to more properly position the longitudinal axis of the upper arm (more specifically, the abduction/adduction plane of the shoulder joint) coplanar with the scapular plane. Thus, the adjustability of the flexion/extension device may be more beneficial than a fixed flexion/extension device of 30 degree flexion where a person&#39;s scapular plane may be angularly offset either greater than or less than 30 degrees relative to a coronal plane, for example. 
     As seen in  FIGS. 7B through 7F , the adjustable flexion/extension device  14 ′ of this embodiment includes first and second load-bearing plates  40 ′,  44 ′, respectively. The second load-bearing plate  44 ′ is coupled to the first load-bearing plate  40 ′ to allow for rotational movement of the second load-bearing plate, and in turn, rotational movement of the abduction/adduction device  16  and the internal/external rotation device  18 , about the first load-bearing plate, generally within a plane defined by a transverse plane of the person&#39;s body. In particular, the illustrated first load-bearing plate  40 ′ includes upper and lower angular displacement members  42 ′ that are generally in the form of arcuate rails or tracks. The illustrated second load-bearing plate  44 ′ includes cantilevered upper and lower hook members  45 ′ that slidably engage the arcuate tracks  42 ′ to slidably secure the second load-bearing plate  44 ′ to the first load-bearing plate  40 ′. As can be seen from  FIG. 7D , the mounting surface  46 ′ of the second load-bearing plate  44 ′, to which the abduction/adduction device  16  is secured, remains in planes that are substantially tangential to the arcuate tracks as the second load-bearing plate slides along the arcuate tracks  42 ′. As such, the arcuate tracks  42 ′ provide limited rotational movement of the second load-bearing plate  44 ′ relative to the first load-bearing plate  40 ′, and in turn, the flexion/extension device  14 ′ facilitates selective adjustment of the degree of flexion and/or extension of the shoulder joint. A chamfered anterior edge  43 ′ of the first load-bearing plate  40 ′ provides clearance for the second load-bearing plate  44 ′ when the second load-bearing plate is slid to an anterior position on the first load-bearing plate. In the illustrated embodiment, the axis of rotation of the flexion/extension device  14 ′ is generally aligned vertically (inferior-superior) with the flexion/extension rotation axis of the shoulder joint. 
     A set screw  47 ′ of the flexion-extension device  14 ′ releasably fixes or locks the second load-bearing plate  44 ′ in a selected position on the tracks  42 ′ to facilitate positioning the shoulder joint in a selected degree of flexion and/or extension. The set screw  47 ′ extends through an opening in a free end portion  48 ′ of the lower hook member  48 ′ and engages the lower track  42 ′ to releasable fix the second load-bearing plate  44 ′ on the first load-bearing plate  40 ′. Loosening of the set screw  47 ′ allows the second load-bearing plate  44 ′ to slide on the tracks  42 ′ for repositioning the second load-bearing plate and adjusting the degree of flexion and/or extension of the shoulder joint. An access opening  49 ′ extending through the first load-bearing plate  40 ′ is substantially aligned with the lower hook member  45 ′ to provide access to the set screw  47 ′ for loosening and tightening the set screw, such as through use of a suitable tool. As seen in  FIG. 7B , the access opening  49 ′ is disposed between the thoracic support  20  and the waist support  22  so that it is exposed, at least when the torso-securing device  12  is not secured to the person. Alternatively, an opening can be formed in the torso-securing device. Other ways of releasably locking the position of the second load-bearing plate  44 ′ relative to the first load-bearing plate  40 ′ (more broadly, the position of a shoulder therapy device relative to the torso-securing device  12 ) do not depart from the scope of the present disclosure. 
     It is understood that the flexion/extension device  14 ′ may be selectively adjustable in other ways to allow for selective positioning of the shoulder joint in a selected degree of flexion and/or extension, without departing from the scope of the present disclosure. For example, the flexion/extension device  14 ′ may include a simple hinge joint operatively coupling the abduction/adduction device  16  (or other shoulder therapy device) to the torso-securing device  12 . In one embodiment, a simple hinge joint may couple the second load-bearing plate  44  to the first load-bearing plate  40 . Other configurations do not depart from the scope of the present disclosure. 
     The adjustable flexion/extension device  14 ′ may be configured to place the shoulder joint in a selected degree of a plurality of degrees ranging from about 5 degrees to about 90 degrees of flexion, more specifically, about 10 degrees to about 60 degrees flexion, or about 15 degrees to about 45 degrees flexion, or about 20 degrees to about 40 degrees, or about 25 degrees to about 35 degrees. In another embodiment, the number of selectable degrees from which the shoulder joint may be discrete and predetermined. For example, the selectable degrees may be 25 degrees, 30 degrees and 35 degrees. In another embodiment, the selectable degrees may be substantially any degree within the range of degrees, and therefore, theoretically the number of degrees is infinite. For example, the selectable degrees may be any degree that within the range (e.g., between 25 degrees and 35 degrees). The illustrated flexion/extension device  14 ′ facilitates placement of the shoulder joint in theoretically any degree of flexion within the range of about 0 degrees to about 30 degrees. 
     Moreover, the flexion/extension device  14  may be configured to facilitate positioning of the shoulder joint at a selected degree of a plurality of degrees of extension, such as ranging from about 1 degrees of extension to about 10 degrees. The number of selectable degrees of extension may be discrete and predetermined or theoretically infinite, as disclosed above with respect to the degrees of flexion. The flexion/extension device  14  may have other configurations without departing from the scope of the present disclosure. 
     It is also contemplated that the flexion/extension device  14  may include a drive mechanism to facilitate flexion and/or extension of the shoulder joint to move and position the shoulder joint at a selected degree of flexion or extension. Such drive mechanism may include one of the drive mechanisms employed in the abduction/adduction device  16  and the internal/external rotation device  18 . Other suitable drive mechanisms may be used. This particular embodiment allows the flexion/extension device to function as a shoulder therapy device like the illustrated abduction/adduction device  16  and the illustrated internal/external rotation device  18 . 
     It is understood that the flexion/extension device  14  may have other configurations without departing from the scope of the present disclosure. For example, the flexion/extension device may be formed integrally with a portion of a torso securing device, such as being formed integrally with a thoracic support or a waist support. Moreover, the flexion/extension device may be integrally formed with a portion of the abduction/adduction device or another shoulder therapy device. 
     Abduction/Adduction Device 
     As used herein, the term “abduction/adduction device” is a device that is configured to position and/or move the shoulder joint in at least one of a selected degree of abduction and a selected degree of adduction or only one of a selected degree of abduction and a selected degree of adduction. The “abduction/adduction device” may be selectively adjustable, to allow for selective adjustment of the degree of abduction/adduction of the shoulder and provide corresponding treatment during abduction and/or adduction, as seen in the embodiments of  FIGS. 7-13 , or the abduction/adduction device may be non-adjustable, such that the degree of abduction/adduction of the shoulder is substantially fixed at a selected degree (not shown). 
     Referring now to  FIGS. 7-13 , the shoulder abduction/adduction device  16  of the illustrated embodiment is generally in the form of an adjustable bracket including a stationary bracket member, generally indicated at  50 , which is secured to the flexion/extension device  14  and remains substantially stationary relative to the torso of the person, and a movable bracket member, generally indicated at  52  (broadly, a force-imparting member), which is secured to the internal/external rotation device  18  and moves relative to the torso of the person. The bracket members  50 ,  52  are hingedly connected to one another by a pivot pin  54  ( FIGS. 8, 10 and 13 ) such that the movable bracket is pivotable toward and away from the fixed bracket member about the pivot pin and within an abduction/adduction plane. In the illustrated embodiment, the stationary bracket member  50  has a securement plate  58  secured to the mounting surface  46  of the second load-bearing plate  44 , which is in turn secured to the angular displacement member  42  of the flexion/extension device  14 , such that the abduction/adduction plane is offset a non-orthogonal angle (e.g., 30 degrees) relative to a sagittal plane to provide the selected degree of shoulder flexion, as set forth above. 
     The shoulder abduction/adduction device also includes an abduction/adduction drive assembly, generally indicated at  64 , and a force transmitting mechanism, generally indicated at  66 , for selectively pivoting the movable bracket member  52  relative to the stationary bracket member  50 , to thereby facilitate adduction or abduction of the shoulder joint. In general, the abduction/adduction drive assembly  64  imparts torque to the brackets  50 ,  52  via the force transmitting mechanism  66 . 
     With particular reference to  FIGS. 10-12 , the drive assembly  64  includes a drive shaft  70 , having a knob or handle  72  that is rotatable by hand. Alternatively, the drive shaft  70  may be driven by a motor (not shown), which may be controlled by servo control circuits, the circuit possibly including a computer with a human interface connected by wires, or a wireless network. The drive shaft  70  is operatively coupled to a spool  74 , on which a cable  76  ( FIG. 13 ) of the force transmitting mechanism  66  is wound. As explained in more detail below, the cable  76  is further wound around pulley wheels (identified below) to impart a mechanical advantage to the rotational force applied to the spool  74  by the drive assembly  64 . 
     In one embodiment (see, for example,  FIGS. 7-13 ), a rotational position of drive shaft  70 , and thus a selected degree of abduction/adduction of the shoulder joint, is maintained by a rotation control subassembly device, generally indicated at  80 , which enables an operator to rotate the drive shaft  70  to adjust a tension of the abduction/adduction device  16 , and concomitantly prevents rotation of drive shaft incident to forces imparted by a load. Loading forces include, for example, gravitational forces acting upon the body, or body tissue resisting stretching. 
     Referring to  FIGS. 11 and 12 , the rotation control subassembly  80  includes inner and outer raceways, or races  82 ,  84 , respectively, defining peripheral inner spaces  86  therebetween, and rotatable elements, such as pins  88  or spheres, disposed within the spaces  86 . When one of races  82 ,  84  is rotated with respect to the other, the pins  88  are urged along a ramp  90  associated with one of the races, whereby the pins become pinched and bind between the ramp and an inner surface  92  of the outer race  84 , thereby preventing further movement, or creating a lock-up condition, of one of the races relative to the other. The ramps  90  are provided for both possible directions of rotation of the inner race  82 . The outer race  84  is fixed against rotation, whereby when the races  82 ,  84  become fixed relative to each other, neither race rotates. Exterior teeth  94  on the outer race  84  are provided to engage a stop (now shown) on the stationary bracket member  50 . In this manner, the outer race  84  cannot rotate relative to the abduction/adduction device  16 , or the drive assembly  64 . 
     Drive shaft  70  is connected via bushing  98 , or other known means, to a series of engagement dogs  100 , which are interposed in the spaces  86  between the inner and outer races  82 ,  83 , respectively. When drive shaft  70  is rotated about its axis, bosses  102  associated with the dogs  100  engage cams  104  associated with the inner race  82 , whereby drive shaft  70  operates to rotate, or drive, the inner race. The engagement dogs  100  simultaneously impinge at surface  106  upon the pins  88 , enabling free rotation of drive shaft  70  by ensuring that the pins  88  do not travel sufficiently far along the ramp  90  to bind between the races  82 ,  84 . In the embodiment illustrated, the inner race  82  bears the ramps  90 , however it should be understood that one skilled in the art could switch the roles of the inner and outer ramps, whereby the ramps are disposed upon an inner surface of the outer race  84 , and the inner race is fixed. A retainer  108 , and other supporting means, may be provided to secure the components of rotation control subassembly  80  together. Additional components may be included, as known by one skilled in the art, to secure subassembly  80  within the drive assembly  64 . 
     A shaft (not shown) is secured within a hex-shaped aperture  110  defined by the inner race  82 . The shaft passes axially through the spool  74  to operatively connect the shaft to the spool such that rotation of the shaft imparts rotation of the spool. Broadly, the spool  74  functions as a lever and the cable  76  functions as a tensioning member. It is understood that other devices operative to transmit the rotational force of the drive shaft  70  to the cable  76  may be used, including a bar, eccentric spool or cam, pincher, or grasper. In each case, the rotational force imparted by drive shaft  70  is applied to the other device to cause the device to apply a tensioning force to the cable  76 . It is understood that the rotation control subassembly  80  may be of other configurations. Moreover, the shoulder orthosis  10  may not include the rotation control subassembly  80  without departing from the scope of the present disclosure. 
     In another embodiment ( FIG. 13 ) the drive assembly may include one way clutch comprising fixed, ramped pawl teeth  111 , and mating slots  112  within the spool  74 , which enable a tensioning rotation in one direction only. A spring  113  urges the spool  74  against the pawl teeth  111 . To disengage tension, the spool  74  is pressed, as with fingertips to compress the spring  113  and move the spool away from engagement with the pawl teeth  111 , whereupon the spool is substantially free to counter rotate. 
     As set forth above, the force transmitting mechanism  66  includes the cable  76 . Any form of cable or cord, spring, or other force transmitting device as described herein may be used with the force transmitting mechanism  66 . Referring to  FIGS. 8-10 and 13 , in addition to the cable  76 , the force transmitting mechanism  66  includes proximal and distal shackles  114 ,  116 , respectively. A clevis pin  118  pivotally couples ends of the proximal and distal shackles  114 ,  116  to one another at a hinged shackle joint, and further supports at least one pulley wheel  120  at the shackle joint. Respective opposite ends of the proximal and distal shackles  114 ,  116  are pivotally coupled to the respective stationary and movable bracket members  50 ,  52 , respectively, via respective shackle pins  122 ,  124 . At least two adjacent pulley wheels, each indicated at  128 , are secured to the stationary bracket member  50  via a pin  130 . 
     As seen in  FIG. 13 , the cable  76 , which is affixed to and at least partially wound around the spool  74 , as set forth above herein, is partially wound around each of the pulley wheels  120 ,  128  and is tethered to the distal shackle  114 , such as by a tying a knot at the free end of the cable, after inserting the free end through an aperture  130  in the distal shackle. The manner of affixing the cable  76  may be varied. The pulley configuration described operates to pull the clevis pin  118  towards the hinged connection of the bracket members  50 ,  52  as the spool  74  is wound in a tightening direction. The pulley wheels  120 ,  128  operate together to increase the mechanical advantage of the force applied to spool  74 , facilitating operation by a user. For example, in the embodiment shown, a mechanical advantage is obtained resulting in one third less force required to rotate the knob  72 . Other pulley configurations may be employed within the scope of the disclosure, as would be understood by one skilled in the art. 
     With reference to  FIG. 10 , a torsional spring  134 , received on the shackle pin  122 , is operative to maintain a minimum tension on the cable  76 , to reduce entanglement, and to maintain the cable in proper engagement with the pulley wheels  120 ,  128  when the cable is not in tension. The spring  134  urges the proximal shackle  114  away from the hinged connection between the bracket members  50 ,  52 . The spring  134  may further be selected to apply a therapeutic force, in addition to a resilient force of the cable  76 . 
     While the hinged shackles  114 ,  116  are described in connection with changing an angle of bracket members  50 ,  52 , it should be understood that other methods may be employed, as are known in the art or which may be discovered. For example, a cantilever (not shown) may extend from a bracket member, acted upon by cable connected at a cantilever extremity. 
     The cable  76  may be composed of any of a variety of materials, including natural or synthetic fibers, solid, wound or braided materials, or other durable and flexible material selected for a desired resiliency based upon an intended therapeutic application. Examples include cotton or polypropylene cord, plastic tape or strands, wire wound spring or woven wire fabricated from stainless steel or shape metal alloy material, and rubber or latex containing material. Accordingly, the resiliency of the cable may be selected by the type of material, as well as how it is prepared. In accordance with the disclosure, a cable may be selected to exhibit a significant resistance to stretching, such as a steel cable, or the ability to stretch considerably, such as a rubber or latex cable. The practitioner may thus select a cable resilience to correspond to the therapeutic objective. Additionally, depending on the materials and configuration of the orthosis  10 , resiliency may be contributed by the device itself, wherein a cable is selected in consideration of the observed resiliency of the device as configured. 
     Referring to  FIG. 1A  through  FIG. 5 , an upper arm securing device, generally indicated at  140 , is operatively connected to the movable bracket member  52 . The upper arm securing device  140  includes a support  140   a  and a releasable strap  140   b  that positions the longitudinal axis of the upper arm within a plane that is generally coplanar with the abduction/adduction plane. The upper arm securing device  140  is configured to inhibit anterior and posterior movement of the upper arm, while allowing the upper arm to rotate about its axis when the upper arm is secured thereto. In the illustrated embodiment (seen in  FIGS. 4 and 5 ), the upper arm securing device  140  is secured to a telescoping extension member  142  of the internal/external rotation device  18 . The extension member  142  is telescopingly connected to the movable bracket member  52 , and in turn, to the abduction/adduction device  16 . More specifically, the telescoping extension member  142  is slidably coupled to the movable bracket member  52  by a tongue and groove connection to allow for adjustment of the distance between the internal/external rotation device  18 , and in turn the upper arm securing device  140 , and the torso securing device  12  to accommodate various arm lengths. A set screw  144  is used to fix the selective position of the telescoping extension member  142  on the movable bracket member  52 . 
     During use of the abduction/adduction device  16 , the drive shaft  70  is rotated, such as by using the knob  72 , to increase the angle between the proximal and distal shackles  114 ,  116 , and in turn, move the movable bracket member  52  away from the stationary bracket member  50 . Movement of the movable bracket member  52  away from the stationary bracket member  50  imparts abduction of the shoulder joint, which stretches tissue associated with the shoulder joint. Movement of the movable bracket member  52  toward the stationary bracket member  50  imparts adduction of the shoulder joint, which may also stretch tissue associated with the shoulder joint. During static stretching, as tissue stretches, the force required to maintain a stretched position decreases, and may ultimately fall to zero. If the cable  76  is resilient, however, a minimum amount of dynamic stretching force is maintained throughout the stretching period. The amount of dynamic stretching force is a function of the resiliency of cable  76 . 
     In one example, the abduction/adduction device may be configured to facilitate selective abduction and adduction and positioning of the shoulder joint from about 0 degrees of abduction to about 90 degrees of abduction. The abduction/adduction device may facilitate a different range-of-motion of the shoulder without departing from the scope of the present disclosure. 
     Internal/External Rotation Device 
     With particular reference to  FIGS. 14-17 , the internal/external rotation device  18  includes an L-shaped gearbox, generally indicated at  150 , connected to, e.g., integrally formed with, the telescoping extension member  142 . As seen in  FIGS. 16 and 17 , the gearbox  150  houses an input gear  152  operatively connected to an end margin of an input shaft  154  having a knob or handle  156  at an opposite end. A transmission gear  158  ( FIG. 17 ) engages the input gear  152 . In the illustrated embodiment, the input gear  152  is a worm, and the transmission gear  158  is a worm gear, although the transmission gear may be a worm, and the input gear may be worm gear. Other configurations do not depart from the scope of the present disclosure. 
     Referring to  FIGS. 15-17 , the transmission gear  158  is operatively connected to a drive shaft  160 , which drives an output pinion gear  162 . The pinion gear  162  engages an arcuate rack gear, generally indicated at  166 , which includes teeth  168  that are arranged along an arcuate path, which may or may not generally follow the overall shape of the rack gear. As the knob  156  of the input shaft  154  is rotated, the rotational movement is translated through the input gear  152  and the transmission gear  158  to turn the drive shaft  160 , thereby turning the pinion gear  162  and driving the rack gear  166  along an arcuate path. A rack support member, generally indicated at  172 , supports the rack gear and operatively connects the rack gear to the gearbox  150 . The support member  172  includes at least one projection or tongue  174  inserted into smooth, arcuate shaped grooves or tracks  176  in the rack gear  166 . The tracks  176  generally follow the arcuate path of the teeth  168  and provide support and guidance for the rack gear as it is driven by the pinion gear  162 . 
     A force-imparting member, generally indicated at  180 , of the internal/external rotation device extends outward from the rack gear  166 . The force-imparting member  180  moves with the rack gear  166 , along the arcuate path of the rack gear, and is configured to impart or transmit force from the rack gear to a forearm and a hand of the person that is secured to the force-imparting member. The force-imparting member  180  includes a substantially rigid, cantilever arm  182  and forearm and hand securing devices  184 ,  186 , respectively, secured to the arm. The arm  182  has a longitudinal axis lying substantially coplanar with the teeth  168  of the rack gear  166 . The forearm securing device  184  removably secures the forearm of the person to the internal/external rotation device and imparts the force of the cantilever arm  182  to the forearm. In the illustrated embodiment, the forearm securing device  184  comprises a support  190  and an adjustable strap  192  (together referred to as a cuff), which restricts the forearm and the elbow from lifting out of position relative to the internal/external rotation device  18  as a therapeutic force is applied. The hand securing device  186  is telescopingly connected to the distal end of the cantilever arm  182 . The hand securing device  186  comprises a support  194  (e.g., a pad) and an adjustable strap  196 , which restricts the hand, and further restricts the forearm and elbow, from lifting out of position as a therapeutic force is applied. The support  194  is selectively slidable along the axis of the cantilever arm  182 , such as by a tongue and groove configuration and a set screw, allowing for various forearm lengths. The force-imparting member  180  may also include an elbow support for supporting the elbow. 
     Referring to the internal/external rotation device, as knob  156  is rotated, internal or external (medial or lateral) rotation of the shoulder joint is effectuated. The cantilever arm  182  rotates within an internal/external rotation plane. In the illustrated embodiment, the orthosis  10  is configured such that the elbow is maintained at 90 degrees of flexion when the person&#39;s arm is properly secured to the orthosis. The elbow may be flexed at another angle, other than 90 degrees, without departing from the scope of the present disclosure. It is also understood that the degree of elbow flexion may be adjustable. Moreover, when the person&#39;s arm is properly positioned, the pivot point of internal/external rotational device  18  is along the axis of the upper arm. 
     In one example, the internal/external rotation device may be configured to facilitate selective internal rotation and positioning of the shoulder from about 0 degrees to about 90 degrees of internal rotation. Moreover, the internal/external rotation device may be configured to facilitate selective external rotation and positioning of the shoulder from about 0 degrees to about 90 degrees of external rotation. The internal/external rotation device may facilitate a different range-of-motion of the shoulder without departing from the scope of the present disclosure. 
     When stretching tissue of the shoulder, internal/external rotation angle is set for optimized beneficial effect with respect to the glenohumeral joint. The internal/external rotation angle may be changed to alter to application of force at the glenohumeral joint. Moreover, the internal/external rotation angle may be changed to effectuate a therapeutic benefit upon the elbow. It should further be understood that effectuators as are known and described in the art may be fitted to the wrist portion of device  10  in order to carry out stretching therapy upon the wrist. 
     Exemplary Materials for Fabrication 
     Devices may be made using flexible or rigid polymeric material, metal, or other biocompatible materials capable of exerting loading when flexed, stretched or compressed. An exemplary orthosis, including a flexible section is disclosed in U.S. Pat. No. 5,685,830 entitled “Adjustable Orthosis having one-piece connector section for flexing” to Bonutti, the contents of which are herein expressly incorporated by reference in their entirety. 
     The components of the disclosure that are rigid members made of, for example, aluminum, stainless steel, polymeric, or composite materials. The member and extensions are sufficiently rigid so as to be able to transmit the necessary forces, and cooperate to provide a resilient force, where dynamic tension is desired. It should be understood that any material of optimal rigidity can be used. More particularly, a resilient frame may advantageously be employed to contribute a continuous force to the joint, cooperating with a resilient cable, or providing the sole resilient force for stretching tissue associated with a joint. 
     Flexible sections can be made of a shape memory or reactive material, where a change in temperature, or application of an electrical current, results in a shape or position change of the flexible section. The change in shape of a flexible section can be used to change the position of adjacent frame brackets. Alternatively, the change in shape of a flexible section can be used to provide a force to adjacent frame brackets. 
     For example, the components can be made by injection molding. Generally for injection molding, tool and die metal molds of the components are prepared. Hot, melted plastic material is injected into the molds. The plastic is allowed to cool, forming components. The components are removed from the molds and assembled. In addition to being bolted together, portions of the device in accordance with the invention may be assembled by welding, adhesives, or other means. In addition, adjustable connections may be achieved by clamps, springs, hook and loop fasteners, and other removable means. 
     Furthermore, it is contemplated that the components can be made of polymeric or composite materials such that the device can be disposable. For example, at least some or all of the components can be made of a biodegradable material such as a biodegradable polymer. Among the important properties of these polymers are their tendency to depolymerize relatively easily and their ability to form environmentally benign byproducts when degraded or depolymerized. One such biodegradable material is poly (hydroxyacids) (“PHA&#39;s”) such as polyactic acid (“PLA”) and polyglycolic acid (“PGA”). 
     Additionally, the device can be made of a nonmagnetic material. In such an instance, the device can be used as a positioning device for use in imaging devices, such as a MRI device. It is also contemplated that the device can be used as a positioning device for use during surgical procedures, where it may be necessary to adjust and hold the position of the joint. 
     Exemplary Methods of Using Embodiment(s) of the Orthosis 
     In an exemplary use, the shoulder orthosis  10  is operated to extend the shoulder joint in the following manner. The torso securing device  12  is secured to the person, such as in the manner set forth above. The person&#39;s upper arm, forearm, and hand are then attached to the orthosis  10 , such as in the manner set forth above. In an illustrated embodiment, seen in  FIGS. 1A and 1B , the person&#39;s shoulder joint is in a selected flexion (e.g., 30 degrees of flexion) upon securing the person&#39;s arm to the orthosis  10 . Adduction and or abduction of the shoulder joint can then be actuated (or selected before securing the arm to the orthosis) by rotating the knob  72 . Either the person himself/herself or an assistant can rotate the knob  72 . Rotating the knob  72  causes connective tissue of the joint to be stretched. The orthosis  10  may be maintained in a position for a predetermined treatment time, utilizing the principles of stress relaxation to stretch the connective tissue of the joint. Where the cable  76  is resilient, an application of force restricts a relaxation of the connective tissue of the joint, utilizing the principles of creep to further stretch the connective tissue of the joint. After the expiration of the treatment time, the orthosis  10  may be returned to an initial position, relieving the joint. While in one embodiment, the loading or forces applied are substantially constant, they also may gradually increase, decrease, pulse between a first and second amount of force, or be varied in other ways such as described in the cited references. 
     Optionally, knob  72  can be rotated to a third or additional positions, further increasing the stretch of the connective tissue of the joint, for example at discrete time intervals to incrementally increase the stretch of the joint through the treatment cycle. In each of the movements, the cable  76  provides a substantially constant force to the joint, preventing a relaxation of the connective tissue of the joint. After completion of the treatment cycle, the knob may be counter rotated, and the spool  74  may be moved away from engaging pawls, as described above, to relieving tension on the joint. 
     Internal and/or external rotation of the shoulder joint can be actuated by rotating the knob  156  of the internal/external rotation device  18 . Either the person himself/herself or an assistant can rotate the knob  156 . Internal or external rotation of the shoulder can be actuated when the shoulder is in a selected degree of adduction. Rotating the knob  156  causes connective tissue of the joint to be stretched. The orthosis  10  may be maintained in a position for a predetermined treatment time, utilizing the principles of stress relaxation to stretch the connective tissue of the joint. A resilient type of an application of force may be used to prevent a relaxation of the connective tissue of the joint, utilizing the principles of creep to further stretch the connective tissue of the joint. After the expiration of the treatment time, the orthosis  10  may be returned to an initial position, relieving the joint. While in one embodiment, the loading or forces applied are substantially constant, they also may gradually increase, decrease, pulse between a first and second amount of force, or be varied in other ways such as described in the cited references. The shoulder joint can be moved to a third or additional positions. 
     The force applied in one treatment interval may differ in degree, profile, or duration of force applied in another treatment interval, although in some cases the applied force may be substantially the same for two or more, or even for all treatment intervals. 
     The degree of force applied, for example, may be varied from one treatment interval to another, and likewise the degree of force applied may be adjusted depending upon different factors or patient needs. 
     Additionally, adjustments also may be made during a treatment interval. For example, adjustments may be made during a treatment interval in order to increase or decrease the forces imparted, even though the geometric angle or position of the device remains unchanged. In one example, the initial force imparted at the beginning of a treatment interval may be low, but then increased over time according to a patient&#39;s progress or according to a predetermined time schedule. In another example, it may be desirable to initially apply a greater force in order to help accelerate a patient&#39;s progress, but then later relieve or reduce the forces applied after achieving a satisfactory degree of stretching or after a predetermined time. 
     In addition, the flexion/extension device  14 , and/or the abduction/adduction device  16  and/or the internal/external rotation device  18  can include a force control system for control of the force applied, as in an automated control for the respective drive assemblies. A pneumatic or hydraulic system, for example, may have controls for the amount of force imparted by any or all of the force elements as well as the force profile and direction of applied forces. Likewise, a servo-mechanical force control system may be used to vary the amount of deflection or preload of spring-like force elements. These auxiliary systems could be under control of a computer. The computer could control joint stretching based upon sensors, including sensing of physiological indicators. 
     In an embodiment, an electric motor (not shown) may be operatively connected to one or more of the flexion/extension device  14 , the abduction/adduction device  16 , and the internal/external rotation device  18 . A battery (not shown) may provide electric power to the motor, or it may be powered from another source. A microprocessor (not shown) can be used to operate the motor to more accurately control positioning of the device, or to allow for automation of some steps of treatment such as moving from one position to another. The motor may also operate within a control system that allows for remote operation of the device by a healthcare professional or technician. The microprocessor and motor together can be used to cycle the devices to move the shoulder joint within a range-of-motion, hold a position while tissue stretches, then move further in that direction; or in any other manner. In another manner of use, the orthosis can be set to cycle to one end of the joint&#39;s range-of-motion and hold there for a predetermined period of time, then cycle to the other end of the joint&#39;s range-of-motion and hold there. Given the benefit of this disclosure, one may program and control the microprocessor so that desired motion is attained. This embodiment is ideally suited for continuous passive motion exercise, because it can be programmed with the desired sequence of movements. Preferably, at least this embodiment also would be a portable device so that it may be provided to a patient to use in the home, at work, or wherever they may desire. 
     It should be understood that the particular physical arrangement of the motor, the battery, and the microprocessor may be varied, as known in the relevant art. Additionally, another type of actuation, other than an electric motor, can also be used. For example, the use of a hydraulic or pneumatic motor as the drive mechanism is contemplated. 
     Another embodiment can include a monitor for use with device  10 , which provides assurances the person is properly using device  10  during his/her exercise period. For instance, the monitor can have a position sensor, a temperature sensor, a clock or timer, or a device type sensor for monitoring the patient&#39;s implementation of a protocol. The information obtained from these monitoring devices may be stored for later analysis or confirmation of proper use or may be transmitted in real-time during use of the device. The data obtained from the monitor can be analyzed by a healthcare professional or technician and the protocol can be adjusted accordingly. This analysis may be conducted remotely, thereby saving the time and expense of a home visit by a healthcare professional or technician. An exemplary monitoring system is provided in U.S. Publication No. 2004/0215111 entitled “Patient Monitoring Apparatus and Method for Orthosis and Other Devices,” to Bonutti et al., the content of which is herein expressly incorporated by reference in its entirety 
     One or more embodiments of the orthosis  10  can be custom made to fit a particular individual, or can be an off the shelf item. One or more embodiments of the orthosis  10  can also be used, for example, to eliminate contractures or stress soft tissue. It can be used for patients with cerebral palsy, stroke, spastic paralysis, burns, as well as in post-traumatic or post-surgical cases. As previously discussed, the orthosis  10  also may be used to extend the rotational capability of a joint. Additionally, the device can be used for tissue transport, bone lengthening, stretching skin or tissue fascia, etc. For example, device of the invention can be incorporated in an external bone fixation device, such as an Ilizarov device, where the device is affixed to the bones on the body portions using pins. 
     Furthermore, one or more embodiments of the orthosis  10  is disclosed as utilizing the principle of stress relaxation, and in some instances, creep. However, it is contemplated that one or more embodiments of the orthosis  10  can include additional treatment protocols. For example, in continuous passive motion (“CPM”), the device continually moves the joint through a range-of-motion. The motion may be provided by an electric or hydraulic motor or a pneumatic system attached to the device. As the CPM moves the joint through its range-of-motion, however, it may be less effective in increasing the range of motion. 
     One or more embodiments of the orthosis  10  can be incorporated into a CPM device, where the CPM device would stop at an end range position. As previously discussed, a drive assembly may be provided to move the joint from its normal position at the end range position of the CPM to a second position, thereby stretching the tissue using the principles of stress relaxation. As the tissue relaxes, a force application assembly may be utilized to provide an additional force, utilizing the principles of creep to stretch the tissue. After a set time period, the drive assembly may be moved to a third position to further stretch the tissue or the CPM device may resume movement of the joint through the range-of-motion. Before CPM movement resumes, the drive assembly may be returned to an original position so that the range-of-motion of the CPM is returned to its original state, or the drive assembly may be used to alter the range-of-motion that the CPM follows. In this manner CPM device can be utilized to increase the range-of-motion of the joint. 
     It should be understood that the static and dynamic portions of one or more embodiments of the orthosis  10  as shown and described herein may both be statically adjustable, or both be dynamically adjustable, as defined herein. 
     When introducing elements of the present invention or preferred embodiments thereof, the articles “a”, “an”, “the”, and “said” are intended to mean that there are one or more of the elements. The terms “comprising”, “including”, and “having” are intended to be inclusive and mean that there may be additional elements other than the listed elements. 
     As various changes could be made in the above constructions and methods without departing from the scope of the invention, it is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.