Patent Publication Number: US-11039949-B2

Title: Orthopedic devices

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation in part and claims the priority benefit of U.S. Non-Provisional patent application Ser. No. 13/791,696 as filed on Mar. 8, 2013 and titled “Arm Cuff for Reducing Shoulder Impingement,” which is hereby incorporated by reference in its entirety. 
    
    
     FIELD OF THE INVENTION 
     The present application is directed generally to methods and devices for limiting arm and foot movement. 
     BACKGROUND 
     The shoulder joint is one of the largest joints in the human body and has the greatest range of motion of any joint. The shoulder joint is the area where the head of the humerus bone joins the scapula. While the shoulder joint is considered a ball and socket joint, the socket is relatively shallow. The shallow socket contributes to the joint&#39;s range of motion. Other bones that play a crucial role in the functionality of the shoulder include the acromion and coracoids process that project from the scapula and the clavicle that is connected to the acromion by the acromioclavicular ligament. 
     A variety of soft tissues hold the shoulder joint in place and allow the wide range of motion. These tissues include the rotator cuff which comprises several muscles and tendons surrounding the shoulder joint, bursae which are sacs of fluid that provide protection and lubrication within the rotator cuff, and the glenoid labrum which is a fibrocartilaginous rim around the socket in the scapula. Additionally, many other ligaments, tendons, and muscles assist in the function of the shoulder joint. 
     Because of the loose fit between the humerus and the scapula, the wide range of motion of the joint, and the general abuse the joint receives, shoulder injuries are common. Strains and tears of ligaments and tendons, and tears of the tissue comprising the rotator cuff are frequent occurrences for people with an active lifestyle or job, as well as the elderly. Injuries may also occur due to a single event such as lifting a heavy object or an accident. 
     Each of these injuries typically result in a significant amount of pain, particularly when moving the arm. The most intense pain may occur when the arm is moved towards the extremes of motion and soft tissue is impinged between the head of the humerus and the acromion. 
     SUMMARY 
     The present application is directed to methods and devices for reducing shoulder impingement for a person in a lying position. The device may comprise a generally tubular cuff having an inner radius defining an open passage through the cuff and extending from a proximal end to a distal end, an outer radius defining a sidewall thickness between the inner radius and the outer radius, and a length from the proximal end to the distal end. The outer diameter may be selected to provide a sidewall thickness that restricts movement of the arm such that shoulder flexion, extension, adduction, abduction, lateral rotation, and medial rotation are each limited. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is an anterior view of the skeletal anatomy of the shoulder. 
         FIG. 2  is a posterior view of the skeletal anatomy of the shoulder. 
         FIG. 3  is a lateral view of the skeletal anatomy of the shoulder. 
         FIG. 4  is an anterior view of the skeletal anatomy of the shoulder and deep level soft tissue. 
         FIG. 5  is a lateral cutaway view of the right shoulder joint socket. 
         FIG. 6  illustrates arm movement associated with shoulder flexion and extension. 
         FIG. 7  illustrates arm movement associated with shoulder adduction and abduction. 
         FIG. 8  illustrates arm movement associated with shoulder lateral and medial rotation. 
         FIG. 9  is a perspective view of an arm movement restraining device according to various embodiments. 
         FIG. 10  is a perspective view of an arm movement restraining device according to various embodiments. 
         FIG. 11  is a perspective view of an arm movement restraining device according to various embodiments. 
         FIG. 12  is a perspective view of an arm movement restraining device according to various embodiments. 
         FIG. 13  is an end view of an arm movement restraining device according to various embodiments. 
         FIG. 14  is an end view of an arm movement restraining device according to various embodiments. 
         FIG. 15  illustrates a person in a lying position with an arm movement restraining device engaged on a forearm. 
         FIG. 16  illustrates a person in a lying position with an arm movement restraining device engaged on a forearm. 
         FIG. 17  illustrates a person in a lying position with an arm movement restraining device engaged on a forearm. 
         FIG. 18  illustrates a person in a lying position with an arm movement restraining device engaged on a forearm. 
         FIG. 19  illustrates a person in a lying position with an arm movement restraining device engaged on a forearm. 
         FIG. 20  illustrates a person in a lying position with an arm movement restraining device engaged on a forearm. 
         FIG. 21A  is a perspective view of an arm movement restraining device according to various embodiments. 
         FIG. 21B  is a perspective view of an arm movement restraining device according to various embodiments. 
         FIG. 22  is an exemplary flow diagram of a method for reducing shoulder impingement for a person in a lying position according to various embodiments. 
         FIG. 23  is a perspective view of a foot movement restraining device according to various embodiments. 
         FIG. 24  is another perspective view of a foot movement restraining device according to various embodiments. 
     
    
    
     DETAILED DESCRIPTION 
     The present application is directed to methods and devices for reducing shoulder impingement for a person in a lying position. The device may comprise a generally tubular cuff having an inner radius defining an open passage through the cuff and extending from a proximal end to a distal end. The open passage may be adapted to releasably engage a forearm of the person therein. The cuff may also have an outer radius defining a sidewall thickness between the inner radius and the outer radius, and a length from the proximal end to the distal end. The outer diameter may be selected to provide a sidewall thickness that, when the cuff is engaged on the forearm of the person, restricts movement of the arm such that shoulder flexion, extension, adduction, abduction, lateral rotation, and medial rotation are each limited. 
       FIGS. 1 and 2  illustrate anterior and posterior views, respectively, of the skeletal anatomy of the shoulder  100  (also referenced as shoulder joint  100 ). The shoulder joint is comprised of the humerus  105  (the bone of the upper arm) and the scapula  110  (commonly referred to as the shoulder blade). A terminal portion of the humerus, or the head of the humerus  115 , mates with the scapula  110  at the glenoid cavity  120 . The acromion  125  and coracoid process  130  extend outwardly from the scapula  110  partially surrounding the head of the humerus  115  and providing mounting surfaces for a number of muscles and tendons (see  FIG. 5 ). The clavicle  135  extends above the scapula  110  and terminates in proximity to the acromion  125 . 
       FIG. 3  illustrates a lateral view of the skeletal anatomy of the shoulder  100  without the humerus  105 . In this view, the glenoid cavity  120  is more clearly presented, along with the glenoid labrum  305 . The glenoid labrum  305 , or glenoid ligament, comprises a fibrocartilaginous rim about the periphery of the glenoid cavity  120 . Together, the glenoid cavity  120  and the glenoid labrum  305  form the “socket” of the shoulder ball and socket joint, with the head of the humerus  115  forming the “ball.” 
       FIG. 4  illustrates an anterior view of the skeletal anatomy of the shoulder  100  with the deep layer soft tissue (muscles, ligaments, and tendons) present. The coraco-clavicular ligament  405  and the conoid ligament  410  connect the clavicle  135  to the scapula  110  by attaching to the coracoid process  130 . The terminal end of the clavicle  135  is connected to the acromion  125  by the acromioclavicular ligament  415 . The coracoacromial ligament  420  also connects the coracoid process  130  to the acromion  125 . The head of the humerus  115  is connected to the scapula  110  by the coracohumeral ligament  425  that attaches to the coracoid process  130  and the glenohumeral ligaments  430 . The supraspinatus muscle  435  runs from the top of the humerus  105  to the scapula  110  and passes between the coracoid process  130  and the acromion  125 . The biceps muscle  440  is connected to the shoulder joint  100  by the biceps tendon  445  which attaches to the glenoid labrum  305 . The soft tissue generally either connecting or positioned between the humerus  105  and the scapula  110  comprise the rotator cuff  450 . 
       FIG. 5  presents a cut away lateral view of the right shoulder joint  100  to further illustrate the soft tissue. A joint capsule  505  surrounds the ball and socket joint between the head of the humerus  115  and the glenoid cavity  120 . The joint capsule  505  provides a watertight sac around the ball and socket joint and provides the main source of stability for the shoulder, holding the ball and socket joint in place and preventing the ball and socket joint from dislocating. Surrounding the joint capsule  505  are a series of muscles including the teres minor muscle  510 , the infraspinatus muscle  515 , the supraspinatus muscle  520 , and the subcapularis muscle  525  that in part form the rotator cuff  450 . Positioned between these rotator cuff muscles and the acromion  125  is the subacromial bursa  530 . A second bursa, the subcoracoid bursa  535 , is positioned between the rotator cuff muscles and the coracoid process  130 . The bursae  530 ,  535  are sacs of lubricating fluid that are positioned where two body parts may rub against one another where there is no joint structure. 
     As illustrated above, the glenoid cavity  120  and the glenoid labrum  305  form a relatively shallow socket for receiving the head of the humerus  115 . This shallow socket combined with the complex soft tissue structure of the shoulder joint  100  allow a wide range of arm motion which allows the hand to achieve a variety of positions. This range of arm movement involving movement at the shoulder joint  100  is illustrated in  FIGS. 6 through 8 .  FIG. 6  illustrates shoulder flexion (A), or rotation of a straight arm positioned at the side to above the head, and extension (B), or rotation of a straight arm towards the back, without crossing the arm over the torso. The typical range of flexion rotation is about 180 degrees measured from the arm at the side, and typical range of extension rotation is about 50 degrees.  FIG. 7  illustrates shoulder adduction (C), or rotation of a straight arm in a raised position and extending straight out from the body across the chest, and abduction (D), or rotation of the same raised straight arm towards the back. The typical range of adduction rotation is about 45 degrees measured from the arm positioned straight out from the body, and the typical range of abduction rotation is about 130 degrees.  FIG. 8  illustrates shoulder lateral rotation (E), or rotation of the arm away from the body with the elbow bent at 90 degrees, and medial rotation (F), or rotation of the same bent arm in front of the body. The typical range of lateral rotation is about 60 degrees measured from the forearm positioned upward, and the typical range of medial rotation is about 105 degrees. 
     As illustrated in  FIGS. 6 through 8 , the shoulder joint  100  has the widest range of motion of any joint in the body. However, due to the relatively small and shallow size of the socket formed by the glenoid cavity  120  and the glenoid labrum  305 , the shoulder joint  100  is inherently unstable and prone to injury as well as a variety of diseases. One common injury is known as impingement syndrome. When the arm is abducted more than about 90 degrees, a projection on the back of the head of the humerus  115  compresses the rotator cuff  450 , and in particular the subacromial bursa  530 , against the acromion  125  causing pain and loss of range of motion. Additionally, tendonitis associated with the supraspinatus muscles  435  and subacromial bursitis in the subacromial bursa  530  may cause inflammation that compresses the subacromial bursa  530  against the acromion  125 . 
     Another common shoulder injury is a rotator cuff  450  tear. The tear may be in any of the four muscles comprising the rotator cuff  450 , or in the surrounding ligaments and tendons. Since the rotator cuff  450  supports essentially all movement of the shoulder, any shoulder movement tends to cause pain when a tear is present. 
     More severe trauma can lead to broken bones and separated ligaments. For example, a shoulder joint  100  subjected to extreme forces could result in an anterior or posterior dislocation of the head of the humerus  115  from the glenoid cavity  120 , a tearing of the glenoid labrum  305 , or even a fracture of the head of the humerus  115 . Similarly, a partial or complete tear of the acromioclavicular ligament  415 , coraco clavicular ligament  405 , or conoid ligament  410  associated with the clavicle  135  may result. 
     The injuries and diseases of the shoulder joint  100  described above, along with a variety of others, can lead to extreme pain when moving the arm and may require surgery and physical therapy. During pre-operative and post-operative periods, as well as during physical therapy, the shoulder joint  100  may cause pain when the arm is moved beyond a limited range of motion before healing is completed. Painful movements may be exacerbated when the injured person is lying down and trying to sleep because the arm may be moved considerably in order to find a comfortable position. While an arm sling may be worn while sleeping, the position of the arm in the sling (generally medially rotated, see  FIG. 8 ) while lying down tends to drive the head of the humerus  115  upwards into the rotator cuff  450  which tends to cause pain and discomfort. 
       FIG. 9  illustrates various embodiments of an arm movement restraining device  900  that may be worn while lying down to restrict movement of the arm such that impingement or other excessive movements of the shoulder joint  100  may be reduced. The restraining device  900  may comprise a generally tubular body or cuff  905 . The body  905  may comprise an inner radius R 1  defining an open axial passage  920  extending through the body  905  from a proximal end  910  to a distal end  915 . The inner radius R 1  may be selected such that the restraining device  900  may fit comfortably on a forearm of the user. Generally, the fit of the restraining device  900  is such that the restraining device  900  is tight enough to stay on forearm without slipping off but loose enough so that blood flow in the forearm is not impeded. The value of R 1  may vary from about 2 inches to about 6 inches depending on the size of the forearm. 
     In various embodiments, the body  905  may also comprise an outer radius R 2  that, in conjunction with the inner radius R 1 , defines a wall thickness T of the body  905 . As discussed in further detail below, the outer radius R 2  may be selected to provide a wall thickness T sufficient to restrict movement of the arm while the user is lying down such that rotational movement of the shoulder is minimized, thereby reducing shoulder impingement. The wall thickness T may be selected based on a variety of factors including, but not limited to, height, weight, gender, and physical condition of the user; desired amount of arm movement desired; length of forearm; length of upper arm; typical sleeping position of the user (on the back, side, or stomach); and the like. Generally, the wall thickness T may range from about 2 inches to about 10 inches, and the corresponding outer radius R 2  may range from about 5 inches to about 16 inches. In various embodiments, the wall thickness T may be selected to limit shoulder flexion, extension, adduction, abduction, lateral rotation, and medial rotation are each limited to a maximum of about 30 degrees when the restraining device  900  is engaged on the forearm of the user. 
     The body  905  may have a length L selected such that the proximal end  910  is positioned in proximity to the user&#39;s elbow, and the distal end  915  is positioned in proximity to the user&#39;s wrist when the restraining device  900  is placed on the user&#39;s forearm. In general, the length L is greater than a length of the user&#39;s upper arm. For adult users the length may range from about 5 inches to about 16 inches. For child or adolescent users, a reduced length L may be required. As will be evident to one skilled in the art, any inner radius R 1 , outer radius R 2 , wall thickness T, length L, and combinations thereof, are within the scope of this disclosure. 
       FIG. 10  illustrates various embodiments of the restraining device  900  comprising a strap  1005 . The strap  1005  may be placed over the shoulder of the user to function as a sling, for example, to support the arm and the weight of the restraining device  900  should the user get out of bed for a short period of time. The strap  1005  may also be adapted for placement about the waist of the user to further restrain movement of the arm. 
     Although  FIGS. 9 and 10  illustrate the body  905  being generally cylindrical with parallel side walls, other shapes are contemplated and within the scope of the present disclosure. For example,  FIG. 11  illustrates various embodiments in which the wall thickness T decreases from the proximal end  910  to the distal end  915  such that the outer radius R 2  at the proximal end is greater than an outer radius R 3  at the distal end. The tapered design of  FIG. 11  may be more comfortable for some users by not elevating the hand as much as the design illustrated in  FIG. 9 . Similarly,  FIG. 12  illustrates various embodiments in which the body  905  has an hourglass shape, which may be more comfortable if the user places their arm across their stomach while lying down. 
       FIGS. 13 and 14  illustrate various embodiments in which a cross-section of the body  905  is not generally circular. In  FIG. 13 , a portion of the outer surface of the body  905  may be flattened which may provide more stability while the user is lying down.  FIG. 14  illustrates that the cross-sectional shape of the body  905  need not be rounded or circular at all, and may comprise a plurality of generally flat surfaces. 
       FIGS. 15 through 20  illustrate the user in a variety of lying positions with the restraining device  900  engaged on the forearm corresponding to an injured or diseased shoulder according to various embodiments.  FIG. 15  illustrates the user lying on his back with the right shoulder as the affected shoulder. In this position, the right arm may tend to laterally and medially rotate to the extremes, which may cause immediate pain and prevent or disturb sleep. The restraining device  900  may tend to restrict rotation within a more manageable range. In addition, maintaining the arm in a neutral position (with reference to lateral and medial rotation) to minimize impingement is an unnatural position. The restraining device  900  may buttress the arm in place without immobilizing the shoulder joint  100  making it easier for the user to maintain the neutral position. Further, in  FIG. 16  the user may try to fully extend the right arm along his side. The restraining device  900  may contact the bed and prevent the arm from fully extending because maintaining a slightly bent elbow while lying on the back may reduce pressure on the shoulder joint  100 . 
       FIG. 17  illustrates the user lying on the right side with the left shoulder being the affected shoulder. In this case, the restraining device  900  may prevent the user from rolling over on his stomach with his left arm underneath. Rolling over on his stomach may force the arm to fully rotate medially, putting sudden and intense pressure on the shoulder joint  100  which may result in significant pain and perhaps further injury. 
     In  FIGS. 18 and 19 , the user is lying on his back and moves the arm from a flexion position ( FIG. 18 ) to an extension position ( FIG. 19 ) while maintaining a bend in the elbow. The restraining device  900  stops the shoulder joint  100  from full flexion rotation in  FIG. 18 , and provides a natural and comfortable neutral position when the arm is extended as in  FIG. 19 . 
     In  FIG. 20 , the user is lying on the right side, which is the side with the affected shoulder. To relieve impingement, the user should place the right arm in a neutral position at his side; however, that is an unnatural position. The user may tend to extend the right arm such that the right hand is above the head, but this position will cause impingement and resulting pain, making sleep difficult. However, with the restraining device  900  on the right forearm, flexion rotation of the arm is restricted and impingement does not occur or may be significantly reduced. 
     In various embodiments as illustrated in  FIGS. 21A and 21B , the body  905  of the restraining device  900  may be obtained by the user in a flat sheet form that the user rolls ( FIG. 21B ) into a cylindrical shape and secures the body  905  with closure straps  2105  (or other closure mechanism). Thus, the user may adjust the tightness of the restraining device  900  on the forearm by loosening or tightening the closure straps  2105 . 
     Although not shown in the drawings, the body  905  may contain an internal void. The void may comprise a bladder that may be filled with gas or liquid to inflate the body  905  to the desired wall thickness T, as well as adjust the pressure exerted on the forearm. In other embodiments, the void may be filled with a cold or hot pack, or a pack adapted to dispense pharmaceutical agents. 
     The body  905  may be constructed of a lightweight foam such as polyethylene, urethane, polyurethane, neoprene, polystyrene, latex, or any combination thereof. The material of construction may be chosen such that the foam will not collapse an appreciable amount under the weight of the user&#39;s arm, thereby generally maintaining the outer radius R 2 . 
       FIG. 22  illustrates a general flow chart of various embodiments of a method  2200  for reducing shoulder impingement for a person in a lying position. At step  2205 , a generally tubular body or cuff  905  may be provided. The body  905  may comprise an inner radius R 1  defining an open axial passage  920  extending axially from a proximal end  910  to a distal end  915 . The opening axial passage  920  may be adapted to releasably engage a forearm of the person therein. The body  905  may further comprise an outer radius R 2  defining a sidewall thickness between the inner radius R 1  and the outer radius R 2 , and may comprise a length L from the proximal end to the distal end. 
     At step  2210 , the outer radius R 2  may be selected to provide a sidewall thickness T that restricts movement of the person&#39;s arm such that shoulder flexion, extension, adduction, abduction, lateral rotation, and medial rotation are each limited when the body  905  is engaged on the forearm. In various embodiments, the shoulder flexion, extension, adduction, abduction, lateral rotation, and medial rotation are each limited to a maximum of 30 degrees. 
       FIG. 23  is a perspective view of a foot movement restraining device according to various embodiments. 
     Shown in  FIG. 23  is a generally cylindrical cuff  2300 , outer diameter  2305 , optional vent  2310 , inner radius  2315 , foot position  2320 , and bottom end enclosure  2325 . An opening with Velcro® straps in order to get the leg in and out of the brace is also shown. 
     Dorsiflexion is the movement of the foot upwards, so that the foot is closer to the shin. For a movement to be considered dorsiflexion, the foot should be raised upward between 10 and 30 degrees. Dorsiflexion uses the muscles in the front part (anterior) of the foot. The tendons of the muscles that pass through the front of the foot and into the ankle joint include the tibialis anterior, extensor hallucis longus, and extensor digitorum longus. These tendons are located on the front of the leg and are supplied by the deep peroneal nerve. Damage to this nerve can stop a person from being able to raise their foot. 
     Plantar fasciitis is one of the most common causes of heel pain. It involves inflammation of a thick band of tissue that runs across the bottom of the foot and connects the heel bone to the toes (plantar fascia). 
     People use dorsiflexion when they walk. During the middle stages of weight bearing and just before pushing off the ground, the foot will reach its end range of dorsiflexion. If there are problems with dorsiflexion, then the body will compensate naturally, which in turn can cause issues elsewhere. 
     Referring again to  FIG. 23 , according to various exemplary embodiments, a method for maintaining a foot in a neutral dorsiflexion position  2320  for a person in a lying position comprises providing a generally cylindrical cuff  2300  extending from a proximal end of a person&#39;s leg just below the person&#39;s knee cap to an inner distal end near the person&#39;s foot bottom, the generally cylindrical cuff  2300  comprising an inner radius  2315  defining an open passage through the generally cylindrical cuff  2300 . The passage is configured to releasably engage the foot of the person in the neutral dorsiflexion position  2320 . A generally round bottom enclosure  2325  is selected at an outer distal end near the person&#39;s foot bottom and perpendicular to the generally cylindrical cuff for enclosing the foot. An outer diameter  2305  of the generally cylindrical cuff is selected to provide a sidewall thickness that restricts movement of the foot of the person, and elevates the person&#39;s leg without elevating the person&#39;s knee to limit knee flexion when the generally cylindrical cuff is releasably engaged on the foot of the person. 
       FIG. 24  is another perspective view of a foot movement restraining device according to various embodiments. 
     Shown in  FIG. 24  is the generally cylindrical cuff  2300 , distal end  2405 , proximal end  2410  and knee flex  2415 . An opening with Velcro® straps in order to get the leg in and out of the brace is also shown. 
     In various exemplary embodiments, the proximal end  2410  is near the knee cap of the person and the distal end  2405  is near the toes of the person when the device is positioned on the foot of the person. The sidewall thickness may range from about 3 inches to about 8 inches. Furthermore, the generally cylindrical cuff  2300  may be constructed of a lightweight foam material, including polyethylene, urethane, polyurethane, neoprene, polystyrene, latex, or a combination thereof. According to further exemplary embodiments, the cuff may comprise an inflatable bladder to vary the inner radius, thereby adjusting an amount of pressure exerted on the foot. The generally cylindrical cuff  2300  may further comprise an inflatable bladder to vary the outer radius. The generally cylindrical cuff  2300  may exude one or more pharmaceutical agents, or apply heat or cold. 
     As shown in  FIG. 24 , according to exemplary embodiments, the foot is maintained in a neutral dorsiflexion position  2320  ( FIG. 23 ) for a person in a lying position. Accordingly, it allows the person to turn in bed from side to side or from front to back. The device also maintains elevation. In further exemplary embodiments, the cuff may be vented for comfort. 
     In most exemplary embodiments, the device does not limit knee flexion. Additionally, the device may be used to cover a cast for cleanliness or comfort, or may be used as a plantar fasciitis splint. 
     Spatially relative terms such as “under”, “below”, “lower”, “over”, “upper”, and the like, are used for ease of description to explain the positioning of one element relative to a second element. These terms are intended to encompass different orientations of the device in addition to different orientations than those depicted in the figures. Further, terms such as “proximal”, “distal”, and the like, are also used to describe various elements, regions, sections, etc. and are also not intended to be limiting. Like terms refer to like elements throughout the description. 
     As used herein, the terms “having”, “containing”, “including”, “comprising”, and the like are open ended terms that indicate the presence of stated elements or features, but do not preclude additional elements or features. The articles “a”, “an” and “the” are intended to include the plural as well as the singular, unless the context clearly indicates otherwise. 
     The present invention may be carried out in other specific ways than those herein set forth without departing from the scope and essential characteristics of the invention. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive, and all changes coming within the meaning and equivalency range of the appended claims are intended to be embraced therein.