Abstract:
A reusable support device is provided with an open web section to permit interface of therapeutic delivery devices with the wearer and to thereby permit the dispensing of medicaments or the direct application of other therapeutic treatment. The open web section allows communication with the wearer&#39;s skin and the treatment delivery devices may be positioned by engagement with the web, and secured with an overwrap. Therapeutic delivery devices may be inserted and removed from supports without removing the support devices from the wearer.

Description:
[0001]     The present application claims priority from U.S. Provisional Application No. 60/580,615 filed Jun. 17, 2004. 
     
    
     FIELD OF THE INVENTION  
       [0002]     The present invention relates generally to therapeutic support braces, and more particularly to an improved construction and design of wearable braces to provide both therapy and support.  
       BACKGROUND OF THE INVENTION  
       [0003]     Orthopedic compression bandages, braces, and sleeves have long been employed to provide support for athletic and medical purposes. These are commonly worn over the wrist, elbows, knees and ankles, and may also be employed on lower legs and forearms, and less frequently on upper legs and arms. In addition, braces are often worn to support the wearer&#39;s back. Compression devices may provide support during normal movement which may be especially required by persons recovering from injuries. Compression devices also provide support for ligaments, tendons, muscles and joints against the stresses of over-extension which may occur during exercise. In addition, wound dressings have often been used to position absorbent material adjacent to injured tissue or in some cases to apply antibiotic or moisturizing ointments and lotions. Wound dressings have lacked the ability to provide support, and most orthopedic compression devices have not possessed the ability to provide therapeutic action.  
         [0004]     One attempt to overcome the shortcoming of therapeutic braces was provided by Williams, U.S. Pat. No. 5,415,624, which discloses a wearable therapeutic brace having pockets that can receive insertable hot and cold packs. However, this brace must be removed in order to insert the temperature management packs and does not permit the therapeutic packs to contact the wearer&#39;s skin. A variety of heat wraps and adhesive heating patches have also been offered, however, such wraps generally fail to provide one or more of therapeutic support, the ability to change the therapeutic pack without removing the product, or contact of the therapeutic pack with the wearer&#39;s skin.  
       SUMMARY OF THE INVENTION  
       [0005]     The present invention resolves the shortcomings of the prior art devices and provides a greatly improved therapeutic brace which is comfortable, permits use with a variety of therapeutic packs, including those requiring contact with the wearer&#39;s skin to administer medicaments or therapeutic relief, and in some embodiments permits changing of therapeutic packs without removing the brace from the wearer&#39;s body.  
         [0006]     The reusable support device provides generally a stretchable sleeve in its most preferred embodiments adapted to be fitted on the wearer&#39;s leg, arm, wrist, knee, ankle or torso that has a relatively open or webbed section adapted to receive a therapeutic pack. The sleeve also has a strap that may be designed to accommodate therapeutic packs and which overlays the open section of the sleeve providing additional support to that section and allowing the wearer to adjust the compression provided by the sleeve. In a less preferred embodiment, the support device may constitute only a wrap, but with specially designed and webbed pockets to hold therapeutic inserts.  
       OBJECTS AND ADVANTAGES OF THE INVENTION  
       [0007]     A principal object and advantage of the present invention is to provide a reusable compression support device for the ankle, knee, arm, wrist, elbow, and back that is capable of receiving an insert to administer medicaments such as topical analgesic or temperature relief such as heat or cold.  
         [0008]     It is a further object of the invention to provide a support sleeve having openings to permit a therapeutic pack placed in the sleeve to communicate directly with the wearer&#39;s skin.  
         [0009]     It is yet another object of the invention to provide therapeutic packs designed to interface with openings in the support sleeve.  
         [0010]     It is yet another object of the invention to provide a support sleeve permitting the insertion and removal of therapeutic packs without the necessity of removing the sleeve from the wearer&#39;s body.  
         [0011]     Other objects and advantages of the invention will become apparent from the following description taken in conjunction with the accompanying drawings wherein are shown by way of illustration and examples certain embodiments of the invention. 
     
    
     BRIEF DESCRIPTION OF THE DRAWING  
       [0012]      FIG. 1  is a view of the support device positioned on a wearer&#39;s knee ready for acceptance of a therapeutic delivery device.  
         [0013]      FIG. 2  is the support device of  FIG. 1  in its closed position after any desired therapeutic delivery device has been installed.  
         [0014]      FIG. 3  is a photograph of the support device configured for the wearer&#39;s knee showing a sponge element in the place of a therapeutic delivery device.  
         [0015]      FIG. 4  shows the knee support of  FIG. 3  in its closed position.  
         [0016]      FIG. 5  shows the knee support of  FIGS. 3 and 4  in use.  
         [0017]      FIG. 6  illustrates the positioning of a cold temperature therapeutic delivery device in the overwrap portion of the knee support device of  FIG. 1 .  
         [0018]      FIG. 7  illustrates the positioning of a hot temperature therapeutic delivery device in the overwrap portion of the knee support device of  FIG. 1 .  
         [0019]      FIG. 8   a  shows a support device according to the present invention adapted for use on the wearer&#39;s back ready to receive therapeutic delivery device.  
         [0020]      FIG. 8   b  shows an alternate support device according to the present invention adapted for use on the wearer&#39;s back in a wrap form with a pocket to receive therapeutic inserts.  
         [0021]      FIG. 9  is a photograph of a support device intended for use on a wearer&#39;s back having an alternative open configuration to receive therapeutic delivery devices.  
         [0022]      FIG. 10  illustrates a support device for an ankle according to the present invention in an open position ready to receive a therapeutic delivery device.  
         [0023]      FIG. 11  illustrates a support device for an arm or elbow according to the present invention in an open position ready to receive a therapeutic delivery device.  
         [0024]      FIG. 12  illustrates a support device for a wrist according to the present invention in an open position ready to receive a therapeutic delivery device.  
         [0025]      FIG. 13  is a photograph of a support device for a wearer&#39;s wrist in an open position ready to receive a therapeutic delivery device.  
         [0026]      FIG. 14  is a photograph of the wrist support device of  FIG. 13  in its closed position.  
         [0027]      FIG. 15   a  is a top view of a web structure particularly suitable for use with a knee support according to the present invention.  
         [0028]      FIG. 15   b  is a side sectional view of the web structure of  FIG. 15A .  
         [0029]      FIG. 16  is a top plan view of a web structure particularly suitable for use in an elbow support device according to the present invention.  
         [0030]      FIG. 17  is a top plan view of a web structure particularly suitable for use in an ankle support device according to the present invention.  
         [0031]      FIG. 18  is a top plan view of a web structure particularly suitable for use in a wrist support device according to the present invention.  
         [0032]      FIG. 19  is a perspective illustration of the web structure of  FIG. 15   a  illustrating alternative constructions of the web and alternative systems to interface with therapeutic delivery devices.  
         [0033]      FIG. 20  is a perspective view of a support device adapted for the knee, elbow, arm or leg prior to sealing the ends of the body sheet to form a sleeve and showing details of possible structure and manufacture of the support.  
         [0034]      FIG. 21  illustrates a configuration for a therapeutic delivery device that can mechanically attach to the web structure located in the support.  
         [0035]      FIG. 22  illustrates an alternative structure for the web structure and therapeutic delivery devices.  
         [0036]      FIGS. 23   a - 23   d  depict a medicament dispensing device adapted for use in the invention.  
         [0037]      FIG. 24  illustrates an alternative design for an ankle support of the invention.  
         [0038]      FIG. 25  illustrates the ankle support of  FIG. 24  in a closed position. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0039]     The invention may be explained with reference to  FIG. 1  which depicts a knee support  10  according to the present invention having a brace body  11  rolled into a sleeve  12  that can receive a wearer&#39;s leg. Located within the brace body  11  is web  13  having ribs  33  separating apertures  29 . The configuration of web  13  may take many forms but is designed to provide a structure that helps to position or secure therapeutic delivery devices such as medicament dispensing inserts and also to permit communication between such devices and the wearer&#39;s skin. In addition, the web  13  may provide structural integrity to the sleeve. Also shown is overwrap  14  which has an edge  25  secured to sleeve  12  and an opposite end with securing means such as hook fasteners  20  that will attach to the nappy surface or landing zones of brace body  11 . The intermediate section of overwrap  14  may have a cupped depression  18  preferably covered by a liner  19  to form a pocket. Therapeutic delivery devices may also be inserted in cup  18  and held in position by liner  19 . Alternatively, the overwrap  14  may operate without liner  19  and therapeutic delivery devices may be held in place by pressure of overwrap  14  exerted against the web  13  when fastened. Thus, the sleeve  12  forms a lumen to receive a wearer&#39;s limb or joint. The lumen wall has a web section  13 . On a first side of the web section  13 , an overwrap  14  is joined to the lumen wall. Preferably, the overwrap  14  is permanently joined at this first side, as by seam  25 . Alternatively, overwrap  14  may be releasably joined as by hook and loop fasteners. The overwrap  14  extends from the first side across the web section  13  to the opposite second side of the web section and is there releasably secured by fastener  20  either to the lumen wall, or if completely encircling the sleeve, the fastener  20  may attach to the overwrap  14  itself.  
         [0040]     Once a treatment device is either secured to web  13 , or inserted in cup  18  and held in place by liner  19 , or alternatively merely positioned in place, the overwrap  14  is closed over the web  13  and about the sleeve  12  as shown in  FIG. 2 .  FIG. 3  shows a photograph of a knee support similar to that illustrated in  FIG. 1 , while  FIG. 4  shows the knee support  10  in its closed position similar to the illustration of  FIG. 2 .  FIG. 5  shows the knee support in use after the overwrap has been secured.  FIGS. 6 and 7  illustrate the positioning of a therapeutic delivery device such as cold pack  30   a  in  FIG. 6  or hot pack  30   b  in  FIG. 7  within the cup  18  and liner  19 . Alternatively, in the absence of a liner  19 , cold pack  30   a  or hot pack  30   b  may simply be placed over web  13 . When overwrap  14  is wrapped about the sleeve  12  of knee support  10 , these therapeutic packs  30   a,    30   b  are held in position over the web  13  and temperature therapy is applied to the region of the wearer&#39;s knee.  
         [0041]      FIG. 8   a  depicts a similar support  110  specially designed for use on the wearer&#39;s torso, and particularly to administer therapy to the wearer&#39;s back. Support  110  comprises a brace body  111  formed into a sleeve  112  which is preferably elasticized and slipped onto the wearer&#39;s body. However, as shown in  FIG. 8   b,  particularly in the case of back support  110   b,  the brace body may not be secured into a fixed sleeve, but may be left in sheet form for attachment by the wearer using hook and loop fasteners  120  or the like. The wrap form back support  110   b  comprises a wrap  114  with a first edge  114   a,  a body  114   b,  and a trailing edge  114   c  with fasteners  120 . A liner  119  is attached to body  114   b  as by seam  125  along the sides and bottom. No web structure is required to maintain strength because wrap  114  has no external openings. Instead, web patterns  113  are placed in liner  119 . In this fashion, liner  119  forms a pocket to hold therapeutic devices  30 , while providing openings to permit the therapeutic devices to contact the wearer&#39;s skin. The wrap-style brace of  FIG. 9  illustrates another structure for positioning a therapeutic device  30  next to web  113 .  
         [0042]      FIG. 10  depicts yet another support according to the present invention, in this case an ankle brace  210  is formed from brace body  211  and creates a sleeve  212 . In this instance, sleeve  212  is not purely cylindrical but substantially L-shaped with opening  201  to receive the wearer&#39;s heel and thereby position sleeve  212  securely at the ankle. Web  213  is again positioned at a location where therapy is to be applied to the wearer, and it is to be understood that the shape of the web  213  may be varied according to the type of therapeutic delivery devices intended to be utilized with the brace  210 . Overwrap  214  is attached to sleeve  212  and has cup  218  with liner  219  that may receive therapeutic delivery devices. After therapeutic delivery devices are either attached to web  213 , placed on web  213 , or placed in cup  218 , the overwrap  214  is closed about the ankle and securing means such as hooks  220  attach the overwrap to the sleeve. The liner  219  is not required, but when present forms a pocket into which therapeutic devices  30  may be held until overwrap  214  is fastened. As is the case of the other illustrated support devices, the overwrap  214  not only assists in securely positioning the therapeutic delivery device utilized with the support, but due to the inherent weakness caused by openings in the web  213  portion of the sleeve, the overwrap also preferably both serves as a structural component of the support and provides a method to adjust the compression provided by the support.  
         [0043]      FIG. 11  shows an alternative brace embodiment  310  adapted for use on the arm and elbow. Again, brace  310  is formed from a body  311  fastened into a sleeve  312  forming a lumen which is received on the wearer&#39;s arm. Web section  313  is positioned where treatment is to be applied and the treatment device is secured by either web  313  or within cup  318  in the overwrap  314 . Once the treatment device is positioned, overwrap  314  is closed about the sleeve  312  and attached to the surface of the sleeve by securing devices such as microhooks  320 . If liner  319  is included, it may form a pocket to receive therapeutic inserts that do not engage with web  313 .  
         [0044]      FIG. 12  depicts a wrist support  410  according to the present invention, again formed from a body  411  configured into sleeve  412  to form a lumen and received on the wearer&#39;s arm with a web section  413  allowing apertures  429  opening directly to the wearer&#39;s skin. Again, a treatment delivery device may be secured either to web  413  or within cup  418  and covered by liner  419  in the overwrap  414 . Alternatively, the treatment delivery device may be placed on web  413  so that contact is made with the wearer&#39;s skin through apertures  429 . When the treatment delivery device is positioned, overwrap  414  is closed about the web  413  and held in place by securing means such as microhooks  420 .  
         [0045]      FIGS. 13 and 14  depict a slightly modified embodiment of wrist brace  410  having an opening  402  in the sleeve  412  to receive the wearer&#39;s thumb and thereby more securely position sleeve  412  in place at the wrist.  FIG. 13  depicts the wrist support  412  in its open treatment delivery device receiving form, and  FIG. 14  depicts wrist support  410  in its closed position.  
         [0046]      FIGS. 15 through 18  show structures of a family of webs that may be utilized in supports according to the present invention.  FIGS. 15   a  and  15   b  depict web  13  designed for use in a knee support  10  such as that shown in  FIG. 1 . The web  13  comprises an inner ring  34  and outer ring  35  connected by ribs  33  and defining uniformly shaped apertures  29  therebetween. At opposite sides of the outer ring  35  the web section a border extends to ends  36  and may be joined with or formed as a portion of the brace body  11  (not shown).  
         [0047]     Similarly,  FIG. 16  is a top plan view of a web configuration suitable for use in the in elbow support device  310  according to the present invention. The web  313  is comprised of an inner arcuate section  334  and outer arcuate section  335  connected by ribs  333  and defining uniformly shaped apertures  329  therebetween.  
         [0048]     In  FIG. 17 , a web  213  is shown optimized for use with an ankle support  210  according to the present invention such as that shown in  FIG. 10 . The web  213  comprises an inner curved section  234 , an outer curved section  235  which are almost sinusoidal in appearance but connected by ribs  233 . The ribs  233  define openings  229  which are substantially uniform in configuration. Similarly,  FIG. 18  shows web  413  optimized for use in connection with wrist support  410  according to the present invention such as that depicted in  FIG. 12 . Again, inner curved segment  434  and outer curved segment  435  are connected by ribs  433  and defining uniformly shaped apertures  429 .  
         [0049]      FIG. 19  illustrates two constructions of web  13  and three methods of joining therapeutic medicament dispensing packs  40  to the web  13 . The web  13  may advantageously be made of a laminate with a nappy lycra surface  15  that microhooks may attach to, over a conformable foam/wax core  16  with a lycra bottom surface  17 . Alternatively, the web  13  is shown constructed of a non-tearable foam with a smooth surface. This foam is stitchable and may be supplied in a variety of colors, as may be lycra  15 ,  17 , or, the foam may even be translucent.  
         [0050]     To join the medicament dispensing packs  40  to the web  13 , the medicament dispensing packs  40  are constructed of a series of medicament dispensing sections  41  joined by a backing  42 . The backing  42  is typically a nonwoven to prevent medicaments, such as typical analgesics, from migrating into the overwrap  14 . Intermediate the medicament dispensing sections  41  which might be a permeable foam impregnated with medicament, are intermediate sections  45  which may or may not be perforated  43  to permit separation of the medicament dispensing sections  41 . In the intermediate area  45  between medicament dispensing sections  41 , one securing option is to provide microhooks  44   a  that will attach to nappy Velcro  15  on ribs  33  of web  13 . Another securing alternative is to have a cohesive foam surface  44   b  that forms a bond with cohesive foam surface on non-tearable foam ribs  33 . Alternatively, the intermediate section  45  between medicament dispensing portions  41  can be made flexible so as to allow medicament dispensing sections  41  to pinch around the ribs  33 . Yet another alternative is for the medicament dispensing device  40  simply to interfit with web  13  almost like puzzle pieces to hold device  40  in place while an overwrap is secured to hold the device  40  during the wearing of the brace.  
         [0051]      FIG. 20  illustrates one possible laminate structure with top nappy lycra  15 , intermediate wax filled foam  16 , and bottom lycra  17  used to form the body  11  of knee support  10 . The left edge  21  and right edge  22  of body  11  are joined to form a sleeve as depicted in  FIG. 1 . The overwrap  14  is joined along one edge  25  to the body  11  and has a cup  18  and securing means such as Velcro  20 .  
         [0052]      FIG. 21  illustrates a mechanical pinch configuration for therapeutic delivery devices such as medicament packs  40  in greater detail with the intermediate section  45  forming a hinge to allow to medicament sections  41  to be bent apart and the hinge section  45  placed on rib  33  of web  13 . When the medicament sections  41  are released, they conform slightly around the rib  33  and hold the treatment pack  40  in place on web  13 . One disadvantage to mechanical hinge configuration is that medicament packs  40  must always be applied in pairs of medicaments sections  41  and groups of four or eight medicaments sections  41  must be separated into pairs and then applied. Furthermore, single medicaments sections  41  cannot be attached to web  13  with the rib pinching technique.  
         [0053]     Another alternative for medicament packs  40  is illustrated in  FIG. 22  where packs  40  have a medicament dispensing section  41  and backing film  42  where, at least around the periphery of the backing film  42  the film forms a semi-rigid downwardly shaped edge  44 . The ribs  33  of web  13  are formed from foam with upward shaped openings  45  that are adapted to receive the downward edges  44  of the medicament packs  40 . This structure effectively permits edges  44  the medicament packs  40  to snap on to the ribs  33  defining openings  29  in the web section  13 . In each instance, it can be seen that the uniform shape of the medicament packs  40  and medicament dispensing sections  41  permits those sections to be utilized in a variety of web configurations such as those shown in  FIGS. 15 through 18 . The packs  40  may be supplied in the form of rings of 8 sections  41  but may be separated into groups of two or three sections and attached to or about the ribs  33  of various web configurations.  
         [0054]     A preferred medicament treatment device  140  is shown in  FIGS. 23   a - 23   d.    FIG. 23   a  shows the bottom  142  of the device  140 , which may be advantageously formed of hydrophilic foam to capture active or volatile ingredients as described in Palinczar, U.S. Pat. No. 4,339,550 which is incorporated herein by reference. A preferred active and volatile ingredient for pain relief is menthol or its natural precursor, peppermint oil.  FIG. 23   b  shows a side plan view of treatment device  140  where sections  141  are shown divided by channels  145 . A top plan view in  FIG. 23   c  reflects the eight somewhat triangular or pie slice shaped sections  141  and central section  149  separated by channels  145 . Optimal perforations  143  are shown around central section  149  and between each pair of triangular sections  141 . A perspective view is shown in  FIG. 23   d.  The perforations permit the device  140  to be separated to fit in configurations where the web  13  does not form a complete circle. The channels  145  fit upon the ribs  33  of webs  13  and act to constrain the movement of the adjacent sections  141 . When further secured by a tensioned overwrap  14 , the device  140  or sections  141  are held in position during wearing of the brace. Medicament containing devices  140  are preferably packaged in resealable foil pouches to provide adequate shelf life and to permit unused sections  141  to be resealed and stored for an intermediate length of time for future use. It is preferred that the medicament containing device be generally dividable into fourths or even finer increments to fit various web and aperture configurations. To allow the use of curved aperture configurations as shown in  FIGS. 12 and 15 - 17 , the preferred device shape is that of a disk having generally triangular sections  141  separated by radial channels  145 .  
         [0055]      FIGS. 24 and 25  show yet another embodiment of an ankle brace  510  with two openings  529  to receive treatment delivery devices  540 . In this case, the treatment devices may adhere directly to the wearer&#39;s skin as is common with analgesic patches in the market today. Alternatively, the devices  540  may simply fit into openings  529  and be held in place by overwrap  514 .  
         [0056]     Although preferred embodiments of the present invention have been disclosed in detail herein, it will be understood that various substitutions and modifications may be made to the disclosed embodiment described herein without departing from the scope and spirit of the present invention as recited in the appended claims.