Abstract:
An apparatus for applying pressure to a body part comprising multiple interconnectable bands of compressible or noncompressible material. Optional spine to further interconnect the bands. Interconnectable pieces designed for covering specific body areas. Modular arrangement of the individual components. Customized or off-the-shelf availability of the apparatus.

Description:
RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 10/975,590 filed Oct. 28, 2004 (now U.S. Pat. No. 8,663,144), which claims the benefit of U.S. Provisional Patent Application Ser. No. 60/555,150 filed Mar. 22, 2004. 
     U.S. patent application Ser. No. 10/975,590 and U.S. Provisional Patent Application Ser. No. 60/555,150 are both hereby incorporated by reference. 
    
    
     BACKGROUND 
     The Background Art 
     Excessive interstitial fluid accumulation, referred to as edema, may arise from a variety of illnesses and conditions, including venous valvular insufficiency, postphlebotic syndrome, and lymphedema. Control of this edema by reduction of interstitial fluids is important to increase PO2 delivery to tissues, relieve pain from swelling, and decrease risk of infection. Decreasing drainage of fluid from sores, skin breaks, and/or ulcerations promotes wound closure, prevents wound breakdown, and decreases risk of blood clot formation in veins. 
     Thus, it is desirable to have a customizable or off-the-shelf compressive device that can be readily available for application to a body part to prevent excessive fluid accumulation resulting from a variety of diseases and maladies. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is an illustration of one embodiment of a modular compression garment according to the present disclosure. 
         FIG. 2  is a perspective view of a band used in the modular compression garment of  FIG. 1 . 
         FIG. 3  is a break-away view of the compression garment of  FIG. 1  including one embodiment of a spine used for connecting a plurality of bands such as those shown in  FIG. 2 . 
         FIGS. 4 and 5  are alternative embodiments of a modular compression garments of the present invention. 
         FIG. 6  is a side perspective view of a footpiece for use with a modular compression garment. 
         FIG. 7  is a side view of a liner for use with a modular compression garment. 
         FIG. 8  is an illustration of an order form for ordering a customized compression garment. 
     
    
    
     DETAILED DESCRIPTION 
     The present disclosure relates generally to treatment of edema and, more specifically, to a device for applying compressive pressure to a person&#39;s body in order to facilitate reduction of interstitial fluids from a body trunk and/or limb extremity and to provide support and fatigue relief. 
     It is to be understood that the present disclosure provides many different embodiments, or examples, for implementing different features of various embodiments. Specific examples of components and arrangements are described below to simplify the present disclosure. These are, of course, merely examples and are not intended to be limiting. In addition, the present disclosure may repeat reference numerals and/or letters in the various examples. This repetition is for the purpose of simplicity and clarity and does not, in itself, dictate a relationship between the various embodiments and/or configurations discussed. Moreover, the formation of a first feature over or on a second feature in the description that follows may include embodiments in which the first and second features are formed in direct contact, and may also include embodiments in which additional features may be formed interposing the first and second features, such that the first and second features may not be in direct contact. 
       FIG. 1  illustrates one embodiment of the present disclosure applied as a lower limb compression garment  100 . In this embodiment, the lower limb compression garment  100  includes several bands  102  that are of adjustable size by way of attachment mechanisms  104  for conforming, in the present embodiment, to a human leg  106 . The lower limb compression garment  100  also includes an anklet  108  for conforming to a human ankle. 
     It is understood that the present invention is not limited to use with the leg, but can be used in various limbs and trunks of humans. It is further understood the invention is not limited to humans, but may apply for veterinarian use such as for a horse, dog, or other animal. For example, another embodiment may be used to compress an entire leg or arm of a human or a leg of a horse or dog. Various embodiments of the present disclosure may also provide for maximal access to a portion of a limb. These embodiments may have the compression band  102  over the affected area on top, with the proximal and distal compression bands underlapping. This may allow removal of a compression band or bands  102  over the affected area, while not requiring removal of the entire garment. Thus, the rest of the garment  100  may remain therapeutic while the area is accessed. 
     1. The Bands  102  and Attachment Mechanisms  104   
     Referring also to  FIG. 2 , the bands  102  may include an inner layer  114  and an outer layer  112  with optional elastomeric compression material layer  110 . In one embodiment an elastomeric loop material  112  such as Shelby Elastics Mon-3 or WonderWrap (Shelby, N.C.) may be sewn onto a backing of elastomeric fabric  114  such as Schoeller® Prestige 58012 (Sevelen, Switzerland). The elastomeric fabric  114  may be sewn on-the-bias so as to provide more stretch. For higher compression for a given amount of stretch, the fabric  114  may be sewn not-on-the-bias. Therefore sewing a highly elastic loop fabric  114  onto the backing of the material  110  may alternate percentage stretchability and alternate the compression gradient, based upon material selection and if it is sewn on-the-bias or not on-the-bias. Sewing such elastomeric fibers  114  on-the-bias may allow more stretch but less compression. For example, sewing the WonderWrap on the Schoeller fiber on-the-bias may result in a 20-30% elastomeric range with good compression. Sewing the WonderWrap on the Schoeller fiber not on-the-bias may result in a 15-20% elastomeric range with more compression. This way several embodiments can be easily engineered to provide different common classes of compression such as 8-15 mm, 15-20 mm, 20-30 mm, 30-40 mm, or 40+mm. This may allow the garment  100  to be applied lightly or tighter and more therapeutic. If applied past the range of the therapeutic stretch, then the compression applied may be directly proportional to that the user applies. 
     In other embodiments, a thin semi-compressible layer  110  is provided between an inner layer  114  and the outer layer  112  of the bands  102 . This layer  110  may be made of polyurethane foam such as Rosidal Soft (Lohmann Rauscher Neuwied, Germany). Such foam would ideally by 0.3 cm thick, although other ranges of thickness 0.05 cm to 5 cm are possible. The layer  110  may include particles made of compressible, high resiliency, low density, open cell plastic foam. Such particles ground up and of different particle sizes and shaped particles can create areas of high pressure areas and intersecting networks of low pressure areas at the seams. Use of such particles for compression garments is known in the art and sold as the Tribute™ (Solaris Inc. Brookfield, Wis.). Other materials for the compressible layer  110  may include rubber, plastic air bubbles, foam air bubbles, or non-convolute foam. The semi-compressible layer  110  may have channels sewn in them to create lines of natural lymph flow or criss-cross pattern. Alternatively, in other embodiments the foam may serve as the inner layer with a loop-compatible fabric or elastomeric material as the outer layer. 
     In still other embodiments, the bands  102  may not be multi-layered, as described above, but consist essentially of elastomeric yarns, for example, PowerNet™ nylon or nylon/spandex, ComfortWeave™ polyester/spandex, Clearspan® spandex manufactured by Radici, Dorlastain® spandex manufactured by Bayer, Lycra® spandex manufactured by DuPont, and any other spandex yarn, or special woven cotton fabrics such as Comprilan® short-stretch bandage, manufactured by Beiersdorf AG. Another elastomeric compression material that may be used is Lovetex® Industrial Corporation Breathe Freely (Taipei, Taiwan). It is understood in the spirit of the disclosure that any suitable elastic material may be used and is not limited to those listed above. In the present example, the chosen material would be in a range of 15% to 100% elastic stretch, although other ranges are anticipated. 
     In still other embodiments, the band  102  may include the elastomeric semi-compressible layer and a thin outer layer of Velcro® (hook and loop) compatible fabric. Such a garment may be sold as a reusable, semi-disposable, or disposable garment. For example, as single-use embodiment might be sold sterile and for application directly after surgery on an affected limb in order to control swelling and prevent wound dehiscence, or to allow selective access postoperatively to access directly over incision or wound, while leaving rest of garment in tact. Other single-uses may include general hospital use or as outpatient clinic or home use in order to reduce or control interstitial edema. Alternative uses may be to hold a bandage or medication against a limb member. 
     The attachment mechanisms  104 , which is connected to or connectable to the bands  102 , allow the bands to interconnect to one another. The attachment mechanisms  104  can be of various types such as hooks, snaps, buttons, and glue/adhesive, and some mechanisms for some bands  102  may be different than those for other bands on the same garment  100 . In the example of  FIG. 2 , the attachment mechanisms include a hook-and-loop fastener, such as a Velcro® strip. Each band  102  may fasten to itself in such a way as the user can apply the band under compression and it will hold the compression against the body part. The hook of the hook-and-loop fastener may be sewn onto one end of the band and the body of the band or a portion thereon may have the loop material. 
     In this embodiment, some or all of the exterior surfaces  112  of the bands  102  may include elastomeric loop material. The material therefore may interlock with the hook material of the attachment mechanisms  104  and/or a spine (discussed below). The use of loop material along the outside layer  112  of the band  102  allows each band to apply to a wider range of compression. Also, the use of elastomeric loop material may allow the dual function of attachment to the other end of the band, which has hook material, as well providing active compression. 
     In varying embodiments, the bands  102  interconnect to each other in a temporary, semi-permanent, or permanent manner. The connections may use chemical, thermal, or mechanical bonds. Mechanical temporary and semi-permanent bonds may include hook and loop, snaps, button and button-holes, or ties and eyelets. Mechanically bonded permanent attachments may include methods such as sewing and stapling. Chemical bonding includes methods such as fabric glue and super glue. Such glue is well-known in the art and used extensively in the industry for upholstery, furniture, and other products. Other forms of chemical bonding include tape adhesive such as PEELnSTICK and the acid-free acrylic double-sided adhesive SuperTape (Therm O Web, Wheeling II). Thermal bonding may include iron-on interfacing, ultrasonic welding of compatible components, or thermal melting of compatible components or iron-on interfacing. Such iron-on interfacing may for example include one or more layers of HEATNBOND® Ultrahold (Them O Web, Wheeling II). Some of the bonds (e.g., hook and loop) allow the garment  100  to be reused many times. Other bonds (e.g., fabric glue) may allow the garment  100  to be reused only a certain number of times. For example, the fabric glue may be reusable for a period of days, but afterwards may loose its adhesion properties. Still other bonds (e.g., thermal welding) are for a single use. 
     For example, a lower perimeter  114   a  (towards the foot in the present embodiment) of the interior layer  114  may include a relatively soft hook material. The soft hook material  114   a  may overlap on the band  102  immediately below, thus interlocking between the adjacent bands and providing additional stability of the device. Alternatively, an upper perimeter  112   a  (away from the foot in the present embodiment) of the outer layer  112  may include hook material. The lowest band may attach to loop material sewn onto the anklet  108  or attach to the elastomeric loop band at the top of the footpiece. In some embodiments, there will be no soft hook material at the facing edges of the bands and the bands will simply overlap each other with the lowest band overlapping an anklet or footpiece. 
     Small geographic symbols may be drawn or printed on each band  102  which will change shape in a characteristic way when the proper compression is applied so that the user knows the prescribed therapeutic compression is being applied. Such symbols are well known in the art, and are applied currently to short-stretch bandages such as sold by SSL International PLC under the trade name of Setopress (London, England). In another embodiment, material color or material markings will differentiate different bands of varying levels of compression. 
     2. The Spine  120   
     Referring now to  FIG. 3 , in one embodiment, the bands  102  are joined together at a spine  120 . The bands  102  can be joined to the spine  120  in various manners, and in the present embodiment they are sewn together. The spine  120  may comprise non-elastic or elastic material. There may be no difference in bulk or therapeutic application of this embodiment. Furthermore, the bands  102  may be partially or completely sewn together. In this embodiment, the bands  102  and spine  120  may be separately pre-manufactured, and then sewn together once measurements are made of the affected limb. By modifying the degree of overlap of the bands and the number of bands, a wide geometry of limbs may be fitted. The anklet  108  ( FIG. 1 ) may be sewn to either or both of the spine  120  and the adjacent band  102 . 
     In the embodiment of  FIG. 3 , the spine  120  extends both on an inside (adjacent the leg) and outside (external) of the lower limb compression garment  100 . In furtherance of the example, the spine  120  includes hook material  122  for engaging with loop material  124  on the bands  102  (the loop material can be on both the inside and outside portions of the bands). An outer layer  126  is also provided, which may be either relatively stiff or rigid, which can facilitate the assembly and fitting of the lower limb compression garment  100 , or may have elasticity which can facilitate the movement of the lower limb compression garment once in place. 
     Other embodiments may use one spine, one on the inside or one on the outside. Other embodiments may forego the spine as the hook-and-loop fastener or other connective means lengthwise centrally in each band  102  and overlapping may provide adequate connection to hold the device together as a single unit for application or storage. 
     In some embodiments, the spine  120  may also serve to connect the anklet  108  ( FIG. 1 ). In other embodiments, the bands  102 , spine  120 , and/or anklet  108  can be attached using other mechanisms, such as glue or adhesive, snaps, or buttons. Furthermore, the spine  120  can be sewn or otherwise segregated into increments  128  so that it can easily be cut or shortened, as needed. For a lower limb, the spine may be 12, 13, 14, or 15 inches in length with increments, although single lengths of spine for different uses are within the scope of the present disclosure. For use as an upper limb compression device, for example, the spine may preferentially go the entire length of the arm along the outside edge. This may necessitate a longer spine and such permeations are within the scope of the present disclosure. Additionally, the spine may wrap around from one side to the other to allow for attachment of excess length or for additional stability of the device. Additionally, it is understood that other modular configurations exist within the scope of the present disclosure, such as any other attachment of the spine to the compression bands or method of attachment of one band to another. These may include buttons, snaps, zippers, or other methods of attachment. 
     Referring now to  FIG. 4 , in another embodiment, there are two bands, designated  102   a ,  102   b , for each band “level.” These bands  102   a ,  102   b  interconnect to each other and/or the spine  120 . The spine may include slits  120   a  to assist in interconnection of the garment  100 . The interconnectivity of the spine  120  to the bands  102   a ,  102   b  may be any method of mechanical, chemical, or thermal. In yet another embodiment, a single band ( 102 ,  FIG. 1 ) can be fed through the slits  120   a  to position each band on the spine  120 . 
     Referring to  FIG. 5 , in yet another embodiment, the spine  120  includes horizontal slits  120   b  and an optional cover member  129 . The bands  102  fit against the spine  120  and may or may not attach at positions  122   a  for the spine and  112   b  for the band. The cover member  129  can then be weaved in and out of the slits  120   b  in order to hold the bands against the spine. The cover member  129  may attach just at the ends, or may attach at locations between each band  102 . Again, any interconnections may be temporary or permanent and may include mechanical, chemical, or thermal bonds or a combination thereof. 
     Not all of the bands  102  need to be similarly constructed. For example, one of the bands in  FIG. 5 , designated with reference numeral  102   c , is formed as a chevron, connecting with the spine  120  at the apex of the chevron. Such shape of a band may be desirable to create a more ergonomic angle on the limb. Such angles are preferably applied perpendicular to the skin, with more angle around the upper and lower curves of the calf than the rest of the garment. Such angles may vary according to limb geometry and garment size. Also, different bands can have different levels of elasticity. This would allow the garment  100  to be placed in different scenarios, such as over a bladder used for pneumatic pumps for preventing deep veinous thrombosis. Also different levels of compression can be provided for bands  102  nearer the ankle (or wrist, or shoulder) than further away from the ankle. This selection of a specific elasticity can therapeutically treat edema or decreasing vein size to prevent blood clots. 
     Furthermore, bands  102  can have different amounts of compressions and expansion, either compared to each other or different amounts along the band itself. Using different levels of compression may be desirable for different garments. Further, graduated compression may be accomplished by using bands of various levels of compression in the same garment. For example, generally more compression may be desired in the ankle portion and less proximally for a leg compression garment. By using different band composition to vary the stretch, different levels of compression may be achieved. In another example, a band may have less stretch in the portions that intersect the spine  120 , and more compression near the ends that are used for the locking mechanism  104 . Thus, an assembled device can therapeutically apply varying levels of compression. When the user feels that the band no longer stretches, then the compression becomes different and proportional to the tension placed on the band. The user can thus learn to “dial in” to this difference and so more reliably and predictably apply the desired level of compression. By varying the length and width of a band and/or the composition of the band, any desired level of compression can be created in the band. 
     3. The Anklet  108   
     Referring again to  FIG. 1 , the anklet  108  can be configured as a sock or stocking, being relatively thin so that a shoe can be worn over the garment. In one embodiment, the anklet  108  is made of a synthetic stretch-fiber fabric such as a Lycra® brand material. In some embodiments the anklet  108  may or may not fasten to the rest of the garment  100 . For example, a compression anklet can be used and placed in position with, but not attached to, the garment  100 . 
     Referring now to  FIG. 6 , in another embodiment, a footpiece  130  can be used as a different kind of anklet. In one embodiment, the footpiece  130  includes an inner sock-like member  132  of cotton/Lycra blend and three outer bands  134   a ,  134   b ,  134   c  of elastomeric material. Other materials and construction can be chosen in order to alter the compression level of the device. Construction may be made of same materials and layers as in  FIG. 2 . In some embodiments, the material may be an elastic or non-elastic material and of one single layer or many overlapping layers. 
     The three elastomeric bands  134   a ,  134   b ,  134   c  are arranged so that the first elastomeric band  134   a  fastens over the forefoot, the second elastomeric band  134   b  is angled at approximately ninety degrees to the surface of the midfoot, and the third elastomeric band  134   c  is fastened parallel to the back of the Achilles. In the present embodiment, the third elastomeric band  134   c  is unique from the other two in that it can attach in place across, or across and downward onto the dorsum of the footpiece. Thus the design is unique in that it allows to fit a variety of foot sizes and to apply variable compression as desired to be most therapeutic. 
     The footpiece  130  also includes a single band  134   c  sewn in place in the middle with both free ends with sewn hook material. The hook material may be fastened circumferentially across just below the ankle, or may reach down toward the forefoot and across to the opposite side, for example. The flexibility of this band allows a number of geometries to be accounted for. In one embodiment, the band is just over three inches wide. The length of the band may be any desired length for therapeutic use. For example, lengths of 6 inches, 8 inches, 10 inches, 12 inches, 14 inches, 16 inches, and 18 inches, or other lengths are possible. 
     4. Stockings and Liners 
     Referring to  FIGS. 1 and 6 , a stocking liner  140  may be provided under the garment  100  to reduce itching and minimize effects of overlapping on the skin. The liner can extend the entire length of the garment  100 , including any ankle  108  or foot piece  130 , or may cover only a portion thereof. The liner  140  can be formed of a cotton/Lycra® blend or other material and may have a foam lining. The foam lining may include sewn channels to follow the body&#39;s natural lymphatic drainage lines. The foam lining also may have foam with stitches or carved portions to create a waffle-like pattern in order to facilitate lymphatic drainage in the un-compressed portions. The thickness of such a liner  140  may be quite thick, such as can be achieved with the JoviPak UE-P-AG1 (Tri-D Corporation Kent, Wash.). The foam may include a granular-type material. A fabric cover may also be included on all or part of the foam lining. 
     Referring also to  FIG. 7 , the liner  140 , shown here being used with an arm compression garment, would have a multiplicity of pressure-applying resilient protrusions, or high pressure areas  142  and channels  144  there between. The channels  144  potentially facilitate lymphatic drainage while reducing interstitial edema along the high pressure areas  142 . The liner  140 , which may be constructed similarly to commercial products known under the brand JoviPak, Tribute™ or Komprex II, may be a cotton or blended material with thicker woven fabric as seen in many commercially available socks. 
     Another embodiment of the liner  140  may include one or two layers of cotton or cotton/Lycra blend or another similar woven or formed material, with semi compressible material woven between the inner and out layers of the liner. The liner  140  may also include the channels  144  which are in the form of sewn pockets with openings  146  for insertion of a semi-compressible insert  148  to form the high pressure areas  142 . Such an embodiment may have distinct advantages over other commercially available liners since it may be much thinner but with similar performance. This allows more comfort for long-term wear and improved breathability of the liner  140 . The liner  140  may be designed for a specific use, but may have additional uses under other commercially available compression devices, such as The Cinch (Innovative Medical Solutions, Seattle Wash.), ReidSleeve (Peninsula Medical Inc., Scotts Valley Calif.), short-stretch or medium-stretch bandages, CircAid (San Diego Calif.) or other commercially used products for treatment of edema, venous and lymphedema. The insert  148  is preferentially thin and less than 1 cm, although larger sizes may also be desirable. 
     In another embodiment, foam padding can be positioned in-between the liner  140  and the straps  102 . The foam padding can be used to reduce lymphedema. One possibility is to use dense foam such as Komprex foam (Lohmann Rauscher Neuwied, Germany). In this embodiment, the foam is cut into small squares of 0.25 cm to 2 cm along each side. These squares may or may not have a pyramid shape facing the inner layer. These pyramid-shaped areas massage the affected area during wear and can break up fibrotic areas, effectively reducing lymphedema long-term. Alternatively, one solid piece of foam with a grid but out on one side may achieve the same function. Other foam padding includes JoviPak Multi-Purpose pads (Tri-D Corporation Kent, Wash.) or other commercially available products such as the Jovi Le-C-Advi sheet foam liner. Such pads are sewn chips or pieces of polyurethane or similar foam and may or may not have channels sewn into place. 
     5. Business Method 
     Referring now to  FIG. 8 , the garments  100  discussed above can be provided in response to receiving a customer order form  200 . The form  200  includes an order information section  202 , a shipping information section  204 , a billing information section  206 , a measurement section  208 , and a measurement guide  210 . A customer can obtain and fill out the form  200  where measurements are taken of key components of the affected limb. If the place of assembly for the garment  100  is the same as the place of sale, then the measurements may be compared to pre-stocked components and the proper number and type of components can be selected. The modularity of the garment  100  facilitates a sales facility in having a reduced inventory yet still being able to provide a highly-customized solution. 
     Furthermore, the amount of overlap of bands may be varied to accommodate a variety of leg lengths. In one embodiment, the bands  102  are just over three inches in height, and each lower limb compression device may have 4-6 bands, one to two spines  120 , and a footpiece or anklet  108 . Since the spine  120  may be modular, one spine may accommodate an arm or a lower leg. Other spines, such as for an entire lower limb device, may also be provided. In another embodiment, the spine  120  may include a material backing with iron-on interfacing. This will allow quick permanent assembly of a plurality of bands  102  with or without an anklet. This customization can be done at the time of measurement of the actual limb, or can be done at a remote location using the measurement form  200 . 
     In some embodiments, one or more of the bands  102  can be overlapped and connected (e.g. sewn together) prior to delivering to a doctor or patient. In other embodiments, some or all of the garment  100  can be sterilized prior to delivery. 
     Some embodiments of the form  200  can include information that would allow a doctor or provider to custom select certain bands  102  for different purposes. For example, different levels of edema (e.g., minimal, extreme) can be addressed by selecting an appropriate elasticity of the bands  102 . Also, the height and/or weight of a patient can factor into the selection of band size, placement (e.g., more elastic bands near the ankle) and composition. The bands  102  can include a marker such as a position number that will indicate their placement on the spine  120 . 
     The foregoing has outlined features of several embodiments according to aspects of the present invention. Those skilled in the art should appreciate that they may readily use the present disclosure as a basis for designing or modifying other processes and structures for carrying out the same purposes and/or achieving the same advantages of the embodiments introduced herein. Those skilled in the art should also realize that such equivalent constructions do not depart from the spirit and scope of the present disclosure, and that they may make various changes, substitutions and alterations herein without departing from the spirit and scope of the present disclosure.