Abstract:
A compression device can treat edema with a number of curved shells, each having an internal pad. A ligature network employing tensioners is routed across the shells for compressing them. Tensioners on at least some of the shells can separately adjust tension in different portions of the ligature network. The ligature network is (a) releasably mounted on the shells, and (b) repositionable to allow spatial adjustment of compression forces produced by the compression device. By adjusting the routing of the ligature network across the shells, tailored compression forces are provided. With a body part embraced by the padded shells, tension is separately adjusted in different portions of the ligature network to provide different compression forces at spaced positions along the plurality of padded shells.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    1. Field of the Invention 
         [0002]    The present invention relates to devices and method for treating a patient with compression, and in particular, to techniques employing separate shells. 
         [0003]    2. Description of Related Art Edema is a medical condition that requires careful treatment. Lymphedema, a type of edema, is a swelling of a body part, often the result of the abnormal accumulation in the affected area of protein-rich edema fluid (primarily lymph fluids). Lymphedema is classified as either primary or secondary. Primary lymphedema is the result of lymphatic dysplasia. It may be present at birth but more often develops later in life without obvious cause. Secondary lymphedema is much more common and is the result of surgery or is a side effect of radiation therapy for cancer. Secondary forms may also occur after injury, scarring, trauma, or infection of the lymphatic system. Lymphedema treatment options offered in the United States include surgery, medication, pneumatic compression pump therapy, Manual Lymph Drainage (MLD), and Complete Decongestive Therapy (CDT). 
         [0004]    Surgery and medication have their place, but their success is not guaranteed and comes with risks. The pneumatic compression pump is a mechanical device that “milks” the lymph fluid out of the swollen extremity. The problems with pneumatic pumps are numerous and any results achieved are usually very temporary. 
         [0005]    Lymphedema physical therapy treatment would not be possible without compression therapy employing bandages and elastic compression garments. Elastic compression garments are easily used and sold under the trade names: Solaris, JoviPak, CircAid, Biacare, and Reid Sleeve. Another compression therapy involves bandaging with short stretch bandages and is a highly skilled procedure designed to take advantage of natural pumping pressures. 
         [0006]    Lymph is propelled through the various lymph vessels by muscular activity, breathing, etc. Bandaging/garments improve the efficiency of the muscle and joint pump and also prevents the re-accumulation of evacuated lymph fluid. These techniques will also break up deposits of accumulated scar and connective tissue. 
         [0007]    The nature of compression varies greatly when a comparison is made between short stretch bandages and elastic compression garments. Both are necessary complements to a program of Complete Decongestive Therapy (CDT) when utilized by competent and well-trained therapists. The distinction lies in the working and resting forces generated by these two forms of compression. Elastic compression garments are designed to provide a pressure gradient favoring proximal fluid flow and are comfortable and convenient. However, they tend to produce constant resting pressure without enhanced working pressure. Short stretch compression bandages supports a limb without constant “squeezing” (i.e. will exhibit low resting pressure), but when a limb is exercised produces relatively high working pressure. 
         [0008]    No effective homecare device exists to maintain/reduce lymphedema/edema consistent with the principles of CDT (Complete Decongestive Therapy). Therefore, patients are saddled with the responsibility of life-long lymphedema control, but the task is arduous, tedious and time consuming. When self-applied compression is performed with less than sufficient skill, it can also be painful, counter-therapeutic or even damage the limbs&#39; health. 
         [0009]    Aftermarket compression products have tried alternative solutions to replace multilayered compression bandages. Treatment at joints is most problematical for these products. Even at the limb segments (between joints) the solutions offered utilize unsatisfactory materials and tensioning techniques to generate pressure. As a result these products lack continuous working pressure (cast-like containment) longitudinally as well as structure to prevent buckling and bulging of tissues. 
         [0010]    See also U.S. Pat. Nos. 4,676,233; 5,152,302; 6,526,592; 6,785,905; 7,135,005; and 6,991,612; as well as US Patent Application Publication Nos. 2005/0066412; 2006/0135902; and 2008/0228117. 
       SUMMARY OF THE INVENTION 
       [0011]    In accordance with the illustrative embodiments demonstrating features and advantages of the present invention, there is provided a compression device for treating edema. The device includes a plurality of curved shells, each having an internal pad. The device also includes a ligature network routed across the plurality of shells. The network includes a plurality of tensioners. The tensioners are mounted on at least some of the plurality of shells and are operable to separately adjust tension in different portions of the ligature network. 
         [0012]    In accordance with another aspect of the invention, a compression device is provided for treating edema. The device includes a plurality of curved shells, each having an internal pad. The device also includes a ligature network routed across the shells. The ligature network includes a plurality of tensioners mounted on at least some of said plurality of shells. At least at least a portion of the ligature network is releasably mounted and repositionable on the shells to allow spatial adjustment of compression forces produced by said compression device 
         [0013]    In accordance with yet another aspect of the invention, a method is provided for treating edema with a ligature network and a plurality of padded shells. The method includes the step of routing the ligature network across the plurality of shells. Also, with a body part embraced by the padded shells, the method performs the step of separately adjusting tension in different portions of the ligature network to affect the balance of compression forces at spaced positions along the plurality of padded shells. 
         [0014]    In accordance with still yet another aspect of the invention, a method is provided for treating edema with a ligature network and a plurality of padded shells. The method includes the step of adjusting routing of the ligature network across the plurality of shells to provide tailored compression forces at spaced positions along the plurality of padded shells. Also, with a body part embraced by the padded shells, the method performs the step of adjusting tension in the ligature network to adjust compression forces along the plurality of padded shells. 
         [0015]    By employing devices and methods of the foregoing type an improved technique is achieved for treating edema. For example, lymphedema limb areas need not be immobilized and the present device does not function as a cast or an immobilizer. Areas of joint articulation can sustain movement without abrasion or discomfort. The natural muscle and joint pumps will be allowed to activate a natural fluid pumping effect. Allowing movement within a compression device tends to reverse lymphostatic fibrosis. 
         [0016]    A disclosed embodiment is presented for treating the hand, although treatment of other body parts is described. The embodiment for treating the hand employs a pair of padded shells, one placed on the palm and one on the dorsum. 
         [0017]    These padded shells each have a heat-treatable, plastic panel that is relatively stiff, so that the shells can apply transaxial pressure without squeezing the hand laterally. This arrangement cancels out high lateral pressures, and accentuates high dorsal and palmar pressures. 
         [0018]    These panels are fashioned to accommodate the specific body part being treated. For example, an outline of a hand may be applied to plastic panels and used to trim them accordingly, although the final panel outline need not follow the exact outline of the hand. Typically, the panel will be notched to allow articulation of the thumb. 
         [0019]    The panels may be heated to soften and bend them into a curve that accommodates the curves of the hand or other body part under treatment. 
         [0020]    Lymphedema is a staged condition according to disease severity (stages 1, 2, 3). As such it requires modifications in the approach according to the quantity of swelling and tissue integrity. The above noted shells apply the external force, but inner-padding materials must be tailored to modify the force according to the disease severity, desired gradient of pressure, limb girth and abnormal contours if any. 
         [0021]    With this in mind, the inside of the disclosed panels will be fitted with pads; for example, multiple layers of foam material. In one case the layer on the plastic panel is a closed cell foam that readily accommodates transaxial force, while the layer contacting skin tissue is an open cell foam that conforms more closely to the curves of the hand and increases comfort. In some cases one or more of the layers will not be one continuous piece, but will be formed from multiple disjoint segments that are fashioned to tailor the pressure being applied to the body part under treatment. 
         [0022]    Proper treatment requires that skin integrity be preserved to combat any localized immune deficiency. To address this requirement the shells&#39; pads ought to be hypoallergenic, customized to the patient, and hygienic. Moreover, any inner layer in contact with the skin should be exchanged regularly. 
         [0023]    Lymphedema treatment requires that a gradient of pressure be exerted regardless of the contour of the swollen limb. Pressure applied to hypothetical conical shapes will respond according to the “law of Laplace” (P=Tc/R), however swollen limbs are not always conical. To address this anatomical requirement “zones” of pressure are created and padding modified suitably to direct fluid from distal areas towards proximal areas. Limbs that have received treatment in the clinic (e.g., with CDT) become more normally shaped (from columnar to conical again) and readily responsive to the above compression device. 
         [0024]    In order to achieve an appropriate pressure, a disclosed embodiment employs a ligature network that is formed from a number of cords that are routed across the padded shells. Specifically, these cords are routed through guides strategically placed at various locations on the opposing shells. A disclosed network has two circuits that are independently tightened by two tensioners. The disclosed tensioners are cord winders placed in strategic locations on one or more of the shells. 
         [0025]    In this embodiment, the guides and winders are easily repositioned to modify the routing of the cords in the ligature network. Specifically, the guides and winders are attached to the outside of the shells by hook and loop fasteners. 
         [0026]    Devices of this type may be used as an adjunct to, or a follow-up after, professional therapy. Also, after the initial fitting of the device, a user will be able to readily remove the device and later place it back on the body part under treatment without the need for professional assistance. In addition, since the tension in the ligature network is readily adjusted, a user can easily adjust tension throughout the day as needed. 
         [0027]    Devices according to the foregoing principles can achieve high working pressure, and low resting pressure throughout. Such devices are adaptable to the edema reduction process by allowing movement, and normal activity. In the disclosed embodiment, tension is easily adjusted so a user is able to regularly conduct subtle re-tensioning. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0028]    The above brief description as well as other objects, features and advantages of the present invention will be more fully appreciated by reference to the following detailed description of illustrative embodiments in accordance with the present invention when taken in conjunction with the accompanying drawings, wherein: 
           [0029]      FIG. 1  is a top view of a compression device in accordance with principles of the present invention; 
           [0030]      FIG. 2  is a bottom view of the compression device of  FIG. 1 ; 
           [0031]      FIG. 3  is a side view of the compression device of  FIGS. 1 and 2 ; 
           [0032]      FIG. 4  is a sectional view of a fragment of one of the padded shells of the device of  FIGS. 1 and 2 ; 
           [0033]      FIG. 5  is a side view of one of the tensioners of  FIG. 1 ; 
           [0034]      FIG. 6  is a perspective view of one of the guides of  FIGS. 1 and 2 ; 
           [0035]      FIG. 7  is a perspective view of the curved guide of  FIG. 2 ; 
           [0036]      FIG. 8  is a fragmentary, perspective view of a tensioner in a ligature network that is an alternate to that shown in  FIGS. 1 and 2 ; 
           [0037]      FIG. 9  is an inside view of a padded shell that is an alternate to that shown in  FIG. 2 ; 
           [0038]      FIG. 10  is a perspective view of a compression device that is an alternate to that shown in  FIGS. 1-3 ; 
           [0039]      FIG. 11  is an end view of the device of  FIG. 10 ; and 
           [0040]      FIG. 12  is an end view of a device that is an alternate to that of  FIG. 11 . 
       
    
    
     DETAILED DESCRIPTION 
       [0041]    Referring to  FIGS. 1-7 , the illustrated compression device has a palmar shell  10  and a dorsal shell  12 , each designed for right hand H. Each of the shells  10  and  12  have a heat-deformable plastic panel  14  ( FIG. 4 ). Various types of thermoplastics will operate satisfactorily as a panel, and the Aquaplast® moldable sheets from Patterson Medical (1.6 to 3.2 mm thick, perforated) will operate satisfactorily. Panel  14  ought to be relatively stiff in order to transmit compression forces normal to its surface. In this embodiment the opposite faces of panel  14  have a coterminous covering  16  and  18  in the form of a sheet of hook and loop material (loop material prominent) on a breathable plastic substrate. 
         [0042]      FIG. 1  shows the outline of padded shell  12 , it being understood that the right and left edges are rolled about 45°, except at the extension  12 A provided for thumb T. One can establish the outline of shell  12  by tracing the outline of the hand (hand H of  FIG. 2 ) on panel  14  and trimming appropriately. The trimmed panel  14  will have additional material for the rolling of the right and left panel edges and will make accommodations for the extended thumb region  12 A. 
         [0043]    Thereafter, panel  14  can be heated by, for example, immersion in hot water. When heated, the right and left edges of panel  14  can be rolled as noted above, while the central region can be given an appropriate curve to accommodate the natural curves of hand H. The outline and curvature of panel  14  may be refined based on the judgment and experience gathered by a properly trained therapist. Also, after an initial shaping, panel  14  can be placed against hand H to determine what areas need correction before possibly trimming and reshaping the panel again. 
         [0044]      FIG. 2  shows the outline of padded shell  10  with the right and left edges again rolled about 45°, except in the vicinity of notch  10 A provided for thumb T. Panel  14  of shell  10  can be trimmed and curved in a manner similar to that described in connection with shell  12 . 
         [0045]    The faces of panels  14  of shells  10  and  12  that face the skin are fitted with an internal pad, shown in  FIG. 4  as a pair of resilient layers  20  and  22 . Layers  20  and  22  will be trimmed to be coterminous with their associated shells  10  and  12 . 
         [0046]    Distal layer  20  may be formed of a closed cell foam material of the type typically used in compression therapy for lymphedema patients. Such lymphedema grade foams are available under the trade names Jobst Foam or Komprex Foam. Foams of this type are resilient but still tend to transmit compression forces substantially perpendicular to shell panel  14 . Layer  20  will be secured onto hook and loop material  18 , using, if necessary, an additional hook and loop sheet (hooks prominent). 
         [0047]    It is desirable that proximal layer  22  be more compliant than layer  20  to add to the wearer&#39;s comfort. Also, a softer material will tend to feather the compression forces near the edges of the device, thereby avoiding the tendency to apply undesired lateral compression. Open cell foam material has been found satisfactory for this purpose, although other types of resilient materials can be used as well. An acceptable open cell foam material is available from Canal Rubber Supply Co. of New York (light to medium density). 
         [0048]    In this embodiment layer  22  is ½ inch thick (1.3 cm). In other embodiments the layer thickness may be varied, although typically remaining within a range of ¼ to ¾ inch (0.6 to 1.9 cm) thick, with the thickness chosen to accommodate the needs of the patient. 
         [0049]    Padded shells  10  and  12  are pressed together with a ligature network employing nylon cords arranged in a pair of circuits  24  and  26 . Circuit  24  terminates at network tensioner  28 , while circuit  26  terminates at network tensioner  30 . In this embodiment tensioners  28  and  30  are identical, but need not be so. Circuit  24  has cord segment  24 A running atop shell  12  through plastic tube  36 A, which tube is designed to decrease cord friction. Cord segment  24 A traverses the edge of shell  12  and crosses over to run atop shell  10 , as shown by cord segment  24 B. 
         [0050]    Cord segment  24 B is threaded through network guide  32 A, which is releasably secured atop shell  10 . Guide  32 A is shown in  FIG. 6  as a slab  32 A- 1  supporting sleeve  32 A- 2 , which has through bore  32 A- 3  for receiving previously mentioned cord segment  24 B. A sheet of hook and loop fastening material  32 A- 4  glued on the underside of slab  32 A- 1  is designed to releasably attach guide  32 A to mating sheet  16  ( FIG. 4 ) on shell  10 . Guide  32 A is identical to guides  32 B,  32 C,  32 D and  32 E shown in  FIGS. 1 and 2  (these guides sometimes being referred to as annular implements). 
         [0051]    Cord segment  24 B traverses the edge of shell  10  and passes between forefinger I and middle finger M before running atop shell  12 , as shown by cord segment  24 C. Cord segment  24 C is threaded through guides  32 B and  32 C, which are mounted atop shell  12 . Cord segment  24 B traverses the edge of shell  12  and passes between ring finger A and pinky finger S before running atop shell  10 , as shown by cord segment  24 D. Cord segment  24 D is threaded through guide  32 D, which is releasably secured atop shell  10 . Cord segment  24 D traverses the edge of shell  10  to run atop shell  12 , as shown by cord segment  24 E. Cord segment  24 E passes through friction reducing tube  36 B. 
         [0052]    Referring now to circuit  26 , cord segment  26 A runs atop shell  12  and traverses the edge of shell  12  before running atop shell  10  as shown by cord segment  26 B. Cord segment  26 B is threaded through guide  32 E, which is releasably secured atop shell  10 . Cord segment  26 B traverses the edge of shell  10  before running atop shell  12 , as shown by cord segment  26 C, which passes through friction reducing tube  36 C. Cord segment  26 C traverses the edge of shell  12  before running atop shell  10 , as shown by cord segment  26 D. Cord segment  26 D runs through a channel in network guide  34 , which is releasably secured atop shell  10 . 
         [0053]    In  FIG. 7  guide  34  is shown with a platform  34 A having a curved outside edge (approximately a quarter circle curve) and an inside edge leading to a curved wall  34 B (approximately a quarter circle curve). A similarly curved shelf  34 C projecting from atop wall  34 B forms a curved channel  34 D to guide previously mentioned cord segment  26 D. Hook and loop fastener  34 E glued on the underside of platform  34 A will releasably attach guide  34  to hook and loop fastening material  16  atop shell  10 . 
         [0054]    Tensioner  28  is shown in  FIG. 5  having a dial  28 A rotatably mounted on body  28 B, which sits atop base  28 C. Cord segment  24 A is shown passing through hole  28 D in body  28 B. It will be appreciated that cord segment  24 E passes through another hole (not shown) on the other side of body  28 B. Tensioner  28  operates as a manually operable winder. Specifically, dial  28 A can be rotated clockwise (counterclockwise) to wind (unwind) cord segments  24 A relative to a reel (not shown) inside winder body  28 B. Cord segment  24 E will not be wound although winding may be implemented in other embodiments. Winders of this type can be obtained from Boa Technology, Inc. of Steamboat Springs, Colo. 
         [0055]    A sheet of hook and loop material  28 E is glued to the underside of winder base  28 C to act as a fastening device that will releasably attach the winder  28  by mating to hook and loop material  16  atop shell  12  ( FIG. 1 ). 
         [0056]    Referring to  FIG. 8 , a different type of manually operable winder (tensioner) is illustrated. Components corresponding to those previously described in connection with  FIG. 5  have the same reference numeral but increased by  100 . The winder  128  has mounted atop base  128 C a body  128 B containing a winding reel (not shown) that is driven by dial  128 A. Rotation of dial  128 A will wind or unwind band  124 A, which will be part of a ligature network similar to that previously described. However, in this embodiment, winder  128  only works with one end of band  124 A, whose opposite end may either be anchored at another location or connected to another winder. Moreover, band  124 A is not routed in a closed circuit in this embodiment. 
         [0057]    An alternate guide  132 A is shown as a cloth strip stitched into a loop that holds annular implement  133 . Band  124 A is shown routed through implement  133 . Cloth loop  132 A may be attached atop a padded shell by hook and loop fastening means, snaps, mechanical clips, etc. 
         [0058]    Referring to  FIG. 9 , palmar shell  10 ′ is designed for left hand H′ and is substantially the mirror image of shell  10  of  FIG. 2 . As before, shell  10 ′ has a heat deformable plastic core  14  with the same covering  16  and  18  as mentioned previously. In this embodiment, the layer  20  previously mentioned in  FIG. 4  has been replaced with three disjoint segments  120 A,  1208  and  120 C (also referred to as discrete panels). While three segments are shown, in other embodiments a greater or lesser number may be employed instead. 
         [0059]    Segment  120 A is an elongated slab with rounded ends designed to engage the knuckles of hand H′. Segment  120 B has a teardrop shaped outline and is designed to engage the fleshy part of the palm at the base of thumb T′. Segment  120 C is shaped to treat most of the remaining area of the palm of hand H′ and has an outline that is roughly a triangle with rounded corners. Segment  120 C is given some flexibility to bend along one of its edges by a pair of grooves  38 . 
         [0060]    It will be appreciated that the chosen outline, placement, thickness, and materials of segments  120 A- 120 C will be tailored by the therapist that sets up the device, these choices being made to accommodate and best treat hand H′. Also, each of the discrete segments  120 A- 120 C may be formed from the same material as layer  20  of  FIG. 4 , but in some cases each of the segments may use a different material with different characteristics adapted to accommodate the hand H′ under treatment. 
         [0061]    Panel segments  120 A- 120 C may be overlaid (face to face) with a full panel (not shown) having an outline substantially the same as that of core panel  14  and made of material similar to panel  22  of  FIG. 4 . In other embodiments the roles may be reversed with the layer adjacent to the skin tissue being segmented, and the other layer being continuous. 
         [0062]    Referring to  FIG. 10 , the illustrated compression device is designed to treat a different body part, namely forearm F instead of hand H. Components in this Figure corresponding to those of the embodiment of  FIGS. 1-7  have the same reference numerals but increased by  200 . Padded shell  212  is shown on the extension side of forearm F and padded shell  210  is shown on the volar side of the forearm. Shells  210  and  212  are roughly semicylindrical and are layered in substantially the same manner as shown in  FIG. 4 . 
         [0063]    Mounted on shell  212  are winders  230  and  228 , which each have independently adjustable circuits  224  and  226 , respectively. Winder  228  is shown connected to cord segments  224 A and  224 E of circuit  224 . Winder  230  is shown connected to cord segments  226 A and  226 E of circuit  226 . 
         [0064]    Circuit  224  extends along cord segment  224 E on shell  212 , crossing over to shell  210  to form cord segment  224 D, which passes through guide  232 D before returning to shell  212  to form the cord segment  224 C, passing through guide  232 C. Cord segment  224 C will pass through another guide (not shown) before taking a looping turn on a guide (not shown) on shell  210 , eventually returning as cord segment  224 A. It will be appreciated that circuit  224  has topographically the same routing as circuit  24  of  FIGS. 1 and 2 . 
         [0065]    Circuit  226  is topographically the same as circuit  26  of  FIGS. 1 and 2 . Specifically, cord segment  226 A crosses from shell  212  to shell  210  where cord segment  226 B passes through guide  232 E on shell  210  before returning to shell  212  to form cord segment  226 C. Cord segment  226 C will make a looping turn on a guide (not shown) on shell  210  before returning as cord segment  226 E. It will be appreciated that circuit  226  has topographically the same routing as circuit  26  of  FIGS. 1 and 2 . 
         [0066]    A third winder  40  on shell  212  connects to a third independently adjustable circuit  42  at cord segments  42 A and  42 E. Circuit  42  cooperates with a pair of guides at the proximal corner of shell  212 , one such guide being shown as guide  44 B. Guide  44 A is mounted along the edge of shell  210  and a corresponding guide (not shown) is mounted at the opposite edge of shell  210  at the same longitudinal position. 
         [0067]    Cord segment  42 A extends across shell  212 , crossing over to shell  210  where cord segment  42 B passes through guide  44 A before returning to shell  212  to form cord segment  42 C, which passes through guide  44 B and the complementary guide on the other side of shell  212 . It will be appreciated that cord segment  42 C crosses over to shell  210  and loops back in a manner similar to that shown for cord segment  42 B. 
         [0068]    As before, winders  228 ,  230  and  40  are releasably secured to shell  212  to allow a therapist to adjust the position of each. Similarly positionable are the guides (e.g., illustrated guides  232 C- 232 E and  44 A- 44 B). 
         [0069]    As shown in  FIG. 11 , previously mentioned padded shells  210  and  212  have gaps at approximately the three o&#39;clock and nine o′clock positions. In other embodiments such as shown in  FIG. 12  three shells  46 ,  48 , and  50  may be arranged with gaps at approximately the two o&#39;clock, six o&#39;clock and  10  o&#39;clock positions (i.e., shell  46  on the extension side and shells  48  and  50  primarily on the volar side). 
         [0070]    While the devices of  FIGS. 10-12  are mentioned for treating a forearm, they can equally be applied to different body parts such as the upper arm, calf, or thigh. 
         [0071]    To facilitate an understanding of the principles associated with the foregoing apparatus, its operation will be briefly described in connection with the embodiment of  FIGS. 1-7 . 
         [0072]    Heat deformable panel  14  is trimmed to size based on the size and proportions of hand H. To customize padded shell  12 , hand H may be placed atop panel  14 , palm up, and the outline of the hand may be traced with a pencil or other writing instrument. Panel  14  will then be trimmed to extend longitudinally from the end of the wrist to the base of the fingers. Panel  14  will also be trimmed to extend from the right to the left edge of the hand H with a little excess to allow the panel to curl slightly around the edge of the hand. Panel  14  will be allowed to extend outwardly slightly outwardly along extension  12 A to cover a portion of the thumb knuckle. This extension will be useful in applying pressure in this region without restricting the mobility of thumb T. 
         [0073]    To customize padded shell  10 , hand H may be placed atop panel  14 , palm down, and the outline of the hand may be traced with a pencil or other writing instrument. Panel  14  will be trimmed as before except that previously mentioned thumb extension  12 A will be replaced with a thumb notch  10 A. This notch will be useful in allowing articulation of thumb T. In fact, the wrist, thumb T and all the fingers of hand H can be moved so the user will retain most of the function of hand H. This ability to move the wrist and fingers and thereby exercise the hand will enhance the natural ability of the body to reduce edema by means of the natural pumping action produced when exercising the fingers and wrist. 
         [0074]    Panels  14  of shells  10  and  12  can be further shaped by immersion in hot water to soften the panels. The panels may be curved in a general way to accommodate the shape of hand H. Special attention may be given to the right and left edges of panel  14  to roll these edges slightly around the hand H. For thumb extension  12 A, panel  14  may be bowed about the thumb axis to provide a proper fit. 
         [0075]    The foregoing trimming and shaping may be performed after a session with a therapist who examines and measures hand H. The therapist may either personally perform the trimming and shaping, but in some cases the information gathered by the therapist will be sent to a specialized lab along with a general description of the characteristics of hand H, so that the lab can customize the panel  14 . In any event, this trimming and shaping will be based upon a therapist&#39;s experience and judgment. 
         [0076]    Pads  20  and  22  ( FIG. 4 ) may be provided as a kit having a variety of padding materials. The materials will offer a selection of different thicknesses, softness, etc. As noted above, the padding materials can include commercially available, closed cell foams that are designed for the treatment of lymphedema. The padding materials can also include softer, open cell foams of various types. In some cases the padding will be some other type of non-foam, synthetic material. 
         [0077]    As noted previously, the padding may be cut into discrete segments as shown in  FIG. 9 . Again, the selection and arrangement of padding materials will be based on the therapist&#39;s experience and judgment. 
         [0078]    Pad  20  may be secured in place by taking advantage of a natural propensity to adhere to hook and loop material  18 . Where such a propensity does not exist, a mating sheet of a hook and loop material may be glued to pad  20 . Likewise, hook and loop material may be used to connect pads  20  and  22  together. The advantage of using hook and loop material is that the therapist can experiment with a variety of combinations of pads and pad shapes. This ability to modify will be important when initially establishing the most desirable combination and also afterward when the arrangement needs to be modified as the patient&#39;s condition changes. 
         [0079]    Also, while hook and loop fastening material will work satisfactorily, in some embodiments other fastening means may be employed, including releasable adhesives that allow repositioning and replacement of pads. 
         [0080]    Next, a therapist will make judgments about the zones where pressure ought to be applied. In the embodiment of  FIGS. 1-7 , two compression zones are achieved by using two tensioners  28  and  30  and two independent circuits  24  and  26 . A therapist can determine the course of circuits  24  and  26  by positioning guides  34  and  32 A- 32 E. In the disclosed embodiment, circuit  24  is arranged with four crossovers between shells  10  and  12 , which determine the compression forces between the shells. 
         [0081]    For circuit  24 , the compression affects primarily the knuckles at the base of the fingers. Specifically, the crossover between courses  24 A and  24 B applies pressure on the proximal and outer side of the knuckle for forefinger I. The crossover between courses  24 B and  24 C applies pressure on the distal side of the knuckles for fingers I and M, at the gap between those fingers. The crossover between courses  24 C and  24 D applies pressure on the distal side of the knuckles for fingers A and S, at the gap between those fingers. The crossover between courses  24 D and  24 E applies pressure on the distal and outer side of the knuckles for finger S. 
         [0082]    For circuit  26 , compression affects the portion of the hand H spaced proximally from the knuckles. Specifically, the crossover between courses  26 A and  26 B applies pressure on the pinky side of the hand about midway between the fingers and wrist. The crossover between courses  26 B and  26 C applies pressure on the pinky side of the hand at a position that is fairly close to the wrist. The crossover between courses  26 C and  26 D applies pressure on the thumb side of the hand between the thumb T and wrist. The crossover between courses  26 D and  26 E applies pressure on the thumb side of the hand about midway between thumb, T and forefinger I. 
         [0083]    It will be appreciated that therapist can adjust the routing of courses  24  and  26  to change the manner in which pressure is applied to hand H. Also, since panels  14  of shells  10  and  12  are relatively stiff, the forces applied by the shells are substantially perpendicular to the palmar and dorsal surfaces of hand H, so that the hand is not squeezed laterally. 
         [0084]    Winders  28  and  30  can be independently adjusted to establish the compression forces and their respective regions. By tightening (loosening) circuit  24  compression forces can be increased (reduced) around the knuckles at the base of the fingers. By tightening (loosening) circuit  26  compression forces can be increased (reduced) around the portion of hand H between the wrist and the knuckles at the base of the fingers. Normal forces will be transmitted primarily by pad  20 . Pad  22  will usually be a softer material to increase comfort and to provide feathering of compression forces near the edges of shells  10  and  12 . 
         [0085]    Initially, the compression forces will be the established at the time the therapist first places the device on hand H. However, the patient will be taught how to independently place the device on hand H without professional assistance. Thereafter, the patient can wear the device during the time periods recommended by the therapist. In some cases, a patient may be asked to wear a compression glove under the device in order to assist in reducing edema, but this choice will depend upon the specific condition of this patient. 
         [0086]    To don the device, one will start with winders  28  and  30  arranged to fully slacken circuits  24  and  26 . A patient can then slip the fingers between shells  10  and  12  on the proximal edge of the shells. When hand H is positioned as shown in  FIGS. 1-3 , winders  28  and  23  can be adjusted to produce the tension in circuits  24  and  26  recommended by a therapist. 
         [0087]    During the course of a day, a patient may find it necessary to increase or decrease the compression forces. Since winders  28  and  30  are easily adjusted, these compression forces can be easily changed. Also, the patient can be given a supply of replacement pads in order to replace pad  22  when it becomes soiled. 
         [0088]    Also, the device is easily removed by using winders  28  and  30  to remove all tension on circuits  24  and  26 . Thereafter, hand H is withdrawn in a direction opposite to the direction used to don the device. Accordingly, the patient can temporarily remove the device for routine activities such as bathing. 
         [0089]    When the device is worn, the compression forces will tend to reduce the edema. The compression forces will tend to urge edematous fluids in a proximal direction. Also, the patient&#39;s fingers and thumb will remain highly mobile. Thus, the patient can perform most daily activities. Accordingly, the fingers and thumb will be routinely exercising, which will produce a natural pumping effect that tends to reduce edema. In addition, the device is relatively open so that air can reach the hand H, which will enhance comfort and avoid elevated temperatures. 
         [0090]    The patient will still need to periodically visit a therapist to check the progress and to perform different types of CDT. At these visits the therapist can inspect the condition of the body part. If necessary, therapist can change pads  20  and  22  to a different type of pad. 
         [0091]    The advantages of this device are: time savings and ease of application, comfort, safety, and therapeutic efficacy. Using appropriate materials and an effective tensioning system, this device offers a high working, low resting pressure environment similar to that which his offered to lymphedema patients during CDT using short stretch (non-elastic) bandaging materials. Furthermore compression is achieved while avoiding trauma to the lymphatic, hemodynamic and neurological system, by using customizable thermoplastics and padding to areas like the hand, forearm, upper arm, calf, thigh and other body parts. 
         [0092]    It will be appreciated that various modifications may be implemented with respect to the above described embodiments. In some cases a variety of shells may be manufactured in sizes and shapes designed to accommodate the affected body part of most patients. In some embodiments shells may be provided with a large number of molded eyes or lacing hooks, so that the therapist can effectively route a tensioning cord through almost any desired route by selecting different eyes or hooks. In still other embodiments, the winders may be mounted in fixed positions, in which case the ligature network is adjusted by changing the routing of the cords connected to the tensioner. In some cases the ligature network will be formed of a single cord but will be segregated into different independent sections by tying some intermediate point on the cord to an anchor, so that tension is not transferred from one section to the other. While a double layer pad is disclosed, in some embodiments the pad may be a single layer or may employ more than two layers. 
         [0093]    Obviously, many modifications and variations of the present invention are possible in light of the above teachings. It is therefore to be understood that within the scope of the appended claims, the invention may be practiced otherwise than as specifically described.