Therapeutic compression device and method

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.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to devices and method for treating a patient with compression, and in particular, to techniques employing separate shells.

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).

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.

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.

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.

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.

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' health.

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.

SUMMARY OF THE INVENTION

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

Proper treatment requires that skin integrity be preserved to combat any localized immune deficiency. To address this requirement the shells' pads ought to be hypoallergenic, customized to the patient, and hygienic. Moreover, any inner layer in contact with the skin should be exchanged regularly.

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.

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.

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.

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.

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.

DETAILED DESCRIPTION

Referring toFIGS. 1-7, the illustrated compression device has a palmar shell10and a dorsal shell12, each designed for right hand H. Each of the shells10and12have a heat-deformable plastic panel14(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. Panel14ought to be relatively stiff in order to transmit compression forces normal to its surface. In this embodiment the opposite faces of panel14have a coterminous covering16and18in the form of a sheet of hook and loop material (loop material prominent) on a breathable plastic substrate.

FIG. 1shows the outline of padded shell12, it being understood that the right and left edges are rolled about 45°, except at the extension12A provided for thumb T. One can establish the outline of shell12by tracing the outline of the hand (hand H ofFIG. 2) on panel14and trimming appropriately. The trimmed panel14will have additional material for the rolling of the right and left panel edges and will make accommodations for the extended thumb region12A.

Thereafter, panel14can be heated by, for example, immersion in hot water. When heated, the right and left edges of panel14can 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 panel14may be refined based on the judgment and experience gathered by a properly trained therapist. Also, after an initial shaping, panel14can be placed against hand H to determine what areas need correction before possibly trimming and reshaping the panel again.

FIG. 2shows the outline of padded shell10with the right and left edges again rolled about 45°, except in the vicinity of notch10A provided for thumb T. Panel14of shell10can be trimmed and curved in a manner similar to that described in connection with shell12.

The faces of panels14of shells10and12that face the skin are fitted with an internal pad, shown inFIG. 4as a pair of resilient layers20and22. Layers20and22will be trimmed to be coterminous with their associated shells10and12.

Distal layer20may 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 panel14. Layer20will be secured onto hook and loop material18, using, if necessary, an additional hook and loop sheet (hooks prominent).

It is desirable that proximal layer22be more compliant than layer20to add to the wearer'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).

In this embodiment layer22is 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.

Padded shells10and12are pressed together with a ligature network employing nylon cords arranged in a pair of circuits24and26. Circuit24terminates at network tensioner28, while circuit26terminates at network tensioner30. In this embodiment tensioners28and30are identical, but need not be so. Circuit24has cord segment24A running atop shell12through plastic tube36A, which tube is designed to decrease cord friction. Cord segment24A traverses the edge of shell12and crosses over to run atop shell10, as shown by cord segment24B.

Cord segment24B is threaded through network guide32A, which is releasably secured atop shell10. Guide32A is shown inFIG. 6as a slab32A-1supporting sleeve32A-2, which has through bore32A-3for receiving previously mentioned cord segment24B. A sheet of hook and loop fastening material32A-4glued on the underside of slab32A-1is designed to releasably attach guide32A to mating sheet16(FIG. 4) on shell10. Guide32A is identical to guides32B,32C,32D and32E shown inFIGS. 1 and 2(these guides sometimes being referred to as annular implements).

Cord segment24B traverses the edge of shell10and passes between forefinger I and middle finger M before running atop shell12, as shown by cord segment24C. Cord segment24C is threaded through guides32B and32C, which are mounted atop shell12. Cord segment24B traverses the edge of shell12and passes between ring finger A and pinky finger S before running atop shell10, as shown by cord segment24D. Cord segment24D is threaded through guide32D, which is releasably secured atop shell10. Cord segment24D traverses the edge of shell10to run atop shell12, as shown by cord segment24E. Cord segment24E passes through friction reducing tube36B.

Referring now to circuit26, cord segment26A runs atop shell12and traverses the edge of shell12before running atop shell10as shown by cord segment26B. Cord segment26B is threaded through guide32E, which is releasably secured atop shell10. Cord segment26B traverses the edge of shell10before running atop shell12, as shown by cord segment26C, which passes through friction reducing tube36C. Cord segment26C traverses the edge of shell12before running atop shell10, as shown by cord segment26D. Cord segment26D runs through a channel in network guide34, which is releasably secured atop shell10.

InFIG. 7guide34is shown with a platform34A having a curved outside edge (approximately a quarter circle curve) and an inside edge leading to a curved wall34B (approximately a quarter circle curve). A similarly curved shelf34C projecting from atop wall34B forms a curved channel34D to guide previously mentioned cord segment26D. Hook and loop fastener34E glued on the underside of platform34A will releasably attach guide34to hook and loop fastening material16atop shell10.

Tensioner28is shown inFIG. 5having a dial28A rotatably mounted on body28B, which sits atop base28C. Cord segment24A is shown passing through hole28D in body28B. It will be appreciated that cord segment24E passes through another hole (not shown) on the other side of body28B. Tensioner28operates as a manually operable winder. Specifically, dial28A can be rotated clockwise (counterclockwise) to wind (unwind) cord segments24A relative to a reel (not shown) inside winder body28B. Cord segment24E 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.

A sheet of hook and loop material28E is glued to the underside of winder base28C to act as a fastening device that will releasably attach the winder28by mating to hook and loop material16atop shell12(FIG. 1).

Referring toFIG. 8, a different type of manually operable winder (tensioner) is illustrated. Components corresponding to those previously described in connection withFIG. 5have the same reference numeral but increased by100. The winder128has mounted atop base128C a body128B containing a winding reel (not shown) that is driven by dial128A. Rotation of dial128A will wind or unwind band124A, which will be part of a ligature network similar to that previously described. However, in this embodiment, winder128only works with one end of band124A, whose opposite end may either be anchored at another location or connected to another winder. Moreover, band124A is not routed in a closed circuit in this embodiment.

An alternate guide132A is shown as a cloth strip stitched into a loop that holds annular implement133. Band124A is shown routed through implement133. Cloth loop132A may be attached atop a padded shell by hook and loop fastening means, snaps, mechanical clips, etc.

Referring toFIG. 9, palmar shell10′ is designed for left hand H′ and is substantially the mirror image of shell10ofFIG. 2. As before, shell10′ has a heat deformable plastic core14with the same covering16and18as mentioned previously. In this embodiment, the layer20previously mentioned inFIG. 4has been replaced with three disjoint segments120A,1208and120C (also referred to as discrete panels). While three segments are shown, in other embodiments a greater or lesser number may be employed instead.

Segment120A is an elongated slab with rounded ends designed to engage the knuckles of hand H′. Segment120B has a teardrop shaped outline and is designed to engage the fleshy part of the palm at the base of thumb T′. Segment120C 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. Segment120C is given some flexibility to bend along one of its edges by a pair of grooves38.

It will be appreciated that the chosen outline, placement, thickness, and materials of segments120A-120C 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 segments120A-120C may be formed from the same material as layer20ofFIG. 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.

Panel segments120A-120C may be overlaid (face to face) with a full panel (not shown) having an outline substantially the same as that of core panel14and made of material similar to panel22ofFIG. 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.

Referring toFIG. 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 ofFIGS. 1-7have the same reference numerals but increased by200. Padded shell212is shown on the extension side of forearm F and padded shell210is shown on the volar side of the forearm. Shells210and212are roughly semicylindrical and are layered in substantially the same manner as shown inFIG. 4.

Mounted on shell212are winders230and228, which each have independently adjustable circuits224and226, respectively. Winder228is shown connected to cord segments224A and224E of circuit224. Winder230is shown connected to cord segments226A and226E of circuit226.

Circuit224extends along cord segment224E on shell212, crossing over to shell210to form cord segment224D, which passes through guide232D before returning to shell212to form the cord segment224C, passing through guide232C. Cord segment224C will pass through another guide (not shown) before taking a looping turn on a guide (not shown) on shell210, eventually returning as cord segment224A. It will be appreciated that circuit224has topographically the same routing as circuit24ofFIGS. 1 and 2.

Circuit226is topographically the same as circuit26ofFIGS. 1 and 2. Specifically, cord segment226A crosses from shell212to shell210where cord segment226B passes through guide232E on shell210before returning to shell212to form cord segment226C. Cord segment226C will make a looping turn on a guide (not shown) on shell210before returning as cord segment226E. It will be appreciated that circuit226has topographically the same routing as circuit26ofFIGS. 1 and 2.

A third winder40on shell212connects to a third independently adjustable circuit42at cord segments42A and42E. Circuit42cooperates with a pair of guides at the proximal corner of shell212, one such guide being shown as guide44B. Guide44A is mounted along the edge of shell210and a corresponding guide (not shown) is mounted at the opposite edge of shell210at the same longitudinal position.

Cord segment42A extends across shell212, crossing over to shell210where cord segment42B passes through guide44A before returning to shell212to form cord segment42C, which passes through guide44B and the complementary guide on the other side of shell212. It will be appreciated that cord segment42C crosses over to shell210and loops back in a manner similar to that shown for cord segment42B.

As before, winders228,230and40are releasably secured to shell212to allow a therapist to adjust the position of each. Similarly positionable are the guides (e.g., illustrated guides232C-232E and44A-44B).

As shown inFIG. 11, previously mentioned padded shells210and212have gaps at approximately the three o'clock and nine o'clock positions. In other embodiments such as shown inFIG. 12three shells46,48, and50may be arranged with gaps at approximately the two o'clock, six o'clock and 10 o'clock positions (i.e., shell46on the extension side and shells48and50primarily on the volar side).

While the devices ofFIGS. 10-12are mentioned for treating a forearm, they can equally be applied to different body parts such as the upper arm, calf, or thigh.

To facilitate an understanding of the principles associated with the foregoing apparatus, its operation will be briefly described in connection with the embodiment ofFIGS. 1-7.

Heat deformable panel14is trimmed to size based on the size and proportions of hand H. To customize padded shell12, hand H may be placed atop panel14, palm up, and the outline of the hand may be traced with a pencil or other writing instrument. Panel14will then be trimmed to extend longitudinally from the end of the wrist to the base of the fingers. Panel14will 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. Panel14will be allowed to extend outwardly slightly outwardly along extension12A 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.

To customize padded shell10, hand H may be placed atop panel14, palm down, and the outline of the hand may be traced with a pencil or other writing instrument. Panel14will be trimmed as before except that previously mentioned thumb extension12A will be replaced with a thumb notch10A. 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.

Panels14of shells10and12can 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 panel14to roll these edges slightly around the hand H. For thumb extension12A, panel14may be bowed about the thumb axis to provide a proper fit.

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 panel14. In any event, this trimming and shaping will be based upon a therapist's experience and judgment.

Pads20and22(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.

As noted previously, the padding may be cut into discrete segments as shown inFIG. 9. Again, the selection and arrangement of padding materials will be based on the therapist's experience and judgment.

Pad20may be secured in place by taking advantage of a natural propensity to adhere to hook and loop material18. Where such a propensity does not exist, a mating sheet of a hook and loop material may be glued to pad20. Likewise, hook and loop material may be used to connect pads20and22together. 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's condition changes.

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.

Next, a therapist will make judgments about the zones where pressure ought to be applied. In the embodiment ofFIGS. 1-7, two compression zones are achieved by using two tensioners28and30and two independent circuits24and26. A therapist can determine the course of circuits24and26by positioning guides34and32A-32E. In the disclosed embodiment, circuit24is arranged with four crossovers between shells10and12, which determine the compression forces between the shells.

For circuit24, the compression affects primarily the knuckles at the base of the fingers. Specifically, the crossover between courses24A and24B applies pressure on the proximal and outer side of the knuckle for forefinger I. The crossover between courses24B and24C applies pressure on the distal side of the knuckles for fingers I and M, at the gap between those fingers. The crossover between courses24C and24D applies pressure on the distal side of the knuckles for fingers A and S, at the gap between those fingers. The crossover between courses24D and24E applies pressure on the distal and outer side of the knuckles for finger S.

For circuit26, compression affects the portion of the hand H spaced proximally from the knuckles. Specifically, the crossover between courses26A and26B applies pressure on the pinky side of the hand about midway between the fingers and wrist. The crossover between courses26B and26C applies pressure on the pinky side of the hand at a position that is fairly close to the wrist. The crossover between courses26C and26D applies pressure on the thumb side of the hand between the thumb T and wrist. The crossover between courses26D and26E applies pressure on the thumb side of the hand about midway between thumb, T and forefinger I.

It will be appreciated that therapist can adjust the routing of courses24and26to change the manner in which pressure is applied to hand H. Also, since panels14of shells10and12are 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.

Winders28and30can be independently adjusted to establish the compression forces and their respective regions. By tightening (loosening) circuit24compression forces can be increased (reduced) around the knuckles at the base of the fingers. By tightening (loosening) circuit26compression 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 pad20. Pad22will usually be a softer material to increase comfort and to provide feathering of compression forces near the edges of shells10and12.

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.

To don the device, one will start with winders28and30arranged to fully slacken circuits24and26. A patient can then slip the fingers between shells10and12on the proximal edge of the shells. When hand H is positioned as shown inFIGS. 1-3, winders28and23can be adjusted to produce the tension in circuits24and26recommended by a therapist.

During the course of a day, a patient may find it necessary to increase or decrease the compression forces. Since winders28and30are easily adjusted, these compression forces can be easily changed. Also, the patient can be given a supply of replacement pads in order to replace pad22when it becomes soiled.

Also, the device is easily removed by using winders28and30to remove all tension on circuits24and26. 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.

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'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.

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 pads20and22to a different type of pad.

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.

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.