Therapeutic compression device and method of use

Abstract

A therapeutic compression device used to apply pressure to the limbs. [Solution] A therapeutic compression device comprising a main wrap having a proximal end and a distal end, and a secondary wrap having a proximal end and a distal end, wherein the proximal end of the secondary wrap is connected to the distal end of the main wrap, and at least one bladder is formed within the connected main and secondary wraps. The therapeutic compression device further comprises an inflation source capable of inflating at least one bladder to a pressure amount of a plurality of set mmHg values, wherein the inflation source is connected to at least one bladder via a single inflation port on the main wrap and forms a sealed system configured to prevent over-inflation of at least one bladder.

Description

Technical Field

[0001] (Related Application) This application claims priority from Provisional Application No. 62 / 378,581, filed Aug. 23, 2016, and from co-pending applications, and this PCT application is a continuation-in-part of U.S. Patent Application No. 13 / 444,600, which is a divisional of U.S. Patent Application No. 12 / 855,185, filed Aug. 12, 2010, and issued as U.S. Patent No. 9,033,906, the entire contents of which are incorporated herein by reference for all purposes.

[0002] (Background of the Invention) The present invention generally relates to devices for applying compression to the limbs, and more particularly to a therapeutic device for applying compression to a person's legs in conjunction with the treatment of conditions such as chronic venous insufficiency and lymphedema. The device includes a bladder having a device for applying compression to a limb such as the patient's calf and foot, and a wrap having an inflation means for the bladder.

Background Art

[0003] Normally, healthy leg muscles help return blood to the heart when, for example, squeezing the deep veins of the legs and feet. One-way valves in the deep leg veins maintain the circulation of blood towards the heart. However, standing or sitting for long periods can cause stretching of the walls of the deep leg veins. Over time, in individuals with no resistance, this can weaken the vein walls, damage the valves, cause blood to pool in the veins, and increase the blood pressure in the veins. This results in a condition known as chronic venous insufficiency (CVI).

[0004] Treatment for chronic venous edema (CVI) typically involves the use of compression stockings or medical socks to reduce chronic swelling. Compression stockings are elastic stockings that compress the veins to improve venous circulation and prevent excess blood from flowing backward. Compression stockings can also help heal skin ulcers or congestive ulcers that often occur in conjunction with CVI. In addition, compression stockings are commonly used with compression bandages to apply pressure to the legs. In this context, the bandages apply constant tension, creating graduated compression with the highest pressure at the ankle. However, the technique is difficult and is often performed by highly skilled caregivers.

[0005] Highly effective mechanical compression devices have also been developed to treat CVI, disclosed, for example, in U.S. Patents No. 7,276,037 and No. 7,559,908, the entirety of which is incorporated herein by reference. These devices include a flexible wrap carrying a manually inflatable air bladder and are adapted to be fixedly positioned around an individual's leg to apply localized pressure to the treatment site. The device also includes a fluid-filled wound dressing, which is applied directly to the skin to apply localized pressure, and furthermore, medication can be applied to the venous ulcer when the wound dressing is wrapped in the flexible wrap. While the device is effective for applying localized compression to the leg, it is not configured to apply localized compression to the foot to prevent swelling and further improve venous circulation.

[0006] Lymphedema, also known as lymphatic occlusion, is another condition of localized fluid retention and tissue swelling, caused by an immunocompromised lymphatic system. Treatment for lymphedema varies depending on the severity of the edema and the degree of fibrosis in the affected limb. The most common treatments for lymphedema are manual compression lymphatic massage, compression garments, or bandaging. Elastic compression garments are typically worn by people with lymphedema on the affected limb, following treatment with a perfect decongestant effect to maintain edema reduction.

[0007] Compression bandaging, also known as wrapping, requires the application of several layers of packing and short elastic bandages to the affected area. The short elastic bandages are preferably placed over the long elastic bandages (such as those typically used to treat sprains) because the long elastic bandages cannot generate the appropriate therapeutic tension necessary to safely reduce lymphedema and, in practice, do not provide an improved tourniquet effect. During activity, whether exercise or daily activities, the short elastic bandages enhance the pumping action of the lymphatic vessels by increasing the rebound force they exert. This helps to promote lymphatic fluid flow and soften the fluid-expanded area.

[0008] Known methods for treating CVI and lymphedema, such as compression bandaging, have several drawbacks. Bandaging is time-consuming, and its effectiveness is limited by the skill of the provider. In some cases, bandages may be applied too tightly or too loosely, causing them to slip out of their intended position and reducing their effectiveness. When this occurs, the bandages must be removed and reapplied, further prolonging the application time and compromising the consistency of treatment application.

[0009] The effectiveness of many current compression therapies is limited by the application of the current products. Because current compression therapies are performed either manually or with electromechanical systems, these therapies either require application by a skilled medical professional and / or require the patient to remain still for an extended period. Stockings and / or bandages can be put on and self-administered by the patient, but it is extremely difficult for them to put them on and for inexperienced medical professionals to apply them consistently and effectively.

[0010] Furthermore, many current treatment options for CVI and lymphedema, including the use of currently known devices, apparatus, bandages, stockings, socks, etc., can cause venous ulcers. A venous ulcer is a lesion and loss of skin above the ankle, which is a result of problems related to the veins in the leg. Venous ulcers typically develop on the side of the lower leg, above the ankle, and below the calf. They are difficult to heal and often recur.

[0011] The veins in the legs are divided into superficial and deep systems, depending on their location relative to the fascia. The deep veins, together forming the popliteal and femoral veins, are located within the fascia and are responsible for venous return from the leg muscles. Broad, valveless sinusoidal vessels are also located within the fascia (more specifically, within the soleus and gastrocnemius muscles). These sinusoidal vessels are filled with blood when the legs are at rest.

[0012] The great saphenous vein, which extends along the inner side of the leg from the foot to the groin, and the small saphenous vein, which extends along the posterior part of the calf from the foot to the knee, are the major vessels of the superficial venous system. These vessels are located outside the fascia and play a role in venous return from the epidermis and subcutaneous fat.

[0013] Communicating veins, sometimes called perforating branches because they puncture the deep fascia, connect two systems. Like other veins in the leg, perforating branches contain valves that allow blood to flow in only one direction, either laterally or medially from the superficial system to the deep veins.

[0014] The venous pressure at the ankle of a subject lying supine is approximately 10 mmHg, but in an upright position, this venous pressure will increase significantly due to the increase in hydrostatic pressure (equivalent to the weight of the vertical column of blood from the measurement point to the right atrial appendage of the heart).

[0015] During walking, the foot is flexed dorsally, causing the calf muscles to contract, compressing the deep veins and soleus sinus, thereby emptying them of blood. When the foot is flexed at the sole, the pressure within the veins decreases, the proximal valves close, and the veins are refilled with blood passing through the perforating branches from the superficial system. During this cycle, in a normal leg, the distal valves of the deep veins and the valves of the perforating branches ensure that the released blood can only move upward in one direction, ensuring return to the heart.

[0016] Occlusion or damage to the venous system disrupts normal blood flow, and this disruption can manifest in many different ways depending on the location and extent of the damage. If valves in the superficial system are affected, venous return is impaired, food accumulates in the veins, the valves swell, and this can lead to the formation of varicose veins (abnormally swollen veins).

[0017] If the function of the perforating valves is impaired, the gastrointestinal pump tends to cause blood to flow in the reverse direction, i.e., into the superficial system, increasing the likelihood of damage to superficial blood vessels.

[0018] Following deep vein thrombosis resulting in complete or partial occlusion of deep veins, the unchanging pressure generated by the calf muscle pump over the perforating valves can cause these superficial vessels to become dysfunctional. When this occurs, a significant increase in pressure occurs within the superficial system, potentially pushing proteins and red blood cells out of the capillaries and into the surrounding tissue. Here, the red blood cells degrade, releasing red pigments that produce skin staining, i.e., a precursor indicator of possible ulcer formation.

[0019] Venous leg ulcers are usually superficial and red in color. The skin surrounding the ulcer is often discolored due to the aforementioned staining. Dysfunctioning perforating venous valves can also dilate the malleolar veins, appearing as fine red lines around the ankle. This condition is called ankle inflammation and is also a sign of venous ulcers.

[0020] Arteries transport oxygenated blood from the heart to other parts of the body. Veins return deoxygenated blood to the heart. When the veins in the lower extremities have difficulty returning blood to the heart, it is called chronic venous insufficiency (CVI), and symptoms known as chronic venous disease (CVD) develop. CVI usually occurs as a result of blood clots in the deep veins of the legs and is a condition known as deep vein thrombosis (DVT). CVI can also be caused by pelvic tumors and vascular malformations, and in some cases, the cause is unknown. When a person is standing or sitting, blood in the veins of the legs flows upward. When a person is walking, the calf muscles and other muscles in the feet contract to compress the veins, pushing blood upward. To keep the blood flowing upward and prevent it from flowing downward, veins house one-way valves. CVI occurs when these valves are damaged, causing blood to flow backward downwards. Such valve damage can result from aging, prolonged sitting or standing, or a combination of aging and reduced mobility. When veins and valves weaken and blood does not flow properly to the heart, blood pressure in the veins of the lower extremities remains high for extended periods, leading to CVI. This condition is more common in older adults and, if left untreated, can lead to capillary rupture, localized tissue inflammation, internal tissue damage, varicose veins, ulcers, and superficial skin wounds.

[0021] CVI can reduce the capacity of the venous system and increase the burden on the lymphatic system within the affected area. The lymphatic system then needs to transport larger volumes of water and protein to reduce the fluid load in the affected tissues of the legs, a particularly difficult situation for patients with lymphedema, varicose veins, and other lower limb lesions.

[0022] One non-surgical option often used to help prevent or treat the aforementioned lower limb lesions is the use of compression stockings. Compression stockings help prevent leg fatigue, ankle and foot swelling, spider veins, and varicose veins. They improve blood circulation in the legs, especially when used in conjunction with regular exercise and leg elevation. Compression stockings maintain pressure on the legs while allowing normal walking. Increasing pressure in the tissues beneath the skin reduces excess fluid leakage from capillaries and increases the absorption of tissue fluid by capillaries and lymphatic vessels. Furthermore, the increased pressure reduces the size of the veins, thereby helping blood flow faster and preventing blood pooling.

[0023] The airtightness of compression stockings typically varies between 15 and 50 minutes of HG. The airtightness of a given stocking depends on its specific composition and class. For example, stockings with a compression pressure of 15-20 minutes of HG are considered light compression stockings. Class-1 stockings have a compression pressure of 20-30 mmHg, Class II stockings 30-40 mmHg, and Class III stockings 40-50 mmHg.

[0024] While compression stockings are a commonly used non-invasive treatment for lower leg lesions, they present numerous challenges. Wearing tightly fitting stockings can be cumbersome or time-consuming, and may require assistance from another person if the wearer is injured, elderly, or has some form of disability. Furthermore, the pressure applied by the stockings remains relatively constant during use, unless any option is chosen regarding increases or decreases in airtightness. Because compression stockings are worn repeatedly, they lose their elasticity and therefore their airtightness over time. Once this loss of elasticity and airtightness occurs, the stockings become little or no value and need to be replaced due to their looseness, requiring the purchase of a new pair to achieve the desired compression.

[0025] Medical stockings represent a useful and convenient method of applying compression to a leg of normal shape to prevent the onset or recurrence of leg ulcers. However, these stockings have limited evaluation in the treatment of active ulcer formation and are difficult to apply over dressings. In such situations, compression bandages currently represent the treatment of choice. Compression bandages apply pressure to the limb, and this pressure is directly proportional to the bandage tension but inversely proportional to the radius of curvature of the limb to which the pressure is applied. Therefore, this means that a bandage applied with constant tension to a limb of normal proportion automatically creates graduated compression with the highest pressure at the ankle. This pressure gradually decreases down the leg as it increases towards the periphery.

[0026] As can be easily understood, applying uniform tension to a compression bandage when it is applied to the limb being treated is complicated and difficult, and therefore can only be achieved by a highly skilled caregiver. Furthermore, once the bandage is secured to the limb being treated, care and attention must be taken to ensure that it does not slip or come off as it subsequently forms multiple layers, which can lead to localized areas of high pressure and potentially expose the patient to a direct risk of skin necrosis.

[0027] Mechanical compression therapy has also been proposed. A typical compression device is described in U.S. Patent No. 5,031,604 by Dye. Generally, an arrangement of a chamber surrounding the leg is provided, as described in reference to column 2, line 33 et seq. An active pneumatically driven control system controls the pressure within the chamber to compress the leg near the ankle, and then sequentially compress upward toward the knee to move blood from the limb toward the heart. As described in column 4, lines 20-59 of U.S. Patent No. 6,488,643 by Tumey et al., mechanically generated compression levels can cause ischemic effects (i.e., localized tissue anemia) not described by similar compression levels obtained through bandaging. It can also cause cellular infiltration (i.e., a decrease in pulsating blood flow in the leg). Furthermore, pneumatically driven control systems are bulky and heavy, significantly limiting the movement of the patient during treatment. Furthermore, the pneumatically driven control system lacks a mechanism to ensure that excessive pressure, which could cause necrosis, is not applied to the treated limb. These limitations have made most mechanical compression devices unsuitable for patients with deep vein thrombosis. Consequently, those skilled in the art have avoided using such mechanical compression devices for the treatment of venous ulcers or edema in the limbs until now.

[0028] The commonly-owned U.S. Patent Publication No. 2004 / 0193084, which is hereby incorporated by reference in its entirety, discloses a device for applying pressure to a human leg for use in conjunction with the treatment of varicose veins. The device includes a flexible member and at least one air bladder chamber integrated with the member and adapted to tightly wrap around a human leg. A tube in fluid communication with the air bladder chamber(s) extends to a pneumatic pumping mechanism that operates to inflate the air bladder chamber(s) to a pressurized state. The flexible member preferably includes an opening at the knee joint level through which the patella can protrude. Further, the flexible member preferably extends below the knee joint level and is adapted to tightly wrap around the lower portion of the leg to provide stability to the leg. The air bladder chamber of the device preferably has a first dimension that is substantially longer than a second dimension orthogonal thereto, such that the air bladder chamber can be positioned to cover a portion of the human leg that is relatively long in the direction of the vertical dimension and narrow in the direction of the horizontal dimension.

[0029] The commonly owned U.S. Patent No. 7,276,037, which is hereby incorporated by reference in its entirety, discloses an apparatus for applying compressive therapy to the distal end of a human body, such as a part of a human leg. This device includes a flexible member and an air bladder chamber. The flexible member is adapted to be wrapped around the distal end to secure the air bladder chamber to the distal end. The air pumping mechanism is operated to inflate the air bladder chamber to a pressurized state. One or more fluid-filled pressurizing members are provided, each member being separate and distinct from the flexible member and the air bladder chamber, and thus being easily movable relative to the flexible member and the air bladder chamber. The pressurizing member(s) are operatively disposed between the distal end and the flexible member, and there, during use, the pressurizing member applies an increasing localized pressure to the distal end. The air bladder chamber preferably has a first dimension that is substantially longer than a second dimension perpendicular thereto, such that the air bladder chamber can extend longitudinally along the distal end so as to cover a relatively long and narrow portion of the distal end. The position of the air chamber can be easily adapted to apply local pressure to a desired body part, such as a particular vein channel. The pressurizing member(s) can be positioned during use, such that, as a result, the pressurizing member covers a venous ulcer (or other treatment site) and applies an increased localized pressure to the treatment site to promote treatment.

[0030] All currently known treatment devices, devices, bandages, stockings, and socks have problems regarding stability, maintenance of sufficient effective pressure without overpressure complications, maintenance of compression, etc. Further, all currently known treatment devices, devices, bandages, stockings, and socks, particularly current treatment devices and devices, can only be connected to one source of compression or inflation means, and a universal inflation port for a connector is not known, and in that regard, a patient cannot change the treatment by changing the inflation source and inflation means for the treatment device or device.

[0031] Other known problems with current therapeutic devices, bandages, stockings, and socks include the need for skilled caregivers to operate them. Such skilled caregivers are not always available for all patients, particularly those without long-term care insurance or those for whom skilled home care is not provided. Yet another known problem is leakage of set compression within therapeutic devices, resulting in ineffective treatment and ineffective devices or equipment that may be provided without benefit to the patient and user. Further problems with current therapeutic devices, bandages, stockings, and socks include their inflexibility, as the inflation means or compression source may be set manually, mechanically, or electrically, and the inflation port or inflation means may not be universal and interchangeable. Yet another problem with current therapeutic devices, bandages, stockings, and socks is that the inflation means or source may be static or intermittent, and such devices cannot be changed again during treatment.

[0032] The apparatus, methods, assemblies, and systems of the present invention offer benefits and advantages that can overcome many of the problems with known compression techniques, particularly those arising from the difficulties in applying current compression wrap techniques. The present invention provides an alternative to known techniques that employ rigidly fixed therapeutic elastic garments that cause discomfort to the patient and lose their elasticity, i.e., their effectiveness over time. Those skilled in the art will readily understand that it would be beneficial to provide therapeutic compression devices for treating CVI, DVT, and lymphedema that are adapted and configured to apply localized compression to the legs and feet to prevent swelling and further improve venous circulation, and that can be effectively self-managed by the patient. [Overview of the project]

[0033] The present invention relates to a therapeutic compression device. This therapeutic compression device comprises a main wrap and a secondary wrap, and optionally a stirrup. The main wrap surrounds at least a first portion of an limb, such as a leg, and applies compression thereto. The main wrap has a horizontal proximal edge for positioning toward, for example, the knee of the leg, a horizontal distal edge for positioning toward, for example, the ankle of the leg, and first and second peripheral edges perpendicular to the horizontal proximal and horizontal distal edges. The secondary wrap surrounds at least a portion of an limb, such as the foot of the leg, and applies compression thereto. The stirrup is integrated with the main wrap along the horizontal distal edge to secure the main wrap to the limb, such as the leg, and the stirrup is positioned between the main wrap and the secondary wrap.

[0034] A therapeutic compression device may further comprise at least one bladder operably associated with a main wrap for applying pressure to a treatment site on a limb, such as a leg. The main wrap may include at least one internal pocket for housing at least one bladder. Alternatively, at least one bladder may be integrated with the main wrap. One or more means for attaching the main wrap may be operably associated along first and second peripheral edges of the main wrap for securing the main wrap around a limb.

[0035] At least one bladder may be fitted and configured to form a predetermined gradient pressure profile when at least one bladder is filled. The at least one bladder may be a wedge-shaped bladder, a conical bladder, a disc-shaped bladder, or a rectangular bladder. The at least one bladder may also include a plurality of fluid chambers. The therapeutic compression device may further include at least one means for regulating the pressure coupled to at least one bladder in order to control the amount of pressure supplied to the treatment site by the main wrap.

[0036] The auxiliary wrap can be attached to the stirrup. The auxiliary wrap may be configured to wrap around the limbs of the foot, such as the toes, and / or around the heel of the foot. The auxiliary wrap may also be configured as an adjustable strap around the foot.

[0037] The therapeutic compression device may further include an adjustable belt along the proximal horizontal edge of the main wrap to secure the main wrap around an limb, such as a leg. The main wrap may be formed from at least a portion of an inelastic composite material comprising several distinct layers. In one embodiment, the composite material may include three distinct layers: an inner laminate layer, an outer hook-fitting layer, and an intermediate inelastic layer provided between the inner and outer layers. The composite material may also be provided with several sewn-in darts and gathers to contour the main wrap around an limb, such as a leg.

[0038] The present invention also covers a bladder assembly for a compression device for providing pressure to a limb. The bladder assembly includes at least one bladder having first and second flexible walls fixed to each other around a peripheral edge to form an air pocket, and at least one spot weld located deep within the peripheral edge connecting to each other with the first and second walls to define a plurality of chambers within the bladder. The geometric arrangement of the at least one spot weld determines the pressure profile of the at least one bladder.

[0039] Inflation means for inflating a bladder, such as an air pocket, through at least one inflation port may be provided within a first wall of the bladder assembly. The inflation means may be detachable from at least one inflation port. At least one pressure valve may be operably associated with the inflation means for controlling the amount of pressure in the bladder and the air pocket in the bladder. The inflation port includes a check valve to maintain a given pressure in the bladder of the therapeutic compression device. The inflation port may be versatile in that it is configured to be connectable to and accommodating multiple inflation sources and inflation means, such as manual pumps, mechanical pumps, electric pumps, battery-operated pumps, static pumps, intermittent pumps, pneumatic pumps, negative pressure sources, and other deformables.

[0040] The present invention includes a therapeutic treatment device used to treat CVI, DVT and / or lymphedema by applying primary and secondary wraps by a patient around a limb, inserting an inflation means into an inflation port, inflating bladder within the primary and secondary wraps, and maintaining a specific pressure to treat CVI, DVT and / or lymphedema.

[0041] Another embodiment of the present invention includes an assembly according to the present invention, which includes a pressure mechanism having a flexible member for attachment to a limb and an air chamber that can be pressurized to a desired pressurized state; a separate, relatively small pre-filled air bladder; an absorbent foam, sponge, or dressing material coupled to the pre-filled air bladder; and a suction conduit coupled to a negative pressure source (suction) and in fluid communication with the absorbent foam, sponge, or dressing material. In a preferred embodiment, the pre-filled air bladder, absorbent foam, sponge, or dressing material and the suction conduit are formed together as a unit.

[0042] According to one aspect of the present invention, the flexible member of the pressure mechanism is adapted to wrap around the leg or arm and over the pre-filled air bladder to secure the pre-filled air bladder and foam, sponge, or dressing material to a wound or ulcer within the toe. Thus, the flexible member is provided together with some fixing structure, such as a face-fastening mechanism. The pneumatic feeding mechanism is preferably coupled to the air chamber of the pressure mechanism to inflate the air chamber to a pressurized state. The air chamber of the pressure mechanism is preferably designed to apply pressure along a predetermined area (e.g., the saphenous vein of the leg) as opposed to around the entire limb.

[0043] According to another aspect of the present invention, the suction conduit is placed between a pre-filled air bladder and an absorbent foam, sponge, or dressing material bonded to a smaller air bladder, or the pre-filled air bladder is formed as a donut with a central opening, and the suction conduit extends through the central opening. By connecting the suction conduit to a negative pressure source, exudate from the wound or ulcer is drawn into the suction conduit through the foam, sponge, or dressing material.

[0044] One method of the present invention includes placing a pre-filled air bladder and a foam, sponge, or dressing material over a limb-like wound or ulcer; wrapping a flexible member of a pressure mechanism around the limb together with an air chamber placed on the pre-filled air bladder / absorbent foam, sponge, or dressing material; and fastening the pneumatic pressure mechanism using a fixing structure. Once the device is properly positioned and attached to the limb, the air chamber inflates to preferably 30-40 mmHg, thereby applying pressure to the limb, more specifically, the wound through the pre-filled air bladder. The suction device is activated by turning on a negative pressure source, drawing exudate from the wound or ulcer through the absorbent foam, sponge, or dressing material into a suction conduit.

[0045] Another embodiment of the present invention includes a device for applying intermittent pressure to a portion of the human body, such as a region of the human leg, which assists in the healing and treatment of various conditions, such as venous ulcers or wounds, by promoting blood flow and increasing drainage within and outside the region. The device includes a foot bladder and a leg bladder, each bladder having an inflatable chamber for containing fluid that enters by expansion. The bladders are fluid-coupled by fluid conduits, and each bladder is preferably equipped with means for positioning it over a portion of the human body. In a preferred embodiment, the foot bladder is positioned at the bottom of the foot, and the leg bladder is positioned above the lower part of the leg. When a person walks while wearing the device, the person's foot (heel) strikes the ground due to the external pressure positioned on the foot bladder, causing a portion of the foot bladder to expand, thereby pushing fluid from the foot bladder through the fluid conduit to the leg bladder and increasing the pressure within the leg bladder. As a person's foot rotates from heel to toe during a standard walking motion, the external pressure from the person's weight is removed from the foot bladder, resulting in a higher pressure in the leg bladder than in the foot bladder. In this way, the fluid returns to the foot bladder through the fluid conduit and then expands back to its original state, resulting in equalization of the pressure in both the foot and leg bladder. This process is repeated when a person walks, creating a pumping or kneading force on the leg as the pressure in the leg bladder intermittently increases and decreases, thereby promoting blood flow, fluid drainage, treatment, and healing to various parts of the leg.

[0046] These and other related aspects of the present invention will become more readily apparent from the following description, which will be read in conjunction with the drawings. [Brief explanation of the drawing]

[0047] Preferred embodiments of the present invention will be described in detail below with reference to the drawings, so that those skilled in the art to which the present invention belongs may more easily understand how to manufacture and use the apparatus of the present invention.

[0048] [Figure 1]This is a perspective view of one embodiment of the present invention, which includes a therapeutic compression device, the therapeutic compression device is wrapped around the right leg and foot of the user, having both a stirrup at the base of the foot and an adjustable strap below the knee, the device having a pocket (shown by a hidden line) provided on the inner surface of the main wrap for securing a fluid bladder, the bladder being provided together with a removable air pump and pressure gauge, and the main and sub-wraps being separated from each other. [Figure 2A] Figure 1 is a perspective view of the therapeutic compression device, in which the main and secondary wraps are illustrated in an unwrapped state, the inner surface of the wraps is shown, and the secondary wrap is shown as being integrated with the stirrup. [Figure 2B] Figure 1 is a perspective view of the therapeutic compression device, in which the main wrap and secondary wrap are illustrated in an unwrapped state, the inner surface of the main wrap is shown to have a bladder within the pocket of the main wrap, and the secondary wrap is shown to be integrated with the stirrup. [Figure 3] This is a front view of the upper outer surface of the main wrap according to the present invention, which has numerous sewn darts and gathers outlined around the leg, and the main wrap is illustrated to show most of the outer surface of the main wrap. [Figure 4] Figure 3 is a cross-sectional view cut along line 12'-12' illustrating the main lap composite material of the present invention, which has three distinct layers. [Figure 5] This is a disassembled and assembled perspective view of a bladder according to the present invention, the bladder having multiple spot welds, a pressure gauge, and an air pump, which is also illustrated as being separated from the bladder. [Figure 6A] This is a side view of the inflated bladder in the inflated state shown in Figure 5. [Figure 6B] This is a cross-sectional view cut along line 36'-36', illustrating how spot welds, positioned to maximize their effectiveness within the bladder, join the upper and lower walls of the bladder to form the desired gradient profile. [Figure 7]These are cross-sectional views of a wedge-shaped bladder in a non-expanded state (left) and an expanded state (right). [Figure 8] These are cross-sectional views of a conical bladder in its non-expanded state (left) and in its expanded state (right). [Figure 9] These are cross-sectional views of the disc-shaped bladder in the non-expanded state (left) and the expanded state (right). [Figure 10] These are cross-sectional views of a rectangular bladder in its non-expanded state (left) and in its expanded state (right). [Figure 11] This is a top view of another typical embodiment of the present invention, including a therapeutic compression device configured according to the present invention, showing the layout of through-holes, heel pads, and ankle pads throughout the compression garment as viewed from the inside of the garment. [Figure 12] Figure 11 is a bottom view of the therapeutic compression device, showing the welding pattern for connecting the outer sheet to the inner sheet, which defines the bladder within the inner and outer sheets when viewed from the outside of the garment. [Figure 13] Figure 11 is a disassembled and assembled perspective view of the therapeutic compression device, showing the layout of the outer sheet, inner sheet, and face fasteners. [Figure 14] This is a detailed cross-sectional view of a therapeutic compression device, cut along line 4-4 in Figure 11, illustrating a leg compression bladder in a contracted state. [Figure 15] This is a detailed cross-sectional view of a therapeutic compression device, cut along line 4-4 in Figure 11, illustrating a leg compression bladder in an inflated state. [Figure 16] These are frontal perspective and medial perspective views, respectively, of the therapeutic compression device shown in Figure 11, worn on the lower leg. [Figure 17] These are frontal perspective and medial perspective views, respectively, of the therapeutic compression device shown in Figure 11, worn on the lower leg. [Figure 18] This is a detailed cross-sectional view of a therapeutic compression device, cut along line 8-8 in Figure 17, illustrating a leg compression bladder in an inflated state. [Figure 19] This is a perspective view of another embodiment of the present invention, including an assembly according to the present invention. [Figure 20A]Figure 19 is an isometric view of the compression mechanism according to the present invention, showing the mechanism in a state where it is not wrapped.

[0049] [Figure 20B] This is an isometric view of an alternative compression mechanism according to the present invention, showing the mechanism in an unwound state. [Figure 21A] Figure 19 shows another embodiment of the compression mechanism according to the present invention, which is intended to be wrapped around the lower leg to apply localized pressure to the lower leg near the small saphenous vein, and is shown in its unwrapped state with its body contact surface facing outwards on this page. [Figure 21B] Figure 19 shows another embodiment of the compression mechanism according to the present invention, which is intended to be wrapped around the upper leg (e.g., thigh) to apply localized pressure to the upper leg near the great saphenous vein, and is shown in its unwrapped state with its body contact surface facing outwards on this page. [Figure 22] This is a perspective exploded view of an embodiment of a unit comprising a pre-filled air bladder, absorbent foam, sponge, or dressing material, and a suction conduit, where the suction conduit extends to the center of the unit. [Figure 23A] This is a perspective view of a unit with straps for securing the unit in place. [Figure 23B] This is a perspective view of a unit with straps for securing the unit in place. [Figure 24] This is a schematic diagram of another embodiment of the present invention, which includes a compression device of the present invention in which the leg bladder and foot bladder are fluidly connected by a fluid conduit. [Figure 25A] Figure 24 is a perspective view of the leg bladder. [Figure 25B] Figure 25A is a top view of the leg bladder. [Figure 25C] Figure 25A is a side cross-sectional view of the leg bladder. [Figure 26] This is a side view of another embodiment of the foot bladder shown in Figure 24, which is fixed to the heel of the foot. [Figure 27] This is a side view of another embodiment of the present invention, showing a foot bladder positioned above the heel of the foot and a leg bladder positioned around the lower part of the leg. [Figure 28A] This is a perspective view of the present invention showing the foot and leg bladder, fluid conduit, a one-way valve connected to the fluid conduit, and a flexible member wrapped around the leg. [Figure 28B] Figure 28A is a partially cut perspective view of the flexible member wrapped around a leg, which has a leg bladder sandwiched between the leg and the flexible member. [Figure 29A] This is a schematic diagram of another embodiment of the present invention relating to a therapeutic compression device including a valve for an inflation means or source that can be coupled to the compression device. [Figure 29B] Figure 29A is an exploded assembly diagram of an embodiment of the present invention relating to a therapeutic compression device. [Figure 30A] Figure 29 is an enlarged view of the valve mechanism of the compression device. [Figure 30B] Figure 29 is an enlarged view of the valve mechanism of the compression device. [Figure 31A] This is one embodiment of the pump of the present invention for a therapeutic compression device. [Figure 31B] Figure 31A is a side view of an embodiment of the pump of the present invention for a therapeutic compression device.

[0050] [Figure 31C] Figure 31A is a top view of an embodiment of the pump of the present invention for a therapeutic compression device. [Figure 32A] This is another embodiment of the pump of the present invention for a therapeutic compression device. [Figure 32B] Figure 32A is a close-up of the check valve in an embodiment of the pump of the present invention for a therapeutic compression device. [Figure 33] This is another embodiment of the pump of the present invention for a therapeutic compression device. [Figure 34] Figure 33 is an internal cross-sectional view of an embodiment of the pump of the present invention for a therapeutic compression device. [Figure 35]This is an internal cross-sectional view of another embodiment of the pump of the present invention for a therapeutic compression device. [Figure 36] This is an internal cross-sectional view of another embodiment of the pump of the present invention for a therapeutic compression device. [Figure 37] This is another embodiment of the present invention of a compression device for treating the arm. [Figure 38] Another embodiment of the present invention relates to a therapeutic compression device for the arm, in which two separate therapeutic compression devices are joined by a selectable tab. [Figure 39] This is a schematic diagram of another embodiment of the present invention of a therapeutic compression device including an electric inflation mechanism. [Figure 40] Figure 39 shows an embodiment of a therapeutic compression device including an electric inflation mechanism. [Modes for carrying out the invention]

[0051] Preferred embodiments of the present invention are described below with reference to the accompanying drawings, where similar reference numerals represent the same or similar elements. Those skilled in the art will understand that although the devices discussed herein relate to compression therapy of the legs and feet, the scope of the present invention is not limited to these typical applications and can be sized and shaped to suit anatomical parts where compression therapy is required.

[0052] The present invention provides a simpler and more convenient method than current systems for compressing a patient's limb, including, for example, the lower leg and foot, or the extremities including the arm and hand. Any limb or body part may be compressed by an immediate therapeutic compression device, such as the foot, calf, thigh, knee, leg, buttocks, hip, torso, ribs, shoulder, arm, hand, fingers, neck, head, etc.

[0053] The present invention provides a system for preventing swelling of limbs, such as the feet, using an inelastic binder and a bladder that can be used to provide and apply compression. The bladder is provided within an inelastic wrap and creates compression in a manner that allows for consistent measurement of the supplied pressure and enables the patient to apply the compression safely, comfortably, conveniently, effectively, and to self.

[0054] Where a range of values ​​is provided, unless explicitly indicated between the upper and lower limits of that range, it is understood that each intermediate value between the upper and lower limits of that range and any other descriptive or intervening value within which the described range is encompassed in the present invention shall be one-tenth of the lower limit unit. These smaller upper and lower limits may independently be included in smaller ranges and also encompassed in the present invention, and apply to any specifically excluded limits within the described range. If a described range includes one or both of the limits, a range excluding either of those included limits is also included in the present invention.

[0055] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art. Any methods and materials similar to or equivalent to those described herein may also be used in carrying out or testing the present invention, but typical methods and materials will be described below. All publications referenced herein are incorporated herein by reference and disclose and describe the methods and / or materials related thereto.

[0056] When used herein and in the appended claims, the singular forms "a," "an," and "the" refer to multiple objects unless the context explicitly indicates otherwise. For example, a reference to "stimulus" refers to multiple such stimuli, and a reference to "signal" refers to one or more signals and their equivalents that are known to those skilled in the art.

[0057] The publications discussed herein are provided only for their disclosures prior to the filing date of this application. Nothing in this specification should be construed as acknowledging that the present invention does not have prior rights to such publications due to prior inventions. Furthermore, the dates of the publications provided may differ from the dates of the actual publications, which may need to be independently verified.

[0058] Referring here to Figure 1, a typical embodiment of the therapeutic compression device 10 according to the present invention is illustrated, showing the outer surface 11 of the main wrap 12 of the therapeutic compression device 10 wrapped around the right leg of a patient. In this embodiment, the therapeutic compression device 10 is adapted and configured to provide compression to the patient's lower leg 2 and foot 6. The therapeutic compression device 10 consists of a main wrap 12 that wraps around the lower leg 2 and can be used to apply compression to the lower leg 2. The main wrap 12 has an associated bladder 22 provided on the inner surface 9 of the main wrap 12. As shown in Figure 1, the main wrap 12 wraps around the lower leg 2, and when the bladder 22 is tilled or inflated, compression is applied to the desired therapeutic location. In particular, the main wrap 12 is made of an inelastic material that allows for increased localized compression of the treatment site. The therapeutic compression device 10 also includes either a permanent or removable pressure gauge 28 that can be removed at an inlet or inflation port 24. Pump 30 is provided for manually pumping air into the bladder 22 through tube 26. Other inflation means that outperform the manual pump may be used. Additional features of the main wrap 12, the secondary wrap 14, and the bladder 22 will be described in turn herein.

[0059] The main wrap 12 may be attached to a patient's limb, such as the lower leg 2, by, for example, wrapping the wrap around the lower leg 2 and attaching it to the peripheral edges 5 and 7 using any number of connecting structures. The main wrap can be secured around the lower leg 2 by connecting hook-and-loop fastener tabs such as 32a, 32b, 32c, and 32d, as illustrated in Figures 1 and 2A to 2B, to connect the peripheral edges 5 and 7 on the opposite side of the main wrap 12. Alternatively, the main wrap 12 may also be attached around a patient's limb using hook-and-loop fastener tabs, buckles, straps, snaps, or other known structures to fasten the main wrap 12 to itself. The number and position of the connecting tabs 32a, 32b, 32c, and 32d can be selected based on the anatomical location of the patient's treatment site so that the main wrap 12 is secured without tangling or sagging of the main wrap 12 material and without causing discomfort to the patient.

[0060] In this example, a selectable garter or adjustable belt 18 is provided at the horizontal proximal end 1 of the main wrap 12 toward the knee 8 to further secure the main wrap 12 around the lower leg 2. The adjustable belt 18 can be attached around the leg 2 using connecting tabs, buckles, or other known connecting structures. As shown in Figure 3, the main wrap 12 is also manufactured together with a number of sewn-in darts 50 and gathers 52 that are strategically placed to contour the main wrap 12 around the specific limb being treated.

[0061] The main wrap 12 is preferably made of a composite material that is inelastic and has one or more core material layers, because the material is inelastic, so the main wrap 12 remains rigid and does not stretch, for example, when the bladder 22 is filled or expanded. Referring to Figure 4, the composite material of the main wrap 12 has three separate layers 12a, 12b, and 12c, as shown in the figure. The inner layer 12a is in contact with the patient's skin and includes an inner surface 9 which is inelastic and preferably made of a core material, a non-hook-fastener compatible material. The core material of this inner layer 12a is characterized by its ability to remove sweat and other unwanted moisture from the limb being treated. The non-hook-fastener compatible nature of the inner layer 12a is desirable because, for example, if hook-fastener tabs are used, the main wrap 12 does not get caught on the connecting tabs 32a, 32b, 32c, 32d. Furthermore, the non-hooking material to the patient's skin also reduces inflammation that may arise from hooking materials. The outer layer 12c has at least a portion that is hook-compatible so that connecting tabs 32a, 32b, 32c, and 32d are secured to the peripheral edge of the main wrap 12 around the limb. The bottom surface of the outer layer 12c is the outer surface 11 of the main wrap 12 and is also non-elastic and breathable. The inner layer 12b, positioned between the inner layer 12a and the outer layer 12c, is usually made of a breathable laminated material.

[0062] Referring to Figures 2A and 2B, the stirrup 16 is also provided in this example to help secure the main wrap 12 in place around the limb, which is the base of the foot 6. As is best seen in Figure 1, the stirrup 16 in this embodiment surrounds a portion of the foot 2 and is connected to the horizontal distal edge 3 of the main wrap 12 at two points on either side of the main wrap 12 near the ankle 4. The stirrup 16 is positioned between the main wrap 12 and the secondary wrap 14. As shown in Figures 2A and 2B, the stirrup 16 is typically a single continuous piece of elastic material connected to and integrated with the secondary wrap 14.

[0063] The auxiliary wrap 14 of the therapeutic compression device 10, in this example, surrounds the limb, and the foot 6 can be used both to apply compression to the limb, such as the foot 6, like the main wrap 12, or, as an alternative, as a protective covering for wound healing dressings. The auxiliary wrap 14 helps prevent swelling of the limb, such as the foot 6. Swelling can occur on itself or as a result of compression of the lower leg 2. As shown in Figures 2A-2B, the auxiliary wrap 14 may be made in a continuous piece together with the stirrup 16 if necessary. Alternatively, as shown in Figure 1, the auxiliary wrap 14 may be provided independently of the main wrap 12.

[0064] The secondary wrap 14 is typically formed of an elastic material, but may be formed of an inelastic material, or a combination of the two. The secondary wrap 14 may be a single piece of the material to be connected. Alternatively, the secondary wrap 14 may also be secured around the foot 6, or another limb or body part, by any number of mechanical fastening devices, such as one or more hook-and-loop fastener tabs as shown in Figure 1, or by straps, buckles, snaps, etc. In this embodiment, the secondary wrap 14 provides compression to the foot 6 by retracting and tightening the hook-and-loop fastener tabs, thereby applying pressure around the foot 6.

[0065] The auxiliary wrap 14 can have many configurations depending on the patient's treatment needs. As shown in Figure 1, the auxiliary wrap 14 may be an open-toe design to expose the toes of the patient's foot 6. Alternatively, the auxiliary wrap 14 may be configured as a closed-toe boot. Furthermore, the auxiliary wrap 14 may have an open heel, as shown in Figure 1, or a closed heel similar to a boot (not shown).

[0066] The main wrap 12 provides compression to the patient's limb by inelastically holding at least one bladder 22 around the treatment site. In one embodiment, for example, localized pressure is provided by the therapeutic compression device 10 near the saphenous vein of the lower leg 2. As shown in Figure 2B, the main wrap 12 covers the bladder 22 associated with the main wrap 12. The fluid in the bladder 22 may be a liquid, gas, or gel. The bladder 22 serves to provide compression to the leg 2 when the bladder 22 is filled into the therapeutic compression device 10.

[0067] The bladder 22 may be inserted into one or more pockets 20, which are provided within the main wrap 12 for housing the bladder 22 in the location where compression will be primarily applied. In this embodiment, the bladder 22 is removable from the therapeutic compression device 10. In another embodiment, the bladder 22 is permanently integrated within the main wrap 12 and is not removable (not shown).

[0068] According to the present invention, the bladder 22 may have many additional features for monitoring, setting, and adjusting the pressure required for a desired therapeutic or holistic treatment. In the typical embodiments shown in Figures 1 and 5, the bladder 22 includes a pressure gauge 28. The pressure gauge 28 is a pressure measuring instrument such as a manometer, which measures the pressure difference between the closed pressure applied in the bladder 22 and the open pressure on the other side of the pressure gauge 28. The measured pressure increment depends on the density of the liquid used and the diameter of the piping.

[0069] The pressure gauge 28 operates in conjunction with a fluid or air pump 30 that pumps air into the bladder 22 through the expansion tube 26 at the expansion inlet 24a. The pump 30 may be a manual or electronic pump for supplying air to the bladder 22. An overflow valve 46 may also be provided, together with a one-way valve 48 for releasing air from within the bladder 22, to limit the amount of air that can enter the bladder 22, thereby reducing the pressure within the bladder 22. As shown in Figure 5, the pressure gauge 28 and the pump 30 may be provided detachably from the bladder 22 at the connector 24b.

[0070] In another embodiment, the bladder 22 itself may function as its own pressure gauge, and the expansion of the bladder 22 indicates the amount of pressure inside the bladder 22 as it expands, in this example the pressure of the bladder 22 is pre-calibrated. Alternatively, more than one bladder 22 may be used, or a bladder 22 having multiple chambers may be used, in which the expansion of one or more bladder 22 or bladder chambers may indicate the internal pressure. The present invention typically provides pressure inside the bladder 22 in the range of 20 to 50 mmHg.

[0071] Several different embodiments of the bladder 22 can be used within the therapeutic compression device 10 of the present invention. Figure 5 shows a perspective view of one embodiment of the bladder 22 having a plurality of spot welds 36 according to the present invention. The spot welds 36 are arranged in a predetermined pattern within the bladder 22 to obtain maximum effect based on a desired gradient profile for the compression required at the treatment site of the patient. Figure 6A is a side view of the inflated bladder 22 illustrated in Figure 5, forming an angle with respect to the horizontal axis of the bladder 22. The bladder 22 has a first side wall 21 and a second side wall 23 that are sealed to each other along a peripheral edge seam 25. The spot welds 36 are arranged to obtain maximum effect in joining the first side wall 21 and the second side wall 23 to each other. These spot welds 36 allow the bladder 22 to change its gradient profile and take on many configurations when inflated. The geometric arrangement of spot welds 36 within the bladder 22 increases the expansion of specific portions of the bladder 22, creating one or more fluid chambers within the bladder 22. Figure 6B is a cross-sectional view of the expanded bladder 22 cut along line 36'-36'. When the bladder 22 is used within the main lap 12, as shown in Figure 5, the bladder 22 expands more at one end of the main lap 12 than at the other end, creating a gradient, compression profile. This configuration is particularly useful when compression is needed to improve fluid movement within the body (blood, lymph, etc.).

[0072] In addition to the bladder 22 with spot welds 36 illustrated in Figures 5 and 6B, several other bladder configurations shown in Figures 7 to 10 can be used in the therapeutic compression device 10 of the present invention. Figure 7 is a cross-sectional view of a wedge bladder in an uninflated state 38a (left) and an inflated state 38b (right) that can be used in the therapeutic compression device 10 according to the present invention. The wedge bladder 38b provides a comfortable and efficient gradient profile to the lower leg 2 when inflated and positioned within the main lap 12. When inflated, the wedge bladder 38b has a pyramidal shape, as illustrated in Figure 7. One of the three pyramidal sides is rigid and can prevent the wedge bladder 38b from expanding away from the desired treatment area. Alternatively, the side closest to the treatment area can be attached to or connected to a rigid material positioned within the pocket 20 of the main lap 12 to prevent the wedge bladder 38b from expanding away from the desired treatment area. The wedge-shaped bladder 38b is preferably positioned to accommodate the normal anatomical structure where the ankle 4 is thinner than the lower leg 2. Therefore, when the wedge-shaped bladder 38b is positioned on the leg 2, the thinner portion is positioned toward the knee 8, and the thicker end is positioned toward the ankle 4. Referring to Figure 8, the conical bladder 40b is similar to the wedge-shaped bladder 38b and forms a cone when inflated. The inflated conical bladder 40b is preferably used within the normal anatomical structure where the ankle 4 is thinner than the lower leg 2.

[0073] Referring to Figure 9, cross-sectional views of a disc-shaped bladder are shown in the uninflated state 42a (left) and the inflated state 42b (right). The disc-shaped bladder 42b is formed from two walls and has a disc or dish shape when inflated. The rectangular bladder shown in Figure 10, in the uninflated state 44a (left) and the inflated state 44b (right), offers additional advantages to the disc-shaped bladder 42b. The rectangular bladder 44b is also known as a three-dimensional bladder, which allows compression without bulging or expanding away from the treatment area. The rectangular bladder 44b expands uniformly throughout its length and width. This uniform expansion reduces the bulge that may occur at the center of the disc-shaped bladder 42b shown in Figure 9. The walls of the rectangular bladder 44b can be elastic or inelastic. Alternatively, a combination of both inelastic and elastic walls may be used. One or more portions of the wall of the rectangular bladder 44b may be formed of a rigid material, or may be attached to a rigid material placed within the pocket 20 of the main lap 12 to avoid expansion.

[0074] Referring to Figures 11-13, a typical embodiment of the therapeutic compression device 100 configured according to the present invention shows a compression bladder 102 integrally formed within the therapeutic compression device 100. The therapeutic compression device 100 is configured and fitted to surround a patient's limb, which in this example is the lower leg through the use of a main or primary wrap 103 and a secondary or foot wrap 104 formed outward from a continuous outer sheet 108 and inner sheet 106. The therapeutic compression device 100 is a wrap member having a proximal end portion (upper orientation in Figures 11 and 12) and an opposing distal end portion (bottom orientation in Figures 11 and 12), which is configured and fitted to conform around the patient's lower leg and provide compression through the inflation of the bladder 102. The inner sheet 106 and outer sheet 108 are made from nylon laminated polyurethane sheets configured and fitted to be RF welded together. However, any other suitable material can be used that is weldable or otherwise joined while being airtight. A continuous peripheral weld line 110 forms an airtight boundary of the integrally formed bladder 102. In this typical embodiment, the bladder 102 is a single continuous bladder throughout the main wrap 103 and secondary wrap 104. However, it is conceivable that the secondary wrap 104 may have an independent bladder that is either separately inflatable or inflatable via a one-way valve or other desired inflation / deflation configuration. The secondary wrap 104 may also be configured and adapted to provide different pressures from the lower leg wrap 103. In a typical embodiment, the bladder 102 located within the secondary wrap 104 is configured and adapted to be positioned along the underside of the patient's foot. The bladder 102 within the secondary wrap 104 can be adjusted as desired to provide compression to a desired portion of the patient's foot.

[0075] In this embodiment, the hook-and-loop fastener 124 is provided along the edges of the inner and outer sheets to facilitate adjustment and secure the therapeutic compression device 100 over a patient's limb, such as the lower leg and foot. It is also envisioned that the therapeutic compression device 100 may be secured to the patient's lower leg by other means, such as a cuff formed by a zipper, button, or other suitable means. Furthermore, it is envisioned that the hook-and-loop fastener 124 may be replaced with a material similar to the material of the ankle strap 122 described below, and may be welded / sewn / attached to the bladder 102 to improve comfort.

[0076] In this embodiment, the inflation means is a device 130 which is a hand pump capable of being attached to the inflation port 112 to inflate the bladder 102. It should also be understood that a mechanical or automatic inflation pump (not shown) can be attached to the inflation port 112 to inflate and deflate the bladder 102 to provide pulsating pressure to the user's lower leg. Several or various inflation means, such as a manual pump, hand pump, foot pump, mechanical pump, electric pump, battery pump, static pump, intermittent pump, variable pump, automatic pump, pneumatic pump, negative pressure pump, suction pump or vacuum, pulse pump, or any other known or advanced inflation source can be used to provide a specific pressure within the bladder and thus provide compression when used by the patient. In addition, a vent valve (not shown) may be incorporated in the therapeutic compression device 100 or together with the inflation means 130 to allow the user to selectively deflate the bladder 102. Furthermore, a check valve or safety valve may be incorporated together with either the inflation means 130 or the bladder 102 to prevent over-inflation once the maximum pressure is detected. Examples of safety valves are described in U.S. Patent Nos. 7,276,037 and 7,850,629, the disclosures of which are incorporated herein by reference in their entirety.

[0077] Referring here to Figures 14-15, the position and desired pre-configured compression gradient profile can be obtained cost-effectively by forming the bladder 102 so as to be integrated within the inner sheet 106 and the outer sheet 108. Several different embodiments of the bladder configuration can be used in the therapeutic compression device of the present invention, such as the configuration described above. Figures 11 and 12 show a therapeutic compression device 100 having a bladder 102 with a plurality of spot welds 114 inside. The spot welds 114 are arranged in a predetermined pattern within the bladder 102 to obtain maximum effect based on the desired gradient profile for compression required at the treatment site of the patient. The spot welds 114 allow the bladder 102 to define the gradient profile when expanded via the expansion 112. The geometric arrangement of the spot welds 114 within the bladder 102 can increase the expansion of specific parts of the bladder 102, creating one or more fluid chambers within the bladder 102. This configuration is particularly useful when compression is needed to improve fluid movement within the body (e.g., blood, lymph, etc.). Furthermore, the linear weld line 116 allows for better compression along the posterior part of the patient's calf by increasing the tension applied to the posterior part of the patient's calf. This increased tension can generate more effective calf compression to increase venous flow. The linear weld line 116, positioned laterally along the posterior part of the calf, creates a wavy section that keeps the inflation profile of the therapeutic compression device 100 small, which can further enhance the patient's walking mobility and reduce interference with the patient's clothing. In another embodiment, the secondary wrap 104 can also be made from elastic clothing without the bladder 102.

[0078] It should be understood that different pressure gradients may be used depending on the location of the therapeutic compression device. Examples of other bladder pressure gradient profiles are described in U.S. Patent Application No. 12 / 911,563 and U.S. Patent Application No. 12 / 855,185, and their disclosures are incorporated herein by reference in their entirety.

[0079] Referring to Figures 16-17, once the therapeutic compression device 100 is fixed around the patient's lower leg, the bladder 102 cannot be moved, thus increasing comfort and reducing fit problems for the patient. To improve the patient's ability to walk easily, in a typical embodiment, an ankle cushion 126 can be attached to the adjacent heel port 120 to prevent pinching and reduce pressure on the patient's Achilles tendon. An ankle strap 122 can be used in combination with the ankle cushion 126. In a typical embodiment, the ankle strap 122 may include non-elastic foam at the bottom of the lower leg wrap 103 and the top of the secondary wrap 104 to prevent pinching. A further advantage of providing the ankle strap 122 is that the bladder 102 immediately adjacent to the ankle strap 122 fits snugly against the patient's leg, improving compression near the patient's heel. The ankle strap 122 is conveniently wrapped around the patient's ankle and foot before the hook-and-loop fastener 124 is attached. As can be seen in Figure 18, to improve comfort, through-holes 118 are placed throughout the therapeutic compression device 100 to allow ventilation around the patient's leg while the therapeutic compression device 100 is worn in an inflated state. For clarity, not all through-holes 118 are necessarily identified by reference letters in the figure.

[0080] In a typical embodiment, the inner sheet 106 further includes a layer (not shown) having a first modulus of elasticity, and the inner sheet 106 has a second modulus of elasticity. The first modulus of elasticity is smaller than the second modulus of elasticity in the transverse direction with respect to the proximal and distal end portions of the therapeutic compression device 100, which wraps around the leg when the leg compression bladder is inflated. In a typical embodiment, the inner sheet 106 includes a sub-sheet (not shown) disposed on its inner surface so as to be in direct contact with the lower leg when in use. The sub-sheet may be a fabric layer which is elastic in a first direction and inelastic in a second direction so as to allow the wrap member to curl around the leg when the leg compression bladder is inflated.

[0081] In another typical embodiment, the upper leg strap 128 is configured and fitted to improve the fit of the therapeutic compression device 100 by positioning a portion of the bladder 102 above the widest part of the patient's calf, thereby providing stability to the therapeutic compression device 100 by preventing it from slipping down the patient's lower leg, which would render the therapeutic compression device 100 ineffective when providing calf compression.

[0082] Referring to Figure 19, another embodiment of the present invention is provided, including a medical assembly 150. This medical assembly generally comprises a compression mechanism A, a pre-filled air bladder B, an absorbent foam, sponge or dressing material C, and a suction conduit D coupled to a suction device S. The pre-filled air bladder B, the absorbent foam, sponge or dressing material C, and the suction conduit D may be provided as a unit. As shown in the figure, the compression mechanism A includes an optional foot strap E that can wrap around the patient's leg L and the patient's foot F. The suction conduit D is of a desired length for coupling the assembly 1 to the suction source S.

[0083] Referring to Figure 20A, another embodiment of a therapeutic compression device 200 (corresponding to compression mechanism A in Figure 19) for applying pressure to a patient's leg, such as the lower leg of the human body, is provided. The therapeutic compression device 200 preferably includes a flexible wrap member 212 and one or more inflatable air bladder chambers 214 (preferably a single air chamber as shown in the figure). The inflatable air bladder chamber 214 is preferably fixed to the flexible wrap member 212 in an unenclosed state. For example, the flexible wrap member 212 may include two layers of elastomer material together with the air bladder chamber 214, the air bladder chamber being bonded between these two layers by nylon screws or other suitable fastening means. Alternatively, the flexible member 212 may include a pocket into which the air bladder chamber(s) 214 are removably inserted and securely held therein. In yet another optional embodiment, the air bladder may be bonded or welded to the inner surface of the member 212. The elastomer material of member 212 may be made of nylon, polyurethane, cotton, or other suitable material. A tube 216, which is in fluid communication with the air bladder chamber(s) 214, extends to a pressure ball 218. The pressure ball 218 is preferably made of rubber and includes a valve 220 for adjusting the amount of air being pumped into the air bladder chamber(s) 214 via the tube 216. Air is pumped into the air bladder chamber(s) 214 by squeezing the pressure ball 218. In this way, the air bladder chamber(s) 214 is placed under pressure. Preferably, a pressure gauge 222 is operably coupled to the air bladder chamber(s) 214 to provide a visual indication of the internal pressure level. An automatic pressure safety valve 223 and a manual pressure safety valve 224 may be operably coupled to the air bladder chamber(s) 214, for example, via the tube 216. The automatic pressure safety valve 223 automatically vents the air in the chamber(s) 214 to the ambient environment when the internal pressure reaches a specific threshold maximum pressure. In a preferred embodiment, this threshold maximum pressure is 30-40 mmHg, most preferably about 40 mmHg. However, it can be varied based on the desired treatment.Thus, the pressure within the chamber 214 cannot exceed the threshold maximum pressure, thereby reducing the risk of necrosis and other complications resulting from excessive pressure. The manual pressure safety valve 224, when manually activated by the patient (or caregiver), ventilates the air within the chamber(s) 214 and the surrounding environment. This facilitates quick and easy control of the internal pressure of the air chamber(s) 214. In alternative embodiments, the manual pressure safety valve 224 and a possible automatic safety valve 223 may be integrated into a common package.

[0084] The air chamber 214 is positioned such that its length in a first dimension (e.g., the vertical dimension in Figure 20A) is substantially longer than its length in a second dimension perpendicular to it (e.g., the horizontal dimension in Figure 20A), and as a result, the air chamber 214 can be positioned to extend substantially longitudinally along the lower leg to apply localized pressure along its length (vertical dimension). Such localized pressure is substantially constant along the length of the chamber 214. In an exemplary embodiment, the air chamber 214 is positioned so that it extends along the calf of the lower leg, allowing the air chamber 214 to apply localized pressure to the patient's small saphenous vein when it is securely wrapped around the patient's lower leg and inflated. However, the flexible member 212 and the air chamber 214 can be adapted to be positioned along another portion of the lower leg (e.g., a portion of the leg below the knee), allowing the air chamber 214 to apply localized pressure to such a portion of the lower leg when inflated.

[0085] The flexible member 212 may include a strap (not shown) extending around the heel (and / or other part) of the foot during use. This strap restricts the upward movement of the flexible member 212 during use. The strap may also have suspender hooks or slots (not shown) that allow suspenders to engage with them, and the mechanism 210 is supported by a band that wraps around the knee or thigh. The suspenders restrict the downward movement of the flexible member 212 during use. These features reduce the progression of the flexible member 212 along the length of the leg so that its desired position is maintained throughout use. The flexible member 212 may be positioned not only on the foot but also on other limbs or body parts such as the calf, thigh, hip, buttocks, torso, ribs, arm, hand, fingers, shoulder, neck, and head.

[0086] In an alternative embodiment, the flexible member 212 and the air chamber 214 may be adapted so that they are positioned along a portion of the upper leg (e.g., a portion of the thigh), allowing the air chamber 214 to apply localized pressure to such portion of the upper leg when inflated. In the case of upper leg treatment, the flexible member 212 may define an opening (not shown) at the knee joint level through which the kneecap can protrude. In this configuration, the flexible member 212 may extend below the knee joint level and securely wrap around a portion of the lower leg, providing leg stability. The flexible member may also have suspender hooks or slots (not shown) that allow suspenders to fit into them, and the mechanism 210 is supported by a waist belt when in use. The suspenders restrict the downward movement of the flexible member 212 when in use, thereby maintaining the flexible member 212 in its desired position.

[0087] Preferably, the flexible member 212 includes a plurality of face-fastening mechanisms 226A, 226B (e.g., VELCRO® members). In a preferred embodiment, the flexible member includes four face-fastening mechanisms, as shown in Figure 20A. These multiple fasteners allow the flexible member 212 and the air chamber(s) 214 to securely wrap around a portion of a human leg. If necessary, other suitable fastening means can be used to secure the flexible member and the air chamber(s) to the human leg. For example, the flexible member may be adapted to form a sleeve-like shape with a zipper that stretches along its length. Alternatively, the zipper can be omitted, and the sleeve-like flexible member can slide over the patient's leg until positioned in the desired location.

[0088] Preferably, the pressure inside the air chamber(s) is reduced / removed by user operation of a manual safety valve 224 or check valve (for example, the air chamber(s) are deflated), and the pneumatic compression mechanism is removed from the leg by manually removing the face fastener and releasing the flexible member 212 from around the leg.

[0089] Figure 20B illustrates an alternative compression mechanism 210 (corresponding compression mechanism A in Figure 19) comprising a flexible member 212 and one or more pre-expanded (pre-filled) and airtight air chambers 214 (preferably a single air chamber as shown in the figure). The pre-expanded and airtight air chambers 214 are preferably fixed to the flexible member 212 when not wrapped. For example, the flexible member 212 may comprise two layers of elastomer material together with the air bladder chambers 214, the air bladder chambers being bonded between the two layers by nylon screws or other suitable fastening means. Alternatively, the flexible member 212 may comprise a pocket into which the airtight air chambers 214 are detachably inserted and held securely inside. In yet another alternative embodiment, the air chambers may be bonded or welded to the inner surface of the member 212. Regardless, a pressure gauge 222 is operably coupled to the air chambers 214 to provide a visual indication of the internal pressure level. The flexible member 212 also includes a plurality of straps 225 having face-fastening mechanisms 226A, 22613 (e.g., VELCRO® members), and a plurality of openings 227 for receiving the straps. In a preferred embodiment, the flexible member includes three straps 225 and three openings 227. During use, the straps are screwed through the openings and returned to themselves so that the face-fastening mechanisms 226A and 226B engage with each other. By pulling the fixed straps and fastening them using the fastening mechanisms, some pressure may be applied to the pre-filled chamber, thereby applying some pressure to the limb to which the compression mechanism is applied. The amount of pressure applied can be read by a pressure gauge 222 which may have a numerical or other visual display.

[0090] Referring here to Figure 21A, an alternative embodiment of the pneumatic compression mechanism (corresponding to compression mechanism A in Figure 19) is shown. The compression mechanism 210' includes a flexible member 212' and one or more inflatable air chambers 214' (preferably a single air bladder, as shown in the figure). The inflatable air chamber 214' may preferably be formed from two walls joined together by heat sealing around the flange portion in a manner similar to that of the fluid-filled member 230, as described herein. The air chamber 214' is preferably fixed to the inner surface of the flexible member 212' by glue, welding, or other suitable fastening means. Alternatively, the flexible member 212' may include two layers of elastomer material together with air bladder chambers 214', the air bladder chambers being bonded between these two layers by nylon screws or other suitable fastening means. The flexible member 212' may preferably be realized from nylon, polyurethane, cotton, or other suitable material. Connector 216A' is preferably in fluid communication with the air chamber 214' via a port (not shown) extending through the bottom surface of the air bladder chamber 214'. Connector 216A' mates with the aforementioned pressure ball or expansion tube (not shown) for fluid connection to the expansion mechanism. The automatic pressure safety valve 323' and manual pressure safety valve are preferably in fluid communication with the air chamber(s) 214' via additional ports (not shown) extending through the bottom surface of the air bladder chamber(s) 214'.

[0091] Preferably, the flexible member 212' includes a plurality of face-fastening mechanisms (e.g., VELCRO® members) that enable the flexible member 212' (and the air chamber(s) 214' to which it is fixed) to be securely wrapped around a portion of a human leg. In a typical embodiment of Figure 20A, the flexible member 212' includes three hook buttons 226A1', 226A2', and 226A3' disposed on the body-contacting surface of the member 212' that faces a larger loop panel area 226B' disposed on the opposite side of the member 212'. If necessary, the flexible member 212' and the air bladder chamber(s) 214' can be fixed to a human leg using other suitable fastening means. For example, the flexible member 212' may be adapted to form a sleeve-like shape with a zipper that stretches along its length. Alternatively, the zipper can be omitted, and a flexible member 212', such as a sleeve, can slide over the patient's leg until it is positioned as desired. The flexible member 212' may also include a cutout (not shown) that provides enhanced flexibility to the member 212'.

[0092] During use, air is pressurized into the air chamber(s) 214' by the operation of a pressure ball (or other inflation mechanism). The air chamber(s) 214' are substantially longer in a first dimension (e.g., the vertical dimension in Figure 21A) than in a second dimension perpendicular to it (e.g., the horizontal dimension in Figure 21A), and as a result, the air chamber(s) 214' can be positioned to extend substantially longitudinally along its legs to apply local pressure along its length (vertical dimension). Such local pressure is substantially constant along the length of the chamber(s) 214'.

[0093] In the typical embodiment shown in the figure, the air chamber 214' has a length of 13.00 inches (vertical dimension) and widths of 3.77 inches and 3.51 inches (horizontal dimension) at its upper and lower ends, respectively, as shown in the figure. The width of the chamber 214' tapers as it extends away from the upper and lower ends to the minimum width, with the minimum width being relatively closer to the lower end, as shown in the figure. It will be understood that the air chamber 214' can take on other shapes and sizes.

[0094] In another alternative embodiment, as shown in Figure 21B, the flexible member 212'' and air chamber 214'' of the compression mechanism 210'' (corresponding to compression mechanism A in Figure 19) are adapted to be positioned along a portion of the upper leg (e.g., a portion of the thigh), allowing the air chamber 214'' to apply localized pressure to such portion of the upper leg when inflated. The structure and operation of the components of mechanism 210'' are the same as those of mechanism 210'' described above with respect to Figure 21A, and therefore, for the sake of simplicity, a description of such components is omitted.

[0095] In the typical embodiment shown in the figure, the flexible member 212'' is contoured to match the upper leg when wrapped around it. The air bladder chamber 214'' has a length of 11.75 inches and a maximum width of 6.00 inches (horizontal dimension) at its lower end, as shown in the figure. The width of the chamber 214'' tapers as it extends away from the lower end to the upper end, as shown in the figure. It will be understood that the air chamber 214'' can take on other shapes and sizes.

[0096] It will be understood that the chamber in either embodiment of Figures 21A and 21B can be pre-filled and sealed as described above with reference to Figure 20B. It will also be understood that the air chamber, arranged to receive air, can be inflated using a manual pressure ball (as shown in Figure 20A) or by an electric air pump (not shown) which can use a battery or AC wall current to pressurize air into the chamber. Any known air or fluid may be used with any manual, mechanical, electric, battery-powered, or any other power supply pump or pressure generator. The inflation means may be a manual pump, hand pump, foot pump, mechanical pump, electric pump, battery-powered pump, static pump, intermittent pump, variable pump, automatic pump, pneumatic pump, negative pressure pump, suction pump or vacuum, pulse pump, or any other known or advanced inflation source to provide a specific pressure within the bladder to provide compression by the patient during use.

[0097] Other embodiments of the compression mechanism may include a combination of a sealing fluid-filled bladder, an absorbent foam, a sponge or dressing material, and a suction conduit, such as the bladder B, foam, sponge or dressing material C, and suction conduit D shown in Figure 19, which correspond to at least a portion of the bladder B, foam, sponge or dressing material C, and suction conduit D.

[0098] The fluid-filled member 238 can be formed in a great many ways. In one configuration, the fluid-filled member preferably includes two walls 242A, 242B joined to each other by heat sealing around a flange port (not shown). These two walls define a chamber 246 between which is filled with fluid. The fluid held in the chamber 246 can be a gas (such as air), a liquid (such as water), or a gel. The fluid in the chamber 246 can be mixed with one or more therapeutic agents, such as antibiotics, growth factors, or absorption agents. In such a configuration, the bottom wall 242B is realized from a semipermeable material that allows the therapeutic agent held in the chamber 246 to move to the treatment site while maintaining a desired internal pressure within the chamber 246. Such a fluid may also be a gelling agent that retains heating and / or cooling useful for heating and / or cooling treatment of the treatment site.

[0099] The fluid-filled member 238 preferably has an elliptical shape with a length of about 4 to 6 inches, a width of about 2 to 4 inches, and a height of about one to three quarter inches. Sufficient fluid is preferably provided to prevent the walls of the member 238 from sagging and coming into contact with each other, although some degree of sagging may be acceptable. The walls of the fluid-filled member 238 can be formed from polyurethane, polyvinyl chloride, nylon, or other plastics known in the art, and the fluid-filled member 238 is sufficiently thick (i.e., sufficiently strong) so as not to burst when 40 mmHg is applied to it by the compression mechanism. It will be understood that the fluid-filled member 238 may take on other shapes and sizes and may be made from other materials.

[0100] An absorbent foam, sponge, or dressing material 245 (hereinafter referred to as "sponge") is attached to the fluid-filling member 238. The sponge 245 has the ability to absorb exudate from a wound or ulcer. Furthermore, the sponge preferably has an open-cell structure that helps to absorb exudate from the wound or ulcer. The sponge 245 is preferably similar in size and shape to the fluid-filling member. The sponge 245 is preferably fixed to the bottom wall 242B of the fluid-filling member with adhesive so that the sponge 245 and the fluid-filling member 238 cannot be easily separated from each other. Alternatively, the sponge may be lightly attached to the fluid-filling member 242B with an adhesive film so that the sponge can be peeled off and replaced. Alternatively, the fluid-filling member 238 may be provided with a peripheral retaining flap for the sponge 245 that can be inserted into and removed from the flap as desired. If necessary, the edges of the sponge can be sealed by either injecting a sealant into the sponge or by eliminating the open air bubble structure of the sponge. Sealing the edges of the sponge can help reduce air entering the sponge when suction is applied to the unit, as described below.

[0101] Embodiments within unit 230 may include, for example, a suction conduit 247 provided between the fluid-filling member 238 and the sponge 245. More specifically, the suction conduit 247 may be a tube having a branched distal end 249 defining a series of holes 251. Since the holes 251 are directed downward toward the sponge 245, when a negative pressure source is applied to the suction conduit 247, the negative pressure can be applied to the wound or ulcer through the sponge 245. As a result, exudate can be drawn out by capillary action and sucked from the wound or ulcer through the sponge 245 into the conduit 247. In another embodiment, the branched distal end 249 of the suction conduit 247 extends only to a portion of the periphery of unit 230. The proximal end of the conduit can be connected to a bottle or container which is then connected again to the negative pressure source S (shown in Figure 19). Alternatively, the proximal end of the conduit may be terminated with a fluid coupling 259, which can be sequentially coupled to a bottle or container and an elongated conduit (extension tube) that is coupled to a negative pressure source. In this way, the conduit can be easily detached from the unit so that the patient can walk and be transported away from the suction source while pressure is still being applied to the wound or ulcer.

[0102] The suction conduit 247 can be held between the fluid-filled member 238 and the sponge 245, preferably with an adhesive (not shown), which is applied to the upper and lower ends of the distal end 249 of the conduit 247, securing the distal end 249 to the sponge 245 on its bottom and to the fluid-filled member 238 on its upper part. Alternatively, the suction conduit 247 may be heat-sealed or laser-sealed to the fluid-filled member 238 and / or the sponge 245. In embodiments where the sponge 245 is removable from the fluid-filled member 238, the conduit 247 is preferably bonded only to the bottom of the fluid-filled member 238.

[0103] Another embodiment of the unit incorporating a pre-filled air bladder, sponge, and suction conduit (corresponding to bladder B, foam, sponge or dressing material C, and suction conduit D in Figure 19) may differ from the unit 230' of a previous typical embodiment, namely that the fluid-filled member 238' in this embodiment defines a central hole 239 (i.e., it is donut-shaped), and the distal end 249 of the suction conduit 247' does not branch and does not contain a series of holes, but extends through the central hole of the fluid-filled member 238' and has an open end 251' located in the sponge 245'. Preferably, the distal end 249' of the suction conduit 247' is held in place within the central hole 239 by an adhesive (not shown) that fixes the distal end 249' of the fluid-filled member 238' defining the central hole 239. Alternatively, the suction conduit 247' can be held in place by friction or other means so that it can be removed from the pre-filled air bladder and sponge unit. As in previous embodiments, the sponge and the fluid-filling member may be strongly or weakly bonded to each other, or the sponge may be detachable from the flange element of the fluid-filling member that holds the sponge. Furthermore, the sponge may be sealed at its periphery.

[0104] A third embodiment of a unit comprising a pre-filled air bladder, sponge, and suction conduit (corresponding to bladder B, foam, sponge or dressing material C, and suction conduit D in Figure 11) is shown in Figure 22. Unit 230'' is similar to units 230 and 230' disclosed above as earlier embodiments, except that the suction conduit 247'' is oriented horizontally between the fluid-filling member 238'' and the sponge 245'' and includes a distal end 249'' having an open end 251. The open end 251'' is preferably located in the center of unit 230'' and oriented downward (i.e., the upper half of the conduit 247'' extends further than the bottom half). The suction conduit 247'' can be held between the fluid-filling member 238'' and the sponge 245'', preferably with an adhesive (not shown), the adhesive of which is applied to the upper and lower ends of the distal end 249'' of the conduit 247'', fixing the distal end 249'' to the sponge 245'' on its bottom and to the fluid-filling member 238'' on its upper part. In embodiments in which the sponge 245'' is removable from the fluid-filling member 238'', the conduit 247'' is preferably bonded only to the bottom of the fluid-filling member 238''. If necessary, the sponge 245'' can be sealed at its periphery.

[0105] According to one aspect of the present invention, units 230, 230', and 230'' having additional means for holding the unit in place on a wound or ulcer may be provided. For this purpose, the peripheral portion of the unit may be provided with a biocompatible adhesive. The adhesive may be provided on a sponge, or the fluid-filled member may be provided with a flange (not shown) having a biocompatible adhesive. As an alternative, and as shown in Figures 23A and 23B, a strap 277 may be provided as a means for holding and securing the unit in place. In one embodiment, the strap is formed from the same material and integrally with the fluid-filled members 238, 238', and 238'' and extends from one side of the fluid-filled member. The strap is fitted to be long enough to encircle the limb L. The ends of the strap are provided with an adhesive used to bond the strap to the other side of the fluid-filled member. As an alternative, the fluid-filled member may be provided with a slot (not shown) to which the strap can be secured for tightening. In another embodiment, the strap is formed separately and attached to the fluid-filled member. Again, the ends of the strap may be provided with an adhesive for bonding the strap to the other side of the fluid-filled member. Alternatively, the fluid-filled member may be provided with slots (not shown) into which a separately formed strap can be secured for tightening.

[0106] During use, the patient or practitioner will select unit 230, 230', 230'' and place the unit's sponge surface over the wound or ulcer. If the unit includes a strap, the unit can be secured in place on the limb. Alternatively, if the unit includes an adhesive ring, the unit is positioned such that the adhesive ring is preferably placed on the healthy skin opposite the wound or ulcer. Once the unit is positioned, the appropriate compression mechanism 10, 110, 210, 210', 210'' of the other embodiment is wrapped around the limb together with the air chambers 14, 214, 214', 214'', 114 of the other embodiment, which are positioned on unit 230, 230', 230''. If desired, the air chamber is pressurized (or pressure is applied by securing the wrap), and the pressure is applied to the limb and unit by the compression mechanism. Pressurizing the unit applies specific pressure to the wound or ulcer, aiding in the healing process. Furthermore, if desired, suction is applied to the wound or ulcer by applying a negative pressure source to the unit via suction tubes 247, 247', 247''. When the sponge is sealed at the periphery, the amount of suction required to move the exudate is reduced. Suction and pressure can be applied together or individually (alternatingly), or, as needed, one or the other may be applied constantly while the other is repeatedly switched on and off. When applied together, positive mechanical pressure is applied to the wound or ulcer by the compression mechanism and unit, while negative pneumatic pressure is applied to the wound or ulcer via the sponge by the negative pressure source, thereby removing the exudate and further assisting the healing process. Furthermore, if necessary, a pressure sensor (not shown) may be incorporated with units 230, 230', 230'' and electrically coupled to a suction source S (typically via a wire running along suction tubes 247, 247', 247'', not shown), where the suction source S has an on / off control (not shown). Thus, when the negative pressure source S is detected by a sensor (not shown), it can be turned on and off as a function of the mechanical pressure applied by the compression mechanism and unit.Therefore, if the pressure exceeds a desired threshold, the suction may be turned on; if the pressure is less than that, or below a lower threshold, the suction may be turned off; or, if necessary, if the pressure exceeds a desired threshold, the suction may be turned off; if the pressure is less than that, or below a lower threshold, the suction may be turned on. A pressure sensor (not shown) may be placed between the fluid-filled members 238, 238', 238'' and the sponges 245, 245', 245'', or within the sponges, or on the surface of the fluid-filled members. Other embodiments of the air chambers 14, 114, 214, 214', 214'', or the flexible members 12, 112, 212, 212, 212', 212'' may be associated with other embodiments.

[0107] If the sponge is separable from the fluid-filled chamber, the sponge can be replaced at desired intervals. If it is not separable, the entire unit can be replaced as needed. If the unit has a fluid coupling, the suction tube can be removed before replacing the unit. Since this unit can be placed under the therapeutic compression devices 10, 100, 200, 300, 400 and assembly 310, negative pressure is combined with compression for the treatment of CVI, DVT and / or lymphedema.

[0108] For illustrative and illustrative purposes, and for non-limitation, another typical embodiment of the present invention, including a therapeutic compression device 200, is shown in Figures 18 to 24, and / or aspects thereof, shown in Figures 18 to 24 and generally designated by reference letter 200. Another typical embodiment or aspects thereof, shown in Figures 25 to 34 and generally designated by reference letter 300, and assemblies are designated by 310.

[0109] Referring to Figure 24, another embodiment of the therapeutic compression device 300 is shown, which includes an inflatable means for providing intermittent pressure to a part of the human body, such as a leg, and which promotes blood flow and drainage and treats various conditions, including venous ulcers or wounds. In this embodiment, the device utilizes a main bladder 312 and a secondary bladder 314, each bladder having an inflatable chamber 312a, 314a capable of accommodating fluid flowing in by inflation. The bladder 312, 314 are fluid-coupled by a fluid conduit 316, which is attached to the main bladder 312 and the secondary bladder 314 at their respective ends 316a, 316b, thereby allowing fluid to flow back and forth between the main bladder 312 and the secondary bladder 314. As described in the preferred alternative embodiments further discussed below, when one of the two bladders 312, 314 undergoes intermittent contraction, the other of the two bladders 312, 314 undergoes intermittent expansion and an increase in pressure.

[0110] Referring to Figures 25A to 25C, the main bladder 312 is most clearly visible. The main bladder 312 has a lower wall 320 and an upper wall 322 preferably bonded together by therapeutic sealing on the flange portion 324 of the lower wall 320. The lower wall 320 and the upper wall 322 define an inflatable chamber 312a between them. The upper wall 322 extends perpendicularly from the flange portion 324, forming a side wall 326, and then curves to form a top wall 328, which is usually parallel to the lower wall 320. Since the lower wall 320, including the flange portion 324, and the upper wall 322 are flexible, the lower wall 320 can be bent to conform to the surface contour of the leg. A lower layer 330 of material is optionally provided on the lower wall 320 of the main bladder 312. The lower layer 330 is preferably a semipermeable material (e.g., sponge) that absorbs sweat, pus, or other fluids and provides a more delicate contact surface to the wound. If necessary, an adhesive film may be provided on the flange portion 324 to help secure the main bladder 312 to the leg.

[0111] In one embodiment, the main bladder 312 has a nozzle or connector element 318 extending through an upper wall 322 having a first end 318a inside the inflatable chamber 312a and a second end 318b outside the inflatable chamber 312a. The nozzle 318 receives the fluid conduit 316 (Figure 24) at its first end 316a. The second end 318b of the nozzle 318 can, as an alternative, be positioned at the same height as the side wall 326 rather than outside the inflatable chamber 312a, provided that an airtight seal is provided between the nozzle 318 and the upper wall 322. The nozzle is preferably provided with an internal valve (not shown) only when the fluid conduit 316 is inserted into the nozzle 318, but when the fluid conduit 316 is removed from the nozzle 318, the internal valve closes to prevent fluid leakage. As shown in Figure 25C, the nozzle 318 preferably extends through the portion of the side wall 3326 of the upper wall 322 which is parallel to the lower wall 320, so that when the main bladder 312 is positioned to cover a wound on the leg, the nozzle 318 extends in a direction that is mainly parallel to the surface of the leg. Provided that the nozzle 318 being parallel to the surface of the leg prevents the creation of a bulge or projection perpendicular to the surface of the leg, the nozzle can create additional pressure directly on the area of ​​the leg below the nozzle 318 when the main bladder 312 is attached to the leg, as will be further discussed below. Furthermore, maintaining the nozzle 318 being parallel to the surface of the leg will facilitate the attachment of the fluid conduit 316 to the main bladder 312 in a direction that is mainly parallel to the surface of the leg, i.e., a configuration in which the covering can more easily cover the main bladder 312.

[0112] In another embodiment (not shown), the main bladder 312 does not include a nozzle 318. Instead, the first end 316a of the fluid conduit 316 is integrally formed with the main bladder 312, and as a result, the fluid conduit 316 cannot be separated from the main bladder 312. An optional one-way valve 68 is provided, as described below. Unless otherwise specified, the system is a closed system that is pressurized during the manufacturing process, and therefore the main bladder 312, or any other component of the apparatus 10, does not need to be pressurized before its operation.

[0113] Referring to Figures 25A-25C, the main bladder 312 is optionally equipped with a number of straps 332 designed to extend around the leg to secure the main bladder 312 to the lower part of the leg. The straps 332 may include Velcro portions 356 (Figure 25A) that are wrapped around the leg and then overlapped and attached to each other. The straps 332 also have elastic properties and can generate axial compressive forces when they are wrapped around the leg. In one embodiment, the straps 332 are wrapped under tension to cover the inflatable chamber 312a after passing around the leg, so that when the VELCRO® portions 356 are connected, the straps 332 apply a continuous compressive force over the inflatable chamber 312a. In other embodiments (not shown), the strap 332 is fixed horizontally around the leg or crosses over the main bladder 312 to secure the main bladder 312 to the leg and provide resistance to the outwardly expanding inflatable chamber 312a, and thus, as will be further discussed below, pressure can be applied over the wound area when the additional fluid is pushed into the inflatable chamber 312a.

[0114] The lower wall 320, upper wall 322, and lower layer 330 of the fluid main bladder 312 can be formed from various shapes and materials, but flexible plastic or rubber is preferred, so that the fluid main bladder 312 can bend to adapt to a specific contour and the curvature of a given leg. The size of the main bladder 312 may vary, and various sizes may be selected depending on the size and location of the wound. The upper wall 322 of the fluid main bladder 312 is preferably made from a flexible and elastic plastic (e.g., polyurethane, polyvinyl chloride (PVC), or polypropylene), such that these materials can change shape and increase the volume of the expandable chamber 312a as additional fluid enters it. The material of the upper wall 322 needs to be non-rigid so that as the pressure increases inside the expandable chamber 312a, the pressure is not absorbed by the upper wall 322 but rather transmitted to the leg through the wall. The operation of the main bladder 312 as part of the overall apparatus 10 will be discussed in more detail below.

[0115] The fluid secondary bladder 314 is best illustrated with reference to Figure 26. The secondary bladder 314 has a lower wall 334 with a flange 342, and an upper wall 336 forming side walls 338 and a top wall 340. The fluid secondary bladder 314 may be formed similarly to the main bladder 312. The lower wall 334 and the upper wall 336 are preferably joined to each other by heat sealing on the flange 342 of the lower wall 334. The upper wall 336 and the lower wall 334 define an inflatable chamber 314a. The upper wall 336 extends perpendicularly from the flange 342 to form the side walls 338 and curves to form the top wall 340, and the upper wall is usually parallel to the lower wall 334. Because the lower wall 334 with the flange 342 and the upper wall 336 are flexible, the lower wall 334 can be bent to conform to the surface contour of the ankle.

[0116] In one embodiment, as shown in Figure 27, the sub-bladder 314 is worn in a curved configuration that matches the heel. The size and shape of the inflatable chamber 314a of the sub-bladder 314 can vary considerably, for example, between about 3 to 6 inches in length, about 1 and a half to 3 inches in width, and about a quarter to one and a half inches in height when inflated. The shape of the inflatable chamber 314 preferably matches the shape of the foot or heel. A lower layer 344 of material is optionally provided on the lower wall 334 of the sub-bladder 314. If the fluid sub-bladder 314 is worn without any footwear covering it, the lower layer 344 may provide additional cushioning for the heel and / or a non-slip surface having a greater static friction coefficient than the lower wall 334. The fluid sub-bladder 314 can also be raised and lowered for wear, and an inflatable chamber 314a is movably disposed on its outside, with the lower layer 344 disposed on its inside in direct contact with the heel. As will be discussed in more detail below, the main function of the sub-bladder 314 is to pump fluid into the main bladder 312 during normal walking motion and to receive fluid back from the main bladder 312, so the lower layer 330 can be optionally selected in any of these configurations.

[0117] In one embodiment, the secondary bladder 314 may have a nozzle or connector element 346 extending through the upper wall 336, which has a first end 346a on the inside of the inflatable chamber 314a and a second end 346b on the outside of the inflatable chamber 314a. The nozzle 346 receives the fluid conduit 316 at the second end 316b of the fluid conduit 316 (Figure 24). The nozzle 346 is preferably provided with an internal valve (not shown), which is open as long as the fluid conduit 316 is inserted into the nozzle 346, and closed to prevent fluid leakage when the fluid conduit 316 is removed from the nozzle 346. The nozzle 346 is preferably bent in a configuration in which the secondary bladder 314 has a nozzle 346 extending upward in a direction generally parallel to the rear of the leg, so as to extend through the portion of the side wall 338 of the upper wall 336 which is parallel to the lower wall 334.

[0118] In another embodiment, the secondary bladder 314 does not include the nozzle 346. Instead, the second end 316b of the fluid conduit 316 is integrally formed with the secondary bladder 314, and as a result, the fluid conduit 316 cannot be separated from the secondary bladder 312. As described above, an optional one-way valve 368 is provided, as described below. If not provided, the system is a closed system pressurized during the manufacturing process, and therefore the secondary bladder 314, or any other component of the apparatus 10, does not need to be pressurized before its operation.

[0119] As shown in Figure 27, in the bending configuration described above, the inflatable chamber 314a of the secondary bladder 314 can be described as being divided into a compression portion 348 and a connecting portion 350. The secondary bladder 314 is attached to the heel of the foot (further discussed below), and the compression portion 348 of the inflatable chamber 314a is operably positioned directly below the heel, while the connecting portion 350 is oriented in a direction generally parallel to the direction of the leg (Figure 27). Positioning the nozzle 346 extending in the direction of the connecting portion 350 perpendicular to the compression portion 348 prevents the nozzle 346 from being compressed when the user steps on the compression portion 348 while walking. Furthermore, positioning the nozzle 346 perpendicular to the compression portion 348 allows the fluid conduit 316 to be attached to the secondary bladder 314 parallel to the leg, preventing the fluid conduit 316 from being compressed by the ankle or leg while the person is walking.

[0120] The secondary bladder 314 is preferably equipped with at least two front and / or rear straps 352, 354 that wrap around the foot to secure the fluid secondary bladder 314 to the underside of the foot. The straps 352, 354 preferably include Velcro portions 360 that overlap and attach to each other after being wrapped around the leg. The front strap 352 extends from a front flap 358 attached to the lower wall 334 or flange 342 of the secondary bladder 336 by heat sealing, bonding, sewing, or other equivalent means. The front strap 352 extends away from the front flap 358. The rear strap 354 is directly connected to either the flange 342 or lower wall 334 of the secondary bladder 314 by heat sealing, bonding, sewing, or other equivalent means. The rear strap 354 starts from the rear portion of the secondary bladder 314 and is pulled upward toward the upper part of the foot at the front of the leg, and can be wrapped around the upper part of the foot. The rear strap 354 also has VELCRO® portions (not shown) that overlap and attach to each other at the upper part of the foot. In one embodiment, the front and rear straps 352, 354 are wrapped under tension over the upper part of the foot, and a continuous compressive force is applied to the inflatable chamber when the inflatable chamber 314a is fixed and positioned at the heel. The rear strap 354 should not be pulled so tightly that the nozzle 346 extending upward from the connecting portion 350 is compressed.

[0121] Various embodiments of the secondary bladder may include a crescent shape having an inflatable chamber 314a' and a nozzle 346, or a rectangular shape having an inflatable chamber 314a'' and a nozzle 346''. The secondary bladders 314' and 314'' are mounted on the heel, so that the majority of each inflatable chamber 314a', 314a'' is operably positioned beneath the heel and lower part of the foot. In such embodiments, the inflatable chamber is not divided into a compression portion 348 and a connecting portion 350, because most of the portion of the inflatable chamber is compressed when the heel strikes the ground.

[0122] In all embodiments, the amount of fluid in the secondary bladder is selected so that the primary bladder can accommodate all of the fluid in the secondary bladder as the fluid is pushed out of the secondary bladder by walking motion. Preferably, the system is arranged so that the primary bladder applies a constant pressure of approximately 30–40 mmHg to the wound site, and the pressure in the primary bladder increases by an additional 10–20 mmHg as the fluid is pushed out of the secondary bladder by walking motion. Higher intermittent pressures (e.g., 80 mmHg) can be tolerated, but a maximum pressure of 50–60 mmHg is preferred.

[0123] In Figure 26 and other possible embodiments described above, the fluid conduit 316 can be attached to the inflatable chambers 314a', 314a'' of the secondary bladder 314', 314''. Alternatively, the secondary bladder 314', 314'' can be provided with nozzle or connector elements 346', 346'' extending through a first inner end of the inflatable chamber and a second outer end of the inflatable chamber. The second end of the nozzle is preferably positioned behind the heel so that the nozzle 346', 346'' is not crushed by the foot in a standing position or during walking.

[0124] As shown in Figure 26, the secondary bladder 314'' can be provided together with the front and rear straps 352'', 354'', which are shortened and provided together with adhesive portions 366 located at the ends of the straps 352'', 354 for direct attachment to the foot (or sock).

[0125] In embodiments of the present invention in which the fluid conduit 316 is integrally formed with and permanently connected to the bladder 312, 314, the device 10 is a closed system. Such embodiments do not require pressurization of either the bladder 312, 314 or the fluid conduit 316 before use. Conversely, during the manufacturing process of the device 10, the ends 316a, 316b of the fluid conduit 316 are fluid-coupled and form an airtight seal together with the inflatable chambers 312a, 314a. During the heat sealing of one or both of the inflatable chambers 312a, 314a, the amount of fluid confined within the tire system is controlled. Alternatively, if a one-way valve / nozzle 368 is provided, the fluid conduit 316 is permanently attached to the bladder 312, 314, and pressurization of the therapeutic compression device 300 and assembly 310 can be performed by means of the one-way valve / nozzle 368, such as a check valve or safety valve. A one-way valve / nozzle 368 is used to pressurize the therapeutic compression device 300 and assembly 310 to a desired pressure by connecting to a fluid source such as an air pump. Once the desired pressure (which can be the air pressure of the environment) is reached, the fluid source is disconnected from the one-way valve 368 and closed. In such embodiments, nozzles 318, 346 are unnecessary because the therapeutic compression device 300 and assembly 310 is a closed system. Fluid flows freely between bladder 312, 314 via fluid conduit 316 (with the pressure in each of the bladder 312, 314 changing as the therapeutic compression device 300 and assembly 310 are operated in the manner described below), but no additional fluid is permitted in the device 10. As described herein, the device 10 is fixed to the body by attaching the foot and main bladder 314, 312 to the foot and leg. Alternatively, the one-way valve 368, such as a check valve or safety valve, may be positioned on one of the inflatable chambers 312a, 314a of the bladder 312, 314 rather than on the fluid conduit 316.

[0126] In other embodiments, the fluid conduit 316 is removably connected to nozzles 318, 346 of the main bladder 312 and the secondary bladder 314. In such embodiments, the ends 316a, 316b of the fluid conduit are inserted through the nozzles 318, 346, allowing the main bladder 312 to fluidly couple with the secondary bladder 314 in an airtight manner. The airtight connection between the fluid conduit 316 and the nozzles 318, 346 can be achieved by male and female threaded surfaces, bayonet locks, or other equivalent means known in the art. The nozzles 318, 346 may house a two-way valve (not shown) for pressurizing either or both of the chambers 312a, 314a that can be inflated before or after the installation of the fluid conduit 316. The fluid conduit 316 is preferably made of rubber or plastic and has, for example and not limited to, a diameter in the range of 1 / 4 to 1 / 2 inch, a length in the range of 2 to 12 inches, and a wall thickness in the range of 1 / 8 to 1 / 2 inch. The wall thickness is recommended to prevent or minimize expansion of the fluid conduit 316 because the pressure changes inside the fluid conduit throughout the operation of the therapeutic compression device 300 and assembly 310 (i.e., the tube can preferably withstand a pressure of 60 mmHg, or higher if there is no expansion).

[0127] In embodiments in which the fluid conduit 316 is permanently attached to the bladder 312, 314, the therapeutic compression device 300 and assembly 310 are assembled by simply attaching the foot and main bladder 314, 312 to the foot and leg, as described herein. No additional assembly is required.

[0128] In embodiments where the fluid conduit 316 is detachably connected to the bladder 312, 314, the device can be assembled by either first attaching the foot and main bladder 314, 312 to the foot and leg and then connecting the fluid conduit 316 to the nozzle 318, 346, or by first connecting the fluid conduit 316 to the foot and main bladder 314, 312 and then connecting the foot and main bladder 314, 312 to the foot and leg. In such embodiments, fluid is supplied from a fluid source, such as an air pump, through the nozzle 318, 346 to either (or both) the inflatable chamber 312a of the main bladder 312 or the inflatable chamber 314a of the secondary bladder 314. As the fluid is supplied, the bladder(s) 312, 314 expand and pressurize. When the fluid source is removed from the nozzle 318, 346, valves within the nozzles will maintain the pressure in each bladder 312, 314. Next, the fluid conduit 316 can be clamped at one of its two ends 316a, 316b, while the other end of the two ends 316a, 316b is coupled to one of the nozzles 318, 346. When the fluid conduit 316 enters, it opens a valve in the nozzle. Then the clamped end of the fluid conduit 316 is coupled to the other nozzle, which opens its nozzle valve, and then the device 10 is ready to operate. The fluid used inside the therapeutic compression device 300 and assembly 310 can be air, liquid, or a combination of the desired pressure and specific material used, depending on the desired fluid source.

[0129] In yet another embodiment of the present invention, the main bladder 312 is positioned on the leg by a flexible leg wrap device 370, such as one disclosure in the shared U.S. Patent No. 7,276,037, which is incorporated herein by reference in its entirety. The leg wrap device 370 is shown in Figures 28A–28B and has an inflatable air bladder chamber 372 fixed to a flexible wrap member 373. The flexible member 373 is designed to wrap around the leg in a configuration that wraps together with the air bladder chamber 372 operably disposed on the inner surface of the flexible member 373, so that the flexible member 373 applies pressure over a large area of ​​the leg. In this embodiment, there is no need for a strap or other attachment means to be connected to the main bladder 312, because the flexible member 373 serves two functions: positioning the main bladder 312 on the leg (the main bladder 312 is sandwiched between the inflatable air bladder chamber 372 and the leg), and applying additional pressure to other areas of the leg.

[0130] In one embodiment, the inflatable chambers 312a, 314a of the leg and secondary bladder 312, 314 are pre-filled so that they are fixed to the leg and foot and used in conjunction with the leg wrap device 370, which allows the main bladder 312 to substantially deflate when the patient is lying down or raising their foot while walking (i.e., when the foot is not pressing on the secondary bladder 314). In such embodiments, it is preferable that the fluid moving from the main bladder 314 to the secondary bladder 312 allows the inflatable chamber 312a of the secondary bladder 312 to inflate to about half to three-quarters of its maximum capacity. In these embodiments, the leg wrap device 370 alone applies pressure over the patient's saphenous vein while the patient is lying down or raising his or her foot while walking. When the secondary bladder 314 is compressed during standard walking motion, fluid is circulated from the secondary bladder 314 to the primary bladder 312, increasing the internal pressure. This intermittent on-off compression helps promote blood flow to the primary bladder 312 and the ulcers placed on the patient's leg beneath the leg wrap device 370.

[0131] An inflatable air bladder 372 is optionally provided with a pressure gauge and an automatic pressure safety valve coupled to the inflatable air bladder chamber 372, which releases air from the chamber 372 to the ambient environment when the internal pressure reaches a threshold maximum pressure. For example, the therapeutic compression device 300 and assembly 310 can be attached to the leg and foot as described above in any embodiment. The flexible member 373 is then tensilely wrapped around the leg and over the main bladder 312, which has an air bladder chamber 372 that contacts and pressurizes the inflatable chamber 312a (Figures 28A and 28B). If the inflatable air bladder 372 becomes higher than the threshold maximum pressure during operation of the therapeutic compression device 300 and assembly 310, the automatic pressure safety valve releases air from the chamber 372, reducing the tension in the flexible member 373. The flexible leg wrap device 370 can be used in conjunction with all embodiments of the device 10 disclosed herein.

[0132] Once the therapeutic compression device 300 and assembly 310 are assembled and fastened to a person as described above, the therapeutic compression device 300 and assembly 310 operate even when the person is walking. While a standard heel sustains the toe movement of walking, the compression portion 348 of the auxiliary bladder inflatable chamber 314a is compressed between the heel and the ground, and the chamber applies external pressure to the compression portion 348, forcing all or most of the internal fluid output (i.e., the compression portion 348 of the auxiliary bladder 314's inflatable chamber 314a deflates when the heel strikes the ground). Thus, the fluid is pushed through the connection portion 350 of the inflatable chamber 314a into the main bladder 312 via the fluid conduit 316. The main bladder 312's inflatable chamber 312a expands to accommodate the fluid. As the inflatable chamber 312a inflates, the side walls 326 of the inflatable chamber 312a press against the straps 332 of the main bladder and / or the flexible members 373 of the leg wrap device 370. The straps 332 and / or flexible members 373 are securely fastened to the legs under tension and preferably extend over the top of the inflatable chamber 312a, providing resistance to bending or outward curvature of the side walls 326 and limiting the volume increase of the inflatable chamber 312a. Thus, the additional fluid flowing into the inflatable chamber 312a increases the internal pressure. This increased pressure is transmitted to the legs via the lower walls 320 and / or lower layer 330.

[0133] As a person's foot moves from heel to toes, the external pressure from the person's weight is removed from the heel. At that point, the pressure in the fluid conduit 316 and inflatable chamber 312a of the main bladder 312 is higher than the pressure in the inflatable chamber 314a of the secondary bladder 314. In equilibrium, the pressures become equal, and a portion of the fluid in the main bladder 312 recirculates through the fluid conduit 316 into the inflatable chamber 314a of the secondary bladder 314. The inflatable chamber of the secondary bladder then expands back to its original state until the internal pressure equals the pressure in the main bladder 312 and the fluid conduit 316. This process is repeated when a person walks, and walking creates a pumping or kneading force over the wound area of ​​the leg where the main bladder 312 is located, as the pressure in the main bladder 312 increases or decreases, thereby promoting blood flow, drainage, treatment, and healing to various parts of the leg.

[0134] The pressure within the inflatable chamber 312a of the main bladder 312 is affected by several factors. Note that if the main bladder 312 is pressurized before it is placed on the legs, the pressure inside the inflatable chamber 312a increases when it is placed on the legs before the straps 332 are secured, because the volume of the inflatable chamber 312a decreases slightly as the lower wall 3320 curves to conform to the shape of the legs. The straps 332 further increase the pressure on the inflatable chamber 312a because they are secured there. Furthermore, in embodiments where the fluid conduit 316 is removable, the pressure inside the apparatus 10 can be changed by pressurizing one or both of the main bladder 312 and the secondary bladder 314, or by using a longer or wider fluid conduit 316, which increases the internal volume of the apparatus 10. The pressure can also vary as a function of the tightness of the strap 332 wrapped around the leg and / or positioned over the inflatable chamber 312a, and the tension of the straps 352, 354 wrapped around the foot and / or positioned over the inflatable chamber 314a. For example, the higher the tension of the straps around the leg and / or the inflatable chamber 312a of the main bladder 312, the higher (minimum) compressive force directed inward over the leg. The device 10 that inflates the inflatable chamber 312a generates further pressure over the leg as the inflatable chamber 312a inflates, receiving resistance from the straps and continuing to fill with fluid without increasing the corresponding volume.

[0135] Figure 29 shows yet another embodiment of the present invention, which is a therapeutic compression device 400 configured according to the present invention, and shows a compression bladder 402 integrally formed within the therapeutic compression device 400. In this case, the compression bladder 402 is a single bladder inside both the main and secondary wraps 403, 404. The therapeutic compression device 400 is configured and adapted to wrap around a patient's limb, such as the lower leg, through the use of a main wrap 403 (such as a calf wrap) and a secondary wrap 404 (such as a secondary wrap 404), each of which is formed from a continuous outer sheet 408 and an inner sheet 406. The therapeutic compression device 400 is a wrap member having a proximal end (upper part oriented in Figures 29A and 29B) and an opposite distal end (lower part oriented in Figures 29A and 29B), configured and fitted to fit around a patient's limb, such as the lower leg, and to provide compression via a bladder 402, wherein the wrap member may be a main bladder within the therapeutic compression device 400 or a single bladder. In one embodiment of the present invention, the inner sheet 406 and the outer sheet 408 are made from nylon laminated polyurethane sheets configured and fitted to be RF welded to each other. However, any other suitable material that is weldable or otherwise joined while being airtight may be used. A continuous peripheral weld line 410 forms an airtight boundary of the integrally formed bladder 402. In this typical embodiment, the bladder 402 is a single continuous bladder across the entire main wrap 403 and secondary wrap 404. However, it is conceivable that the auxiliary wrap 404 may have an independent bladder that is either separately inflatable or inflatable via a one-way valve or other desired inflation / deflation configuration. The auxiliary wrap 404 may also be configured and adapted to provide different pressure from the main wrap 403. In a typical embodiment, the bladder 402 located within the auxiliary wrap 404 is configured and adapted to be positioned along the underside of the patient's foot. The bladder 402 within the auxiliary wrap 404 can be adjusted as desired to provide compression to a desired portion of the patient's foot.

[0136] The hook-and-loop fasteners 424 are provided along the edges of the inner and outer sheets to facilitate adjustment and securing of the therapeutic compression device 400 over the patient's lower leg and foot. It is also envisioned that the therapeutic compression device 400 may be secured to the patient's lower leg by other means, such as a cuff formed by a zipper, button, or other suitable means. Furthermore, the hook-and-loop fasteners 424 may be replaced with materials similar to those of the ankle strap 422 described below, and it is also envisioned that they may be welded / sewn / attached to the bladder 402 to improve comfort.

[0137] In one embodiment of the present invention, the inflation means 700 is a hand pump that can be attached to the inflation port 500 to inflate the bladder 402. It should also be understood that a mechanical or automatic inflation pump (not shown) can be attached to the inflation port 500 to inflate and deflate the bladder 402 and provide pulsating pressure to the user's lower leg. Several or various inflation means, such as a manual pump, hand pump, foot pump, mechanical pump, electric pump, battery pump, static pump, intermittent pump, variable pump, automatic pump, pneumatic pump, negative pressure pump, suction pump or vacuum, pulse pump, or any other known or advanced inflation source may be used to provide a specific pressure within the bladder and thus provide compression when used by the patient, but are not limited to these. A vent valve may also be incorporated in the therapeutic compression device 400 or together with the inflation means 700 to allow the user to selectively deflate the bladder 402. Furthermore, a check valve or safety valve may be incorporated together with either the inflation means 700 or the bladder 402 to prevent over-inflation once the maximum pressure is detected. Examples of safety valves are described in U.S. Patent Nos. 7,276,037 and 7,850,629, the disclosures of which are incorporated herein by reference in their entirety. Further examples are shown in Figures 30A and 30B.

[0138] In another embodiment of the present invention, the therapeutic compression device 400 may be formed by first integrating a bladder 402 within an inner sheet 406 and an outer sheet 408, so that its position and desired pre-configured compression gradient profile can be obtained cost-effectively. Several different embodiments of the bladder configuration can be used in the therapeutic compression device of the present invention, such as the configuration described above. In another embodiment, the therapeutic compression device 400 may have a bladder 402 with a plurality of spot welds 414 inside. The spot welds 414 can be arranged within the bladder 402 in a predetermined pattern to obtain maximum effect based on the desired gradient profile for compression required at the treatment site of the patient. The spot welds 414 allow the bladder 402 to define the gradient profile when inflated through the expansion port 500. The geometric arrangement of the spot welds 414 within the bladder 402 can increase the expansion of specific parts of the bladder 402, creating one or more fluid chambers within the bladder 402. This configuration is particularly useful when compression is needed to improve fluid movement within the body (e.g., blood, lymph, etc.). Furthermore, the linear weld line 416 allows for better compression along the posterior part of the patient's calf by increasing the tension applied to the posterior part of the patient's calf. This increased tension can generate more effective calf compression to increase venous flow. The linear weld line 416, positioned laterally along the posterior part of the calf, creates a wavy section that keeps the inflation profile of the therapeutic compression device 400 small, which can further enhance the patient's walking mobility and reduce interference with the patient's clothing. The auxiliary wrap 404 can also be made from elastic clothing without the bladder 402.

[0139] It should be understood that different pressure gradients may be used depending on the location of the therapeutic compression device placed on a part of the patient's body or limb. Examples of other bladder pressure gradient profiles are described in U.S. Patent Application No. 12 / 911,563 and U.S. Patent Application No. 12 / 855,185, their disclosures which are incorporated herein by reference in their entirety.

[0140] Once the therapeutic compression device 400 is fixed around a patient's limb, such as the lower leg, the bladder 402 cannot move from its position, thus increasing comfort and reducing positional adjustments to the patient's tissues. To improve the patient's ability to walk easily, in a typical embodiment, an ankle cushion 426 can be attached to the adjacent heel port 420 to prevent pinching and reduce pressure on the patient's Achilles tendon. An ankle strap 422 can be used in combination with the ankle cushion 426. In a typical embodiment, the ankle strap 422 may include non-elastic foam to prevent pinching at the lower part of the lower leg wrap 403 and the upper part of the secondary wrap 404. A further advantage of providing the ankle strap 422 is that the bladder 402 immediately adjacent to the ankle strap 422 fits snugly against the patient's leg, improving compression near the patient's heel. The ankle strap 422 is conveniently wrapped around the patient's ankle and foot before the hook-and-loop fastener 424 is attached. To improve comfort, through-holes 418 are positioned throughout the therapeutic compression device 400, as can be seen in Figure 29, allowing ventilation around the patient's legs while the therapeutic compression device 400 is worn in an inflated state. For clarity, not all through-holes 418 are necessarily identified by reference letters in the figure.

[0141] In a typical embodiment, the inner sheet 406 further includes a layer (not shown) having a first modulus of elasticity, and the inner sheet 406 has a second modulus of elasticity. The first modulus of elasticity is smaller than the second modulus of elasticity in the transverse direction with respect to the proximal and distal end portions of the therapeutic compression device 400, which wraps around the leg when the leg compression bladder is inflated. In a typical embodiment, the inner sheet 406 includes a sub-sheet (not shown) disposed on its inner surface so as to be in direct contact with the lower leg when in use. The sub-sheet may be a fabric layer which is elastic in a first direction and inelastic in a second direction so as to cause the wrap member to curl around the leg when the leg compression bladder is inflated.

[0142] In another typical embodiment, the upper leg strap 428 is configured and fitted to improve the fit of the therapeutic compression device 400 by positioning a portion of the bladder 402 above the widest part of the patient's calf, thereby providing stability to the therapeutic compression device 400 by preventing it from slipping down the patient's lower leg, which would render the therapeutic compression device 400 ineffective when providing calf compression.

[0143] The inflation means or mechanism in each of the various embodiments of the present invention may include a hand pump, electric pump, battery-operated pump, remote-controlled pump, air pump, gas pump, or any other known inflation means. Several or various inflation means, such as a manual pump, hand pump, foot pump, mechanical pump, electric pump, battery-operated pump, static pump, intermittent pump, variable pump, automatic pump, pneumatic pump, negative pressure pump, suction pump or vacuum, pulse pump, or any other known or advanced inflation source, may be used to provide a specific pressure within the bladder and thus provide compression when used by a patient. Figures 30A and 30B include various valves used in the present invention. Furthermore, the inflation means may include means for monitoring or regulating inflation. The inflation means may include programming such that the bladder inflates and deflates to set pressures at various intervals throughout the day and night, or at set times, when the compression device is worn and used by a patient. For example, as a mere example, the inflation means may be set for each individual patient throughout the day and night, such as being set to 40 mmHg at 9 a.m., then to deflate to 20 mmHg at 11 a.m., and then to inflate to 30 mmHg at 12 p.m., and so on. In one embodiment of the present invention, the dial 610 includes symbols for pressure quantities such as "35", "45", "55", and "65", or letters such as "A", "B", "C", and "D", each corresponding to a specific pressure such as 25 mmHg, 35 mmHg, 45 mmHg, and 55 mmHg. The specific predetermined pressures corresponding to the symbols are infinite and are not limited to the examples herein.

[0144] Furthermore, the therapeutic compression device may be deflated by a valve cap, or in another embodiment, it may have a button or switch for deflating the main and / or secondary bladder and thus releasing the pressure. In any embodiment where there is one bladder running the length of both the main and secondary laps, the term “main lap and / or secondary lap” shall mean only the main bladder or compression bladder (402). In another embodiment, as shown in Figures 31A–31C and 35, the switch may have a plurality of integrated umbrella valves, i.e., one umbrella valve is set and closed to maintain pressure in the main and / or secondary bladder, in contrast to a second umbrella valve which releases a specific amount of air or fluid in the main and / or secondary bladder to release pressure while the patient is walking (pressure increases on the calf with each step) or flying (pressure increases based on altitude), and a third umbrella valve which releases all air or fluid in the main and / or secondary bladder and thus releases all pressure, causing the therapeutic compression device to deflate. For example, as a mere example, a first umbrella valve is set to a closed position when activated so that it maintains the amount of air or fluid in the main and / or secondary bladder and thus maintains it at a set pressure, e.g., 45 mmHg; a second umbrella valve is set to release the air or fluid in the main and / or secondary bladder and return the pressure to 45 mmHg (for example, when at high altitude or in other pressure increases), and then maintain the pressure at 45 mmHg; and a third umbrella valve is set to open and release all the air or fluid in the main and / or secondary bladder and thus release all the pressure when the patient is activated to deflate the main and / or secondary bladder and the therapeutic compression device.As another example, the dial may include diagrams such as: (A) “Walking” where the umbrella valve remains in the closed position, thus maintaining the set pressure while the patient walks, causing the pressure to repeatedly rise and fall at regular intervals; (B) then “Air” where the set pressure is maintained by this umbrella valve, which occasionally releases pressure when the pressure increases beyond a set amount or value, i.e., the umbrella valve acts to release air or fluid in the main and / or auxiliary bladder, further releasing pressure, then closing, and remaining closed to maintain the set pressure; and (C) “Release” or “Contraction” where the pressure is released, and air or fluid in the main and / or auxiliary bladder is released and contracted, and this umbrella valve is always in the open position. In this embodiment, there are three umbrella valves, namely, one set to always open the main and / or auxiliary bladder to completely release pressure, one set to always close to maintain air or fluid in the main and / or auxiliary bladder to maintain pressure, and a third set to open or release at a predetermined or set pressure point. In all embodiments referring to the umbrella valve, the umbrella valve may also be a switch (manual or otherwise) or a digital switch, or any other known means for opening, closing, or partially releasing air or fluid in the bladder, thereby maintaining, changing, or releasing internal pressure.

[0145] The inflation means and valve shown in Figures 30A and 30B include an inflation port having an elbow connector 510 welded to the compression device so that air can flow into the compression device. A check valve or safety valve is inserted into the elbow connector 510. A dust cap 520 or valve cap is included to prevent dust from clogging the check valve and, when inserted in the reverse configuration, the inflated bladder is manually deflated. This is because a spring is equipped so that the inflation means inflates the bladder, and once the inflation means is removed, the spring seals the bladder, and as a result the pressure is not released until it is reduced or deflated manually or automatically. The check valve may also be non-spring actuated and actuated by any other means. The inflation means may include a ball-type, electric, battery-operated, or electrical means. The inflation means may include a dial as shown in the figures, or a simpler dial, or a single valve. Further embodiments are shown in Figures 31-38.

[0146] The inflation means 700 shown in Figures 31A, 31B, and 31C includes a hand pump 700. This inflation means 600 includes a tube 690 connected to a pump assembly including a valve dial 614, and in this embodiment includes three umbrella valves 616, as well as a label 612 for use by the user to see various pressure levels of the therapeutic compression device 10, 100, 200, 300, or 400. The valve dial 614 is connected to the hand pump ball 700 by a valve, base 620. The hand pump ball 700 may be a compression ball, or any other known hand pump or ball. As shown in Figure 31B, which is a cross-sectional view of Figure 31A, the valve dial 614 may include a check valve 630, which is a safety component to prevent the user from over-inflating the compression device and causing harm to the user. The check valve 630 may be coupled to the valve base 620 via any known means, such as adhesive 640, for example, just as an example. The valve dial 614 may further include, as an example, an O-ring 650 and a lubricant such as grease 660 applied to the O-ring 650. Furthermore, the valve dial 614 may include a drive screw 670 and a washer 680. The inflation means 600 may further include a retaining spring 655 and a retaining ball 656, as shown in Figure 31C. The retaining spring 655 and the retaining ball 656 have an audible "click" and provide a tactile and audible way for the user to know that the pressure is changing.

[0147] Another embodiment of the inflation means is shown in Figures 32A and 32B, 33 and 34. The inflation means 810 includes a tube 811 and a dial 818. The dial 818 is of the monometer type, and the pointer rotates based on the pressure through the sphere 700. The dial 818 is connected to a check valve 830 to prevent the user from over-inflating the compression device. The dial 818 is connected to the tube 811 and the check valve 830 via any known fitting means, which in this embodiment is shown as a t-connector 820, just as an example.

[0148] Another embodiment of the inflation means (not shown) includes a plunger assembly. This plunger assembly includes a bevel valve (similar to the bevel valve 616 shown in Figure 31A). The bevel valve includes an O-ring assembled in a slot to prevent air leakage from a spring hole. The plunger assembly has a predetermined height to control the buffer pressure in the dial 618 or dial valve 610. The plunger assembly further includes at least one or more buffer slots to allow air pressure to access the bevel valve itself.

[0149] Figure 34 is a cross-sectional view of another embodiment of the expansion means, in which the dial 610 includes a recess 930 that increments to allow the umbrella valve 910 to expand and have varying buffer pressures. A pointer 920 is included in this embodiment to resist the spring load and press the dial 610 to a precise height. A compression spring 910 drives the valve retainer upward within the expansion means 900. The dial 610 has a pointer 920 located above the slide 940. The compression spring 910 and O-ring 990 are arranged along the slide 940. The umbrella valve 10 is connected below the slide 940. The expansion means further includes a washer 950 and a screw drive 960. Also shown are a check valve 980 and a valve base 980. The distal end of the ball 700 is also shown.

[0150] Another embodiment of the inflation means 1000 is shown in Figure 35 and includes a dial 1050 having a retaining ball 1010 and a retaining spring 1020. The retaining ball 1010 and the retaining spring 1020 operate as an audible and tactile method for the user to know the pressure change. The insertion tip 1030 is shown to be coupled to the tube 690. In this embodiment, three umbrella valves may be set as follows: one is always in the open position, releasing air or fluid in the main and / or secondary bladder and thus releasing pressure toward the deflated position of the bladder; a second umbrella valve can be set in the closed position to retain air or fluid in the main and / or secondary bladder and maintain pressure; and a third umbrella valve is at a set pressure amount or value, and as the pressure increases, the umbrella valve closes, releasing excess pressure and maintaining the set pressure amount or value.

[0151] Another embodiment of the inflation means 1100 is shown in Figure 36. The dial 1110 includes a label 1120 for the user to visualize the pressure amount during use. The dial 1610 further includes at least one, in this embodiment, two or three umbrella valves 1140 in cross-sectional view. In this embodiment, the three umbrella valves may be set as follows: one is always in the open position to release air or fluid in the main and / or auxiliary bladder, and thus release pressure toward the deflated position of the bladder; a second umbrella valve can be set in the closed position to retain air or fluid in the main and / or auxiliary bladder and maintain pressure; and a third umbrella valve is at a set pressure amount or value, and as the pressure increases, the umbrella valve closes to maintain the set pressure amount or value by releasing and releasing excess pressure. A drive screw 1150 and a washer 1160 are further included. An O-ring 1170 is included and is lubricated via grease 1180. The valve body 1130 is coupled to the connecting ball 700 via any known connection or coupling means, which in this embodiment is, just as an example, adhesive 1190. The check housing 1220 includes a check valve and a silicon disc 1210.

[0152] In another embodiment of the present invention, the compression device may be a standalone thigh compression device or a thigh compression device added to leg and foot compression devices of various other disclosed embodiments. The thigh compression device includes an inner layer and an outer layer. The outer layer has an inflation port connected to the thigh compression device which can be connected to or coupled to an inflation means. The inner layer includes a plurality of fasteners. In one embodiment, the thigh compression device includes, as just one example, hook-and-loop fasteners along the edge for facilitating adjustment on the patient's thigh and for securing the therapeutic compression device. Since other uses of the thigh compression device may be used on the back, calf, arm, stomach, torso, shoulder, and other body parts, the designation as a “thigh” compression device is not limited to use of such a device on the patient’s thigh. It is also envisioned that the compression device may be secured to the patient’s thigh or other body parts by other means such as a cuff formed by a zipper, button, or other such preferred means.

[0153] Figures 37 and 38 show yet another embodiment of the present invention, comprising a compression device configured for use on a patient's arm. This arm compression device 1300 includes a layer 1310 and an inflation port 1305 which can be connected to or coupled to an inflation means. The outer layer 1310 includes a plurality of fasteners 1324 which can be fastened around the patient's thumb 1395 and fingers 1390. In one embodiment, the thigh compression device 1300 includes, as merely an example, hook-and-loop fasteners 1324 along the edge for facilitating adjustment on the patient's arm and for securing the therapeutic compression device 1300. Other applications of the arm compression device 1300 are that it can be used on the back, shoulder, torso, calf, arm, stomach, and other body parts, so the designation as “arm” compression device is not limited to the use of such device 1300 on a patient’s arm. It is also conceivable that the compression device 1300 may be fastened to the patient’s arm or other body parts by other means such as a cuff formed by a zipper, button, or other such preferred means. To improve comfort, as can be seen in Figure 38, through-holes 1313 are arranged throughout the compression device 1300 to allow ventilation around the patient's arm or other body part during widened wear of the compression device 1300. For clarity, not all through-holes 1313 are necessarily identified by reference letters in the figure. The compression device 1300 may include a portion 1330 for use around the patient's elbow, as shown in Figure 37, and may include an opening. In another embodiment, as shown in Figure 38, two smaller compression devices (compared to the device in Figure 29A) are used on the patient's forearm and upper arm, having multiple tabs 1405, the tabs of which can be connected to each other, such as face fasteners or VELCRO®, or any other known connecting means such as buckles, straps, buttons, snaps, zippers, and combinations thereof. As shown in Figure 38, at least two therapeutic compression devices 1400 can connect or bond inflation means and can be connected to each other via the tabs 1405. The outer layer 1410 includes a plurality of fasteners 1424 that can be fastened around the patient's thumb 1495 and fingers.Using other configurations, patients can apply pressure and compression to parts of their body, such as their legs, arms, wrists, hands, shoulders, hips, torso, and chest.

[0154] The therapeutic compression device of the present invention can be housed in a toolbox containing various wound dressings and / or bandages. Wound dressings and / or bandages may be more frequently arranged, and the therapeutic compression device of the present invention is applied in combination with or in use with wound dressings and / or bandages. In one embodiment, the therapeutic compression device is used above or on top of a wound dressing applied to the skin.

[0155] Another embodiment of the invention includes a method for applying a measured amount of compression with feedback. As shown in Figure 39, a compression bladder A is inflated by an expansion source C, and the property of compression bladder A is that the amount of compression is determined by the amount of expansion medium (usually air) that is pumped from C to A. In this design, the expansion source C is also coupled to a bladder B having a constant volume of air. When compression bladder A inflates, it will compress bladder B when it compresses the item to be compressed F. The expansion source C can read the linear pressure from the coupling line E and calculate the boundary pressure from bladder B in this design. The expansion source C can provide only the amount of expansion medium required for compression bladder A, as calculated by calibrating and fitting the desired boundary pressure from bladder B. Other configurations may be used to obtain feedback from the expansion means and compression device.

[0156] Another embodiment of the present invention involves continuous gradient compression with a single chamber. As shown in Figure 40, the compression device includes an inflatable bladder that applies continuous (first filling the foot and thus upward) compression as well as gradient compression. In this embodiment, as shown in Figure 40, the inflatable device A is coupled to a device with two locations (intake port C and exhaust port D). The foot bladder portion E inflates first before the main bladder F by inflating and supplying air that enters directly into channel B. The air is then exhausted from exhaust port D. In this design, the inflation can be coupled intermittently for gradient and continuous compression, or the inflation can be held at a constant level and simply provide a gradient profile.

[0157] Another embodiment of the present invention includes an electric or other automated inflation means, the bladder being inflated to a set volume or by reading the back pressure filling it. A pressure cycling function may be included. Furthermore, embodiments may have an inflation means such that inflation is maintained within the bladder(s) after the inflation means has been removed. Such an inflation means may be integrated into the compression device itself or may be detachable. Such an inflation means may include an integrated circuit and / or wireless capability for tracking the patient's adherence to the method of use, pressure, and maintaining a specific pressure recommended by the physician or as part of the patient's treatment plan, as well as other health data such as standing pressure and pressure during movement or activity, pedometer (steps), heart rate, blood pressure, and any other possible monitoring of the patient. In response to the feedback obtained, the inflation means may be programmed to increase or decrease the pressure without manual modification by the patient. Furthermore, the inflation means may be configured so that the physician or other healthcare professional can remotely increase or decrease the pressure based on that feedback. Other combinations may include automated means or combinations of electrical or digital means to manually change the dial or inflation mechanism.

[0158] The illustrated dial is non-digital, but is merely an example and not limited to it; digital means may also be used. An electric pump and a digital display may be used. The valve may include digital or electrical means for changing or correcting the pressure at a set rate or interval, or based on feedback from monitoring means. The device may include various sensors and monitors.

[0159] During use, the therapeutic compression device 10, 100, 200, 300, or 400 may be placed near the patient, physician, or caregiver on a selected limb, such as the calf and foot of the lower leg, or the foot wrap may be fastened around the patient's foot. An opening for the ankle is set by the patient for comfort. Moving upward from the foot, the patient, physician, or caregiver fastens or secures the fastening tabs (32a, 32b, 32c, 32d, and 424, etc.) up to the knee. If additional straps are present positioned on the proximal end of the primary bladder or calf or leg bladder (near the knee), the first strap should be fastened or secured tightly, but not too tightly, so that the therapeutic compression device fits snugly, and the second strap near the distal end of the secondary wrap (near the foot) should be fastened or secured loosely, but not too tightly, so that the therapeutic compression device fits snugly. Next, the patient, physician, or caregiver removes the valve cap from the valve located on the therapeutic compression device, for example, on the main lap. Then, the patient, physician, or caregiver selects a pressure value on the dial of the inflation device, depending on the treatment and whether the patient is walking, sitting, lying down, or traveling in a vehicle, train, or airplane. Once a pressure amount or value is selected on the dial (such as a given pressure amount like "35" mmHg, or letters like "Walking," "Air," or "Moving," or "Low," "Medium," or "High"), the corresponding umbrella valve or switch is activated to maintain the pressure thereafter (closed position), or to adjust the pressure as it changes with activity or altitude during use. Then, the patient, physician, or caregiver inserts the end of the inflation device into the valve of the therapeutic compression device, and the air or fluid increases, inflating the main and / or auxiliary bladders, thus achieving the desired pressure amount or valve. In this case as well, the inflation means may be a hand pump, an electric pump, a battery-operated pump, a remotely controlled pump, an air pump, a gas pump, or any other known inflation means.Several or various inflation means, such as manual pumps, hand pumps, foot pumps, mechanical pumps, electric pumps, battery pumps, static pumps, intermittent pumps, variable pumps, automatic pumps, pneumatic pumps, negative pressure pumps, suction pumps or vacuum pumps, pulse pumps, or any other known or advanced inflation source, may be used to provide a specific pressure within the bladder and thus provide compression when used by the patient. Depending on the inflation means used, such inflation means may be removed, the valve cap may be replaced, and the pressure will not decrease except by taking note of the "air" or "walking" position. At any point during use, the patient, physician, or caregiver may inflate the main and / or auxiliary bladder by either inserting the valve cap or by the valve cap pressing against the valve spring, thereby releasing air or fluid within the main and / or auxiliary bladder and reducing the pressure; or the patient, physician, or caregiver may reinsert the inflation device and select "deflate" or "release," causing the corresponding umbrella valve to move to the open position, releasing air or fluid within the main and / or auxiliary bladder and reducing the pressure until a deflated state is achieved for the bladder and the therapeutic compression device. The therapeutic compression device can be reinflated and deflated many times during use.

[0160] The present invention is illustrated and described with respect to its specific embodiments, which are typical and illustrative of the principles of the present invention and are not intended to limit the embodiments exclusively or otherwise. For example, in the embodiments described above, the therapeutic compression device is described as having an inflatable bladder, but the therapeutic compression device may also include additional compression members that are not configured for inflation and / or deflation (e.g., by adhesive, high-frequency welding, etc.) integrally formed or attached. For example, the additional compression members may be realized using a variety of arbitrary pre-formed and / or pre-filled cushioning materials such as foam cushions and / or air, gel, or other fluid-filled non-inflatable cushions, and such compression members may be combined with the integral compression bladder to generate sufficient compression. Furthermore, it should be understood that specific shapes, sizes, and materials are described for illustrative purposes, but any variety of shapes or sizes may be used, and the materials described are not exclusive but merely illustrative. Also, as described above, the illustrated bladder is inflated using air, but it should be understood that any other medium such as liquid or gel may be used. Furthermore, as mentioned above, the bladder may be configured to have multiple pneumatically independent and / or pneumatically coupled bladder portions, and may also be configured to have various contours or lobes.

[0161] The therapeutic compression devices described herein can be used for any suitable condition that can be treated by compression therapy or the like. For example, the therapeutic compression devices according to the present invention can be used for venous compression for the treatment of venous ulcers, CVI, DVT, lymphedema (where it is the circulation of fluid in the lymphatic system rather than in the venous system that is promoted), etc.

[0162] The therapeutic compression device of the present invention described herein solves many problems associated with the prior art, as well as in industrial and patient treatment. The therapeutic compression device can be applied by the patient to a part of the patient's body without requiring or demanding a skilled caregiver, which is required by current devices and apparatuses. Furthermore, it can maintain sufficiently effective pressure and compression without causing overpressure complications.

[0163] The therapeutic compression device of the present invention includes a universal inflation port configured to be connected to one or more inflation sources or means, so that the patient can modify the treatment by changing the inflation source and inflation means for the therapeutic device or device. For example, the patient can use the therapeutic compression device of the present invention to alternate between manual, mechanical, or electrical inflation means, or between inflation and pressure sources. Furthermore, when using the therapeutic compression device of the present invention, the patient can alternate between static or intermittent inflation and pressure.

[0164] The therapeutic compression device of the present invention also reduces the problem of leakage of set pressure within therapeutic devices and instruments, dressings, stockings, and socks, and conversely promotes more effective treatment for CVI, DVT, and / or lymphedema, as well as other treatments.

[0165] The present invention can be exemplified by the following embodiments. [Clause 1] A therapeutic compression device, A main wrap having a proximal end, a distal end, and a main wrap, A sub-wrap having a proximal end and a distal end, wherein the proximal end of the sub-wrap is connected to the distal end of the main wrap, At least one bladder in the main wrap and / or sub-wrap, An expansion means connected to the bladder via an expansion port on the main wrap, comprising an expansion means including a check valve, A therapeutic compression device in which the expansion port is configured to be universally connectable to various expansion means. [Clause 2] A therapeutic compression device according to Clause 1, comprising: (a) an inner sheet configured and adapted to be positioned facing a limb when in use; and (b) an outer sheet bonded to the inner sheet together with a bladder defined between the inner sheet and the outer sheet. [Clause 3] The therapeutic compression device according to Clause 1, wherein the inflation means is selected from the group consisting of a manual pump, a static pump, an intermittent pump, an electric inflation pump, a battery-powered inflation pump, a gasoline-powered inflation pump, a static pneumatic compression pump, an intermittent pneumatic pump, and combinations thereof. [Clause 4] The therapeutic compression device according to Clause 1, wherein at least one bladder is configured to have one chamber that allows for continuous gradient pressure when connected to an inflation means. [Clause 5] A therapeutic compression device according to Clause 1, comprising an inflation means configured to hold the pressure created by the inflation means to create an inflated state of the bladder within at least one bladder, to release a set amount of pressure to create a partially deflated state of the bladder within at least one bladder, and to release all pressure to create a fully deflated state of the bladder within at least one bladder. [Clause 6] The therapeutic compression device according to Clause 1, wherein the inflation means includes a real-time pressure measurement mechanism. [Clause 7] The therapeutic compression device according to Clause 1, further comprising a face connector, a check valve, and a valve cap, wherein the valve cap can release pressure produced by an inflation means in at least one bladder. [Clause 8] The therapeutic compression device according to Clause 1, further comprising a check valve operably connected to at least one bladder to protect against over-inflation. [Clause 9] A therapeutic compression device as described in Clause 8, wherein a check valve is set to open at a predetermined pressure. [Clause 10] A therapeutic compression device as described in Clause 8, wherein the check valve is configured to open at a user-selectable pressure. [Clause 11] A therapeutic compression device according to Clause 8, further comprising a vent valve operably connected to the main bladder for compression. [Article 12] The therapeutic compression device according to Clause 1, further comprising at least two tabs connected to either the proximal end of a main wrap or the distal end of a secondary wrap, wherein the tabs include connecting means configured to connect at least two therapeutic compression devices together along a plane. [Clause 13] A therapeutic compression device, A main lap having a distal end and a proximal end, comprising a main lap and at least one bladder, A sub-wrap having a proximal end and a distal end, wherein the proximal end of the sub-wrap is connected to the distal end of the main wrap, An expansion means connected to a bladder via an expansion port on the bladder, wherein the expansion port includes a check valve, A therapeutic compression device comprising: an assembly having a) a flexible member for attachment around a limb; a pressure mechanism having an air chamber that takes a first depressurized state and a second pressurized state, wherein the air chamber has a length and a width, the width of which is less than half the width of the flexible member; b) a pre-filled air bladder having a length and width smaller than the width of the air chamber; c) an absorbent foam, sponge, or dressing material coupled to the pre-filled air bladder; and d) a suction conduit adapted to be in fluid communication with the absorbent foam, sponge, or dressing material and to be coupled to a negative pressure source. [Clause 14] The therapeutic compression device according to Clause 13, wherein the assembly of a pre-filled air bladder, absorbent foam, sponge or dressing material, and suction conduit are bonded together as a unit with the suction conduit positioned between the absorbent foam, sponge or dressing material and the pre-filled air bladder. [Article 15] The suction conduit of the assembly terminates at one end within a fluid connector, as described in Clause 13 of the therapeutic compression device. [Clause 16] The therapeutic compression device according to Clause 13, wherein the suction conduit of the assembly terminates at one end in a branched tube having multiple holes. [Article 17] The therapeutic compression device according to Clause 13, wherein the branched tubes of the assembly extend at least partially around the peripheral portion of an absorbent foam, sponge, or dressing material. [Clause 18] A therapeutic compression device according to Clause 13, wherein a pre-filled air bladder of the assembly defines a central opening, and a suction conduit extends through the central opening. [Article 19] A therapeutic compression device according to Clause 13, wherein the pre-filled air bladder of the assembly has a strap, and an absorbent foam, sponge, or dressing material has a sealed periphery. [Clause 20] The therapeutic compression device according to Clause 13, wherein the pre-filled air bladder of the assembly has a peripheral portion provided with a biocompatible adhesive. [Article 21] A method for treating a limb that has a wound or ulcer, a) To obtain a therapeutic compression device including an assembly, wherein the assembly includes (i) a pressure mechanism having a flexible member for attachment around a limb and an air chamber that takes a first depressurized state and a second pressurized state; (ii) a pre-filled air bladder; (iii) an absorbent foam, sponge, or dressing material coupled to the pre-filled air bladder; and (iv) a suction conduit that is in fluid communication with the absorbent foam, sponge, or dressing material. b) Applying an absorbent foam, sponge, or dressing to the wound or ulcer and placing a pre-filled air bladder on top thereof, c) Placing the air chamber on a pre-filled air bladder and arranging the pressure mechanism on the limb portion, d) Connecting the suction conduit to a negative pressure source, e) A method comprising: bringing an air chamber into a second pressurized state to apply pressure to a wound or ulcer. [Article 22] The method according to Clause 21, wherein a second pressurized state is brought about simultaneously with the application of suction. [Article 23] The method according to clause 21, wherein the second pressurized state and the coupling with a negative pressure source for suction are obtained at different times. [Article 24] Suction is applied as described in Clause 21 when the pressure threshold is reached. [Article 25] The method according to Clause 21, wherein the pre-filled air bladder has a strap, and the method further comprises strapping the pre-filled air bladder to a limb. [Article 26] A therapeutic compression device for applying pressure to the legs of the human body, A foot bladder having a first inflatable chamber for containing fluid that enters the interior upon expansion, A leg bladder having a second inflatable chamber for containing fluid that enters the interior through expansion, A first means for positioning the leg bladder on the legs of a human body, A second means for positioning the foot bladder on the foot of a human body, A fluid conduit that fluidically connects the foot bladder and the leg bladder, wherein fluid can move through the fluid conduit from the foot bladder to the leg bladder and from the leg bladder to the foot bladder. An inflation means connected to the leg bladder via an inflation port on the leg bladder, comprising an inflation means including a check valve, A therapeutic compression device in which the expansion port is configured to be universally connectable to various expansion means. [Article 27] The therapeutic compression device according to Clause 26, wherein the first placement means is a first attachment member that wraps around the leg to secure the leg bladder to the leg. [Article 28] The therapeutic compression device according to Clause 27, wherein the first attachment member is a plurality of straps attached to a leg bladder. [Article 29] The therapeutic compression device according to Clause 27, wherein the first mounting member is a flexible member that wraps around the leg and over the leg bladder, and the leg bladder is sandwiched between the leg and the flexible member. [Clause 30] The therapeutic compression device according to Clause 26, wherein the second placement means is a second attachment member that wraps around the foot to secure the fluid foot bladder to the foot. [Article 31] The therapeutic compression device according to Clause 26, wherein the second attachment member is a plurality of straps attached to a foot bladder. [Article 32] The apparatus according to Clause 31, wherein multiple straps have adhesives or fasteners for attaching the straps to the foot. [Article 33] A therapeutic compression device as described in Clause 26, wherein the foot bladder is attached to the bottom of the heel of the foot. [Article 34] The therapeutic compression device according to Clause 26, wherein the first mounting member includes a secondary air bladder, and the flexible member has a wrapping configuration that wraps around the leg and an open, non-wrapping configuration, the secondary air bladder is supported by the flexible member in the wrapping configuration, and the secondary air bladder is capable of expanding to a pressurized state that supplies a compressive force directed radially inward so as to apply a compressive force to the leg when supported by the flexible member in the wrapping configuration. [Article 35] A therapeutic compression device as described in Clause 26, wherein the fluid is air, gas, or liquid. [Article 36] A therapeutic compression device according to Clause 26, wherein the foot bladder and leg bladder are arranged such that the leg bladder applies additional pressure to the foot when fluid is pushed out from the foot bladder. [Article 37] A therapeutic compression device as described in Clause 36, wherein the additional pressure is an additional pressure of 10-20 mmHg. [Article 38] A therapeutic compression device as described in Clause 37, wherein the leg bladder applies a pressure of 30-40 mmHg to the leg in a first state, and applies a pressure of 50-60 mmHg to the leg when the fluid is pushed out from the foot bladder. [Article 39] The therapeutic compression device according to Clause 26, wherein the fluid conduit has a first end and a second end, and each of the leg bladder and foot bladder has a nozzle for receiving one of the first and second ends of the fluid conduit. [Clause 40] The therapeutic compression device according to Clause 26, wherein the inflation means is selected from the group consisting of a manual pump, a static pump, an intermittent pump, an electric inflation pump, a battery-powered inflation pump, a gasoline-powered inflation pump, a static pneumatic compression pump, an intermittent pneumatic pump, and combinations thereof. [Article 41] A therapeutic compression device according to Clause 26, wherein the main and secondary bladder are configured to have one chamber that allows for continuous gradient pressure when connected to an inflation means. [Article 42] The therapeutic compression device according to Clause 26, further comprising a face connector, a check valve, and a valve cap, wherein the valve cap can release the pressure produced by the inflation means in the main and auxiliary bladder. [Article 43] The therapeutic compression device according to Clause 26, further comprising a check valve operably connected to the main bladder to protect against over-inflation. [Article 44] A therapeutic compression device as described in Clause 43, wherein a check valve is set to open at a predetermined pressure. [Article 45] A therapeutic compression device as described in Clause 43, wherein a check valve is configured to open at a user-selectable pressure. [Article 46] A therapeutic compression device according to Clause 26, further comprising a vent valve operably connected to the main bladder for compression. [Article 47] A method for applying pressure to a part of the human body, The method involves attaching a foot wrap to the sole of the foot and a leg wrap to the leg, wherein the foot wrap and leg wrap are fluidly connected by a fluid conduit. A method of walking, comprising walking such that when the heel of the foot strikes the ground, the foot wrap indents, increasing the pressure within the leg wrap by forcing fluid out of the foot wrap through fluid conduits into the leg wrap, and when the heel of the foot is lifted, the foot wrap expands as fluid is forcibly pushed out of the leg wrap through fluid conduits into the foot wrap. [Clause 48] The method according to Clause 47, wherein the foot wrap includes multiple straps for attaching the foot wrap to the foot. [Article 49] The method according to Clause 47, wherein the leg wrap includes a first nozzle, and the foot wrap includes a second nozzle, and the attachment further includes attaching fluid conduits to the first and second nozzles.

[0166] As described herein, the inventions of this disclosure have been described in relation to preferred and typical embodiments, but those skilled in the art will readily understand that various changes and / or modifications can be made to the inventions without departing from the spirit or scope of the inventions. Several embodiments of intermittent pressure devices, as well as methods for setting them up and likewise operating them, are described and illustrated herein. Specific embodiments of the inventions are described, but the inventions are not intended to be limited thereto, and the inventions are as broad as the scope permitted by the art, and the specification is intended to be read in the same manner. Thus, while specific shapes and sizes of inflatable bladder and straps are disclosed, it should be understood that other shapes, sizes, and mounting means can also be used. Velcro and adhesive means are disclosed to help secure the bladder to the leg and foot, but it should be understood that other types of mounting, such as hooks, snaps, or wraps, can be used. Furthermore, fluid conduits can be removably connected to the bladder using a threaded fitting portion or a bayonet lock, but it should be understood that other means known in the art can be used. Therefore, those skilled in the art should understand that further modifications can be made to the provided invention without departing from the intent and scope asserted in the claims.

Claims

1. Therapeutic compression devices (10, 100, 200, 300, 400, 1300, 1400), A main wrap (12, 103, 403) having a proximal end and a distal end, It comprises a sub-wrap (14, 104, 404) having a proximal end and a distal end, The proximal end of the sub-wrap (14, 104, 404) is connected to the distal end of the main wrap (12, 103, 403), and at least one bladder (22, 102, 402) is formed within the connected main wrap (12, 103, 403) and sub-wrap (14, 104, 404). The therapeutic compression device further comprises an inflation source (130, 600, 700, 810, 900, 1000, 1100) capable of inflating at least one bladder (22, 102, 402) to three set pressure values ​​of mmHg indicated by the dial (610, 614, 818, 1050, 1110) of the inflation source (130, 600, 700, 810, 900, 1000, 1100), The expansion source (130, 600, 700, 810, 900, 1000, 1100) is connected to the at least one bladder (22, 102, 402) via a single expansion port (24, 112, 500, 1305) on the main wrap (12, 103, 403), and the expansion source (130, 600, 700, 810, 900, 1000, 1100) is configured to prevent over-expansion of the at least one bladder (22, 102, 402). The expansion source (130, 600, 700, 810, 900, 1000, 1100) includes at least two check valves (630, 830, 980, 1220) to prevent over-expansion of the at least one bladder (22, 102, 402), and the expansion source (130, 600, 700, 810, 900, 1000, 1100) includes the dial (610, 614, 818, 1050, 1 The switch in 110) includes a switch which corresponds to one of the three set pressure values, and the switch in the expansion source includes three umbrella valves (616, 910, 1140), each umbrella valve (616, 910, 1140) which corresponds to one of the three set pressure values ​​indicated on the dial (610, 614, 818, 1050, 1110). The first umbrella valve (616, 910, 1140) is configured to maintain a selected and set pressure when the at least one bladder (22, 102, 402) is expanded by the expansion source (130, 600, 700, 810, 900, 1000, 1100), The second umbrella valve (616, 910, 1140) is an over-expansion umbrella valve, which, by partially opening, releases excess pressure exceeding the selected pressure while maintaining the expanded at least one bladder (22, 102, 402) at the selected pressure, and when the excess pressure is released, the over-expansion umbrella valve (616, 910, 1140) closes to maintain the selected pressure within the expanded at least one bladder (22, 102, 402). The third umbrella valve (616, 910, 1140) is configured to release all the pressure inside the at least one bladder (22, 102, 402) that has expanded during operation, and to deflate the at least one bladder (22, 102, 402), The single expansion port (24, 112, 500, 1305) can be connected to either a constant expansion source (130, 600, 700, 810, 900, 1000, 1100) or an intermittent expansion source, and when connected to a constant expansion source (130, 600, 700, 810, 900, 1000, 1100), it provides constant compression, or the at least one bladder (22, 102, 402) can be connected to the expansion source (130, 600, 700, 810, 900, 1000, A therapeutic compression device capable of providing intermittent compression to a part of the user's body when inflated by 1100), wherein the single inflation port (24, 112, 500, 1305) includes a check valve (520), the check valve (520) closing when the inflation source (130, 600, 700, 810, 900, 1000, 1100) is removed, maintaining a set constant pressure within the inflated at least one bladder (22, 102, 402).

2. The therapeutic compression device (10, 100, 200, 300, 400, 1300, 1400) according to claim 1, wherein the main wrap (12, 103, 403) includes (a) an inner sheet (106, 406) configured and fitted to be positioned facing a limb when in use, and (b) an outer sheet (108, 408) bonded to the inner sheet (106, 406) such that at least one bladder (22, 102, 402) is defined between the inner sheet (106, 406) and the outer sheet (108, 408).

3. The therapeutic compression device (10, 100, 200, 300, 400, 1300, 1400) according to claim 1, wherein the inflation source (130, 600, 700, 810, 900, 1000, 1100) is selected from the group consisting of a manual pump, a hand pump, a foot pump, a mechanical pump, an automatic pump, an electric pump, a battery-operated pump, a pneumatic pump, a negative pressure pump, a suction or vacuum pump, and combinations thereof.

4. The therapeutic compression device (10, 100, 200, 300, 400, 1300, 1400) according to claim 1, wherein the at least one bladder (22, 102, 402) is configured to have one chamber (22, 102, 114, 214, 214', 214'', 246, 402) that allows for continuous gradient pressure when expanded after being connected to the expansion source (130, 600, 700, 810, 900, 1000, 1100).

5. The therapeutic compression device (10, 100, 200, 300, 400, 1300, 1400) according to claim 1, wherein the expansion source (130, 600, 700, 810, 900, 1000, 1100) includes a real-time pressure measurement mechanism.

6. The device further comprises an elbow connector (510) and a dust cap (530), the dust cap (530) having a distal end (530) that extends in a direction and shape to fit into the elbow connector (510) within the single expansion port (24, 112, 500, 1305), the distal end (530) being inserted into the single expansion port (24, 112, 500, 1305). The therapeutic compression device (10, 100, 200, 300, 400, 1300, 1400) according to claim 1, wherein the check valve (520) of the single expansion port (24, 112, 500, 1305) is pressed down, thereby manually pressing down the check valve (520) of the single expansion port (24, 112, 500, 1305) and deflating the expanded at least one bladder (22, 102, 402).

7. The therapeutic compression device (10, 100, 200, 300, 400, 1300, 1400) according to claim 1, further comprising at least two fasteners (1405) selected from the group consisting of face fasteners, buckles, straps, buttons, snaps, zippers, and combinations thereof, wherein the fasteners (1405) connect together at least two therapeutic compression devices (10, 100, 200, 300, 400, 1300, 1400), such as a forearm therapeutic compression device (1400) and an upper arm therapeutic compression device (1400).

8. A therapeutic compression device (10, 100, 200, 300, 400, 1300, 1400) for applying pressure to the legs and feet of the human body, A wrap having leg bladder (102, 312, 402) and foot bladder (102, 314, 314', 314'', 402), The foot bladder (102, 314, 314', 314'', 402) has a first inflatable chamber for containing fluid that enters the interior upon expansion, The leg bladder (102, 312, 402) has a second inflatable chamber for containing the fluid that enters the interior upon expansion, A first means for fixing the leg bladder (102, 312, 402) onto the leg of the human body, A second means for fixing the foot bladder (102, 314, 314', 314'', 402) onto the foot of the human body, A fluid conduit (22, 102, 316) that fluidically connects the foot bladder (102, 313, 314', 314'', 402) and the leg bladder (102, 312, 402), wherein fluid can move from the foot bladder (102, 314, 314', 314'', 402) to the leg bladder (102, 312, 402) and from the leg bladder (102, 312, 402) to the foot bladder (102, 314, 314', 314'', 402) through the fluid conduit (22, 102, 316), An expansion source (130, 600, 700, 810, 900, 1000, 1100) is provided, which is capable of expanding the leg bladder (102, 312, 402) to a plurality of set pressure values ​​in mmHg indicated by the dial (610, 614, 818, 1050, 1110) of the expansion source, The expansion sources (130, 600, 700, 810, 900, 1000, 1100) are connected to the leg bladder (102, 312, 402) via a single expansion port (24, 112, 500, 1305) on the leg bladder (102, 312, 402), and the expansion sources (130, 600, 700, 810, 900, 1000, 1100) are configured to prevent over-inflation of the leg bladder (102, 312, 402). The expansion source (130, 600, 700, 810, 900, 1000, 1100) includes at least two check valves (630, 830, 980, 1220) to prevent over-expansion of the leg bladder (102, 312, 402), and switches within the dials (610, 614, 818, 1050, 1110), each of the plurality of set pressure values. The switch of the expansion source (130, 600, 700, 810, 900, 1000, 1100) corresponds to one of the three set pressure values ​​indicated on the dial (610, 614, 818, 1050, 1110), and each individual umbrella valve (616, 910, 1140) corresponds to one of the three set pressure values ​​indicated on the dial (610, 614, 818, 1050, 1110). The first umbrella valve (616, 910, 1140) is configured to maintain a selected and set pressure when the leg bladder (102, 312, 402) is inflated by the expansion source (130, 600, 700, 810, 900, 1000, 1100), The second umbrella valve (616, 830, 910, 1140) is an over-expansion umbrella valve, which, by partially opening, maintains the expanded leg bladder (102, 312, 402) at the selected pressure while releasing excess pressure exceeding the selected pressure, and when the excess pressure is released, the over-expansion umbrella valve (616, 830, 910, 1140) closes to maintain the set pressure within the expanded leg bladder (102, 312, 402) and the foot bladder (102, 314, 314', 314'', 402). The third umbrella valve (616, 830, 910, 1140) is configured to release all the pressure in the leg bladder (102, 312, 402) and foot bladder (102, 314, 314', 314'', 402) that are expanded when operated, and to deflate the leg bladder (102, 312, 402) and foot bladder (102, 314, 314', 314'', 402), The single inflation port (24, 112, 500, 1305) can be connected to either a constant inflation source (130, 600, 700, 810, 900, 1000, 1100) or an intermittent inflation source, and when the leg bladder (102, 312, 402) and the foot bladder (102, 314, 314', 314'', 402) are inflated by the inflation source (130, 600, 700, 810, 900, 1000, 1100), a constant compression or A therapeutic compression device capable of providing intermittent compression, wherein the single inflation port (24, 112, 500, 1305) includes a check valve (520), the check valve (520) closing when the inflation source (130, 600, 700, 810, 900, 1000, 1100) is removed, maintaining a set constant pressure within the inflated leg bladder (102, 312, 402) and foot bladder (102, 314, 314', 314'', 402).

9. The therapeutic compression device (10, 100, 200, 300, 400, 1300, 1400) according to claim 8, wherein the first means for fixing the leg bladder (102, 312, 402) is a first mounting member that wraps around the leg to fix the leg bladder (102, 312, 402) to the leg.

10. The therapeutic compression device (10, 100, 200, 300, 400, 1300, 1400) according to claim 9, wherein the first mounting member is a plurality of straps (18, 32a, 32b, 32c, 32d, 223, 277, 332, 422, 424) attached to the leg bladder (102, 312, 402).

11. The therapeutic compression device (10, 100, 200, 300, 400, 1300, 1400) according to claim 9, wherein the first mounting member is a flexible member that is wrapped around the leg portion and over the leg bladder (102, 312, 402), and the leg bladder (102, 312, 402) is sandwiched between the leg portion and the flexible member.

12. The therapeutic compression device (10, 100, 200, 300, 400, 1300, 1400) according to claim 8, wherein the second means for fixing the foot bladder (102, 314, 314', 314'', 402) is a second attachment member that wraps around the foot to fix the foot bladder (102, 314, 314', 314'', 402) to the foot.

13. The therapeutic compression device (10, 100, 200, 300, 400, 1300, 1400) according to claim 12, wherein the second attachment member is a plurality of straps (18, 32a, 32b, 32c, 32d, 223, 277, 332, 352, 352', 352'', 354, 354', 354'', 422, 434) attached to the foot bladder (102, 314, 314', 314'', 402, 434).

14. The therapeutic compression device (10, 100, 200, 300, 400, 1300, 1400) according to claim 13, wherein the plurality of straps (18, 32a, 32b, 32c, 32d, 223, 277, 332, 352, 352', 352'', 354, 354', 354'', 422, 434) have an adhesive or a fastener for attaching the plurality of straps (18, 32a, 32b, 32c, 32d, 223, 277, 332, 352, 352', 352'', 354, 354', 354'', 422, 434) to the foot.

15. The therapeutic compression device (10, 100, 200, 300, 400, 1300, 1400) according to claim 8, wherein the foot bladder (102, 314, 314', 314'', 402) is attached to the bottom of the heel of the foot.

16. The therapeutic compression device according to claim 8 (10, 100, 200, 300, 400, 1300, 1400), wherein the fluid is air, gas, or liquid.

17. The therapeutic compression device (10, 100, 200, 300, 400, 1300, 1400) according to claim 8, wherein the foot bladder (102, 314, 314', 314'', 402) and the leg bladder (102, 312, 402) are arranged such that the leg bladder (102, 312, 402) applies additional pressure to the leg when the fluid is pushed out from the foot bladder (102, 314, 314', 314'', 402).

18. The therapeutic compression device according to claim 17 (10, 100, 200, 300, 400, 1300, 1400), wherein the additional pressure is an additional pressure of 10 to 20 mmHg.

19. The therapeutic compression device (10, 100, 200, 300, 400, 1300, 1400) according to claim 18, wherein the leg bladder (102, 312, 402) applies a pressure of 30 to 40 mmHg to the leg in a first state, and applies a pressure of 50 to 60 mmHg to the leg when the fluid is pushed out from the foot bladder (102, 314, 314', 314'', 402).

20. The therapeutic compression device (10, 100, 200, 300, 400, 1300, 1400) according to claim 8, wherein the fluid conduit (22, 102, 316) has a first end and a second end, and each of the leg bladder (102, 312, 402) and the foot bladder (102, 314, 314', 314'', 402) has a nozzle for receiving one of the first and second ends of the fluid conduit (22, 102, 316).

21. The therapeutic compression device (10, 100, 200, 300, 400, 1300, 1400) according to claim 8, wherein the inflation source (130, 600, 700, 810, 900, 1000, 1100) is selected from the group consisting of a manual pump, a hand pump, a foot pump, a mechanical pump, an automatic pump, an electric pump, a battery-operated pump, a pneumatic pump, a negative pressure pump, a suction or vacuum pump, and combinations thereof.

22. The therapeutic compression device (10, 100, 200, 300, 400, 1300, 1400) according to claim 8, wherein the leg bladder (102, 312, 402) and the foot bladder (102, 314, 314', 314'', 402) are configured to have one chamber that enables continuous gradient pressure when connected to the inflation source (130, 600, 700, 810, 900, 1000, 1100).

23. The device further comprises an elbow connector (510) and a dust cap (530), the dust cap (530) having a distal end (530) that extends in a direction and shape to fit into the elbow connector (510) within the single expansion port (24, 112, 500, 1305), and when the distal end (530) is inserted into the single expansion port (24, 112, 500, 1305), it pushes down the check valve (520) of the single expansion port (24, 112, 500, 1305) The therapeutic compression device (10, 100, 200, 300, 400, 1300, 1400) according to claim 8, wherein (520) is manually pressed down to release the pressure created by the expansion source (130, 600, 700, 810, 900, 1000, 1100) in the leg bladder (102, 312, 402) and the foot bladder (102, 314, 314', 314'', 402).

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