Multi-bladder therapeutic compression devices, systems, and methods of use

Abstract

A therapeutic compression device for a body limb of the present invention comprises at least one wrap having at least two bladders configured to apply compression or pressure to the limb; and a universal inflation port for each bladder, the universal inflation port connectable to both the static inflation device and the intermittent inflation device and comprising a sealing device configured to include an open position and a closed position wherein the closed position maintains the at least one bladder in an inflated state or a deflated state, and when coupled to the inflator, the sealing device is in the open position such that the at least one bladder is in the same inflated state as the inflator. A method includes the steps of inflating and deflating each of the bladders to the same or different pressure levels and also enabling sequential inflation and deflation of each individual bladder.

Description

[0001] Related patent applications

[0002] This application claims priority to U.S. provisional application serial number 63 / 425,662, filed on November 15, 2022, and entitled “Multiple Bladder inventive therapeutic compression apparatus, System and Methods of use,” and is a continuation-in-part of U.S. application serial number 17 / 608,323, filed on November 2, 2021, and entitled “Therapeutic Compression System and Methods of Use,” which is based on application serial number PCT / US2020 / 31227 filed on May 2, 2020, and on application serial number 62 / 842,165 filed on May 2, 2019, the entire contents of which are hereby incorporated by reference into this document for all purposes. Background Art Technical Field

[0003] The subject invention generally relates to a system for applying compression to one or more limbs simultaneously, and more particularly, to a system for applying compression to an individual's leg and / or foot and / or thigh in conjunction with the treatment of conditions such as deep vein thrombosis (DVT), chronic venous insufficiency (CVI), lymphedema, and swelling. The system comprises at least one therapeutic compression device of the present invention, such as a wrap having more than one bladder and inflation means for the bladders, wherein the device is capable of applying compression to a limb, such as the entire leg, thigh, calf, knee, and / or foot of a patient; and a port connected to the inflation means, wherein the bladders are inflated simultaneously or sequentially at the same or different pressure levels.

[0004] Related technical background

[0005] Normally, healthy muscles, such as those in the legs, squeeze the deep veins in the legs and feet to help move blood back to the heart. One-way valves in the deep leg veins keep blood flowing back toward the heart. However, prolonged standing or sitting can cause the walls of the deep leg veins to stretch. Over time, in susceptible individuals, this can weaken the vein walls and damage the valves, causing blood to pool in the veins and increase venous pressure. This can lead to a condition known as chronic venous insufficiency (CVI).

[0006] Treatment for CVI typically involves the use of compression stockings or medical hosiery to reduce chronic swelling. Compression stockings are elastic stockings that compress the veins to improve venous circulation and prevent excessive blood backflow. Compression stockings also help heal skin sores or stasis ulcers that often occur with CVI. Compression bandages are also commonly used to apply pressure to the legs. The bandage is applied with constant tension to create a gradient of compression, with the highest pressure at the ankle and less pressure or compression at the knee or thigh area, due to the anatomy of the leg. However, this technique is difficult and is usually performed by highly skilled caregivers.

[0007] Highly effective mechanical compression devices for treating CVI have also been developed, which are disclosed in, for example, U.S. Patents Nos. 7,276,037 and 7,559,908, the disclosures of which are incorporated herein by reference in their entirety. These devices include a flexible wrapper that carries a manually inflatable air bag and is adapted to be securely positioned around an individual's leg to apply localized pressure to the treatment site. Some of these devices also include a fluid-filled wound dressing that, when the venous ulcer is encapsulated by the flexible wrapper, can be applied directly to the skin for applying localized pressure and even medication to the venous ulcer. Although these devices are effective for applying localized compression to the leg, they are not configured to apply localized compression to the user's calf, thigh, or foot to reduce, treat, or prevent swelling and further improve venous circulation to the calf, thigh, foot, or entire leg.

[0008] Lymphedema, also known as lymphatic obstruction, is another condition characterized by localized fluid retention and tissue swelling, and is caused by a damaged lymphatic system. Treatment for lymphedema varies depending on the severity of the edema and the extent of fibrosis in the affected limb. The most common treatments for lymphedema are manual compression lymphatic massage, compression garments, or bandages. Elastic compression garments are typically worn by people with lymphedema on the affected limb after undergoing complete decongestive therapy to keep the edema down.

[0009] Compression bandaging (also known as wrapping) involves applying several layers of padding and a short-stretch bandage to the affected area. Short-stretch bandages are preferred over long-stretch bandages (such as those commonly used to treat sprains) because long-stretch bandages cannot create the appropriate therapeutic tension required to safely reduce lymphedema and can actually end up creating a tourniquet effect. During activity, whether exercise or daily activities, short-stretch bandages enhance the pumping action of the lymphatic vessels by providing them with increased resistance against pushing. This promotes lymphatic flow and helps soften areas of fluid swelling.

[0010] Known methods for treating CVI and lymphedema, such as compression bandaging, have several disadvantages. Bandaging is time-consuming, and its effectiveness is limited by the skill of the provider. In some cases, the bandage may be applied too tightly or too loosely and may slip from its intended position, thereby reducing its effectiveness. When this happens, the bandage must be removed and reapplied, thereby further increasing the application time and reducing the consistency of the applied treatment. In addition, when a compression bandage is applied to the calf, knee, or thigh area of the leg, the bandage may slide down the leg when the user walks or even moves around in bed, which may be due to the anatomical shape of the thigh tapering towards the knee area and the anatomical shape of the calf tapering towards the ankle area.

[0011] The effectiveness of many current compression therapies is limited by the application of current products. Because current compression therapies are applied using manual wraps or electromechanical systems, they require skilled medical professionals to apply and / or require the patient to remain still for extended periods of time. While stockings and / or bandages can be worn and self-applied by the patient, they are very difficult for the patient to put on and pose a challenge to unskilled medical professionals to apply consistently and effectively. However, once the user walks or moves around, the stocking and / or bandage tends to slide down the thigh toward the knee and down the leg toward the ankle.

[0012] CVI and lymphedema can also lead to deep vein thrombosis (DVT), a condition that causes blood clots, particularly in the lower legs. When patients are not ambulatory, they face an increased risk of developing blood clots. These blood clots, which typically accumulate or lodge in a patient's calf or thigh, are not overly dangerous in themselves. However, when the blood clots break loose, they can cause pulmonary emboli, which can lodge in the patient's heart, brain, or lungs, where they can cause significant damage or death. An estimated 2 to 2.5 million Americans suffer from DVT each year, leading to 600,000 patients seeking medical care, of which 300,000 die from the effects of pulmonary embolism. Of those who develop DVT, one-third will have long-term complications (post-thrombotic syndrome), such as swelling, pain, discoloration, and peeling of the affected limb. In addition, approximately one-third (approximately 33%) of those diagnosed with a blood clot will have a recurrence within ten years. Therefore, there is a need for a system, device, and method for preventing, reducing, and / or treating DVT that is easy for patients to use at home, ambulatory, as they can work and walk around inside and outside the home, and simpler than currently known DVT systems. The number of Americans who suffer from DVT may be affected or at increased risk due to the following reasons: (a) recent surgery, which reduces the patient's mobility and increases inflammation in the body, which can lead to clotting; (b) medical conditions that limit mobility, such as injury or stroke; (c) long-term travel that limits mobility; (d) deep vein injury; (e) inherited blood disorders that increase clotting; (f) pregnancy; (g) cancer treatment; (h) smoking; (i) obesity; and (j) many other conditions. Therefore, there is a need for a system, device, and method for treating DVT.

[0013] Many current treatment options for CVI and lymphedema lead to venous ulcers, including the use of currently known devices, equipment, bandages, stockings, socks, etc. Venous ulcers are skin damage and loss above the ankle caused by leg vein problems. Venous ulcers usually develop on either side of the lower leg, above the ankle and below the calf. They are difficult to heal and often recur. They also develop near the groin area on the thigh, on the inner thigh part or the outer thigh area, and on the leg. In addition, venous ulcers can develop around the knee, behind the knee, along the side, and in front of the knee. In addition, it is known that due to the structure of the lower leg and foot and the fact that the foot moves and is under pressure when walking, ulcers or wounds on the lower leg including the foot are usually difficult to treat. Conventional compression bandages, and even non-compression bandages, will not adhere to the foot, whether on the top of the arch of the foot or under the sole of the foot. In addition, the foot area may become hot and humid, resulting in a lack of adhesion, but diabetic foot may be extremely dry, and it is necessary to select an adhesive that does not stimulate or affect the dry skin of diabetic individuals. The structure of the foot can also be problematic in keeping a bandage or wound dressing in place and adhered to the foot.

[0014] Other leg ulcers, such as diabetic ulcers, can form on or under the soles of the feet, on the toes, between the toes, on the tops of the feet, on the arches of the feet, and even on the ankles and heels. People with diabetes may have more foot ulcers, sometimes related to a complication called neuropathy, which can cause a person to lose sensation in their feet. Scrapes, cuts, or puncture wounds on the skin can turn into ulcers, but if a person has neuropathy and cannot feel the pain of a cut or wound, they may not be aware of the ulcer. Ulcers can lead to infection, and in extreme cases, the infection cannot heal, resulting in amputation of part of the foot or toe. It is estimated that approximately 15% of people with diabetes in the United States will develop a foot or toe ulcer, and approximately 14% to 24% of people with diabetes in the United States will require amputation after developing an ulcer. Diabetic foot ulcers are the leading cause of foot amputations. As of 2020, an estimated 537 million people worldwide have diabetes, of whom approximately 19% to 34% will develop a diabetic foot ulcer in their lifetime. Unfortunately, approximately 20% of individuals who develop a diabetic foot ulcer will require a lower limb amputation, either a minor amputation (below the ankle), a major amputation (above the ankle), or a combination of both. More than 80% of amputations begin with a foot ulcer. More extreme, approximately 10% of people with a diabetic foot ulcer will die within a year of their first diabetic foot ulcer diagnosis. Additionally, foot and toe ulcers can occur in many people but may be more common in Black people, Native Americans, and Hispanics. Individuals are also at higher risk if they have eye, kidney, or heart disease related to diabetes. Approximately 15% of people with diabetes develop an ulcer, which is usually located on the soles of the feet. Some of these people will be hospitalized for complications.

[0015] Individuals are also at higher risk for developing ulcers in the lower legs, feet, and toes if they have any of the following conditions: circulation problems, heart disease, obesity, foot conditions such as bunions or hammertoes, kidney disease, and some lifestyle factors like smoking and alcohol consumption. Therefore, increasing circulation in the lower legs and feet and preventing or reducing tissue swelling, DVT, and CVI are necessary for these patients and users. Additionally, arterial ulcers can be caused by a condition called peripheral arterial disease, which reduces blood flow to the extremities. When this occurs, tissue in the lower legs and feet may begin to die. Ulcers formed by reduced blood flow are called arterial ulcers. Arteries are blood vessels that carry blood from the heart to the rest of the body, including the feet and toes. Anyone can develop an arterial ulcer, but individuals who smoke or have diabetes, high blood pressure, or high cholesterol are at higher risk. Therefore, there is a need for a therapeutic compression device for the leg that treats or prevents venous and arterial ulcers on the leg or foot, that has an SSI greater than 10 to help increase circulation while reducing or preventing tissue swelling, and that also reduces, treats or prevents lymphedema, CVI, DVT and other ulcers, that is also easy to apply by an individual alone or by a medical professional, and that improves healing time, reduces complications and aids in overall healing.

[0016] The veins of the leg are divided into superficial and deep systems based on their location relative to the fascia. The deep veins lie within the fascia and are responsible for venous drainage of the leg muscles. The deep veins unite to form the popliteal and femoral veins. Dilated, valveless sinusoids are also located within the fascia (more specifically in the soleus and gastrocnemius muscles). When the leg is at rest, these sinusoids are filled with blood.

[0017] The long saphenous vein, which runs along the inside of the leg from the foot to the groin, and the short saphenous vein, which runs at the back of the calf from the foot to the knee, are the main vessels of the superficial venous system. These vessels lie outside the fascia and are responsible for venous return from the skin and subcutaneous fat. Compression of the long saphenous vein may be recommended in the treatment of certain conditions, while in other conditions, compression of the long saphenous vein on the inside of the leg is less recommended and compression of the short saphenous vein in the leg, which runs at the back of the leg (including the thigh), is more recommended. Communicating veins, sometimes called perforators because they penetrate the deep fascia, connect the two systems. Like the other veins in the leg, the perforators include valves that only allow blood to flow in one direction, from the external or superficial system inward to the deep veins.

[0018] The venous pressure at the ankle of a supine subject is approximately 10 mmHg, but this will rise significantly when standing due to the increase in hydrostatic pressure (equivalent to the weight of a vertical column of blood stretched from the measurement point to the right auricle of the heart). During walking, as the foot flexes dorsally, contraction of the calf muscles compresses the deep veins and soleus sinus, emptying them of blood. When the foot plantar flexes, the pressure in the veins drops, the proximal valve closes, and the veins are refilled with blood from the superficial system through the perforator. During this cycle, in a normal leg, the distal valves of the deep veins and the valve of the perforator will ensure that the discharged blood can only go in one direction - upwards back to the heart.

[0019] Blockage or damage to the venous system will result in an interruption of normal blood flow, which can manifest itself in a variety of different ways depending on the location and extent of the damage. If valves in the superficial system are affected, venous return will be impaired, and blood may accumulate in the veins, causing them to become dilated, leading to the formation of varicosities (varicose veins). Such varicose veins may be located in the thigh, knee, calf, ankle, or foot areas of the user's legs.

[0020] If the function of the perforator valve is impaired, the action of the calf muscle pump will tend to cause blood to flow in the opposite direction into the superficial system, increasing the likelihood of damaging the superficial vessels. Likewise, current compression therapies are performed with manual wraps or electromechanical systems, so they require a skilled medical professional to apply and / or require the patient to remain still for extended periods of time. There is a need for a new system to treat this type of medical problem. One in which there may be minimal blood flow upwards into the thigh and the rest of the body, resulting in problems for the patient along the body, including the patient's thigh, calf, ankle, and entire leg. Therefore, there is a need for a compression device having multiple bladders whereby compression is applied to the leg at different levels of compression in different bladders, or whereby the bladders are inflated and deflated by intermittent pressure on the device, thereby applying different levels of compression across the leg.

[0021] Following a deep vein thrombosis (DVT), which results in complete or partial obstruction of a deep vein, the unrelieved pressure on the perforator valves created by the calf muscle pump can cause these valves to become incompetent. If this occurs, pressure in the superficial system rises dramatically, which can force proteins and red blood cells out of the capillaries and into the surrounding tissues. Here, the red blood cells break down, releasing a red pigment that stains the skin and is an early indicator that an ulcer may form. Ulcers can form anywhere on the body, including the legs, groin, thighs, knees, calves, ankles, and feet.

[0022] Venous leg ulcers are typically shallow and red in color. The skin around the ulcer often changes color due to the aforementioned staining. Incompetent perforated venous valves can also cause dilation of the ankle veins, which manifest as thin red lines around the ankle and any area of the leg, thigh, knee, calf, or foot. This condition, called ankle laxity, is also diagnostic of venous ulcers. This condition can also be seen in the thigh, including the inner mid-thigh area or the outer thigh area, or around the knee or groin area.

[0023] Arteries carry oxygenated blood from the heart to the rest of the body. Veins return oxygen-depleted blood to the heart. When the veins in the lower extremities of the body have difficulty transporting blood back to the heart, a condition called chronic venous insufficiency (CVI), also known as chronic venous disease (CVD), develops. The most common cause of CVI is a blood clot in the deep veins of the legs, a disease known as deep vein thrombosis (DVT). CVI is also caused by pelvic tumors and vascular malformations, and sometimes occurs for unknown reasons. When a person stands or sits, the blood in the leg veins flows in an upward direction. When a person walks, the muscles in the calf and feet contract to squeeze the veins and push the blood upward. To keep blood flowing upward and prevent it from flowing downward, the veins contain one-way valves. CVI occurs when these valves are damaged and allow blood to leak back in the opposite direction. Such valve damage may occur due to aging, prolonged sitting or standing, or a combination of aging and reduced mobility. When veins and valves weaken and blood cannot flow properly upward to the heart, blood pressure in the veins of the lower extremities can remain elevated for long periods of time, leading to CVI. This condition is more common in older individuals and, if not properly treated, can lead to broken capillaries, local tissue inflammation, internal tissue damage, varicose veins, ulcers, and open sores on the skin's surface. Broken capillaries can be seen on patients' legs, including the thighs, knees, and groin.

[0024] CVI reduces the capacity of the venous system and increases the workload of the lymphatic system in the affected area. The lymphatic system must then transport larger volumes of water and protein to reduce the fluid load in the affected tissues of the legs, a situation that is particularly challenging for patients with lymphedema, varicose veins, and other lower extremity pathologies.

[0025] A non-surgical option commonly used to help prevent or treat the aforementioned leg and 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 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 ambulation. Increasing pressure in the tissues beneath the skin reduces excess fluid leakage from the capillaries and increases absorption of tissue fluid by the capillaries and lymphatic vessels. In addition, the increased pressure reduces the size of the veins, which allows blood to flow more quickly and helps prevent pooling. Compression stocking tightness typically varies between 15 mmHG and 50 mmHG. The tightness of a given stocking depends on its specific configuration and category. For example, stockings with a compression pressure of 15 mmHG to 20 mmHG are considered mild compression stockings. Class I stockings are 20 mmHg to 30 mmHg, Class II stockings are 30 mmHg to 40 mmHg, and Class III stockings are 40 mmHg to 50 mmHg.

[0026] While such compression stockings are a common, non-invasive treatment for leg ailments, they present a number of problems. Putting on tight-fitting stockings can be tedious or time-consuming, and may require the assistance of another person if the wearer is injured, elderly, or has some form of disability. Any tight-fitting stocking intended for the lower leg must be donned by the user over the foot, ankle, and upper calf. Putting on tight-fitting stockings over the thigh area is even more difficult because the user must pull the tight-fitting stocking over the foot, ankle, calf, knee, and finally to the thigh area. Also, due to the shape of the calf and thigh, these tight-fitting stockings will slide down the leg at certain points as the user walks or moves around.

[0027] Furthermore, the pressure exerted by the stockings typically remains relatively constant during use, without any option to increase or decrease the tightness level. When compression stockings are worn repeatedly, they lose elasticity and, therefore, tightness over time. Once such prescribed elasticity and tightness are lost, the stockings have little or no value and need to be replaced due to their sagging, requiring the purchase of a new pair of stockings to achieve the desired compression. Furthermore, given the shape of the thigh, the top or upper portion of the stocking must be very tight to prevent it from sliding down the thigh, which in turn can lead to its own complications due to excessive tightness.

[0028] Medical stockings represent a useful and convenient way to apply compression to normally shaped legs to prevent the development or recurrence of leg ulcers. However, these stockings are of limited value in treating active ulcers and are difficult to apply over dressings. In such cases, compression bandages currently represent the treatment of choice. Compression bandages apply pressure to the limb that is proportional to the bandage tension but inversely proportional to the radius of curvature of the limb to which it is applied. This means that a bandage applied at constant tension to a normally proportioned limb will automatically produce a gradient of compression, with the highest pressure at the knee. As the circumference increases, this pressure gradually decreases towards the thigh.

[0029] As can be readily appreciated, applying uniform tension to a compression bandage once it has been applied to the limb being treated is cumbersome and difficult, and can only be accomplished by highly skilled caregivers. Furthermore, once secured to the limb being treated, care and attention must be taken to ensure that the bandage does not slip or shift, as this would result in the formation of multiple layers, which in turn could lead to localized areas of high pressure, which could place the patient at immediate risk of skin necrosis.

[0030] Mechanical compression therapy has also been proposed. An exemplary compression device is described in U.S. Pat. No. 5,031,604 to Dye. As generally described in column 2, line 33 and below, an arrangement of chambers around the legs is provided. An active pneumatic control system controls the pressure in the chamber to squeeze the leg near the ankle and then squeeze upward toward the knee in order to move blood from the limbs toward the heart. As described in column 4, lines 20-59 of U.S. Pat. No. 6,488,643 to Tumey et al., the compression level generated mechanically can produce unnoticed local ischemia (i.e., local tissue anemia) at similar compression levels obtained by bandaging. It can also produce warping (i.e., reduced pulsating blood flow in the legs). The pneumatic control system is also bulky and heavy, which severely limits the patient's mobility during treatment. In addition, the pneumatic control system cannot provide a mechanism to ensure that excessive pressure that may cause necrosis is not applied to the limb to be treated. These limitations have resulted in most mechanical compression devices being prohibited for use in patients exhibiting DVT. Therefore, those skilled in the art have heretofore had to avoid the use of such mechanical compression devices for the treatment of venous ulcers or edema of the extremities.

[0031] DVT is widely recognized as a major risk factor for patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA). Without prevention (prophylactic treatment), up to 80% of orthopedic surgery patients will develop DVT, and 10% to 20% will develop pulmonary embolism (PE). Even when appropriate preventive measures are taken, an estimated 3% of orthopedic surgery patients will develop DVT, and 1.5% will develop PE. DVT and PE remain the most common causes of emergency readmission and death after joint replacement surgery. In a survey conducted, patients surveyed after THA or TKA reported a wide range of problems with their prevention: 83% reported problems with lack of walking, 74% used compression stockings, 57% used mechanical compression, 58% used anticoagulant pills, 46% used anticoagulant injections, and 42% used aspirin. (https: / / www.stoptheclot.orn / about-clots / toolkir-for-knee-hip-replacement-patients / orthopedic-surgery-fact-sheet / ) Therefore, there is a need for a prophylaxis that is easy for the patient to use at home or in the workplace (outside of a hospital setting or with the assistance of a medically trained professional as described above) that is mobile so that the patient can walk and return to life activities.

[0032] Knee replacements can also lead to DVT as a post-operative complication. Following knee surgery, most DVTs occur in the lower leg. While less likely to result in PE, these clots are more difficult to detect. Less than a third of DVT patients experience typical signs of calf discomfort, swelling, venous distension, or foot pain. It has been noted that the risk of developing DVT persists for at least three months after total knee replacement. The risk is greatest two to five days after surgery; the second peak development period occurs approximately 10 days after surgery. Currently, it has been noted that patients at home are experiencing an increase in DVT due to lack of activity and mobility. While a patient is in the hospital, they can be connected to an electric pump integrated with the therapeutic compression device of the present invention. However, once discharged, current products are limited as described herein, such that most therapeutic compression devices of the present invention are manually pumped, allowing the patient to walk, work, etc., and those that are electric typically need to be tethered to an electrical outlet, or the electric pump is integral to the therapeutic compression device of the present invention and is not practical for daily life. Therefore, there is a need for a system that can be used to prevent, reduce or even treat DVT, as well as reduce the risk of PE, that is practical, mobile and easily administered by patients following total knee replacement surgery, or any other knee, hip or leg surgery. There is a need that allows the user to walk around while maintaining the compression characteristics, while not being limited to an electrical plug or some other separate source that continues, maintains or even increases and then decreases the compression. There is a need for an integrated valve or other device in a compression garment, wrap, device or apparatus to maintain the set compression.

[0033] Further compression therapy has been discussed in "Effect of High-pressure, Intermittent Pneumatic Compression for the Treatment of Peripheral Arterial Disease and Critical Limb Ischemia in Patients Without a Surgical Option" by Oscar M. Alvarez, Martine E. Wendelken, Lee Markoqitz, and Christopher Comfort (Wounds, Vol. 27, No. 11, pp. 293-301, November 2015), in which thirty-six patients with symptomatic peripheral arterial disease (PAD) or critical limb ischemia (CLI) who were experiencing claudication pain, chronic rest pain, numbness, and ischemic lower leg / foot ulcers were randomized into two treatment groups. Eighteen of these patients received high-pressure intermittent pneumatic compression (HPIPC) treatment for 60 minutes twice daily for 16 weeks, and 16 subjects received standard care, which consisted of an exercise regimen consisting of walking for 20 minutes twice daily for 16 weeks. The HPIPC device delivers a bidirectional pressure of 120 mmHg. The cycle time provides 4 seconds (+ / - 0.5 seconds) of sequential compression, followed by a 16-second rest period (+ / - 3.0 seconds), resulting in a 20-second cycle or 3 cycles per minute. The study was designed to measure patient-centered outcomes. The primary endpoint was peak walking time (PWT), which was defined as the time to reach maximum tolerated claudication pain. The conclusion at the end of the study was that a therapy consisting of HPIPC for 2 hours per day for 16 weeks significantly improved PWT, reduced rest pain, and improved cure rate, physical function, and physical pain. There were no device-related complications, allowing long-term use. A further conclusion is that HPIPC provides an excellent alternative for palliative care of patients with PAD and CLI symptoms. Therefore, there is a need for a system comprising HPIPC that can be easily administered by patients in a home environment.

[0034] 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 person's leg for use in conjunction with the treatment of varicose veins. The device comprises a flexible member and at least one air chamber integral therewith, the air chamber being adapted to securely wrap around a person's leg. A tube in fluid communication with the air chamber extends to an air pumping mechanism that operates to inflate the air chamber to a pressurized state. The flexible member preferably includes an opening at the level of the knee joint to allow the patella to protrude therethrough. Furthermore, the flexible member preferably extends below the level of the knee joint and is adapted to securely wrap around the lower portion of the leg to provide stability. Preferably, the air chamber of the device is significantly longer in a first dimension than in a second, orthogonal dimension, such that the air chamber can be positioned to cover a portion of the person's leg that is relatively long in the vertical dimension and relatively narrow in the horizontal dimension.

[0035] Commonly owned U.S. Patent No. 7,276,037, the entirety of which is hereby incorporated by reference herein, discloses an apparatus for applying compression therapy to a portion of a human limb, such as a leg. The apparatus includes a flexible member and an air chamber. The flexible member is adapted to be wrapped around the limb to secure the air chamber to the limb. An air pumping mechanism is operated to inflate the air chamber to a pressurized state. One or more fluid-filled pressurizing members are provided, each separate and distinct from the flexible member and the air chamber, and thus easily movable relative to the flexible member and the air chamber. The pressurizing member is operably disposed between the limb and the flexible member, thereby applying increased localized pressure to the limb during use. Preferably, the air chamber is significantly longer in a first dimension than in a second dimension orthogonal thereto, so that it can extend longitudinally along the limb to cover a relatively long and narrow portion of the limb. The position of the air chamber can be easily adapted to apply localized pressure to a desired body part (such as a venous access). The compression member may be positioned during use such that it overlies the venous ulcer (or other treatment site) and applies increased localized pressure to the treatment site to promote healing.

[0036] One way to measure the compression efficacy of a therapeutic device is the static stiffness index (SSI). The static stiffness index (SSI) is a valuable parameter that characterizes the efficacy of a specific compression product in narrowing / occluding the venous lumen. It is the difference between the standing pressure and the resting pressure. This is a prerequisite for reducing venous return and exerting a massage effect, which is necessary to improve venous pumping function during movement. Any value above 10 SSI is considered "inelastic". Most (if not all) current therapeutic compression devices of the present invention have an SSI of about 2-12, wherein inelastic devices have an SSI of about 10-12. There is a need for therapeutic compression devices with an SSI of at least 10 and higher. The higher the SSI, the better the compression at the target limb part. A higher SSI means that the compression level is comfortable. In contrast, if the SSI is high, the blood vessels are pushed and the blood is not restricted.

[0037] While compression levels greater than 10 SSI are beneficial, there is a need for a therapeutic compression device that also includes multiple inflatable bladders that can be inflated and deflated sequentially (such as intermittent compression) and / or can be inflated at different levels of pressure and compression.

[0038] Sequential compression or having multiple bladders with different levels of compression or pressure would be beneficial for patients undergoing sclerotherapy, a medical procedure used to eliminate varicose and spider veins. Sclerotherapy typically involves injecting a solution, usually a saline solution, directly into the vein. The solution activates the lining of the blood vessels, causing them to collapse and stick together, and allows the blood to clot. Postoperative procedures may require compression bandages or stockings, both of which have the aforementioned issues with static compression on the target limb area.

[0039] Generally speaking, known compression devices may include inflatable devices that can provide a constant static pressure over a period of time and an intermittently varying pressure over a period of time, but currently known devices are bulky because the inflatable device or pump is an integral part of the wrapping mechanism. Such known compression devices are restrictive because the patient cannot walk or function while wearing bulky leg, foot, thigh or other limb wraps at work, school or otherwise. In addition, some known compression devices only allow intermittent pressure changes when directly connected to a power source, further limiting the patient's use because he or she is literally tied to a wall outlet. In addition, known compression devices or devices lack check valves to prevent overinflation and to seal and prevent deflation when the user is engaged in activities or resting in place. There is a need for a therapeutic compression system that includes a compression device having multiple bladders that are sequentially inflated and deflated or inflated to different compression or pressure levels and having an integrated valve (and preferably a self-sealing valve) for maintaining the compression level and preventing the bladders from deflation.

[0040] Additionally, sequential compression can be helpful in the treatment of lymphedema, CVT, CVI, DVT, and the like. Having multiple bladders within a compression device is known, but requires a streamlined inflation mechanism to feed each bladder and a control mechanism to allow each bladder to be inflated sequentially. There is also a need for a foot bladder that is separate from the lower leg bladder and / or upper leg or thigh bladder, so that each bladder has an individual compression level and, when inflated, again has a coordinated sequential compression or pressure. There is also a need for each of the individual bladders to have an SSI of at least about 12 or greater.

[0041] There is a need for a system in which a compression garment includes a universal connector for connecting to various pumps. Thus, a user can switch between an intermittent pneumatic pressure pump, for example, while sitting, and then change to a set pressure pump, for example, while walking. The user can connect to a hand pump, an electric pump, a mechanical pump, and any other type of conventional pump or the pump of the present invention without any additional conversion. The various types of pumps are not limited to the two listed above, but can be any type of pump with a universal connector.

[0042] Furthermore, there is a further need for a system including an inflation device that can simultaneously inflate multiple therapeutic compression devices of the present invention. There is also a need for a system including an inflation device that can switch between a constant static pressure level and an intermittently varying pressure level. The inflation device is further configured to provide a constant static pressure over a period of time and a varying intermittent pressure over a period of time and to alternate between such pressure settings.

[0043] There is a further need for a system including an inflatable device that is smaller than known systems. The user can therefore return to life activities more quickly than known compression systems, prophylactic systems, and other treatment systems that restrict the user's ability to walk around the home and outdoors due to power constraints on the system (electrical, mechanical, battery, manual, etc.). In addition, there is a need for a non-elastic compression device or wrap that anatomically conforms to the target limb (such as the lower leg, calf, entire leg, knee, thigh, arm, torso, or any other limb).

[0044] There is an additional need for a system that includes one or more sensors that measure the pressure on the skin, limb movement, blood pressure sensors, GPS sensors, etc. of a user's limb while using the system. Such sensors can be connected to the inflatable device to adjust the pressure from the inflatable device and increase or decrease the current pressure level. Such sensors can also be connected to a database and can be accessed by a medical professional and / or user in real time or stored over time.

[0045] There is a need for a system with multiple compression garments having individually applied pressures. For example, a thigh compression garment can be used in conjunction with a lower leg compression device such as those described in U.S. Pat. No. 9,033,906 and U.S. Pat. No. 7,967,766 and U.S. Pat. No. 7,559,908 and U.S. Serial No. 13,444,600 and U.S. Serial No. 16 / 328,718 (and incorporated herein by reference), and thus a user can wear two separate therapeutic compression devices of the present invention over the entire leg and can also include an optional knee wrap. In this case, the user can have one pressure level on the thigh therapeutic compression device of the present invention, while the calf compression garment can have a second pressure level, and both compression garments are connected to a pneumatic pump configured with multiple pressure outlets. There is such a need for such a system.

[0046] All currently known therapeutic devices, apparatuses, bandages, stockings and hosiery have issues with stability (no slippage), maintaining sufficient effective pressure without over-pressure complications, maintaining compression, etc. Furthermore, all known devices, apparatuses, bandages, stockings and hosiery, but especially current therapeutic non-elastic devices and apparatuses, are only capable of an SSI no higher than about 10-12, such that there is a need for therapeutic compression devices with an SSI higher than about 10, preferably about 15-25.

[0047] The subject invention provides an alternative to the known art, which employs tight-fitting therapeutic elastic garments that are uncomfortable and bulky for the patient and impractical to wear in daily life, and which, over time, lose their elasticity and slide down the leg, thereby losing their effectiveness, and inelastic garments and devices having an SSI of less than about 10-12. Those skilled in the art will readily appreciate that it would be beneficial to provide a therapeutic compression device and system for treating CVI, DVT, lymphedema, and tissue swelling that is adapted and configured to apply localized compression to the leg, thigh, calf, and / or foot to prevent swelling and further improve venous circulation, that can also be effectively self-administered by the patient, and that has an adequate SSI of greater than about 10, preferably about 15 to about 35. Other body parts may also be compressed, such as the arm, wrist, torso, shoulder, etc.

[0048] Without limitation, the therapeutic compression system of the present invention having multiple bladders can be used with any desired compression therapy, such as venous disease, vascular disease, lymphedema, post-operative (such as, but not limited to, TKR, KRA, HRA, TI-IR, and sclerotherapy, etc.). The therapeutic compression system of the present invention can be used to treat any general swelling, as well as post-operative use, including, for example, in the case of sclerotherapy or vein ablation. The therapeutic compression system of the present invention having multiple bladders can also be used by people who are used for compression therapy, such as athletes and those with lactic acid accumulation, or pregnant women, as well as any individual who walks excessively or stands on their feet during work hours. Other uses of the system of the present invention are contemplated. Summary of the Invention

[0049] The present invention relates to a therapeutic compression system and method of use thereof. The therapeutic compression system comprises one or more compression devices, each having multiple bladders and, depending on the target limb, two, three, or more bladders, all of which are connected to an inflation device and each device having a check valve in an inflation port on the device that maintains pressure within the inflated bladder when the inflation device is disconnected from the device. Each therapeutic compression device of the present invention has an SSI of at least about 10 or greater. The therapeutic compression system comprises a therapeutic compression device and an inflation device, wherein the inflation device is smaller than known inflation devices. The inflation device includes at least two settings, a constant inflation or pressure setting and a variable or intermittent inflation or pressure setting. The therapeutic compression system of the present invention may include at least one sensor, such as a motion sensor, a pressure sensor, a blood pressure sensor, a sphygmomanometer sensor, or other sensor, to monitor use of the system of the present invention by a patient and / or a medical professional.

[0050] The system includes various therapeutic compression devices of the present invention, such as, but not limited to, devices for use on the legs, calves, thighs, hips, pelvis, knees, feet, torso, arms, neck, or other body parts.

[0051] The therapeutic compression system includes a therapeutic compression device of the present invention, which may further include at least one bladder operatively associated with the therapeutic compression device of the present invention for applying pressure to a treatment area on a limb, such as a leg, the bladder having an SSI of at least about 10 or greater. The therapeutic compression device of the present invention includes attachment means such as loops and hook material for wrapping the therapeutic compression device of the present invention around a limb of a user, such as a leg. Alternatively, the at least one bladder may be integral with the attachment means or the wrapping, and depending on the target limb, there may be at least two or at least three separate bladders within the device. One or more attachment means may be operatively associated along a first peripheral edge and a second peripheral edge of the therapeutic compression device of the present invention for securing it around a limb.

[0052] The multiple bladders can be adapted and configured to form a predetermined gradient compression profile and / or gradient pressure profile when the bladders are filled. The gradient compression profile and / or gradient pressure profile can be determined by the locations of various spot welds that create the gradient compression profile and / or gradient pressure profile on the bladders, and when inflated, the device of the present invention has an SSI of at least about 10 or greater. The gradient compression profile and / or gradient pressure profile can alternatively be determined by an inflation device connected to or integrated with the therapeutic compression device of the present invention. In another embodiment, the gradient compression profile and / or gradient pressure profile can be determined by the pressure generated in one direction within the bladder by the inflation device and subsequently leaving the bladder through an exhaust port or other outlet device. The at least one bladder can be one of a wedge-shaped bladder, a conical bladder, a disc-shaped bladder, or a rectangular bladder. The at least one bladder can also include multiple fluid chambers. As part of the system of the present invention, the therapeutic compression device of the present invention can also include at least one device for regulating pressure, which is connected to the at least one bladder to control the amount of pressure supplied to the treatment site. In devices with more than one bladder, each bladder is connected to the same inflation device, and the inflation device inflates each bladder sequentially, which may be the same or different pressure levels, and once disconnected, the check valves in the inflation ports on each individual bladder maintain the current pressure level.

[0053] The therapeutic compression device of the present invention may include an inelastic portion and an elastic portion, such as on the upper portion of at least one bladder when worn on the lower leg, such as around the upper calf area of the limb. When placed on an arm limb, the elastic portion may be located near the user's elbow, wrist, or shoulder. When placed on the user's thigh or lower torso, or hip or buttocks area, the elastic portion may be located in the user's groin area. Other locations may be employed depending on the limb of the user that is subjected to the therapeutic compression system.

[0054] The therapeutic compression device of the present invention for providing pressure to a limb includes a bladder assembly. The bladder assembly includes: at least one bladder, the at least one bladder having a first flexible wall and a second flexible wall secured to each other around its peripheral edge to form an air trap; and at least one spot weld, the at least one spot weld being disposed in a predetermined position inside the peripheral edge, connecting the first wall and the second wall to each other to define a plurality of chambers within the bladder. In one embodiment, the geometric arrangement of the at least one spot weld determines a compression profile and / or a pressure profile of the at least one bladder. The pressure profile and / or the compression profile may be a gradient pressure profile and / or a gradient compression profile. The bladder assembly has an SSI of at least about 10 or greater when inflated. The top portion of the bladder assembly is adjacent an elastic portion that can provide a tighter fit for the user when the entire therapeutic compression device of the present invention is worn on the user's target limb.

[0055] An inflation device for inflating a bladder (such as an air trap) through at least one inflation port may be disposed in the first wall of the bladder assembly. The inflation device may be detachable from at least one inflation port. At least one pressure valve may be operatively associated with the inflation device for controlling the amount of pressure within the bladder and the air trap within the bladder. The inflation port includes a check valve to maintain a given pressure within the bladder of the therapeutic compression device of the present invention. The inflation port may be universal in that it is configured to be connected to and accept multiple inflation sources and inflation devices, such as manual pumps, mechanical pumps, electric pumps, battery-powered pumps, static pumps, intermittent pumps, pneumatic pumps, negative pressure sources, and other variations. When there is more than one bladder in the device, each bladder is inflated sequentially and can be deflated sequentially and repeatedly, or pressure can be maintained once the inflation device is disconnected from the inflation port located on each individual bladder.

[0056] The bladder is connected to an inflation port that includes a valve configured such that when the valve is in a closed position, the pressure profile and / or compression profile remains at the prevailing pressure and / or compression level. The valve is configured such that when it is in an open position, fluid, such as air, flows from the inflation device into the bladder, and if not connected to the inflation device, the fluid escapes from the bladder and is deflated. The valve can be self-sealing or can be connected to a device for opening and closing the valve, such as a lever, knob, screw, or other opening and closing means.

[0057] The methods of the present invention include a therapeutic compression system comprising a therapeutic treatment device for treating CVI, DVT, tissue swelling, arterial and / or venous ulcers, and / or lymphedema by applying a primary wrap and a secondary wrap around a limb by a patient, inserting an inflation device into an inflation port, and inflating bladders within the primary wrap and the secondary wrap and maintaining a pressure to treat the CVI, DVT, tissue swelling, arterial and / or venous ulcers, and / or lymphedema, wherein the therapeutic compression system has an SSI of at least about 10 or greater when inflated.

[0058] Another embodiment of the present invention includes an assembly according to the present invention, comprising: a pressure mechanism having a flexible member for attachment to a limb and an air chamber that can be pumped into a desired pressurized state; a separate, relatively small, pre-filled bladder; an absorbent foam, sponge, or dressing coupled to the pre-filled bladder; and a suction conduit coupled to a source of negative pressure (suction) and in fluid communication with the absorbent foam, sponge, or dressing. In a preferred embodiment, the pre-filled bladder, absorbent foam, sponge, or dressing, and suction conduit are formed together as a unit.

[0059] According to one aspect of the present invention, the flexible member of the pressure mechanism is adapted to be wrapped around a leg or arm and over a pre-filled bladder to secure the pre-filled bladder and foam, sponge, or dressing to a wound or ulcer in the limb. Accordingly, the flexible member is provided with some securing structure, such as a hook-and-loop closure. An air pumping 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 designed to apply pressure along a predetermined area (e.g., the saphenous vein in the leg) rather than around the entire limb.

[0060] According to another aspect of the present invention, a suction conduit is positioned between the pre-filled balloon and an absorbent foam, sponge, or dressing adhered to the small balloon, or the pre-filled balloon is formed as a ring with a central opening, and the suction conduit extends through the central opening. By coupling the suction conduit to a source of negative pressure, exudate from the wound or ulcer is drawn through the foam, sponge, or dressing and into the suction conduit.

[0061] One method of the present invention comprises: positioning a pre-filled bladder and a foam, sponge, or dressing over a wound or ulcer on a limb; wrapping a flexible member of a pressure mechanism around the limb, with an air chamber positioned over the pre-filled bladder / absorbent foam, sponge, or dressing; and securing the pneumatic pressure mechanism in place with a securing structure. When the device is properly positioned and attached to the limb, the air chamber is inflated, preferably to 30-40 mmHg, thereby applying pressure to the limb, and more specifically, to the wound via the pre-filled bladder. The suction device is activated by turning on a source of negative pressure, and exudate from the wound or ulcer is drawn through the absorbent foam, sponge, or dressing into a suction catheter.

[0062] Another embodiment of the present invention includes a system comprising a device for applying intermittent pressure to a portion of the human body, such as an area of a person's leg, to aid in the healing and treatment of various conditions, such as venous ulcers or wounds, by promoting blood flow into and out of the area and by increasing drainage. The device may include a thigh bladder or a foot bladder and a leg bladder, each having an inflatable chamber that inflates to contain incoming fluid (there is at least one and possibly two or more bladders within each device). These bladders are fluidically coupled via a fluid conduit, and each bladder is preferably equipped with a means for positioning it on a portion of the body. In a preferred embodiment, the thigh bladder is positioned between the user's pelvis, groin, or hip area and the user's knee. As a person walks while wearing the device, due to the external pressure applied to the foot bladder, when the person's leg moves and the foot (heel) strikes the ground, a portion of the thigh bladder deflates, forcing fluid out of the foot bladder, through the fluid conduit, and into the leg bladder, increasing the pressure therein. As a person's foot rolls from heel to toe in a standard walking motion, external pressure from the person's weight is removed from the foot bladder, causing the pressure in the leg bladder to be higher than the pressure in the foot bladder. Fluid then flows back through the fluid conduit and into the foot bladder, which then inflates back to its original state, equalizing the pressure in the foot and leg bladders. This process repeats as the person walks, creating a pumping or pinching force on the leg as the pressure in the leg bladder intermittently increases and decreases, promoting blood flow, fluid drainage, treatment, and healing in various parts of the leg.

[0063] In one embodiment of the present invention, the therapeutic compression system includes an inflation device connected to a belt so that the user can wear it around his or her waist during daily use, and such inflation device can be connected to the therapeutic compression device of the present invention by, for example, a hose or tube, which provides inflation to the therapeutic compression device of the present invention and / or the bladder within the wrap.

[0064] In another embodiment of the present invention, the therapeutic compression system includes an inflation device that can switch between a constant static pressure level (different pressure levels, such as 20 mm-Hg, 30 mm-Hg, 40 mm-Hg, up to 200 mm-Hg, etc.) and an intermittent varying pressure level, thereby applying pressure to the therapeutic compression device of the present invention via a hose or tube. The inflation device can be capable of inflating each bladder individually and sequentially, and then deflating, or repeatedly inflating and deflating as needed.

[0065] In other embodiments, the inflation device is connected to two or more tubes, and thus to two or more bladders, whether multiple bladders within a therapeutic compression device of the present invention or individual bladders within multiple therapeutic compression devices of the present invention, or a combination thereof. In another embodiment, the inflation device comprises a pump having a manifold having multiple chambers, each chamber corresponding to a bladder within one or more devices, such that the inflation device connected to the manifold is connected to multiple hoses, which are then connected to each individual bladder for sequential inflation and deflation of each individual bladder.

[0066] In another embodiment, the system includes one or more sensors to monitor movement of the therapeutic compression device of the present invention, pressure levels, blood pressure of the patient, tension measurements of the target limb, or other sensor data.

[0067] These and other aspects of the contact of the subject invention will become more apparent from the following description taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0068] In order to make it easier for those skilled in the art to understand how to make and use the device of the subject invention, preferred embodiments thereof will be described in detail below with reference to the accompanying drawings, in which:

[0069] Figure 1 is a view of one embodiment of the present invention comprising a lower leg therapeutic compression device of the present invention connected to a tube connected to an inflatable device positioned on a retaining device such as a band;

[0070] Figure 2 Another embodiment of the invention for use on a human comprises two lower leg therapeutic compression devices of the invention each connected to a tube and a thigh therapeutic compression device of the invention, all three tubes connected to one inflatable device positioned on a retaining device such as a belt;

[0071] Figure 3 For example Figure 1 and Figure 2 an exploded view of the illustrated embodiment of the harness, inflator, and battery pack;

[0072] Figure 4A for Figure 1 A cross-sectional view of an inflation device showing a sensor port and an inflation port, both connected to a tube that inflates and deflates the therapeutic compression device of the present invention.

[0073] Figure 4B for Figure 2 A cross-sectional view of an inflation device of the present invention showing a sensor port and three inflation ports, all of which are connected to tubes that inflate and deflate all three therapeutic compression devices of the present invention or three separate bladders within one or more therapeutic devices; or in the alternative, can be connected to at least three tubes that can be connected to three separate bladders within one therapeutic compression device of the present invention, or in the alternative, three tubes can be connected to at least three separate therapeutic compression devices of the present invention, or a combination thereof.

[0074] Figure 5A for Figure 1 and Figure 2 sectional view of the inflation port of , showing one embodiment of a self-sealing check valve in an open position when the bladder is inflated;

[0075] Figure 5B for Figure 1 and Figure 2 sectional view of the inflation port of , showing one embodiment of a self-sealing check valve in a closed position to prevent deflation of the bladder once inflated;

[0076] Figure 6 is another embodiment of the therapeutic compression device of the present invention, wherein an inflation device is connected to an air inlet port and a separate air exhaust port of such therapeutic compression device of the present invention;

[0077] 7A to 7E An embodiment representing a flow chart of a method of using the system of the present invention including the lower leg therapeutic compression device of the present invention and the thigh therapeutic compression device of the present invention;

[0078] Figures 8A to 8K Yet another embodiment is shown as a flow chart of a method of using the system of the present invention including the lower leg therapeutic compression device of the present invention.

[0079] Figure 9 is yet another embodiment of the present invention, comprising three separate therapeutic compression devices of the present invention (foot, lower leg, and thigh) configured to be connected to one inflatable device via a manifold in the inflatable device, wherein the lower leg device comprises three separate bladders and the thigh device comprises two separate bladders, and a sock beneath the foot and lower leg devices;

[0080] Figure 10 is yet another embodiment of the present invention, comprising three separate therapeutic compression devices of the present invention (foot, lower leg, and thigh) configured to be connected to one inflation device via a manifold in the inflation device, wherein the foot and lower leg devices each have only one bladder and the thigh device includes two separate bladders, and socks beneath the foot and lower leg devices;

[0081] Figure 11 is yet another embodiment of the present invention, comprising three separate gradient therapeutic compression devices of the present invention (foot, lower leg, and thigh) configured to be connected to one inflatable device via a manifold in the inflatable device, wherein the lower leg device comprises three separate bladders and the thigh device comprises two separate bladders, each bladder being configured with a gradient compression profile;

[0082] Figure 12 is another embodiment of the present invention, comprising a manifold connected to or integral with an inflation device capable of individually and sequentially inflating each of the individual bladders in one or more therapeutic compression devices of the present invention via switches or valves connected to hoses or tubes, the hoses or tubes further connected to corresponding common inflation ports on each of the devices;

[0083] Figure 13 Yet another embodiment of the present invention comprises two separate therapeutic compression devices of the present invention (foot and full leg) having an elastic knee portion connecting the upper and lower leg portions of the full leg device, and a sock underneath the foot device and the lower leg portion of the full leg device;

[0084] Figure 14 for Figure 1 Another embodiment of the present invention has two separate bladders, two inflation ports, two hoses, and two connectors to a manifold and inflation device within the lower leg therapeutic compression device of the present invention;

[0085] Figure 15 for Figure 1 Another embodiment of the present invention has three separate bladders, three inflation ports, three hoses, and three connectors to a manifold and inflation device within the lower leg therapeutic compression device of the present invention;

[0086] Figure 16A -C is another embodiment of the invention of a separate therapeutic foot compression device of the invention, which can be connected to an inflation device, which is connected to other devices, wherein Figure 14 A shows a front view, Figure 14 B shows a rear view, and Figure 14 C shows a side perspective view;

[0087] Figure 17 It is an exploded view of FIG16;

[0088] Figure 18 A top view of another embodiment of a therapeutic compression device for a foot of the present invention and a toeless sock underneath the therapeutic compression device for a foot of the present invention;

[0089] Figure 19 is yet another embodiment of the thigh therapeutic compression device of the present invention (in an exploded view of the device) having two separate bladders;

[0090] Figure 20 is yet another embodiment of the present invention, comprising a perspective view of a lower leg therapeutic compression device of the present invention having two separate bladders (an upper calf portion and a lower calf portion with a foot) connectable to the same inflation means, wherein the device includes an elastic portion at the upper calf portion and having a sock or sleeve connected to the lower leg therapeutic compression device of the present invention;

[0091] Figure 21 is yet another embodiment of the present invention, comprising a perspective view of a lower leg therapeutic compression device of the present invention having three separate bladders (upper calf, lower calf, and foot) that can be connected to the same or different inflation means, wherein the device includes an elastic portion at the upper calf and having a sock or sleeve connected to the lower leg therapeutic compression device of the present invention; and

[0092] Figure 22A -C is another embodiment of the present invention, comprising two different variations of a manifold having holes for inserting a connection device on a hose ( Figure 22A and Figure 22B ), and yet another embodiment of the present invention of an inflation device connected to a manifold having four hoses connected within the manifold. DETAILED DESCRIPTION

[0093] Preferred embodiments of the subject invention are described below with reference to the accompanying drawings, wherein like reference numerals represent the same or similar elements. Those skilled in the art will appreciate that while the devices discussed herein relate to compression therapy of the legs and feet, the scope of the invention is not limited to those exemplary applications and can be sized and shaped for any anatomical part requiring compression therapy.

[0094] The subject invention provides compression to a patient's limbs, including all four extremities, including, for example, the user's legs, and more particularly, the user's thighs, in a manner that is simpler, less bulky, more practical, more flexible, and more convenient than current systems. The present invention system, including the therapeutic compression device of the present invention, can compress any limb or body part, such as, for example, the foot, calf, thigh, knee, leg, hip, buttocks, waist, torso, ribs, shoulder, arm, hand, finger, neck, head, etc.

[0095] The subject invention provides a system for providing compression and preventing swelling of a limb, such as a leg, using a non-elastic adhesive and a bladder that can be used for compression. The device has at least one, and preferably more than one, individual bladder within the device and is connected to an inflation device that includes a dual device with both a constant static pressure level and a varying intermittent pressure level, and the bladders are inflated sequentially. The system is provided in a manner that allows for consistent measurement of the pressure supplied and is safe, comfortable, more practical, more flexible, convenient, effective, and self-administered by the patient.

[0096] Where a range of values is provided, it is understood that unless the context clearly dictates otherwise, each intervening value, to the tenth of the unit of the lower limit, between the upper and lower limits of that range, and any other specified or intervening values in the stated range, are encompassed within the present invention. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges and are also encompassed within the present invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either of those included limits are also encompassed within the present invention.

[0097] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present invention, exemplary methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and / or materials in conjunction with the cited publications.

[0098] It must be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a stimulus" will include a plurality of such stimuli, and reference to "the signal" will include reference to one or more signals and equivalents thereof known to those skilled in the art, and so forth.

[0099] The publications discussed herein are provided solely for their disclosure prior to the filing date of the present patent application. Nothing herein should be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Furthermore, the publication dates provided may differ from the actual publication dates, which may need to be independently confirmed.

[0100] Now see Figure 1 , shows an exemplary embodiment of a system 100 of the present invention, which includes a therapeutic compression device 200 of the present invention, an inflation device 150, and a connecting device 160. In some embodiments, the inflation device 150 is connected to a retaining device 180 such as a strap. In some embodiments, the therapeutic compression device of the present invention is a lower leg compression device, such as the Sun Scientific, Inc. And disclosed in U.S. Patent No. 9,033,906 and U.S. Patent No. 7,967,766 and U.S. Patent No. 7,559,908 and U.S. Serial No. 13 / 444,600 and U.S. Serial No. 16 / 328,718, all of which are incorporated herein by reference. In some embodiments, the inflatable device can be a manual hand pump, a foot pump, a mechanical pump, an electric pump, a battery-driven pump, a static pump, an intermittent pump, a variable speed pump, an automatic pump, a pneumatic pump, a negative pressure pump, a suction pump or a vacuum pulse pump or any combination thereof or any other known or developed inflation source to provide a certain pressure within the therapeutic compression device of the present invention, thereby providing compression when used by the patient. In some embodiments, the inflatable device is connected to the therapeutic compression device of the present invention by a hose or tube 160. In some embodiments, the inflatable device is connected to a retaining device, such as a strap or wrap worn by the user.

[0101] The therapeutic compression device 200, 300, 500 of the present invention may include at least one bladder 202, 302, 502, and may include more than one bladder, such as, by way of example only, 202A, 202B, 202C, 302A, 302B (and may include multiple bladders 202D, 202E, 302C, 302D, 502A, 502B, 502C, etc., not shown), wherein the bladder is, for example, a compression bladder integrally formed in the therapeutic compression device 200, 300, 500 of the present invention, or the therapeutic compression device 200, 300, 500 of the present invention is configured to be inserted (not shown) into the therapeutic compression device 200, 300, 500 of the present invention. The therapeutic compression device 200, 300, 500 of the present invention is configured and adapted to be wrapped around a patient's limb, such as, for example, a leg, calf, knee, foot, ankle, thigh, torso, arm, neck, or any other limb. The therapeutic compression devices 200, 300, 500 of the present invention are not limited to the limbs or body parts listed above, but can be any body part, such as, but not limited to, the foot, ankle, calf, lower leg, knee, thigh, groin, hip, leg, buttocks, torso, stomach, chest, shoulder, arm, elbow, hand, wrist, neck, head, etc. and any combination thereof. Figure 1 As shown, one embodiment of the therapeutic compression device of the present invention is a lower leg therapeutic compression device 200, and as shown Figure 2 As shown, the thigh therapeutic compression device 300 of the present invention is also included together with a second lower leg therapeutic compression device 200. Figures 1 to 2 and Figure 8 to Figure 10 The therapeutic compression device 200 of the present invention is shown as having a proximal end portion (e.g. Figures 1 to 2 and Figure 8 to Figure 10 The distal end portion (eg, a mid-orientation portion closer to the top of the user's knee) and an opposing distal end portion (eg, Figures 1 to 2 and Figure 8 to Figure 10 The wrap member 220 (of the bottom of the foot, which is oriented in a neutral direction and wraps around the user's foot) is configured and adapted to conform around the patient's lower leg (including the foot and calf) and to provide compression through inflation of the bladder. In this embodiment, the lower leg therapeutic compression device 200 of the present invention includes an inner sheet 203 and an outer sheet 201 made of nylon laminated polyurethane sheets, which are configured and adapted to be RF welded together to form the wrap 220. However, any other suitable material (such as a film, polymer, etc.) that can be welded or otherwise joined and is also airtight to form a bladder may be used, and in some embodiments (not shown), there is only one sheet without a bladder, wherein the sheet has an SSI of at least greater than 10. As shown in FIG. Figures 1 to 2 Figure 8 to Figure 11 and Figures 13 to 21As shown, the continuous perimeter weld line 216, 316, 516 forms an airtight boundary of the integrally formed bladder 202, 302, 502. Figures 1 to 2 and Figure 8 to Figure 10 In the exemplary embodiment of the present invention, the bladder 202 is a single continuous bladder extending from the lower leg portion through the foot portion of the therapeutic compression device 200 of the present invention; however, it is contemplated that the therapeutic compression device 200 of the present invention may have multiple independent bladders (202A, 202B, 202C, etc.) that may be individually inflated or deflated via one-way valves or other desired inflation / deflation configurations, such as Figure 9 、 Figure 11 、 Figures 14 and 15 and 20 to Figure 21 Certain non-limiting embodiments are shown.

[0102] In this embodiment, hook-and-loop fasteners 224 are provided along the edges of the inner and outer sheets to facilitate adjustment and securing of the lower leg therapeutic compression device 200 of the present invention to a patient's limb (such as, for example, the calf or foot). It is contemplated that the thigh therapeutic compression device 300 of the present invention may include hook-and-loop fasteners 322, 324, but may also be secured to the patient's thigh by other means, such as a zipper, button, or by other such suitable means to form a cuff. Additionally, it is contemplated that the hook-and-loop closures 224, 324, 524 may be replaced by materials similar to ankle straps, knee straps, hip straps, or any other type of strap (including those described below) and welded / sewn / attached to the bladder to improve comfort. In another embodiment, the foot therapeutic compression device 500 of the present invention may include hook-and-loop fasteners 522, 524, but may also be secured to the patient's foot by other means, such as a zipper, button, or by other such suitable means to form a cuff.

[0103] Now see Figures 1 to 2 In this embodiment, the therapeutic compression device 200 of the present invention has a bladder integrated into the inner sheet 203 and the outer sheet 201, with a cost-effectively obtained location and desired pre-configured compression gradient distribution. Several different embodiments of bladder configurations can be used for the lower leg therapeutic compression device 200 of the present invention, such as those described above and Figure 11 、 Figures 14 and 15 and Figures 20 to 21 , which has different gradient compression distributions and / or gradient pressure distributions based on the positioning and selection of spot welds 215 and weld lines 216, which also applies to the foot therapeutic compression device 500 of the present invention including the selected and positioned spot welds 514 and weld lines 516, and to the thigh therapeutic compression device 300 of the present invention including the selected and positioned spot welds 314 and weld lines 316. Figures 1 to 2A therapeutic compression device 200 of the present invention is shown having a bladder with a plurality of spot welds 214 therein. Figure 11 、 Figures 14 and 15 and Figures 20 to 21 In any embodiment (and those not shown), spot welds 214 are strategically placed in bladder 202 in a predetermined pattern based on the desired gradient distribution of compression required at the patient's treatment site. Spot welds 214 and / or weld lines 216 enable bladder 202 to define a gradient compression distribution and / or gradient pressure distribution when inflated by inflation port 212. The geometric arrangement of spot welds 214 and / or weld lines 216 in bladder 202 allows for increased inflation of certain portions of bladder 202 and can produce one or more fluid chambers in bladder 202. This configuration is particularly useful when compression is needed to improve fluid movement (e.g., blood, lymph, etc.) in the body. In addition, line welds 216 allow better compression along the calf of the patient's leg by increasing the tension applied and the patient's sole area. This increased tension can produce more effective compression to increase venous flow. The wire welds 216 positioned laterally along the calf form a ribbed section which keeps the inflated profile of the therapeutic compression device 200 of the present invention compact, which further enhances ambulation and reduces interference with the patient's clothing. Figure 20 Compared with the geometric arrangement and design of the curved welding line 216 in Figure 21 The vertically positioned line weld lines 216 shown along the shank create vertical ribs and Figures 1 to 2 、 Figure 11 and Figures 14 and 15 A different gradient compression distribution is shown, which produces yet another different gradient compression distribution on the user's lower leg. Other geometric configurations and placements or locations of both spot welds 214 and weld lines 216 are contemplated to produce an infinite number of different gradient compression distributions and / or gradient pressure distributions.

[0104] It will be appreciated that different pressure gradients and / or compression gradients and their distributions may be utilized depending on the location of the therapeutic compression device 200 of the present invention. Other possible gradient pressure distributions are envisioned based on the geometric location of the spot welds 214, either alone or in combination with the line welds 216. Figures 1 to 2 、 Figures 14 to 17 、 Figure 19 and Figure 21 The spot welds 214, 314, 514 shown in FIG are circular in shape, wherein Figure 20The spot welds 214 in the present invention are of different geometric shapes, such as a teardrop shape, although any geometric shape and any placement position on the lower leg, thigh, or foot of the present invention may be used, and further, the weld lines 216 may be used to separate the bladders within each of the therapeutic compression devices 200, 300, 500 of the present invention to create and separate bladders 202A and 202B, or 202A and 202B and 202C, or 302A and 302B, or 502A and 502B, etc. within each therapeutic compression device 200, 300, 500 of the present invention. For example, in the thigh therapeutic compression device 300 of the present invention, the line welds 316 and the spot welds 314 may have different geometric shapes, such as a teardrop shape, depending on the location of the limb to be compressed, such as the mid-region of the thigh. Figures 1 to 2 Likewise, the gradient pressure distribution and / or gradient compression distribution can be based on the geometric pattern of the spot welds 314, alone or in combination with the line welds 316. In another embodiment of the therapeutic compression device of the present invention (not shown), the gradient compression distribution and / or gradient pressure distribution can be based on the pressure level of the inflatable device, alone or in combination with the overall shape of the bladder 202, 302.

[0105] It will be appreciated that depending on where on the patient's body part or limb the therapeutic compression device of the present invention is placed, different pressure gradients may be utilized, such as on the wrist, arm, shoulder, torso, neck, and other anatomical body parts. Furthermore, depending on the treatment (general swelling, lactic acid buildup, arterial ulcers, venous ulcers, lymphedema, post-sclerotherapy, CVT, DVT, etc.) and the treatment site, different pressure gradients and / or compression gradient profiles may be employed. Other examples of bladder pressure gradient profiles are described in the following patent applications: U.S. Patent Application Serial No. 12 / 911,563 and U.S. Patent Application Serial No. 12 / 855,185, the disclosures of which are incorporated by reference in their entirety.

[0106] The configuration and shape of the bladder 202, 302, 502 may not include numerous spot welds 214, 314, 514 or weld lines 216, 316, 516, such as Figures 9 and 10 、 Figure 13 and Figure 18 , wherein the front portion of the therapeutic compression device 200, 300, 500 of the present invention does not show any such welds, but rather any welds are located on the bottom portion of the respective therapeutic compression device 200, 300, 500 of the present invention.

[0107] When inflated, the bladder 202, 302, 502 within the therapeutic compression devices 200, 300, 500 of the present invention has an SSI of at least about 10 or greater. The inelastic inflatable bladder has an SSI of at least about 10, and preferably about 10-50. The SSI facilitates compression therapy for the user to prevent or treat CVT, CVI, DVT, lymphedema, and other swelling problems, as well as arterial and venous ulcers, on the user's limbs. Elastic bandages or garments typically have an SSI in the range of about 1 to about 5 or about 6, while some known inelastic compression devices have an SSI in the range of about 5-10. Thus, inelastic compression devices including bladders do not have an SSI greater than about 10 when such bladders are inflated. An SSI of about 10 is generally acceptable for inelastic compression devices, with the therapeutic compression devices of the present invention having an SSI of at least about 10 and typically greater than 15. The higher the SSI, the better the compression the user generally experiences when the bladder is inflated. In contrast, in situations where blood vessels are pushing but blood is restricted, a higher SSI generally translates into a comfortable level of compression. The therapeutic compression devices of the present invention are capable of combining compression to prevent or treat both arterial and venous disease. However, arterial disease requires blood vessels and blood flow, while venous disease requires compression, which is found in the therapeutic compression devices of the present invention when the bladder is inflated and the device is on the user's target limb. For users with mixed conditions of both arterial and venous disease, inelastic compression is preferred, which has the added benefit of high pressure without constantly constricting the blood vessels. The therapeutic compression devices 200, 300, 500 of the present invention are capable of achieving both high pressure and high stiffness, which is beneficial for preventing and treating venous disease, lymphedema, CVT, CVI, and the like. The therapeutic compression devices 200, 300, 500 of the present invention have been measured to have an SSI of up to about 40-50, preferably about 10 to about 30 when inflated and in use.

[0108] Compression therapy is a widely used standard of care in the treatment of various swelling conditions, such as chronic venous insufficiency and lymphedema. Compression therapy relies on the external application of pressure to squeeze the underlying anatomical structures and helps to reduce swelling and improve circulation. Gradient compression is particularly effective, where more pressure is applied more distally (further away) from the heart, with pressure decreasing proximally (closer). This helps to squeeze the body in a way that helps stimulate circulation and reduce limb size. Generally, there are two types of compression, static and intermittent. Static is the most common and is continuous compression meant to be worn all day, while intermittent is compression applied by a pump cycle and is particularly beneficial for occasional use when the user is sedentary.

[0109] There are a variety of compression products and technologies for static all-day compression, but generally static compression has two mechanisms of action. For example, the support effect can help reduce the available limb volume to manage the amount of leg swelling. In addition, the dynamic effect can include compression, which causes or helps improve the circulation of blood and fluids, especially when the user is walking around. Compression squeezes the circulatory system into better contact with the muscles (e.g., calf to lower leg compression) to improve the body's fluid movement efficiency. People with chronic venous disease may not be able to achieve fully effective circulation without compression. When used correctly, compression therapy is widely considered to be an effective treatment for lower leg swelling diseases. By squeezing the outside of the leg, compression helps reduce swelling and improve the circulation of trapped fluids. To be effective, compression must be used consistently and frequently, especially static compression when you are standing and walking around.

[0110] There are two ways static compression helps: 1. supportive compression (compression that helps prevent further swelling in the leg) and 2. dynamic compression (compression that helps improve the body's natural circulation, especially when moving, because it keeps the circulatory system engaged with the musculoskeletal system). There are different types of known compression products that can be used for different situations, some of which are pulled up like a sock and some are rolled up as a bandage. Each of these types of products can be categorized on a scale of elastic to inelastic, depending on how much the material stretches.

[0111]

[0112] As mentioned above, compression therapy has been effectively used to treat patients with chronic venous insufficiency. Due to the inherent stiffness and elasticity of the compression device, it works by improving venous hemodynamics and reducing edema. There are several types of known conventional compression options, such as medical-grade elastic compression stockings, non-elastic compression stockings, and non-elastic compression wraps. Each of these has advantages and disadvantages. Compared to elastic compression, non-elastic compression provides higher stiffness and, therefore, better controls venous hemodynamic impairment in patients with more severe venous disease. Compared to compression stockings, compression wraps offer easier application for patients. The therapeutic compression devices of the present invention address these issues by preventing or treating arterial and venous problems, as the therapeutic compression devices 200, 300, 500 of the present invention, when inflated and wrapped around the user's target limb, have an SSI of at least approximately 10 or greater. Stiffness is the rigidity of an object, that is, its resistance to deformation in response to an applied force. The stiffness of the device can be calculated by measuring the interface pressure between the compression device and the skin. The SSI is defined as the difference between the standing pressure and the supine pressure measured at point B1. Point B1 is the transition point between the gastrocnemius tendon and the muscle approximately 10-15 cm above the medial malleolus. Compared to inelastic devices that exhibit an SSI > 10, elastic compression devices typically have an SSI < 10, sometimes less than 5. The therapeutic compression devices 200, 300, 500 of the present invention have an SSI of at least about 10 or greater, preferably about 15 to about 40. Notably, in conditions such as Figures 20 to 21 In certain embodiments shown, the therapeutic compression device 200, 300 of the present invention also has an elastic portion 205, 318 that is configured to conform to the shape of the target limb and anatomy and to maintain the inflated therapeutic compression device 200, 300 of the present invention on the target limb without sliding down the limb (such as the calf and thigh in these non-limiting examples) when the user is moving or walking. Thus, there is a combination of an SSI of at least about 10 and a particular elastic portion on the therapeutic compression device 200, 300, 500 of the present invention, with other embodiments not shown.

[0113] Elastic materials are always compressing, meaning they can feel "tight" and constricting even when you're still. But as you move around, the elastic material stretches, which means it can give up some of its compression, reducing the dynamic compression effect. As venous and lymphatic blood returns to the calf, the calf muscles play a crucial role in helping to push fluid upward into the body and back into circulation against gravity. In fact, the calf has been called the second heart. Due to the material's properties, the elastic compression of the leg eventually stretches when the leg (both the calf and thigh, as well as the knee and ankle) is engaged, losing some of the inward pressure and fluid return effect. In contrast, non-elastic materials are known to feel more comfortable when still and stretch much less when moving around, allowing them to provide comfortable, supportive compression and more effective dynamic compression. For example, compression stockings are elastic and pulled up into place. They are manufactured as circular knits with a predefined stretch built into them through yarn selection. They are known to be difficult to apply at the higher, medically required compression levels. In contrast, compression bandages are wound into rolls and are typically applied by a skilled caregiver around the leg, overlapping to apply compression. Compression bandages can be made with different levels of elasticity and are typically applied in multiple layers with different levels of elasticity in an attempt to achieve a specific level of compression or amount of SSI.

[0114] When the wrap 220 is placed on the user's target limb and the bladder 202, 302, 502 is inflated, the therapeutic compression device 200, 300, 500 of the present invention comprises an SSI of at least about 10 or greater. Figures 1 to 4B 、 Figure 12 、 Figures 14 and 15 and Figure 22C As shown, one of the inflation devices is device 150, which is a pneumatic pump that can be attached to the inflation port 212 (212A, 212B, 212C), 312 (312A, 312B), 512 to inflate the bladder 202 (202A, 202B, 202C), 302 (302A, 302B), 502 within the therapeutic compression device 200, 300, 500 of the present invention. It is understood that other mechanical or automatic inflation pumps (not shown) may also be attached to the inflation ports 212 (212A, 212B, 212C), 312 (312A, 312B), 512 to inflate and deflate the bladders (202A, 202B, 202C), 302 (302A, 302B), 502 within the therapeutic compression devices 200, 300, 500 of the present invention, thereby providing pulsating pressure to the user's limb. For example, Figure 2 and Figures 8G to 8HAs shown, the inflation device 150 is a pneumatic pump, and the second inflation device 150 is a manual pump 400, which includes a bulb 420 for manually pumping air fluid and a manual dial 410 including a check valve therein. Many or a variety of inflation devices can be used, such as a manual pump, a hand pump, a foot pump, a mechanical pump, an electric pump, a battery-powered pump, a static pump, an intermittent pump, a variable speed pump, an automatic pump, a pneumatic pump, a negative pressure pump, a suction pump or a vacuum pulse pump, or any other known or developed inflation source, to provide a certain pressure within the bladder to provide compression when used by a patient. Valve 290 is incorporated into the therapeutic compression device 200 of the present invention at the inflation port 212 to allow the user to selectively deflate the bladder 202 of the therapeutic compression device 200 of the present invention. In addition, a check valve (not shown) or a safety valve (not shown) is incorporated into the inflation device 150 or bladder 202 to prevent overinflation once a maximum pressure is detected. Examples of safety valves are described in U.S. Patent No. 7,276,037 and U.S. Patent No. 7,850,629, the disclosures of which are incorporated by reference in their entireties. The inflator 150 may include, for example, Figure 12 and Figures 22A to 22C 1 and 2, and a manifold 190 is shown as a non-limiting example in FIG, which controls the inflation, retention and deflation of each bladder 202 (202A, 202B, 202C), 302 (302A, 302B), 502 connected to the applicable inflation port 212 (212A, 212, 212C), 312 (312A, 312B), 512 via a hose 160 (160A, 160B, 160C, 160D, 160E, 160F). In this embodiment, each therapeutic compression device 200, 300, 500 of the present invention may have more than one bladder (such as 202A, 202B, 202C and 302A, 302B) such that separate hoses 160A, 160B, 160C, 160D, and 160E are connected to the applicable inflation ports 212A, 212B, 212C, and 312A, 312B, as shown. Figures 9 to 11 、 Figures 13 to 15 and Figures 20 to 21 Other configurations are possible depending on the number of individual bladders within each therapeutic compression device 200, 300, 500 of the present invention.

[0115] Now see Figures 1 to 2 、 Figures 8J to 8K and Figures 14 and 15Once the therapeutic compression device 200, 300 of the present invention is secured around the patient's lower leg, the bladders 202 (202A, 202B, 202C), 302 (302A, 302B) are inflated and cannot move out of position, thereby increasing comfort and reducing fit issues for the patient. To increase the ease of ambulation for the patient and the patient's practicality and mobility, in this exemplary embodiment, the inflation device 150 is connected to a retaining device 180, such as a strap. Any retaining device 180 may be used, such as, for example, a thigh strap, a hip strap, or a waist strap, but not shown. If a strap is used, the strap may be tightened against the patient's legs and hips to reduce sliding of the therapeutic compression device 200, 300 and inflation device 150 of the present invention.

[0116] In this embodiment, the retaining device 180 is a belt or strap and includes a buckle 181A (male connector) and a clip 181B (female connector) that are joined together by inserting the buckle 181A into the clip 181B and then snapping them together. Other embodiments not shown may include a garter belt system or a belt buckle or any other known closure or connection device. Likewise, the retaining device 180, if a belt, may be closed or connected by other connection devices such as, for example, but not limited to, hook and loop closures or VELCRO. TM Or any other known connecting means such as buckles, straps, buttons, snaps, zippers, hooks and other combinations. Figure 1 To Figure 4 and Figures 14 and 15 As shown, the retaining device 180 strap is worn around the patient's waist. In another exemplary embodiment, the retaining device 180 can be a hip strap (not shown) or a waist strap (not shown, as shown in the strap embodiment) that is configured and adapted to improve the wearability of the inflatable device 150 and increase the patient's ambulation.

[0117] Inelastic hook-and-loop ("Velcro") wraps have been introduced that have a hook-and-loop outer material on a neoprene-like material that has a small amount of stretch, with the straps pulled to apply a higher stiffness than elastic stocking compression. These products offer a significant improvement over the known problems of elastic stockings and rolled bandages because, given their hook-and-loop attachment, they are easier to wrap around the leg; however, they have a significant disadvantage in that they require manual force to pull the straps to the desired level of compression. These products require a certain amount of stretch in their base material to apply the desired compression, but this stretch also means that the product's inelasticity is suboptimal. It is also very difficult to quantify the applied pressure using this hand force technique.

[0118] Completely inelastic materials are not used because compression cannot be applied statically or a proper anatomical fit cannot be obtained without sewing multiple pieces together in a pattern that accommodates the multiple contours of the body. The therapeutic compression devices 200, 300, 500 of the present invention are compression garments that anatomically conform to the leg and foot but are made primarily of inelastic materials. Current conventional inelastic compression devices, when laid flat and not inflated, look like a cone for the lower leg because the upper portion that is placed closer to the knee is wider than the narrower portion that is placed closer to the ankle because it simulates the wider portion of the calf on the lower leg compared to the user's ankle area. As Figures 20 to 21 As shown, the therapeutic compression device 200 of the present invention includes an elastic portion 205 located above the upper hole 204 of the device 200 / wrap 220 to help the device 200 / wrap 220 anatomically fit when placed on the user's lower leg. Currently known compression wraps have a tapered shape from bottom to top, so they must be cut off by the user or extend further than necessary when placed on the lower leg and do not wrap around the calf, which is a problem. The therapeutic compression device 200 of the present invention solves this problem by including the elastic portion 205 to help the device 200 / wrap 220 fit snugly on the lower leg when placed on the user. Furthermore, by using an airtight inelastic material and an inflation device, the garment can be applied around the leg and then inflated with a compressive fluid (typically air), resulting in compression with better inelastic properties (a higher static stiffness index greater than about 10, preferably greater than 15 or in the range of about 10 to about 50). Air or any suitable compressive fluid can also be measured by measuring the actual amount applied or by feedback pressure, thereby allowing the manner in which the applied pressure is measured, controlled and adjusted, such as by Figure 12 The therapeutic compression devices 200, 300, 500 of the present invention can be designed in a manner that applies more compression distally than proximally through the plurality of inflation channels, or by designing the shape of the bladder 202, 302, 502 or the location and placement and pattern of the spot welds 214, 314 and weld lines 216, 316, 516, by way of non-limiting example shown, via switches or valves 197 (197A, 197B, 197V, 197D, 197E, 197F, etc.) or via other sensors not shown.

[0119] To provide a proper anatomical fit on, for example, the lower leg, the lower leg therapeutic compression device 2000 of the present invention may have an elastic insert 205 that is placed in a pre-stretched configuration during the manufacturing process, thereby providing the desired 3D shape to a non-elastic garment. This process of laying the material on pins (not shown) with different elastic properties at varying amounts of stretch means that 3D-shaped garments can be manufactured in a flat state, providing significant cost and efficiency improvements over other manufacturing methods. For example, these steps may include: (1) placing the non-elastic outer sheet 201 on a flat surface with pins; (2) the elastic insert 205 is pre-stretched and held in a stretched state on the same pins; (3) laying the non-elastic inner sheet on the same pins within the holes 204, sandwiching the pre-stretched elastic insert 205 between the inner sheet 201 and the outer sheet 203; (4) fusing the three layers together in a flat state (RF welding, ultrasonic welding, sewing, or any other connecting means), and (5) removing the lower leg therapeutic compression device 200 of the present invention from the pins, thereby allowing the pre-stretched elastic portion 205 material to be free and contract, thereby rolling the lower leg therapeutic compression device 200 of the present invention into the desired 3D shape. In this embodiment, the inner sheet 201 and the outer sheet 203 are non-elastic and may be composed of a multi-layer laminate, which can be airtight and inflatable. In other embodiments, the non-elastic material may have an additional elastic insert or mesh portion 217 that is inserted in a manner that provides a 3D anatomical shape and a predetermined compression distribution by stretching more or less depending on the location of the desired compression distribution. Due to the non-elastic portion of the lower leg therapeutic compression device 200 of the present invention, the additional elastic or mesh portion 217 can assist in anatomical positioning and heat release from the user's limb. Similarly, the thigh therapeutic compression device 300 of the present invention includes an elastic portion 318 to conform to the anatomy of the groin area and prevent the thigh therapeutic compression device 300 of the present invention from sliding down the user's leg and thigh when the user is moving and, in particular, walking, and thereby providing assistance and better efficacy in reducing, treating and even preventing tissue swelling, lymphedema, ulcers (arterial and venous), CVI and DVT, and increasing circulation in the thigh and entire leg of the individual user.

[0120] It should be understood that the chambers of the bladders 202 (202A, 202B, 202C), 302 (302A, 302B), 502 can be filled with air, fluid, or other known inflatable means. It should also be understood that the bladders 202 (202A, 202B, 202C), 302 (302A, 302B), 502 can be arranged to receive air and be pumped using a manually pumped bulb (e.g., Figure 2) or can be inflated by an electric air pump 150 which can use batteries or AC wall current to pump air into the chamber. Figures 9 to 11 、 Figures 14 and 15 and Figures 20 to 21 The therapeutic compression of the present invention is shown as an example of a therapeutic compression device 200, 300 of the present invention, which includes two separate bladders 202A, 202B or 302A, 302B or three separate bladders 202A, 202B, 202C. Each of these separate bladders can be sequentially inflated, then released, then inflated, and repeated depending on the target pressure of the target limb and each part of the target limb. The inflation port 212 (212A, 212B, 212C) of the therapeutic compression device 200 of the present invention is universal in that it can be connected to a variety of different types of inflation devices. Any known air or fluid source can be used, whether a pump or pressure generator that is manual, mechanical, electric, battery-driven, or any other power source. The inflation device 150 can be a manual pump, a hand pump, a foot pump, a mechanical pump, an electric pump, a battery-powered pump, a static pump, an intermittent pump, a variable speed pump, an automatic pump, a pneumatic pump, a negative pressure pump, a suction pump or a vacuum pulse pump, or any other known or developed inflation source to provide a certain pressure within the bladder to provide compression when used by the patient.

[0121] like Figure 1 To Figure 4, Figures 9 to 11 and Figures 14 and 15 As shown, the inflatable device 150 is connected to the therapeutic compression device 200 of the present invention via a connecting device such as a tube 160 or a hose, and as shown Figure 9 and Figures 12 to 13As shown, there are a plurality of hoses 160A-160F that pass through the manifold 190 and connect to the applicable inflation ports 212A, 212B, 212C, 312A, 312B, 502. In addition to the non-limiting examples of tubes and hoses, any other known connection means may be employed. The connecting device tube or hose 160 (160A, 160B, 160C, 160D, 160E, 160F) has two ends, one of which is inserted into the corresponding inflation port 212 (212A, 212B, 212C), 312 (312A, 312B), 512, and has a tip or insertion portion 195 (195A, 195B, 195C, 195C, 195D, 195E, 195F) on the other end, which is inserted into the hole 197 (197A, 197B, 197C, 197D, 197E, 197F) in the manifold 190. The manifold divides the air from the air pump 150 into each of the corresponding tubes 160 or hoses, and there are sensors, valves, switches, or some gateway in selecting the pressure level of each individual tube 160 or hose and whether to inflate, maintain, or deflate the corresponding bladder 202 (202A, 202B, 202C), 302 (302A, 302B), 502. The embodiment shown includes transparent tubes 160 (160A, 160B, 160C, 160D, 160E, 160F) connected to the inflation device 150 or handheld manual pump 400, and another embodiment of the tubes 160 is shown with a covering 162 (shown as black cloth 162) on the tubes to allow the user to more easily wear the covered tubes 160 under clothing, or to make it less likely to be seen when worn over clothing. The tube 160 (160A, 160B, 160C, 160D, 160E, 160F) is connected to the therapeutic compression device of the present invention by inserting, for example, a male Luer slider 161 into the inflation port 212 (212A, 212B, 212C), 312 (312A, 312B), 512. At the opposite end of the tube 160, the tube 160 is inserted into the inflation device 150 via the pump output port 152, as shown. Figures 4A to 4B As shown, but also inserted into the inflatable device through the manifold 190 by inserting the connector 195 (195A, 195B, 195C, 195D, 195E, 195F) into each corresponding hole 197 (197A, 197B, 197C, 197D, 197E, 197F), as shown Figure 12 and Figures 22A to 22C shown, although other configurations are possible (not shown).

[0122] exist Figure 1The inflatable device 150 shown in the embodiment of Fig. 4 is a pneumatic pump, which can be recharged via an electric charger, but the pump can also be battery-driven or any other known power source. In this embodiment, the inflatable device 150 comprises a base 151 that is connected to a retaining device 180 straps. The base 151 is connected to the main pump assembly via a series of screws 154 and O-rings 153. The main pump assembly is shown as 156, but the internal mechanical part and the electric part are not shown. The inflatable device 150 of this embodiment is an electric air pump (for example, to prevent DVT or treat CVI) with an interface pressure of 50mm-Hg. Pump 156 can statically and constantly apply pressure, or can apply pressure intermittently, for example, by applying 50mm-Hg, hold for 10 seconds, then release until the next cycle of 30-45 seconds, and repeat for a period of time. Other embodiments may include pressure levels of 60 mm-Hg, 75 mm-Hg, 80 mm-Hg, 90 mm-Hg, 100 mm-Hg, or other known pressure levels, depending on the patient's treatment plan and target limb. Multiple pressure levels may also exist within the pump so there are varying pressures during treatment. Figures 9 to 21 In the illustrated embodiment, pressure levels can be recorded by the manifold 190 and various sensors (197A, 197B, 197C, 197D, 197E, 197F) corresponding to each bladder 202A, 202B, 202C, 302A, 302B, 502, so that the bladders are sequentially inflated and deflated or maintained, and the amount of pressure can vary with respect to each individual bladder. Each therapeutic compression device 200, 300, 500 of the present invention has one or more bladders 202, 302, 502 connected to the inflatable device 150 by a controller (such as a sensor, switch or valve 197 (197A, 197B, 197C, 197D, 197E, 197F) within the inflatable device 150 and manifold 190) that is capable of sequential intermittent pneumatic compression or any other type of compression, while also being capable of being detached from the inflatable device 150 while still maintaining or maintaining static compression. Figure 12 and Figures 22A to 22CAs shown, the controller or manifold 190 may utilize sensors, valves, switches, check valves, or mechanisms thereof to inflate, hold or maintain pressure, or deflate the applicable bladder 202 (202A, 202B, 202C), 302 (302A, 302B), 502 at a current pressure level (such as 20 mm-Hg, 30 mm-Hg, 40 mm-Hg, 50 mm-Hg, 60 mm-Hg, or higher). Each of the sensors 197 (197A, 197B, 197C, 197D, 197E, 197F) is capable of opening, closing, or venting air flow from the inflation device 150 to the applicable bladder via the applicable tube or hose 160A-160F so that a predetermined inflation sequence (which is sequential) produces different or the same pressure within the different bladders 202 (202A, 202B, 202C), 302 (302A, 302B), 502, although other combinations and other pressure sources besides air flow may be employed. When inflated, the therapeutic compression devices 200, 300, 500 of the present invention have an SSI of at least about 10 or greater.

[0123] like Figure 3 4, the main pump 156 of the inflatable device 150 includes a display 157 which, in this embodiment, shows the remaining battery power level, the limb being compressed (or Figures 9 to 21 In the embodiment shown, the specific bladder is inflated) and the elapsed time of that transient phase (in hours and tenths of hours). The display 157 can be modified to show the changing pressure level, the other limbs being compressed, the remaining time of activation within the set time period, etc. USB port 159 and cover 158 are located on opposite sides of this embodiment of the main pump 156 for recharging the pump battery (internal mechanism not shown). An on-off switch 165 is included in this embodiment, but the on-off switch in other embodiments can be digital and include various options such as pressure level, static or intermittent state, time to operate at each pressure level and / or state, limb to be compressed (if the pump 156 is connected to multiple therapeutic compression devices 200 of the present invention), etc.

[0124] Figure 1 4 is a flexible cover 158 to protect the inflatable device 150 from being dropped by the user or simply from the usual wear and tear on the pump mechanism, or even to prevent overheating or chafing of the user's waist. The flexible cover 158 can be made of a polymer, rubber, or other flexible material, etc.

[0125] Once the therapeutic compression device 200, 300, 500 of the present invention is secured around a patient's limb, such as, for example, the leg, the bladder 202 (202A, 202B, 202C) cannot shift out of position, thereby increasing comfort and reducing fit issues for the patient, along with the elastic portion 205 and the like. Figures 20 to 21 Additional mesh insert 217 is shown. To increase patient mobility, in an exemplary embodiment, the inflation device 150 is connected to the bladders 202 (202A, 202B, 202C) via male Luer sliders 161, and the inflation device 150 is connected to the manifold 190 via connectors 195 (195A, 195B, 195C, 195D, 195E, 195F). The inflation device 150 is also connected to a retaining device 180, which in this embodiment is a belt. The user can then activate the main pump 156 via an on-off switch 165. The user then wears the inflation device 150, which is similar to a mobile phone, on an individual belt. In this embodiment, the retaining device 180 is a belt that can be adjusted to the user's waist via an adjustment device 182, such as, for example, a triglide and / or end clips. Thus, the user has increased mobility compared to conventional therapeutic compression devices where the inflatable device is integral to the device.

[0126] The inflation device or mechanism for each of the various embodiments of the present invention may include a hand pump, an electric pump, a battery-powered pump, a remote control pump, an air pump, an air pump, or any other known inflation device. Many or multiple inflation devices may be used, such as a manual pump, a hand pump, a foot pump, a mechanical pump, an electric pump, a battery-powered pump, a static pump, an intermittent pump, a variable speed pump, an automatic pump, a pneumatic pump, a negative pressure pump, a suction pump or a vacuum pulse pump, or any other known or developed inflation source, to provide a certain pressure within the bladder to provide compression when used by the patient. In addition, the inflation device may include a device for monitoring or regulating inflation. The inflation device may include programming so that when the compression device is worn on the patient for use, the bladder 202 (including multiple bladders, such as Figures 9 to 21The illustrated embodiment enables sequential inflation and deflation of the bladders 202A, 202B, 202C, 302A, 302B, 502 to be inflated and deflated to set pressures at intervals or set times throughout the day or night. For example, by way of example only, the inflation device may be set to 40 mm-Hg at 9:00 AM, then deflated to 20 mm-Hg at 11:00 AM, then inflated to 30 mm-Hg at 12:00 PM, and so on, with respect to sequential inflation and deflation of each applicable bladder 202, 302, 502, 202A, 202B, 202C, 302A, 302B, individually for each patient throughout the day and night. In another embodiment of the present invention, if the therapeutic compression device of the present invention has two separate bladders (bladders 202A and 202B or 202A, 202B, 202C or 302A, 302B or other embodiments not shown, such as 502A, 502B or 302C or 202D, etc.), there may be two separate inflation ports 212A, 212B, 212C or 312A, 312B, each connected to the same inflation device 150 via a manifold 190, and the pressure levels of the first bladder 202A and the second bladder 202B may be the same or have different pressure levels compared to bladders 302A and 302B, etc., which have constant or sequential inflation and / or deflation. For example, by way of example only, the inflatable device may be set to 40 mm-Hg for the first bladder 202A and 20 mm-Hg for the second bladder 202B, or each may be varied, and the inflatable device may be set to sequentially inflate, deflate, inflate, or maintain pressure and compression for a period of time throughout the day as described above. Figure 2 and Figure 4B As shown, multiple therapeutic compression devices 200, 300 of the present invention can be connected to a main pump 150, 156, so that the pressure level of each bladder 202 (202A, 202B, 202C), 302 (302A, 302B), 502 in each therapeutic compression device of the individual therapeutic compression devices 200, 300, 500 of the present invention can be the same or different. By way of example only, for the bladder 202 in the right calf therapeutic compression device 200 of the present invention, the right calf therapeutic compression device 200 of the present invention can be set to 40 mm-Hg, and for the bladder 202 in the left calf therapeutic compression device 100 of the present invention can be set to 20 mm-Hg, or each can be changed, and the inflation device is set to be sequentially inflated, deflated, inflated, or maintain pressure and compression for a period of time, etc. within a day as described above. The main pump 156 can be connected to three or more separate bladders within one therapeutic compression device 200 of the present invention, or can be connected to three or more separate therapeutic compression devices 200, 300 of the present invention, such as Figure 2 and Figure 4B , three separate therapeutic compression devices of the present invention are shown, but in this embodiment, only two hoses 160 are connected to the inflation device 150, so the left lower leg therapeutic compression device 100 of the present invention must be inflated via a hand pump 400 or a second inflation device (not shown). When inflated, the therapeutic compression device 200 of the present invention has an SSI of at least about 10 or greater.

[0127] For example, a treatment option would include 60 minutes of intermittent pneumatic compression (HPIPC) twice daily for 16 weeks. In this example, the inflatable device would have a pressure level of 120 mm-HG and a bidirectional pressure of 120 mm Hg during the cycle time to provide 4 seconds (+ / - 0.5 seconds) of sequential compression followed by a 16-second rest period (+ / - 3.0 seconds), resulting in a 20-second cycle or 3 cycles per minute. This treatment can help reduce vascular problems such as lymphedema, DVT, CVI, etc.

[0128] In another example, a treatment option may include reducing DVT by applying preoperative pressure to the target limb, such as for knee surgery, TKR, KRA, hip surgery, THR, HRA, etc., over a period of days, weeks, or months before the surgery date. Prior to surgery, the patient will apply compression via the therapeutic compression device of the present invention and the inflatable device of the present invention system to reduce swelling of the target limb. During the actual operation and immediately after surgery, while still in the hospital environment, the patient will use the same or different therapeutic compression device of the present invention connected to an inflatable device such as an intermittent compression pump accessible through the wall of the patient's room or pushed into the room, which can be considered mechanical DVT prevention. Once discharged from the hospital environment, the patient can retain the same therapeutic compression device of the present invention and use it at home by applying pressure via the inflatable device 150 of the electric pump, which is configured to apply both constant static pressure and intermittent varying pressure based on the treatment plan. Use of this method can reduce or prevent DVT, CVI, and other vascular problems. The therapeutic compression device of the present invention has a universal inflation port that is configured so that it can be connected to a hand pump (400) and an electric pump (156) as well as a hospital pump (not shown) and many other pumps. This method of use of the system of the present invention can reduce swelling before and after surgery and also reduce or prevent circulation problems, as well as reduce, treat or even prevent tissue swelling, arterial ulcers, venous ulcers, lymphedema, VU, DVT and other postoperative complications. As described above, using the system 100 of the present invention including the inflation device 150 attached to the holding device 180 strap, it is easier for the patient to move around. The system is also simpler than current postoperative compression systems and other products on the market, which themselves weigh many pounds.

[0129] In another embodiment of the method of using the system 100 of the present invention, the system is used before, during and after lower body surgery. In particular, for lower leg joint replacement (knee and hip) surgery, the risk of DVT increases along with pre- and post-operative problems associated with leg swelling. Due to the universal nature of the inflation port (or valve) on the therapeutic compression device of the present invention, it can be connected to a hand pump, a battery-powered pump or an existing intermittent pneumatic compression DVT system on the market. However, the cannulas of these existing DVT systems are not worn to reduce swelling, static compression cannot be applied, and cannot be used for mechanical DVT prevention without an IPCDVT control unit. Thus, another method of use for improving outcomes includes the following steps: (a) administering to the patient the therapeutic compression device 200, 300, 500 of the present invention at least 3 days prior to surgery to reduce limb volume and leg swelling, which can be achieved through static or intermittent compression pressure levels, and then (b) connecting the therapeutic compression device 200, 300, 500 of the present invention to an IPC DVT control unit in a hospital or clinic or outpatient setting during and immediately after surgery, and the IPC is cycled intermittently to provide standard DVT mechanical prevention, and thereafter (c) when the patient is discharged from the hospital, administering to the patient the therapeutic compression device 200, 300, 500 of the present invention along with either or both of a hand compression pump or a battery-powered (or electric) inflation device 150 (such as pump 156) to take home to manage the risk of DVT while preventing further swelling.

[0130] It is contemplated that the system 100 of the present invention may be used in conjunction with a lower leg compression device, such as those described in U.S. Pat. No. 9,033,906, U.S. Pat. No. 7,967,766, U.S. Pat. No. 7,559,908, U.S. Pat. No. 7,276,037, and U.S. Ser. No. 13,444,600, and that one inflatable device may be connected to each of the two compression devices, e.g. Figures 1 to 21As shown. The inflation device may include programming (not shown) connected to the sensors 197 (197A, 197B, 197C, 197D, 197E, 197F) such that when the compression device is worn on the patient, the bladders of the two therapeutic compression devices 200 of the present invention and the bladders 202 or bladders 202A, 202B of the lower leg compression device 200 are each (or simultaneously) inflated and deflated to set pressures (whether sequentially or not) at intervals or set times throughout the day or night. For example, by way of example only, the inflation device 150 may be set to 40 mm-Hg at 9:00 AM, then set to deflate to 20 mm-Hg at 11:00 AM, then set to inflate to 30 mm-Hg at 12:00 PM, and so on, for each patient throughout the day and night. In another embodiment of the present invention, for example, and by way of example only, the inflation device may be set to 40 mm-Hg for the thigh bladder 300 and 20 mm-Hg for the lower leg bladder 202 (or calf bladder 202B or foot bladder 202A, etc.), or each may be varied, and the inflation device may be set to sequentially inflate, deflate, inflate, or remain inflated for a period of time, etc., throughout the day as described above. Each of these bladders may be set to the same or different pressure levels throughout the day and night, depending on the treatment plan for the patient and depending on the particular patient. When inflated, the therapeutic compression device 200 of the present invention has an SSI of at least about 10 or greater.

[0131] In one embodiment of the present invention, the inflation device comprises a manual pump (e.g. Figure 2 8 ), and the dial includes graphics of pressure amounts 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 mm-Hg, 35 mm-Hg, 45 mm-Hg, and 55 mm-Hg. The specific predetermined pressures corresponding to the graphics are unlimited and not limited to the examples herein.

[0132] Furthermore, the therapeutic compression device of the present invention may be deflated via a button or switch to deflate the bladder 202 (202A, 202B, 202C), 302 (302A, 302B), 502 and thereby release the pressure and / or compression distribution. In another embodiment (not shown), the switch may have multiple integrated umbrella valves such that one umbrella valve is set and closed to maintain pressure within the bladder 202 (202A, 202B, 202C), 302 (302A, 302B), 502, while a second umbrella valve will release a certain amount of air or fluid within the bladder 202 (202A, 202B, 202C), 302 (302A, 302B), 502 to relieve pressure, such as when the patient is walking (pressure increases with each step on the thigh or on the foot portion of the lower leg therapeutic compression device of the present invention) or flying (pressure increases based on altitude), and a third umbrella valve that will release all of the air or fluid in the bladder 202 (202A, 202B, 202C), 302 (302A, 302B), 502, thereby releasing all pressure and deflating the therapeutic compression device 200, 300, 500 of the present invention. For example, by way of example only, a first umbrella valve is set in a closed position so that when activated, it maintains the amount of air or fluid in the bladder 202, and thus maintains a set pressure, e.g., 45 mm-Hg, and if the pressure exceeds 45 mm-Hg, a second umbrella valve is set to release the air or fluid within the bladder 202 and reduce the pressure to 45 mm-Hg (such as when at high altitude or other increased pressure) and then maintain the pressure at 45 mm-Hg, and a third umbrella valve is set to open and release all of the air or fluid within the bladder 202, and thus release all of the pressure, when activated by the patient, so as to deflate the bladder 202 and the therapeutic compression device 200 of the present invention. By way of another example, the dial or display 157 may include graphics such as (A) "Walk," where a set amount of pressure is maintained while the patient walks, and pressure repeatedly rises and returns over time while the umbrella valve is maintained in a closed position, (B) then an "Air" graphic, where the set amount of pressure is maintained by the umbrella valve occasionally releasing pressure when pressure increases above a set amount or value, such that the umbrella valve is activated to release air or fluid within the bladder 202 and release pressure, then closes and remains closed to maintain the set amount of pressure, and (C) "Release" or "Deflate," where pressure is released and air or fluid within the bladder 202 is released to deflate, with the umbrella valve always in an open position. In this embodiment (not shown), there are three umbrella valves, one of which is set to always open the bladder 202 to fully release pressure, one of which is set to always close to maintain air or fluid in the bladder 202 to maintain pressure, and a third of which is set to open or release at a predetermined or set pressure point.In all embodiments referring to an umbrella valve, the umbrella valve may also be a switch (manual or otherwise) or a digital switch or any other known device to open, close or partially release the air or fluid within the bladder to maintain, change or release the pressure therein.

[0133] The therapeutic system 100 of the present invention includes a sealing device of the present invention connected to the bladder 202, 302, 502 to maintain the gradient compression profile and / or gradient pressure profile when the inflation device 150 is disconnected from the therapeutic compression device 200, 300, 500 of the present invention or the inflation device stops providing additional inflation or pressure. Figure 2 In one embodiment shown, the sealing means is a cap 213 that is inserted over or into the inflation port 212, 209.

[0134] The sealing device also includes a valve 290 in the inflation port 212, 312 (212A, 212B, 212C), 312 (312A, 312B), 512. Figures 5A to 5B As shown in FIG. 2 , which is a cross-sectional view of the inflation port 212 , the valve 290 is located within a housing 209 , which is a tubing or, for example, a Luer connector. In this embodiment, the housing 209 is a plastic female Luer connector, but other materials such as metal, polymer, or rubber may be used, and other housing arrangements may be used. Figure 5A and Figure 5B The valve 290 shown includes a V-shaped notch 291 in the top proximal portion of the valve 290, but other shapes of notches or other holes and openings may be used. In this embodiment, the V-shaped notch 291 helps fluid move from the male luer 161 (fluid flowing from the inflation device 150) into the inflation port 212 and into the bladder 202. The bottom distal portion of the valve 290 is shaped like Figure 5A and Figure 5B The shape shown is such as a plug, wherein the top portion 291 is thinner than the bottom distal portion and has a location 292 that abuts and seals the inflation port when the inflation port rests along the top portion 299 of the indentation 293 in the lower portion of the housing 209. When the two portions 292 and 299 are connected or in contact, the inflation port 212 is sealed and the fluid within the therapeutic compression device 200 of the present invention is sealed within the bladder 202, and thus the pressure and compression therein, and if applicable, maintains a gradient compression profile and / or gradient pressure profile. Figure 5A and Figure 5B As shown, the housing 209 has a circumference that expands in the lower distal portion to accommodate the valve 290. Figure 5A and Figure 5BThe shape shown is not limiting, and any other shape may be used, as long as some portion of the valve 290 contacts a portion of the housing 209 to form a seal and maintain pressure and fluid within the inflated therapeutic compression device 200, 300 of the present invention. Similarly, other shapes may be used to create functionality for the zoom mechanism. Then, in this embodiment, the bottom distal portion 295 of the housing 209 is narrowed or tapered so that when the valve 290 is pushed downward by the male luer 161, the bottom of the valve 290 rests on the top of 295, and fluid passes around the outer circumference of the valve 290 and also through the V-shaped notch 291 and into the bladder 202 via the opening or hole 294. The outer circumference of the bottom distal portion of the valve 290 is slightly smaller than the inner circumference of the bottom distal portion 293 of the housing 209, so that fluid can flow from the inflation device 150 through the hose 160, through the sliding luer 161, through the inflation port 212, and into the bladder 202. The same components and methods may be employed in the thigh therapeutic compression device 300 of the present invention or any other type of inflatable device.

[0135] Figure 5AInflation of the therapeutic compression device 200 of the present invention is shown, wherein the male sliding luer 161 is inserted into the housing 209 of the inflation port 212 (with the optional cap 211 opened and moved to the side) and pushed downward onto the valve 290, causing the bottom of the valve 290 to rest on the bottom distal portion 295 of the housing, which returns to the open position of the valve 290. Fluid, represented by the downward arrow in the middle of the male sliding luer 161, flows into the housing 209, through the valve 290, and into the bladder 202 as shown by the direction of the arrow at the bottom of the figure. Fluid will continue to flow into the bladder 202 until the therapeutic compression device 200 of the present invention is in the proper inflated state. The user then removes the male sliding luer 161 from the housing 209 of the inflation port 212, and the valve 290 is moved in an upward direction, causing the bottom distal portion 292 of the valve 290 to contact the corresponding shape of the top portion 299 of the indentation 293 in the lower portion of the housing 209. The two parts 292 and 299 are connected or in contact, thereby sealing the inflation port 212 and maintaining the fluid in the therapeutic compression device 200 of the present invention at the level before the inflation device 150 was disconnected from the therapeutic compression device 200 of the present invention. Fluid is represented by the upward arrow in the middle of the housing 209, flows out of the bladder 202 and into the bottom of the recessed housing 293, and the fluid is scaled by the valve 290. The inflation device 150 can also be a manual pump 400 and any other static or intermittent inflation device. When the bladder 202 is deflated by the user, the valve 290 will again be pushed downward by the male sliding luer interface 161, but no fluid or inflation will be applied at this time, so that the fluid flows out of the inflation port through the valve 290 and will remain in a deflated state. By inserting the male sliding luer interface 161 or through a rod or other extension of the cap 211 (shown in Figure 8K The valve 290 can be manually pushed downward to deflate by pushing the valve 290 in a downward direction (in the embodiment of the present invention) or by any other implement. In this embodiment, the valve 290 is self-expanding, but other sealing devices may be used, such as any movable rod, screw, switch, stopcock or other mechanical device to seal the inflation port and retain the fluid therein.

[0136] The system 100 of the present invention may be included in a kit comprising the therapeutic compression device 200, 300, 500 of the present invention, an inflation device 150, a retaining device 180 such as a strap, and a connecting device such as tubes 160 (160A, 160B, 160C, 160D, 160E, 160F). Depending on the energy source, the inflation device 150 may require a charger, such as an electrical charger (not shown) for connection to a USB port 159, and the kit would include such a charger. Figure 3As shown, a cable such as a USB cable 175 can be connected to the USB port 159 to charge the inflatable device, and the USB cable 175 has two connectors 176, 177 on each side for connecting to a charging source and to the inflatable device 150. Figure 3 As shown, an optional battery 173 can be connected to the inflatable device 150 and worn by the user on a strap 180. In this embodiment, the battery assembly 170 includes a battery 172 placed within a pouch 171 or any other housing device, and the pouch 171 is slid onto the strap 180 via two openings or holes 172 located on the sides of the pouch 171. A USB cable 175 is then connected to the battery 173 on one side 1748, 177 and to the inflatable device 150 at a corresponding USB port 159 on the other side 176. The inflatable device 150 may already be fully charged, but with the optional battery 171, the user can leave the confines of a hospital bed, home, workplace, and walk around and be able to continue inflating without being tethered to an electrical outlet.

[0137] Depending on the therapeutic compression device 200, 300, 500 of the present invention in the kit, a stocking or sock 110 or other layer between the patient's skin and the therapeutic compression device 200, 300, 500 of the present invention may be included. Depending on the embodiment of the inflatable device 150, a flexible cover 158 may be included in the kit. Other devices or equipment may be included in such a kit, or for example, replacement or spare connection devices such as tube 160, spare battery 171, spare USB cable 173, etc. The kit may also include various wound dressings and / or bandages. Wound dressings and / or bandages may be discarded more frequently, and the therapeutic compression device of the present invention is combined with or applied in combination with wound dressings and / or bandages. In one embodiment, the therapeutic compression device of the present invention is used above or on top of a wound dressing applied to the skin.

[0138] Another embodiment of the present invention includes a method of applying a measured amount of compression using feedback. In this embodiment (not shown), a compression bladder A is inflated by an inflation source C - the properties of the compression bladder A are such that the amount of compression is determined by the amount of inflation medium (typically air) pumped from C into A. In this design, the inflation source C is also coupled to a bladder B, which has a fixed volume of air. As the compression bladder A inflates, it squeezes the bladder B as it compresses the compressed article F. The inflation source C is able to read the line pressure from the connection line E to determine the interface pressure from the bladder B - in this design, the inflation source C can be calibrated to provide only the amount of inflation medium required to enter the compression bladder A, as determined by matching the desired interface pressure from the bladder B. Other configurations can be used so that feedback can be obtained from the inflation device and the compression device.

[0139] Another embodiment of the present invention includes utilizing a sequential gradient compression of a single chamber. Figure 6 ), the therapeutic compression device 200 of the present invention includes inflatable bladders to apply not only gradient compression, but also sequential (first filling channel B, then second filling main bladder V, or vice versa) compression. Figure 6 (As shown), the inflation device A is connected to the device at two locations: inlet port C and exhaust port D. By inflating and providing air directly into channel R, channel B is inflated first before the main bladder F. The air is then exhausted from exhaust port D. In this design, inflation can be intermittent to provide a gradient, and sequential compression or inflation can be maintained at a constant level to provide only a gradient distribution.

[0140] The inflatable device 150 may also include a sensor 155 to measure the air pressure applied to the tube 160. Another embodiment of the present invention includes an electric or other automatic inflatable device so that the bladder is inflated to a set volume or inflated by reading the back pressure it is being filled. A pressure cycling function may be included. In addition, one embodiment may have an inflatable device so that the inflation in the bladder is maintained even after the inflatable device is removed. Such an inflatable device may be integrated with the compression device itself or may be removable. Such an inflatable device may include an integrated circuit and / or wireless capability for tracking usage, pressure, patient compliance with certain pressures recommended by a physician or part of such a patient's treatment plan, and other health data, such as standing pressure and moving or working pressure, pedometer (number of steps), heart rate, blood pressure, and any other possible monitoring of the patient. Based on the feedback obtained, the inflatable device can be programmed to increase or decrease the pressure without the patient having to manually change it. In addition, the inflatable device can be configured so that a physician or other treatment professional can remotely increase or decrease the pressure based on feedback. Other combinations may be included, such as manual changes of dials or pneumatic devices combined with automatic or electric or digital devices.

[0141] The system 100 of the present invention may also include other sensors, such as a tensiometer, which is a device that is pressed into the skin to measure the amount of force required to form an indentation in the tissue. The resulting measurement can help measure the degree of firmness or fibrosis (tissue scarring) under the skin, which is a result of worsening lymphedema. Such a tensiometer can be applied to the patient's skin under the therapeutic compression device 200, 300, 500 of the present invention and measure the firmness or fibrosis at such treatment sites on the patient's limbs. Such a tensiometer can be connected to the inflation device via Bluetooth or other digital means and provide feedback to the patient and medical staff, as discussed above.

[0142] like Figures 20 to 21As shown, the elastic portion 205 is inserted into the opening 204 to facilitate better anatomical fit when used on an individual. Additional mesh inserts 217 can be placed within the other holes or openings 215, wherein the mesh or elastic portion 217 facilitates anatomical fit and provides a through-area to reduce or prevent overheating and sweating at the target limb when the therapeutic device 200 of the present invention is wrapped and inflated on the user. Also shown is an elastic portion 226 for the ankle area on the lower leg in these embodiments where the target limb is the lower leg. Compared to the wider upper portion on the calf closer to the knee, the elastic portion 226 facilitates anatomical fit of the thinner ankle portion of the lower leg. When the wrap 220 is closed and secured to the lower leg and then inflated (including maintaining an SSI of at least about 10 or greater), the additional mesh or elastic insert 217 further facilitates anatomical fit on the calf area of the user's lower leg.

[0143] like Figures 1 to 2 、 Figures 14 and 15 and Figures 20 to 21 The illustrated embodiment of the therapeutic compression device 200 of the present invention includes an integrated foot wrap 250 that includes hook-and-loop portions 222, 224. In one embodiment, the bladder 202 flows into the foot wrap 250, providing compression on the arch and underfoot area corresponding to the arch of the user's foot. However, in other embodiments, the bladders are separate, such that the foot bladder 202A is separate from one or two additional bladders 202B, 202C, and the foot bladder 202A is inflated from the inflation device 150, providing compression on the arch and underfoot area. In these figures, additional mesh or elastic inserts 217 are not included, but they can be added to the wrap 220, though not shown here. The illustrated embodiment includes a heel hole 230 and an elastic ankle portion 226. Another element that aids and reduces sweating and heating when the therapeutic compression device of the present invention is inflated on the user's target limb is the various through-holes 208 located on the lower leg treatment device 200 of the present invention, which are located on the hook and loop portions 222, 224 and the non-bladder portion of the wrap 220 and within the spot welds 214. Through-holes 208, 308, 508 can be located throughout the therapeutic compression device 200, 300, 500 of the present invention to allow ventilation around the patient's leg, thigh, arm, or other body part or limb during extended wear of the therapeutic compression device 200, 300, 500 of the present invention. For clarity, not all through-holes are identified with reference numerals in the figures.

[0144] The sock or sleeve 110 is elastic and may include compression throughout, or may have compression elements in only a portion, or may be non-compressive. The elastic sock or sleeve 110 may be constructed of materials such as nylon, wool, cotton, or any other compatible elastic material. The elastic sock or sleeve 110 itself may have compression characteristics that are another level of compression coupled to the wrap 200, 220, 300, 500 and / or the compression or pressure of the bladder 202 (202A, 202B, 202C), 302 (302A, 302B), 502 once inflated. In such Figures 20 to 21 In one embodiment shown, the foot portion of the elastic sock or sleeve 110 includes a compression portion 112 located around the arch and sole of the foot portion. An optional compression strap (not shown) may be included, which may have loop and hook portions to secure the compression foot strap together. Other known attachment means for the compression strap may be included, such as, but not limited to, VELCRO®. TM , hooks, snaps, adhesion, stitching, buttons, etc. The elastic sock or sleeve 110 also includes a connection means to connect to the therapeutic compression device 200, 300, 500 of the present invention, such as via adhesion, stitching, welding, gluing, snaps, hooks, buttons, Velcro TM or any other known connection means. Figures 20 to 21 The attachment means is shown by way of example only as a button 113 on the elastic sock or sleeve 110 that can be inserted and secured within the slot 223 on the device 200. The number of attachment means 113 can be at least one, but can be sufficient to attach the elastic sock or sleeve 110 to the wrap 200, 220. The area of the elastic sock or sleeve 110 is attached or joined to the area of the therapeutic compression device 200 of the present invention located along the upper calf portion and above the ankle region 226 (at Figures 20 to 21 Other embodiments may include VELCRO TM Or loop and hook features. Ease of manufacture, cost, and use by individual users may influence the connection means so that it can be a set of buttons, where the male portion of the buttons 113 on the elastic sock or sleeve 110 mates with the female opening portion 223 on the therapeutic compression device 200. In this embodiment, the female opening portion 223 is a slit hole, but it can be any other type of hole, or if the connection means is a buckle, it will be a combination of the female and male portions of the buckle. Other connection means may include buckles, hooks, buckles, straps, zippers, and other combinations of known connection means.

[0145] In such Figure 13In yet another embodiment of the present invention, the therapeutic compression device of the present invention has two wraps and bladders 202, 302 connected by an elastic knee sleeve 650, making the device a full-leg device. A separate foot therapeutic compression device 500 of the present invention is also shown, which is connected to the same inflation device 150 as the full-leg therapeutic compression device. In this embodiment, a single inflation device can sequentially inflate, hold, deflate, and other combinations of each of the multiple connected bladders 202, 302, 502. By way of non-limiting example only, bladder 502 can be inflated and then held, then bladder 202 can be inflated and then held, then bladder 302 can be inflated and then held, then bladder 502 can be deflated for a period of time, then bladder 202 can be deflated for a period of time, then bladder 302 can be deflated for a period of time, and then the cycle can be repeated for a period of time. This method of inflation and deflation, and where applicable, maintaining pressure, can be employed in all embodiments shown and not shown.

[0146] Additionally, an optional support may be included on each of the therapeutic compression devices 200, 300, 500 of the present invention to reduce tearing of the wrap 220 or hook 222 when the hook portion 222 is pulled from the loop portion 224. Figure 19 As shown, a series of strain relief portions 221 are included between each of the hook portions 222 to reduce tearing of the material after repeated use by an individual. These optional strain relief portions 221 can be connectors to strengthen the area between the hook fasteners 224 to prevent tearing of the material when used continuously by an individual.

[0147] The SSI of the therapeutic compression device 200, 300, 500 of the present invention when inflated can be measured by known methods, such as, by way of example only, measuring pressure and Picopres. In one such measurement, as an example, the therapeutic compression device 200, 300, 500 of the present invention is placed on the lower leg of an individual, wrapped around the leg, and inflated to the following three different pressure or compression readings. Picopres is measured, indicating an SSI of at least 12 or higher:

[0148] right leg

[0149]

[0150] left leg

[0151] 20-30 38 56

[0152] 30-40 44 72

[0153] 40-50 54 89

[0154] In another embodiment, the therapeutic compression system 100 of the present invention has sensors that measure the positioning and movement of the therapeutic compression devices 200, 300, 500 of the present invention. Such sensors can be interpreted as giving a readout (via an interface, a computer plug-in, or sent to an application) to the user or clinician regarding compliance, activity (a pedometer for measuring steps, stairs climbed, etc.), and providing suggestions / alerts to improve treatment. In one such embodiment with sensors, the therapeutic compression devices 200, 300, 500 of the present invention will be programmed to automatically adjust the type and level of compression applied—for example, it is known in the art that static compression is sufficient for lower leg compression therapy when walking, so if the sensor detects that the user is walking, it will maintain static, non-intermittent compression of the clothing. If the sensor senses that the lower leg is not walking and is stationary, the user can be alerted to switch to intermittent compression or it can automatically switch to intermittent compression to promote blood flow. In one embodiment, the sensor will be able to measure skin fibrosis and adjust the compression level required to improve swelling reduction. These sensors listed are not limiting, and any other known or future developed sensors can be used with the system of the present invention.

[0155] The sensors described above are non-limiting and may be non-digital, or digital devices may be employed. A motorized pump and digital display may be used. The valve may include a digital or electric device to change or modify the pressure at a set rate or interval, or based on feedback from a monitoring device. The system may include a variety of sensors and monitors. For example, other sensors may be time-set, such that if the system is rented, the system stops functioning once the sensor triggers the expiration of the rental days or hours. In this case, the sensor can be reset if additional rental time is purchased.

[0156] The therapeutic compression system 100 of the present invention can be used to treat patients after surgery, such as after a sclerotherapy procedure. Sclerotherapy post-operative sclerosis treatment can also be effective with the thigh therapeutic compression device 300 of the present invention, where the lateral bladder is closed via a closure device (shown as Figure 19The weld lines 316 in the thigh compression device 300 of the present invention are closed and maintained in a non-inflated state, or can be slightly inflated to a lower pressure level, or can be inflated to any pressure level desired by the patient. In this embodiment, the middle bladder is inflated to apply compression and pressure to the treatment site as part of a post-operative treatment plan. Reference is made to U.S. patent application No. 16 / 846211 filed on April 10, 2020, which is incorporated herein. The same approach can be used for other post-operative procedures. The two bladders 302A, 302B within the thigh therapeutic compression device 300 of the present invention, wherein the lateral bladder 302B is separated from the middle bladder 302A. The lateral bladders 302B can be inflated to a set pressure level during manufacture, or not inflated and maintained in an uninflated state during use. The side bladders 302B are connected to the inflation device 150 via the inflation ports 302B and the hose 160 (160B or 160C, 160D, 160E or 160F or higher as applicable, depending on the total number of individual bladders on the user undergoing the sequential compression) and can have a different pressure level than the pressure within the center bladder 302A. Figure 19 As shown, the lateral bladders 302B can be individually inflatable or inflatable through an inflation device 150 including ports 312A (309A), 311B, such as, but not limited to, one-way valves or other desired inflation / deflation configurations. The lateral bladders 302B can also be configured and adapted to provide a different pressure than the middle bladder 302A. For example, when the thigh therapeutic compression device 300 of the present invention is employed following a sclerotherapy procedure, the lateral bladders 302B are separate and not connected to the middle bladder, and thus, in this embodiment, as part of a post-operative treatment plan, the middle bladder 302A is inflated to apply a certain predetermined gradient compression profile and pressure to the treatment site, while a different predetermined gradient compression profile and pressure can be applied to the posterior or lateral portions of the user's thigh.

[0157] The therapeutic compression system 100 of the present invention can be used for other treatments, such as tissue swelling, arterial and / or venous ulcers, lymphedema, CVI, DVT or any other vascular related problems. In use, the therapeutic compression device 200, 300, 500 of the present invention can be placed on a selected limb (such as, for example, a leg) by the patient, a practitioner or a caregiver and fastened around the patient's limb. When moving up or down from the knee and / or hip and / or foot, the patient, a practitioner or a caregiver fastens or secures the fastening tabs upward or downward to the limb. If there are additional optional straps positioned on the proximal end of the device, the first strap should be closed or secured in a tight manner so that the therapeutic compression device 200 of the present invention fits tightly but not too tight, and the second strap should be closed or secured in a tight manner so that the therapeutic compression device 200 of the present invention fits tightly but not too tight. The patient, practitioner, or caregiver then removes the valve cap 213 from the valve on the therapeutic compression device 200 of the present invention, thereby opening the inflation port 212 (212A, 212B), i.e., the female sliding luer interface 209. The patient, practitioner, or caregiver then selects a pressure value on the display 157 or dial of the inflation device 150, depending on the treatment and whether the patient is walking, sitting, lying down, or traveling in a car, train, or airplane. Once a pressure value or value is selected on the dial (such as a given pressure value such as "35" mm-Hg or text such as "walking" or "air" or "travel" or "low" or "medium" or "high"), the corresponding umbrella valve or switch is activated so that the pressure is thereafter maintained (closed position) or modified to maintain pressure as it changes with activity or altitude during use. The patient, practitioner, or caregiver then inserts the end of the tube 160 portion, such as the male Luer slider 161, into the inflation port 212 on the therapeutic compression device 200 of the present invention, presses the on / off button 149 of the inflation device 150 or uses the hand pump 165, and adds air or fluid to inflate the bladder 202 and thereby achieve the desired amount of pressure or pressure valve. Similarly, the inflation device can be a hand pump, an electric pump, a battery-powered pump, a remote-controlled pump, an air pump, an air pump, or any other known inflation device. Many or multiple inflation devices can be used, such as a manual pump, a hand pump, a foot pump, a mechanical pump, an electric pump, a battery-powered pump, a static pump, an intermittent pump, a variable speed pump, an automatic pump, a pneumatic pump, a negative pressure pump, a suction pump, or a vacuum pulse pump, or any other known or developed inflation source, so as to provide a certain pressure within the bladder to provide compression when used by the patient. By Inflation: Units employing this type of inflation may be removed and the bonnet replaced and the pressure will not decrease unless noted in the "Air" or "Walk" position.At any point during use, the patient, practitioner, or caregiver can deflate the bladder by inserting the valve cap, which depresses the valve spring, thereby releasing air or fluid from the bladder and reducing pressure. Alternatively, the patient, practitioner, or caregiver can reinsert the inflation device and select "Deflate" or "Release," which causes the corresponding umbrella valve to open, releasing air or fluid from the bladder and reducing pressure until the bladder and the therapeutic compression device of the present invention reach a deflated state. The therapeutic compression device of the present invention can be reinflated and deflated; this process can be repeated repeatedly during use. When inflated, the therapeutic compression device 200, 300, 500 of the present invention has an SSI of at least about 10 or greater.

[0158] The method of using the system of the present invention is also Figure 7A and Figures 8A to 8K . The present invention has been illustrated and described with respect to specific embodiments of the present invention. These embodiments are examples and illustrations of the principles of the present invention and are not intended to be exclusive or otherwise limiting embodiments. For example, although in the aforementioned embodiments. The therapeutic compression device 200 is described as having an inflatable bladder, the therapeutic compression device 200 may additionally include an integrally formed or attached (e.g., by adhesive, radio frequency welding, etc.) compression member that is not configured for inflation and / or deflation. For example, any of a variety of pre-formed and / or pre-filled cushioning materials may be used to implement the additional compression member, such as a foam pad and / or a non-inflatable pad filled with air, gel, or other fluid, provided that such compression member produces sufficient compression in combination with the integral compression bladder. In addition, although specific shapes, sizes, and materials are described for illustrative purposes, it should be understood that any of a variety of shapes or sizes may be used and that the materials described are not exclusive but are merely exemplary. Moreover, as described above, although the bladder is shown as being inflated with air, it should be understood that any other fluid or medium, such as a liquid or gel, may be used. Additionally, it should be noted that the bladder can be configured to have multiple pneumatically independent and / or pneumatically coupled bladder portions, and can also be configured to have various profiles or lobes.

[0159] The therapeutic compression system 100 of the present invention described herein can be used for any suitable condition treatable by compression therapy, etc. For example, the system of the present invention including the therapeutic compression device 200 according to the present invention can be used to compress the venous system to treat swelling, venous and arterial ulcers, CVI, DVT, for treating lymphedema (wherein it is to promote fluid circulation in the lymphatic system rather than the venous system), etc. Notably, the non-elastic portion having an SSI greater than about 10 facilitates such treatment, and the elastic portion ensures that compression or pressure is not lost due to the therapeutic compression device 200, 300, 500 of the present invention sliding downward due to gravity and the user moving or walking, and reduces or eliminates gaps between the user's anatomy (such as the hip, groin, knee, or ankle) and the actual therapeutic compression device 200, 300, 500 of the present invention.

[0160] like Figure 2 As shown, the method of use may include two or three therapeutic compression devices connected to one inflatable device. In this example, a thigh therapeutic compression device 300 and two lower leg therapeutic compression devices 200 are each individually connected to the inflatable device via two tubes or hoses, each tube connected to the therapeutic compression device at one end and to the inflatable device at the other end. The method includes wherein (1) placing a thigh therapeutic compression device of the present invention on the thigh region with the elastic portion 317 along the groin region and placing a lower leg therapeutic compression device 200 of the present invention on the lower leg with the elastic portion 204 along the upper portion of the calf region below the knee, and each being secured to the limb with hooks and loops 322, 324, 222, 224, (2) first inflating and maintaining the lower leg therapeutic compression device 200 at a determined pressure level, then (3) inflating and maintaining the thigh therapeutic compression device 300 at a determined pressure level, then (4) fully deflating the thigh therapeutic compression device 300 or only deflating it to a lower pressure level, and thereafter (5) fully deflating the lower leg therapeutic compression device 200 or only deflating it to a lower pressure level. In this example, the pressure level can be a constant static state or an intermittently varying pressure state. Furthermore, in this example, the pressure levels can be the same or different, or the line pressure can be the same, but the interface pressure can be adjusted using the shape of each of these bladders (whether spot welds and / or line welds or a combination to form a gradient pressure distribution).

[0161] In an alternative method (not shown), after inflation steps (1) and (2), the thigh therapeutic compression device 300 is (3) fully deflated or only deflated to a lower pressure level, and thereafter (4) one or both lower leg therapeutic compression devices 200 are fully deflated or only deflated to a lower pressure level. In yet another alternative method (not shown), after inflation steps (1) and (2), the lower leg therapeutic compression device 200 is then (3) fully deflated or only deflated to a lower pressure level, and thereafter (4) the thigh therapeutic compression device 300 is fully deflated or only deflated to a lower pressure level. Figure 2 and 7A to 7D In all of these examples, the pressure level can be a constant static state or an intermittent varying pressure state. Additionally, in this example, the pressure levels can be the same or different, or the line pressure can be the same, but the interface pressure can be adjusted using the shape of each of the bladders (whether spot welded and / or line welded or combined to form a gradient pressure distribution). Finally, the order of first inflation can be reversed, where the tube from the inflation device can be connected to the thigh therapeutic compression device 300, and then the tube connects the thigh therapeutic compression device 300 and the lower leg therapeutic compression device 200, so that the thigh therapeutic compression device 300 is inflated first, followed by the lower leg therapeutic compression device 200, and then the lower leg therapeutic compression device 200 is deflated (partially or completely), followed by deflation of the thigh therapeutic compression device 300. Other variations are possible if the first therapeutic compression device is an arm or hip or torso therapeutic compression device, followed by the thigh therapeutic compression device 300, or any other combination of the lower leg therapeutic compression device 200 and another limb therapeutic compression device.

[0162] In an alternative method (not shown), after the inflation steps (1) and (2), the thigh therapeutic compression device 300 of the present invention is (3) fully deflated or only deflated to a lower pressure level, and thereafter (4) one or both lower leg therapeutic compression devices 200 of the present invention are fully deflated or only deflated to a lower pressure level. In yet another alternative method (not shown), after the inflation steps (1) and (2), the lower leg therapeutic compression device 200 of the present invention is then (3) fully deflated or only deflated to a lower pressure level, and thereafter (4) the thigh therapeutic compression device 300 of the present invention is fully deflated or only deflated to a lower pressure level. Figure 2 and 7A to 7DIn all of these examples, the pressure level can be a constant static state or an intermittent varying pressure state. Additionally, in this example, the pressure levels can be the same or different, or the line pressure can be the same, but the interface pressure can be adjusted using the shape of each of the bladders (whether spot welded and / or line welded or combined to form a gradient pressure distribution). Finally, the order of the first inflation can be reversed, where the tube from the inflation device can be connected to the thigh therapeutic compression device 300 of the present invention, and then the tube connects the thigh therapeutic compression device 300 of the present invention and the lower leg therapeutic compression device 200 of the present invention, so that the thigh therapeutic compression device 300 of the present invention is inflated first, followed by the lower leg therapeutic compression device 200 of the present invention, and then the lower leg therapeutic compression device 200 of the present invention is deflated (partially or completely), followed by deflation of the thigh therapeutic compression device 300 of the present invention. Other variations are possible if the first therapeutic compression device of the present invention is an arm or hip or torso therapeutic compression device of the present invention, followed by a thigh therapeutic compression device 300 of the present invention or any other combination of a lower leg therapeutic compression device 200 of the present invention and another limb therapeutic compression device of the present invention.

[0163] As shown in another embodiment of the method of use, an inflation device is included, a tube or hose connected to the inflation device and a first therapeutic compression device of the present invention (in this case, the lower leg therapeutic compression device 200 of the present invention), a second tube connected to the first therapeutic compression device of the present invention, the second therapeutic compression device of the present invention, and the third therapeutic compression device of the present invention (in this case, the third therapeutic compression device 300 of the present invention), and a tube or hose connected to an exhaust port in the inflation device and the second therapeutic compression device of the present invention (in this case, the thigh therapeutic compression device 300 of the present invention). In this example, the thigh therapeutic compression device 300 of the present invention and the lower leg therapeutic compression device 200 of the present invention are connected to one another via tubes or hoses, and one therapeutic compression device of the present invention (in this case, the lower leg therapeutic compression device 200 of the present invention) is connected to the inflation device via a separate second tube or hose, and a third tube or hose connects the second therapeutic compression device of the present invention (in this case, the thigh therapeutic compression device 300 of the present invention) to the inflation device or the exhaust port. As 7A to 7CThe method shown includes wherein (1) the lower leg therapeutic compression device 200 of the present invention is first inflated and maintained at a determined pressure level, then (2) the thigh therapeutic compression device 300 of the present invention is inflated and maintained at a determined pressure level, the inflation being applied via a tube or hose connecting the thigh therapeutic compression device 300 of the present invention and the lower leg therapeutic compression device 200 of the present invention, then (3) the thigh therapeutic compression device 300 of the present invention is deflated (completely or only to a lower pressure level) via a tube or hose connected to an exhaust port or release port in the inflation device, and thereafter (4) the lower leg therapeutic compression device 200 of the present invention is deflated (completely or only to a lower pressure level). In an alternative method (not shown), after the inflation steps (1) and (2), the lower leg therapeutic compression device 200 of the present invention is then (3) deflated completely or only to a lower pressure level, and thereafter (4) the thigh therapeutic compression device of the present invention is deflated completely or only to a lower pressure level. In yet another alternative method (not shown), after the inflation steps (1) and (2), both the lower leg therapeutic compression device 200 of the present invention and the thigh therapeutic compression device 300 of the present invention are then (3) simultaneously deflated, either completely or only to a lower pressure level. While in this example of the method of use, the second therapeutic compression device of the present invention is connected to an exhaust port or release port in the inflation device, other embodiments may employ exhaust ports or release ports that are integral to the therapeutic compression devices of the present invention themselves, such as as part of or adjacent to the inflation ports 212, 312 in the therapeutic compression devices 200, 300 of the present invention. 7A to 7C In all of these examples, the pressure level can be a constant static state or an intermittent varying pressure state. Additionally, in this example, the pressure levels can be the same or different, or the line pressure can be the same, but the interface pressure can be adjusted using the shape of each of the bladders (whether spot welded and / or line welded or combined to form a gradient pressure distribution). Finally, the order of the first inflation can be reversed, where the tube from the inflation device can be connected to the thigh therapeutic compression device 300 of the present invention, and then the tube connects the thigh therapeutic compression device 300 of the present invention and the lower leg therapeutic compression device 200 of the present invention, so that the thigh therapeutic compression device 300 of the present invention is inflated first, followed by the lower leg therapeutic compression device 300 of the present invention, and then the lower leg therapeutic compression device 200 of the present invention is deflated (partially or completely), followed by deflation of the thigh therapeutic compression device 300 of the present invention. Other variations are possible if the first therapeutic compression device of the present invention is an arm or hip or torso therapeutic compression device of the present invention, followed by a thigh therapeutic compression device 300 of the present invention or any other combination of a lower leg therapeutic compression device 200 of the present invention and another limb therapeutic compression device of the present invention.

[0164] like Figures 8A to 8K , a method of using the therapeutic system 100 of the present invention is shown in one embodiment, wherein the user removes the lower leg therapeutic compression device 200 and sock 110 and places the sock 110 on the lower leg. The user then places the lower leg therapeutic compression device 200 on the leg, connects the button 113 on the sock or sleeve 110 into the hole 223, and ensures that the elastic portion 204 fits tightly and conforms to the area below the knee on the back of the leg. The user then connects the upper portion of the hook and loop 222, 224, followed by the foot portion 222, 224, and then the middle portion of the lower leg 222, 224. The user checks to ensure that there is room for inflation and gradient compression, such as by placing two fingers between the sock 110 and the therapeutic compression device 220. The user then selects the inflation device 150, either the powered pump 165 or the manual hand pump 400. If a manual pump is selected, the user selects a pressure range on the dial 410, inserts the male sliding luer 161 into the inflation port 212, specifically the female luer 209, and then pumps the bulb 420 until the therapeutic compression device is inflated, then removes the male sliding luer 161, which triggers the valve 290 to move in an upward direction and seal the bladder 202. If the pump 156 is selected in this embodiment, the user puts on the harness 180, adjusts it using the adjuster 182, and then tightens it using 185A and 185B. The user then opens the cap 211 and inserts the male sliding luer 161 into the inflation port 212, specifically the female luer 209, then presses the pump 156, possibly selecting a set pressure amount (static or intermittent), and once the therapeutic compression device is inflated, removes the male sliding luer 161, which triggers the valve 290 to move in an upward direction and seal the bladder 202. In either case, the user can place the cap 211 on top of the female sliding luer 209 to further seal the bladder 202. To deflate, the user can then remove the cap 211, invert it, and push the stem into the female sliding luer 209 to release the seal and deflate the bladder 202. The user can also deflate using the hand pump dial 410 or by lowering or setting the pump 156 to the deflated position on the pump 156. Other methods of inflation and deflation are also possible. When inflated, the therapeutic compression device 200 of the present invention has an SSI of at least about 10 or greater, and the elastic portion 204 conforms to the anatomical structure of the knee, so that the lower leg therapeutic compression device 200 of the present invention has uniform compression and pressure along the entire lower leg and even the upper calf area to eliminate gaps in this anatomical area, and the lower leg therapeutic compression device 200 of the present invention can help treat, reduce, or even prevent tissue swelling, lymphedema, venous and arterial ulcers, CVI and DVT, as well as improve circulation in the user's feet and lower and upper legs.

[0165] As described herein, the possible therapeutic compression devices to be used in the system of the present invention are limited to the target limb or body part to be compressed or subjected to pressure treatment, so as to improve circulation and reduce and treat tissue swelling, lymphedema, CVI, DVT, arterial and / or venous ulcers or any other medical problems, as well as improve and treat circulation diseases or problems in the feet, calves, lower legs and thighs and other body parts (such as wrists, arms, trunk, shoulders) and any other target areas of the patient or user. For example, the therapeutic compression device can be used for the feet, ankles, calves, lower legs, knees, thighs, groins, hips, buttocks, trunk, stomach, back, shoulders, chest, arms, elbows, wrists, hands, neck, head, etc. and any combination thereof. The creative system of the present invention described herein solves many problems in the prior art and the industry and treatment of patients. The therapeutic compression device 200, 300, 500 can be applied by the patient on the patient's body part without the need or requirement of a skilled caregiver as required by current devices and equipment. It is also capable of maintaining sufficient effective pressure without overpressure complications, maintaining compression and pressure, etc.

[0166] The therapeutic compression devices 200, 300, 400 of the present invention of the therapeutic compression system 100 include a universal inflation port that is configured to be connected to more than one compression or inflation device source, allowing the patient to change treatment by changing the inflation source and inflation device used for the treatment device or device. For example, a patient using the therapeutic compression devices 200, 300, 500 of the present invention can alternate between manual, mechanical, or electric inflation devices or inflation sources and pressures. In addition, when using the system of the present invention and the inflation device 150 pump, the patient can alternate between static or intermittent inflation and pressure.

[0167] The therapeutic compression system 100 of the present invention also reduces the problem of lack of mobility because the inflation device is not integral to the therapeutic compression device of the present invention, instead allowing the patient to walk and perform work, school, or recreational activities. The system 100 of the present invention includes an inflation device that is not tethered to a wall outlet, but rather a main pump that is configured to apply constant static pressure at one pressure level, or maintain constant static pressure at a selection of different pressure levels, or apply intermittent pressure at one level, or apply intermittent pressure at multiple pressure levels, or apply a selection of constant static pressure levels and intermittent pressure levels. The ability to switch between pressure levels and / or between constant static pressure and intermittent pressure facilitates more effective treatment of CVI, DVT, and / or lymphedema, tissue swelling, poor and decreased circulation, arterial and venous ulcers, and other treatments.

[0168] Another embodiment (not shown) may include a variety of sensors so that the pump itself can adjust the pressure level or switch from an intermittent pressure level (when the patient is sitting or with their legs elevated) to a constant static pressure (when the patient is walking or running). Such sensors may be connected to a database accessible by a medical provider, which can remotely adjust the pressure level or state change from intermittent to constant or vice versa.

[0169] The system 100 of the present invention can be used as part of a preventive or treatment plan, is easy for the patient to use at home or in the workplace (outside of a hospital setting or with the help of a medically trained professional as described above), and is mobile, allowing the patient to walk and return to daily activities. The system of the present invention can be used as a preventive measure for swelling in any part of the body. The system can also be used for pre- and post-operative treatment of many different surgeries, including but not limited to knee surgery, hip surgery, TKR, KRA, NMR, HRA, sclerotherapy, and many other surgical procedures on other limbs or parts of the body that may have an increased risk of CVI and / or DVT. The system 100 of the present invention can be used to prevent, reduce, or even treat DVT, and is practical, mobile, and easily administered to patients following total knee replacement, hip, or leg surgery of any other knee joint. In addition, the system of the present invention can also be used for HPIC treatment, and can be easily administered by patients in a home setting as well as a rehabilitation setting or a nursing home setting because it allows the patient to be ambulatory.

[0170] The system of the present invention includes an inflatable device that is smaller than the known system. The user is therefore able to return to life activities faster than other treatment systems that limit the user's walking at home and outdoors due to known compression systems, prevention systems and power constraints (electric, mechanical, battery, manual, etc.) on the system. In addition, the system of the present invention may include one or more sensors, blood pressure sensors, GPS sensors, etc. that measure the user's limbs about pressure on the skin and limb movement when the system is used. Such sensors can be connected to the inflatable device to adjust the pressure from the inflatable device and increase or decrease the current pressure level. Such sensors can also be connected to a database and may be accessed in real time by a medical professional and / or user or saved over time.

[0171] Additionally, the system includes multiple compression garments, wherein each therapeutic compression device of the present invention can have a separate applied pressure level simultaneously or can vary over time and based on the user's activity, and the individual bladders 202A, 202B, 202C, 302A, 302B, 502 can have a separate applied pressure level simultaneously or can vary over time and based on the user's activity.

[0172] In addition, the therapeutic compression system 100 of the present invention includes multiple compression devices 200, 300, 500, wherein each therapeutic compression device 200, 300, 500 can have a separate effective pressure level simultaneously, or can vary over time and based on the user's activity. Notably, the therapeutic compression devices 200, 300, 500 of the present invention have an SSI of at least about 10 or greater for the non-elastic portion (whether including a bladder or without a bladder), while the elastic portion conforms to the user's anatomy, thereby reducing or eliminating gaps or openings between the limb and the therapeutic compression devices 200, 300, 500 of the present invention (such gaps or openings would reduce the compression or pressure on the user, thereby reducing the effectiveness of the treatment), and thus there is increased or more uniform compression and pressure along the entire target limb (such as the lower leg and even the upper calf area). The therapeutic compression devices 200, 300, 500 of the present invention, including an elastic portion, reduce or eliminate gaps in anatomical regions such as the ankle, foot, knee, groin, hip, wrist, elbow, shoulder, sacrum, neck, and other regions along the target limb, and thus the therapeutic compression devices 200, 300, 500 of the present invention can help treat, reduce, and even prevent tissue swelling, lymphedema, venous and arterial ulcers, CVI and DVT, as well as improve circulation in the target limb, such as the user's foot and lower and upper legs. The therapeutic compression devices 200, 300, 500 of the present invention include a non-elastic portion (with or without an inflatable bladder) having an SSI greater than about 10 (in the range of about 10 to about 50) and an elastic portion configured to conform to the target body region, such as the foot, ankle, knee, groin, hip, wrist, elbow, shoulder, torso, sacrum, neck, and any other body part.

[0173] The therapeutic compression devices 200, 300, 500 of the present invention may have a set level of pressure or compression, such as Figures 9 and 10 As shown in 13, or as shown in Figures 1 to 2 、 Figure 11 、 Figures 14 and 15 and Figures 20 to 21The gradient compression shown is particularly effective by applying more pressure distally (farther from the heart) and reducing pressure proximally (closer to the heart) relative to the heart. This helps compress the body in a way that helps stimulate circulation and reduce limb size, such as in the feet, calves, lower legs, and thigh areas. The therapeutic compression devices 200, 300, 500 of the present invention (whether set or gradient compression) help reduce tissue swelling and water volume within the limbs during use to manage the amount of leg swelling. This also improves blood and fluid circulation, particularly when the user is walking around, as the compression squeezes the circulatory system into better contact with the muscles (e.g., calf vs. lower leg compression) to improve the body's fluid movement efficiency. The therapeutic compression devices 200, 300, 500 of the present invention are more effective than known compression stockings, socks, bandages, and even devices because they apply compression and a static stiffness index of at least greater than 10 to improve venous hemodynamics and reduce edema, due (without being bound by theory) to the potential stiffness and elasticity of the therapeutic compression devices 200, 300, 500 of the present invention. It overcomes many of the shortcomings of known and conventional compression products.

[0174] Furthermore, the therapeutic compression devices 200, 300, 500 of the present invention overcome problems with known and conventional compression products that do not have sequential inflation and deflation, thereby reducing the dynamic compression effect, but instead, the therapeutic compression devices 200, 300, 500 of the present invention include sequential compression by inflating and deflating the bladders 202 (202A, 202B, 202C), 302 (302A, 302B), 502. The therapeutic compression devices 200, 300, 500 of the present invention solve this and other problems by maintaining and improving static and dynamic compression for the treatment of arterial ulcers, venous ulcers, poor circulation, tissue swelling, lymphedema, CVI, and DVT.

[0175] While the subject invention has been described with respect to preferred and exemplary embodiments, it will be readily understood by those skilled in the art that various changes and / or modifications may be made to the invention without departing from the spirit and scope of the invention as described herein. While several embodiments have been described and exemplified herein and specific embodiments of the invention have been described, it is not intended to limit the invention thereto, as it is intended that the scope of the invention be as broad as the art will allow and the description should be read as such. Thus, while specific shapes and sizes of the inflatable bladder and straps have been disclosed, it will be understood that other shapes, sizes, and attachment arrangements may be used. Therefore, it will be understood by those skilled in the art that other modifications may be made to the invention without departing from the spirit and scope of the invention as claimed.

Claims

1. A therapeutic compression system for applying pressure to at least one limb of a human body, the therapeutic compression system comprising: at least one wrap configured to be worn on a limb of a user, the at least one wrap comprising two inelastic layers joined to form at least two bladders, each bladder connected to a separate universal inflation port, the universal inflation port configured to be connectable to a static or intermittent inflation device; a connection from each universal inflation port to the inflation device, the connection having a distal end and a proximal end, wherein an insert on the distal end is configured to be inserted into a hole in a manifold on the inflation device; as well as at least one sensor configured to inflate, maintain, or deflate each of the bladders at a selected pressure level or time period, The universal inflation port includes a sealing device, which is configured to include an open position and a closed position, wherein the closed position maintains the at least one bladder in an inflated state or a deflated state, and when connected to the inflation device, the sealing device is in the open position so that the at least one bladder is in the same inflation state as the inflation device.

2. The therapeutic compression system of claim 1, wherein the at least one wrap is configured to be secured to a foot, lower leg, or thigh of the user.

3. The therapeutic compression system of claim 1, wherein one bladder is capable of inflating or deflation at a different time than a second bladder.

4. The therapeutic compression system of claim 1, wherein the sensor is a switch configured to inflate at least one bladder, maintain pressure within the inflated bladder, or deflate the at least one bladder.

5. The therapeutic compression system of claim 1 , further comprising a second wrap configured to wrap around a second limb of the user, wherein the limb is selected from the group consisting of: a foot, ankle, calf, lower leg, knee, thigh, upper leg, entire leg, waist, torso, chest, arm, shoulder, elbow, wrist, hand, neck, or any combination thereof.

6. The therapeutic compression system of claim 5 , wherein the first wrap and the second wrap are not connected to each other when connected to the same inflation device, and wherein when the first wrap and the second wrap are both inflated by the same inflation device, the second wrap has an inflation pressure that is the same as or different from the inflation pressure of the first wrap.

7. The therapeutic compression device of claim 1, further comprising an elastic sleeve placed over the limb of the user beneath the at least one wrap.

8. The therapeutic compression system of claim 1, wherein the inelastic portion of the at least one wrap has a static stiffness index greater than 10.

9. The therapeutic compression system of claim 1, wherein the inelastic portion of the at least one wrap has a static stiffness index between about 10 and about 50.

10. The therapeutic compression system of claim 1, wherein the inelastic portion of the at least one wrap has a static stiffness index between about 20 and about 40.

11. The therapeutic compression system of claim 1 , wherein the connection device is selected from the group consisting of a hose, a tube, a catheter, and combinations thereof.

12. The therapeutic compression system of claim 1, wherein the at least one wrap is configured to be secured to the lower leg of a user and further comprises an elastic portion configured to be placed on the user's calf.

13. The therapeutic compression system of claim 1, wherein the at least one wrap is configured to be placed on a user's lower leg and further comprises an elastic portion configured to be placed on an upper calf below the user's knee area.

14. The therapeutic compression system of claim 9 or 10, wherein the at least one wrap is configured to further include a second elastic portion configured to be placed over an ankle portion of a user.

15. The therapeutic compression system of claim 1, wherein the at least one wrap is configured to be placed on a thigh of a user and further comprises an elastic portion configured to be placed on a groin area of a user.

16. The therapeutic compression system of claim 1, wherein the at least two bladders are configured with spot welds and dot lines in a geometric pattern to apply a gradient of compression on the limb of the user.

17. The therapeutic compression system of claim 1 , wherein the inflation device is selected from the group consisting of a manual pump, a static pump, an intermittent pump, an electric inflation pump, a battery inflation pump, a gas-powered inflation pump, a static pneumatic compression pump, an intermittent pneumatic pressure pump, and combinations thereof, and the inflation device for the at least one bladder is selected from the group consisting of air, gas, fluid, or combinations thereof.

18. The therapeutic compression system of claim 1, wherein the inflation device comprises a manual pump configured to provide static inflation or a powered pump configured to provide static and / or intermittent inflation.

19. The therapeutic compression system of claim 1, wherein the inflatable device includes a real-time pressure measurement mechanism and is connected to a fixation device configured to be worn on the body of the user.

20. The therapeutic compression system of claim 1, wherein the sealing device is selected from the group consisting of a valve, a cap, a lever, a switch, a screw, a shut-off valve, a stopcock, or a combination thereof, and the inflation port is a self-sealing inflation port configured to prevent deflation of the at least one bladder and includes a check valve.

21. The therapeutic compression system of claim 1 , further comprising a pressure sensor operatively connected to the inflation device to prevent overinflation, and wherein the check valve is set to open at a predetermined or user-selectable pressure.

22. The therapeutic compression system of claim 1 , wherein the wrap is configurable to wrap around a limb of the user, wherein the limb is selected from the group consisting of: a foot, ankle, calf, lower leg, knee, thigh, upper leg, entire leg, waist, torso, chest, arm, shoulder, elbow, wrist, hand, neck, or any combination thereof.

23. A method for reducing tissue swelling and applying compressive pressure to a part of the human body, the method comprising: A therapeutic compression device is placed on a body part of a user, the therapeutic compression device comprising at least one wrap having (a) at least two air bags connected to an inflator, (b) at least two common inflation ports connected to each bladder, the at least two common inflation ports having sealing means, the sealing means being configured to include (i) an open position and a closed position, wherein the closed position maintains the bladder in an inflated state or a deflated state, and when coupled to the inflatable device, the sealing means is in the open position such that the bladder is in the same inflated state as the inflatable device, (ii) an elbow, a check valve and a valve cap, wherein the valve cap is capable of releasing pressure generated by the inflatable device within the at least one bladder, (iii) connection means from the common inflation port to the inflatable device, (c) a connection from the universal inflation port to the inflation device, the connection having a distal end and a proximal end, wherein an insert on the distal end is configured to be inserted into a manifold on the inflation device, and (d) at least one sensor configured to inflate, maintain, or deflate each of the bladders at a selected pressure level or time period; inserting the connection device on the proximal end into one of the universal inflation ports and inserting the connection device on the distal end into the manifold; activating the inflatable device and the sensor at a selected pressure level; inflating the first bladder and then inflating the second bladder for a period of time; deflation of the first bladder and then deflation of the second bladder for a period of time; repeating said inflation and deflation steps of said method through said final inflation step; removing the connecting means from the universal inflation port and activating the sealing means on the universal inflation port; as well as After the wrap has been worn for a period of time, the at least one bladder is deflated by opening the sealing means and releasing the pressure within the at least one bladder.

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