CN120500318A

CN120500318A - Multiple bladder therapeutic compression device, system and method of use

Info

Publication number: CN120500318A
Application number: CN202380090386.7A
Authority: CN
Inventors: S·拉维库马尔; V·拉维库马尔; G·奥斯本; A·阿尔沃德
Original assignee: Shengke Co ltd
Current assignee: Shengke Co ltd
Priority date: 2022-11-15
Filing date: 2023-11-15
Publication date: 2025-08-15
Also published as: IL320906A; WO2024107864A1; EP4618929A1

Abstract

The therapeutic compression apparatus 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 connectable to both static and intermittent inflation means and comprising a sealing means configured to comprise an open position and a closed position, wherein the closed position maintains the at least one bladder in an inflated or deflated state, and when coupled to the inflation means, the sealing means is in the open position such that the at least one bladder is in the same inflated state as the inflation means. A method includes the step of inflating and deflating each of the bladders to the same or different pressure levels and also sequentially inflating and deflating each individual bladder.

Description

Multiple bladder therapeutic compression device, system and method of use

Related patent application

The present application claims priority from U.S. provisional application serial No. 63/425,662, filed 11/15/2022, entitled "Multiple Bladder inventive therapeutic compression apparatus, SYSTEM AND Methods of Use (multi-bladder therapeutic compression device, system, and method of Use of the present application"), and continues with application serial No. 17/608,323, filed 11/2021, entitled "Therapeutic Compression SYSTEM AND Methods of Use," based on application serial No. PCT/US2020/31227 filed 5/2/2020, filed 5/2/2019, and incorporated herein by reference in its entirety for all purposes.

Background

Technical Field

The subject invention relates generally to a system for simultaneously applying compression to one or more limbs, and more particularly to a system for applying compression-coupled conditions such as Deep Vein Thrombosis (DVT), chronic Venous Insufficiency (CVI), lymphedema and swelling therapy to a subject's legs and/or feet and/or thighs. The system includes at least one therapeutic compression device of the present invention, such as a wrap having more than one bladder and an inflation means for the bladder, wherein the device is capable of applying compression to a limb, such as a patient's full leg, thigh, calf, knee and/or foot, and a port connected to the inflation means, wherein the bladders are inflated simultaneously or sequentially at the same or different pressure levels.

Background of the related art

Typically, healthy muscles, such as healthy leg muscles, squeeze the deep veins of the legs and feet to help move blood back to the heart. A one-way valve in the deep leg vein keeps blood flowing back toward the heart. However, prolonged standing or sitting can result in stretching of the walls of the deep leg veins. Over time, in susceptible individuals, this can weaken the vein wall and damage the valve, causing blood to pool in the vein and increase venous blood pressure. This can lead to a condition known as Chronic Venous Insufficiency (CVI).

Treatment of CVI typically involves the use of compression stockings or medical stockings to reduce chronic swelling. Compression stockings are elastic stockings that squeeze veins to improve venous circulation and prevent excessive blood reflux. Compression stockings also help to heal skin sores or stasis ulcers that often occur with CVI. Compression straps are also commonly used to apply pressure to the leg. In this regard, the bandage is applied at a constant tension so as to create a gradual compression with 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 typically done by highly skilled caregivers.

Efficient mechanical compression devices for treating CVI have also been developed, which are disclosed, for example, in U.S. patent 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 wrap carrying a manually inflatable balloon and 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 can be applied directly to the skin for applying local pressure and even medication to the venous ulcer when the venous ulcer is enclosed by a flexible wrap. While 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.

Lymphedema, also known as lymphoobstruction, is another condition of localized fluid retention and tissue swelling, and is caused by an impaired lymphatic system. Treatment of lymphedema varies depending on the severity of the edema and the degree of fibrosis of the affected limb. The most common treatment for lymphedema is manual compression of lymphatic massage, compression of clothing or bandaging. Elastic compression garments are typically worn on the affected limb by a person suffering from lymphedema after a complete decongestive therapy to maintain edema reduction.

Compression bandaging (also known as wrapping) involves applying several layers of filled and short stretch bandages to the area involved. Short stretch bandages are preferred over long stretch bandages (such as those commonly used to treat sprains) because long stretch bandages do not produce the proper therapeutic tension required to safely reduce lymphedema and may in fact ultimately produce a tourniquet effect. During an activity, whether exercise or daily, the short stretch bandages enhance the pumping action of the lymphatic vessels by providing increased resistance to pushing against the lymphatic vessels. This promotes lymphatic flow and helps soften the fluid swelling area.

Known methods for CVI and lymphedema treatment, such as compression bandaging, have several drawbacks. Bandaging is time consuming and the effect is limited by the skill of the provider. In some cases, the bandage may be applied too tightly or too loosely and may slip off its intended location, thereby reducing its effectiveness. When this occurs, the bandages must be removed and reapplied, further increasing the application time and reducing the consistency of the applied treatment. Furthermore, when the dressing is pressed on the calf, knee or thigh area of the leg, the dressing slides down the leg as the user walks or even moves around on the 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.

The effectiveness of many of the current compression therapies is limited by the administration of current products. Because current compression therapies are performed with manual wraps or electromechanical systems, they require a skilled medical professional to apply and/or require the patient to rest for an extended period of time. While stockings and/or bandages may be worn and self-administered by a patient, they are very difficult for a patient to put on and are a challenge for unskilled medical professionals to consistently and effectively administer. However, once the user walks or moves around, the stocking and/or bandage will slide down the thigh towards the knee and down the leg towards the ankle.

CVI and lymphedema can also lead to DVT, a affliction that leads to blood clots (especially the lower leg ends). When the patient is not ambulatory, the patient is exposed to elevated risk factors for the generation of blood clots. These blood clots, which typically accumulate or reside in the patient's lower leg or thigh, are not themselves overly dangerous. However, when blood clots loosen, they create a pulmonary embolism, which can reside in the heart, brain, or lungs of a patient, where it can cause significant injury or death. It is estimated that between 200 and 250 tens of thousands of americans are afflicted with DVT each year, resulting in 600,000 patients seeking medical care, 300,000 of which die from the effects of pulmonary embolism. In people with DVT, one third will have long-term complications (post-thrombotic syndrome) such as swelling, pain, discoloration and desquamation of the affected limb. In addition, about one-third (about 33%) of the people diagnosed with blood clots will relapse within ten years. Accordingly, there is a need for a system and apparatus and method for preventing, reducing and/or treating DVT that is easy to use, walk around by a patient at home because the patient can work and walk around inside and outside the home and is simpler than currently known DVT systems. The number of americans with DVT may be affected or at increased risk based on (a) recent surgery that reduces patient mobility and increases inflammation in the body, which may lead to clotting, (b) medical conditions that limit mobility, such as injury or stroke, (c) long-term travel that limits mobility, (d) deep vein damage, (e) genetic blood disorders that increase clotting, (f) pregnancy, (g) cancer treatment, (h) smoking, (i) obesity, and (j) many other conditions. Accordingly, there is a need for systems, devices, and methods for treating DVT.

Many current treatment options for CVI and lymphedema result in venous ulcers, including the use of currently known devices, equipment, bandages, stockings, socks, and the like. Venous ulcers are injuries and losses of skin above the ankle caused by venous problems in the legs. Venous ulcers typically develop on either side of the lower leg, above the ankle, and below the lower leg. They are difficult to cure and frequently recur. They also develop on the thigh, on the medial thigh or lateral thigh area, and near the inguinal area on the leg. In addition, venous ulcers may develop around, behind, along the sides of, and in front of the knee. Furthermore, it is known that ulcers or wounds on the lower leg, including the foot, are often difficult to treat due to the structure of the lower leg and foot and the fact that the foot moves and is under pressure when walking. Conventional compression bandages, and even non-compression bandages, do not adhere to the foot, either on top of the arch or underneath the foot. Furthermore, the foot area may become hot and moist, resulting in lack of adhesion, however the diabetic foot may be extremely dry, and an adhesive must be selected that does not irritate or affect the dry skin of the diabetic individual. Foot construction is also problematic in holding bandages or wound dressings in place and adhering to the foot.

Other leg ulcers such as diabetic ulcers may form at the bottom or under the sole of the foot, on the toes, between the toes, on the top of the foot, on the arch of the foot, and even on the ankle and heel of the foot. Diabetics may have more foot ulcers, sometimes associated with a complication known as neuropathy, which can lead to loss of consciousness of the individual's foot. A scratch, cut or puncture on the skin may turn into an ulcer, but if an individual suffers from neuropathy and does not feel the wound or pain of the wound, they may not know that an ulcer is present. Ulcers may lead to infections that, in extreme cases, fail to heal, resulting in amputation of the foot or toe portion of the individual. It is estimated that about 15% of diabetics in the united states will develop foot or toe ulcers, and about 14% to 24% of diabetics in the united states need amputation after the occurrence of ulcers. Diabetic foot ulcers are a major cause of foot amputation. By 2020, 5.37 million diabetics are estimated worldwide, of which about 19% to 34% will develop diabetic foot ulcers throughout their lives. Unfortunately, in individuals with diabetic foot ulcers, about 20% of the individuals need lower limb amputation, either small amputation (below the ankle), large amputation (above the ankle), or both. Over 80% of amputation begins with foot ulcers. More extremely, of those with diabetic foot ulcers, about 10% will die within one year after the first diagnosis of the diabetic foot ulcer. Furthermore, foot and toe ulcers may occur on many people, but may be more common in black, american native and spanish. Individuals are also at higher risk if they suffer from diabetes-related eye, kidney or heart diseases. About 15% of diabetics suffer from ulcers, which are usually located on the sole of the foot. Some of these people will be hospitalized for complications.

The risk of individuals suffering from leg, foot and toe ulcers is also higher if any of the following conditions are present, such as blood circulation problems, heart disease, obesity, bunions or hammer toe foot disorders, kidney disease, and some lifestyle patterns of smoking and drinking. Thus, increasing circulation of the lower leg and foot and preventing or reducing tissue swelling, DVT and CVI are desirable for such patients and users. In addition, arterial ulcers may be caused by a condition known as peripheral arterial disease that reduces blood flow to the extremities. When this occurs, the lower leg and foot tissue may begin to die. Ulcers formed by reduced blood flow are known as arterial ulcers. Arteries are blood vessels that carry blood from the heart to other parts of the body, including the feet and toes. Anyone may suffer from arterial ulcers, but smoking or individuals with diabetes, hypertension or high cholesterol are at higher risk. Accordingly, 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 of greater than 10 to help increase circulation while reducing or preventing tissue swelling, and also reduces, treats or prevents lymphedema, CVI, DVT, and additional ulcers, that is also easy to apply by individuals alone or by medical professionals, and that improves healing time, reduces complications, and helps overall healing.

Veins of the leg are classified into a superficial system and a deep system according to their position relative to fascia. The deep veins lie within the fascia and are responsible for venous return of the leg muscles, which join together to form the popliteal and femoral veins. The dilated valveless sinusoids are also located within the fascia (more specifically in the soleus and gastrocnemius muscles). When the leg is stationary, the sinus is filled with blood.

Long saphenous vein extending from the foot to the groin along the inside of the leg and short saphenous vein extending from the foot to the knee at the rear of the calf are the main blood vessels of the superficial venous system. These vessels are located outside the fascia and are responsible for venous return from the skin and subcutaneous fat. In the treatment of certain conditions it may be recommended to compress the long saphenous vein, while in other conditions it is less recommended to compress the long saphenous vein inside the leg, while it is more recommended to compress the short saphenous vein of the leg extending over the rear of the leg (including the thigh). The communicating veins, sometimes referred to as perforators, connect the two systems because they penetrate the deep fascia. As with other veins in the leg, the perforator includes a valve that allows blood to flow inward in only one direction from the external or superficial system to the deep vein.

The venous pressure at the ankle of a supine subject is about 10mmHg, but this will rise significantly when standing due to the increase in hydrostatic pressure (equivalent to the weight of a vertical column of blood stretching from the measurement point to the right auricle of the heart). During walking, as the foot bends dorsally, the contraction of the calf muscle compresses the deep veins and the flatfish sinuses, emptying them of blood. When the plantar flexion occurs, the pressure in the vein drops, the proximal valve closes, and the vein is refilled with blood from the superficial system through the perforator. During this cycle, in the normal leg, the distal valve of the deep vein and the valve of the perforator will ensure that the expelled blood can only return in one direction-up to the heart.

Occlusion or injury to the venous system will result in interruption of normal blood flow, which may manifest itself in a number of different ways depending on the location and extent of the injury. 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 varicose veins (varicosities) (varicose veins). Such varicose veins may be located in the thigh, knee, calf, ankle or foot areas of the user's legs.

If the function of the perforator valve is compromised, 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 blood vessels. Also, 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 rest for an extended period of time. There is a need for new systems to treat such medical problems. With minimal blood flow that may flow up the thighs and rest of the body, resulting in problems for the patient along the body, including the thighs, calves, ankles, and entire legs of the patient. Accordingly, there is a need for a compression device having multiple bladders to apply compression to the leg at different compression levels in different bladders, or the bladders are inflated and deflated by intermittent pressure on the device to apply different compression levels across the leg.

After deep vein thrombosis, which results in complete or partial occlusion of the deep vein, unreleased pressure on the perforator valves by the calf muscle pump may cause these valves to become dysfunctional. If this occurs, the pressure in the superficial system will rise substantially, which may force proteins and erythrocytes out of the capillaries and into the surrounding tissue. Here, the red blood cells disintegrate to release a red pigment, which leads to skin staining, which is an early indication of the possible formation of ulcers. Ulcer formation may occur in any part of the body, including the legs, groin, thigh, knee, calf, ankle, and foot.

Venous leg ulcers are typically light and red in color. The skin around ulcers often changes color due to the aforementioned coloration. A malfunctioning perforated venous valve may also cause expansion of the ankle vena cava and appear as a thin red line around the ankle and any area of the thigh, knee, calf or foot or leg. This condition, known as ankle laxity, is also a diagnosis of venous ulcers. The condition may also be seen on the thigh, including the medial region within the thigh or the lateral region of the thigh, or around the knee or inguinal region of the patient's body.

The arteries transport oxygen-supplemented blood from the heart to the rest of the body. The veins return oxygen depleted blood to the heart. When it is difficult for veins of the lower extremities of the body to transport blood back to the heart, a condition known as Chronic Venous Insufficiency (CVI), also known as Chronic Venous Disease (CVD), develops. CVI most commonly occurs due to blood clots 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, blood in the leg veins flows in an upward direction. As the person walks, the muscles in the calf muscles and feet contract to squeeze the veins and push the blood upward. To keep blood flowing upward and prevent it from flowing downward, veins contain one-way valves. CVI occurs when these valves become damaged and allow blood to leak back down in the opposite direction. Such valve damage may occur due to aging, sitting or standing for a long period of time, or a combination of aging and reduced mobility. When veins and valves weaken and blood cannot flow properly up to the heart, blood pressure in the lower limb veins may remain elevated for a long period of time, resulting in CVI. Such conditions are more common in elderly individuals and, if not properly treated, can lead to capillary rupture, local tissue inflammation, internal tissue damage, varicose veins, ulcers and open sores on the surface of the skin. Broken capillaries can be seen on the patient's legs, including thighs, knees and groin.

CVI can reduce venous system capacity and increase the workload of lymphatic systems in the affected area. The lymphatic system must then deliver a greater volume of water and protein to reduce fluid load in the affected tissues of the leg, a condition that is particularly difficult for patients with lymphedema, varicose veins, and other lower limb lesions.

One non-surgical option commonly used to help prevent or treat the above-mentioned leg and limb lesions is to use 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 combination with frequent exercise and leg lifting. The compression stocking maintains pressure on the leg while allowing normal ambulation. Increasing the pressure in the tissue under the skin reduces excessive leakage of fluid from capillaries and increases the absorption of tissue fluid by capillaries and lymphatic vessels. In addition, the increased pressure reduces the size of the vein, which allows blood to flow faster and helps prevent pooling thereof. Compression stockings generally vary in tightness between 15mmHG and 50mmHG. The tightness of a given stocking depends on its particular configuration and class. For example, stockings having a compression pressure of 15 to 20mmHG are considered to be lightly compression stockings. The class I stockings are 20mmHg to 30mmHg, the class II stockings are 30mmHg to 40mmHg, and the class III stockings are 40mmHg to 50mmHg.

While such compression stockings are a common non-invasive treatment for leg lesions, they present a number of problems. Fitting a stocking snugly is 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 close fitting stocking to be worn on the lower leg must be worn by the user on the upper part of the foot, ankle and lower leg, and placing the close fitting stocking on the thigh area is more difficult to wear because the user must pull on the close fitting stocking to cover the foot, ankle, lower leg, knee and eventually reach the thigh area. Also, due to the shape of the lower and upper legs, these close fitting stockings will slide down the legs at some point as the user walks or moves around.

Furthermore, during use, the pressure exerted by the stocking generally remains relatively constant without any option of increasing or decreasing the tightness level. When compression stockings are repeatedly worn, they lose elasticity and thus tightness over time. Once such prescribed elasticity and tightness are lost, stockings have little or no value and need to be replaced due to their looseness, which requires the purchase of a new pair of stockings to obtain the desired pressure. Furthermore, considering the shape of the thigh, the top or upper part of the stocking must be very tight in order to prevent slipping down the thigh, which in turn can lead to its own complications due to excessive tightness.

Medical socks represent a useful and convenient method of applying pressure to normally shaped legs to prevent the development or recurrence of leg ulcers. However, these stockings have limited value in treating active ulcers and are difficult to apply to a dressing. In this case, compression bandages represent the treatment of choice. Compression bandages apply pressure to the limb which is proportional to the tension of the bandage but inversely proportional to the radius of curvature of the limb to which it is applied. This therefore means that bandages applied to a normal proportion of the limb with constant tension will automatically produce gradual compression with highest pressure at the knee. As the circumference increases, the pressure will gradually decrease up to the thigh.

It can be readily appreciated that when the compression bandage is applied to the limb to be treated, it is cumbersome and difficult to apply a uniform tension thereto, and this is done only by highly skilled caregivers. Furthermore, once secured to the limb to be treated, care and attention must be taken to ensure that the bandage does not slip or shift, as this will result in the formation of multiple layers, which in turn can lead to localized areas of high pressure, which may put the patient at direct risk of skin necrosis.

Mechanical compression therapy has also been proposed. An exemplary compression device is described in U.S. patent number 5,031,604 to Dye. As generally described in column 2, line 33 and below, an arrangement of chambers around the legs is provided. The active pneumatic control system controls the pressure in the chamber to squeeze the leg near the ankle, which in turn squeezes upward toward the knee to move blood from the limb toward the heart. As described in column 4, lines 20-59 of united states patent No. 6,488,643 to Tumey et al, mechanically generated compression levels can produce unnoticed ischemia (i.e., ischemia) at similar compression levels obtained by bandaging. It may also produce a warp (i.e., a reduction in pulsatile blood flow in the legs). Pneumatic control systems are also bulky and heavy, which severely limits the mobility of the patient during treatment. Furthermore, pneumatic control systems do not provide a mechanism to ensure that excessive pressure is not applied to the limb to be treated, which could lead to necrosis. These limitations have led to the fact that most mechanical compression devices are prohibited for patients exhibiting DVT. Thus, those skilled in the art have heretofore had to avoid the use of such mechanical compression devices to treat venous ulcers or limb oedema.

DVT is widely recognized as a major risk factor faced by patients undergoing Total Hip Arthroplasty (THA) and Total Knee Arthroplasty (TKA). Without prophylaxis (prophylactic treatment), up to 80% of orthopedic patients will develop DVT, and 10% to 20% will develop Pulmonary Embolism (PE). Even when appropriate precautions are taken, it is estimated that 3% of orthopedic patients will develop DVT, and 1.5% will develop PE. DVT and PE remain the most common causes of emergency readmission and death following joint replacement surgery. In one investigation conducted, the problems stated in terms of their prophylaxis by the patients investigated after THA or TKA vary greatly: 83% report the problem of lack of walking, 74% use compression stockings, 57% use mechanical compression, 58% use anticoagulant pills, 46% use anticoagulant injections, and 42% use aspirin .(https://www.stoptheclot.orn/about-clots/toolkir-for-knee-hip-replacement-patients/orthopedic-surgery-fact-sheet/). thus, there is a need for prophylaxis that is easy for the patient to use at home or workplace (outside the hospital environment or by means of a medical trained professional as described above), that is mobile so that the patient can walk and return to life activities.

Knee replacement can also lead to DVT as a postoperative complication. After knee surgery, most DVT occurs in the lower leg. Although less likely to result in PE, these clots are more difficult to detect. Less than one third of DVT patients exhibit typical signs of calf discomfort, edema, venous distension or foot pain. It has been noted that the risk of developing DVT continues for at least three months after total knee replacement. The risk is greatest two to five days after surgery, and the second peak development period occurs about 10 days after surgery. At present, it has been noted that patients at home are experiencing an increase in DVT due to lack of activity and movement. When a patient is in a hospital he or she may be connected to an electric pump in combination with the therapeutic compression device of the invention, however, once discharged, the current products are limited as described herein, whereby most therapeutic compression devices of the invention are manually pumped so that the patient can walk, work, etc., and those that are electric typically need to be tethered to an electrical outlet, or an electric pump is integral with the therapeutic compression device of the invention and not practical to walk around in life. Thus, there is a need for a system useful for preventing, reducing or even treating DVT, and reducing the risk of PE, that is practical, mobile and easy to administer by a patient after total knee replacement surgery, any other knee, hip or leg surgery. There is a need to allow a user to walk around while maintaining the compression feature while not being limited to an electrical plug or some other separate source of continuous, sustained or even increased and then decreased compression. There is a need for an integrated valve or other device for use in a compression garment, wrap, device or apparatus to maintain a set compression.

Further compression treatment has been discussed in Oscar m.alvarez, martine e.wendelken, lee Markoqitz and Christopher Comfort, volume "Effect of High-pressure,Intermittent Pneumatic Compression for the Treatment of Peripheral Arterial Disease and Critical Limb Ischemiain Patients Without a Surgical Option"(Wounds,, volume 27, 11, pages 293-301, month 2015 11), wherein thirty-six patients suffering from symptomatic Peripheral Arterial Disease (PAD) or Critical Limb Ischemia (CLI) experiencing lameness pain, chronic resting pain, numbness and ischemic lower leg/foot ulcers were randomly divided into 2 treatment groups. Eighteen of these patients received twice daily High Pressure Intermittent Pneumatic Compression (HPIPC) treatment for 60 minutes, for 16 weeks, and 16 subjects received standard care consisting of an exercise regimen of walking twice daily for 20 minutes for 16 weeks. HPIPC devices deliver a bi-directional pressure of 120 mmHg. The cycle time provides a sequential compression of 4 seconds (+/-0.5 seconds) followed by a rest period of 16 seconds (+/-3.0 seconds), resulting in a cycle of 20 seconds or 3 cycles per minute. The study was designed to measure patient-centric results. The primary endpoint is peak walking time Peak (PWT), which is defined as the time to reach maximum tolerance for lameness pain. The conclusion at the end of the study was that therapy consisting of HPIPC hours per day for 16 weeks significantly improved PWT, reduced resting pain, and improved cure rate, body function, and body pain. There are no complications associated with the device, allowing for long term use. It was further concluded that HPIPC provided an excellent alternative to palliative care for patients with PAD and CLI symptoms. Thus, there is a need for a system including HPIPC that can be easily administered by a patient in a home environment.

Commonly owned U.S. patent publication 2004/0193084, which is incorporated herein by reference in its entirety, discloses a device for applying pressure to a person's leg for use in connection with the treatment of varicose veins. The device includes a flexible member and at least one balloon chamber integral therewith, the balloon chamber adapted to be securely wrapped around a person's leg. A tube in fluid communication with the bladder chamber extends to an air pumping mechanism that operates to inflate the bladder chamber to a pressurized state. The flexible member preferably includes an opening at the level of the knee joint to enable the patella to protrude therefrom. Further, the flexible member preferably extends below the knee level and is adapted to securely wrap around the lower portion of the leg to provide stability to the leg. Preferably, the balloon chamber of the device is substantially longer in a first dimension than in a second dimension orthogonal thereto, such that the balloon chamber may be positioned to cover a portion of a person's leg that is relatively longer in the vertical dimension and narrower in the horizontal dimension.

Commonly owned U.S. patent No. 7,276,037, which is hereby incorporated by reference in its entirety, discloses an apparatus for applying compression therapy to a limb of a human body, such as a portion of a human leg. The device includes a flexible member and a balloon chamber. The flexible member is adapted to wrap around the limb to secure the balloon chamber to the limb. The air pumping mechanism is operated to inflate the airbag chamber to a pressurized condition. One or more fluid-filled compression members are provided, each separate and distinct from the flexible member and the balloon chamber, and thus easily movable relative to the flexible member and the balloon chamber. The compression member is operatively disposed between the limb and the flexible member whereby it applies increased localized pressure to the limb during use. Preferably, the balloon chamber is substantially longer in a first dimension than in a second dimension orthogonal thereto, such 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 local pressure to a desired body part, such as a certain venous channel. The pressurizing member may be positioned during use such that it covers the venous ulcer (or other treatment site) and applies increased localized pressure to the treatment site in order to promote healing.

One way to measure the compression efficacy of therapeutic devices is the Static Stiffness Index (SSI). The Static Stiffness Index (SSI) is a valuable parameter characterizing the efficacy of a particular compression product to narrow/occlude a venous lumen, which is the difference between standing and resting pressures. This is a prerequisite for reducing venous return and for exerting the massaging action necessary for improving the venous pumping function during movement. Any value above 10SSI is considered "inelastic". Most, if not all, of the current therapeutic compression devices of the present invention have an SSI of about 2-12, with the inelastic device having an SSI of about 10-12. There is a need for therapeutic compression devices having SSI of at least 10 and higher. The higher the SSI, the better the compression at the target limb site. A higher SSI means that the compression level is comfortable, whereas if the SSI is higher, the blood vessel is pushed and the blood is not restricted.

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

Sequential compression or having multiple bladders with different compression or pressure levels would be beneficial to patients undergoing sclerotherapy, a medical procedure for eliminating varicose veins and spider veins. Sclerotherapy generally involves the direct injection of a solution (typically a saline solution) into a vein. The solution initiates the inner layers of the vessel, causing them to collapse and stick together and cause the blood to coagulate. The post-operative procedure may require compression bandages or stockings, both of which have the problems described above with respect to static compression on the target limb area.

Generally, known compression devices may include an inflatable device capable of providing a constant static pressure over a period of time and providing an intermittent pressure change 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 limiting in that the patient is unable to walk or function while working, school, or otherwise wearing heavy leg, foot, thigh, or other limb wraps. Furthermore, some known compression devices only allow for varying intermittent pressures when directly connected to a power source, thereby further limiting the patient's use, as he or she is literally tethered to a wall outlet. Furthermore, known compression devices or apparatus lack check valves to prevent over-inflation and to seal and prevent deflation when the user is engaged in activity 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 deflation of the bladders.

In addition, sequential compression may aid in the treatment of lymphedema, CVT, CVI, DVT, etc. It is known to have multiple bladders within a compression apparatus, but a streamlined inflation device is required to supply each bladder and a control mechanism is required to cause each bladder to be inflated sequentially. There is also a need for a foot bladder separate from the lower leg bladder and/or upper leg or thigh bladder such that each bladder has a separate compression level and again has a coordinated sequential compression or pressure when inflated. It is also desirable that each of the individual bladders have an SSI of at least about 12 or greater.

There is a need for a system in which the compression garment includes universal connectors that connect to various pumps. Thus, the user may exchange between intermittent pneumatic pressure pumps, for example while sitting, and then change to a set pressure pump, for example while walking. The user may be connected to hand pumps, electric pumps, mechanical pumps 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 may be any type of pump with a universal connector.

In addition, there is a further need for a system that includes an inflation device that can inflate multiple therapeutic compression devices of the present invention simultaneously. There is also a need for a system that includes an inflatable device that is switchable between a constant static pressure level and an intermittently varying pressure level. The inflator is also configured to provide a constant static pressure over a period of time and a varying intermittent pressure over a period of time and alternate between such pressure settings.

There is a further need for a system including an inflator that is smaller than known systems. The user is thus able to return to life activities faster than known compression systems, prophylaxis systems and other therapeutic systems that limit the user's walking in the home and outdoors due to power constraints on the system (electric, mechanical, battery, manual, etc.). Furthermore, there is a need for a non-elastic compression device or wrap that anatomically conforms to a target limb (such as a lower leg, calf, full leg, knee, thigh, arm, torso, or any other limb).

There is an additional need for a system that includes one or more sensors, sphygmomanometer sensors, GPS sensors, etc. that measure the pressure of a user's limb on the skin, movement of the limb, when the system is in use. Such sensors may be connected to the inflator to regulate pressure from the inflator and increase or decrease the current pressure level. Such sensors may also be connected to a database and may be accessible in real time or stored over time by a medical professional and/or user.

There is a need for a system having multiple compression garments with independently applied pressure. For example, a thigh compression garment may be used in combination with lower leg compression devices such as those described in U.S. 9,033,906 and U.S. 7,967,766 and U.S. 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 may wear two separate therapeutic compression devices of the present invention over the entire leg, and may also include an optional knee wrap. In this case, the user may have one pressure level on the thigh therapeutic compression device of the invention, while the calf compression garment may have a second pressure level, and both compression garments are connected to one pneumatic pump configured with multiple pressure outlets. There is a need for such a system.

All currently known therapeutic devices, apparatus, bandages, stockings and socks have the problems of stability (no slippage), maintaining sufficient effective pressure without overpressure complications, maintaining compression, etc. Furthermore, all known devices, apparatuses, bandages, stockings and socks, but especially current therapeutic inelastic devices and apparatuses are only capable of having an SSI of not more than about 10 "12, such that there is a need for a therapeutic compression device having an SSI of more than about 10, preferably about 15-25.

The subject invention provides an alternative to the known art that employs a tightly fitting therapeutic elastic garment that causes patient discomfort and is bulky and impractical to wear in everyday life, and loses its elasticity and slips down the legs over time, and thus loses its effectiveness, as well as inelastic garments and devices having SSI less than about 10 "12. It will be readily appreciated by those skilled in the art 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 legs, thighs, calves and/or feet to prevent swelling and further improve venous circulation, that is also effective for self-administration by a patient, and that has a sufficient SSI of greater than about 10, preferably about 15 to about 35. Other body parts may also be subject to compression, such as arms, wrists, torso, shoulders, etc.

The therapeutic compression system of the present invention having multiple bladders may be used with any desired compression therapy, such as, without limitation, venous disease, vascular disease, lymphedema, post-operative (such as, but not limited to TKR, KRA, HRA, TI-IR and sclerotherapy, etc.), and the like. The therapeutic compression system of the present invention may be used to treat any general swelling, as well as for use post-operatively, including for example in the case of sclerotherapy or venous ablation. The therapeutic compression system of the present invention having multiple bladders may also be used by people for compression therapy, such as athletes and lactic acid aggregators, or pregnant women, as well as any individual who is walking too much or standing with his feet during periods of work. Other uses of the system of the present invention are contemplated.

Disclosure of Invention

The present invention relates to a therapeutic compression system and methods of use thereof. The therapeutic compression system includes one or more compression devices, each having multiple bladders and may have two, three or more bladders depending on the target limb, all connected to one inflation apparatus and each device having a check valve in an inflation port on the device that is capable of maintaining pressure within the inflated bladder when the inflation apparatus 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 inflatable means, wherein the inflatable means is smaller in volume than the known inflatable means. 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, pressure sensor, blood pressure meter sensor, or other sensor, to monitor the use of the system of the present invention by a patient and/or medical professional.

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

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 site 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 a collar and hook material to wrap 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 connecting means or wrap, and there may be at least two or at least three separate bladders within the device, depending on the limb of interest. One or more attachment means may be operatively associated along the first and second peripheral edges of the therapeutic compression device of the present invention for securing it around the limb.

The plurality of bladders may 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 may be determined by the location of the various spot welds that produce the gradient compression profile and/or gradient pressure profile on the bladder, and when inflated, the apparatus of the present invention has an SSI of at least about 10 or greater. The gradient compression profile and/or gradient pressure profile may alternatively be determined by an inflatable device connected to or integral with the therapeutic compression apparatus of the present invention. In another embodiment, the gradient compression profile and/or gradient pressure profile may be determined by the pressure generated by the inflation device within the bladder in one direction and then exiting the bladder through the exhaust port or other outlet device. The at least one bladder may be one of a wedge-shaped bladder, a cone-shaped bladder, a disc-shaped bladder, or a rectangular bladder. The at least one bladder may also include a plurality of fluid chambers. As part of the system of the present invention, the therapeutic compression device of the present invention may further comprise at least one means for adjusting pressure coupled to the at least one bladder for controlling the amount of pressure supplied to the treatment site. In an apparatus having 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, a check valve within the inflation port on each individual bladder maintains the current pressure level.

The therapeutic compression device of the present invention may include a non-elastic portion and an elastic portion, such as on an upper portion of at least one bladder when worn on a lower leg, such as around an upper calf region of a limb. The elastic portion may be located near the user's elbow, wrist or shoulder when placed on the arm limb. The elastic portion may be located at the groin area of the user when placed on the thigh or lower torso or hip or buttock area of the user. Other positions may be employed depending on the limb on the user undergoing the therapeutic compression system.

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 having first and second flexible walls secured to one another about a peripheral edge thereof to form an air pocket, and at least one spot weld disposed in a predetermined location inboard of the peripheral edge connecting the first and second walls to one another to define a plurality of chambers within the bladder. In one embodiment, the geometric arrangement of the at least one spot weld determines the compression profile and/or pressure profile of the at least one bladder. The pressure profile and/or 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 to the resilient portion, which may provide a closer fit to the user when the entire therapeutic compression device of the present invention is worn on the user's target limb.

An inflation device for inflating a bladder (such as a gas trap) through at least one inflation port may be disposed in the first wall of the bladder assembly. The inflation device is detachable from the 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 able to connect to and accept a plurality of inflation sources and inflation devices, such as manual pumps, mechanical pumps, electric pumps, battery-driven pumps, static pumps, intermittent pumps, pneumatic pumps, negative pressure sources, and other variations. When more than one bladder is present in the device, each bladder is inflated sequentially and may be deflated sequentially and repeated repeatedly, or pressure may be maintained once the inflation device is disconnected from the inflation ports located on each individual bladder.

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 is maintained at the current 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 may be self-sealing or it may be attached to a device to open and close the valve, such as with a lever, knob, screw, or other means of opening and closing.

The method of the present invention includes a therapeutic compression system including a therapeutic treatment device for treating CVI, DVT, tissue swelling, arterial and/or venous ulcers, and/or lymphedema by applying primary and secondary wraps around a limb by a patient and inserting an inflation device into an inflation port and inflating a bladder within the primary and secondary wraps and maintaining a pressure to treat the CVI, DVT, tissue swelling, arterial and/or venous ulcers, and/or lymphedema, and having an SSI of at least about 10 or greater when inflated.

Another embodiment of the invention includes an assembly according to the 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 balloon, an absorbent foam, sponge or dressing coupled to the pre-filled balloon, and a suction catheter 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 balloon, absorbent foam, sponge or dressing, and the aspiration catheter are formed together as a unit.

According to one aspect of the invention, the flexible member of the pressure mechanism is adapted to wrap around the leg or arm and over the pre-filled balloon in order to secure the pre-filled balloon and foam, sponge or dressing to a wound or ulcer in the limb. Thus, the flexible member is provided with some securing structure, such as a hook and loop closure mechanism. The air pumping mechanism is preferably coupled to an air chamber of the pressure mechanism so as 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 of the leg) rather than around the entire limb.

According to another aspect of the invention, the suction catheter is located between the pre-filled balloon and the absorbent foam, sponge or dressing adhered to the small balloon, or the pre-filled balloon is formed as a ring with a central opening through which the suction catheter extends. By coupling the suction catheter to a negative pressure source, exudates from the wound or ulcer are sucked into the suction catheter through the foam, sponge or dressing.

One of the methods of the present invention includes positioning a pre-filled balloon and foam, sponge or dressing over a wound or ulcer on a limb, wrapping a flexible member of a pressure mechanism around the limb, wherein an air chamber is positioned over the pre-filled balloon/absorbent foam, sponge or dressing, and securing a pneumatic pressure mechanism in place with a fixed structure. When the device is properly positioned and attached to the limb, the air chamber is inflated, preferably to 30mmHg-40mmHg, to apply pressure to the limb and, more specifically, to the wound via the pre-filled balloon. The suction device is activated by turning on the negative pressure source and exudates from the wound or ulcer are pulled through the absorbent foam, sponge or dressing into the suction catheter.

Another embodiment of the invention includes a system comprising a device for applying intermittent pressure to a portion of a human body, such as an area of a human leg, which aids in healing and treating various disorders, such as venous ulcers or wounds, by promoting blood flow into and out of the area and by increasing drainage. The devices may include thigh bladders or foot bladders and leg bladders, each having an inflatable chamber (at least one and possibly two or more bladders within each device) that contains an incoming fluid by inflation. The bladders are fluidly coupled by a fluid conduit, and each bladder is preferably equipped with means for positioning it on a portion of the body. In a preferred embodiment, the thigh bladder is positioned between the pelvis or inguinal or hip area of the user and the knee of the user. As the person walks while wearing the device, a portion of the thigh bladder deflates as the person's leg moves the foot (heel) to strike the ground due to external pressure exerted on the foot bladder, forcing fluid out of the foot bladder, through the fluid conduit and into the leg bladder, which increases the pressure therein. When a person's foot rolls from heel to toe in standard walking movements, external pressure from the person's weight is removed from the foot bladder, resulting in a higher pressure in the leg bladder than in the foot bladder. The fluid thus flows back through the fluid conduit and into the foot bladder, which is then re-inflated to its original state, such that the pressure of the foot bladder and the leg bladder are equalized. This process repeats as the person walks, creating pumping or kneading forces on the leg as the pressure in the leg bladder increases and decreases intermittently, thereby promoting blood flow, fluid drainage, treatment, and healing of the various parts of the leg.

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

In another embodiment of the invention, the therapeutic compression system comprises an inflatable device that is switchable between a constant static pressure level (different pressure levels, such as 20mm-Hg, 30mm-Hg, 40mm-Hg, up to 200mm-Hg, etc.) and intermittent varying pressure levels, thereby applying pressure to the therapeutic compression apparatus of the invention via a hose or tube. The inflation device may be capable of separately and sequentially inflating each bladder and then deflating, or repeatedly inflating and deflating as desired.

In other embodiments, the inflation device is connected to two or more tubes, and thus to two or more bladders, whether multiple bladders within one inventive therapeutic compression apparatus or a single bladder within multiple inventive therapeutic compression apparatuses, or a combination thereof. In another embodiment, the inflation device includes a pump having a manifold with a plurality of chambers, each chamber corresponding to a bladder within one or more of the apparatus, such that the inflation device connected to the manifold is connected to a plurality of hoses which are then connected to each individual bladder for sequential inflation and deflation of each individual bladder.

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

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.

Drawings

In order to make it easier for a person of ordinary skill in the art to which the subject invention pertains to understand how to make and use the apparatus of the subject invention, preferred embodiments thereof will be described in detail below with reference to the drawings, in which:

fig. 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 inflation device positioned on a retaining device such as a harness;

Fig. 2 is another embodiment of the present invention for use on a person, comprising two inventive lower leg therapeutic compression devices each connected to a tube and an inventive thigh therapeutic compression device, all three tubes being connected to one inflation device positioned on a holding device such as a harness;

FIG. 3 is an exploded view of the embodiment of the harness, inflator and battery shown in FIGS. 1 and 2;

Fig. 4A is a cross-sectional view of the inflatable device of fig. 1, showing the sensor port and one inflation port, both connected to one tube that inflates and deflates the therapeutic compression device of the present invention.

Fig. 4B is a cross-sectional view of the inflatable device of fig. 2 showing the sensor port and three inflation ports, all connected to a tube that inflates and deflates three individual bladders within all three therapeutic compression devices of the invention or one or more therapeutic devices, or in the alternative, at least three tubes that may be connected to three individual bladders within one therapeutic compression device of the invention, or in the alternative, three tubes may be connected to at least three individual therapeutic compression devices of the invention, or a combination thereof.

FIG. 5A is a cross-sectional view of the inflation port of FIGS. 1 and 2 showing one embodiment of a self-sealing check valve in an open position when the bladder is inflated;

FIG. 5B is a cross-sectional view of the inflation port of FIGS. 1 and 2 showing one embodiment of a self-sealing check valve in a closed position to prevent deflation of the bladder once inflated;

Fig. 6 is another embodiment of the therapeutic compression device of the present invention wherein an inflation means is connected to the intake port and separate exhaust port of such therapeutic compression device of the present invention;

fig. 7A-7E are embodiments of a flow chart representation of a method of use of the present system including the lower leg therapeutic compression device of the present invention and the thigh therapeutic compression device of the present invention;

fig. 8A-8K are yet another embodiment of a flow chart representation of a method of use of the system of the present invention including the lower leg therapeutic compression device of the present invention.

Fig. 9 is a further 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 under the foot and lower leg device;

Fig. 10 is a further 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 foot and lower leg devices each have only one bladder and the thigh device comprises two separate bladders, and a sock under the foot and lower leg devices;

Fig. 11 is a further 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 configured with a gradient compression profile;

Fig. 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 one or more individual bladders in the therapeutic compression device of the present invention via a switch or valve connected to a hose or tube that is further connected to a respective universal inflation port on each of the devices;

Fig. 13 is a further embodiment of the present invention comprising two separate therapeutic compression devices of the present invention (foot and full leg) having a resilient knee portion connecting the upper and lower leg portions of the full leg device, and a sock under the lower leg portions of the foot device and full leg device;

fig. 14 is another embodiment of the invention of fig. 1 with 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 invention;

Fig. 15 is another embodiment of the invention of fig. 1 with three separate bladders, three inflation ports, three hoses and three connectors to the manifold and inflation device within the lower leg therapeutic compression device of the invention;

Fig. 16A-C are another embodiment of the present invention of the foot therapeutic compression device of the present invention alone, capable of being connected to an inflator that is connected to other devices, wherein fig. 14A shows a front view, fig. 14B shows a rear view, and fig. 14C shows a side perspective view;

FIG. 17 is an exploded view of FIG. 16;

fig. 18 is a top view of yet another embodiment of the foot therapeutic compression device of the present invention, and an apodized sock under the foot therapeutic compression device of the present invention;

Fig. 19 is yet another embodiment of the thigh therapeutic compression device of the invention (in an exploded view of the device) having two separate bladders;

Fig. 20 is a perspective view of yet another embodiment of the present invention comprising a lower leg therapeutic compression device of the present invention having two separate bladders (upper calf portion and lower calf portion with foot) connectable to the same inflation means, wherein the device comprises a resilient portion at the upper calf portion and has a sock or sleeve connected to the lower leg therapeutic compression device of the present invention;

Fig. 21 is a perspective view of yet another embodiment of the present invention including a lower leg therapeutic compression device of the present invention having three separate bladders (upper calf, lower calf and foot) connectable to the same or different inflatable means, wherein the device includes a resilient portion at the upper calf and has a sock or sleeve connected to the lower leg therapeutic compression device of the present invention, and

Fig. 22A-C are another embodiment of the invention comprising two different variants of a manifold having holes for inserting connection means on hoses (fig. 22A and 22B), and yet another embodiment of the invention of an inflator device connected to the manifold having four hoses connected within the manifold.

Detailed Description

Preferred embodiments of the subject invention are described below with reference to the drawings, wherein like reference numerals represent the same or similar elements. Those of ordinary skill in the art will appreciate that while the devices discussed herein relate to compression therapies for legs and feet, the scope of the invention is not limited to those exemplary applications and may be sized and shaped for anatomical portions requiring compression therapies.

The subject invention provides compression to a patient's limb, including the 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 inventive system comprising the inventive therapeutic compression device may compress any limb or body part such as, for example, feet, calves, thighs, knees, legs, hips, buttocks, waist, torso, ribs, shoulders, arms, hands, fingers, neck, head, etc.

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 bladder available for compression, the apparatus having at least one and preferably more than one individual bladder within the apparatus and being connected to an inflation device comprising a dual device having both a constant static pressure level and a varying intermittent pressure level, and the bladders being inflated sequentially. The system is provided in a manner that allows for consistent measurement of the supplied pressure as well as being safe, comfortable, more practical, more flexible, convenient, effective, and self-administered by the patient.

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

Unless defined otherwise, 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, the 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 connection with which the publications are cited.

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.

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

Referring now to fig. 1, an exemplary embodiment of a system 100 of the present invention is shown, comprising a therapeutic compression device 200, an inflation apparatus 150, and a connection apparatus 160 of the present invention. In some embodiments, the inflator 150 is connected to a retainer 180, such as a strap. In some embodiments, the therapeutic compression device of the present invention is a lower leg compression device, such as Sun Scientific, incAnd are 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. sequence No. 13/444,600 and U.S. sequence No. 16/328,718, which are all incorporated herein by reference. In some embodiments, the inflation device may be a manual hand pump, foot pump, mechanical pump, electric pump, battery-driven pump, static pump, intermittent pump, variable speed pump, automatic pump, pneumatic pump, negative pressure pump, suction pump, or 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 to provide compression when used by a patient. In some embodiments, the inflation device is connected to the therapeutic compression apparatus of the present invention by a hose or tube 160. In some embodiments, the inflation device is connected to a holding device, such as a belt or wrap worn by a user.

Therapeutic compression device 200, 300, 500 of the present invention may include at least one bladder 202, 302, 502 and may be more than one bladder, such as 202A, 202B, 202C, 302A, 302B (not shown may include multiple bladders 202D, 202E, 302C, 302D, 502A, 502B, 502C, etc.), by way of example only, such as compression bladders integrally formed in therapeutic compression device 200, 300, 500 of the present invention, or therapeutic compression device 200, 300, 500 are configured for insertion (not shown) of a bladder within 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 wrap around a limb of a patient such as, for example, a leg, calf, knee, foot, ankle, thigh, torso, arm, neck, or any other limb. The therapeutic compression device 200, 300, 500 of the present invention is not limited to the limbs or body parts listed above, but may be any body part such as, but not limited to, feet, ankles, calves, lower legs, knees, thighs, groin, hips, legs, buttocks, trunk, stomach, chest, shoulders, arms, elbows, hands, wrists, neck, head, and the like, and any combination thereof. One embodiment of the therapeutic compression device of the present invention is a lower leg therapeutic compression device 200, as shown in fig. 1, and also includes a thigh therapeutic compression device 300 of the present invention in conjunction with a second lower leg therapeutic compression device 200, as shown in fig. 2. The therapeutic compression device 200 of the present invention as shown in fig. 1-2 and 8-10 is a wrap member 220 having a proximal end portion (as oriented closer to the top of the user's knee in fig. 1-2 and 8-10) and an opposite distal end portion (as oriented at the bottom of the wrap around the user's foot in fig. 1-2 and 8-10) configured and adapted to conform around the lower leg (including foot and lower leg) of a patient and provide compression by 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 configured and adapted for RF welding together to form a wrap 220. However, any other suitable material (such as films, polymers, etc.) that can be welded or otherwise joined and at the same time be airtight to form a bladder may be used, and in some embodiments (not shown) there is only one sheet without a bladder, where the sheet has an SSI of at least greater than 10. As shown in fig. 1-2, 8-11, and 13-21, the continuous peripheral weld lines 216, 316, 516 form the airtight boundary of the integrally formed bladders 202, 302, 502. In the exemplary embodiment of fig. 1-2 and 8-10, bladder 202 is a single continuous bladder extending from the lower leg portion through the foot portion of therapeutic compression device 200 of the present invention, however, it is contemplated that therapeutic compression device 200 of the present invention may have multiple independent bladders (202A, 202B, 202C, etc.) that may be inflated or deflated individually by a one-way valve or other desired inflation/deflation arrangement, as shown in certain non-limiting embodiments of fig. 9, 11, 14-15 and 20-21.

In this embodiment, hook and loop fasteners 224 are provided along the edges of the inner and outer sheets to facilitate adjusting and securing the lower leg therapeutic compression device 200 of the present invention to a patient's limb, such as, for example, a calf or foot. It is contemplated that thigh therapeutic compression device 300 of the present invention may include hook and loop fasteners 322, 324, but may also be secured to the thigh of the patient by other means, such as a zipper, buttons, or by other such suitable means to form a cuff shape. In addition, it is also contemplated that the hook and loop closures 224, 324, 524 may be replaced with a material similar to ankle straps, knee straps, hip straps, or any other type of strap (including those described below) and welded/stitched/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, buttons, or by other such suitable means to form a cuff shape.

Referring now to fig. 1-2, in this embodiment, the therapeutic compression device 200 of the present invention has a bladder integrated in the inner and outer sheets 203, 201 with a cost-effectively achieved position and desired pre-configured compression gradient profile. Several different embodiments of bladder configurations may be used with the lower leg therapeutic compression device 200 of the present invention, such as those described above and the embodiments shown in fig. 11, 14-15, and 20-21, having different gradient compression profiles and/or gradient pressure profiles based on the positioning and selection of spot welds 215 and weld lines 216, which also apply 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. Fig. 1-2 illustrate a therapeutic compression device 200 of the present invention having a bladder with a plurality of spot welds 214 therein. In any embodiment such as fig. 11, 14-15, and 20-21 (and those not shown), spot welds 214 are strategically placed within bladder 202 in a predetermined pattern based on a desired gradient profile relative to the compression required at the patient treatment site. Spot welds 214 and/or weld lines 216 enable bladder 202 to define a gradient compression profile and/or a gradient pressure profile when inflated through inflation port 212. The geometric arrangement of spot welds 214 and/or weld lines 216 within bladder 202 allows for increased inflation of certain portions of bladder 202 and may create one or more fluid chambers within bladder 202. This configuration is particularly useful when compression is required to improve fluid movement (e.g., blood, lymph, etc.) within the body. In addition, wire bond 216 allows for better compression along the calf of the patient's leg by increasing the applied tension and the patient's plantar region. This increased tension may create more effective compression to increase venous flow. The ribbed portion of wire bond 216 positioned laterally along the lower leg maintains the compact inflation profile of therapeutic compression device 200 of the present invention, which may further increase ambulation and reduce interference with the patient's clothing. In contrast to the geometric arrangement and design of the curved weld line 216 in fig. 20, the line weld line 216, which is vertically positioned along the lower leg as shown in fig. 21, creates a vertical ribbed portion and a different gradient compression profile than that shown in fig. 1-2, 11 and 14-15, which creates yet another gradient compression profile on the lower leg of the user. Other geometric configurations and placement or locations of both spot welds 214 and weld lines 216 are contemplated to produce infinitely different amounts of gradient compression profiles and/or gradient pressure profiles.

It is understood that different pressure gradients and/or compression gradients and their distribution may be utilized depending on the location of therapeutic compression device 200 of the present invention. Other possible gradient pressure profiles may be envisioned based on the geometric location of the spot welds 214, alone or in combination with the wire welds 216. The spot welds 214, 314, 514 shown in fig. 1-2, 14-17, 19, and 21 are in a circular shape, wherein the spot welds 214 in fig. 20 are of different geometries, such as drop shapes, although having any geometry and any placement location on the lower leg, thigh, or foot of the present invention, and further, the weld line 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 of the therapeutic compression devices 200, 300, 500 of the present invention. For example, in thigh therapeutic compression device 300 of the present invention, wire bonds 316 and spot bonds 314 may have different geometric configurations than those shown in fig. 1-2, depending on the location of the limb to be compressed, such as the mid-region of the thigh. Likewise, the gradient pressure profile and/or gradient compression profile may be based on the geometric pattern of spot welds 314 alone or in combination with wire welds 316. In another embodiment of the therapeutic compression apparatus (not shown) of the present invention, the gradient compression profile and/or gradient pressure profile may be based on the pressure level of the inflatable device alone or in combination with the overall shape of the bladders 202, 302.

It will be appreciated that depending on where the therapeutic compression device of the present invention is placed on a patient's body part or limb, 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 accumulation, arterial ulcers, venous ulcers, lymphedema, post-sclerotherapy, CVT, DVT, etc.) and the treatment site, different pressure gradients and/or pressure gradient profiles may be employed. Other examples of bladder pressure gradient profiles are described in U.S. patent application Ser. No. 12/911,563 and U.S. patent application Ser. No. 12/855,185, the disclosures of which are incorporated by reference in their entirety.

The configuration and shape of bladders 202, 302, 502 may not include a number of spot welds 214, 314, 514 or weld lines 216, 316, 516, such as the non-limiting embodiments shown in fig. 9-10, 13, and 18, wherein the front portion of 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 corresponding therapeutic compression device 200, 300, 500 of the present invention.

When inflated, the bladders 202, 302, 502 within the therapeutic compression device 200, 300, 500 of the present invention have an SSI of at least about 10 or greater. The inelastic pneumatic bladder has an SSI of at least about 10 and preferably about 10-50. SSI aids in compression therapy of the user to prevent or treat CVT, CVI, DVT, lymphedema and other swelling problems on the user's limb, as well as arterial and venous ulcers. Commonly known SSIs for elastic bandages or garments are in the range of about 1 to about 5 or about 6, while certain known inelastic compression devices have SSIs in the range of about 5-10. At this point, the inelastic compression device comprising the bladder does not have an SSI of greater than about 10 when such bladder is inflated. For inelastic compression devices, an SSI of about 10 is generally acceptable, with 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 user's compression with the bladder inflated. In contrast, in the case of vascular pushing but limited blood, higher SSI often translates to a comfortable compression level. The therapeutic compression device of the present invention can combine compression to prevent or treat arterial and venous diseases. However, arterial disease requires blood vessels and blood flow, and venous disease requires compression, which is found in the therapeutic compression device of the present invention when the bladder is inflated and the device is on the user's target limb. For users with mixed diseases of both arterial and venous diseases, it is desirable to perform inelastic compression, which has the added benefit of high pressure, without constantly constricting the blood vessel. The therapeutic compression device 200, 300, 500 of the present invention is capable of achieving high pressure and high rigidity, which is advantageous in preventing and treating venous diseases, lymphedema, CVT, CVI, etc. The therapeutic compression device 200, 300, 500 of the present invention has been measured as having an SSI of up to about 40-50, preferably about 10 to about 30 when inflated and when in use.

Compression therapy is a widely used standard of care in the treatment of various tumescent disorders such as chronic venous insufficiency diseases and lymphedema. Compression therapy relies on external use of pressure to compress underlying anatomy and helps reduce swelling and improve circulation. Gradient compression is particularly effective, where more pressure is applied more distally (farther) from the heart, where the pressure decreases proximally (closer). This helps to squeeze the body in a way that helps to stimulate the circulation and reduce the size of the limb. Generally, there are two types of compression, static and intermittent. Static is most common and means continuous compression worn throughout the day, whereas intermittent is the application of compression by pump cycles and is particularly beneficial for occasional use when the user is sitting for a long time.

For static all-day compression, there are a variety of compression products and techniques, but static compression generally has two mechanisms of action. For example, the supportive effect may help reduce the available limb volume to manage the amount of leg swelling. Furthermore, dynamic effects may include compression that causes or helps to improve circulation of blood and fluid, particularly when the user is walking around. The compression circulatory system is pressed into better contact with the muscles (e.g., calf and lower leg presses) to improve the fluid movement efficacy of the body. Persons suffering from chronic venous disease may not be able to achieve a fully effective circulation without compression. Compression therapy, when used correctly, is widely recognized as an effective treatment for lower leg swelling disease. Compression helps reduce swelling and improves circulation of captured fluid by squeezing the outside of the leg. To be effective, compression must be used consistently and frequently, especially static compression as you stand and walk around.

The two ways that static compression helps are 1. Supportive compression (compression that helps prevent further swelling of the legs) and 2. Dynamic compression (compression that helps improve the natural circulation of the body, especially when moving, because it keeps the circulatory system engaged with the musculoskeletal system). There are different types of known compression products available for different situations, some of which are pulled up like socks and some of which are rolled up as bandages. Each of these types of products may be classified by the degree of stretch of the material on a level of elasticity to inelastic.

As described above, compression therapy has been effectively used to treat patients with chronic venous insufficiency. Because of its potential rigidity and elasticity, the compression device works by improving venous hemodynamics and reducing oedema. There are several types of known conventional compression options, such as medical grade elastic compression stockings, inelastic compression stockings and inelastic compression wraps. Each of these has advantages and disadvantages. Inelastic compression provides higher stiffness than elastic compression and thus better controls venous hemodynamic damage in patients with more severe venous disease. The compression wrap provides for easier application to the patient when compared to compression stockings. The therapeutic compression device of the present invention addresses these problems by preventing or treating arterial and venous problems because the therapeutic compression device 200, 300, 500 of the present invention has an SSI of at least about 10 or greater when inflated and wrapped around a user's target limb. Stiffness is the rigidity of an object, i.e., the extent to which it resists deformation in response to an applied force. The stiffness of the device may be calculated by measuring the interfacial pressure between the compression device and the skin. SSI is defined as the difference between standing pressure and supine pressure measured at point B ₁. Point B ₁ is the transition point between the gastrocnemius tendon and the muscle about 10cm-15cm above the medial malleolus. Elastic compression devices typically have an SSI <10, sometimes less than 5, as compared to inelastic devices exhibiting SSI > 10. The therapeutic compression device 200, 300, 500 of the present invention has an SSI of at least about 10 or greater, preferably about 15 to about 40. Notably, in certain embodiments such as those shown in fig. 20-21, the therapeutic compression device 200, 300 of the present invention also has a resilient portion 205, 318 that is configured to conform to the shape of the target limb and anatomy and to retain the inflated therapeutic compression device 200, 300 of the present invention on the target limb without sliding down the limb (such as the lower leg and thigh in these non-limiting examples) while the user is moving or walking. Thus, there is a combination of SSI of at least about 10 with a specific elastic portion on the therapeutic compression device 200, 300, 500 of the present invention, with other embodiments not shown.

The elastic material is always under compression, which means that it can feel "tight" and clamped even at rest. But as you walk around the elastic material stretches, which means that it can give up some of its compression, reducing the dynamic compression effect. With the return of the calf vein and lymphatic blood, the calf muscles play a very important role in helping to squeeze fluid up into the body against gravity and back into the circulation. In fact, the lower leg is called the second heart. Due to the material properties, the elastic compression of the leg eventually stretches as the leg (both the calf and thigh, and knee and ankle) is engaged, losing some of the inward pressure of the compression and losing the fluid return effect. In contrast, inelastic materials are known to feel more comfortable at rest and to have much less stretch when walking around, allowing them to have comfortable supportive compression and more efficient dynamic compression. For example, compression stockings are elastic and are pulled up into place. They are manufactured as circular knitted fabrics with a predefined stretch built in by yarn selection. They are known to be difficult to apply at the higher medical 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 the compression. Compression bandages can be made with different levels of elasticity and are typically applied with multiple layers of different levels of elasticity in an attempt to achieve a particular level of compression or amount of SSI.

When wrap 220 is placed on a user's target limb and bladder 202, 302, 502 is inflated, therapeutic compression device 200, 300, 500 of the present invention includes an SSI of at least about 10 or greater. As shown in fig. 1-4B, 12, 14-15, and 22C, one of the inflation devices is device 150, which is a pneumatic pump that is attachable to inflation ports 212 (212 a,212B, 212C), 312 (312 a, 312B), 512 to inflate bladders 202 (202 a,202B, 202C), 302 (302 a, 302B), 502 within therapeutic compression devices 200, 300, 500 of the present invention. It is understood that other mechanical or automatic inflators (not shown) may also be attached to the inflation ports 212 (212 a,212b,212 c), 312 (312 a,312 b), 512 to inflate and deflate the bladders (202 a,202b,202 c), 302 (302 a,302 b), 502 within the therapeutic compression devices 200, 300, 500 of the present invention to provide pulsatile pressure to the user's limb. For example, as shown in fig. 2 and 8G to 8H, the inflator 150 is a pneumatic pump, and the second inflator 150 is a manual pump 400 including a bulb 420 for manually pumping an air fluid and a manual dial 410 including a check valve therein. Many or more inflation devices may be employed, such as manual pumps, hand pumps, foot pumps, mechanical pumps, electric pumps, battery-driven pumps, static pumps, intermittent pumps, variable speed pumps, automatic pumps, pneumatic pumps, negative pressure pumps, suction or vacuum pulse pumps, 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 therapeutic compression device 200 of the present invention at inflation port 212 to allow a user to selectively deflate bladder 202 of therapeutic compression device 200 of the present invention. In addition, a check valve (not shown) or safety valve (not shown) is incorporated with the inflatable device 150 or bladder 202 to prevent over-inflation once the 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 entirety. The inflation device 150 may include a manifold 190 as shown in the non-limiting examples in fig. 12 and 22A-22C that controls inflation, retention, and deflation of each bladder 202 (202A, 202b, 202C), 302 (302A, 302 b), 502 connected to the applicable inflation ports 212 (212A, 212C), 312 (312A, 312 b), 512 via hoses 160 (160 a,160b,160C,160d,160e,160 f). 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 individual hoses 160A, 160B, 160C, 160D and 160E are connected to the applicable inflation ports 212A, 212B, 212C and 312A, 312B, as shown in fig. 9-11, 13-15 and 20-21. Other configurations are possible depending on the number of individual bladders within each therapeutic compression device 200, 300, 500 of the invention.

Referring now to fig. 1-2, 8J-8K, and 14-15, once the therapeutic compression device 200, 300 of the present invention is secured around the lower leg of a patient, the bladders 202 (202 a,202b,202 c), 302 (302 a,302 b) are inflated and prevented from moving out of position, thereby increasing comfort and reducing fit problems to the patient. To increase the convenience of patient ambulation and the practicality and mobility of the patient, in this exemplary embodiment, the inflator 150 is connected to a retainer 180, such as a strap. Any retention means 180 may be employed, such as, for example, thigh straps, hip straps, or waist straps may be used, but are not shown. If straps are used, the straps may be tightened against the patient's legs and hips to reduce slippage of the therapeutic compression device 200, 300 and the inflation apparatus 150 of the present invention.

In this embodiment, the retention device 180 is a strap or a strap and includes a buckle 181A (male connector) and a strap clip 181B (female connector) that are joined together by inserting the buckle 181A into the strap clip 181B and then snapping together. Other embodiments not shown may include a sock lacing system or lacing buckles or any other known closing or connecting means. Likewise, the retention device 180, if a strap, may be closed or connected by other connection means such as, for example and without limitation, a hook and loop closure or VELCRO ^TM or any other known connection means such as a clasp, strap, button, clasp, zipper, hook, and other combinations. As shown in fig. 1-4 and 14-15, the retention device 180 belt is worn about the waist of the patient. In another exemplary embodiment, the retention device 180 may be a hip strap (not shown) or a waist strap (not shown, as shown in the harness embodiment) configured and adapted to improve the wearability of the inflator device 150 and increase patient ambulation.

Inelastic hook and loop ("Velcro") wraps have been introduced with a hook and loop outer material on a neoprene-type material with little stretch, where the strap is pulled to exert a higher stiffness than the elastic stocking compression. These products offer a significant improvement over the known problems of elastic stockings and rolled bandages in that they are more prone to wrap around the leg in view of their hook and loop attachment, however, there are significant drawbacks in that they require a manual amount of force to pull the strap to the desired compression level. These products require some amount of stretch in their base material to apply the compression to be applied, but this stretch also means that the inelastic properties of the product are suboptimal. It is also very difficult to quantify the applied pressure using this manual technique.

No completely inelastic material is used because compression cannot be applied in a static state or proper anatomic fit cannot be obtained without stitching the multiple sheets together in a pattern that conforms to the multiple contours of the body. The therapeutic compression device 200, 300, 500 of the present invention is a compression garment anatomically conforming to the legs and feet but made primarily of inelastic material. Current conventional inelastic compression devices look like a cone for the lower leg when laid flat without inflation 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 upper calf of the lower leg than the ankle area of the user. As shown in fig. 20-21, the therapeutic compression device 200 of the present invention includes a resilient portion 205 located over the upper aperture 204 of the device 200/wrap 220 to aid in the anatomical fit of the device 200/wrap 220 when placed on the lower leg of a user, whereas currently known compression wraps are tapered in shape from bottom to top so they must be cut by the user or extend farther than they need to be when placed on the lower leg and do not bind the lower leg, which is a problem. The therapeutic compression device 200 of the present invention solves this problem by including an elastic portion 205 to help the device 200/wrap 220 fit over the lower leg when placed on the user. Further, 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 having better inelastic properties (higher than about 10, preferably higher than 15 or higher static stiffness index in the range of about 10 to about 50). Air or any suitable forcing fluid can also be measured by measuring the actual amount applied or by feedback pressure, allowing the manner in which the applied forcing is measured, controlled, and adjusted, such as by way of non-limiting example shown in fig. 12, via switches or valves 197 (197A, 197B, 197V, 197D, 197E, 197F, etc.) or via other sensors not shown. The therapeutic compression device 200, 300, 500 of the present invention may be designed in such a way that more compression is applied distally than proximally through multiple inflation channels, or the shape of the bladders 202, 302, 502 or the location and placement and pattern of the spot welds 214, 314 and weld lines 216, 316, 516.

In order to have a proper anatomical fit on, for example, 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 to provide the desired 3D shape for the inelastic garment. This process of laying material under different amounts of stretch on pins (not shown) having different elastic properties means that 3D shaped garments can be manufactured in a flat state, providing significant cost and efficiency improvements for other manufacturing means. For example, the steps may include (1) placing the inelastic outer sheet 201 on a flat surface with pins, (2) the elastic insert 205 being pre-stretched and held in a stretched state on the same pins, (3) laying the inelastic inner sheet on the same pins within the aperture 204 sandwiching the pre-stretched elastic insert 205 between the inner and outer sheets 201, 203, (4) fusing the three layers together in a flat state (radio frequency welding, ultrasonic welding, stitching or any other means of attachment), 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 contracted, thereby crimping the lower leg therapeutic compression device 200 of the present aspect to the desired 3D shape. In this embodiment, the inner sheet 201 and outer sheet 203 are inelastic and may be composed of a multi-layer laminate, capable of being airtight and inflatable. In other embodiments, the inelastic material may have additional elastic inserts or mesh portions 217 that are inserted in a manner that provides a 3D anatomical shape and a predetermined compression profile by stretching more or less depending on the location of the desired compression profile. Because of the inelastic portion of the lower leg therapeutic compression device 200 of the present invention, the additional elastic or mesh portion 217 may aid in anatomical positioning and heat release from the user's limb. Similarly, the thigh therapeutic compression device 300 of the present invention includes a resilient portion 318 to conform to the anatomy of the inguinal region and prevents the thigh therapeutic compression device 300 of the present invention from sliding down the user's legs and thighs when the user is moving and especially walking, and in turn provides assistance and better efficacy in reducing, treating, and even preventing tissue swelling, lymphedema, ulcers (arteries and veins), CVI and DVT, and increasing circulation over the individual user's thighs and entire legs.

It should be appreciated that the chambers of bladders 202 (202A, 202B, 202C), 302 (302A, 302B), 502 may be filled with air, fluid, or other known inflation devices. It should also be appreciated that bladders 202 (202 a,202b,202 c), 302 (302 a,302 b), 502 may be arranged to receive air and inflate using a manual pumping bulb (as shown in fig. 2), or may be inflated by electric air pump 150, which may pump air into the chamber using a battery or AC wall current. The therapeutic compression of the present invention as shown in fig. 9-11, 14-15, and 20-21 gives examples of therapeutic compression devices 200, 300 of the present invention that include two individual bladders 202A,202B or 302A,302B or three individual bladders 202A,202B, 202C. Each of these individual bladders may be sequentially inflated, then released, then inflated and repeated depending on the target limb and the target pressure of each portion of the target limb. Inflation ports 212 (212 a,212b,212 c) of therapeutic compression device 200 of the present invention are universal in that they can be connected to a variety of different types of inflation devices. Any known source of air or fluid, whether manual, mechanical, electrical, battery-driven, or any other source of power, pump or pressure generator may be employed. The inflation device 150 may be a manual pump, hand pump, foot pump, mechanical pump, electric pump, battery-driven pump, static pump, intermittent pump, variable speed pump, automatic pump, pneumatic pump, negative pressure pump, suction pump or 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.

As shown in fig. 1-4, 9-11, and 14-15, the inflation device 150 is connected to the therapeutic compression apparatus 200 of the present invention via a connection device such as a tube 160 or hose, and as shown in fig. 9-12-13, 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. Any other known connection means may be employed, other than the non-limiting examples of tubes and hoses. The connection device tube or hose 160 (160 a,160b,160c,160d,160e,160 f) has two ends, one of which is inserted into a corresponding inflation port 212 (212 a,212b,212 c), 312 (312 a,312 b), 512, and has a tip or insertion portion 195 (195 a,195b,195c,195d,195e,195 f) on the other end that is inserted into a hole 197 (197 a,195b, 197c,197d,197e, 197f) in the manifold 190. The manifold diverts air from the air pump 150 into each of the respective tubes 160 or hoses, and there is a sensor, valve, switch, or some gateway in selecting the pressure level of each individual tube 160 or hose and whether to inflate, hold, or deflate the respective bladders 202 (202 a,202b,202 c), 302 (302 a,302 b), 502. The illustrated embodiment includes a transparent tube 160 (160 a,160b,160c,160d,160e,160 f) connected to the inflator 150 or the hand-held manual pump 400, and another embodiment of the tube 160 is shown with a cover 162 (shown as a black cloth 162) over the tube to allow the user to more easily wear the cover tube 160 under clothing or less likely to be visible when worn over clothing. The tube 160 (160 a,160b,160c,160d,160e,160 f) is connected to the therapeutic compression device of the present invention by inserting, for example, a male luer slip 161 into the inflation ports 212 (212 a,212b,212 c), 312 (312 a,312 b), 512. At the opposite end of the tube 160, the tube 160 is inserted into the inflator 150 via the pump output port 152 as shown in fig. 4A-4B, but is also inserted into the inflator via the manifold 190 by inserting a connector 195 (195 a,195B,195C,195d,195e,195 f) into each corresponding aperture 197 (197a, 197b,197c,197d,197e, 197f), as shown in fig. 12 and 22A-22C, although other configurations are possible (not shown).

The inflator 150 shown in the embodiment of fig. 1-4 is a pneumatic pump that can be recharged via an electrical charger, but the pump can also be battery driven or any other known power source. In this embodiment, the inflator 150 includes a base 151 that is connected to a strap of the retainer 180. 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 at 156, but the internal mechanical and electrical parts are not shown. The inflatable device 150 of this embodiment is an electric air pump having an interface pressure of 50mm-Hg (e.g., to prevent DVT or treat CVI). The pump 156 may apply pressure statically, constantly, or may intermittently apply pressure, for example by applying 50mm-Hg for 10 seconds, then release until the next 30-45 second cycle, and repeat for a period of time. Other embodiments may include pressure levels of 60mm-Hg, 75mm-Hg, 80mm-Hg, 90mm-Hg, 100mm-Hg, or other known pressure levels, depending on the patient's treatment plan and the targeted limb. There may also be multiple pressure levels within the pump, so there are varying pressures during treatment. In the embodiment shown in fig. 9-21, pressure levels may be recorded by manifold 190 and various sensors (197a, 197b,197c,197d,197e, 197f) corresponding to each bladder 202A, 202B, 202C, 302A, 302B, 502, such that the bladders are sequentially inflated and deflated or maintained, and the amount of pressure may be varied relative 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 capable of sequential intermittent pneumatic compression or any other type of compression, such as sensors, switches or valves 197 (197a, 197b,197c,197d,197e, 197f) within the inflatable device 150 and manifold 190, while also being capable of being separated from the inflatable device 150 while still maintaining or maintaining static compression. As shown in fig. 12 and 22A-22C, the controller or manifold 190 may utilize a sensor, valve, switch, check valve, or mechanism thereof to inflate, maintain, or maintain pressure or deflate the applicable bladder 202 (202A, 202b, 202C), 302 (302A, 302 b), 502 at a current pressure level (such as 20mm-Hg, 30mm-Hg, 40mm-Hg, 50mm-Hg, 60mm-Hg, or higher). Each of the sensors 197 (197a, 197b,197c,197d,197e, 197f) is capable of opening, closing, or exhausting the flow of air from the inflatable device 150 to the applicable bladder via the applicable tube or hose 160A-160F such that the predetermined inflation sequence (which is sequential) creates different or the same pressure within the different bladders 202 (202 a,202b,202 c), 302 (302 a,302 b), 502, although other combinations and sources of pressure other than air flow may be employed. The therapeutic compression device 200, 300, 500 of the present invention has an SSI of at least about 10 or greater when inflated.

As shown in fig. 3-4, the main pump 156 of the inflator 150 includes a display 157 that, in this embodiment, shows the remaining battery power level, the limb being compressed (or the particular bladder being inflated as in the embodiment shown in fig. 9-21), and the elapsed time (in hours and tenths of an hour) of this transient period. The display 157 may be modified to show varying pressure levels, other limbs being pressed, the remaining time activated for a set period of time, etc. USB port 159 and cap 158 are located on opposite sides in this embodiment of 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 switches in other embodiments may be digital and include various options such as pressure levels, static or intermittent conditions, time to operate at each pressure level and/or condition, limb to be compressed (if pump 156 is connected to multiple therapeutic compression devices 200 of the present invention), and the like.

The optional protective cover shown in fig. 1-4 is a flexible cover 158 to protect the inflator 150 when dropped by a user or only upon the usual wear and tear on the pump mechanism, or even to prevent overheating or abrasion of the user's waist. The flexible cover 158 may be constructed of a polymer, rubber, or other flexible material, etc.

Once the therapeutic compression device 200, 300, 500 of the present invention is secured around a patient's limb, such as, for example, a leg, the bladder 202 (202 a,202b,202 c) cannot be displaced out of position, thereby increasing comfort and reducing patient compliance problems, along with the resilient portion 205 and the additional mesh insert 217 as shown in fig. 20-21. To increase the convenience of patient ambulation, in the exemplary embodiment, inflatable device 150 is connected to bladder 202 (202 a,202b,202 c) via male luer slip 161, and inflatable device 150 is connected into manifold 190 via connector 195 (195 a,195b,195c,195d,195e,195 f), and inflatable device 150 is connected to retaining device 180, which in this embodiment is a strap. The user may then activate the main pump 156 via the on-off switch 165. The user then wears an inflatable device 150 similar to a mobile phone on the individual's belt. In this embodiment, the retention device 180 is a belt that is adjustable to the waist of the user via an adjustment device 182 such as, for example, a three-pin only (triglide) and/or an end clip. Thus, the user has increased mobility compared to conventional therapeutic compression devices in which the inflation means is integral with the device.

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-operated pump, a remote pump, an air pump, or any other known inflation device. Many or more inflation devices may be employed, such as manual pumps, hand pumps, foot pumps, mechanical pumps, electric pumps, battery-driven pumps, static pumps, intermittent pumps, variable speed pumps, automatic pumps, pneumatic pumps, negative pressure pumps, suction or vacuum pulse pumps, or any other known or developed inflation source to provide a certain pressure within the bladder to provide compression when used by a patient. Additionally, the inflation device may include means for monitoring or adjusting inflation. The inflation apparatus may include programming such that when the compression device is worn on a patient for use, bladder 202 (including a plurality of bladders, such as the embodiment shown in fig. 9-21, such that sequential inflation or deflation occurs in bladders 202A, 202B, 202C, 302A, 302B, 502) inflates and deflates to a set pressure at intervals or set times throughout the day or night. For example, by way of example only, for each patient, with respect to sequential inflation and deflation of each suitable bladder 202, 302, 502, 202A, 202B, 202C, 302A, 302B, the inflation device may be set to 40mm-Hg at 9 AM, then to 20mm-Hg at 11 AM, then to 30mm-Hg at 12 PM, and so forth 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 manifold 190, and the pressure level of the first bladder 202A and the second bladder 202B may be the same or have different pressure levels as compared to bladders 302A and 302B, etc. having constant or sequential inflation and/or deflation. For example, by way of example only, the inflation device may be set to 40mm-Hg for the first bladder 202A and 20mm-Hg for the second bladder 202B, or each may vary, and the inflation device may be set to sequentially inflate, deflate, inflate, or maintain pressure and compression for a period of time as described above throughout the day. As shown in fig. 2 and 4B, a plurality of inventive therapeutic compression devices 200, 300 may be connected to one main pump 150, 156 such that the pressure level of each bladder 202 (202 a,202B,202 c), 302 (302 a, 302B), 502 within each of the individual inventive therapeutic compression devices 200, 300, 500 may be the same or different, for example only, for bladder 202 within inventive right calf therapeutic compression device 200, inventive right calf therapeutic compression device 200 may be set to 40mm-Hg and for bladder 202 within inventive left calf therapeutic compression device 100 may be set to 20mm-Hg, or each may vary, and the inflation means may be set to sequentially inflate as described above during the day, Deflating, inflating, or maintaining pressure and compression for a period of time, etc. The main pump 156 may be connected to three or more separate bladders within one inventive therapeutic compression device 200, or may be connected to three or more separate inventive therapeutic compression devices 200, 300, as shown in fig. 2 and 4B, showing three separate inventive therapeutic compression devices, but in this embodiment only two hoses 160 are connected to the inflation apparatus 150, so the inventive lower left leg therapeutic compression device 100 would have to be inflated via the hand pump 400 or a second inflation apparatus (not shown). When inflated, the therapeutic compression device 200 of the present invention has an SSI of at least about 10 or greater.

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

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

In another embodiment of the method of use of the system 100 of the present invention, the system is used before, during and after a lower body procedure. In particular for lower leg joint replacement (knee and hip) surgery, the risk of DVT increases along with the pre-and post-operative problems associated with leg swelling. Because of the universal nature of the inflation port (or valve) on the therapeutic compression device of the present invention, it can be coupled with hand pumps, battery-driven pumps, or existing intermittent pneumatic compression DVT systems available on the market. However, the bushings of these existing DVT systems are not worn to reduce swelling, cannot apply compression of a static nature, and cannot be used for mechanical DVT prevention without IPC DVT control units. Thus, another method of use for improving outcome includes the steps of (a) administering the therapeutic compression device 200, 300, 500 of the present invention to a patient at least 3 days prior to surgery to reduce limb volume and leg swelling, which can be accomplished by static or intermittent compression pressure levels, 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 environment during and immediately after surgery, and IPC intermittently cycling to provide standard DVT mechanical prophylaxis, and thereafter (c) administering the therapeutic compression device 200, 300, 500 of the present invention to the patient along with either or both of a hand compression pump or battery-powered (or electric) inflation device 150 (such as pump 156) to take home to manage the risk of DVT while preventing further swelling when the patient is discharged.

It is contemplated that the system 100 of the present invention may be used in conjunction with lower leg compression devices, such as those described in U.S. 9,033,906 and U.S. 7,967,766 and U.S. 7,559,908 and U.S. 7,276,037 and U.S. serial No. 13,444,600, and that one inflation device may be connected to each of the two compression devices, as shown in fig. 1-21. The inflation means may include programming (not shown) connected to the sensor 197 (197a, 197b,197c,197d,197e, 197f) such that when the compression apparatus is worn for use on a patient, the bladders of the two therapeutic compression apparatus 200 of the invention and bladder 202 or bladders 202A, 202B of the lower leg compression apparatus 200 each (or together) inflate and deflate to a set pressure (whether in sequence 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 40mm-Hg at 9 AM, then to 20mm-Hg at 11 AM, then to 30mm-Hg at 12 PM, and so forth, for each patient throughout the day and night, respectively. In another embodiment of the present invention, for example, by way of example only, the inflation device may be set to 40mm-Hg for thigh bladder 300 and 20mm-Hg for lower leg bladder 202 (or calf bladder 202B or foot bladder 202A, etc.), or each may vary, and the inflation device may be set to sequentially inflate, deflate, inflate, or remain for a period of time, etc., as described above throughout the day. 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.

In one embodiment of the invention, the inflatable device comprises a manual pump (as shown in fig. 2 and 8), and the dial comprises a graphic of the amount of pressure such as "35", "45", "55", and "65", or letters such as "a", "B", "C", "D", each corresponding to a particular pressure such as 25mm-Hg, 35mm-Hg, 45mm-Hg, and 55 mm-Hg. The particular predetermined pressure corresponding to the graphic is infinite and is not limited by the examples herein.

Furthermore, the therapeutic compression device of the present invention may be deflated via a button or switch to deflate the bladders 202 (202 a,202b,202 c), 302 (302 a,302 b), 502 and thus release the pressure and/or compression profile. 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 bladders 202 (202A, 202B, 202C), 302 (302A, 302B), 502, while a second umbrella valve will release a quantity of air or fluid within the bladders 202 (202A, 202B, 202C), 302 (302A, 302B), 502 to release 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 invention) or flying (pressure increases based on altitude), and a third umbrella valve that will release the bladder 202 (202A, 202B, 202C), 302 (302 a,302 b), 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, the first umbrella valve is set in a closed position such that when activated, the umbrella valve maintains the amount of air or fluid in bladder 202, and thus maintains a set pressure, e.g., 45mm-Hg, if the pressure exceeds 45mm-Hg, the second umbrella valve is set to release air or fluid within bladder 202 and reduce the pressure to 45mm-Hg (such as when at a high altitude or other pressure increase), then maintain the pressure at 45mm-Hg, and the third umbrella valve is set to open and release all air or fluid within bladder 202 and thus release all pressure when activated by the patient in order to deflate bladder 202 and 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" in which a set amount of pressure is maintained when the patient walks, and the pressure repeatedly rises and returns over time when the umbrella valve is maintained in the closed position, (B) then a "air" graphic in which when the pressure increases beyond a set amount or value, the set amount of pressure will be maintained by the umbrella valve accidentally releasing the pressure, such that the umbrella valve is activated to release air or fluid within the bladder 202 and release the pressure, then closed and maintained closed to maintain the set amount of pressure, and (C) "release" or "deflate" in which the pressure will be released and the air or fluid within the bladder 202 is released to deflate and the umbrella valve is always in the open position. In this embodiment (not shown), there are three umbrella valves, one of which is set to always open bladder 202 to fully release pressure, one of which is set to always close to maintain air or fluid in 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 air or fluid within the bladder, thereby maintaining, changing, or releasing the pressure therein.

The inventive treatment system 100 includes the inventive sealing device coupled to the bladder 202, 302, 502 to maintain a gradient compression profile and/or gradient pressure profile when the inflation device 150 is disconnected from the inventive therapeutic compression apparatus 200, 300, 500 or the inflation device ceases to provide additional inflation or pressure. In one embodiment as shown in fig. 2, the sealing means is a cap 213 inserted over or into the inflation ports 212, 209.

The sealing device also includes a valve 290 within the inflation ports 212,312 (212 a,212b,212 c), 312 (312 a,312 b), 512. As shown in fig. 5A-5B (which are cross-sectional views of inflation port 212), valve 290 is located within housing 209, which is tubing or, for example, a luer. In this embodiment, the housing 209 is a plastic female luer, but other materials, such as metal, polymer, or rubber, may be employed, and other housing means may be employed. The valve 290 as shown in fig. 5A and 5B includes a V-shaped notch 291 in the top proximal portion of the valve 290, although other shaped notches or other holes and openings may be employed. In this embodiment, V-shaped notch 291 facilitates movement of fluid from male luer 161 (fluid flowing from inflation device 150) into inflation port 212 and into bladder 202. The bottom distal portion of the valve 290 is in the shape shown in fig. 5A and 5B, such as a plug, with the top portion 291 being thinner than the bottom distal portion, and having a location 292 that abuts and seals the inflation port when the inflation port is resting along the top portion 299 of the indent 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 seals the pressure and compression therein and, if applicable, maintains a gradient compression profile and/or gradient pressure profile. As shown in fig. 5A and 5B, the housing 209 has a circumference that expands in the lower distal portion to accommodate the valve 290. The shape shown in fig. 5A and 5B is not limiting and any other shape may be employed as long as portions of valve 290 contact a portion of housing 209 to form a seal and maintain pressure and fluid within the inflated therapeutic compression apparatus 200, 300 of the present invention. Also, other shapes may be employed such that a function is created for the zoom apparatus. Then, in this embodiment, the bottom distal portion 295 of the housing 209 narrows or tapers such that when the valve 290 is pushed down by the male luer 161, the bottom of the valve 290 rests on 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 aperture 294. The outer circumference of the bottom distal portion of valve 290 is slightly smaller than the inner circumference of bottom distal portion 293 of housing 209 so that fluid may flow from inflatable device 150 through hose 160, through sliding luer 161, through inflation port 212 and into bladder 202. The same components and methods may be employed in thigh therapeutic compression device 300 of the present invention or any other type of inflatable device.

Fig. 5A illustrates inflation of therapeutic compression device 200 of the present invention, wherein male sliding luer 161 is inserted into housing 209 of inflation port 212 (optional cap 211 is opened and removed to the side) and pushed down onto valve 290 such that the bottom of valve 290 rests on bottom distal portion 295 of the housing, which returns to the open position of valve 290. Fluid, represented by the downward arrow in the middle of the male luer slip 161, flows into the housing 209 and through the valve 290 and into the bladder 202 as shown by the arrow at the bottom of the figure. Fluid will continue to flow into bladder 202 until therapeutic compression device 200 of the present invention is in the proper inflated state. The user then removes the male luer slip 161 inserted from the housing 209 of the inflation port 212 and the valve 290 is moved in an upward direction such that the bottom distal portion 292 of the valve 290 contacts the corresponding shape of the top portion 299 of the indent 293 in the lower portion of the housing 209. The two portions 292 and 299 are connected or in contact, thereby sealing the inflation port 212 and maintaining the fluid within the therapeutic compression device 200 of the present invention at a level prior to disconnection of the inflation apparatus 150 from the therapeutic compression device 200 of the present invention. Fluid, represented by the upward arrow in the middle of housing 209, flows from bladder 202 and into the bottom of recessed housing 293, which is scaled by valve 290. The inflator 150 may also be a manual pump 400 and any other static or intermittent inflator. When bladder 202 is deflated by the user, valve 290 will again be pushed downwardly by male sliding luer 161, but no fluid or inflation will be employed at this time, so that fluid flows out of the inflation port through valve 290 and will remain deflated. Valve 290 may be manually pushed downward to deflate by inserting male luer slide 161 or by a stem or other extension of cap 211 (shown in fig. 8K) or by any other means pushing valve 290 in a downward direction. In this embodiment, valve 290 is self-expanding, but other sealing means may be employed, such as any movable rod, screw, switch, plug valve, or other mechanical means to seal the inflation port and retain fluid therein.

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 apparatus 150, a retention apparatus 180, such as a strap, and a connection apparatus, such as a tube 160 (160 a,160b,160c,160d,160e,160 f). Depending on the energy source, the inflator 150 may require a charger, such as an electrical charger (not shown) for connection to the USB port 159, and the kit will include such a charger. As shown in fig. 3, a cable such as USB cable 175 may be connected to USB port 159 to charge the inflator, and USB cable 175 has two connectors 176, 177 on each side for connection to the inflator source and to inflator 150. As shown in fig. 3, an optional battery 173 may be connected to the inflator 150 and worn by a user on the 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. USB cable 175 is then connected on one side 1748, 177 to battery 173 and on the other side 176 to inflator 150 at the corresponding USB port 159. The inflator 150 may already be fully charged, but with optional battery 171, the user may leave the hospital bed, house, workplace area and walk around and be able to continue to inflate without being tethered to an electrical outlet.

Therapeutic compression devices 200, 300, 500 according to the present invention in a kit may include stockings or socks 110 or other layers between the patient's skin and therapeutic compression devices 200, 300, 500 of the present invention. According to an embodiment of the inflator 150, a flexible cover 158 may be included in the kit. Other devices or apparatus may be included in such kits, or for example, alternate or backup connection devices such as tube 160, backup battery 171, backup USB cable 173, and the like. 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 applied in combination or combination with a wound dressing and/or bandage. In one embodiment, the therapeutic compression device of the present invention is used on top of or on top of a wound dressing applied to the skin.

Another embodiment of the invention includes a method of applying a measured compression amount using feedback. In this embodiment (not shown), bladder a is inflated by inflation source C-the nature of bladder a is such that the amount of compression is determined by the amount of inflation medium (typically air) pumped into a from C. In this design, the inflation source C is also coupled to a bladder B having a fixed air volume. When compression bladder a is inflated, it will compress bladder B as it compresses compressed article F. Inflation source C is able to read the line pressure from coupling line E to determine the interface pressure from bladder b—in this design inflation source C can be calibrated to provide only the amount of inflation medium needed to press bladder a, as determined by matching the desired interface pressure from bladder B. Other configurations may be employed such that feedback may be obtained from the inflator and the compression device.

Another embodiment of the invention includes sequential gradient compression using a single chamber. In such embodiments (as shown in fig. 6), the therapeutic compression device 200 of the present invention includes an inflatable bladder to apply not only gradient compression, but also sequential compression (first filling channel B, then second filling primary bladder V, or vice versa). In this embodiment (as shown in fig. 6), the inflator a is coupled to the device at two locations (an intake port C and an exhaust port D). By inflating and providing air directly into channel R, channel B is first inflated before primary bladder F. The air is then discharged from the discharge port D. In this design, the inflation may provide the gradient intermittently, and the sequential compression or inflation may be maintained at a constant level to provide only the gradient profile.

The inflator 150 may also include a sensor 155 to measure the air pressure applied in the tube 160. Another embodiment of the invention includes an electric or other automatic inflation device that causes the bladder to be inflated to a set volume or by reading the back pressure it is being filled with. A pressure cycling function may be included. In addition, one embodiment may have an inflation device such that inflation in the bladder is maintained even after removal of the inflation device. Such inflation means may be integral with the compression apparatus itself or may be removable. Such inflation devices may include integrated circuits and/or wireless capabilities for tracking usage, pressure, patient compliance with maintaining certain pressures recommended by a physician or a portion of a treatment plan for such patient, and other health data such as standing pressure and movement or work pressure, pedometer (step count), heartbeat, blood pressure, and any other possible monitoring of the patient. Based on the feedback obtained, the inflatable device may be programmed to increase or decrease pressure without requiring manual patient change. Additionally, the inflation device may be configured such that a physician or other treatment professional may increase or decrease pressure remotely based on feedback. Other combinations may be included, such as a combination of manual changes to a dial or inflation device with an automatic device or an electric or digital device.

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 may help to measure the degree of compactness or fibrosis (tissue scarring) under the skin, which is a result of the deterioration of lymphedema. Such tensiometers may be applied to the patient's skin underneath the therapeutic compression device 200, 300, 500 of the present invention and measure the tightness or fibrosis at such treatment sites on the patient's limb. Such tensiometers may be connected to the inflation device via bluetooth or other digital means and provide feedback to the patient and medical personnel, as discussed above.

As shown in fig. 20-21, the resilient portion 205 is inserted into the opening 204 to facilitate a better anatomical fit when used on an individual. Additional mesh inserts 217 may be placed within other holes or openings 215, wherein the mesh or elastic portion 217 aids in anatomical fit and provides a through area to reduce or prevent overheating and perspiration at the target limb when the therapeutic device 200 of the present invention is wrapped and inflated on a user. Also shown is the elastic portion 226 for the ankle region on the lower leg in those embodiments where the subject limb is the lower leg. The elastic portion 226 facilitates anatomical fit of the thinner ankle portion of the lower leg as compared to the wider upper portion of the lower leg nearer the knee. The additional mesh or elastic insert 217 also aids in anatomical fit over the calf region of the user's 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 embodiment of the therapeutic compression device 200 of the present invention as shown in fig. 1-2, 14-15, and 20-21 includes an integrated foot wrap 250 that includes hook and loop portions 222, 224. In one embodiment, bladder 202 flows into foot enclosure 250 such that the compression is located on the arch and underfoot areas corresponding to the arch of the user's foot, while in other embodiments the bladder is separate such that bladder 202A is separate from one or both additional bladders 202B, 202C, and bladder 202A is inflated from inflation device 150 such that the compression is located on the arch and underfoot areas. In these figures, additional mesh or elastic inserts 217 are not included, but they may be added to the wrap 220, but are not shown here. The illustrated embodiment includes a heel aperture 230 and a resilient ankle portion 226. Another element that assists and reduces perspiration 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 therapy device 200 of the present invention, located on the non-bladder portions of the shackle portions 222, 224 and wrap 220 and within the spot welds 214. The through holes 208, 308, 508 may be located throughout the therapeutic compression device 200, 300, 500 of the present invention to allow ventilation around the legs, thighs, arms, or other body parts or limbs of a patient during long-term wear of the therapeutic compression device 200, 300, 500 of the present invention. For clarity, not all vias are identified with reference numerals in the figures.

Sock or sleeve 110 is elastic and may include compression therethrough, or only a portion may have compression elements, or be non-compression. The elastic sock or sleeve 110 may be constructed of a material such as nylon, wool, cotton, or any other compatible elastic material. The elastic sock or sleeve 110 itself may have a compression feature that is another level of compression coupled with the wrap 200, 220, 300, 500 and/or compression or pressure of the bladder 202 (202 a,202b,202 c), 302 (302 a,302 b), 502 once inflated. In one embodiment as shown in fig. 20-21, the foot portion of the elastic sock or sleeve 110 includes a compression portion 1l2 located around the arch and sole of the foot portion. An optional compression strap (not shown) may be included that may have loop portions and hook portions to secure the compression foot strap together. Other known attachment means for compressing the strap may be included, such as but not limited to VELCRO ^TM, hooks, snaps, adhesive, stitching, buttons, and the like. The elastic sock or sleeve 110 also includes connection means to connect to the therapeutic compression device 200, 300, 500 of the present invention, such as via adhesion, stitching, welding, gluing, snapping, hooks, buttons, velcro ^TM, or any other known connection means. Fig. 20 to 21 show by way of example only the connection means as buttons 113 on the elastic sock or sleeve 110, which can be inserted and fixed in slits 223 on the device 200. The number of connecting means 113 may be at least one, but may be an amount sufficient to connect the elastic sock or sleeve 110 to the wraps 200, 220. The region of the elastic sock or sleeve 110 is connected or joined to a region of the therapeutic compression device 200 of the present invention (shown in fig. 20-21) that is located along the upper calf portion and above the ankle area 226. Other embodiments may include VELCRO ^TM or loop and hook features. Ease of manufacture, cost and use by an individual user may affect the connection means so that it may be a set of buttons, wherein the male portion of button 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 aperture, but it may be any other type of aperture, or if the connection device is a clasp, it will be a combination of female and male portions of the clasp. Other connection means may include snaps, hooks, buckles, straps, zippers, and other combinations of known connection means.

In yet another embodiment of the present invention as shown in fig. 13, the therapeutic compression device of the present invention has two wraps and bladders 202, 302 connected by an elastic knee sleeve 650, such that the device is a full leg device. Also shown is a separate foot therapeutic compression device 500 of the present invention that is connected to the same inflation apparatus 150 as a full leg therapeutic compression device. In this embodiment, a single inflation device may sequentially inflate, hold, deflate, and other combinations for each of the plurality of connected bladders 202, 302, 502. For non-limiting example only, bladder 502 may be inflated and then held, then bladder 202 inflated and then held, then bladder 302 inflated and then held, then bladder 502 deflated for a period of time, then bladder 202 deflated for a period of time, then bladder 302 deflated for a period of time, and then the cycle is repeated for a period of time. This inflation and deflation method and where applicable the holding pressure may be employed in all embodiments shown and not shown.

Further, optional supports may be included on each therapeutic compression device 200, 300, 500 of the present invention to reduce tearing of wrap 220 or hooks 222 when hook portion 222 is pulled from loop portion 224. As shown in fig. 19, 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 may be connectors to strengthen the area between the hook fasteners 224 to prevent tearing of the material as the individual continues to use.

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

Right leg

Left leg

20-30 38 56

30-40 44 72

40-50 54 89

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 may be interpreted as giving the user or clinician a readout (via an interface, a plug-in to a computer or sent to an application) regarding compliance, activity (pedometer for measuring steps, climbing stairs, etc.), and advice/alerts to improve treatment. In one such embodiment with a sensor, the therapeutic compression device 200, 300, 500 of the present invention will be programmed to automatically adjust the type and level of compression applied-for example, as is known in the art, 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 garment. If the sensor senses that the lower leg is not walking and is stationary, the user may be alerted to switch to intermittent compression or may automatically switch to intermittent compression to promote blood flow. In one embodiment, the sensor will be able to measure skin fibrosis and adjust the level of compression required to improve the reduction in swelling. The list of sensors is not limiting and any other known or future developed sensor may be used with the system of the present invention.

The above-described sensors are non-limiting and may be non-digital, or digital devices may be employed. A motorized pump and a digital display may be used. The valve may include digital or electric means to change or modify the pressure at a set rate or interval or based on feedback from the monitoring means. The system may include various sensors and monitors. For example, other sensors may be time-set, if the system is leased, such that once the sensor triggers that the number of lease days or lease hours has expired, the system stops working. In this case, the sensor may be reset if additional lease time is purchased.

Therapeutic compression system 100 of the present invention may be used to treat a patient after surgery, such as after a sclerotherapy procedure. The sclerotherapy post-operative sclerotherapy treatment may also be effective for the thigh therapeutic compression device 300 of the present invention, wherein the lateral bladder is closed via a closure means (shown as weld line 316 in fig. 19) and remains in a non-inflated state, either slightly inflated to a lower pressure level, or inflated to any pressure level desired by the patient. In this embodiment, the intermediate bladder is inflated to apply compression and pressure to the treatment site as part of the post-operative treatment plan. U.S. patent application Ser. No. 16/846211, filed on even date 10 and 4 in 2020, incorporated herein by reference. Other post-operative procedures may employ the same approach. The thigh therapeutic compression device 300 of the present invention has two bladders 302A, 302B with the lateral bladder 302B separated from the medial bladder 302A. The lateral bladder 302B may be inflated to a set pressure level at the time of manufacture or may be non-inflated and remain in an un-inflated state at the time of use. The lateral bladder 302B is connected to the inflatable device 150 via the inflation port 302B and hose 160 (160B or applicable 160C, 160D, 160E or 160F or higher, depending on the total number of individual bladders on the user experiencing sequential compression), and the lateral bladder 302B may have a pressure level that is different from the pressure within the medial bladder 302A. As shown in fig. 19, the lateral bladder 302B may be individually inflatable or inflatable by an inflation device 150 including ports 312A (309A), 311B, such as, but not limited to, a one-way valve or other desired inflation/deflation configuration. The lateral bladder 302B may also be configured and adapted to provide a different pressure than the medial bladder 302A. For example, when employing thigh therapeutic compression device 300 of the present invention after a sclerotherapy procedure, lateral bladder 302B is separate and not connected to the medial bladder, and thus in this embodiment, medial 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 may be applied to the posterior or lateral portion of the user's thigh, as part of the post-operative treatment plan.

Therapeutic compression system 100 of the present invention may be used for other treatments such as tissue swelling, arterial and/or venous ulcers, lymphedema, CVI, DVT, or any other vascular related problem. In use, the therapeutic compression device 200, 300, 500 of the present invention may be placed on and secured around a selected limb (such as, for example, a leg) by a patient, medical practitioner, or caregiver. The patient, practitioner or caregiver secures or secures the fastening tab up or down to the limb as it moves from the knee and/or hip and/or foot up or down position. 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 such that the therapeutic compression device 200 of the present invention fits tightly but is not too tight, and the second strap should be closed or secured in a tight manner such that the therapeutic compression device 200 of the present invention fits tightly but is not too tight. The patient, medical practitioner, or caregiver then removes the valve cap 213 from the valve located on the therapeutic compression device 200 of the present invention, thereby opening the inflation port 212 (212 a,212 b), i.e., the female sliding luer 209. The patient, medical practitioner or caregiver then selects the value of the amount of pressure on the display 157 or dial of the inflator 150 depending on the treatment and whether the patient is walking, sitting, lying down or traveling in a vehicle, train or plane. Once the amount or value of pressure is selected on the dial (such as a given amount of pressure such as "35" mm Hg or text such as "walk" or "air" or "travel" or "low" or "medium" or "high"), the corresponding umbrella valve or switch is activated so that thereafter the pressure is maintained (closed position) or modified to maintain pressure as it varies with activity or altitude in use. The patient, medical practitioner, or caregiver then inserts an end of the tube 160 portion, such as male luer slip 161, into the inflation port 212 on the therapeutic compression device 200 of the present invention, presses the switch button 149 of the inflation device 150 or uses the hand pump 165, and increases the air or fluid to inflate the bladder 202 and thereby achieve the desired amount of pressure or pressure valve. Also, the inflation device may be a hand pump, an electric pump, a battery-operated pump, a remote pump, an air pump, or any other known inflation device. Many or more inflation devices may be employed, such as manual pumps, hand pumps, foot pumps, mechanical pumps, electric pumps, battery-driven pumps, static pumps, intermittent pumps, variable speed pumps, automatic pumps, pneumatic pumps, negative pressure pumps, suction or vacuum pulse pumps, or any other known or developed inflation source to provide a certain pressure within the bladder to provide compression when used by a patient. According to inflation, devices employing such inflatable devices may be removed and the bonnet replaced, and the pressure will not drop unless noted in the "air" or "walk" position. At any point in use, the patient, medical practitioner or caregiver may deflate the bladder by inserting the valve cap to depress the valve spring and thereby release the air or fluid in the bladder and decrease the pressure, or the patient, medical practitioner or caregiver may reinsert the inflation device and select "deflate" or "release", and the corresponding umbrella valve will be in an open position to release the air or fluid in the bladder and decrease the pressure until the bladder and therapeutic compression device of the present invention reach a deflated state. the therapeutic compression device of the present invention may be re-inflated and deflated and may be used repeatedly. The therapeutic compression device 200, 300, 500 of the present invention has an SSI of at least about 10 or greater when inflated.

The method of using the system of the present invention is also depicted in fig. 7A and 8A through 8K. The invention has been illustrated and described with respect to specific embodiments thereof. 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 foregoing embodiments. Therapeutic compression device 200 is described as having an inflatable bladder, but therapeutic compression device 200 may additionally include compression members that are not configured for integral formation or attachment (e.g., by adhesive, radio frequency welding, etc.) for inflation and/or deflation. For example, additional compression members, such as foam cushions and/or air, gel, or other fluid-filled non-inflatable cushions, may be implemented using any of a variety of preformed and/or pre-filled cushioning materials, provided that such compression members in combination with the integral compression bladder produce sufficient compression. Further, although specific shapes, dimensions, and materials are described for illustrative purposes, it should be understood that any of a variety of shapes or dimensions may be used, and that the materials are not exclusive, but merely exemplary. Moreover, as described above, while the bladder is shown inflated with air, it should be understood that any other fluid or medium may be used, such as a liquid or gel. Further, it should also be noted that the bladder may be configured with a plurality of pneumatically independent and/or pneumatically coupled bladder portions, and may also be configured with various contours or lobes.

Therapeutic compression system 100 of the present invention described herein may be used for any suitable condition treatable by compression therapy or the like. For example, the inventive system including therapeutic compression device 200 according to the present invention may be used to compress the venous system to treat swelling, venous and arterial ulcers, CVI, DVT, to treat lymphedema (where it promotes fluid circulation in the lymphatic system rather than in the venous system), and the like. Notably, having a non-elastic portion of SSI greater than about 10 facilitates this 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.

As shown in fig. 2, the method of use may include two or three therapeutic compression devices connected to one inflatable device. In this example, thigh therapeutic compression device 300 and two lower leg therapeutic compression devices 200 are each individually connected to an inflatable means via two tubes or hoses, each tube being connected at one end to the therapeutic compression device and at the other end to the inflatable means. The method includes wherein (1) the thigh therapeutic compression device of the present invention is placed over the thigh area with the elastic portion 317 along the groin area and the lower leg therapeutic compression device 200 of the present invention is placed over the lower leg with the elastic portion 204 along the upper portion of the lower leg area below the knee and each secured to the limb with shackles 322, 324, 222, 224, (2) the lower leg therapeutic compression device 200 is first inflated and maintained at a determined pressure level, then (3) the thigh therapeutic compression device 300 is inflated and maintained at a determined pressure level, then (4) the thigh therapeutic compression device 300 is completely deflated or only deflated to a lower pressure level, and thereafter (5) the lower leg therapeutic compression device 200 is completely deflated or only deflated to a lower pressure level. In this example, the pressure level may be a constant static state or an intermittent varying pressure state. Further, in this example, the pressure levels may be the same or different, or the line pressures may be the same, but the interface pressure may be adjusted using the shape of each of these bladders (whether spot and/or line welded or combined to form a gradient pressure profile).

In an alternative method (not shown), after inflation steps (1) and (2), (3) the thigh therapeutic compression device 300 is completely deflated or deflated only to a lower pressure level, and thereafter (4) the one or both lower leg therapeutic compression devices 200 are completely deflated or deflated only to a lower pressure level. In yet another alternative method (not shown), after inflation steps (1) and (2), then (3) deflating lower leg therapeutic compression device 200 completely or only to a lower pressure level, and thereafter (4) deflating thigh therapeutic compression device 300 completely or only to a lower pressure level. In all of these examples of fig. 2 and 7A-7D, the pressure level may be a constant static state or an intermittent varying pressure state. Further, in this example, the pressure levels may be the same or different, or the line pressures may be the same, but the interface pressure may be adjusted using the shape of each of these bladders (whether spot and/or line welded or combined to form a gradient pressure profile). Finally, the order of the first inflation may be reversed, wherein the tube from the inflation device may be connected to the thigh therapeutic compression device 300, then the tube connects the thigh therapeutic compression device 300 and the lower leg therapeutic compression device 200, such that the thigh therapeutic compression device 300 is inflated first, followed by the lower leg therapeutic compression device 200, then the lower leg therapeutic compression device 200 is deflated (partially or completely), followed by the 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 thigh therapeutic compression device 300 or any other combination of lower leg therapeutic compression device 200 and another limb therapeutic compression device.

In an alternative method (not shown), after inflation steps (1) and (2), (3) the thigh therapeutic compression device 300 of the invention is completely deflated or deflated only to a lower pressure level, and thereafter (4) the lower leg therapeutic compression device 200 of one or both of the invention is completely deflated or deflated only to a lower pressure level. In yet another alternative method (not shown), after inflation steps (1) and (2), then (3) fully deflating or deflating only the lower leg therapeutic compression device 200 of the present invention to a lower pressure level, and thereafter (4) fully deflating or deflating only the thigh therapeutic compression device 300 of the present invention to a lower pressure level. In all of these examples of fig. 2 and 7A-7D, the pressure level may be a constant static state or an intermittent varying pressure state. Further, in this example, the pressure levels may be the same or different, or the line pressures may be the same, but the interface pressure may be adjusted using the shape of each of these bladders (whether spot and/or line welded or combined to form a gradient pressure profile). Finally, the order of the first inflation may be reversed, wherein the tube from the inflation device may be connected to the inventive thigh therapeutic compression device 300, then the tube connects the inventive thigh therapeutic compression device 300 and the inventive lower leg therapeutic compression device 200, such that the inventive thigh therapeutic compression device 300 is inflated first, followed by the inventive lower leg therapeutic compression device 200, then the inventive lower leg therapeutic compression device 200 is deflated (partially or completely), followed by the deflation of the inventive thigh therapeutic compression device 300. 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 thigh therapeutic compression device 300 of the present invention or any other combination of lower leg therapeutic compression device 200 of the present invention and another limb therapeutic compression device of the present invention.

As shown in another embodiment of the method of use, there is included an inflatable device, a tube or hose connected to the inflatable device and the first therapeutic compression apparatus of the present invention (in this case, the lower leg therapeutic compression apparatus 200 of the present invention), a second tube connected to the first therapeutic compression apparatus of the present invention, the second therapeutic compression apparatus of the present invention and the third therapeutic compression apparatus of the present invention (in this case, the third therapeutic compression apparatus 300 of the present invention), and a tube or hose connected to the inflatable device and the exhaust port in the second therapeutic compression apparatus of the present invention (in this case, the thigh therapeutic compression apparatus 300 of the present invention). In this example, the inventive thigh therapeutic compression device 300 and the inventive lower leg therapeutic compression device 200 are connected to one another via a tube or hose, and one inventive therapeutic compression device (in this case, the inventive lower leg therapeutic compression device 200) is connected to an inflatable means via a separate second tube or hose, and a third tube or hose connects the inventive second therapeutic compression device (in this case, the inventive thigh therapeutic compression device 300) to an inflatable means or an exhaust port. The method as shown in fig. 7A-7C includes wherein (1) the inventive lower leg therapeutic compression device 200 is first inflated and maintained at a determined pressure level, then (2) the inventive thigh therapeutic compression device 300 is inflated and maintained at a determined pressure level, the inflation being applied via a tube or hose connecting the inventive thigh therapeutic compression device 300 and the inventive lower leg therapeutic compression device 200, then (3) the inventive thigh therapeutic compression device 300 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 inventive lower leg therapeutic compression device 200 is deflated (completely or only to a lower pressure level). In an alternative method (not shown), after inflation steps (I) and (2), then (3) fully deflating or deflating only the lower leg therapeutic compression device 200 of the present invention to a lower pressure level, and thereafter (4) fully deflating or deflating only the thigh therapeutic compression device of the present invention to a lower pressure level. In yet another alternative method (not shown), after inflation steps (1) and (2), then (3) deflating both the lower leg therapeutic compression device 200 of the invention and the thigh therapeutic compression device 300 of the invention simultaneously, either completely or only to a lower pressure level. While in this example of a method of use, the second inventive therapeutic compression device is connected to an exhaust port or release port in an inflatable apparatus, other embodiments may employ an exhaust port or release port that is integral with the inventive therapeutic compression device itself, such as being part of or in the vicinity of the inflation ports 212, 312 in the inventive therapeutic compression devices 200, 300. In all of these examples of fig. 7A-7C, the pressure level may be a constant static state or an intermittent varying pressure state. Further, in this example, the pressure levels may be the same or different, or the line pressures may be the same, but the interface pressure may be adjusted using the shape of each of these bladders (whether spot and/or line welded or combined to form a gradient pressure profile). Finally, the order of the first inflation may be reversed, wherein the tube from the inflation device may be connected to the inventive thigh therapeutic compression device 300, then the tube connects the inventive thigh therapeutic compression device 300 and the inventive lower leg therapeutic compression device 200, such that the inventive thigh therapeutic compression device 300 is inflated first, followed by the inventive lower leg therapeutic compression device 300, then the inventive lower leg therapeutic compression device 200 is deflated (partially or completely), followed by the deflation of the inventive thigh therapeutic compression device 300. 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 thigh therapeutic compression device 300 of the present invention or any other combination of lower leg therapeutic compression device 200 of the present invention and another limb therapeutic compression device of the present invention.

As shown in fig. 8A-8K, a method of using the therapeutic system 100 of the present invention is shown in one embodiment, wherein a 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, attaches the buttons 113 on the sock or sleeve 110 into the holes 223, and ensures that the elastic portion 204 fits tightly and conforms to the area under the knee on the back of the leg, then attaches the upper portions of the shackles 222, 224, followed by the foot portions 222, 224, and then the middle of the lower legs 222, 224. The user checks to ensure that there is room for inflation and gradient compression, such as placing two fingers between sock 110 and therapeutic compression device 220. The user then selects the inflation device 150 of either the power pump 165 or the manual hand pump 400. If a manual pump is selected, the user selects a pressure range on dial 410, inserts male sliding luer 161 into inflation port 212, specifically female luer 209, then pumps bulb 420 until the therapeutic compression device is inflated, then removes male sliding luer 161, which triggers valve 290 to move in an upward direction and seal bladder 202. If pump 156 is selected in this embodiment, the user wears the securement device for strap 180, adjusts it using adjuster 182, and then fastens it using 185A, 185B. The user then opens cap 211 and inserts male luer slip 161 into inflation port 212, specifically female luer 209, then presses pump 156, possibly selecting a set amount of pressure (static or intermittent), and once the therapeutic compression device is inflated, removes male luer slip 161, which triggers valve 290 to move in an upward direction and seal bladder 202. In both cases, the user may place cap 211 on top of female sliding luer 209 to further seal bladder 202. To deflate, the user may then remove cap 211, invert it and push the stem into female sliding luer 209 to release the seal and deflate bladder 202, which the user may also deflate using hand pump dial 410 or set pump 156 down or to a deflate position on pump 156. Other methods of inflation and deflation may also be employed. When inflated, the therapeutic compression device 200 of the present invention has an SSI of at least about 10 or greater and the resilient portion 204 conforms to the anatomy of the knee such 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 region of the lower leg so as to eliminate gaps at that anatomical region 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, and improve circulation at the user's foot and lower and upper legs.

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 in order 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 to improve and treat circulatory diseases or problems in the foot, lower leg and thigh, and other body parts (such as the wrist, arm, torso, shoulder) and any other target areas of the patient or user. For example, the therapeutic compression device may be used on the foot, ankle, calf, lower leg, knee, thigh, groin, hip, buttock, torso, stomach, back, shoulder, chest, arm, elbow, wrist, hand, neck, head, and the like, as well as any combination thereof. The inventive system of the present invention described herein solves many problems in the prior art as well as in the patient's industry and treatment. Therapeutic compression device 200, 300, 500 may be applied by a patient to a body part of the patient without the need or requirement of a skilled caregiver as required by current apparatus and devices. It also maintains sufficient effective pressure without overpressure complications, maintains compression and pressure, and the like.

The therapeutic compression device 200, 300, 400 of the present invention of therapeutic compression system 100 includes a universal inflation port configured to be connectable to more than one compression or inflation device source such that a patient may vary treatment by varying the inflation source and inflation device for the therapeutic device or apparatus. For example, a patient using the therapeutic compression device 200, 300, 500 of the present invention may alternate between manual or mechanical or electrical inflation means or inflation sources and pressures. Furthermore, when using the system and inflatable device 150 pump of the present invention, the patient may alternate between static or intermittent inflation and pressure.

The therapeutic compression system 100 of the present invention also reduces the problem of lack of mobility because the inflation device is not integral with the therapeutic compression apparatus of the present invention, rather the patient can walk and perform work, learning, and entertainment activities. The system 100 of the present invention includes an inflator that is not tethered to a wall outlet, but rather is a main pump that is configured to apply a constant static pressure at one pressure level, or to remain constant at a static pressure at a selection of different pressure levels, or to apply intermittent pressure at one level, or to apply intermittent pressure at multiple pressure levels, or to apply selected 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 circulation and reduction, arterial and venous ulcers and other treatments.

Another embodiment (not shown) may include various sensors so that the pump itself can adjust the pressure level or switch from intermittent pressure level (when the patient is sitting or leg is raised) to constant static pressure (when the patient is walking or running). Such sensors may be connected to a database accessible by the medical provider that can remotely adjust pressure levels or state changes from intermittent to constant or vice versa.

The system 100 of the present invention may be used as part of a prevention or treatment plan that is easy for a patient to use at home or in a workplace (outside a hospital environment or by means of a medical trained professional as described above), that is mobile so that the patient can walk and return to life activities. The system of the present invention can be used as a prophylactic for swelling of any body part. The system may also be used for pre-and post-operative treatment for many different procedures including, but not limited to, knee surgery, hip surgery, TKR, KRA, n-m, HRA, sclerotherapy, and many other surgical procedures with respect to other limbs or body parts that may have increased risk of CVI and/or DVT. The system 100 of the present invention may be used to prevent, reduce or even treat DVT, and is practical, mobile and easy to administer by a patient after total knee replacement, hip or leg surgery of any other knee. Furthermore, the system of the present invention can also be used for HPIC therapy and can be easily administered by a patient in a home environment as well as in a rehabilitation or nursing home environment, as it allows the patient to be ambulatory.

The system of the present invention includes an inflatable device that is smaller than known systems. The user is thus able to return to life activities faster than known compression systems, prophylaxis systems and other therapeutic systems that limit the user's walking in the home and outdoors due to power constraints on the system (electric, mechanical, battery, manual, etc.). In addition, the system of the present invention may include one or more sensors, sphygmomanometer sensors, GPS sensors, etc. that measure the pressure of the user's limb on the skin, movement of the limb, while the system is in use. Such sensors may be connected to the inflator to regulate pressure from the inflator and increase or decrease the current pressure level. Such sensors may also be connected to a database and may be accessible in real time or stored over time by a medical professional and/or user.

Additionally, the system includes multiple pieces of compression clothing, where each therapeutic compression device of the present invention may have a single applied pressure level at the same time, or may vary over time and based on the activity of the user, and individual bladders 202A, 202B, 202C, 302A, 302B, 502 may have a single applied pressure level at the same time, or may vary over time and based on the activity of the user.

In addition, therapeutic compression system 100 of the present invention includes a plurality of compression devices 200, 300, 500, wherein each of the therapeutic compression devices 200, 300, 500 may have a single applied pressure level at the same time, or may vary over time and based on the activity of the user. Notably, the therapeutic compression device 200, 300, 500 of the present invention has an SSI of at least about 10 or greater for the inelastic portion (whether including a bladder or no bladder), while the elastic portion conforms to the anatomy of the user, thereby reducing or eliminating gaps or openings between the limb and the therapeutic compression device 200, 300, 500 of the present invention (which would reduce 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 region of the lower leg). The therapeutic compression device 200, 300, 500 of the present invention including the elastic portion reduces or eliminates gaps at the anatomical region (such as ankle, foot, knee, groin, hip, wrist, elbow, shoulder, sacrum, neck, and other regions along the target limb), and thus the therapeutic compression device 200, 300, 500 of the present invention may help treat, reduce, and even prevent tissue swelling, lymphedema, venous and arterial ulcers, CVI, and DVT, as well as improve circulation at 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 an inelastic 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 a target body area (such as a foot, ankle, knee, groin, hip, wrist, elbow, shoulder, torso, sacrum, neck, and any other body part).

The therapeutic compression device 200, 300, 500 of the present invention may have a set level of pressure or compression, such as shown in fig. 9-10 and 13, or may employ gradient compression as shown in fig. 1-2, 11, 14-15, and 20-21, which is particularly effective by applying more pressure distally (farther centrifugal) relative to the heart and decreasing pressure proximally (closer to the heart). This helps to squeeze the body in a manner that helps to stimulate the circulation and reduce the size of the limb, such as on the foot, calf, lower leg and thigh areas. The therapeutic compression device 200, 300, 500 of the present invention (whether set or gradient compression) helps reduce tissue swelling and water volume within the limb during use to manage the amount of leg swelling. And improving circulation of blood and fluid, particularly when the user walks around, the compression circulatory system is better contacted with the muscles (e.g., calf and lower leg compression) due to compression to improve fluid movement efficacy of the body. The therapeutic compression device 200, 300, 500 of the present invention is more effective than known compression stockings, socks, bandages, and even devices because it applies compression and a static stiffness index of at least greater than 10 to improve venous hemodynamics and reduce edema due to (without being bound by theory) the potential stiffness and elasticity of the therapeutic compression device 200, 300, 500 of the present invention. It overcomes many of the disadvantages of known and conventional compression products.

Furthermore, the therapeutic compression device 200, 300, 500 of the present invention overcomes the problems of known and conventional compression products that do not have sequential inflation and deflation, thereby reducing the dynamic compression effects, but rather, the therapeutic compression device 200, 300, 500 of the present invention includes sequential compression by inflating and deflating the bladders 202 (202 a,202b,202 c), 302 (302 a,302 b), 502. The therapeutic compression device 200, 300, 500 of the present invention addresses 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.

While the subject invention has been described with respect to preferred and exemplary embodiments, those skilled in the art will readily appreciate 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 illustrated herein and specific embodiments of the present invention have been described, it is not intended that the invention be limited thereto, as the scope of the invention is intended to be as broad as the art will allow and the specification is to be read likewise. Thus, while particular shapes and sizes of inflatable bladders and straps have been disclosed, it should be understood that other shapes, sizes, and attachment means may be used. Accordingly, it will be appreciated 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 configured to be connectable to a static or intermittent inflation device;

A connection device from each universal inflation port to the inflation device, the connection device having a distal end and a proximal end, wherein an insertion portion on the distal end is configured to be inserted into a hole in a manifold on the inflation device, and

At least one sensor configured to inflate, hold, or deflate each of the bladders at a selected pressure level or time period,

Wherein the universal inflation port comprises a sealing device configured to comprise an open position and a closed position, wherein the closed position maintains the at least one bladder in an inflated or deflated state, and when coupled to the inflation device, the sealing device is in the open position such that the at least one bladder is in the same inflated state as the inflation device.

2. A therapeutic compression system according to claim 1, wherein the at least one wrap is configured to be secured to the user's foot, lower leg, or thigh.

3. A therapeutic compression system according to claim 1, wherein one bladder is capable of inflation or deflation at a different time than the second bladder.

4. A therapeutic compression system according to 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. A therapeutic compression system according to claim 1, further comprising a second wrapper 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. A therapeutic compression system according to claim 5, wherein the first wrapper and the second wrapper are not connected to each other when connected to the same inflation device, and wherein the second wrapper has an inflation pressure that is the same as or different from an inflation pressure of the first wrapper when both the first wrapper and the second wrapper are inflated by the same inflation device.

7. A therapeutic compression device according to claim 1, further comprising an elastic sleeve placed over the limb of the user under the at least one wrap.

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

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

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

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

12. A therapeutic compression system according to claim 1, wherein the at least one wrap is configured to be secured on the lower leg of a user and further comprising a resilient portion configured to be placed on the lower leg of a user.

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

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

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

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

17. A therapeutic compression system according to claim 1, wherein the inflation device is selected from the group consisting of a manual pump, a static pump, an intermittent pump, an electric inflator, a battery inflator, a pneumatic inflator, 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. A therapeutic compression system according to 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. A therapeutic compression system according to claim 1, wherein the inflation 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. A therapeutic compression system according to claim 1, wherein the sealing device is selected from the group consisting of a valve, cap, lever, switch, screw, shut-off valve, stopcock, or combination thereof, and the inflation port is a self-sealing inflation port configured to prevent deflation of the at least one bladder and comprises a check valve.

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

22.A therapeutic compression system according to claim 1, wherein the wrap is configured 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 portion of a human body, the method comprising:

Placing a therapeutic compression device on a body part of a user, the therapeutic compression device comprising at least one wrap having

(A) At least two airbags connected to the inflator,

(B) At least two universal inflation ports connected to each bladder, the at least two universal inflation ports having a sealing device configured to include (i) an open position and a closed position, wherein the closed position maintains the bladder in an inflated or deflated state, and when coupled to the inflation device, the sealing device is in the open position such that the bladder is in the same inflated state as the inflation device, (2) an elbow, a check valve, and a bonnet, wherein the bonnet is capable of releasing pressure generated within the at least one bladder by the inflation device, (iii) a connection device from the universal inflation ports to the inflation device,

(C) A connection device from the universal inflation port to the inflation device, the connection device having a distal end and a proximal end, wherein an insertion portion 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, hold, or deflate each of the bladders at a selected pressure level or time period;

inserting the connection device into one of the universal inflation ports on the proximal end and into the manifold on the distal end;

activating the inflator and the sensor at a selected pressure level;

inflating the first bladder and then inflating the second bladder for a period of time;

deflating the first bladder and then deflating the second bladder for a period of time;

Repeating said inflating and deflating steps of said method by said final step inflating;

Removing said connecting means from said universal inflation port and activating said sealing means on said universal inflation port, and

After wearing the wrap for a period of time, deflating the at least one bladder by opening the sealing means and releasing pressure within the at least one bladder.