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EP4618929A1 - Appareil de compression thérapeutique à plusieurs vessies, système et procédés d'utilisation - Google Patents

Appareil de compression thérapeutique à plusieurs vessies, système et procédés d'utilisation

Info

Publication number
EP4618929A1
EP4618929A1 EP23892494.8A EP23892494A EP4618929A1 EP 4618929 A1 EP4618929 A1 EP 4618929A1 EP 23892494 A EP23892494 A EP 23892494A EP 4618929 A1 EP4618929 A1 EP 4618929A1
Authority
EP
European Patent Office
Prior art keywords
inflation
bladder
pressure
therapeutic compression
compression
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP23892494.8A
Other languages
German (de)
English (en)
Inventor
Sundaram Ravikumar
Vikram Ravikumar
Guy Osborne
Allan Alward
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sun Scientific Inc
Original Assignee
Sun Scientific Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sun Scientific Inc filed Critical Sun Scientific Inc
Publication of EP4618929A1 publication Critical patent/EP4618929A1/fr
Pending legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H9/00—Pneumatic or hydraulic massage
    • A61H9/005—Pneumatic massage
    • A61H9/0078—Pneumatic massage with intermittent or alternately inflated bladders or cuffs
    • A61H9/0092—Cuffs therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/16—Physical interface with patient
    • A61H2201/1602—Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support
    • A61H2201/164—Feet or leg, e.g. pedal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/16—Physical interface with patient
    • A61H2201/1602—Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support
    • A61H2201/165—Wearable interfaces
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
    • A61H2201/5002—Means for controlling a set of similar massage devices acting in sequence at different locations on a patient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
    • A61H2201/5058—Sensors or detectors
    • A61H2201/5071—Pressure sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2205/00—Devices for specific parts of the body
    • A61H2205/10—Leg
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2205/00—Devices for specific parts of the body
    • A61H2205/10—Leg
    • A61H2205/106—Leg for the lower legs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2205/00—Devices for specific parts of the body
    • A61H2205/12—Feet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2209/00—Devices for avoiding blood stagnation, e.g. Deep Vein Thrombosis [DVT] devices

Definitions

  • the subject invention is directed generally to a system for applying compression to one or more limbs at the same time, and more particularly, to a system for applying compression to the leg and/or foot and/or thigh of an individual in conjunction with the treatment of conditions such as deep vein thrombosis (DVT), chronic venous insufficiency (CVI), lymphedema, and swelling.
  • DVD deep vein thrombosis
  • CVI chronic venous insufficiency
  • lymphedema lymphedema
  • swelling such as lymphedema, and swelling.
  • the system includes at least one inventive therapeutic compression apparatus, such as a wrap having more than one bladder and an inflation means for the bladders with the apparatus capable of applying compression to a limb such as the full leg, thigh, calf, knee, and/or foot of a patient, and a port connected to the inflation means wherein the bladders are inflated at the same time, with the same or different pressure levels, or sequentially.
  • inventive therapeutic compression apparatus such as a wrap having more than one bladder and an inflation means for the bladders with the apparatus capable of applying compression to a limb such as the full leg, thigh, calf, knee, and/or foot of a patient, and a port connected to the inflation means wherein the bladders are inflated at the same time, with the same or different pressure levels, or sequentially.
  • a healthy muscle for example, a healthy leg muscle squeezes the deep veins of the legs and feet to help move blood back to the heart.
  • One-way valves in the deep leg veins keep blood flowing back towards the heart.
  • prolonged periods of standing or sitting can cause the walls of the deep leg veins to stretch. Over time, in susceptible individuals, this can weaken the vein walls and damage the valves, causing blood to pool in the veins and increase venous blood pressure. This may result in a condition known as chronic venous insufficiency (CVI).
  • CVI chronic venous insufficiency
  • compression stockings are elastic stockings that squeeze the veins to improve venous circulation and prevent.excess blood from flowing backward. Compression stockings can also help to heal skin sores or stasis ulcers that often present in conjunction with CVI. It is also common to employ compression bandages to apply pressure to the leg. In this regard, a
  • SUBSTITUTE SHEET (RULE 26) bandage is applied with constant tension so as to produce graduated compression with the highest pressure at the ankle and less pressure or compression at the knee or thigh area due to the anatomy of the leg.
  • the technique is difficult and is often done by highly skilled caregivers.
  • While these devices are effective for applying localized compression to the leg, they are not configured to apply localized compression to the calf, thigh of a user or the foot to reduce, treat or prevent swelling and to further improve venous circulation to the calf, thigh, foot or whole leg.
  • Lymphedema also known as lymphatic obstruction, is another condition of localized fluid retention and tissue swelling and is caused by a compromised lymphatic system. Treatment for lymphedema varies depending on the severity of the edema and the degree of fibrosis of the affected limb. The most common treatments for lymphedema are manual compression lymphatic massage, compression garments or bandaging. Elastic compression garments are typically worn by persons with lymphedema on the affected limb following complete decongestive therapy to maintain edema reduction.
  • Compression bandaging also called wrapping, involves the application of several layers of padding and short-stretch bandages to the involved areas.
  • Short-stretch bandages are preferred over long- stretch bandages (such as those normally used to treat sprains), as the long-stretch bandages cannot produce the proper therapeutic tension necessary to safely reduce lymphedema and may in fact end up producing a tourniquet effect.
  • the short-stretch bandages enhance the pumping action of the lymph vessels by providing increased resistance for them to push against. This encourages lymphatic flow and helps to soften fluid-swollen areas.
  • CVI and lymphedema may also result in DVT, which is an affliction that causes blood clots particularly in the lower extremities of the legs.
  • DVT is an affliction that causes blood clots particularly in the lower extremities of the legs.
  • the patient faces an elevated risk factor of creating a blood clot.
  • These blood clots which often accumulate or reside in the patient's calf or thigh, are not, in and of themselves, overly dangerous.
  • the blood clot breaks loose, they create a pulmonary embolism which can get lodged in the patient's heart, brain or lungs where it can cause significant damage or death.
  • a system and apparatus and method of use to prevent, reduce and/or treat DVT is needed which is easy to use by the patient at home, ambulatory in that the patient can work and walk about both inside and outside of the home, and less cumbersome than current known DVT systems.
  • the number of Americans who suffer from DVT may be affected or have an increased risk based on (a) recent surgery, which decreases a patient's mobility and increases inflammation in the body, which can lead to clotting; (b) medical conditions that limit mobility, such as an injury or stroke; (c) long periods of travel, which limit mobility; (d) injury to a deep vein; (e) inherited blood disorders that increase clotting; (f) pregnancy; (g) cancer treatment; (h) smoking; (i) obesity; and (j) many other conditions.
  • a system and apparatus and method of use to treat DVT is needed.
  • ulcers or wounds on the lower leg including the foot are typically hard to treat due to the structure of the lower leg and foot and fact that the foot is moved and under pressure when walking.
  • Conventional compression bandages, and even non-compression bandages do not adhere to the foot, either on the top of the arch or below on the sole of the foot.
  • the foot area may become hot and moist contributing to lack of adhesion yet a diabetic foot may be extremely dry and the adhesive must be chosen not to irritate or affect the dry skin of the diabetic individual.
  • the structure of the foot is also problematic in keeping a bandage or wound dressing in place and adhered to the foot.
  • leg ulcers such as diabetic ulcers may form on the bottom or under 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 ankles and heels of the foot.
  • Diabetics may have more foot ulcers sometimes related to a complication called neuropathy that causes the individual to lose feeling in his/her/their feet.
  • a scrape, cut or puncture in the skin can turn into an ulcer, but the individual might not know if s there if they have neuropathy and do not feel the wound or pain from the wound. Ulcers can lead to infections and in extreme cases the infection will not heal resulting in partial amputation of the individual’s foot or toe(s).
  • foot and toe ulcers can happen to many people but might be more common in Black, Native American and Hispanic people. If the individual has an eye, kidney or heart disease related to diabetes, they are also at a higher risk. Of those about 15% of people with diabetes with an ulcer, the ulcer is typically on the bottom of their foot. Some of those people will be hospitalized because of complications.
  • the veins of the leg are divided into the superficial and deep systems according to their position relative to the fascia.
  • the deep veins which come together to form the popliteal and femoral veins lie within the fascia and are responsible for the venous return from the leg muscles.
  • Dilated valveless sinusoids also lie within the fascia (more particularly in the soleus and gastrocnemius muscles). The sinusoids fill with blood when the leg is at rest.
  • the pneumatic control system may also produce cuffing (i.e., a reduction in leg pulsatile blood flow).
  • the pneumatic control system is also bulky and heavy, which severely limits the mobility of the patient during treatment.
  • the pneumatic control system fails to provide a mechanism to ensure that excessive pressure, which can cause necrosis, is not applied to the treated limb.
  • inventive therapeutic compression apparatus While the patient is in the hospital, he or she may be connected to an electrical powered pump in combination with an inventive therapeutic compression apparatus, however, once discharged, the current products are limited as noted herein, whereby most inventive therapeutic compression apparatus are manual pumped so the patient can walk, work, etc. and those that are electric powered typically require being tethered to an electric outlet or the electric pump is integral to the inventive therapeutic compression apparatus and not practical to walk about in life.
  • Co-owned U.S. Pat. No. 7,276,037 which is hereby incorporated by reference herein in its entirety, discloses an apparatus for applying compression therapy to an extremity of the human body, such as a portion of the human leg.
  • the device includes a flexible member and an air bladder chamber.
  • the flexible member is adapted to wrap around the extremity to secure the air bladder chamber to the extremity.
  • An air pumping mechanism is operated to inflate the air bladder chamber to a pressurized state.
  • One or more fluid-filled pressurized members are provided, each separate and distinct from the flexible member and the air bladder chamber and thus readily moveable relative to the flexible member and the air bladder chamber.
  • the pressurized member(s) is operably disposed between the extremity and the flexible member whereby it applies increased localized pressure to the extremity during use.
  • the air bladder chamber is substantially longer in a first dimension than in a second dimension orthogonal thereto such that it can extend longitudinally along the extremity to cover a relatively long and narrow portion of the extremity.
  • the position of the air chamber can be readily adapted to apply local pressure to desired body parts (such as a certain venous channel).
  • the pressurized member(s) can be positioned during use such that it covers a venous ulcer (or other treatment sites) and applies increased localized pressure to the treatment site in order to promote healing.
  • the Static Stiffness Index which is the difference between standing and resting pressure, is a valuable parameter characterizing the efficacy of a specific compression product to narrow/occlude the venous lumen. This is a prerequisite for reducing venous reflux and exerting a massaging effect necessary to improve the venous pumping function during movement. Anything above 10 SSI is considered “inelastic”. Most if not all current inventive therapeutic compression apparatus have a SSI or about 2-12, with the inelastic apparatus having a SSI of about 10-12. A need exists for a therapeutic compression apparatus with a SSI of at least 10 and above. The higher the SSI then the better the compression at the target limb site. Higher SSI means the level of compression is comfortable relatively speaking vascular push and not constricting blood if higher SSI.
  • a need further exists for a therapeutic compression apparatus which also includes multiple inflatable bladders that can be sequentially inflated and deflated such as intermittent compression and/or can be inflated at different levels of pressure and compression.
  • Sequential compression or having multiple bladders with different compression or pressure levels would be beneficial for patients having sclerotherapy which is a medical procedure used to eliminate varicose veins and spider veins. Sclerotherapy typically involves an injection of a solution (generally a salt solution) directly into the vein. The solution initiates the lining of the blood vessel, causing it to collapse and stick together and the blood to clot. Post-operative procedures may require compression bandaging or stockings, both of which have the problems described above in regard to static compression over the target limb area.
  • the known compression devices may include an inflation means capable of providing constant static pressure for a period of time as well as providing intermittent varying pressure for a period of time, but the currently known devices are bulky as the inflation means or pump is an integral part of the wrap mechanism.
  • Such known compression devices are limiting as the patient cannot walk or function in work, school or otherwise wearing bulky leg, foot, thigh or other limb wrap.
  • certain known compression devices only allow for varying intermittent pressure if directly connected to an electrical power source, thereby further limiting the use by the patient as he or she is literally tethered to a wall outlet.
  • known compression devices or apparatus lack a check valve to prevent both over-inflation and to also seal and prevent deflation while the user engages in activities or rests in place.
  • a need exists for a therapeutic compression system including a compression apparatus having multiple bladders sequentially inflated and deflated or inflated to different compression or pressure levels and having an integrated valve to maintain the level of compression and prevent deflation of a bladder, and preferably a self-sealing valve.
  • sequential compression may assist in therapies for lymphedema, CVT, CVI, DVT and the like.
  • Having multiple bladders within a compression apparatus is known but a need exists for a streamlined inflation means to feed each bladder and a controlling mechanism so that each bladder is inflated sequentially.
  • each of the separate bladders has a SSI of at least about 12 or greater.
  • the user could interchange between an intermittent pneumatic pressure pump, for instance when seated, and then change to a set pressure pump for instance when walking.
  • the user could connect to a hand pump, an electrical pump, a mechanical pump and any other type of conventional or inventive pumps without any additional converted needed.
  • the various types of pumps are not limited to the two listed above but could be any type of pump with a universal connector.
  • the inflation means is also configured to provide constant static pressure for a period of time as well as varying intermittent pressure for a period of time and to alternate between such pressure settings.
  • sensors may be connected to the inflation means so as to regulate the pressure from the inflation means and either increase or decrease the current pressure level(s).
  • sensors may also be connected to a database and possibly accessible to a medical professional and/or the user in real time or as saved over time.
  • a thigh compression garment could be used in conjunction with a lower leg compression apparatus such as that described (and incorporated herein as reference) in U.S.
  • All current known treatment apparatus, devices, bandages, stockings and hosiery have the problems of stability (no slippage), maintaining sufficient effective pressure without overpressure complications, maintaining compression and the like. Further all known apparatus, devices, bandages, stockings and hosiery, though especially the current treatment inelastic apparatus and devices are only capable of a SSI of no higher than about 10-12 so that a need exists for a therapeutic compression apparatus having a SSI of above about 10, preferably about 15-25.
  • the subject invention provides an alternative to known technologies that employ tight-fitting therapeutic elastic garments, which cause patients discomfort and are bulky and impractical to wear in daily life, and lose their elasticity as well as have slippage down the leg, and therefore their effectiveness over time as well as inelastic garments and apparatus with a SSI of less than about 10- 12.
  • a therapeutic compression device and system for treating CVI, DVT, lymphedema and tissue swelling that is adapted and configured to apply localized compression to the leg, thigh, calf and/or foot to prevent swelling and further improve venous circulation, that may also be self-administered by a patient effectively, and have a sufficient SSI of about greater than 10, preferably about 15 to about 35.
  • inventive therapeutic compression system having multiple bladders may be used with any required compression therapy, such as venous disease, vascular disease, lymphedema, post-operative (such as but not limited to TKR, KRA, HRA, TI-IR and sclerotherapy, etc.) and the like.
  • inventive therapeutic compression system may be used to treat any general swelling as well as being used post operatively, for example including in cases of sclerotherapy or vein ablation.
  • the inventive therapeutic compression system having multiple bladders may be used also by a person for compression therapy such as athletes and lactic acid build up, or pregnant women, as well as any individual who walks a lot or is on their feet at work for period of time. Other uses for the inventive system may be envisioned.
  • the subject invention is directed to a therapeutic compression system and methods of use.
  • the therapeutic compression system includes one or more compression apparatus each having at multiple bladders and depending on target limb may have two, three or more bladders, all connected to one inflation means and each apparatus having a check valve in an inflation port on the apparatus capable if maintaining the pressure within he inflated bladder when the inflation means is disconnected to the apparatus.
  • Each inventive therapeutic compression apparatus has a SSI of at least about 10 or greater.
  • the therapeutic compression system includes a therapeutic compression apparatus and an inflation means wherein the inflation means is less bulky than known inflation means.
  • the inflation means includes at least two settings, a setting of constant inflation or pressure and a setting of varying or intermittent inflation or pressure.
  • the inventive therapeutic compression system may include at least one sensor, such as a motion sensor, pressure sensor, blood pressure sensor, tonometer sensor, or other sensors to monitor use of the inventive system by the patient and/or medical professionals.
  • the system includes different inventive therapeutic compression apparatus such as but not limited to an apparatus for use on a leg, calf, thigh, hip, pelvis, knee, foot, torso, arm, neck or other body parts.
  • the therapeutic compression system includes an inventive therapeutic compression apparatus which such apparatus may further comprise at least one bladder operatively associated with the inventive therapeutic compression apparatus for applying pressure to a treatment site on the limb such as a leg having a SSI of at least about 10 or above.
  • the inventive therapeutic compression apparatus includes a connecting means such as a loop and hook material in order to wrap the inventive therapeutic compression apparatus around the limb, such as a leg, of the user.
  • the at least one bladder may be integral with the connecting means or wrap and depending on the target limb may have at least two or at least three separate bladders within the apparatus.
  • One or more connecting means may be operatively associated along the first and second peripheral edges of the inventive therapeutic compression apparatus for securing it around the limb.
  • the multiple 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 various spot welds on the bladder to create the gradient compression profile and/or gradient pressure profile and when inflated the inventive apparatus has a SSI or at least about 10 or greater.
  • the inventive therapeutic compression apparatus may include an inelastic portion and an elastic portion, such as on the upper portion of the at least one bladder when worn on a lower leg, such as around the upper calf area of the limb.
  • the elastic portion may be located near the elbow, wrist or shoulder of a user 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 buttocks area of the user. Other locations may be employed depending on the limb being subject to the therapeutic compression system on the user.
  • the subject inventive therapeutic compression apparatus for providing pressure to a limb including a bladder assembly.
  • the bladder assembly comprises: 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 provided in a predetermined location inward of the peripheral edge connecting the first and second walls to one another to define a plurality of chambers within the bladder.
  • the geometric placement of the at least one spot weld determines a compression profile and/or pressure profile of theat least one bladder in one embodiment.
  • the pressure profile and/or compression profile may be a gradient pressure profile and/or a gradient compression profile.
  • the bladder assembly when inflated has a SSI of at least about 10 or greater.
  • the top portion of the bladder assembly is adjacent to an elastic portion which may provide a tighter fit to the user when the entire inventive therapeutic compression apparatus is worn on the user’s target limb.
  • An inflation means for inflating the bladder such as the air pocket through at least one inflation port may be provided in the first wall of the bladder assembly.
  • the inflation means may be detachable from the at least one inflation port.
  • At least one pressure valve may be operatively associated with the inflation means for controlling an amount of pressure within the bladder and the air pocket within the bladder.
  • the inflation port includes a check valve so as to maintain a given pressure within the bladder of the inventive therapeutic compression apparatus.
  • the inflation port may be universal in that it is configured to be capable of connecting to and accepting a plurality of inflation sources and inflation means such as a manual pump, mechanical pump, electrical pump, battery-operated pump, static pump, intermittent pump, pneumatic pump, negative pressure source and other variations. Where there are more than one bladder within the apparatus, each bladder is sequentially inflated, and may be sequentially deflated and repeated on and on, or the pressure may be maintained once the inflation means is disconnected to the inflation port located on each separate bladder.
  • a method of the invention includes the therapeutic compression system including a therapeutic treatment apparatus used to treat CVI , DVT, tissue swelling, arterial and/or venous ulcers, and/or lymphedema by applying the primary and secondary wraps around a limb by a patient and inserting an inflation means into an inflation port and inflating the bladders within the primary and secondary wraps and maintaining a certain pressure to treat the CV1, DVT, tissue swelling, arterial and/or venous ulcers and/or lymphedema and having a SSI of at least about 10 or greater when inflated.
  • Another embodiment of the present invention includes an assembly according to the invention includes a pressure mechanism having a flexible member for attachment to a limb and an air chamber which may be pumped up into a desired pressurized state, a separate relatively small pre-filled air bladder, an absorbent foam, sponge or dressing coupled to the pre-filled air bladder, and a suction conduit coupled to a source of negative pressure (suction) and in fluid communication with the absorbent foam, sponge or dressing.
  • a pressure mechanism having a flexible member for attachment to a limb and an air chamber which may be pumped up into a desired pressurized state, a separate relatively small pre-filled air bladder, an absorbent foam, sponge or dressing coupled to the pre-filled air bladder, and a suction conduit coupled to a source of negative pressure (suction) and in fluid communication with the absorbent foam, sponge or dressing.
  • the pre-filled air bladder, the absorbent foam, sponge or dressing and the suction conduit are formed together as a unit.
  • the flexible member of the pressure mechanism is adapted to wrap around a leg or arm and over the pre-filled air bladder in order to secure the pre-filled air bladder and the foam, sponge or dressing to a wound or ulcer in the extremity.
  • the flexible member is provided with some fixation structure such as a hook and loop closure mechanism.
  • An air pumping mechanism is preferably coupled to the air chamber of the pressure mechanism in order to inflate the air chamber to a pressurized state.
  • the air chamber of the pressure mechanism is designed to apply pressure along a predefined area (e.g., the saphenous vein of a leg) as opposed to around an entire limb.
  • the suction conduit is located either between the prefilled air bladder and the absorbent foam, sponge or dressing which is adhered to the small air bladder, or the pre-filled air bladder is formed as a donut with a central opening and the suction conduit extends through the central opening.
  • One of the methods of the invention include locating the pre-filled air bladder and foam, sponge or dressing over a wound or ulcer on a limb, wrapping the flexible member of the pressure mechanism around a limb with the air chamber located over the pre-filled air bladder/ absorbent foam, sponge or dressing, and fastening the pneumatic pressure mechanism in place with the fixation structure.
  • the air chamber is inflated, preferably to 30-40 mm Hg, thereby applying pressure to the limb and more specifically via the pre-filled air bladder to the wound.
  • the suction apparatus is activated by turning on the source of negative pressure, and exudate from the wound or ulcer is pulled through the absorbent foam, sponge or dressing into the suction conduit.
  • Another embodiment of the present invention includes a system including an apparatus for applying intermittent pressure to a portion of the human body, such as an area of the human leg, which assists with the healing and treatment of various conditions such as venous ulcers or wounds by promoting blood flow into and out of the area and by increasing drainage.
  • the apparatus may include a thigh bladder or a foot bladder and a leg bladder, each having inflatable chambers (at least one and possibly two or more bladders within each apparatus) that accommodate an entering fluid by inflating.
  • the bladders are fluidly coupled by a fluid conduit, and each is preferably equipped with a means for locating it on a portion of the body.
  • the thigh bladder is positioned between the pelvis or groin or hip area of the user and the knee of the user.
  • a portion of the thigh bladder deflates as the person's leg moves foot (heel) strikes the ground due to the external pressure placed on the foot bladder, thereby forcing fluid out of the foot bladder, through the fluid conduit, and into the leg bladder, which raises the pressure therein.
  • the external pressure from the person's weight is removed from the foot bladder, resulting in the pressure of the leg bladder being higher than the pressure in the foot bladder.
  • Fluid thus flows back through the fluid conduit and into the foot bladder, which then inflates again to its original state, such that the pressures of the foot bladder and leg bladder are equalized.
  • This process repeats as a person walks, thereby creating a pumping or kneading force on the leg as the pressure in the leg bladder intermittently increases and decreases, thereby promoting blood flow, fluid drainage, treatment, and healing to various parts of the leg.
  • the therapeutic compression system includes an inflation means connected to a belt so the user can wear it around his or her waist in daily use, such inflation means may be connected to the inventive therapeutic compression apparatus by, for example, a hose or a tube, which provides inflation to the bladder within the inventive therapeutic compression apparatus and/or wrap.
  • the therapeutic compression system includes an inflation means which can switch between constant static pressure levels (different pressure levels such as 20 mm-Hg, 30 mm-Hg, 40 mm-Hg, up to 200 mm-Hg, etc.) and intermittent varying pressure levels, whereby the pressure is applied to the inventive therapeutic compression apparatus via a hose or tube.
  • the inflation means may be capable of sequentially inflating each bladder separately, and then deflating, or repeating the inflation and deflation as required.
  • the inflation means is connected to two or more tubes and thereby connected 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.
  • the inflation means includes one pump with a manifold having multiple chambers each corresponding to a bladder within the apparatus or multiple apparatus, such that the inflation means connected to the manifold is connected to multiple hoses which then connected to each separate bladder, for sequential inflation and deflation of each separate bladder.
  • the system includes one or more sensors to monitor movement of the inventive therapeutic compression apparatus, pressure levels, blood pressure of the patient, tonometry of the target limb, or other sensor data.
  • FIG. 1 is a view of one embodiment of the present invention including a lower leg inventive therapeutic compression apparatus connected to a tube connected to an inflation means located on a retaining means such as a belt;
  • FIG. 2 is another embodiment of the present invention in use on a person including two lower leg inventive therapeutic compression apparatuses each connected to a tube and a thigh inventive therapeutic compression apparatus, all three tubes connected to one inflation means located on a retaining means such as a belt;
  • FIG. 3 is an exploded view of the embodiment of the belt, inflation means and battery pack as seen in FIGS. 1 and 2;
  • FIG. 4A is a cut away view of the inflation means of FIG. 1 showing the sensor port and one inflation port, both connected to one tube which inflates and deflates the inventive therapeutic compression apparatus.
  • FIG. 4B is a cut away view of the inflation means of FIG. 2 showing the sensor port and three inflation ports, all connected to a tube which inflates and deflates all three inventive therapeutic compression apparatus or three separate bladders within one or more therapeutic apparatus, or in the alternative could be connected to at least three tubes may be connected to three separate bladders within one inventive therapeutic compression apparatus or the three tubes could in the alternate be connected to at least three separate inventive therapeutic compression apparatus, or a combination thereof.
  • FIG. 5A is a cut away view of the inflation port of FIGS. 1 and 2 showing one embodiment of the self-sealing check valve in the-open position as the bladder is being inflated;
  • FIG. 5B is a cut away view of the inflation port of FIGS. 1 and 2 showing one embodiment of the self-sealing check valve in the closed position to prevent deflation of the bladder once inflated;
  • FIG. 6 is a further embodiment of an inventive therapeutic compression apparatus wherein the inflation means is connected to an intake port and to a separate exhaust port of such inventive therapeutic compression apparatus;
  • FIG. 11 is yet another embodiment of the present invention including three separate gradient inventive therapeutic compression apparatus (foot, lower leg and thigh) configured to connect to one inflation means via a manifold in a inflation means, with the lower leg apparatus including three separate bladders and the thigh apparatus including two separate bladders, each bladder configured with a gradient compress profile;
  • FIG. 12 is another embodiment of the present invention including a manifold connected to or integral with the inflation means capable of separately and sequentially inflating each of the separate bladders in the one or more inventive therapeutic compression apparatus via a switch or valve connected to a hose or tube further connected to a respective universal inflation port(s) on each of the apparatus;
  • FIG. 15 is another embodiment of the present invention of FIG. 1 with three separate bladders within the lower leg inventive therapeutic compression apparatus, three inflation ports, three hoses, and three connectors to the manifold and inflation means;
  • FIG. 16A-C is another embodiment of the present invention of a separate foot inventive therapeutic compression apparatus capable of connecting to the one inflation means connected to other apparatus, with FIG. 14A showing the front view, FIG. 14B showing the back view and FIG. 14C showing the 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 inventive therapeutic compression apparatus of the present invention, as well as a toeless short sock under the foot inventive therapeutic compression apparatus;
  • FIG. 19 is yet another embodiment of a thigh inventive therapeutic compression apparatus having two separate bladders, in an exploded view of the apparatus;
  • FIG. 20 is yet another embodiment of the present invention including a perspective view of a lower leg inventive therapeutic compression apparatus having two separate bladders (upper calf and lower calf with foot) capable of connection to the same inflation means, with the apparatus including an elastic portions at the upper calf, and with a sock or sleeve connected to the lower leg inventive therapeutic compression apparatus;
  • FIG. 21 is yet another embodiment of the present invention including a perspective view of a lower leg inventive therapeutic compression apparatus having three separate bladders (upper calf, lower calf and foot) capable of connection to the same or different inflation means, with the apparatus including an elastic portion at the upper calf, and with a sock or sleeve connected to the lower leg inventive therapeutic compression apparatus; and
  • FIGs. 22A-C is another embodiment of the present invention including two different variation of the manifold having apertures for insertion of a connecting means on the hoses (FIGs. 22A and 22B) and yet another embodiment of the present invention of the inflation means connected to the manifold having four hoses connected within the manifold.
  • the subject invention provides compression to a patient's limbs, including the extremities, including for example, the leg of a user and more specifically the thigh of a user, in a manner that is simpler, less bulky, more practical, more mobile, and more convenient than current systems.
  • Any limb or body part may be compressed by the instant system including an inventive therapeutic compression apparatus such as for instance a foot, calf, thigh, knee, leg, hip, buttocks, waist, torso, ribs, shoulder, arm, band, fingers, neck, head or the like.
  • the subject invention provides system for providing compression and preventing swelling of a limb such as for instance the leg using a non-elastic binder and bladder which can be used for compression, which apparatus has at least one and preferably more than one separate bladders within the apparatus, and is connected to an inflation means including a dual means having both constant static pressure levels and varying intermittent pressure levels and the bladders are inflated sequentially.
  • the system is provided in in a manner that allows for consistent measuring of the pressure supplied, as well as safe, comfortable, more practical, more mobile, convenient, effective, and self-application by the patient.
  • inventive therapeutic compression apparatus 200 including an inventive therapeutic compression apparatus 200, an inflation means 150 and a connecting means 160.
  • the inflation means 150 is connected to a retaining means 180 such as a belt.
  • inventive therapeutic compression apparatus is a lower leg compression apparatus such as the Aero-Wrap® by Sun Scientific, Inc. and disclosed in U.S. Patent No. 9,033,906 and U.S. Patent No. 7,967,766 and U.S. Patent No. 7,559,908 and U.S. Serial No. 13/444,600 and U.S. Serial No. 16/328,718 which are all incorporated herein.
  • the inflation means may be a manual hand pump, foot pump, mechanical pump, electrical pump, battery-operated pump, static pump, intermittent pump, varying pump, automatic pump, pneumatic pump, negative pressure pump, suction pump or vacuum, pulsing pump, or any combination thereof or any other known or developed source of inflation so as to provide a certain pressure within the inventive therapeutic compression apparatus so to provide compression in use by the patient.
  • the inflation means is connected to the inventive therapeutic compression apparatus by a hose or tube 160.
  • a retaining means such as a belt or wrap to be worn by the user.
  • the inventive therapeutic compression apparatus 200, 300, 500 may be comprised of at least one bladder 202, 302, 502 and may be more than one bladder such as by way of example only 202A, 202B, 202C, 302A, 302B (not shown could include multiple bladders 202D, 202E, 302C, 302D, 502A, 502B, 502C and more) with the bladders being for example a compression bladder either integrally formed in the inventive therapeutic compression apparatus 200, 300, 500 or the inventive therapeutic compression apparatus 200, 300, 500 is configured for the bladder to be inserted (not shown) within the inventive therapeutic compression apparatus 200, 300, 500.
  • the inventive therapeutic compression apparatus 200, 300, 500 is configured and adapted to wrap around a patient's limb such as in for instance a leg, calf, knee, foot, ankle, thigh, torso, arm, neck or any other limbs.
  • the inventive therapeutic compression apparatus 200, 300, 500 is not limited to the limbs or body parts listed above but could be any body part such as without limitation a foot, ankle, calf, lower leg, knee, thigh, groin, hip, leg, buttocks, torso, stomach, chest, shoulder, arm, elbow, hand, wrist, neck, head or the like and any combinations thereof.
  • one embodiment of the inventive therapeutic compression apparatus is a lower leg therapeutic compression apparatus 200 and as shown in FIG.
  • inventive therapeutic compression apparatus 200 also includes a thigh inventive therapeutic compression apparatus 300 along with a second lower leg therapeutic compression apparatus 200.
  • the inventive therapeutic compression apparatus 200 as shown in FIGS. 1-2 and 8-10 is a wrap member 220 with a proximal end portion (top as oriented in FIGS. 1-2 and 8-10 closer to the knee of the user) and opposed distal end portion (bottom as oriented in FIGS. 1- 2 and 8-10 wrapped around the foot of the user) which is configured and adapted to conform around a patient's lower leg including the foot and calf and provide compression through the inflation of bladder.
  • the inventive lower leg therapeutic compression apparatus 200 includes an inner sheet 203 and outer sheet 201 which are made out of a nylon laminated polyurethane sheet which are configured and adapted to be RF welded together to form the wrap 220.
  • any other suitable materials which are weldable or otherwise joined while being airtight to form a bladder can be used such as films, polymers and the like, and in some embodiments (not shown) there is only one sheet and no bladder with the sheet having a SSI of at least greater than 10.
  • continuous peripheral weld lines 216, 316, 516 form an airtight boundary of integrally formed bladder 202, 302, 502.
  • FIGs. 1-2, 8-11 and 13-21 continuous peripheral weld lines 216, 316, 516 form an airtight boundary of integrally formed bladder 202, 302, 502.
  • bladder 202 is a single continuous bladder throughout from the lower leg portion to the foot portion of the inventive therapeutic compression apparatus 200, however, it is envisioned that the inventive therapeutic compression apparatus 200 could have multiple independent bladders (202A, 202B, 202C, etc.) either separately inflatable or inflatable through a one-way valve or other desired inflation/deflation configuration as shown in certain non-limiting embodiments of FIGs. 9, 11, 14-15 and 20-21.
  • hook and loop fasteners 224 are provided along the edge of inner and outer sheets in order to ease adjustment and secure lower leg inventive therapeutic compression apparatus 200 on a patient's limb such as for example a calf or foot.
  • the thigh inventive therapeutic compression apparatus 300 can includes hook and loop fasteners 322, 324 but also could be secured to a patient's thigh by other means, such as zippered, buttoned, or be cuff shaped by other such suitable means.
  • the gradient pressure profile and/or the gradient compression profile may be based on the geometric pattern of the spot welds 314 alone or in combination with linear welds 316.
  • the gradient compression profile and/or gradient pressure profile may be based on the pressure level from the inflation means alone, or combined with the overall shape of the bladder 202, 302.
  • the bladder 202, 302, 502 configuration and shape may not include many spot welds 214, 314, 514 or weld lines 216, 316, 516 such as the non-limiting embodiments shown in FIGs. 9-10, 13, and 18 where the front portion of the inventive therapeutic compression apparatus 200, 300, 500 do not shown any such welds and instead any welds are on the bottom portion of the respective inventive therapeutic compression apparatus 200, 300, 500.
  • the bladder 202, 302, 502 when inflated within the inventive therapeutic compression apparatus 200, 300, 500 has a SSI of at least about 10 or greater.
  • the inelastic inflated bladder has a SSI of at least about 10, preferably about 10-50.
  • the SSI assists in the compression therapy for the user to prevent or treat CVT, CVI, DVT, lymphedema and other swelling issues on the user’s limb as well as venous and arterial ulcers.
  • Commonly known SSI for elastic bandages or garments are in the range of about 1 to about 5 or about 6, while certain known inelastic compression apparatus have a SSI in the range of about 5-10.
  • no inelastic compression apparatus including a bladder when such bladder is inflated has a SSI of greater than about 10.
  • a SSI of about 10 is generally acceptable for an inelastic compression apparatus with the inventive therapeutic compression apparatus having a SSI of at least about 10 and generally greater than 15.
  • the higher the SSI then typically the better compression for the user with the bladder is inflated.
  • the higher SSI translates generally to a level of compression comfortable relatively speaking with vascular push but constricting blood.
  • the inventive therapeutic compression apparatus is able to combine compression to prevent or treat both arterial and venous disease. Whereas the arterial disease needs vessel and flow, the venous disease needs compression, which are found in the inventive therapeutic compression apparatus when the bladder is inflated and the apparatus is on the target limb of the user.
  • inventive therapeutic compression apparatus 200, 300, 500 is able to achieve both high pressure and high stiffness which is then beneficial to prevent and treat venous disease, lymphedema, CVT, CVI and the like.
  • inventive therapeutic compression apparatus 200, 300, 500 has been measured with a SSI of up to about 40-50, preferably when inflated and in use of about 10 to about 30.
  • Compression therapy is a widely used standard of care in the treatment of a variety of swelling disorders, such as chronic venous insufficiency disease and lymphedema.
  • Compression therapy relies on the external use of pressure to squeeze the underlying anatomy and helps to reduce swelling and improve circulation.
  • Gradient compression is particularly effective with more pressure being applied more distally (further) from the heart with the pressure reducing proximally (closer). This helps to squeeze the body in a manner to help spur circulation and reduce the limb size.
  • static and intermittent Static is most common and is constant compression meant for all day wear while intermittent is the cyclical application of compression through a pump and has benefits particularly for sporadic use when the user is sedentary.
  • a supporting effect may help to reduce the available limb volume to manage the amount of leg swelling.
  • a dynamic effect may include compression that causes or helps to improve circulation of blood and fluid, particularly when the user walks around. Compression squeezes the circulatory system into better contact with the muscles (for example, calf with lower-leg compression) to improve the body’s efficacy of fluid movement. Those with chronic venous disease may not get fully effective circulation without compression. Compression therapy is widely regarded as effective treatment for lower leg swelling diseases when used properly. By squeezing the outside of the legs, compression helps to bring down swelling and to improve circulation of the trapped fluids. To be effective, compression must be used consistently and often - especially static compression when on your feet and walking around.
  • compression therapy has been used effectively for treating patients with chronic venous insufficiency. It works by improving venous hemodynamics and reducing edema because of the underlying stiffness and elastici ty of the compression device.
  • conventional compression options such as medical grade elastic compression stockings, inelastic compression stockings and inelastic compression wraps. Each of these have advantages and disadvantages. Inelastic compression compared to elastic provides higher stiffness and therefore better control of venous hemodynamic impairment in patients with more severe venous disease. Compression wraps offer easier application for patients when compared to compression stockings.
  • the inventive therapeutic compression apparatus solves these problems by prevent or treating arterial and venous issues in that the inventive therapeutic compression apparatus 200, 300, 500 has a SSI of at least about 10 or greater when inflated and wrapped on the 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 a compression device can be calculated by measuring the interface pressure between the device and the skin.
  • the SSI is defined as the difference between the standing and the supine pressure measured at the Bi point.
  • Bi point is the transition point between the gastrocnemius tendon and muscle about 10-15 cm above the inner malleolus.
  • Elastic compression devices typically have SSI ⁇ 10, sometimes less than 5, compared to inelastic devices showing an SSI >10.
  • the inventive therapeutic compression apparatus 200, 300, 500 has a SSI of at least about 10 or greater, preferably from about 15 to about 40 Notably in certain embodiments such as shown in FIGs. 20-21 the inventive therapeutic compression apparatus 200, 300 also has an elastic portion 205, 318 configured to conform to the shape of the target limb and anatomy and keep the inflated inventive therapeutic compression apparatus 200, 300 on the target limb without slipping down the limb (such as the calf and thigh in these non-limiting examples) when the user is moving or walking.
  • SSI of at least 10 with a certain elastic portion on the inventive therapeutic compression apparatus 200, 300, 500 with other embodiments not shown.
  • Elastic materials compress all the time, meaning that they can feel “tight” and pinch even when at rest. But when you walk around, they stretch, meaning that they can give up some of their compression, reducing the dynamic compression effect. With lower leg venous and lymphatic blood return, the calf muscle plays a very important role in helping squeeze fluid against gravity up into the body and back into circulation. In fact, the calf is known as the second heart. Elastic compression of the leg, by the material properties, ends up stretching when the leg is engaged (both calf and thigh as well as knee and ankle), losing some of the inward pressure of the compression and losing fluid return effectiveness.
  • the inventive therapeutic compression apparatus 200, 300, 500 includes a SSI of at least about 10 or greater when the wrap 220 is placed on the user’s target limb and the bladder 202, 302, 502 is inflated.
  • one of the inflation means is a device 150 which is a pneumatic pump capable of attaching to inflation ports 212 (212A, 212B, 212C), 312 (312A, 312B), 512 to inflate bladder 202 (202A, 202B, 202C), 302 (302A, 302B), 502 within the inventive therapeutic compression apparatus 200, 300, 500.
  • the inflations means 150 is a pneumatic pump and a second inflation means 150 is a hand manual pump 400 including a bulb 420 for manually pumping of air fluid and a hand dial 410 including a check valve within.
  • a number or variety of inflation means can be employed such as a manual pump, hand pump, foot pump, mechanical pump, electrical pump, battery-operated pump, static pump, intermittent pump, varying pump, automatic pump, pneumatic pump, negative pressure pump, suction pump or vacuum, pulsing pump, or any other known or developed source of inflation so as to provide a certain pressure within the bladder so to provide compression in use by the patient.
  • a valve 290 is incorporated into inventive therapeutic compression apparatus 200 in the inflation port 212 to allow a user to selectively deflate bladder 202 of the inventive therapeutic compression apparatus 200.
  • a check valve (not shown) or relief valve is incorporated with either inflation means 150 or bladder 202 to prevent over-inflation once a maximum pressure is detected.
  • the inflation means 150 may include a manifold 190 as shown by non-limiting examples in FIGS. 12 and 22A-22C that controls inflation, maintenance and deflation of each bladder 202 (202A, 202B, 202C), 302 (302A, 302B), 502 connected via a hose 160 (160A, 160B, 160C, 160D, 160E, 160F) to the applicable inflation port 212 (212A, 212, 212C), 312 (312 A, 312B), 512.
  • a manifold 190 as shown by non-limiting examples in FIGS. 12 and 22A-22C that controls inflation, maintenance and deflation of each bladder 202 (202A, 202B, 202C), 302 (302A, 302B), 502 connected via a hose 160 (160A, 160B, 160C, 160D, 160E, 160F) to the applicable inflation port 212 (212A, 212, 212C), 312 (312 A, 312B), 512.
  • each inventive therapeutic compression apparatus 200, 300, 500 may have more than one bladder such as 202A, 202B, 202C and 302A, 302B such that a separate hose 160A, 160B, 160C, 160D and 160E connect to the applicable inflation port 212A, 212B, 212C and 312A, 312B as shown in FIGs. 9-1 1 , 13-15 and 20- 21.
  • Other configurations are possible depending on the number of separate bladders within each inventive therapeutic compression apparatus 200, 300, 500.
  • bladder 202, (202A, 202B, 202C), 302 (302A, 302B) is inflated and not able to shift out of place, thus increasing comfort and reducing fitting issues on the patient.
  • the inflation means 150 is connected to a retaining means 180, for example a belt. Any retaining means 180 may be employed such as for instance, and not shown, a thigh, hip or waist strap can be used. If a strap is used, the strap may be pulled tight against a patient's leg and hip so as to reduce slippage of the inventive therapeutic compression apparatus 200, 300 and the inflation means 150.
  • the retaining means 180 is a belt or strap and includes a belt snap 181 A (male connector) and a belt clip 18 IB (female connector), which are joined together by the belt strap 181B being inserted within the belt clip 181 A and then snapped together.
  • Other embodiments not shown may include a garter belt system or a belt buckle or any other known closing or connecting means.
  • the retaining means 180 if a belt may be closed or connected though other connecting means such as for example and not limited to hook and loop closure or VELCROTM or any other known connecting means such as buckles, straps, buttons, snaps, zippers, hooks and other combinations. As shown in FIGS.
  • the retaining means 180 belt is worn at the waist of the patient.
  • the retaining means 180 may be a hip strap (not shown) or a waist strap (not shown as what is shown is a belt embodiment) is configured and adapted to improve wearability of the inflation means 150 and increased ambulation for the patient.
  • Inelastic hook and loop (“Velcro”) wraps have been introduced that have a hook and loop outer material onto a neoprene-like material with a small amount of stretch with straps that are pulled over to apply a stiffer than elastic stocking compression.
  • the inventive therapeutic compression apparatus 200, 300, 500 is a compression garment that anatomically fits the leg and foot but is made primarily from inelastic materials.
  • Current conventional inelastic compression apparatus look like a cone for the lower leg when lying flat not inflated in that the upper portion to be placed nearer the knee is wider compared to the less wide portion to be placed nearer the ankle as it mimics the wider portion of the calf on the lower leg compared to the ankle area for users. As shown in FIGs.
  • the inventive therapeutic compression apparatus 200 includes an elastic portion 205 located on the upper aperture 204 of the apparatus 200/wrap 220 to assist in the anatomical fit of the apparatus 200/wrap 220 when placed on the lower leg of the user versus the current known compression wraps are in the shape of the cone from bottom to top so they have to be either cut down by the user or when placed on the lower leg stick out further than it needs to be and does not hug the calf which is a problem.
  • the inventive therapeutic compression apparatus 200 solves this problem by including the elastic portion 205 to assist in the fit of the apparatus 200/wrap 220 on the lower leg when placed on the user.
  • the inventive therapeutic compression apparatus 200, 300, 500 can be designed in a way to apply more compression distally than proximally through multiple inflation channels, or design of 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.
  • the inventive lower leg therapeutic compression apparatus 2000 may have an elastic insert 205 that are placed during the manufacturing process in a pre-stretched configuration, providing a desired 3D shape to an inelastic garment.
  • the steps may include: (1) an inelastic outer sheet 201 is laid down on a flat surface with pins; (2) the elastic insert 205 is pre-stretched and held in the stretched state on the same pins; (3) the inelastic inner sheet is laid down on the same pins within the aperture 204, sandwiching the pre-stretched elastic insert 205 between this inner 201 and outer sheet 203; (4) the three layers are fused together in the flat state (radio frequency welding, ultrasonic welding, sewing, or any other means to connect) and (5) the inventive lower leg therapeutic compression apparatus 200 is removed from the pins, allowing the pre-stretched elastic portion 205 material to be free and to contract, curling the inventive lower leg therapeutic compression apparatus 200 into the desired 3D shape.
  • the inner 201 and outer 203 sheets are inelastic and may consist of multi-layer laminates, capable of being air-tight and inflatable.
  • the inelastic materials could have additional elastic inserts or mesh portions 217 inserted in a way that provides a 3D anatomical shape and also the predetermined compression profile, by stretching more or less depending on where the compression profile is desired.
  • the additional elastic or mesh portions 217 may assist in anatomical positioning as well as heat release for the user’s limb due to the inelastic portions of the inventive lower leg therapeutic compression apparatus 200.
  • the inventive thigh therapeutic compression apparatus 300 includes an elastic portion 318 to conform to the anatomy of the groin area and prevent slippage of the inventive thigh therapeutic compression apparatus 300 down the leg and thigh of the user when he or she is moving and notably walking and in turn assists and has better efficacy in reducing, treating and even preventing tissue swelling, lymphedema, ulcers (arterial and venous), CVI and DVT as well as increasing circulation on the thigh and overall leg of the individual user.
  • the chambers of the bladder 202 may be filled by air, fluid or other known means of inflation.
  • the bladder 202 (202A, 202B, 202C), 302 (302A, 302B), 502 can be arranged to receive air and be inflated using a manual pumping bulb (as shown in FIG. 2), or can be inflated by an electric air pump 150 which can use batteries or AC wall current to pump air into the chamber(s).
  • a manual pumping bulb as shown in FIG. 2
  • an electric air pump 150 which can use batteries or AC wall current to pump air into the chamber(s).
  • inventive therapeutic compression apparatus 200 300 including two separate bladders 202A, 202B or 302A, 302B or three separate bladders 202A, 202B, 202C. Each of these separate bladders may be sequentially inflated, then released, then inflated and repeated depending on the target limb and the target pressure for each part of the target limb.
  • the inflation port 212 (212A, 212B, 212C) of the inventive therapeutic compression apparatus 200 is universal in that it can connect to a multiple of different types of inflation means. Any known source of air or fluid may be employed whether manual, mechanical, electrical, battery-operated or any other power sourced pump or pressure creator.
  • the inflation means 150 may be a manual pump, hand pump, foot pump, mechanical pump, electrical pump, battery-operated pump, static pump, intermittent pump, varying pump, automatic pump, pneumatic pump, negative pressure pump, suction pump or vacuum, pulsing pump, or any other known or developed source of inflation so as to provide a certain pressure within the bladder so to provide compression in use by thepatient.
  • the inflation means 150 is connected to the inventive therapeutic compression apparatus 200 via a connecting means such as a tube 160 or hose and as shown in FIGS. 9 and 12-13 there are multiple hoses 160A-160F going through a manifold 190 and connected to the applicable inflation port 212A, 212B, 212C, 312A, 312B, 502. Any other known connecting means may be employed beyond the non-limiting examples of tubes and hoses.
  • the connecting means tubes or hoses 160 (160 A, 160B, 160C, 160D, 160E, 160F) has two ends with one inserted into the respective inflation port 212 (212A, 212B, 212C), 312 (312A, 312B), 512 and on the other end has a tip or insertion part 195 (195A. 195B. 195C, 195C, 195D, 195E, 195F) that is inserted into apertures 197 (197A, 197B, 197C, 197D, 197E, 197F) in the manifold 190.
  • the manifold splits the air from the air pump 150 into each of the respective tube 160 or hose and there is a sensor, valve, switch or some gateway in selecting the pressure level for each separate tube 160 or hose as well as whether to inflate, hold or deflate the respective bladder 202 (202A, 202B, 202C), 302 (302A, 302B), 502.
  • the embodiments shown include a clear tube 160 (160A, 160B, 160C, 160D, 160E, 160F) connected to the inflation means 150 or hand held manual pump 400 and another embodiment of the tube 160 is shown with a covering 162 on the tube, shown as black cloth 162 so as to allow the user to wear the covered tubes 160 more easier under clothing or less likely to be seen when worn over clothing.
  • the tube 160 (160A, 160B, 160C, 160D, 160E, 160F) is connected to the inventive therapeutic compression apparatus by inserting, for instance a male luer slip 161, into the inflation port 212 (212A, 212B, 212C) ,312 (312A, 312B), 512.
  • the tube 160 is inserted into the inflation means 150 via the pump output port(s) 152 as shown in FIGs.
  • the inflation means 150 shown in the embodiment in FIGS. 1-4 is a pneumatic pump which is rechargeable via an electric charger, though the pump could also be battery operated or any other known power source.
  • the inflation means 150 in this embodiment includes a base 151 connected to the retaining means 180 belt.
  • the base 151 is connected to the main pump assembly via a series of screws 154 and 0-rings 153.
  • the main pump assembly is shown as 156 though the inner mechanical and electrical portion is not shown.
  • the inflation means 150 of this embodiment is an electric powered air pump with interface pressure of 50 mm-Hg (for example to prevent DVT or treat CVI).
  • the pump 156 may apply pressure constantly in a static status or may apply pressure intermittently, for example by applying 50 mm-Hg, holding for 10 seconds, then releasing until next cycle of 30-45 seconds, and repeating for a period of time.
  • Other embodiments could include pressure levels of 60 mm-Hg, 75 mm-Hg, 80 mm-Hg, 90 mm- Hg, 100 nun-Hg or other known pressure levels, depending on the treatment plan and the target limb of the patient. There could also be multiple pressure levels within the pump so there is varying pressure during treatment. In the embodiment shown in FIGS.
  • the pressure levels may be noted through the manifold 190 and various sensors (197A, 197B, 197C, 197D, 197E, 197F) corresponding with each bladder 202A, 202B, 202C, 302A, 302B, 502 such that the bladders are inflated and deflated or maintained sequentially and the amount of pressure can vary vis-a-vis each separate bladder.
  • Each inventive therapeutic compression apparatus 200, 300, 500 has one or more bladders 202, 302, 502 connected to an inflation means 150 with a controller such as the sensors, switches or valves 197 (197A, 197B, 197C, 197D, 197E, 197F) within the inflation means 150 and manifold 190 capable of sequential intermittent pneumatic compression, or any other type of compression, while also capable of being detached from the inflation means 150 while still holding or maintaining static compression. As shown in FIGS.
  • the controller or manifold 190 may utilize a sensor, valve, switch, check valve or ither mechanism to inflate, hold or maintain pressure or deflate the applicable bladder 202, (202A, 202B, 202C), 302 (302A, 302B), 502 at the then current pressure level such as 20 mm-Hg, 30 mm-Hg, 40 mm-Hg, 50 mm-HG, 60 mm-Hg or higher.
  • Each of the sensors 197 are capable of opening, closing, or venting the air flow from the inflation means 150 to the applicable bladder via the applicable tube or hose 160A-160F such that the predetermined inflation sequence, which is sequential, produces different or the same pressures within different bladders 202, (202A, 202B, 202C), 302( 302A, 302B), 502 though other combinations may be employed as well as other sources of pressure beyond air flow.
  • the inventive therapeutic compression apparatus 200, 300, 500 has a SSI of at least about 10 or greater.
  • the inflation means 150 main pump 156 includes a display 157 which in this embodiment shows remaining battery power level, the limb being compressed (or the specific bladder being inflated as in the embodiments shown in FIGS. 9-21), and elapsed time of this instant session in hours and tenth of hour.
  • the display 157 can be modified to show varying pressure levels, other limbs being compressed, time left for activation in a set time period, or the like.
  • the USB port 159 and cover 158 are on the opposite side in this embodiment of main pump 156, for recharging of the pump battery (internal mechanisms not shown).
  • An ON-OFF switch 165 is included in this embodiment though the ON-OFF switch in other embodiments may be digital and includes various selections such as pressure level, static or intermittent status, time to operate at each pressure level and/or status, limb to be compressed if the pump 156 is connected to multiple inventive therapeutic compression apparatus 200, or the like.
  • An optional protective cover shown in FIGS. 1-4, is a flexible cover 158 so to protect the inflation means 150 when dropped by the user or just common wear and tear on the pump mechanism or even to prevent over heating or chaffing at the waist of the user.
  • the flexible cover 158 may be comprised of a polymer, rubber or other flexible materials or the like.
  • bladder 202 (202A, 202B, 202C) is not able to shift out of place, thus increasing comfort and reducing fitting issues on the patient, along with the elastic portion 205 as well as the additional mesh inserts 217 as shown in FIGs. 20-21.
  • another method of use to improve the outcomes includes the steps of (a) at least 3 days pre-surgery, the patient is given the inventive therapeutic compression apparatus 200, 300, 500 to reduce limb volume and leg swelling, which can be achieved with either static or intermittent compression pressure levels, then (b) during surgery and immediately post-operative the inventive therapeutic compression apparatus 200, 300, 500 is connected to the IPC DVT control unit in the hospital or clinic or outpatient office setting, and the IPC cycles intermittently to provide standard DVT mechanical prophylaxis, and thereafter (c) as the patient is discharged, the patient is given the inventive therapeutic compression apparatus 200, 300, 500 to bring home along with either or both the hand compression pump or battery operated (or electrical powered) inflation means 150, such as pump 156, to manage the risk of DVT along with preventing further swelling.
  • inventive system 100 could be used in conjunction with a lower leg compression apparatus (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 one inflation means could be connected to each of the two compression apparatus as shown in FIGS. 1-21.
  • a lower leg compression apparatus 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
  • one inflation means could be connected to each of the two compression apparatus as shown in FIGS. 1-21.
  • the inflation means could include programming (not shown) connected to the sensors 197 (197A, 197B, 197C, 197D, 197E, 197F) such that the bladders of both the inventive therapeutic compression apparatus 200 and the bladder 202 or bladders 202A, 202B of the lower leg compression apparatus 200 are each (or together at the same time) inflated and deflated to a set pressure at intervals or at set times throughout the day or night when the compression apparatus is in use worn on the patient, whether sequentially or not.
  • the inflation means 150 could be set to 40 mm-Hg at 9 am and then set to deflate to 20 mm-Hg at 11 am and then set to inflate to 30 mm-Hg at 12 pm and so on throughout the day and night for each patient individually.
  • the inflation means could be set to 40 mm-Hg for a thigh bladder 300 and set to 20 mm-Hg for the lower leg bladder 202 (or calf bladder 202B or foot bladder 202A, etc.), or each could vary and the inflation means be set to sequentially inflate, deflate, inflate, or hold for a period of time, etc. throughout the day as described above.
  • each of the bladders could be set to the same or different pressure levels though out the day and night.
  • the inventive therapeutic compression apparatus 200 has a SSI of at least about 10 or greater.
  • the inflation means includes a manual pump (as shown in FIGS. 2 and 8) and the dial includes graphics of pressure amount such as “35, “45', “55' and “65” or lettering such as "A”, "B", “C”, “D” which each would correspond to a certain pressure such as 25 mmHg, 35 mm-Hg, 45 mm-Hg and 55 mm-Hg.
  • the specific pre-determined pressure to correspond with the graphic is endless and not limited by the examples herein.
  • inventive therapeutic compression apparatus may be deflated by a button or a switch to deflate the bladder 202 (202A, 202B, 202C), 302 (302A, 302B), 502 and thus release the pressure and/or compression profile.
  • the switch may have a plurality of integrated umbrella valves so that one umbrella valve is set and closed to maintain the pressure within the bladder 202 (202A, 202B, 202C), 302 (302A, 302B), 502, while a second umbrella valve would release a certain amount of air or fluid within the bladder 202 (202A, 202B, 202C), 302 (302A, 302B), 502, so as to release the pressure such as while the patient is walking (pressure increases on the thigh with each step or on the foot portion of a lower leg inventive therapeutic compression apparatus) or flying (pressure increases based on altitude), and a third umbrella valve which would release all the air or fluid in the bladder 202 (202A, 202B, 202C), 302 (302A, 302B), 502, thus release all pressure and deflate the inventive therapeutic compression apparatus 200, 300, 500).
  • the first umbrella valve is set in a closed position so that when activated this umbrella valve maintains the amount of air or fluid in the bladder 202 and thus maintains the set pressure, say for instance at 45 mmHg
  • the second umbrella valve is set to release the air or fluid within the bladder 202 if the pressure within exceeds 45 mm-Hg and bring the pressure down to 45 mm-Hg (such as when in high altitude or other increases in pressure) and then maintain the pressure at 45 mm-Hg
  • a third umbrella valve is set to open and release all the air or fluid within the bladder 202 and thus release all pressure when activated by the patient so as to deflate the bladder 202 and the inventive therapeutic compression apparatus 200.
  • the dial or display 157 may include graphics such as (A) "Walk” wherein the set pressure amount is maintained while the patient walks and the pressure spikes and returns over and over in time as the umbrella valve remains in the closed position, (B) then a graphic of "Air” wherein the set pressure amount will be maintained by this umbrella valve occasionally releasing pressure as the pressure increases over the sci amount or value so that the umbrella valve is activated to release air or fluid within the bladder 202 and release the pressure yet then close and stay closed to maintain the set pressure amount, and (C) “Release” or “Deflate” wherein the pressure will be released and the air or fluid within the bladder 202 released to deflate and this umbrella valve is always in the open position.
  • A "Walk” wherein the set pressure amount is maintained while the patient walks and the pressure spikes and returns over and over in time as the umbrella valve remains in the closed position
  • B then a graphic of "Air” wherein the set pressure amount will be maintained by this umbrella valve occasionally releasing pressure as the pressure increases over the sci amount or value so that the umbrella valve is
  • umbrella valves there are three umbrella valves with one set to always open the bladder 202 to release pressure completely, one set to always close to maintain air or fluid in the bladder 202 to maintain pressure, and a third set to open or release at a predetermined or set pressure point.
  • the umbrella valve may also be a switch (manual or otherwise) or a digital switch or any other known means to open, close or partial release air or fluid within a bladder and thereby maintain, change or release pressure therein.
  • the inventive therapeutic system 100 includes an inventive sealing means connected to the bladder 202, 302, 502 so as to maintain the gradient compression profile and/or gradient pressure profile when the inflation means 150 is either disconnected from the inventive therapeutic compression apparatus 200, 300, 500 or the inflation means stops providing additional inflation or pressure.
  • the sealing means is a cap 213 which is inserted onto or into the inflation port 212, 209.
  • the sealing means also includes a valve 290 within the inflation port 212, 312 (212A, 212B, 212C), 312 (312A, 312B), 512.
  • the valve 290 is located within a housing 209, the housing being tubing or for instance a luer.
  • the housing 209 is a plastic female luer but other materials can be employed such as metal, polymers, or rubbers and other housing means can be employed.
  • the valve 290 as shown in FIGS. 5 A and 5B includes a V-notch 291 in the top proximal portion of the valve 290 though other shapes of notches or other apertures and openings may be employed.
  • the V-notch 291 in this embodiment assists in movement of the fluid from the male luer 161 (fluid flowing from the inflation means 150) into the inflation port 212 and into the bladder 202.
  • the bottom distal portion of the valve 290 is in a shape as shown in FIGS. 5 A and 5B such as a plug where the top portion 291 is thinner than the bottom distal portion and has a location 292 which abuts and seals the inflation port when it rests along the top portion 299 of the indent 293 in the lower portion ofthe housing 209.
  • the inflation port 212 is sealed and the fluid within the inventive therapeutic compression apparatus 200 is sealed within the bladder 202 and thus the pressure and compression within is sealed and if applicable the gradient compression profile and/or gradient pressure profile is maintained.
  • the housing 209 has a circumference which expands in a lower distal portion to house the valve 290.
  • the shape as shown in FIGS. 5 A and 5B is not limiting and any other shapes may be employed, as long as some portion of the valve 290 touches a portion of the housing 209 so as to create a sealing means and maintain the pressure and fluid within the inflated inventive therapeutic compression apparatus 200, 300. Again other shapes may be employed such that the functionality is created for a scaling means.
  • the bottom distal portion 295 of the housing 209 in this embodiment then narrows or tapers so that when the valve 290 is pushed down by the male luer 161 the bottom of the valve 290 rest on top of 295 and the fluid passes around the outer circumference of the valve 290 and also through the V-notch 291 and flows into the bladder 202 via the opening or aperture 294.
  • the outer circumference of the bottom distal portion of the valve 290 is slightly smaller than the inner circumference of the bottom distal portion 293 of the housing 209 so that the fluid can flow from the inflation means 150 through the hose 160 through the slip luer 161 through the inflation port 212 and into the bladder 202.
  • the same components and method may be employed in the thigh inventive therapeutic compression apparatus 300 or any other type of inflatable apparatus.
  • FIG. 5 A shows the inflation of the inventive therapeutic compression apparatus 200 with the male slip luer 161 inserted within the housing 209 of the inflation port 212 (the optional cap 21 1 is open and off to the side) and pushes down on the valve 290 so that the valve 290 bottom rests on the bottom distal portion 295 of the housing which is returned to as the open position for the valve 290.
  • the fluid represented by the downward arrow in the middle of the male slip luer 161 flows into the housing 209 and past the valve 290 and into the bladder 202 as shown by the arrow direction in the bottom of the figure. The fluid will continue to flow into the bladder 202 until such time as the inventive therapeutic compression apparatus 200 is in the appropriate inflated state.
  • the two portions 292 and 299 are connected or touching thereby sealing the inflation port 212 and the fluid within the inventive therapeutic compression apparatus 200 is maintained at the level prior to the inflation means 150 being disconnected to inventive therapeutic compression apparatus 200.
  • the fluid is represented by the upward arrow in the middle of the housing 209 flowing from the bladder 202 and into the bottom portion of the indented housing 293 is scaled by the valve 290.
  • the inflation means 150 could be a manual pump 400 as well and any other static or intermittent inflation means.
  • valve 290 When the bladder 202 is deflated by the user the valve 290 will again be pushed down by the male slip luer 161 but no fluid or inflation will be employed at that time so that the fluid flows out of the inflation port past the valve 290 and the deflated state will be maintained.
  • the valve 290 can be manually pushed down to deflate by inserting the male slip luer 161 or by a stem or other extending portion of the cap 21 1 (shown in FIG. 8K) or by any other appliance to push the valve 290 in a downward direction.
  • the valve 290 is self-scaling but other sealing means can be employed such as any moveable lever, screw, switch, stop cock, or other mechanical means to seal the inflation port and maintain the fluid within.
  • the inventive system 100 may be included in a kit including an inventive therapeutic compression apparatus 200, 300, 500, an inflation means 150, a retaining means 180 such as a belt, and a connecting means such as a tube 160 (160A, 160B, 160C, 160D, 160E, 160F).
  • the inflation means 150 may require a charger depending on the source of energy, such as an electric charger (not shown) for connecting to the USB port 159 and the kit would include such a charger.
  • a cable such as a USB cable 175 may be connected to the USB port 159 to charge the inflation means and the USB cable 175 has two connectors 176, 177 on each side for connecting to a charging source and connecting to the inflation means 150.
  • a cable such as a USB cable 175 may be connected to the USB port 159 to charge the inflation means and the USB cable 175 has two connectors 176, 177 on each side for connecting to a charging source and connecting to the inflation means 150.
  • the inventive therapeutic compression apparatus is used over or on top of the wound dressing applied to the skin.
  • Another embodiment of the present invention includes a method of applying a measured compression amount with feedback.
  • Compression Bladder A is inflated by Inflation Source C - the nature of Compression Bladder A is such that the amount of compression is determined by the amount of inflation medium (typically air) pumped into A from C.
  • Inflation Source C is also coupled with Bladder B, which has a fixed volume of air. When Compression Bladder A inflates, it will squeeze Bladder Bas it compresses Compressed Item F.
  • Inflation Source C is able to read the line pressure from the 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 necessary into Compression Bladder A as determined by matching the desired interface pressure from Bladder B. Other configurations may be employed so that feedback may be obtained from the inflation means and compression apparatus.
  • Another embodiment of the present invention includes a Sequential Gradient Compression with Single Chamber.
  • the inventive therapeutic compression apparatus 200 includes an inflation bladder to apply not only gradient compression but sequential (filling up either the channel B first and then filling up the main bladder V second, or the opposite) compression. In this embodiment (shown as FIG.
  • Inflation Device A is coupled to the device in two places (Intake Port C and Exhaust Port D). By inflating and providing air that goes directly into Channel R, the Channel B inflates first, before the Main Bladder F. Air then exits out of Exhaust Port D.
  • the inflation can be intermittently provided for gradient and sequential compression or inflation can be held at a constant level to provide just the gradient profile.
  • the inflation means 150 may also include a sensor 155 to measure the air pressure being applied in the tube 160.
  • a sensor 155 to measure the air pressure being applied in the tube 160.
  • Another embodiment of the present invention include an electric or other automated inflation means such that the bladder is inflated to a set volume or by reading the back pressure of which is being filled in. A pressure cycling function may be included.
  • an embodiment may have an inflation means such that the inflation maintains in the bladder(s) even after the inflation means is removed.
  • Such inflation means may be integral to the compression apparatus itself or may be removable.
  • Such inflation means may include an integrated circuit and/or wireless capability for tracking of usage, pressure, compliance by the patient in regard to maintaining certain pressures recommend by a physician or part of such patient's treatment plan, and other health data such as standing pressure and moving or working pressure, pedometer (number of steps), heartbeat, blood pressure and any other possible monitoring of the patient.
  • the inflation means may be programmed to increase or decrease the pressure without manual changing by the patient.
  • the inflation means may be configured so that the physician or other treatment professional may increase or decrease the pressure remotely based on the feedback.
  • Other combinations may be included such as manual changing of the dial or inflation means in combination with automated means or electric means or digital means.
  • the inventive system 100 may also include other sensors such as a tonometer, which is a device pressed into the skin to measure the amount of force required to make an indent in the tissue. The resulting measurement can help gauge the degree of firmness or fibrosis (tissue scarring) under the skin, which is a consequence of worsening lymphedema.
  • a tonometer could be applied to the patient's skin under the inventive therapeutic compression apparatus 200, 300, 500 and measure the firmness or fibrosis at such treatment site on the limb of the patient.
  • Such a tonometer could be connected to the inflation means via Bluetooth or other digital means and provide feedback to the patient and medical staff as discussed above.
  • the elastic portion 205 is inserted into the opening 204 to assist in better anatomical fit when in use on the individual person.
  • Additional mesh inserts 217 may be placed within other apertures or openings 215 with the mesh or elastic portions 217 assisting in the anatomical fit as well as providing through areas to reduce or prevent excessive heat and sweating at the target limb when the inventive therapeutic apparatus 200 is wrapped and inflated on the user.
  • elastic portions 226 for the ankle area on the lower leg in these embodiments where the target limb is the lower leg.
  • the elastic portion 226 assists in anatomical fit of the thinner ankle portion of the lower leg compared to the wider upper portion nearer the knee over the calf.
  • the additional mesh or elastic inserts 217 also assist in anatomical fit over the calf area of the user’s lower leg when the wrap 220 is closed and secured onto the lower leg, then inflated including maintaining a SSI of at least about 10 or greater.
  • the embodiment of the inventive therapeutic compression apparatus 200 as shown in FIGs. 1-2, 14-15 and 20-21 include an integrated foot wrap 250 including a hook and loop portions of 222, 224.
  • the bladder 202 flows into the foot wrap 250 so that compression is located on the arch and under foot area corresponding with the arch of the user’s foot whereas in other embodiments the bladder is separate so that the foot bladder 202A is separate from either one or two additional bladders 202B, 202C, and the foot bladder 202A is inflated from the inflation means 150 so that compression is located on the arch and under foot area.
  • the additional mesh or elastic inserts 217 are not included but they may be added to the wrap 220, just not shown here.
  • the embodiment shown includes a heel aperture 230 and the elastic ankle portion 226.
  • Another element which assists and reduces sweating and heating when the inventive therapeutic compression apparatus is inflated on the user’s target limb are various through holes 208 located on lower leg inventive therapeutic apparatus 200, which are located on the hook and loop portions 222, 224 and the non-bladder portions of the wrap 220 and within the spot welds 214.
  • the through holes 208, 308, 508 may be located throughout the inventive therapeutic compression apparatus 200, 300, 500 in order to allow for ventilation about a patient's leg, thigh, arm or other body part or limb during extended wear of inventive therapeutic compression apparatus 200, 300, 500.
  • not all of the through-holes are identified with reference characters in the Figures.
  • the sock or sleeve 110 is elastic and can include compression throughout, or only a portion having a compression element, or be non-compression.
  • the elastic sock or sleeve 110 may be comprised of materials such as nylon, wool, cotton or any other compatible elastic material.
  • the elastic sock or sleeve 110 may have a feature of compression itself which is then another level of compression coupled with the wrap 200, 220, 300, 500 and/or compression or pressure of the bladder 202 (202A, 202B, 202C), 302 (302A, 302B), 502 once inflated. In one embodiment as shown in FIGS.
  • the foot portion of the elastic sock or sleeve 110 includes a compression portion 112 located around the arch and sole of the foot portion.
  • An optional compression strap (not shown) may be included which could have a loop portion and hook portion to secure the compression foot strap together.
  • Other known connecting means for the compression strap may be included such as without limitation VELCROTM, hooks, snaps, adhesion, sewing, buttons, or the like.
  • the elastic sock or sleeve 110 also includes a connecting means to connect to the inventive therapeutic compression apparatus 200, 300, 500 such as via adhesion, sewing, welding, gluing, snaps, hooks, buttons, VelcroTM or any other known connecting means.
  • connecting means as buttons 113 located on the elastic sock or sleeve 110 which can be inserted and secured within slits 223 on the apparatus 200.
  • the number of connecting means 113 can be at least one but may be in an amount sufficient to connect the elastic sock or sleeve 1 10 to the wrap 200, 220.
  • the area of elastic sock or sleeve 110 is connected or joined to the area (shown in FIGS. 20-21) on the inventive therapeutic compression apparatus 200 located above the along the calf portion and above the ankle area 226.
  • Other embodiments could include VELCROTM or loop and hook features.
  • the connecting means may be a set of buttons wherein a male portion of the button 113 located on the elastic sock or sleeve 1 10 which mates to the female opening portion 223 located on the therapeutic compression apparatus 200.
  • the female opening portion 223 is a slit aperture but it could be any other type of aperture or if the connecting means was a snap it would be the combination of the female and male portions of the snap.
  • Other connecting means could include snaps, hooks, buckles, straps, zippers and other combinations of known connecting means.
  • the inventive therapeutic compression apparatus has two wraps and bladders 202, 302 connected y an elastic knee sleeve 650 so that the apparatus is a full leg apparatus. Also shown is a separate inventive foot therapeutic compression apparatus 500 connected to the same inflation means 150 as the full leg therapeutic compression apparatus.
  • the single inflation means can sequentially inflate, hold, deflate and other combinations of each of the multiple connected bladders 202, 302, 502.
  • bladder 502 could be inflated then held, followed by bladder 202 inflated then held, followed by bladder 302 inflated then held, followed by bladder 502 deflated for a period of time, followed by bladder 202 deflated for a period of time, followed by bladder 302 deflated for a period of time, and then the cycle repeated for a period of time.
  • This method of inflation and deflation, and holding pressure where applicable, can be employed in all the embodiments shown and not shown.
  • optional supports may be included on each inventive therapeutic compression apparatus 200, 300, 500 to reduce tearing of the wrap 220 or hook 222 when pulling the hook portion 222 off the loop portion 224. As seen in FIG.
  • the inventive therapeutic compression system 100 has sensors that measure the positioning and movement of the inventive therapeutic compression apparatus 200, 300, 500. Such sensors could be interpreted to give readouts (via the interface, a plug-in to a computer, or sent to an app) to the user or clinician as to the compliance, activity (pedometer to measure steps, stairs climbed, etc.), and give advice/alerts to improve the treatment.
  • the inventive therapeutic compression apparatus 200, 300, 500 would be programmed to automatically adjust the type and level of compression administered- for example, it is known in the art that while walking static compression is adequate for lower- leg compression therapy so if the sensors detect that the user is walking it would maintain a static, non-intermittent compression of the garment.
  • the senor senses that the lower leg is not walking and is at rest it could either alert the user to switch to intermittent compression or could automatically switch over to intermittent compression to promote blood flow.
  • the sensors would be able to measure skin fibrosis and adjust the level of compression required to improve swelling reduction.
  • the sensors described above are non-limiting and could be non-digital or digital means may also be employed.
  • a motorized pump and digital display may be used.
  • the valve may include digital or electric means to change or modify pressure at a set rate or intervals or based on feedback from the monitoring means.
  • the system may include various sensors and monitors. Other sensors could be time set for instance if the system was rented so that the system would stop working once the sensor triggered that the rental days or rental hours had expired. In this instance, the sensor could be reset if additional rental time was purchased.
  • the inventive therapeutic compression system 100 may be used to treatment a patient post-operation, such as post-operative sclerotherapy procedures.
  • Post-operative sclerotherapy treatment can also be effective with thigh inventive therapeutic compression apparatus 300 wherein a lateral bladder is closed via a closing means (shown as weld lines 316 in FIG. 19) and either remains in a non-inflated state or may be slightly inflated to a lower pressure level, or could be inflated to any pressure level desire by the patient.
  • a medial bladder is inflated as part of the post-operative treatment plan to apply compression and pressure to the treatment site.
  • the lateral bladder 302B may be inflated at manufacture to a set pressure level or not inflated and remain in an uninflated state when in use.
  • he lateral bladder 302B is connected to the inflation means 150 via an inflation port 302B and hose 160 (160B or as applicable 160C, 160D, 160E, or 160F or higher depending on the total number of separate bladders on the user subject to the sequential compression), and the lateral bladder 302B may have a different pressure level than the pressure within the medial bladder 302A.
  • hose 160 160B or as applicable 160C, 160D, 160E, or 160F or higher depending on the total number of separate bladders on the user subject to the sequential compression
  • the lateral bladder 302B can be separately inflatable or inflatable through an inflation means 150 including port 312A (309A), 31 IB, such as but not limited to a one-way valve or other desired inflation/ deflation configuration.
  • the lateral bladder 302B can also be configured and adapted to provide a differing pressure from the medial bladder 302A.
  • the lateral bladder 302B is separate and not connected to the medial bladder and thus in this embodiment, the medial bladder 302A is inflated as part of the post-operative treatment plan 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 back or lateral portion of the user's thigh.
  • the inventive therapeutic compression system 100 may be used for other treatments such as tissue swelling, arterial and/or venous ulcers, lymphedema, CVI, DVT or any other vascular related issue.
  • the inventive therapeutic compression apparatus 200, 300, 500 may be placed by the patient, practitioner or caregiver on the chosen limb, such as for instance the leg and fastened around the limb of the patient. Moving in an upward or downward position from the knee and/or hip and/or foot, the patient, practitioner or caregiver fastens or secures the fastening tabs up or down to the limb. If there are additional optional straps located on the proximal end of the apparatus the first strap should be closed or secured in a tight fashion so that the inventive therapeutic compression apparatus 200 fits snugly but not too tight and the second strap should be closed or secured in a tight fashion so that the inventive therapeutic compression apparatus 200 tits snugly but not too tight.
  • the patient, practitioner or caregiver then removes the valve cap 213 from the valve located on the inventive therapeutic compression apparatus 200 thus opening the inflation port 212 (212A, 212B), namely the female slip luer 209.
  • the patient, practitioner or caregiver selects a pressure amount of value on the display 157 or dial of the inflation means 150 depending on the treatment and whether the patient will be walking, sitting, lying down or traveling in a vehicle, train or airplane.
  • the corresponding umbrella valve or switch is activated such that the pressure is thereafter maintained (closed position) or modified so as to maintain the pressure as it changes with the activity or altitude when in use).
  • the patient, practitioner or care-giver then inserts an end of the tube 160 portion such as the male luer slip 161 into the inflation port 212 on the inventive therapeutic compression apparatus 200, presses the ON- OFF button 149 of the inflation means 150 or uses the hand pump 165, and the air or fluid is increased to inflate the bladder 202 and thus achieve a desired pressure amount or valve.
  • this inflation means may be a hand pump, electric pump, battery- operated pump, remote controlled pump, air pump, gas pump, or any other known inflation means.
  • inventive therapeutic compression system 1 00 described herein can be used for any suitable condition treatable by compression therapy and the like.
  • inventive system including a therapeutic compression apparatus 200 in accordance with the present invention can be used for compression of the venous system for the treatment of swelling, venous and arterial ulcers, CVI, DVT, for the treatment of lymphedema (where it is circulation of fluids in the lymph system rather than in the venous system that is promoted), and the like.
  • the pressure levels can be either the same or different or the line pressure can be the same but the interface pressure can be adjusted with the shaping of each of the bladders (whether shape or combination of spot welds and/or line welds to form a gradient pressure profile).
  • the order of first inflation could be reversed in that the tube from the inflation means could be connected to the thigh inventive therapeutic compression apparatus 300 and then a tube connects the thigh inventive therapeutic compression apparatus 300 and the lower leg inventive therapeutic compression apparatus 200 so that the thigh inventive therapeutic compression apparatus 300 is inflated first, followed by the lower leg inventive therapeutic compression apparatus 200 and then the lower leg inventive therapeutic compression apparatus 200 is deflated (partially or entirely) followed by deflation of the thigh inventive therapeutic compression apparatus 300.
  • the first inventive therapeutic compression apparatus is an ann or hip or torso inventive therapeutic compression apparatus followed by the thigh inventive therapeutic compression apparatus 300 or a lower leg inventive therapeutic compression apparatus 200 and any other combination of another limb inventive therapeutic compression apparatus.
  • the method of use includes one inflation means, one tube or hose connected to the inflation means and the first inventive therapeutic compression apparatus (in this instance the lower leg inventive therapeutic compression apparatus 200), a second tube connected to the first and second or third inventive therapeutic compression apparatus (in this instance a third inventive therapeutic compression apparatus 300) and then a tube or hose connected to an exhaust port in the inflation means and the second inventive therapeutic compression apparatus (in this instance a thigh inventive therapeutic compression apparatus 300).
  • first inventive therapeutic compression apparatus in this instance the lower leg inventive therapeutic compression apparatus 200
  • a second tube connected to the first and second or third inventive therapeutic compression apparatus in this instance a third inventive therapeutic compression apparatus 300
  • a tube or hose connected to an exhaust port in the inflation means and the second inventive therapeutic compression apparatus in this instance a thigh inventive therapeutic compression apparatus 300.
  • the thigh inventive therapeutic compression apparatus 300 and the lower leg inventive therapeutic compression apparatus 200 are connected to the other via a tube or hose and one inventive therapeutic compression apparatus (in this instance the lower leg inventive therapeutic compression apparatus 200) is connected to the inflation means via a separate second tube or hose and a third tube or hose connects the second inventive therapeutic compression apparatus (in this instance the thigh inventive therapeutic compression apparatus 300) to the inflation means or an exhaust port.
  • one inventive therapeutic compression apparatus in this instance the lower leg inventive therapeutic compression apparatus 200
  • a third tube or hose connects the second inventive therapeutic compression apparatus (in this instance the thigh inventive therapeutic compression apparatus 300) to the inflation means or an exhaust port.
  • the lower leg inventive therapeutic compression apparatus 200 is inflated first and holds at a determined pressure level, then (2) the thigh inventive therapeutic compression apparatus 300 is inflated and holds at a determined pressure level which inflation is administered via a tube or hose connecting the thigh inventive therapeutic compression apparatus 300 and the lower leg inventive therapeutic compression apparatus 200, then (3) the thigh inventive therapeutic compression apparatus 300 is deflated (either entirely or just a lower pressure level) via a tube or hose connected to an exhaust port or release port in the inflation means and thereafter (4) the lower leg inventive therapeutic compression apparatus 200 is deflated (either entirely or just a lower pressure level).
  • oilier embodiments may employ an exhaust port or release port integral to the inventive therapeutic compression apparatus themselves, such as part of or near the inflation port 212, 312 in an inventive therapeutic compression apparatus 200, 300.
  • the pressure level could be either constant static status or an intermittent varying pressure status.
  • the pressure levels can be either the same or different or the line pressure can be the same but the interface pressure can be adjusted with the shaping of each of the bladders (whether shape or combination of spot welds and/or line welds to form a gradient pressure profile).
  • first inflation could be reversed in that the tube from the inflation means could be connected to the thigh inventive therapeutic compression apparatus 300 and then a tube connects the thigh inventive therapeutic compression apparatus 300 and the lower leg inventive therapeutic compression apparatus 200 so that the thigh inventive therapeutic compression apparatus 300 is inflated first, followed by the lower leg inventive therapeutic compression apparatus 300 and then the lower leg inventive therapeutic compression apparatus 200 is deflated (partially or entirely) followed by deflation of the thigh inventive therapeutic compression apparatus 300.
  • first inventive therapeutic compression apparatus is an arm or hip or torso inventive therapeutic compression apparatus followed by the thigh inventive therapeutic compression apparatus 300 or a lower leg inventive therapeutic compression apparatus 200 and any other combination of another limb inventive therapeutic compression apparatus.
  • the user checks to make sure there is room for inflation and gradient compression such as places two fingers between the sock 1 10 and the therapeutic compression apparatus 220.
  • the user then chooses either the inflation means 150 of powered pump 165 or a manual hand pump 400. If choosing the manual pump the user chooses the pressure range on the dial 410, inserts the male slip luer 161 into the inflation port 212, specifically the female luer 209, and then pumps the bulb 420 until the therapeutic compression apparatus is inflated and then removes the male slip luer 161 which triggers the valve 290 to move in an upward direction and seals the bladder 202.
  • the user puts on the securing means of the belt 180, adjusts it using the adjusters 182, and then buckles it using 185 A, 185B.
  • the user then opens the cap 21 1 and inserts male slip luer 161 into the inflation port 212, specifically the female luer 209, and then presses the pump 156 on, possibly choosing a set pressure amount (static or intermittent) and once the therapeutic compression apparatus is inflated, removes the male slip luer 161 which triggers the valve 290 to move in an upward direction and seals the bladder 202.
  • the user can place the cap 21 1 on top of the female slip luer 209 to further seal the bladder 202.
  • the inventive therapeutic compression apparatus 200 When inflated the inventive therapeutic compression apparatus 200 has a SSI of at least about 10 or greater and the elastic portion 204 conforms to the anatomy of the knee such that the inventive lower leg therapeutic compression apparatus 200 has uniform compression and pressure along the entire lower leg and even the upper calf area so as to eliminate a gap at that anatomical area and the inventive lower leg therapeutic compression apparatus 200 can assist in treating, reducing and even preventing tissue swelling, lymphedema, venous and arterial ulcers, CVI and DVT as well as improve circulation at the foot and lower leg and upper leg of the user.
  • the possible therapeutic compression apparatus to be used in the inventive system are only limited to the target limbs or body part to be compressed or subject to pressure treatments in order to improve circulation and reduce and treat tissue swelling, lymphedema, CVI, DVT, arterial and/or venous ulcers or any other medical issue as well as improve and treat circulation disease or problems in the foot, calf, lower and upper leg as well as other body parts such as wrist, arm, torso, shoulder and any other target area on the patient or user.
  • the therapeutic compression apparatus could be for a foot, ankle, calf, lower leg, knee, thigh, groin, hip, buttocks, torso, stomach, back, shoulder, chest, arm, elbow, wrist, hand, neck, head, or the like and any combinations thereof.
  • the inventive system of the instant invention described herein solves many problems with the prior art and in the industry and treatment of patients.
  • the therapeutic compression apparatus 200, 300, 500 may be applied on the patient's body part by the patient without the need or requirement of a skilled caregiver as required by current devices and apparatus. It further is capable of maintaining sufficient effective pressure without overpressure complications, maintaining compression and pressure and the like.
  • the inventive therapeutic compression apparatus 200, 300, 400 of the instant invention of the therapeutic compression system 100 includes a universal inflation port which is configured to be capable of connecting to more than one source of compression or inflation means such that the patient could vary treatment through varying the inflation source and inflation means for the treatment apparatus or device.
  • a patient using the inventive therapeutic compression apparatus 200, 300, 500 of the instant invention can alternate between a manual or mechanical or electrical inflation means or source of inflation and pressure. Further, the patient can alternate between static or intermittent inflation and pressure when using the inventive system and inflation means 150 pumps.
  • the inventive therapeutic compression system 100 also reduces the problem of lack of mobility in that the inflation means is not integral to the inventive therapeutic compression apparatus and instead the patient can walk about and go to work, school, recreational activities.
  • the inventive system 100 includes inflation means which is not tethered to a wall outlet and instead is a main pump which is configured to either apply constant static pressure at one pressure level, or constant at static pressure at a choice of different pressure levels, or intermittent pressure at one level, or intermittent pressure at multiple pressure levels, or a choice of either constant static pressure level and intermittent pressure levels.
  • the ability to switch between pressure levels and/or switch between constant static pressure and intermittent pressure promotes a more effective treatment for CVI, DVT and/or lymphedema, tissue swelling, poor and decreased circulation, arterial and venous ulcers and other treatments.
  • Another embodiment may include a variety of sensors so that the pump on its own may adjust the pressure level or switch from intermittent pressure level (which the patient is sitting or the kg is elevated) to constant static pressure (when the patient is walking or running).
  • Such sensors may be connected to a database accessible by a medical provider which could remotely adjust the pressure levels or status change from intermittent to constant or the reverse.
  • the inventive system 100 may be used as a prophylaxis or as part of a treatment plan which is easy for the patient to use at home or work (outside a hospital setting or with the aid of a medically trained professional as noted above) which is ambulatory so that the patient can walk and return to life activities.
  • the inventive system can be used as a prophylaxis for swelling in any body part.
  • the system can also be used in pre-operative and post-operative treatments for many different surgeries including but not limited to knee surgeries, hip surgeries, TKR, KRA, n-m.,HRA, sclerotherapy and many other surgical procedures regarding other libs or body parts which could have an increased risk of CVI and/or DVT.
  • the inventive system 100 may be used to prevent, reduce or even treat DVT and the system is practical to use, mobile and easy to be administered by the patient post-operative total knee replacement of any other knee, hip or leg surgery. Further the inventive system could also be used in HPIC treatment and this inventive system can be easily administered by a patient in the home setting as well as a rehabilitation setting or nursing home setting as it allows the patient to be ambulatory.
  • the inventive system includes an inflation means which is less bulky than known systems. The user can thus return to life activities sooner than with known compression systems, prophylaxis systems and other treatment systems which limit the user's ambulation both within and outside the home due to power constraints (electrical, mechanical, battery, manual, etc.) on the system.
  • the inventive system may include one or more sensors to measure the user's limb in regard to pressure on the skin, motion of the limb, blood pressure, tonometer sensor, GPS sensor, and the like while the system is in use. Such sensors may be connected to the inflation means so as to regulate the pressure from the inflation means and either increase or decrease the current pressure level(s).
  • Such sensors may also be connected to a database and possibly accessible to a medical professional and/or the user in real time or as saved over time.
  • the system includes multiple of compression garments which each inventive therapeutic compression apparatus may have separate active pressure levels at the same time or can vary over time and based on the user's activities as well as individual bladders 202A, 202B, 202C, 302A, 302B, 502 may have separate active pressure levels at the same time or can vary over time and based on the user's activities.
  • the inventive therapeutic compression system 100 includes multiple of compression apparatus 200, 300, 500 with each therapeutic compression apparatus 200, 300, 500 may have separate active pressure levels at the same time or can vary over time and based on the user's activities.
  • the inventive therapeutic compression apparatus 200, 300, 500 has a 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 reducing or eliminating a gap or opening between the limb and the inventive therapeutic compression apparatus 200, 300, 500 (which such gap or opening would reducing the compression or pressure on the user thereby reducing the effectiveness of the treatment) and therefore there is increased or more uniform compression and pressure along the entire target limb such as the lower leg and even the upper calf area.
  • the inventive therapeutic compression apparatus 200, 300, 500 including an elastic portion reduces or eliminates a gap at that anatomical area (such as the ankle, foot, knee, groin, hip, wrist, elbow, shoulder, sacral, neck, and other areas along the target limb) and thus the inventive therapeutic compression apparatus 200, 300, 500 can assist in treating, reducing and even preventing tissue swelling, lymphedema, venous and arterial ulcers, CVI and DVT as well as improve circulation at the target limb such as the foot and lower leg and upper leg of the user.
  • anatomical area such as the ankle, foot, knee, groin, hip, wrist, elbow, shoulder, sacral, neck, and other areas along the target limb
  • the inventive therapeutic compression apparatus 200, 300, 500 includes an inelastic portion (with or without an inflated bladder) having a SSI of greater than about 10, in the range of about 10 to about 50, and an elastic portion configured to confirm to a target body area such as a foot, ankle, knee, groin, hip, wrist, elbow, shoulder, torso, sacral, neck and any other body part.
  • the inventive therapeutic compression apparatus 200, 300, 500 may have one set level of pressure or compression such as shown in FIGs. 9-10 and 13 or may employ gradient compression as shown in FIGs. 1-2, 11, 14-15 and 20-21 which is particularly effective with more pressure being applied more distally (further) from the heart with the pressure reducing proximally (closer).
  • the inventive therapeutic compression apparatus 200, 300, 500 (whether set or gradient compression) in use assists in reducing the tissue swelling and water volume within the limb to manage the amount of leg swelling.
  • the inventive therapeutic compression apparatus 200, 300, 500 is more effective than known compression stockings, sock, bandages and even devices as it applies compression and a static stiffness index of at least greater than 10 to improve venous hemodynamics and reduce edema because (not being bound by theory) of the underlying stiffness and elasticity of the inventive therapeutic compression apparatus 200, 300, 500. It overcomes the many disadvantages of the known and conventional compression products.
  • inventive therapeutic compression apparatus 200, 300, 500 overcomes the problems of known and conventional compression products that do not have sequential inflation and deflation thereby reducing the dynamic compression effect, but in contrast the inventive therapeutic compression apparatus 200, 300, 500 includes sequential compression by inflating and deflating the bladders 202, (202A, 202B, 202C), 302 (302A, 302B), 502.
  • inventive therapeutic compression apparatus 200, 300, 500 solves this and other problems by maintaining and improving both static and dynamic compression for the treatment of arterial ulcers, venous ulcers, poor circulation, tissue swelling, lymphedema, CVI and DVT.

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  • Health & Medical Sciences (AREA)
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Abstract

Un appareil de compression thérapeutique selon l'invention pour un membre corporel comprend au moins une enveloppe ayant au moins deux vessies conçues pour appliquer une compression ou une pression sur le membre ainsi qu'un orifice de gonflage universel pour chaque vessie pouvant être raccordé à un moyen de gonflage statique ou intermittent, un moyen d'étanchéité étant en outre conçu pour présenter une position ouverte et une position fermée, la position fermée maintenant ladite au moins une vessie dans un état gonflé ou dégonflé, la position ouverte étant adoptée lors d'un accouplement au moyen de gonflage de sorte que ladite au moins une vessie présente le même état de gonflage que le moyen de gonflage. Un procédé comprend les étapes consistant à gonfler et à dégonfler chacune des vessies à un niveau de pression identique ou différent, permettant en outre de gonfler et de dégonfler séquentiellement chaque vessie séparée.
EP23892494.8A 2022-11-15 2023-11-15 Appareil de compression thérapeutique à plusieurs vessies, système et procédés d'utilisation Pending EP4618929A1 (fr)

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US202263425662P 2022-11-15 2022-11-15
PCT/US2023/079854 WO2024107864A1 (fr) 2022-11-15 2023-11-15 Appareil de compression thérapeutique à plusieurs vessies, système et procédés d'utilisation

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GB201219244D0 (en) * 2012-10-26 2012-12-12 3M Innovative Properties Co Monitoring system for use in compression therapy
US20140276296A1 (en) * 2013-03-15 2014-09-18 Compression Therapy Concepts, Inc. Deep Vein Thrombosis Prevention Garment Having Integrated Fill Tube
CN116261442A (zh) * 2019-05-02 2023-06-13 昇科股份有限公司 治疗性压迫系统及其使用方法
WO2021081453A2 (fr) * 2019-10-23 2021-04-29 Sun Scientific, Inc. Appareil de compression thérapeutique, système et procédés d'utilisation

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