Pre-formed absorbent wound dressing with bladder, compression system and methods of use

Abstract

A pre-formed absorbent compression wound dressing with bladder including a bladder and at least three other layers around the bladder being a porous hydrophilic wound contact layer, an absorbent layer and a hydrophobic moisture transfer layer, as well as an optional wicking layer. The pre-formed absorbent compression wound dressing with bladder is shaped and pre-formed configured for application on a selected or target body part such as a foot, ankle, leg, calf, knee, thigh, hip, torso, chest, shoulder, arm, elbow, wrist, hand, neck, and head. An inventive compression system includes the pre-formed absorbent compression wound dressing with bladder with an offloader, bolster, medicated layer or a therapeutic compression apparatus.

Description

PRE-FORMED ABSORBENT WOUND DRESSING WITH BLADDER, COMPRESSION SYSTEM AND METHODS OF USERELATED APPLICATIONS

[0001] The present application claims priority from U.S. provisional application Serial No. 63 / 683,685 filed August 15, 3024 entitled “Pre-formed Absorbent Wound Dressing With Bladder, Compression System, and Methods of Use” and is a continuation-in-part of U.S. provisional application Serial No. 63 / 696,723 filed September 19, 2024 entitled “Pre-formed Absorbent Wound Dressing, Compression System, and Methods of Use”, and a continuation-in-part of PCT / US2024 / 042582 filed August 15, 2024 entitled “Pre-formed Absorbent Wound Dressing, Compression System and Methods of Use, the entire contents of which are hereby incorporated herein by reference for all purposes.BACKGROUND OF THE INVENTIONI. Field of the Invention

[0002] The subject invention is directed generally to compression wound dressings and more particularly to a pre-formed absorbent wound dressing including a bladder for applying compression to a body part such as a foot, ankle, calf, lower leg, knee, thigh, full leg, hip, torso, chest, shoulder, arm, elbow, wrist, hand, neck, head or any body part of an individual, optionally in conjunction with a bolster dressing, elevation member, or another dressing with a medication imbedded within it for use to treat a wound during trauma or for post-surgical uses such as knee or hip replacements or in the treatment of conditions such as ulcers, vein thrombosis (DVT), chronic venous insufficiency (CVI) and lymphedema.IL Background of the Related Art

[0003] Wound dressings for centuries has concentrated on cotton or gauze bandages that absorb exudate from a wound, but then have the problem of leakage onto the user’s clothes, bedsheets, furniture and other objects. There are a number of tapes and bandages that are available for application to a wound site or ulcer but they require a skilled medical professional to apply in rolled form onto the target body part with enough tension to keep the wound dressing on the target body part as the person goes about their daily life with walking, moving arms, head, and other body parts. Further, in cases of emergency the medical professional needs a wound dressing that can be applied immediately to the wound site without the time and skill of rolling bandages and wound dressings on the target body part. The anatomy and structure of the foot, leg, though, hip, torso, arm, shoulder, head and other body parts cause problems with adhesion and pressure of known wound dressings complicating any treatment and healing, as well as leakage or exudating of the wound site onto the individual’s sock, clothing, bedsheets, couch and the like.

[0004] Wounds or ulcers on the foot are typically hard to treat due to the structure of the foot and fact that the foot is moved and under pressure when walking. Conventional bandages do not adhere to thefoot, either on the top of the arch or below on the sole of the foot Further, 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 for example a diabetic individual. The structure of the foot is also problematic in keeping a bandage or wound dressing in place and adhered to the foot On the other side of the body any wound or ulcer on the head, face, scalp or neck is likewise hard to treat due to the structure of the head and bleed factors due to the structure of skin over the skull and bony prominences of the head. Any wound or ulcer bleeds more on the foot or head or for example elbow of hand than a similar wound or ulcer on other body parts. A need exists for a pre-formed absorbent wound dressing for body parts to address wounds, exudate and application to the target body part at initial dressing as well as being able to open and check on the wound after application while being able to reclose said wound dressing by the individual themselves without a skilled medical provider while at the same time applying therapeutic compression onto the wound site.

[0005] Diabetic ulcers may affect the foot resulting in exudating wounds. These ulcers may be 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 it’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). It is estimated that about 15% of people with diabetes in the United States will get a foot or toe ulcer and around 14% to 24% of people with diabetes in the U.S. need an amputation after they get an ulcer. Diabetic foot ulcers are the leading cause of foot amputations. As of 2020, of the estimated 537 million people worldwide who had diabetes about 19% to 34% will develop a diabetic foot ulcer in their lifetime. Unfortunately, of those individuals who develop a diabetic foot ulcer, approximately 20% of them will require lower-extremity amputation, either minor (below the ankle), major (above the ankle), or both. More than 80 percent of amputations start with a foot ulcer. Even more extreme, of those who develop a diabetic foot ulcer about 10% will die within one year of their first diabetic foot ulcer diagnosis. Further, 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.

[0006] Individuals are also at a higher risk of getting foot and toe ulcers if they have any of the following conditions: blood circulation issues, heart disease, obesity, a foot condition like a bunion or hammertoe, kidney disease, and some lifestyle behaviors of using tobacco and alcohol. Ulcers are open wounds in the skin that can take on almost any shape. Some shapes are more common than others on specific parts of thebody. For example, ulcers on the foot or toe might be shaped like a crater or a wedge. The ulcer can go down even into the bone resulting in amputation or even death.

[0007] Neurotrophic ulcers occur primarily in people with diabetes, although they can affect anyone who has impaired sensation in their feet. They can be found anywhere on the feet but typically develop on the parts of the feet and toes that are most sensitive to weight (pressure points). Neurotrophic or diabetic ulcers on the foot can occur on the sole of the foot, heel, and under the toes as well as the top of the arch. While neurotrophic or diabetic ulcers don’t cause pain based on the lack of feeling on the foot due to neuropathy, this can be worse because the individual will not realize they have an ulcer until it is weeping or exudating. Further, autonomic neuropathy is associated with decreased production of sweat and components of the natural moisturizing factor leaving the skin dry that leads to disruption of the epidermal barrier resulting in dryness and the presence of fissures or cracks that may become a portal of entry for bacteria on the foot and even in between the toes. Areas with blisters, cuts, scratches, redness, or hemorrhage are indicative of local damage from local trauma, friction, or shear commonly caused by walking barefoot and poorly fitting footwear. Callus formation is a reaction to increased local pressure and heralds impending skin breakdown and ulceration. Yet another complication is a fungal infection which is not uncommon in the feet of diabetics. The most occlusive areas are the fourth and fifth toe web spaces allowing excessive moisture accumulation that promotes fungal proliferation as evident by skin maceration in the area as yet another complication on diabetic foot Diabetic foot ulcers that aren’t treated promptly can cause major complications. In addition to being significantly more susceptible to ulceration, a diabetic patient will also generally take a significantly longer period for such ulceration to heal. It is not uncommon for it to take 10-12 weeks for an ulcer on the foot of a diabetic patient to heal even when using a cast or other more permanent treatment or therapy where the individual may be on crutches with complete off-loading of any weight or pressure on the foot. In comparison, such an ulcer would likely heal in less than seven days in a healthy individual. A need exists for a wound dressing that is easy to apply by the individual alone or by a medical professional, exudates the ulcer or wound and applies compression thereby improving circulation, healing times, reducing complications and assisting in healing and pain reduction overall.

[0008] Arterial ulcers may be caused by a condition called peripheral arterial disease which reduces blood flow to your extremities. When this happens the foot tissue may start to die. The ulcers that form from reduced blood flow are called arterial ulcers. Arteries are blood vessels that transport blood from the heart to the rest of the body, inducting the feet and toes. Anyone can get an arterial ulcer, but individuals who smoke or have diabetes, high blood pressure or high cholesterol are at higher risk. Unlike neurotrophic ulcers, arterial ulcers can form on many parts of the foot, including on the tips of the toes, between the toes typically where the toes rub together, the nail bed on the top of the toes, and the bony parts of the feet and toes that rub against bed sheets, socks or shoes, and even.

[0009] Both diabetic ulcers and arterial ulcers are wounds or open sores that do not heal, or otherwise recurrepeatedly, and cause persistent swelling as well as burning, itching, irritation and discoloration of the skin. Conventional treatment and therapy for such ulcers generally includes topical protection of the wound, as well as compression and antimicrobial treatment of the affected area. Other treatment plans include draining the ulcer or wound site, orthotics to try to reduce or shift pressure points on the foot, removing pressure from the area by wearing a cast, elevation of the foot for extended periods of time (which is difficult for individuals working), debridement and removal of infected tissue, plantar exostectomy which is removal of parts of the sole of the foot, shaving or removing bones that in infected, tenotomy which is removal of scar tissue that has developed at the ulcer or wound site, and even reconstructive surgery using skin grafts to replace the infected ulcer or would site.

[0010] Other wounds that need immediate attention may be emergency situations such as automobile crashes, explosions, fires, and other traumas. The medical professionals in that instance may be an Emergency Medical Technician in an ambulance arriving at the scene of a trauma and needing to control bleeding immediately. Time is of the essence in such situations and a pre-fbrmed absorbent wound dressing including a bladder for compression would greatly enhance bleeding control and reduce risk of contamination at the wound site. For example, head wounds bleed at a higher rate than leg wounds due to a large amount of tiny arteries and veins serving the individual muscles and skin on the head, including superficial arteries and veins close to the surface of the skin on the head. It is noted that sometimes even small lacerations to the head can lead to very large amounts of bleeding that need to be controlled immediately. Thus a need exists for a pre-formed wound dressing including a compression bladder to assist in stopping or controlling bleeding for application to the scalp and / or head.

[0011] Further wounds that need attention include various post-surgery wounds such as by way of example only liposuction, sclerotherapy, knee and / or hip replacement, and any surgery on the foot, leg, hip, elbow, hand, arm, shoulder, torso, chest, neck and head or any other body parts. These wounds require exudation, removal of body fluids, keeping out infection, having some moisture but not too much to promote healing, and are prone to repeated replacement as well as slippage of the wound dressing on the body part if the patient is ambulatory and moving around, even if that movement is within a bed. Thus a need exists for a wound dressing with less slippage once applied to the target body area including a therapeutic compression bladder.

[0012] There are a number of tapes and bandages that are available for application to a wound site or ulcer but the anatomy and structure of the foot, ankle, leg, knee, though, hip, shoulder, arm, elbow, wrist, hand, neck and head causes problems with adhesion, pressure complicating any treatment and healing, as well as leakage or exudating of the ulcer onto the individual’s clothing, bedsheets, couch and the like. A need exists for a wound dressing on the foot, ankle, leg, knee, though, hip, shoulder, arm, elbow, wrist, hand, neck and head for ulcers or any type of wound including a therapeutic compression bladder to apply compression thereby improving circulation and overall healing. Notably, common wounds, scrapes, cuts and the like onthe foot, ankle, leg, knee, though, hip, shoulder, arm, elbow, wrist, hand, neck and head take longer to heal even in healthy individuals again due to the anatomy and structure of the target body part. Further complicating the situation may be traumas such as surgery, car accidents, explosions, fires, and other emergencies where there is massive bleeding and time is of the essence in order to stop the bleeding and triage the wound site whether on a bony prominence or certain anatomy as well as any other treated body part. These body parts would benefit with a wound dressing including a compression bladder to assist in controlling and / or stopping bleeding at the wound site.

[0013] A need exists for a wound dressing including a compression bladder for any wound on the foot regardless of whether the individual has diabetes, circulation issues or is a healthy individual with a foot wound. As of2015, costs related to diabetic foot ulcer s alone were greater than $1 billion annually and rising yearly. As of 2022 it was estimated that overall diabetes care in the U.S. accounts for an estimated $273 billion in direct and $90 billion in indirect costs annually. Foot complications such as ulcers and infections represent a major source of costs among people with diabetes, leading to higher rates of hospital admission, emergency department visits, outpatient visits and home health care utilization, and excess annual expenditures of 50% to 200% above the baseline cost of diabetes-related care. Advanced-stage ulcers cost upwards of $50,000 per wound episode, and direct costs of major amputation are even higher. These numbers likely underestimate the true economic burden of diabetic foot ulcers given out-of-pocket expenses, loss of productivity, and decreased employment associated with diabetic foot ulcers. A need exists for a treatment plan to improve healing times and outcomes while reducing complications such as infections and amputations for diabetic foot ulcers as well as arterial ulcers, while also improving function and quality of life and reducing health care costs. A further need exists for a wound dressing that includes a bladder for compression on the foot, leg or other body part to assist with healing and reducing complications.

[0014] For those individuals with circulation issues, foot and leg ulcers are problematic as the muscles, veins and arteries are not healthy in the individual’s leg or foot resulting in worsening ulcers. Normally, 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 However, 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). Treatment of CVI typically involves the use of compression stockings or medical hosiery to decrease chronic swelling. 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 bandage is applied with constant tension so as to produce graduatedcompression with the highest pressure at the ankle. However, the technique is difficult and is often done by highly skilled healthcare professionals.

[0015] The current method of treatment for ulcers, typically on the lower leg, foot, thigh, hip, torso, shoulder, arm, elbow, wrist, hand, neck and head includes placing a wound dressing over the ulcer or skin area to keep the skin moist and prevent infection from entering the open wound or sore and to assist in healing or closing the open wound or ulcer. Depending on the patient though this time frame can be much longer than days but lead into weeks or even months where the ulcer does not close or heal and in some patients the ulcer never fully heals or closes. Currently venous and related wound dressings are limited to various bandages and dressings that the care giver must wrap around the lower leg and then add some sort of securing means such as surgical tape or other medical grade tape. The care giver must learn how to wrap the dressing around the target ulcer skin area to keep it tight so that the open sore does not ooze onto the patient’s clothes or bed linens while not wrapping it too tight to inadvertently cut off circulation in the limb. This is a very long learning curve in managing the tightness at the right level for the caregiver to learn over time. The actual patient usually cannot apply the wound dressing themselves as they may be bed ridden or non-ambulatoiy. Thus, a need exists for an absorbent wound dressing that is pre-formed in the shape of a limb or extremity which includes a compression bladder for use in the treatment of wounds, post-surgical locations on the body, venous ulcers, CVI, lymphedema and DVT.

[0016] Further, the state of the art of bandages has been the same for centuries, using cotton and gauze material to absorb the exudate such as blood, pus, weeping edema and the like. Historically, wet-to-diy dressings have been used extensively for wounds requiring debridement. In 1600 BC, it is noted that linen strips soaked in oil or grease covered with plasters was used to occlude wounds. Traditional wound dressing products including gauze, lint, plasters, bandages (natural or synthetic) and cotton wool are dry and used as primary or secondary dressings for protecting the wound from contamination. Gauze dressings made out of woven and non-woven fibers of cotton, rayon, polyesters afford some sort of protection against bacterial infection. Some sterile gauze pads are used for absorbing exudates and fluid in an open wound with the help of fibers in these dressings. These dressings require frequent changing to protect from maceration of healthy tissues and thus are costly and time consuming, both for the patient and the medical profession. Further, due to excessive wound drainage, dressings become moistened and tend to become adherent to the wound making it painful when removing.

[0017] Generally in the 1980s- 1990s wound dressings developed to facilitate the function of the wound rather than just to cover it. These dressings are focused to keep the wound from dehydration and promote healing. Current conventional wound dressings may be based on synthetic polymers and are classified as passive, interactive and bioactive products. Passive products are non-occlusive, such as gauze and tulle dressings, used to cover the wound to restore its function underneath. Interactive dressings are semiocclusive or occlusive, available in the forms of films, foam, hydrogel and hydrocolloids. These dressings actas a barrier against penetration of bacteria to the wound environment. Current wound dressings are supposed to provide moisture while also absorbing fluids and include hydrogels, hydrocolloids, alginates, synthetic foam dressings, silicone meshes, tissue adhesives, vapor-permeable adhesive films and silver / collagen containing dressing. However, the need to combine the wound dressing with compression therapy remains problematic for both the user and the medical profession. The level of compression and the maintenance of that compression level needs to be addressed while at the same time a wound dressing underneath the compression garment has to exudate the wound but still maintain some level of air. Thus a need exists for a wound dressing including a bladder, which bladder may be gradient so that gradient pressure and / or gradient compression is applied to the target body area.

[0018] Historically for the last century or longer bandages were the main wound dressing. There are three main components to typical wound dressing, notably though not limited to venous ulcer wounds or lymphatic wounds or wounds related to edema and leg swelling. Bandages was key role to do multiple steps in the manage of wound care. Sometime the bandage acted as a wound dressing, absorbing the drainage aka exudate management while also providing very limited compression therapy. Bandages for the last 30 years included wound dressing technology adding optional materials (alginates, foams, skin substitutes) and properties (silver impregnated). Bandages have progressed by adding multiple layers and improving the compression properties. Multi-bandage can absorb more fluid and have slower compression decay with more inelastic properties than a single layer gauze bandage. But the problem remains that the bandage, even if multiple layer, needs separate layers to manage the wound exit exudate and a then add a second or multiple layers for compression. This treatment plan requires a skilled care giver to do it properly and very importantly such compression bandages are not reusable. In use, such conventional and known compression bandages must be cut off to see the wound below the wrapper bandage. This in turn traps the patient into being seen by a clinician if there is treatment and severely limits the patients ability to engage in common tasks such as bathing, etc. Such a need exists for an absorbent bandage in combination with a compression bladder that can be removed by the patient without medical assistance and is reusable, both to save cost and time on behalf of the patient and all medical professionals such a clinicians.

[0019] Another problem exists especially with exudating or draining wounds in that any compression bandage once becoming wet in contact with the exudating liquid, loses most if not all compression levels. Further, the liquid is trapped against the skin of the patient causing discomfort, irritation, maceration or worsening of the symptoms, infection and other complications. Many wounds including post-surgical wounds and venous ulcers that exudate have metabolic waste and proteins that prevent healing so leaving the fluid in contact with the wound is counter-productive for healing. Having a waterproof backing layer is not sufficient as the wound still requires some level of measurable air to assist in healing. Thus a need exists for a wound dressing including a bladder that has measurable air while not promoting leakage onto the patient’s clothes or bedsheets or furniture, exudates the wound, applies compression therapy at a consistent level andis reusable.

[0020] From a lifestyle and economics view, in regard to venous wound care most visits to medical professionals such as clinicians are for everyday dressing changes and not for monitoring the progress of the wound, thereby causing increased costs (to the patient, the insurance company and even loss of other billable time for the medical provider) and time management of all involved. This creates a large burden to health care system due to medical professionals such as clinicians basically removing and reapplying compression bandages every few days for patients resulting in lost opportunity to do other procedures and cost to the insurance companies, Medicare, and the patient’s co-pays every few days for weeks, months or even years on end. For the medical professional who is tasked with removing and then applying a new compression bandage, he or she will cut off and remove the typically soaked foul smelling bandage with debris flying around and leaking liquids, pus, blood and the like, then cleaning off the exudating and foul-smelling wound site and finally having to wrap the new replacement compression bandage around and around the wound site. This is a messy, odorous and arduous procedure which the clinical or medical professional may repeat ever few days for every single patient, over and over again for weeks, months or even years. Further, the patient has multiple burdens on their time to travel to and from the medical office every few days, economic costs and notably reduced quality of life as not able to engage in everyday activities such as bathing and the like. In addition, the clinical or medical professional may need an assistant depending on the body part being treated as in certain cases a swollen leg can weight 100 pounds itself, which needs to be lifted while being conventionally bandaged. A need exists for a pre-formed wound dressing that the user himselflherself can apply with their own two hands, or a clinical or medical professional can apply without needing assistance from a second clinical or medical professional which includes a bladder for compression therapy.

[0021] The treatment using conventional compression bandages may not be effective for certain conditions such as lymphedema where the entire leg weeps resulting in drainage through the skin without a specific ulcer being present on the skin. Further, for some post-operative patients there is localized swelling or acute swelling or seepage from a surgery cut resulting in high level of exudate or liquid to be absorbed by the compression bandage. Again, in these instances the compression level of the compression bandages is significantly reduced or even eviscerated to zero compression. This a need exists for a wound dressing including a bladder that can compress the limb while absorbing exudate and fluids such as blood or pus while at the same time maintaining the target compression level. Indeed another problem with maintaining the compression level of a compression bandage is that once the immediate swelling is reduced then the compression level is directly reduced as the circumference of the limb is lower resulting in gaps and lower compression or zero compression.

[0022] Another conventional wound dressing of plasters or other such as the Unna boot may be helpful for the impregnated additives to assist healing, but such materials and wound dressings do not have compression. Such materials may be comprised of a pad or alternative wound contact dressing with impregnated materialsbut no compression therapy is available even when first applied, never mind when the initial swelling is reduced and then there is a gap between the skin of the patient and the set plaster or Unna boot.

[0023] The inventive pre-formed wound dressing including a bladder and the system solves these and other problems and fill many needs by providing a multi-layer system which is comfortable, non-stick, absorbent, and has backing layer that prevents strike through leakage onto the user’s clothes or other materials such as furniture while at the same time enabling vapor transfer so it is not occlusive which no build up in Co2 or bacteria growth, thus assisting in healing and pain relief while reducing complications to the patient and also providing cost savings to the user and the medical field as a whole. The inventive pre-formed wound dressing including a bladder and the system addresses these and other problems and issues for the medical field and the patient or user. A need for a wound dressing compression system that provides measurable air to the wound site, a compression level that is maintainable throughout the treatment plan, is capable of selfapplication by the patient including being able to remove the system and reuse it, is met by the inventive wound dressing compression system. Notably, anyone can properly place the wound dressing compression system on the user in a more effective way than known conventional compression bandages, which reducing edema and assisting in wound healing.

[0024] As stated above, many known wound dressing and bandages have added waterproof backings to assist in leakage of exudate problems, but for compression needs the waterproof backing reduces the compression levels. This is notably important for treating venous ulcers, pressure ulcers, and conditions such as edema, lymphedema, chronic venous insufficiency (CVI), Deep Vein Thrombosis (DVT), Cerebral Venous Thrombosis (CVT), and other types of conditions related to circulation, veins, and pressure points as well as emergency traumas being treated at the location outside a medical facility such as an automobile accident, fire, explosion, gun shooting, war zone and the like. Turning to certain treatment plans or methods to treat CVI and lymphedema, compression bandaging is typically employed but has several disadvantages. The bandaging is time consuming, and the effectiveness is limited to the skill of the provider. In some instances, bandages can be applied too tightly or too loosely and may slip from their intended position, decreasing their effectiveness. When this occurs, bandages must be taken off and reapplied, further increasing the time of application and decreasing the consistency of application of the therapy. Further, when the compression bandaging is on the leg, thigh, knee, arm, shoulder, torso, chest or other area of the body the bandaging slips down the leg, arm, or other body part when the user walks or moves around even in bed, possibly due to the anatomical shape of the tapering downward of the body part. Further, compression dressing is typically non-absofbent so therefore the patient has leakage or oozing from the wound such as a leg ulcer, that leaks onto bed sheets or clothes. Thus a need exists for a pre-formed absorbent wound dressing including a bladder to apply to the patient or user’s limb or extremity more easily than current wound dressings, avoid or reduce slippage and apply compression therapy to the wound site.

[0025] The effectiveness of many of the current compression therapies is also limited by the application ofcurrent products. Because current compression therapy is done either with manual wraps or electromechanical systems, they require either a skilled medical processional to apply and / or the need for the patient to be stationary for extended periods of time. Although stockings and / or bandages can be worn by patients and self-administered, they are very difficult for the patient to put on and pose a challenge for unskilled medical professionals to apply consistently and effectively. Again though, the stockings and / or bandages will slip down the thigh towards the knee or down the calf to the ankle once the user walks or moves around. The same is true for bandages or wound dressing on the lower or upper arm, torso, chest, neck or head as well.

[0026] CVI and lymphedema may also result in DVT, which is an affliction that causes blood clots particularly in the lower extremities of the legs. When a patient is not ambulatory, 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. However, when 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. It is estimated that in each year 2 to 2.5 million Americans are afflicted by DVT causing 600,000 patients to seek medical care with 300,000 patients succumbing to the effects of the pulmonary embolism. Among people who have had a DVT, one-third will have long-term complications (post-thrombotic syndrome) such as swelling, pain, discoloration, and scaling in the affected limb. Further, about one-third (about 33 percent) of people who are diagnosed with blood clots will have a recurrence within ten years. Thus, 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 cunent 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. Thus, a system and apparatus and method of use to treat DVT is needed including for a wound dressing including a bladder which dressing does not promote leakage onto the patient’s clothes or bedsheets or furniture, exudates the wound, applies compression therapy at a consistent level and is reusable.

[0027] Many of the current treatment options for CVI and lymphedema cause venous ulcers including the use of current known devices, apparatus, bandages, stocking, hosiery and the like. A venous ulcer is damage and loss of skin above the ankle that is the result of a problem with the veins in the leg. Venous ulcers typically develop on either side of the lower leg, above the ankle and below the calf. They are difficult to heal and often recur. They also develop on the thigh, on the inner portion of the leg thigh orouter thigh area as well as near the groin area on the leg. Further, venous ulcers may develop around the knee, behind the knee, along the sides and on the front of the knee as well. These venous ulcers may ooze blood, pus or other liquids thus requiring constant wound dressings applied to the target area or limb. Current wound dressings lack support or shape of the target limb or extremity and are instead typically flat and wrapped around and around the target limb or extremity. A need exists for a preformed absorbent wound dressing in the shape of the target limb or extremity including a bladder that applies compression therapy at a gradient pressure level and is reusable.

[0028] 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 long saphenous vein which runs along the medial side of the leg from foot to groin and the short saphenous vein which runs at the back of the calf from foot to knee are the major vessels of the superficial venous system. These vessels lie outside the fascia and are responsible for the venous return from the skin and subcutaneous fat. Compression on the long saphenous vein may be recommended in treatment of certain conditions whereas in other conditions there may be less compression recommendation on the long saphenous vein on the medial side of the leg and more compression recommended on the short saphenous vein of the leg which runs on the back portion of the leg, including the thigh. Communicating veins, sometimes called perforators because they perforate the deep fascia, join the two systems. The perforators, like the other veins in the leg, contain valves that permit the flow of blood in one direction only, from the outer or superficial system inwards to the deep veins.

[0029] The venous pressure at the ankle of a subject who is lying supine is around 10 mmHg, but on standing this will rise considerably due to an increase in hydrostatic pressure (equivalent to the weight of a vertical column of blood stretching from the point of measurement to the right auricle of theheart). During walking, as the foot is dorsally flexed, the contraction of the calf muscle compresses the deep veins and soleal sinuses thereby emptying them of blood. As the foot is plantarly flexed, the pressure in the veins falls, the proximal valves close, and the veins are refilled by blood passing through the perforators from the superficial system. During this cycle, in a normal leg, the distal valves of the dee veins and the valves of the perforators will ensure that the expelled blood can go in only one direction- upwards, back to theheart. Blockage or damage to the venous system will cause disruption to normal blood flow, which may manifest itself in a number of different ways according to the site and extent of the damage. If the valves in the superficial system are affected, venous return will be impaired and blood may accumulate in the veins causing them to become distended, leading to the formation of varicosities (varicose veins). Such varicosities may be located in the thigh, knee, calf, ankle or foot area of the user's leg.

[0030] If the function of the perforator valves is impaired, the action of the calf muscle pump will tend tocause blood to flow in the reverse direction into the superficial system increasing the possibility of damage to the superficial vessels. Again, the current compression therapy is done either with manual wraps or electromechanical systems, they require either a skilled medical processional to apply and / or the need for the patient to be stationary for extended periods of time. A need exists for a new system to treat such medical issues. There may be minimal blood flow upward into the thigh and the rest of the body, causing issues for the patient along the body including the thigh, calf, ankle and entire leg of the patient.

[0031] Following a deep vein thrombosis that results in complete or partial obstruction of a deep vein, the unrelieved pressures produced by the calf muscle pump on the perforator valves may cause these to become incompetent. If this occurs, there will be a large rise in the pressure in the superficial system, which may force proteins and red cells out of the capillaries and into the surrounding tissue. Here, the red cells break down releasing a red pigment that causes staining of the skin, an early indicator of possible ulcer formation. The ulcer formation can be in any part of the body, including the leg, groin, thigh, knee, calf, ankle and foot. Venous leg ulcers are generally shallow and red in color. The skin surrounding the ulcer is frequently discolored due to the staining described previously. Incompetent perforating vein valves can also cause malleolar venules to become dilated and appear as fine red threads around the ankle as well as the thigh, knee, calf or foot are of the leg or any area of the leg. This condition, called ankle flair, is also diagnostic of a venous ulcer. The condition may also be seen on the thigh, including the inner medial thigh area or outer lateral thigh area, or around the knee or groin area of the patient's body.

[0032] Arteries transport oxygen replenished blood from the heart to the rest of the body. Veins return oxygen depleted blood back to the heart. When the veins in the lower extremities of the body have difficulty transporting blood back to the heart, a condition develops called chronic venous insufficiency (CVI), also known as chronic venous disease (CVD). CVI. Most commonly occurs as the result of a blood clot in the deep veins of the legs, a disease known as deep vein thrombosis (DVT). CVI also results from pelvic tumors and vascular malformations, and sometimes occurs for unknown reasons. When a person is standing or sitting, blood in the veins of the legs flows in an upward direction. When the person walks, the calf muscles and muscles in the feet contract to squeeze the veins and push the blood upward. To keep the blood flowing upward and prevent it from flowing downward, the veins contain one-way valves. CVI occurs when these valves become damaged and allow the blood to leak back downward in the opposite direction. Such valve damage may occur as the result of aging, extended sitting or standing, or a combination of aging and reduced mobility. When the veins and valves become weakened and the blood does not properly flow up to the heart, blood pressure in the veins of the lower extremities can stay elevated for long periods of time, leading to CVI. This condition is more common in older individuals, and if not properly treated, can lead to burst capillaries, local tissue inflammation, internal tissue damage, varicose veins, ulcers, and open sores on the skin's surface. The burst capillariescan be seen on the patient's leg including the thigh, knee and groin. CVI can diminish the capacity of the venous system and increase the workload of the lymphatic system in the affected area. The lymphatic system must then transport larger volumes of water and protein to reduce the fluid load in the affected tissues of the legs, a situation which is especially difficult for patients with lymphedema, varicose veins, and other lower extremity pathology. One non-surgical option often used to help prevent or treat the leg extremity pathologies discussed above is the use of compression stockings. Compression stockings help prevent leg fatigue, ankle and foot swelling, spider veins, and varicose veins. They improve circulation in the legs, especially when used in conjunction with frequent exercise and leg elevation. Compression stockings maintain pressure on the legs while allowing for normal ambulation. Increasing pressure in the tissues beneath the skin reduces excess leakage of fluid from the capillaries and increases absorption of tissue fluid by the capillaries and lymphatic vessels. In addition, the increased pressure decreases the size of the veins, which causes the blood to flow faster and helps prevent it from pooling.

[0033] Compression stocking tightness typically varies between 15-50 mm HG. The tightness of a given stocking depends on its particular configuration-and class. For example, stockings having a compression pressure of 15-20 mm HG are considered light compression stockings. Class I stockings are 20-30 mm Hg, class II stockings are 30-40 mm Hg, and Class II stockings are 40-50 mm Hg. While such compression stockings are a commonly utilized non-invasive treatment of leg pathology, the issues they present are numerous. Wearing a tightly fitting stocking can be tedious or time consuming to put on, and may require help from another person if the wearer is injured, elderly, or has some form of disability. Any tight-fitting stocking to be worn on the thigh area has a harder time being put on as the user has to pull the tight-fitting stocking over the foot, ankle, calf, knee and finally up to the thigh area. Again, due to the shape of the thigh, these tight-fitting stockings will slip down the thigh at some point due to the user walking or moving about. In addition, the pressure applied by the stocking generally stays relatively constant during use without any option of increasing or decreasing the tightness level. As compression stockings are repeatedly worn, they lose elasticity and thus tightness over time. Once such prescribed elasticity and tightness is lost, the stocking is of little or no value, and needs to be replaced on account of its looseness, which requires buying a new pair to obtain the desired pressure. Further, given the shape of the thigh, the top or upper portion of the stocking must be very tight in order to prevent slippage down the thigh, which can in turn lead to complications of its own due to the excessive tightness. Typical compression stockings are also non-absorbent so require an additional wound dressing on the target area of the ulcer to be applied and then the compression stocking is pulled up over the target limb or extremity. A need exists for a pre-formed absorbent wound dressing in the shape of the target limb or extremity to be applied or placed over the ulcer including bladder for compression therapy.

[0034] Medical hosiery represents a useful and convenient method of applying compression to normalshaped legs in order to prevent the development or recurrence of leg ulcers. However, these stockings are of limited value in the treatment of active ulceration, bring difficult to apply over dressings. In such situations compression bandages currently represent the treatment of choice. Compression bandages apply a pressure to the limb that is directly proportional to bandage tension but inversely proportional to the radius of curvature of the limb to which it is applied. This means, therefore, that a bandage applied with constant tension to a limb of normal proportions will automatically produce graduated compression with the highest pressure at the knee. This pressure will gradually reduce up the thigh as the circumference increases.

[0035] As can be readily appreciated, it is cumbersome and difficult to apply uniform tension to the compression bandage as it is applied to the treated limb, and thus this is accomplished only by highly skilled caregivers. Moreover, once secured to the treated limb, care and attention must be given to ensure that the bandage does not slip or become displaced as this will lead to multiple layers forming, which in turn may lead to localized areas of high pressure, which can place the patient in direct risk of skin necrosis. Further, as most compression dressings are non-absorbent, the provider must apply two layers of dressing, first an absorbent wound dressing and then a compression dressing, requiring even more skill for both dressing applications. Thus a need exists for one piece which is both a wound dressing including a bladder to apply compression therapy while also reducing leakage onto the patient’s clothes or bedsheets or furniture, exudates the wound, and is reusable.

[0036] DVT is widely recognized as a major risk factor facing patients who undergo total hip arthroplasty (THA) and total knee arthroplasty (TKA). Without prophylaxis (preventive treatment), up to 80 percent of orthopedic surgical patients will develop DVT, and 10 to 20 percent will develop PE. Even when proper prevention measures are taken, it is estimated that 3 percent of orthopedic surgical patients will develop DVT, and 1.5 percent will develop PE. DVT and PE remain the most common cause for emergency readmission and death following joint replacement surgeries. In one survey conducted the patients surveyed after a THA or TKA stated problems with their prophylaxis varied widely: 83 percent reported issues with lack of ambulation, 74 percent used compression stockings, 57 percent used mechanical compression, 58 percent used an anticoagulant pill, 46 percent used an anticoagulant injection, and 42 percent used aspirin. (https: / / www.stoptheclot.orn / about-clots / toolkir-for-knee-hip-replacement- patients / orthopedic-surgery-fact-sheet / ). Thus, a need exists for a prophylaxis 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 while also exudating the wound and applying compression therapy through bladder included in the wound dressing.

[0037] Knee replacements may also result in DVT as a post-operative complication. After knee surgery, most DVTs occur in the calf. Although less likely to lead to a PE, these clots are more difficult to detect. Less than one third of patients with DVT present with the classic signs of calf discomfort,edema, distended veins, or foot pain. It has been noted that the risk of developing DVT extends for at least three months after a total knee replacement. The risk is greatest two to five days after surgery; and a second peak development period occurs about 10 days after surgeiy. Currently, it has been noted that patients at home are experiencing an increase in DVT due to lack of activity and movement. While the patient is in the hospital, he or she may be connected to an electrical powered pump in combination with a therapeutic compression apparatus, however, once discharged, the cunent products are limited as noted herein, whereby most 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 therapeutic compression apparatus and not practical to walk about in life. Thus a need exists for a system which can be used to prevent, reduce or even treat DVT which 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. A need also exists for a pre-formed absorbent wound dressing including a bladder applied over a surgical wound that is healing which can be opened to check on the wound site and closed again with one or two hands without the need for a medical professional or skilled caregiver. Further, a need exists so that the user can walk around with the compression profile maintained while not being limited to an electrical plug or some other separate source of continued, maintained or even increased then decreased compression while also having exudation of the wound with a wound dressing that is pre-formed for the target body area.

[0038] Further compression treatments have been discussed in "Effect of High-pressure, Intermittent Pneumatic Compression for the Treatment of Peripheral Arterial Disease and Critical Limb Ischemia in Patients Without a Surgical Option", by Oscar M. Alvarez, Martine E. Wendelken, Lee Markoqitz and Christopher Comfort (Wounds, Vol. 27, Issue 11, pages 293-301, November 2015) wherein thirty-six patients with symptomatic peripheral arterial disease (PAD) or critical limb ischemia (CLI) who were experiencing claudication pain, chronic resting pain, numbness, and ischemic lower leg / foot ulceration were randomized into 2 treatment groups. Eighteen of these patients received treatment with high- pressure, intermittent pneumatic compression (HPIPC) 60 minutes twice daily for 16 weeks, and 16 subjects received standard care consisting of an exercise regimen of walking for 20 minutes twice daily for 16 weeks. The HPIPC device delivers bilateral pressures of 120 mm Hg. Cycle times provide sequential compression for 4 seconds (+ / - 0.5 seconds) followed by a 16-second rest period (+ / - 3.0 seconds), resulting in a 20-second cycle or 3 cycles per minute. The study was designed to measure patient-centered outcomes. The primary endpoint was peak walking time (PWT), defined as time to maximally tolerated claudication pain. The conclusion at the end of the study was that therapy consisting of HPIPC for 2 hours daily for a period of 16 weeks significantly improved PWT, reduced resting pain, and improved healing rates, physical function, and bodily pain. There were no device related complications, allowing for long-term use. A further conclusion was that HPIPC offers anexcellent alternative for the palliative care of patients with PAD and CLI symptoms. Thus, a need exists for a wound dressing including a gradient bladder which can be easily administered by a patient in the home setting which includes HPIPC.

[0039] Co-owned U.S. Publication No. 2004 / 0193084, which is hereby incorporated by reference herein in its entirety, discloses a device for applying pressure to the human leg for use in conjunction with treatment of varicose veins. The device includes a flexible member and at least one air bladder chamber integral thereto that are adapted to securely wrap around the human leg. A tube in fluid communication with the air bladder chamber(s) extends to an air pumping mechanism that operates to inflate the air bladder chambers) to a pressurized state. The flexible member preferably includes an opening at the knee joint level to enable a patella to protrude therethrough. In addition, the flexible member preferably extends below knee joint level and is adapted to securely wrap around a lower portion of a leg to provide stability to the leg. Preferably, the air bladder chamber of the device is substantially longer in a first dimension than in a second dimension orthogonal thereto such that the air bladder chamber can be positioned to cover a portion of the human leg that is relatively long in the vertical dimension and narrow in the horizontal dimension. However, this device lacks a wound dressing aspect. 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 members) is operably disposed between the extremity and the flexible member whereby it applies increased localized pressure to the extremity during use. Preferably, 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. Again this device lacks a wound dressing component necessitating two separate devices. Further co-owned WO 2018 / 052676 and U.S. publications 2015 / 0245975 and 2009 / 0124944, which are all incorporated in whole herein, disclose therapeutic compression apparatus, devices and systems to apply compression on a body part but each lack a wound dressing element and so the medical professional or user would have to first inset a wound dressing on the skin of the user and then apply the compression apparatus or device over the separate wound dressing andthen activate the compression. A need exists for one device or apparatus which is a wound dressing and applies compression at the same time to save cost, precious time, reduce or control or stop bleeding as well as increasing circulation and assist in overall healing while reducing complications. Each of the wound dressing and the separate therapeutic compression apparatus is device has manufacturing and wearing application challenges that are not obvious to combine in one apparatus or device.

[0040] Co-owned PCT / US2024 / 010513 and PCT / US2024 / 042582 which is incorporated in whole herein, discloses a pre-formed absorbent wound dressing in the shape of a selected or target limb or extremity but there is a separate therapy compression apparatus and also the wound dressing has a tendency to slip down on the patient when being worn alone or even if having a second therapeutic compression apparatus over the pre-formed wound dressings. Again, the wound dressing and a separate therapeutic compression apparatus or device has manufacturing, material, functionality and wearing application challenges that are not obvious to combine in one apparatus or device. Thus a need exists for a pre-formed absorbent wound dressing including a bladder which is easier to place on the wound site, ulcer or surgical site wound and lasts longer than common bandages and wound dressings. The preformed absorbent wound dressing including a bladder reduces or eliminates slippage while also applying compression therapy on the target body part, preferably gradient compression and gradient pressure. Further a need exists for a wound dressing including a bladder that has measurable air while not promoting leakage onto the patient’s clothes or bedsheets or furniture, exudates the wound, applies compression therapy at a consistent level and is reusable. Other uses for the inventive pre-formed absorbent wound dressing including a bladder may be envisioned.SUMMARY OF THE INVENTION

[0041] The subject invention is directed to a pre-formed absorbent wound dressing shaped for the target limb or extremity such as a foot, ankle, calf, thigh, knee, leg, torso, chest, shoulder, arm, wrist, hand, elbow, neck, head, scalp or any other limb, with the wound dressing having a bladder to apply compression therapy. The inventive pre-formed absorbent wound dressing including bladder is comprised of multiple layers including a wound contact layer, an absorbent layer, a bladder layer which may be two layers forming the bladder, and a waterproof vapor layer and the wound dressing is configured in a shape to conform to the target limb. The target limb can be any body part but may be a foot, lower leg, though, arm or head of a person, as well as other body parts where wounds are present and hard to shape over such bony area or otherwise shaped area such as the head or scalp. The preformed absorbent wound dressing including a bladder may also include an indicator for when the exudate within the absorption layer has reached a certain capacity level and the inventive pre-formed absorbent wound dressing needs to be replaced. The pre-formed absorbent wound dressing including bladder incudes at least one bladder and depending on target limb may have two, three or morebladders, all connected to one inflation means. The pre-formed wound dressing including bladder is less bulky than known apparatus and combinations. 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 pre-formed wound dressing including bladder 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. In use, the pre-formed absorbent wound dressing including bladder is placed on the target limb or extremity, secured, and then the bladder is inflated via the inflation means. The wound dressing including bladder may also include a dressing which is impregnated with an additive such as medication, vitamins, anti-bacterial coating, silver or zinc oxide. The wound dressing compression system may also include a wound bolster or other elevating apparatus such as a pre-filled bladder in combination with an absorbent foam or other material adhered to the wound site under or around the pre-formed wound dressing including bladder.

[0042] The pre-formed absorbent wound dressing including bladder is in a shape pre-formed for use on a limb, leg, calf, thigh, hip, pelvis, knee, foot, ankle, torso, arm, neck or other body parts. The preformed wound dressing including bladder has an inner layer that is in contact with the wound site and surrounding skin area, another absorbent layer for the exudate (which absorbent layer may itself be comprised of multiple layers), a bladder layer, and an outer layer that is non-absorbent but allows moisture vapor transfer from the wound site to facilitate and assist in treatment at the wound site as well as healing plus applying compression therapy, and a shaping component so that the preformed wound dressing is in the shape of the target limb or extremity. The pre-formed absorbent wound dressing including bladder includes a securing or closing means as well as in some embodiments an adjusting means. Alternatively, the at least one bladder may be at least two or at least three separate bladders within the pre-formed wound dressing. One or more connecting means may be operatively associated along the first and second peripheral edges of the pre-formed absorbent wound dressing for securing it around the limb. The at least one bladder may be adapted and configured to form a predetermined gradient compression profile and / or gradient pressure profile when the at least one bladder is 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 which may be at least about 12 or greater. The gradient compression profile and / or gradient pressure profile instead may be determined by the inflation means connected or integral to the inventive pre-formed wound dressing including bladder. In another embodiment, the gradient compression profile and / or gradient pressure profile may be determined by pressure being created in one direction within the bladder by the inflation means and then exiting the bladder through an exhaust port or other exit means. The at least one bladder may also include a plurality of fluid chambers. The inventive pre-formed wound dressing including bladder mayfurther comprise at least one means for adjusting pressure coupled to the at least one bladder for controlling an amount of pressure supplied to the treatment site. In an apparatus with more than one bladder, each bladder is connected to the same inflation means and the inflation means sequentially inflates each bladder, which could be the same or different pressure levels, and once disconnected a check valve within an inflation port on each separate bladder maintains the then current pressure level.

[0043] A method of the invention includes the per-fonned absorbent wound dressing including bladder being placed at the wound site on the target limb by the patient or user and being able to secure it on the target limb with two hands alone and without the aid of a skilled medical provider or caretaker. The user places the inventive pre-formed absorbent wound dressing including bladder on the target limb, removes the adhesive tabs on the closing or securing means and places the adhesive portion on the outer layer of the preformed absorbent wound dressing to close and secure it to the target limb. The pre-formed absorbent wound dressing adhesive tabs can be opened and closed a number of times for the user to check on the wound site. Optionally, the pre-formed absorbent wound dressing adhesive tabs include an end portion that does not have adhesive but can be easily gripped by the user in order to open and close the adhesive tabs to check on the wound site. The closing or securing or fastening means may also be a hook and loop connection or other known securing means. The inventive pre-formed absorbent wound dressing including bladder can be used over any wound such as a surgical site, a cut (whether small or gaping in an emergency situation), an ulcer, a burn or any type of wound. The bladder is then inflated within the pre-formed wound dressing to apply compression therapy. The pre-formed wound dressing including bladder can be used to apply pressure on a wound, a post-surgical site, a trauma site, or used to treat CVI , DVT and / or lymphedema. Optionally a wound dressing impregnated with silver or zinc oxide may be placed over the wound site alone or in combination with the wound bolster. 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. In a preferred embodiment, the pre-filled air bladder, the absorbent foam, sponge or dressing and the suction conduit are formed together as a unit. According to one aspect of the invention, the flexible member of the pressure mechanism is adapted to wrap around 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. Thus, 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 preferably designed to apply pressure along a predefined area (e.g., the saphenous vein of a leg) as opposed to around an entire limb. According to another aspect of the invention, the suctionconduit is located either between the pre- filled 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. By coupling the suction conduit to a source of negative pressure, exudate from the wound or ulcer is sucked through the foam, sponge or dressing into the suction conduit.

[0044] One of the methods of the invention include locating a pre-filled air bladder and foam, sponge or dressing over a wound or ulcer on a limb, placing the pre-fonned absorbent wound dressing on the target limb or extremity over the pre-filled air bladder and foam, sponge or dressing, then wrapping the flexible member of the pressure mechanism around a limb with the air chamber located over the pre-formed absorbent wound dressing and fastening the pneumatic pressure mechanism in place with the fixation structure. When the apparatus is properly located and affixed to the limb, 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.

[0045] Another embodiment of the present invention includes a pre-formed wound dressing including bladder 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. It 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. In a preferred embodiment, the thigh bladder is positioned between the pelvis or groin or hip area of the user and the knee of the user. As a person walks while wearing the apparatus, 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. As the person's foot rolls from heel to toe in the standard walking motion, 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.

[0046] In another embodiment including a pre-formed absorbent wound dressing including bladder is inthe shape of thigh and / or lower leg depending on the location of the wound or ulcer including a foot bladder, the foot bladder is positioned over a second pre-formed absorbent wound dressing placed around the ankle and foot of the user such that the foot bladder is applied over the wound dressing on a bottom of a foot and the leg bladder is positioned on a lower portion of a leg. As a person walks while wearing the apparatus, a portion of the foot bladder deflates as the person's 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. As the person's foot rolls from heel to toe in the standard walking motion, 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.

[0047] In one embodiment of the present invention, the wound dressing including bladder 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 therapeutic compression apparatus by, for example, a hose or a tube, which provides inflation to the bladder within the therapeutic compression apparatus and / or wrap. In another embodiment of the present invention, the wound dressing including bladder 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 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.

[0048] In other embodiments the inflation means is connected to two or more tubes and thereby connected to two or more bladders, whether multiple bladders within one therapeutic compression apparatus or a single bladder within multiple therapeutic compression apparatuses, or a combination thereof. In another embodiment 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. In another embodiment the system includes one or more sensors to monitor movement of the therapeutic compression apparatus, pressure levels, blood pressure of the patient, tonometry of the target limb, or other sensor data. These and other aspects of the contacts of the subject invention will become more readily apparent from the following description taken in conjunction with the drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0049] So that those having ordinary skill in the art to which the subject invention pertains will more readily understand how to make and use the apparatuses of the subject invention, preferred embodiments thereof will be described in detail herein below with reference to the drawings, wherein:

[0050] FIG. 1A is a side view of an embodiment of the present invention of a lower leg pre-formed absorbent wound dressing including a bladder in the pre-formed shape of a foot and calf portion with FIG. 1B being a front view of FIG. 1A, in this instance on the right foot and leg;

[0051] FIG. 2 is a side view of an embodiment of the present invention of a lower leg pre-formed absorbent wound dressing with bladder in the pre-formed shape of a lower leg and calf and then a second separate embodiment of the present invention of a foot pre-formed absorbent wound dressing with bladder in the preformed shape of a foot, in this instance on the right foot and leg;

[0052] FIG. 3 is another embodiment of the present invention of a lower leg pre-formed absorbent wound dressing with bladder in the pre-formed shape of a lower leg and calf and then a second foot pre-formed absorbent wound dressing (without a bladder) in the pre-formed shape of a foot with toe spacers, in this instance on the right foot and leg;

[0053] FIG. 4 is an exploded view of the lower leg pre-formed absorbent wound dressing with bladder of FIG. 1 A including a hook and loop securing means;

[0054] FIG. 5 is an exploded view of another embodiment of the present invention of a lower leg pre-formed absorbent wound dressing with bladder in the pre-formed shape of a foot and calf portion including a adhesive securing means;

[0055] FIG. 6A is the back or outer view of FIG. 5 in an open position prior to welding the bottom foot portion together with FIG 6B being the inner view of FIG. 5 in an open position prior to welding the bottom foot portion together;

[0056] FIG. 6 is an exploded view of another larger embodiment of the present invention of a lower leg preformed absorbent wound dressing;

[0057] FIG. 7 is another embodiment of the present invention of a lower leg pre-formed absorbent wound dressing with bladder in the pre-formed shape of a foot and calf portion including a different shaped bladder than shown in FIG.s 4-5;

[0058] FIG. 8 is a back or outer view of FIG. 1 A in an open position prior to welding the bottom foot portion together;

[0059] FIG. 9 is a back right side perspective view of another embodiment of a lower leg pre-formed absorbent wound dressing with bladder in the pre-formed shape of a calf portion of the lower leg in an opened position including elastic as the shaping means;

[0060] FIG. 10 is a back right side perspective view of another embodiment of a lower leg pre-formed absorbent wound dressing with bladder in the pre-formed shape of a calf portion of the lower leg in an opened position including plastic as the shaping means and adhesive as the securing means;

[0061] FIG. 11 is an exploded view of FIG. 10;

[0062] FIG. 12 is an exploded view of another larger embodiment of the present invention of a lower leg preformed absorbent wound dressing with bladder in the pre-formed shape of a calf portion of the lower leg having a longer side portion for a larger calf on the user and hook and loop as the securing means;

[0063] FIG. 13 is a back or outer view of FIG. 10 in an open position but with a hook and loop securing means;

[0064] FIG. 14 is front left side perspective of a foot pre-formed absorbent wound dressing with bladder in the pre-formed shape of a foot on a right foot in the closed position with an adhesive securing means;

[0065] FIG. 15A is an outer view of the inventive foot pre-formed absorbent wound dressing of FIG. 14 during manufacture before it is connected at the portion around the heel of the foot, with FIG. 15B being an inner view of the inventive foot pre-formed absorbent wound dressing of FIG. 14;

[0066] FIG. 16 is an exploded view of the inventive foot pre-formed absorbent wound dressing of FIG. 14;

[0067] FIG. 17 is an exploded view of another embodiment of the present invention of a foot pre-formed absorbent wound dressing with bladder in the pre-formed shape of a foot including a different shaped bladder than shown in FIG. 16;

[0068] FIG. 18A is an outer view of another embodiment of the present invention of a foot pre-formed absorbent wound dressing during manufacture before it is connected at the portion around the heel of the foot but in this embodiment with a hook and loop securing means, with FIG. 18B being an inner view of the inventive foot pre-formed absorbent wound dressing of FIG. 18A;

[0069] FIG. 19A is another embodiment of the present invention of a head pre-formed absorbent wound dressing with bladder in the pre-formed shape of a head in use on a head in the closed position with a securing means being a chin strap that slides, with FIG. 19B a different embodiment of FIG. 19A with the inflation bladder on the other side of the face and a different chin securing means;

[0070] FIG. 20 is exploded view of the inventive head pre-formed absorbent wound dressing with bladder of FIG. 19A;

[0071] FIG. 21 A is an inner view of the inventive head pre-formed absorbent wound dressing with bladder of FIG. 19A during manufacture before it is connected at the portion around the back of the head and FIG. 21B is an outer view of the inventive foot pre-formed absorbent wound dressing of FIG. 19A during manufacture before it is connected at the portion around flie back of the head;

[0072] FIG. 22A is a front outer view of another embodiment of the present invention of a knee pre-formed absorbent wound dressing with bladder in the pre-formed shape of a knee in an open position with an adhesive securing means and a larger top shaping means, with FIG. 22B a front outer view of anotherembodiment of the present invention of a knee pre-formed absorbent wound dressing with bladder in the preformed shape of a knee in an open position with a hook and loop securing means and a both shaping means of the same size;

[0073] FIG. 23 is exploded view of the inventive knee pre-fonned absorbent wound dressing with bladder of FIG. 22A;

[0074] FIG. 24 is an exploded view of another embodiment of the of the present invention of a thigh preformed absorbent wound dressing with bladder in the pre-formed shape of a thigh with an adhesive securing means on the top portion and in this version on the left side and a hook and loop securing means on the right side, with a mirror image if applied on the other leg;

[0075] nG. 25 is front outer view of FIG. 24;

[0076] FIG. 26A is a front outer view of another embodiment of the present invention of a deltoid or shoulder pre-formed absorbent wound dressing with bladder in the pre-formed shape of a shoulder or deltoid area in an open position with an adhesive securing means, with FIG. 26B a front outer view of another embodiment of the present invention of a deltoid or shoulder pre-formed absorbent wound dressing with bladder in the pre-formed shape of a shoulder or deltoid area in an open position with a hook and loop securing means and the top shaping means moved lower compared to FIG. 26A; and

[0077] FIG. 27 is an exploded view of FIG. 26A.DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0078] Preferred embodiments of the subject invention are described below with reference to the accompanying drawings, in which like reference numerals represent the same or similar elements. One of ordinary skill in the art would appreciate that while the apparatuses discussed herein relate to compression therapy of the leg and foot, the scope of the invention is not limited to those exemplary applications and may be sized and shaped for the anatomical portion for which compression therapy is needed.

[0079] The subject invention provides a wound dressing including bladder to apply compression to a patient's limbs, including the extremities, including for example, the foot, ankle and / or leg of a user, in a manner that is simpler, less bulky, more practical, more mobile, and more convenient than current systems and also exudates the wound site. Any limb or body part may be subject such as for instance a foot, calf, thigh, knee, leg, hip, buttocks, waist, torso, ribs, shoulder, arm, band, fingers, neck, head or the like.

[0080] The subject invention provides a pre-formed absorbent wound dressing including bladder to control bleeding, remove and manage exudate from the wound site, and also employ compression therapy to reduce ort prevent swelling of a limb such as for instance the foot, ankle, lower leg, calf, knee, thigh, arm, shoulder and / or deltoid using a pre-formed wound dressing with bladder including an inner hydrophilic wound site contact layer, a second absorbent layer, a bladder layer, and an outer non-absorbent waterproof hydrophobic moisture vapor transfer layer with a support or shaping means to provide the pre-formed shape of the target limb or extremity. The bladder may be a set pressure or gradient and also is at least one bladder forcompression, and can also include more than one bladder, which bladder is connected to an inflation means to be inflated. The inflation means includes a dual means having both constant static pressure levels and varying intermittent pressure levels and the bladders are inflated sequentially. The inventive pre-formed wound dressing including at least one bladder 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 of the wound dressing. It also provides and meet a need of one apparatus or device which can reduce, control or stop bleeding as well as store exudate and also apply compression which can reduce, control or stop bleeding as well as reduce or stop swelling and at the same time promote healing and reduce complications.

[0081] Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges and are also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either both of those included limits are also included in the invention. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present invention, exemplary methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and / or materials in connection with which the publications are cited.

[0082] It must be noted that as used herein and in the appended claims, the singular forms "a", "an," and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a stimulus" would include a plurality of such stimuli and reference to "the signal" would include reference to one or more signals and equivalents thereof known to those skilled in the art, and so forth. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may differ from the actual publication dates, which may need to be independently confirmed.

[0083] Referring now to FIGs. 1 A-B and 4-8, there is illustrated an exemplary embodiment of the inventive pre-formed wound dressing including a bladder 100 where the bladder is within the wound dressing in the pre-formed shape of a lower leg with foot. Other embodiments of the inventive preformed absorbent wound dressing include a lower leg portion without a foot 200 as well as two different foot embodiments 300, 900 as shown in FIGs. 2-3 and 9-18, head embodiments 400 as shown in FIGs. 19A-B, 20 and 21-B, knee embodiment 500 as shown in FIGs. 22A-B and 23, thigh or hipembodiments 600 shown in FIG.s 24-25, and shoulder or deltoid embodiments 700 as shown in FIG.s 26A-B and 27. Not shown are embodiments for the full arm, upper arm and lower arm as well as hand, torso, back, neck and a full leg version as any target body part can be the subject of shaping in the preformed wound dressing with bladder.

[0084] The pre-formed wound dressing including a bladder 100, 200, 300, 400, 500 600, 700 has an inner layer 115, 215, 315, 415, 515, 615, 715, 915 in contact with the wound site and skin of the patient or user. The inner absorbent layer 115, 215, 315, 415, 515, 615, 715 may be comprised of a polymer, cotton or any material compatible with human skin and wounds. The inner wound contact layer 115, 215, 315, 415, 515, 615, 715 may be a hydrophilic material such as cotton, linen, foam, sponge, fibers, and other suitable materials that can absorb exudates and other moisture from the wound as well as hydroconductive materials. The inventive pre-formed wound dressing including a bladder 100, 200, 300, 400, 500, 600, 700 includes an outer layer 125, 225, 325, 425, 525, 625, 725 which may be in contact with the clothes of the patient or user or a couch, chair or bed linens if the patient or user is nonambulatory. The outer layer 125, 225, 325, 425, 525, 625, 725 is preferably non-absorbent or less- absorbent. The outer layer 125, 225, 325, 425, 525, 625, 725 may be a hydrophobic material or even waterproof, but should also be able to transfer moisture vapor. The outer layer 125, 225, 325, 425, 525, 625, 725 may be comprised of materials such as paper, film, polymers, rubber, metal and the like. The inventive pre-formed wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 includes a middle or central absorbent layer 120, 220, 320, 420, 520, 620, 720 which can absorb exudates and other moisture from the wound and traps such exudate in the middle layer. As shown in FIG. 4 there is a preformed foot with toe spacers wound dressing 900 without a bladder, though a bladder could be added (not shown) on the portion below the foot. In this embodiment there is an outer layer 925, inner layer 915 and not shown is the middle layer 920 and again a bladder (not shown) could be added which would be 940.

[0085] The inner porous layer 115, 215, 315, 415, 515, 615, 715 may be comprised of any material compatible with human skin and wounds such as for instance a polymer, a nonwoven polyester, fibers, and the like. The inner layer 115, 215, 315, 415, 515, 615, 715 may be a hydrophilic layer or a hydroconductive layer. The inner porous layer 115, 215, 315, 415, 515, 615, 715 may be flexible, porous, and non-toxic. As used herein, the term “flexible” is meant to cover a range of materials, which exhibit one or more properties such as being flexible, compliant, elastic, or memory retentive. For example, “flexible” is also meant to refer to materials that exhibit elastic or memory properties, i.e., the ability for the material to return to its original shape when stresses applied thereto are reduced or eliminated. The flexible material is preferably flexible or compliant, to allow the flexible substrate to be placed on the desired surface (such as skin, organ, tissue, or the like) in a manner that allows the flexible substrate to conform to the topology of the desired surface. Likewise, the flexible material is preferably porous, to allow the exudate from the woundsite, cut, gash, burn, ulcer and the like to pass through or permeate through the flexible material and be trapped in the central absorbent layer 120, 220, 320, 420, 520, 620, 720. By “porous” is meant herein either that the bulk of the inner porous layer 115, 215, 315, 415, 515, 615, 715 has pores, such that the exudate from the ulcer or wound site is soaked up or passed through holes or voids in this inner porous layer 115, 215, 315, 415, 515, 615, 715. For example, the inner layer 115, 215, 315, 415, 515, 615, 715 may also be a wicking layer would be in contact with the wound and skin and may be comprised of a porous material for transfer of the exudates and moisture from the wound to the sandwiched absorbent layer 120, 220, 320, 420, 520, 620, 720. The inner wicking or porous layer 115, 215, 315, 415, 515, 615, 715 permits the transmission of wound fluids and moisture vapor from the wound and skin down into the middle absorbent layer 120, 220, 320, 420, 520, 620, 720. The inner porous layer 115, 215, 315, 415, 515, 615, 715 may have perforations to assist in the transfer of the exudates and moisture into the inner and then into the middle absorbent layer 120, 220, 320, 420, 520, 620, 720. The materials of the porous layer 115, 215, 315, 415, 515, 61, 715 may be woven or non-woven fabrics, polymers, films and the like. The inner hydrophilic layer 115, 215, 315, 415, 515, 615, 715 may be comprised of any material that transfers moisture such as woven and nonwoven materials (e.g. a nonwoven web of fibers), polymeric materials such as apertured plastic films, e.g. apertured formed thermoplastic films and hydroformed thermoplastic films; porous foams; reticulated foams; reticulated thermoplastic films; and thermoplastic scrims. Suitable woven and nonwoven materials can be comprised of natural fibers or from a combination of natural and synthetic fibers. Examples of suitable synthetic fibers which may comprise all or part of the inner layer 115, 215, 315, 415, 515, 615, 715 include but are not limited to polyamide (e.g. nylon), acrylic (e.g. polyacrylonitrile), aromatic polyamide (e.g. aramide), polyolefin (e.g. polyethylene and polypropylene), polyester, butadiene-styrene block copolymers, natural rubber, latex, spandex (polyurethane) and combinations thereof.

[0086] The middle or central absorbent layer 120, 220, 320, 420, 520, 620, 720 may be a cotton, polymer, and the like having absorption properties and functionality. The inner layer 115 and / or the middle absorbent layer 120 may itself be comprised of multiple layers such as wicking layer, absorbent layer, gel layer, and any combination of layers than can absorb and trap exudate from a wound. The middle or central absorbent layer 120, 220, 320, 420, 520, 620, 720, 720 may be a hydrophilic material such as cotton, linen, foam, sponge, fibers, and other suitable materials that can absorb and trap exudates and other moisture from the ulcer or wound site. The middle or central absorbent layer 120, 220, 320, 420, 520, 620, 720 may be cotton, pulp, cellulose, cellulose derivatives, polymers, high molecular water absorbent polymers, thermoplastic resin, cellulosic fiber, acrylic (salt) polymer, foam, woven or nonwoven material selected from the group consisting of rayon, polyester, polyurethane, polyolefin, orlon, hydrogel polymeric material, and combinations thereof. A second absorbent layer as shown in FIG. 4 for the foot embodiment including toe spacers which adds absorption levels and also cushioning to the ball of the foot when worn mostly under the foot such as on the sole of the foot, or cushioning on the arch of the foot whenworn mostly on the top of the foot. The central absorbent layer 120, 220, 320, 420, 520, 620, 720 may be comprised of cotton, linen, foam, any material with plurality of open cells and may include at least one of polyurethane, silicone, polyethylene, and gauze. Further, the absorbent layer may be comprised of a comprise a wide variety of liquid-absorbent materials commonly used in disposable diapers, incontinence products and other absorbent articles such as comminuted wood pulp, which is generally referred to as air felt or fluff. Examples of other suitable absorbent materials include creped cellulose wadding; melt blown polymers, including co-form; chemically stiffened, modified or cross-linked cellulosic fibers; tissue, including tissue wraps and tissue laminates, absorbent foams, absorbent sponges, superabsorbent polymers (such as superabsorbent fibers), absorbent gelling materials, or any other known absorbent materials or combinations of materials. Examples of some combinations of suitable absorbent materials are fluff with absorbent gelling materials and / or superabsorbent polymers, and absorbent gelling materials and superabsorbent fibers etc.

[0087] The inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 includes an outer layer 125, 225, 325 425, 525, 625, 725 which may be in contact with the sock or clothes of the patient or user or a couch, chair or bed linens if the patient or user is non-ambulatory. The outer layer 125, 225, 325 425, 525, 625, 725 is preferably non-absorbent or less-absorbent. The outer layer 125, 225, 325 425, 525, 625, 725 may be a hydrophobic material. The outer layer 125, 225, 325 425, 525, 625, 725 may be comprised of materials such as paper, film, polymers, laminate, rubber, metal and the like. Not shown but envisioned is a layer on the outer materials which indicates when the inner porous layer 115, 215, 315, 415, 515, 615, 715 or central absorbent layer 120, 220, 320, 420, 520, 620, 720 has reached a moisture level that the entire absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 should be replaced such as for example a hydrochromic ink or other indicator. The outer layer 125, 225, 325, 425, 525, 625, 725 may also be an outer waterproof vapor transfer layer that is moisture permeable and liquid impermeable. Suitable materials include hydrophobic materials such as by way of example polymers, woven and non-woven materials, films, laminates and combinations thereof. Further, the outer layer 125, 225, 325 425, 525, 625, 725, 825, 725, 925 prevents the exudates absorbed by the inner and / or absorbent layers 115, 120, 215, 220, 315, 320, 415, 420, 515, 520, 615, 620, 715, 720 and prevent contact of the exudate with clothing, linens, bed sheets, furniture and the like. The outer layer 125, 225, 325 425, 525, 625, 725 may be substantially impervious to liquids (e.g., blood, pus, etc.) and comprises a laminate of a nonwoven and a thin plastic film such as a thermoplastic film. Other suitable outer layer 125, 225, 325 425, 525, 625, 725 materials may include breathable materials that permit vapors to escape from the inventive pre-formed wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 while still preventing exudates from passing through the outer layer 125, 225, 325 425, 525, 625, 725. Exemplary breathable materials may include materials such as woven webs, nonwoven webs, composite materials such as film-coated nonwoven webs, and microporous films. Not shown but envisioned is a layer on the outer materials which indicates when the inner layer or middle layer has reached a moisture level that theentire pre-formed absorbent wound dressing should be replaced. Other embodiments are envisioned that allow the user to know when to replace parts of the system.

[0088] The inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 include a bladder 140, 240, 340, 440, 540, 640, 740 to apply compression pressure onto the target body part. The bladder 140, 240, 340, 440, 540, 640, 740 is placed below the outer layer 125, 225, 325, 425, 525, 625, 725 so it is located in between the outer layer 125, 225, 325, 425, 525, 625, 725 and the middle or central absorbent layer 120, 220, 320, 420, 520, 620, 720. The bladder 140, 240, 340, 440, 540, 640, 740 is connected to an inflation port 112, 212, 312, 412, 512, 612, 712 which is then connected through the outer layer 125, 225, 325, 425, 625, 725 via openings or apertures 121, 221, 321, 421, 521, 621, 721 so as to facilitate inflation, pressure and compression via the inflation means (not shown 150). The inflation port 112, 212, 312, 412, 512, 612, 712 has a dust cap 113, 213, 313, 413, 513, 613, 713 that can keep dust out of the inflation port and also be turned over to deflate the inflated bladder 140, 240, 340, 440, 540, 640, 740. The inflation port 112, 212, 312, 412, 512, 612, 712 includes parts 111, 112A, 112B, 112C, 113, 211, 212A, 212B, 212C, 213, 311, 312A, 312B, 312C, 313, 411, 412A, 412B, 412C, 413, 511, 512A, 512B, 512C, 513, 611, 612A. 612B, 612C, 613, 711, 712A, 712B, 712C, 7133 as shown in FIG.s 1-27. In addition, the inflation port 112, 212, 312, 412, 512, 612, 712 is attached including a housing 112B, 212B, 312B, 412B, 512B, 612B, 712B, the housing being tubing, connection to the inflation means may be via for instance a luer such as by way of example only a plastic female luer 112C, 212C, 312C, 412C, 512C, 612C, 712C but other materials can be employed such as metal, polymers, or rubbers and other housing means can be employed, with the housing including a sealing valve 112A, 212A, 312A, 412A, 512A, 612A, 712B, as well as a dust cap 113, 213, 313, 413, 513, 613, 713 to prevent dust into the inflation port and to also deflate the bladder 140, 240, 340, 440, 540, 640, 740 when inflated by placing the other side longer tip of the dust cap 113, 213, 313, 413, 513, 613, 713 into the sealing valve to push down and release the inflation within the inflated bladder 140, 240, 340, 440, 540, 640, 740 manually if needed. Other embodiments of the inflation port 112, 212, 312, 412, 512, 612, 712 may be employed as well as various inflation means such as static constant inflation, intermittent changing inflation, mechanical inflation, manual inflation, electric inflation and other known inflation means.

[0089] The bladder 140, 240, 340, 440, 540, 640, 740 to apply compression pressure onto the target body part may be formed or manufactured separately so as to be inserted in between the outer layer 1 15, 215, 315, 415, 515, 615, 715 and the middle or central absorbent layer 120, 220, 320, 420, 520, 620, 720 during manufacture as shown in exploded views of FIG.s 4-5, 7, 11-12, 16-17 20 and 23-24.Various sizes of the bladder 140, 240, 340, 440, 540, 640, 740 are shown in various embodiments. Not shown is a manufacturing method wherein the bladder 140, 240, 340, 440, 540, 640, 740 is created by connecting or welding two or more materials together as disclosed in co-owned PCT / US23 / 79854 andPCT / US23 / 37286 and WO 2018 / 052676, the entire contents of which are hereby incorporated herein by reference for all purposes. The bladder 140, 240, 340, 440, 540, 640, 740 applies compression pressure onto the target body part when inflated, in this non-limiting instance being an air bladder. The inflated or activated bladder 140, 240, 340, 440, 540, 640, 740 applies compression pressure onto the target body part which can reduce, control or stop bleeding at the wound site as well as reduce, control or stop swelling at the wound site or on portion of the target body part adjacent to the wound site. Thus the inventive pre-formed wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 fills a need of reducing, controlling or stopping bleeding as well as other exudate at a wound site while also applying compression that assists in this reduction, control or stoppage of bleeding as well as reducing, controlling or stopping swelling including edema, lymphedema, CVI, DVT and surgical or trauma caused swelling.

[0090] The bladder 140, 240, 340, 440 540, 640, 740 is activated or inflated when an inflation means (not shown) is connected to the inflation ports 112, 212, 312, 412, 512, 612, 712. The inflation or pressure can be static or intermittent such as a pulsating pressure to a user's limb. Non-limiting examples not shown of the inflations means is a pneumatic pump , hand manual 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 140, 240, 340, 440, 540, 640, 740 so to provide compression in use by the patient or user. Further, a check valve (not shown) or relief valve (not shown) is incorporated with the inflation port 112, 212, 312, 412, 512, 612, 712 to prevent over-inflation once a maximum pressure is detected. Examples of check or relief valves are described in co-owned U.S. Pat No. 7,276,037 and U.S. Pat. No. 7,850,629 and U.S. publication 2022 / 0160574 and U.S. publication 2021 / 0275386, the disclosures of which are incorporated by reference in their entirety. In another embodiment (not shown), the inflation means includes a switch that may have a plurality of integrated umbrella valves so that one umbrella valve is set and closed to maintain the pressure within the bladder 140, 240, 340, 440, 540, 640, 740, while a second umbrella valve would release a certain amount of air or fluid within the bladder 140, 240, 340, 440, 540, 640, 740, 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 140, 240, 340, 440, 540, 640, 740, thus release all pressure and deflate the bladder 140, 240, 340, 440, 540, 640, 740. For instance by way of example only, 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 140, 240, 340, 440, 540, 640, 740 and thus maintains the set pressure, say for instance at 45 mm-Hg, the second umbrella valve is set to release the air or fluid within the bladder 140, 240, 340, 440, 540, 640, 740 if the pressure within exceeds 45 mm-Hg and bring the pressure down to 45 mm-Hg (such as when in higlr altitudeor other increases in pressure) and then maintain the pressure at 45 mm-Hg, and a third umbrella valve is set to open and release all the air or fluid within the bladder 140, 240, 340, 440, 540, 640, 740 and thus release all pressure when activated by the patient so as to deflate the bladder 140, 240, 340, 440, 540, 640, 740 and the inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700. By way of another example, the dial or display on the inflation means (not shown) 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 amount or value so that the umbrella valve is activated to release air or fluid within the bladder 140, 240, 340, 440, 540, 640, 740 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 140, 240, 340, 440, 540, 640, 740 released to deflate and this umbrella valve is always in the open position. In this embodiment (not shown) there are three umbrella valves with one set to always open the bladder 140, 240, 340, 440, 540, 640, 740 to release pressure completely, one set to always close to maintain air or fluid in the bladder 140, 240, 340, 440, 540, 640, 740 to maintain pressure, and a third set to open or release at a predetermined or set pressure point. In all of the embodiments referring to umbrella valve 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 inflation port 112, 212, 312, 412, 512, 612, 712 includes an inventive sealing means connected to the bladder 140, 240, 340, 440, 540, 640, 740 so as to maintain the static compression profile and / or gradient pressure profile when the inflation means is either disconnected from the inflation port 112, 212, 312, 412, 512, 612, 712 or the inflation means stops providing additional inflation or pressure. In other embodiments not shown the inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 may have more than one bladder with a pressure level either the same or different in each of the more than one bladder 140, 240, 340, 440, 540, 640, 740. Further, each bladder can be in different shapes and configurations such as shown in FIGs. 4- 5, 7, 11-12, 16-17, 20, 23-24 as well as different gradient compression profiles and / or gradient pressure profiles based on the position and selection of the spot welds 114, 214, 314, 414, 514, 614, 714 and weld lines 116, 216, 316, 416, 516, 616, 716.

[0091] The inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 includes a securing means 130, 230, 330, 430, 530, 630, 730 for placing and securing the preformed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 to the selected or target body part. These embodiments also include a securing means 130, 230, 330, 430, 530, 630, 730 by way of non-limiting example only as fasteners or tabs 135, 235, 335, 435, 440, 446, 448, 535, 635,735. The fasteners or tabs 135, 235, 335, 435, 440, 446, 448, 535, 635, 735 have in one embodiment an adhesive (not shown) and a portion 137, 237, 337, 437, 537, 637, 737 which can be peeled or removed fiom the inner surface of the fasteners or tabs 135, 235, 335, 435, 535, 635, 735 to expose or release the adhesive so that the fasteners or tabs 135, 235, 335, 435, 535, 635, 735 can secure one side of the outer layer 125, 225, 325 425, 525, 625, 735 of the inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 when closed on the user’s selected body part or in another embodiment have a loop and hook connection where the hook portion is 138, 238, 338, 438, 538, 638, 728 and the loop portion is on the other side of the fastener or tab 135, 235, 335, 435, 635, 735, which is only shown as 536 in FIG. 22B but is applicable in all other embodiments. Other securing means 130, 230, 330, 430, 530, 630, 720 may be employed such as hook and loop, buttons, zippers, fasteners and other means of securing the inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600 onto the user’s selected or target body part, limb or extremity. In certain embodiments the distal end of the fasteners or tabs 135, 235, 335, 435, 535, 635, 735 include a portion without any adhesive 139, 239, 339, 439, 539, 639, 739 (not all shown) so that the user can pull off the fastener or tab 135, 235, 335, 435, 535, 635, 735 to open the pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 to check the wound site. Thus the user only has to have one hand to grip and pull off the fastener or tab 135, 235, 335, 435, 535, 635, 735 making it easier to view and check the wound site for healing or complications. Further in some embodiments of the inventive preformed absorbent wound dressing there is one fastener or tab, or two fastener or tabs, or three or more fasteners or tabs, depending on the body anatomy of the selected or target body part. The adhesive for the fastener or tabs 135, 235, 335, 435, 535, 635, 735 may be comprised of a material that maintains it adhering properties even when opened and closed repeatedly, so that the user can remove the pre-formed wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 to engage in a activities such as bathing and then replacing the pre-formed wound dressing with bladder back onto the wound site after completing a bath or shower. This importantly allows the patient or user to have a lifestyle not affected by their wound dressing, compared to common conventional compression bandages and plasters, etc.

[0092] The inventive pre-formed wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 also includes in certain embodiments a shaping or support means 124, 224, 524, 624, 724 such as plastic, wires, elastic or any other material capable of shaping and / or supporting the inventive pre-formed absorbent wound dressing with bladder 100, 200, 500, 600, 700 into by way of non-limiting example a cone shape for the lower leg or arm (not shown). Other shaping or support means provide a curve over the target body part such as the knee 500, thigh 600 or shoulder / deltoid 700. While not shown in these embodiments the foot 300 could include a shaping or support means as well as the head 400. Different non-limiting shaping or supporting means 124, 224, 524, 624, 724 are shown but other may be employed, such as plastic or wires in FIG.s 1-8, 10-13, 22A-27 and elastic in FIG. 9. The shapingmeans may be bent into the required shape. The shaping means 124, 224, 524, 624, 724 are secured to the outer layer 125, 225, 525, 625, 725 via a means such as a strip 122, 222, 522, 622, 722 including adhesive during the manufacturing process so that the strip 122, 222, 522, 622, 722 is welded on three sides and then the shaping or support means 124, 224, 524, 624, 724 either placed within the created channel 121 as shown in FIG. 5 or just placed on the outer layer 125, 225, 525, 625, 725 and then welded on. Other manufacturing and creation means may be employed besides those shown in the Figures and discussed herein.

[0093] Turning to the lower leg with foot embodiment 100 of the pre-formed absorbent wound dressing with bladder as shown in FIGs. 1-2 and 4-8, there is a distal portion 129A, 129B configured for the user’s ankle 610 on the foot as well as an opening aperture or curve 106 for above the ankle 610 with no coverage of the toes 660 as well as a proximal portion 117 configured for better wear at the user’s calf nearer the knee 650. Thus the lower leg with foot embodiment 100 of the pre-formed absorbent wound dressing with bladder is configured to the shape of the lower leg and foot as the selected or target body part. Based on this shape configuration, the inventive lower leg with foot embodiment 100 of the preformed absorbent wound dressing with bladder fits better onto the lower leg and foot based on the lower leg anatomy, thus assisting in healing of the wound. The lower leg with foot embodiment 100 also includes certain weld spots 114 and weld lines 116 to better shape the inventive lower leg with foot embodiment 100, though other non- welded sections are contemplated for shape and fit. In this embodiment and by way of non-limiting example, the inventive lower leg with foot pre-formed absorbent wound dressing with bladder 100 may be manufactured or created by die-cutting the outer layer 125, bladder 140, middle absorbent layer 120 and inner layer 115 as separate operations. Then all layers are aligned on pins and RF welded together via three channels and the outer layer 125 to the shaping cover 122. Further the layers are aligned and then RF welding it to the perimeter, outer layer 125 to inner layer 115 with the bladder 140 and middle absorbent layer 120 in between. In this embodiment then the two curved wires or bands 124 are either inserted into the two channels 121 or just welded onto the outer layer 125 with the cover 122 to constrain the wires 124 or bands. A second welding occurs along the bottom or distal end forming a heel 610 opening or aperture. Finally, in this embodiment the securing means 130 whether is sets of fasteners or tabs 135 having adhesive on the underside and release liners 137 or a hook 138 and loop 136 (not shown) under the fastener 135 are added, with the adhesive if employed capable of maintaining a level of adhesion to be opened and closed repeatedly. As shown in FIG.s 1A-1B, 4 and 7-8 the securing means is hook 138 and loop whereas the securing means in FIG.s 2-3, and 5-6 are adhesive fasteners 135 with release tabs 137.

[0094] Another embodiment is directed to the lower leg without foot 200 of the pre-formed absorbent wound dressing with bladder as shown in FIGs. 9-13, there is a distal portion 218 configured for the user’s ankle on the foot as well as an opening aperture or curve 219 for the bony back section of theankle as well as a proximal portion 217 configured for better wear at the user’s calf nearer the knee 650. Thus the lower leg embodiment 200 of the pre-formed absorbent wound dressing with bladder is configured to the shape of the lower leg as the selected or target body part Based on this shape configuration, the inventive lower leg embodiment 200 of the pre-formed absorbent wound dressing with bladder fits better onto the lower leg based on the lower leg anatomy, thus assisting in healing of the wound. The lower leg embodiment 200 of the pre-formed absorbent wound dressing with bladder also includes certain weld spots 214 and weld lines 216 to better shape the inventive lower leg embodiment 200, though other non-welded sections are contemplated for shape and fit. In this embodiment and by way of non-limiting example, the inventive lower leg pre-formed absorbent wound dressing with bladder 200 may include varied shapes of bladders 240 as well as various pressure levels such as static pressure or gradient pressure as shown in FIG.s 1 land 12. The securing means 130 can also vary such as adhesive fasteners or tabs 235 and release tabs 237 as shown in FIG.s 9-11 compared to hook 238 and loop fasteners 235 as shown in FIG.s 12-13. Different sizes are also shown in FIG.s 11-12 with a larger left side in FIG. 12 for use with patients and user having lager calves. Other sizes and embodiments may be employed.

[0095] The lower leg with foot 100 and without foot 200 embodiments include shaping means 124, 224 such as plastics, wood, metals, polymers, films, alloys that have a shape memory such as nitinol, and the like. In other embodiments the shaping or support means are plastic that are placed in the layers flat and then rolled up in packing and transport so that the plastic 124, 224 takes on a curved shape, sometimes referred to as plastic creeping wherein the plastic deforms permanently under the influence of constant stress: tensile, compressive, shear, or flexural. In the other embodiment shown in FIG. 9, the shaping or support means is two elastic bands 226 formed at the top of the lower leg pre-formed absorbent wound dressing with bladder 200 and further down on the calf portion, though it is contemplated that there could only be one elastic portion 226, or three or more elastic portions as needed for the selected or target body part if not a lower leg, such as a thigh, torso, hip, chest, shoulder, arm, elbow, wrist, hand, neck or head.

[0096] On the inventive lower leg with foot 100 or without foot 200 pre-formed absorbent wound dressing with bladder, the proximal portion 117, 217 of the inner layer 115, 215 and matching outer layer 125, 225 is configured for better placement along the user’s calf or knee 650 on the leg and on the distal end has a distal portion 218, 219 configured for better placement along the user’s ankle on the foot. These portions are shaped so that when the inventive lower leg pre-formed absorbent wound dressing with bladder 100, 200 is secured on the lower leg there is no gap between the calf or knee 650 or along the ankle above the foot Other configurations and shapes may be employed depending on the limb where the inventive pre-formed absorbent wound dressing with bladder 100, 200 is being placed, such as the thigh, knee, foot, arch, torso, arm, hand, elbow, shoulder, chest, neck and other body parts.The configurations shown are non-limiting examples of the lower leg limb in these embodiments.

[0097] Many of the embodiments of the inventive lower leg with foot 100 or without foot 200 or a foot 300 pre-formed absorbent wound dressing configured for application on the foot as shown in FIGs. 1- 18B are shown on the right foot of the individual when in use, there is either a unilateral design where it can be used on either the left foot or right foot or there is a mirror image of the embodiments such as 900 which may be employed for application on the left foot of the individual user and indeed in the embodiments shown the inventive foot pre-formed absorbent wound dressing with bladder 100, 300 is ambidextrous and not right or left specific. The inventive foot pre-formed absorbent wound dressing with bladder 300 is sized in a range dependent on the target limb such as the width and length of the inventive foot pre-formed absorbent wound dressing with bladder 300 may be sized according to known shoe sizes for youth, men, women, etc.

[0098] The inventive foot pre-formed absorbent wound dressing with bladder 300 may be created or manufactured as shown in the exploded view of FIG.s 16-17 and partially constructed in FIGs. 15A-B and 18A-B. By way of non-limiting example of manufacture, the outer layer 325, the bladder 340, middle layer 320, and inner layer 315 are die-cut as separate operations. Then all layers are aligned on pins and KF welded together via the outer edges 316 with a multiple of dot welds 314 located through all layers but seen in these Figures on the outer layer 325 configured to create a pre-formed shape of the selected body part of the foot when in use, and including below the opening 305 or apertures for the heel 610. Additionally, the securing means such as two tabs 335 in this example are added with an adhesive (not shown 336) and plastic release tabs 337, notably the adhesive or tape is capable of maintain is adhesion to be opened and closed repeatedly. Other embodiments include hook 238 and loop fastener 235 combination for the securing means and the number of fasteners 235 can be one on each side, two on one side, one on a side with two on the opposite side, three on one side, two on each side or other combinations as long as they secure the inventive foot pre-formed wound dressing with bladder 300 on the foot with ability to open and close the dressing repeatedly. During manufacture the final step is for the two straight parts along the curved section 318 for the heel are welded or joined forming the aperture 305 for insertion of the heel 610 when in use, as shown in FIG. 1615A-18B and then shown in FIG. 14 applied onto the foot of the user.

[0099] The shape of each side portion of the inventive foot pre-formed absorbent wound dressing 300 includes one side which has either two or three wide portions 327 including a longer section though any number of portions could be employed or just one portion with these portions 327 being typically placed on the arch of the foot first when in use. The opposite side has either one larger portion or two or three thinner portions 326 with a shorter slit(s) and each portion 326 has a fastener or tab 335 connected so that the at least one thinner portions 326 are placed over the first portion 327 already on the foot and if using an adhesive securing means 230 then the tab release(s) 337 are removed activating the adhesive(not shown) under the fastener or tabs 335 and they are adhered to the top of the portion 327 thereby securing the inventive foot pre-formed absorbent wound dressing 300 on the foot as shown in FIG. 2 and 14 with other views of this embodiment shown in FIG.s 15 A- 17. In another embodiment the opposite may be employed with longer thinner portions 327 having the fastener or tab 335 connected so that the two thicker portions 326 are placed on the foot first and then the thinner portions 327 are placed over the two thicker or wider portions 326 and the tab releases 337 are removed activating the adhesive (not shown) under the fastener or tabs 335 and they are adhered to the top of the thicker portion 326 securing the inventive foot pre-formed absorbent wound dressing 300 on the foot. In another embodiment shown the securing means is a hook 338 and loop fastener 235 as shown in FIG. 18A-B though other known securing means can be employed. Also shown are different sized bladders 340 in FIG.s 16-17 and other sizes and type of bladders 340 may be employed. FIG. s 2 and 14 show the inventive foot pre-formed absorbent wound dressing 300 on a foot with the aperture 3005 configured on the heel 610 of the foot and where the portions 326, 327 overlap there is a slight aperture 306, though in other embodiments not shown the overlap may be complete so there is not aperture 306 present.

[0100] The method of securing the inventive foot pre-formed absorbent wound dressing 300 configured for application to the user’s foot includes placing the inventive foot pre-formed absorbent wound dressing with bladder 300 on the user’s foot with the inner layer 315 against the target ulcer or wound site and the heel of the user placed within the opening or aperture 305 and optionally the inventive preformed foot absorbent wound dressing with bladder 300 may be placed over an already applied and secured wound dressing 50 and / or elevation apparatus or bolster 75 then the user places the portion without the tabs 335 over the arch of the foot (either 326 or 327) and then places the other side (either 326 or 327) over and activates the adhesive by removing the release tabs 337. The inflation port 312 is connected to the bladder 340 via the openings 321 and connected to an inflation means (not shown) and the bladder is activated and inflated to apply compression onto the foot. The inflated bladder maintains compression even when the inflation means is removed due to the sealing means within the inflation port 312. The inflated bladder can be deflated at any time by placing the dust cap 313 upside down into the inflation port 312 or through the inflation means if connected to the inflation port 312. The inflation means can be static or intermittent inflation to apply pressure and compression to the foot In the embodiment shown in FIG. 15B the fastener or tabs 335, 335 including a portion 339, 339 that does not have adhesive so that the user can grip it and pull the fastener or tabs 335, 335 off to open the closed and secured inventive foot pre-formed absorbent wound dressing with bladder 300 to check on the wound site and then close it up again. In some embodiments of the method an optional gauze wound dressing 50 impregnated with medication, anti-bacterial coating, one or more coatings, silver, or zinc oxide may be placed first on the target ulcer or wound site before the foot pre-formed absorbent wound dressing with bladder 300 is placed on the foot. As shown in FIG. 2 a second pre-formed absorbentwound dressing with bladder 100 configured for the lower leg is placed on the lower leg below the knee 650 and above the ankle with the inner layer 115 against the skin of the leg and any ulcer or wound site, after the foot pre-formed absorbent wound dressing with bladder 300 configured for the foot has been secured on the foot of the user as the lower leg pre-formed absorbent wound dressing with bladder 100 overlaps the foot pre-formed absorbent wound dressing with bladder 300 around the ankle and heel area 610 area. The user places the inner layer 115 against the skin of the leg and any ulcer or wound site (optionally over any wound dressing 50 and / or elevation apparatus or bolster 75 already placed on the skin over an ulcer or wound site) and closes the tabs 135 by activating the adhesive (not shown) by removing the tabs 137 and then inflating the bladder 140 through the inflation port 112 connected to an inflation means 150. Further, another inventive therapeutic compression apparatus as disclosed in coowned PCT / US23 / 79854 and PCT / US23 / 37286 and WO 2018 / 052676, the entire contents of which are hereby incorporated herein by reference for all purposes, may be placed over all of the inventive preformed absorbent wound dressing with bladder 100, 300.

[0101] FIG. 3 shows another embodiment of the present invention of a foot and toe spacer pre-formed absorbent wound dressing 900 which include multiple openings, or apertures 905 for placement of the toes of the individual when placed onto the foot and toe spacing 922 which goes between the toes 660 on the foot when in use. This assists in securing the inventive foot and toe spacer pre-formed absorbent wound dressing 900 onto the foot and less movement of the inventive foot and toe spacer pre-formed absorbent wound dressing 900 once placed onto the foot The foot and toe spacer pre-formed absorbent wound dressing 900 includes a securing means which as shown includes by way of non-limiting example two fasteners or tabs 935, 935 with such shown as configured to be placed on the ankle or around the foot such as on top of the arch of the foot if the larger portion 942 (also including portion 943) of the foot and toe spacer pre-formed absorbent wound dressing 900 is placed on the bottom of the foot, or the reverse with the second fastener or tab 935 placed on the bottom of the foot if the larger portion 942 is placed on the top of the foot with portion 943 on the front of the ankle. Other securing means can be used as well including hook and loop as shown in other embodiments of the present invention as well as tape, wraps, buckles, snaps, and the like to keep the foot and toe spacer pre-formed absorbent wound dressing 900 applied on the foot. The fastener or tabs 935, 935 include an adhesive layer (not shown) for securing the it to the foot of the individual and a portion 937 which can be peeled or removed from the inner surface of the fasteners or tabs 935 to expose or release the adhesive so that the straps 935 can be applied and secured on the foot (top or bottom ) or ankle of the foot. Other securing means 930 may be employed such as hook and loop, buttons, zippers, fasteners and other means of securing the foot and toe spacer pre-formed absorbent wound dressing 900 onto the user’s foot. While not shown the pre-formed wound dressing with toe spacers 900 can include a bladder 940 (not shown) so as to apply compression and pressure upon the foot whether on the bottom sole of thefoot or the top arch of the foot location. In this embodiment the inflation port 912 has a sealing means and is capable of connection to an inflation means. The foot and toe spacer pre-formed absorbent wound dressing 900 is configured in the shape of a foot where in the larger portion 942 can placed under the sole of the foot or on top of the arch of the foot, depending on the location of the target wound site or ulcer, burn, gash, cut or surgical site. The smaller portion 941 is located above the openings 905 when the foot and toe spacer pre-formed absorbent wound dressing 900 is laid flat. The smaller portion 941 will be applied and placed either on top or below the foot depending on the location of the target wound site or ulcer, burn, gash, cut or surgical site. While not shown here, the smaller portion 941 can be applied or placed on the top of the foot if the target foot wound site or ulcer, burn, gash, cut or surgical site is located under the foot, and the opposite as shown in FIG. 3 where the smaller portion 941 will be applied on the bottom of the foot (ball of the foot below the toe area) if the target wound site or ulcer, burn, gash, cut or surgical site is located on the top of the foot. The smaller portion 941 includes securing means such as an adhesive layer as shown which is activated or released by removing the paper or film tab 937. The configuration of placement of the fasteners or tabs 935 can be in different locations (shown in co-owned PCT / 2024 / 042582) where they are parallel on one side, compared to another embodiment where the location of the fasteners or tabs 935, 935 are perpendicular to each other and one a side and bottom of the foot and toe spacer pre-formed absorbent wound dressing 900. In each embodiment as shown there are release tabs 937 which have to be removed to activated the adhesive layer (not shown) below. Again, other securing means may be employed and if the adhesive layer is employed it typically will not be located so as to adhere to the target foot ulcer or wound site, though in some embodiments not shown that could be employed depending on the adhesive properties or such as a skin substitute or liquid bandage. The adhesive layer is any material compatible with the skin and body of the user. The adhesive layer may be comprised of a material that maintains it adhering properties even when opened and closed repeatedly, so that the user can remove the foot and toe spacer pre-formed absorbent wound dressing 300 to engage in a activities such as bathing and then replacing the absorbent foot wound dressing back onto the foot ulcer or wound site after completing a bath or shower. This importantly allows the patient or user to have a lifestyle not affected by their wound dressing, compared to common conventional compression bandages, casts, and plasters, etc.

[0102] Many of the embodiments shown are for the right foot of the individual when in use, but the mirror image of the embodiments may be employed for application on the left foot of the individual user. Given the anatomy of the foot by the toes 660 the current embodiments are specific for a right or left foot, but it is envisioned other embodiments may be ambidextrous and not depending the specific foot chosen such as the foot pre-formed wound dressing with bladder 300 and the lower leg with foot 100 and the lower leg 200. The inventive foot pre-formed wound dressing with bladder 300 and the toe spacer pre-formed absorbent wound dressing 900 are sized in a range so that the larger portion 326, 942 (combined with943) may be placed either under the foot or on top of the foot. The length of such larger portion 942 (combined with 943) can be as small as just over the ball of the foot, or longer to be placed over the ball through under arch of the foot, or still longer to be placed over the entire underside of the foot, or even longest to be placed on the entire underside of the foot and partially up onto the heel area of the foot. In yet other embodiments the width and length of the larger portion 942 (combined with 943) may be sized according to known shoe sizes. In some embodiments of the method an optional gauze 50 impregnated with medication, anti-bacterial; coatings, one or more coatings, silver or zinc oxide may be placed first on the target ulcer or wound site before the inventive foot pre-formed wound dressing with bladder 300 and / or toe spacer pre-formed absorbent wound dressing 900 is placed on the foot, as well as a metatarsal elevation member or bolster (not shown but disclosed in co-owned application Serial No. PCT / US23 / 25642 entitled “Elevation Apparatus, System and Methods of Use”, the entirety of within is incorporated herein). The inventive pre-formed absorbent wound dressings with bladder 300, 900 may be used by emergency personnel on location of a trauma to control bleeding or by clinical and medical professional post-surgery or for treatment and prevention of ulcers and bed sores on the foot, toes, in between the toes, sole, arch, and side of the foot or for post-surgical procedures. The multiple shapes for configuration of placement on the inventive pre-formed absorbent wound dressing with bladder 300, 900 are merely non-limiting examples and other shapes may be employed. While not shown, the inventive foot with toe spacers pre-formed absorbent wound dressing 900 may include at least one bladder 940 within the inner layer 915 and outer layer 925 including an inflation port 912 to connect to an inflation means to inflate the at least one bladder to apply compression therapy to one or more parts of the foot. The at least one bladder 940 could be on the bottom sole of the foot, or on one or more sides of the foot, or along the heel 610 or by the ankle or on the top arch of the foot, or any one or more combinations of locations along the foot, toes, and ankle of the user.

[0103] Another embodiment of the present invention is shown in FIGs. 19A-21B for use on the head of an individual. The inventive head pre-formed absorbent wound dressing with bladder 400 may be used by emergency personnel on location of a trauma to control bleeding or by clinical and medical professional post-surgery or for treatment and prevention of ulcers and bed sores on the back or side off the head or for post-surgical procedures. The inventive head pre-formed absorbent wound dressing with bladder 400 is absorbent and includes a retaining or securing means such as a chin strap 442, 460 or 466, 468 or adhesive to place the inventive pre-formed wound dressing with bladder 400 on the head of the individual for better fit over the wound. The inventive head pre-formed absorbent wound dressing with bladder 400 includes two openings or apertures 405, 405 for the ears 705 and optionally additional adjusting securing means 435. As shown in FIG. 20 it has an inner porous hydrophilic layer 415, a bladder 440, a middle or central absorbent layer 420 and an outer hydrophobic vapor transfer layer 425, each having a slit 470 on the top portion through which the adjusting securing means 431, 435 isconnected during manufacture of the inventive head pre-formed absorbent wound dressing with bladder 400. The inventive head pre-formed absorbent wound dressing with bladder 400 may be created or manufactured by die-cutting the outer layer 425, absorbent layer 420 and inner layer 415, each including the corresponding slit 470, as separate operations. Then by way of non-limiting example only the bladder 440 is included between layer 415 and 420 with an opening 421 to connect to the inflation port 412 and the inflation means, with then all layers 415, 420, 425 are aligned on pins and RF welded together as well as spot welds 414 strategically chosen based on the configuration of the shape of the selected or target body part, this embodiment being the head. Further the layers are aligned and then RF welded to the perimeter 416 with the outer layer 425 to inner layer 415 having absorbent layer 420 and bladder 440 in between. The adjusting securing means 435 (including layers 431, 433) which is then partially inserted and in this non-limiting example RF welded into the slit 470 so that a flap is formed that is configured to move and connect to the hook portion 401 with the underside loop portion 431 of the fastener or tab 435. As shown in FIG. 20 the fastener or tab 435 of the adjusting means has multiple layers including a layer 433 comprised of by way of non-limiting example a polymer such as polyethylene net and an outer layer 435 comprised of by way of non-limiting example a polyester or film, and then the fastening or adjusting layer 431 which in this example is a loop material capable of connecting and fastening to the hook layer 401. As shown in FIG. 20 the hook portion 401 is a rectangle compared to the shape as shown in FIGs. 25-26 of co-owned PCT / US2024 / 042582 where is it a trapezoid type shape, though many other shapes and configurations are possible as long as the fastened means 435 can be moved and connected on the underside loop portion 431 to the hook portion 401. Next the chin strap 460, 442, 466, 4685 or securing means 430 is connected to the inventive head preformed absorbent wound dressing with bladder 400 again by way of non-limiting example of RF welding. The chin strap 460 as shown in FIGs. 19A, 20 and 21A-B includes a sliding portion 442 having two apertures or openings 462, 462 through which the chin strap 460 is inserted and allows in this configuration for the sliding portion 442 to be moved along the chin strap 460 for placement by the user at the chin of the individual wearing the inventive head pre-formed absorbent wound dressing with bladder 400, which takes into account various sizes of heads and faces by individuals who would have the inventive head pre-formed absorbent wound dressing with bladder 400 placed upon them. The opening for the face has a certain shape in the embodiments shown but the shape can be changed so that more or less of the forehead is covered by the inventive head pre-formed absorbent wound dressing with bladder 400 or the sides can be changed so that more or less of the cheeks are visible and covered or less cove red by the inventive head pre-formed absorbent wound dressing with bladder 400. While not shown it is envisioned that an embodiment can be used to cover the face with opening or apertures for the nose, mouth and / or eyes and then wound site or sites on the face can be covered to control bleeding and remove exudate. The inventive head pre-formed absorbent wound dressing with bladder400 includes at least one bladder 440 within the inner layer 415 and outer layer 425 including an inflation port 412 to connect to an inflation means to inflate the at least one bladder to apply compression therapy to one or more parts of the head. As shown in FIG. 19A the inflation port is on the left side of the user when on while in FIG. 19B it is shown on the right side of the user when on though other locations may be employed as well depending on other embodiments not shown where the bladder 440 is only on one side of the head or just on the back side of the head and other possibilities. The at least one bladder 440 could be on the base of the head along the neck, or on one or more sides of the head, or along the face portion near the cheeks, ears or eyes, on the back of the head, on the top of the head, or any one or more combinations of locations along the neck, face, ears, and head of the user. In the embodiments the chin strap 460, 466, 468 is connected on one end to the inventive head pre-formed absorbent wound dressing with bladder 400 via RF welding and the other end has a loop portion on the underside of the film or polymer chin strap 460, 466, 468 that can be secured or connected to the hook 438 welded onto the opposite face side of the inventive head pre-formed absorbent wound dressing with bladder 400. In another embodiment as shown in FIG. 19B the fastening or securing means 430 is two fasteners or tabs or chin straps 466, 468 which can be connected on one end each to the inventive head pre-formed absorbent wound dressing with bladder 400 via by way of non-limiting example welding and the other side by any known fastening means such as adhesives or hook and loop portions. In this embodiment there are two chin straps 466, 468 but there could be only one or three or more as needed for the configuration. Not shown but possible is a underside portion that is hook or loop capable of connection to a corresponding securing means such as a hook or loop portion such as the loop portion 411. Other connecting or securing or fastening means may be employed such as snaps, buckles, connectors and combinations thereof. Again at least one bladder 402 may be included in this embodiment of the head per-formed wound dressing in various locations with only one bladder 402 or multiple bladders 402. The inflation port 412 has a sealing means and is capable of connection to any known inflation means including those disclosed in co-owned PCT / US20 / 031227 and WO 2018 / 052676 for either static or intermittent inflation.

[0104] In use the emergency, clinical or medical personnel places the inventive head pre-formed absorbent wound dressing with bladder 400 on the head with the ears placed with the apertures or openings 405, 405. Next the user can either attached the chin strap 440, 466, 468 first or adjust the face opening via the adjusting means or fastener 435. If the user chooses to first connect the chin strap 440, 466, 468 it can be connected in these embodiments via the hook on the underside of the chin strap 440, 466, 468 to the loop portion 411 and moved up and down to secure the inventive head pre-formed absorbent wound dressing with bladder 400 on the chin and head of the patient or individual needing bleeding control and wound management. The user can then adjust the fit and tightness at the face near the forehead in these embodiments through the adjusting means such as the flap or fastener 435 usingthe underside loop layer 431 connected to the hook portion 401. Through this adjustment the opening for the face is tightened to prevent blood and exudate from going onto the face. This adjusting securing means is only one of various possibilities and others may be employed to better fit the inventive head pre-formed absorbent wound dressing with bladder 400 onto the head when in use. The bladder 440 is then inflated via the inflation port 412 and compression is applied to the head location. The inventive head pre-formed absorbent wound dressing with bladder 400 may also be placed on the head over an optional gauze 50 impregnated with medication, anti-bacterial; coatings, one or more coatings, silver or zinc oxide already on the wound site as well as an elevation member or bolster (not shown but various embodiments are disclosed in co-owned application Serial No. PCT / US23 / 25642 such as a circle or oval to be placed on the wound site to assist in treatment and prevention of bed sores on the head as well as a crescent shape for use around the ear 705 and other shapes may be employed. The advantages of the inventive head pre-formed absorbent wound dressing with bladder 400 is that it has the pre-formed shape of the head for quick and easy application onto the head during an emergency situation or by any clinical or medical professional as well as the user himselfZherself given its pre-formed shape. Further, the user can apply compression to the wound and also adjust the shape of the face making it tighter as needed, and also the user can remove the chins strap or fasteners 460, 466, 468 so that one can view the wound site and check for healing as well as infection, and the individual wearing it can take a shower or go about daily living then place the inventive head pre-formed absorbent wound dressing with bladder 400 back on the head using the chin strap or fasteners 460, 466, 468. Other advantages are contemplated by the inventive head pre-formed absorbent wound dressing with bladder 400 as well as other shapes and securing or shaping means. If this embodiment of the inventive head pre-formed absorbent wound dressing with bladder 400 includes at least one bladder 440, the bladder is inflated by inserting the inflation means into the inflation port 412 and after inflation the inflated bladder 440 thus applies compression therapy to the wound site. Head wounds bleed a lot so a single device or apparatus that can apply compression to reduce, control or even stop bleeding and swelling as well as the wound dressing component of the invention also reducing, controlling and stopping bleeding and other exudates can literally save lives.

[0105] In yet another embodiment of the present invention a knee pre-formed absorbent wound dressing with bladder 500 is shown in FIG. 29. In this version there are four fasteners or tabs 535 for securing the knee pre-formed absorbent wound dressing with bladder 500 to the lower thigh and upper calf though the number of fasteners 535 could be more or less depending on the type chosen and width of the user’s leg. As shown in FIG.s 22A the securing means is an adhesive (not shown) with the fasteners 535 having release liners 537 which are removed in use to activate the adhesive, while in FIG. 22B the top portion securing means remains adhesive for placement on the user’s lower thigh skin with the side securing means is a hook 538 and loop 536 below the fasteners 535 for placement around the lowerthigh and upper calf. The top or proximal portion is placed on the skin of the user to secure the entire pre-formed wound dressing with bladder 500 onto the user and to reduce slippage when the user moves or walks. In this embodiment the top adhesive fasteners 535 are connected to the outer layer by another connector such as a very strong adhesive or welding 570. This top securing means cannot be hook and loop as it is secured onto the user’s skin and any adhesive must be skin compliant. The shaping means 522 are shown as different lengths as the width and length as well as location may change depending on the width of the leg of the user with the shaping or support means 522 in these embodiments being plastic or wires though other materials may be employed. The shaping or securing means 522 as shown in FIG. 22A is two elements and one is larger or longer which is placed closer to the proximal or top portion of the knee pre-formed wound dressing with bladder 500 compared to the top or proximal shaping or support means 522 in FIG. 22B. Other lengths and widths of the shaping or support means 722 can be employed as well as other locations on the inventive knee pre-formed wound dressing with bladder 500. The shape of the actual wound dressing with bladder 500 is also useful in securing to the user such as the curved portion 517 for above the knee on the lower thigh area and the distal bottom curved portion 519 for placement along the calf of the user. The knee pre-formed wound dressing with bladder 500 has in this embodiment four layers including the inner layer 615, central or middle absorbent layer 520, the at least one bladder 540 and the outer layer 525 including an inflation port 512 connected to the bladder 540 via the openings 521 and connected to an inflation means to inflate the at least one bladder 540 to apply compression therapy to one or more parts of the knee. The at least one bladder 540 could be along the knee portion, or covering the knee and upper calf or shin, or the knee and lower thigh or the entirety of the pre-formed wound dressing with bladder 500. This embodiment is very useful following knee replacements and knee surgeries as the body parts are hard to cover with bandages and compression devices or apparatus. Further knee traumas and emergencies can benefit from the inventive knee pre-formed wound dressing with bladder 500 to reduce, control or even stop bleeding and most importantly reduce, control or stop swelling at the knee which has a tendency to swell a lot during accidents, emergencies, traumas and surgical or medical procedures. Thus the knee pre-formed wound dressing with bladder 500 meets many needs in the medical field.

[0106] In yet another embodiment of the present invention a thigh pre-formed absorbent wound dressing with bladder 600 is shown in FIG.s 24-25. In this version there are two fasteners or tabs 635 for securing a proximal or top portion of the thigh pre-formed absorbent wound dressing with bladder 600 to the upper thigh and hip and then three fasteners or tabs 635 on the side for securing around the upper thigh or hip, though the number of fasteners 635 could be more or less depending on the type chosen and width of the user’s thigh area. As shown in FIG.s 24-25 the top or proximal securing means is an adhesive (not shown) with the fasteners 635 having release liners 637 which are removed in use to activate the adhesive, while side securing means is a hook 638 and loop 636 below the fasteners 635 forplacement around the upper thigh and hip. The top or proximal portion is placed on the skin of the user to secure the entire thigh pre-formed wound dressing with bladder 600 onto the user and to reduce slippage when the user moves or walks. This top securing means cannot be hook and loop as it is secured onto the user’s skin and any adhesive must be skin compliant The shaping means 622 are shown as the same length though different lengths and width and length as well as location may change depending on the width of the thigh of the user with the shaping or support means 622 in these embodiments being plastic or wires though other materials may be employed. The shape of the actual wound dressing with bladder 600 itself assists in securing to the user such as the portion along the groin which is curved 617 and the distal bottom portion curved 619 for placement on the upper thigh of the user. As shown in FIG. 24 the thigh pre-formed wound dressing with bladder 600 has in this embodiment four layers including the inner layer 615, central or middle absorbent layer 620, the at least one bladder 640 and the outer layer 625 including an inflation port 612 connected to the bladder 640 via the openings 621 and connected to an inflation means to inflate the at least one bladder 640 to apply compression therapy to one or more parts of the thigh. The at least one bladder 640 could be along the thigh portion, or the saphenous vein, the inner thigh or the outer thigh or the hip or the groin area or the entirety of the pre-formed wound dressing with bladder 600. This embodiment is very useful following hip replacements and thigh surgeries such as sclerotherapy and other vein procedures as the body parts are hard to cover with bandages and compression devices or apparatus. Further upper leg and hip traumas and emergencies can benefit from the inventive thigh pre-formed wound dressing with bladder 600 to reduce, control or even stop bleeding and most importantly reduce, control or stop swelling at the thigh following hip replacement or sclerotherapy and other upper leg medical procedures where there is a lot of swelling during accidents, emergencies, traumas and surgical or medical procedures. Thus the thigh pre-formed wound dressing with bladder 600 meets many needs in the medical field.

[0107] In yet another embodiment of the present invention a shoulder or deltoid pre-formed absorbent wound dressing with bladder 700 is shown in FIG.s 26A-B and 27. In this version there are five fasteners or tabs 735 for securing the shoulder or deltoid pre-formed absorbent wound dressing with bladder 700 to the shoulder area and over the deltoid muscle though the number of fasteners 735 could be more or less depending on the type chosen and width of the user’s upper arm. As shown in FIG.s 26A and 27 all of the securing means are adhesive (not shown) with the fasteners 735 having release liners 737 which are removed in use to activate the adhesive, while in FIG. 26B the side portion securing means is a hook 738 and loop (not shown) below the fasteners 735 for placement around the upper arm. The top or proximal portion is placed on the skin of the user to secure the entire shoulder pre-formed wound dressing with bladder 700 onto the user and to reduce slippage when the user moves or uses their arm including when under clothes. In this embodiment the top adhesive fasteners 735 are connected to the outer layer by another connector such as a very strong adhesive or welding 770. Thistop securing means cannot be hook and loop as it is secured onto the user’s skin and any adhesive must be skin compliant. The shaping means 722 are shown as different lengths and locations as the width and length as well as location may change depending on the width of the upper arm of the user with the shaping or support means 722 in these embodiments being plastic or wires though other materials may be employed. The shaping or securing means 722 as shown in FIG. 26A is two elements and one is closer to the proximal or top portion of the should or deltoid pre-formed wound dressing with bladder 700 compared to the top or proximal shaping or support means 722 in FIG. 26B. Other lengths and widths of the shaping or support means 722 can be employed as well as other locations on the inventive thigh pre-formed wound dressing with bladder 700. The shape of the distal or bottom portion of the inventive pre-formed wound dressing with bladder 700 also assist in reducing slippage and securing to the user as the curved portion 719 is placed along the bicep and upper arm of the user. As shown in FIG. 27 the shoulder pre-formed wound dressing with bladder 700 has in this embodiment four layers including the inner layer 615, central or middle absorbent layer 720, the at least one bladder 740 and the outer layer 725 including an inflation port 712 connected to the bladder 740 via the openings 721 and connected to an inflation means (not shown 150) to inflate the at least one bladder 740 to apply compression therapy to one or more parts of the shoulder. The at least one bladder 740 could be along the inner arm or outer arm or the entirety of the shoulder pre-formed wound dressing with bladder 700. This embodiment is very useful following shoulder replacements, rotator cuff repair, bicep tenodesis and upper arm surgeries as the body parts are hard to cover with bandages and compression devices or apparatus and the person uses their arm constantly so slippage occurs quickly. Further upper arm traumas and emergencies can benefit from the inventive shoulder or deltoid pre-formed wound dressing with bladder 700 to reduce, control or even stop bleeding and most importantly reduce, control or stop swelling during accidents, emergencies, traumas and surgical or medical procedures. Thus the shoulder pre-formed wound dressing with bladder 700 meets many needs in the medical field and for users at home.

[0108] In yet another embodiment of the present invention not shown a lower arm pre-formed absorbent wound dressing and upper arm pre-formed absorbent wound dressing with bladder may be employed. In the lower arm pre-formed absorbent wound dressing with bladder there may be anywhere from two to 4 to more fasteners or tabs for securing the lower arm pre-formed absorbent wound dressing with bladder to the arm and wrist area with the fastener or tab on the distal portion wrapping around the thumb, though other securing means may be employed. The distal portion of the inventive lower arm preformed absorbent wound dressing is shaped to fit over the wrist and ends before the elbow. The other embodiment of the upper arm pre-formed absorbent wound dressing with bladder includes at least two fasteners or tabs as well as a shaping or support means, by way of non-liming example a plastic support to shape for an upper arm and bicep area above the elbow and below the shoulder. In this embodimentan elastic member is included over the elbow area but there could also be a joining or connecting means (not shown) to connect with the lower arm pre-formed absorbent wound dressing with bladder with the upper arm pre-formed absorbent wound dressing with bladder. The number of fasteners or tabs in each embodiment may be increased or decreased as needed for the selected or target body part. The lower arm and / or upper arm pre-formed wound dressing with bladder has in this embodiment four layers including the inner layer, central or middle absorbent layer, the at least one bladder and the outer layer including an inflation port to connect to an inflation means to inflate the at least one bladder to apply compression therapy to one or more parts of the lower and / or upper arm. The at least one bladder could be along the inner arm or outer arm or the entirety of the arm pre-formed wound dressing with bladder. This embodiment is very usefill following rotator cuff repair, bicep tenodesis, brachioplasty or an arm lift, elbow joint replacements for arthritis, Tommy John surgery (ulnar collateral ligament reconstruction), forearmplasty, wrist or elbow or hand arthroplasty and other upper or lower arm surgeries as the body parts are hard to cover with bandages and compression devices or apparatus and the person uses their ann constantly so slippage occurs quickly. The upper arm or lower arm wound dressing with bladder could also be used after dialysis on the arm or after a mastectomy such as disclosed in co-owned application PCT / US20 / 057224 entitled "Therapeutic Compression System and Methods of Use”, the entirety which is incorporated herein. Further upper and / or lower arm traumas and emergencies can benefit from the inventive pre-formed wound dressing with bladder to reduce, control or even stop bleeding and most importantly reduce, control or stop swelling during accidents, emergencies, traumas and surgical or medical procedures thereby meeting various needs in the medical field and for users at home. In use either the lower arm pre-formed absorbent wound dressing with bladder or the upper arm pre-formed absorbent wound dressing with bladder may be placed on the arm over a wound dressing including silver or zinc oxide 50 and a bolter or elevation member 75 and under a therapeutic compression apparatus or even a dialysis compression apparatus as disclosed in co-owned application PCT / US22 / 024121 and U.S. Patent Application 18 / 285853 entitled “Arm Therapeutic Compression System, Apparatus and Methods of Use”, the entire contents of which are incorporated herein, fastened around the lower or upper arm and the bladder inflated or activated via the inflation port and inflation means. The at least one bladder could be on the bottom portion of the lower arm or upper arm, or on one or more sides of the lower arm or upper arm, or along the wrist or by the elbow or shoulder, or any one or more combinations of locations along the hand, wrist, lower arm, elbow, and upper arm of the user.

[0109] The inventive pre-formed absorbent wound dressing including bladder 100, 200, 300, 400, 500, 600, 700 has the components of the embodiments shown in FIGs. 1-27 with the at least one bladder 140, 240, 340, 440, 540, 640, 740 being in different shapes and sizes as well as either preformed prior to manufacture or formed during manufacture of the entire wound dressing with bladder and may be aset pressure level or a gradient compression bladder configured and capable of applying gradient compression therapy on the target body part while still exudating the wound site without leakage of the wound onto the user’s clothes, furniture of outer layer 125, 225, 325, 425, 525, 625, 725. Non-gradient bladders can be employed as well but the advantages of using gradient compression therapy for the lower leg include reducing or eliminating swelling, lymphedema and other pooled liquids in the foot or ankle portion of the leg. The gradient bladder is formed based on spot welds placed on the bladder to form the gradient profile and when inflated the bladder applies gradient compression therapy onto the lower leg and if applicable the foot portion as well as the other target body part such as the knee, thigh, shoulder, upper arm, lower arm or head.

[0110] When in use the inventive pre-formed wound dressing including bladder 100, 200, 300, 400, 500, 600, 700 has many advantages such as reduced slippage down the target body part, compression therapy when the at least one bladder is inflated, increased and more targeted exudation of wounds, reduce post-operative complications (such as from knee or hip or shoulder replacements or liposuction or sclerotherapy or any surgical procedure as well as burn treatment), ambulatory use by the patient or user, decreased staining of the patient’s or user’s clothes and furniture and the like, and assisting with treatment of venous ulcers, CVI, DVT and lymphedema as well as just overall promotion of better healing with the combination of exudating layer and compression therapy. Notably there is now the advantage of just one apparatus as the wound dressing including at least one bladder for compression therapy when inflated, this advantage being in manufacture, storage at medical facilities and for the user, as well as cost and application by the user on their own in the their own home rather than having to rely on a medical professional to place compression bandages and separate compression apparatus to the target body part

[0111] The inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 has many advantages in that it may absorb the execute from the ulcer or wound site while cushioning the wound area and surrounding limb such as the leg, foot, knee, thigh, hip, arm, torso, shoulder, or head and based on its shape and openings (118, 119, 218, 219, 305, 306, 319, 517, 519, 617, 619, 719 ) is more secure on the leg, foot, knee, thigh hip, head, arm, shoulder and other body parts when in use, particularly when walking as well as on the arm or head. The outer layer 125, 225, 325, 425, 525, 625, 725 does not allow the excretion, pus, blood or the like from harming the user’s socks, clothes, bed linens, couch or the like as it is non-absorbent or less-absorbent than the inner layer 115, 215, 315, 415, 515, 615, 715 and the central or middle absorbent layer 120, 220, 320, 420, 520, 620, 720. The securing means such as the fasteners and tabs 135, 235, 335, 435, 535, 635, 735 support the shape of the target limb such as the lower leg, foot, knee, thigh hip, shoulder, or upper or lower arm so it does not fall down on the ankle or bunch under or on top of the foot when the user walks or down the wrist of the arm or even moving around the head and neck. Currently, a user would have gauze or rolls of surgicaltape and wrap these known wound dressings around the leg, foot, knee, thigh, hip, shoulder, arm or head which is cumbersome, uneven, and has gaps on the calf, ankle, toes, arch, sole, foot, knee, arm, elbow, wrist, shoulder or neck and head. The inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 solves these problems and is a secure wound dressing whether used alone or in a system with a second therapeutic compression apparatus, and / or the wound dressing 50 and / or the elevation apparatus or bolster 75.

[0112] The inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 has compression as well as the wound dressing element resulting in increased healing and reduced complications for so many medical procedures as listed above but notably for knee, hip, shoulder and elbow replacements as well as CVI and DVT and various skin ulcers due to poor circulation and also post sclerotherapy, brachioplasty or an arm lift, Tommy John surgery (ulnar collateral ligament reconstruction), forearmplasty, wrist or elbow or hand arthroplasty, after dialysis on the arm or after a mastectomy and other medical procedures. For older patients the inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 can be applying compression therapy while also cushioning the wound site and assisting in healing by whisking away blood and exudate at the wound site into the middle or central absorbent layer 120, 220, 320, 420, 520, 620, 720 and can also be opened and closed easily through the securing means 130, 230, 330, 430, 530, 630, 730 such as fasteners 135, 235, 335, 435, 535, 635, 735 to check on the progress of the wound site. Besides the medical procedures above the inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 can also be used during treatment of burns. Compression garments is a common treatment following a burn injury to help manage and improve the healing process of the scar tissue by apply consistent pressure to the affected area, which helps to reduce scar formation, flatten raised scars, and improve the overall appearance of the skin. The inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 has the dual benefits of exudating the burn site while at the same time applying compression.

[0113] Optionally, the inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 may include a drain port in fluid communication with either the inner layer 115, 215, 315, 415, 515, 615, 715 or middle absorbent layer 120, 220, 320, 420, 520, 620, 720 to drain excessive exudate, serum or blood from the ulcer or wound site. Optionally another layer may be employed that is filled with a filler material such as, for example, a gel that can be, for example, a silicon gel or polytetrafluoroethylene (PTFE). The gel-like substance may have a flow characteristic that allows the inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600 conform to the contour of the wound site. Optionally, the inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 may include an indicator to show when the inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 has a level of exudate within and should be changed, or any otherindicators such as moisture, filled capacity, temperature of the target limb, pulse rate at the target limb or a pressure measurement device having a digital readout for the target limb such as the ankle or foot or leg or knee or the like of the individual user. Non-limiting examples of indicators are moisture level sensors or pressure sensors or measurements devices include a micro-array of pressure sensors at different sites including the target ulcer or wound site and sites around the target ulcer or wounds site on the foot or leg or other limbs. Further, the pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 may include sensors regarding CO2 levels, temperature, pulse rate, and combinations thereof.

[0114] The inventive compression system includes the inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 with an optional gauze wound dressing 50 impregnated with medication, anti-bacterial coating, one or more coatings, silver, or zinc oxide and a bolter or elevation apparatus such as those disclosed in co-owned PCT / US23 / 25642. There may also be added a second therapeutic compression apparatus over the inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 such as those Applicant products known as the AeroDVX, Aero- Wrap, Hemo- Wrap and Sun Wrap and those disclosed in co-owned PCT / US23 / 79854; PCT / US23 / 37286; WO 2018 / 052676; U.S. Patent No. 9,033,906; U.S. Patent No. 7,967,766; U.S. Patent No. 7,559,908; Serial No. 13 / 444,600; and Serial No. 16 / 328,718, which are incorporated in their entirety herein, as well as the previously cited arm therapeutic apparatus for use with the inventive lower arm and upper arm pre-formed absorbent wound dressings. In some embodiments the additional therapeutic compression apparatus is capable of compression via an inflation means which 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 therapeutic compression apparatus so to provide compression in use by the patient. In some embodiments the inflation means is connected to the therapeutic compression apparatus by a hose or tube. In some embodiments of the inflation means is connected to a retaining means such as a belt or wrap to be worn by the user.

[0115] The inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 has many advantages in that it may absorb the execute from the wound while cushioning the wound area and surrounding the target body part based on its pre-formed shape it hugs or is more secure on the leg, foot, knee, thigh, hip, shoulder, arm, head or other body part when in use, particularly when walking and moving such as over the ankle and below or above the knee area or along the hip or tight area or around the wrist or elbow area and well as the shoulder and upper arm or lower arm area of the head. The outer layer 125, 225, 325 425, 525, 625, 725, 925 does not allow the excretion, pus, blood or the like from harming the user’s clothes, bed linens, couch or the like as it is non-absorbent or less- absorbent than the absorbent inner layer 115, 215, 315, 415, 515, 615, 715, 915. The shaping meanssuch as the wires, plastic or elastic 122, 222, 322, 422, 522, 622, 722 support the shape of the limb or target body part so that the inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 does not fall down on their foot, knee, thigh, hip or leg when the user walks or wears clothes over it and the arm or shoulder when the user moves the arm or wears clothes. The shape configuration of the foot and lower leg version of the inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, including the heel opening or aperture 305 and the shape or configuration of the ankle area 118, 119, 218, 219 and below the knee 117, 217 to prevent or reduce the inventive preformed absorbent wound dressing 100, 200, 300 from falling down when the user is walking, both barefoot and when the inventive pre-formed absorbent wound dressing 100, 200, 300 is within a sock or shoe or under clothes. In addition, the inventive foot and toe spacer pre-formed absorbent wounds dressing 900 is shaped for easy application to the bony foot and toes 660 bony the user or patient as well as emergency, clinical and / or medical personnel. Currently, a user would have gauze or rolls of surgical tape and wrap these known wound dressings around the leg, in between the toes or foot, which is cumbersome, uneven, and has gaps on the leg at the calf, knee 650, ankle, toes 660 and foot. The inventive pre-formed wound dressing with bladder 400 solves the problems of head injuries with the opening for the ears 406 and the adjusting and securing means 435 located on the top, in this embodiment, of the head portion. Further, the knee pre-fonned wound dressing with bladder 500 is shaped with curved portions 517 for above the knee where the thigh is usually larger and below the knee at the calf 519 for increased stability and securing it to the knee, thigh and lower leg on the user. The inventive thigh pre-formed wound dressing with bladder 600 is shaped with curved portions 617 for along the groin area on the thigh and then along the lower portion 619 of the thigh which is typically larger for increased stability and securing it to the thigh and hip on the user. Th inventive shoulder preformed wound dressing with bladder 700 is shaped with curved portion 719 for around the bicep and also including adhesive fasteners 735 on the top portion to secure to the shoulder, together for increased stability and securing it to the shoulder and upper arm on the user. The inventive pre-formed absorbent wound dressings 100, 200, 300, 400, 500, 600, 700 solves these problems and is a secure compression wound dressing. The inventive pre-formed absorbent wound dressings with bladder 100, 200, 300, 400, 500, 600, 700 can also be used over a (not shown) bolster and below a therapeutic compression apparatus such as disclosed in co-owned PCT applications cited above.

[0116] The inventive pre-formed absorbent wound dressings with bladder 100, 200, 300, 400, 500, 600, 700 can also be used over a (not shown) bolster and below a therapeutic compression apparatus such solve the problem of irregular bandaging or wound treatment. Typically a nurse or care giver will cunent wrap gauze around leg such that some portions of the wrapped gauze are thicker and other portions thinner resulting in irritation on the wound area as well as leakage of the exudate from the wound site. The user themselves may not be able to self-apply and even a skilled caretaker or medical professional may wrap sucha wound dressing either too tight resulting in circulation problems or too loose with leakage and gaps. Currently there is no consistency in applying absorbent wound dressing over a wound site on certain limbs. The inventive pre-formed absorbent wound dressings with bladder 100, 200, 300, 400, 500, 600, 700 solves this problem by having a pre-formed shaped configured for the selected or target body part. The inventive pre-formed absorbent wound dressings with bladder 100, 200, 300, 400, 500, 600, 700 includes a certain level of shape and stiffness, such as via a set of wires or plastic or other materials such that the inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 conforms to the shape of the target limb as well as the actual shape of the pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 including curved portions such as 117, 118, 119, 217, 218, 219, 319, 405, 517, 519, 617, 619, 719. The inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 has better fit, hugs or secures the absorbent wound dressing to the target limb while also not allowing leaks of exudates, puss, blood or the like with a non-absorbent outer layer. These and other advantages can be found with the use of the inventive preformed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 as well as applying compression therapy via the inflated bladder 702, 802.

[0117] The inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 make drainage management for wounds and exudate easier for both the emergency, clinical and medical personnel as well as the individual wearing and using the inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700. The shaping or support means such as the wires, plastic bands or elastic 122, 124, 126, 724, 824 make it easy to apply and to open to check on the wound site and close it up again multiple times. Notably the user or patient can self-manage their care in between appointments with clinical or medical professionals.

[0118] The inventive wound dressing compression system including the inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 also reduces the problem of lack of mobility in that the patient can move and walk about and go to work, school, recreational activities. The inventive system also includes an 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, burn recovery, dialysis, mastectomy, sclerotherapy, various replacement surgeries and other treatments. Another embodiment (not shown) may include a variety of sensors including realtime 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 thepatient 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.

[0119] The inventive system including the pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 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 and pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 can be used as a prophylaxis for wound care and / or swelling in any body part. The inventive 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, elbow and wrist and hand and shoulder surgeries, TKR, KRA,n-m., HR A, sclerotherapy and many other surgical procedures regarding other libs or body parts which have exudating wounds as well as an increased risk of CVI and / or DVT. The inventive system 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 HPIPC 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.

[0120] The inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 alone or in combination with the inventive system democratizes the wound health care in that the user can remove the wound dressing to engage in everyday activities such as bathing and does not need to travel to a medical professional every few days for removal of wound dressings and replacement. It allows the user to self-apply the inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700. Further, the user saves money in travel costs and co-pays as well as time with reduced visits to the medical professional. Notably the inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 is reusable saving money and time. The inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 provides measurable air to the target ulcer or wound site, a compression level that is maintainable throughout the treatment plan, is capable of self-application by the patient including being able to remove the inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 and reuse it Notably, anyone can properly place the inventive preformed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 on the user in a more effective way than known conventional compression bandages, which exudating the wound site or ulcer and assisting in wound healing and reduced swelling.

[0121] This inventive pre-formed absorbent wound dressings 100, 200, 300, 400, 500, 600, 700 ease of reapplication directly correlates to compliance by the patient with the treatment plan. The inventive preformed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 assist in healing andreduction of complications by providing a multi-layer design which is comfortable, non-stick, absorbent, and has an outer backing layer 135 that prevent strike through but allow vapor transfer so not occlusive to the target foot ulcer or wound site by reducing build up in Co2 or bacteria growth and importantly includes compression and pressure to the wound site as well as the adjacent skin and tissue on the target body part. The inventive pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 provides measurable air to the wound site while also applying compression therapy.

[0122] While the subject invention of the present disclosure has been described with respect to preferred and exemplary embodiments, those skilled in the art will readily appreciate that various changes and / or modifications can be made to the invention without departing from the spirit or scope of the invention as described he rein. There have been described and illustrated herein several embodiments of an pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 and a method of applying and securing same onto a target limb of a user as well as a system including the inventive pre-formed absorbent wound dressings 100, 200, 300, 400, 500 600, 700. While particular embodiments of the invention have been described, it is not intended that the invention be limited thereto, as it is intended that the invention be as broad in scope as the art will allow and that the specification be read likewise. Thus, while particular shapes and sizes of pre-formed absorbent wound dressings and their components have been disclosed, it will be appreciated that other shapes, sizes, and attachment means may be used as well. It will also be understood that while adhesive means have been disclosed for helping to secure the pre-formed absorbent wound dressing with bladder 100, 200, 300, 400, 500, 600, 700 to the selected or target body part and other types of attachments such as hooks, snaps, or wraps may be used. In addition, it will be appreciated that certain materials have been disclosed for the various hydrophilic, absorbent, wicking, hydrophobic and hydroconductive layers while other materials known in the art may be used. It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its spirit and scope as claimed.

Claims

CLAIMSWe claim:

1. A pre-formed absorbent compression wound dressing for use on a selected body part, comprising: an inner porous layer having contact with a wound site; at least one bladder; a middle absorbent layer configured to remove and store exudate from the wound site; an outer waterproof vapor transfer layer; a plurality of connections sealing the inner and outer layers together over the at least one bladder and the middle absorbent layer; and a securing means for securing the pre-formed absorbent compression wound dressing to the selected body part, wherein the pre-formed absorbent compression wound dressing is configured in a shape for placement on the selected body part2. The pre-formed absorbent compression wound dressing of claim 1 wherein the selected body part is selected from the group of foot, ankle, leg, calf, knee, thigh, hip, torso, chest, shoulder, arm, elbow, wrist, hand, neck, and head.

3. The pre-formed absorbent compression wound dressing of claim 1 wherein the first inner porous layer is a hydrophilic layer or a hydroconductive layer.

4. The pre-formed absorbent compression wound dressing of claim 1 wherein the middle absorbent layer is selected form the group consisting of cotton, pulp, cellulose, cellulose derivatives, polymers, high molecular water absorbent polymers, thermoplastic resin, cellulosic fiber, acrylic (salt) polymer, foam, woven or nonwoven material selected from the group consisting of rayon, polyester, polyurethane, polyolefin, orlon, hydrogel polymeric material, and combinations thereof.

5. The pre-formed absorbent compression wound dressing of claim 1 wherein the inner or middle absorbent layer further includes a wicking layer.

6. The pre-formed absorbent compression wound dressing of claim 1 wherein the outer waterproof vapor transfer layer is moisture permeable and liquid impermeable.

7. The pre-formed absorbent compression wound dressing of claim 1 wherein the outer waterproof vapor transfer layer is hydrophobic and is selected from the group consisting of polymers, woven and nonwoven materials, films, laminates and combinations thereof.

8. The pre-formed absorbent compression wound dressing of claim 1 wherein the outer waterproof vapor transfer layer further comprises a hydrochromatic ink.

9. The pre-formed absorbent compression wound dressing of claim 1 wherein the inner porous layer further includes medications, anti-bacterial coatings, zinc oxide, silver or combination thereof.

10. The pre-formed absorbent compression wound dressing of claim 1 wherein the at least one air bladder is configured to include an inflation port and capable of connection to inflation means sleected from the group consisting of manual pumps, static pumps, intermittent pumps, electrical inflation pumps, battery inflation pumps, gas powered inflation pumps, static pneumatic compression pumps, intermittent pneumatic inflation pumps, and the combinations thereof and the inflation means for the at least one bladder is selected from the group consisting of air, gas, fluid or combinations thereof.

11. The pre-formed absorbent compression wound dressing of claim 1 wherein the plurality of connections seals all three layers together on a plurality of edges of said three layers.

12. The pre-formed absorbent compression wound dressing of claim 1 wherein the securing means is selected from the group of adhesives, hook and loop, straps, buckles, snaps, and combinations thereof.

13. The pre-formed absorbent compression wound dressing of claim 1 wherein the securing means is either an adhesive or hook and loop combination capable of sealing, releasing and sealing multiple times.

14. The pre-formed absorbent compression wound dressing of claim 13 wherein the securing means includes a tab having a distal portion without any adhesive configured to all the user to grip the securing means for opening and closing.

15. The pre-formed absorbent compression wound dressing of claim 1 further comprising a support means configured so the pre-formed absorbent compression wound dressing is in a shape for placement on the selected body part wherein the support means is selected from the group consisting of plastic, polymers, wires, elastic, and combinations thereof.

16. The pre-formed absorbent compression wound dressing of claim 1 wherein the selected body part is a lower leg from a knee portion to a toe portion, and the pre-formed absorbent compression wound dressing is configured in the shape of lower leg and foot including an opening for the front of the ankle, the toe portion and below the knee.

17. The pre-formed absorbent compression wound dressing of claim 1 wherein the selected body part is a lower leg from a knee portion to an ankle portion, and the pre-formed absorbent compression wound dressing is configured in the shape of lower leg including an opening for the front and back of the ankle and below the knee.

18. The pre-formed absorbent compression wound dressing of claim 1 wherein the selected body part is a foot and the pre-formed absorbent compression wound dressing is configured including an opening for a heel of the foot and capable of being wrapped over an arch of the foot leaving a toe area of the foot unwrapped.

19. The pre-formed absorbent compression wound dressing of claim 1 wherein the selected body part is a head and the pre-formed absorbent compression wound dressing is configured including a plurality of openings for a face and two ears of a head and further comprising an adjusting means configured to adjust the opening at the face and wherein the securing means is configured to be placed on a chin of the head.

20. The pre-formed absorbent compression wound dressing of claim 20 wherein the adjusting means includes either an adhesive or a hook portion and a loop portion configured for the user to adjust the open face portion at a forehead area of the head and the securing means further includes a chin support configured to slide along the securing means for placing the chin support at the widest point of the chin on the face when in use on ahead.

21. The pre-formed absorbent compression wound dressing of claim 21 wherein the adjusting means is comprised of a slit in the top portion of the pre-formed absorbent compression wound dressing located over the head, a hook portion on top portion of the head and a loop portion under a flap.

22. The pre-formed absorbent compression wound dressing of claim 1 wherein the selected body part is a lower arm and the pre-formed absorbent compression wound dressing is configured including a securing means for securing around a thumb of the user at a wrist location.

23. The pre-formed absorbent compression wound dressing of claim 1 wherein the selected body part is an upper arm and the pre-formed absorbent compression wound dressing is configured including a shaping means for securing at the upper arm and bicep area.

24. The pre-formed absorbent compression wound dressing of claim 1 wherein the selected body part is a thigh or hip area and the pre-formed absorbent compression wound dressing is configured including a shaping means for securing at the upper thigh and / or hip area.

25. The pre-formed absorbent compression wound dressing of claim 1 wherein the selected body part is a knee are and the pre-formed absorbent compression wound dressing is configured including a shaping means for securing at the lower thigh and upper calf arm.

26. The pre-formed absorbent compression wound dressing of claim 1 wherein the selected body part is a should or deltoid are and the pre-formed absorbent compression wound dressing is configured including a shaping means for securing at the shoulder and upper arm.

27. The pre-formed absorbent compression wound dressing of claims 16-17 or 22-26 wherein the support means are wires, plastic or elastic and are located along the calf, thigh, hip, or arm area.

28. A wound dressing and compression system for use on a body part, comprising:(a) a pre-formed absorbent compression wound dressing for use on a selected body part, comprising (i) an inner porous layer having contact with a wound site, (ii) at least one bladder, (iii) a middle absorbent layer configured to remove and store exudate from the wound site, (iv) an outer waterproof vapor transfer layer, (v) a plurality of connections sealing the inner and outer layers together over the middle absorbent layer, and (vi) a securing means for securing the pre-formed absorbent compression wound dressing to the selected body part, wherein the pre-formed absorbent compression wound dressing is configured in a shape for placement on the selected body part; and(b) an elevation or bolster having a foam or hydrophilic portion and a bladder portion configmed to elevate or bolster a selected body part.

29. The wound dressing and compression system of claim 28 wherein the elevation or bolster is in the shape of a circle, oval, crescent, dog bone, rectangle, square, semi-circle, and any other known shape.

30. The wound dressing and compression system of claim 28 further including a second dressing including a coating selected from the group of medication, anti-bacterial materials, silver, zinc oxide or combinations thereof.

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