Elevating apparatus, system, and method of use

Abstract

A raising device for raising an osseous process of a user, such as the heel, ankle, foot, metatarsal, elbow, hip, sacrum, scapula or other bones. The elevation device includes a permeable skin-compatible adhesive layer, an absorbent layer, a protective layer, and at least one inflatable or pre-inflatable bladder including at least one aperture configured for a selected osseous process.

Description

[0001] Related patent applications

[0002] This application claims priority to provisional application serial number 63 / 353,438, filed on June 17, 2023, and entitled “Elevation Apparatus, System and Methods of Use,” the entire contents of which are hereby incorporated by reference into this document for all purposes. Background Art

[0003] I. Technical field

[0004] The subject invention generally relates to an apparatus and system for elevating bony prominences on a user's body to reduce or prevent pressure sores and skin ulcers.

[0005] II. Related Art Background

[0006] Pressure ulcers (injuries) are localized injuries of the skin and soft tissues on the bony prominences caused by external forces, and are one of the most resistant chronic wounds. Pressure ulcers may be caused by friction with clothing or by various diseases of the patient. Some pressure ulcers are also commonly referred to as "bedsores". These pressure skin ulcers may form on patients in nursing homes and hospitals, and may even form these pressure skin ulcers at home if the patient rests for a long time. The areas where bones are close to the surface (called "bone prominences") and the areas under the greatest pressure are at the greatest risk of developing pressure ulcers or sores. Certain bone prominences are more common in pressure ulcers or bedsores, such as the soles of the feet, under the metatarsals, ankles, hips, sacrum or coccyx, knees (including the front, back and sides), elbows and backs (including shoulder blades).

[0007] It is well known that pressure ulcers or bedsores can be treated with various dressings after they develop, but preventing or reducing the occurrence of pressure ulcers or bedsores is less known. Patients who develop these pressure ulcers or bedsores often have other underlying conditions, such as diabetes and circulation problems, which prevent the pressure ulcers or bedsores from clearing quickly. Often, once a pressure ulcer or bedsore develops, patients who are confined to bed in a nursing home, hospital, or at home will not recover. Also, these patients often develop pressure ulcers on the ankles, sacrum, and hips, as well as other bony prominences.

[0008] When patients are unable to ambulate, they face high risk factors for pressure ulcers or bedsores due to immobility and pressure, including increased pressure on bony prominences such as the ankles, heels, metatarsals, elbows, back and hips, sacrum, and other parts of the body. Such pressure ulcers often occur on the sides of the lower legs, around or on the prominent ankle bones, and around or on the hip bones and coccyx. Such pressure ulcers and bedsores are difficult to heal, and even if they are partially healed, they often recur repeatedly and eventually develop infections. In addition, for people who spend most of the day in a wheelchair, skin ulcers or bedsores may develop around the knees, on both sides of the knees, in front of the knees, and on the back of the knees.

[0009] Some studies have found that seventy-five percent of pressure ulcer or bedsore injuries occur around the pelvic girdle, most commonly at the ischia, greater trochanter, and sacrum. In addition to local ischemia, other factors that impede proper healing include malnutrition, infection, edema, persistent moisture, fecal and urine contamination, and shear forces. Specific risk factors for sacral pressure ulcers and bedsores include supine positioning and fecal incontinence. Likewise, simply placing a pillow under the coccyx does not mitigate risk because the individual will dislodge the pillow with any movement in bed or chair. Treat bleeding or oozing pressure ulcers or bedsores with bandages; dressings alone do not address pressure points.

[0010] Pressure ulcers or bedsores can be caused by a combination of pressure, friction, and shear. Continuous pressure on any part of the body can reduce blood flow to the skin and underlying tissues. Without these essential oxygen and other nutrients, the skin and nearby tissues can become damaged and may eventually die. For people with limited mobility, this pressure often occurs in areas that are not well padded with muscle or fat and sit over bones, such as the heels, ankles, balls or metatarsals, spine, coccyx or sacrum, shoulder blades, hips, and elbows, which are all bony prominences. Friction, which occurs when skin rubs against clothing or bedding, can also cause pressure ulcers and bedsores. This friction can make delicate skin more vulnerable to injury, especially if the skin is wet. Finally, shear can occur, such as when two surfaces move in opposite directions. For example, when a person lies in bed, they may slide downward, such as when the sacrum or coccyx moves downward, and the skin over the bone may stay in place—pulling in the opposite direction. All of these can lead to pressure ulcers and bedsores.

[0011] In addition to the usual bleeding and pain, pressure ulcers and bedsores can lead to more serious injuries such as cellulitis, infection, cancer, and even sepsis or death. Cellulitis is an infection of the skin and connected soft tissues that can cause heat, inflammation, and swelling in the affected area. People with nerve damage usually do not feel pain in the area affected by cellulitis. Infections caused by pressure ulcers and bedsores can invade joints and bones. Joint infections (septic arthritis) can damage cartilage and tissue. Bone infections (myelitis) can also reduce joint and limb function. In some cases, pressure ulcers and bedsores can lead to cancer. Wounds that do not heal for a long time (Marjolin's ulcers) can develop into a type of squamous cell carcinoma. In some cases, pressure ulcers and bedsores can also lead to sepsis and even death. Therefore, there is a need to treat, relieve, and even prevent pressure ulcers and bedsores.

[0012] Many individuals who develop pressure ulcers and bedsores also suffer from lymphedema, also known as lymphatic obstruction, which is a condition of localized fluid retention and tissue swelling and is caused by damage to the lymphatic system. Treatment for lymphedema varies depending on the severity of the edema and the degree of fibrosis in the affected limb. The most common treatments for lymphedema are manual compression lymphatic massage, compression garments, or bandaging. Elastic compression garments are often worn by the person with lymphedema on the affected limb after full decongestive therapy has been administered to keep the edema down. These individuals who develop pressure ulcers and bedsores with lymphedema do not recover from the pressure ulcers and bedsores and can remain with the skin for months or longer.

[0013] Diabetic ulcers may affect the foot and ankle area, causing wounds that ooze. These ulcers may be located on or under the sole of the foot, on the ball of the foot, along the metatarsal bones, on the toes, between the toes, on the top of the foot, on the arch, and on the ankle and heel. People with diabetes may have more foot ulcers, sometimes related to a complication called neuropathy, which causes an individual to lose sensation in their foot. Scrapes, cuts, or puncture wounds on the skin may turn into ulcers, but if an individual has neuropathy and cannot feel wounds or pain in the ankle, heel, or foot area, they may not know the ulcer is there. The ulcers may lead to infection, and in extreme cases, the infection cannot heal, resulting in amputation of part of the individual's foot or toe. It is estimated that about 15% of people with diabetes in the United States will develop a foot or toe ulcer, and about 14% to 24% of people with diabetes in the United States will require an amputation after developing an ulcer. Diabetic foot ulcers are the leading cause of foot amputations. As of 2020, there are an estimated 537 million people with diabetes worldwide, of whom approximately 19% to 34% will develop a diabetic foot ulcer during their lifetime. Unfortunately, of the individuals who develop a diabetic foot ulcer, approximately 20% will require a lower limb amputation, either a minor amputation (below the ankle), a major amputation (above the ankle), or both. More than 80% of amputations begin with a foot ulcer. More extreme, of those who develop a diabetic foot ulcer, approximately 10% will die within a year of their first diagnosis of a diabetic foot ulcer. Additionally, foot ulcers can occur in many people, but may be more common in blacks, Native Americans, and Hispanics. Individuals are also at higher risk if they have eye, kidney, or heart disease associated with diabetes. Approximately 15% of people with diabetes develop an ulcer, which is usually located on the sole of the foot. Some of these individuals will be hospitalized for complications.

[0014] Individuals are also at higher risk for foot and toe ulcers if they have any of the following conditions: circulation problems, heart disease, obesity, foot conditions such as bunions or hammer toes, kidney disease, and some lifestyles that involve smoking and drinking. Ulcers are open wounds on the skin that can take on almost any shape. Some shapes are more common in certain parts of the body than others. For example, an ulcer on the foot or toes may be shaped like a crater or a wedge. Ulcers can even grow deep into the bone, leading to amputation or even death.

[0015] Neurotrophic ulcers occur primarily in patients with diabetes, although anyone with impaired sensation in the feet can be affected. They can occur anywhere on the foot, but usually occur in areas of the foot and toes that are most sensitive to weight (pressure points), such as the ankles, heels, and soles. Although neurotrophic or diabetic ulcers do not cause pain due to the loss of sensation in the feet caused by neuropathy, the situation may be worse because individuals will not realize that they have an ulcer until the ulcer oozes or oozes. In addition, autonomic neuropathy is associated with sweating and a decrease in natural moisturizing factor components, which dries the skin, causing the epidermal barrier to break down, leading to dryness and the appearance of cracks or fissures, which may become entrances for bacteria on the foot and even between the toes. Areas where blisters, cuts, scratches, redness, or bleeding occur indicate local injuries caused by local trauma, friction, or shearing, which are often caused by walking barefoot and ill-fitting shoes. The formation of callus tissue is a response to increased local pressure, indicating that the skin is about to break down and ulcerate. Another complication is fungal infection, which is not uncommon in the feet of patients with diabetes. Diabetic foot ulcers can lead to serious complications if left untreated. In addition to being significantly more susceptible to developing ulcers, patients with diabetes often take significantly longer for their ulcers to heal. It is not uncommon for an ulcer on the foot, heel, or ankle in a diabetic patient to take 10-12 weeks to heal, even when a cast or other more permanent treatment or therapy is used, where the individual may be on crutches, completely removing any weight or pressure from the foot. In contrast, such ulcers in healthy individuals may heal in seven days. There is a need for an elevation device that is easily used by an individual, either alone or by a medical professional, to prevent pressure sores and, if a sore or ulcer already exists, drain the sore or wound, shorten healing time, reduce complications, and aid in overall healing.

[0016] Arterial ulcers can be caused by a condition called peripheral arterial disease, which reduces blood flow to the extremities. When this happens, tissue in the foot may begin to die. Ulcers that form due to reduced blood flow are called arterial ulcers and usually form near the ankle. Arteries are blood vessels that carry blood from the heart to the rest of the body, including 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 a higher risk. Unlike neurotrophic ulcers, arterial ulcers can form in many areas of the foot, most notably on the bony parts of the foot, such as the sole, along the metatarsal bones, heel, and ankle areas, which rub against sheets, socks or shoes, or even furniture such as sofas or chairs.

[0017] Diabetic ulcers and arterial ulcers are wounds or open sores that fail to heal or recur repeatedly, causing persistent swelling of the skin as well as burning, itching, irritation, and discoloration. Conventional treatment and therapy for these types of ulcers usually involves topical protection of the wound, as well as compression and antimicrobial therapy to the affected area. Other treatment plans for the foot, heel, ankle, hip, and sacral areas include draining the ulcer or wound site, using orthotics to try to reduce or divert pressure points on the foot, removing pressure from the area by wearing a cast, elevating the targeted bony prominence for long periods of time (which can be difficult for workers), debridement and removal of infected tissue, shaving or removal of infected bone, tenotomy (removal of scar tissue that has formed at the ulcer or wound site), and even reconstructive surgery using skin grafts to replace the infected ulcer or wound site.

[0018] Many current treatment options, including the use of currently known devices, apparatus, bandages, stockings, socks, etc., only treat bleeding or oozing pus and do nothing to prevent or reduce the development of pressure ulcers and bedsores. Other treatments include placing pillows under the individual's heel or ankle, but once the individual moves even a little, the body part is again in contact with the bed, and the pillows themselves may form or contribute to pressure ulcers and bedsores, even if they are properly positioned by trained caregivers. Currently known lifting devices and apparatus have not been successful in preventing pressure ulcers on the foot, heel, ankle, hip, and sacral process.

[0019] The venous pressure at the ankle of a supine subject is approximately 10 mmHg, but this will rise significantly when standing due to the increase in hydrostatic pressure (equivalent to the weight of a vertical column of blood stretched from the measurement point to the right auricle of the heart). During walking, as the foot flexes dorsally, contraction of the calf muscles compresses the deep veins and soleus sinuses, emptying them of blood. When the foot is plantar flexed, the pressure in the veins drops, the proximal valve closes, and the veins are refilled with blood from the superficial system through the perforator. During this cycle, in a normal leg, the distal valves of the deep veins and the valve of the perforator will ensure that the drained blood can only go in one direction - up back to the heart. Therefore, any bandage or dressing placed on pressure ulcers and bedsores must take these venous pressures into account so that the bandage or dressing is not too tight or too loose.

[0020] Likewise, many individuals with pressure ulcers and bedsores also suffer from CVI, which occurs when these valves become damaged and cause blood to leak back down in the opposite direction. This type of valve damage can occur due to aging, prolonged sitting or standing, or a combination of aging and decreased mobility. When the veins and valves weaken and blood cannot flow upward to the heart appropriately, blood pressure in the veins of the lower extremities can remain elevated for long periods of time, leading to CVI. This condition is more common in older individuals and, if not properly treated, can lead to broken capillaries, localized tissue inflammation, internal tissue damage, varicose veins, ulcers, and open sores on the surface of the skin. Broken capillaries can be seen in patients' legs, including the ankles, knees, thighs, hips, sacrum, back, and groin. CVI helps prolong the recovery time of pressure ulcers and bedsores.

[0021] In addition to pain and discomfort, and potential cancer and sepsis, the prevalence of pressure ulcers and bedsores also creates an economic burden. Again, pressure on bony prominences, particularly the heels, ankles, sacrum, and hip bones, can lead to bedsores and ulcers after a few hours, secondary to the continued pressure on the skin and blood supply to the area. Initially just redness, over time, with continued immobility, the redness turns into an ulcer that often spreads to the bone. Once an ulcer forms, it takes months to heal and causes discomfort and pain, while also creating a huge economic burden in nursing homes and hospitals. The economic pressure is compounded by the cost of materials for changing dressings, plus the time it takes for medical staff to change the large number of dressings on these pressure ulcers and bedsores. A single patient in a nursing home or hospital may have 4-5 pressure ulcers and bedsores that all require bandage and dressing changes, then multiplied by the number of residents in the nursing home or assisted living facility, as well as the hospital. This can result in full-time medical staff moving from patient to patient, residence, etc. all day long during each shift. Therefore, there is a need to treat, reduce, or even prevent pressure ulcers and bedsores.

[0022] Currently, there are many tapes and bandages that can be used on wound sites or ulcers, but the anatomy and structure of the foot, heel, ankle, hip and sacral regions can cause adhesions, pressure issues, complicating any treatment and healing, and can cause ulcers to leak or seep onto an individual's socks, clothing, bed sheets, couches, etc. A wound dressing for use on the foot, heel, ankle, hip and sacrum is needed to treat ulcers or any type of wound. It is worth noting that common wounds, scrapes, cuts, etc. on these bony areas take longer to heal, even in healthy individuals, due to the anatomy and structure of the bony prominences.

[0023] There is a need for a wound dressing that can be used for any wound on the foot, regardless of whether the individual has diabetes, circulation problems, or is a healthy individual with a foot wound. As of 2015, costs associated with diabetic foot ulcers alone exceeded $1 billion per year and are rising year by year. It is estimated that overall diabetes care in the United States will cost an estimated $273 billion per year in direct costs and $90 billion in indirect costs by 2022. Foot complications such as ulcers and infections are a major source of cost for people with diabetes, resulting in increased hospitalizations, emergency department visits, outpatient visits, and home health care utilization, with annual expenditures exceeding baseline diabetes-related care costs by 50% to 200%. Advanced ulcers, regardless of where they occur (including the heel, ankle, hip, and / or sacrum), can cost up to $50,000 per wound episode, and major amputations can cost even more in direct costs. These figures likely underestimate the true economic burden of diabetic foot ulcers and all pressure ulcers, given the out-of-pocket costs, lost productivity, and reduced employment associated with such ulcers or open sores. There is a need for a device to elevate such bony prominences and a treatment plan that will improve healing time and outcomes while reducing complications such as infection and amputation of such ulcers and arterial ulcers, while improving function and quality of life and reducing health care costs.

[0024] Therefore, there is a need for a device that elevates, treats, reduces, and even prevents pressure ulcers and bedsores, which elevates bony prominences while also treating any current pressure ulcers and bedsores. There is also a need for a device that does not shift or move when an individual is moved in a bed, chair, or otherwise partially or completely immobilized. There is also a need for a device that can be used when an individual is walking again without shifting or moving on the skin. There is also a need for a device that includes a pre-filled or partially filled air bladder to elevate bony prominences and is able to evenly distribute pressure on the underlying anatomical structures for optimal compression and comfort.

[0025] The apparatus, systems and methods of the subject invention provide benefits and advantages that overcome many of the problems associated with the known art, particularly problems resulting from the difficulty of applying current dressings and elevation with pillows or other known devices over pressure ulcers and bedsores. Those skilled in the art will readily appreciate that it would be beneficial to provide an elevation device for preventing, treating, alleviating, assisting in the healing and recovery of, or even preventing, pressure ulcers and ulcers over bony prominences. Other uses of the apparatus of the present invention are contemplated. Summary of the invention

[0026] The present invention relates to an apparatus, system and method for treating, alleviating or even preventing pressure ulcers and / or bedsores near or on bony prominences of the foot, ankle, heel, hip, elbow, shoulder blade and / or sacrum in an individual.

[0027] According to one aspect of the invention, the device includes a flexible member adapted to be adhered to the skin of an individual, the flexible member including a pre-inflated bladder or an air bladder configured to be partially filled once adhered to the skin. The flexible member may be a foam, sponge, or dressing over or around a bony prominence to elevate the target body part when the individual is immobile for a period of time, or to serve as a layer or barrier between the skin and clothing, bed sheets, furniture, or other forces.

[0028] These and other aspects of the contact of the subject invention will become more apparent from the following description taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] In order to make it easier for those skilled in the art to understand how to make and use the device of the subject invention, the preferred embodiments of the device will be described in detail below with reference to the accompanying drawings, in which:

[0030] Figures 1A to 1D are a perspective view (1A), a side top view (1B), a bottom view (1C), and a top view (1D) of one embodiment of the present invention including an apparatus for elevating the sacrum;

[0031] Figure 2 yes Figures 1A to 1D Exploded diagram of

[0032] FIG. 3A to FIG. 3D is a perspective view (3A), a side top view (3B), a bottom view (3C), and a bottom view (3D) of another embodiment of the present invention including an apparatus for elevating the sacrum having an inflatable bladder with an inlet valve and two bladders joined together;

[0033] FIG. 4A to FIG. 4D are perspective views (4A), side top views (4B), bottom views (4C), and top views (4D) of another embodiment of the present invention including an apparatus for elevating a hip or elbow and one side of an ankle or heel;

[0034] Figure 5 yes FIG. 4A to FIG. 4D An exploded view of an embodiment of

[0035] FIG. 6A to FIG. 6D are perspective views (6A), side top views (6B), bottom views (6C), and top views (6D) of another embodiment of the present invention including a device for elevating a metatarsal or sole of the foot or any slightly elongated bony prominence;

[0036] Figure 7 yes FIG. 6A to FIG. 6D An exploded view of an embodiment of

[0037] FIG. 8A to FIG. 8Dare perspective views (8A), side views (8B), bottom views (8C), and top views (8D) of yet another embodiment of the present invention including an apparatus for elevating a user's heel;

[0038] Fig. 9 yes FIG. 8A to FIG. 8D An exploded view of an embodiment of

[0039] FIG. 10A to FIG. 10D are perspective views (10A), side views (10B), bottom views (10C), and top views (10D) of yet another embodiment of the present invention comprising an apparatus for elevating each side of a user's heel and ankle, the apparatus comprising three separate pre-inflated bladders;

[0040] Fig.11 yes FIG. 10A to FIG. 10D An exploded view of an embodiment of

[0041] FIG. 12A to FIG. 12D are perspective views (12A), side views (12B), bottom views (12C), and top views (12D) of yet another embodiment of the present invention including an apparatus for elevating each side of a user's heel and ankle, the apparatus including a pre-inflated bladder;

[0042] Fig.13 yes FIG. 12A to FIG. 12D An exploded view of an embodiment of

[0043] Fig.14 is a perspective view of yet another embodiment of a device for elevating each side of a user's heel and ankle incorporating the present invention, the device comprising an inflatable bladder having an inlet valve; and

[0044] FIG. 15A to FIG. 15D Figure 8 to Fig. 9 Flowchart of a method for applying a device to the heel and securing it to the sole of the foot and the side of the ankle. DETAILED DESCRIPTION

[0045] Preferred embodiments of the subject invention are described below with reference to the accompanying drawings, wherein like reference numerals represent identical or similar elements. One of ordinary skill in the art will appreciate that while the devices discussed herein relate to the elevation and treatment of certain bony prominences such as the ankle, heel, hip, and sacrum, the scope of the invention is not limited to those exemplary body parts and applications, and may be sized and shaped for the anatomical portion in need of elevation and treatment.

[0046] The present invention provides compression to a patient's limbs (including bony prominences, including, for example, ankles, heels, hips, coccyx or sacrum, and knees and shoulder blades) in a simpler and more convenient manner than current devices and systems. The present device can compress any limb or body part, such as, for example, the foot, calf, thigh, knee, leg, hip, buttocks, waist, trunk, ribs, shoulders, arms, hands, fingers, neck, head, etc.

[0047] The present invention provides a device for elevating bony prominences to treat, relieve, and even prevent pressure ulcers and bedsores. The device of the present invention provides elevation and relieves pressure on the skin at bony prominences in a manner that allows consistent and constant relief when the user is stationary in a bed or chair and when moving, so that the device does not move once adhered or connected to the user's skin. The device of the present invention provides safe, comfortable, convenient, and effective self-application for the patient or user.

[0048] Where a numerical range is provided, it is to be understood that, unless the context clearly indicates otherwise, each intervening value to one tenth of the unit of the lower limit between the upper and lower limits of the range, and any other specified or intermediate values ​​within the specified range are encompassed within the present invention. The upper and lower limits of these smaller ranges may be independently included in the smaller ranges and are also encompassed within the present invention, subject to any specifically excluded limitations within the range. Where the range includes one or both of the limits, the range excluding any of those included limits is also encompassed within the present invention.

[0049] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present invention, exemplary methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and / or materials in conjunction with the cited publications.

[0050] It must be noted that as used herein and in the appended claims, the singular forms "a", "an", and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to "a stimulus" will include a plurality of such stimuli and reference to "the signal" will include reference to one or more signals and equivalents thereof known to those skilled in the art, and so forth.

[0051] The publications discussed herein are provided only for their disclosure prior to the filing date of this patent application. Nothing herein should be construed as an admission that the present invention is not entitled to preempt such publications by virtue of prior inventions. In addition, the publication dates provided may differ from the actual publication dates which may require independent confirmation.

[0052] Referring now to FIG. 1 , an exemplary embodiment of a device 100 for elevating the sacrum of a user according to the subject invention is illustrated. The device 100 is configured to elevate the sacrum when applied to the skin of a patient. Figures 1A to 1D and Figure 2 As shown in , this embodiment of the device 100 is configured to follow the shape of the bony prominences of the sacrum so as to be applied on the back of the user above the buttocks. In this embodiment, the shape is similar to a heart, with two pre-inflated bladders 110 (110A, 110B) and an opening or orifice 120 that is configured to be inserted into the bony prominences (in this embodiment, the sacrum). Other shapes may also be used in embodiments not shown, such as an oval, rectangular, square, circular, crescent, "U" shape, or any other known shape, wherein the sacrum can rest in the shape when the pre-inflated bladders 110 elevate the bony prominences of the sacrum. In FIG. 3A to FIG. 3D In another embodiment shown, the bladder 100 is not pre-filled, but there is an inflation port 170 (for example, in this embodiment, but not limited to such an inlet valve) to inflate the inflatable bladders 110 (110A, 110B, 110C). In this embodiment, only one inflatable bladder is shown with a connector 110C between the two bladders 110A, 110B. This component can also be used in Figures 1 to Figure 2 Although not shown, the pre-inflated bladders 110A, 110B are also shown. FIG. 3A to FIG. 3D as well as Fig.14 The non-limiting exemplary inflation port 170 shown in FIG. 1 includes a tube 171 or other connection device and a valve 172 into which a fluid source enters to inflate the inflatable bladder 110 ( 110A, 110B, 110C).

[0053] Other bony prominences may be elevated by various embodiments of the present invention, such as the hip or elbow and the side of the ankle or heel (see FIGS. 4 to 5). Figure 5 ), or metatarsals or soles of feet or other elongated bony processes (as shown in Figures 6 to Figure 7 as shown), or the heel (as shown in Figures 8 to Fig. 9 ), or a combination of the heel and ankle sides (as shown in Figures 10 to Fig.14 In some of these embodiments, the apertures 120, 220, 320, and 420 are configured to allow the target bony prominence to rest within the opening or aperture 120, 220, 320, 420 while the bladder 110, 210, 310, 410 elevates the target bony prominence. Various non-limiting exemplary shapes are included, such as circular, oval, rounded rectangular, or square, although other shapes may be employed in embodiments not shown, such as crescent, "U", "V", or any other known shape.

[0054] In all embodiments 100, 200, 300, 400 of the present invention as shown including a pre-inflated bladder 110, 210, 310, 410 configured to provide elevation to a target bony prominence, the pre-inflated bladder 110, 210, 310, 410 is formed by joining two sheets (an outer sheet 112, 212, 312, 412 and an inner sheet 114, 214, 314, 414), and in a non-limiting example, air is provided before the outer sheet 112, 212, 312, 412 and the inner sheet 114, 214, 314, 414 are welded together. In embodiments including inflatable bladders 110, 410, inflation ports 170, 470 are connected to inflatable bladders 110, 410, such as by welding, before or after the outer sheet 112 and the inner sheet 114 are joined, although other types of inflation ports 170, 470 may be used. In any embodiment, the outer sheet 112, 212, 312, 412 and the inner sheet 114, 214, 314, 414 may be joined via welding, bonding, or any other known connection means. In some embodiments, the outer sheet 112 comprises or functions as a portion of a support for a lifting device of the present invention, such as in FIGS. 1 to 4. Fig.14 In the embodiment including inflatable bladder 110,410, inflation port 170,470 includes tube 171,471 and inlet valve 172,472, but other types of inflation ports may also be used. The inflation source is not shown, but may be a pump, such as a hand pump or an intermittent pump connected to a valve or hose in a paired bladder. Other inflatable devices may also inflate the inflatable bladder to be enough to raise the target bone protrusion, such as sacrum, hip bone, heel, metatarsal bone, ankle, scapula or any other body part. Many or multiple inflatable devices may be used, such as a hand pump, a hand pump, a foot pump, a mechanical pump, an electric pump, a battery-driven pump, a static pump, an intermittent pump, a variable speed pump, an automatic pump, a pneumatic pump, a negative pressure pump, a suction pump or a vacuum pulse pump, or any other known or developed inflation source, so that inflation is provided in the inflatable bladder, thereby providing elevation when used by the patient.

[0055] In each of these embodiments, the lifting device of the present invention includes a foam portion 140, 240, 340, 440. The foam portion 140, 240, 340, 440 cushions the body part being lifted by the pre-inflated or inflatable bladder 110, 210, 310, 410. If a pressure ulcer, bedsore, or open wound already exists, the foam portion 140, 240, 340, 440 can also absorb any bleeding or leakage of blood, dye, pus, etc. from the pressure ulcer, bedsore, or open wound. Figure 7 Figure 12 to Fig.14In the embodiment of the present invention, the foam portion 140, 240, 340, 440 also includes an adhesive layer on the skin-facing side of the lifting device 100, 200, 300, 400 of the present invention. The adhesive is compatible with human skin to facilitate application of the device 100, 200, 300, 400 of the present invention to the patient's skin. Fig.11 In other embodiments shown, the foam portion 140, 240, 340, 440 is connected to the bladder 110, 210, 310, 410 and optionally the inner sheet 112, 212, 312, 412, or to the protective layer 150, 250, 350, 459 via a separate adhesive layer 255, 355. Fig.11 In the illustrated embodiment, the separate adhesive layer 255, 355 has the same shape as the hydrophobic layer 150, 250, 350, 450, and in these embodiments, they are welded together, but any other connection means, including additional adhesive, may be used. The separate adhesive layer 255, 355 may be perforated or non-perforated, but must be hydrophilic and allow wound exudate to pass through the skin and pressure ulcers, bedsores or open wounds and enter the foam portion 140, 240, 340, 440. By way of example only, the perforations may be holes that allow exudate and fluid to flow through the separate adhesive layer 255, 355. The perforations or holes should be small enough to help prevent tissue from growing inwardly into the foam portion 140, 240, 340, 440, but still allow exudate and fluid to flow out of the pressure ulcer, bedsore or open wound. The perforations may be, for example, slits or holes ranging in size from 0.015 mm to 1.5 mm. The adhesive on the skin-facing portion of the adhesive layer can be any adhesive that is compatible with the skin, such as (by way of example only) a silicone adhesive that has sufficient tack to allow the elevation device 100, 200, 300, 400 of the present invention to remain on the skin, but can be removed without causing trauma to the skin, especially without causing pressure ulcers or open sores on the skin. Whether the adhesive is on the skin-facing side of the foam portion 140, 240, 340, 440 or part of a separate adhesive layer 255, 355, it can be composed of a pressure-sensitive acrylic adhesive or a silicone adhesive, but can also be composed of a polymer (such as silicone, ethyl vinyl acetate, polyethylene, polypropylene, or polyester, or a combination thereof).

[0056] The lifting device 100, 200, 300, 400 of the present invention may also include a paper, polymer, coating, film or other material that is a protective layer 160, 260, 360, 460 that is configured to keep the adhesive inactive during shipping and storage (whether on the skin side of the foam portion 140, 240, 340, 440 or on the additional adhesive layer 255, 355), but such protective layer 160, 260, 360, 460 is removed before application to the patient's skin. For easier application by the user, the film or paper protective layer 160, 260, 360, 460 can be one piece (not shown), two pieces (as shown in Figures 1 to 3), or a plurality of pieces (as shown in Figures 1 to 4). Fig. 9 As shown), three pieces (as shown in Figures 10 to Fig.13 In some of these embodiments, the protective layer 160, 260, 360, 460 has a small tab 161 (161A, 161B), 261, 361, 461 (461A, 461B) that extends beyond the circumference of the lifting device 100, 200, 300, 400 of the present invention to facilitate removal of the protective layer 160, 260, 360, 460 by the user.

[0057] The hydrophobic layer 150, 250, 350, 450 is used to maintain the shape of the lifting device 100, 200, 300, 400 and protect the user from the transfer of exudate within the foam portion 140, 240, 340, 440 to the user's clothing, bed linens, furniture, etc. The hydrophobic layer 150, 250, 350, 450 can be composed of a film, polyester, or other material that is impermeable to liquids while still being a breathable, moisture-permeable layer to allow moisture to evaporate from the lifting device 100, 200, 300, 400 of the present invention. The shape of the protective layer 150, 250, 350, 450 depends on the target bony prominence being lifted and the anatomical structure of the skin and bone surrounding the bony prominence. For example, for the sacrum, the shape (as shown in Figures 1 to 4) is preferably 1 to 20. Figure 5 112; and for the hip, elbow, shoulder blade, ankle or other bony prominence, the shape is a circle or a rounded square 212. In FIGS. 6 to 7, the heart shape is rounded and flared around the corresponding heart shape 112; and for the hip, elbow, shoulder blade, ankle or other bony prominence, the shape is a circle or a rounded square 212. Figure 7 In the case of a metatarsal, sole or other bony prominence, the shape is a rounded and flared rectangle extending beyond the rounded rectangle 312. Fig.14 The heel and ankle shape configurations in are only three possible variations that take into account the anatomy of the heel and ankle region of the body, and other variations on the shapes may be employed.

[0058] The foam portion 140, 240, 340, 440 may be made of any material compatible with human skin, such as (by way of example only) an open-cell polyurethane foam. The foam portion 140, 240, 340, 440 may reduce the discomfort of the patient and provide absorption of any exudate, bleeding or other exudate on the patient's skin at the location of a pressure ulcer, bedsore or open wound. The foam portion 140, 240, 340, 440 may be composed of a soft, hydrophilic polyurethane foam layer that may be used to reduce the risk of maceration, exudation of any wound fluids that still maintain the patient's comfort and, importantly, maintain a moist wound healing environment for the pressure ulcer or skin sore. In some embodiments, the foam 140, 240, 340, 440 may be an absorbent foam, sponge or dressing (not shown and hereinafter referred to as a "sponge") that may have the ability to absorb exudate from a wound or ulcer. In addition, the foam or sponge 140, 240, 340, 440 preferably has an open cell structure, which helps to wick away exudate from existing pressure ulcers and bedsores. The foam portion 140, 240, 340, 440 can be absorbent, hydrophilic and polymeric, and can have a specific range of cell sizes from 10 microns to 1000 microns. The foam portion 140, 240, 340, 440 is a hydrophilic foam and can be an open cell foam or a mixture of open and closed cells, as long as it can absorb wound exudate and preferably absorb wound exudate quickly. The faster the foam portion 140, 240, 340, 440 absorbs exudate, any accumulation of blood, pus and exudate will be reduced or even eliminated, thereby helping the healing of pressure ulcers, bedsores or open wounds. The foam portion or sponge 140, 240, 340, 440 may be silicone, hydrophilic, conformable, elastic, and porous, thereby allowing exudate to be drawn away from the pressure ulcer, bedsore, or open wound and into the elevation device 100, 200, 300, 400 of the present invention. However, the material selected should still maintain a sufficiently moist wound healing environment so as not to dry out the pressure ulcer, bedsore, or open wound and maintain a balanced moist atmosphere under the elevation device 100, 200, 300, 400 of the present invention. This balance between drawing exudate away from the skin surface while maintaining an adequate humidity level is an integral part of the material selected for the foam portion or sponge 140, 240, 340, 440. In some embodiments, the foam or sponge 140, 240, 340, 440 can be gently attached to the patient's skin via the adhesive film 160, 260, 360, 460 so that the foam or sponge 140, 240, 340, 440 can be peeled off or removed by the user and replaced multiple times if necessary, so that it can be reused for a period of time until the foam portion or sponge 140, 240, 340, 440 needs to be replaced due to trapped exudate.Optionally, the foam portion or sponge 140, 240, 340, 440 is composed of an open cell polyurethane foam for balanced absorption and a silicone layer for safe application and removal from the skin by the user.

[0059] 1 to 3 , the target bony prominence is the sacrum. The pre-inflated bladder 110 ( 110A, 110B) is formed by connecting an outer sheet 112 and an inner sheet 114 (as shown in FIGS. 1 to 3 ). Figure 2 ), and in embodiments where the bladder is inflatable ( FIG. 3A to FIG. 3D ), the inflatable bladder 110 (110A, 110B, 110C) is formed by the connection of the outer sheet 112 and the inner sheet 114, with the optional inflation port 170 also connected during this stage. In this embodiment, the shape of the formed bladder 110 and outer layer 112 is similar to a heart, and the orifice 120 is configured in the shape of the sacrum, but other shapes besides the heart shape can also be used. The shape also depends on the size of the patient's sacrum, and for adults, some length and width ranges are about 2 inches to 8 inches (preferably about 4 inches to 7 inches) in width, and about 2 inches to 10 inches in length (preferably about 4 inches to 7 inches in length), with pediatric patients smaller as needed. When inflated, the height of the bladder 110 can be about 0.1 inches to 5 inches, preferably about 0.25 inches to 2 inches, whether it is inflated with a pre-inflated bladder or the inflatable bladder 110 (110A, 110B, 110C). In such Figure 2In one embodiment of the formation shown, the bladder 110 and the outer layer 112 are connected to the hydrophobic layer 150 via the adhesive layer 130. The adhesive layer does not contact the skin and therefore does not need to be skin compatible. Any known adhesive can be used and an optional film can be used to provide additional structure for the lifting device 100 of the present invention. In the embodiment shown in Figures 1 to 3, the shape of the hydrophobic layer 150 is rounded and flared, and can depend on the size of the patient's sacrum, and for adults, some lengths and widths range from about 3 inches to 15 inches (preferably about 5 inches to 10 inches) in width, and about 3 inches to 15 inches in length (preferably about 5 inches to 10 inches in length), and pediatric patients are smaller as needed. In the case where the foam part or sponge 140 is different from the shape, length and width of the hydrophobic layer 150, the hydrophobic layer also includes a skin-compatible adhesive for the part that is not covered by the foam part or sponge 140 on the lower side. The foam portion or sponge 140 is then attached to the underside of the hydrophobic layer 150 via an adhesive, which does not have to be skin compatible, although the skin-facing side of the foam portion or sponge 140 must include a skin compatible adhesive. Finally, a film or paper protective layer 160 is attached to the underside adhesive of the foam portion or sponge 140. In use, a person removes the film or paper protective layer 160 (160A, 160B), preferably pulling tabs 161 (161A, 161B), thereby activating and exposing the adhesive on the foam portion or sponge 140 and the portion of the underside of the hydrophobic layer not covered by the foam portion or sponge 140. The lifting device 100 of the present invention is then placed over the target bony prominence (in this example, the sacrum), with the foam portion or sponge 140 positioned over any pressure ulcer, bedsore, or open wound that is present. The user can then lie still by elevating the sacrum via the prefilled bladder 110 (110A, 110B) while any exudate from the pressure ulcer, bedsore, or open wound is transferred into the foam portion or sponge 140 and the hydrophobic layer 150 protects the user's clothing, bed sheets, furniture, etc. from the exudate.

[0060] Figure 4 to Figure 5 The present invention is shown with a lifting device 200 in the shape of a circle or a rounded square, and thus the target bony prominence may include the hip bone, elbow, side of the ankle, shoulder blade, or many other bony prominences. Figure 5As shown, the pre-inflated bladder 210 is formed by connecting an outer sheet 212 and an inner sheet 214. In this embodiment, the shape of the formed bladder 210 and outer layer 212 is similar to a circle or a rounded square, and is configured to elevate the hip bone, elbow, side of the ankle, shoulder blade and other bony prominences, but other shapes besides circles or rounded squares may be used. The shape also depends on the size of the target bony prominence, and for adults, some lengths and widths range from about 2 inches to 6 inches (preferably about 3 inches to 5 inches) in width and length, and pediatric patients are smaller as needed. The height of the pre-inflated bladder 210 can be about 0.1 inches to 5 inches, preferably about 0.25 inches to 2 inches. An embodiment in which the bladder 210 is inflatable is not shown, and in this case, once inflated, the height range will be similar. In the example Figure 5 In one embodiment of the formation shown, the bladder 210 and outer layer 212 are connected to the hydrophobic layer 250 via an adhesive layer 230. The adhesive layer does not contact the skin and therefore does not need to be skin compatible. Any known adhesive may be used and an optional film may be used to provide additional structure to the elevation device 200 of the present invention. Figure 5In the illustrated embodiment, the hydrophobic layer 250 is shaped as a round or square with rounded corners and flared shapes, and may depend on the size of the target bony prominence of the patient, and for adults, some lengths and widths range from about 3 inches to 10 inches (preferably about 4 inches to 8 inches) in width and length, and pediatric patients are smaller as needed. In the case where the foam portion or sponge 240 is different in shape, length and width from the hydrophobic layer 250, the hydrophobic layer also includes a skin-compatible adhesive for the portion of the lower side that is not covered by the foam portion or sponge 240. Then, the foam portion or sponge 240 is connected to the lower side of the hydrophobic layer 250 via an adhesive, which does not have to be skin-compatible, although the skin-facing side of the foam portion or sponge 240 must include a skin-compatible adhesive. Finally, a film or paper protective layer 260 is connected to the lower side adhesive of the foam portion or sponge 140. In use, a person removes the film or paper protective layer 260 (260A, 260B), preferably pulling the tab 261 (not shown, it can be an embodiment where each of the protective layers 260A, 260B has tabs 261A, 261B), thereby activating and exposing the adhesive on the foam portion or sponge 240 and the portion of the underside of the hydrophobic layer not covered by the foam portion or sponge 240. The lifting device 200 of the present invention is then placed on the target bony prominence (such as the hip bone, elbow, one side of the ankle, shoulder blade and other bony prominences), with the foam portion or sponge 240 located over any pressure ulcers, bedsores or open wounds that are present. The user can then lie still with the hip bone, elbow, one side of the ankle, shoulder blade and other bony prominences elevated via the pre-filled bladder 210, while any exudate from the pressure ulcer, bedsore or open wound is transferred to the foam portion or sponge 240, and the hydrophobic layer 250 protects the user's clothing, bed sheets, furniture, etc. from the exudate.

[0061] Figure 6 to Figure 7 The present invention is shown in the shape of a rounded rectangular elevation device 300, and thus the target bony prominences may include the sole of the foot, metatarsal bones, or many other bony prominences. Figure 7As shown, the pre-inflated bladder 310 is formed by the connection of an outer sheet 312 and an inner sheet 314. In this embodiment, the shape of the formed bladder 310 and outer layer 312 is similar to a rounded rectangle and is configured to elevate the ball of the foot, metatarsals and other bony prominences, but other shapes other than rounded rectangles may be used. The shape also depends on the size of the targeted bony prominence, and for adults, some length and width ranges are about 0.5 inches to 5 inches (preferably about 1 inch to 3 inches) in width and about 0.5 inches to 6 inches in length (preferably about 2 inches to 5 inches), with pediatric patients being smaller as needed. The height of the pre-inflated bladder 310 may be about 0.1 inches to 5 inches, preferably about 0.25 inches to 2 inches. An embodiment in which the bladder 310 is inflatable is not shown, and in this case, once inflated, the height range will be similar. In the example shown in FIG. Figure 7 In one embodiment of the formation shown, the bladder 310 and the outer layer 312 are connected to the hydrophobic layer 350 via an adhesive layer 330. The adhesive layer does not contact the skin and therefore does not need to be skin compatible. Any known adhesive may be used and an optional film may be used to provide additional structure to the elevation device 300 of the present invention. Figure 7In the illustrated embodiment, the hydrophobic layer 350 is shaped as a rounded and flared rectangle, and may depend on the size of the target bony prominence of the patient, and for adults, some lengths and widths range from about 2 inches to 10 inches (preferably about 3 inches to 6 inches) in width, and about 3 inches to 15 inches in length (preferably about 5 inches to 10 inches in length), and pediatric patients are smaller as needed. In the case where the foam portion or sponge 340 is different in shape, length, and width from the hydrophobic layer 350, the hydrophobic layer also includes a skin-compatible adhesive for the portion of the lower side that is not covered by the foam portion or sponge 340. The foam portion or sponge 340 is then connected to the lower side of the hydrophobic layer 350 via an adhesive, which does not have to be skin-compatible, although the skin-facing side of the foam portion or sponge 340 must include a skin-compatible adhesive. Finally, a film or paper protective layer 360 is connected to the lower side adhesive of the foam portion or sponge 340. In use, a person removes the film or paper protective layer 360 (360A, 360B; not shown are optional tabs 361 (361A, 361B)), thereby activating and exposing the foam portion or sponge 340 and the adhesive on the underside of the hydrophobic layer not covered by the foam portion or sponge 340. The lifting device 300 of the present invention is then placed over the target bony prominences (such as the soles of the feet, metatarsals, and other bony prominences), with the foam portion or sponge 340 positioned over any pressure ulcers, bedsores, or open wounds that are present. The user can then lie still with the soles of the feet, metatarsals, and other bony prominences elevated via the pre-filled bladder 310, while any exudate from the pressure ulcers and bedsores or open wounds is transferred to the foam portion or sponge 340, and the hydrophobic layer 350 protects the user's clothing, bed linens, furniture, etc. from the exudate.

[0062] Figure 8 to Fig.14 4 and 5. Various embodiments for raising the heel and / or ankle are shown in FIG. The shape of the hydrophobic layer 450 varies depending on the embodiment selected, but all raise the heel and some further raise the sides of the heel and ankle. The heel and ankle are some of the most common locations for pressure ulcers and bedsores or open wounds, and depending on the patient, one or more of these exemplary embodiments and other configurations and shapes may be used as long as the heel and / or ankle sides are raised to prevent or treat pressure ulcers and bedsores and open wounds on the sides of the heel and / or ankle. FIG. 8 to FIG. Fig. 9 15 shows an elevation device 400 of the present invention, wherein the pre-inflated bladder 410 and the outer layer 412 are in the shape of a rounded rectangle, and the protective layer 450 is shaped like a circle or a rounded square and has certain cutouts or holes 470 so that the elevation device 400 of the present invention can be adhered to the anatomical structure of the ankle above the heel. In this embodiment, as Fig. 9As shown, the pre-inflated bladder 410 is formed by the connection of an outer sheet 412 and an inner sheet 414. In this embodiment, the shape of the formed bladder 410 and outer layer 412 is similar to a rounded rectangle and is configured to elevate the heel, but other shapes other than rounded rectangles may be used. The shape also depends on the size of the targeted bony prominence, and for adults, some length and width ranges are about 0.5 inches to 5 inches (preferably about 1 inch to 3 inches) in width, and about 0.5 inches to 6 inches in length (preferably about 2 inches to 5 inches), with pediatric patients being smaller as needed. The height of the pre-inflated bladder 310 may be about 0.1 inches to 5 inches, preferably about 0.25 inches to 2 inches. An embodiment in which the bladder 410 is inflatable is not shown, and in this case, once inflated, the height range will be similar. In the example shown in FIG. Fig. 9 In one embodiment of the formation shown, the bladder 410 and the outer layer 412 are connected to the hydrophobic layer 450 via an adhesive layer 430. The adhesive layer does not contact the skin and therefore does not need to be skin compatible. Any known adhesive may be used and an optional film may be used to provide additional structure to the elevation device 300 of the present invention. Fig. 9 In the embodiment shown, the shape of the hydrophobic layer 450 is rounded and flared circular or square, and may depend on the size of the target bony prominence of the patient, with some length and width ranges being about 4 inches to 15 inches (preferably about 6 inches to 12 inches) in width and length for adults, and about 4 inches to 15 inches in length (preferably about 6 inches to 12 inches in length), with pediatric patients being smaller as needed. In this embodiment, the foam portion or sponge 440 is disposed between the hydrophobic layer 450 and the separate adhesive layer 455, and thus the foam portion or sponge does not need to include a skin-compatible adhesive on the underside because the separate adhesive layer 455 has a skin-compatible adhesive on its skin-facing side. Finally, a film or paper protective layer 460 (460A, 460B) is connected to the underside adhesive layer 455. As shown in FIG. Fig.15A As shown, in use, a person removes the film or paper protective layer 460 (460A, 460B) ( Fig.15A is not shown, but Figures 8 to Fig. 9 461A, 461B), thereby activating and exposing the adhesive on adhesive layer 455. The user or (e.g. Fig. 15B ) The caregiver moves the lifting device 400 of the present invention under the patient's leg 500, places portion 450A under the user's foot, with the foam portion or sponge 440 of the lifting device 400 of the present invention placed over the heel, with side portion 450B on the right side of the ankle, and portion 450C on the left side of the ankle. Fig. 15CAs shown, portion 450A is adhered to the sole of leg 500 through aperture 470, thereby allowing portions 450B and 450C to remain under leg 500. Next, as Fig.15D As shown, a caregiver or user can move portions 450B and 450C upward onto the user's ankle to adhere the lifting device 400 to the person's foot. The user can then lie still with the heel and other bony prominences elevated via the pre-filled bladder 410, while any exudate from the pressure ulcer, bedsore, or open wound is transferred into the foam portion or sponge 440, and the hydrophobic layer 450 protects the user's clothing, bed linens, furniture, etc. from the exudate. The angle and length of the aperture or opening or cutout 470 can vary depending on the anatomical structure of the target location, such as the foot, heel, and ankle of the leg 500.

[0063] Figure 10 to Fig.11 , where the target bony prominences are the heel and both sides of the ankle, but the shoulder blades and upper back can also be targets for this shape configuration, which can be a "T" shape. In this exemplary lifting device 400 of the present invention, there are three separate pre-inflated bladders 410A, 410B, 410C, each of which is in the shape of a rounded rectangle, and the protective layer 450 is shaped like a rounded rectangle, with another rounded rectangle located in the middle at a right angle, so that the lifting device 400 of the present invention can adhere to the anatomical structure of the ankle above the heel while lifting the heel and both sides of the ankle. In this embodiment, as Fig.11 As shown, three pre-inflated bladders 410A, 410B, 410C are formed by the connection of an outer sheet 412 and an inner sheet 414, have an integral form, and include certain through holes 480, which are used both as exhaust and for alignment in manufacturing, and also include fillet welds 416 for better support. In this embodiment, the shape of the formed bladders 410A, 410B, 410C is similar to a rounded rectangle and is configured to elevate each side of the heel and ankle of the foot, but other shapes other than rounded rectangles may also be used. The shape also depends on the size of the target bone prominence, and for adults, some lengths and widths range from about 0.5 inches to 5 inches (preferably about 1 inch to 3 inches) in width, and about 0.5 inches to 6 inches in length (preferably about 2 inches to 5 inches), and pediatric patients are smaller as needed. The height of the pre-inflated bladders 410A, 410B, 410C can be about 0.1 inches to 5 inches, preferably about 0.25 inches to 2 inches. Not shown is an embodiment where the bladders 410 are inflatable via inflation ports and possibly connected to each other, or perhaps just two bladders are connected to another bladder 410, and in this case, once inflated, the altitude ranges would be similar. Fig.11In one embodiment of the formation shown, the pre-inflated bladders 410A, 410B, 410C and the outer layer 412 and formation 416 are connected to the hydrophobic layer 450 via an adhesive layer 430. The adhesive layer does not contact the skin and therefore does not need to be skin compatible. Any known adhesive may be used and an optional film may be used to provide additional structure to the elevation device 300 of the present invention. In FIGS. 10 to 11 , the pre-inflated bladders 410A, 410B, 410C and the outer layer 412 and formation 416 are connected to the hydrophobic layer 450 via an adhesive layer 430. The adhesive layer does not contact the skin and therefore does not need to be skin compatible. Any known adhesive may be used and an optional film may be used to provide additional structure to the elevation device 300 of the present invention. Fig.11 In the embodiment shown, the hydrophobic layer 450 is in the shape of a rounded rectangle with another rounded rectangle located in the middle of the right ankle, so there are three sections labeled 450A, 450B, 450C with one pre-inflated bladder 410 (410A, 410B, 410C) on each section. The size range of this embodiment can vary depending on the size of the target bony prominence of the patient, and some length and width ranges are about 5 inches to 15 inches in width (preferably about 6 inches to 12 inches wide) and about 8 inches to 25 inches in length (preferably about 10 inches to 20 inches in length) for adults, with pediatric patients being smaller as needed. In this embodiment, the foam portion or sponge 440 is in the shape of a rectangle between the two pre-inflated bladders 410A, 410B, and then another rounded rectangle at right angles at the center of the long section including the third pre-inflated bladder 410C. For adults, the foam portion or sponge itself has a shape range of about 3 inches to 12 inches wide (preferably about 4 inches to 10 inches wide) and about 6 inches to 20 inches long (preferably about 8 inches to 18 inches in length), and pediatric patients are smaller as needed. The foam portion or sponge 440 is arranged between the hydrophobic layer 450 and the separate adhesive layer 455, and therefore the foam portion or sponge 440 does not need to include a skin-compatible adhesive on the lower side because the separate adhesive layer 455 has a skin-compatible adhesive on its skin-facing side. Finally, a film or paper protective layer 460 (460A, 460B, 460C) is connected to the lower side of the adhesive layer 455. In use, the person removes the film or paper protective layer 460 (460A, 460B, 460C), thereby activating and exposing the adhesive on the adhesive layer 455. The user moves the lifting device 400 of the present invention under the patient's leg 500, places portion 450C under the user's foot (with pre-inflated bladder 410C over the heel), and places portion 450A on the left side of the ankle (with pre-inflated bladder 410A over the bony prominence of the ankle), and finally places portion 450B on the right side of the ankle (with pre-inflated bladder 410B over the bony prominence of the right ankle). The foam portion or sponge 440 places the lifting device 400 of the present invention over the heel with side portion 450B on the right side of the foot and portion 450C on the left side of the foot. Fig. 15CAs shown, portion 450A is adhered to the sole of the leg and the user can then lie still by elevating the heel and other bony prominences via three pre-inflated bladders 410A, 410B, 410C, while any exudate from pressure ulcers and bedsores or open wounds is transferred to the foam portion or sponge 440 and the hydrophobic layer 450 protects the user's clothing, bed sheets, furniture, etc. from the exudate.

[0064] Figure 12 to Fig.14 Another embodiment for raising the bony prominences on both sides of the heel and ankle is shown in FIG. Fig.13 As shown, the pre-inflated bladder 410 is formed by connecting an outer sheet 412 and an inner sheet 414, and in an embodiment where the bladder is inflatable ( Fig.14 ), the inflatable bladder 410 is formed by the connection of the outer sheet 412 and the inner sheet 414, wherein the optional inflation port 470 is also connected during this stage. In this embodiment, there is only one bladder 410, which has a plurality of open orifices 420 for two bony protuberances to rest on and provide support and movement of the bladder 410 when it is adhered to the user's foot. In this embodiment, the shape of the bladder 410 and outer layer 412 formed is similar to a rounded rectangle and a second rounded rectangle located at a right angle at the center of the first rounded rectangle, but other shapes besides a "T" shape may also be used. The shape also depends on the size of the patient's foot and calf, and for adults, some length and width ranges are about 2 inches to 20 inches in width (preferably about 4 inches to 15 inches in width) and about 2 inches to 25 inches in length (preferably about 4 inches to 15 inches in length), and pediatric patients are smaller as needed. When inflated, the height of the bladder 410 can be about 0.1 inches to 5 inches, preferably about 0.25 inches to 2 inches, whether inflated with a pre-inflated bladder or an inflatable bladder 410. Fig.13In one embodiment of the formation shown, the bladder 410 and outer layer 412 are connected to a reinforcement or support layer 490 (490A, 490B) that is used to support the lifting device 400 because the bladder 410 is the entire width and length of the lifting device 400 of the present invention. The reinforcement or support layer 490 can be a one-piece, or as shown in this embodiment, a two-piece, wherein there is a small gap between the horizontal portion of the bladder 410 (portion 490A) and the vertical portion of the bladder (portion 490B). The reinforcement or support layer is in the shape of the outer circumference of the bladder 410 and will contact the user's skin. The hydrophobic layer 450 is then connected to the reinforcement or support layer 490 via the adhesive layer 330. The adhesive layer 430 does not contact the skin and therefore does not need to be skin compatible. Any known adhesive can be used and an optional film can be used to provide additional structure to the lifting device 100 of the present invention. In the case where the foam portion or sponge 440 is different in shape, length and width from the hydrophobic layer 550, the hydrophobic layer also includes a skin-compatible adhesive for the portion of the lower side not covered by the foam portion or sponge 440. The foam portion or sponge 440 is then connected to the lower side of the hydrophobic layer 450 via an adhesive that does not have to be skin-compatible, although the skin-facing side of the foam portion or sponge 140 must include a skin-compatible adhesive. Finally, a film or paper protective layer 460 is connected to the lower side adhesive of the foam portion or sponge 440. In use, a person removes the film or paper protective layer 460 (460A, 460B), preferably pulling tab 461, and then removing portions 460B and 460, thereby activating and exposing the adhesive on the foam portion or sponge 440 and the portion of the lower side of the hydrophobic layer not covered by the foam portion or sponge 440 and any exposed portion of the reinforcement or support layer 490 (490A, 490B). The lifting device 400 of the present invention is then placed over the target bony prominence (heel and ankle in this example) with the vertical portion (closure 490B with rounded rectangular shaped openings 420) placed under the user's foot and heel, and then the two circular shaped openings 420 are placed over the bony prominence on each side of the ankle. The inner openings 420 are used to move the ankle when the lifting device 400 of the present invention is adhered to the user's skin. The user can then lie still by elevating the foot, heel and ankle sacrum on both sides via the pre-filled or inflated bladder 410 while any exudate from the pressure ulcer, bedsore or open wound is transferred to the foam portion or sponge 440 and the hydrophobic layer 450 protects the user's clothing, bed linen, furniture, etc. from the exudate.

[0065] The devices 100, 200, 300, 400 of the present invention are configured to apply localized elevation and reduce pressure, friction and shear, and thus treat, reduce or even prevent pressure ulcers, bedsores and open wounds that occur when a user is immobile or moves and rubs against clothing, bed sheets, furniture, etc. The pre-inflated bladder 110, 210, 310, 410 is set at a height above a target bony prominence (such as a metatarsal, foot bone, ankle, heel, hip bone, elbow, shoulder blade or coccyx / sacrum) to elevate the bony prominence when the user rests the body part on a chair or bed or another surface. The air bladder can also be set to an uninflated state and then inflated via an inflation device after the lifting device of the present invention is applied to the user's skin.

[0066] Other embodiments now shown may include, for example, a suction conduit disposed between the foam 140, 240, 340, 440 and the skin, wherein the suction conduit may be oriented downward toward the sponge so that when a negative pressure source is applied to the suction conduit, the negative pressure is applied to the pressure ulcer via the sponge. Thus, exudate may be wicked and drawn away from the pressure ulcer and bedsore via the sponge and into a conduit such as a tube and other device. In one embodiment, the conduit may be easily detached from the apparatus 100, 200, 300, 400 of the present invention so that the patient may be walked or transported away from the suction source while still applying pressure to the pressure ulcer and bedsore.

[0067] Certain target bony prominences include elevating and exuding the heel and / or ankle when the user is lying in bed and resting on either side of the ankle, and relieving pressure on the Achilles tendon. This portion of the ankle and calf is prone to pressure ulcers and bedsores, and requires elevation to treat, heal, and prevent injuries. In use, the pre-inflated bladder 410 (410A, 410B, 410C) elevates the bony prominences of the ankle and heel above the bed sheet or chair or other location where the ankle and heel are located, and reduces pressure on these skin locations, thereby treating, reducing, or even preventing pressure ulcers and bedsores. Other target bony prominences include the sacrum and hip bones, which, if elevated with the lifting devices 100, 200 of the present invention, can reduce, treat, or even prevent pressure ulcers and bedsores at the hip and sacrum locations. In fact, the pressure level felt by the patient at the pressure ulcer and bedsore or open wound site is reduced. Not shown but contemplated are optional medications or treatments included in the skin contact adhesive layer, such as silver, zinc oxide, antibiotics, analgesics, etc. Not included but contemplated are sensors that alert the user when the foam portion or sponge 140, 240, 340, 440 is filled with exudate and the elevation device 100, 200, 300, 400 needs to be replaced.

[0068] The lifting devices 100, 200, 300, 400 of the present invention solve many problems associated with pressure ulcers, bedsores and open wounds. To prevent the occurrence of pressure ulcers and bedsores, the present invention includes foam application, which helps control bleeding and leakage of other body fluids, and the improvement is to lift the bony prominence from the bed, chair, sofa or other place where the individual rests. Pre-filled or fillable air bladders are added to lift the bony prominence from the bed, chair, sofa or other place where the body part rests. This can be used to relieve pain and suffering, while also alleviating the economic pressure in nursing homes, assisted living facilities, hospitals and clinics after surgery or other reasons, while the user may be bedridden for a period of time. In addition, the lifting around the bony prominence reduces ulcers, bedsores and open wounds at the skin on the bony prominence, which reduces the possibility of ulcers forming thereon.

[0069] The present invention has been illustrated and described with respect to specific embodiments of the present invention. These embodiments are examples and illustrations of the principles of the present invention and are not intended to be exclusive or otherwise limiting embodiments. The system or kit of the present invention may include compression wraps, such as the compression wraps of the application serial number 16 / 328718 called Aero-Wrap, which is co-owned by the applicant, and those older compression wraps co-owned (and incorporated herein by reference) in U.S. 9,033,906 and U.S. 7,967,766 and U.S. 7,559,908 and U.S. serial number 13,444,600. All of these compression wraps can be placed on the lifting device of the present invention and further treat pressure ulcers, bedsores and open wounds.

[0070] In addition, although in the aforementioned embodiments, any one of a variety of preformed and / or prefilled cushioning materials can be used to implement additional components, such as foam pads and / or non-inflatable pads filled with air, gel or other fluids. In addition, although specific shapes, sizes and materials are described for the purpose of illustration, it should be understood that any one of a variety of shapes or sizes can be used, and the materials are not exclusive, but are only exemplary. Moreover, as described above, although the bladder shown is inflated with air, it should be understood that any other fluid or medium, such as liquid or gel, can be used. In addition, it should also be noted that the bladder can be configured to have a plurality of pneumatically independent and / or pneumatically connected bladder parts, and can also be configured to have various profiles or convex angles. In addition, the foam and adhesive layer can include drugs (such as anti-inflammatory drugs) for treating current pressure ulcers and sores, drugs for reducing or treating infections, drugs for reducing or treating pain in the site, and any other drugs or nutrients applied to the lesions of pressure ulcers and bedsores. Other additions are also possible and included in the present invention.

[0071] Although the subject invention of the present disclosure has been described with respect to preferred and exemplary embodiments, it will be readily understood by those skilled in the art that various changes and / or modifications may be made to the present invention without departing from the spirit or scope of the present invention as described herein. Several embodiments of intermittent pressure devices and methods of mounting and operating the same have been described and illustrated herein. Although specific embodiments of the present invention have been described, it is not intended to limit the present invention thereto, as it is intended that the scope of the present invention be as broad as the art allows, and the specification should be understood as such. Therefore, although specific shapes and sizes of inflatable bladders and strips have been disclosed, it should be understood that other shapes, sizes, and attachments may also be used. It should also be understood that although adhesive devices have been disclosed for assisting in securing the skin, other types of attachments, such as wraps, may also be used. Therefore, it should be understood by those skilled in the art that other modifications may be made to the present invention without departing from the spirit and scope of the claimed invention.

Claims

1. A lifting device for lifting a bony prominence on a user, the lifting device comprising: a permeable skin-compatible adhesive layer; an absorbent layer for absorbing wound exudate; a hydrophobic layer above the absorbent layer; as well as At least one pre-inflated bladder is coupled to the hydrophobic layer, the at least one pre-inflated bladder comprising at least one orifice configured for placement over the bony prominence being elevated.

2. The elevation device of claim 1, wherein the absorbent layer is a foam or a sponge.

3. The elevation device of claim 2, wherein the absorbent layer is selected from the group consisting of open cell foam, closed cell foam, partially open and closed cell foam, silicone foam, and combinations thereof.

4. The elevation device of claim 1, wherein the absorbent layer has the permeable skin-compatible adhesive layer therein and is a foam or is disposed between the permeable skin-compatible adhesive layer and the hydrophobic layer.

5. The elevation device of claim 1, wherein the bony prominence is selected from the group consisting of a heel, a metatarsal, an ankle, an elbow, a hip, a scapula, or a sacrum.

6. The elevation device of claim 1, wherein the at least one pre-inflated bladder includes at least one aperture, and the pre-inflated bladder and the aperture are configured to be placed over a heel of a user.

7. The elevation device of claim 1, wherein the at least one pre-inflated bladder includes at least one orifice, and the pre-inflated bladder and the orifice are configured to be placed over a hipbone or elbow of a user.

8. The elevation device of claim 1, wherein the at least one pre-inflated bladder includes at least one aperture, and the pre-inflated bladder and the aperture are configured to be placed over a metatarsal of a user.

9. The elevation device of claim 1, wherein the at least one pre-inflated bladder includes at least three apertures, and the pre-inflated bladder and the apertures are configured to be placed over both sides of a user's heel and ankle.

10. The lifting device of claim 1 further comprising a second pre-inflated bladder and a third pre-inflated bladder, each of the three pre-inflated bladders comprising an orifice, and the three pre-inflated bladders and the orifices are configured to be placed over both sides of a user's heel and ankle.

11. The elevation device of claim 1 further comprising a second pre-inflated bladder each forming an orifice, and wherein the two pre-inflated bladders and the one orifice are configured to be placed over a user's sacrum.

12. The elevation device of claim 1, wherein the shape of the elevation device is selected from the group consisting of a circle, a square, a rectangle, a heart, a rounded square, a rounded rectangle, a "T" shape, a "U" shape, a "V" shape, and combinations thereof.

13. The elevation device of claim 1, further comprising a drug, silver, zinc oxide, antibiotics, analgesics, etc. impregnated into the permeable skin-compatible adhesive layer.

14. The lifting device of claim 1, wherein the bony prominence is a hipbone or an elbow of a user, the at least one pre-inflated bladder is in the shape of a circle or a rounded square having a length and a width of about 2 inches to about 6 inches, and the hydrophobic layer is in the shape of a circle or a rounded square having a length and a width of about 3 inches to about 15 inches.

15. The lifting device of claim 1, wherein the bony protrusion is a metatarsal or the sole of the foot of the user, the at least one pre-inflated bladder is in the shape of a rounded rectangle having a length of about 0.5 inches to about 5 inches and a width of about 0.5 inches to about 6 inches, and the hydrophobic layer is in the shape of a rounded rectangle having a length of about 1 inch to about 10 inches and a width of about 1 inch to about 10 inches.

16. The lifting device of claim 1, wherein the bony protrusion is a combination of a heel, and the at least one air bladder is in the shape of a rounded rectangle having a length of about 0.5 inches to about 6 inches and a width of about 0.5 inches to about 5 inches, and the hydrophobic layer is in the shape of a circle or a rounded square having a length and a width of about 4 inches to about 15 inches, the lifting device further comprising at least three slits in the hydrophobic layer, the at least three slits being configured for adhesion to the side of the ankle of the user.

17. The elevation device of claim 1, wherein the bony prominence is a combination of the heel and both sides of the ankle, the elevation device further comprising a second pre-inflated bladder and a third pre-inflated bladder each having a length of about 0.5 inches to about 6 inches and a width of about 0.5 inches to about 5 inches, and the absorbent layer is in a "T" shape having a length of about 6 inches to about 20 inches and a width of about 3 inches to about 12 inches, and the hydrophobic layer is in a "T" shape having a width of about 6 inches to about 12 inches and a length of about 8 inches to about 25 inches.

18. The elevation device of claim 1, wherein the bony prominence is the sacrum, the elevation device further comprising a second air bladder, and the hydrophobic layer is in the shape of a heart or rounded heart, square, or circle having a length and width of about 2 inches to about 10 inches.

19. The lifting device of claim 1, wherein the bony protrusion is a hipbone or an elbow of a user, the at least one pre-inflated bladder is in the shape of a circle or a rounded square having a length and a width of about 2 inches to about 6 inches, and the hydrophobic layer is in the shape of a circle or a rounded square having a length and a width of about 2 inches to about 10 inches.

20. The elevation device of claim 1, further comprising a second pre-inflated bladder coupled to the first pre-inflated bladder.

21. The elevation device of claim 1, further comprising a protective layer over the permeable skin-compatible adhesive layer, wherein the protective layer is comprised of a film, a polymer, a paper, or a combination thereof.

22. A lifting device for lifting a bony prominence on a user, the lifting device comprising: a permeable skin-compatible adhesive layer; an absorbent layer for absorbing wound exudate; a hydrophobic layer above the absorbent layer; as well as At least one inflatable bladder inflatable via an inflation port and an inflation device, the at least one inflatable bladder connected to the hydrophobic layer, including at least one aperture, is configured for placement over the bony prominence being elevated.

23. The elevation device of claim 22, wherein the absorbent layer is selected from the group consisting of foam, sponge, open cell foam, closed cell foam, partially open and closed cell foam, silicone foam, and combinations thereof.

24. The elevation device of claim 22, wherein the absorbent layer has the permeable skin-compatible adhesive layer therein and is a foam or is disposed between the permeable skin-compatible adhesive layer and the hydrophobic layer.

25. The elevation device of claim 22, wherein the bony prominence is selected from the group consisting of a heel, a metatarsal, an ankle, an elbow, a hip, a shoulder blade, or a sacrum.

26. A method of elevating a bony prominence of a user, the method comprising: removing an elevation device from a package, the elevation device comprising at least one pre-inflated bladder, a hydrophobic layer, an absorbent layer, and a permeable skin-compatible adhesive layer; removing the protective layer comprised of a film, polymer, paper, or combination thereof, thereby activating the permeable skin-compatible adhesive layer beneath the protective layer on the elevation device; as well as Placing the at least one pre-inflated bladder and the absorbent layer for absorbing wound exudate over the bony prominence and pressing the elevation device so that the bony prominence is in contact with the permeable skin-compatible adhesive layer.

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