WO2019060311A1

WO2019060311A1 - Hidradenitis suppurativa wound care system

Info

Publication number: WO2019060311A1
Application number: PCT/US2018/051553
Authority: WO
Inventors: Victor Bor-Chang HSUE; Abhishek UMASHANKAR; Leena Tushar RAMANI; Jennifer Haru JANG
Original assignee: Thomas Jefferson University
Priority date: 2017-09-19
Filing date: 2018-09-18
Publication date: 2019-03-28

Abstract

A dressing that includes a front wing, the front wing being configured to anchor at a front side of a shoulder joint; a back wing, the back wing being configured to anchor at a back side of a shoulder joint; a proximal wing, the proximal wing being configured to receive a torso portion; a distal wing, the distal wing being configured to receive a limb portion, wherein the front wing, the backwing, the proximal wing, and the distal wing form a continuous countour that is a substantially hyperbolic paraboloid shape.

Description

HYDRADENITIS SUPPURATIVA WOUND CARE SYSTEM FIELD OF INVENTION

[0001] This application is generally related to a dressing for wound care to certain skin conditions on the body, especially those related to Hidradenitis Suppurativa or having similar skin phenotypes on the body.

BACKGROUND OF INVENTION

[0002] Hidradenitis Suppurativa (HS) is a chronic, inflammatory skin condition that causes red, swollen, painful bumps to form on the body, usually in intertriginous areas (places where two areas of skin may touch or rub together) with high friction. The boils that form from HS cause excruciating pain, can spontaneously drain with exudate, and also can emanate a foul odor. Areas where HS most commonly presents are the groin, axilla, and inframammary fold (e.g., under breasts). Patients currently struggle with bandaging their wounds due to the unusual shapes and inaccessibility of these regions, as well as the limited mobility associated with the severe pain HS causes. Due to the aforementioned challenges limiting patients' independence, many of them with axillary HS only have one free hand and are reliant on family members to help them with dressing their wounds. To limit the pain from friction of fabric on the wounds, patients also wear very specific types of clothing, ranging from very baggy clothing to compression pieces (sports bra, compression shorts or pants, etc.).

[0003] The psychological component of this condition is also troubling. Because there is no effective bandaging technique for the axilla, patients with more severe/unmanageable HS isolate themselves to avoid the social embarrassment associated with this condition. They are worried about drainage leaking through their bandages and becoming visible on their clothing. Patients are also concerned with the strong odor whether perceived by others or themselves. [0004] Patients with axillary wounds do not have adequate bandages/dressings that conform to the axillary region. Furthermore, existing options frequently cause pain due to friction of material against the wound. Every day/generic T-shirts are not tight enough to provide an anchor for an absorptive pad or other adhesive bandages that are necessary to protect and cover the axillary region.

[0005] Accordingly, patients spend lots of money on inefficient bandaging techniques in an effort to meet their needs. Unfortunately, daily use of adhesive bandages causes trauma and irritation to unaffected skin, which, in many cases exacerbates the conditions instead of providing relief or protection. Thus, patients are worried about inadequate protection from their dressings or about causing further irritation or trauma. Patients who currently use regular bandaging options such as gauze and tape create a loose fit around the wound. Movements while wearing these options can cause the fabric to constantly rub against the wound, creating constant, debilitating pain.

[0006] Furthermore, these inefficient techniques make changing of regular bandaging options nearly impossible without assistance. This leads to patients both having to use soiled materials, or face shame or embarrassment, whether real or perceived, while in public and private spaces.

[0007] What is needed is a new solution to allow patients the freedom to individually dress the areas of irritation from HS. This will give patients the confidence to face public situations and improve their quality of life, while at the same time providing highly efficient long term care.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] FIGs. 1A-1 D depict perspective views of a dressing according to one implementation of the disclosure. FIG. 1 A represents a top aerial view of a dressing. It is 177.0 mm long, the shorter end is 70.0 mm wide while the longer end is 1 18.0 mm wide. FIG. 1 B shows an upside-down side view of the dressing to emphasize its curvature. The drop from the highest to lowest point is 90.8 mm. FIG. 1 C shows an upside down, rear- facing view, emphasizing the curvature of the dressing. FIG. 1 D is an angled view of the dressing, with the larger end in the front. It also shows the width of the dressing: 5mm. This is approximately the angle at which it will sit in the axilla.

[0009] FIG. 2 depicts the five layers of a dressing according to one implementation of the disclosure. A top sheet that can both be moisture wicking as well as comfortable. The second layer is an acquisition distribution layer (ADL) that can equally spread fluid across the bandage horizontally and vertically, leading to the third, superabsorbent core layer, which in preferred embodiments is a mixture of superabsorbent polymers and absorbent fabrics, such as fluff pulp. A Flexible skeleton is the next layer, which, in some embodiments is combined. The flexible skeleton is made of a material that is both flexible and has memory, such as foam or silicone. This helps the entire dressing hold its shape, even under stress. The final layer is the bottom sheet that does not allow fluid to leak through. Lastly, there is an adhesive on the bottom of the dressing that would allow it to stick to a garment.

[00010] FIGs. 3A-3D depict a shrug (Bolero) style garment accommodating a dressing according to one implementation of the disclosure. FIG. 3A shows a rear view of a person wearing the shrug. FIG. 3B shows a left side view of a person wearing the shrug. FIG. 3C shows a front view wearing the shrug. FIG. 3D shows a front view of a person wearing the shrug, illustrating a patient opening up the shrug to show the dressing positioned in the axilla. The dotted lines outline the location of the pad underneath the bandage.

[00011] FIGs. 4A-4D depict a holster style garment accommodating a dressing according to one implementation of the disclosure. FIG. 4A depicts a back view of a person wearing the holster (article of clothing with a cross-shaped back behind the shoulder blades to allow ease of movement in sports) style anchoring point that helps to hold the dressing in place and equalize the pressure on the back. FIG. 4B shows a left side view of a person wearing the holster. FIG. 4C shows a front view of person wearing the holster. FIG. 4D shows a front view of a person wearing the holster, illustrating a patient opening up the shirt to show the dressing positioned in the axilla. The dotted lines outline the location of the dressing underneath the holster.

[00012] FIGs. 5A-5D depict a t-shirt style garment accommodating a dressing according to one implementation of the disclosure. FIG. 5A shows a back view of a person wearing the t-shirt. FIG. 5B shows a left-side view of a person wearing the t-shirt. FIG. 5C shows a front view of a person wearing the t-shirt. FIG. 5D shows a front view of a person wearing the t-shirt, illustrating a patient opening up the shirt to show the dressing positioned in the axilla. The dotted lines outline the location of the dressing underneath the bandage. This is the shirt that opens in the front to allow easy access to the dressing.

[00013] FIGs. 6A-6D depict the compression undershirt accommodating a dressing according to one implementation of the disclosure. FIG. 6A shows a back view of a person wearing the compression undershirt. FIG. 6B shows a left-side view of a person wearing the compression undershirt. FIG. 6C shows a front view of a person wearing the compression undershirt. FIG. 6D shows a front view of a person wearing the compression undershirt, illustrating a patient pulling up the shirt to show the dressing positioned in the axilla. The dotted lines outline the location of the dressing underneath the bandage.

[00014] FIGs. 7A-7D depict the cropped compression undershirt accommodating a dressing according to one implementation of the disclosure. FIG. 7A shows a back view of a person wearing the cropped compression undershirt. FIG. 7B shows a left-side view of a person wearing the cropped compression undershirt. FIG. 7C shows a front view of a person wearing the cropped compression undershirt. FIG. 7D shows a front view of a person wearing the cropped compression undershirt, illustrating a patient pulling up the shirt to show the dressing positioned in the axilla. The dotted lines outline the location of the dressing underneath the bandage. [00015] FIGs. 8A-8D depict a compression vest accommodating a dressing according to one implementation of the disclosure. FIG. 8A shows a back view of a person wearing the cropped compression vest. FIG. 8B shows a left-side view of a person wearing the compression vest. FIG. 8C shows a front view of a person wearing the compression vest. FIG. 8D shows a front view of a person wearing the compression vest, illustrating a patient opening up the shirt to show the dressing positioned in the axilla. The dotted lines outline the location of the dressing underneath the bandage. FIG. 8A shows a central panel of fabric on the back made of a separate, stronger knit fabric. The rest of the vest is made of 4-way stretch material, and opens in the front, allowing for easy access to change dressings when needed.

[00016] FIGs. 9A-9D depict the cropped compression vest accommodating a dressing according to one implementation of the disclosure. FIG. 9A shows a back view of a person wearing the cropped compression vest. FIG. 9B shows a left-side view of a person wearing the cropped compression vest. FIG. 9C shows a front view of a person wearing the cropped compression vest. FIG. 9D shows a front view of a person wearing the cropped compression vest, illustrating a patient opening up the vest to show the dressing positioned in the axilla. FIG. 9A Shows a central panel of fabric on the back made of a separate, stronger knit fabric. The rest of the vest is made of 4-way stretch material, and opens in the front, allowing for easy access to change dressing when needed.

SUMMARY OF INVENTION

[00017] This application describes a dressing for precision bandaging of certain, otherwise hard to treat diseases or skin conditions. The bandaging system comprises two components, a dressing and a garment, that can be used alone or, most preferably, together, to create a sanitary bandaging system.

[00018] In preferred embodiments, the bandaging system comprises a two-component bandaging system for axillary wounds associated with Hidradenitis Suppurativa (HS) consisting of a disposable padded dressing (from here on referred to as the "dressing") to manage the wound and a reusable garment to secure the dressing against the body. Each component has unique properties, as described below.

[00019] In a preferred embodiment, a dressing is a disposable flexible hyperbolic paraboloid pad. Preferably the disposable flexible dressing is custom-modeled from the shape of an individual's axilla, captured via 3d scanning or direct molding.

[00020] In preferred embodiments, a dressing comprises a first and a second layer, said first layer being an absorptive layer comprising a blend of fluff pulp and SAPs (absorptive materials), and said second layer adjacent to said first layer, capable of being pre-formed into a unique shape and maintaining said form, comprised of foam.

[00021] In preferred embodiments, the dressing comprises at least three layers, said first layer being a moisture wicking topsheet made of hyprophilic nonwoven poplypropylene or polyethylene, a middle absorptive layer, comprising a blend of fluff pulp and SAPs (absorptive materials), and a third layer adjacent to the middle layer, capable of being pre-formed into a unique shape and maintaining said form, comprised of foam.

[00022] In preferred embodiments, the dressing comprises at least four layers, said first layer being a moisture wicking topsheet made of hyprophilic nonwoven poplypropylene or polyethylene, a second ADL layer, a third layer capable of absorbing and maintaing shape comprising a blend of fluff pulp and SAPs (absorptive materials), and a fourth backsheet layer comprised of hydrophobic nonwoven poplypropylene or polyethylene, adjacent to the third layer, to prevent leakage of exudate.

[00023] In a further preferred embodiment, a dressing comprises a least five layers, said first layer being a moisture wicking topsheet made of hyprophilic nonwoven poplypropylene or polyethylene, a second ADL layer, a third absorptive layer comprised of fluff pulp, a fourth skeletal layer of foam to maintain the unique shape and form, and a fifth backsheet layer comprised of hydrophobic nonwoven poplypropylene or polyethylene, adjacent to the third layer, to prevent leakage of exudate.

[00024] In each of the embodiment, a dressing may further comprising an ahdesive layer disposed of on the back of an othermost layer. Furthermore, embodiments may further comprising an anti-microbial ointment, a petroleum ointment, a fragrant agent, or a therapeutic layer on the top layer. Further, at least one layer may further comprising an odor-blocking mechanism.

[00025] In preferred embodiments, a dressing, whether in two, three, four, or five layers, is advantageously paired with a garment having a supporting structure capable of supporting the dressing within the axilla, wherien the garment allows for the dressing to be adjacent the axilla without the need for an adhesive against the skin surface. For example, the garment may be a: t-shirt style, a holster style, or a front-closure style.

[00026] Therefore, a preferred embodiment is directed towards a system comprising a dressing according to the above, having between two to five layers, and a garment defined to secure and hold in place the dressing for a prescribed period of time and allows for ease of access to axilla region for disposal and replacement of the dressing and is easy to take on and off for a single user.

[00027] A further embodiment is directed towards a hygenic axilla support and dressing comprising: a washable custom fit backing having a paraboloid shape defined for fit adjacent to the axilla of a patient; said backing comprising a flexible skeleton layer faving a top face and a bottom face, and a water resistant bottom sheet having a top and bottom face; and a disposable attachable component comprising a topsheet, an ADL layer, and a superabsorbent core, each having a top and bottom face; the top face of the flexible skeleton layer securing to the bottom face of the superabsorbent core, with the ADL layer sandwiched between the superabsorbent core and the topsheet. DETAILED DESCRIPTION OF THE EMBODIMENTS

[00028] As described herein, applicant details a new product comprising one or more of the following features, which can be used individually, or together with two or more pieces in a system.

[00029] The term "dressing" is defined in this paragraph. A dressing means a medical device having a flexible structure in a substantially hyperbolic paraboloid shape. The dressing includes at least a proximal wing that receives a portion of a user's torso; a distal wing that receives a portion of a user's limb; a front wing; and a back wing. The front wing has an end. The back wing has an end. The back wing has a width larger in comparison to the front wing. The proximal wing, the distal wing, the front wing, and the back wing form a continuous contour that is substantially a three dimensional hyperbolic paraboloid shape. The dressing maintains substantially a hyperbolic paraboloid shape when the dressing is not under any external force (e.g., when free standing). The dressing is flexible such that it bends or reshapes under certain external forces, e.g., when the dressing is in use by a patient. When the applied external forces disappear, the dressing regains its substantially hyperbolic paraboloid shape. Different exemplary embodiments of a dressing are disclosed in FIGs. 1 A-1 D and FIG. 2.

[00030] The term "bandaging system" herein means a combination of a dressing and a garment, wherein the garment accommodates the dressing and secures the dressing to the contour of a body portion of the user.

[00031] Patients with axillary wounds do not have adequate bandages/dressings that conform to the contour of an axillary region. Indeed, patients with HS frequently struggle with bandaging their wounds due to the unusual shape and inability to visualize this region. The axilla, as with any joint area, is a difficult area to apply a regular bandage since it changes shape as the arm moves. When a flat bandage is placed in this area, bending of the arm can create "pockets" between the bandage and the arm through which drainage can escape from the dressing and leak.

[00032] As depicted in FIGs. 1A-D, a dressing 100 is economically shaped, having a "hyperbolic paraboloid" shape to fit the contours of the axilla. The dressing contains several components that provide its shape and functionality for supportive use and care of HS.

[00033] As shown in FIGs. 1A-1 D, a dressing 100 includes a back wing 102, a front wing 104, a proximal wing 106, and a distal wing 108, a bottom surface 1 12, and a top surface 1 10. The directional adjectives, i.e. , front, back, proximal, and distal, are used in reference to a human body. When the dressing 100 is in use, the front wing 104 is pointing to the front of the user; the back wing 102 is pointing to the back of the user; the proximal wing 106 is in contact with the torso (proximal to the torso); the distal wing 108 is pointing away from the torso (distal to the torso, e.g., in contact with an upper arm portion). It is noted the "top" direction as shown in Figures 1 B to 1 D is pointing to user's head, when the dressing 100 is in use.

[00034] A dressing 100 is a medical device having a flexible structure in a substantially hyperbolic paraboloid shape. The proximal wing 106 is shaped to receive a portion of a user's torso, for example, a torso portion slightly below an armpit. The distal wing 108 is shaped to receive a portion of a user's arm, e.g., an upper arm portion adjacent to the armpit. The front wing 104 protrudes upward from both the proximal wing 106 and the distal wing 108 forming a continuous contour. The front wing 104 has a front end 105 that is the highest elevation point of the contour of the front wing 104. The back wing 102 has a back end 103 that is the highest elevation point of the contour of the back wing 102.

[00035] The proximal wing 106, the distal wing 108, the front wing 104, and the back wing 102 form a continuous contour of a substantially hyperbolic paraboloid shape. When in use, the dressing 100 forms a cavity with the axilla, wherein the dressing loosely seals the axilla.

[00036] The elevational contour of the front wing 104 and the back wing 102 enhance the sealing of the axilla. The elevational contour of the front wing 104 catches dripping exudate when the user is bending forward or lays on his stomach. The elevational contour of the back wing 102 catches dripping exudate when the user is bending backward or lays on his back.

[00037] The dressing 100 maintains substantially a hyperbolic paraboloid shape when the dressing is not under any external force (e.g., when free standing). The dressing 100 is flexible such that it bends or reshapes under certain external forces, e.g., when a patient is using the dressing. When the applied external forces disappear, the dressing regains its substantially hyperbolic paraboloid shape.

[00038] In one embodiment, the dressing 100 may include a single layer. This single layer is flexible and maintains a hyperbolic paraboloid without external forces. This single layer may also be absorptive to body fluids or exudate that flow from wounds or sores.

[00039] In one embodiment, the dressing 100 may comprise at least two layers consisting of an absorptive layer and a shaping or structural layer to provide support and shape to the device. However, as described herein, additional layers are advantageous in certain embodiments. The absorptive layer is useful in ensuring that any fluids or exudate that flow from wounds or sores are contained. At the same time, the unique memory material (the support layer) is preferably a flexible skeleton layer as described in the product description also ensures that the dressing fits within the axilla and stays up against the skin for maximum functionality, while still enabling the user to have a wide range of motion.

[00040] This dressing 100 is beneficial for HS patients as existing options frequently cause pain due to friction of material against the wound. Before they open, the blisters associated with HS wounds are painful when contacted by surfaces such as clothing. As mentioned above, the axilla is a difficult location to apply a bandage to because of the changing shape with arm movements. Patients who currently use regular bandaging options such as gauze and tape create a loose fit around the wound. Movements while wearing these options can cause the fabric to constantly rub against the wound, creating constant, debilitating pain.

[00041] Advantageously, the dressing 100 can be used with a supporting garment. Herein, the disclosure describes several garment options to hold the dressing into position and prevent it from unnecessary motion (causing friction and discomfort), and also maintaining it in place to ensure efficacy. Several different configurations are suitable for the garment (See FIGs. 3-9). Indeed, variations of the garments are designed having components with compression materials such as neoprene or spandex which creates a tight, but breathable fit to hold the dressing against the skin. This minimizes the friction between the dressing and the axilla due to the dressing's conformable shape which allows it to be positioned in the axilla and bend with the user's arm movements.

[00042] The precise fit of the dressing 100, combined with the secure attachment from the garment allows for a secure and precise fit for a user, thus alleviating expensive and inefficient regular bandaging techniques. As one regular bandaging techniques for the axilla, many patients resort to using gauze and paper tape. Unfortunately, this does not adhere to the area well and is not sufficiently absorbent, requiring multiple changes throughout the day. One method female patients use to avoid adhesives is to place excess gauze into the sides of their brassiere in the hopes of positioning the bandage over the wound. This technique results in material waste and does not guarantee wound coverage. Some patients use tubular, elastic netting to hold gauze and other dressing pads in place; this is also expensive and inconvenient to use on a daily basis because the material needs to be cut into a personalized shape each time. On the other end of the spectrum, there are patients who do not use any dressings at all, allowing drainage from their wounds to freely flow onto their clothing.

[00043] With the dressing 100, a patient will have easier access to an absorptive dressing that will fit well without additional manipulation or products for a variety of reasons described below. Users will spend less time dressing their wounds since they no longer need to find ways to keep a dressing stable in the axilla. The garment eliminates the need for the patient to invent their own bandaging solution. Furthermore, as mentioned earlier, the disclosed garments are all designed with ease of changing in mind. The garments have front openings so that old dressings can be removed and new dressings inserted, as seen in the front view (c) in Figs. 3, 4, 5, 8, 9.

[00044] Use of the dressing 100 alone, or with the garment, provides a secure and comfortable fit for the user and prevents the existing and unnecessary use of adhesive bandages. Indeed, many patients suffer from trauma and irritation to unaffected skin adjacent to the axilla, as they seek to bandage the affected skin. Unfortunately, the use of adhesive bandages is not recommended for daily use due to irritation of the skin caused by the adhesive. When patients have to change their dressings multiple times a day, significant trauma to the otherwise healthy skin can occur. Furthermore, many patients with HS have other skin conditions as well, so they are even more sensitive and reactive to products on their skin. Other bandages with more gentle adhesives, such as silicone foam dressings, are too expensive for patients to use in high frequency and volume.

[00045] The garment product designed to be used with the dressing 100 comprises several features that create a significant improvement over use of existing everyday/generic T-shirts. Generic T-shirts do not provide sufficient support to provide an anchor for securing the dressing 100. Additionally, most users currently do not wear clothing with sleeves that would be tight enough around the axilla to hold the dressing. Because the garment is designed to keep the dressing securely in place, the garment can be worn under typical, everyday clothing.

[00046] By ensuring a secure fit of the dressing to the axilla area, the concern faced by many patients about inadequate protection from their dressings is reduced. Currently, with no effective bandaging technique for the axilla, patients with more severe/unmanageable HS socially isolate themselves to save themselves from the social embarrassment associated with this condition. They are worried about drainage leaking through their bandages and becoming visible on their clothing. Patients are also concerned with the strong odor associated with the drainage whether perceived by others or themselves. Even when there is no actual smell, patients still live in fear that others can smell something different about them and know about their condition.

[00047] With the dressing 100, users have the comfort of knowing that their wounds are being covered and protected and that any exudate will be absorbed. The discreet design and odor blocking properties of the dressing will also prevent the users from drawing attention to themselves and their wounds. Dressings will come in different sizes to ensure that there is adequate coverage regardless of the area of one's wound.

[00048] It is recognized that with regular bandaging options, patients have significant difficulty changing dressings themselves, without assistance. Indeed, a key reason for this is that axillary wounds can limit mobility of the arm. This makes dressing oneself more difficult, especially when certain clothing requires one to lift an arm above one's head. Without a spouse, partner, friend, caretaker, etc. , patients can have trouble simply getting dressed, let alone applying a bandage to the axilla with one hand.

[00049] In the case where a patient has limited mobility of their arms, a dressing solves this problem by having a garment that is easy to put on by oneself. As well, the garment allows for a simple, single-handed insertion of the dressing into the axilla from the front opening of the garment, so that the patient does not have to lift their arm up too high, as shown in FIGs 3D, 4D, 5D, 6D, 7D, 8D, and 9D.

[00050] Accordingly, as described and depicted in the figures, the dressing comprises a pad, having a specific shape, contoured to fit the axilla. This component is economically designed in the form of a truncated 3-dimensional hyperbolic paraboloid pad, modeled to fit in a patient's axilla. Preferably this comprises at least an absorptive layer and a skeleton layer to ensure appropriate shape of the absorptive layer. The skeleton layer is shown in detail in FIG. 1 However, additional layers are advantageous as described below.

[00051] FIG. 2 shows an embodiment of a dressing 100 with five different layers according to one embodiment of the disclosure. The dressing 100 includes a top sheet 202 (axilla facing surface), an acquisition distribution layer (ADL) 204, an absorption layer 206, a flexible skeleton layer 208, and a bottom sheet 210.

[00052] The top sheet 202 possesses a quick absorbing property which can be made of a comfortable, non-woven material such as polypropylene, apertured polyethylene, or cotton, since this layer is in direct contact with the user's skin. The top sheet 202 may provide some absorbency. The top sheet 202 allows the exudates to quickly flow through itself. In one example, the top sheet 202 has repeated structured apertures, e.g., in triangles, rectangles, pentagon, or hexagon shapes.

[00053] The acquisition distribution layer (ADL) 204 is a layer that allows exudates to be equally distributed in all directions, avoiding oversaturating a specific spot. In one embodiment, the ADL 204 under the top sheet distributes the fluid in the horizontal plane (all directions) and then transfer it in the vertical direction downwards to the next absorptive layer.

[00054] The absorption layer 206 is a layer that absorbs large quantity of fluids. The absorption layer 206 is the main absorbent layer consisting of a combination of superabsorbent polymers (SAP) and cellulose-based fluff pulp that will retain fluid well and not release it if pressure is applied. In one embodiment, an appropriate combination of SAP and fluff pulp will allows the dressing 100 to retain its 3D-shape even while saturated with exudate. In another embodiment, the absorption layer 206 may include some structural materials, e.g., polyethylene, acrylic, etc. , that may be shaped/molded under heat. Such structural material may provide support to maintain the hyperbolic paraboloid shape, even if the absorption layer 206 is saturated.

[00055] The flexible skeleton layer 208 is a structural layer. The flexible skeleton layer 208 is made with flexible materials and maintains the hyperbolic paraboloid shape. Potential material can be silicone, polyethylene, acrylic, etc.

[00056] The bottom sheet 210, is comprised of a protective polyethylene or polypropylene plastic to prevent any fluid from leaking through the dressing. In one embodiment, the back sheet is wrapped around the edges of the dressing 100 to prevent leakage from the sides.

[00057] In preferred embodiments, the skeleton layer 208 is made of a flexible material specialized for retaining its shape memory. In one embodiment, the skeleton layer 208 can be combined with the absorption layer 206. Advantageously, two additional layers, as depicted in FIG. 2 are placed above the superabsorbent core, the ADL 204 and the top sheet 202, as described below. Furthermore, a bottom sheet 210 is preferably attached to the bottom face of the flexible skeleton layer 208.

[00058] In preferred embodiments, one or more of the layers comprises further odor blocking and masking properties. For example, certain deodorants may be included within one or more of the five layers 202, 204, 206, 208, 210 to prevent odor. In part, the absorption layer 206 will trap materials and liquids that otherwise typically cause odor, and thus these are eliminated in part, by the design of the product. [00059] The preferred shape used for the dressing 100 is modeled to conform to the negative space around one's axilla, forming a loosely sealed cavity. The top of the resulting "hyperbolic paraboloid" sits flush against the general contour of one's axilla. The diminishing shape of the "paraboloid" secures around an axilla and prevents the dressing 100 from slipping. In one embodiment, the dressing 100 can be wider in the front wing 104 than the back wing 102, the dressing 100 uses the front of the patient's shoulder joint as an anchor to prevent the dressing 102 from slipping backwards. Furthermore, this shape minimizes the appearance under clothing.

[00060] The skeletal layer 208 of the dressing 100 is composed of a flexible material that retains its shape, such as flexible foam or silicone. The "memory" of this material is important so that as the user bends and lifts his/her arm, the pad will compress and relax to stay as close to the skin as possible. Thus, the pad will constantly provide adequate protection.

[00061] The dressing 100 will also have odor blocking and masking properties, such as with the inclusion of baking soda, activated charcoal, or fragrant agents in the top sheet layer 202 and/or absorption layer 206. In preferred embodiments, the top layer 202 of the dressing 100 will also be impregnated with topical ointments such as anti-microbial ointments or petroleum jelly. Those of ordinary skill in the art will also recognize that other topical therapeutics may be further added into the top sheet or the ADL. For example, it may be advantageous to add in a moisture bound therapeutic, which is released only upon being saturated. This allows for active targeting with a therapeutic when there is active drainage into the material.

[00062] In preferred embodiments, because of the nature of the pads, each pad is designed to be thrown out after a single use.

[00063] On the backside 212 of the bottom sheet 210 is an adhesive mechanism 212 for the dressing to stick to the garment securely that can still be removed easily. Adhesive mechanisms can be glue, hook/loop fasteners, or the acrylate and vinyl resins used on adhesive bandages. The adhesive can be directly applied to ordinary clothes worn by the user, but preferably the dressing is used with a garment as specifically described herein.

[00064] The dressing is preferably made of several different layers, each having a feature to ensure fit and function. Finding the proper shape and size of the axilla required use of a 3D scan of several different sized people, to best identify a range and fit for the dressing. The scan allows for a computerized model of the negative space around an armpit. This model allows us to manipulate the shape and size of the final dressing.

[00065] The dressing can take a custom fit of an individual axilla through several known mechanisms. For example, a 3D scan can be used, or use a moldable polymer or material to generate a shape for the custom fit. With the model of this shape, a mold is generated that can be used to create the skeletal layer of the dressing. Accordingly, a user can then buy replacement dressings based on their stored measurements and specifications to have a custom fit dressing. For example, a user can then purchase a particular size, shape, and or fit, similar to buying a particular size shoe.

[00066] In further preferred embodiments, however, at least two layers can be non- disposable. A user may have a particularly molded skeletal layer 208 and bottom sheet 210 that are custom fit for the user, wherein the skeletal layer 208 and the bottom sheet 210 are not reusable. These may be made of materials that can be washed or sanitized by the user. The user can then individually purchase a sized component that is a top sheet, ADL, and superabsorbent core. This provides a custom fit component (208 and/or 210), and then a generic component (202, 204, and/or 206) that can be molded into and compressed to the non-disposable component.

[00067] In one embodiment, the top sheet 202 may be a woven or non-woven fabric, material, such as polyethylene or polypropylene. These materials are advantageous because they provide for a comfortable feel against the skin and has greater wicking properties than a polyethylene apertured film. Other materials include woven or non- woven cotton or other fibers. Certain fibers have greater or lesser absorptive properties. It may be an advantage in certain embodiments to have the top layer be absorptive, or in other embodiments have the top layer serve merely to wick moisture to the inner layers.

[00068] In one embodiment, the ADL 204 is useful to distribute the collected fluid first in the horizontal plane and then in the vertical plane, especially because of the 3D nature of the dressing. ADLs 204 are preferably made of non-woven apertured polymeric films using either the thermobonded or hot air through technique. In certain embodiments, this layer can be omitted. For example, certain dressings may be sold with greater or lesser absorptive properties, similar to how diapers or sanitary products are sold, based on the needs of the user. Different embodiments of the dressing 100 may have different absorptive properties and thus may include or omit certain layers, for example this ADL layer.

[00069] In one embodiment, the absorptive layer 206 is a material that will absorb enough exudate. Preferably, materials include cellulose fluff pulp solely as the absorptive layer. Further embodiments may comprise fluff pulp as both the skeletal and absorptive layers; however, while dry fluff pulp will hold its shape, once wet, it will turn into a "ball of fluff". One way to prevent this from happening is by using an optimal combination of cellulose fluff pulp and a superabsorbent polymer (SAP) that maintains the shape while wet. For example, suitable combinations include about 10% to about 90% cellulose fluff pulp and about 10% to about 90% SAP. Further components may be included to impart additional stability, support, or other properties as necessary. Depending on the application, certain dressings, for example those which are completely disposable may use more materials to impart structure. By contrast, those dressings placed in a more rigid skeletal structure may require less structural materials. As with sanitary products, the particular need of each user may determine the precise combination of components to meet the absorbency needs of the user.

[00070] Another suitable material for absorption layer 206 that could act as both the absorptive and skeletal layers is a medical-grade polyurethane foam. However, polyurethane foam is more expensive and the absorptive properties of foam are not ideal for the dressing. Using foam would still require having an SAP layer underneath that the fluid would transfer to; foam is also not fast absorbing and will release whatever fluid it is holding when put under pressure (like a sponge). Those materials currently used in infant diapers, adult diapers, and female sanitary pads are can be used, as these have a long history of safe use adjacent to the skin surface. However, new superabsorbent polymers are now commonly made from the polymerization of acrylic acid blended with sodium hydroxide in the presence of an initiator to form a poly-acrylic acid sodium salt (sometimes referred to as sodium polyacrylate). This polymer is the most common type of SAP made in the world today. Other materials are also used to make a superabsorbent polymer, such as polyacrylamide copolymer, ethylene maleic anhydride copolymer, cross-linked carboxymethylcellulose, polyvinyl alcohol copolymers, cross-linked polyethylene oxide, and starch grafted copolymer of polyacrylonitrile to name a few. The latter is one of the oldest SAP forms created. Today superabsorbent polymers are made using one of three primary methods: gel polymerization, suspension polymerization or solution polymerization. Each of the processes have their respective advantages but all yield a consistent quality of product. Accordingly, those of skill in the art will recognize that several suitable materials exist, including natural materials, synthetic materials, and combinations thereof, the precise nature of which is dependent on the absorbency needs of the user.

[00071] In one embodiment, skeletal layer 208 is generated to provide the structural support for the dressing to maintain its unique shape and memory. The preferred material that has both of these properties is a flexible foam. Silicone was also considered for this layer. However, silicone will make the pad heavier and reduce air flow, exacerbating patient's wounds; it would also cost more. As provided herein, this may be disposable, or molded specifically for each user and be washable and re-usable with a disposable absorbent layer, comprising the top sheet, ADL, and superabsorbent core

[00072] In one embodiment, the back sheet 210 is preferably a plastic polyethylene or polypropylene layer. The back sheet 210 is provided to prevent leakage of any exudate from the internal absorptive layers. Preferable materials for the back sheet include either non-woven hydrophobic plastic polyethylene or polypropylene. Other suitable materials include petroleum-based plastic, or plastic treated materials, or bioplastic materials, such as PLA.

[00073] On the back side of the back sheet is provided a securing means or securing member. For example a hook and loop, adhesive, snap, or the like, which can be secured to the garment.

[00074] The product will advantageously use inexpensive materials that are highly compatible with the human body. The materials must minimize or eliminate injury to the body, include materials that do not cause allergenic responses in the majority of users.

[00075] In a disposable material, the dressings will come pre-formed, with the skeletal layer providing the necessary shape.

[00076] Alternatively, the dressing 100 may be secured to a pre-formed garment (non- disposable feature) that can be reused and washed for sanitary purposes.

[00077] Advantageously, the dressing 100 is used in a system which comprises a garment as described below.

[00078] Described and depicted in FIGS. 3-9 are several variations of a form fitting garment. These garments are easy to use independently and provide for easy access to the axilla area for easy changing of the dressing for an individual. With the garment worn, most users will be able to change dressings with a single hand.

[00079] By use of the disclosed garments, users will either be able to adhere the dressing to the garment directly via the securing member on the back sheet, or secure the dressing within the garment via mechanisms such as elastic straps. If the dressing adheres directly to the fabric of the bandaging garment, this prevents the need to have the dressing adhere directly to skin. This is important because daily users will avoid unnecessary skin trauma and irritation from adhesives. The structure of the garment supports the pad in place in the axilla.

[00080] The garment is designed to conform to the body using compression material to be sleek and form fitting.

[00081] FIGs. 3A-3D depict a shrug (Bolero) style garment 300 accommodating a dressing according to one implementation of the disclosure. The garment 300 includes a torso portion 302 and sleeves 304.

[00082] FIG. 3A shows a rear view of a person wearing the shrug 300. FIG. 3B shows a left side view of a person wearing the shrug 300. FIG. 3C shows a front view wearing the shrug 300. FIG. 3D shows a front view of a person wearing the shrug 300, illustrating a patient opening up the shrug to show the dressing 100 positioned in the axilla. The dotted lines outline the location of the dressing 100 underneath the garment 300.

[00083] FIGs. 3A-3D show a shrug garment 300, a cropped cardigan like garment with short sleeves 304. The two sleeves 304 are connected to each other in the back through the torso portion 302, but not in the front. The garment 300 is made of a compression type material, spandex or neoprene, and has inserts to change the dressing 100.

[00084] FIGs. 4A-4D depict a holster style garment 400 accommodating a dressing 100 according to one implementation of the disclosure. The garment 400 includes shoulder straps 402, back cross 404, and anchoring point 406. [00085] FIG. 4A depicts a back view of a person wearing the holster 400. The holster 400 is an article of clothing with a cross-shaped back 404 behind the shoulder blades to allow ease of movement in sports. The shoulder straps 402 wrap around the shoulders to further secure the garment 400. The holster 400 provides an anchoring point 406 that helps to hold the dressing 100 in place and equalize the pressure on the back. FIG. 4B shows a left side view of a person wearing the holster 400. FIG. 4C shows a front view of person wearing the holster 400. FIG. 4D shows a front view of a person wearing the holster 400, illustrating a patient opening up the shirt to show the dressing 100 positioned in the axilla. The dotted lines outline the location of the dressing underneath the holster.

[00086] One embodiment of the garment 400 can use a 4-way stretch neoprene material, and cut it in the front to insert a ladder lock adjuster. It is attached in the back via a racerback style to allow for movement and increased reinforcement. In this method, the dressing 100 would have some adhesive on the bottom that keeps it in place with the neoprene holster. The seams of the garment 400 can be finished along the edges.

[00087] FIGs. 5A-5D depict a t-shirt style garment 500 accommodating a dressing according to one implementation of the disclosure. The garment 500 includes a torso portion 502, sleeves 504, and connection means 506 (e.g., zippers, buttons, etc.).

[00088] FIG. 5A shows a back view of a person wearing the t-shirt 500. FIG. 5B shows a left-side view of a person wearing the t-shirt 500. FIG. 5C shows a front view of a person wearing the t-shirt 500. FIG. 5D shows a front view of a person wearing the t-shirt 500, illustrating a patient opening up the shirt 500 to show the dressing positioned in the axilla. The dotted lines outline the location of the dressing 100 underneath the garment 500. This is the shirt that opens in the front with a connection means 506 (e.g., zippers, buttons, etc.) to allow easy access to the dressing 100.

[00089] The garment 500 can be made of either cotton or a compression material. [00090] FIGs. 6A-6D depict the compression undershirt 600 accommodating a dressing according to one implementation of the disclosure. The compression undershirt 600 includes a torso portion 602 and sleeves 604.

[00091] FIG. 6A shows a back view of a person wearing the compression undershirt 600. FIG. 6B shows a left-side view of a person wearing the compression undershirt 600. FIG. 6C shows a front view of a person wearing the compression undershirt 600. FIG. 6D shows a front view of a person wearing the compression undershirt 600, illustrating a patient pulling up the shirt to show the dressing 100 positioned in the axilla. The dotted lines outline the location of the dressing underneath the garment 600.

[00092] FIGs. 7A-7D depict the cropped compression undershirt 700 accommodating a dressing according to one implementation of the disclosure. The compression undershirt 700 includes a torso portion 702 and sleeves 704.

[00093] FIG. 7A shows a back view of a person wearing the cropped compression undershirt 700. FIG. 7B shows a left-side view of a person wearing the cropped compression undershirt 700. FIG. 7C shows a front view of a person wearing the cropped compression undershirt 700. FIG. 7D shows a front view of a person wearing the cropped compression undershirt 700, illustrating a patient pulling up the shirt 700 to show the dressing 100 positioned in the axilla. The dotted lines outline the location of the dressing underneath the shirt 700.

[00094] FIGs. 8A-8D depict a compression vest 800 accommodating a dressing 100 according to one implementation of the disclosure. The compression vest 800 includes a torso portion 802 and sleeves 804.

[00095] FIG. 8A shows a back view of a person wearing the cropped compression vest 800. FIG. 8B shows a left-side view of a person wearing the compression vest 800. FIG. 8C shows a front view of a person wearing the compression vest 800. FIG. 8D shows a front view of a person wearing the compression vest 800, illustrating a patient opening up the shirt 800 to show the dressing 100 positioned in the axilla. The dotted lines outline the location of the dressing underneath the bandage. FIG. 8A shows a central panel of fabric on the back made of a separate, stronger knit fabric. The rest of the vest is made of 4-way stretch material, and opens in the front, allowing for easy access to change dressings when needed.

[00096] FIGs. 9A-9D depict the cropped compression vest 900 accommodating a dressing 100 according to one implementation of the disclosure. The vest 900 includes a torso portion 902 and anchor points 910.

[00097] FIG. 9A shows a back view of a person wearing the cropped compression vest 900. FIG. 9B shows a left-side view of a person wearing the cropped compression vest 900. FIG. 9C shows a front view of a person wearing the cropped compression vest 900. FIG. 9D shows a front view of a person wearing the cropped compression vest 900, illustrating a patient opening up the vest 900 to show the dressing 100 positioned in the axilla. FIG. 9A shows a central panel of fabric on the back made of a separate, stronger knit fabric. The rest of the vest is made of 4-way stretch material, and opens in the front, allowing for easy access to change dressing when needed.

[00098] In one embodiment, both vests 800 and 900 are made of 4-way stretch material 812, 912 and open from the front. At the middle of the back and front of the vest are reinforced sections to improve the fit and strength of the vest.

[00099] In another embodiment, the front of the dressing 100 is attached to the back with a 2-way stretch neoprene band that could be adjustable with ladder locks.

[000100] Garment materials

[000101] Materials used for the garments may include double knit polyester, 4 way stretch neoprene, 4 way stretch, power knit neoprene, 2 way stretch neoprene, or cotton spandex. [000102] Cleaning

[000103] The garment can be reusable. All of these fabric choices are machine washable and can be re-worn.

[000104] Other conditions besides Hidradenitis Suppurativa (HS) that require axillary wound care are hyperhidrosis, folliculitis, and surgical wounds from mastectomies and lymphadenectomies. These conditions may benefit from using of the dressing 100 disclosed herein.

[000105] Hyperhidrosis

[000106] Hyperhidrosis refers to excessive sweating. People with hyperhidrosis sweat even when it is not necessary to cool down the body. Most often, people with this disease sweat from the palms, feet, axilla, or head. When sweating from the axilla, it often soaks through clothing, leaving a residue and can be very embarrassing.

[000107] Folliculitis

[000108] Folliculitis is a common skin condition in which hair follicles become inflamed. It's usually caused by a bacterial or fungal infection. At first it may look like small red bumps or white-headed pimples around hair follicles— the tiny pockets from which each hair grows. The infection can spread and turn into non-healing, crusty sores. Folliculitis can also occur from extended contact with adhesive tape and bandages.

[000109] If these sores become open, proper wound care with topical antibiotics and a dry bandage will become necessary.

[000110] Benign Familial Pemphigus (Hailey-Hailey Disease)

[000111] Rare, inherited skin condition that appears as blisters or erosions in intertriginous areas. Affected areas become itchy and uncomfortable if the skin keeps rubbing, and in rare cases, can impair a patient's ability to work. These blisters and red areas are most commonly on the sides of the neck, in the axilla, groin, or inframammary folds. Sunlight, heat, sweat, and friction all aggravate this disorder. [000112] Hailey-Hailey affects men and women equally, and is approximately prevalent in 1 in 50,000 people. It usually affects patients after puberty, and is a chronic condition; however, patients generally see that their condition improves as they get older.

[000113] Cold compresses, dressings, and mild corticosteroid creams for improving mild symptoms of Hailey-Hailey, while more serious cases would require stronger corticosteroids or antibiotics. The most studied and effective treatments include botulinum toxin, CO2 ablation surgery, and dermabrasion.

[000114] HS not only affects the axilla, but also frequently the groin area. A pad of similar composition, consisting of the previously described 5 layers, can be used to manage wounds surrounding the groin. Similar processes of using 3d scanning or direct molding can be used to generate the unique shape to fit this area.

[000115] Inframammary Fold

[000116] Another common area for HS to present in women is the inframammary fold (under the breasts). A dressing f similar composition, consisting of the previously described 5 layers, can be used to manage wounds in the inframammary fold. Similar processes of using 3d scanning or direct molding can be used to generate the unique shape to fit this area.

[000117] Accordingly, the dressing described herein, comprising a plurality of layers for support and collection of bodily fluids due to certain skin and inflammatory diseases. While the axilla is a primary target for support, additional areas, including the groin and inframammary fold both suffer from similar issues. The inframammary fold may be targeted by use of the garments as described herein, wherein a contoured bandage layer can be attached to the garment for protection of these areas. By contrast, the groin area may be advantageously targeted with a particularly shaped bandage, and then adhered to ordinary undergarments.

Claims

What is claimed is:

1 . A dressing, comprisng:

a front wing, the front wing being configured to anchor at a front side of a shoulder joint;

a back wing, the back wing being configured to anchor at a back side of a shoulder joint;

a proximal wing, the proximal wing being configured to receive a torso portion;

a distal wing, the distal wing being configured to receive a limb portion, wherein the front wing, the backwing, the proximal wing, and the distal wing form a continuous countour that is a substantially hyperbolic paraboloid shape.

2. The dressing according to claim 1 , further comprising a flexible skeleton layer, wherein the flexible skeleton layer maintains the substantially hyperbolic paraboloid shape, the flexible skeleton layer deforms under external pressure, the flexbile skeleton layer reforms the substantially hyperbolic paraboloid shape when the external pressure disappears.

3. The dressing according to claim 2, further comprising an absoption layer disposed on top of the flexible skeleton layer, wherein the absorption layer includes a superabsorbent polymers and/or cellulose-based fluff pulp.

4. The dressing according to claim 3, further comprising a top sheet disposed above the absoption layer, wherein the top sheet is a non-woven fabric.

5. The dressing according to claim 4, further comprising a bottom sheet disposed under the flexible skeleton layer, wherein the bottom sheet is liquid impermeable, the bottom sheet covers an entire bottom surface of the dressing.

6. The dressing according to claim 5, further comprising an acquisition distribution layer (ADL), wherein the ADL is made with non-woven apertured polymeric films.

7. The dressing according to claim 5, wherein the top sheet, the flexible skeleton layer, the absorption layer, and/or the ADL are in contact with at least one deodorant.

8. A bandaging system, comprising:

a garment, the garment including a torso portion;

a dressing, the dressing being configured to be in contact with the torso portion of the garment at least partially, the dressing further including

a proximal wing, the proximal wing being configured to receive a torso portion; and

a distal wing, the distal wing being configured to receive a limb portion,

wherein the front wing, the backwing, the proximal wing, and the distal wing form a continuous countour that is a substantially hyperbolic paraboloid shape.

9. The bandage system according to claim 8, wherein the dressing further comprises:

a flexible skeleton layer, wherein the flexible skeleton layer maintains the substantially hyperbolic paraboloid shape, the flexible skeleton layer deforms under external pressure, the flexbile skeleton layer reforms the substantially hyperbolic paraboloid shape when the external pressure disappears.

10. The bandage system according to claim 9, wherein the dressing further comprises:

an absoption layer disposed on top of the flexible skeleton layer, wherein the absorption layer includes a superabsorbent polymers and/or cellulose-based fluff pulp.

1 1 . The bandage system according to claim 10, wherein the dressing further comprises:

a top sheet disposed above the absoption layer, wherein the top sheet is a non-woven fabric.

12. The bandage system according to claim 1 1 , wherein the dressing further comprises:

a bottom sheet disposed under the flexible skeleton layer, wherein the bottom sheet is liquid impermeable, the bottom sheet covers an entire bottom surface of the dressing.

13. The bandage system according to claim 12, wherein the dressing further comprises: an acquisition distribution layer (ADL), wherein the ADL is made with non- woven apertured polymeric films

The bandage system according to claim 12,

wherein the top sheet, the flexible skeleton layer, the absorption and/or the ADL are in contact with at least one deodorant.

15. A method of forming a dressing, comprising:

scanning a contour of one of the following body portion: axilla, groin, or inframammary fold under breasts;

producing a dressing to fit the contour scanned, the dressing includes a front wing;

a back wing;

a proximal wing, the proximal wing being configured to receive a torso portion;

a distal wing, the distal wing being configured to receive a limb portion or another torso portion,

wherein the front wing, the backwing, the proximal wing, and the distal wing form a continuous countour that is a substantially hyperbolic paraboloid shape that fits the contour scanned.

16. The method according to claim 15, wherein the dressing further comprises:

The method according to claim 16, wherein the dressing further comprises: an absoption layer disposed on top of the flexible skeleton layer, wherein the absorption layer includes a superabsorbent polymers and/or cellulose-based fluff pulp.

The method according to claim 16, wherein the dressing further comprises: a top sheet disposed above the absoption layer, wherein the top sheet is a non-woven fabric.

The method according to claim 18, wherein the dressing further comprises: a bottom sheet disposed under the flexible skeleton layer, wherein the bottom sheet is liquid impermeable, the bottom sheet covers an entire bottom surface of the dressing.

The method according to claim 19, wherein the dressing further comprises: an acquisition distribution layer (ADL), wherein the ADL is made with non- woven apertured polymeric films.

A bandaging system for a patient, comprising

a dressing, the dressing being shaped to loosely seal an axilla of the patient, and

a garment configured to cover a portion of a shoulder of the patient, the garment having an anchor point configured to cover a torso portion proximal to the axilla, the anchor point having an elasticity to press against the torso portion proximal the axilla, wherein the anchor point is configured to receive at least a portion of the dressing between a layer of the garment and a surface of the torso such that provide contact between the dressing and the torso.

22. The bandaging system according to claim 21 , wherein

the garment is a shrug style garment and wherein the torso portion is configured to receive a neck portion of the patient, the shrug style garment having two arm sleeves, the torso portion having a continuous back surface configured to cover a back portion of the torso, the torso portion has an open front surface.

23. The bandaging system according to claim 21 , wherein

the garment is a holster style garment and wherein the torso portion is configured to receive a neck portion of the patient, the torso portion comprising a four-strip cross-shape back surface configured to cover a back portion of the patient, the torso portion having an open front surface.

24. The bandaging system according to claim 21 , wherein

the garment is a T-shirt style garment, and wherein the torso portion is configured to receive a neck portion of the patient, the T-shirt sytle garment having two arm sleeves, the torso portion having a continuous back surface configured to cover a back portion of the patient, the torso portion having an open front surface with a resealable fastener to close the open front surface.

25. The bandaging system according to claim 21 , wherein the garment is comprised of a material having compression properties.