TITLE: COMPOUND (MULTI-LAYER) WATERPROOF BANDAGE OR DRESSING COVER

CROSS-REFERENCE TO RELATED APPLICATION:

This application claims the benefit of provisional patent application Ser. Nr. 62/988,805, filed 2020 Mar 12 by the present inventors, which is incorporated by reference in its entirety.

FIELD OF INVENTION

The present invention pertains to medical bandages, in particular to waterproof bandages or dressings to protect wounds, sensitive sites or medical dressings.

BACKGROUND

Keeping cuts, scrapes, stitches, small burns, dressings over peripheral and other catheter insertion sites, cardiac ports, casts, and other wounds or sensitive sites dry and/or clean facilitates healing and prevents infection. Keeping sterile dressings in good condition between dressing changes and protecting attached medical devices or transdermal drug delivery patches, for example, facilitates successful treatment and reduces costs and disruptions to care. However, it is difficult to keep such sites dry and clean during ordinary life activities and especially when showering or bathing.

In order to protect such sites, conventional waterproof bandages and coverings to protect dressings for bathing are designed to create a full adhesive seal to skin or other surfaces around the protected site using waterproof materials, which keep water and other contaminants from the site and keep the site dry and clean. Pressure is an alternative method of creating a seal to exclude water, for example, a tight opening to a waterproof cover to protect casts.

Commercially available bandages and shower protection systems leak despite being marketed as “water resistant” or “waterproof’. We have noticed that waterproof bandages’ ability to keep out water is dependent on the integrity of the adhesive or pressure seal to the skin which is difficult to make perfect

We have further noticed that almost any small flaw in a bandage seal to the skin can result in a significant leak during bathing or showering because of capillary action. Additionally, we have observed that sweat forming under protective waterproof coverings that may be used to protect wounds or medical dressings during daily activities or bathing, can affect the wound or dressing underneath similarly to water intrusion from leaks. We have also observed that surfactants used in bathing reduce surface tension of water, allowing it to more readily wick into small flaws in adhesive seals. Online-published consumer testing of waterproof bandages missed the need for real-world testing conditions with surfactants and thus missing a major contributor to leaks.

Leaks resulting from bandage seal flaws compromise the hygiene of wounds or sensitive sites, and put patients at risk of infection. Water leaks and sweat further compromise the integrity of said seals. This is especially a concern when protecting medical dressings or other devices that are used over extended periods, such as peripheral catheter insertion site dressings, where exposure of sterile dressings to water from bathing may result in peeling, and require premature change by a nurse to avoid risking site infection or damage to the line. Waterproof dressings on the market have relied on increasing adhesive strength or bandage pressure to create a kind of "perfect” seal. From our observation, in the presence of even tiny imperfections, leaks are almost inevitable, and a reliably perfect seal to skin or other surfaces is very difficult to achieve. Many commercial bandages leak, as the presence of rough skin texture, skin oils, sweat, hair, surfactant residue from washing, flawed application by the user, and other irregularities make complete seals difficult to achieve. Although products have been made to increase bandage adhesive strength and/or add pressure to reduce leaking, these strategies don’t eliminate leaking and can be uncomfortable to the wearer, difficult to remove, and have the potential to damage the sensitives sites they are intended to protect.

This problem was partially solved in narrow applications by the implementation of very large-area adhesive waterproof bandages made of thin materials that cause some flaws to collapse, but these had and still have significant problems, fox example they axe difficult to apply, expensive, and must adhere tightly to a large area. They are often used as longer- duration sterile medical dressings and thus in need of protection themselves during showering and many life activities to maintain their integrity.

Current shower protectors operate on the same principle of excluding water with a waterproof cover. Sweat underneath can undermine the adhesive seal of the dressings to be protected, especially at the edges, and any tiny flaw in the shower protector can result in leakage that compromises the integrity of the dressing underneath or even absorbs into the wound or sensitive site.

Therefore, a need exists in the field for a waterproof bandage capable of reliably keeping a sensitive site dry and/or clean during activities of daily life, bathing, showering or other exposure to wetness, despite the presence of flaws in the bandage seal. A further need exists for a bandage design that does not rely purely on pressure or adhesive strength to keep sites dry and/or clean, one that is capable of keeping such sites dry and/or undamaged even if the bandage seal is flawed or interrupted.

Our invention keeps sensitive sites dry without relying on perfect seals to the skin, thus representing an improvement to the state of the art. DETAILED DESCRIPTION

The following disclosures provide descriptions and illustrations of several possible embodiments but should not be construed as limiting the scope of the embodiments. The scope of the embodiments should be determined from the appended claims.

Terminology used to describe the various aspects and embodiments disclosed below should be interpreted to have the same meaning as would be apparent to someone with a basic understanding of the present field. Interpretation of said terminology should be consistent with the context of the following embodiments and disclosures unless explicitly defined otherwise.

The term “waterproof bandage” as used herein refers to multiple embodiments wherein said bandage may be utilized in different capacities, including as a waterproof bandage, a waterproof or water-resistant cover to protect other dressings or bandages, a waterproof cast cover, a bandage or cover to protect against dirt, microbes, or liquids other than water, and additional capacities.

Brief Summary

One embodiment consists of layers that provide protection from water intrusion: an inner bandage consisting of an absorbent material covered by a larger waterproof adhesive material, similar to a typical bandage for covering a wound, and an outer bandage, also consisting of an absorbent layer that overlaps and is bonded to the outer layer of the inner bandage in a manner that it absorbs water away from all edges of the inner bandage and is covered by a larger waterproof adhesive material that adheres to the skin.

The outer bandage provides protection from water intrusion via the waterproof covering and its adhesive seal to the skin, but more importantly, the absorbent material under the outer layer is designed and positioned so as to prevent leakage from infiltrating or affecting the inner waterproof covering even if the inner bandage and outer bandage seals to the skin are not perfect, and leakage into the outer bandage occurs. Even if said outer waterproof layer fails, the outer absorbent layer, if properly constructed, sized and positioned, prevents intrusion into the inner bandage and the protected site, and protects the integrity of the inner bandage seal, even if the outer absorbent layer becomes saturated and even if the inner bandage seal contains flaws.

Description of the Drawings - Figures

Some embodiments of the present invention are illustrated as an example and are not limited by the figures of the accompanying drawings:

FIG. 1 depicts an exploded view of the first embodiment of the waterproof bandage.

FIG. 2 depicts a section cut through the first embodiment

FIG. 3 A depicts a second embodiment of the waterproof bandage encircling an arm and shows the directions of the section cuts in FIG. 3C and FIG. 3D.

FIG. 3B depicts the second embodiment, wherein the straps securing the bandage have been loosened.

FIG. 3C is a cross-section through the embodiment depicted in FIG. 3 A marked A - A.

FIG. 3D is a cross-section through the embodiment depicted in FIG. 3A marked B - B.

FIG. 4 depicts another embodiment similar to that depicted in FIG. 3 A, wherein the waterproof bandage is of tubular shape with a longitudinal slit, and is wrapped around an appendage.

FIG. 5 depicts another embodiment encircling an arm past the joint with an attached end cap covering the hand.

Drawings - Reference Numbers

1 Inner absorbent layer (layer 1)

2 Inner waterproof layer (layer 2)

3 Outer absorbent layer (layer 3) 4 Outer waterproof layer (layer 4)

5 Bonding layer (layer 5)

6 Skin or other surface the waterproof bandage is adhered to

7 Compression straps to secure tubular bandage components

8 Sealing strip for wrapped bandage

9 End cap or glove

Detailed Description - FIGS. 1 and 2 - First Embodiment

FIG. 1 depicts an exploded view of elements that comprise the first embodiment of the waterproof bandage. Layers 1 and 2 comprise the inner bandage while layers 3 and 4 comprise the outer bandage. Layers 1 and 3 are made of substantially absorbent material, and layers 2 and 4 are made of substantially waterproof flexible material with adhesive on one or both sides. Layer 5, as shown, comprises an adhesive bonding layer used to bond layers 2 and 3 together. Adhesive layer 5 may alternatively comprise a different attachment method or agent.

FIG. 2 depicts a cross section through this embodiment of the waterproof bandage. In this embodiment, the outer bandage, comprised of layers 3 and 4, is placed over the inner bandage, comprised of layers 1 and 2, to protect the inner bandage from water intrusion and/or to protect the inner bandage seal from damage if water does intrude through layer 4. Layer 3 overlaps the edges of layer 2 to ensure that water is absorbed by layer 3, protecting the edges of layer 2 and potential seal flaws it may contain from wicking in leakage. Bonding layer 3 to layer 2 ensures their proper registration and proper functioning. In the present embodiment, adhesive layer 5 adheres the absorbent layer of the outer bandage to the waterproof layer of the inner bandage. In FIG. 2, adhesive layer 5 comprises strips of a nonliquid adhesive substance placed along the edges of layer 2. Adhesive layer 5 may alternatively comprise a different attachment method or agent or may be removed if needed. Adhering waterproof layer 2 to absorbent layer 3 ensures layer 3 remains in contact with layer 2, allowing absorbent layer 3 to absorb water away from the edges of waterproof layer 2. Reference number 6 indicates the surface of the skin of the user, or another surface to which the bandage is adhered. FIG. 3 - Second Embodiment

FIG. 3 A depicts an assembled view of this embodiment attached to an appendage. In this embodiment, layers 1-5 are substantially tubular in shape when applied, and can be slid onto the appendage similarly to a sleeve as depicted in FIG. 3A and FIG- 3B. The section marked A-A is a perpendicular cross section of the waterproof bandage depicted in FIG. 3C, and the section marked B-B is a parallel cross section of the waterproof bandage depicted in FIG.

3D. Compression straps 7 may be made of an adhesive or non-adhesive material and securing mechanism to hold the components in their proper locations. Compression straps at the ends of outer waterproof layer 4 seal the ends from water intrusion. The straps under the outer waterproof layer 4 hold outer absorbent layer 3 in proper relative position relative to inner waterproof layer 2. This configuration of compression straps 7 is used as an example only, as there are other possible configurations. This embodiment can be configured to attach to any appendage or extremity including, but not limited to, arms, legs, fingers, or toes above, below, or across a joint. In this embodiment, layers 1-4 may be made of substantially reusable and washable materials, and/or substantially disposable materials.

FIG- 3B depicts the embodiments presented in FIG. 3 A, but with the external compression straps 7 released.

FIG. 3C depicts a perpendicular cross section view A-A in FIG. 3A Inner bandage layers 1 and 2 are stacked beneath the outer bandage layers 3 and 4. Layers 2 and 3 may be bonded together using an adhesive similar to layer 5 in FIG. 1, by some adhesive or non-adhesive bonding method, or be unbonded. Additionally, layers 1 and/or 2 may also be separated or applied separately from layers 3 and 4, for example, as in the case of an existing bandage being protected by layers 3 and 4.

FIG- 3D depicts a parallel cross section view B-B in FIG. 3 A. As in FIG. 3C, the inner bandage layers 1 and 2 are stacked beneath outer bandage layers 3 and 4. In this depiction, layer 5 is not shown in this view, but layer 3 may still be bonded to layer 2 in order to ensure that layer 3 overlaps the edges of layer 2 at both ends of layer 2 or is otherwise properly registered. Compression pads 7 underneath outer waterproof layer 4 can be used to position waterproof layer 3 in proper proximity and alignment relative to inner waterproof layer 2.

FIG. 4-5 - Additional Embodiments:

FIG. 4 depicts an alternate embodiment similar to the second embodiment depicted in FIG.

3 A, with the addition of a longitudinal slit in outer waterproof layer 4 to allow an alternate method of applying layer 4. Sealing strip 8 is used to seal the slit in waterproof layer 4 when the bandage is applied. There may be more than one sealing strip present in similar embodiments where more than one layer contains a longitudinal slit.

FIG. 5 depicts an assembled view of an additional embodiment of the waterproof bandage. In this embodiment, the bandage is sized to cover an entire appendage including the joint. Additionally, end cap 9 has been placed over the end of the appendage. The cap may be an integral part of the waterproof bandage, or be attached after the bandage is applied. In this embodiment, end cap 9 may consist of a single waterproof layer, multiple waterproof layers, be fully integrated into the waterproof bandage and comprised of the same materials, or be removed entirely. In this embodiment, the bandage may include an adhesive or non-adhesive method to secure layers 1 -4 to the appendage or surface. In this embodiment, the bandage may also be made of substantially reusable materials, and/or substantially disposable materials.

Testing:

Prototypes of the first embodiment depicted in FIG. 1 and FIG. 2 were subjected to testing during development by the second inventor on various appendages and body parts (arms, legs, trunk, and back) under shower conditions with soap and warm water for showers and a bath, each of approximately 15 minutes in length. Shower and bath testing was approved by an Institutional Review Board as exempt research; no disclosures were made to the Board.

In some tests, flaws were induced in the adhesive seals of the prototypes in both the inner bandage and outer bandage waterproof layers, breaching the full width from the outer edge of the adhesive layer to the absorbent layer. These were then tested both as full prototypes of the fust embodiment and separately as individual components. After each test, each prototype or component was examined for evidence of water intrusion into all absorbent layers.

Although in full prototypes, flaws induced in outer bandage seals allowed water to enter “outer bandages”, this water was absorbed by layer 3 and was prevented from entering into “inner bandages” (which also had induced flaws). This method of absorbing water away from the edges of layer 2 prevented water intrusion into sites protected by “inner bandages” and prevented water-induced damage to seals of said “inner bandages”. Prototypes were found to have a 0% rate of water intrusion into protected sites even with induced flaws in both inner bandage and outer bandage waterproof layers, and even when, as in many of the tests, the absorbent layer of the outer bandage became very wet or saturated during testing.

When inner bandage and outer bandage components were tested separately rather than combined in a full prototype, the leakage rate was between 10% and 45% with no induced flaws in the adhesive seals. When flaws were induced in adhesive seals, leakage rates of separately tested inner bandage and outer bandage components increased to as high as 80%. The outer absorbent layer provided by absorbent layer 3, properly registered in reference to and properly bonded to layer 2, was demonstrated to be the feature that resulted in completely eliminating leakage to the protected sites.

Prototypes of first embodiment achieved 100% efficacy in preventing water intrusion into protected sites, even when outer waterproof layers failed and when both “inner bandages” and “outer bandages” had induced seal flaws. The outer absorbent layer reliably kept sweat and external water intrusion from the inner bandage pad even when saturated.

Advantages:

Accordingly, from the above description and testing results, one or more aspects of the embodiments provide advantages, including, but not limited to the following:

- Reliably protects a site or dressing during showering or bathing even if the adhesive to skin or other seal leaks. - The design provides a novel mechanism by which leakage is prevented from reaching protected sites.

- Protects edges and integrity of dressing or inner bandage layer even in the presence of water intrusion.

- High-strength adhesives not required for perfect seals since the design is insensitive to seal leaks, which eases removal of the bandage

- Design is compatible with other overall configurations to provide protection for different applications or circumstances, such as use as a waterproof bandage, waterproof cast cover, or waterproof site dressing cover, among other uses.

- Can be made in different shapes to achieve a configuration best suited for a target application

- Outer bandage can be separately removable and/or be reusable to increase the life of the inner bandage

- Reusable layers are possible to reduce waste.

- Can be constructed from easily obtainable materials at relatively low cost

- Less sensitive to user error in application, while providing more reliable protection as compared to existing art