WO2020072765A1

WO2020072765A1 - Adhesive tape system and method

Info

Publication number: WO2020072765A1
Application number: PCT/US2019/054485
Authority: WO
Inventors: Bart PATENAUDE
Original assignee: Creative Technology Concepts, Llc
Priority date: 2018-10-03
Filing date: 2019-10-03
Publication date: 2020-04-09

Abstract

A method and system for atraumatic securement of medical devices, and/or atraumatic wound care. Preferably, the system uses thin film adhesive substrates comprising at least three coextensive layers and an adhesive layer. The thin film substrate is resilient, but remains flexible for accurate and smooth application for use as a base substrate and releasable substrate for securement of medical dressings and devices.

Description

ADHESIVE TAPE SYSTEM AND METHOD

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the priority benefit of U.S. Provisional Patent Application Serial No. 62/740,608, filed October 3, 2018, entitled ADHESIVE TAPE SYSTEM AND METHOD, incorporated by reference in its entirety herein.

BACKGROUND OF THE INVENTION

Field of the Invention

The present invention relates to an adhesive tape system and method for atraumatic medical care.

Description of Related Art

Medical adhesive-related skin injury (MARSI) occurs when tape causes stripping, separation, or tearing of the epidermal layers. Erythema can also occur medical tape is removed from the skin. These injuries generally occur when the tape adhesive is stronger than the skin layers, causing removal of superficial dermal layers or skin layers to separate. These injuries can occur regardless of the type of tape (paper, cloth, foam, or other material) or adhesive used (acrylate or silicone adhesives). These injuries are more common in at-risk patients. Such at-risk patient populations include elderly patients, neonates, and other patients with fragile skin. At-risk patients also include those requiring a long-term use of adhesive tape, or wounds requiring constant monitoring or dressing change, which over time can weaken and damage the skin through repeated application and removal of the tape. Lower adhesive tapes are generally recommended for use with these kinds of patients; however, in many cases, a stronger adhesive tape is nonetheless required to adequately secure the medical device, wound dressing, etc. to the patient. In other words, the risk of inadvertent removal of the device or dressing outweighs the risk of patient skin damage. Nevertheless, MARSI wounds still present a high risk of causing secondary complications for such patients. Thus, there remains a need in the art for improved approaches for securing medical devices and general wound care that reduces the risk of MARSI.

SUMMARY OF THE INVENTION

The present invention is broadly concerned with methods and system for atraumatic securement of medical devices, and/or atraumatic wound care. The methods generally comprise atraumatically securing a base thin film substrate directly to a subject’s tissue, wherein the base substrate is durably adhered to the subject’s tissue. Next, a releasable thin film substrate is removably affixed to the base substrate, wherein said releasable substrate is releasably adhered on top of the base thin film substrate, so that release and re-engagement of the releasable thin film substrate and the base substrate can be repeated as needed for care of the subject, without unduly disturbing the subject’s underlying tissue (e.g., without tearing or abrading the tissue). In one or more embodiments, the releasable thin film substrate is further optionally secured to one or more of a medical device or wound dressing applied to the subject.

Embodiments described herein also concern systems for atraumatic securement of medical devices, and/or atraumatic wound care. The systems generally comprise a base thin film atraumatically secured directly to a subject’s tissue, wherein the base substrate is durably adhered to the subject’s tissue. The systems further comprise a releasable thin film substrate removably affixed to the base substrate, wherein said releasable substrate is releasably adhered on top of the base thin film substrate, so that release and re-engagement of the releasable thin film substrate and the base substrate can be repeated as needed for care of the subject, without unduly disturbing the subject’s underlying tissue. In one or more embodiments, the system further comprises one or more medical devices and/or wound dressings applied to the subject, which are secured to the subject by the releasable thin film substrate.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure (Fig.) 1 is a perspective view of a multi-layer substrate 10 or 10’ in accordance with embodiments of the invention;

Fig. 2 is an exploded view of the multi-layer substrate in Fig. 1 showing the individual layers;

Fig. 3 is an enlarged cross-sectional view of the multi-layer substrate in Fig. 1 showing the layers;

Fig. 4A is a perspective view of a multi-layer substrate 10 or 10’ in accordance with embodiments of the invention;

Fig. 4B is an exploded view of the multi-layer substrate in Fig. 4A showing the individual layers;

Fig. 5 illustrates use of the system for packing a wound and atraumatically securing the wound dressing to a subject’s arm;

Fig. 6 is an illustration of a cross-section of a wound when the system is used to pack a wound and atraumatically secure a wound dressing over the wound, further illustrating removal of the releasable substrate via peeling an edge;

Fig. 7 illustrates use of the system for atraumatically securing an IV line (44) to a patient’s skin, where the releasable substrate is secure over the IV line;

Fig. 8 illustrates use of the system for atraumatically securing an IV line (44) to a patient’s skin, where the releasable substrate is use as an anchor for atraumatically secured suture lines to hold the IV in place;

Fig. 9 illustrates use of the system for atraumatically securing an endotracheal tube (44) to a patient’s skin, where the releasable substrate is use as an anchor for atraumatically secured suture lines to hold the tube in place;

Fig. 10A illustrates use of the system for atraumatically securing a wound packing and dressing to a subject’s skin;

Fig. 10B illustrates use of the system for atraumatically securing a wound packing and dressing to a subject’s skin, including peeling an edge of the releasable substrate;

Fig. 10C illustrates use of the system for atraumatically securing a wound packing and dressing to a subject’s skin, including removal of the releasable substrate on one side of the wound to inspect, remove and/or clean the wound or packing;

Fig. 11 A illustrates use of the system for atraumatically securing a tube to a subject’s skin;

Fig. 11B illustrates use of the system for atraumatically securing a tube to a subject’s skin, including peeling an edge of the releasable substrate on one side of the tube;

Fig. 11C illustrates use of the system for atraumatically securing a tube to a subject’s skin, including removal of the releasable substrate and tube to inspect, remove and/or clean the tube; and

Fig. 11D illustrates a cross-section view of a releasable substrate on top of a base substrate.

DESCRIPTION OF THE INVENTION

The present invention is concerned with new systems and methods involving multi-layered adhesive substrates for atraumatic securement of medical devices, and/or general atraumatic wound care. The term“atraumatic” is used herein to denote that the wound care system and method involves no penetration or piercing of the subject’s tissue, for example with a needle, staples, etc. and further minimizes and preferably avoids medical adhesive-related skin injury (MARSI), which occurs when medical tape removal causes stripping, separation, erythema, and even tearing of the epidermal layers. The method generally comprises providing an underlayment or base substrate layer that is first secured to the subject’s skin (42). This underlayment or base substrate layer is“durably adhered” to the subject’s skin, meaning that it remains stably secured for at least a period of several days without needing to be removed. In one or more embodiments, the base substrate remains durably adhered and retains from about 80% to about 100% of its initial adhesion strength for up to 14 days, preferably up to about 7 days. In one or more embodiments, the base substrate remains durably adhered and retains from about 80% to about 100% of its initial adhesion strength for at least 3 days, and preferably from about 3 to about 7 days. As such, the base substrate provides a semi-permanent underlayment to which a medical tape or other secondary adhesive substrate can be removably affixed, rather than adhering directly to the tissue of the subject.

In one or more embodiments, the approach includes a dual thin film system comprising a first or base thin film substrate secured directly to the subject’s tissue and a second releasable thin film substrate that is releasably adhered on top of the base thin film substrate, so that release and re-engagement of the releasable thin film substrate and the base substrate can be repeated as needed for care of the subj ect, without unduly disturbing the subj ecf s underlying tissue. Advantageously, in the dual thin film system, the releasable thin film substrate adheres strongly to the base substrate, such that it resists substantial separation from the base substrate when subjected to a force applied in a direction away from the skin (e.g., generally upwardly, vertical or approx perpendicular to the skin). In this manner, it can stably secure medical devices (e.g., tubes, etc.) and dressings to the subject. However, the releasable thin film substrate can be disengaged without applying undue force to the subject’s skin by progressively peeling the releasable thin film away from the base substrate incrementally through application of a force that this substantially parallel to the skin surface while pulling the releasable thin film substrate back over itself. Pulling forces can be further minimized by supporting the base substrate (and underlying skin) at the peel line, and keeping the releasable thin film substrate substantially horizontal (i.e., parallel) and close to the skin surface during this peeling motion. Advantageously, during removal of the releasable thin film substrate, the pulling force is distributed over the surface area of the base substrate, and prevents any localized excess pulling force from being translated to the underlying skin. Thus, this system and method minimizes and preferably avoids any trauma and/or any wear and tear to the skin through repeated release and re-attachment during care of the subject.

In preferred embodiments, the thin film adhesive substrates for use as either the base substrate and/or releasable substrate are of the various types described in detail in U.S. Patent No. 9,492,171, issued November 15, 2016, as well as those described in WO 2018/136653, published July 26, 2018, each of which is incorporated by reference herein. In particularly preferred embodiments, both the base substrate and the releasable substrate are the same general type of substrate, as the dual thin film system described herein is particularly advantageous; however, it will be appreciated that the inventive thin film substrates may also serve as underlayments for other kinds of medical tapes (e.g., cloth tapes, etc.) without departing from the spirit of the invention.

Preferably, suitable multilayered thin film adhesive substrate for use in the invention comprises a semi-rigid mesh, webbing, or lattice core layer that facilitates easy handling and shaping of the adhesive thin film substrate. The layered construction of the substrate allows much easier handling of these thin films with adhesive. It also allows cutting, resizing, and shaping to any geometry without loss of this ease of handling.

With reference to Fig. 1, the substrate 10 and/or 10’ comprises first 12 and second 14 opposing major surfaces, referred to herein as a front surface 12 and a back surface 14, respectively, and outer edges lOa, lOb (which define the perimeter of the substrate). The average total thickness of the substrate 10 and/or 10’ will generally range from about 1 mil (0.001 inch) to about 10 mil (0.010 inch), preferably from about 1 mil to about 5 mil, and more preferably from about 2 mil to about 5 mil. The thickness of the substrate 10 and/or 10’ preferably has little variation across the expanse of the substrate 10 and/or 10’. In other words, the thickness of the substrate 10 and/or 10’ is preferably substantially uniform as measured from the front surface 12 to the back surface 14 edge-to-edge.

The front surface 12 of the substrate 10 and/or 10’ generally remains exposed to the environment, and is preferably free of any adhesives. The back surface 14 of the substrate 10 and/or 10’ is configured to engage or contact an underlying surface, such as tissue. The substrate 10 and/or 10’ is attached to the underlying surface via an adhesive (aka glue) interposed between the back surface 14 of the substrate 10 and/or 10’ and this underlying surface. In one or more embodiments, the adhesive is provided separately from the substrate 10 and/or 10’. The adhesive is dispensed or applied onto the underlying surface, followed by mounting or attaching the substrate 10 and/or 10’ to the underlying surface with the back surface 14 of the substrate 10 and/or 10’ adjacent (i.e., in face-to-face contact with) the adhesive. In one or more embodiments, the back surface 14 of the substrate 10 and/or 10’ comprises an adhesive pre-mounted to the back surface 14, which can be in the form of a layer adjacent (i.e., in face-to-face contact with) the back surface 14. In one or more embodiments, the adhesive covers substantially the entire surface area of the back surface 14. In other words, the adhesive extends edge-to-edge over both the central region and the peripheral margins of the back surface 14, such that the adhesive layer 15 (see Fig. 2) outer edges are coextensive (in alignment) with the outer edges of the back surface 14.

Suitable adhesives include pressure sensitive adhesives, as well as heat- or radiation- activated adhesives. It will be appreciated that the appropriate adhesive will depend upon the ultimate intended use of the substrate 10 and/or 10’. For example, if the substrate 10 and/or 10’ will be topically applied to skin, the adhesive should have good initial tack and long-term adhesion, and be able to tolerate the presence of moisture without releasing, such that they form a durable adhesive bond with the skin. Pressure-sensitive adhesives generally comprise elastomers that are inherently tacky or include tackifying resins. Exemplary adhesives for use in the invention include rubber elastomers, acrylics, acrylates (e.g., cyanoacrylates), epoxies, silicones, zinc oxides (or other hot melt adhesives), solvent-based adhesives, solvent-free adhesives, photosensitive adhesives, hydrocolloids, hydrogels, polyurethanes, styrene block co-polymers, and the like. In some embodiments, the adhesive is biocompatible. Numerous types of suitable adhesives are known in the art, and are commercially-available from suppliers such as 3M, Loctite (e.g., Duro- Tak), Adhesives Research, Ashland Chemical (e.g., Aroset), Dow (e.g., Robond), Polymer Science (e.g., Sofsil, Neosil), DuPont, and ITW Formex. Particularly preferred adhesives will have strong tissue adhesion properties, and adhesives suitable for use in medical tapes and dressings are preferred in some embodiments of the invention. Low trauma adhesives can also be used, but are particularly preferred for use only with the releasable thin film substrate 10’.

The substrate 10 and/or 10’ is generally a continuous flat/planar and flexible/bendable, but non-elastic (aka inelastic) body. In other words, the substrate 10 and/or 10’ can bend and conform in all directions to underlying surfaces to which the substrate 10 and/or 10’ may be applied, such as for example, conformable topical application to human or animal skin. However, the substrate 10 and/or 10’ is preferably not elastic and does not stretch or extend from a relaxed/resting position to an extended position any appreciable degree. In one or more embodiments, materials used in the substrate 10 and/or 10’ are preferably non-metallic. In other words, preferred embodiments of the substrate 10 and/or 10’ are free of any metals or other rigid materials. The substrate 10 and/or 10’ can be provided in various shapes and sizes, including an elongated sheet, rectangular, circular, triangular, or other shape. For example, the substrate 10 and/or 10’ can have a pair of laterally spaced longitudinal side edges lOa and a pair of laterally spaced transverse ends lOb, defining a substantially rectangular or square shape, as depicted in Fig. 1. In other embodiments, the substrate 10 and/or 10’ can be provided with any other geometric shape, such as having an annular lateral edge defining a substantially circular shape or three lateral edges forming a triangular shape (not shown).

The substrate 10 and/or 10’ can be provided in its useable configuration as one or more sheets or strips, each with a releasable liner (not shown) covering the adhesive (when present) to prevent indiscriminate adherence or sticking of the substrate 10 and/or 10’ to an undesired surface and/or preserve the adhesive properties of the adhesive layer 15 and/or protect the adhesive layer 15 from attracting dirt, debris, and the like until use. In some embodiments, the substrate 10 and/or 10’ can be an elongated strip wound about a spool or dispensing apparatus. In one or more embodiments, the substrate 10 and/or 10’ is provided as a large sheet that can be cut down to the necessary size. For example, dimensions such as 30 cm x 30 cm are envisioned.

As noted above, and illustrated in the exploded view in Fig. 2, the substrate 10 and/or 10’ thin film body is multi-layered (aka multi-ply or laminated) and comprises at least three layers (preferably not including adhesive layers), comprising a first layer 16 (aka bottom layer), a second layer 18 (aka top layer), and an intermediate mesh or webbing layer 20 embedded between the first layer 16 and second layer 18. The layers may be annealed (i.e., subjected to elevated bonding temperature), or not annealed (e.g., bonded through room temperature adhesive). A cross-sectional image of the layers is depicted in Fig. 3. It should be noted that the cross-section layers in Fig. 3 have been enlarged for illustration and clarity, and the respective thicknesses should not be taken as limiting on the invention.

The first layer 16 comprises a first major surface 22 (aka interior major surface 22) and a second major surface 24 (aka exterior major surface 24) and an outer edge(s) 26 defining the perimeter of the layer 16. It will be appreciated that the exterior (second) major surface 24 of the first layer 16 corresponds to the back surface 14 of the substrate 10 and/or 10’. The second layer 18 likewise comprises a first major surface 28 (aka exterior major surface 28) and a second major surface 30 (aka interior major surface 30) and an outer edge(s) 32 defining the perimeter of the layer 18. It will be appreciated that the exterior (first) major surface 28 of the second layer 18 corresponds to the top surface 12 of the substrate 10 and/or 10’. In general, the mesh layer 20 is embedded in an intermediate layer of adhesive 34 between the first 16 and second 18 layers.

The mesh layer 20 is likewise in a planar configuration with the mesh or webbing extending between outer edges 36 defining the perimeter of the layer 20. Importantly, the outer edges 26, 32, and 36, of each of the first layer 16, second layer 18, and intermediate mesh layer 20 are coextensive (in alignment). This means that the outer edges of the layers each terminate in alignment with one another, such as along a shared (vertical) plane E that runs perpendicular to the plane lateral of the substrate 10 and/or 10’ as illustrated in Fig. 3. In other words, the first 16 and second 18 layers are laminated with respective interior major surfaces 22, 30 in a face-to-face relationship with the intermediate mesh layer 20, and the intermediate mesh layer 20 extending along the entire (i.e., coextensive with) surface area of each of the interior major surfaces 22, 30. It will be appreciated that the mesh or webbing layer 20 will thus be“embedded” between the first layer 16 and second layer 18, preferably in an intermediate adhesive layer 34, as depicted in Fig. 3. The intermediate adhesive layer 34 can be provided as part of the first layer 16, and applied or pre-formed on the interior major surface 22 of the first layer 16. Alternatively, the intermediate adhesive layer 34 can be provided as part of the second layer 18, and applied or pre-formed primarily on the interior major surface 30 of the second layer 18, as depicted in Fig. 3. Any suitable adhesive material can be used for intermediate adhesive layer 34, including materials described herein. It will be appreciated that since the intermediate adhesive layer 34 remains interior to the film 10, it does not necessarily have to be compatible for skin contact, and a wider variety of suitable (and preferably stronger more permanent) adhesives may be used.

Exemplary materials for the first 16 and/or second 18 layer include suitable thin film materials, such as polyurethane, polyethylene, polypropylene, polyamide, polytetrafluoroethylene, polystyrene, silicones, rubbers, latex, rayon, composites thereof, copolymers thereof, combinations thereof, and the like. The first 16 and/or second 18 layer may itself be a laminated or extruded sheet, or may comprise woven or nonwoven fibers. In some embodiments, the first 16 and/or second 18 layer materials are preferably biocompatible. Preferably, the materials are water resistant, but“breathable” in that they allow moisture to pass through the layer, while excluding dirt, bacteria, viral particles, and the like. Preferably, the materials selected for the first 16 and/or second 18 layers are translucent, transparent, or substantially visually transparent, with a percent visible light transmittance of at least 50%.

Notably, each of the first 16 and/or second 18 layers can be made of the same material, or a different material may be selected for each of the first layer 16 and second layer 18, without departing from the scope of this invention. In some embodiments, the physical configuration of the first layer 16 can be different from the second layer 18. For example, in some embodiments, the first layer 16 is substantially solid, whereas the second layer 18 comprises a plurality (e.g., pattern) of holes, voids, or openings 38 formed through the thickness of the layer 18 across the first 28 and second 30 major surfaces, as depicted in Fig. 4A and Fig. 4B. These apertures 38 in the second layer 18 permit egress of moisture and contribute to the“breathability” of the multi- layered substrate 10 and/or 10’. The pattern and/or density of the openings 38 in the second layer 18 can be adjusted to allow more or less fluid to pass and to make the substrate 10 and/or 10’ more flexible and have more of the properties of a single layer film with adhesive. These apertures 38 also facilitate access to the mesh layer 20 lattice/strands for atraumatic suturing or securement of medical devices with thread, wire, etc. Further, the non-contiguous top surface 28 of the second layer 18 formed by the apertures 38 in combination with the mesh 20, when used for the base substrate 10, facilitate easy release and reattachment of the releasable thin film substrate 10’ by providing a non-uniform or inconsistent top surface 28 onto which the releasable thin film substrate 10’ is adhered (as illustrated in Fig. 11D), such that across the interface between the two substrates 10 and 10’, less strongly adhered portions ( L ) where the top surface 28 of the base substrate 10 contains apertures 38, and more strongly adhered portions (M) where the top surface 28 is solid. In this way, the releasable thin film substrate 10’ is stably secured across the surface area of this interface, except that the less strongly adhered portions (L) separate easier than the more strongly adhered portions (M) such that the releasable thin film substrate 10’ can be incrementally peeled away without undue force. In general, the size of the openings 38 will range from about 1 micron to about 10 mm, or from about 100 microns to about 5 mm, or from about 500 microns to about 5 mm, or from about 1 mm to about 5 mm, depending upon the embodiments.

The material thickness of each of the first 16 and/or second 18 layers is preferably from about 0.5 mil to about 5 mil, preferably from about 0.5 mil to about 2.5 mil, and more preferably from about 0.5 mil to about 2 mil The thickness of each of the first 16 and/or second 18 layers preferably has little variation across the expanse of the substrate 10 and/or 10’. In other words, the thickness of the substrate 10 and/or 10’ is preferably substantially uniform as measured between the first and second major surfaces edge-to-edge (it being appreciated that this thickness will vary in portions of the second layer 18 containing openings, as discussed above).

As noted above, in certain embodiments, at least one (and preferably only one) major surface of the first 16 and/or second 18 layers each comprises an adhesive (or layer of adhesive) pre-mounted to the surface, which can be in the form of a layer adjacent 34 (i.e., in face-to-face contact with) the one major surface. In one or more embodiments, the adhesive covers substantially the entire surface area of the major surface (e.g., from edge to edge). In some embodiments, both major surfaces 22, 24 of the first layer 16 may be covered with an adhesive layer (such that an additional layer of adhesive is adjacent the mesh or webbing layer 20, not depicted). Alternatively, the thickness and material of the intermediate adhesive layer 34 is such that the mesh layer 20 is embedded in the adhesive layer (not shown) between the first 16 and second 18 layers of the substrate 10 and/or 10’.

In one or more embodiments, the intermediate mesh layer 20 comprises polypropylene or other synthetic (e.g., plastic) netting or mesh, such as nylon, polyethylene, polyester, and the like. In general, synthetic mesh or netting materials with approximately 4-mm square openings are preferred, although other configurations are suitable. Monofilament synthetic woven or nonwoven fibers can be used with varying fiber size (diameter), thread count, and hole size. The mesh, webbing, or lattice configuration is preferably uniform across the expanse of the layer 20 for example with the individual strands respectively oriented in a grid or matrix pattern. In other words, the density (number) of openings in a first portion of the layer 20 will be substantially equivalent to the density of openings in a second, different portion of the layer 20 having the same surface area. The mesh or webbing may also be knitted mesh or non-knitted sheet forms, woven or nonwoven fibers, and the like. The material selected may be absorbent, non-absorbent, absorbable, non-absorbable or a combination of absorbable and non-absorbable materials. In some cases, the mesh layer 20 can even be a porous mat or web spun from fibers in an irregular pattern. Regardless of the embodiment, the mesh or webbing material should be selected to provide a flexible but resilient skeleton, scaffolding, or core that maintains an amount of rigidity to the thin film layers (first 16 and second 18 layers) and facilitates easy handling and shaping of the substrate 10 and/or 10’, while allowing the substrate 10 and/or 10’ to still conform to the skin. As such, the substrate 10 and/or 10’ does not fold in on itself under gravity when the liner is removed, and is not susceptible to static cling.

A significant advantage of the inventive substrate 10 and/or 10’ is that it is severable. As used herein, the term“severable” means that the substrate 10 and/or 10’ can be cross-sectionally cut into one or more pieces that conform to the desired shape without losing functionality. In other words, the term is directed towards cutting through the substrate 10 and/or 10’ along a plane that cuts across (and is preferably generally perpendicular to) the multi-layers, and does not encompass separating the substrate 10 and/or 10’ along the plane defined by the front and back surfaces (for example, pulling apart layers in the multi-layered substrate 10 and/or 10’). The substrate 10 and/or 10’ can be cut or severed using conventional scissors, medical shears, utility knives, scalpels, and the like. In some embodiments, the substrate 10 and/or 10’ may be tearable. The substrate 10 and/or 10’ could also be provided with perforations that can be torn.

In one or more embodiments, medications, antimicrobials (chlorhexidine), anti-fungals, and other active agents for delivery to the patient (e.g., topical delivery to skin tissue) and preventing infection on the skin can be included in the substrate 10 and/or 10’ as part of the adhesive layer(s), the film itself, or as pockets of medication (e.g., imbedded time release capsule or the like). See US20110290259, filed January 7, 2010, for an example of chlorhexidine- containing antimicrobial laminates, incorporated by reference herein to the extent it does not contradict the present disclosure. Medications include pain relief medications, analgesics, anti inflammatory medications, steroidal medications, and the like.

The multi-layered adhesive substrate 10 and/or 10’ is particularly suited for use in medical (or veterinary) applications, such as a medical/veterinary tape, for fixation of medical/veterinary devices, and/or fixation of primary dressings. However, non-medical uses of the improved thin film substrate 10 and/or 10’ are also envisioned, such as an improved utility or craft tape. In medical or veterinary uses, the substrate 10 and/or 10’ is non-implantable, and suited primarily for topical (external) applications. Thus, the materials used in the substrate 10 and/or 10’, and particularly the first 16 and second 18 layers (i.e., the external layers) are preferably non absorbable, non-resorbable, non-degradable, water-proof or at least moisture resistant, and are not suitable or compatible for implantation into a subject’s body.

In use, the substrate 10 and/or 10’ can be provided as one or more sheets or strips, each with a releasable liner covering and removably attached to the adhesive layer to prevent indiscriminate adherence or sticking of the substrate 10 and/or 10’ to an undesired surface and/or preserve the adhesive properties of the adhesive layer and/or protect the adhesive layer from attracting dirt, debris, and the like until use. In some embodiments, the substrate 10 and/or 10’ can be an elongated strip wound about a spool or dispensing apparatus. In one or more embodiments, the substrate 10 and/or 10’ is provided as a large sheet that can be cut down to the necessary size.

As noted above, prior to application, the substrate 10 and/or 10’ may first need to be released from the releasable liner to expose the adhesive layer 15, when pre-mounted onto the substrate 10 and/or 10’. In some embodiments, to enhance adhesion, the tissue of the subject (e.g., human, non-human animal, etc.) can be prepared before applying the substrate 10 and/or 10’ or adhesive. Suitable skin preparation techniques include hair removal, and/or wiping the skin around and near a wound area, or other area where the substrate 10 and/or 10’ will be adhered, with isopropyl alcohol (e.g., Preppies Skin Barrier Wipes; Kendall), betadine, chlorhexidine, and the like. The substrate 10 and/or 10’ is then applied (and adhered) to the subject’s tissue with the adhesive layer adjacent the tissue. Even when it is removed from the liner, the substrate 10 and/or 10’ resists gravity and static cling and does not fold in on itself. The ease of handling of the substrate 10 and/or 10’ facilitates accurate and smooth application of the substrate 10 and/or 10’ so that no ridges, air bubbles, or creases are present in the applied substrate 10 and/or 10’. The lack of a separate rigid frame also permits the flexible substrate 10 and/or 10’ to be applied smoothly over contours of the underlying body structures without gapping or creasing. The substrate 10 and/or 10’ is useful for human therapeutic applications, as well as in veterinary applications for animals, such as dogs, cats, horses, rodents, primates, avian species, as well as for basic research.

Methods of using the substrates 10 and 10’ include methods of applying the substrates 10 and 10’ to a subject’s tissue. The substrates 10 and 10’ can also be applied to a dressing or medical device to secure it to the subject. The substrates 10 and 10’ may also be used for bandaging, antimicrobial therapy, or topical chemo therapy, and may be combined with additional active agents for delivery to skin tissue, such as pain relief medications, analgesics, anti-inflammatory medications, steroidal medications, or even being impregnated with bismuth, lead, or the like to shield the applied area against radiation, for example when using targeted X-Ray therapy.

With references to Figs. 5 and 6, methods of the invention relate to atraumatic care of a wound of a subject. This is particularly advantageous for packings that need to be removed and replaced daily or multiple times per day, and avoids the repeat trauma to the patient that is encountered by repeated application and removal of dressing tape and other similar coverings. The base substrate 10 is adhered to the subject’s tissue adjacent (i.e., next to) the wound edges on a first side of the wound and a second side of the wound opposite the first side. The wound (which can optionally be packed and/or covered with a skin graft) is covered with a dressing. A dressing (e.g., gauze), webbing, and/or mesh is then used to cover the wound. The dressing is then secured to the wound by adhering the releasable substrate 10’ to the base substrate 10 on the first side of the wound, and onto the base substrate 10 on the second side of the wound. A portion of the releasable substrate 10’ on each side of the wound also adheres to the dressing, webbing, or mesh 40 used to hold the dressing in place. When a dressing change is needed or the wound needs to be monitored one side of the releasable substrate 10’ can be peeled away from its respective base substrate 10, and the resulting“flap” can be lifted away from the wound area (see inset in Fig. 6). The releasable substrate 10’ can then be reattached to the base substrate 10 after the wound is monitored/cleaned. This process can be repeated as necessary to care for the wound. If necessary, both sides of the releasable substrate 10’ can be removed and the entire dressing discarded, leaving the base substrates 10 in place. A new dressing 40 comprising the releasable substrate 10’ and wound dressing can then be applied. The system can be used to secure bolster dressings or other like dressings often used for bum wounds and skin grafts, as well as pressure dressing to stop bleeding and temporarily stabilize the patient until definitive care can be obtained. Regardless, the underlying tissue of the subject is not disturbed and the base substrate 10 remains adhered to the tissue. This is an additional benefit of significance to patient care. After the applicable dressing, packing, or the like is removed from the patient at the appropriate stage of healing (i.e., by removing the releasable substrate 10’), the base substrate 10 can remain in place adjacent (i.e., next to) the wound. Using thread, the system can then be used to subsequently close the wound for permanent healing. Again, the system provides a significant advantage in that the tissue adjacent (i.e., next to) the wound does not have to undergo additional trauma from the application and/or removal of tape, adhesives, and the like, to remove the dressings, packing, etc., and does not have to be pierced or punctured using staples or suture to subsequently close the wound. This provides an important advancement in the state of the art of wound care and closure.

Similarly, with references to Figs. 7-9, the system can be used for atraumatic securement of a medical device to a patient’s tissue. In general, the medical device is inserted into or placed onto the patient. The base substrate 10 is adhered to the patient’s tissue adjacent (i.e., next to) where the device has been inserted into the patient on a first side of the device and on a second side of the device opposite the first side. Alternatively, the base substrate may be adhered to the patient’s tissue underneath the device (e.g., under the iv port, tubing, etc.), when such devices rest on the patient’s skin. In one or more embodiments, the releasable substrate 10’ is then adhered to the base substrate 10, and further adheres to at least a portion of the device. In some embodiments, this may include crossing over the device, such as by using the omega technique commonly used for securing tubes. In this technique, the tubing or other device is positioned over the base substrate 10, and the releasable substrate 10’ is likewise positioned over the device, generally with the device/tubing being centered on the releasable substrate 10’. The releasable substrate 10’ encircles the tube, preferably at least half of the circumference of the tube, and preferably the entire circumference of the tube, such that the tape meets on the opposite side of the tube, such that the adhesive side can be pinched together around the tube. The remainder of the releasable substrate 10’ is then adhered to the base substrate 10, as depicted in Fig. 7.

In an alternative embodiment, as depicted in Fig. 8, a thread is secured to a first anchoring member (e.g., lattice/mesh opening) on the releasable substrate 10’ on the first side of the device (such as by accessing the mesh lattice through the apertures 38 and tying it off on one of the anchoring members) and also to the device itself. A thread (same or different) is also secured to a second anchoring member on the releasable substrate 10’ on the second side of the device and to the device itself. The back and forth process can be repeated using various anchoring members on either side of the device until sufficiently secured in place to avoid being dislodged. It will be appreciated that the device can be secured using a single continuous thread, or multiple threads that are tied off or fastened at various points in the threading process. It will also be appreciated that the thread can be passed through a single anchoring member multiple times during the lacing process, which unlike a conventional suture, allows that single point to be tethered and stabilized from multiple directions, reducing any single directional force/tension on the tissue at that spot. Those skilled in the art will also appreciate that one advantage of the invention is that there is little to no additional localized trauma to the patient to secure the device, which can be easily removed by cutting or removing the thread. The thread on each side of the device is under opposing forces (tension), which stabilizes the device and prevents dislodgement of the device from the patient. The thread and releasable substrate 10’ can be removed as needed to care for the patient and/or remove or change the tubing, port, etc., while the base substrate remains in place, and the underlying tissue of the subject remains undisturbed (and unharmed). A further technique for securing an endotracheal tube to a patient is illustrated in Fig. 9.

Thus, it will be appreciated that this dual thin film substrate system can be used for fixation and/or securement of primary dressings (e.g., cotton, gauze, etc.), as well as any number of medical devices, such as IV lines, tracheal tubes, nasogastric tubes, ventilators, drains, catheters, central lines, arterial lines, and the like. It will be appreciated that the substrate system may be first adhered to the subject before being affixed to the device or dressing, or may be simultaneously applied to both.

As illustrated in the inset image in Fig. 6, the releasable substrate 10’ can be removed by peeling a portion of an edge of the substrate back from the base substrate 10 along a direction of peeling P , followed by careful peeling/removal of the remainder of the releasable substrate 10’ without disturbing the underlying skin. This is also illustrated in Figs. 10A, 10B, and 10C which show a wound care system attached to a subject’s skin 42 using gauze and mesh 40 to pack and cover a wound. Fig. 10B and 10C depict removal of the releasable substrate 10’ by peeling one edge along a direction of peeling P. It will be appreciated that this system can be used to easily uncover the wound and replace, clean, and/or inspect the packing and/or wound without disturbing the subject’s underlying skin area 42. Likewise, Fig. 11 A depicts use of the system for securing a tube 44 to a subject’s skin 42, using the bases substrate 10 and releasable substrate 10’. As illustrated in Figs. 11B and 1 1C, the releasable substrate 10’ can be removed by peeling a portion of an edge back from the base substrate 10’ along a direction of peeling 1 such that the tube 44 can be removed, cleaned, and/or inspected without disturbing the subject’s underlying skin area 42.

The base substrate 10 can ultimately be removed as needed. The base substrate 10 can be removed using a similar peeling motion. Advantageously, the adhesive for the base substrate 10 can be designed to lose adhesion after a predefined period of time or range of time to facilitate easier removal. Depending upon the type of adhesive used, solvents can be used to facilitate removal, such as acetone, oils (e.g., paraffin oil), and/or saline.

Additional advantages of the various embodiments of the invention will be apparent to those skilled in the art upon review of the disclosure herein and the working examples below. It will be appreciated that the various embodiments described herein are not necessarily mutually exclusive unless otherwise indicated herein. For example, a feature described or depicted in one embodiment may also be included in other embodiments, but is not necessarily included. Thus, the present invention encompasses a variety of combinations and/or integrations of the specific embodiments described herein.

As used herein, the phrase "and/or," when used in a list of two or more items, means that any one of the listed items can be employed by itself or any combination of two or more of the listed items can be employed. For example, if a composition is described as containing or excluding components A, B, and/or C, the composition can contain or exclude A alone; B alone; C alone; A and B in combination; A and C in combination; B and C in combination; or A, B, and C in combination. The term“adjacent” means adjoining, abutting (touching) so as to have a common interface/surface or border. In the case of layers, a layer is considered to be adjacent when it shares a common interface^. e., is in face-to-face contact) with the adjacent structure. With respect to wound tissue, tissue that is adjacent to the wound refers to tissue proximate to the wound but not involving the wound edges (i.e., tissue spaced slightly from the wound edges themselves).

The present description also uses numerical ranges to quantify certain parameters relating to various embodiments of the invention. It should be understood that when numerical ranges are provided, such ranges are to be construed as providing literal support for claim limitations that only recite the lower value of the range as well as claim limitations that only recite the upper value of the range. For example, a disclosed numerical range of about 10 to about 100 provides literal support for a claim reciting "greater than about 10" (with no upper bounds) and a claim reciting "less than about 100" (with no lower bounds).

Claims

CLAIMS:

1. A method for atraumatic securement of medical devices, and/or atraumatic wound care, said method comprising:

atraumatically securing a base thin film substrate directly to a subject’s tissue, wherein said base substrate is durably adhered to the subject’s tissue;

removably affixing a releasable thin film substrate to said base substrate, wherein said releasable substrate is releasably adhered on top of the base thin film substrate, so that release and re-engagement of the releasable thin film substrate and the base substrate can be repeated as needed for care of the subject, without unduly disturbing the subject’s underlying tissue,

wherein said releasable thin film substrate is further optionally secured to one or more of a medical device or wound dressing applied to the subject.

2. The method of claim 1, further comprising removing at least a portion of said releasable thin film substrate from said base substrate, said method comprising peeling an edge of said releasable thin film substrate and folding said releasable thin film substrate back onto itself until released from said base substrate, and optionally removing said medical device or wound dressing from said subject.

3. The method of claim 2, further comprising:

re-packing said wound with a sterile packing;

covering said wound with a dressing; and

securing said dressing to said wound by removably affixing said releasable thin film substrate to said base substrate thereby securing said dressing to said wound.

4. The method of claim 1, wherein said base substrate is secured by applying adhesive to said subject’s tissue and mounting said base substrate to said adhesive with a major surface being in contact with said adhesive.

5. The method of claim 1, wherein said device is selected from the group consisting of tracheal tubes, nasogastric tubes, ventilators, drains, catheters, IVs, central lines, arterial lines, and combinations thereof.

6. The method of claim 1, wherein said base substrate and said releasable substrate each comprises a releasable liner in face-to-face relationship adjacent an adhesive layer, said method further comprising removing said releasable liner prior to securing and affixing each of said substrates.

7. The method of claim 6, wherein each of said substrates does not fold in on itself after removing said liner.

8. Th method of claim 1, wherein said base substrate is smooth and non-creased after securing to said subject’s tissue.

9. The method of claim 1, wherein said base substrate and/or said releasable substrate is flexible and inelastic.

10. The method of claim 1, wherein said base substrate and/or said releasable substrate has a respective thickness of from about 1 mil to about 10 mil.

11. The method of claim 1, wherein said base substrate and/or said releasable substrate is severable.

12. The method of claim 1, wherein said base thin film substrate and/or said releasable thin film substrate is a multilayered thin film adhesive substrate having opposing front and back major surfaces, and comprising:

a first layer having an outer edge, an interior major surface, and an exterior major surface presenting said opposing back major surface of said substrate;

a second layer having an outer edge, an interior major surface, and an exterior major surface presenting said opposing front major surface;

a resilient, intermediate mesh layer between the first layer and second layer, said intermediate mesh layer having an outer edge, and being in face-to-face relationship adjacent said respective interior major surfaces; and

a layer of adhesive having an outer edge, and being in face-to-face relationship adjacent said opposing back major surface,

wherein the outer edge of each of said layers is in alignment.

13. The method of claim 12, further comprising an intermediate adhesive layer between said first layer and said second layer adjacent said intermediate mesh layer.

14. The method of claim 12, wherein said first layer or second layer comprises a material selected from the group consisting of polyurethane, polyethylene, polypropylene, polyamide, polytetrafluoroethylene, polystyrene, silicone, rubber, latex, rayon, composites thereof, copolymers thereof, and combinations thereof.

15. The method of claim 12, wherein the adhesive layer comprises a material selected from the group consisting of rubber elastomers, acrylics, acrylates, epoxies, silicones, hot melt adhesives, solvent-based adhesives, solvent-free adhesives, photosensitive adhesives, hydrocolloids, hydrogels, polyurethanes, styrene block co-polymers, and combinations thereof.

16. The method of claim 12, wherein said intermediate mesh layer comprises polypropylene, nylon, polyethylene, or polyester netting.

17. The method of claim 12, wherein said intermediate mesh layer comprises woven or non woven fibers.

18. The method of claim 12, wherein said second layer comprises a plurality of openings formed therein, said openings extending through a thickness of said second layer.

19. The method of claim 18, wherein said openings facilitate access to said intermediate mesh layer.

20. The method of claim 19, wherein said wound dressing or medical device is secured by thread tied to said intermediate mesh layer through said openings.

21. A system for atraumatic securement of medical devices, and/or atraumatic wound care, said system comprising:

a base thin film substrate atraumatically secured directly to a subject’s tissue, wherein said base substrate is durably adhered to the subject’s tissue;

a releasable thin film substrate removably affixed to said base substrate, wherein said releasable substrate is releasably adhered on top of the base thin film substrate, so that release and re-engagement of the releasable thin film substrate and the base substrate can be repeated as needed for care of the subject, without unduly disturbing the subject’s underlying tissue,

said system further optionally comprising one or more of a medical device or wound dressing applied to the subject, which are secured by said releasable thin film substrate.

22. The system of claim 21, wherein said base thin film substrate and/or said releasable thin film substrate is a multilayered thin film adhesive substrate having opposing front and back major surfaces, and comprising:

wherein the outer edge of each of said layers is in alignment.

23. The system of claim 22, further comprising an intermediate adhesive layer between said first layer and said second layer adjacent said intermediate mesh layer.

24. The system of claim 22, wherein said first layer or second layer comprises a material selected from the group consisting of polyurethane, polyethylene, polypropylene, polyamide, polytetrafluoroethylene, polystyrene, silicone, rubber, latex, rayon, composites thereof, copolymers thereof, and combinations thereof.

25. The system of claim 22, wherein the adhesive layer comprises a material selected from the group consisting of rubber elastomers, acrylics, acrylates, epoxies, silicones, hot melt adhesives, solvent-based adhesives, solvent-free adhesives, photosensitive adhesives, hydrocolloids, hydrogels, polyurethanes, styrene block co-polymers, and combinations thereof.

26. The system of claim 22, wherein said intermediate mesh layer comprises polypropylene, nylon, polyethylene, or polyester netting.

27. The system of claim 22, wherein said intermediate mesh layer comprises woven or non woven fibers.

28. The system of claim 22, wherein said second layer comprises a plurality of openings formed therein, said openings extending through a thickness of said second layer.

29. The system of claim 22, wherein said base substrate and/or said releasable substrate is flexible and inelastic.

30. The system of claim 22, wherein said base substrate and/or said releasable substrate has a respective thickness of from about 1 mil to about 10 mil.