WO2020018734A1 - Systèmes et méthodes pour réduire ou modifier laforce de liaison de d'application et de retrait de champs adhésifs désactivés par la lumière - Google Patents

Systèmes et méthodes pour réduire ou modifier laforce de liaison de d'application et de retrait de champs adhésifs désactivés par la lumière Download PDF

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Publication number
WO2020018734A1
WO2020018734A1 PCT/US2019/042318 US2019042318W WO2020018734A1 WO 2020018734 A1 WO2020018734 A1 WO 2020018734A1 US 2019042318 W US2019042318 W US 2019042318W WO 2020018734 A1 WO2020018734 A1 WO 2020018734A1
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WO
WIPO (PCT)
Prior art keywords
drape
photosensitive adhesive
tissue
adhesive portions
light
Prior art date
Application number
PCT/US2019/042318
Other languages
English (en)
Inventor
Timothy Mark Robinson
Ashwatha PRICE
Justin Long
Original Assignee
Kci Licensing, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Kci Licensing, Inc. filed Critical Kci Licensing, Inc.
Publication of WO2020018734A1 publication Critical patent/WO2020018734A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/00051—Accessories for dressings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive plasters or dressings
    • A61F13/023—Adhesive plasters or dressings wound covering film layers without a fluid handling layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive plasters or dressings
    • A61F13/0246—Adhesive plasters or dressings characterised by the skin adhering layer
    • A61F13/0253—Adhesive plasters or dressings characterised by the skin adhering layer characterized by the adhesive material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive plasters or dressings
    • A61F13/0259—Adhesive plasters or dressings characterised by the release liner covering the skin adhering layer

Definitions

  • the present application relates generally to the field of tissue treatment, and more specifically to a system and method for facilitating the application and removal of a drape from a tissue site.
  • tissue treatment systems require the use of an adhesive drape to secure all or a portion of the tissue treatment system to a tissue site.
  • an adhesive drape can be used to secure a gauze portion of a bandage to a wound site by adhering to the skin or other tissue surrounding the wound.
  • Drapes intended for use with negative pressure wound therapy (NPWT) have certain desirable characteristics.
  • the drape is easy to apply, doesn't adhere well to itself if folded (e.g., adhesive to adhesive) upon application to tissue, achieves a good seal with the tissue, adheres well to tissue and to its film (e.g., polyurethane) covering when layered or overlapped, enables atraumatic removal, is highly breathable, is repositionable upon application, and achieves adhesion that is not affected by patient heat or sweat.
  • AWD advanced wound dressing
  • a challenge with bordered AWDs is to get a balance of adhesive strength vs. trauma upon removal at the optimum point for a wide range of users and skin types.
  • AWDs are used on a wide range of chronic wounds and thus on a wide range of patients, some of whom have delicate and friable skin and others who have a high degree of sensitivity to pain. If the adhesive is insufficiently strong, the adhesive can give way during wear and result in fluid leaks which can be distressing for the patient, or the dressing can come away from the patient. If the adhesive is too aggressive, it can be painful upon removal and result in skin-stripping.
  • Silicones and other adhesives have been used to try to reduce trauma; however, these can lack bond strength and can be adversely affected by moisture. Therefore, a strong adhesive drape is needed which maintains adhesion during the length of the wound therapy but does not result in any trauma to the tissue when the dressing is removed.
  • a light switchable adhesive for no-trauma AWD incorporates certain photo initiators that, when exposed to certain light wavelengths, is deactivated, thus decreasing the bond strength of the adhesive.
  • This light switchable adhesive has a strong bond (e.g., approximately 18 N/25 mm) before exposure to light and a much lower bond strength (e.g., approximately 1 N/25 mm) after exposure to light.
  • the bond strength of the adhesive is much lower when the dressing is ready to be removed, the adhesion may still be higher than some of the silicone dressings available in the market.
  • the adhesion of the light activated adhesive may be reduced by simply increasing the concentration of the photo initiators. However, at some point, the reduction in bond strength via this method may be limited. Furthermore, high concentrations of photo initiators may risk sensitization reactions from the patient tissue. Therefore, the disclosed embodiments lower the bond strength of the light switchable adhesive without increasing photo initiator concentrations.
  • a removable light blocking film layer is opaque to block deactivating wavelengths from prematurely reaching the light switchable adhesive.
  • the opaque removable light blocking film layer is breathable and also enables a user to be able to view the wound exudate (and its associated color) when changing the dressing.
  • the opaque removable light blocking film layer is selectively applied to only certain parts of the dressing.
  • a light deactivated adhesive drape system configured to be coupled to tissue, the system comprising: a drape comprising: an acrylic and/or polyurethane film; a plurality of photosensitive adhesive portions disposed in a pattern coat on the film and configured to adhere to the tissue and having at least one release agent disposed within the adhesive layer, wherein the at least one release agent is configured to weaken a bond of the adhesive layer to the tissue upon exposure to at least one of a plurality of light wavelengths; a plurality of non-adhesive portions on the film; and a removable blocking layer configured to block the plurality of light wavelengths that activate the at least one release agent, wherein the plurality of light wavelengths are wavelengths comprising a portion of the visible light spectrum.
  • the pattern coat is disposed onto 50% of the film.
  • the plurality of photosensitive adhesive portions comprise a plurality of dots.
  • the plurality of photosensitive adhesive portions comprise a mesh.
  • the plurality of photosensitive adhesive portions comprise first portions having a first deactivation time and second portions having a second deactivation time, the first deactivation time being longer than the second deactivation time.
  • the first deactivation time is between 5 to 10 minutes and the second deactivation time is 1 minute.
  • the removable blocking layer comprises a plurality of perforations configured to enable some of the plurality of photosensitive adhesive portions to be exposed to the plurality of light wavelengths and deactivated while a remainder of the plurality of photosensitive adhesive portions are activated.
  • the remainder of the plurality of photosensitive adhesive portions are deactivated by removing the removable blocking layer from the drape to expose the remainder of the plurality of photosensitive adhesive portions to the plurality of light wavelengths.
  • a light deactivated adhesive drape system is configured to be coupled to tissue, the system comprising: a drape comprising: an acrylic and/or polyurethane film; a plurality of first photosensitive adhesive portions disposed in a first pattern coat on the film and configured to adhere to the tissue and having at least one release agent disposed within the adhesive layer, wherein the at least one release agent is configured to weaken a bond of the adhesive layer to the tissue upon exposure to at least one of a plurality of light wavelengths; a plurality of second photosensitive adhesive portions disposed in a second pattern coat on the film and configured to adhere to the tissue and having at least one release agent disposed within the adhesive layer; and a removable blocking layer configured to block the plurality of light wavelengths that activate the at least one release agent, wherein the plurality of light wavelengths are wavelengths comprising a portion of the visible light spectrum, wherein the first photosensitive adhesive portions and the second photosensitive adhesive portions have different deactivation rates.
  • the first pattern coat is disposed onto 50% of the film and the second pattern coat is disposed onto 50% of the film.
  • the plurality of first photosensitive adhesive portions and the plurality of second photosensitive adhesive portions comprise a plurality of dots.
  • the plurality of first photosensitive adhesive portions and the plurality of second photosensitive adhesive portions comprise a mesh.
  • the plurality of first photosensitive adhesive portions have a first deactivation time and the plurality of second photosensitive adhesive portions have a second deactivation time, the first deactivation time being longer than the second deactivation time.
  • the first deactivation time is between 5 to 10 minutes and the second deactivation time is 1 minute.
  • the plurality of first photosensitive adhesive portions and the plurality of second photosensitive adhesive portions are deactivated by removing the removable blocking layer from the drape to expose the plurality of first photosensitive adhesive portions and the plurality of second photosensitive adhesive portions to the plurality of light wavelengths.
  • a light deactivated adhesive drape system is configured to be coupled to tissue, the system comprising: a drape comprising: a non-opaque acrylic and/or polyurethane film; a photosensitive adhesive layer configured to adhere to the tissue and having at least one release agent disposed within the adhesive layer, wherein the at least one release agent is configured to weaken a bond of the adhesive layer to the tissue upon exposure to at least one of a plurality of light wavelengths; and an opaque removable blocking layer configured to block the plurality of light wavelengths that activate the at least one release agent, wherein the plurality of light wavelengths are wavelengths comprising a portion of the visible light spectrum, and wherein the opaque removable blocking layer has at least one non-opaque portion configured to allow the plurality of light wavelengths that activate the at least one release agent to pass through the at least one non-opaque portion.
  • the opaque removable blocking layer is disposed in a pattern coat onto a surface of the film. In some embodiments, the pattern coat is disposed onto 50% of the film. In some embodiments, the opaque removable blocking layer is screen printed onto a surface of the film. In some embodiments, the opaque removable blocking layer comprises graphene. In some embodiments, the opaque removable blocking layer comprises one or more reflective materials. In some embodiments, the opaque removable blocking layer comprises one or more of micro and nano optical structures configured to diffract the plurality of light wavelengths. In some embodiments, the opaque removable blocking layer comprises one or more carbon nanotubes. In some embodiments, the at least one non-opaque portion comprises a perforation.
  • the at least one non-opaque portion comprises a channel. In some embodiments, the at least one non-opaque portion comprises a plurality of perforations configured to enable moisture vapor from the tissue to be transmitted through the perforations. In some embodiments, the at least one non-opaque portion comprises a plurality of channels configured to enable moisture vapor from the tissue to be transmitted through the channels. In some embodiments, the at least one non-opaque portion comprises a viewing area configured to enable viewing of the tissue beneath the drape. In some embodiments, the viewing area is centrally located on the drape and surrounded by the opaque removable blocking layer.
  • the terms“a” and“an” are defined as one or more unless this disclosure explicitly requires otherwise.
  • the term“substantially” is defined as largely but not necessarily wholly what is specified (and includes what is specified; e.g., substantially 90 degrees includes 90 degrees and substantially parallel includes parallel), as understood by a person of ordinary skill in the art.
  • the terms“substantially,”“approximately,” and “about” may be substituted with“within [a percentage] of’ what is specified, where the percentage includes 0.1, 1, 5, and 10 percent.
  • a method that“comprises,”“has,”“includes” or “contains” one or more steps possesses those one or more steps, but is not limited to possessing only those one or more steps.
  • terms such as“first” and“second” are used only to differentiate structures or features, and not to limit the different structures or features to a particular order.
  • any embodiment of any of the disclosed methods, systems, system components, or method steps can consist of or consist essentially of— rather than comprise/include/contain/have— any of the described elements, steps, and/or features.
  • the term“consisting of’ or“consisting essentially of’ can be substituted for any of the open-ended linking verbs recited above, in order to change the scope of a given claim from what it would otherwise be using the open-ended linking verb.
  • FIGs. 1A-1B are cross-sectional views of a light deactivated adhesive drape system in accordance with an illustrative embodiment of the present disclosure.
  • FIGs. 2A-2C are cross-sectional views of a light deactivated adhesive drape system in accordance with another illustrative embodiment of the present disclosure.
  • FIG. 3 is a top-down view of a light deactivated adhesive drape system in accordance with another illustrative embodiment of the present disclosure.
  • FIG. 4 is a top-down view of a light deactivated adhesive drape system in accordance with another illustrative embodiment of the present disclosure.
  • FIG. 5 is a top-down view of a light deactivated adhesive drape system in accordance with another illustrative embodiment of the present disclosure.
  • FIG. 6 is a perspective view of a light deactivated adhesive drape system in accordance with another illustrative embodiment of the present disclosure.
  • FIG. 7 is a top-down view of an opaque removable light blocking layer in accordance with an illustrative embodiment of the present disclosure.
  • FIG. 8 is a top-down view of an opaque removable light blocking layer in accordance with another illustrative embodiment of the present disclosure.
  • FIG. 9 is a top-down view of an opaque removable light blocking layer in accordance with another illustrative embodiment of the present disclosure.
  • FIG. 10 is a perspective view of a light deactivated adhesive drape system in accordance with another illustrative embodiment of the present disclosure.
  • FIG. 11 is a flowchart illustrating a process for using a light deactivated adhesive drape system in accordance with an illustrative embodiment of the present disclosure.
  • FIG. 12 is a flowchart illustrating a process for using a light deactivated adhesive drape system in accordance with another illustrative embodiment of the present disclosure.
  • Reduced pressure generally refers to a pressure less than the ambient pressure at a tissue site that is being subjected to treatment. In most cases, this reduced pressure will be less than the atmospheric pressure of the location at which the patient is located.
  • vacuum and “negative pressure” can be used to describe the pressure applied to the tissue site, the actual pressure applied to the tissue site can be significantly less than the pressure normally associated with a complete vacuum. Consistent with this nomenclature, an increase in reduced pressure or vacuum pressure refers to a relative reduction of absolute pressure, while a decrease in reduced pressure or vacuum pressure refers to a relative increase of absolute pressure.
  • the term “coupled” includes “indirect coupling” via a separate object.
  • a drape can be coupled to the tissue site if both the drape and the tissue site are coupled to one or more third objects, such as a release agent or a second adhesive layer.
  • the term “coupled” also includes “directly coupled,” in which case the two objects touch each other in some way.
  • the term “coupled” also encompasses two or more components that are continuous with one another by virtue of each of the components being formed from the same piece of material.
  • the term “coupled” includes chemical coupling, such as via a chemical bond, and electrostatic coupling.
  • Various aspects of the present invention comprise a system and method for systems and methods for mitigating premature light deactivation of light deactivated adhesive drapes, a portion of which is shown in each of the FIGS. 1A-12.
  • Various embodiments can facilitate the removal of the drape from the tissue site with less trauma to a patient than conventional drapes while preventing premature deactivation of the adhesive.
  • the tissue site may be skin tissue, wound tissue, bone tissue, or any other type of tissue.
  • Various embodiments of the system and method described herein comprise, or can be used with reduced or negative pressure wound healing technology.
  • FIGS. 1A and 1B an illustrative embodiment of a light deactivated adhesive drape system 100 disposed onto patient tissue 104 is shown.
  • the system 100 comprises an absorbent portion 108 (e.g., absorbent drape portion), a drape cover 112, an adhesive layer 116 having at least one photosensitive adhesive portion 120 and at least one acrylic and/or polyurethane adhesive portion 124.
  • both adhesive portions 120 and 124 are coupled to the drape cover 112.
  • a drape can be generally understood to be a covering over a tissue 104 that is preferably sterilizable.
  • a drape can comprise a biocompatible thin film material, such as a polymer, a woven or non- woven material, an elastic or non-elastic material, an occlusive or nonocclusive material, and a flexible or inflexible material.
  • a drape can comprise an impermeable, semi- permeable, or permeable material. Permeability characteristics can be selected according to desired moisture and gas (e.g., oxygen) transmission.
  • the drape comprises a material relatively impermeable to moisture and relatively permeable to oxygen.
  • a drape can be coated with a material, for example, to control breathability.
  • a drape can comprise a material which allows or facilitates transmission of external stimuli, such as light, sound, moisture or heat.
  • a drape material can be semi- or substantially transparent to electromagnetic radiation, such as visible, ultraviolet (UV), or infrared light.
  • a drape can be composed of one or more layers.
  • a drape can be a bilayer drape.
  • three, four, or more drape layers may be used, with combinations of materials selected according to desired function.
  • the absorbent portion 108 is a tissue contacting material that is therapeutic and promotes healing of a wound.
  • the absorbent portion 108 can be a hydrophillic foam, foam and absorbent laminate, algenate, hydro-polymer, textile, and/or non- woven or bio-polymer such as a collagen. This list of absorbent materials is non-exhau stive and any suitable absorbent, protective, and therapeutic material can be used.
  • the absorbent portion 108 can form a central island in the drape system 100 about which the adhesive layer 116 is used to fixate the absorbent material to the patient for the benefit of the wound and management of fluids.
  • drape cover 112 is placed over absorbent portion 108.
  • adhesive layer 116 comprising photosensitive adhesive portions 120 and acrylic and/or polyurethane adhesive portions 124 on its underside (skin/island facing side).
  • acrylic and/or polyurethane adhesive portions 124 can be used to hold the drape system 100 together.
  • adhesive layer 116 extends around the border of the island of absorbent portion 108 (e.g., absorbent material) and is used to affix the AWD to a patient.
  • adhesive layer 116 can be pattern printed to provide areas of adhesive and areas without adhesive where greater MVTR can allow for improved evaporation from the absorbent portion 108.
  • Both the drape cover 112 and adhesive layer 116 should not impede the transmission of the appropriate wavelengths and intensities of light required to activate and cause the switching of the photosensitive adhesive portions 120. In some embodiments, it may be optimal if the drape cover 112 and adhesive layer 116 are optically transparent. In some embodiments, the drape cover 112 and/or adhesive layer 116 may be tinted with a color. In these embodiments, the tint color should not disrupt the passage of the appropriate wavelengths and intensities of light required to activate and cause the switching of the photosensitive adhesive portions 120.
  • the drape cover 112 may be a breathable and/or semiporous film such as polyurethane or a thin foam but other suitable materials may be used. There are a range of materials which the drape cover 112 can be formulated from although they generally need to be thin, flexible and have a moderate to high MVTR.
  • the adhesive layer 116 adheres to the tissue 104 thereby coupling the drape cover 112 to the tissue 104.
  • the drape cover 112 may cover any portion of the absorbent portion 108, the adhesive layer 116, and the tissue 104 as may be required.
  • the adhesive portions 124 can comprise one or more materials including, but not limited to, polyurethane, acrylic (e.g., cyanoacrylate), hydrogel, silicon or silicone based material, natural rubber, synthetic rubber, styrene block copolymers, polyvinyl ethers, poly(meth)acrylates, polyolefins, hydrocolloid (e.g., a rubber based hydrocolloid), or a combination thereof.
  • the adhesive portions 124 comprises a polymer or co-polymer.
  • the adhesive portions 124 can comprise a co-polymer of polyurethane and silicone or various acrylic co-polymers.
  • the photosensitive adhesive portions 120 may include at least one release agent 128 comprising a release material.
  • photosensitive adhesive portions 120 have a plurality of release agents 128 (represented by dots).
  • the release agent 128 can physically or chemically affect adhesion characteristics between a drape and a tissue 104.
  • a release agent 128 can comprise a variety of molecular compositions depending on the particular embodiment being implemented, including but not limited to a photopolymer, an oil particle, a gas particle, a solvent, a lipid, and/or one or more micro structures. Release agents 128 can be present in an inert or inactive form in, on, or near adhesive portions 120.
  • a release agent 128 can be mixed with the adhesive; on the surface of the adhesive with a random or patterned coverage; coupled to the drape with a random or patterned coverage; or contained within a microstructure located in these or other locations.
  • release agents 128 can migrate within the adhesive portions 120 or along an interface between adhesive portions 120 and a tissue 104 to facilitate the removal of a drape affixed thereto.
  • the release agent 128 is configured to transition from an unreleased state (shown in FIG. 1A) to a release state 132 (represented by diagonal lines in FIG. 1B) to weaken a bond of adhesive portions 120 to the tissue 104 upon exposure to an external stimulus.
  • an unreleased state shown in FIG. 1A
  • a release state 132 represented by diagonal lines in FIG. 1B
  • Non-limiting examples of the external stimulus include electromagnetic (e.g., UV, visible, or infrared light), magnetic, sound, pH, pressure (e.g., positive atmospheric pressure, negative atmospheric pressure, shear force, direct force), thermal, moisture, or a substance.
  • the external stimulus can also be a substance, compound, liquid, or gas capable of reacting with a release agent 128 in adhesive portions 120 such that the release agent 128 transitions from an unreleased state to a released state.
  • the external stimulus is one or more of a plurality of light wavelengths.
  • the weakened bond that occurs as a result of the release of release agent 128 allows a user of the light deactivated adhesive drape system 100 to apply an upward force on drape cover 112, such as a force indicated by arrow 136, to remove drape cover 112 from tissue 104.
  • the weakened bond reduces the stress applied to tissue 104 in the removal of drape cover 112 from tissue 104.
  • a residue of molecules from adhesive layer 116 might remain on tissue 104 after removal of drape cover 112 depending on a variety of factors such as the type of release agent used.
  • release agents 128 are inertly dispersed within adhesive portions 120 and can be located anywhere within adhesive portions 120, as well as any of the outer surfaces of adhesive portions 120, such as an interface between adhesive portions 120 and drape cover 112.
  • release agents 128 can be bonded or coupled directly to drape cover 112, and a separate film layer (not shown in FIG. 1A), can separate release agents 128 from adhesive portions 120.
  • the presence of an external stimulus can weaken, break-down, or increase the permeability of the separate film layer such that release agents 128 are allowed to migrate into adhesive portions 120 to facilitate the removal of drape cover 112 from tissue 104. As shown in FIG.
  • release agents 128 may be released in the presence of external stimulus such that release agents 128 are allowed to migrate within adhesive portions 120 and the interface between adhesive portions 120 and tissue 104.
  • a light source 140 exposes drape cover 112 and adhesive layer 116 to a plurality of light wavelengths 144.
  • the light source 140 can be a UV light source or a light source that emits visible light wavelengths.
  • exposure to the plurality of light wavelengths 144 can cause microstructures containing release agents 128 to rupture or tear, thereby releasing release agents 128 from the interior of the microstructures.
  • release agents 128 can then be interspersed into adhesive portions 120 and the interface between adhesive portions 120 and tissue 104, thereby weakening the bond between drape cover 112 and tissue 104 and facilitating the removal of drape cover 112 from tissue 104.
  • release agents 128 may transition from an unreleased state (as shown in FIG. 1A) to a released state 132 (as shown in FIG. 1B) as they are exposed to the plurality of light wavelengths 144.
  • the UV wavelengths may be within a range of 280 nm - 395 nm, although it may be preferable to have the UV wavelengths be UVA wavelengths within a range of 315 nm - 395 nm.
  • the visible light wavelengths may be within a range of 400 nm - 700 nm, although it may be preferable to have the visible light wavelengths be wavelengths within a range of 400 nm - 500 nm.
  • the photosensitive adhesive portions 120 can be optimized to deactivate in ⁇ 5 minutes of exposure to a range of ambient light levels, wavelengths, and intensities ranging from environments such as a domestic location with artificial light bulbs (e.g., hospital wards) and strong outdoor light.
  • the intensity of the light source may affect the time it takes for the switchable adhesive to deactivate (i.e., the deactivation time may be less when the intensity of the light is higher such as when exposed to outdoor sunlight vs. indoor ambient light). Switchable adhesives with other deactivation times may be used, such as times within a range of 30 seconds to 6 minutes.
  • light deactivated adhesive drape system 200 is configured to release adhesive portions 120 upon exposure to ambient, visible light instead of UV light.
  • adhesive portions 120 release upon exposure to visible light is advantageous in that it doesn’t require a specific UV light source and enables release to occur in any environment having ambient light, it also can increase a likelihood that the adhesive portions 120 will prematurely deactivate.
  • the adhesive portions 120 may be constructed with release agents 128 that only release upon exposure to certain wavelengths of visible light.
  • release agents 128 will only transition to a released state 132 when exposed to visible light wavelengths in the blue and violet portions of the visible light spectrum.
  • a blocking layer 204 is disposed over drape cover 112 of the drape.
  • blocking layer 204 is configured to block the visible light wavelengths that release the adhesive portions 120 while allowing other visible light wavelengths to pass through.
  • blocking layer 204 when exposed to visible light, blocking layer 204 will block the blue and violet wavelengths but allow the red, orange, yellow, and/or green wavelengths to pass through. In this way, blocking layer 204 can be partially transparent and enables a clinician or a nurse to visually inspect the drape and the wound site without premature deactivation of the adhesive portions 120.
  • blocking layer 204 can be opaque and/or partially or fully light occlusive.
  • blocking layer 204 is a colored layer that contains a dye or other coloring agent corresponding to one or more colors of the visible light spectrum that have wavelengths that do not deactivate the adhesive portions 120 (e.g., red, orange, yellow, and/or green).
  • blocking layer 204 is a photo-reactive polymer or can incorporate a photo-reactive dye such that blocking layer 204 is transparent when exposed to light of a wavelength/intensity insufficient to deactivate the switchable adhesive but becomes fully light occlusive when exposed to light of a wavelength/intensity sufficient to trigger the deactivation the switchable adhesive.
  • blocking layer 204 is configured to be removable. This enables the adhesive portions 120 to be deactivated at a time a user desires to remove the drape from tissue 104.
  • the blocking layer 204 can be a printed layer printed directly onto the drape cover 112 or the adhesive portions 120.
  • blocking layer 204 can be a peelable layer that adheres to the outer surface of drape cover 112. In the embodiment shown, blocking layer 204 can cover the entire surface of drape cover 112. In other embodiments, blocking layer 204 can cover only the surfaces of drape cover 112 over adhesive portions 120.
  • a user of the light deactivated adhesive drape system 200 can apply a force on blocking layer 204, such as a force indicated by arrows 208, to remove blocking layer 204 from drape cover 112.
  • the adhesive portions 120 can be exposed to deactivation wavelengths (e.g., ambient light 212) that comprises light wavelengths configured to deactivate adhesive portions 120.
  • deactivation wavelengths e.g., ambient light 212
  • release agents 128 can transition from an unreleased state to a released state 132.
  • the drape including drape cover 112 can then be removed from tissue 104. If any residue of adhesive portions 120 remains on tissue 104 after removal of the drape, it may be removed.
  • blocking layer 204 is a frequency/intensity/UV blocking film layer which may be transparent or fully occlusive. Transparency will depend on the ability of the selected material to completely and totally block any activating wavelengths from the switchable adhesive under all light and environmental conditions. This material should optimally be highly breathable with a high MVTR. It can also incorporate an adhesive that may be acrylic, polyurethane, or other suitable material; however, the bond strength should be tuned such that the material is retained in its position but requires approximately 1-2 N in order to remove layer.
  • blocking layer 204 may include printing or may be colored such that it provides indication to a user of the system that the blocking layer 204 should not be removed until removal of the drape is desired and deactivation of the switchable adhesive is necessary.
  • blocking layer 204 can be disposed over the entire surface area of drape cover 112. In other embodiments, blocking layer 204 may only be aligned and fitted to surface areas of drape cover 112 where the switchable adhesive portions 120 are located.
  • blocking layer 204 may be a printed/coated dye/particulate layer that is printed over the photosensitive adhesive portions 120 to prevent premature deactivation.
  • FIG. 3 shows a top view of drape system 300, which includes a drape having photosensitive adhesive portions 304 and non-adhesive/low-adhesive portions 308.
  • photosensitive adhesive portions 304 and non-adhesive/low-adhesive portions 308 can be disposed in adhesive layer 116 of drape cover 112 that completely surrounds a central island of absorbent portion 108.
  • photosensitive adhesive portions 304 and non-adhesive/low-adhesive portions 308 can be disposed onto an entire tissue facing surface of drape cover 112.
  • the photosensitive adhesive portions 304 are dots that are pattern coated onto the tissue facing surface of drape cover 112. In this way, less of the surface area of the tissue facing surface of drape cover 112 is covered by adhesive portions, leaving a large surface area of non-adhesive/low-adhesive portions 308 remaining.
  • This configuration enables the drape system to have a lower adhesive bond to the patient tissue than a drape system entirely coated by the photosensitive adhesive.
  • the surface area ratio covered by photosensitive adhesive portions 304 and non-adhesive/low-adhesive portions 308 can vary by application.
  • the bond strength can be reduced from 18 N/25 mm to 9 N/25 mm before exposure to light and from 1 N/25 mm to 0.5 N/25 mm after exposure to light. If a higher tack is desired, a larger surface area (e.g., 75%) can be pattern coated with the photosensitive adhesive portions 304. Bond strength, as used herein, corresponds to a peel strength of the adhesive as measured by a 180 degree angle peel strength test on stainless steel. Similarly, if a lower tack is desired, a smaller surface area (e.g., 25%) can be pattern coated with the photosensitive adhesive portions 304.
  • FIG. 4 shows a top view of drape system 400, which includes a drape having photosensitive adhesive portions 404 and non-adhesive/low-adhesive portions 408.
  • the pattern coat of the adhesive is a mesh configuration instead of the dot configuration shown in FIG. 3.
  • FIG. 5 shows a top view of drape system 500, which includes a drape having first photosensitive adhesive portions 504, second photosensitive adhesive portions 508, and non-adhesive/low-adhesive portions 512.
  • first photosensitive adhesive portions 504 comprise a first type of light sensitive adhesive
  • second photosensitive adhesive portions 508 comprise a second type of light sensitive adhesive.
  • first photosensitive adhesive portions 504 have a slower reaction rate to deactivating light wavelengths than second photosensitive adhesive portions 508, which in turn have a faster reaction rate to deactivating light wavelengths than first photosensitive adhesive portions 504.
  • first photosensitive adhesive portions 504 may take between 5-10 minutes to deactivate upon exposure to the deactivating light wavelengths while second photosensitive adhesive portions 508 may only take 1 minute to deactivate upon exposure to the deactivating light wavelengths.
  • each of the first photosensitive adhesive portions 504 and second photosensitive adhesive portions 508 may be pattern coated onto the tissue facing surface of drape cover 112 and drape cover 112 can be entirely covered by blocking layer 204. Upon removal of the blocking layer 204, the first photosensitive adhesive portions 504 and second photosensitive adhesive portions 508 will deactivate at different rates upon exposure to the deactivating light wavelengths (i.e., the first photosensitive adhesive portions 504 have one deactivation time and second photosensitive adhesive portions 508 have another, different deactivation time).
  • This configuration may be useful when a user does not want to or have time to wait for the longer deactivation time period of first photosensitive adhesive portions 504. Instead, the user can merely wait for the shorter deactivation time period of second photosensitive adhesive portions 508 to enable low trauma dressing removal in applicable situations. This configuration would also enable a no trauma dressing removal if the user waits for both first photosensitive adhesive portions 504 and second photosensitive adhesive portions 508 to be deactivated. In some instances, there may be a risk that the faster reacting adhesive (i.e., second photosensitive adhesive portions 508) may be partially deactivated in placement due to a delayed application onto the drape cover 112 and inadvertent exposure to light.
  • the faster reacting adhesive i.e., second photosensitive adhesive portions 508
  • the slower reacting adhesive i.e., first photosensitive adhesive portions 504
  • deactivation time means the amount of time it takes for a particular peak wavelength of light used to activate the adhesive from the designed or maximum peel/bond strength to the 90 percent of the minimum peel/bond strength or designed removal peel/bond strength.
  • FIG. 6 shows a perspective view of drape system 600, which includes a light blocking film 604, a photosensitive adhesive layer 608, and a plurality of perforations 612 disposed in the light blocking film 604.
  • light blocking film 604 is bonded onto a surface of the photosensitive adhesive layer 608 that faces away from the patient tissue.
  • Light blocking film 604 may correspond to blocking layer 204 shown in FIGs. 2A-2C and may be removable in some embodiments.
  • Perforations 612 disposed in light blocking film 604 enable some areas (i.e., photosensitive adhesive portions) of the light sensitive adhesive to be exposed to deactivating light wavelengths for a prolonged period of time. This enables the photosensitive adhesive portions corresponding to perforations 612 to deactivate and reduce the tack of the photosensitive adhesive layer 608.
  • the entire drape system 600 including both light blocking film 604 and photosensitive adhesive layer 608) may be perforated with perforations 612 to achieve a similar reduction in bond strength.
  • FIGs. 7-8 illustrative embodiments of an opaque removable light blocking layer 700, 800 disposed onto a light switchable adhesive layer is shown.
  • Opaque may correspond to a material or layer that reflects or absorbs a substantial or majority portion of a particular type of light and/or that does not transmit a substantial or majority portion of the particular type of light.
  • FIG. 7 shows a top view of opaque removable light blocking layer 700.
  • layer 700 is a transparent or translucent (i.e., non-opaque) breathable film 704 that is not opaque and enables certain visible light wavelengths to pass through the film.
  • the layer may be transparent or translucent to visible light (or UV light), i.e., transmit a substantial or majority portion of visible or UV light and/or not reflect or absorb a substantial or majority portion of visible or UV light.
  • film 704 may be an acrylic or polyurethane layer.
  • film 704 may be bonded to an outer surface of a light sensitive skin adhesive film layer with a removable opaque adhesive.
  • the light blocking layer 700 is comprised of an opaque adhesive casted or coated onto a surface facing away from patient tissue of transparent or translucent breathable film 704.
  • Application of the opaque adhesive can be achieved via various suitable methods such as screen printing, coating or lamination, embodying reflective materials, etc.
  • transparent or translucent (i.e., non-opaque) breathable film 704 is a thin and flexible layer that can be screen printed with an opaque ink to form an opaque removable light blocking layer 700.
  • the opacity of this layer protects the light sensitive adhesive layer in contact with the skin from exposure to deactivating light wavelengths and undesirable premature deactivation of the adhesive.
  • the screen printed transparent or translucent breathable film 704 may be weakly or reversibly bonded onto the light sensitive skin adhesive film to enable easy removal by a user when deactivation of the adhesive is desired.
  • transparent or translucent breathable film 704 covers the entire outer surface of the light sensitive adhesive layer. However, breathability of the drape system must be maintained in order to achieve effective wound therapy.
  • the transparent or translucent breathable film 704 may contain one or more perforations 708.
  • perforations 708 may be holes that extend entirely through the transparent or translucent breathable film 704 between an outer surface and the light switchable adhesive facing surface. In some embodiments, perforations 708 also extend through the light sensitive adhesive layer.
  • FIG. 8 shows a top view of opaque removable light blocking layer 800 according to another embodiment.
  • opaque removable light blocking layer 800 includes opaque light blocking portions 804 that are pattern coated onto an outer surface of a light sensitive adhesive layer.
  • the pattern coat of the opaque ink is a mesh configuration instead of the perforation configuration shown in FIG. 7.
  • opaque light blocking portions 804 cover portions of the light sensitive adhesive layer that need to be protected from premature deactivation to achieve adequate adhesion of the drape to the tissue.
  • opaque removable light blocking layer 800 includes channels 808 that increase breathability of the dressing by enabling moisture vapor to be transmitted or pass through channels 808.
  • channels 808 may be openings that extend entirely through the transparent or translucent breathable film between an outer surface and the light switchable adhesive facing surface. In some embodiments, channels 808 also extend through the light sensitive adhesive layer.
  • multiple different light blocking portions may be used, such as 804 and 804a as illustrated in FIG. 8.
  • the light blocking portions may have different features or shapes, such as illustrated in FIG. 8. Both light blocking portions may be opaque, one may be opaque, or neither may be opaque.
  • one of the light blocking portions (804 or 804a) is patterned on the removable light blocking layer and the other is integral with the light blocking layer 800.
  • FIG. 9 shows a top view of opaque removable light blocking layer 900 according to another embodiment.
  • layer 900 is a transparent or translucent breathable film 904.
  • the opaque removable light blocking layer 900 can be perforated with perforations 908 or pattern coated to selectively increase moisture vapor transmission rate (MVTR) by enabling moisture vapor to be transmitted or pass through perforations 908.
  • MVTR moisture vapor transmission rate
  • opaque removable light blocking layer 900 completely surrounds a central viewing area 912 that is centrally located on transparent or translucent breathable film 904.
  • central viewing area 912 is a portion of transparent or translucent breathable film 904 that is not coated or covered with opaque ink or pigment and enables a user to view the wound area through central viewing area 912.
  • a selective section (depending on the requirement of the size of viewing area) of the transparent or translucent breathable film 904 is left uncovered by the opaque ink or pigment during the screen printing process to create central viewing area 912.
  • the opaque removable light blocking layer 900 can be formed or fabricated such that a surface thereof defines a plurality of apertures or through holes.
  • FIG. 10 shows a perspective view of drape system 1000, which includes a transparent or translucent breathable film 1004, an opaque light blocking film 1008, a photosensitive adhesive layer 1012, and a plurality of perforations 1016 disposed in the opaque removable light blocking film 1008.
  • transparent or translucent breathable film 1004 is bonded onto a surface of the photosensitive adhesive layer 1012 that faces away from the patient tissue.
  • Light blocking film 1008 may correspond to blocking layer 204 shown in FIGs. 2A-2C and may be removable in some embodiments.
  • transparent or translucent breathable film 1004 is bonded to photosensitive adhesive layer 1012 via opaque light blocking film 1008.
  • perforations 1016 may also be disposed in transparent or translucent breathable film 1004.
  • opaque light blocking film 1008 is applied to a surface of transparent or translucent breathable film 1004 via screen printing or coating/lamination.
  • bond strength can be reduced from 18 N/25 mm to 9 N/25 mm in the photosensitive adhesive layer 1012, and will also further increase the breathability of the opaque light blocking film 1008.
  • graphene may be imprinted or otherwise deposited (e.g., via electrodeposition, photolithography, etc.) onto the transparent or translucent breathable film to create the desired amount of opacity.
  • Activated charcoal maybe also be used to create opacity via printing. Activated charcoal may also achieve odor absorption of the wound in addition to the desired opacity.
  • Additional reflective materials such as metallic or metal coated films may also be incorporated onto/into the transparent or translucent breathable film to create additional opacity.
  • micro/nano optical structures may also be imprinted or embossed onto/into the transparent or translucent breathable film to diffract light to create opacity.
  • carbon nanotubes can be“'grown” on the surface of the transparent or translucent breathable film or extruded within the transparent or translucent breathable film to create opacity.
  • FIG. 11 depicts a flowchart illustrating a general process 1100 for facilitating removal of a light deactivated adhesive drape system (e.g., 100, 200, 300, 400, 500, 600, or 1000) from a tissue 104 in accordance with an illustrative embodiment of the disclosure.
  • the process illustrated in FIG. 11 can be implemented by a user of a reduced or negative pressure treatment system.
  • the process begins by applying a drape to a tissue 104 (step 1104).
  • adhesive portions 120 can bind to the tissue 104.
  • reduced or negative pressure can be applied to the tissue 104 using a reduced or negative pressure treatment system.
  • the process determines whether to remove the drape from the tissue 104 (step 1108).
  • step 1108 If the process determines not to remove the drape from the tissue 104, the process returns to step 1108. If the process determines to remove the drape from the tissue 104, the process applies an external stimulus to the drape, including the adhesive portions 120 coupled to the drape (step 1112). In this step, a release agent 128 can be released in accordance with any of the illustrative embodiments described above to facilitate the removal of the drape from the tissue 104. The process then removes the drape from the tissue 104 (step 1116).
  • FIG. 12 depicts a flowchart illustrating process 1200 for facilitating removal of a light deactivated adhesive drape system (e.g., 100, 200, 300, 400, 500, 600, or 1000) from a tissue 104 in accordance with an illustrative embodiment of the disclosure.
  • process 1200 begins by coupling a drape to a tissue (step 1204).
  • the drape may have a removable blocking layer similar to layer 204 discussed above.
  • Process 1200 continues by, when the drape is desired to be removed, the blocking layer is removed to expose the photosensitive adhesive layer to light (step 1208).
  • Process 1200 continues by applying certain deactivating light wavelengths to the photosensitive adhesive layer to deactivate the adhesive (step 1212). The process then enables a removal of the drape from the tissue (step 1216).
  • FIGS. 11 and 12 Such flowcharts and block diagrams may be useable with the drapes of FIGS. 1A, 1B, 2A-2C, and 3-10.
  • the function or functions noted in the block can occur out of the order noted in the figures.
  • the function or functions noted in the block can occur out of the order noted in the figures.
  • two blocks shown in succession can be executed substantially concurrently, or the blocks can sometimes be executed in the reverse order, depending upon the functionality involved.
  • a function of one or more blocks may be omitted.
  • a function of a block of another method or device described herein can be added.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Dermatology (AREA)
  • Materials For Medical Uses (AREA)

Abstract

L'invention concerne un système et une méthode d'application et de retrait atraumatiques de champs adhésifs désactivés par la lumière. Un aspect de l'invention concerne un système comprenant un champ, au moins une partie adhésive photosensible comprenant un agent antiadhésif et au moins une partie non adhésive, le système étant conçu pour être raccordé à un site tissulaire et libéré de celui-ci lors d'une exposition à un stimulus externe tel que de la lumière. Le système peut comprendre une couche de blocage amovible pour empêcher l'adhésif photosensible d'être exposé à des longueurs d'onde qui provoqueraient une désactivation prématurée. Un autre aspect concerne un système comprenant un champ, au moins une première partie adhésive photosensible et au moins une seconde partie adhésive photosensible, chacune ayant des temps de désactivation différents.
PCT/US2019/042318 2018-07-18 2019-07-18 Systèmes et méthodes pour réduire ou modifier laforce de liaison de d'application et de retrait de champs adhésifs désactivés par la lumière WO2020018734A1 (fr)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999018136A1 (fr) * 1997-10-02 1999-04-15 Smith & Nephew Plc Adhesifs
US20090216170A1 (en) * 2008-02-27 2009-08-27 Timothy Mark Robinson System and method for healing a wound at a tissue site
WO2014202935A1 (fr) * 2013-06-17 2014-12-24 Lumina Adhesives Ab Éléments couvrants médicaux de protection cutanée, champs opératoires pour incision, barrières bactériennes pour recouvrir des plaies, dispositifs de fermeture cutanées et méthodes de traitement les utilisant
WO2016124339A1 (fr) * 2015-02-05 2016-08-11 Lumina Adhesives Ab Adhésifs commutables à base de polyuréthane
WO2019161321A1 (fr) * 2018-02-19 2019-08-22 Kci Licensing, Inc. Systèmes et méthodes d'application et de retrait atraumatiques de champs adhésifs désactivés par la lumière

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999018136A1 (fr) * 1997-10-02 1999-04-15 Smith & Nephew Plc Adhesifs
US20090216170A1 (en) * 2008-02-27 2009-08-27 Timothy Mark Robinson System and method for healing a wound at a tissue site
WO2014202935A1 (fr) * 2013-06-17 2014-12-24 Lumina Adhesives Ab Éléments couvrants médicaux de protection cutanée, champs opératoires pour incision, barrières bactériennes pour recouvrir des plaies, dispositifs de fermeture cutanées et méthodes de traitement les utilisant
WO2016124339A1 (fr) * 2015-02-05 2016-08-11 Lumina Adhesives Ab Adhésifs commutables à base de polyuréthane
WO2019161321A1 (fr) * 2018-02-19 2019-08-22 Kci Licensing, Inc. Systèmes et méthodes d'application et de retrait atraumatiques de champs adhésifs désactivés par la lumière

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