US20200008980A1 - Hybrid drape having a gel-coated perforated mesh - Google Patents

Abstract

A system for treating a tissue site with negative-pressure is described. The system includes a manifold configured to be positioned adjacent to the tissue site and a drape configured to be positioned over the tissue site and the manifold to form a sealed space. The system also includes a negative-pressure source configured to provide negative-pressure to the sealed space. The drape includes a film layer, a layer of a bonding adhesive coupled to the film layer, and a mesh coupled to the layer of the bonding adhesive. The mesh includes a coating of a sealing adhesive and one or more bonding apertures. Methods of manufacturing the drape are also described.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application is a divisional of U.S. patent application Ser. No. 14/619,714, filed Feb. 11, 2015, entitled “HYBRID DRAPE HAVING A GEL-COATED PERFORATED MESH,” which claims priority to and the benefit of U.S. Provisional Patent Application No. 61/945,882, filed Feb. 28, 2014, entitled “HYBRID DRAPE HAVING A GEL-COATED PERFORATED MESH,” each of which is hereby incorporated by reference for all purposes.
FIELD
• The present disclosure relates generally to dressings for adhering to a wound or tissue site, and more particularly, but without limitation, to a hybrid drape having a gel-coated perforated mesh.
BACKGROUND
• Clinical studies and practice have shown that reducing pressure in proximity to a tissue site can augment and accelerate growth of new tissue at the tissue site. The applications of this phenomenon are numerous, but it has proven particularly advantageous for treating wounds. Regardless of the etiology of a wound, whether trauma, surgery, or another cause, proper care of the wound is important to the outcome. Treatment of wounds or other tissue with reduced pressure may be commonly referred to as “negative-pressure therapy,” but is also known by other names, including “negative pressure wound therapy,” “reduced-pressure therapy,” “vacuum therapy,” and “vacuum assisted closure,” for example. Negative-pressure therapy may provide a number of benefits, including migration of epithelial and subcutaneous tissues, improved blood flow, and micro-deformation of tissue at a wound site. Together, these benefits can increase development of granulation tissue and reduce healing times.
• While the clinical benefits of negative-pressure therapy are widely known, the cost and complexity of negative-pressure therapy can be a limiting factor in its application, and the development and operation of negative-pressure systems, components, and processes continues to present significant challenges to manufacturers, healthcare providers, and patients.
SUMMARY
• According to an illustrative, non-limiting embodiment, a dressing for treating a tissue site with negative pressure is described. The dressing may include a tissue interface configured to be positioned adjacent to the tissue site; and a sealing member configured to be positioned over the tissue interface and the tissue site to form a sealed environment. The sealing member may include a film layer, a layer of a bonding adhesive coupled to the film layer, and a mesh coupled to the layer of the bonding adhesive. The mesh may have a coating of a sealing adhesive and one or more bonding apertures.
• According to another illustrative embodiment, a system for treating a tissue site with negative-pressure is described. The system may include a manifold configured to be positioned adjacent to the tissue site and a drape configured to be positioned over the tissue site and the manifold to form a sealed space. The system may also include a negative-pressure source configured to provide negative-pressure to the sealed space. The drape may include a film layer, a layer of a bonding adhesive coupled to the film layer, and a mesh coupled to the layer of the bonding adhesive. The mesh may have a coating of a sealing adhesive and one or more bonding apertures.
• According to another illustrative embodiment, a method for manufacturing a drape for a negative-pressure system is described. A film layer may be provided, and a layer of a bonding adhesive may be coupled to the film layer. A mesh may be formed and coated with a sealing adhesive. One or more bonding apertures may be formed in the mesh, and the mesh may be coupled to the layer of the bonding adhesive.
• Other aspects, features, and advantages of the illustrative embodiments will become apparent with reference to the drawings and detailed description that follow.
BRIEF DESCRIPTION OF THE DRAWINGS
• Illustrative embodiments are described in detail below with reference to the attached drawings, which are incorporated by reference herein, and wherein:
• FIG. 1 is a schematic diagram of an illustrative embodiment of a system for treating a tissue site with negative pressure;
• FIG. 2 is an exploded perspective view of a drape that may be used with some embodiments of the systems ofFIG. 1;
• FIG. 3A is a plan view of a mesh that may be used with some embodiments of the drape ofFIG. 2;
• FIG. 3B is a perspective view of a portion of the mesh ofFIG. 3A;
• FIG. 3C is a side elevation view of a portion of the mesh ofFIG. 3A;
• FIG. 4 is a sectional view illustrating additional details that may be associated with some embodiments of the drape ofFIG. 2 in a first state; and
• FIG. 5 is a sectional view of the portion of the drape ofFIG. 4 in a second state.
DETAILED DESCRIPTION
• The following description of example embodiments provides information that enables a person skilled in the art to make and use the subject matter set forth in the appended claims, but may omit certain details already well-known in the art. The following detailed description is, therefore, to be taken as illustrative and not limiting.
• The example embodiments may also be described herein with reference to spatial relationships between various elements or to the spatial orientation of various elements depicted in the attached drawings. In general, such relationships or orientation assume a frame of reference consistent with or relative to a patient in a position to receive treatment. However, as should be recognized by those skilled in the art, this frame of reference is merely a descriptive expedient rather than a strict prescription.
• FIG. 1 is a sectional view of an example embodiment of a negative-pressure therapy system100 illustrating details that may be associated with some embodiments for treating atissue site102 with negative pressure. As shown in the illustrative embodiment ofFIG. 1, the negative-pressure therapy system100 may include adressing104 fluidly coupled to a negative-pressure source106. In some embodiments, the negative-pressure source106 may be fluidly coupled to thedressing104 by a conduit, such as atube112, and a connector, such as aconnector114. Thedressing104 may generally include a drape, such as adrape108, and a tissue interface, such as amanifold110. Thedrape108 may have afilm layer124, a layer of a bondingadhesive126, and amesh128. Thedrape108 may be attached to anepidermis116.
• In general, components of the negative-pressure therapy system100 may be coupled directly or indirectly to each other. For example, the negative-pressure source106 may be directly coupled to theconnector114 and indirectly coupled to themanifold110 through theconnector114. Components may be fluidly coupled to each other to provide a path for transferring fluids (such as, liquid, gas, or both liquid and gas) between the components.
• In some embodiments, components may be fluidly coupled with a tube, such as thetube112, for example. A “tube,” as used herein, broadly refers to a tube, pipe, hose, conduit, or other structure with one or more lumina adapted to convey fluids between two ends. Typically, a tube is an elongated, cylindrical structure with some flexibility, but the geometry and rigidity may vary. In some embodiments, components may additionally or alternatively be coupled by virtue of physical proximity, being integral to a single structure, or being formed from the same piece of material. Coupling may also include mechanical, thermal, electrical, or chemical coupling (such as a chemical bond) in some contexts.
• In operation, a tissue interface, such as themanifold110, may be placed within, over, on, against, or otherwise adjacent to a tissue site. For example, themanifold110 may be placed against thetissue site102, and thedrape108 may be placed over themanifold110 and sealed to tissue proximate to thetissue site102. Tissue proximate to a tissue site is often undamaged epidermis peripheral to the tissue site. Thus, thedrape108 can provide a sealedtherapeutic environment118 proximate to thetissue site102. The sealedtherapeutic environment118 may be substantially isolated from the external environment, and the negative-pressure source106 can reduce the pressure in the sealedtherapeutic environment118. Negative pressure applied uniformly through a tissue interface in the sealedtherapeutic environment118 can induce macrostrain and microstrain in thetissue site102, as well as remove exudates and other fluids from the tissue site. The removed exudates and other fluids can be collected in a container and disposed of properly.
• The fluid mechanics of using a negative-pressure source to reduce pressure in another component or location, such as within a sealedtherapeutic environment118, can be mathematically complex. However, the basic principles of fluid mechanics applicable to negative-pressure therapy are generally well-known to those skilled in the art, and the process of reducing pressure may be described illustratively herein as “delivering,” “distributing,” or “generating” negative pressure, for example.
• In general, exudates and other fluids flow toward lower pressure along a fluid path. This orientation is generally presumed for purposes of describing various features and components of negative-pressure therapy systems herein. Thus, in the context of negative-pressure therapy, the term “downstream” typically implies something in a fluid path relatively closer to a negative-pressure source, and conversely, the term “upstream” implies something relatively further away from a negative-pressure source. Similarly, it may be convenient to describe certain features in terms of fluid “inlet” or “outlet” in such a frame of reference. However, a fluid path may also be reversed in some applications, such as by substituting a positive-pressure source, and this descriptive convention should not be construed as a limiting convention.
• The term “tissue site” in this context broadly refers to a wound or defect located on or within tissue, including but not limited to, bone tissue, adipose tissue, muscle tissue, neural tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendons, or ligaments. A wound may include chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure, or venous insufficiency ulcers), flaps, and grafts, for example. The term “tissue site” may also refer to areas of tissue that are not necessarily wounded or defective, but are instead areas in which it may be desired to add or promote the growth of additional tissue. For example, negative pressure may be used in certain tissue areas to grow additional tissue that may be harvested and transplanted to another tissue location. In an illustrative embodiment, thetissue site102 may be a wound that extends through theepidermis116, through adermis120, and intosubcutaneous tissue122.
• “Negative pressure” generally refers to a pressure less than a local ambient pressure, such as the ambient pressure in a local environment external to a sealedtherapeutic environment118 provided by thedrape108. In many cases, the local ambient pressure may also be the atmospheric pressure in a patient's vicinity. Alternatively, the pressure may be less than a hydrostatic pressure associated with tissue at the tissue site. Unless otherwise indicated, values of pressure stated herein are gauge pressures. Similarly, references to increases in negative pressure typically refer to a decrease in absolute pressure, while decreases in negative pressure typically refer to an increase in absolute pressure.
• A negative-pressure source, such as the negative-pressure source106, may be a reservoir of air at a negative pressure, or may be a manual or electrically-powered device that can reduce the pressure in a sealed volume, such as a vacuum pump, a suction pump, a wall-suction port available at many healthcare facilities, or a micro-pump, for example. A negative-pressure source may be housed within or used in conjunction with other components, such as sensors, processing units, alarm indicators, memory, databases, software, display devices, or operator interfaces that further facilitate negative-pressure therapy. While the amount and nature of negative pressure applied to a tissue site may vary according to therapeutic requirements, the pressure typically ranges between −5 millimeters of mercury (mm Hg) (−667 Pa) and −500 mm Hg (−66.7 kPa). Common therapeutic ranges are between −75 mm Hg (−9.9 kPa) and −300 mm Hg (−39.9 kPa).
• A tissue interface, such as the manifold110, can generally be adapted to contact a tissue site or other layers of a dressing. A tissue interface may be partially or fully in contact with a tissue site. If a tissue site is a wound, for example, a tissue interface may partially or completely fill the wound, or may be placed over the wound. A tissue interface may take many forms, and may be many sizes, shapes, or thicknesses depending on a variety of factors, such as the type of treatment being implemented or the nature and size of a tissue site. For example, the size and shape of a tissue interface may be adapted to the contours of deep and irregular shaped tissue sites.
• In some embodiments, a tissue interface may be a manifold, such as themanifold110. A “manifold” in this context generally includes any substance or structure providing a plurality of pathways adapted to collect or distribute fluid across a tissue site under negative pressure. For example, a manifold may be adapted to receive negative pressure from a source and distribute the negative pressure through multiple apertures across a tissue site, which may have the effect of collecting fluid from across a tissue site and drawing the fluid toward the source. In some embodiments, the fluid path may be reversed or a secondary fluid path may be provided to facilitate delivering fluid across a tissue site.
• In some illustrative embodiments, the pathways of a manifold may be channels interconnected to improve distribution or collection of fluids across a tissue site. For example, cellular foam, open-cell foam, reticulated foam, porous tissue collections, and other porous material such as gauze or felted mat generally include pores, edges, and/or walls adapted to form interconnected fluid pathways. Liquids, gels, and other foams may also include or be cured to include apertures and flow channels. In some illustrative embodiments, a manifold may be a porous foam material having interconnected cells or pores adapted to uniformly (or quasi-uniformly) distribute negative pressure to a tissue site. The foam material may be either hydrophobic or hydrophilic. In one non-limiting example, a manifold may be an open-cell, reticulated polyurethane foam such as GranuFoam® dressing available from Kinetic Concepts, Inc. of San Antonio, Tex.
• In some embodiments, such as embodiments in which the manifold110 may be made from a hydrophilic material, the manifold110 may also wick fluid away from a tissue site while continuing to distribute negative pressure to the tissue site. The wicking properties of the manifold110 may draw fluid away from a tissue site by capillary flow or other wicking mechanisms. An example of a hydrophilic foam is a polyvinyl alcohol, open-cell foam such as V.A.C. WhiteFoam® dressing available from Kinetic Concepts, Inc. of San Antonio, Tex. Other hydrophilic foams may include those made from polyether. Other foams that may exhibit hydrophilic characteristics include hydrophobic foams that have been treated or coated to provide hydrophilicity.
• A tissue interface may further promote granulation at a tissue site if pressure within the sealedtherapeutic environment118 is reduced. For example, any or all of the surfaces of the manifold110 may have an uneven, coarse, or jagged profile that can induce microstrains and stresses at a tissue site if negative pressure is applied through themanifold110.
• In some example embodiments, a tissue interface may be constructed from bioresorbable materials. Suitable bioresorbable materials may include, without limitation, a polymeric blend of polylactic acid (PLA) and polyglycolic acid (PGA). The polymeric blend may also include without limitation polycarbonates, polyfumarates, and capralactones. The tissue interface may further serve as a scaffold for new cell-growth, or a scaffold material may be used in conjunction with the tissue interface to promote cell-growth. In general, a scaffold material may be a biocompatible or biodegradable substance or structure used to enhance or promote the growth of cells or formation of tissue, such as a three-dimensional porous structure that provides a template for cell growth. Illustrative examples of scaffold materials include calcium phosphate, collagen, PLA/PGA, coral hydroxy apatites, carbonates, or processed allograft materials.
• In some embodiments, thedrape108 may provide a bacterial barrier and protection from physical trauma. Thedrape108 may also be constructed from a material that can reduce evaporative losses and provide a fluid seal between two components or two environments, such as between a therapeutic environment and a local external environment. Thedrape108 may be, for example, an elastomeric film or membrane that can provide a seal adequate to maintain a negative pressure at a tissue site for a given negative-pressure source. In some example embodiments, thedrape108 may be a polymer drape, such as a polyurethane film, that is permeable to water vapor but impermeable to liquid. Such drapes typically have a thickness in the range of about 25 microns to about 50 microns. For permeable materials, the permeability generally should be low enough that a desired negative pressure may be maintained.
• An attachment device may be used to attach thedrape108 to an attachment surface, such as undamaged epidermis, a gasket, or another cover. The attachment device may take many forms. For example, an attachment device may be a medically-acceptable, pressure-sensitive adhesive that extends about a periphery, a portion, or an entire sealing member. In some embodiments, for example, some or all of thedrape108 may be coated with an acrylic adhesive having a coating weight between about 25 grams per square meter (gsm) to about 65 gsm. Thicker adhesives, or combinations of adhesives, may be applied in some embodiments to improve the seal and reduce leaks. Other example embodiments of an attachment device may include a double-sided tape, paste, hydrocolloid, hydrogel, silicone gel, or organogel.
• A “container” broadly includes a canister, pouch, bottle, vial, or other fluid collection apparatus. A container, for example, can be used to manage exudates and other fluids withdrawn from a tissue site. In many environments, a rigid container may be preferred or required for collecting, storing, and disposing of fluids. In other environments, fluids may be properly disposed of without rigid container storage, and a re-usable container could reduce waste and costs associated with negative-pressure therapy. In some embodiments, a container may be a component of a negative-pressure source, such as the negative-pressure source106.
• A “connector,” such as theconnector114, may be used to fluidly couple a tube to a sealed therapeutic environment. The negative pressure developed by a negative-pressure source may be delivered through a tube to a connector. In one illustrative embodiment, a connector may be a T.R.A.C.® Pad or Sensa T.R.A.C.® Pad available from Kinetic Concepts, Inc. of San Antonio, Tex. In one exemplary embodiment, theconnector114 may allow the negative pressure generated by the negative-pressure source106 to be delivered to the sealedtherapeutic environment118. In other exemplary embodiments, a connector may also be a tube inserted through a drape.
• Negative-pressure therapy is increasingly being performed with smaller devices that use battery power rather than a connection to an electrical outlet. Use of battery power decreases the total power supply available to a device. As a result, power drains that would be considered negligible in a device powered through an electrical outlet connection may significantly reduce the performance of a battery-powered device. Power drains may be caused by low-level dressing leaks, for example, which can drain power by repeatedly triggering operation of the a negative-pressure source to maintain a therapeutic negative pressure at the tissue site. Power drains can shorten the useful life of a device by draining the device battery faster, requiring more frequent disposal of the device, recharging of the battery, or battery replacement. Leak detection techniques may help to identify some leaks that may be sealed by the user; however, low-level leaks can challenge the most sensitive leak detection systems and may often go undetected.
• Low-level dressing leaks may occur between a drape and epidermis surrounding a tissue site if the drape fails to completely seal to the epidermis. Generally, a drape suitable for covering a tissue site for negative-pressure therapy may comprise a film having a thickness between about 25 microns and about 50 microns that is water-vapor permeable and formed of a polymer. The film, often formed of polyurethane, may be coated with an adhesive having a coating weight between about 25 gsm and about 65 gsm. The adhesive may often be acrylic-based and pressure sensitive. A standard acrylic adhesive may have a bond strength between about 1.8 Newton/centimeter (N/cm) and about 3.8 N/cm on stainless steel substrate at 23° C. at 50% relative humidity based on the American Society for Testing and Materials (“ASTM”) standard ASTM D3330. A pressure-sensitive adhesive increases in bond strength when pressed against the surface to which the adhesive is being bonded. In some applications, a pressure-sensitive adhesive may undergo a physical change when compressed against a surface. In other applications, a pressure-sensitive adhesive may flow into crevices of a surface when compressed, increasing the bond strength without undergoing a physical change. A drape using a standard acrylic adhesive as described above is generally suitable for a dressing where a negative-pressure source powered by a continuous power supply is available to compensate for a dressing leak.
• Some drapes may use a bonding adhesive instead of the standard acrylic adhesive. A bonding adhesive may be an adhesive having a bond strength that is greater than the bond strength of a standard acrylic adhesive. In some embodiments, a bonding adhesive may be a type of acrylic adhesive. A bonding adhesive may be better for sealing, but the increased bond strength may cause significantly more discomfort if the drape is removed. In addition, removing a drape having a bonding adhesive may cause significant damage to delicate or damaged skin.
• A drape that has a sealing adhesive can fill gaps between the drape and the epidermis to limit leaks and can be easy to remove with low discomfort to the patient. Generally, a sealing adhesive may have a lower bond strength than a standard acrylic adhesive and a bonding adhesive. Generally, a sealing adhesive may flow into gaps and crevices more readily than a standard acrylic adhesive or a bonding adhesive. Various sealing, gap-filling adhesives, such as silicone, hydrocolloids, and hydrogels, have been used but each can have drawbacks. For example, hydrogel adhesives are usually low tack and prone to swelling, creep, and mobility when used with fluid systems. Available hydrogels and hydrocolloids may not adhere well and may move when anchored. In another example, silicone adhesives can fill gaps and seal, but are not breathable and may lose mechanical bonding strength as the silicone adhesives interact with moisture during use. To counter these problems, silicone adhesives may require additional materials to secure the silicone adhesive to a patient. For example, a low-leak drape may be formed from two adhesive layers: a thick sealing adhesive, perhaps in the shape of a gasket or ring, and a thinner bonding adhesive layer used to keep the sealing adhesive in place. Low-leak drapes constructed in this way can be more complex than a drape using a single adhesive, increasing the complexity of manipulation and operation.
• A hybrid drape having a thick sealing layer that is perforated and laminated over an adhesive-coated film can overcome many of these challenges. For example, a hybrid drape may include a film layer having a bonding adhesive applied directly to the film layer, and a sealing adhesive applied directly to the bonding adhesive. The sealing adhesive can be perforated to expose the bonding adhesive. When the drape is applied to a patient, the bonding adhesive can be pushed through the perforations of the sealing adhesive to secure the sealing adhesive to the patient. This laminated configuration may provide the benefits of the sealing adhesive and the bonding adhesive over the entire drape area. For example, the laminated configuration may be conformable and of sufficient strength to ensure an initial seal, can inhibit the development of typical low-level leaks, and can mechanically affix to an epidermis without secondary processes. The laminated configuration may also minimize application care by a user and can be removable with minimal trauma to a patient.
• However, construction of a laminated configuration can require additional assembly steps and can increase an amount of materials that may be needed for drape construction, which can also significantly increase costs. In addition, as two layers of adhesive are applied to the film layer, the total thickness of the drape can significantly increase, reducing breathability of the drape. Still further, as two full layers of adhesive are applied, significantly more adhesive material is needed to construct the drape.
• Other hybrid drapes may register a bonding adhesive and a sealing adhesive. These hybrid drapes apply both a bonding adhesive and a sealing adhesive directly to a film layer. The bonding adhesive and the sealing adhesive may each cover different portions of a film layer to reduce the overall thickness of a hybrid drape and decrease the amount of adhesive needed to construct the hybrid drape. However, the complexity of the manufacturing process may also increase costs relative to other drapes. While using less adhesive than the laminated hybrid drapes, registered hybrid drapes may still use more adhesive in construction than standard drapes.
• Some hybrid drapes may use a gel coated mesh having mesh apertures with a diameter between about 5 millimeters (mm) and about 15 mm. However, a gel-coated mesh having apertures of this size may be unable to form a seal with a tissue site. The sealing properties of the gel-coated mesh may be improved by increasing an average diameter of the fibers used to form the mesh; however, the increased diameter of the fibers may also increase a prominence of a mesh where two fibers intersect. A prominence may be a relative height of a feature compared to surrounding features. If two fibers intersect so that a first fiber overlaps a second fiber, a prominence may be a distance between a top of a first fiber and the top of the second fiber. Generally, the prominence at an intersection of two fibers may be the diameter of the largest of the two intersecting fibers. Consequently, if the diameters of the fibers are increased to increase the sealing properties of a gel-coated mesh, the raised contours associated with fiber cross-over may create leaks that are difficult to seal.
• As disclosed herein, the negative-pressure therapy system100 can overcome these challenges and others by providing a substantially flat mesh coated with a sealing adhesive. In some embodiments, for example, thedrape108 may comprise a layer of a bonding adhesive coupled to a film layer, and a mesh layer coupled to the layer of bonding adhesive. The mesh layer may be a mesh formed of small diameter fibers and can be perforated to form bonding apertures. The mesh may be coated with a sealing adhesive.
• FIG. 2 is an exploded perspective view, illustrating details that may be associated with some embodiments of thedrape108. Thefilm layer124 may be liquid-impermeable and vapor-permeable, allowing vapor to egress and inhibiting liquid from exiting. Thefilm layer124 may be a flexible film that is breathable and may have a high moisture-vapor transfer rate (MVTR). For example, in some embodiments, the MVTR may be greater than or equal to about 300 g/m²/24 hours. Thefilm layer124 may be formed from a range of medically approved films that typically range in thickness from about 15 microns (μm) to about 50 microns (μm). In other embodiments, a drape having a low MVTR or that allows no vapor transfer may be used. Thefilm layer124 can also function as a barrier to liquids and microorganisms.
• Thefilm layer124 may be formed from numerous materials, such as one or more of the following: hydrophilic polyurethane (PU), cellulosics, hydrophilic polyamides, polyvinyl alcohol, polyvinyl pyrrolidone, hydrophilic acrylics, hydrophilic silicone elastomers, and copolymers of these. In an illustrative embodiment, thefilm layer124 may be formed from a breathable cast matt polyurethane film sold by Expopack Advanced Coatings of Wrexham, United Kingdom, under the name INSPIRE 2301. The illustrative film may have an MVTR (inverted cup technique) of 14400 g/m²/24 hours and may be approximately 30 microns thick.
• Thebonding adhesive126 may be coupled directly to thefilm layer124. Thebonding adhesive126 may be a medically-acceptable, pressure-sensitive adhesive. For example, thebonding adhesive126 may be formed from an acrylic adhesive, rubber adhesive, high-tack silicone adhesive, polyurethane, or other substance. In some illustrative embodiments, thebonding adhesive126 may be formed from an acrylic adhesive with a coating weight of about 15 gsm to about 70 gsm. Thebonding adhesive126 may also be a high-bond strength acrylic adhesive, patterrubber adhesive, high-tack silicone adhesive, or polyurethane, for example. In some embodiments, thebonding adhesive126 may have a peel adhesion or resistance to being peeled from a stainless steel material between about 6N/25 mm to about 10N/25 mm on stainless steel substrate at 23° C. at 50% relative humidity based on the ASTM D3330.
• Thebonding adhesive126 may be a continuous layer of material or may be a layer with apertures (not shown). The apertures may be formed after application of thebonding adhesive126 or may be formed by coating thebonding adhesive126 in patterns on a carrier layer. The apertures may be sized to help control the resultant tackiness of thebonding adhesive126. The apertures may also be sized to enhance the MVTR of thedrape108. Thebonding adhesive126 may couple thefilm layer124 to themesh128.
• In some embodiments, themesh128 may be a polymeric mesh, such as Mepitel® produced by Molnlycke Health Care, Adaptic® produced by Systagenix, and Noveface produced by Zodiac Aerospace Group. In some embodiments, themesh128 may be substantially flat. For example, themesh128 may have athickness129, and individual portions of themesh128 may have a minimal tolerance from thethickness129. In some embodiments, thethickness129 of themesh128 may be about 1 mm, and the tolerance of thethickness129 may be less than about 2 mm. In another exemplary embodiment, a tolerance of thethickness129 of themesh128 may be less than about 1 mm. In other embodiments, a tolerance of thethickness129 of themesh128 may be less than about 0.5 mm. In some embodiments, themesh128 may be formed withbonding apertures134. Thebonding apertures134 may be numerous shapes, for example, circles, squares, stars, ovals, polygons, slits, complex curves, rectilinear shapes, triangles, or other shapes.
• FIG. 3A is a plan view, illustrating details that may be associate with some embodiments of themesh128. Generally, a mesh may include a structure of connected strands of metal, fiber, or other flexible or ductile material having openings between the strands. In some embodiments, a mesh may have evenly spaced openings between adjacent strands. In some embodiments, themesh128 may have a plurality offibers136. In some embodiments, thefibers136 may be formed from a monofilament, a plurality of twisted monofilaments, a plurality of filaments, or a plurality of staple fibers. A filament may be a fiber that is formed in a continuous or near-continuous length. A monofilament may be a single filament. In some embodiments, a monofilament may be made from a single synthetic fiber of plastic, for example. Monofilaments may have a tensile strength related to a diameter of the monofilament and the type of material from which the monofilament is formed. A staple fiber may be a fiber of a selected standardized length, and the staple fiber may be formed of a suitable composition for used with a medical device. Each of thefibers136 may have adiameter127. In some embodiments, thediameter127 may be no greater than about 1 mm. Thefibers136 may be formed from a range of materials including, but not limited to, silicone, cellulose acetate, and other similar materials.
• In some embodiments, antimicrobial agents may be added to themesh128. In other embodiments, thefibers136 may have antimicrobial properties. For example, in some embodiments, silver ions may be added to thefibers136. In still other embodiments, thefibers136 may be formed from elastomers to permit easier coverage of complex contours.
• The plurality offibers136 may be woven, knitted, knotted, linked or otherwise connected to form a regular pattern of mesh apertures. In some embodiments, each of the plurality offibers136 may be separated fromadjacent fibers136 to formmesh apertures139. In some embodiments, thefibers136 may be separated adistance138 from adjacent fibers, which may be between about 0.5 mm and about 4 mm. In some embodiments, each of thefibers136 may be separated from adjacent fibers in a second direction by adistance140. In some embodiments, thedistance140 may be between about 0.5 mm and about 4 mm. In some embodiments, the first direction of thedistance138 and the second direction of thedistance140 may be perpendicular. In some embodiments, thedistance138 and thedistance140 may be the same. In other embodiments, the first direction of thedistance138 and the second direction of thedistance140 may be other angles, and thedistance138 and thedistance140 may not be the same.
• In some embodiments, themesh apertures139 may have an average effective diameter of about 1 mm. An effective diameter of a non-circular area may be a diameter of a circular area having the same surface area as the non-circular area. For example, the surface area of amesh aperture139 where thedistance138 is 0.5 mm and thedistance140 is 0.5 mm may be 0.25 mm². The diameter of a circular area having a 0.25 mm²surface area is about 0.56 mm; consequently, the effective diameter of theexemplary mesh aperture139 is about 0.56 mm. Similarly, if thedistance138 is about 4 mm and thedistance140 is about 4 mm, the effective diameter of themesh aperture139 may be about 4.51 mm.
• In some embodiments, themesh128 may include thebonding apertures134. Thebonding apertures134 may have a uniform pattern or may be randomly distributed on themesh128. Thebonding apertures134 may be formed through one ormore fibers136. In some embodiments, thebonding apertures134 may extend into themesh apertures139. Eachbonding aperture134 of the plurality ofbonding apertures134 may have an effective diameter. The average effective diameter of eachbonding aperture134 may be in the range of about 5 mm to about 15 mm.
• In some embodiments, themesh128 may be coated with a gel, such as a sealingadhesive144. In some embodiments, the sealing adhesive144 may have a coating weight of about 100 gsm to about 500 gsm. In other embodiments, the sealing adhesive144 may have a coating weight greater than about 200 gsm. The coating of themesh128 with the sealing adhesive144 may fill in a portion of eachmesh aperture139. In some embodiments, themesh apertures139 may remain at least partially open after the coating of themesh128 with the sealingadhesive144.
• A sealing adhesive may be a soft material that provides a good seal with thetissue site102. A sealing adhesive may be formed of a silicone gel (or soft silicone), hydrocolloid, hydrogel, polyurethane gel, polyolefin gel, hydrogenated styrenic copolymer gels, or foamed gels with compositions as listed, or soft closed cell foams (polyurethanes, polyolefins) coated with an adhesive (for example, 30 gsm-70 gsm acrylic), polyurethane, polyolefin, or hydrogenated styrenic copolymers. In some embodiments, a sealing adhesive may have a stiffness between about 5 Shore OO and about 80 Shore OO. A sealing adhesive may be hydrophobic or hydrophilic. A sealing adhesive may be an adhesive having a low to medium tackiness, for example, a silicone polymer, polyurethane, or an additional acrylic adhesive. In some embodiments, a sealing adhesive may a bond strength between about 0.5N/25 mm and about 1.5N/25 mm on a stainless steel substrate at 23° C. at 50% relative humidity based on ASTM D3330. A sealing adhesive may have a tackiness such that the sealing adhesive may achieve the bond strength above after a contact time of less than 60 seconds. Tackiness may be considered a bond strength of an adhesive after a very low contact time between the adhesive and a substrate. In an illustrative embodiment, a sealing adhesive may have a tackiness that may be about 30% to about 50% of the tackiness of a bonding adhesive.
• In some embodiments, thebonding apertures134 may be formed prior to coating of themesh128 with the sealingadhesive144. In other embodiments, thebonding apertures134 may be formed in themesh128 following coating of themesh128 with the sealingadhesive144.
• In some embodiments, thefibers136 of themesh128 may form a plurality ofintersections142. In some embodiments, anintersection142 may be a location of themesh128 where at least twofibers136 overlap, cross-over, or meet, for example.
• FIG. 3B is a perspective view, illustrating additional details that may be associated with some embodiments of themesh128 ofFIG. 3A. In some embodiments, themesh128 may be formed so that at eachintersection142, the intersectingfibers136 may be fused so that theintersection142 is planar. In some embodiments, themesh128 may be molded, extruded, or expanded to form themesh128. In embodiments where themesh128 is molded, extruded, or expanded, thefibers136 at anintersection142 may be fused or joined so that a prominence at theintersection142 is less than about 1 mm. In some embodiments, the prominence at anintersection142 may be about 0 mm. In some embodiments, a substantially flat mesh may have a thickness at theintersections142 that may be substantially the same as a thickness of themesh128 surrounding theintersections142.
• FIG. 3C is a side elevation view, illustrating additional details that may be associated with some embodiments of themesh128. In some embodiments, themesh128 may be formed by weaving or knitting thefibers136. If thefibers136 are woven or knitted, theintersections142 may have aprominence141. In some embodiments, theprominence141 of thefibers136 at theintersections142 may be equal to thediameter127 of thefibers136. In some embodiments, theprominence141 may be reduced by compressing themesh128 following weaving or knitting thefibers136. Theprominences141 of thefibers136 may also be reduced by passing themesh128 through a calender, which may apply pressure to themesh128 to smooth out themesh128. In some embodiments, theprominence141 may be less than about 1 mm.
• FIG. 4 is a sectional view, illustrating additional details that may be associated with some embodiments of thedrape108. In the assembled state, thebonding adhesive126 may be coupled to thefilm layer124, and themesh128 may be coupled to thebonding adhesive126. If themesh128 is placed proximate to or in contact with theepidermis116, the sealing adhesive144 coating themesh128 may form sealingcouplings146 with theepidermis116. In some embodiments, thediameter127 of thefibers136, the thickness of the sealing adhesive144, and thebonding apertures134 may create a gap between the bonding adhesive126 and theepidermis116.
• FIG. 5 is a sectional view, illustrating additional details that may be associated with some embodiments of thedrape108 ofFIG. 4 in a second position. If thedrape108 is in a desired location, pressure may be applied to thefilm layer124. The pressure may cause thebonding adhesive126 to be pressed at least partially into contact with theepidermis116 to formbonding couplings150. Thebonding couplings150 may provide secure, releasable mechanical fixation to theepidermis116. The sealingcouplings146 between the sealing adhesive144 and theepidermis116 may be sufficient to seal thefilm layer124 to theepidermis116. The sealingcouplings146 may not be as mechanically strong as thebonding couplings150 between the bonding adhesive126 and theepidermis116. Thebonding couplings150 may also anchor thedrape108 to theepidermis116, inhibiting migration of thedrape108 and the sealingadhesive144.
• The average effective diameter of thebonding apertures134 of the sealing adhesive144 may be varied as one control of the tackiness or adhesion strength of thedrape108. In this regard, there may be an interplay between three main variables for each embodiment: thediameter127 of thefibers136, the average effective diameter of the plurality ofbonding apertures134, and the tackiness of thebonding adhesive126. Themore bonding adhesive126 that extends through thebonding apertures134, the stronger thebonding coupling150. The smaller thediameter127 of thefibers136, the more thebonding adhesive126 generally extends through thebonding apertures134 and the greater thebonding coupling150. As an example of the interplay, if a very tacky bonding adhesive126 is used and thediameter127 of thefibers136 of themesh128 is small, the average effective diameter of the plurality ofbonding apertures134 may be relatively smaller to maintain a same adhesion strength of thedrape108.
• In other embodiments, themesh128 may be formed from a perforated film which is then coated with the sealing adhesive144 and laminated to thefilm layer124 or thebonding adhesive126. In other embodiments, themesh128 may be coated with thebonding adhesive126 and then pattern-coated with the sealingadhesive144. Themesh128 may then be laminated directly to thefilm layer124. Thebonding adhesive126 may be exposed through the areas of themesh128 that were not pattern-coated with the sealingadhesive144.
• In some embodiments, the adhesives may be mixed with blowing or expanding agents, for example organic and inorganic low temperature boiling point liquids. The blowing or expanding agents allow for the adhesives to expand under the application of heat or light to increase the thickness of the adhesive following deposition by one of the above described processes. The blowing or expanding agents may reduce the amount of adhesive needed and decrease the cost of production. In some embodiments, the application of heat or light may be delayed until application of thedrape108 to theepidermis116 so that the contact area with theepidermis116 may increase as thebonding adhesive126 and the sealing adhesive144 warm by contact with theepidermis116. The application of light or heat following application of thedrape108 to theepidermis116 can provide a better seal for some embodiments of thedrape108 to theepidermis116.
• A drape having a coated mesh may provide a lower cost solution that makes more efficient use of a sealing adhesive. The increase in efficiency of the use of a sealing adhesive may be accomplished without the complication of adding extruders and pattern coaters that may be required for pattern printing of adhesives. A drape having a coated mesh may have a higher MVTR than other drapes as the inclusion of mesh apertures can permit greater passage of moisture without interfering with sealing.
• Although certain features and their advantages have been disclosed in the context of certain illustrative, non-limiting embodiments, it should be understood that various changes, substitutions, permutations, and alterations can be made without departing from the scope of the appended claims. It will be appreciated that features that may be described in connection to one embodiment may also be applicable to other embodiments. It will also be understood that the benefits and advantages described above may relate to one embodiment or may relate to several embodiments. It will further be understood that reference to “an” item refers to one or more of those items.
• The steps of the methods described herein may be carried out in a suitable order, or simultaneously where appropriate.
• Where appropriate, aspects of the embodiments described above may be combined with aspects of the other embodiments described to form further examples having comparable or different properties and addressing the same or different problems.
• It will be understood that the embodiments described herein are given by way of example only and that various modifications may be made by those skilled in the art. The above specification, examples and data provide a complete description of the structure and use of exemplary embodiments. Although various embodiments have been described above with a certain degree of particularity, or with reference to one or more individual illustrations, those skilled in the art could make numerous alterations to the example embodiments without departing from the scope of the claims.

Claims (17)

1.-34. (canceled)

35. A method for manufacturing a drape for a negative-pressure system, the method comprising:

providing a film layer;

coupling a layer of a bonding adhesive to the film layer;

forming a mesh;

coating the mesh with a sealing adhesive;

forming one or more bonding apertures in the mesh; and

coupling the mesh to the layer of the bonding adhesive.

36. The method ofclaim 35, wherein the bonding apertures are formed in the mesh before coating the mesh.

37. The method ofclaim 35, wherein forming the mesh comprises weaving a plurality of fibers to form the mesh.

38. The method ofclaim 35, wherein forming the mesh comprises knitting a plurality of fibers to form the mesh.

39. The method ofclaim 35, wherein forming the mesh comprises extruding a plurality of fibers to form the mesh.

40. The method ofclaim 39, wherein extruding the plurality of fibers to form the mesh further comprises extruding the fibers so that the fibers intersect with a prominence less than about 1 millimeter.

41. The method ofclaim 35, wherein the mesh comprises a plurality of fibers and a diameter of each fiber is less than about 1 millimeter.

42. The method ofclaim 35, wherein the mesh comprises a plurality of fibers and each fiber comprises a monofilament.

43. The method ofclaim 35, wherein the mesh comprises a plurality of fibers and each fiber comprises a plurality of twisted monofilaments.

44. The method ofclaim 35, wherein the mesh comprises a plurality of fibers and each fiber comprises a staple fiber.

45. The method ofclaim 35, wherein forming the mesh comprises forming the mesh from a plurality of fibers having intersections and compressing the mesh to reduce a prominence at each intersection of the fibers.

46. The method ofclaim 35, wherein forming the mesh comprises forming the mesh from a plurality of fibers having intersections and calendaring the mesh to reduce a prominence at each intersection of the fibers.

47. The method ofclaim 35, wherein forming the mesh comprises forming the mesh to have a plurality of mesh apertures each having an effective diameter between about 0.5 millimeters and about 4 millimeters.

48. The method ofclaim 35, wherein coating the mesh comprises applying a coating weight of the sealing adhesive between about 100 grams per square meter and about 500 grams per square meter.

49. The method ofclaim 35, wherein forming the bonding apertures in the mesh comprises forming each bonding aperture with an effective diameter between about 5 millimeters and about 15 millimeters.

50. (canceled)

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