WO2018226624A1 - Composite dressings for improved granulation and reduced maceration with negative-pressure treatment - Google Patents

Composite dressings for improved granulation and reduced maceration with negative-pressure treatment Download PDF

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Publication number
WO2018226624A1
WO2018226624A1 PCT/US2018/035957 US2018035957W WO2018226624A1 WO 2018226624 A1 WO2018226624 A1 WO 2018226624A1 US 2018035957 W US2018035957 W US 2018035957W WO 2018226624 A1 WO2018226624 A1 WO 2018226624A1
Authority
WO
WIPO (PCT)
Prior art keywords
layer
dressing
manifold
film
fenestrations
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/US2018/035957
Other languages
English (en)
French (fr)
Inventor
Christopher Brian Locke
Timothy Mark Robinson
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
KCI Licensing Inc
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
Priority to BR112019025031-0A priority Critical patent/BR112019025031A2/pt
Priority to CA3060588A priority patent/CA3060588A1/en
Priority to EP23174149.7A priority patent/EP4233812A3/en
Priority to SG11201909386S priority patent/SG11201909386SA/en
Priority to AU2018282156A priority patent/AU2018282156B2/en
Priority to KR1020207000167A priority patent/KR20200016934A/ko
Priority to RU2019142454A priority patent/RU2019142454A/ru
Priority to CN201880036520.4A priority patent/CN110709038B/zh
Application filed by KCI Licensing Inc filed Critical KCI Licensing Inc
Priority to JP2019567266A priority patent/JP7204685B2/ja
Priority to EP18734368.6A priority patent/EP3634335B1/en
Publication of WO2018226624A1 publication Critical patent/WO2018226624A1/en
Anticipated expiration legal-status Critical
Priority to AU2024203188A priority patent/AU2024203188B2/en
Ceased legal-status Critical Current

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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
    • A61F13/05—Bandages or dressings; Absorbent pads specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
    • 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 bandages or dressings
    • A61F13/0203—Adhesive bandages or dressings with fluid retention members
    • A61F13/0223—Adhesive bandages or dressings with fluid retention members characterized by parametric properties of the fluid retention layer, e.g. absorbency, wicking capacity, liquid distribution
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/22—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons containing macromolecular materials
    • A61L15/225—Mixtures of macromolecular compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00—Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16—Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42—Use of materials characterised by their function or physical properties
    • A61L15/425—Porous materials, e.g. foams or sponges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/91—Suction aspects of the dressing
    • A61M1/915—Constructional details of the pressure distribution manifold
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/96—Suction control thereof
    • A61M1/962—Suction control thereof having pumping means on the suction site, e.g. miniature pump on dressing or dressing capable of exerting suction
    • 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 bandages or dressings
    • A61F13/0203—Adhesive bandages or dressings with fluid retention members
    • A61F13/0206—Adhesive bandages or dressings with fluid retention members with absorbent fibrous layers, e.g. woven or non-woven absorbent pads or island 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 bandages or dressings
    • A61F13/0203—Adhesive bandages or dressings with fluid retention members
    • A61F13/0213—Adhesive bandages or dressings with fluid retention members the fluid retention member being a layer of hydrocolloid, gel forming 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
    • A61F2013/00089—Wound bandages
    • A61F2013/00217—Wound bandages not adhering to the wound
    • 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
    • A61F2013/00089—Wound bandages
    • A61F2013/00246—Wound bandages in a special way pervious to air or vapours
    • A61F2013/00251—Wound bandages in a special way pervious to air or vapours with macroscopic openings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/91—Suction aspects of the dressing
    • A61M1/916—Suction aspects of the dressing specially adapted for deep wounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/92—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing with liquid supply means

Definitions

  • the first layer 205 may have a contact angle with water of no more than 150 degrees.
  • the contact angle of the first layer 205 may be in a range of at least 70 degrees to about 120 degrees, or in a range of at least 120 degrees to 150 degrees. Water contact angles can be measured using any standard apparatus.
  • contact angle measuring instruments can often include an integrated system involving a level stage, liquid dropper such as a syringe, camera, and software designed to calculate contact angles more accurately and precisely, among other things.
  • integrated systems may include the FTA125, FTA200, FTA2000, and FTA4000 systems, all commercially available from First Ten Angstroms, Inc., of Portsmouth, VA, and the DTA25,
  • the area density of the first layer 205 may vary according to a prescribed therapy or application. In some embodiments, an area density of less than 40 grams per square meter may be suitable, and an area density of about 20-30 grams per square meter may be particularly advantageous for some applications.
  • the first layer 205 may comprise or consist essentially of a hydrophobic polymer, such as a polyethylene film or ethyl methyl acrylate (EMA).
  • a hydrophobic polymer such as a polyethylene film or ethyl methyl acrylate (EMA).
  • EMA ethyl methyl acrylate
  • the simple and inert structure of polyethylene can provide a surface that interacts little, if any, with biological tissues and fluids, providing a surface that may encourage the free flow of liquids and low adherence, which can be particularly advantageous for many applications.
  • tie layers may be used, such as ethylene vinyl acetate, or modified polyurethanes.
  • An ethyl methyl acrylate (EMA) film may also have suitable hydrophobic and welding properties for some configurations.
  • the first layer 205 may include a polymer film of polylactic acid, carboxymethyl cellulose, or polycaprolactone.
  • the first layer 205 may include a film of xanthan gum mixed with at least one of collagen, oxidized regenerated cellulose, and alginate.
  • the first layer 205 includes a film of xanthan gum and citric acid mixed with at least one of collagen, oxidized regenerated cellulose, and alginate.
  • the first layer 205 may include a film co -polymerized with dialkylcarbamoylchloride in some embodiments.
  • Liquids, gels, and other foams may also include or be cured to include apertures and fluid pathways.
  • the second layer 210 may additionally or alternatively comprise projections that form interconnected fluid pathways.
  • the second layer 210 may be molded to provide surface projections that define interconnected fluid pathways. Any or all of the surfaces of the second layer 210 may have an uneven, coarse, or jagged profile
  • the 25% compression load deflection of the second layer 210 may be at least 0.35 pounds per square inch, and the 65% compression load deflection may be at least 0.43 pounds per square inch.
  • the tensile strength of the second layer 210 may be at least 10 pounds per square inch.
  • the second layer 210 may have a tear strength of at least 2.5 pounds per inch.
  • the second layer 210 may be foam comprised of polyols such as polyester or polyether, isocyanate such as toluene diisocyanate, and polymerization modifiers such as amines and tin compounds.
  • the second layer 210 may be a reticulated polyurethane foam such as used in GRANUFOAMTM dressing or V.A.C. VERAFLOTM dressing, both available from KCI of San Antonio, Texas.
  • the second layer 210 may be hydrophobic to minimize retention or storage of liquid in the dressing 104.
  • the second layer 210 may be hydrophilic.
  • the second layer 210 may also wick fluid away from a tissue site, while continuing to distribute negative pressure to the tissue site. The wicking properties of the second layer 210 may draw fluid away from a tissue site by capillary flow or other wicking mechanisms, for example.
  • An example of a hydrophilic second layer 210 is a polyvinyl alcohol, open-cell foam such as V.A.C. WHITEFOAMTM dressing available from KCI of San Antonio, Texas.
  • 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.
  • the perforations may be continuous or discontinuous through the structure, and when more than one layer is included, the layers may incorporate films to control flow direction.
  • cellulose may be treated to make the material hydrophobic, and the tissue interface may be perforated after adherence to a mat.
  • the second layer 210 may comprise or consist essentially of a layered structure of sheets of hydrofiber material, which may be stitched together to form a mat. The stitching may assist with pressure and fluid communication.
  • the stitched structure may be inter-spaced or replaced with a foamed version of this material, formed by means such as freeze drying, adding foaming agents, or by gas injection under high pressure during manufacture.
  • the second layer 210 generally has a first planar surface and a second planar surface opposite the first planar surface.
  • the thickness of the second layer 210 between the first planar surface and the second planar surface may also vary according to needs of a prescribed therapy. For example, the thickness of the second layer 210 may be decreased to relieve stress on other layers and to reduce tension on peripheral tissue.
  • the thickness of the second layer 210 can also affect the conformability of the second layer 210. In some embodiments, a thickness in a range of about 5 millimeters to 10 millimeters may be suitable.
  • the second layer 210 may be foam, mesh, or non-woven coated with an antimicrobial agent.
  • the first layer may comprise antimicrobial elements, such as fibers coated with an antimicrobial agent.
  • some embodiments of the first layer 205 may be polymer coated or mixed with an antimicrobial agent.
  • the fluid conductor 250 may additionally or alternatively be treated with one or more antimicrobial agents. Suitable antimicrobial agents may include, for example, metallic silver, PHMB, iodine or its complexes and mixes such as povidone iodine, copper metal compounds, chlorhexidine, or some combination of these materials.
  • Individual components of the dressing 104 may be bonded or otherwise secured to one another with a solvent or non-solvent adhesive, or with thermal welding, for example, without adversely affecting fluid management.
  • Figure 6 is a side view of another example configuration of the fluid restrictions 220, illustrating additional details that may be associated with some embodiments of the first layer 205.
  • the fluid restrictions 220 include a combination of fenestrations having raised edges 405 and perforations having holes 500.
  • a central zone of the first layer 205 may include a higher proportion of perforations than fenestrations.
  • the central zone may cover about 50% of the area of the first layer 205, and the central zone may be coextensive with about 50% of a manifolding area.
  • the peripheral zone may be coextensive with about 50% of the manifolding area.
  • a ratio of perforations to fenestrations in the central zone of the first layer 205 may be greater than about 1: 1.
  • the central zone of the first layer 205 may have a ratio of perforations to fenestrations of about 8:2.
  • the release liner 245 may be removed to expose the first layer 205, which may be placed within, over, on, or otherwise proximate to a tissue site, particularly a surface tissue site and adjacent epidermis.
  • the first layer 205 may be interposed between the second layer 210 and the tissue site and adjacent epidermis, which can substantially reduce or eliminate adverse interaction with the second layer 210.
  • the first layer 205 may be placed over a surface wound (including edges of the wound) and undamaged epidermis to prevent direct contact with the second layer 210.
  • a filler may also be disposed between a tissue site and the first layer 205.
  • a wound filler may be applied interior to the periwound, and the first layer 205 may be disposed over the periwound and the wound filler.
  • the filler may be a manifold, such as an open- cell foam.
  • the filler may comprise or consist essentially of the same material as the second layer 210 in some embodiments.
  • the tissue interface 114 may be formed into strips suitable for use as bridges or to fill tunnel wounds, for example. Strips having a width of about 5 millimeters to 30 millimeters may be suitable for some embodiments.
  • the first layer 205 may comprise reinforcing fibers to increase its tensile strength, which may be advantageous for use in tunnel wounds.
  • the third layer 705 may have a periphery 710 surrounding or around an interior portion 715, and apertures 720 disposed through the periphery 710 and the interior portion 715.
  • the interior portion 230 may correspond to a surface area of the second layer 210 in some examples.
  • the third layer 705 may also have corners 725 and edges 730. The corners 725 and the edges 730 may be part of the periphery 710.
  • the third layer 705 may have an interior border 735 around the interior portion 715, disposed between the interior portion 715 and the periphery 710.
  • the interior border 735 may be substantially free of the apertures 720, as illustrated in the example of Figure 3.
  • the interior portion 715 may be symmetrical and centrally disposed in the third layer 705.
  • the diameter of the apertures 720 in the periphery 710 of the third layer 705 may be larger than the diameter of the apertures 720 in the interior portion 715 of the third layer 705.
  • the apertures 720 disposed in the periphery 710 may have a diameter between about 9.8 millimeters to about 10.2 millimeters.
  • the apertures 720 disposed in the corners 725 may have a diameter between about 7.75 millimeters to about 8.75 millimeters.
  • the apertures 720 disposed in the interior portion 715 may have a diameter between about 1.8 millimeters to about 2.2 millimeters.
  • the release liner 245 may be attached to or positioned adjacent to the third layer 705 to protect the adhesive 240 prior to use.
  • the release liner 245 may have a surface texture that may be imprinted on an adjacent layer, such as the third layer 705.
  • a release agent may be disposed on a side of the release liner 245 that is configured to contact the third layer 705.
  • the third layer 705 may be coupled to the cover 116 to enclose the second layer 210 and the first layer 205, wherein the third layer 705 is configured to face a tissue site. Additionally or alternatively, the first layer 205, the third layer 705, or both may be disposed on both sides of the second layer 210 and bonded together to enclose the second layer 210.
  • the apertures 720 may be sized to expose a portion of the first layer 205, the fluid restrictions 220, or both through the third layer 705.
  • one or more of the apertures 720 may be sized to expose more than one of the fluid restrictions 220.
  • some or all of the apertures 720 may be sized to expose two or three of the fluid restrictions 220.
  • the length of each of the fluid restrictions 220 may be substantially equal to the diameter of each of the apertures 720. More generally, the average dimensions of the fluid restrictions 220 are substantially similar to the average dimensions of the apertures 720.
  • FIG 10 is a schematic view of another example of the third layer 705, illustrating additional details that may be associated with some embodiments.
  • the third layer 705 may have one or more fluid restrictions, such as valves 1000, instead of or in addition to the apertures 720 in the interior portion 715.
  • the valves 1000 may be elastomeric.
  • the first layer 205 may be omitted.
  • the tissue interface 114 may consist essentially of the second layer 210 and the third layer 705 of Figure 10 with the valves 705 disposed in the interior portion 415.
  • Figure 11 and Figure 12 illustrate other example configurations of the valves 1000, in which the valves 1000 each generally comprise a combination of intersecting slits or cross-slits.
  • the valves 1000 generally have a "Y" shape.
  • the valves 1000 generally have a cross or plus shape.
  • the release liner 245 may be removed to expose the third layer 705, which may be placed within, over, on, or otherwise proximate to a tissue site, particularly a surface tissue site and adjacent epidermis.
  • the third layer 705 and the first layer 205 may be interposed between the second layer 210 and the tissue site, which can substantially reduce or eliminate adverse interaction with the second layer 210.
  • the third layer 705 may be placed over a surface wound (including edges of the wound) and undamaged epidermis to prevent direct contact with the second layer 210.
  • the interior portion 715 of the third layer 705 may be positioned adjacent to, proximate to, or covering a tissue site.
  • the first layer 205, the fluid restrictions 220, or both may be exposed to a tissue site through the third layer 705.
  • the periphery 710 of the third layer 705 may be positioned adjacent to or proximate to tissue around or surrounding the tissue site.
  • the third layer 705 may be sufficiently tacky to hold the dressing 104 in position, while also allowing the dressing 104 to be removed or re -positioned without trauma to the tissue site.
  • Removing the release liner 245 can also expose the adhesive 240 and the cover 116 may be attached to an attachment surface, such as epidermis peripheral to a tissue site, around the second layer 210 and the first layer 205.
  • the adhesive 240 may be in fluid communication with an attachment surface through the apertures 420 in at least the periphery 710 of the third layer 705.
  • the adhesive 240 may also be in fluid communication with the edges 730 through the apertures 720 exposed at the edges 730.
  • the adhesive 240 may be pressed through the apertures 720 to bond the dressing 104 to the attachment surface.
  • the apertures 720 at the edges 730 may permit the adhesive 240 to flow around the edges 730 for enhancing the adhesion of the edges 730 to an attachment surface.
  • apertures or holes in the third layer 705 may be sized to control the amount of the adhesive 240 in fluid communication with the apertures 720.
  • the relative sizes of the apertures 720 may be configured to maximize the surface area of the adhesive 240 exposed and in fluid communication through the apertures 720 at the corners 725.
  • the edges 730 may intersect at substantially a right angle, or about 90 degrees, to define the corners 725.
  • the corners 725 may have a radius of about 10 millimeters.
  • the bond strength of the adhesive 240 may vary in different locations of the dressing 104.
  • the adhesive 240 may have lower bond strength in locations adjacent to the third layer 705 where the apertures 720 are relatively larger, and may have a higher bond strength where the apertures 720 are smaller.
  • Adhesive 240 with lower bond strength in combination with larger apertures 720 may provide a bond comparable to adhesive 240 with higher bond strength in locations having smaller apertures 720.
  • the dressing 104 may permit re-application or re-positioning to reduce or eliminate leaks, which can be caused by creases and other discontinuities in the dressing 104 or a tissue site.
  • the ability to rectify leaks may increase the reliability of the therapy and reduce power consumption in some embodiments.
  • the dressing 104 can provide a sealed therapeutic environment proximate to a tissue site, substantially isolated from the external environment, and the negative-pressure source 102 can reduce the pressure in the sealed therapeutic environment.
  • the third layer 705 may provide an effective and reliable seal against challenging anatomical surfaces, such as an elbow or heel, at and around a tissue site.
  • the dressing 104 may permit re-application or re-positioning, to correct air leaks caused by creases and other discontinuities in the dressing 104, for example. The ability to rectify leaks may increase the efficacy of the therapy and reduce power consumption in some embodiments.
  • Negative pressure applied through the tissue interface 114 can create a negative pressure differential across the fluid restrictions 220 in the first layer 205, which can open or expand the fluid restrictions 220.
  • the fluid restrictions 220 may comprise substantially closed fenestrations through the first layer
  • a pressure gradient across the fenestrations can strain the adjacent material of the first layer 205 and increase the dimensions of and/or deform the fenestrations to allow liquid movement through them, similar to the operation of a duckbill valve. Opening the fluid restrictions 220 can allow exudate and other liquid movement through the fluid restrictions
  • the first layer 205 and the third layer 705 can also substantially reduce or prevent exposure of tissue to the second layer 210, which can inhibit growth of tissue into the second layer 210. Deformation of the first layer 205 may occur to a greater extent at a central portion than at a peripheral zone, which may allow a greater volume of fluid to flow through the fluid restrictions 220 or the fenestrations 400. [00112] In some embodiments, by mixing the occurrence of the perforations
  • fluid flow may be more readily controlled to increase the flow of fluid in the central zone of the dressing 104, while restricting fluid back flow.
  • the higher valving functionality of the peripheral zone which is more likely to cover a periwound or intact skin, may reduce fluid reflux and the risk of maceration.
  • the tendency of a higher flow and/or lower pressure drop over the central zone of the dressing may encourage fluid to be drawn away from the dressing perimeter.
  • the perforations and the fenestrations may reduce a risk of fluid arriving at and/or lingering at a periwound or intact skin zone.
  • a filler may also be disposed between a tissue site and the third layer 705.
  • a tissue site is a surface wound
  • a wound filler may be applied interior to the periwound
  • the third layer 705 may be disposed over the periwound and the wound filler.
  • the filler may be a manifold, such as an open-cell foam.
  • the filler may comprise or consist essentially of the same material as the second layer 210 in some embodiments.
  • instillation solution or other fluid may be distributed to the dressing 104, which can increase the pressure in the tissue interface 114.
  • the increased pressure in the tissue interface 114 can create a positive pressure differential across the fluid restrictions 220 in the first layer 205, which can open the fluid restrictions 220 to allow the instillation solution or other fluid to be distributed to a tissue site.
  • Figure 14 is a schematic section view of an example manifold that may be associated with some embodiments of the second layer 210.
  • the manifold may be a fluid management assembly 1402, which may include a first wicking layer 1404, a second wicking layer 1406, and optionally an absorbent 1408.
  • the absorbent 1408 may be positioned between the first wicking layer 1404 and the second wicking layer 1406.
  • the first wicking layer 1404 may have a grain structure (not shown) adapted to wick fluid along a surface of the first wicking layer 1404.
  • the second wicking layer 1406 may have a grain structure (not shown) adapted to wick fluid along a surface of the second wicking layer 1406.
  • the first wicking layer 1404 and the second wicking layer 1406 may wick or otherwise transport fluid in a lateral direction along the surfaces of the first wicking layer 1404 and the second wicking layer 1406, respectively. Fluid may be transported in this manner with or without application of reduced pressure.
  • Materials suitable for the absorbent 1408 may include Luquafleece® material, Texsus FP2326, BASF 402c, Technical Absorbents 2317 available from Technical Absorbents (www.techabsorbents.com), sodium polyacrylate super absorbers, cellulosics (carboxy methyl cellulose and salts such as sodium CMC), or alginates.
  • Materials suitable for the first wicking layer 1404 and the second wicking layer 1406 may include any material having a grain structure capable of wicking fluid, such as Libeltex TDL2 80gsm.
  • Figure 15 is a perspective view of an example manifold that may be associated with some embodiments of the second layer 210.
  • the manifold may be a polymer mesh 1500, which may include an array of interconnected ovules 1502 having a truncated ellipsoidal shape.
  • the array of interconnected ovules may include corner ovules 1504, edge ovules 1506, and optionally but preferably at least one central ovule 1508.
  • the array may contain about 50 rows and about 50 columns, but it should be understood that the array may be of any reasonable size and may comprise any number of rows and any number of columns sufficient to assist in treating a tissue site.
  • At least a portion of the interconnected ovules may include one or more grooves on an outer surface of each ovule that extend at least partially in a direction of its longest principal axis.
  • each groove may have an average depth no more than 30% of a diameter of each interconnected ovule along a principal axis direction other than the longest principal axis.
  • at least a portion of the interconnected ovules may have an external texture, whether in relief or counter-relief, which may be systematic or random, such as texture patterns commercially available from Standex Int'l. Ltd. of London, England.
  • portions of the ellipsoidal surfaces of the interconnected ovules forming the upper surface of the array, the lower surface of the array, or both, can be desirable, in some embodiments, for portions of the ellipsoidal surfaces of the interconnected ovules forming the upper surface of the array, the lower surface of the array, or both, to protrude above/below portions defining the fluid pathways through the array.
  • one or more of the sizes of, the shapes of, and the component materials making up the interconnected ovules and defining the fluid pathways therebetween may be tailored to allow negative pressure to be communicated across the array, such as through the fluid pathways without complete collapse under applied negative pressure.
  • the second layer 1500 may optionally comprise one or more additional materials.
  • optional components may include, for example, active materials such as preservatives, stabilizing agents, plasticizers, matrix strengthening materials, dyestuffs, and combinations thereof.
  • Such optional components may additionally or alternatively include passive materials, for example in situations when ex vivo detection may be important, such as a sufficient amount of magnetic, metal, or ceramic material to allow ready ex vivo detection, such as via an x-ray or MRI apparatus.
  • the second layer 1500 may comprise one or more additional active materials, for example, antimicrobial agents that may be effective to aid in tissue healing.
  • the second layer 210 may comprise or consist essentially of the manifold 1500. Additionally or alternatively, the manifold 1500 may be combined with other manifold structures, other functional layers, or both in the second layer 210.
  • Figure 16 is a partial view of another example of a manifold that may be associated with some embodiments of the second layer 210.
  • Figure 16 illustrates a manifold having protrusions 1604 extending from a substrate 1606.
  • the shape of the protrusions 1604 may be substantially cylindrical.
  • the cross-sectional shape of the protrusions 1604 may be square, rectangular, triangular, polygonal, elliptical, or any other suitable shape.
  • the protrusions 1604 may be tapered or of uniform cross-sectional area throughout.
  • the height, H, of the protrusions 1604 is preferably between about 0.1 and 5.0 millimeters, and more preferably about 2 millimeters.
  • the width, W, of each protrusion is between about 0.1 and 2.0 millimeters, and more preferably about 0.25 to 0.5 millimeters.
  • the width of the protrusions 1604 may equal that of the diameter since the cross- sectional shape of each protrusion 1604 is circular. If the protrusions 1604 are square in cross-sectional shape, the width of the protrusions 1604 are an edge length of the square. For other cross-sectional shapes, the width is the average of the longest lateral distance through the centroid of the cross section and the shortest lateral distance through the centroid of the cross section.
  • the lateral, center-to-center spacing between each protrusion 1604 is preferably between about 0.1 and 1.0 millimeters, and more preferably about 0.5 millimeters.
  • the presence and sizing of the protrusions 1604 can allow the protrusions 1604 to distribute reduced pressure to the tissue site, but can substantially reduce or prevent new tissue that grows at the tissue site from attaching to the protrusions 1604 of the second layer 1600.
  • new tissue may not be able to wrap around the walls that form the pores or cells. While new tissue may grow into the field of protrusions 1604 and may even wrap around some of the protrusions 1604, the new tissue may not be capable of securing itself to the protrusions 1604 since the base of each protrusion is anchored to the backing substrate 1606.
  • the second layer 210 may comprise or consist essentially of a manifold having protrusions 1604. Additionally or alternatively, the protrusions 1604 may be combined with other manifold structures, other functional layers, or both in the second layer 210.
  • the systems, apparatuses, and methods described herein may provide significant advantages.
  • the dressing 104 is simple to apply without customization or special skills, which can reduce the time to apply and remove the dressing
  • the dressing 104 may be a fully-integrated negative-pressure therapy dressing that can be applied to a tissue site (including on the periwound) in one step, without being cut to size, while still providing or improving many benefits of other negative- pressure therapy dressings that require sizing.
  • benefits may include good manifolding, beneficial granulation, protection of the peripheral tissue from maceration, protection of the tissue site from shedding materials, and a low-trauma and high-seal bond.
  • the wound may be granulated while reducing opportunity for in-growth of granulation tissue into the manifold. These characteristics may be particularly advantageous for surface wounds having moderate depth and medium-to-high levels of exudate.
  • the dressing 104 may provide macro-stain to edges of a tissue site, and may substantially reduce or prevent maceration of peripheral tissue.
  • the dressing 104 may conform to and within a significant wound space.
  • Some embodiments of the dressing 104 may remain on the tissue site for at least 5 days, and some embodiments may remain for at least 7 days.
  • Antimicrobial agents in the dressing 104 may extend the usable life of the dressing 104 by reducing or eliminating infection risks that may be associated with extended use, particularly use with infected or highly exuding wounds.
  • Felted foam may allow for a reduced profile of the dressing 104 in some embodiments, which may improve conformability.
  • a biopolymer such as ORC collagen, may additionally impart the benefits of the biopolymer.
  • Some embodiments may allow for fluid to be absorbed at a tissue site, and some embodiments may have a greater area behind the film layers to allow for greater valve movement.
  • some embodiments may provide a means to reduce biofilm and bacterial build-up within the dressing structure.
  • Components may be also be combined or eliminated in various configurations for purposes of sale, manufacture, assembly, or use.
  • the dressing 104, the container 106, or both may be separated from other components for manufacture or sale.
  • components of the dressing 104 may also be manufactured, configured, assembled, or sold independently or as a kit.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Materials Engineering (AREA)
  • Epidemiology (AREA)
  • Dispersion Chemistry (AREA)
  • Materials For Medical Uses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
PCT/US2018/035957 2017-06-07 2018-06-05 Composite dressings for improved granulation and reduced maceration with negative-pressure treatment Ceased WO2018226624A1 (en)

Priority Applications (11)

Application Number Priority Date Filing Date Title
RU2019142454A RU2019142454A (ru) 2017-06-07 2018-06-05 Композитные перевязочные материалы для улучшенной грануляции и сниженной мацерации для лечения посредством отрицательного давления
EP23174149.7A EP4233812A3 (en) 2017-06-07 2018-06-05 Composite dressings for improved granulation and reduced maceration with negative-pressure treatment
SG11201909386S SG11201909386SA (en) 2017-06-07 2018-06-05 Composite dressings for improved granulation and reduced maceration with negative-pressure treatment
AU2018282156A AU2018282156B2 (en) 2017-06-07 2018-06-05 Composite dressings for improved granulation and reduced maceration with negative-pressure treatment
KR1020207000167A KR20200016934A (ko) 2017-06-07 2018-06-05 음압 치료를 이용한 육아 개선 및 침연 감소용 복합 드레싱재
BR112019025031-0A BR112019025031A2 (pt) 2017-06-07 2018-06-05 penso para tratar um sítio de tecido com pressão negativa e sistemas, aparelhos e métodos
EP18734368.6A EP3634335B1 (en) 2017-06-07 2018-06-05 Composite dressings for improved granulation and reduced maceration with negative-pressure treatment
CN201880036520.4A CN110709038B (zh) 2017-06-07 2018-06-05 用于通过负压治疗来改善肉芽生长和减少泡软的复合敷料
JP2019567266A JP7204685B2 (ja) 2017-06-07 2018-06-05 陰圧治療での肉芽形成を促進し浸軟を低減させる複合ドレッシング
CA3060588A CA3060588A1 (en) 2017-06-07 2018-06-05 Composite dressings for improved granulation and reduced maceration with negative-pressure treatment
AU2024203188A AU2024203188B2 (en) 2017-06-07 2024-05-14 Composite dressings for improved granulation and reduced maceration with negative-pressure treatment

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US201762516540P 2017-06-07 2017-06-07
US201762516566P 2017-06-07 2017-06-07
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US62/516,566 2017-06-07
US62/516,550 2017-06-07
US62/516,540 2017-06-07
US201762565754P 2017-09-29 2017-09-29
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