WO2021033051A1 - Pansement pour extrémité pour la gestion d'humidité à écoulement d'air forcé - Google Patents

Pansement pour extrémité pour la gestion d'humidité à écoulement d'air forcé Download PDF

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Publication number
WO2021033051A1
WO2021033051A1 PCT/IB2020/057195 IB2020057195W WO2021033051A1 WO 2021033051 A1 WO2021033051 A1 WO 2021033051A1 IB 2020057195 W IB2020057195 W IB 2020057195W WO 2021033051 A1 WO2021033051 A1 WO 2021033051A1
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WO
WIPO (PCT)
Prior art keywords
wound
wound dressing
treatment system
layer
displacement device
Prior art date
Application number
PCT/IB2020/057195
Other languages
English (en)
Inventor
Christopher Brian Locke
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 WO2021033051A1 publication Critical patent/WO2021033051A1/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
    • A61F13/05—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
    • 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
    • A61F13/022—Adhesive bandages or dressings with fluid retention members having more than one layer with different fluid retention characteristics
    • 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

Definitions

  • the present disclosure relates generally to the field of treating wounds (e.g., bums, lacerations, surgical incisions, sores, ulcers, damaged tissue, nerve damage, etc.) and more particularly to managing excess moisture during the treatment of a wound.
  • wounds e.g., bums, lacerations, surgical incisions, sores, ulcers, damaged tissue, nerve damage, etc.
  • the wound and surrounding skin may be isolated from the ambient environment by a wound dressing to stimulate quicker healing.
  • the wound dressing is typically defined by a fluid absorbency capacity that remains unchanged over time.
  • the wound dressing will be incapable of absorbing or holding any additional fluid. In such situations, the exposure of the wound dressing to any additional fluid may put the wound dressing at a risk of leaking, swelling, and becoming detached.
  • excess moisture within the wound dressing may decrease the effectiveness of wound treatment and lead to patient discomfort.
  • excess moisture within a wound dressing may act as a thermal insulator, which induces sweating and patient discomfort.
  • sustained exposure to moisture increases the risk of tissue maceration — particularly when the wound dressing is applied over large areas of periwound.
  • users are often required to increase the frequency with which wound dressings are changed during the treatment of the wound.
  • a wound treatment system includes a wound dressing, a support layer, and a spacer structure.
  • the wound dressing is configured to be attached to an extremity of a user, and includes a moisture vapor permeable backing layer.
  • the support layer is attached to the wound dressing and extends along an outer surface of the wound dressing.
  • the spacer structure extends between the backing layer and the support layer.
  • the spacer structure defining a flow path along the outer surface of the wound dressing.
  • the wound dressing is configured to be attached around the extremity of the user such that the wound dressing circumscribes the extremity of the user.
  • an air displacement device is fluidly coupled to the flow path via an opening in the support layer.
  • the air displacement device is optionally integrated into a control module.
  • the control module has a filter-covered opening and fluidly couples the air displacement device with the ambient atmosphere. The entirety of the control module extends along the outer surface of the wound dressing.
  • a pump is fluidly coupled to an opening formed in the backing layer.
  • the pump is optionally integrated into the control module.
  • the filter-covered opening of the control module fluidly couples the pump with the ambient atmosphere.
  • the pump may also be configured to be fluidly coupled to the flow path via an opening in the support layer.
  • the flow path is fluidly coupled to the ambient atmosphere via a plurality of vent openings provided by the support layer.
  • the wound dressing optionally defines a glove-like structure configured to receive and be attached to a hand of a patient. Vent openings are formed along a length of at least one finger- receiving portion of the glove-like structure.
  • the wound dressing further includes a wound-interface layer, and an optional manifold layer positioned between the wound-interface layer and the moisture vapor permeable layer.
  • An absorbent layer may be positioned between the manifold layer and the moisture vapor permeably layer. The absorbent layer optionally extends along only a portion of the manifold layer.
  • a wound treatment system includes a wound dressing including a moisture vapor permeable backing layer.
  • the wound dressing defines a glove- like structure configured to receive and be attached to a hand of a patient.
  • a manifold element is configured to extend along at least a portion of an outer surface of the wound dressing.
  • the manifold element is configured to define a channel along an outer surface of the backing layer when the manifold element is attached to the wound dressing.
  • the wound dressing is configured to be attached to the hand of the patient such that the wound dressing envelops the hand of the patient.
  • a support layer is optionally configured to extend along an outer surface of the manifold.
  • the channel is further defined by the support layer when the support layer is attached to the manifold element.
  • an air displacement device is configured to be fluidly coupled to the channel via an opening formed through the support layer.
  • the support layer may defines vents located along a length of at least one finger-receiving portion of the glove -like structure.
  • a wound treatment system includes a wound dressing and a moisture management system.
  • the wound dressing has a moisture vapor permeable backing layer and defines a cavity configured to receive and surround an extremity of a patient.
  • the moisture management system includes an air displacement device and is configured to extend along an outer surface of the wound dressing to define a flow path along the backing layer.
  • the air displacement device is configured to be fluidly coupled to the flow path.
  • An edge of the wound dressing may define an opening into the cavity.
  • the edge may also be configured to be attached around a portion of a patient’s skin to substantially seal the cavity from an ambient atmosphere.
  • the edge may be configured to be attached to a portion of a patient’s skin to substantially seal the cavity from the ambient atmosphere.
  • the moisture management system optionally further includes a support layer and a support structure. The support structure is configured to extend between a lower surface of the support layer and the outer surface of the wound dressing to define the flow' path.
  • a control module attached around an opening formed in the support layer.
  • the air displacement device is integrated into the control module such that an outlet of the air displacement device is fluidly coupled to the flow path via the opening in the support layer.
  • the control module may further include a filter-covered opening fluidly coupled to an inlet of the air displacement device.
  • a method for treating a tissue site includes surrounding an extremity of a patient with a wound dressing having a moisture vapor permeable backing layer and sealing the wound dressing to the patient.
  • One or more flow channels are provided along an outer surface of the backing layer and are fluidly coupled to an air displacement device.
  • providing the one or more flow channels including providing a support layer and spacer structure along the outer surface of the wound dressing.
  • the one or more flow channels are defined between a lower surface of the support layer, the spacer structure and the outer surface of the wound dressing upon attachment of the support layer and spacer structure to the outer surface of the wound dressing.
  • the support layer and spacer structure are optionally provided preattached to the backing layer. In other embodiments, the support layer and spacer structure are provided separately from the backing layer.
  • the support layer and spacer structure are provided along the outer surface of the wound dressing by attaching the support layer and spacer structure relative to the outer surface of the wound dressing.
  • the one or more flow channels are coupled to the air displacement device by sealingly attaching the air displacement device around an opening extending through the support layer that is in fluid communication with the one or more flow channels.
  • the air displacement device is operated to generate a flow of air through the one or more flow channels and along the outer surface of the wound dressing.
  • the flow of air generated by the air displacement device is fluidly isolated from a treatment space defined underneath the wound dressing.
  • the extremity of the patient is surrounded by the wound dressing by enveloping the extremity within a cavity defined by the wound dressing.
  • the wound dressing is optionally defined by a glove-like configuration.
  • FIG. 1A illustrates a perspective view of a wound treatment system, according to an exemplary embodiment.
  • FIG. IB illustrates a cross-sectional view of the wound treatment system of FIG. 1A, taken along line 1B-1B, according to an exemplary embodiment.
  • FIG. 1C illustrates a cross-sectional view of the wound treatment system of FIG. 1A, taken along line 1C- 1C, according to an exemplary embodiment.
  • FIG. 2 illustrates an exploded perspective view of the wound treatment system of FIG. IB.
  • FIG. 3 illustrates a perspective view of a moisture management system spacer structure and fdm layer, according to an exemplary embodiment.
  • FIG. 4 illustrates a perspective view of a moisture management system spacer structure and fdm layer, according to an exemplary embodiment.
  • FIG. 5 illustrates a perspective view of a moisture management system spacer structure and fdm layer, according to an exemplary embodiment.
  • FIG. 6 illustrates a perspective view of a moisture management system spacer structure and fdm layer, according to an exemplary embodiment.
  • FIG. 7 illustrates an exploded perspective view of a moisture management system spacer structure and fdm layer, according to an exemplary embodiment.
  • FIG. 8 illustrates an exploded perspective view of a moisture management system spacer structure and fdm layer, according to an exemplary embodiment.
  • FIG. 9 illustrates a perspective view of a wound treatment system, according to an exemplary embodiment.
  • FIG. 10 is a schematic representation of the flow of air through the wound treatment system during operation in a positive pressure mode, according to an exemplary embodiment.
  • FIG. 11 is a schematic representation of the flow of air through the wound treatment system during operation in a negative pressure mode, according to an exemplary embodiment.
  • FIG. 12 is a schematic representation of the flow of air through the wound treatment system during operation in a positive pressure mode, according to an exemplary embodiment.
  • FIG. 13 is a schematic representation of the flow of air through the wound treatment system during operation in a negative pressure mode, according to an exemplary embodiment.
  • FIG. 14 illustrates a perspective view of a wound treatment system, according to an exemplary embodiment.
  • FIG. 15 illustrates forced air flow through the wound treatment system of FIG. 14 during operation of the wound treatment system in a positive pressure mode, according to an exemplary' embodiment.
  • FIG. 16 illustrates a partial cross-sectional view of the wound treatment system of FIG. 15 taken along line 16-16, according to an exemplary embodiment.
  • the wound treatment system 100 generally includes a wound dressing 200 configured to be positioned around a wound (e.g. covering the wound), and a moisture management system 300 configured to increase the rate at which moisture is removed from a treatment space defined underneath the wound dressing 200.
  • the moisture management system 300 is configured to increase the rate at which moisture is removed from the wound dressing 200 by generating and directing a forced flow of dry air along an upper surface 203 of a liquid permeable drape layer 202 of the wound dressing 200.
  • a forced flow of dry air along an upper surface 203 of a liquid permeable drape layer 202 of the wound dressing 200.
  • moles of moisture which have permeated the drape layer 202 and pooled on an upper surface 203 thereof are lifted and removed by the dry air from the upper surface 203 of the drape layer 202.
  • This removal of pooled moisture from the drape layer 202 allows additional moisture located within the treatment space to permeate through the liquid permeable drape layer 202.
  • the wound treatment system 100 actively extends the life of the static capacity of the wound dressing 200, which in turn prolongs the wear time of the wound dressing 200 without the need for an external reservoir to collect fluids removed from the treatment space.
  • the wound treatment system 100 advantageously minimizes the inconveniences to a user during the treatment of the wound.
  • the ability of the wound treatment system 100 to accelerate the evaporation of fluid from within a wound dressing 200 may also advantageously further be used to minimize, or eliminate, patient discomfort typically associated with excess moisture at a wound site (such as, e.g., the increased risk of periwound maceration, increased sweating, etc.).
  • the wound dressing 200 may be defined by a variety of different types of wound dressings.
  • the wound dressing 200 may also be configured to treat a variety of different types of wounds, and for use in a variety of different types of wound treatments.
  • the wound dressing 200 may be used as a stand-alone wound treatment, or may be a component of an additional wound therapy system with which the wound treatment system 100 is used, such as, e.g., a negative pressure wound treatment (“NPWT”) system, an instillation therapy system, etc.
  • NGWT negative pressure wound treatment
  • the wound dressing 200 includes a drape layer 202, and optionally any number and combination of additional layers,
  • the number and selection of the additional dressing l ayers forming the wound dressing 200 may vary depending on a variety of factors, including, but not limited to: the type of wound being treated, the location of the wound being treated, the type of treatment being provided to the wound, the type of optional additional wound therapy system with which the wound treatment system 100 is used, etc.
  • additional dressing layers which may form a part of the wound dressing 200 include e.g., an absorbent layer 204, an interface layer 206, a manifold layer 208, a wicking layer, etc.
  • the drape layer 202 of the wound dressing 200 supports the additional layers of the wound dressing 200 (e.g., the absorbent layer 204, the interface layer 206, the manifold layer 208, etc.) at the wound site.
  • the additional layers of the wound dressing 200 e.g., the absorbent layer 204, the interface layer 206, the manifold layer 208, etc.
  • an upper surface 203 of the drape layer 202 delimits a lower portion of the flow path 340 of the wound treatment system 100.
  • a perimeter of the drape layer 202 extends beyond (e.g., circumscribes) a perimeter of the absorbent layer 204 (e.g., such as shown in FIG. IB), a perimeter of the manifold layer 208 (e.g., as shown in FIG. 1C) and/or the perimeter of any other additional dressing layer(s) to provide an adhesive-coated margin for adhering the additional layers of the wound dressing 200 to the skin of a patient adjacent to the wound site being treated.
  • the adhesive-coated margin can be eliminated and wound dressing 200 can be adhered to the skin of a patient using other techniques.
  • the drape layer 202 may be formed from any number of different types of materials that are substantially impermeable to liquid and substantially permeable to moisture vapor.
  • the drape layer 202 is permeable to water vapor, but not permeable to liquid water or wound exudate. This increases the total fluid handling capacity of the wound dressing 200 while promoting a moist wound environment.
  • the drape layer 202 is also impermeable to bacteria and other microorganisms.
  • a suitable material for the drape layer 202 is a high moisture vapor transmission rate (“MVTR”) material. As described in detail below, the wound treatment system 100 exploits the high MVTR of the drape layer 202 to manage fluids within the wound dressing 200.
  • MVTR moisture vapor transmission rate
  • the drape layer 202 is a thin layer of polyurethane film.
  • a suitable material for the drape layer 202 is the polyurethane film known as ESTANE 5714F.
  • Other suitable polymers for forming the drape layer 202 include poly alkoxyalkyl acrylates and methacrylates, such as those described in Great Britain Patent Application No. 1280631A filed November 22, 2002, the entire disclosure of which is incorporated by reference herein.
  • the wound dressing 200 is an absorbent wound dressing comprising an absorbent layer 204 that is adapted to collect (e.g. store) fluid from the wound site.
  • the size and shape of the absorbent layer 204 may be varied as desired.
  • the absorbent layer 204 comprises superabsorbent particles held within a liquid-tight envelope (e.g. a woven or non-woven pouch).
  • Other non-limiting examples of absorbent layer 204 materials include superabsorbent fibers, superabsorbent polymers, hydrofibers, sodium carboxymethyl cellulose, alginates, sodium polyacrylate, hydrogels, hydrocolloids, etc.
  • the wound dressing 200 in various embodiments includes a manifold layer 208 configured to allow fluid (e.g. exudates, liquids, a vacuum created by the operation of the pump of the NPWT system) to be transmitted (e.g. distributed) to/from the wound.
  • fluid e.g. exudates, liquids, a vacuum created by the operation of the pump of the NPWT system
  • the manifold layer 208 may optionally include an open-cell foam marketed as GRANUFOAMTM by ACELITYTM
  • the manifold layer 208 may instead include a foam that is more hydrophilic than standard GRANUF OAMTM.
  • the ability' of the manifold layer 208 to retain fluid may additionally assist in the fluid management of the wound dressing 200, with exudates and other fluids absorbed by the manifold layer 208 being evaporated by the forced airflow through the flow path 340 generated during operation of the air displacement device 350.
  • Non-limiting examples of additional materials from which the manifold layer 208 may be formed include cellular foam, un- reticulated open-cell foam, porous tissue collections, gauze, felted mat and/or any other material comprising a plurality of flow channels or pathways via which fluids may be distributed.
  • the interface layer 206 is configured to reduce potential adherence of the wound dressing 200 to the wound and/or to prevent ingrowth of skin to the wound dressing 200.
  • the interface layer 206 may be defined by a nonporous material comprising a plurality of perforations (fenestrations, holes, airways, windows, slits, etc.) extending therethrough that allow air and fluid to pass between the wound and the other layers of the wound dressing 200.
  • the interface layer 206 is made of a hydrophobic material such as polyethylene (PE) or other hydrophobic polymers.
  • the interface layer 206 may comprise a liquid-impermeable, elastomeric film having a plurality of bi-directional, pressure-responsive perforations formed therethrough.
  • the interface layer 206 is optionally dimensioned such that an outer perimeter of the interface layer 206 is coextensive with, or slightly greater than the manifold layer 208 and/or absorbent layer 204 (e.g., the area of the interface layer 206 is between approximately 5% and 10% greater than the area of the manifold layer 208 and/or absorbent layer 204).
  • the fluid restrictions define elastic passages that can expand (e.g. open) in response to a pressure gradient to allow flow therethrough.
  • the passages may be sufficiently small to form a seal or fluid restriction, thereby reducing or preventing liquid flow through the interface layer 206.
  • various materials from which the film defining the interface layer 206 in such embodiments may be formed include polyurethane, polyethylene, acrylics, polyolefin (such as cyclic olefin copolymers), polyacetates, polyamides, polyesters, copolyesters, PEBAX block copolymers, thermoplastic elastomers, thermoplastic vulcanizates, polyethers, polyvinyl alcohols, polypropylene, polymethylpentene, polycarbonate, styreneics, silicones, fluoropolymers, acetates, etc.
  • the film may have thickness between approximately 50 microns and approximately 250 microns, and more specifically between approximately 100 microns and approximately 200 microns.
  • the perforations comprise linear slots having a length less than approximately 4 millimeters (e.g. 3 millimeters), with adjacent slots spaced approximately 3 millimeters from one another.
  • the perforations may be defined by other configurations (e.g. holes) that are arranged in generally linear clusters having a length less than approximately 4 millimeters or less (e.g. 3 millimeters), with adjacent clusters optionally spaced approximately 3 millimeters from one another.
  • the perforations may be defined by any other variety of arrangements and dimensions.
  • the moisture management system 300 operates to control moisture levels in a treatment space defined underneath the wound dressing 200 of the wound treatment system 100 by forcing airflow along an upper, outer surface of the wound dressing 200.
  • the management of moisture levels in the treatment space may, in some embodiments, optionally be supplemented via the direct removal of fluids from the treatment space using a source of forced negative airflow (e.g. a pump) fluidly coupled to the treatment space — the management of moisture levels using the moisture management system 300 of the wound treatment system 100 described herein does not itself require fluid communication with the treatment space beneath the wound dressing 200. Rather, the forced airflow along the wound dressing 200 generated during operation of the moisture management system 300 indirectly removes moisture from the treatment space (i.e. removes moisture from the treatment space even in the absence of any fluid communication with the treatment space) by accelerating the diffusion and evaporation of fluid within the treatment space through the high MVTR drape layer 202 of the wound dressing 200.
  • the moisture management system 300 generally includes a film layer 310, a spacer structure 320, and an air displacement device 350.
  • the film layer 310 and spacer structure 320 are configured to be coupled (e.g. attached, supported by, adhered, etc.) to the wound dressing 200 to define a flow' path 340 that extends along an upper (e.g., exterior, outer, etc.) surface of the wound dressing 200 (i.e., along the upper surface 203 of the drape layer 202).
  • the air displacement device 350 is configured to be fluidly coupled to the flow path 340, with operation of the air displacement device 350 being used to generate air flow across the upper surface 203 of the drape layer 202 of the w ound dressing 200.
  • the moisture management system 300 may be single use, or may optionally be configured to be re-used with different wound dressings 200.
  • the moisture management system 300 is configured for stand-alone treatment of a w ound (i.e., wherein the w ound treatment system 100 operates independent of any other wound therapy system or device).
  • the moisture management system 300 may be configured for use alongside other wound therapy systems, such as, e.g., an NPWT system.
  • the film layer 310 (e.g. support layer) of the moisture management system 300 delimits an upper portion of a flow path 340 that extends along the upper surface 203 of the drape layer 202.
  • an opening 312 extending through the film layer 310 fluidly couples the flow path 340 to the air displacement device 350.
  • the opening 312 defines an inlet via which airflow generated by the air displacement device 350 enters the flow path 340.
  • the opening 312 defines an outlet via which air is evacuated from the flow path 340 by the air displacement device 350.
  • the film layer 310 optionally also includes and/or defines a plurality of vents 314 via w hich air flow s into or out from the flow path 340 during operation of the air displacement device 350.
  • the film layer 310 optionally supports a connector 360 (e.g., a port, a SENSAT.R.A.C.TM connection pad marketed by ACELITYTM, etc.) via which the air displacement device 350 is coupled to the flow path 340.
  • the connector 360 may indirectly couple the air displacement device 350 to the flow path 340 via a conduit 354 that is attached to and extends between the connector 360 and a remotely located air displacement device 350.
  • the air displacement device 350 and the connector 360 are components of an integrated module 400 (described in more detail below) that is supported relative to the film layer 310 (see, e.g., FIG. 9) around (e.g. adjacent to, surrounding, etc.) an outer periphery of the opening 312 in the film layer 310, such that the wound treatment system 100 defines a single, unitary structure.
  • the opening 312 extends through a substantially central location of the film layer 310, so as to facilitate a generally uniform distribution of air flow along the upper surface of the wound dressing 200.
  • the fluid opening 312 (and corresponding connection between the air displacement device 350 and the flow path 340) may be arranged at other locations relative to the film layer 310 and/or wound dressing 200.
  • the opening 312 is optionally formed at a location along the film layer 310 that will overlie a region of the wound that exudes fluid at a high rate.
  • the fluid opening 312 may be formed at a location adjacent to a lower perimeter of the film layer 310.
  • the dimensions of the film layer 310 may be smaller, the same as, or larger than the dimensions of the wound dressing 200 of the wound treatment system 100.
  • the dimensions of the film layer 310 relative to the wound dressing 200 may be selected based on an intended treatment protocol. For example, given the detrimental effect moisture may have on a periwound, in various embodiments the film layer 310 is sized to be coextensive with, or extend beyond, the outer perimeter of the wound dressing 200 to which the moisture management system 300 is attached, such as, e.g., representatively illustrated in FIGS 1A-1C.
  • Such an arrangement advantageously allows the flow path 340 to be defi ned across the entirety ' of the upper surface 203 of the drape layer 202 — including those portions of the drape layer 202 that overlay the periwound.
  • the film layer 310 is dimensioned smaller than the wound dressing 200, such that a flow path 340 is defined along only a designated portion of the upper surface 203 of the drape layer 202.
  • Such a configuration may be advantageous in situations in which it is desired to reduce l evels of moisture at a specific location along a wound without significantly effecting moisture levels at other locations along the wound (such as, e.g. may occur during the treatment of larger wounds) and/or to minimize unnecessary power consumption resulting from the operation of the air displacement device 350 to cause air flow across a greater area than needed.
  • the film layer 310 is attached to an underlying surface (e.g. an upper surface of the wound dressing 200, the skin of a patient, etc.) in situ during the attachment of the wound treatment system 100 to the patient.
  • adhesive is optionally provided along portions, or the entirety, of the perimeter of the lower surface 311 of the film layer 310 to facilitate the attachment of the film layer 310 to the underlying surface.
  • the film layer 310, spacer structure 320 and drape layer 202 are optionally provided as a single, integrated assembly, in which the perimeter of the film layer 310 is preattached (via, e.g., adhesive, welding, etc.) to the drape layer 202.
  • the film layer 310 includes and/or defines one or more vents 314 via which air is forced out from or into the flow path 340 during operation of the air displacement device 350.
  • the vents 314 include openings 315 (e.g. apertures, etc.) that extend through the film layer 310.
  • the vents 314 may also optionally be defined by unattached portions 316 of a perimeter of the film layer 310 that are not directly coupled to an underlying surface (e.g. the wound dressing 200, the skin of a patient, etc.).
  • an underlying surface e.g. the wound dressing 200, the skin of a patient, etc.
  • the flow elements 322 of the spacer structure 320 (described below) that are located around (e.g.
  • the perimeter of the film layer 310 are formed having a greater height (e.g., the flow elements 322 extend further downward relative to an upper surface 313 of the film layer 310) than flow elements 322 that are located along an interior portion of the lower surface 311 of the film layer 310.
  • Such an increased height of the flow elements 322 located around the outer perimeter of the film layer 310 is configured to ensure that the unattached portions 316 of the outer periphery of the film layer 310 remain offset from the underlying surface to which the film layer 310 is attached (e.g. the wound dressing 200, the skin of the patient, etc.) and do not occlude flow into/out from the flow path 340.
  • val ves and/or filters are optionally located within some or all of the vents 314.
  • the optional valves e.g. slit valves 318
  • the optional filters are configured to prevent microorganisms or other harmful particles from entering the flow path 340 (and air displacement device 350).
  • the spacer structure 320 (e.g. spacer assembly, support structure, manifold element) of the moisture management system 300 vertically offsets (e.g., spaces apart, separates, elevates, etc.) the lower surface 311 of the film layer 310 from the upper surface 203 of the drape layer 202 upon assembly of the wound treatment system 100.
  • the space e.g., void, air gap, channels, etc.
  • the space defines a portion of the flow path 340 of the wound treatment system 100
  • the spacer structure 320 includes one or more flow elements 322 each having an outer surface that extends between a first end 321 (e.g., an upper end) and a second end 323 (e.g., a lower end).
  • the spacer structure 320 is arranged relative to the wound dressing 200 and film layer 310 so that the first ends 321 of the flow elements 322 are located adjacent and extend downwards relative to the lower surface 311 of the film layer 310.
  • the second ends 323 of the flow elements 322 are located adjacent to and extend upwards relative to the upper surface 203 of the drape layer 202.
  • the second ends 323 of the flow elements 322 are optionally coated with an adhesive via which the spacer structure 320 can be attached relative to the upper surface 203 of the drape layer 202.
  • the upper ends 321 of the spacer structure 320 may also optionally be coated with an adhesive via which the spacer structure 320 can be attached relative to the lower surface 311 of the film layer 310.
  • the drape layer 202, spacer structure 320 and film layer 310 are provided a single, integrated structure, such that assembly of the wound treatment system 100 in situ requires no more effort than would typically be required to assemble a wound dressing comprising a separately attachable backing layer (e.g. a drape layer).
  • a separately attachable backing layer e.g. a drape layer
  • the flow elements 322 may be defined by a variety of different structures having any number of different shapes, sizes and configurations. According to various embodiments, the flow element(s) 322 of the spacer structure 320 are provided as separate and discrete structure(s) from the film layer 310, and are arranged relative to the film layer 310 and wound dressing 200 during assembly of the wound treatment system 100.
  • the spacer structure 320 and film layer 310 are optionally provided as a single, integral one-piece structure.
  • the spacer structure 320 is monolithically formed with the film layer 310, with the flow elements 322 including structures that are defined by the lower surface 311 of the film layer 310.
  • the flow elements 322 defining the spacer structure 320 include discrete structures that are attached to the lower surface 311 of the film layer 310.
  • the flow elements 322 in some such embodiments include adhesive dots 324 (e.g. beads, islands, patches, etc.) formed from a cured semi- permanent or permanent adhesive (e.g., viscose UV curing adhesive).
  • the adhesive dots 324 define discrete structures that are adhered at their respective first ends 321 to locations along the lower surface 311 of the film layer 310.
  • the second ends 323 of the adhesive dots 324 adhere the film layer 310 relative to the upper surface 203 of the drape layer 202.
  • the adhesive dots 324 are formed having a thickness (i.e.
  • an adhesive composition may alternatively be applied to the lower surface 31 1 of the film layer 310 (and/or to the upper surface 203 of the drape layer 202) to form the adhesive dots 324 along the lower surface 311 of the film layer 310 and/or along the upper surface 203 of the drape layer 202 during assembly of the wound treatment system 100.
  • the discrete and separate flow elements 322 that define a single, unitary spacer structure 320 and film layer 310 assembly may instead include one or more flow walls 328 that are attached (e.g. adhered) to the lower surface 311 of the film layer 310.
  • the flow wall(s) 328 can be defined by a variety of different shapes, sizes, and configurations.
  • FIG. 5 and 6 Exemplary embodiments of spacer structures 320 that are monolithically formed with the film layer 310 are shown in FIG. 5 and 6.
  • the lower surface 311 of the film layer 310 is textured, and includes a plurality of peaks 325 that are separated from one another by valleys 326.
  • the flow elements 322 correspond to the peaks 325 of the textured surface, and are defined by portions of the lower surface 311 of the film layer 310 that extend further downward from an upper surface 313 of the film layer 310 (i.e. have an increased thickness) as compared to the portions of the lower surface 311 of the film layer 310 defining the valleys 326.
  • the peaks 325 defining the flow elements 322 are shown as being truncated pyramids, the peaks 325 may be formed into a variety of other different shapes (e.g. ridges, ribs, posts, etc.).
  • a lower surface 311 of the film layer 310 is embossed to define a plurality of raised portions 327 (i.e. non-embossed portions of the film layer 310).
  • the flow elements 322 are defined by the raised portions 327 of the lower surface 311.
  • the upper surface 313 of the film layer 310 may be debossed, and the flow elements 322 are defined by the downwardly projecting, debossed portions of the upper surface 313 of the film layer 310 (not shown).
  • the spacer structure 320 and drape layer 202 may alternatively be provided as an integral, one-piece assembly.
  • FIGS. 7 and 8 Shown in FIGS. 7 and 8 are exemplary embodiments of spacer structures 320 that are provided separately and discretely from the film layer 310, and which are arranged and optionally attached relative to the film layer 310 during assembly of the wound treatment system 100.
  • the flow elements 322 include a plurality of struts 329 (e.g. walls) that are interconnected to form a scaffold which defines the spacer structure 320.
  • the discretely and separately provided spacer structure 320 is defined by a porous layer 330.
  • the porous layer 330 may be formed of a variety of different porous materials.
  • the porous layer 330 optionally includes a felted foam (having, e.g., a thickness of between approximately lcm and 3cm), or a non-felted foam (having, e.g., a thickness of less than approximately 5mm).
  • the porous material from which the porous layer 330 is formed defines the flow element 322 of the spacer structure 320.
  • the porous material e.g.
  • felted or non-felted foam used to form the porous layer 330 that defines the space structure 320 of FIG. 8 may also be used to form the flow elements 322 of other spacer structure 320 embodiments, such as, e.g., flow walls 328 (see, e.g., FIG. 4), struts 329 (see, e.g., FIG. 7), etc.
  • the shape, size, and arrangement of flow elements 322 of the spacer structure 320 may be varied as desired, such as, e.g., to define a flow path 340 that directs air in a manner along specific portions of the upper surface of the wound dressing 200.
  • the flow elements 322 may be arranged such that flow channels defined between adjacent flow elements 322 are fluidly interconnected and define a single flow path 340 that extends across the entirety of the portion of the upper surface 203 of the drape layer 202 (e.g., as representatively illustrated by the arrangement of flow elements 322 in FIGS. 3, 5 7 and 8).
  • the shape, size, and arrangement of flow elements 322 may be selected to define one or more enclosed flow channels that are discrete and fluidly isolated from other portions of the flow path 340 (such as, e.g., representatively illustrated by the embodiments of FIGS. 4 and 6).
  • the arrangement of flow elements 322 in a non-uniform distribution, and/or the selection of flow elements 322 having varying sizes may be used to accelerate the rate of moisture removal at the target locations.
  • the arrangement of flow elements 322 in a greater density and/or the arrangement of flow elements 322 having larger dimensioned second ends 323 at locations relative to portions of the wound dressing 200 that do not correspond to target locations minimizes the degree to which air flowing through the flow path 340 passes along the upper surface 203 of the drape layer 202 at such non-target locations. Resulting, less moisture is acquired by the air flowing through the flow path 340 prior to the air reaching a target location (e.g. a portion of the flow path 340 overlaying the periwound).
  • drier air has a greater capacity to lift moisture from the upper surface 203 of the drape layer 202
  • the decreased moisture level of the air flowing through the flow path 340 along the target locations increases the rate at which moisture may be removed from the target locations.
  • a similar effect of delivering drier air flow to desired target locations may also be accomplished using an optional blocking structure (e.g. a thicker layer of adhesive, an intermediate layer of material, etc.) that is arranged between the spacer structure 320 and drape layer 202 along the portions of the wound dressing 200 that do not correspond to the target locations.
  • an optional blocking structure e.g. a thicker layer of adhesive, an intermediate layer of material, etc.
  • the air displacement device 350 may include any number of different air-moving devices (e.g., manual or automatic pump, blower, bellows, etc.) ⁇ As shown in FIG. 1, upon assembly of the wound treatment system 100, a remotely located air displacement device 350 is fluidly coupled to the flow path 340 via a conduit 354. Alternatively (as described in detail below), the air displacement device 350 is provided as a component of a module 400 that is supported by the film layer 310, such that the assembled wound treatment system 100 defines a single, self-contained device (see, e.g., FIG.
  • Operation of the air displacement device 350 is configured to generate a flow of air through the flow path 340 of the wound treatment system 100.
  • operation of the air displacement device 350 in a positive pressure mode causes air to flow' from the air displacement device 350, through the opening 312 in the film layer 310, through the flow path 340 defined by the flow ' elements 322 of the spacer structure 320, through one or more vents 314, and into the ambient environment.
  • operation of the air displacement device 350 in a negative pressure mode generates a vacuum that evacuates air through the opening 312 in the film layer 310 that has been drawn into the flow path 340 via the vents 314.
  • the air displacement device 350 forces air into (or out from) the flow path 340 at a rate of between approximately 0.5L/min and approximately 2L/min, which creates a back- pressure of approximately lOmmHg.
  • the air displacement device 350 may be provided in addition to the pump of the additional wound treatment system (e.g., a NPWT system), such that such that the wound treatment system 100 is capable of being operated independently and separately from the NPWT system (or other wound treatment system).
  • the additional wound treatment system e.g., a NPWT system
  • the pump of the NPWT system (or other additional wound therapy system with which the wound treatment system 100 is used) defines the air displacement device 350.
  • the shared pump is fluidly coupled to a connector 360 comprising a NPWT vacuum conduit 361 fluidly coupled to a space defined underneath the drape layer 202, and a moisture management conduit 363 fluidly coupled to the flow path 340.
  • the connector 360 optionally also includes a pressure monitoring conduit that is fluidly coupled to one or both of the treatment space underneath the drape layer 202 and the flow path 340.
  • the connector 360 optionally includes one or more valves via which the shared pump is selectively fluidly coupled to either the NPWT conduit 361 or the moisture management conduit 363 based on the desired treatment.
  • the connector 360 includes an optional proportional leak valve configured to fluidly couple the pump to moisture management conduit 363 while fluidly isolating the NPWT conduit 361 during operation of the shared pump to generate pressures in excess of a predetermined threshold (e.g. at negative pressures above 150mmHg).
  • a predetermined threshold e.g. at negative pressures above 150mmHg.
  • the valve is configured to fluidly couple the pump to the NPWT conduit 361, while fluidly isolating the moisture management conduit 363.
  • the shared pump that defines the air displacement device 350 is operated to simultaneously provide treatment using each treatment system.
  • the wound treatment system 100 is operated in a negative pressure mode concurrently with the operation of the pump to provide NPWT treatment.
  • an optional valve of the connector 360 is selectively actuated such that each of the NPWT conduit 361 and moisture management conduit 363 are fluidly coupled to the pump.
  • the wound treatment system 100 can also be operated in the positive pressure mode concurrently with the operation of the pump to provide NPWT treatment.
  • an outlet of the pump is coupled (e.g. via a valve) to the moisture management conduit 363, with that exhaust airflow resulting from the operation of the pump to generate a vacuum for the NPWT treatment being used as the positive forced airflow that is delivered to the flow path 340 via the moisture management conduit 363.
  • an optional valve is selectively actuated to restrict (e.g.
  • the decrease in pressure resulting from air flow through the restriction in the NPWT conduit 361 causes positive forced airflow to be directed through the Venturi tube (or passageway) and into the flow path 340.
  • the wound treatment system 100 may optionally be formed as an integral self- contained system that may be supported entirely by a patient.
  • the air displacement device 350, as well as any additional optional components of the wound treatment system 100 are housed in an optional module 400.
  • the module 400 may optionally also support a patient interface comprising a display and/or user inputs (e.g., buttons) via which information may be provided to and/or received from a user during operation of the wound treatment system 100.
  • the module 400 may also contain a reservoir (e.g., an absorbent material, a canister, etc.) configured to store fluid that has been evaporated from the wound dressing 200 and/or that is evacuated from the treatment space defined underneath the wound dressing 200 and/or any other number of components of the additional wound therapy system.
  • a reservoir e.g., an absorbent material, a canister, etc.
  • the module 400 optionally includes an engagement structure configured allow the module 400 to be sealingly secured around (e.g. adjacent to, surrounding, etc.) an outer periphery of the opening 312 in the film layer 310 via an engagement to an optional connector 360 supported relative to the film layer 310.
  • the module 400 may also be secured directly to the film layer 310 using adhesive, welding, etc.
  • bacterial and/or hydrophobic filters 380 are optionally provided between the opening 312 in the film layer 310 and an inlet of the module 400.
  • filters 380 may be attached to any one or more of the opening 312 in the film layer 310, the connector 360, and the engagement structure of the module 400 to prevent fluid and/or bacterial ingress and contamination of the module 400 during use of the wound treatment system 100 and/or during attachment or removal of the module 400 to or from wound dressing 200.
  • Various operations of the wound treatment system 100 may be controlled by an optional controller 500 (shown, e.g., in FIG. 9).
  • the controller 500 may turn the air displacement device 350 on/off, and/or can be used to vary the speed at which the air displacement device 350 is operated.
  • the controller 500 may also provide selective control over the actuation of any optional valves of the connector 360 during operation of the wound treatment system 100 (e.g. to switch operation of the air displacement device 350 between positive and negative pressure modes, to switch between the type of treatment being provided during operation of the wound treatment system 100 in conjunction with an additional wound therapy system, etc.).
  • the controller 500 may be configured to operate the various components of the wound treatment system 100 (e.g. the air displacement device 350, valves, etc.) based on a variety of different inputs received from any number of different sources. For example, in some embodiments, the controller 500 may operate the wound treatment system 100 based on inputs received from a user. In other embodiments, the controller 500 may be configured to operate the wound treatment system 100 in accordance to one or more preprogrammed modes stored in a memory of the controller 500. For example, the controller 500 may operate the wound treatment system 100 in an alternating pressure mode, in which operation of the air displacement device 350 is periodically varied between operation in the positive pressure mode, and operation in the negative pressure mode. Such periodic alternation between positive and negative air flow may advantageously be used disrupt regions of dense flow within the treatment space underneath the wound dressing 200 and to allow moisture to be removed more uniformly from the wound.
  • the controller 500 may operate the various components of the wound treatment system 100 based on a variety of different inputs received from any number of different sources. For example, in some embodiments,
  • the controller 500 is configured to operate the wound treatment system 100 responsive to readings or measurement obtained from one or more sensors (e.g. moisture sensor, humidity sensor, pressure sensor, etc.) incorporated into the wound treatment system 100.
  • the wound treatment system 100 includes a moisture level sensor assembly comprising one or more moisture indicators and an optical reader configured to detect changes in the indicators.
  • the indicators are advantageously selected to be capable of providing a dynamic, two-way (i.e. reversible), near real-time indication as to both increases and decreases in moisture levels within the wound dressing 200 over the course of use of the wound treatment system 100.
  • Such an incorporation of indicators into the wound treatment system 100 allows the wound dressing 200 to remain integral and sealed, and thus advantageously minimizes the risk of exudates, or other fluids or substances from the treatment space underneath the wound dressing 200, contaminating the components of the optionally included module 400.
  • the moisture indicators are incorporated into (i.e. positioned in direct contact with) one or both of the drape layer 202 and an additional dressing layer (e.g., an absorbent layer 204, a manifold layer 208, etc.), so as to be capable of dynamically responding to changes in moisture levels within the wound dressing 200 (e.g. changes in the fluid capacity of the absorbent layer 204, moisture levels at a portions of the drape layer 202 overlaying the periwound, etc.).
  • the indicators are advantageously positioned directly below the drape layer 202 to facilitate the ability of the optical reader to detect changes in the visual appearance of the indicators through the drape layer 202.
  • a fusible fiber optionally secures the indicators relative to the wound dressing 200 to ensure contact of the indicators with the absorbent layer 204 and/or to ensure that the indicators are aligned relative to the module 400 such that visual transformations of the indicators are capable of being detected by the optical reader.
  • the optical reader is optionally incorporated into the module 400, or is otherwise positionable relative to the upper surface of the wound treatment system 100 [0089]
  • the controller 500 is optionally configured to operate the air displacement device 350 in a manner configured to minimize power consumption.
  • the controller 500 may optionally be configured to initiate operation of the air displacement 350 to generate airflow through the flow path 340 only in response to the detection of a visual transition of an indicator indicative of the moisture level in the treatment space underneath the wound dressing 200 being equal to, or exceeding, a predetermined upper threshold moisture level. Additionally, or alternatively, in some embodiments the controller 500 may optionally be configured to initiate operation of the air displacement 350 to generate airflow through the flow path 340 in response to the detection of a visual transition of an indicator indicative of the moisture level at the periwound being equal to, or exceeding, a predetermined upper threshold moisture level.
  • the controller 500 Upon detecting (e.g. via a visual transition of the indicators) that the moisture level has decreased to a level equal to or below an intermediate moisture level, the controller 500 is optionally configured to reduce the speed at which the air displacement device 350 is operated. Once the moisture level within the treatment space has reached a level equal to or below a predetermined lower threshold (e.g. between approximately 40% and less than approximately 50% of the fluid capacity of the wound dressing 200), the controller 500 ceases operation of the air displacement device 350 to save power until such a time when the moisture level in the treatment space (e.g. a moisture level of an optional absorbent layer 204, a moisture level at the periwound, etc.) is detected to again be equal to or greater than the upper predetermined threshold. Such selective operation of the air displacement device 350 may continue one or more times during the operation of the wound treatment system 100.
  • a predetermined lower threshold e.g. between approximately 40% and less than approximately 50% of the fluid capacity of the wound dressing 200
  • the controller 500 may be configured to continuously receive readings and measurements from one or more sensors (e.g., from a moisture level sensor assembly). Alternatively — to further conserve power — the controller 500 may instead be configured to selectively obtain sensor readings only at predetermined intervals (e.g., every 3-5 minutes). In some such embodiments, the predetermined interval at which the sensor readings are obtained may vary in response to the detection of various threshold sensor readings. For example, the controller 500 may be configured to obtain moisture level readings at a more frequent interval following the detection (using, e.g., the moisture level sensor assembly) that a moisture level underneath the wound dressing 200 is equal to, or exceeds, an upper moisture level threshold.
  • the air displacement device 350 optionally comprises a plurality of independently operable air displacement devices 350 that are fluidly coupled at various locations to the flow path 340 around (e.g. adjacent to, surrounding, etc.) the outer peripheries of various openings 312 in the film layer 310.
  • the operation of some or all of the air displacement devices 350 is optionally independently controllable, allowing moisture levels to be managed as needed at specific target areas along the wound dressing 200.
  • each individual air displacement device 350 is individually controllable responsive to a moisture level reading (or other sensed condition) obtained from a moisture indicator (or other sensor) positioned at a location relative to the wound that corresponds to the location at which the respective air displacement device 350 is positioned.
  • a moisture level reading or other sensed condition
  • a moisture indicator or other sensor
  • the wound treatment system 100 may include a variety of different types of wound dressings 200, may be defined by a one-piece, integrated design, and is optionally useable in conjunction with additional wound therapy systems.
  • One exemplary embodiment illustrative of such a self-contained, combined wound treatment system 100 and additional wound therapy system is described with reference to the hand treatment system 600 representatively illustrated in FIGS. 14-16.
  • NPWT therapy often benefits from NPWT therapy.
  • NPWT therapy often faces a number of challenges.
  • NPWT treatment often requires either a frequent changing of the wound dressing and/or the use of an external canister to collect the increased levels of fluids exuded by the wound during such treatment.
  • the hand-shaped configuration of the components of the wound treatment system 100 e.g., the wound dressing 200, film layer 310, spacer structure 320, etc.
  • the hand treatment system 600 advantageously provides the user with increased dexterity as compared to conventional wound dressings.
  • the hand treatment system 600 is described as comprising a combined wound treatment system 100 and a NPWT system, according to other embodiments, the hand treatment system 600 may instead comprise a stand-alone wound treatment system 100 used without a NPWT system (or any other additional wound therapy system). In yet other embodiments, the hand treatment system 600 may comprise a w ound treatment system 100 used with any other additional wound therapy systems besides a NPWT system.
  • the hand-like wound dressing 200 of the hand treatment system 600 comprises a closed, annularly extending structure that defines a cavity configured to receive the hand of a patient.
  • the hand-like w ound dressing 200 of the hand treatment system 600 includes an outer, exterior portion (e.g. surface) that faces the ambient environment and an inner, interior portion (e.g. surface) that faces the cavity.
  • Each of the outer portion and inner portion of the hand-like wound dressing 200 terminate in a single, annularly extending free edge 611.
  • the edge 611 defines an opening 613 via which the cavity is fluidly coupled to the ambient environment.
  • the hand treatment system 600 defines a hand-like wound dressing 200 having a glove-like structure comprising five peninsular projections 615 that extend from a central region 610 in the shape of a hand. Each of the five peninsular projections 615 corresponds to one finger or thumb of a patient.
  • an optional cuff 622 extends along, or adjacent to, the edge 611 of the wound dressing 200.
  • the cuff 622 may be produced as an integrated piece of the hand-like wound dressing 200, or may be provided as a separate piece (e.g., as an adhesive strip) configured to be attached relative to the edge 611.
  • the cuff 622 is configured to be sealingly coupled to the wrist of the patient to substantially fluidly seal the hand from the ambient environment.
  • An adhesive or other sealing structure e.g. a wiper seal
  • the cuff 622 is additionally configured to sealingly couple the film layer 310 of the moisture management system 300 to the wrist of the patient and/or to the upper surface of the hand- like wound dressing 200.
  • the hand-like wound dressing 200 may be made available in various sizes corresponding to different hand sizes (i.e., different dimensions of the central region 610 and the peninsular projections 615 of the layers).
  • the hand-like wound dressing 200 may be available in a small size, a medium size, a large size, etc. to allow fitting to various patients without requiring individual/patient- specific customization.
  • a hand-like wound dressing 200 (or features thereof) that may be used in the hand treatment system 600 are described in more detail in co-pending application US 62/883,424, filed August 6, 2019 and titled “HAND DRESSING FOR USE WITH NEGATIVE PRESSURE WOUND THERAPY,” as well as in co-pending application US 62/881,591, filed August 1, 2019 and titled “HAND DRESSING FOR USE WITH NEGATIVE PRESSURE WOUND THERAPY,” the entireties of which are incorporated herein by reference.
  • the hand-like wound dressing 200 may be formed from any number of different layers.
  • the hand-like wound dressing 200 includes a high MVTR drape layer 202, a manifold layer 208, optional absorbent layer 204 and optional interface layer 206, such as, e.g., described with reference to the wound dressing 200 of the wound treatment system 100 of FIGS. 1-13.
  • the manifold layer 208 has a thickness that is thinner than that typically used in wound dressings 200 (e.g. the manifold layer 208 has a thickness in a range between approximately 6mm and 10mm) to facilitate flexion of the hand treatment system 600.
  • fluid management in the hand treatment system 600 may further be supplemented via the inclusion of an optional absorbent layer 204 in the hand-like wound dressing 200.
  • the absorbent layer 204 may extend along the entirety of the hand-like wound dressing 200.
  • the absorbent layer 204 may instead extend along a portion of (see, e.g. FIGS. 15 and 16) of the hand-like wound dressing 200, so as to minimize the impact of the additional wound dressing 200 layer on the flexion of the hand treatment system 600.
  • the hand treatment system 600 may additionally, or alternatively, include an external fluid storage device that is used in conjunction with the moisture management system 300 to manage fluid levels in the treatment space underneath the hand-like wound dressing 200.
  • the external fluid storage device may comprise an absorbent or super absorbent structure that is located within the module 400, in-line in as a large-cross section conduit 354, as a flexible pouch, etc.
  • the moisture management system 300 may be incorporated into the hand treatment system 600 in a manner similar to the incorporation of the moisture management system 300 into a wound treatment system 100 as described with reference to FIGS. 1-13 above.
  • the film layer 310 and spacer structure 320 are configured to be supported relative to the outer, exterior surface 203 of the drape layer 202 of the hand-like wound dressing 200.
  • the spacer structure 320 and film layer 310 are shown as extending along the entirety of the hand-like wound dressing 200 of the hand treatment system 600 embodiment of FIGS. 14-16, in other embodiments, the spacer structure 320 and film layer 310 may optionally extend along less than all of (i.e. along only portions of) the outer surface of the hand-like only portion of the wound dressing 200 outer surface.
  • the film layer 310 and spacer structure 320 may be provided along only the central, palm portion (e.g. the central region 610) of the wound dressing 200, along only a top surface of the wound dressing 200 outer surface, etc.
  • the vents 314 of the hand treatment system 600 may also include one or each of openings 315 that extend through the film layer 310 as well as unattached portions 316 of the film layer 310 that are not directly coupled to the outer surface of the hand-like wound dressing 200.
  • the vents 314 may be arranged according to a variety of different configurations, and may be formed/provided at one or more locations on the hand treatment system 600. As shown in FIGS. 14 and 15, in various embodiments, the vents 314 are arranged along the sides of the peninsular projections 615 of the hand-like wound dressing 200.
  • the wound dressing 200, spacer structure 320 and film layer 310 are constructed as a single, integral structure.
  • the wound dressing 200 is provided separately from the spacer structure 320 and film layer 310.
  • the spacer structure 320 and film layer 310 may be provided as a single, integral glove-like structure configured to be applied over the glove-like wound dressing 200 of FIGS. 14-16.
  • the spacer structure 320 and film layer 310 may be provided as sheets that are configured to be attached along the outer surface 203 of the drape layer 202 of the glove-like wound dressing 200 of FIGS. 14- 16.
  • the flow path 340 defined between the hand-like wound dressing 200 and the spacer structure 320 and film layer 310 may be fluidly couple to an air displacement device 350 located remotely from the patient via a conduit 354 or tubing that is fluidly connected to the opening 312 in the film layer 310
  • the air displacement device 350 (as well as any additional components of the hand treatment system 600) is housed in a module 400 that is supported by the hand treatment system 600.
  • the module 400 is shown in FIGS. 14 and 15 as being supported along an upper portion of the central region 610 of the hand- like wound dressing 200, according to other embodiments, the module 400 may optionally be supported at other locations relative to the hand-like wound dressing 200.
  • the module 400 may optionally be supported along the cuff 622 of the hand treatment system 600.
  • FIGS. 14-16 show a glove-shaped hand treatment system 600 (i.e., with individually-differentiated fingers formed by peninsular projections 615), other embodiments of the hand treatment system 600 may be formed having other shapes.
  • the hand treatment system 600 may be mitten-shaped (i.e., includes a unified area for four fingers and a separate projection for a thumb), may define a three-compartment glove where the two pairs of fingers each share a compartment and the thumb has a compartment, etc.
  • variations in the shape, size and configuration of the hand treatment system 600 can be tailored for to provide a self-contained, combined wound treatment system 100 and NPWT system for use in treating wounds on different patient extremities or other anatomical locations.
  • a variation of the hand treatment system 600 suitable for use on a foot may be formed as a sock, with or without a separate pocket/proj ection for each toe, rather than as a glove as illustrated in the hand treatment system 600 embodiments shown in FIGS. 14-16.
  • the hand treatment system 600 may be formed to define a pouch-like structure defining a cavity accessible via a single opening 613 that is configured to be sealed to a patient’s skin (e.g.
  • the configuration of the hand treatment system 600 may also be varied to define an enclosed sleeve that may be attached to and encircle (e.g. circumscribe, extend annularly around, etc.) an extremity (e.g. a user’s arm, leg, etc.).

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Abstract

La présente invention concerne un système de traitement de plaie pour une extrémité comprenant un pansement avec une couche de support perméable à la vapeur d'humidité et un système de gestion d'humidité. Le système de gestion d'humidité comprend une couche de film, et un ensemble d'espacement configuré pour être supporté au-dessus de la surface supérieure du pansement. Lors de l'assemblage, un trajet d'écoulement est défini entre une surface supérieure du pansement et une surface inférieure de la couche de film. Un dispositif de déplacement d'air est configuré pour générer un écoulement d'air forcé à travers le trajet d'écoulement. Lorsque de l'air s'écoule à travers le trajet d'écoulement, l'air sec accélère la diffusion et l'évaporation du fluide du pansement, augmentant la capacité de fluide du pansement.
PCT/IB2020/057195 2019-08-22 2020-07-30 Pansement pour extrémité pour la gestion d'humidité à écoulement d'air forcé WO2021033051A1 (fr)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996014765A1 (fr) * 1994-11-15 1996-05-23 W.L. Gore & Associates, Inc. Gant de protection
WO2009066106A1 (fr) * 2007-11-21 2009-05-28 Smith & Nephew Plc Pansement de plaie
WO2012141999A1 (fr) * 2011-04-12 2012-10-18 Kci Licensing, Inc. Pansements absorbants de type polymère, systèmes et méthodes basés sur des dispositifs d'évaporation
CN206414542U (zh) * 2016-09-20 2017-08-18 河北医科大学第三医院 手部vsd负压引流器械
WO2019002086A2 (fr) * 2017-06-30 2019-01-03 Smith & Nephew Plc Couche d'espacement à utiliser dans un pansement
WO2019089522A1 (fr) * 2017-11-02 2019-05-09 Systagenix Wound Management, Limited Pansement avec capteur colorimètre d'humidité

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996014765A1 (fr) * 1994-11-15 1996-05-23 W.L. Gore & Associates, Inc. Gant de protection
WO2009066106A1 (fr) * 2007-11-21 2009-05-28 Smith & Nephew Plc Pansement de plaie
WO2012141999A1 (fr) * 2011-04-12 2012-10-18 Kci Licensing, Inc. Pansements absorbants de type polymère, systèmes et méthodes basés sur des dispositifs d'évaporation
CN206414542U (zh) * 2016-09-20 2017-08-18 河北医科大学第三医院 手部vsd负压引流器械
WO2019002086A2 (fr) * 2017-06-30 2019-01-03 Smith & Nephew Plc Couche d'espacement à utiliser dans un pansement
WO2019089522A1 (fr) * 2017-11-02 2019-05-09 Systagenix Wound Management, Limited Pansement avec capteur colorimètre d'humidité

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