WO2025008418A1 - Dispositifs et procédés de thérapie de plaie par pression négative - Google Patents

Dispositifs et procédés de thérapie de plaie par pression négative Download PDF

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Publication number
WO2025008418A1
WO2025008418A1 PCT/EP2024/068768 EP2024068768W WO2025008418A1 WO 2025008418 A1 WO2025008418 A1 WO 2025008418A1 EP 2024068768 W EP2024068768 W EP 2024068768W WO 2025008418 A1 WO2025008418 A1 WO 2025008418A1
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WO
WIPO (PCT)
Prior art keywords
wound
dressing
substrate layer
filler
wound dressing
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.)
Pending
Application number
PCT/EP2024/068768
Other languages
English (en)
Inventor
Maria ASPIOTI
Varuni Rachindra BROWNHILL
Cameron George HAY
Allan Kenneth Frazer Grugeon HUNT
Samuel John MORTIMER
Luke Michael PARRY
Neill John RAWSON
Hannah Bailey WEEDON
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TJ Smith and Nephew Ltd
Original Assignee
TJ Smith and Nephew Ltd
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Filing date
Publication date
Application filed by TJ Smith and Nephew Ltd filed Critical TJ Smith and Nephew Ltd
Publication of WO2025008418A1 publication Critical patent/WO2025008418A1/fr
Anticipated expiration legal-status Critical
Pending 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
    • A61F13/01—Non-adhesive bandages or dressings
    • A61F13/01021—Non-adhesive bandages or dressings characterised by the structure of the dressing
    • A61F13/01029—Non-adhesive bandages or dressings characterised by the structure of the dressing made of multiple layers
    • 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
    • A61F13/01—Non-adhesive bandages or dressings
    • A61F13/01034—Non-adhesive bandages or dressings characterised by a property
    • A61F13/01038—Flexibility, stretchability or elasticity
    • 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
    • A61F2013/00182—Wound bandages with transparent part
    • 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
    • A61F2013/00348—Wound bandages lint-free, i.e. non-linting or frying
    • 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
    • A61F2013/00361—Plasters
    • A61F2013/00365—Plasters use
    • A61F2013/00536—Plasters use for draining or irrigating wounds

Definitions

  • Embodiments described herein relate to apparatuses, systems, and methods for the treatment of wounds, for example using dressings in combination with negative pressure wound therapy.
  • TNP therapy sometimes referred to as vacuum assisted closure, negative pressure wound therapy, or reduced pressure wound therapy, is widely recognized as a beneficial mechanism for improving the healing rate of a wound.
  • TNP therapy assists in the closure and healing of wounds by reducing tissue edema, encouraging blood flow, stimulating the formation of granulation tissue, removing excess exudates and may reduce bacterial load. Thus, reducing infection to the wound.
  • TNP therapy permits less outside disturbance of the wound and promotes more rapid healing.
  • Existing negative pressure therapy wound fillers such as foam or gauze, may shed fibers and/or particulates into a wound, which can cause inflammation, redness, irritation, infection, and/or increased wound treatment time. Further, removal of foam or gauze wound filler materials may cause pain to a patient and potentially inadvertently cause removal of healthy granulated tissue from the wound.
  • foam, gauze, or other wound fillers may need to be sized, shaped, layered, or otherwise prepared to better accommodate such variation in size and shape.
  • existing foam, gauze, or other wound fillers may be cut to certain size or shape, the adjustment may be limited by various factors, such as the size or the shape of the original foam, gauze, or other wound fillers.
  • a wound may change in size or shape as negative pressure treatment is applied to the wound.
  • Embodiments of the present disclosure relate to materials, devices, methods, and systems for wound treatment. Some disclosed embodiments relate to materials, devices, methods, and systems for delivering negative pressure to a wound. It will be understood by one of skill in the art that application of the materials, devices, methods, and systems described herein are not limited to a particular tissue or a particular injury.
  • a wound dressing for use in negative pressure wound therapy may comprise a porous wound filler and a laminated substrate layer configured to reduce shedding of particles from the porous wound filler.
  • the laminated substrate layer may be positioned on the bottom and/or the top of the porous wound filler.
  • the wound dressing may comprise foam or slits.
  • the slits may be arranged in an alternating pattern, individual slits oriented 90 degrees from individual adjacent slits.
  • the wound filler may comprise a plurality of castellations on a surface of the wound filler.
  • the wound filler may comprise a plurality of castellations on a top surface of the wound filler and on a bottom surface of the wound filler.
  • the laminated substrate layer or layers may comprise silicone.
  • the laminated substrate layer or layers may be transparent.
  • the laminated substrate layer or layers may comprise perforations.
  • the shape of the perforations may be a circle, oval, oblong, square, or rectangle.
  • the perforations may be arranged in a staggered pattern.
  • the wound filler may comprise a plurality of holes extending at least partially through a thickness of the wound filler.
  • the wound dressing may further comprise individual plugs positioned in individual holes, the plugs comprising a material different from the wound filler. In certain examples, individual plugs may comprise an active ingredient.
  • a wound treatment apparatus for use in negative pressure wound therapy may comprise an assembly of interconnected conformable wound dressings, individual conformable wound dressings comprising a porous wound filler encased in a perforated substrate layer.
  • the wound filler may comprise wool.
  • the substrate layer may comprise silicone.
  • individual conformable wound dressings may be configured to be removed from the assembly such that the assembly is shaped to the contours of a wound.
  • the wound treatment apparatus may comprise connections to connect the interconnected conformable wound dressings. Individual connections may comprise perforations. Individual connections may comprise silicone.
  • a method of preparing a wound dressing device for use in negative pressure therapy may comprise providing a wound filler comprising a plurality of perforations, the plurality of perforations configured to form a plurality of predetermined shapes; and removing at least one of the plurality of predetermined shapes.
  • kits that include the negative pressure wound therapy device of any of the preceding paragraphs and/or any of the devices, apparatuses, or systems disclosed herein and one or more wound dressings.
  • Figure 1 A illustrates an embodiment of a negative pressure wound therapy system.
  • Figure IB illustrates another embodiment of a negative pressure wound therapy system.
  • Figure 2A illustrates a side view of an example of a wound dressing device having a wound filler and a substrate layer.
  • Figure 2B illustrates a side view of an example of a wound dressing device having a wound filler and two substrate layers.
  • Figure 3 illustrates a top view of an example of a wound dressing device having a perforated substrate layer.
  • Figure 4A illustrates a perspective view of an example of a wound dressing device having slits.
  • Figure 4B illustrates a perspective view of the wound dressing device shown in Figure 4 A having two substrate layers.
  • Figure 5 A illustrates a perspective view of an example of a wound dressing device having castellations.
  • Figure 5B illustrates a top view of an example of a wound dressing device having castellations and through holes.
  • Figure 5C illustrates a perspective view of an example of a wound dressing device having castellations and a substrate layer.
  • Figure 6 A illustrates a top view of an example of a wound dressing device having holes.
  • Figure 6B illustrates a top view of the wound dressing device shown in Figure 6A having a plug.
  • Figure 7A illustrates a side view of an example of a wound dressing device having a plug.
  • Figure 7B illustrates a side view of the wound dressing device shown in Figure 7A applied to a wound.
  • Figure 7C illustrates a side view of the wound dressing device shown in Figure 7A applied to a wound.
  • Figure 8 A illustrates an example of a wound dressing device having a “bowtie” shape.
  • Figure 8B illustrates an example of a wound dressing device having a circular shape.
  • Figure 8C illustrates an example of a wound dressing device having an oval shape.
  • Figure 8D illustrates an example of a wound dressing device having a strip shape.
  • Figure 9A illustrates an example of a wound dressing device having perforations defining predetermined shapes.
  • Figure 9B illustrates the wound dressing device shown in Figure 9A relative to a wound.
  • Figure 9C illustrates the wound dressing device shown in Figure 9A configured to be applied to the wound shown in Figure 9B.
  • Figure 9D illustrates the wound dressing device shown in Figure 9A relative to a wound.
  • Figure 9E illustrates the wound dressing device shown in Figure 9A configured to be applied to the wound shown in Figure 9D.
  • Figure 10 illustrates an example of a conformable wound dressing having a wound filler material and a contact layer.
  • Figure 11 illustrates an example of a conformable wound dressing conformed to a wound.
  • Figure 12A illustrates an example assembly of wound dressings.
  • Figure 12B illustrates an example assembly of wound dressings.
  • Figure 12C illustrates an example assembly of wound dressings.
  • Figure 12D illustrates an example assembly of wound dressings.
  • Figure 13 A illustrates an example of a wound dressing that may be cut to size.
  • Figure 13B illustrates an example of a wound dressing with a closure strip.
  • Figure 14A illustrates an example of a wound dressing that may be folded.
  • Figure 14B illustrates an example of a folded wound dressing.
  • Embodiments disclosed herein relate to systems and methods of treating and/or monitoring a wound.
  • Some embodiments of the negative pressure wound therapy devices disclosed herein can include a negative pressure source configured to be connected and/or fluidically coupled, via a fluid flow path, to a wound covered by a wound dressing and provide negative pressure to a wound.
  • a wound is to be broadly construed and encompasses open and closed wounds in which skin is torn, cut or punctured or where trauma causes a contusion, or any other superficial or other conditions or imperfections on the skin of a patient or otherwise that benefit from pressure treatment.
  • a wound is thus broadly defined as any damaged region of tissue where fluid may or may not be produced.
  • wounds include, but are not limited to, abdominal wounds or other large or incisional wounds, either as a result of surgery, trauma, sterniotomies, fasciotomies, or other conditions, dehisced wounds, acute wounds, chronic wounds, subacute and dehisced wounds, traumatic wounds, flaps and skin grafts, lacerations, abrasions, contusions, bums, diabetic ulcers, pressure ulcers, stoma, surgical wounds, trauma and venous ulcers or the like.
  • Embodiments of systems and methods disclosed herein can be used with topical negative pressure (“TNP”) or reduced pressure therapy systems.
  • TNP topical negative pressure
  • negative pressure wound therapy assists in the closure and healing of many forms of “hard to heal” wounds by reducing tissue oedema, encouraging blood flow and granular tissue formation, or removing excess exudate and can reduce bacterial load (and thus infection risk).
  • the therapy allows for less disturbance of a wound leading to more rapid healing.
  • TNP therapy systems can also assist in the healing of surgically closed wounds by removing fluid.
  • TNP therapy can help to stabilize the tissue in the apposed position of closure.
  • a further beneficial use of TNP therapy can be found in grafts and flaps where removal of excess fluid is important and close proximity of the graft to tissue is required in order to ensure tissue viability.
  • reduced or negative pressure levels represent pressure levels relative to normal ambient atmospheric pressure, which can correspond to 760 mmHg (or 1 atm, 29.93 inHg, 101.325 kPa, 14.696 psi, etc.). Accordingly, a negative pressure value of -X mmHg reflects pressure that is X mmHg below 760 mmHg or, in other words, a pressure of (760-X) mmHg. In addition, negative pressure that is “less” or “smaller” than X mmHg corresponds to pressure that is closer to atmospheric pressure (for example, -40 mmHg is less than -60 mmHg).
  • Negative pressure that is “more” or “greater” than -X mmHg corresponds to pressure that is further from atmospheric pressure (for example, -80 mmHg is more than -60 mmHg).
  • local ambient atmospheric pressure is used as a reference point, and such local atmospheric pressure may not necessarily be, for example, 760 mmHg.
  • Systems and methods disclosed herein can be used with other types of treatment in addition to or instead of reduced pressure therapy, such as irrigation, ultrasound, heat or cold, neuro stimulation, or the like. In some cases, disclosed systems and methods can be used for wound monitoring without application of additional therapy. Systems and methods disclosed herein can be used in conjunction with a dressing, including with compression dressing, reduced pressure dressing, or the like.
  • a healthcare provider such as a clinician, nurse, or the like, can provide a TNP prescription specifying, for example, the pressure level or time of application.
  • the healing process is different for each patient and the prescription may affect the healing process in a way the clinician or healthcare provider did not expect at the time of devising the prescription.
  • a healthcare provider may try to adjust the prescription as the wound heals (or does not heal), but such process may require various appointments that can be time consuming and repetitive.
  • Embodiments disclosed herein provide systems, devices, or methods of efficiently adjusting TNP prescriptions and delivering effective TNP therapy.
  • FIG. 1A schematically illustrates a negative pressure wound treatment system 100’ (sometimes referred to as a reduced or negative pressure wound therapy system, a TNP system, or a wound treatment system).
  • the negative pressure wound treatment system 100’ can include a wound filler 102 placed on or inside a wound 104 (which may be a cavity).
  • the wound 104 can be sealed by a wound cover 106, which can be a drape, such that the wound cover 106 can be in fluidic communication with the wound 104.
  • the wound filler 102 in combination with the wound cover 106 can be referred to as a wound dressing.
  • a tube or conduit 108’ (also referred to herein as a flexible suction adapter or a fluidic connector) can be used to connect the wound cover 106 with a wound therapy device 110’ (sometimes as a whole or partially referred to as a “pump assembly”) configured to supply reduced or negative pressure.
  • the conduit 108’ can be a single or multi lumen tube.
  • a connector can be used to removably and selectively couple a conduit or tube of the device 110’ with the conduit 108’.
  • a wound therapy device can be canisterless, wherein, for example and without limitation, wound exudate is collected in the wound dressing or is transferred via a conduit for collection at another location.
  • any of the wound therapy devices disclosed herein can include or support a canister.
  • any of the wound therapy devices can be mounted to or supported by the wound dressing or adjacent to the wound dressing.
  • the wound filler 102 can be any suitable type, such as hydrophilic or hydrophobic foam, gauze, inflatable bag, and so on.
  • the wound filler 102 can be conformable to the wound 104 such that the wound filler 102 substantially fills the cavity of the wound 104.
  • the wound cover 106 can provide a substantially fluid impermeable seal over the wound 104.
  • the wound cover 106 can have a top side and a bottom side. The bottom side can adhesively (or in any other suitable manner) seal with the wound 104, for example by sealing with the skin around the wound 104.
  • the conduit 108 or any other conduit disclosed herein can be formed from polyurethane, PVC, nylon, polyethylene, silicone, or any other suitable material.
  • the wound cover 106 can have a port (not shown) configured to receive an end of the conduit 108.
  • the conduit 108 can otherwise pass through or under the wound cover 106 to supply reduced pressure to the wound 104 so as to maintain a desired level of reduced pressure in the wound 104.
  • the conduit 108 can be any suitable article configured to provide at least a substantially sealed fluid flow pathway or path between the wound therapy device 110’ and the wound cover 106, so as to supply the reduced pressure provided by the wound therapy device 110’ to wound 104.
  • the wound cover 106 and the wound filler 102 can be provided as a single article or an integrated single unit. In some cases, no wound filler is provided and the wound cover by itself may be considered the wound dressing.
  • the wound dressing can then be connected, via the conduit 108, to a source of negative pressure of the wound therapy device 110’.
  • the wound therapy device 110’ can be miniaturized and portable, although larger conventional negative pressure sources (or pumps) can also be used.
  • the wound cover 106 can be located over a wound site to be treated.
  • the wound cover 106 can form a substantially sealed cavity or enclosure over the wound.
  • the wound cover 106 can have a film having a high water vapour permeability to enable the evaporation of surplus fluid, and can have a superabsorbing material contained therein to safely absorb wound exudate.
  • the components of the TNP systems described herein can be particularly suited for incisional wounds that exude a small amount of wound exudate.
  • the wound therapy device 110’ can operate with or without the use of an exudate canister.
  • the wound therapy device 110’ can include an exudate canister.
  • configuring the wound therapy device 110’ and conduit 108’ so that the conduit 108’ can be quickly and easily removed from the wound therapy device 110’ can facilitate or improve the process of wound dressing or pump changes, if necessary.
  • Any of the pump assemblies disclosed herein can have any suitable connection between the conduit 108’ and the pump.
  • the wound therapy device 110’ can deliver negative pressure of approximately -80 mmHg, or between about -20 mmHg and -200 mmHg. Note that these pressures are relative to normal ambient atmospheric pressure thus, -200 mmHg would be about 560 mmHg in practical terms. In some cases, the pressure range can be between about -40 mmHg and -150 mmHg. Alternatively, a pressure range of up to -75 mmHg, up to -80 mmHg or over -80 mmHg can be used. Also in some cases a pressure range of below -75 mmHg can be used. Alternatively, a pressure range of over approximately -100 mmHg, or even -150 mmHg, can be supplied by the wound therapy device 110’.
  • the negative pressure wound treatment system 100’ can be configured to provide a connection 332 to a separate or remote computing device 334.
  • the connection 332 can be wired or wireless (such as, Bluetooth, Bluetooth low energy (BLE), Near-Field Communication (NFC), WiFi, or cellular).
  • the remote computing device 334 can be a smartphone, a tablet, a laptop or another standalone computer, a server (such as, a cloud server), another pump device, or the like.
  • Figure IB illustrates another negative pressure wound treatment system 100.
  • the negative pressure wound treatment system 100 can have any of the components, features, or other details of any of the other negative pressure wound treatment system disclosed herein, including without limitation the negative pressure wound treatment system 100’ illustrated in Figure 1A or the negative pressure wound treatment system 400 illustrated in Figure 4, in combination with or in place of any of the components, features, or other details of the negative pressure wound treatment system 100 shown in Figure IB and/or described herein.
  • the negative pressure wound treatment system 100 can have a wound cover 106 over a wound 104 that can seal the wound 104.
  • a conduit 108 such as a single or multi lumen tube can be used to connect the wound cover 106 with a wound therapy device 110 (sometimes as a whole or partially referred to as a “pump assembly”) configured to supply reduced or negative pressure.
  • the wound cover 106 can be in fluidic communication with the wound 104.
  • the conduit 108 can have a bridge portion 130 that can have a proximal end portion and a distal end portion (the distal end portion being closer to the wound 104 than the proximal end portion, and an applicator 132 at the distal end of the bridge portion 130 forming the flexible suction adapter (or conduit) 108.
  • a connector 134 can be disposed at the proximal end of the bridge portion 130, so as to connect to at least one of the channels that can extend along a length of the bridge portion 130 of the conduit 108 shown in Figure IB.
  • a cap 140 can be coupled with a portion of the conduit 108 and can, in some cases, as illustrated, be attached to the connector 134.
  • the cap 140 can be useful in preventing fluids from leaking out of the proximal end of the bridge portion 130.
  • the conduit 108 can be a Soft Port manufactured by Smith & Nephew.
  • the negative pressure wound treatment system 100 can include a source of negative pressure, such as the device 110, capable of supplying negative pressure to the wound 104 through the conduit 108.
  • the device 110 can also include a canister or other container for the storage of wound exudates and other fluids that can be removed from the wound.
  • the device 110 can be connected to the connector 134 via a conduit or tube 142.
  • the applicator 132 can be placed over an aperture formed in a cover 106 that is placed over a suitably -prepared wound or wound 104.
  • the wound therapy device 110 can be activated to supply negative pressure to the wound.
  • Application of negative pressure can be applied until a desired level of healing of the wound is achieved.
  • the bridge portion 130 can comprise an upper channel material or layer positioned between an upper layer and an intermediate layer, with a lower channel material or layer positioned between the intermediate layer and a bottom layer.
  • the upper, intermediate, and lower layers can have elongate portions extending between proximal and distal ends and can include a material that is fluid-impermeable, for example polymers such as polyurethane. It will of course be appreciated that the upper, intermediate, and lower layers can each be constructed from different materials, including semi-permeable materials. In some cases, one or more of the upper, intermediate, and lower layers can be at least partially transparent. In some instances, the upper and lower layers can be curved, rounded or outwardly convex over a majority of their lengths.
  • the upper and lower channel layers can be elongate layers extending from the proximal end to the distal end of the bridge 130 and can each preferably comprise a porous material, including for example open-celled foams such as polyethylene or polyurethane.
  • one or more of the upper and lower channel layers can be comprised of a fabric, for example a knitted or woven spacer fabric (such as a knitted polyester 3D fabric, Baltex 7970.RTM., or Gehring 879.RTM.) or a nonwoven material, or terry-woven or loop-pile materials.
  • the fibers may not necessarily be woven, and can include felted and flocked (including materials such as Flotex.RTM.) fibrous materials.
  • the materials selected are preferably suited to channeling wound exudate away from the wound and for transmitting negative pressure or vented air to the wound site, and can also confer a degree of kinking or occlusion resistance to the channel layers.
  • the upper channel layer can include an open-celled foam such as polyurethane, and the lower channel layer can include a fabric.
  • the upper channel layer is optional, and the system can instead be provided with an open upper channel.
  • the upper channel layer can have a curved, rounded or upwardly convex upper surface and a substantially flat lower surface, and the lower channel layer can have a curved, rounded or downwardly convex lower surface and a substantially flat upper surface.
  • the fabric or material of any components of the bridge 130 can have a three-dimensional (3D) structure, where one or more types of fibers form a structure where the fibers extend in all three dimensions.
  • a fabric can in some cases aid in wicking, transporting fluid or transmitting negative pressure.
  • the fabric or materials of the channels can include several layers of material stacked or layered over each other, which can in some cases be useful in preventing the channel from collapsing under the application of negative pressure.
  • the materials used in some implementations of the conduit 108 can be conformable and pliable, which can, in some cases, help to avoid pressure ulcers and other complications which can result from a wound treatment system being pressed against the skin of a patient.
  • the distal ends of the upper, intermediate, and lower layers and the channel layers can be enlarged at their distal ends (to be placed over a wound site), and can form a "teardrop" or other enlarged shape.
  • the distal ends of at least the upper, intermediate, and lower layers and the channel layers can also be provided with at least one through aperture. This aperture can be useful not only for the drainage of wound exudate and for applying negative pressure to the wound, but also during manufacturing of the device, as these apertures can be used to align these respective layers appropriately.
  • a controlled gas leak 146 (sometimes referred to as gas leak, air leak, or controlled air leak) can be disposed on the bridge portion 130, for example at the proximal end thereof.
  • This air leak 146 can comprise an opening or channel extending through the upper layer of the bridge portion 130, such that the air leak 146 is in fluidic communication with the upper channel of the bridge portion 130.
  • gas such, as air
  • the gas can then be suctioned into the lower channel of the bridge portion 130 by passing through the apertures through the distal ends of the upper, intermediate, and lower layers.
  • the air leak 146 can include a filter.
  • the air leak 146 is located at the proximal end of the bridge portion 130 so as to minimize the likelihood of wound exudate or other fluids coming into contact and possibly occluding or interfering with the air leak 146 or the filter.
  • the filter can be a microporous membrane capable of excluding microorganisms and bacteria, and which may be able to filter out particles larger than 45 pm.
  • the filter can exclude particles larger than 1.0 pm, and more preferably, particles larger than 0.2 pm.
  • some implementations can provide for a filter that is at least partially chemically-resistant, for example to water, common household liquids such as shampoos, and other surfactants.
  • the filter can be composed of a suitably-resistant polymer such as acrylic, polyethersulfone, or polytetrafluoroethylene, and can be oleophobic or hydrophobic.
  • the gas leak 146 can supply a relatively constant gas flow that does not appreciably increase as additional negative pressure is applied to the conduit 108. In instances of the negative pressure wound treatment system 100 where the gas flow through the gas leak 146 increases as additional negative pressure is applied, preferably this increased gas flow will be minimized and not increase in proportion to the negative pressure applied thereto.
  • any of the wound therapy devices can provide continuous or intermittent negative pressure therapy.
  • Continuous therapy can be delivered at above 0 mmHg, -25 mmHg, -40 mmHg, -50 mmHg, -60 mmHg, -70 mmHg, -80 mmHg, -90 mmHg, -100 mmHg, -120 mmHg, -125 mmHg, -140 mmHg, -160 mmHg, -180 mmHg, -200 mmHg, or below -200 mmHg.
  • Intermittent therapy can be delivered between low and high negative pressure set points (sometimes referred to as setpoint).
  • Low set point can be set at above 0 mmHg, -25 mmHg, -40 mmHg, -50 mmHg, -60 mmHg, -70 mmHg, -80 mmHg, -90 mmHg, -100 mmHg, -120 mmHg, -125 mmHg, -140 mmHg, -160 mmHg, -180 mmHg, or below -180 mmHg.
  • High set point can be set at above - 25 mmHg, -40 mmHg, -50 mmHg, -60 mmHg, -70 mmHg, -80 mmHg, -90 mmHg, -100 mmHg, -120 mmHg, -125 mmHg, -140 mmHg, -160 mmHg, -180 mmHg, -200 mmHg, or below -200 mmHg.
  • negative pressure at low set point can be delivered for a first time duration, and upon expiration of the first time duration, negative pressure at high set point can be delivered for a second time duration. Upon expiration of the second time duration, negative pressure at low set point can be delivered.
  • the first and second time durations can be same or different values.
  • the wound filler 102 can be inserted into the cavity of the wound 104, and wound cover 106 can be placed so as to seal the wound 104.
  • the wound therapy device 110’ can provide negative pressure to the wound cover 106, which can be transmitted to the wound 104 via the wound filler 102.
  • Fluid (such as, wound exudate) can be drawn through the conduit 108’ and stored in a canister. In some cases, fluid is absorbed by the wound filler 102 or one or more absorbent layers (not shown).
  • Wound dressings that can be utilized with the pump assembly and systems of the present application include Renasys-F, Renasys-G, Renasys AB, and Pico Dressings available from Smith & Nephew. Further description of such wound dressings and other components of a negative pressure wound therapy system that can be used with the pump assembly and systems of the present application are found in U.S. Patent Publication Nos. 2012/0116334, 2011/0213287, 2011/0282309, 2012/0136325, U.S. Patent No. 9,084,845, and International App. No. PCT/EP2020/078376, each of which is incorporated by reference in its entirety as if fully set forth herein. In some cases, other suitable wound dressings can be utilized.
  • the negative pressure wound therapy device 110 may include a pump assembly and a canister.
  • the pump assembly and canister can be connected, thereby forming the wound therapy device 110.
  • the pump assembly can include an interface panel having a display, one or more indicators, or one or more controls or buttons, including, for example and without limitation, a therapy start and pause button or an alarm/alert mute button.
  • the interface panel can have one or more input controls or buttons that can be used to control any functions of the pump assembly or the interface panel.
  • one or more of the buttons can be used to turn the pump assembly on or off, to start or pause therapy, to operate and monitor the operation of the pump assembly, to scroll through menus displayed on the display, or to control or perform other functions.
  • the command buttons can be programmable, and can be made from a tactile, soft rubber.
  • the interface panel can have visual indicators that can indicate which of the one or more buttons is active.
  • the interface panel can also have a lock/unlock control or button that can be configured to selectively lock or unlock the functionality of the various buttons or the display. For example, therapy setting adjustment can be locked/unlocked via the lock/unlock control.
  • the lock/unlock button is in the locked state, depressing one or more of the various other buttons or the display will not cause the pump assembly to change any display functions or performance functions of the device. This way, the interface panel will be protected from inadvertent bumping or touching of the various butons or display.
  • the interface panel can be located on an upper portion of the pump assembly, for example and without limitation on an upward facing surface of the pump assembly.
  • the display which can be a screen such as an LCD screen, can be mounted in a middle portion of the interface panel.
  • the display can be a touch screen display.
  • the display can support playback of audiovisual (AV) content, such as instructional videos, and render a number of screens or graphical user interfaces (GUIs) for configuring, controlling, and monitoring the operation of the pump assembly.
  • AV audiovisual
  • GUIs graphical user interfaces
  • the one or more indicators can be lights (such as, LEDs) and can be configured to provide a visual indication of alarm conditions and or a status of the pump.
  • the one or more indicators can be configured to provide a visual indication of a status of the pump assembly or other components of the negative pressure wound treatment system 100, including without limitation the conduit 108 or the wound cover 106 (such as, to provide an indication of normal operation, low batery, a leak, canister full, blockage, overpressure, or the like).
  • Any one or more suitable indicators can be additionally or alternatively used, such as visual, audio, tactile indicator, and so on.
  • the pump assembly of the wound therapy device 110 can include a speaker for producing sound.
  • the speaker can generate an acoustic alarm in response to deviations in therapy delivery, non-compliance with therapy delivery, or any other similar or suitable conditions or combinations thereof.
  • the speaker can provide audio to accompany one or more instructional videos that can be displayed on the display.
  • the pump assembly can be configured to provide easy access (such as, an access door on the casing of the pump assembly) to one or more filters of the pump assembly, such as antibacterial filters. This can enable a user (such as, a healthcare provider or patient) to more easily access, inspect or replace such filters.
  • the pump assembly can also include a power jack for providing power to the pump assembly or for charging and recharging an internal power source (such as, a batery). Some implementations of the pump assembly can include a disposable or renewable power source, such as one or more bateries, so that no power jack is needed.
  • the pump assembly can have a recess formed therein to facilitate gripping of the pump assembly.
  • the canister can hold fluid aspirated from the wound 104.
  • the canister can have an 800 mL (or approximately 800 mL) capacity, or from a 300 mL or less capacity to a 1000 mL or more capacity, or any capacity level in this range.
  • the canister can include a tubing for connecting to the conduit 108 in order to form a fluid flow path.
  • the canister can be replaced with another canister, such as when the canister has been filled with fluid.
  • the wound therapy device 110 can include a canister inlet tube 142 (also referred to herein as a dressing port connector) in fluid communication with the canister.
  • the canister inlet tube 142 can be used to connect with the conduit 108.
  • the canister can be selectively coupleable and removable from the pump assembly.
  • a canister release button can be configured to selectively release the canister from the pump assembly.
  • the canister can have one or more fill lines or graduations to indicate to the user and amount of fluid or exudate stored within the canister.
  • the wound therapy device 110 can have a handle that can be used to lift or carry the wound therapy device 110.
  • the handle can be coupled with the pump assembly and can be rotatable relative to the wound therapy device 110 so that the handle can be rotated upward for lifting or carrying the wound therapy device 110 or the pump assembly, or rotated into a lower profile in a more compact position when the handle is not being used.
  • the handle can be coupled with the pump assembly in a fixed position.
  • the handle can be coupled with an upper portion of the pump assembly or can be removable from the wound therapy device 110.
  • a control system can be employed in any of the wound therapy devices described herein, such as in the wound therapy device 110.
  • Electrical components can operate to accept user input, provide output to the user, operate the pressure source, provide connectivity, and so on.
  • a first processor (such as, a main controller) can be responsible for user activity, and a second processor (such as, a pump controller) can be responsible for controlling another device, such as a pump.
  • An input/output (I/O) module can be used to control an input and/or output to another component or device, such as the pump, one or more sensors (for example, one or more pressure sensors configured to monitor pressure in one or more locations of the fluid flow path), or the like.
  • the I/O module can receive data from one or more sensors through one or more ports, such as serial (for example, I2C), parallel, hybrid ports, and the like.
  • Any of the pressure sensors can be part of the wound therapy device or the canister.
  • any of the pressure sensors can be remote to the wound therapy device, such as positioned at or near the wound (for example, in the dressing or the conduit connecting the dressing to the wound therapy device).
  • any of the remote pressure sensors can communicate with the I/O module over a wired connection or with one or more transceivers over a wireless connection.
  • the main controller can receive data from and provide data to one or more expansion modules, such as one or more USB ports, SD ports, Compact Disc (CD) drives, DVD drives, FireWire ports, Thunderbolt ports, PCI Express ports, and the like.
  • the main controller along with other controllers or processors, can store data in memory (such as one or more memory modules), which can be internal or external to the main controller.
  • Any suitable type of memory can be used, including volatile or non-volatile memory, such as RAM, ROM, magnetic memory, solid-state memory, Magnetoresistive random-access memory (MRAM), and the like.
  • the main controller can be a general purpose controller, such as a low- power processor or an application specific processor.
  • the main controller can be configured as a “central” processor in the electronic architecture of the control system, and the main controller can coordinate the activity of other processors, such as the pump controller, one or more communications controllers, and one or more additional processors.
  • the main controller can run a suitable operating system, such as a Linux, Windows CE, VxWorks, etc.
  • the pump controller can control the operation of a pump, which can generate negative or reduced pressure.
  • the pump can be a suitable pump, such as a diaphragm pump, peristaltic pump, rotary pump, rotary vane pump, scroll pump, screw pump, liquid ring pump, diaphragm pump operated by a piezoelectric transducer, voice coil pump, and the like.
  • the pump controller can measure pressure in a fluid flow path, using data received from one or more pressure sensors, calculate the rate of fluid flow, and control the pump.
  • the pump controller can control the pump actuator (such as, a motor) so that a desired level of negative pressure is achieved in the wound 104.
  • the desired level of negative pressure can be pressure set or selected by the user.
  • the pump controller can control the pump (for example, pump motor) using pulse-width modulation (PWM) or pulsed control.
  • a control signal for driving the pump can be a 0-100% duty cycle PWM signal.
  • the pump controller can perform flow rate calculations and detect alarms.
  • the pump controller can communicate information to the main controller.
  • the pump controller can be a low- power processor.
  • Any of the one or more communications controllers can provide connectivity (such as, a wired or wireless connection).
  • the one or more communications controllers can utilize one or more transceivers for sending and receiving data.
  • the one or more transceivers can include one or more antennas, optical sensors, optical transmitters, vibration motors or transducers, vibration sensors, acoustic sensors, ultrasound sensors, or the like. Any of the one or more transceivers can function as a communications controller. In such case, the one or more communications controllers can be omitted. Any of the one or more transceivers can be connected to one or more antennas that facilitate wireless communication.
  • the one or more communications controllers can provide one or more of the following types of connections: Global Positioning System (GPS), cellular connectivity (for example, 2G, 3G, LTE, 4G, 5G, or the like), NFC, Bluetooth connectivity (or BLE), radio frequency identification (RFID), wireless local area network (WLAN), wireless personal area network (WPAN), WiFi connectivity, Internet connectivity, optical connectivity (for example, using infrared light, barcodes, such as QR codes, etc.), acoustic connectivity, ultrasound connectivity, or the like.
  • Connectivity can be used for various activities, such as pump assembly location tracking, asset tracking, compliance monitoring, remote selection, uploading of logs, alarms, and other operational data, and adjustment of therapy settings, upgrading of software or firmware, pairing, and the like.
  • Any of the one or more communications controllers can provide dual GPS/cellular functionality.
  • Cellular functionality can, for example, be 3G, 4G, or 5G functionality.
  • the one or more communications controllers can communicate information to the main controller.
  • Any of the one or more communications controllers can include internal memory or can utilize memory.
  • Any of the one or more communications controllers can be a low-power processor.
  • the control system can store data, such as GPS data, therapy data, device data, and event data. This data can be stored, for example, in memory. This data can include patient data collected by one or more sensors. The control system can track and log therapy and other operational data. Such data can be stored, for example, in the memory 350.
  • the control system can upload any of the data stored, maintained, or tracked by the control system to a remote computing device, such as the device.
  • the control system can also download various operational data, such as therapy selection and parameters, firmware and software patches and upgrades, and the like (for example, via the connection to the device).
  • the one or more additional processors such as processor for controlling one or more user interfaces (such as, one or more displays), can be utilized.
  • any of the illustrated or described components of the control system can be omitted depending on an embodiment of a wound monitoring or treatment system in which the control system is used.
  • any of the negative pressure wound therapy devices described herein can include one or more features disclosed in U.S. Patent No. 9,737,649 or U.S. Patent Publication No. 2017/0216501, each of which is incorporated by reference in its entirety.
  • the negative pressure wound treatment system can include a wound therapy device capable of supplying negative pressure to the wound site or sites, such as wound therapy device 110.
  • the wound therapy device 110 can be in fluidic communication with one or more wound dressings so as to supply negative pressure to one or more wounds.
  • a first fluid flow path can include components providing fluidic connection from the wound therapy device 110 to the first wound dressing.
  • the first fluid flow path can include the path from the first wound dressing to the wound therapy device 110 or the path from the first wound dressing to an inlet of a branching attachment (or connector) in fluidic connection with the wound therapy device 110.
  • a second fluid flow path can include components providing fluidic connection from the wound therapy device 110 to the second wound dressing.
  • the system can be similar to the system 100 with the exception that multiple wounds are being treated by the system.
  • the system can include any one or more of the components of the system 100, such as, one or more wounds 104and one or more covers 106.
  • the system can include a plurality of wound dressings (and corresponding fluid flow paths) in fluidic communication with the wound therapy device 110 via a plurality of suction adapters, such as the adapter 108.
  • the suction adapters can include any one or more of the components of the adapter 108, such as, one or more bridge portions 130, one or more connectors 134, and one or more caps 140.
  • the wound therapy device 110 can be fluidically coupled via the tube 142 with the inlet of the connector.
  • the connector can be fluidically coupled via branches and tubes or conduits with the connectors 134, which can be fluidically coupled with the tubes or conduits 130.
  • the tubes or conduits 130 can be fluidically coupled with the dressings 106. Once all conduits and dressing components are coupled and operably positioned, the wound therapy device 110 can be activated, thereby supplying negative pressure via the fluid flow paths to the wounds 104. Application of negative pressure can be applied until a desired level of healing of the wounds 104 is achieved.
  • two wounds and wound dressing are described, some implementations of the wound therapy device 110 can provide treatment to a single wound (for instance, by closing the unused branch of the connector) or to more than two wounds (for instance, by adding branches to the connector).
  • the system can include one or more features disclosed in U.S. Patent Publication No. 2020/0069850 or International Publication No. WO2018/167199, each of which is incorporated by reference in its entirety.
  • FIG. 2A illustrates an embodiment of a wound dressing 200.
  • the wound dressing 200 may be used with a negative pressure wound therapy system such as described herein.
  • the wound dressing 200 can include a wound filler material 202 and a substrate layer 204, which may function as a bottom substrate layer or a wound contact layer when placed on the bottom of the wound filler material and as a top substrate layer when placed on top of the wound filler material.
  • the wound filler 202 may be foam.
  • the wound filler 202 may be another suitable porous material.
  • the substrate layer 204 may be adhered to the wound filler 202.
  • the substrate layer 204 may be a laminated substrate, which is laminated onto the wound filler 202.
  • the substrate layer 204 may be silicone.
  • the substrate layer 204 may include polyurethane, 3D spacer fabric, reticulated foam, siliconized foam, Allevyn foam, iodine impregnated substrate, silver impregnated substrate, chitosan impregnated substrate, hydrogels, hydro-morphic polymers, super absorbent materials, or any other suitable material.
  • the substrate layer 204 may be transparent. In certain embodiments, the substrate layer 204 may be opaque.
  • FIG. 2B illustrates an embodiment of a wound dressing 200 having a wound filler 202 and substrate layers 204 and 206.
  • substrate layers 204 and 206 may be positioned on multiple sides of the wound filler 202.
  • substrate layers 204 and 206 may be positioned on both sides of the wound filler 202 as a top substrate layer and a bottom substrate layer.
  • the substrate layer 204 may be positioned on a single side of the wound filler 202.
  • the substrate layer may be positioned on the top and/or bottom and/or sides of the wound filler.
  • the substrate layers 204 and 206 of Figure 2B may be constructed from any of the materials described above in relation to the substrate layer of Figure 2 A.
  • the wound dressing 200 may be configured to reduce or prevent contact between the wound filler 202 and the wound.
  • the wound dressing 200 may be configured such that, when placed into a wound, the substrate layer 204 or 206 contacts the surface of the wound, and the wound filler 202 does not contact the surface of the wound or only minimally contacts the surface of the wound.
  • Such an approach may provide several advantages. For example, providing a substrate layer on the bottom of the wound filler and reducing or preventing contact between the wound filler 202 and the wound may advantageously reduce the risk of wound filler fibers being shed into the wound, reduce pain caused to the patient during removal of the wound dressing 200, and reduce the risk of removal of healthy granulated tissue during removal of the wound dressing 200.
  • a substrate layer may reduce tissue ingrowth into the structure, thereby limiting further damage to wound site upon removal of the dressing.
  • wound filler fibers may be shed into a wound when the wound dressing is cut, torn, or shaped to the size of the wound. Further, wound filler fibers may simply shed from the wound dressing during the ordinary course of treatment.
  • the substrate layer 204 may be perforated. Perforations 300 in the substrate layer 204 may permit fluid to flow through the substrate layer. For example, perforations 300 in the substrate layer 204 may permit wound exudate to flow through the substrate layer 204 and subsequently through the wound filler 202 when negative pressure is applied to the wound site. Additionally, the perforation serve to improve transmission of negative pressure to the wound bed. As will be understood by one of skill in the art, perforations 300 in the substrate layer 204 may be circular, oval, oblong, square, rectangular, polygonal, or of any suitable shape. In certain embodiments, the perforations may be slits. Perforations 300 may be arranged in any suitable pattern.
  • FIG 3 illustrates an embodiment in which adjacent perforations 300 are substantially aligned.
  • perforations 300 may be arranged in a staggered pattern.
  • perforations 300 may be positioned randomly within substrate layer 204 or in any suitable pattern, such as an array.
  • Perforations 300 may be uniform in size.
  • perforations 300 may be of various sizes, such as having a diameter from about: .1 to 20 mm, 1-10mm, 2-8mm, 2.5mm to 5mm, or about 3mm.
  • the perforations may be non-uniform, meaning that perforations may have different diameters within a single layer.
  • the wound filler material 202 may include structural features, patterns, or characteristics, which may advantageously improve exudate flow through the wound filler material 202, facilitate pressure distribution upon application of negative pressure to the wound, and/or increase conformability of the wound filler material 202.
  • the wound filler 202 may include slits 400, which may also be referred to as cuts or perforations 400.
  • the wound filler 202 may include ACHCOAT (by Smith and Nephew) slits 400 with alternative slits in different directions which may be positioned at an angle to one another such as about: 90 degrees, 45 degrees, or 30 degree.
  • slits 400 may extend through the thickness of the wound filler material 202.
  • slits 400 may extend only partially through the wound filler material 202. Slits 400 in the wound filler material 202 may advantageously improve exudate flow, pressure distribution, and/or conformability.
  • the wound filler material 202 may include castellations 500, which may also be referred to as notches or raised and lowered portions 500.
  • Figure 5A depicts a wound filler material 202 having castellations 500 on the top of the filler material 202.
  • the filler material 202 may include castellations 500 on one or more sides of the filler material 202.
  • the filler material 202 may include castellations 500 on the top and bottom of the filler material 202. Castellations 500 in the filler material 202 may advantageously improve exudate flow, pressure distribution, and/or conformability.
  • the wound filler material 202 may include through holes 502 positioned between the castellations 500. Through holes 502 positioned between castellations 500 of the wound filler material 202 may improve exudate flow through the filler material 202. In certain examples, the holes may be positioned through every intersection, every other intersection, every third intersection, or any other suitable arrangement. In certain examples, the holes have a diameter between about 1 mm to 10mm, 2 mm to 8mm, 2.5mm to 5mm, or about 3 to 4 mm.
  • a substrate layer 204 may be positioned on, adjacent to, or otherwise applied to a surface of the wound filler material 202 having castellations 500. As previously discussed, the substrate layer 204 may have perforations 300, which may further improve exudate flow through the wound filler material 202 and substrate layer 204.
  • the wound filler material 202 may include holes 600, which may also be referred to as cuts or perforations 600.
  • holes 600 may extend through the thickness of the wound filler material 202.
  • holes 600 may extend only partially through the wound filler material 202.
  • Holes 600 in the wound filler material 202 may be circular, oval, oblong, square, rectangular, polygonal, or of any suitable shape.
  • Holes 600 may be arranged in any suitable pattern.
  • Figures 6A-6B illustrate an embodiment in which the holes 600 are in a staggered pattern. In other embodiments, holes 600 may be arranged in a substantially aligned pattern. In other embodiments, holes 600 may be positioned randomly within wound filler material 202.
  • Holes 600 may be uniform in size. Alternatively, holes 600 may vary in size. In certain examples, the diameter of the holes may be from about: .1 to 5 mm, .5 to 4 mm, 1 to 3 mm, or about 1 mm. In some examples, the diameter of the holes may be between 1 to 2.1 mm. In some examples, there may between about: 5-50 holes, 10-30 holes, 15 to 25 holes or about 19 holes. In certain embodiments, the holes may penetrate the entire wound filler and have a length of about: 1 to 30cm, 2 to 25 cm, 3 to 20 cm, 5 to 15 cm, or about 10 cm.
  • a plug 602 may be added to fill one or more holes 600.
  • the plug 602 may substantially fill a hole 600.
  • the plug 602 may partially fill a hole 600.
  • a wound filler material 202 may include a single plug 602.
  • a wound filler material 202 may include multiple plugs 602.
  • plugs 602 include super absorbent materials, gel forming materials, hydro-morphic polymers, wicking materials, and active ingredients such as iodine, silver, charcoal, IODOSORB, hydrogel, or any combination of thereof.
  • materials such as super absorbent materials, gel forming materials, hydro-morphic polymers, wicking materials may be combined with active ingredients which are configured to be released.
  • the plug 602 may include an active ingredient that may advantageously aid in treatment of a wound 104.
  • an active ingredient that may advantageously aid in treatment of a wound 104.
  • the negative pressure may cause the plug 602, such as an active ingredient, to spill or otherwise be applied to the bed of the wound 104, which may aid in treatment of the wound 104.
  • the wound filler 202 of the wound dressing 200 may be sized, shaped, or otherwise configured such that the wound dressing 200 may be applied to wounds of having various shapes and sizes.
  • the wound filler material 202 may be rectangular.
  • the wound filler material 202 may be square, circular, oval, polygonal, or any other suitable shape such as a the shape of a wound.
  • Figures 8A-8D illustrate various embodiments of a wound filler material 202.
  • Figure 8A depicts a wound filler material 202 having a “bowtie” shape.
  • Figure 8B depicts a wound filler material 202 having a circular shape.
  • Figure 8C depicts a wound filler material 202 having an oval shape.
  • Figure 8D depicts a wound filler material 202 having an elongate rectangular shape, which may otherwise be referred to as a strip.
  • a wound filler material 202 in the form of a strip may advantageously assist in treatment of wounds having a tunneling feature.
  • the wound filler material 202 may include perforations 900.
  • the perforations 900 may be positioned such that the perforations 900 define predetermined shapes within the wound filler material 202. As depicted in Figures 9B-9E, the perforations 900 may permit a user to remove undesired, unnecessary, or excess portions of the wound filler material 202, such that the remaining wound filler material 202 has a desired size and/or shape. For example, a user may remove portions of the wound filler material 202 along a line formed by perforations 900, resulting in a wound filler material 202 sized, shaped, or otherwise configured to be applied to a wound 104 having a particular size and shape.
  • a wound filler material 202 having perforations 900 configured to allow a user to customize the size and/or shape of the filler material 202 may advantageously reduce the amount of time required to prepare the filler material 202 for application to a particular wound 104.
  • a wound filler material 202 having perforations 900 may further reduce the risk of fibers or particulates from being shed into the wound 104 during preparation and/or application of the wound filler material 202.
  • such wound filler materials may be combined with any suitable substrate layer described herein.
  • FIG 10 illustrates a conformable wound dressing 1000.
  • the conformable wound dressing 1000 may also be referred to as a wound filler bag.
  • the filler bag may have dimensions similar to those of RENASYS-F by Smith and Nephew.
  • a large filler bag may have dimensions of approximately 25x15 cm, a medium bag of about 20x13 cm, a small bag of about 10x8 cm, and an extra small bag of about 3x3 cm.
  • the conformable wound dressing 1000 may comprise a wound filler material 1002 and a substrate layer 1004 configured to be in contact with a wound or other tissue.
  • the wound filler material 1002 may be positioned within the substrate layer 1004.
  • the substrate layer 1004 may contact the wound, thereby reducing or preventing contact between the wound filler 1002 and the wound.
  • the wound substrate layer(s) may be perforated to allow fluid flow and negative pressure transmission.
  • the wound substrate layers may be constructed from any suitable material described herein, such as, for example, silicone.
  • the substrate layer may be constructed from various materials such as polyurethane, 3D spacer fabric, reticulated foam, siliconized foam, Allevyn foam, iodine impregnated substrate, silver impregnated substrate, chitosan impregnated substrate, hydrogels, hydro-morphic polymers, super absorbent materials, or any other suitable material.
  • the wound filler material 1002 may be a porous material.
  • the wound filler material 1002 may be natural or synthetic wool or any other suitable material described herein.
  • the use of wool as a wound filler material 1002 may advantageously provide various benefits.
  • wool filler material 1002 may have natural spring characteristics, which may allow the wound filler material 1002 to return to its natural shape after being folded, stretched, compressed, or otherwise reshaped.
  • Wool filler material 1002 may provide thermal insulation benefits, which may assist with regulating temperature at or near the wound. Wool filler material 1002 may be resistant to bacteria, mold, and mildew, thus reducing the risk of allergic reactions at or near the wound.
  • Wool filler material 1002 may also have absorbent characteristics, which may allow the wound filler material 1002 to absorb and release moisture, such as wound exudate. Wool filler material 1002 may absorb pollutants and not re-emit the pollutant, thus reducing undesired odors. Wool filler material 1002 may respond to changes in humidity due to the wool’s structure, thus preventing or reducing the growth and breeding of dust mites and/or other organisms. Wool filler material 1002 may naturally generate little or no static electricity, thus reducing attraction of lint, dirt, and dust, and assisting in maintaining the cleanliness of the filler material 1002.
  • Wool filler material 1002 may have natural flame-resistant properties, such as resistance to ignition, resistance to flame spread, resistance to heat, resistance to melting, and/or natural self-extinguishing properties. Further, wool filler material 1002 may provide a renewable, sustainable, and/or biodegradable source of filler material 1002. Although some embodiments may use wool as the wound filler material 1002, other embodiments may use other porous materials as the wound filler material 1002.
  • the substrate layer 1004 may be silicone or any other suitable substrate material described herein. In other embodiments, the substrate layer 1004 may include polyurethane or any other suitable materials.
  • the substrate layer 1004 may be transparent, which may advantageously permit monitoring of the wound while the substrate layer 1004 is positioned within the wound. In such an example where a transparent substrate is used to monitor the wound, the filler material may be made to be at least partially transparent and/or may include one or more holes for viewing.
  • the substrate layer 1004 may be perforated, which may advantageously allow fluid to flow through the substrate layer and allow transmission of negative pressure. For example, a perforated substrate layer 1004 may allow wound exudate to flow through the substrate layer 1004 and subsequently through the wound filler 1002 when negative pressure is applied to the wound site.
  • FIG 11 illustrates an example of the wound dressing 1000 conformed to a wound 104 such that the wound dressing 1000 substantially fills the cavity of the wound 104.
  • a negative pressure wound treatment system 100 may include a conformable wound dressing 1000.
  • the negative pressure wound treatment system 100 can include a source of negative pressure, such as the device 110, capable of supplying negative pressure to the wound 104 through the conduit 108.
  • the wound dressing 1000 may conform to the size, shape, surface, profile, and/or contour of a wound 104.
  • the wound dressing 1000 may conform to the wound 104 such that the wound dressing 1000 substantially fills the cavity of the wound 104.
  • the substrate layer 1004 may be positioned such that the substrate layer 1004 contacts the wound’s 104 surface, or wound bed.
  • the wound filler material 1002 may be positioned such that it contacts the substrate layer 1004 and such that the wound filler material 1002 substantially fills the cavity of the wound 104.
  • the substrate layer 1004 may be silicone, and the wound filler material 1002 may be wool.
  • the conformability of the wound dressing 1000 may advantageously provide various benefits.
  • the conformable wound dressing 1000 may reduce or eliminate the need to cut the wound dressing 1000 to size and shape, thereby reducing material wastage and preparation time.
  • the conformable wound dressing 1000 may facilitate substantially equal distribution of negative pressure throughout the wound.
  • Figure 12A illustrates an example of an assembly 1200 of conformable wound dressings 1000 similar to the wound dressings described above in relation to Figures 10-11.
  • Figure 12A depicts an assembly having two wound dressings 1000.
  • the assembly 1200 may have three, four, five, six, seven, eight, nine, ten, or any combination thereof of wound dressings 1000.
  • the wound dressings 1000 of assembly 1200 may be removably connected to each other.
  • the wound dressings 1000 may be removably connected to each other by connection 1202.
  • the connection 1202 may be silicone, polyurethane, or any other suitable material.
  • the connection 1202 may be perforated, which may advantageously assist with separation of the wound dressings 1000 from each other.
  • the connection 1202 may comprise part of the wound substrate layer 1004.
  • FIG. 12B illustrates two wound dressings 1000 having been separated from assembly 1200.
  • the wound dressings 1000 may be separated from each other by cutting, tearing, or otherwise disconnecting the connection 1202.
  • a perforated silicone connection 1202 may facilitate disconnection of the wound dressings 1000 from each other.
  • the assembly 1200 of wound dressings 1000 may advantageously assist with treatment of wounds having various sizes and shapes. For example, a single separated wound dressing 1000 may be applied to a relatively small wound. Multiple wound dressings 1000 may be applied to larger wounds.
  • FIG. 12C illustrates an assembly 1200 having four conformable wound dressings 1000 in a removably connected configuration.
  • the wound dressings 1000 may be removably connected to each other by connections 1202.
  • connections 1202 may be silicone, polyurethane, or any other suitable material.
  • connections 1202 may be perforated substrate layer 1004, which may advantageously assist with separation of the wound dressings 1000 from each other.
  • Figure 12D illustrates an assembly 1200 having conformable wound dressings 1000 that are in the process of being disconnected from each other.
  • the wound dressings 1000 may be separated from each other by cutting, tearing, or otherwise disconnecting the connections 1202, which may advantageously assist with treatment of wounds having various sizes and shapes.
  • Figure 13A illustrates a conformable wound dressing 1000 that may be cut to a desired size and/or shape.
  • the wound dressing 1000 may be cut along line 1300 such that the wound dressing is cut to a desired size. Cutting the conformable wound dressing 1000 to a desired size may further assist in applying the conformable wound dressing 1000 to wounds of various sizes.
  • FIG. 13B illustrates a conformable wound dressing 1000 having a closure strip 1302.
  • the wound dressing 1000 may be cut to a desired size.
  • a closure strip 1302 may be used to close the wound filler dressing 1000 and thereby enclose the wound filler material 1002.
  • the closure strip 1302 may be silicone, polyurethane, or any other suitable material.
  • the closure strip 1302 may comprise part of the substrate layer 1004.
  • the closure strip may be attached to the substrate layer 1004.
  • the closure strip 1302 may be adhered to, laminated to, or otherwise attached to the substrate layer 1004.
  • the closure strip 1302 may be removed from the wound dressing 1000.
  • the closure strip 1302 may but cut, torn, or otherwise removed from the wound dressing 1000.
  • Figure 14A illustrates a conformable wound dressing 1000 that may be folded to a desired size and/or shape.
  • Figure 14B illustrates an example of the wound dressing 1000 of Figure 14A in a folded configuration.
  • the conformable wound dressing 1000 may be folded along line 1400.
  • the wound dressing 1000 may then be maintained in a desired folded configuration using a securing strip 1402.
  • the securing strip 1402 may be silicone, polyurethane, or any other suitable material.
  • the securing strip 1402 may be attached to the substrate layer 1004.
  • the securing strip 1402 may be adhered to, laminated to, or otherwise attached to the substrate layer 1004.
  • the securing strip 1402 may be removed from the wound dressing 1000.
  • the securing strip 1402 may be cut, torn, or otherwise removed from the wound dressing 1000.
  • systems, devices, and/or methods disclosed herein can be applied to other types of therapies usable standalone or in addition to TNP therapy.
  • Systems, devices, and/or methods disclosed herein can be extended to any medical device, and in particular any wound monitoring and/or treatment device.
  • systems, devices, and/or methods disclosed herein can be used with devices that provide one or more of ultrasound therapy, oxygen therapy, neurostimulation, microwave therapy, active agents, antibiotics, antimicrobials, or the like.
  • Such devices can in addition provide TNP therapy.
  • systems, devices, and/or methods disclosed herein can be used with a wound debridement system, patient monitoring system, or the like.
  • the systems and methods disclosed herein are not limited to medical devices and can be utilized by any electronic device.
  • Any of transmission of data described herein can be performed securely.
  • one or more of encryption, https protocol, secure VPN connection, error checking, confirmation of delivery, or the like can be utilized.
  • any value of a threshold, limit, duration, etc. provided herein is not intended to be absolute and, thereby, can be approximate.
  • any threshold, limit, duration, etc. provided herein can be fixed or varied either automatically or by a user.
  • relative terminology such as exceeds, greater than, less than, etc. in relation to a reference value is intended to also encompass being equal to the reference value. For example, exceeding a reference value that is positive can encompass being equal to or greater than the reference value.
  • relative terminology such as exceeds, greater than, less than, etc. in relation to a reference value is intended to also encompass an inverse of the disclosed relationship, such as below, less than, greater than, etc. in relations to the reference value.
  • the various components illustrated in the figures or described herein may be implemented as software and/or firmware on a processor, controller, ASIC, FPGA, and/or dedicated hardware.
  • the software or firmware can include instructions stored in a non-transitory computer-readable memory.
  • the instructions can be executed by a processor, controller, ASIC, FPGA, or dedicated hardware.
  • Hardware components such as controllers, processors, ASICs, FPGAs, and the like, can include logic circuitry.
  • User interface screens illustrated and described herein can include additional and/or alternative components. These components can include menus, lists, buttons, text boxes, labels, radio buttons, scroll bars, sliders, checkboxes, combo boxes, status bars, dialog boxes, windows, and the like. User interface screens can include additional and/or alternative information. Components can be arranged, grouped, displayed in any suitable order. [0136] Conditional language used herein, such as, among others, “can,” “could”, “might,” “may,” “e.g.,” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements and/or states.
  • each in addition to having its ordinary meaning, can mean any subset of a set of elements to which the term “each” is applied.
  • the terms “generally parallel” and “substantially parallel” refer to a value, amount, or characteristic that departs from exactly parallel by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degree.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un système de traitement de plaie par pression négative et des procédés d'utilisation d'un tel système. Des modes de réalisation préférés permettent la fermeture de la plaie par contraction préférentielle afin d'assurer le mouvement du tissu. Certains modes de réalisation peuvent comprendre des dispositifs de pansement ayant une charge de plaie et une couche de substrat stratifiée. Certains modes de réalisation peuvent comprendre un ensemble de dispositifs de pansement pouvant se conformer à une plaie.
PCT/EP2024/068768 2023-07-05 2024-07-03 Dispositifs et procédés de thérapie de plaie par pression négative Pending WO2025008418A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP23386055.0 2023-07-05
EP23386055 2023-07-05

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WO2025008418A1 true WO2025008418A1 (fr) 2025-01-09

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EP4201436A1 (fr) * 2021-12-22 2023-06-28 Mölnlycke Health Care AB Mousse de polyuréthane à utiliser dans des pansements pour plaies

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