EP4665286A1 - Apparatus for supplying fluid to a tissue area - Google Patents

Apparatus for supplying fluid to a tissue area

Info

Publication number
EP4665286A1
EP4665286A1 EP24756440.4A EP24756440A EP4665286A1 EP 4665286 A1 EP4665286 A1 EP 4665286A1 EP 24756440 A EP24756440 A EP 24756440A EP 4665286 A1 EP4665286 A1 EP 4665286A1
Authority
EP
European Patent Office
Prior art keywords
fluid
receptacle
tissue
permeable layer
wall portion
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
EP24756440.4A
Other languages
German (de)
French (fr)
Inventor
Robin Le-Ching CHANG
Eglantine Penelope Mary LAYEC
Dexter Chi Lun Cheung
Howard Kuo-Hao CHIU
Thomas Heinrich Barnes
Margaret Shi LU
Stephen William Mcphee
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fisher and Paykel Healthcare Ltd
Original Assignee
Fisher and Paykel Healthcare Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from AU2023900374A external-priority patent/AU2023900374A0/en
Application filed by Fisher and Paykel Healthcare Ltd filed Critical Fisher and Paykel Healthcare Ltd
Publication of EP4665286A1 publication Critical patent/EP4665286A1/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/02Adhesive bandages or dressings
    • A61F13/0203Adhesive bandages or dressings with fluid retention members
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/02Adhesive bandages or dressings
    • A61F13/0203Adhesive bandages or dressings with fluid retention members
    • A61F13/0206Adhesive bandages or dressings with fluid retention members with absorbent fibrous layers, e.g. woven or non-woven absorbent pads or island dressings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/02Adhesive bandages or dressings
    • A61F13/0203Adhesive bandages or dressings with fluid retention members
    • A61F13/022Adhesive bandages or dressings with fluid retention members having more than one layer with different fluid retention characteristics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F13/05Bandages 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]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/92Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing with liquid supply means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/94Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing with gas supply means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00089Wound bandages
    • A61F2013/0017Wound bandages possibility of applying fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00089Wound bandages
    • A61F2013/00314Wound bandages with surface treatments
    • A61F2013/00327Wound bandages with surface treatments to create projections or depressions in surface
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F13/00Bandages or dressings; Absorbent pads
    • A61F2013/00361Plasters
    • A61F2013/00365Plasters use
    • A61F2013/00536Plasters use for draining or irrigating wounds

Definitions

  • the present invention relates to an apparatus for supplying fluid to a tissue area.
  • the application of topical oxygen to a tissue area can improve tissue health.
  • the application of topical oxygen can aid healing. This is because healing can involve increased cell metabolic activity (which demands a large amount of oxygen).
  • the application of topical oxygen to the wound can help to meet this demand.
  • Exposing the wound surface to a negative-pressure environment can also aid healing. The negative-pressure environment helps to contract the wound and remove exudate from the wound.
  • a tissue care dressing comprises a receptacle having at least one wall, the at least one wall having an outer surface, wherein at least a section of the outer surface comprises a rough surface.
  • the rough surface may be configured to present a reduced surface area of the outer surface available for contact with contaminants.
  • the rough surface may be configured for hindering the adherence of contaminants to the outer surface.
  • the rough surface can make the receptacle easier to clean, thereby improving the cleanliness of the receptacle.
  • the rough surface may be present on multiple sections of the outer surface. At least a portion of the rough surface may be present on a section of the outer surface configured for contacting the tissue. At least a portion of the rough surface may be present on a section of the outer surface configured not to contact the tissue.
  • the rough surface may be configured to present a substantially random variation in the topology of the at least one section of the outer surface.
  • the rough surface may be irregular.
  • the rough surface may have a height of between about 0.2 micrometres to 400 micrometres from a low point to a high point thereof.
  • the rough surface may have a plurality of raised or recessed elements that vary in height.
  • the height of the elements may be between about 0.2 micrometres to 200 micrometres.
  • the height of the elements may be measured from a common baseline.
  • the rough surface may have a plurality of raised and/or recessed elements that vary in width.
  • the width of the elements may be between about 0.2 micrometers to 200 micrometers.
  • the receptacle may have a head portion and a tail portion.
  • the rough surface may be present on at least a portion of the head portion and/or at least a portion of the tail portion.
  • the rough surface may be present on substantially the entirety of the head portion and/or the tail portion.
  • the at least one wall of the receptacle may have an inner surface, and at least a section of the inner surface may comprise a rough surface.
  • the at least one wall of the receptacle may be flexible.
  • the receptacle may be inflatable.
  • the receptacle may be configurable to press against the tissue of a patient.
  • the receptacle may be configured for receiving a fluid therein.
  • the tissue care dressing may be configured to deliver the fluid to the tissue of a patient through the at least one wall of the receptacle.
  • the at least one wall may comprise at least one section adapted to allow the fluid to pass from the receptacle to the tissue by pore flow.
  • the at least one wall may comprise at least one section adapted to allow molecules within the fluid to diffuse from the receptacle to the tissue.
  • the fluid may be oxygen.
  • At least a section of the outer surface may include a plurality of microstructures.
  • the microstructures may be configured for encouraging cell growth.
  • the tissue care dressing may further comprise a cover positionable over the receptacle to form a compartment substantially bounded by the cover, the receptacle and the tissue.
  • an apparatus for supplying fluid to tissue of a patient comprises an inflatable receptacle positionable at a tissue area, the receptacle comprising one or more walls and being adapted to receive a fluid, the one or more walls comprising at least one section adapted to allow molecules within the fluid to diffuse from the receptacle to the tissue area; and a cover positionable over the receptacle to form a compartment substantially bounded by the cover, the receptacle and the tissue area.
  • an apparatus for supplying fluid to a tissue area comprises a receptacle positionable at a tissue area, the receptacle comprising one or more walls and being adapted to receive a fluid, the one or more walls comprising at least one section adapted to allow the fluid to pass from the receptacle to the tissue area; an inlet via which fluid is deliverable to the receptacle; an outlet via which fluid is receivable from the receptacle; and a cover positionable over the receptacle to form a compartment substantially bounded by the cover, the receptacle and the tissue area, the cover having a cover outlet via which fluid is receivable from the compartment substantially bounded by the cover, the receptacle and the tissue area.
  • the apparatus of any of the aspects described herein may further comprise a pressure spreading device adapted for contacting tissue of the patient.
  • the pressure spreading device may encapsulate at least a portion of a fluid inlet conduit and/or a first fluid outlet conduit.
  • the pressure spreading device may be configured to spread a force applied to the tissue of the patient by the fluid inlet conduit and/or the first fluid outlet conduit across a width of the pressure spreading device so as to mitigate patient discomfort.
  • the receptacle may comprise a head portion and a tail portion.
  • the pressure spreading device may comprise at least one cavity providing fluid communication between the fluid inlet conduit and the tail portion of the receptacle and/or the tail portion of the receptacle and the first fluid outlet conduit.
  • the cavity may have a width dimension that increases from a fluid inlet end of the cavity and/or fluid outlet end of the cavity to the tail portion end of the cavity.
  • the width dimension of the cavity may increase gradually from the fluid inlet end of the cavity and/or fluid outlet end of the cavity to the tail portion end of the cavity.
  • the cavity may have one or more cavity ridges extending substantially from a fluid inlet end of the cavity to a tail portion end of the cavity or from a fluid outlet end of the cavity to the tail portion end of the cavity.
  • the one or more cavity ridges may comprise a plurality of the cavity ridges disposed in a configuration such that the spacing between adjacent ridges increases from the fluid inlet end or fluid outlet end of the cavity to the tail portion end of the cavity.
  • the tail portion of the receptacle may have at least one ridge.
  • One or more cavity ridges may be positioned so as to be offset from the at least one ridge of the tail portion.
  • the one or more cavity ridges may overlap longitudinally with the at least one ridge of the tail portion.
  • the one or more cavity ridges may comprise an extension of the at least one ridge of the tail portion into the cavity.
  • the pressure spreading device may be adapted to receive an end portion of the fluid inlet conduit and an end portion of the first fluid outlet conduit therein, such that the end portions terminate inside the pressure spreading device.
  • the pressure spreading device may be adapted to receive an end portion of the fluid inlet conduit and an end portion of the first fluid outlet conduit therein, such that the end portions are permitted to terminate inside the tail portion.
  • the pressure spreading device may include an inlet conduit channel and an outlet conduit channel adapted for receiving the respective fluid inlet conduit or the first fluid outlet conduit therein.
  • the pressure spreading device may comprise at least one conduit locating feature adapted for locating an end of the fluid inlet conduit or first fluid outlet conduit.
  • the conduit locating feature may comprise a stop.
  • the conduit locating feature may be positioned in the inlet conduit channel and/or the outlet conduit channel.
  • the conduit locating feature may be positioned at the fluid inlet end of the cavity and/or the fluid outlet end of the cavity.
  • the fluid inlet conduit channel and/or the first fluid outlet conduit channel may have at least one recessed feature configured to facilitate adhesion between features of the pressure spreading device and/or the fluid inlet conduit or first fluid outlet conduit.
  • the at least one recessed feature may comprise a trench.
  • the trench may be configured to receive adhesive material therein.
  • the trench may provide a space into which adhesive material may flow.
  • the at least one recessed feature may additionally or alternatively comprise at least one channel at least partially surrounding or extending alongside at least a portion of the fluid inlet conduit channel and/or the first fluid outlet conduit channel.
  • the channel may be configured to receive adhesive material therein.
  • the channel may be configured to provide a space into which adhesive material may flow. The channel may thereby guide flow of adhesive material to one or more channel locations.
  • the pressure spreading device may comprise both at least one trench and at least one channel.
  • an apparatus for supplying fluid to target tissue within a tissue area of a patient comprising: a permeable layer having at least one section configured to permit molecules within the fluid to pass through the permeable layer and to be deformable; and a carrier layer configured to operatively define one or more apertures and to be disposable between the permeable layer and the tissue area so as to position the one or more apertures between the target tissue and the permeable layer such that the at least one section deforms into the one or more apertures and supplies molecules within the fluid to the target tissue.
  • the at least one section may comprise substantially the entirety of the permeable layer.
  • the at least one section may be deformable under pressure operatively imparted by the fluid on the permeable layer towards the tissue area.
  • the permeable layer may be flexible.
  • the permeable layer may be stretchable.
  • the at least one section may comprise a plurality of microstructures arranged on an operatively tissue area facing surface of the permeable layer.
  • the apparatus may comprise a receptacle adapted to receive the fluid, the receptacle comprising an operatively tissue area facing first wall portion, the first wall portion having the permeable layer.
  • the permeable layer may comprise substantially the entirety of the first wall portion.
  • the at least one section may deform under pressure operatively imparted by the fluid on the permeable layer towards the tissue area through inflation of the receptacle by the fluid. At least a part of the at least one section may have a substantially convex shape in an inflated position of the receptacle.
  • the receptacle may be formed from the first wall portion and an opposing second wall portion.
  • the second wall portion may have a thickness that is greater than a thickness of the at least one section of the permeable layer.
  • the at least one section of the permeable layer may have a thickness of between approximately 40pm to 70pm, or between approximately 45pm to 65pm, or between approximately 50pm to 60pm.
  • the at least one section of the permeable layer may have a thickness of approximately 55pm.
  • the second wall portion may have a thickness of between approximately 100pm to 300pm, or between approximately 150pm to 250pm or between approximately 175pm to 225pm.
  • the second wall portion may have a thickness of approximately 200pm.
  • the receptacle may be formed by joining the first wall portion and the second wall portion at a seam.
  • the first wall portion and the second wall portion may be non-porous.
  • a surface of the second wall portion disposed towards an interior of the receptacle may comprise at least one ridge.
  • the apparatus may comprise an indicator of an orientation of the receptacle.
  • the tissue area comprises a cavity
  • the receptacle may be substantially flexible so as to at least in part be positionable within the cavity.
  • the receptacle may be configured for inflation biased towards deforming the at least one section.
  • Configuration of the receptacle for inflation biased towards deforming the at least one section may comprise the first wall portion having a greater surface area relative to the second wall portion in an uninflated position of the receptacle.
  • the first wall portion may have a convex shape operatively disposed towards the tissue area in the uninflated position.
  • the at least one section may have a convex shape operatively disposed towards the tissue area in the uninflated position.
  • the apparatus may comprise a cover configured to hold the receptacle onto the tissue area.
  • the cover may constrain deformation of the receptacle away from the tissue area during inflation of the receptacle.
  • the at least one section may be configured to permit molecules within the fluid to pass through the permeable layer by diffusion alone or by a combination of diffusion and pore flow.
  • the supply of the molecules within the fluid to the target tissue may comprise the molecules within the fluid operably diffusing through the at least one section of the permeable layer towards the target tissue.
  • the at least one section may be configured to permit molecules within the fluid to pass through the permeable layer by pore flow.
  • the carrier layer may be configured to enable the one or more apertures to correspond to a shape and/or a location and/or geometry of the target tissue.
  • the carrier layer may comprise an absorbent material and/or a non-absorbent material.
  • the carrier layer may be an absorbent material.
  • the absorbent material may be a foam material.
  • the carrier layer may comprise a plurality of absorbent material sections.
  • the carrier layer material may allow absorption of exudate from the target tissue.
  • the carrier layer may be configured to wick exudate from the target tissue. Supply of the molecules within the fluid to the target tissue and absorption of exudate by the carrier layer material may occur substantially concurrently.
  • the carrier layer may be configured to adhere to at least a part of the tissue area and/or at least a part of the permeable layer.
  • the carrier layer may be affixable to the patient at or about the tissue area by adhesive tape.
  • the carrier layer may provide cushioning between the tissue area and at least a part of the permeable layer.
  • the fluid may be a therapeutic fluid.
  • the therapeutic fluid may be oxygen and/or carbon dioxide and/or carbon monoxide, and/or nitric oxide.
  • the apparatus may enable targeting of treatment towards the target tissue.
  • the receptacle may be configured to receive a fluid comprising therapeutic molecules, the at least one section configured to permit the therapeutic molecules within the fluid to pass through the permeable layer from an interior of the receptacle.
  • Deformation of the at least one section into the one or more apertures may be proportional to the pressure imparted on the permeable layer by the fluid. Deformation of the at least one section into the one or more apertures may be proportional to the pressure imparted on the permeable layer by the fluid contained in an interior of the receptacle.
  • the at least one section may deform into the one or more apertures to contact the target tissue. Where the at least one section contacts the target tissue, the at least one section contacting the target tissue may displace exudate from the target tissue towards a periphery of the one or more apertures.
  • the receptacle may comprise an inlet, the receptacle adapted to receive the fluid via a fluid inlet conduit in fluid communication with the inlet.
  • the receptacle may comprise an outlet, the receptacle adapted to allow the fluid to exit the receptacle via a fluid outlet conduit in fluid communication with the outlet.
  • the inlet and the outlet may be arranged substantially adjacent one another.
  • the inlet and the outlet may be located at a tail portion of the receptacle.
  • the apparatus may comprise a pressure spreading device configured to mitigate a pressure applied to the patient by the fluid inlet conduit and/or the fluid outlet conduit.
  • the pressure spreading device may comprise an indicator of an orientation of the receptacle.
  • the pressure spreading device may have a substantially flat surface at an operatively patient facing side.
  • the carrier layer may be configured to operatively define the one or more apertures by having one or more pre-cut apertures.
  • the one or more pre-cut apertures may be chamfered at an operatively permeable layer facing side of the carrier layer.
  • the carrier layer may be configured to operatively define the one or more apertures at a perforated region provided in the carrier layer.
  • the carrier layer may be configured to operatively define a plurality of apertures.
  • the carrier layer may be configured to be disposed between the permeable layer and the tissue area such that the at least one section deforms into each of the plurality of apertures to supply molecules within the fluid to the target tissue.
  • the permeable layer may have a plurality of sections configured to permit molecules within the fluid to pass through the permeable layer and to be deformable.
  • the carrier layer may be configured to be disposed between the permeable layer and the tissue area such that each section of the plurality of sections deforms into at least one aperture of the plurality of apertures to supply molecules within the fluid to the target tissue.
  • the apparatus may comprise a plurality of permeable layers, each permeable layer of the plurality of permeable layers having at least one section configured to permit molecules within the fluid to pass through the permeable layer and to be deformable.
  • the at least one section of each of the plurality of permeable layers may deform into at least one aperture of the plurality of apertures and supply molecules within the fluid to the target tissue.
  • the apparatus may comprise a plurality of receptacles adapted to receive the fluid, each receptacle of the plurality of receptacles comprising an operatively tissue area facing first wall portion, the first wall portion having a permeable layer of the plurality of permeable layers.
  • the apparatus may comprise a plurality of carrier layers, each carrier layer of the plurality of carrier layers configured to operatively define one or more apertures.
  • the plurality of carrier layers may be configured to be disposable between the permeable layer and the tissue area in a layered manner so as to align the one or more apertures of the plurality of carrier layers between the target tissue and the at least one section of the permeable layer such that the at least one section deforms into the one or more apertures of the plurality of carrier layers and supplies molecules within the fluid to the target tissue.
  • Each carrier layer of the plurality of carrier layers may be configured to be disposed between the permeable layer and the tissue area such that the at least one section deforms into the one or more apertures of each carrier layer of the plurality of carrier layers and supply molecules within the fluid to the target tissue.
  • the apparatus may comprise a plurality of permeable layers, each permeable layer of the plurality of permeable layers having at least one section configured to permit the fluid to pass through the permeable layer, the at least one section configured to be deformable, and wherein each carrier layer of the plurality of carrier layers is configured to be disposable between at least one permeable layer of the plurality of permeable layers and the tissue area such that the at least one section of the at least one permeable layer deforms into the one or more apertures of the carrier layer and supplies the fluid to the target tissue.
  • the first wall portion and the second wall portion may each have a permeable layer, the permeable layer of each of the first wall portion and the second wall portion having at least one section configured to permit the fluid to pass through the permeable layer.
  • a method of dressing a tissue area of a patient comprising: applying a carrier layer defining one or more apertures to the tissue area; applying a permeable layer to the carrier layer so as to position the permeable layer over the one or more apertures of the carrier layer, the permeable layer having at least one section configured to permit molecules within a fluid to pass through the permeable layer to supply the molecules to the tissue area.
  • the section may comprise the entirety of the permeable layer.
  • the section of the permeable layer may be adapted to deform under pressure imparted by the fluid on the permeable layer.
  • Applying the permeable layer to the carrier layer may comprise and/or may be followed by deforming the section of the permeable layer, under pressure imparted by the fluid on the permeable layer towards the tissue area, into the one or more apertures of the carrier layer.
  • Deforming the section of the permeable layer may be preceded by supplying the fluid at a side of the permeable layer opposite a side of the permeable layer facing the carrier layer.
  • Applying the carrier layer to the tissue area may be preceded by causing the carrier layer to define the one or more apertures.
  • Causing the carrier layer to define the one or more apertures may comprise causing the carrier layer to define the one or more apertures such that the one or more apertures correspond to a shape and/or a location and/or a geometry of target tissue within the tissue area.
  • the one or more apertures may be chamfered at an operatively permeable layer facing side of the carrier layer.
  • the carrier layer may define a plurality of apertures.
  • the carrier layer may be absorbent.
  • the fluid may comprise a therapeutic fluid.
  • the therapeutic fluid may comprise oxygen and/or carbon dioxide and/or carbon monoxide, and/or nitric oxide.
  • the section may be configured to permit the molecules within the fluid to pass through the permeable layer by diffusion alone or by a combination of diffusion and pore flow.
  • the permeable layer may be non-destructively removable from the carrier layer subsequent to applying the permeable layer to the carrier layer. Applying the permeable layer to the carrier layer may be followed by removing the permeable layer from the carrier layer and applying a further permeable layer to the carrier layer so as to position the further permeable layer over the one or more apertures of the carrier layer, a section of the further permeable layer configured to permit molecules of a fluid to pass through the further permeable layer to supply the molecules of the fluid to the tissue area.
  • a receptacle adapted to receive the fluid may comprise an operatively tissue area facing first wall portion having the permeable layer, the section of the permeable layer deforming under pressure imparted by the fluid on the permeable layer towards the tissue area through inflation of the receptacle by the fluid.
  • the receptacle may be formed from the first wall portion and an opposing second wall portion. The first wall portion and the second wall portion may be non-porous.
  • Deforming the section of the permeable layer may be preceded by connecting an inlet of the receptacle to a fluid source. Connecting the inlet of the receptacle to a fluid source may be followed by at least partially inflating the receptacle through an activation of the fluid source.
  • the fluid source may be connected to the inlet of the receptacle by an inlet conduit.
  • the receptacle may be adapted to allow the fluid to exit the receptacle via a fluid outlet conduit in fluid communication with an outlet of the receptacle.
  • the outlet conduit may comprise a pressure relief (for example a pressure relief valve.)
  • Applying a permeable layer to the carrier layer may be followed by positioning a cover over the receptacle and the tissue area.
  • the cover may operatively constrain deformation of the receptacle away from the tissue area during inflation of the receptacle.
  • a kit of parts for supplying fluid to target tissue within a tissue area of a patient comprising: a receptacle adapted to receive the fluid, the receptacle comprising an operatively tissue area facing first wall portion, the first wall portion having a permeable layer with at least one section configured to permit molecules within the fluid to pass through the permeable layer and to be deformable; a carrier layer configured for application between the tissue area and the first wall portion of the receptacle, the carrier layer operatively defining one or more apertures into which the section of the permeable layer operatively deforms to supply molecules within the fluid to the target tissue.
  • the receptacle may be formed from the first wall portion and an opposing second wall portion.
  • the one or more apertures may be defined in the carrier layer by forming the one or more apertures from a perforated region of the carrier layer.
  • the one or more apertures may be pre-cut into the carrier layer.
  • the kit may comprise a cutter configured for cutting the carrier layer to define the one or more apertures such that the one or more apertures correspond to a shape and/or a location and/or a geometry of the target tissue.
  • the carrier layer may comprise an absorbent material and/or a nonabsorbent material.
  • the absorbent material may be a foam material.
  • the carrier layer may be compressible.
  • the at least one section may operatively deform into the one or more apertures under pressure imparted by the fluid on the permeable layer towards the tissue area through inflation of the receptacle by the fluid.
  • the kit may comprise a cover configured to hold the receptacle onto the tissue area, the cover operatively constraining deformation of the receptacle away from the tissue area during inflation of the receptacle.
  • the kit may comprise a fluid source connectable to an inlet of the receptacle.
  • the kit may comprise an outlet conduit connectable to an outlet of the receptacle, the outlet conduit comprising a pressure relief valve.
  • a tissue care dressing for a tissue area of a patient, the tissue care dressing comprising: a receptacle having an inlet and an outlet, the receptacle adapted to receive a fluid via the inlet and from which the fluid can exit via the outlet, the receptacle formed from an operatively tissue area facing first wall portion and an opposing second wall portion and defining a fluid flow path from the inlet to the outlet, the fluid flow path comprising: a first chamber in fluid flow connection with the inlet, and a second chamber in fluid flow connection with the first chamber and the outlet, the second chamber partitioned from the first chamber by a juncture between the first wall portion and the second wall portion.
  • the juncture may be formed by a bond between an inner surface of the first wall portion and an inner surface of the second wall portion.
  • At least one of the first chamber and the second chamber may be configured to be positionable at the tissue area, the first wall portion of the at least one of the first chamber and the second chamber having a permeable layer with at least one section configured to permit molecules within the fluid to pass through the permeable layer.
  • the at least one section may be deformable under pressure imparted by the fluid on the first wall portion.
  • the at least one section of the at least one of the first chamber and the second chamber may comprise a plurality of microstructures arranged at an operatively tissue area facing surface of the first wall portion.
  • the inlet may be substantially adjacent the outlet.
  • the inlet and the outlet may be disposed at a tail portion of the receptacle.
  • the receptacle may be adapted to receive the fluid via a fluid inlet conduit in fluid communication with the inlet and from which the fluid can exit via a fluid outlet conduit in fluid communication with the outlet.
  • the tissue care dressing may comprise a pressure spreading device configured to mitigate a pressure applied to the patient by the fluid inlet conduit and/or the fluid outlet conduit.
  • the pressure spreading device may have a substantially flat surface at an operatively patient facing side thereof.
  • the tissue care dressing may comprise an indicator of an orientation of the receptacle.
  • the pressure spreading device may comprise the indicator.
  • the second wall portion may comprise one or more ridges extending a distance along the fluid flow path at an inner surface of the second wall portion.
  • At least one of the first chamber and the second chamber may have a generally elongate shape or curved shape or rectangular shape or square shape or oval shape or round shape.
  • One of the first chamber and the second chamber may be configured to be positionable at the tissue area, the first wall portion of the one of the first chamber and the second chamber having a larger surface area relative to the surface area of the first wall portion of the other of the first chamber and the second chamber.
  • the other of the first chamber and the second chamber may comprise a conduit between the inlet or the outlet for the fluid to or from the one of the first chamber and the second chamber.
  • an apparatus for supplying fluid to various target tissue within a tissue area of a patient comprising a plurality of permeable layers, each permeable layer of the plurality of permeable layers configured to supply a fluid to a target tissue of the various target tissue through an aperture of a carrier layer or plurality of carrier layers operatively disposed between the permeable layer and the target tissue.
  • the plurality of permeable layers may be applied to the carrier layer or plurality of carrier layers to be separately disposed about the tissue area.
  • Each permeable layer of the plurality of permeable layers may be deformable into the aperture of the carrier layer.
  • the permeable layer may have a convex shape operatively disposed towards the tissue area.
  • Each permeable layer of the plurality of permeable layers may be an operatively tissue area facing first wall portion of a receptacle adapted to receive the fluid.
  • the receptacle may receive the fluid via an inlet in fluid flow connection with a manifold connected to a fluid source.
  • Fig. l is a cross-sectional schematic view of an embodiment of an apparatus for supplying fluid to a tissue area
  • FIG. 1 A is a view of an embodiment of an apparatus for supplying fluid to a tissue area
  • FIG. 2 is a cross-sectional schematic view of an embodiment of an apparatus for supplying fluid to a tissue area
  • FIG. 3 is a cross-sectional schematic view of an embodiment of an apparatus for supplying fluid to a tissue area, having a fluid inlet conduit and first and second fluid outlet conduits;
  • FIG. 3 A is a cross-sectional schematic view of an embodiment of an apparatus for supplying fluid to a tissue area, having a fluid inlet conduit, first and second fluid outlet conduits, and first and second films forming a cover;
  • FIG. 4 is a cross-sectional schematic view of an embodiment of an apparatus for supplying fluid to a tissue area, having multiple receptacles;
  • FIG. 5 is a cross-sectional schematic view of an embodiment of an apparatus for supplying fluid to a tissue area, having multiple receptacles and a manifold;
  • FIG. 6 is a cross-sectional schematic view of another embodiment of an apparatus for supplying fluid to a tissue area, having multiple receptacles and a manifold;
  • Fig. 7 is a cross-sectional schematic view of a further embodiment of an apparatus for supplying fluid to a tissue area;
  • FIG. 8 is a cross-sectional schematic view of an embodiment of an apparatus for supplying fluid to a tissue area, having a pressure relief valve;
  • FIG. 9 is a schematic plan view of an embodiment of the apparatus including a through-hole in the receptacle
  • FIG. 10 is a schematic plan view of an embodiment of the apparatus including a plurality of through-holes in the receptacle;
  • FIG. 11 is a schematic plan view of an apparatus having multiple receptacles
  • FIG. 12 is a cross-sectional schematic view of a further embodiment of the apparatus including fasteners
  • FIG. 13 is a cross-sectional schematic view of a further embodiment of the apparatus including an absorbent material layer
  • Fig. 14a and Fig. 14b are a schematic plan view and schematic cross- sectional view of an embodiment of the apparatus having combined fluid conduits;
  • Fig. 15a and Fig. 15b are a schematic plan view and schematic cross- sectional view of another embodiment of the apparatus having combined fluid conduits;
  • Fig. 16a and Fig. 16b are a schematic plan view and schematic cross- sectional view of a further embodiment of the apparatus having combined fluid conduits;
  • Fig. 17a and Fig. 17b are a schematic plan view and schematic cross- sectional view of a still further embodiment of the apparatus having combined fluid conduits;
  • FIG. 18 is a schematic cross-sectional view of another apparatus for supplying fluid to a tissue area having a receptacle
  • Fig. 19 is a schematic cross-sectional view of the apparatus of Fig. 18, including a dressing;
  • FIG. 20 is a schematic cross-sectional view of another apparatus for supplying fluid to a tissue area having a receptacle
  • FIG. 20A is a view of another apparatus for supplying fluid to a tissue area having a receptacle
  • Fig. 21 is a schematic cross-sectional view of the apparatus of Fig. 20, including a dressing;
  • FIG. 21 A is a view of a pressure spreading device, fluid inlet conduit and first fluid outlet conduit of an emboduiment of the apparatus, protruding from a cover wrapped around a model of a leg of a patient;
  • FIG. 2 IB is a view of a receptacle, fluid inlet conduit and first fluid outlet conduit of an embodiment of the apparatus in situ on a wound on a model of a leg of a patient;
  • FIG 21C is an enlarged view of a receptacle of an embodiment of the apparatus in situ on a wound on a model of a leg of a patient;
  • Fig. 22 is a schematic cross-sectional view of another apparatus for supplying fluid to a tissue area having multiple receptacles;
  • Fig. 23 is a schematic cross-sectional view of the apparatus of Fig. 22, including a dressing;
  • Fig. 24 is a schematic cross-sectional view of another apparatus for supplying fluid to a tissue, including a pressure relief valve;
  • Fig. 25 is a schematic cross-sectional view of the apparatus of Fig. 24, including a dressing;
  • Fig. 26 is a schematic plan view of a receptacle according to an embodiment of the apparatus.
  • Fig. 27 is a schematic cross-sectional view through the line A- A of Fig. 26;
  • Fig. 28 is a schematic cross-sectional view through the line B-B of Fig. 26 in i) an inflated configuration and ii) a configuration in which the receptacle is not inflated;
  • Fig. 28 A is a view of a receptacle in i) an inflated configuration and ii) a configuration in which the receptacle is not inflated;
  • Fig. 29 is a schematic cross-sectional view through the line B-B of Fig. 26 with a) first rough surface and b) a first rough surface and a second rough surface, in accordance with an embodiment
  • FIG. 30 is a close-up view of an example embodiment of the first rough surface of Fig. 29a and Fig. 29b, and Fig 63a and Fig 63b;
  • Fig. 31 is a schematic cross sectional view of an inner surface of a receptacle with a) a plurality of ridges and b) a second wall portion pressed onto the ridge of a first wall portion of a receptacle according to an embodiment;
  • Fig. 32 is a schematic cross sectional view of the embodiment of Fig. 31, with i) overlapping ridges at a first wall portion and a second wall portion and ii) non-overlapping ridges at the first wall portion and the second wall portion;
  • Fig. 33 is a partial schematic cross-sectional representation of a ridge according to the embodiment of Fig. 31 adjoining a first and/or second wall portion with a) a small fillet radius; b) a medium fillet radius; c) a large fillet radius; and d) an overhanging comer;
  • Fig. 34 is a schematic plan view of a receptacle according to an embodiment showing embodiments of ridge configurations: a) ridges extend through tail portion; b) ridges extend through tail portion and head portion; c) non-straight ridges;
  • FIG. 35 is a schematic cross-sectional view of a further receptacle according to an embodiment of the apparatus.
  • Fig. 35 A is a schematic schematic cross-sectional view of a further receptacle according to an embodiment of the apparatus in a (i) unfolded configuration and (ii) folded configuration;
  • Fig. 35B is a schematic schematic cross-sectional view of a further receptacle according to an embodiment of the apparatus in a (i) unfolded configuration and (ii) folded configuration;
  • Fig. 36 is a schematic cross-sectional view of an embodiment of the apparatus with a pressure relief valve at a fluid outlet port;
  • Fig. 37 is an embodiment of a receptacle with a pressure relief valve at a fluid outlet port
  • Fig. 38 is an embodiment of a receptacle having a thicker material layer
  • Fig. 39 is an embodiment of a receptacle having a plurality of apertures in an upper layer
  • Fig. 40 is a schematic cross-sectional view of a further embodiment of the apparatus.
  • Fig. 41 is a schematic plan view of the embodiment of Fig. 40;
  • Fig. 42 is an enlarged schematic view of an opening of an internal flow guide of the embodiment of Figs. 40 and 41;
  • Fig. 43 i) to iv) are example embodiments of cross-sectional shapes of a surround of the opening of Figs. 40-42;
  • Fig. 43A and Fig. 43B are views of a receptacle showing overlap of an opening surround and ridges
  • Fig 43C is a cross-sectional view of the opening surround and ridges at arrows A-A of Fig. 43B;
  • Fig. 43D is a schematic plan view of a circulation opening and opening surround of an internal flow guide of the embodiment of Figs. 40 and 41;
  • Fig. 43E is a schematic plan view of the circulation opening and opening surround of an internal flow guide of Fig. 43D including ridges;
  • Fig. 43F is a schematic plan view of another circulation opening and opening surround of an internal flow guide of the embodiment of Figs. 40 and 41;
  • Fig. 44 a is a schematic cross-sectional view of the embodiment of Fig. 40 showing the attachment of the fluid inlet and outlet conduits to the receptacle;
  • Fig. 44 b is an enlarged detail view of the attachment of the fluid inlet and outlet conduits to the receptacle;
  • Fig. 45 is schematic cross-sectional view of a further embodiment of the apparatus;
  • Fig. 46 is a further schematic plan view of the embodiment of the apparatus of Fig. 45;
  • Fig. 47 is a schematic plan view of a further embodiment of the apparatus.
  • Fig. 48 is a further cross-sectional side view of the embodiment of the apparatus of Fig. 47;
  • Fig. 49 is a schematic cross-sectional view of a further embodiment of the apparatus.
  • Fig. 50 a is a schematic cross-sectional view of a further embodiment of the apparatus in which the fluid inlet and outlet conduits are disposed side by side;
  • Fig. 50 b is a further schematic cross sectional view of the embodiment of the apparatus of Fig. 50 a), looking in the direction shown at line A- A in Fig. 50 a);
  • Fig 51 a) and b) is a schematic diagram of example embodiments of internal ridges of the embodiments of Figs. 41 to 50;
  • Fig. 52 is a schematic cross-sectional view of a further embodiment of the apparatus.
  • Fig. 53 is a schematic cross-sectional view of the tail portion and pressure spreading device of a receptacle and fluid inlet and outlet conduits of an embodiment of the apparatus;
  • Fig. 54 is another schematic view of the tail portion and pressure spreading device of a receptacle and fluid inlet and outlet conduits of an embodiment of the apparatus;
  • Fig. 55 is an exploded view of a pressure spreading device and tail portion of a receptacle, of an embodiment of the apparatus;
  • Fig. 56 is a partial section view of the pressure spreading device and tail portion of Fig. 55, including a cavity in the pressure spreading device, inlet conduit channel and outlet conduit channel;
  • Fig. 57 is a partial section view of the pressure spreading device and tail portion of Fig. 55, including a cavity in the pressure spreading device, inlet conduit channel and outlet conduit channel;
  • Fig. 58 is a cross-section view of the pressure spreading device of Fig. 55, showing a conduit locating feature of the inlet conduit channel;
  • Figs. 59(a)-(d) are schematic plan views of alternative receptacle shapes
  • Figs. 60 (a)-(d) are schematic plan views of alternative receptacle shapes that have a tail portion and a pressure spreading device;
  • Fig. 61 is a schematic representation of an embodiment of the apparatus, including an optional regulator and optional calibrated leak orifice upstream of the fluid inlet;
  • Fig. 62 is a schematic partial representation of a variation of the embodiment of the apparatus of Fig. 61, including a conduit connector and holder.
  • Fig. 63 is a schematic cross-sectional view through the line B-B of Fig. 26 with a) first rough surface or b) a first rough surface and a second rough surface, in accordance with variations of an embodiment;
  • Fig. 64 is a partial section view of the pressure spreading device and tail portion of Fig. 55, including a trench in the inlet conduit channel and outlet conduit channel, and a channel at least partially surrounding the inlet conduit channel and outlet conduit channel;
  • Fig. 65 is a cross-sectional schematic side representation of an apparatus for supplying fluid to target tissue within a tissue area of a patient;
  • Fig. 66 is a side view of an embodiment of an apparatus for supplying fluid to target tissue within a tissue area of a patient, (a) through (e) showing increasing pressure imparted on a permeable layer of a receptacle of the apparatus by fluid in an interior of the receptacle;
  • Fig. 67 is a side view embodiment of an apparatus for supplying fluid to target tissue within a tissue area of a patient, with an aperture of a carrier layer of the apparatus having a chamfered edge;
  • Fig. 68 is a side view of an embodiment of an apparatus for supplying fluid to target tissue within a tissue area of a patient;
  • Fig. 69 is a cross-sectional schematic side representation of a variation of an apparatus for supplying fluid to target tissue within a tissue area of a patient;
  • Fig. 70 is a side view of an embodiment of the apparatus of Fig. 69, comprising a plurality of receptacles for supplying fluid to target tissue within the tissue area of a patient;
  • Fig. 71 is a side view of an embodiment of an apparatus for supplying fluid to target tissue within a tissue area of a patient, comprising a receptacle formed from a first wall portion and a second wall portion having the same structural features;
  • Fig. 72 is a top view of an embodiment of a tissue care dressing
  • Fig. 73 is a top view of a variation of the embodiment of the tissue care dressing of Fig. 72;
  • Fig. 74 is a perspective view of a variation of the tissue care dressing of Fig. 73 with a receptacle in an inflated position and comprising a pressure spreading device;
  • Fig. 75 is a schematic cross sectional view of the embodiment of the tissue care dressing of Fig. 74 with the receptacle in an inflated position, looking in the direction shown at line B-B in Fig. 74;
  • Fig. 76 is a side view of the embodiment of the tissue care dressing of Fig. 74 in an uninflated position of the receptacle;
  • Fig. 77 is a top view of a variation of the embodiment of the tissue care dressing of Fig. 73 comprising an indicator;
  • Fig. 78 is a schematic flow diagram of a method of dressing a tissue area of a patient.
  • FIG. 1 shows an embodiment of an apparatus for supplying fluid to a tissue area.
  • a tissue area may include target tissue that is to be treated and an area of tissue surrounding the target tissue.
  • Target tissue may include one or more of healthy tissue, a wound or a part of a wound, healed wound tissue, scar tissue, muscle, bone and the like. It will be appreciated that there may be multiple tissue areas of a patient, and tissue areas of a patient can be in close proximity with one another or disposed at completely different parts of the patient.
  • the apparatus may supply fluid to tissue on an external surface of the patient (e.g. skin) or it may supply fluid to tissue on an internal surface of the patient (e.g.
  • tissue it may supply fluid to an intestinal wall or to the wall of an internal organ during surgery).
  • tissue that the apparatus may be applied to is a wound.
  • the embodiments described herein are described with reference to a wound. However, it will be appreciated that they are, in general, applicable to other tissue areas as described above.
  • the apparatus 100 includes a receptacle 10 that is positioned at a wound area 20, for example a chronic wound as may be found on a lower limb of a diabetic patient.
  • the wound area 20 includes the wound 22 and an area of healthy skin 24 that surrounds the wound 22.
  • the wound area 20 is also referred to as the tissue area throughout this specification.
  • the apparatus further includes a cover 30 that is positionable over the receptacle to form a compartment 35 that is substantially bounded by the cover 30, the receptacle 10, and the wound area 20.
  • the compartment may also be bounded by additional components of the apparatus that may be present and still be substantially bounded by the cover 30, the receptacle 10 and the wound area 20.
  • the compartment may be further bounded by one or more fluid inlet conduits and/or fluid outlet conduits as will be described herein.
  • the receptacle 10 consists of an inflatable, hollow bag that is fluidly connectable to a fluid source 40 for inflating the receptacle 10 with a fluid.
  • the receptacle 10 may be connected to a fluid inlet conduit 50 for delivery of the fluid from the fluid source 40 to the receptacle 10.
  • the connection of the fluid source 40 to the fluid inlet conduit 50 is shown schematically in the Figures and may not be shown directly. It will be appreciated that one or more additional conduits (not shown) may be included in the connection between the fluid inlet conduit 50 and the fluid source 40.
  • the receptacle 10 may be for single use on a single patient. It may be used continuously at the wound for up to several days (e.g. 7 days or 10 days), and may be changed as and when a dressing, for example a bandage, is changed.
  • the fluid may comprise a gas and/or a liquid.
  • the fluid may comprise oxygen gas, carbon dioxide gas, carbon monoxide gas, nitric oxide gas, ambient air, aerosols and gases at different humidity levels and/or other therapeutic gases that may be beneficial in treating the wound and/or assisting the wound to heal.
  • the fluid may comprise combinations of any of the aforesaid gases.
  • the fluid may also comprise a liquid, for example it may comprise water, water with molecularly dispersed substances, or saline solution.
  • the fluid source 40 may be a gas source such as a wall source, oxygen or carbon dioxide or carbon monoxide, nitric oxide bottle, oxygen or carbon dioxide or carbon monoxide, nitric oxide concentrator, oxygen or carbon dioxide or carbon monoxide, nitric oxide pump or the like, suitable to meet a predetermined concentration and/or pressure and/or flow rate of oxygen or other therapeutic fluid as will be described further below.
  • the fluid source 40 may comprise a flow and/or pressure regulator 76 (shown in Figure 61) for controlling a flow rate and/or pressure of fluid issuing from the fluid source 40.
  • the fluid source 40 is reusable, as is the flow and/or pressure regulator 76.
  • the pressure regulator 76 may be integrated into a housing of the fluid source 40 or provided separate to the fluid source 40.
  • the fluid source 40 may comprise at least one filter 73 (shown in Figure 61) to remove contaminants from the fluid before it is delivered to the receptacle 10.
  • the filter 73 may be integrated into a housing of the fluid source 40 or provided separate to the fluid source 40.
  • the filter 73 may be an inline filter.
  • the filter 73 may be positioned upstream and/or downstream of the flow and/or pressure regulator 76. Some embodiments may not include the filter 73.
  • the receptacle 10, and each of the receptacles 110, 210, 210A, 310, 410, 510, 610 and 710 described in this disclosure, may be formed of one or more walls 15 of a flexible material.
  • the receptacle 10 may be formed from a single wall or two or more walls attached together via heat sealing or otherwise.
  • the receptacle 10 may contain oxygen gas, however other therapeutic fluids, for example carbon dioxide gas or carbon monoxide gas nitric oxide gas, or ambient air may also be used as described herein.
  • the one or more walls 15 of the receptacle 10 has at least one section that is made from a material that is adapted to allow molecules within the fluid in the receptacle 10 to diffuse to outside of the receptacle 10.
  • the entire receptacle 10 may be formed of the material that allows molecules within the fluid in the receptacle to diffuse through it, whereas in other embodiments the receptacle 10 (other than the at least one section) may be made of a material of a different thickness to the material of the at least one section, or it may be made of a different material.
  • the material section(s) may have a thin wall.
  • the material may have a thickness of between approximately 10 micrometres and 150 micrometres, for example between approximately 20 micrometres and 140 micrometres, or between approximately 30 micrometres and 130 micrometres, or between approximately 35 micrometres and 100 micrometres, or between approximately 60 micrometres and 105 micrometres, or between approximately 40 micrometres and 80 micrometres, or between approximately 40 micrometres to 70 micrometres, or between approximately 30 micrometres to 60 micrometres, or between approximately 20 micrometres to 60 micrometres, or between approximately 45 micrometres and 55 micrometres.
  • the wall thickness is approximately 60 micrometres. In some embodiments, the wall thickness is approximately 50 micrometres.
  • the wall thicknesses and/or layer thicknesses disclosed herein and throughout the specification may refer to the the thickness of the relevant wall or layer in a non-inflated state of the receptacle.
  • the thickness of one or more walls and/or layers may decrease.
  • the thickness may decrease as a result of stretching of the walls and/or layers.
  • the thinness of the material allows the wall 15 of the receptacle 10 to be flexible. This flexibility may help to maximise the surface contact between the receptacle 10 and the wound area, by allowing the wall of the receptacle 10 to conform to the wound surface, regardless of the wound topology.
  • the material section(s) may be made of a stretchable material (that may deform elastically). The material section(s) may stretch in response to the amount of fluid in the receptacle. The stretchable material may help to maximise the surface contact between the receptacle 10 and the wound area, by allowing the wall of the receptacle 10 to conform to the wound surface, regardless of the wound topology.
  • FIG. 65 shows a cross-sectional schematic side representation of an apparatus 500 for supplying fluid to target tissue 522 within a tissue area 525 of a patient.
  • the target tissue 522 within the tissue area 525 is indicated by dashed line for ease of reference only, and target tissue 522 need not be distinct from the tissue area 525 and can be any target tissue or various target tissue within the tissue area 525 and having any shape and/or size and/or geometry.
  • target tissue 522 may be the whole wound or any part or parts of the wound and/or healthy tissue around the wound and/or healed wound tissue and/or scar tissue and/or muscle and/or bone and the like.
  • target tissue 522 can be selected as a part or parts of the tissue area 525 to which the supply of fluid is to be targeted, for example to promote healing, such as an area or areas of the wound that is slower to heal than the remainder of the wound or an area or areas of the wound which is deepened.
  • tissue area 525 need however not be a wound, a part of a wound or include a wound, and can be or include healthy tissue, healed wound tissue, scar tissue, muscle, bone and the like.
  • the apparatus 500 includes a permeable layer 505 having at least one section 520 permitting molecules within the fluid to pass through the permeable layer 505 (generally in the direction indicated by arrows X) and deformable, for example, under pressure operatively imparted by the fluid on the permeable layer 505 towards the tissue area 525.
  • the section 520 may make up the whole of the permeable layer 505 or any part thereof.
  • the section 520 may permit molecules within the fluid to pass through the permeable layer 505 by diffusion and/or pore flow, for example as further discussed herein with reference to receptacles 10, 110, 210, 210A, 310, 410, 510, 610 and 710.
  • the section 520 may further be flexible and/or stretchable such that it is deformable.
  • the section 520 can comprise the entirety of the permeable layer 505 as a non-porous membrane, a non-limiting example of which is flexible liquid silicone rubber as discussed further herein below, and thereby the section 520 permits molecules within the fluid to pass through the permeable layer 505 by diffusion alone while also being deformable.
  • the apparatus 500 is shown to further comprise a carrier layer 530 which is configured to define an aperture 535 such that, when applied to the tissue area 525, the carrier layer 530 is disposed between the permeable layer 505 and the tissue area 525 so as to position the aperture 535 between any target tissue 522 and the permeable layer 505.
  • the section 520 can deform into the aperture 535 and supply fluid to the target tissue 522.
  • the aperture 535 may, for example, be any hole, slit, gap, opening or the like made, formed or otherwise defined through the carrier layer 530.
  • the aperture 535 can be made, formed or otherwise defined in the carrier layer 530 to correspond to a shape and/or size and/or geometry of any intended target tissue 522. Conversly, the shape and/or size and/or geometry of the aperture 535 may act to define the target tissue 522 when the carrier layer 530 is applied to the tissue area 525. The size of the aperture 535 may be selected to ensure that it is smaller than the surface of the permeable layer 505. This can allow for the above described deformation of the section 520.
  • section 520 makes up the whole of the permeable layer 505
  • only a part of the section 520 which is provided over the aperture 535 may necessarily deform into the aperture 535 when the permeable layer 505 is applied to the carrier layer 530.
  • deformation of the section 520 with reference to apparatus 500 is intended to include reference to deformation of any part of the section 520 or the whole of the section 520.
  • Figure 66 shows an example embodiment of the apparatus 500.
  • the apparatus 500 includes a receptacle 510 formed from a first wall portion 515a and an opposing second wall portion 515b.
  • the receptacle 510 may, by way of non-limiting example, have the same features and structure as a receptacle 610 as shown in Figures 72 through 77 and discussed further herein, which can be formed from joining a first wall portion 615a and a second wall portion 615b as separate walls at a seam 665 or from a first wall portion 615a and a second wall portion 615b as a single wall.
  • the receptacle 510 is applied so as to position the receptacle 510 at the tissue area 525 with the first wall portion 515a facing the tissue area 525.
  • the first wall portion 515a in this embodiment has the permeable layer 505 comprising substantially the entirety of the first wall portion 515a.
  • the first wall portion 515a may therefore be a membrane as described herein, for example with reference to receptacles 10, 110, 210, 210A, 310, 410, 610 and 710 with at least one section 520 permitting molecules within the fluid to pass through the first wall portion 515a from an interior of the receptacle 510.
  • the section 520 comprises substantially the entirety of the permeable layer 505 and thereby also substantially the first wall portion 515a. Accordingly, the section 520 is deformable under pressure imparted on the first wall portion 515a by the fluid contained in the interior of the receptacle 510.
  • the apparatus 500 includes the carrier layer 530 to support or carry the first wall portion 515a thereon, and thereby the permeable layer 505, when the receptacle 510 is applied so as to be positioned at the tissue area 525.
  • the carrier layer 530 may further provide cushioning between the tissue area and at least a part of the permeable layer 505.
  • the carrier layer 530 can be or can include in part a compressible material, for example a compressible foam material.
  • the carrier layer 530 can be or can include an absorbent material and/or non-absorbent material as further described herein.
  • the carrier layer 530 may still further be configured to adhere to at least a part of the tissue area 525, for example the carrier layer 530 can comprise adhesive at a tissue area 525 side thereof.
  • This example embodiment will be described further with reference to the carrier layer 530 as a compressible foam material.
  • the foam material may be adhesive backed, such as an adhesive backed absorbent foam, for example an adhesive backed absorbent foam rubber which allows the carrier layer 530 to be adhered to the tissue area 525.
  • the carrier layer 530 need however not be adhesive backed and can, instead or in addition to comprising an adhesive backing, be affixed to the patient at or about the tissue area 525, for example by adhesive, such as adhesive tape.
  • the carrier layer 530 is configured to define the aperture 535 such that, when applied to the tissue area 525, the carrier layer 530 is disposed between the first wall portion 515a of the receptacle 510 and the tissue area 525, thereby the aperture 535 is positioned between target tissue 522 and the section 520 of the permeable layer 505.
  • the aperture 535 can be defined in the carrier layer 530 prior to or in the course of applying the carrier layer 530 to the tissue area 525.
  • the carrier layer 530 can have a perforated region (not shown) which allows tearing out the perforated region to define the aperture 535 in the carrier layer 530.
  • the aperture 535 can also be pre-cut into the carrier layer 530, for example during manufacturing, or manually using a cutter, prior to or in the course of applying the carrier layer 530 to the tissue area 525. It will be appreciated that there are several ways in which the carrier layer 530 can be caused to define the aperture 535, whether in the course of its application to the tissue area 525 or prior thereto.
  • the interior of the receptacle 510 receives the fluid from a fluid source 40, for example as described with reference to receptacle 10, or may already contain the fluid. It will be appreciated that, when the receptacle 510 receives the fluid, the fluid may inflate or partially inflate the receptacle 510, but this need not necessarily occur. Introducing the fluid into the interior of the receptacle 510 in this regard can be performed in a similar manner as described herein with reference to receptacles 10, 110, 210, 210A, 310, 410, 610 or 710.
  • the fluid in the receptacle 510 imparts pressure on the permeable layer 505 towards the tissue area 525, which can cause at least the part of the section 520 disposed over the aperture 535 to deform into the aperture 535.
  • Figures 66(a) through (e) show in sequence how the section 520 deforms to take a substantially convex shape towards the tissue area 525 as the receptacle 510 is inflated from an uninflated or partially inflated position of the receptacle 510, and as the fluid in the interior of the receptacle 510 imparts more and more pressure on the permeable layer 505 and thereby the section 520.
  • the deformation of the section 520 in this manner can be proportional to the pressure imparted on the permeable layer 505 by the fluid contained in the interior of the receptacle 510.
  • the receptacle 510 can be configured for inflation biased towards deforming the section 520.
  • the second wall portion 515b may have a thickness that is greater than the thickness of the first wall portion 515a and thereby the section 520, similar to that as described with reference to receptacle 10 above, rendering the section 520 more susceptible to deformation under pressure imparted by the fluid on the interior of the receptacle 510.
  • the section 520 can have a thickness of between approximately 20pm to 90pm, or between approximately 50pm to 70pm, between approximately 40pm to 70pm, or between approximately 45pm to 65 pm, or between approximately 50pm to 60pm.
  • the section 520 can have a thickness of approximately 55pm.
  • the second wall portion 515b may have a thickness of between approximately 100pm to 300pm, or between approximately 100pm to 250pm, or between approximately 150pm to 250pm or between approximately 175pm to 225pm.
  • the second wall portion 515b may have a thickness of approximately 200pm. In some embodiments, the second wall portion 515b may have a wall thickness of approximately 160pm.
  • the first wall portion 515a may further or alternatively be formed of a material that is flexible and/or stretchable, such as liquid silicone rubber as discussed further herein.
  • the permeable layer 505 and/or the section 520 may still further or alternatively have a convex shape disposed towards the tissue area 525 when the receptacle 510 is applied to the carrier layer 530 in an uninflated postion of the receptacle 510.
  • the first wall portion 515a may yet further or alternatively have a greater surface area relative to the second wall portion 515b in an uninflated position of the receptacle 510, causing the first wall portion 515a to be biased towards the tissue area 525 when the receptacle 510 is applied, which can aid in the deformation of the section 520.
  • the aperture 535 can also be chamfered 540 at a side of the carrier layer 530 facing the first wall portion 515a in order to facilitate and/or accommodate deformation of the section 520.
  • the edge of the aperture 535 may also become sloped during deformation of the section 520, as the section 520 presses against the carrier layer 530 causing the edge of the aperture 535 to conform to the shape of the deformation of the section 520.
  • the apparatus 500 thereby allows for applying a carrier layer 530 defining one or more apertures 535 to a tissue area 525, and thereafter applying a permable layer 505, per the above example as a first wall portion 515a of a receptacle 510, to the carrier layer 530 so as to position the permeable layer 505 over the one or more apertures 535 of the carrier layer 530.
  • supplying fluid at a side of the permeable layer 505 opposite a side facing the carrier layer 530, or per the above example by introducing the fluid into the interior of the receptacle 510 enables supplying molecules within the fluid to target tissue, over which the one or more apertures 535 are disposed, through a section 520 of the permeable layer 505.
  • the aperture 535 allows the receptacle 510 to supply fluid to the target tissue 522 through at least the part of the section 520 which is disposed over the aperture 535.
  • target tissue 522 may be a part of the tissue area 525 with which the aperture 535 is specifically aligned during application of the carrier layer 535, or it may merely be any part of the tissue area 525 over which the aperture 535 is disposed when the carrier layer 530 is applied to the tissue area 525.
  • the apparatus 500 accordingly allows the supply of molecules within the fluid to be targeted towards any such target tissue 522.
  • the carrier layer 530 need not be the only layer disposed between the first wall portion 515a of the receptacle 510 and the tissue area 525, and a further layer or layers can also be disposed between the first wall portion 515a and the tissue area 525 and even the target tissue 522 without impinging on the functioning of the apparatus 500, such as a medical gauze layer, padding layer, suitable plastic wrap, porous layer or absorbent layer which may further permit molecules within the fluid to pass therethrough.
  • permeability in the present context includes reference to diffusion and/or pore-flow.
  • supply of the fluid in this manner may occur by diffusion and/or pore flow through the section 520.
  • molecules within the fluid can pass through the section 520 by diffusion alone.
  • the first wall portion 515a having the permeable layer can be configured to be non-destructively removable from the carrier layer 530 subsequent to it being applied thereto. This allows removing the receptacle 510 from the tissue area 525 and thereby also from the carrier layer 530 after the supply of fluid to the target tissue 522 without necessitating removal of the carrier layer 530 from the tissue area 525, which may act to reduce trauma to the tissue area 525.
  • a further receptacle for example a receptacle similar to receptacle 510, the same receptacle 510 or any receptacle 10, 110, 210, 210A, 310, 410, 610, 710 as disclosed herein, can again be applied to the same carrier layer 530 so as to be positioned at the tissue area 525 and the carrier layer 530 to further supply a fluid to the target tissue 522 in a similar manner as described above.
  • This allows, for example, for the target tissue 522 to be inspected and/or for a different fluid to be supplied to the same target tissue 522 and/or for a damaged receptacle to be replaced without requiring removal of the carrier layer 530.
  • the carrier layer 530 may also be configured to adhere to the permeable layer 505, for example to at least a part of the first wall portion 515a.
  • the carrier layer 530 can comprise adhesive at a first wall portion 515a side thereof to assist in retaining the receptacle 510 in position at the tissue area 525. It will be understood that this may, for example, assist in allowing the section 520 to deform into the aperture 520.
  • the terms ‘diffuse’ and ‘diffusion’ refer to the process of molecular diffusion.
  • Molecular diffusion is a process by which molecules within a fluid can pass from an upstream side to a downstream side of a material (e.g. a polymer film).
  • Molecular diffusion involves three stages: 1) sorption - the molecules within the fluid on the upstream side of the material are adsorbed onto the upstream surface of the material and then absorbed into the material; 2) diffusion - the molecules diffuse through the material. The direction of diffusion is dependent on a concentration gradient of the molecules within the material.
  • the diffusion stage may be facilitated by the opening and closing of free-volume elements in the material; 3) desorption - the molecules may be desorbed from the downstream surface of the material into the fluid on the downstream side of the material. If the fluid into which the molecules desorb is a gas, then the molecules may be in a gas phase, or dispersed in the gas, after desorption. If the fluid into which the molecules desorb is a liquid, then the molecules may be in a liquid phase, or dispersed in the liquid, after desorption. The molecules will not remain in a liquid phase or a gas phase throughout the diffusion stage. Instead, during this stage, the molecules are considered to be molecularly dispersed in the material.
  • the number of molecules that pass from the upstream side to the downstream side per unit time via molecular diffusion may be a function of, for example: the partial pressures on the upstream and downstream sides, the concentrations on the upstream and downstream sides, the thickness of the material, and the area of the material through which the molecular diffusion can occur.
  • pore refers to pores through which fluid molecules may move from an upstream side towards a downstream side of a material (e.g. a porous foam).
  • a material e.g. a porous foam
  • pore flow For molecules to pass completely through a material via pore flow alone, there must be one or more pores that provide a continuous pathway from the upstream side to the downstream side.
  • molecules move from the upstream side to the downstream side of a material via pore flow they may remain in a particular phase (e.g. liquid or gas) throughout.
  • the material may be a membrane that is adapted to allow molecules within the fluid to diffuse through the membrane.
  • the membrane may be hydrophobic.
  • the material can be treated so that it repels water, for example with a hydrophobic coating or other hydrophobic material.
  • the membrane is substantially pore-free. Accordingly, in those embodiments the membrane material may have no visible discontinuities or pores that are visible with an optical or electron microscope, for example a scanning electron microscope such as a Jeol IT300, at a resolution on the order of 1 micrometre. Transport of fluid through the membrane does not substantially take place via porosity of the membrane. The diffusion transport mechanism provides a more even distribution of fluid molecules diffusing from the receptacle to the wound area when compared with materials having micropores or porous membranes. This is because, some of the pores may become blocked, by exudate for example, causing an uneven distribution of molecules across the membrane.
  • the substantially pore-free membrane helps to prevent wound exudate from clogging or entering the receptacle 10.
  • transport by porosity may occasionally take place, for example, due to the possibility of manufacturing defects occurring in the membrane.
  • the membrane is substantially impermeable to bulk transport (also referred to herein as bulk flow) of fluid. That is, the molecules within the fluid cannot pass from one side of the membrane to the other side of the membrane without becoming molecularly diffused, and therefore cannot pass through the membrane in the fluid form in which they enter it e.g. gas or liquid form.
  • the membrane being impermeable to bulk transport (or bulk flow) of fluid further helps to prevent exudate from entering the receptacle 10.
  • water vapour molecules may pass through the permeable layer 505 from the interior of the receptacle 10, 110, 210, 210A, 310, 410, 510, 610, 710 towards the tissue area 525 or from the tissue area 525 toward the interior of the receptacle 10, 110, 210, 210A, 310, 410, 510, 610, 710, depending on the humidity levels of the fluid provided and the environment of the tissue area 525.
  • Suitable materials for the membrane include any liquid silicone rubber, such as any one of, or a combination including, a liquid silicone rubber having a 70 Shore A hardness elastomer (Silopren® LSR 4070 silicone from Momentive) or a 40 Shore A hardness elastomer (Silopren® LSR 4840 silicone from Momentive); pre-formed silicone sheet or film; silicone hydrogel; multilayer, blown, LLDPE/CaCO3 films, for example resin LLDP/CaCO3 from Reifenhauser (BF110, BF106); materials having silicone coatings; high consistency rubber silicone (HCR); KEG-2000-60-A/B (Shore A hardness of approximately 60) or KEG-2000-40-A/B (Shore A hardness of approximately 40) from Shin Etsu; and a copolymer that comprises polyethylene and polyethylene oxide).
  • a liquid silicone rubber having a 70 Shore A hardness elastomer Silopren® LSR 4070 silicone from Momentive
  • the membrane is made of a liquid silicone rubber having a 60 Shore A hardness that forms sheets having a thickness of 60 micrometres or of 50 micrometres. In some embodiments, the membrane is made of a liquid silicone rubber having a 40 Shore A hardness that forms sheets having a thickness of 60 micrometres or of 50 micrometres. These materials have been found to have suitable durability and suitable ability to hold their shape.
  • the fluid inlet conduit 50 may also be made of this material. In this case, the fluid inlet conduit 50 may be integrally formed with the receptacle 10 or it may be connected to it via a seal. Alternatively, the fluid inlet conduit 50 may be made of soft, pliable material such as silicone tubing, for example Versilic® silicone tubing.
  • the carrier layer 530 can be caused to define an aperture 535 corresponding with the shape and/or location and/or geometry of any target tissue 522, as may be required, to effectively target the target tissue 522 for treatment by a supply of therapeutic molecules within the fluid, for example, through a membrane as a permeable layer 505.
  • Figure 68 shows a further example embodiment of the apparatus 500 similar to that of Figure 66 and like features are given like reference numbers. However, in this example embodiment of Figure 68, a plurality of carrier layers
  • 530.1 through 530. n define a plurality of apertures 535.1 through 535. n. It will be appreciated that this need not be a plurality of carrier layers 530.1 through 530. n and may also be a single carrier layer 530 defining the plurality of apertures
  • the plurality of apertures 535.1 through 535. n correspond to target tissue 522, whether the target tissue 522 is a particular part or parts of the tissue area 525 with which the apertures 535.1 through 535. n are to be aligned, or merely the part or parts of the tissue area 525 over which the apertures 535.1 through 535. n are incidentally disposed when the carrier layers 530.1 through 530. n are applied to the tissue area 525.
  • the carrier layers 530.1 through 530. n are disposed between the section 520, which can comprise a part or substantially the entirety of the first wall portion 515a as a permeable layer 505, and the tissue area 525 so that the section 520 of the receptacle 510 can deform into each of the plurality of apertures 535.1 through 535. n to supply fluid to the target tissue 522.
  • the receptacle 510 can alternatively comprise the first wall portion 515a as a permeable layer 505 which has a plurality of different sections 520, each of which allows molecules within the fluid to pass through the permeable layer 505 and each of which is deformable.
  • the receptacle 510 can be applied to the carrier layers 530.1 through 530. n positioned at the tissue area 525 so as to substantially align the plurality of apertures 535.1 through 535. n with the plurality of sections 520. In this manner, each section of the plurality of sections 520 may deform into an aperture of the plurality of apertures 535.1 through 535. n and supply molecules within the fluid to target tissue 522.
  • the supply of molecules within the fluid can be targeted at any number of parts of a given tissue area 525, which may be advantageous where the tissue area 525 has a large surface area. For example, various target tissue 522 across a large tissue area 525 can be targeted for treatment where the fluid is a therapeutic fluid and/or has therapeutic molecules therewithin.
  • the carrier layer 530 in any embodiment of the apparatus 500 described herein need not be a continuous carrier layer 530 and, as shown in Figure 68, can be a plurality of carrier layers 530.1 through 530. n applied to the tissue area, for example in a substantially side-by-side configuration.
  • the plurality of carrier layers 530.1 through 530. n may collectively define the apertures 535.1 through 535. n.
  • Each of the plurality of carrier layers 530.1 through 530. n can therefore be applied so as to be disposed between the permeable layer 505 and, in this example embodiment constituting the first wall portion 515. a of the receptacle 510, the tissue area 525 such that the section 520 allows the supply of molecules within the fluid to target tissue 522 through the apertures 535.1 through 535. n.
  • FIG. 69 shows a cross-sectional schematic side representation of an apparatus 500 similar to that of Figure 65 and like features are given like reference numbers, but with the apparatus 500 comprising a plurality of permeable layers 505.1 through 505. n.
  • the permeable layers 505.1 through 505. n may be disposed about the tissue area 525 to be separate from one another in various different configurations, denoted by the break shown in chained lines, as may be required for any particular tissue area 525.
  • the permeable layers 505.1 through 505. n can be disposed side-by-side at a tissue area 525. In the example configuration where the permeable layers 505.1 through 505. n are disposed side-by-side at a tissue area 525, the permeable layers 505.1 through 505. n may also overlap to any extent. [0201] In this manner, supplying fluid at a side of each of the permeable layers
  • n opposite a side facing a carrier layer 530, as shown in Figure 69, allows the section 520 of each of the permeable layers 505.1 through 505. n to supply molecules within the fluid to target tissue 522 through an aperture 535 of a carrier layer 530.
  • the apparatus 500 need not necessarily comprise only a single carrier layer 530 and, as shown in Figure 69, can rather comprise a plurality of carrier layers 530.1 through 530. n, each carrier layer 530 of the plurality of carrier layers 530.1 through 530. n defining an aperture 535 or apertures 535.1 through 535. n.
  • the carrier layers 530.1 through 530. n can then be applied to the tissue area 525 in a layered manner so as to align the aperture 535 or apertures
  • the section 520 of the permeable layer 505 or plurality of permeable layers 505.1 through 505. n can allow the supply of fluid to target tissue 522 through the apertures 535.1 through 535. n of the plurality of carrier layers 530.1 through 530.n.
  • Figure 70 shows an example embodiment of the apparatus 500 of Figure 69, which includes a plurality of the receptacles 510.1 through 510.n disposed side-by-side at a tissue area 525 and each of which comprise a first wall portion 515a as a permeable layer 505 of the plurality of permeable layers 505.1 through 505. n. It will be appreciated that the receptacles 510.1 through 5 lO.n need not be disposed side-by-side at the tissue area 525 and can be disposed about the tissue area 525 as may be required.
  • the apparatus 500 is further shown to comprise a carrier layer 530 defining a plurality of apertures 535.1 through 535. n.
  • the carrier layer 530 can be caused to define the plurality of apertures 535.1 through 535. n either before or in the course of applying the carrier layer 530 to the tissue area 525.
  • Each of the receptacles 510.1 through 5 lO.n is adapted to receive a fluid and to be applied to the carrier layer 530 so as to be positioned at the tissue area 525 with its first wall portion 515a facing the tissue area 525.
  • each of the receptacles 510.1 through 510.n enables the supply of molecules within a fluid to target tissue 522 within the tissue area 525 in a similar manner as described herein with reference to Figure 66, through the plurality of apertures 535.1 through 535. n.
  • each of the receptacles 510.1 through 5 lO.n can comprise a part or substantially the entirety of its first wall portion 515a, thereby its permeable layer 505, as a section 520 allowing molecules within the fluid to pass therethrough.
  • the section 520 of each of the receptacles 510.1 through 5 lO.n can also be deformable.
  • the receptacles 510.1 through 5 lO.n may further, and in addition to these features, include features similar to those described herein after with reference to receptacles 10.
  • the carrier layer 530 is applied to the tissue area 525, after which the receptacles 510.1 through 5 lO.n can be applied to the carrier layer 530 so that the carrier layer 530 is disposed between the tissue area 525 and each of the a first wall portions 515a of the receptacles 510.1 through 5 lO.n as shown in Figure 70.
  • a receptacle 510 comprises substantially the entirety of its first wall portion 515a as an above described section 520, this can alleviate the need to position a particular part of the first wall portion 515a over an aperture 535, rather only requiring any part of the first wall portion 515a over an aperture 535.
  • this may enable any part of a first wall portion 515a of any one of the receptacles 510.1 through 5 lO.n to be positioned over any aperture 535 of the plurality of apertures 535.1 through 535. n without impinging on the function of the apparatus 500. It will be appreciated that each of the receptacles 510.1 through 5 lO.n and apertures 535.1 through 535.
  • n may have a different size and/or shape and/or geometry, thereby enabling supply of fluid to target tissue 522 of various sizes, shapes and/or geometries. Therefore, when fluid is received in the interior of each of the receptacles 510.1 through 510.n, for example by a manifold 80 and/or fluid inlet conduits 50 as described with reference to receptacles 10 herein below, the receptacles 510.1 through 510.n enable the supply of molecules within the fluid to any target tissue 522 within a tissue area 525 through their respective sections 520 and the apertures 535.1 through 535. n of the carrier layer 530 or plurality of carrier layers 530.1 through 530.n.
  • Figure 71 shows yet another example embodiment of the apparatus 500 of Figure 69, wherein the plurality of permeable layers 505.1 through 505. n are defined by a first wall portion 715a and an opposing second wall portion 715b of a receptacle 710 respectively.
  • the first wall portion 715a and the second wall portion 715b are flexible, rendering the receptacle 710 suitably flexible so as to be manipulated during application of the receptacle 710 to a carrier layer 530 and/or positionable substantially within a cavity as a tissue area 525 as shown in Figure 71.
  • first wall portion 715a and the second wall portion 715b may have substantially the same features as described herein with reference to a first wall portion 515a according to any embodiment of the receptacle 510.
  • both the first wall portion 715a and the second wall portion 715b may have microstructures 60 on an outer surface thereof.
  • one of the first wall portion 715a and the second wall portion 715b, or both the first wall portion 715a and second wall portion 715b may have ridges 96 on an inner surface thereof, as described herein.
  • first wall portion 715a and the second wall portion 715b need not be separate walls joined together and can comprise portions of a single wall.
  • a receptacle 510, 610, 710 in accordance with any embodiment discussed herein and which comprises a first wall portion 515a, 615a, 715a and a second wall portion 515b, 615b, 715b as the same flexible wall or separate flexible walls joined together may be rendered suitably flexible so as to be manipulated during application of the receptacle 510, 610, 710 to the carrier layer and/or positionable substantially within a cavity as a tissue area 525.
  • At least one carrier layer 530 defining an aperture 535 or a plurality of apertures 535.1 through 535. n as shown in Figure 71 can be applied, for example, to a cavity of the tissue area 525, after which the receptacle 710 is applied to the carrier layer 530 so as to be positioned at least partly within the cavity as shown in Figure 71.
  • the first wall portion 715a and second wall portion 715b are permeable layers 505.1 through 505.
  • the section 520 of each of the first wall portion 715a and second wall portion 715b is thereby able to deform into an aperture 535 of the apertures 535.1 through 535.
  • the single wall may be a permeable layer 505.
  • the permeable layer 505 can accordingly have a plurality of sections as a section 520 of the first wall portion 515a, 615a, 715a and a section 520 of the second wall portion 515b, 615b, 715b.
  • the plurality of sections 520 of a permeable layer 505 need not however comprise a section 520 of both the first wall portion 515a, 615a, 715a the second wall portion 515b, 615b, 715b, and may also be a plurality of sections 520 provided at one of the first wall portion 515a, 615a, 715a and the second wall portion 515b, 615b, 715b.
  • the fluid supply to the receptacle 10, or any one of the other receptacles 110, 210, 210A, 310, 410, 510, 610 or 710 described in this disclosure, may be continuous or it may be intermittent, i.e. supplied periodically.
  • the fluid may have a concentration of up to 100%, for example 99% or 95% or 90% and/or a pressure of between about 6 mmHg and 50 mmHg above atmospheric pressure, for example between about 10 mmHg to 40 mmHg or about 20 mmHg to 30 mmHg.
  • the receptacle 10, or any of the receptacles 110, 210, 210A, 310, 410, 510, 610 or 710 described in this disclosure, may come in various sizes according to the size of a tissue area. When inflated it may have any reasonable shape, for example a spheroid, ovoid, cuboid or cylindrical shape.
  • the one or more walls include a tissue facing portion that faces the tissue of the patient in use.
  • the receptacle 10 has a flattened ovoid cross-sectional shape, such that the tissue facing portion of the one or more walls provides a substantial tissue-facing surface, which in this example is a wound-facing surface 12 for contacting the wound when the receptacle is at least partially inflated.
  • the wound facing surface 12 of the receptacle 10 is made of the membrane adapted to allow molecules to diffuse from the receptacle to the wound 22.
  • the wound facing surface 12 of the receptacle 10 is pressed against the wound surface and forces exudate to move outwards to the periphery of the wound 22. This displacement of exudate from the wound is due to the pressure that the receptacle 10 applies to the wound 22.
  • the wound 22 ‘experiences’ the highest pressure from the receptacle 10 in the radial centre and the lowest pressure from the receptacle 10 at the radial extreme due to the shape of the receptacle 10.
  • This pressure gradient can force exudate to move outwards. Forcing the exudate to move outwards may help to prevent or mitigate pooling of exudate between the wound facing surface 12 of the receptacle 10 and the wound 22. Preventing or mitigating this pooling may be beneficial as it may help to prevent exudate from impeding the movement of molecules from the inside of the receptacle 10 to the wound 22. Whilst exudate is forced outwards from the wound 22, the wound 22 may remain moist.
  • the receptacle configuration of Figure 1 also provides a substantially even distribution of fluid to the wound 22 as a result of the substantial area of the wound facing surface 12.
  • the diffusion of the fluid molecules through the membrane adapted to allow molecules to diffuse from the receptacle 10 to the wound 22 further provides for a substantially even concentration of fluid being applied across the wound 22.
  • Contact between the section 520 and target tissue 522 can, for example, be further facilitated by selecting an appropriate shape and/or size of the receptacle 510, as a larger receptacle 510 and/or certain shapes may be capable of a greater degree of distension.
  • This contact between the section 520 and target tissue 522 can still further be facilitated by considering a number of factors, including but not limited to, thickness of the carrier layer 530, material selection of the section 520, thickness of the section 520, the size of the target tissue 522, the material selection of the carrier layer 530 and the compressibility of the material of the carrier layer 530.
  • a thicker carrier layer 530 provides increased cushioning between the permeable layer 505 and the tissue area and/or absorptive properties when compared with a thinner carrier layer 530.
  • a thinner carrier layer 530 may allow contact between the section 520 and the target tissue 522, but may provide reduced cushioning between the permeable layer 505 and the tissue area and/or absorptive properties.
  • the carrier layer 530 may be between 2mm and 5mm thick.
  • contact between the section 520 and the target tissue 522 can force exudate to move outwards towards the periphery of the aperture 535 or apertures 535.1 through 535. n.
  • this can mitigate against exudate pooling at the target tissue 522 and forming a barrier between the section 520 and target tissue 522 which may hinder supply of fluid to the target tissue 522.
  • exudate can also be absorbed by the carrier layer 530 and this absorbtion of exudate by the carrier layer 530 can occur substantially concurrently with the supply of fluid to the target tissue 522.
  • the apparatus 500 comprises a carrier layer 530
  • contact between a section 520 and the target tissue 522 need however not occur. Fluid can be delivered to the target tissue 522 through the aperture 535 via the section 520 without contacting the target tissue 522.
  • the carrier layer 530 can be configured to wick exudate from the target tissue 522 and thereby reduce or mitigate against pooling of exudate at the target tissue 522.
  • the carrier layer 530 can also be configured to wick exudate in addition to the section 520 contacting the target tissue 522, thereby further facilitating movement of exudate outwards towards the periphery of the aperture 535 or apertures 535.1 through 535.
  • Exudate can also, or additionally be drawn away by way of negative pressure applied to a compartment 35 defined by a cover 30 as described further herein below.
  • n of a carrier layer 530 can be chamfered 540 at a side of the carrier layer 530 facing the permeable layer 505 (as the first wall portion 515a in the example of Figure 67) in order to facilitate and/or accommodate deformation of the section 520.
  • the edge of the aperture 535 may also become sloped during deformation of the section 520, as the section 520 presses against the carrier layer 530 causing the edge of the aperture 535 or apertures 535.1 through 535.
  • the chamfer 540 and/or sloping of the edge of the aperture 535 can act to allow the section 520 to deform so that at least a part thereof takes up substantially the whole of an aperture 535, reducing exudate pooling in any void of the aperture 535. Pooling of exudate may be detrimental to the supply of fluid to the target tissue 522 and/or may compromise tissue exposed to the pooled exudate.
  • the receptacle 10 is shown in use, at least partially inflated, and has an undulating surface when at least partially inflated that may conform particularly well to complex, three-dimensional wound surfaces such that a larger proportion of the wound 22 is contacted by the woundfacing surface 12 of the membrane.
  • the undulating surface may also help facilitate exudate flow away from the wound 22.
  • the receptacle 10, or any one of the receptacles 110, 210, 210A, 310, 410, 510, 610 or 710 described in this disclosure may function as a fluid reservoir in which a volume of fluid may be stored. This can be beneficial if the fluid supply to the receptacle 10 is interrupted, due, for example, to a disconnection of the fluid source 40 from the fluid inlet conduit 50 or a malfunction of the fluid source 40.
  • the receptacle 10 is filled with fluid to ensure a fluid supply to the wound 22 in the event of disruption of the fluid supply from the fluid source 40. The filling of the receptacle 10 may be carried out by a clinician prior to positioning the receptacle 10 at the wound area 20 of the patient or during use of the apparatus.
  • the receptacles 10 may be pre-filled with the fluid during manufacture of the apparatus, for example at the site of manufacture.
  • various methods and configurations may be used to improve contact between the receptacle 10, or any one of the receptacles 110, 210, 210A, 310, 410, 510, 610 or 710 described in this disclosure, and the wound 22.
  • a material such as an absorbent foam
  • the material may be rolled or folded so as to press the receptacle 10 into the wound 22 when the cover 30 is applied.
  • the cover 30 may, for example, comprise a bandage as is discussed later.
  • the receptacle 10 may be inflated prior to the cover 30 being placed over the receptacle 10. This may ensure that the receptacle 10 contacts the wound 22 such that when the cover 30 is attached, the receptacle 10 is pushed into contact with the wound 22.
  • embodiments of the receptacle 10 include a plurality of structures, for example microstructures 60, arranged on the wound facing surface 12 of the receptacle 10. Whilst the microstructures 60 are shown on only a portion of the receptacle 10, they may cover one or more other portions of the one or more walls 15 of the receptacle 10, or of any of the receptacles 110, 210, 210A, 310, 410, 510, 610, 710 described in this disclosure. In an embodiment, the microstructures may be present on each of the one or more walls 15 of the receptacle 10.
  • a benefit of the receptacle 10 having microstructures 60 that may cover one or more other portions of the one or more walls 15 of the receptacle 10 is that the receptacle 10 (or any of the receptacles 110, 210, 210A, 310, 410, 510, 610, 710) can be applied to the wound 22 in any orientation and the microstructures will contact the wound 22.
  • Figure 1 shows a schematic representation of the microstructures 60
  • Figure 1 A shows a view of the receptacle 10 having a plurality of microstructures 60 on a wall 15 of the receptacle.
  • the microstructures 60 are part of the receptacle 10 and whilst the microstructures are shown arranged on the receptacle 10 of the embodiment of Figure 1, they may be included in any of the embodiments of the receptacle(s) described and illustrated in this disclosure.
  • the microstructures are structures of microscale dimensions that are configured to contact the wound area 20 of the patient.
  • the microstructures 60 may be made of the same material as the membrane adapted to allow molecules to diffuse through it and from the receptacle 10 to the wound 22.
  • the microstructures 60 are positioned on and protrude from the wound facing surface 12.
  • the microstructures may exert forces on the wound. These forces may result in microstresses that stretch the underlying cells and cause them to take on the same signalling pathways as those affected by growth factors. This can encourage cell growth.
  • the molecules within the fluid in the receptacle 10 may diffuse through the membrane of the receptacle 10 and into the wound 22, and/or through the membrane of the receptacle, through the microstructures 60, and into the wound 22.
  • the microstructures 60 may be of a semi-spherical, spherical, pyramidal, conical, domed or frustoconical shape, or have a trapezoidal, semi-circular or parabolic shape in profile, or may be formed as small dimples in the surface of the membrane. Any comers or edges of the microstructures 60 may be rounded as sharp edges can cause damage to cells.
  • the microstructures 60 may be formed as elongate structures having e.g. a semi-circular, parabolic, domed or trapezoidal cross-sectional profile as described above, or they may comprise discrete structures, each having e.g.
  • the microstructures 60 are configured in arrays.
  • the microstructures 60 may have a base dimension, e.g. a width or a diameter of between approximately 100 to 400 micrometres, for example between approximately 250 to 350 micrometres, or between approximately 280 to 330 micrometres.
  • the microstructures 60 may be spaced from one another at a distance of between about 0.5mm to 3mm between the bases of adjacent microstructures 60.
  • the microstructures 60 may have a height dimension of between approximately 100 to 200 micrometres, for example between approximately 125 to 175 micrometres.
  • the microstructures may have a base dimension of approximately 310 micrometres and a height dimension of approximately 150 micrometres.
  • the cells typically have a height dimension of between approximately 7 micrometres and 15 micrometres, for example 10 micrometres.
  • the microstructures 60 illustrated in Fig. 1 are not to scale. Whilst the features of the microstructures 60 are described with reference to the receptacle 10, it will be apparent that one or more of the features may also be applied to any of the other receptacles 110, 210, 210A, 310, 410, 510, 610 or 710 described in this disclosure.
  • microstructures 60 can be used in combination with a rough surface 312, 314, on the outer surface of wall 315, as further described below.
  • the cover 30 is configured to at least partially enclose the receptacle 10 to form a compartment 35 substantially bounded by the cover 30, the receptacle 10 and the wound area 20. In some embodiments, for example as shown in Fig. 1, the cover 30 is positionable over the receptacle 10 to fully enclose the receptacle 10 to form the compartment 35.
  • the cover 30 may also be applied to any of the receptacles 110, 210, 210A, 310, 410, 510, 610 or 710 described in this disclosure.
  • the carrier layer 530 and the tissue area 525 can act to hold the receptacle 510 or receptacles 510.1 through 510.n in place over the tissue area 525. Further, the cover 30 can constrain deformation of the receptacle 510 or receptacles 510.1 through 510.n away from the tissue area 525 as fluid enters the interior of the receptacle 510 or during inflation of the receptacle 510. Positioning the cover 30 in this manner can thereby facilitate deformation of a section 520 into an aperture 535 or apertures 535.1 through 535. n.
  • the cover 30 consists of a wall or walls configured to enclose the receptacle 10 and to seal to the healthy skin 24 adjacent the wound 22.
  • a seal 32 for this purpose may comprise an adhesive in the form of an adhesive bead or strip at a sealing surface of the cover 30 or it may be a suction seal.
  • the cover 30 may include a layer of absorbent material 75, seen in Figure 13, such that any exudate from the wound that reaches the cover is absorbed into the layer of absorbent material 75.
  • the absorbent material 75 may be a fibrous fabric.
  • the absorbent material 75 may form part of the cover 30, or it may be provided as a separate layer for use with the cover 30.
  • the absorbent material 75 may be wrapped around a limb or other body part of the patient that has the wound.
  • the cover 30 may be placed over the absorbent material 75.
  • the absorbent material 75 forms part of the cover 30 such that the compartment substantially bounded by the cover 30, the receptacle 10 and the wound area 20 includes the absorbent material 75.
  • the absorbent material 75 may allow exudate to evaporate to the ambient environment.
  • the cover 30 may be impermeable to the bulk flow of fluid. This arrangement is in contrast to some known solutions in which the absorbent material 75 is provided directly over the wound for collecting exudate. In these known solutions, the exudate may saturate and ‘clog’ the absorbent material 75.
  • the cover 30 may be separate to the receptacle 10 or it may be combined with (i.e. connected to) the receptacle 10 to form a single dressing that can be placed at the wound area 20.
  • the cover 30 includes a first opening 34 through which the fluid inlet conduit 50 passes to enter the compartment 35 to provide fluid to the receptacle 10.
  • the cover 30 further includes a second opening 36 via which fluid in the receptacle 10 may exit the receptacle 10.
  • the second opening 36 receives a first fluid outlet conduit 52.
  • the first fluid outlet conduit 52 is integral with or connected to the receptacle 10 and passes through the second opening 36.
  • the cover 30 further includes a third opening 38 through which fluid in the compartment 35 may exit the compartment 35.
  • a second fluid outlet conduit 54 is connected at the third opening 38 of the cover 30 for transporting fluid out of the compartment 35.
  • the first and second fluid outlet conduits 52, 54 may be made from soft, pliable material such as silicone tubing, for example Versilic® silicone tubing.
  • the fluid inlet conduit 50 and the fluid outlet conduits 52, 54 may be for single use on a single patient and may be changed after up to several days (e.g. 7 days or 10 days) continuous use on a patient.
  • the compartment 35 that is substantially bounded by the cover 30, the receptacle 10 and the wound area 20, is further bounded by the fluid inlet conduit 50 and the first fluid outlet conduit 52.
  • the at least one section of the wall 15 of the receptacle 10 may allow molecules within the fluid to diffuse from the receptacle 10 to the wound 22, or the fluid to pass from the receptacle 10 to the wound 22 via pore flow, or alternatively it may allow molecules within the fluid to both diffuse from the receptacle 10 to the wound 22 and also to allow the fluid to pass from the receptacle 10 to the wound 22 via pore flow.
  • the receptacle 10 may include a plurality of the microstructures 60 arranged on the wound facing surface 12 of the receptacle 10.
  • the fluid may comprise a gas, such as oxygen gas or carbon dioxide gas or carbon monoxide gas or nitric oxide gas or ambient air.
  • the fluid may also comprise a combination of the aforesaid gases.
  • the cycling enables a fluid concentration, for example an oxygen gas concentration, within the receptacle 10 to be maintained at a desired level, even if nitrogen and/or other fluid molecules enter the receptacle 10 through the membrane of the receptacle 10.
  • the cycling also enables the fluid, from which molecules diffuse through the wall 15 of the receptacle 10, or which passes through the wall 15 via pore flow, to be replenished.
  • the fluid concentration may be precisely controlled via a controller, for example a controller of the fluid source 40.
  • other fluids, including drugs could be cycled through the receptacle 10 and applied to the wound 22 via diffusion through the wound facing surface 12.
  • the cycling may be applied to any one of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610 or 710 described in this disclosure that have a fluid inlet conduit 50 and a first fluid outlet conduit 52.
  • the apparatus may include a negative pressure source 45 for drawing fluid out of the compartment 35.
  • Negative pressure refers to a pressure below that of the ambient atmosphere around the patient.
  • the pressure in the compartment 35 may be altered to be between approximately 50mmHg to 150mmHg or between approximately 80mmHg to 125mmHg or between 90mmHg to 1 lOmmHg below atmospheric pressure.
  • the negative pressure source may be a pump.
  • the second fluid outlet conduit 54 may connect the compartment 35 to the negative pressure source 45 at the third opening 38 of the cover 30.
  • the connection of the negative pressure source 45 to the second fluid outlet conduit 54 is shown schematically in the Figures and may not be shown directly. It will be appreciated that one or more additional conduits (not shown) may be included in the connection between the second fluid outlet conduit 54 and the negative pressure source 45.
  • the receptacle 10 is positioned on the wound 22 and may be held in place by the cover 30 operating as a negative pressure dressing.
  • the cover 30 seals to the healthy skin 24 of the patient surrounding the wound 22 and, as the negative pressure source 45 draws fluid from the compartment 35, forms a negative pressure compartment enclosing the receptacle 10.
  • the fluid inlet conduit 50 and/or the second fluid outlet conduit 54 may extend through the cover 30 or under an outer edge of the cover 30.
  • the cover 30 may comprise at least one film.
  • the film may comprise an adhesive on one surface of the film.
  • the adhesive may be at an edge of the film, or may cover the entire surface of the film.
  • the adhesive may be arranged around a perimeter, or at least part of the perimeter of the film.
  • the film may be a polyurethane film.
  • the cover 30 may form a seal around each conduit 50, 52, and/or 54 and with the healthy skin 24 of the patient.
  • a slit or cut-out may be made in the outer edge of the cover 30 for each of the first fluid inlet conduit 50, the first fluid outlet conduit 52, and/or the second fluid outlet conduit 54 to allow the cover 30 to wrap around each conduit 50, 52, and 54 and form a seal between the cover 30, each of the first fluid inlet conduit 50, the first fluid outlet conduit 52, and/or the second fluid outlet conduit 54, and the healthy skin 24.
  • the cover 30 may comprise two films with adhesive .
  • the adhesive may extend over substantially the entire surface of each of the two films, or it may extend over only a part of the two films.
  • the adhesive may be arranged in a pattern over the surfaces of the two films.
  • the two films with adhesive form a seal with the healthy skin 24 and with each other.
  • the two films with adhesive may be adhered to each other at an overlapping portion.
  • the two films may have adhesive around the edges and in the overlapping portions.
  • At least one of the fluid inlet conduit 50, the first fluid outlet conduit 52 and the second fluid outlet conduit 54 may extend through the overlapping section between the two films.
  • the two films form a seal around each of the fluid inlet conduit 50, the first fluid outlet conduit 52 and the second fluid outlet conduit 54 that extends through the overlapping section between the two films.
  • a first film 30A of the cover 30 may be placed on the healthy skin 24 adjacent the wound 22 and folded back on itself, such that the adhesive surface both adheres to the healthy skin 24 and the folded portion faces upwards away from the healthy skin 24. Then, the receptacle 10 may be placed on the wound 22 with the fluid inlet conduit 50, the first fluid outlet conduit 52 and/or the second fluid outlet conduit 54 positioned onto the upwards facing adhesive surface of the first film 30A. An absorbent material (not shown) may optionally be placed over the receptacle 10, the wound 22 and/or the healthy skin 24.
  • a second film 30B of the cover 30 may be placed over the receptacle 10 and the absorbent material if present, surrounding the wound 22.
  • the second film 30B may create a seal with the healthy skin 24 and with the upward facing adhesive surface of the first film 30 A.
  • the fluid inlet conduit 50 and the first fluid outlet conduit 52 will extend through the overlapping portion between the first film 30A and the second film 30B, whilst the second fluid outlet conduit 54 extends through a separate opening in the second film 30B.
  • fluid inlet conduit 50, the first fluid outlet conduit 52 and the second fluid outlet conduit 54 will all extend through the overlapping portion between the first film 30A and the second film 30B.
  • fluid may be cycled through the receptacle 10 at the same time as a negative pressure is applied to the compartment 35.
  • the negative pressure is applied to the compartment 35 by the negative pressure source 45, via the second fluid conduit 54 connected to the cover 30 at the third opening 38.
  • the fluid in the receptacle 10 may diffuse through the membrane or pass through it via pore flow at the wound facing surface 12 of the receptacle 10 as the negative pressure is applied to the compartment 35.
  • the apparatus 500 includes a cover 30 which acts to form a compartment 35 together with a negative pressure source to apply a negative pressure to the compartment 35.
  • the carrier layer 530 can comprise an absorbent and/or nonabsorbent material. The application of negative pressure would allow for drawing fluid, including exudate, from the compartment 35 in the absence of or in addition to exudate being wicked and/or absorbed by the carrier layer 530.
  • the carrier layer 530 may therefore comprise a material which allows exudate to pass from a tissue area 525 facing side thereof to a permeable layer 505 facing side thereof, thereby allowing exudate to be drawn from the compartment 35 across the tissue area 525. Exudate may additionally or alternatively be drawn through an aperture 535 or apertures 535.1 through 535. n of the carrier layer 530.
  • the cover 30 includes only the first opening 34 and the third opening 38.
  • fluid is supplied into the receptacle 10 via the fluid inlet conduit 50 and exits the receptacle only via diffusion through the membrane adapted to allow molecules within the fluid to diffuse from the wound facing surface 12 of the receptacle 10.
  • a negative pressure may be applied to the compartment 35 via the second fluid outlet conduit 54 connected to the cover 30 at the third opening 38.
  • the compartment 35 substantially bounded by the cover 30, the receptacle 10 and the tissue area is further bounded by the fluid inlet conduit 50.
  • This arrangement of the apparatus 100 is advantageous over prior solutions that allow a therapeutic fluid (e.g. oxygen) and negative pressure to be applied to a wound simultaneously.
  • a therapeutic fluid e.g. oxygen
  • Many of these existing solutions rely on an arrangement that, when sealed to the heathy skin surrounding a wound, defines a single compartment (a compartment bounded by the inside of the bandage and the wound area). Oxygen is pumped into the compartment while the fluid within the compartment is removed (by a negative pressure pump) to generate the negative pressure environment.
  • the dual compartment arrangement of the apparatus 100 allows negative pressure to be applied to the wound 22 and exudate to be removed into the compartment 35 and through the second fluid outlet conduit 54 without significantly affecting the movement of molecules from the receptacle 10, through the membrane, to the surface of the wound 22.
  • the receptacle 10 of this embodiment may include a plurality of the microstructures 60 arranged on the wound facing surface 12 of the receptacle 10.
  • two or more of the fluid inlet conduit 50, the first fluid outlet conduit 52 and the second fluid outlet conduit 54 may be combined into a single conduit that passes through only a single opening 39 in the cover 30.
  • the fluid inlet conduit 50 and the second fluid outlet conduit 54 may be arranged coaxially.
  • Figure 14a shows the coaxial arrangement of the fluid inlet conduit 50 and the second fluid outlet conduit 54 in plan view.
  • Figure 14b shows the coaxial arrangement of the conduits 50, 54 in use of the apparatus 100.
  • Figure 15a and Figure 15b show another arrangement in which the fluid inlet conduit 50 and the second fluid outlet conduit 54 may be arranged adjacent one another so as to pass through the single opening 39 in the cover 30.
  • the apparatus includes the fluid inlet conduit 50, the first fluid outlet conduit 52 and the second fluid outlet conduit 54, arranged adjacent one another as a combined conduit that passes through the single opening 39.
  • the fluid inlet conduit 50, first fluid outlet conduit 52 and second fluid outlet conduit 54 are arranged coaxially. These arrangements may improve the seal between the apparatus 100 and the skin of the patient or other tissue surface, due to multiple conduits passing through a single opening in the cover rather than through multiple openings. This is because multiple openings may compromise the seal in comparison with a single opening. Whilst a single opening may compromise the seal to some extent, multiple openings will compromise the seal to a greater extent.
  • the single opening 39 provides a larger cover surface area for sealing against the tissue of the patient than would be the case with the first, second and third openings 34, 36, 38.
  • the cover 30 and the receptacle 10 do not share any common walls; they are separate components and the walls of the receptacle 10 and the cover 30 are independent of one another.
  • the cover 30 may be connected to the receptacle 10 via the fluid inlet conduit 50, at the first opening 34.
  • the cover 30 may also be connected to the receptacle 10 via the first fluid outlet conduit 52 at the second opening 36. These one or two connection points may be the only points of connection between the receptacle 10 and the cover 30.
  • the receptacle 10 may include a plurality of the microstructures 60 arranged on the wound facing surface 12 of the receptacle(s) 10.
  • the cover 30 may be formed from wrapping a dressing, for example a compression bandage around a body part, for example a limb, of the patient and over the receptacle 10.
  • the compression bandage holds the receptacle 10 in place on the wound 22 and can absorb exudate and/or allow evaporation of exudate.
  • the compression bandage material allows the bulk transport of gases, however it will be appreciated that it may be wrapped about the patient forming enough layers that it provides a substantial barrier to the bulk flow of gases.
  • the fluid for example oxygen, is supplied to the receptacle 10 at a positive pressure for effective oxygen delivery, even when used under a compression bandage that may compress the receptacle 10 against the wound 22.
  • the apparatus 100 can be used to simultaneously deliver topical oxygen therapy and negative pressure therapy.
  • the fluid inlet conduit 50, first fluid outlet conduit 52 and/or the second fluid outlet conduit 54 may not be connected to the compression bandage but may protrude from a gap in the wrapped layers.
  • the dressing may be an adhesive dressing that adheres to the healthy skin 24 of the patient over the receptacle 10. This embodiment may or may not utilise the negative pressure source 45 to form a negative pressure compartment.
  • the compartment 35 substantially bounded by the cover 30, the receptacle 10 and the tissue area is further bounded by one or more of the fluid inlet conduit 50 and the first fluid outlet conduit 52.
  • this embodiment of the cover 30 is described with reference to the receptacle 10, it will be appreciated that it may be applicable to any of the other receptacles 110, 210, 210A, 310, 410, 510, 610 or 710 described in this disclosure.
  • Figure 4 shows a further embodiment of the apparatus 100 that includes a plurality of the receptacles 10 positioned at the wound area 20.
  • the plurality of receptacles 10 may be distributed over the wound 22 as is also shown schematically in the plan view of Figure 11.
  • the at least one section of the wall 15 of each of the plurality of receptacles 10 may allow molecules within the fluid to diffuse from the plurality of receptacles 10 (also referred to herein as multiple receptacles 10) to the wound 22, or to pass from the multiple receptacles 10 to the wound 22 via pore flow, or to allow molecules within the fluid to diffuse from the multiple receptacles 10 to the wound 22 and also to pass from the multiple receptacles 10 to the wound 22 via pore flow.
  • the fluid may comprise a gas, such as oxygen gas or carbon dioxide gas or carbon monoxide gas or nitric oxide gas or ambient air.
  • the fluid may also comprise a combination of the aforesaid gases.
  • the plurality of receptacles 10 may equally be a plurality of any of the receptacles 110, 210, 210A, 310, 410, 510, 610 or 710 described in this disclosure.
  • Multiple receptacles 10 can provide additional conformability to the wound for complex and/or varying wound topologies. For example, if a wound is small or deep, multiple receptacles 10 may be more easily manipulated to optimise delivery of therapeutic fluid and/or negative pressure therapy. Accordingly, if a wound is deep and/or has an irregular surface, it may be possible to achieve greater surface area contact between the section(s) of the wall(s) 15 through which the molecules can diffuse or pass via pore flow and the wound by using multiple receptacles 10, relative to the contact that could be achieved using one receptacle 10. A large amount of surface area contact can be beneficial as it can result in a more even distribution of therapeutic molecules to the wound. Multiple receptacles 10 can also be used to treat a large wound.
  • Multiple receptacles 10 may also allow for more localised wound healing. For example, if some parts of a wound heal faster than others, one or more of the receptacles 10 can be positioned to promote healing of a wound region that is less healed rather than remaining at the more healed parts. Each receptacle 10 is moveable within the compartment 35 independently of any of the other receptacles 10. Each receptacle 10 may include a plurality of the microstructures 60 arranged on the wound facing surface 12 of the receptacle 10.
  • each of the receptacles 10 has its own fluid inlet conduit 50 associated with it.
  • each of the fluid inlet conduits passes through a separate respective first opening 34 in the cover 30, for connection to a respective separate fluid supply or fluid source.
  • This arrangement allows different fluids to be provided in different receptacles for variable, customisable control of fluid molecule delivery over the wound area 20.
  • any reasonable number of multiple receptacles 10 and fluid inlet conduits 50 may be positioned at the wound area 20 and that the number of receptacles is not limited to the number shown in Figure 4.
  • the number of receptacles 10 may depend on the surface area of the wound 22.
  • Examples include from two, three, four and all numbers of receptacles that may be required to treat the tissue area concerned. Whilst this embodiment is described with reference to a wound, it will be appreciated that it is, in general, applicable to other tissue areas as described elsewhere in this disclosure.
  • the compartment 35 substantially bounded by the cover 30, the receptacle 10 and the tissue area is further bounded by the each of the fluid inlet conduits 50.
  • the fluid inlet conduits 50 are connected together in fluid communication with one another via a manifold 80, the manifold being supplied with fluid via a single fluid supply conduit 85.
  • the manifold 80 joins together the three fluid inlet conduits 50 shown in Figure 5 inside the compartment 35.
  • the manifold 80 joins together the three fluid inlet conduits 50 shown in Figure 6 outside the compartment 35.
  • the Figure 5 arrangement may improve sealing of the cover 30 against the skin when compared with the embodiment of Figure 6, as it requires fewer openings in the cover 30.
  • any reasonable number of multiple receptacles 10 and fluid inlet conduits 50 may be joined together at the manifold 80 and that the number of receptacles is not limited to the number shown in Figure 5 and Figure 6.
  • the number of receptacles 10 may depend on the surface area of the wound 22. Examples include from two, three, four and all numbers of receptacles that may be required to treat the tissue area concerned.
  • the single fluid supply conduit 85 passes through the first opening 34 in the cover 30 for receiving fluid therein from a single fluid source 40.
  • the manifold 80 may include a valve (not shown) on each fluid inlet conduit 50 for individual control of fluid flow through the respective fluid inlet conduits 50.
  • respective first fluid outlet conduits 52 may be used to cycle fluid through the fluid receptacles 10 and to exit the receptacles 10 via the respective first fluid outlet conduits 52.
  • the compartment 35 substantially bounded by the cover 30, the receptacles 10 and the tissue area is further bounded by the fluid inlet conduits 50, the manifold 80 and the fluid supply conduit 85, and the respective fluid outlet conduits 52 if present.
  • the manifold 80 joins together the three fluid inlet conduits 50 outside of the compartment 35.
  • the compartment 35 substantially bounded by the cover 30, the receptacles 10 and the tissue area is further bounded by the fluid inlet conduits 50.
  • the three fluid inlet conduits 50 pass through respective first openings 34 in the cover 30 for receiving fluid therein from a single fluid source 40.
  • the manifold 80 may include a valve (not shown) on each fluid inlet conduit 50 for individual control of fluid flow through the respective fluid inlet conduits 50.
  • respective first fluid outlet conduits 52 may be used to cycle fluid through the receptacles 10.
  • the fluid may enter the receptacles 10 via the fluid supply conduit 85 and the respective fluid inlet conduits 50 and exit the receptacles 10 via the respective first fluid outlet conduits 52.
  • Figures 5 and 6 are schematic illustrations of the manifold 80, fluid inlet conduits 50 and fluid supply conduit 85.
  • the manifold 80, fluid inlet conduits 50 and fluid supply conduit 85 may be made from soft, pliable material such as silicone tubing, for example Versilic® silicone tubing. They may be formed integrally with the receptacles 10, so that they are conformable and comfortable against the wound 22. This embodiment is described with reference to a wound. However, it will be appreciated that it is, in general, applicable to other tissue areas as described elsewhere in this disclosure.
  • FIG. 7 shows an apparatus 200 in which the receptacle 210 is not enclosed within the negative pressure compartment 35.
  • the receptacle 210 may be formed from two sheets of material, for example a wound facing sheet 212 and a cover sheet 230 that are pressed and sealed together at the edges of the receptacle 210.
  • the excess pressed material around the receptacle 210 provides the functionality of the cover 30 of previous embodiments and includes the seal 32 for sealing to the healthy skin 24 of the patient around the wound 22 or other tissue area.
  • the two sheets of material 212, 230 that are pressed and sealed together may be made of the same material.
  • the wound facing sheet 212 and the cover sheet 230 may both be made from the membrane that allows molecules to pass through it.
  • the two sheets that are pressed and sealed together may be made of different material.
  • the wound facing sheet 212 may be made from the membrane that allows molecules to pass through it.
  • the membrane may allow molecules within the fluid to diffuse from the receptacle 210 to the wound 22 or to pass through the membrane via pore flow, or it may allow molecules within the fluid to both diffuse from the receptacle 210 to the wound 22 and to pass from the receptacle 210 to the wound 22 via pore flow.
  • the cover sheet 230 may not allow molecules within the fluid to pass through it.
  • the cover sheet 230 may allow molecules within the fluid to pass through via diffusion or via pore flow, or it may allow molecules within the fluid to both diffuse from the receptacle 210 to the wound 22 and to pass from the receptacle 210 to the wound 22 via pore flow. If the cover sheet 230 is made from the membrane that allows molecules to pass through, then molecules may be able to move from the compartment 35 to the outside of the cover sheet 230.
  • the apparatus 200 may further comprise a negative pressure compartment 35 substantially bounded by the cover sheet 230, the wound facing sheet 212 of the receptacle 10 and the wound area 20.
  • the negative pressure compartment 35 is substantially bounded by the cover 230, the wound facing surface 212 of the receptacle 210 and the wound area 20.
  • the fluid may enter the receptacle 210 via the fluid inlet conduit 50 and, although not shown in Figure 7, it may also be cycled through the receptacle 210 and exit the receptacle 210 via the first fluid outlet 52.
  • the negative pressure compartment 35 is formed by connecting the third opening 38 in the cover sheet 230 to the negative pressure source 45.
  • a cover 30 could be added, for example glued, onto the receptacle 210, over the cover sheet 230, after the receptacle has been formed.
  • the addition of the cover 30 allows a negative pressure compartment 35 to be formed as described in relation to the embodiment of Figure 1 above.
  • the addition of the cover 30 may also allow the wound facing sheet 212 and the cover sheet 230 of the receptacle 210 to be made from the same material, and for a cover 30 made from material that is impermeable to bulk flow of fluid to be glued or otherwise added over the top of the receptacle 210.
  • the cover 30 may have all of the features of the cover 30 described earlier in this disclosure. For example, it may include an absorbent layer such as the absorbent material 75 described in Figure 13. Alternatively, this embodiment may be used without a negative pressure compartment, in which case the first fluid outlet conduit 54 and the negative pressure source 45 need not be included.
  • the receptacle 210 may include a plurality of the microstructures 60 arranged on the wound facing sheet 212 of the receptacle 210.
  • the fluid may comprise a gas, such as oxygen gas or carbon dioxide gas or carbon monoxide gas or nitric oxide gas or ambient air.
  • the fluid may also comprise a combination of the aforesaid gases.
  • the apparatus 200 may require less material to manufacture than the apparatus 100.
  • the apparatus 100 includes a pressure regulator, for example a pressure relief valve 70, that can be configured to open to relieve pressure if the pressure within the receptacle(s) 10 exceeds a threshold value.
  • a pressure regulator for example a pressure relief valve 70
  • the pressure relief valve 70 may be connected to the fluid inlet conduit 50 either at a wall of the fluid inlet conduit 50 or at a wall of a branch line 72 extending from and in fluid communication with the fluid inlet conduit 50.
  • the pressure relief valve 70 may be positioned outside of the compartment 35 formed by the cover 30 as shown in Figure 8, or inside the compartment 35 formed by the cover 30 (not shown).
  • the cover 30 may include a vent to atmosphere, for example an outlet port, a negative pressure port or may be a permeable cover 30 such as a compression bandage, such that gas released from the pressure relief valve 70 on the fluid inlet conduit 50 inlet may be vented from underneath the cover 30 to prevent the compartment 35 formed by the cover 30 from bursting.
  • the pressure relief valve 70 may exhaust fluid to the ambient environment (if positioned outside of the cover 30), or exhaust fluid into the compartment formed by the cover 30 (if positioned inside of the compartment 35).
  • the compartment 35 substantially bounded by the cover 30, the receptacle 10 and the tissue area is further bounded by the fluid inlet conduit 50, branch line 72 if present and the pressure relief valve 70, if present inside the cover 30.
  • a calibrated leak orifice 74 may be included upstream of the fluid inlet conduit 50 and downstream of the fluid source 40.
  • a calibrated leak orifice is a mechanical device that may be calibrated to produce a specific flow rate in response to a certain pressure.
  • the receptacle 10 of the embodiment of Figure 8 is supplied with fluid from a fluid source 40 configured to supply fluid into the fluid inlet conduit 50.
  • the calibrated leak orifice 74 may be used in addition to or in place of the fluid source regulator 76 (shown in Figure 61) to control the flow rate of fluid passing from the fluid source 40 and into the fluid inlet conduit 50.
  • the calibrated leak orifice 74 may be reusable or it may be for single use on a single patient. It may be integrated into a housing of the fluid source 40 or provided separate to the fluid source 40.
  • the pressure relief valve 70 or other pressure regulator is not present at the fluid inlet conduit 50, however a calibrated leak orifice 74 may be disposed on the fluid inlet conduit 50, between the fluid source 40 and the receptacle 10.
  • Any of the pressure relief valve 170 or other pressure regulator or calibrated leak orifice 74 may be present at any of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610 or 710 decribed in this disclosure.
  • the fluid inlet conduit 50 is connected to a fluid source conduit 79 with a conduit connector 77.
  • the first fluid outlet conduit 52 may also be connected to the pressure relief valve 70 with a further conduit connector (not seen in Figure 62).
  • the conduit connectors 77 may be any type of appropriate connector, for example barb connectors, double-ended barb connectors, luer-type connectors, or other connectors that click into place.
  • Each conduit connector 77 may be held by a holder 78.
  • a holder 78 may hold multiple conduit connectors 77 or each connector 77 may be held in a separate holder 78.
  • Each holder 78 may be attachable to the limb, torso, neck or other part or portion of the body.
  • the at least one section of the wall 15 of the receptacle 10 may allow molecules within the fluid to diffuse from the receptacle 10 to the wound 22 or to pass from the receptacle 10 to the wound 22 via pore flow, or it may allow molecules within the fluid to both diffuse from the receptacle 10 to the wound 22 and to pass from the receptacle 10 to the wound 22 via pore flow.
  • the fluid may comprise a gas, such as oxygen gas or carbon dioxide gas or carbon monoxide gas or nitric oxide gas or ambient air.
  • the fluid may also comprise a combination of the aforesaid gases.
  • Figures 9 and 10 show embodiments of the apparatus 100 in which the receptacle 10 has a substantially annular or doughnut shape in plan view so as to include a through-hole 25.
  • the through-hole 25 provides an additional path for exudate to flow away from the wound surface. It provides additional areas of fluid communication between the wound 22 and the cover 30 or the absorbent material 75 (seen in Figure 13) of the cover 30.
  • the through hole 25 may therefore help to facilitate the flow of exudate away from the wound 22, particularly when the compartment 35 is subject to a negative pressure to form a negative pressure compartment.
  • the receptacle 10 includes multiple through-holes 25, providing multiple additional paths for exudate to flow from the wound surface, which may further increase the flow of exudate away from the wound 22.
  • the receptacle 10 may include a plurality of the microstructures 60 arranged on the wound facing surface 12 (not shown in the plan views of Figures 9 and 10) of the receptacle 10.
  • the one or more receptacles 10 are movable by a clinician when being positioned on the wound area 20 on the patient and also in situ, in response to patient movement. However, in some circumstances it may be required to secure the receptacles in place.
  • the apparatus 100 may further include one or more fasteners 80 for securing the receptacle(s) 10 in place at the wound area 20 once they are positioned.
  • the fastener 80 may comprise adhesive, such as adhesive tape as schematically shown in Figure 12 and may be used to secure the receptacle 10 and/or one or more of the fluid inlet conduit 50 and the first fluid outlet conduit 52 (seen in Figure 3), 54 to the healthy skin 24 of the patient or to the cover 30. Securing the receptacle 10 and/or one or more the fluid inlet conduit 50, the first fluid outlet conduit 52, and the second fluid outlet conduit 54 in place may reduce movement of the components within the wound area 20, including the wound 22.
  • Figures 18 to 25 show embodiments of the apparatus 300 that do not include a negative pressure compartment. Whilst shown and described with reference to the receptacle 10, it may apply to any of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 described in this disclosure. These embodiments are described with reference to a wound. However, it will be appreciated that they are, in general, applicable to other tissue areas as described elsewhere in this disclosure. The components of these embodiments are as described in respect of the apparatus 100, 200 and like components are given like reference numbers.
  • the fluid may comprise a gas, such as oxygen gas or carbon dioxide gas or carbon monoxide gas or nitric oxide gas or ambient air.
  • the fluid may also comprise a combination of the aforesaid gases.
  • the apparatus 300 has a receptacle 10 and a fluid inlet conduit 50 through which fluid is introduced into the receptacle 10 from a fluid source 40.
  • the receptacle 10 is formed of one or more walls 15 having at least one section made of the membrane adapted to allow molecules within the fluid to diffuse from the receptacle 10 to the wound area 20.
  • the receptacle 10 is placed in contact with the wound 22, with the wound facing surface 12 of the receptacle 10 facing the wound 22.
  • a schematic representation of a receptacle having a fluid inlet conduit 50 is shown in Figure 26.
  • an optional cover 30 in the form of a bandage may be wrapped around the body part containing the wound 22 such that it is wrapped over the receptacle 10 to provide pressure to the receptacle 10 and press it into contact with the wound 22.
  • the cover 30 contacts the healthy skin 24 of the patient that surrounds the wound at the wound area 20.
  • An optional seal 32 for example an adhesive seal, may be used to fasten the cover 30 to the healthy skin 24 to keep the cover 30 in place.
  • the fluid inlet conduit 50 may pass through the first opening 34 that is formed in between adjacent wrappings of the bandage.
  • the compartment 35 substantially bounded by the cover 30 in the form of the bandage, the receptacle 10 and the tissue area may be further bounded by the fluid inlet conduit 50.
  • Figure 20 shows an embodiment that is very similar to that of Figure 18, with the addition of the first fluid outlet conduit 52. Accordingly, the fluid that enters the receptacle 10 through the fluid inlet conduit 50 may cycle through the receptacle 10 and exit the receptacle 10 through the first fluid outlet conduit 52.
  • a view of a receptacle 10 having a fluid inlet conduit 50 and a first fluid outlet conduit 52 is shown in Figure 20A.
  • the optional cover 30 in the form of a bandage may be wrapped around the body part of the patient having the wound 22 and around the receptacle 10 placed on the wound 22.
  • An optional seal 32 which may be an adhesive seal, may be used to fasten the cover 30 to the healthy skin 24 to keep the cover 30 in place.
  • the fluid inlet conduit 50 and the first fluid outlet conduit 52 may pass through the first opening 34 and the second opening 36 that is formed in between adjacent wrappings of the bandage.
  • the fluid inlet conduit 50 and the first fluid outlet conduit 52 may pass through the bandage as coaxial conduits or adjacent conduits as in the embodiment of Figures 14 to 17, or they may be substantially adjacent conduits as described in relation to Figures 40, 41, 45-50 and 52 elsewhere in this disclosure.
  • Figure 22 shows an arrangement that has multiple receptacles 10, in this case three receptacles. As with the apparatus 100, the number of receptacles 10 shown in Figure 22 is non-limiting and any reasonable number of receptacles 10 may be used depending on the area of the wound surface. Each receptacle 10 has a respective fluid inlet conduit 50 that is supplied with the fluid from the fluid source 40. The receptacles 10 are independent of one another and may be placed on the wound 22 where fluid is required.
  • the receptacles 10 may be moved from time to time to treat other parts of the wound 22, for example a part that is not healing as quickly.
  • Figure 23 shows this arrangement with the optional cover 30 in the form of a bandage wrapped around the body part of the patient having the wound 22 and around the receptacles 10.
  • the optional seal 32 which may be an adhesive seal, may be used to fasten the cover 30 to the healthy skin 24 to keep the cover 30 in place.
  • the respective fluid inlet conduits 50 may pass through respective first openings 34 that are formed in between adjacent wrappings of the bandage.
  • the respective fluid inlet conduits 50 may pass through a single first opening 34.
  • the compartment 35 substantially bounded by the cover 30, the receptacle 10 and the tissue area may be further bounded by the fluid inlet conduits 50.
  • the at least one section of the wall 15 of the receptacle 10 may allow molecules within the fluid to diffuse from the receptacles 10 to the wound 22 or to pass from the receptacles 10 to the wound 22 via pore flow, or it may allow molecules within the fluid to both diffuse from the receptacle 10 to the wound 22 and to pass from the receptacle 10 to the wound 22 via pore flow.
  • Figures 24 and 25 show variations of the arrangements of Figures 18 and 19 that include a pressure relief valve 70 either in the fluid inlet conduit 50 or in a branch line 72 of the fluid inlet conduit 50 as shown in Figures 24 and 25.
  • the at least one section of the wall 15 of the receptacle 10 may allow molecules within the fluid to diffuse from the receptacle 10 to the wound 22 or to pass from the receptacle 10 to the wound 22 via pore flow, or it may allow molecules within the fluid to both diffuse from the receptacle 10 to the wound 22 and to pass from the receptacle 10 to the wound 22 via pore flow.
  • the arrangements are otherwise identical to the arrangements of Figures 18 and 19.
  • the compartment 35 substantially bounded by the cover 30, the receptacle 10 and the tissue area may be further bounded by the fluid inlet conduit 50.
  • the branch line 72 and pressure relief valve 70 may be present inside the cover 30.
  • the cover 30 may include a vent to atmosphere, for example an outlet port, or the cover 30 may be a permeable cover 30 such as a compression bandage, such that gas released from the pressure relief valve 70 on the fluid inlet conduit 50 inlet may be vented from underneath the cover 30 to prevent the compartment 35 formed by the cover 30 from bursting.
  • the compartment 35 substantially bounded by the cover 30, the receptacle 10 and the tissue area may be further bounded by the fluid inlet conduit 50
  • the receptacle(s) may include a plurality of microstructures 60 arranged on the wound facing surface 12 of the receptacle 10, or on any other portion of the wall 15 as shown in Figure 1A.
  • some of the dressings that cover the receptacle(s) 10 may press the receptacle 10 against the wound 22 and the healthy skin 24 around the wound 22.
  • Such dressings may also press some length of the fluid inlet conduit 50 or first fluid outlet conduit 52 connected to the receptacle 10 against the healthy skin 24 around the wound 22 and even the wound 22 itself, depending on the size and position of the receptacle 10 relative to the wound 22.
  • the outer diameter of the conduits 50, 52 is small, for example 5 mm or less, the patient may find it uncomfortable to have the conduit 50, 52 pressed against them in this way.
  • Figure 26 shows a schematic plan view of a variation of a receptacle 110 that is similar to the receptacle 10 in that it has a generally circular shaped head portion 93 that is placed over the wound 22 and further includes an additional tail portion 90 that is formed integrally with and extends from the generally circular shaped head portion 93.
  • the tail portion and the head portion 93 may be formed as two separate components and joined together.
  • the tail portion 90 has a generally elongate rectangular shape when viewed in plan view and it is inflatable with the circular head portion 93 of the receptacle 110.
  • the tail portion 90 may be longer than it is wide.
  • the tail portion 90 may have a width that is less than the width of the head portion 93.
  • the tail portion 90 may be wider that is long. It may have a shape, when viewed in plan view, that is rectangular, square, elliptical or any other suitable shape.
  • the fluid inlet conduit 50 connects to a distal end wall 92 of the tail portion 90 that is furthest from the head portion 93 such that it is in fluid communication with the tail portion 90.
  • the fluid inlet conduit 50 is configured to supply fluid to the head portion 93 via the tail portion 90.
  • the tail portion 90 may extend beyond the wound 22 such that the interface between the fluid inlet conduit 50 and the receptacle 110 is spaced apart from the wound surface, reducing the likelihood of the fluid inlet conduit 50 being pressed into the wound 22 or other tissue site of the patient by the cover 30 in the form of a bandage or other dressing. Furthermore, the tail portion 90 may extend beyond the wound 22 such that the interface between the fluid inlet conduit 50 and the receptacle 110 is beyond the pressing force of the bandage 30 or other dressing, reducing the likelihood of the fluid inlet conduit 50 being pressed into the tissue of the patient by the bandage 30 or other dressing.
  • the pressing force may press the tail portion 90 against the patient rather than the fluid inlet conduit 50. This will be more comfortable for the patient. Whilst not shown in Figure 26, a first fluid outlet conduit 52 may also protrude into the distal edge 92 of the tail portion 90.
  • the tail portion 90 allows the conduits 50, 52 to terminate distally from the wound 22 so that ends of the conduits 50, 52 will not impact the wound 22; that is, the application of a cover 30 in the form of a bandage or other dressing over the receptacle 110 will not press the conduits 50, 52 into the wound.
  • the tail portion 90 may lie over a portion of the wound 22 that is not covered by the head portion 93, particularly where the wound 22 is large and/or of an irregular shape.
  • the cover 30 in the form of a bandage or other dressing may therefore be wrapped over the tail portion 90 rather than directly over the tissue or a wound of the patient,.
  • tissue bordering the wound 22 may also be compromised or at a different stage of healing and may be sensitive and/or easily damaged. Wrapping the cover 30 over the tail portion 90 rather than directly over the wound or the tissue in these cases may help to reduce patient discomfort.
  • the user of the receptacle 10 may also find it more straight forward to seal a negative pressure dressing or cover 30 to an upper surface of the tail portion 90 rather than over the top of multiple, separate conduits.
  • the receptacle 110 may be inflatable.
  • the receptacle 110 is a bag.
  • the receptacle 110 may comprise one or more walls 115 and is adapted to receive a fluid.
  • the one or more walls of the tail portion 90 may be formed from the same material as the one or more walls of the head portion 93.
  • the one or more walls 115 of the head portion 93 and the tail portion 90 of the receptacle 110 may have the same properties as the one or more walls 15 described in this disclosure, and may be flexible and conformable such that they can conform to the wound topology.
  • the wall 115 of the tail portion 90 may be formed continuously with the wall 115 of the head portion 93; that is, they may be the same wall 115.
  • the wall 115 of the tail portion 90 may not be formed continuously with the wall 115 of the head portion 93; that is, they may not be the same wall 115.
  • the one or more walls 115 of the head portion 93 and the tail portion 90 may comprise at least one section adapted to allow molecules within the fluid to move from inside of the receptacle 110 to the tissue area.
  • the one or more walls 115 of the head portion 93 and the tail portion 90 may be adapted to allow the molecules to move through the wall via diffusion.
  • the one or more walls 115 may be substantially pore-free such that molecules do not move through the wall via pore flow.
  • the one or more walls 115 may be substantially impermeable to bulk transport of fluid.
  • the one or more walls 115 that comprise the tail portion 90 of the receptacle 110 may or may not be adapted to allow the molecules to move through the wall via diffusion.
  • the head portion 93 and the tail portion 90 may be formed as separate components that may be pneumatically connected.
  • the tail portion 90 may be inflatable. Alternatively, the tail portion 90 may not be inflatable.
  • the tail portion 90 may be made of a different material to the head portion 93, for example it may be made of a foam.
  • the tail portion 90 may comprise of a foam having a coating that is impermeable to bulk transport of fluid and/or diffusion. Alternatively, it may be made of a material that is adapted to substantially prevent molecules within the fluid from passing through it.
  • the receptacle 110 may include a plurality of microstructures 60 arranged on a wound facing surface 12 of the receptacle 110.
  • the tail portion 90 of the receptacle 110 may include a plurality of the microstructures 60. However, an alternative embodiment of the tail portion 90 of the receptacle 110 may not include the plurality of microstructures 60.
  • Embodiments of the tail portion 90 may provide a bridge between the head portion 93 of the receptacle 110 and the ends of the fluid inlet conduit 50 and first fluid outlet conduit 52 to which the fluid source 40 is connected.
  • the tail portion 90 allows fluid supplied into the fluid inlet conduit 50 to be transported to the head portion 93 for treatment at the wound 22. All other features of the receptacle 110 are the same as for the receptacle 10.
  • the fluid may comprise a gas, such as oxygen gas or carbon dioxide gas or carbon monoxide gas or nitric oxide gas or ambient air.
  • the fluid may also comprise a combination of the aforesaid gases.
  • tail portion 90 Whilst the disclosure of the features of the tail portion 90 are described with reference to the receptacle 110, one or more of the features may apply to any of the receptacles 10, 210, 210A, 310, 410, 510, 610 or 710 described in this disclosure.
  • the fluid inlet conduit 50 is encapsulated in a pressure spreading device 95 that is adjacent the receptacle 110.
  • the pressure spreading device 95 is a silicone component that is moulded with the fluid inlet conduit 50 so as to surround it, as shown in the cross-sectional view of Figure 27.
  • the pressure spreading device 95 spreads the load of the fluid inlet conduit 50 over a greater portion of the healthy skin 24 of the patient adjacent the wound 22 to reduce indentation during and after use of the receptacle 110.
  • the fluid inlet conduit 50 may be bonded to the pressure spreading device 95.
  • the pressure spreading device 95 may encapsulate at least a portion of the fluid inlet conduit 50 between the fluid delivery device and a fluid source.
  • the pressure spreading device 95 may be shaped to reduce a pressure exerted on the patient by the fluid inlet conduit 50.
  • the pressure spreading device 95 may have a width that is greater than an external diameter of the fluid inlet conduit 50.
  • the width may be about 2 to 10 times greater than the external diameter, or about 3 to 9 times greater than the external diameter, or about 4 to 8 times greater than the external diameter, or about 5 to 7 times greater than the external diameter of the fluid inlet conduit 50.
  • Whist some embodiments of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 may have a tail portion 90 and a pressure spreading device 95
  • some embodiments of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 may have a tail portion 90 and no pressure spreading device 95, or they may have a pressure spreading device 95 and no tail portion 90.
  • the tail portion 90 and the pressure spreading device 95 may be formed integrally with one another or they may comprise separate components.
  • the tail portion 90 and the pressure spreading device 95 may be bonded together.
  • the pressure spreading device 95 and the receptacle 110 may be made from the same material.
  • the pressure spreading device 95 may have a generally elliptical crosssection. In some embodiments, it may have a cross-section that is shaped like a convex lens as shown in Figure 27.
  • the fluid inlet conduit 50 may be bonded to the pressure spreading device 95.
  • fluid passes from the fluid inlet conduit 50, into the tail portion 90, through the tail portion 90, and into the head portion 93.
  • This flow of fluid is intended to at least partially inflate both the tail portion 90 and the head portion 93 in order to press the outside of the receptacle 110 to the target tissue, which helps to maximise the surface contact between the receptacle 110 and the wound 22 for delivery of molecules within the fluid to the target tissue, including the wound 22.
  • Inflation of the receptacle 110 is schematically shown in the cross-sectional view of Figure 28(i) and in the view of the inflated receptacle 110 of Figure 28A(i).
  • the receptacle 110 is prevented from at least partially inflating, fluid flow through the receptacle may be impaired or even prevented, reducing or preventing the delivery of molecules within the fluid to the wound 22.
  • the receptacle 110 is made of a smooth silicone material, one or more sections of the inner surface(s) of the one or more walls 115 of the receptacle 110 may adhere together such that the receptacle is unable to inflate.
  • a non-inflated receptacle 110 is shown schematically in Figure 28(ii), and in the view of Figure 28A(ii).
  • FIG. 29 shows a cross- sectional view of an embodiment of a receptacle 310 in which an inner surface of one or more sections of the wall(s) 315. i.e. a non-wound contacting surface, is roughened to form a rough surface.
  • an inner surface of a wall 315 has a roughened section forming a first rough surface 311.
  • multiple sections of the wall(s) 315 can be roughened; the inner surface of the wall 315 has a first roughened section forming a first rough surface 311 and a second roughened section forming a second rough surface 313.
  • the wall(s) 315 may have further roughened sections forming further rough surfaces.
  • Figure 29(a) and Figure 29(b) show roughening of a central section of the inner surface of the wall(s) 315, the roughening may be applied over other sections of the wall(s) 315 or even over the the entirety of the inner surface of the wall(s) 315.
  • first rough surface 311 and the second rough surface 313 are opposite one another, however they may also be on sections of the inner surface of the wall(s) 315 that are not opposite one another.
  • a close-up view of a cross-section of the rough surface 311 of the wall 315 is shown in Figure 30, however the features are equally applicable to the rough surface 313.
  • the rough surface 311 has a rough texture. The roughness causes random variation in the topology of the surface.
  • the rough surface 311 may be irregular; it may vary in height (D) and it may include a plurality of raised and/or recessed elements that vary in width (W) as shown in Figure 30.
  • the elements are added or raised elements from a common baseline within the wall 315.
  • the elements are recessed from a common baseline within the wall 315.
  • the elements are both raised and recessed from a common baseline within the wall 315.
  • the common baseline may be the level of a smooth section of the wall 315 i.e. a section that is not roughened.
  • the height (D) of the elements may be between about 0.2 micrometres to 200 micrometres, or between about 0.2 micrometres and 150 micrometres, or between about 0.2 micrometres and 100 micrometres, or between about 0.3 micrometres and 50 micrometres, or between about 0.5 micrometres and 10 micrometres, from the common baseline.
  • the width (W) of the elements may be between about 0.2 micrometres to 200 micrometres, or between about 0.2 micrometres and 150 micrometres, or between about 0.2 micrometres and 100 micrometres, or between about 0.3 micrometres and 50 micrometres, or between about 0.5 micrometres and 10 micrometres, relative to the common baseline.
  • the height (D) of the rough surface may be measured from a low point to a high point thereof.
  • the height (D) of the rough surface may be between about 0.2 micrometres to 400 micrometres, or between about 0.2 micrometres and 300 micrometres, or between about 0.2 micrometres and 200 micrometres, or between about 0.4 micrometres and 200 micrometres, or between about 0.6 micrometres and 100 micrometres, or between about 1.0 micrometres and 20 micrometres, from a low point to a high point thereof.
  • the outer surface of the wall 315 can be roughened to provide a rough surface 312. This may reduce the surface contact and thus the adherence between the outer surface of the wall 315 and contaminants such as dirt or dust that may be present in the manufacturing space. This can improve the cleanliness of the receptacle 310 due to reduced adherence between the outer surface of the wall 315 and the contaminants. This makes the receptacle 310 easier to clean and to keep clean. At least a portion of the rough surface 312 may be present on a section of the outer surface of the wall 315 configured for contacting the tissue, i.e. a wound or tissue contacting section of the surface that in use is intended to contact the tissue of the patient.
  • the rough surface 312 may be present on a section of the outer surface of the wall 315 configured not to contact the tissue, such as a section of the surface opposing the wound or tissue contacting section of the surface, or a section of the surface adjacent the wound or tissue contacting section of the surface.
  • Figure 63 shows a cross-sectional view of an embodiment of a receptacle 310 in which one or more sections of an outer surface of the wall(s) 315. e.g. a wound or tissue contacting section of the surface, or a section of the surface opposing or adjacent the wound or tissue contacting section of the surface, is roughened to form a rough surface 312.
  • an outer surface of a wall 315 has a roughened section forming a first rough surface 312.
  • multiple sections of the wall(s) 315 can be roughened; the outer surface of the wall 315 has a first roughened section forming a first rough surface 312 and a second roughened section forming a second rough surface 314.
  • the wall(s) 315 may have further roughened sections forming further rough surfaces. Whilst Figure 63(a) and Figure 63(b) show roughening of a central section of the outer surface of the wall(s) 315, the roughening may be applied over other sections of the the wall(s) 315 or even over the entirety of the outer surface of the wall(s) 315.
  • the roughened surface can be applied at least partially to the head portion 93 and/or tail portion 90.
  • the first rough surface 312 and the second rough surface 314 are opposite one another, however they may also be on sections of the outer surface of the wall(s) 315 that are not opposite one another, for example the sections may be adjacent one another.
  • a close-up view of a cross-section of the rough surface 311 of the wall 315 is shown in Figure 30 as described above, however the features are equally applicable to the rough surfaces 312, 314.
  • the rough surface on the outer surface of the wall(s) 315 may be used instead of or in addition to the rough surface on the inner surface of the wall 315.
  • the rough surface is described with respect to the receptacle 310, it will be apparent that it may be applied to any of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610 or 710 described in this disclosure. Accordingly, the rough surface may be combined with one or more features of the receptacles 110, 210, 210A, 310, 410, 510, 610 and 710.
  • the pressure from the dressing may also press walls of the receptacle 10, 110, 210, 210A, 310, 410, 510, 610, 710 together in such a way as to block the flow of fluid through the tail portion 90.
  • Patient movement or position may also cause this kind of blockage if, for example, a patient rolls on top of the receptacle 10, 110, 210, 210A, 310, 410, 510, 610, 710.
  • Such a blockage may stop fluid getting to the head portion 93. If this occurs, the patient will not receive therapy.
  • a feature can be incorporated to help maintain a flow path along the tail portion 90, regardless of the pressure applied, such as by dressings, patient movement or patient position.
  • Figure 31a shows a cross sectional view, such as at line B-B of Figure 26 of an embodiment of the inside surface of a wall 415 of a receptacle 410.
  • the inner surface of the wall 415 includes one or more small, soft, protruding ridges
  • the wall 415 opposing the ridge 96 drapes over the ridge 96, leaving gaps 97 on either side of it as shown in Figure 3 lb.
  • the gaps 97 will generally remain even when tight dressings are applied over the receptacle 410 in use or regardless of patient movement.
  • the ridges 96 are also shown in the views of the receptacle 415 of Figure 28 A.
  • the gaps 97 are formed due to the shape of the corner between each ridge 96 and the section of wall 415 from which it protrudes.
  • the corners may be sharp such that it is substantially non-filleted, or it may have a fillet 98 that is small as shown in Figure 33a.
  • the corner may have a fillet that is so small as to be negligible, within the bounds of manufacturing capabilities. If the size of the fillet 98 is small in comparison with the height of the ridge 96, the likelihood that an opposing section of wall 415, pressed against the section with the ridges 96, will be able to deform in such a way that it fills that gaps 97, is reduced.
  • the fillet radius may be not more than about 30%, for example not more than about 25% or not more than about 20% or not more than about 10 % of the height of the ridge 96.
  • the fillet 98 is large. In this alternative, it is possible that the opposing wall 415 would deform to fill the gaps 97. This would likely result in a blockage within the receptacle 410, which would compromise the therapy.
  • the illustrative examples of the fillets 98 are shown in Figure 33 a-c as having a concave fillet shape. However, the fillets 98 may also be convex or mitre shaped. Alternatively, as shown in Figure 33d, the ridge 96 may overhang the comer to produce a sharp corner. In this embodiment, the corner may be substantially non-filleted, within the bounds of manufacturing capabilities.
  • the one or more ridges 96 may extend through the tail portion 490 of the receptacle 410, as far along the tail portion 490 as is necessary to maintain an open flow path inside the receptacle 410.
  • a plurality of the ridges 96 may extend through the entire tail portion 490 as shown in Figure 34a.
  • Figure 34a shows three ridges 96.
  • any appropriate number of ridges 96 may be included inside the tail portion 490.
  • the ridges 96 may extend across some proportion of the head portion 493 as shown in Figure 34b.
  • the ridges 96 may be straight as in the examples of Figure 34a and Figure 34b.
  • the one or more ridges 96 may comprise two or more ridges arranged substantially parallel to one another as in the examples of Figure 34a and Figure 34b.
  • the ridges 96 may be non-straight, for example they may have a longitudinal form that is a regular or irregular curve 96a, or zigzag 96b as illustrated in the example of Figure 34c.
  • the ridges 96, 96a, 96b maintain a flow path between the entry point of the fluid conduit 50 to the tail portion 490 and the head portion 493.
  • Figure 28 A shows views of an embodiment of the receptacle 110 showing the ridges 96, in both an inflated configuration of the receptacle 110 ( Figure 28A(i)) and a non-inflated configuration ( Figure 28A(ii)). Whilst the ridges 96 are shown for the receptacle 110, it will be apparent that the ridges apply also to any of the receptacles 10, 110, 210, 210A, 310, 310, 410, 510, 610, 710 described in this disclosure.
  • the ridges 96 may be formed of a soft, yielding material such as silicone.
  • the yielding material is not rigid and may give way under pressure. It will deform to an extent under pressure but will regain its original configuration once the pressure is removed.
  • the extent to which the ridges 96 may yield is a balance of the requirements for softer, more yielding ridges to help reduce indentation on the patient tissue while maintaining enough rigidity to maintain the flow path and prevent blockage.
  • the one or more walls 415 of the receptacle 410 may include the first wall portion and the second wall portion opposite the first wall portion.
  • the ridges 96 may be formed integrally with the first wall portion and/or the second wall portion respectively of the receptacle 410.
  • the ridge 96 may have a rounded tip as shown in Figure 3 lb.
  • a height of each ridge 96 may be similar to the height of one of the microstructures 60 described elsewhere in this disclosure.
  • Each ridge 96 may have a height of between approximately 50 to 500 micrometres, for example 75 to 250 micrometres, for example 100 to 200 micrometres, for example between approximately 125 to 175 micrometres.
  • An embodiment of the ridge 96 has a height of 150 micrometres.
  • the height of the ridge 96 is a balance of the requirement for a taller ridge to help maintain a sufficient gap 97 and thereby prevent blockage of the flow path, whilst avoiding an overly tall ridge that may cause indentation in the patient tissue and which may render the ridge 96 susceptible to buckling.
  • a width of each ridge 96 may be similar to the base diameter of the one of the microstructures 60.
  • Each ridge 96 may have a width of between approximately 50 to 500 micrometres, for example 100 to 400 micrometres, for example between approximately 250 to 350 micrometres, or between approximately 280 to 330 micrometres.
  • the ridge 96 increases the thickness of the wall 415 at the particular location of the ridge 96, which may affect the ability of molecules within the fluid to diffuse through the wall 415 at that location.
  • a larger number of ridges 96 may be included in the receptacle 110 to maintain a fluid flow path in the event the receptacle 110 is crushed, the number of ridges 96 should be balanced with the requirement that the molecules within the fluid can diffuse through the wall 415.
  • the thickness of the wall portion opposing the first wall portion or second wall portion of the wall 415 having the ridge 96 formed therewith is also a factor in the size of the gap 97 that is formed as the opposing first wall portion or second wall portion of the wall 415 is pressed onto the ridge 96.
  • a thicker wall portion is less likely to deform into the gap 97, whereas a thinner wall portion is more flexible and thus more likely to deform and fill a gap 97.
  • a thinner wall portion 415 may also have higher rates of diffusion across the wall than a thicker wall portion 415.
  • the wall(s) 415 of the receptacle 410 may be the same material and thickness as those described in respect of receptacle 10 and may be flexible and conformable such that they can conform to the wound topology. Hence, it is important to balance these desirable properties of the first wall portion or second wall portion of the wall(s) 415 with the likelihood of blockage and choose the dimensions of the ridge 96 accordingly e.g. decrease fillet size or increase ridge height to ensure a suitable gap 97 is always present.
  • a thickness dimension of the first wall portion and/or the second wall portion may be less than or approximately equal to a height dimension of the ridge 96.
  • the thickness dimension of the first wall portion and/or the second wall portion may be greater than a height dimension of the ridge 96.
  • the first wall portion and/or the second wall portion of the wall(s) 415 may have a wall thickness of between about 10 micrometres and 150 micrometres, or between about 20 micrometres and 140 micrometres, or between about 30 micrometres and 130 micrometres, or between about 35 micrometres and 100 micrometres, or between about 60 micrometres and about 105 micrometres, or between about 40 micrometres and 80 micrometres, or between about 40 micrometres to 70 micrometres, or between about 30 micrometres to 60 micrometres, or between about 45 micrometres and 55 micrometres.
  • the first wall portion and/or the second wall portion may have a wall thickness of approximately 60 micrometres.
  • the first wall portion and/or the second wall portion may have a wall thickness of approximately 50 micrometres.
  • ridges 96 are provided on each of an opposing first wall portion and second wall portion of the wall(s) 415.
  • the ridges 96 are directly opposed when the surfaces are pressed together.
  • the ridges 96 on opposing inner surfaces of the first wall portion and second wall portion of the wall(s) 415 are offset from one another when the surfaces are pressed together and are not directly opposed. Either embodiment may be used, however the use of non-opposing ridges may be less likely to indent the patient’s tissue when the receptacle 410 is pressed onto the wound 22 and/or surrounding tissue.
  • the ridges 96 and thickness of the walls are described with respect to the receptacle 410, it will be apparent one or more of the features may also be applied to any of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610 or 710 described in this disclosure.
  • the ridges 96 may be used in combination with the rough surface 311, 313 of the receptacle 310 to mitigate indentation of the patient tissue in conjunction with reducing adherence of the inner surfaces of the receptacle 310 to one another.
  • One or more ridges 96 extending through the tail portion 90 into the head portion 93 of the receptacles 110, 310 may contribute to the prevention of the inner surfaces adhering together.
  • Figure 35 shows a further variation of the receptacle 210 that is formed to have an elongated tubular shape through which fluid may be cycled.
  • the receptacle 210 has a fluid inlet conduit 50 at one end of the elongate tube shape, for admission of fluid into the receptacle 210. It also has a first fluid outlet conduit 52 through which fluid may exit the receptacle 210 as with other embodiments of the receptacle 210. All other features of the receptacle 210 are the same as for the receptacle 10.
  • This embodiment of the receptacle 210 may be particularly suitable for use on wounds or other tissue surfaces of a certain shape, for example elongate and/or narrow wound or other tissue area shapes.
  • the receptacle 210 may include a plurality of microstructures 60 arranged on the wound facing surface 12 of the receptacle 10.
  • the fluid may comprise a gas, such as oxygen gas or carbon dioxide gas or carbon monoxide gas or nitric oxide gas or ambient air.
  • the fluid may also comprise a combination of the aforesaid gases.
  • FIG. 35A and Figure 35B A variation of the embodiment of Figure 35 is shown in Figure 35A and Figure 35B.
  • the receptacle 210A is formed to have an elongated tubular shape through which fluid may be cycled.
  • the receptacle 210A has a fluid inlet conduit 50 at one end of the elongate tube shape, for admission of fluid into the receptacle 210A. It also has a first fluid outlet conduit 52 at an opposite end of the receptacle 210A to the fluid inlet conduit 50 through which fluid may exit the receptacle 210A as with other embodiments of the receptacle 210. All other features of the receptacle 210A are the same as for the receptacle 10.
  • the elongate tube shape of the receptacle 210A allows a user to fold the receptacle 210A along its length as shown in Figure 35 A(ii), such that the fluid inlet condit 50 is positioned close to the first fluid outlet conduit 52 when in use on a patient.
  • This arrangement means that fluid entering the receptacle 210A at the fluid inlet conduit 50 must pass along the length of the receptacle 210A to reach the first fluid outlet conduit 52, which may prolong the residence time that the fluid spends inside the receptacle 210A.
  • the receptacle 210A may include one or more ridges extending from the fluid inlet conduit 50 to the first fluid outlet conduit 52, as described in respect of the embodiments of Figures 3 la to Figure 34.
  • the ridges 96 may at least partially maintain open a fluid flow path from the fluid inlet 50, through the receptacle 210A to the first fluid outlet 52 when the receptacle 210A is folded.
  • the receptacle 210A may include a tail portion 90 and/or pressure spreading device 95 at the fluid inlet conduit end of the receptacle 210A and/or the first fluid outlet conduit end of the receptacle 210A.
  • Figures 72 through 77 show variations of an embodiment of a tissue care dressing 600 which comprise a receptacle 610 that is formed from a first wall portion 615a and an opposing second wall portion 615b.
  • the first wall portion 615a and the second wall portion 615b may be of a single wall, in accordance with which the receptacle 610 may, for example, be an inflatable bag.
  • the first wall portion 615a and the second wall portion 615b may further be two separate walls attached together via heat sealing or joined otherwise at a seam 665.
  • the receptacle 610 has an inlet 620 and an outlet 630 which is substantially adjacent to the inlet 620.
  • the inlet 620 and the outlet 630 of the receptacle 610 may be located at or near a tail portion 90 of the tissue care dressing 600.
  • the receptacle 610 is adapted to receive a fluid via the inlet 620, and for the fluid to exit the receptacle via the outlet 630, such as to the ambient environment.
  • the fluid may further pass through a pressure relief valve 70, for example as described with reference to Figure 8 herein above, before exiting to the ambient emvironment.
  • the receptacle 610 can be adapted to receive the fluid via a fluid inlet conduit 50 in fluid communication with the inlet 620. Similarly, the fluid can exit the receptacle via a fluid outlet conduit 52 in fluid communication with the outlet 630.
  • the fluid inlet conduit 50 and the fluid outlet conduit 52 may be arranged to be disposed substantially adjacent one another, as described in respect of the embodiments of Figures 40, 41, 45-50 and 52 below. This embodiment of the receptacle 610 will be further described with reference to its application at a tissue area of a patient so that the first wall portion 615a faces the tissue area.
  • first wall portion 615a and the second wall portion 615b can be configured to be substantially similar, as described herein above with reference to receptacle 710, and therefore reference to the first wall portion 615a herein is not necessarily indicative of a specific side of the receptacle 610 across all intended embodiments within the scope of this disclosure.
  • the first wall portion 615a and the second wall portion 615b are formed so as to define a fluid flow path from the inlet 620 to the outlet 630, this fluid flow path generally indicated by reference FP in Figure 72.
  • the inlet 620 and the outlet 630 may be interchangeable such that the direction of fluid flow along the fluid flow path FP through the receptacle 610 can be in either direction as may be required.
  • the embodiment of the receptacle 610 is however further described herein with reference to the configuration of the inlet 620 and outlet 630 as shown in Figures 72 and 73.
  • the fluid flow path FP is defined through a first chamber 640 in fluid flow connection with the inlet 620, and a second chamber 650 in fluid flow connection with the first chamber 640 and the outlet 630.
  • the first chamber 640 and the second chamber 650 are provided at a head portion 93 of the receptacle 610, with the second chamber 650 being partitioned from the first chamber 640 by a juncture 660 between the first wall portion 615a and the second wall portion 615b.
  • this juncture 660 can be formed by a bond between an inner surface of the first wall portion 615a and an inner surface of the second wall portion 615b as shown schematically in Figure 75. This allows the formation of the fluid flow path substantially through the head portion 93 of the receptacle 610.
  • the first chamber 640 is configured to be positionable at the tissue area, for example it may be shaped and/or sized to conform with a shape and/or size and/or geometry of the tissue area or a part thereof, with the first wall portion 615a thereof as a permeable layer 505 as described with reference to Figure 65 herein and with at least one section 520, as shown in Figure 74, allowing molecules within the fluid to pass through the permeable layer and deformable under pressure imparted by fluid in the interior of the receptacle 610 on the first wall portion 615a.
  • first chamber 640 and/or the second chamber 650 can take any appropriate shape, non-limiting examples of which include generally elongate shapes, curved shapes, rectangular shapes, square shapes, oval shapes and round shapes, and can further be any appropriate size, for example as may be required as a result of the size of the tissue area 525.
  • a potential benefit of a larger first chamber 640 and/or the second chamber 650 may further be the ease with which the receptacle 610 can be secured to the tissue area 525, such as by adhesive tape.
  • the chamber, in this example the first chamber 640, which is configured to be positionable at the tissue area preferably has a first wall portion 615a which has a larger surface area than the first wall portion 615a of the other chamber, in this example the second chamber 650. It will be appreciated that the larger surface area can facilitate correctly positioning of the receptacle 610 at the tissue area.
  • the chamber having a first wall portion with a smaller surface area in this example the second chamber 650, may then allow for a relatively smaller chamber which can act as a conduit, shown by example in Figures 72 and 73 as having a generally curved shape about the first chamber 640, for conveying the fluid to or from the relatively larger chamber towards the inlet 620 or the outlet 630, dependant on the direction of fluid flow as discussed herein above with reference to the configuration of the inlet 620 and the outlet 630 of the receptacle 610.
  • a larger surface area may allow a greater extent of deformation of the first wall portion 615a, such that the first wall portion 615a is more likely to contact the tissue area 525 of the patient.
  • the receptacle 610 may further be applied to a carrier layer 530 as described with reference to receptacle 510, 710 and shown in Figures 65 through 71, the section 520 thereby may supply molecules within the fluid to target tissue 522 within the tissue area 525 through an aperture 535 or apertures 535.1 through 535. n of the carrier layer 530 or carrier layers 530.1 through 530. n. It will be appreciated that in such an example embodiment, the carrier layer 530 or carrier layers 530.1 through 530. n may provide cushioning between the receptacle 610 and the tissue area 525.
  • a carrier layer 530 may provide cushioning between the tissue area 525 and at least a part of the first chamber 640 and/or the second chamber 650 where a part or the whole of the first chamber 640 is applied over an aperture 530 or apertures 530.1 through 530. n of the carrier layer 530.
  • the carrier layer 530 in such an example may further, and if present, provide cushioning between the fluid inlet conduit 50 and fluid outlet conduit 52, a seam 665, juncture 660, a pressure relief valve 7 and/or any part or surface of the receptacle which is not required to contact target tissue 522 within the tissue area 525.
  • FIGS 72 through 74, 76 and 77 show the tissue care dressing 600 comprising a pressure spreading device 95 disposed at the tail portion 90.
  • a pressure spreading device 95 is optional, but may improve patient comfort as it can be configured to mitigate a pressure applied to the patient by the fluid inlet conduit 50 and/or the fluid outlet conduit 52, such as described further herein with reference to receptacle 110.
  • the pressure spreading device 95 can be provided with a substantially flat surface 680 at an operatively patient facing side thereof.
  • Figures 73, 74 and 77 show the second wall portion 615b comprising a plurality of ridges 96 which extend along the fluid flow path at an inner surface of the second wall portion 615b. It will be appreciated that these ridges 96 may alternatively or in addtion be provided at an inner surface of the first wall portion 615a. These ridges 96 can be similar to the ridges 96 further described herein with reference to receptacles 10, 110, 210, 210A, 310, 410, 510 and 710.
  • Figure 74 further shows the first wall portion 615a, and thereby the section 520 of the permeable layer 505 of the first chamber 640, comprising a plurality of microstructures 60 arranged at an operatively tissue facing surface of the first wall portion 615a.
  • These microstructures 60 can be similar to the microstructures 60 further described herein with reference to receptacles 10, 110, 210, 210A, 310, 410, 510 and 710.
  • the first wall portion 615a and the second wall portion 615b can be configured to be substantially similar, and this may allow for the tissue care dressing 600 to be applied to a patient with any one or both of the first wall portion 615a and the second wall portion 615b facing the tissue area of the patient.
  • the first wall portion 615a may be specifically configured to comprise microstructures 60 intended to contact the tissue area.
  • Figure 75 shows the second wall portion 615b may be configured to have a greater thickness than the first wall portion 615a, which thicker second wall portion 615b may also comprise ridges 96 at its inner surface. In such instances, the tissue care dressing 600 is necessarily to be applied to a patient in a particular orientation.
  • the tissue care dressing 600 can comprise an indicator 690 of an orientation of the receptacle 610.
  • the indicator may comprise the word for example, “up” or “top”, or alternatively a graphical indicator, printed, moulded or otherwise provided on the tissue care dressing 600 to indicate, either directly or by implication, a surface of the receptacle 610 which is intended to face away from the patient.
  • this indicator 690 can be provided anywhere on the tissue care dressing 600, for example at the tail portion 90 or head portion 93 of the receptacle 610 itself or on the pressure spreading device 95, should the tissue care dressing 600 include one, and can take various other forms in addition to those described herein above, non-limiting examples of which include colouring, labels and haptic indicators such as textures, patterns and the like.
  • the second wall portion 615b can be configured to mitigate against or prevent fluid to pass therethrough. This may act to advance the passage of molecules within the fluid through the section 520 and/or mitigate against fluids in the environment passing through the second wall portion 615b into the interior of the receptacle 610.
  • the second wall portion 615b can have a thickness as described herein relative the first wall portion 615a and with reference to the second wall portion 515b and/or be of a material which does not allow bulk flow fluid to pass therethrough, and thereby the second wall portion 615b can also substantially prevent diffusion and/or pore flow therethrough.
  • the receptacle 210A is an example of a receptacle that is easily folded or otherwise manipulated for insertion into a wound, however other receptacles 10, 110, 210, 310, 410, 510, 610, 710 described in this disclosure may also be user manipulated for this purpose.
  • adhesive such as tape, can be used to hold the manipulated receptacle in place.
  • a larger receptacle 10, 110, 210, 310, 410, 510, 610, 710 which is formed from one or more walls 15, 115, 515, 615, 715 may further allow for the receptacle 10, 110, 210, 310, 410, 510, 610, 710 to better conform to complex tissue areas due to less constraint by any outer seams formed in the joining of the walls 15, 115, 515, 615, 715, and/or less constraint caused by an adhesive holding the receptacle in place, when compared with a smaller receptacle.
  • the receptacle 10, 110, 210, 310, 410, 510, 610, 710 may have improved contact with a tissue area when compared to a smaller receptacle 10, 110, 210, 310, 410, 510, 610, 710 as it is better able to conform to the shape and/or geometry of the tissue area while aso allowing a greater degree of manipulation to conform to the tissue area during positioning of the receptacle 10, 110, 210, 310, 410, 510, 610, 710.
  • the fluid source 40 may be controlled to maintain a set pressure in the receptacle 10, 110, 210, 210A, 310, 410, 510, 610, 710. That is, the controller may compensate over time for loss of fluid from the receptacle 10, 110, 210, 210A, 310, 410, 510, 610, 710 due to e.g.
  • Figures 36 to 39 show further embodiments of the apparatus 100 having a pressure regulator associated with the fluid outlet 53.
  • the features of the apparatus of any one of the embodiments of Figures 1 to 35 A may feature also in the embodiment of Figs. 36 to 39.
  • the embodiments of Figures 36 to 39 may assist in achieving a substantially consistent concentration of the fluid within the receptacle 10, for example an oxygen concentration within the receptacle 10, by facilitating the cycling of the fluid through the receptacle 10.
  • the fluid inlet conduit 50 has a fluid inlet 55 that is positioned at an end of the fluid inlet conduit 50 that is distal from the receptacle 10.
  • the first fluid outlet conduit 52 of the receptacle 10 has a fluid outlet 53 that is positioned at an end of the first fluid outlet conduit 52 that is distal from the receptacle 10.
  • the fluid inlet 55 and the fluid outlet 53 each provide fluid communication with the receptacle 10, via the fluid inlet conduit 50 and the first fluid outlet conduit 52, respectively, and may comprise a port, connector, or other fitting.
  • a fluid flow path through the receptacle 10 may be defined by the one or more walls of the receptacle 10, the fluid inlet 55 and the fluid outlet 53.
  • a boundary of the fluid flow path through the receptacle 10 may be independent of the tissue of the patient. That is, the tissue of the patient does not form part of the fluid flow path through the receptacle 10. Whether the wall 15 of the receptacle 10 allows molecules within the fluid inside the receptacle 10 to diffuse through the wall 15 to the wound 22, or to pass from the receptacle 10 to the wound 22 via pore flow, the wall 15 is present between the fluid and the wound 22 as the fluid is delivered to the receptacle 10.
  • a pressure regulator in the form of a pressure relief valve 170 is associated with, that is, disposed at the fluid outlet 53. The pressure regulator is disposed in fluid communication with the fluid outlet 53 and thus also with the receptacle 10.
  • the pressure regulator for example the pressure relief valve 170, may be operable to relieve pressure within the fluid outlet 53 and/or the receptacle 10.
  • the pressure relief valve 170 may be positioned in spaced relation from, that is, at a distance away from the receptacle 10, e.g. at the fluid outlet 53 that allows the pressure relief valve 170 to be moved relative to the receptacle 10.
  • the first fluid outlet conduit 52 may have a length, at the distal end of which is the fluid outlet 53.
  • the pressure relief valve 170 may be positioned on the first fluid outlet conduit 52 at the fluid outlet 53, distally from the receptacle 10, which allows it to be positioned outside of any cover 30 As such, the fluid inlet conduit 50 or the first fluid outlet conduit, with the fluid outlet 53 and the pressure relief valve 170, can be moved for ease of wrapping a bandage or other dressing over the receptacle 10.
  • the arrangement allows a cover 30 in the form of a bandage or other dressing to be wrapped over the receptacle 10 without having to also wrap the bandage around the additional bulk of a pressure relief valve 170 or other pressure regulator. As shown in Fig. 36, the pressure relief valve 170 is placed outside of the cover 30.
  • the pressure relief valve 170 may be placed close to, or even in contact with, the receptacle 10.
  • the first fluid outlet conduit 52 may be omitted.
  • the pressure relief valve 170 may be integral with or connected to the receptacle 10.
  • a cover 30 in the form of a bandage or other dressing may be wrapped over the receptacle 10 and the pressure relief valve 170.
  • the cover 30 may comprise a compression bandage wrapped over the receptacle 10, and an outer dressing wrapped over the compression bandage.
  • the pressure relief valve 170 may be placed outside of the compression bandage and under the outer dressing.
  • the receptacle 10 may be maintained at a positive pressure (e.g. the receptacle 10 may be inflated) to encourage molecules within the fluid inside the receptacle 10 to diffuse through the membrane of the receptacle 10 to the wound 22 by generating a pressure gradient across the membrane.
  • the apparatus 100 may be set up so that a constant, low flow of fluid enters the receptacle 10 via the fluid inlet conduit 50.
  • the constant fluid flow in through the fluid inlet 55 also means that there must be a regular fluid flow out through the fluid outlet 53 as the rate of diffusion through the membrane is not high enough to empty the receptacle 10 of all of the fluid entering the receptacle 10 at the fluid inlet 55.
  • the regular fluid flow out through the fluid outlet 53 may not necessarily be constant due to operation of the pressure relief valve 170.
  • the constant or regular flow of fluid in and out of the receptacle 10 cycles the fluid through the receptacle 10 so that the fluid, e.g. oxygen, within the receptacle 10 is maintained at a high concentration. If there was no cycling of the fluid, the fluid in the receptacle 10 could be diluted by other fluids, e.g. nitrogen, that may diffuse in to the receptacle 10 through the membrane from the outside.
  • the fluid e.g. oxygen
  • the pressure regulator on the fluid outlet 53 is important to the cycling process, as it allows cycling of the fluid to be achieved in a controlled manner.
  • the pressure regulator may be configured to ensure cycling does not occur at too high a rate that may lead to wasted fluid, e.g. oxygen, in addition to maintaining a positive pressure within the receptacle 10 as described above.
  • the pressure relief valve 170 is configurable to relieve pressure within the receptacle 10 when the pressure within the receptacle 10 reaches a threshold value.
  • the pressure relief valve 170 may be configurable to adjust the pressure threshold value.
  • the pressure threshold value may be an upper pressure bound, above which the pressure relief valve is to open.
  • cycling of the fluid through the receptacle 10 may only occur if the upper bound is exceeded, therefore a positive pressure may be maintained within the receptacle, providing a pressure gradient between the receptacle 10 and the wound 22.
  • This pressure gradient may aid with diffusion of molecules within the fluid across the membrane from a high pressure side (within the receptacle 10) to a low pressure side outside of the receptacle 10, e.g. at the wound 22. That is, if the pressure gradient results in a high partial pressure of fluid, e.g. oxygen, within the receptacle 10 and a low partial pressure of fluid, e.g.
  • the pressure gradient may drive diffusion of molecules within the oxygen across the membrane to the wound 22.
  • a high partial pressure of nitrogen outside of the receptacle 10 and a low partial pressure of nitrogen within the receptacle 10 may cause nitrogen to diffuse into the receptacle 10 as discussed above, hence cycling of fluid through the receptacle 10 helps to maintain a high concentration of oxygen within the receptacle 10.
  • the purpose of the cycling is to regularly refresh the fluid within the receptacle 10 with fluid of a high oxygen concentration by cycling out fluid already within the receptacle 10 including any other fluids such as nitrogen, so that more of the high oxygen concentration fluid reaches the wound 22.
  • the pressure relief valve 170 may comprise any suitable type of valve such as a spring-loaded check valve with a disc, a spring-loaded check valve with a ball, a diaphragm valve, a lift valve, a butterfly valve or a duckbill valve. Each of these valve types may be set to permit fluid to pass through the pressure relief valve 170 and out of the fluid outlet 53 when a threshold fluid pressure is reached upstream of the pressure relief valve 170.
  • the pressure relief valve 170 may be selectively actuable to an at least partially open position to permit fluid to pass therethrough, and is configured, when in the at least partially open position, to vent the fluid passing there through to the atmosphere, via the fluid outlet 53.
  • the pressure relief valve 170 may be either open or closed, however the pressure relief valve 170 valve may also include at least one partially open position between the open and closed positions.
  • the open position may correspond to a threshold fluid pressure at which the pressure relief valve 170 opens.
  • the at least one partially open position may correspond to at least one other threshold fluid pressure at which the pressure relief valve 170 partially opens.
  • the pressure relief valve 170 may be passively actuated, or it may be actively actuated. Where the pressure relief valve 170 is actively actuated, a sensor, for example a pressure sensor or a flow sensor, may be disposed to sense a parameter of the fluid from which a fluid pressure can be determined. A controller is disposed in communication with the sensor. The fluid pressure may be provided to the controller. The controller may be configured to control the pressure relief valve 170 such that if the pressure sensor detects a fluid pressure that is greater than or equal to one of the threshold fluid pressures, the pressure relief valve 170 will open to the open position or to the at least one partially open position.
  • a sensor for example a pressure sensor or a flow sensor
  • Fig. 37 shows a variation of the embodiment of Fig. 36 in which the cover 30 is not present such that there is no compartment 35.
  • the pressure relief valve 170 is positioned at the fluid outlet 53 of the first fluid outlet conduit 52, in fluid communication with the receptacle 10 as in the embodiment of Figure 36.
  • Figure 38 shows a variation of the embodiment of Figure 37 in which a wall 15 has a first layer and a second layer.
  • the second layer of the wall 15 of the receptacle 10 faces away from the wound 22 and is made of a material having a thickness that is greater than a thickness of a first layer of the wall 15 that faces toward the wound 22.
  • the thicker material may reduce the loss of fluid through areas of the wall 15 that do not face the wound 22 and may result in an increase in efficiency of the apparatus 100.
  • the first layer of the wall 15 of the receptacle 10 may have the wall thickness as described above for the receptacle 10; that is between about 10 micrometres and about 150 micrometres, for example between approximately 20 micrometres and 140 micrometres, or between approximately 20 micrometres and 90 micrometres, or between approximately 30 micrometres and 130 micrometres, or between approximately 35 micrometres and 100 micrometres, or between approximately 40 micrometres and 80 micrometres, or between approximately 40 micrometres to 70 micrometres, or between approximately 50 micrometres to 70 micrometres, or between approximately 30 micrometres to 60 micrometres, or between approximately 20 to 60 micrometres, or between approximately 45 micrometres and 55 micrometres.
  • the first layer of the wall 15 may have a wall thickness of approximately 60 micrometres. In some embodiments, the first layer of the wall 15 may have a wall thickness of approximately 50 micrometres.
  • the second layer of the wall 15 may have a wall thickness of between about 75 micrometres and about 1 mm, for example between approximately 80 micrometres and 800 micrometres, or between approximately 85 micrometres and 600 micrometres, or between approximately 90 micrometres and 400 micrometres, or between approximately 95 micrometres and 300 micrometres, or between approximately 100 micrometres and 200 micrometres, or between approximately 125 micrometres and 175 micrometres, or between approximately 100 micrometres and 250 micrometres. In some embodiments, the wall thickness is approximately 160 micrometres.
  • the wall thickness is approximately 150 micrometres.
  • the wall thickness may be greater than 1 mm provided that the second layer remains flexible such that the apparatus 100 inflates and conforms to the underlying patient tissue at the wound 22.
  • the thicker material of the second layer of the wall 15 may be used with any one of the embodiments of the receptacle 10, 110, 210 310, 410, 510, 610, 710 disclosed herein and this disclosure extends also to those embodiments.
  • the pressure regulator of Figure 36 to Figure 38 is described in the form of a pressure relief valve 170, the pressure regulator may take other forms to achieve a positive pressure within the receptacle 10. Whilst the pressure regulator is described here with respect to the receptacle 10, it will be apparent to the skilled person that tthe following applies to all embodiments of the disclosure that include a pressure regulator for regulating fluid pressure within the receptacle 110, 10, including where a pressure regulator is used with the receptacles 210, 210A, 310, 410, 510, 610, 710.
  • the pressure regulator, including the pressure relief valve 170 may be passively and/or mechanically actuable to permit fluid to pass therethrough, i.e. the pressure regulator is not powered.
  • Alternative pressure regulators to the pressure relief valve 170 may include, for example, that the first fluid outlet conduit 52 may have a small internal diameter and/or a long length that would generate a large resistance to fluid flow exiting the receptacle 10 and a resultant positive pressure in the receptacle 10.
  • the length and the internal diameter of the first fluid outlet conduit 52 will be determined based on the target fluid pressure in the receptacle 10. The skilled person in the art would know to vary the length and/or the internal diameter in order to achieve a target pressure.
  • a series of baffles or changes of direction of the first fluid outlet conduit 52 may be used to form a tortuous section of flow path within the first fluid outlet conduit 52 to generate a large resistance to fluid flow, resulting in a positive pressure in the receptacle 10.
  • the tortuous section could be formed in a block of material or by manipulating the shape of the first fluid outlet conduit 52.
  • a further alternative is to utilise a Tesla valve in the flow outlet conduit 52 to generate a large resistance to fluid flow within the first fluid outlet conduit 52.
  • a calibrated leak orifice similar to the calibrated leak orifice 74 seen in Figure 8 may be used at the fluid outlet 53 to permit a specified leak, which may result in a positive pressure in the receptacle 10.
  • the calibrated leak orifice may be calibrated to provide a leak out of the receptacle 10 that is small enough to maintain a positive pressure within the receptacle 10, but large enough to reduce the chance of pressure within the receptacle 10 becoming undesirably high.
  • Fig. 39 shows an embodiment of a receptacle 10 in which cycling of fluid within the receptacle 10 may be achieved by incorporating at least one aperture 120 in the second layer of the wall 15, that are configured to permit fluid within the receptacle 10 to pass therethrough to exit the receptacle 10.
  • the at least one aperture 120 may comprise a plurality of apertures. The size and/or number of the at least one aperture 120 may be tailored to allow cycling of fluid from within the receptacle 10 to the atmosphere whilst providing enough resistance to fluid flow to achieve a positive pressure in the receptacle 10.
  • the at least one aperture 120 may also help to prevent the pressure within the receptacle 10 from becoming too high and to relieve pressure within the receptacle 10 during use of the apparatus.
  • the at least one aperture 120 may be used where the apparatus does not include a compartment 35.
  • the at least one aperture 120 functions most effectively in the absence of a negative pressure compartment.
  • the at least one aperture 120 may be used instead of the first fluid outlet conduit 52.
  • the at least one aperture 120 may have a border of thicker material to prevent tearing and to maintain the integrity of the material of the second layer surrounding the at least one aperture 120.
  • the border of thicker material may comprise a ring of raised material surrounding the at least one aperture 120 and the border of thicker material may be of any reasonable cross-sectional shape, for example a semi-oval shape, or a rounded rectangular shape or a semi-octagonal shape.
  • the border of thicker material surrounding the at least one aperture 120 may improve the structural integrity of the material of the second layer surrounding the at least one aperture 120 and help to prevent any tear in the at least one aperture 120 from propagating beyond the border.
  • pressure relief valve 170 or other pressure regulator or calibrated leak orifice or the at least one aperture 120 are described with reference to the receptacle 10, any of them may apply also to any of the receptacles 110, 210, 210A, 310, 410, 510, 610, 710 described in this disclosure.
  • Figures 40 to 44 show an embodiment of a receptacle that is similar to the receptacle 110 of Figure 26, and like features are given like reference numbers.
  • the receptacle 110 has a longitudinal axis X-X that extends through the head portion 93 and the tail portion 90 of the receptacle 110.
  • an internal flow guide 140 in the form of an internal wall.
  • the internal wall extends along the longitudinal axis X-X to form two compartments, one either side of the internal wall.
  • the compartments are arranged in a layered or stacked configuration with a first wall portion of the wall 115 (a lower portion of the wall as viewed in Figure 40) and a second wall portion of the wall 115 (an upper portion of the wall as viewed in Figure 40) of the receptacle 110.
  • the internal flow guide 140 has a first flow guide surface 142 that is configured to face the wound 22 and/or healthy skin 24 surrounding the wound 22 during use, and a second flow guide surface 144 that opposes the first flow guide surface 142 and faces away from the wound 22 and/or healthy skin 24 surrounding the wound during use.
  • a layered or stacked configuration of the compartments refers to a first compartment formed between the first wall portion and the first flow guide surface 142 of the internal flow guide 140 and a second compartment formed between the second flow guide surface 144 and the second wall portion of the wall 115.
  • the internal flow guide 140 of Figure 40 extends along the longitudinal axis X-X, in an alternative embodiment it may extend parallel to the longitudinal axis X-X so as to be offset from it. In such an embodiment, the internal flow guide 140 divides the receptacle 110 into two compartments of different sizes.
  • the first wall portion and the second wall portion of the wall 115 are flexible such that, prior to use, the internal flow guide 140 may lie substantially parallel with the first wall portion and the second wall portion of the wall 115 of the receptacle 110, however, in use, of the receptacle 110, the first wall portion and the second wall portion of the wall 115 may be contorted or bent to accommodate a complex wound shape or to fit onto a contoured part of the body, for example, a heel or knee.
  • the internal flow guide 140 extends across the full lateral extent of the receptacle and may be sealed at its periphery to the one or more walls 115 of the receptacle 110.
  • the internal flow guide 140 has a circulation opening 145 towards an end of the internal flow guide 140 that is positioned in the head portion 93 of the receptacle 110.
  • the circulation opening 145 provides a fluid pathway through the receptacle 110 and between the two compartments, as will be described further.
  • the receptacle 110 has a fluid inlet conduit 50 and a first fluid outlet conduit 52, each of which passes through the pressure spreading device 95 and through which fluid respectively enters and exits the receptacle 110.
  • the fluid inlet conduit 50 and the first fluid outlet conduit 52 pass directly into the one or more walls 15, 115 of the receptacle 10.
  • the fluid inlet conduit 50 is shown beneath the first fluid outlet conduit 52, however the converse arrangement may also be used where the fluid inlet conduit 50 is above the first fluid outlet conduit 52.
  • the fluid inlet conduit 50 and the first fluid outlet conduit 52 may also be disposed side by side, as will be described with respect to Figure 50(a) and 50(b).
  • the fluid outlet 53 has a pressure regulator such as a pressure relief valve 170 disposed on it for relieving pressure inside the receptacle 110.
  • the one or more walls 115, the fluid inlet 55, the fluid outlet 53 and the internal flow guide 140 are configured to define a fluid flow path through the receptacle 110 that extends from the fluid inlet 55, past at least a portion of the internal flow guide 140, and out of the fluid outlet 53.
  • fluid enters the receptacle 110 via the fluid inlet 55 of the fluid inlet conduit 50, and flows along the part of the fluid flow path defined by the major portion of the first flow guide surface 142 that lies upstream of the circulation opening 145 and the first wall portion of the wall 115, through the circulation opening 145 and along the part of the fluid flow path defined by the major part of the second flow guide surface 144 and out of the fluid outlet 53 of the first fluid outlet conduit 52 via the pressure relief valve 170 (or other pressure regulator as described above).
  • the pressure relief valve 170 or other pressure regulator as described above.
  • the internal flow guide 140 may prolong a residence time in which fluid entering the fluid inlet 55 spends within the receptacle 110 prior to exiting the receptacle 110 through the fluid outlet 53, relative to a receptacle 110 that does not include an internal flow guide 140.
  • the internal flow guide 140 effectively divides the receptacle 110 into first and second compartments that are fluidly connected by the circulation opening 145.
  • the internal flow guide 140 may permit molecules within the fluid within the receptacle 110 to pass through it and may be made of the same material as the one or more walls 115 of the receptacle 110. However, the internal flow guide 140 may be made of a different material and that material may not allow molecules within the fluid within the receptacle 110 to pass through it.
  • the fluid inlet conduit 50 and the first fluid outlet conduit 52 are disposed at the same end of the receptacle 110.
  • This arrangement is advantageous in that it facilitates ease of handling a dressing, for example a bandage, and the fluid inlet conduit 50, first fluid outlet conduit 52, and any further tubes that are connected to them, during application of the dressing over a wound 22.
  • the fluid inlet conduit 50 and the first fluid outlet conduit 52 may be handled in one hand as the receptacle 110 is applied onto the wound 22, leaving the other hand free to apply a dressing or to wind the bandage over the receptacle 110 and the fluid inlet conduit 50 and first fluid outlet conduit 52, and around a limb or other body part having the wound 22.
  • the fluid inlet conduit 50 and the first fluid outlet conduit 52 are disposed at the same end of the receptacle 110, the fluid inlet conduit 50 and the first fluid outlet conduit 52 can be managed together, minimising the possibility of causing such discomfort.
  • This aspect of the receptacle 110 applies also to the embodiment of the receptacle 10 shown in Figure 16b, described above, in which the fluid inlet conduit 50, first fluid outlet conduit 52 and the second fluid outlet conduit 54 are arranged adjacent one another at the same section of the receptacle 10.
  • the arrangement also encourages an even dispersal of fluid through the receptacle 110, as fluid must travel from the fluid inlet 55 of the fluid inlet conduit 50, along a majority of the length of the receptacle 110, through the circulation opening 145 and back along the majority of the length of the receptacle 110 before it may exit the fluid outlet 53 and via the first fluid outlet conduit 52.
  • the description simply refers to the orientation of the receptacle as it is shown in Figure 40.
  • the receptacle 110 may equally be used in an orientation in which the the first flow guide surface 142 is configured to face away from the wound 22 and/or healthy tissue skin 24 surrounding the wound 22 during use, and the second flow guide surface 144 opposing the first flow guide surface 142 faces the wound 22 and/or healthy skin 24 surrounding the wound.
  • the one or more walls 115 of the receptacle 110 may also have the same properties regardless of orientation of the receptacle 110.
  • the receptacle 110 may accordingly be used in either orientation in use, making the receptacle 110 user friendly.
  • the features of the internal flow guide 140 are described with reference to the receptacle 10, it will be apparent that one or more of the features of the internal flow guide 140 may appy to any of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 described in this disclosure.
  • the circulation opening 145 of the internal flow guide 140 is shown in plan view in Figure 41.
  • it has an oval shape, however it may have any reasonable shape such as a circle, rectangle or slit.
  • the circulation opening 145 is shaped as a slot. It may have a width dimension that is sufficiently large to allow fluid to pass through it across a significant portion of the interior width of the receptacle 110, across the plurality of ridges 96.
  • a width dimension of the circulation opening 145 may be between 5% and 95% of an interior width of the receptacle 110 when not inflated.
  • the width of the circulation opening 145 may be between 15% and 85% or between 25% and 75% or between 30% and 60% of the interior width of the receptacle 110 when not inflated.
  • the circulation opening 145 may be positioned at an end of the receptacle 110 that is distal from the fluid inlet conduit 50 and the first fluid outlet conduit 52 as shown in Figure 41.
  • the circulation opening 145 may be surrounded by an opening surround 148, as seen in Figure 42.
  • Figure 42 is an enlarged plan view of the circulation opening 145 and its opening surround 148.
  • the opening surround 148 may comprise a ring of raised material, such as a rib.
  • the raised material may rise from one of the first flow guide surface 142 or the second flow guide surface 144 or both of the first flow guide surface 142 and the second flow guide surface 144.
  • the ring of raised material may have any reasonable cross-sectional shape. Examples of possible cross-sectional shapes of the ring of raised material are shown in Figure 43.
  • the ring of raised material of the opening surround 148 has a shallow semi -oval cross- sectional shape.
  • the ring of raised material of the opening surround 148 has a deeper ovoid cross-sectional shape.
  • the ring of raised material of the opening surround 148 has a rounded rectangular cross- sectional shape.
  • the rounded rectangular cross-sectional shape is easy to manufacture and does not have any sharp comers that may cause discomfort to the patient.
  • the ring of raised material of the opening surround 148 has a semi-octagonal cross-sectional shape.
  • a variation of this embodiment may have rounded comers rather than the sharp comers shown in Figure 43 (iv).
  • the opening surround 148 may improve the structural integrity of the material surrounding the circulation opening 145 and help to prevent any tear in the internal flow guide 140 at the circulation opening 145 from propagating too far and substantially increasing the size of the circulation opening 145.
  • Figure 43 A to Figure 43 C illustrate how the ridges 96 of the first wall portion and/or the second wall portion of the wall 115 may overlap the opening surround 148.
  • the ridges 96 may alternatively or additionally be present on the first flow guide surface 142 and/or the second flow guide surface 144 of the internal flow guide 140.
  • the overlapping of the ridges 96 with the opening surround 148 helps to maintain the fluid flow path inside the receptacle 10, 110, 210, 210A, 310, 410, 510, 610 and fluid may flow along the side of the ridges 96 as described above and over the opening surround 148 into the circulation opening 145.
  • the ridges 96 are shown on the second wall portion of the wall 115.
  • the microstructures 60 are also visible on the second wall portion of the wall 115.
  • the opening surround 148 on the second flow guide surface 144 of the internal flow guide 140 is shown overlapping with some of the ridges 96.
  • Figure 43C is a view of the circulation opening 145, opening surround 148 and ridge 96 of Figure 43B and illustrates clearly how the ridge 96 overlaps the opening surround 148 at two points, either side of the circulation opening 145.
  • the opening surround 148 may have one or more gaps or discontinuities 149 as shown in Figure 43D to Figure 43F.
  • the opening surround 148 may assist fluid within the receptacle 10,110, 210, 210A, 310, 410, 510, 610, 710 to flow past the opening surround 148 and through the circulation opening 145.
  • the opening surround 148 may include a plurality of the gaps 149.
  • the gaps 149 may be evenly spaced around the opening surround 148 as shown in Figures 43D and 43E or they may be unevenly spaced. At least some of the gaps
  • some of the ridges 96 of the first wall portion and/or the second wall portion of the wall 115 may terminate at the gaps 149 or at the opening surround 148.
  • some of the ridges 96 may terminate at the circulation opening 145.
  • Some of the ridges 96 may pass through the gaps 149 and continue to the opposite side of the circulation opening 145 and/or may pass through a gap 149 on the opposite side of the opening surround 148. Ridges 96 that pass through gaps 149 in the opening surround 148 may be less prone to creating a pressure point on the tissue of the patient in use.
  • the ridges 96 in the vicinity of any one circulation opening 145 may include a mix of termination points as shown in the example of Figure 43E.
  • Figure 43F shows an embodiment of an an opening surround 148 that comprises only sections at the extremities of the circulation opening 145, where the corners are sharp.
  • the sections of the opening surround 148 assist in preventing tears in the material of the internal flow guide 140 at the sharp corners of the circulation opening 145 from propagating through the internal flow guide 140.
  • one or more of the ridges 96 may extend over the circulation opening 145.
  • the internal flow guide 140 may include more than one of the circulation openings 145. Having more than one circulation opening 145 can be beneficial in the event that one of the circulation openings 145 becomes blocked, fluid is still able to pass through another circulation opening 145 to reach the fluid outlet 53.
  • the internal flow guide 140 may include a section that is porous such that it provides a flow path through which fluid may flow. The porous section may be distal from the fluid inlet conduit 50.
  • Figures 44a and 44b show how the fluid inlet conduit 50 and the first fluid outlet conduit 52 attach to the tail portion 90 of the receptacle 110. As shown in Figures 40 to 43, the fluid inlet conduit 50 and the first fluid outlet conduit 52 are encapsulated in the pressure spreading device 95 and extend into the tail portion 90 of the receptacle. Figures 44a and 44b show further detail of the termination of the fluid inlet conduit 50 and the first fluid outlet conduit 52 at the tail portion 90. The ends of the fluid inlet conduit 50 and the first fluid outlet conduit 52 respectively pass through the first wall portion and the second wall portion of the wall 115 of the receptacle 110 and into the interior of the receptacle 110.
  • the ends of the fluid inlet conduit 50 and the first fluid outlet conduit 52 are integrally formed, for example moulded, into the first wall portion and the second wall portion of the at least one wall 115 of the receptacle 110 such that an outlet 57 of the fluid inlet conduit 50 and an inlet 58 of the first fluid outlet conduit 52 are disposed inside the tail portion 90 of the receptacle 110.
  • the outlet 57 and the inlet 58 may take the form of a port, or an end of a fluid inlet conduit or first fluid outlet conduit that protrudes into the tail portion 90 of the receptacle 110.
  • the outlet 57 and the inlet 58 may each comprise of an opening that allows delivery of the fluid from the fluid inlet conduit 50 to the receptacle 110, or from the receptacle 110 to the first fluid outlet conduit 52, by maintaining fluid communication between the receptacle 110 and the respective one of the fluid inlet conduit 50 and the first fluid outlet conduit 52.
  • fluid is supplied to the receptacle 110 via the outlet 57 of the fluid inlet conduit 50 and fluid exits the receptacle 110 through the inlet 58 of the first fluid outlet conduit 52.
  • This attachment of the fluid inlet conduit 50 and the first fluid outlet conduit 52 to the receptacle 110 may apply to all embodiments of the receptacle 110 disclosed herein.
  • the fluid inlet conduit 50 and the first fluid outlet conduit 52 may be integrally formed with and pass directly through the first wall portion and the second wall portion of the one or more walls 15 such that their ends extend into the interior of the receptacle 10, 110, 210, 210A, 310, 410, 510, 610, 710. For example, they may be moulded into the one or more walls 15.
  • the fluid inlet conduit 50 and the first fluid outlet conduit 52 may terminate within the pressure spreading device 95 and do not pass through the one or more walls 15 and into the receptacle 10.
  • a pressure regulator such as a pressure relief valve 170 may be added to the fluid inlet 55 of the fluid inlet conduit 50, either in addition to or instead of at the fluid outlet 53.
  • the embodiment of the apparatus of Figures 40 to 44 may be used with or without the cover 30, which if used may form a compartment 35 which can be a negative pressure compartment or it may comprise a bandage or compression bandage.
  • Figure 45 and Figure 46 show a variation of the embodiment of Figures 41 to 44 in which the circulation opening 145 is replaced with an opening that takes the form of a larger circulation opening or gap 145A.
  • the internal flow guide 140A does not extend the entire longitudinal axis X-X of the receptacle 110, but extends through the tail portion 90 and part way into the head portion 93 where it terminates.
  • the circulation gap 145A spans the distance between an end 141 A of the internal flow guide 140A and the wall 115 of the receptacle 110 at the head portion 93 of the receptacle 110. This embodiment has the benefit of ease of manufacture.
  • the internal flow guide 140 A has a first flow guide surface 142A that is configured to face the wound 22 and/or healthy skin 24 surrounding the wound 22 during use, and a second flow guide surface 144 A that opposes the first flow guide surface 142 A and faces away from the wound 22 and/or healthy tissue skin 24 surrounding the wound 22 during use.
  • the internal flow guide 140A may lie substantially parallel with the first wall portion and the second wall portion of the wall 115 of the receptacle 110.
  • the first wall portion and the second wall portion of the wall 115 is flexible and may be contorted or bent to accommodate a complex wound shape or to fit onto a contoured part of the body, for example a heel or a knee.
  • the internal flow guide 140A effectively divides the receptacle 110 into first and second compartments that are fluidly connected by the circulation gap 145A.
  • fluid enters the receptacle 110 via the fluid inlet 55 of the fluid inlet conduit 50, and flows along the part of the fluid flow path defined by the first flow guide surface 142 A that lies upstream of the circulation gap 145 A and the first wall portion of the wall 115, through the circulation gap 145 A and along the part of the fluid flow path defined by the part of the second flow guide surface 144A and out of the fluid outlet 53 of the first fluid outlet conduit 52 via the pressure relief valve 170 (or other pressure regulator as described above).
  • the fluid inlet conduit 50 and the first fluid outlet conduit 52 are disposed at the same end of the receptacle 110.
  • This arrangement is advantageous in that it facilitates ease of handling a dressing, for example a bandage, and the fluid inlet conduit 50, fluid outlet conduit 52, and any further tubes that are connected to them, during application of the dressing over the wound, as in the embodiment of Figure 41.
  • the arrangement also encourages an even dispersal of fluid through the receptacle 110, as fluid must travel from the fluid inlet 55 of the fluid inlet conduit 50, along a majority of the length of the receptacle 110, through the circulation gap 145A and back along the majority of the length of the receptacle 110 before it may exit the fluid outlet 53 via the first fluid outlet conduit 52.
  • the features of the internal flow guide 140A are described with reference to the receptacle 110, it will be apparent that one or more of the features of the internal flow guide 140 A may apply to any of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 described in this disclosure.
  • Figure 47 shows a plan view of a receptacle 110 that has a longitudinal axis X-X that extends through the head portion 93 and the tail portion 90 of the receptacle 110.
  • Figure 48 is a cross-sectional side view of the receptacle 110.
  • an internal flow guide 140B (best seen in Figure 47) in the form of an internal wall extends along the longitudinal axis X-X so as to extend between the first wall portion and the second wall portion of the wall 115 of the receptacle 110.
  • the internal flow guide 140B is arranged to form side by side compartments within the receptacle 110 rather than upper and lower compartments and bisects the first wall portion and the second wall portion of the wall 115 at its upper and lower bounds, respectively. That is, the internal flow guide 140B has an upper edge that adjoins the second wall portion of the wall 115 of the receptacle 110 and a lower edge that adjoins a first wall portion of the wall 115 of the receptacle 110 during use.
  • the internal flow guide 140B has a first flow guide surface 142B and a second flow guide surface 144B that opposes the first flow guide surface 142B.
  • a portion of the first wall portion of the wall 115 of the receptacle 110 that faces and may come into contact with the tissue of the patient during use is a tissue facing portion of the first wall portion of the wall 115, and is disposed adjacent both the first flow guide surface 142B and the second flow guide surface 144B such that fluid flowing through the receptacle 110 passes the first wall portion of the wall 115 as it passes the first flow guide surface 142B and also the second flow guide surface 144B.
  • the internal flow guide 140B may bisect the first wall portion of the wall 115 into two equal portions, or alternatively the internal flow guide 140B may be disposed parallel to the longitudinal axis X-X so that it is offset from it and thus divides the first wall portion of the wall 115 into two compartments, wherein the compartments are different sizes.
  • the internal flow guide 140B may also be disposed at an angle to the longitudinal axis X-X such that the two compartments are not symmetrical about the longitudinal axis X-X.
  • the internal flow guide 140B has a circulation opening 145B that is the same as the circulation opening 145.
  • the circulation opening 145B is positioned towards an end of the internal flow guide 140B that is positioned in the head portion 93 of the receptacle 110.
  • the circulation opening 145B provides a fluid pathway through the receptacle 110 in the same manner as the circulation opening 145.
  • the receptacle 110 has a fluid inlet conduit 50 and a first fluid outlet conduit 52, each of which passes through the pressure spreading device 95 and through which fluid respectively enters and exits the receptacle 110.
  • the fluid inlet conduit 50 is shown adjacent the first fluid outlet conduit 52 such that they lie side by side.
  • the first fluid outlet conduit 52 may have a pressure regulator such as pressure relief valve 170 disposed on it for relieving pressure inside the receptacle 110.
  • the internal flow guide 140B effectively divides the receptacle 110 into first and second compartments that are disposed side by side and that are fluidly connected by the circulation opening 145B.
  • fluid enters the receptacle 110 via the fluid inlet 55 of the fluid inlet conduit 50, and flows along the part of the fluid flow path defined by the first flow guide surface 142B that lies upstream of the circulation opening 145B and the first wall portion and second wall portion of the wall 115 of the receptacle 110, through the circulation opening 145B and along the part of the fluid flow path defined by the major part of the second flow guide surface 144B and the first wall portion and the second wall portion of the wall 115 out of the fluid outlet 53 of the first fluid outlet conduit 52 via the pressure relief valve 170 (or other pressure regulator as described above).
  • the features of the internal flow guide 140B are described with reference to the receptacle 110, it will be apparent that one or more of the features of the internal flow guide 140B may apply to any of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 described in this disclosure.
  • the fluid flow path extends past the first wall portion of the wall 115 of the receptacle 110 both upon entering the receptacle 110 and when exiting it, which may result in prolonging a period of time that the fluid within the receptacle 110 spends adjacent the membrane of the wall 115 receptacle 110.
  • the internal flow guide 140, 140 A, MOB prevents fluid entering the receptacle 110 from simply exiting through the fluid outlet 53 before it has travelled over a significant portion of the internal wall area, thereby allowing fluid to diffuse through a significant portion of the membrane of the wall 115 to more of the wound area 20.
  • the receptacle 110 may have no internal flow guide 140, 140 A, MOB as shown in the embodiment of Figure
  • the fluid inlet conduit 50 and the first fluid outlet conduit 52 are disposed at the same end of the receptacle 110. This arrangement allows ease of handling the fluid inlet conduit 50 and the first fluid outlet conduit 52 and of applying a dressing over the fluid inlet conduit 50, the first fluid outlet conduit 52, and any further tubes that are connected to them, as with the embodiments of Figures 40 to 48.
  • a pressure regulator such as a pressure relief valve 170 is disposed at the fluid outlet 53 for relieving pressure within the receptacle 110 as has been described in relation to the embodiments of Figures 36 to 39.
  • Figure 50(a) and Figure 50(b) show an example of a receptacle 110 that is similar to that of the embodiment of Figures 40 to 44, and which has an internal flow guide 140 configured in a layered or stacked configuration.
  • the fluid inlet conduit 50 and the first fluid outlet conduit 52 are arranged in a side by side configuration such that the outlet 57 of the fluid inlet conduit 50 and the inlet 58 of the first fluid outlet conduit 52 lie side by side within the interior of the receptacle 110 and/or within the pressure spreading device 95.
  • the internal flow guide 140 separates the outlet 57 from the inlet 58.
  • this is achieved by positioning the internal flow guide 140 to lie underneath the inlet 58 of the fluid inlet conduit 52 and over the outlet 57 of the first fluid outlet conduit 50. However, it may also be achieved by positioning the internal flow guide 140 to lie over the inlet 58 and underneath the outlet 57.
  • the side by side arrangement of the fluid inlet conduit 50 and the first fluid outlet conduit 52 spreads the forces applied by the fluid inlet conduit 50 and the first fluid outlet conduit 52 on the tissue of the patient over a larger area of tissue than if they are arranged one on top of the other, and thus reduces the pressure applied to one portion of the tissue.
  • the overall pressure experienced by the patient from the fluid inlet conduit 50 and the first fluid outlet conduit 52 is reduced as it is spread over a wider area, which may result in a more comfortable experience for the patient.
  • the features of the internal flow guide 140 are described with reference to the receptacle 110, it will be apparent that one or more of the features of the internal flow guide 140 may apply to any of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 described in this disclosure.
  • the receptacle 110 may include a plurality of ridges as described in relation to Figures 31 to 34 above.
  • the disclosure in relation to the embodiments described in relation to Figures 31 to 34 applies also to the embodiments of Figures 41 to 49.
  • Figure 51(a) and Figure 51(b) each show a cross sectional view through the head portion 93, such as at line A-A of Figure 41, of an embodiment of the inside surface of at least one wall 115 of a receptacle 110.
  • the receptacle 110 includes the internal flow guide 140 of the embodiment of Figures 40 to 44, however it may equally be the internal flow guide 140A of Figures 45 and 46 or the internal flow guide 140B of the embodiments of Figures 47 and 48.
  • the inner surface of the wall 115 includes one or more small, soft, protruding ridges 196.
  • the ridges 196 have the same properties as the ridges 96 described in relation to Figures 31 to 34 above and the same disclosure applies.
  • the ridges 196 may be positioned on opposing inner surfaces of the first wall portion and second wall portion of of the one or more walls 115 as shown in Figure 51(a), such that when they are pressed together, the internal flow guide 140 opposing the ridge 196 drapes over the ridge 196, leaving gaps on either side of it in the manner described above in relation to Figure 3 lb.
  • the ridges 196 may be positioned on the first flow guide surface 142 and the second flow guide surface 144 of the internal flow guide 140 as shown in Figure 51(b). As the first wall portion and the second wall portion of the one or more walls 115 are pressed together, they will drape over the ridge 196 on the internal flow guide 140, leaving gaps either side of it.
  • a further alternative configuration is for the ridges 196 to be positioned on an inner surface of the first wall portion of the one or more walls 115 and on the first flow guide surface 142.
  • a yet further alternative configuration is for the ridges 196 to be positioned on an inner surface of the second wall portion of the one or more walls 115 and on the second flow guide surface 144.
  • the ridges 196 may be offset from one another on opposing first wall portion and second wall portion of the one or more walls 115 as shown in Figure 51(a) or on opposing first flow guide surfaces 142, and second flow guide surface 144 as shown in Figure 51(b). However, other arrangements of the ridges 196 may also be used. Each ridge 196 may have a height of between approximately 50 to 500 micrometres, for example 75 to 250 micrometres, for example 100 to 200 micrometres, for example between approximately 125 to 175 micrometres. An embodiment of the ridge has a height of 150 micrometres.
  • the height of the ridge 196 is a balance of the requirement for a taller ridge to help maintain a sufficient gap and thereby prevent blockage of the flow path, whilst avoiding an overly tall ridge that may cause indentation to the tissue of the patient and which may render the ridge susceptible to buckling.
  • Each ridge 196 may have a width of between approximately 50 to 500 micrometres, for example 100 to 400 micrometres, for example between approximately 250 to 350 micrometres, or between approximately 280 to 330 micrometres.
  • ridges 196 Whilst the features of the ridges 196 are described with reference to the receptacle 110, it will be apparent that one or more of the features of the ridges 196 may apply to any of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 described in this disclosure.
  • Figure 52 shows an embodiment of the receptacle 110 that is similar to the embodiment of Figure 40.
  • the receptacle 110 includes an internal flow guide 140C that is configured in the same way as the internal flow guide 140 and has a first flow guide surface 142C and an opposing second flow guide surface 144C.
  • the circulation opening 145C has a pressure regulator such as a pressure relief valve 170C disposed in it, such that fluid flowing through the flow path inside the receptacle 110 must pass through the pressure relief valve 170C before it can exit the receptacle 110 through the fluid outlet 53. Accordingly, there may be no pressure relief valve or other form of pressure regulator at the fluid outlet 53.
  • the pressure relief valve 170C may be used instead of (or in addition to) the pressure relief valve 170 also in the embodiment of Figures 47 and 48 in which the internal flow guide 140B is arranged to form side by side compartments within the receptacle rather the upper and lower compartments.
  • An alternative pressure regulation device such as any of the pressure regulators disclosed herein, may be used instead of the pressure relief valve 170C to achieve the same effect. Whilst the features of the internal flow guide 140C are described with reference to the receptacle 110, it will be apparent that one or more of the features of the internal flow guide 140C may apply to any of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 described in this disclosure.
  • the internal flow guides 140, MOB and 140C may each be roughened on either or both of the first flow guide surface 142, 142A, 142B, 142C, and the second flow guide surface 144, 144A, 144B, 144C.
  • the surface roughening may take the same form as is described in relation to the embodiment of the receptacle 310 shown in Figure 29 and Figure 30.
  • the roughened surface(s) of the internal flow guide 140, MOB, 140C may be in addition to, or instead of, roughening of the internal surface of the receptacle 110 in the manner described in relation to the embodiment of the receptacle 310 shown in Figure 29 and Figure 30.
  • the fluid inlet conduit 50 and the first fluid outlet conduit 52 can be encapsulated in the pressure spreading device 95 of the receptacle 110 so as to extend therefrom in the same direction, as further illustrated in Figure 52.
  • the fluid inlet conduit 50 and the first fluid outlet conduit 52 may be arranged to be disposed substantially adjacent one another.
  • “Substantially adjacent” may include that the fluid inlet conduit 50 and the first fluid outlet conduit 52 are disposed such that they may be joined together, but need not be joined together, or that a space between the fluid inlet conduit 50 and the first fluid outlet conduit 52 may be such that a user of the receptacle 110 can apply a bandage or other dressing over the receptacle 110 at the wound 22 with the one hand as explained earlier in this disclosure, whilst handling both of the fluid inlet conduit 50 and the first fluid outlet conduit 52 with the other hand.
  • a space between the fluid inlet conduit 50 and the first fluid outlet conduit 52 may be between approximately 0 mm to 20 mm, or between approximately 1 mm to 15 mm, or between approximately 1.5 mm to 10 mm, or between approximately 2 mm to 7 mm, or between approximately 2.5 mm to 5 mm, or between approximately 3 mm to 4 mm.
  • the user may typically wrap the dressing over the receptacle 10 from the ankle to the knee in one direction. Arranging the fluid inlet conduit 50 and the first fluid outlet conduit 52 substantially adjacent one another may help to prevent the possibility of one conduit becoming trapped beneath the compression dressing as the leg is being wrapped up, which could cause a pressure injury to the patient.
  • the space between the fluid inlet conduit 50 and the first fluid outlet conduit 52 may be large, e.g. greater than about 20 mm as long as the fluid inlet conduit 50 and first fluid outlet conduit 52 can be handled with one hand to allow the dressing to be applied in this manner.
  • at least an end portion 50A, 52A (shown in Figure 53) of each of the fluid inlet conduit 50 and the first fluid outlet conduit 52 that are closest to the pressure spreading device 95 may be arranged to protrude from the pressure spreading device 95 in a direction substantially aligned with the longitudinal axis of the receptacle 110, prior to use, as shown in Figure 53.
  • the end portions 50A, 52A of the fluid inlet conduit 50 and the first fluid outlet conduit 52 may be arranged substantially parallel with one another.
  • the fluid inlet conduit 50 and the first fluid outlet conduit 52 may be at least partially adjoined so as to extend from the receptacle 110 in a common direction.
  • the fluid inlet conduit 50 is encapsulated in a pressure spreading device 95 that is attached to the receptacle 110.
  • the fluid inlet conduit 50 and the first fluid outlet conduit 52 may be at least partially adjoined or held together with tape, ties, glue, and/or clips (not shown).
  • Such devices could be used to hold the fluid inlet conduit 50 and the first fluid outlet conduit 52 together at the end portions 50A, 52A that are closest to the receptacle 110, or over most of their length, or anything in between. However, in some embodiments, the end portions 50A, 52A of the fluid inlet conduit 50 and the first fluid outlet conduit 52 need not be held together.
  • At least partially adjoining or holding together the end portions 50A, 52A of the fluid inlet conduit 50 and the first fluid outlet conduit 52 may also allow application of a bandage or other dressing over the receptacle 110 and the fluid inlet conduit 50 and the first fluid outlet conduit 52 as described above, as the end portions 50A, 52A protrude from the pressure spreading device 95 parallel with one another.
  • the end portions 50A, 52A of the fluid inlet conduit 50 and first fluid outlet conduit 52 may be arranged to protrude from the pressure spreading device 95 such that there is a relatively small vertical distance between the end portions 50A, 52A of the fluid inlet conduit 50 and first fluid outlet conduit 52, and a lowermost surface of the receptacle 110.
  • end portions 50A, 52A are disposed in close spaced relation from the tissue of the patient during use.
  • “in close spaced relation” may include that the end portions 50A, 52A lie close to the tissue of the patient during use of the receptacle 110 so as to be almost but not quite touching the tissue, as illustrated by the arrows 56 in Fig. 54. This may also allow easier application of a bandage or other dressing over the receptacle 110 and the fluid inlet conduit 50 and the first fluid outlet conduit 52, in the manner described above.
  • the end portions 50A, 52A of the fluid inlet conduit 50 and first fluid outlet conduit 52 may be arranged to protrude from the pressure spreading device 95 so as to be disposed in contact with the tissue of the patient during use.
  • This disclosure may apply to any of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610 described in this disclosure having a pressure spreading device 95, a fluid inlet conduit 50 and a first fluid outlet conduit 52.
  • the pressure spreading device 95 attaches to the the tail portion 90, and the fluid inlet conduit 50 and the first fluid outlet conduit 52 may terminate within the pressure spreading device 95.
  • This arrangement may help to prevent pressure injuries in use of the receptacle 110 from the fluid inlet conduit 50 and the first fluid outlet conduit 52 protruding into the tail portion 90 and creating a pressure point on the tissue of the patient.
  • the pressure spreading device 95 has an upper portion 95 A and a lower portion 95B that together form the pressure spreading device 95.
  • the upper portion 95 A and the lower portion 95B are the same as one another, however as best seen in Figure 55, one is flipped relative to the other to form the pressure spreading device 95.
  • An exterior surface of the upper portion 95 A and the lower portion 95B are smooth, as seen for the upper portion 95A in Figure 55.
  • the pressure spreading device 95 may be made of a smooth silicone material for contact with the tissue of the patient. The smooth exterior surface of the pressure spreading device 95 may assist with patient comfort as it contacts the tissue of the patient.
  • the lower portion 95B and the upper portion 95 A of the pressure spreading device 95 house a first cavity 180 and a second cavity 181 therein that in use enable fluid communication between the fluid inlet conduit 50 and the first fluid outlet conduit 52 and the tail portion 90, as will be described further below.
  • the lower portion 95B of the pressure spreading device 95 has a fluid inlet conduit channel 98 integrally formed therein.
  • the upper portion 95 A of the pressure spreading device 95 has a first fluid outlet conduit channel 99 integrally formed therein.
  • the fluid inlet conduit channel 98 and the first fluid outlet conduit channel 99 serve to guide the positioning of the fluid inlet conduit 50 and the first fluid outlet conduit 52 (not shown) inside the pressure spreading device 95. Consistent positioning of the fluid inlet conduit 50 and the first fluid outlet conduit 52 helps to achieve consistency of flow path length between receptacles 110 and, therefore, consistency of flow characteristics for each receptacle 110.
  • the lower portion 95B of the pressure spreading device 95 may include the first cavity 180 that extends from the fluid inlet conduit channel 98 to the tail portion 90 of the receptacle 110, to enable fluid communication from the fluid inlet conduit 50 into the tail portion 90 of the receptacle 110.
  • the upper portion 95 A of the pressure spreading device 95 includes the second cavity 181, seen in Figure 56, that extends from the tail portion 90 of the receptacle 110 to the first fluid outlet conduit channel 99 to enable fluid communication from the tail portion 90 of the receptacle 110 to the first fluid outlet conduit 52.
  • the first cavity 180 is formed integrally within the lower portion 95B of the pressure spreading device 95.
  • the second cavity 181 is formed integrally within the upper portion 95 A of the pressure spreading device 95.
  • the pressure spreading device 95 includes an internal flow guide 140 in the form of an internal wall, best seen in Figure 55.
  • the internal flow guide 140 includes a portion of the fluid inlet conduit channel 98 on one side thereof and a portion of the first fluid outlet conduit channel 99 on an opposing side thereof.
  • the first cavity 180 and the second cavity 181 are separated by the internal flow guide 140 within the pressure spreading device 95, as are the fluid inlet conduit channel 98 and the first fluid outlet conduit channel 99.
  • fluid may pass from the first cavity 180 into the tail portion 90 of the receptacle 110, into the head portion 93 of the receptacle 110 and through the circulation opening 145 (seen in Figure 55) of the internal flow guide 140, as is described in respect of the embodiment of Figure 50 above. Once fluid passes through the circulation opening 145, it passes back through the head portion 93, into the tail portion 90 and into the second cavity 181 of the pressure spreading device 95.
  • the first cavity 180 and the second cavity 181 each have a shape that gradually expands from a narrow end 182 at the respective fluid inlet conduit channel 98 or the first fluid outlet conduit channel 99 to the tail portion 90.
  • the shape of the first cavity 180 may assist in distributing fluid entering the first cavity 180 across the width of the tail portion 90, encouraging the fluid to reach each of the plurality of ridges 96 in the tail portion 90.
  • the internal flow guide 140 may also have a series of cavity ridges 97 on the first flow guide surface 142 that faces the first cavity 180 (not seen in Figures 55 to 58).
  • FIG 57 three cavity ridges 97 are schematically shown for ease of explanation.
  • the cavity ridges 97 on the first flow guide surface 142 (the underside of the internal flow guide 140) help to maintain a fluid flow path from the fluid inlet conduit 50 to the tail portion 90 even if the first cavity 180 is crushed during use.
  • the series of cavity ridges 97 on the second flow guide surface 144 of the internal flow guide 140 (the upper surface of the internal flow guide 140, seen in Figure 55) help to maintain a fluid flow path from the tail portion 90 to the first fluid outlet conduit 52 even if the second cavity 181 is crushed during use.
  • three cavity ridges 97 are shown on the second flow guide surface 144.
  • the cavity ridges 97 are arranged to taper towards each other at the narrow end 182 of the first cavity 180 of the fluid inlet conduit 50 and at the narrow end 182 of the second cavity 181 of the first fluid outlet conduit 52 , as shown in Figure 55 and also in Figures 56 and 57, following the shape of the respective cavity in which they are positioned.
  • the cavity ridges 97 may be formed on the upper portion 95A and/or lower portion 95B of the pressure spreading device 95 instead of, or in addition to, those formed on the internal flow guide 140.
  • the ridges 96 and the cavity ridges 97 are positioned so as to be offset from one another, to avoid creating pressure points that may lead to patient discomfort.
  • the cavity ridges 97 continue into the tail portion 90 beyond the starting point of the ridges 96. This longitudinal overlap of the ridges 96 and the cavity ridges 97 helps to maintain a fluid flow path between the first cavity 180 and the tail portion 90 and the tail portion 90 and the second cavity 181 even if the first cavity 180 and/or the second cavity 181 is crushed.
  • the ridges 96 of the tail portion 90 of the receptacle 110 may extend into the first cavity 180 and the second cavity 181, terminating towards the narrow end 182 of the respective first cavity 180 or second cavity 181.
  • the cavity ridges 97 are not required.
  • Each of the fluid inlet conduit channel 98 and the first fluid outlet conduit channel 99 may have a conduit locating feature 101, shown in Figure 58.
  • the conduit locating feature 101 is in the form of a stop.
  • the conduit locating feature 101 may be formed as an inwardly directed ring or partial ring that prevents the fluid inlet conduit 50 or first fluid outlet conduit 52 from being over inserted into the respective one of the fluid inlet conduit channel 98 and the first fluid outlet conduit channel 99.
  • the fluid inlet conduit 50 or the first fluid outlet conduit 52 is positioned in the fluid inlet conduit channel 98 or the first fluid outlet conduit channel 99 so that its end contacts the conduit locating feature 101.
  • the conduit locating feature 101 facilitates appropriate termination of the fluid inlet conduit 50 and the first fluid outlet conduit 52 at or near the narrow end 182 of the respective first cavity 180 or second cavity 181, preventing over insertion of the fluid inlet conduit 50 or the first fluid outlet conduit 52 which may cause additional pressure points on the tissue of the patient, increasing patient discomfort.
  • the conduit locating feature 101 may be omitted.
  • the fluid inlet conduit 50 and the first fluid outlet conduit 52 may be configured to terminate in the respective one of the fluid inlet conduit channel 98 and the first fluid outlet conduit channel 99 prior to reaching the first cavity 180 or the second cavity 181, for example at the start of the fluid inlet conduit channel 98 and the first fluid outlet conduit channel 99 or part way along the respective channel.
  • the conduit locating feature 101 may be omitted, or it could be positioned at an appropriate point along the fluid inlet conduit channel 98 and/or the first fluid outlet channel 99.
  • the fluid inlet conduit 50 and the first fluid outlet conduit 52 may be configured to terminate in the first cavity 180 or the second cavity 181.
  • One way of manufacturing the embodiment of the receptacle 110 shown in Figure 55 may be to bond the upper portion 95A, lower portion 95B and internal flow guide 140 together, for example using an adhesive material.
  • each of the fluid inlet conduit channel 98 and/or the first fluid outlet conduit channel 99 may have at least one recessed feature configured to facilitate improved adhesion between features of the pressure spreader device 95.
  • a trench 102 is shown recessed from the fluid inlet conduit channel 98 and/or the first fluid outlet conduit channel 99 in Figure 64.
  • Adhesive material may be received into or flow into the trench 102 and provides improved adhesion between the fluid inlet conduit 50 and the fluid inlet conduit channel 98, and/or the first fluid outlet conduit 52 and the first fluid outlet conduit channel 99.
  • the trench 102 may reduce occlusion of the fluid inlet conduit 50 and/or the first fluid outlet conduit 52 by the adhesive, by providing a space to allow adhesive to flow around the fluid inlet conduit 50 and/or the first fluid outlet conduit 52.
  • the trench 102 may additionally or alternatively reduce occlusion of the fluid inlet conduit channel 98 and/or the first fluid outlet conduit channel 99.
  • the at least one recessed feature may additionally or alternatively comprise at least one channel 103.
  • the channel 103 may be provided in combination with the trench 102, or may be included separately, without the trench 102.
  • the channel 103 at least partially surrounds or extends alongside at least a portion of the fluid inlet conduit channel 98 and/or the first fluid outlet conduit channel 99.
  • the channel 103 provides a space for adhesive to be received in or to flow therein, thereby guiding it to the desired location(s) surrounding or extending alongside at least a portion of the fluid inlet conduit channel 98 and the first fluid outlet conduit channel 99.
  • the pressure spreading device 95 has an upper portion 95 A and a lower portion 95B that together form the pressure spreading device 95.
  • the upper portion 95 A and the lower portion 95B are the same as one another, however as best seen in Figure 55, one is flipped relative to the other to form the pressure spreading device 95.
  • Figure 64 shows a lower portion 95B having a trench 102 and/or a channel 103, the trench 102 and/or channel 103 may also be included on an upper portion 95 A of the pressure spreading device 95.
  • any of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610 or 710 that have a pressure spreading device 95 and a tail portion 90 may have one or more of the features of the first cavity 180, second cavity 181, fluid inlet conduit channel 98, fluid outlet conduit channel 99, conduit locating feature 101, trench 102 or channel 103 described above.
  • the receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 disclosed herein may have a shape that is different to those disclosed in the accompanying Figures and/or the specification. Examples of possible alternative receptacle shapes are shown in Figure 59 and Figure 60, however other shapes are also possible.
  • Figure 59(a) shows a receptacle 10 having a generally elongate rectangular shape.
  • Figure 59(b) shows a receptacle 10 having a generally square shape, with the fluid inlet conduit 50 and the first fluid outlet conduit 52 both extending from or near a mid-point of one side of the receptacle 10.
  • Figure 59(c) shows a receptacle 10 having a generally oval shape with the fluid inlet conduit 50 and the first fluid outlet conduit 52 both extending from a mid-point of an elongate side of the receptacle 10.
  • Figure 59(d) shows another receptacle 10 having a generally oval shape, with the fluid inlet conduit 50 and the first fluid outlet conduit 52 both extending from one end of the receptacle 10. It will be appreciated that the positions of the fluid inlet conduit 50 and the first fluid outlet conduit 52 relative to the receptacle 10 may also be changed from the positions shown in Figure 59 without departing from the scope of the disclosure, as illustrated by the examples of the oval shaped receptacles of Figure 59(c) and Figure 59(d).
  • Each of the possible alternate shapes of the receptacle 10 may include a tail portion 90 and/or a pressure spreading device 95 as shown in Figure 60(a) to (d). Whilst the embodiments shown in Figures Figure 60(a) to (d) have both a tail portion 90 and a pressure spreading device 95, they may alternatively have a tail portion 90 but not a pressure spreading device 95, or they may have a pressure spreading device 95 but not a tail portion 90.
  • the tail portion 90 and/or pressure spreading device 95 may extend from or near a mid-point of an elongate side of the receptacle 10 as shown in the embodiments of Figure 60(a) and Figure 60(b) or they may extend from one end of the receptacle 10 as shown in Figure 60(c) and Figure 60(d). Whilst the receptacles 10 shown in Figure 60 have a sharp corner or squared transition between the tail portion 90 and the head portion 93, they may alternatively have a rounded or gradual transition between the tail portion 90 and the head portion 93 to avoid a sharp corner at the transition.
  • the flow rate of fluid entering the receptacles 10, 110, 210, 310, 410, 510, 610, 710 from the fluid source 40 may be between approximately >0 mL/min to 20 mL/min, or between approximately 5 mL/min to 15 mL/min, or between approximately 7 to 13 mL/min, or between approximately 9 mL/min to 11 mL/min. In an embodiment, the flow rate of fluid entering the receptacle may be approximately 10 mL/min.
  • the amount of fluid leaving the interior of the receptacle 10, 110, 210, 210 A, 310, 410, 510, 610, 710 as a result of molecules within the fluid passing through the one or more walls of the receptacle 10, 110, 210, 210A, 310, 410, 510, 610, 710 e.g.
  • the amount of fluid leaving the interior of the receptacle 10, 110, 210, 210A, 310, 410, 510, 610, 710 as a result of the molecules within the fluid passing through the one or more walls of the receptacle 10, 110, 210, 210A, 310, 410, 510, 610, 710 may be below about 0.5 mL/hr/cm2, as measured using the measuring system.
  • the measuring system includes a jig into which a receptacle, e.g. receptacle 10, is placed.
  • the jig allows diffused fluid molecules to escape from the interior of the receptacle 10.
  • the fluid inlet 55 of the receptacle 10 is fluidly connected to the fluid source 40 via an inlet line.
  • An inlet flow meter is fluidly connected to the inlet line between the fluid source 40 and the fluid inlet 55.
  • An outlet flow meter is fluidly connected to the fluid outlet 53 of the receptacle 10. The measurements are taken as follows.
  • the volumetric flow rate (standardised for temperature and pressure) at the fluid inlet 55 of the receptacle 10 is measured with the inlet flow meter and the volumetric flow rate at the fluid outlet 53 of the receptacle 10 (standardised for temperature and pressure) is measured with the outlet flow meter.
  • the operator must wait until the system has reached equilibrium before taking this data.
  • a difference between the inlet flow rate and the outlet flow rate is calculated.
  • the value obtained corresponds to the amount of fluid leaving the interior of the receptacle 10 as a result of the molecules within the fluid passing through the one or more walls 15 of the receptacle (e.g. via diffusion).
  • the measuring system is leak tested before the measurements are taken to ensure the difference in the two flow meters 507, 511 is not due to a leak but to the molecules within the fluid passing through the one or more walls 15 of the receptacle 10 (e.g. via diffusion).
  • the apparatus disclosed herein may be provided in various kit forms.
  • the kit may comprise one or more receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 and the compression bandage.
  • the apparatus comprises a carrier layer 530, for example a foam material
  • the kit may comprise one or more receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 and the carrier layer 530.
  • the kit may comprise a cutter so as to cause the carrier layer 530 to define one or more apertures in the course of applying the carrier layer 530 or prior thereto.
  • the kit may comprise a plastic layer, such as a transparent plastic wrap, which can be applied to the carrier layer and/or the tissue area, the transparent plastic layer comprising tracing lines to guide the forming of an aperture or apertures in the carrier layer 530.
  • the kit may further comprise a fluid source 40, for example a portable oxygen source such as an oxygen bottle.
  • Another kit may include one or more receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 and instructions to a user to apply a compression bandage for use with the one or more receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710.
  • a further kit may include one or more receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 and a fluid source 40, for example a portable oxygen source such as an oxygen bottle.
  • the receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 may be supplied with one or more of the fluid inlet conduit 50, the first fluid outlet conduit 52 and one or more of the pressure relief valves 70, 170 or other pressure regulator.
  • the kit may comprise one or more of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 and the adhesive dressing.
  • the kit may further comprise a fluid source 40, for example a portable oxygen source such as an oxygen bottle.
  • the kit may comprise one or more of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710.
  • the receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 may be supplied with one or more of the fluid inlet conduit 50 and the pressure relief valve 70, the first fluid outlet conduit 52 and the pressure relief valve 170 or other pressure regulator.
  • a further kit may include a sealing cover 30 and a negative pressure source 45, for example a diaphragm or peristaltic pump.
  • a canister (not shown) may also be supplied for attachment to the pump 45 for exudate collection.

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Abstract

A tissue care dressing, an apparatus for supplying fluid to target tissue within a tissue area of a patient, a method of dressing a tissue area of a patient and a kit of parts for supplying fluid to target tissue within a tissue area of a patient is provided. The tissue care dressing includes a receptacle having at least one wall, the at least one wall having an outer surface. At least a portion of the outer surface comprises a rough surface. The apparatus comprises a permeable layer having at least one section configured to permit molecules within the fluid to pass through the permeable layer and to be deformable. The apparatus further comprises a carrier layer configured to operatively define one or more apertures and to be disposable between the permeable layer and the tissue area so as to position the one or more apertures between the target tissue and the permeable layer such that the at least one section deforms into the one or more apertures and supplies molecules within the fluid to the target tissue.

Description

"Apparatus for supplying fluid to a tissue area"
Technical Field
[0001] The present invention relates to an apparatus for supplying fluid to a tissue area.
Background
[0002] The application of topical oxygen to a tissue area can improve tissue health. For example, in cases where the tissue area comprises a wound, the application of topical oxygen can aid healing. This is because healing can involve increased cell metabolic activity (which demands a large amount of oxygen). The application of topical oxygen to the wound can help to meet this demand. Exposing the wound surface to a negative-pressure environment can also aid healing. The negative-pressure environment helps to contract the wound and remove exudate from the wound.
[0003] Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present disclosure as it existed before the priority date of each of the appended claims.
Summary
[0004] According to an aspect of the disclosure, a tissue care dressing comprises a receptacle having at least one wall, the at least one wall having an outer surface, wherein at least a section of the outer surface comprises a rough surface. The rough surface may be configured to present a reduced surface area of the outer surface available for contact with contaminants. The rough surface may be configured for hindering the adherence of contaminants to the outer surface. The rough surface can make the receptacle easier to clean, thereby improving the cleanliness of the receptacle.
[0005] The rough surface may be present on multiple sections of the outer surface. At least a portion of the rough surface may be present on a section of the outer surface configured for contacting the tissue. At least a portion of the rough surface may be present on a section of the outer surface configured not to contact the tissue.
[0006] The rough surface may be configured to present a substantially random variation in the topology of the at least one section of the outer surface. The rough surface may be irregular. The rough surface may have a height of between about 0.2 micrometres to 400 micrometres from a low point to a high point thereof. The rough surface may have a plurality of raised or recessed elements that vary in height. The height of the elements may be between about 0.2 micrometres to 200 micrometres. The height of the elements may be measured from a common baseline. The rough surface may have a plurality of raised and/or recessed elements that vary in width. The width of the elements may be between about 0.2 micrometers to 200 micrometers.
[0007] The receptacle may have a head portion and a tail portion. The rough surface may be present on at least a portion of the head portion and/or at least a portion of the tail portion. The rough surface may be present on substantially the entirety of the head portion and/or the tail portion.
[0008] The at least one wall of the receptacle may have an inner surface, and at least a section of the inner surface may comprise a rough surface.
[0009] The at least one wall of the receptacle may be flexible. The receptacle may be inflatable. The receptacle may be configurable to press against the tissue of a patient. [0010] The receptacle may be configured for receiving a fluid therein. The tissue care dressing may be configured to deliver the fluid to the tissue of a patient through the at least one wall of the receptacle. The at least one wall may comprise at least one section adapted to allow the fluid to pass from the receptacle to the tissue by pore flow. The at least one wall may comprise at least one section adapted to allow molecules within the fluid to diffuse from the receptacle to the tissue. The fluid may be oxygen.
[0011] At least a section of the outer surface may include a plurality of microstructures. The microstructures may be configured for encouraging cell growth.
[0012] The tissue care dressing may further comprise a cover positionable over the receptacle to form a compartment substantially bounded by the cover, the receptacle and the tissue.
[0013] According to an aspect of the disclosure, an apparatus for supplying fluid to tissue of a patient comprises an inflatable receptacle positionable at a tissue area, the receptacle comprising one or more walls and being adapted to receive a fluid, the one or more walls comprising at least one section adapted to allow molecules within the fluid to diffuse from the receptacle to the tissue area; and a cover positionable over the receptacle to form a compartment substantially bounded by the cover, the receptacle and the tissue area.
[0014] According to an aspect of the disclosure, an apparatus for supplying fluid to a tissue area comprises a receptacle positionable at a tissue area, the receptacle comprising one or more walls and being adapted to receive a fluid, the one or more walls comprising at least one section adapted to allow the fluid to pass from the receptacle to the tissue area; an inlet via which fluid is deliverable to the receptacle; an outlet via which fluid is receivable from the receptacle; and a cover positionable over the receptacle to form a compartment substantially bounded by the cover, the receptacle and the tissue area, the cover having a cover outlet via which fluid is receivable from the compartment substantially bounded by the cover, the receptacle and the tissue area.
[0015] The apparatus of any of the aspects described herein may further comprise a pressure spreading device adapted for contacting tissue of the patient.
[0016] The pressure spreading device may encapsulate at least a portion of a fluid inlet conduit and/or a first fluid outlet conduit.
[0017] The pressure spreading device may be configured to spread a force applied to the tissue of the patient by the fluid inlet conduit and/or the first fluid outlet conduit across a width of the pressure spreading device so as to mitigate patient discomfort.
[0018] The receptacle may comprise a head portion and a tail portion. The pressure spreading device may comprise at least one cavity providing fluid communication between the fluid inlet conduit and the tail portion of the receptacle and/or the tail portion of the receptacle and the first fluid outlet conduit.
[0019] The cavity may have a width dimension that increases from a fluid inlet end of the cavity and/or fluid outlet end of the cavity to the tail portion end of the cavity. The width dimension of the cavity may increase gradually from the fluid inlet end of the cavity and/or fluid outlet end of the cavity to the tail portion end of the cavity.
[0020] The cavity may have one or more cavity ridges extending substantially from a fluid inlet end of the cavity to a tail portion end of the cavity or from a fluid outlet end of the cavity to the tail portion end of the cavity. The one or more cavity ridges may comprise a plurality of the cavity ridges disposed in a configuration such that the spacing between adjacent ridges increases from the fluid inlet end or fluid outlet end of the cavity to the tail portion end of the cavity. [0021] The tail portion of the receptacle may have at least one ridge. One or more cavity ridges may be positioned so as to be offset from the at least one ridge of the tail portion. The one or more cavity ridges may overlap longitudinally with the at least one ridge of the tail portion. The one or more cavity ridges may comprise an extension of the at least one ridge of the tail portion into the cavity.
[0022] The pressure spreading device may be adapted to receive an end portion of the fluid inlet conduit and an end portion of the first fluid outlet conduit therein, such that the end portions terminate inside the pressure spreading device. Alternatively, the pressure spreading device may be adapted to receive an end portion of the fluid inlet conduit and an end portion of the first fluid outlet conduit therein, such that the end portions are permitted to terminate inside the tail portion.
[0023] The pressure spreading device may include an inlet conduit channel and an outlet conduit channel adapted for receiving the respective fluid inlet conduit or the first fluid outlet conduit therein.
[0024] The pressure spreading device may comprise at least one conduit locating feature adapted for locating an end of the fluid inlet conduit or first fluid outlet conduit. The conduit locating feature may comprise a stop. The conduit locating feature may be positioned in the inlet conduit channel and/or the outlet conduit channel. The conduit locating feature may be positioned at the fluid inlet end of the cavity and/or the fluid outlet end of the cavity.
[0025] The fluid inlet conduit channel and/or the first fluid outlet conduit channel may have at least one recessed feature configured to facilitate adhesion between features of the pressure spreading device and/or the fluid inlet conduit or first fluid outlet conduit. For example, between the fluid inlet conduit and the fluid inlet conduit channel, and/or the first fluid outlet conduit and the first fluid outlet conduit. The at least one recessed feature may comprise a trench. The trench may be configured to receive adhesive material therein. The trench may provide a space into which adhesive material may flow.
[0026] The at least one recessed feature may additionally or alternatively comprise at least one channel at least partially surrounding or extending alongside at least a portion of the fluid inlet conduit channel and/or the first fluid outlet conduit channel. The channel may be configured to receive adhesive material therein. The channel may be configured to provide a space into which adhesive material may flow. The channel may thereby guide flow of adhesive material to one or more channel locations.
[0027] The pressure spreading device may comprise both at least one trench and at least one channel.
[0028] According to an aspect of the disclosure, an apparatus for supplying fluid to target tissue within a tissue area of a patient, the apparatus comprising: a permeable layer having at least one section configured to permit molecules within the fluid to pass through the permeable layer and to be deformable; and a carrier layer configured to operatively define one or more apertures and to be disposable between the permeable layer and the tissue area so as to position the one or more apertures between the target tissue and the permeable layer such that the at least one section deforms into the one or more apertures and supplies molecules within the fluid to the target tissue.
[0029] The at least one section may comprise substantially the entirety of the permeable layer. The at least one section may be deformable under pressure operatively imparted by the fluid on the permeable layer towards the tissue area. The permeable layer may be flexible. The permeable layer may be stretchable. The at least one section may comprise a plurality of microstructures arranged on an operatively tissue area facing surface of the permeable layer. [0030] The apparatus may comprise a receptacle adapted to receive the fluid, the receptacle comprising an operatively tissue area facing first wall portion, the first wall portion having the permeable layer. The permeable layer may comprise substantially the entirety of the first wall portion. The at least one section may deform under pressure operatively imparted by the fluid on the permeable layer towards the tissue area through inflation of the receptacle by the fluid. At least a part of the at least one section may have a substantially convex shape in an inflated position of the receptacle.
[0031] The receptacle may be formed from the first wall portion and an opposing second wall portion. The second wall portion may have a thickness that is greater than a thickness of the at least one section of the permeable layer. The at least one section of the permeable layer may have a thickness of between approximately 40pm to 70pm, or between approximately 45pm to 65pm, or between approximately 50pm to 60pm. The at least one section of the permeable layer may have a thickness of approximately 55pm. The second wall portion may have a thickness of between approximately 100pm to 300pm, or between approximately 150pm to 250pm or between approximately 175pm to 225pm. The second wall portion may have a thickness of approximately 200pm.
[0032] The receptacle may be formed by joining the first wall portion and the second wall portion at a seam. The first wall portion and the second wall portion may be non-porous. A surface of the second wall portion disposed towards an interior of the receptacle may comprise at least one ridge. The apparatus may comprise an indicator of an orientation of the receptacle. Where the tissue area comprises a cavity, the receptacle may be substantially flexible so as to at least in part be positionable within the cavity.
[0033] The receptacle may be configured for inflation biased towards deforming the at least one section. Configuration of the receptacle for inflation biased towards deforming the at least one section may comprise the first wall portion having a greater surface area relative to the second wall portion in an uninflated position of the receptacle. The first wall portion may have a convex shape operatively disposed towards the tissue area in the uninflated position. The at least one section may have a convex shape operatively disposed towards the tissue area in the uninflated position.
[0034] The apparatus may comprise a cover configured to hold the receptacle onto the tissue area. The cover may constrain deformation of the receptacle away from the tissue area during inflation of the receptacle.
[0035] The at least one section may be configured to permit molecules within the fluid to pass through the permeable layer by diffusion alone or by a combination of diffusion and pore flow. The supply of the molecules within the fluid to the target tissue may comprise the molecules within the fluid operably diffusing through the at least one section of the permeable layer towards the target tissue. The at least one section may be configured to permit molecules within the fluid to pass through the permeable layer by pore flow.
[0036] The carrier layer may be configured to enable the one or more apertures to correspond to a shape and/or a location and/or geometry of the target tissue. The carrier layer may comprise an absorbent material and/or a non-absorbent material. The carrier layer may be an absorbent material. The absorbent material may be a foam material. The carrier layer may comprise a plurality of absorbent material sections. The carrier layer material may allow absorption of exudate from the target tissue. The carrier layer may be configured to wick exudate from the target tissue. Supply of the molecules within the fluid to the target tissue and absorption of exudate by the carrier layer material may occur substantially concurrently. The carrier layer may be configured to adhere to at least a part of the tissue area and/or at least a part of the permeable layer. The carrier layer may be affixable to the patient at or about the tissue area by adhesive tape. The carrier layer may provide cushioning between the tissue area and at least a part of the permeable layer. [0037] The fluid may be a therapeutic fluid. The therapeutic fluid may be oxygen and/or carbon dioxide and/or carbon monoxide, and/or nitric oxide. The apparatus may enable targeting of treatment towards the target tissue. The receptacle may be configured to receive a fluid comprising therapeutic molecules, the at least one section configured to permit the therapeutic molecules within the fluid to pass through the permeable layer from an interior of the receptacle.
[0038] Deformation of the at least one section into the one or more apertures may be proportional to the pressure imparted on the permeable layer by the fluid. Deformation of the at least one section into the one or more apertures may be proportional to the pressure imparted on the permeable layer by the fluid contained in an interior of the receptacle. The at least one section may deform into the one or more apertures to contact the target tissue. Where the at least one section contacts the target tissue, the at least one section contacting the target tissue may displace exudate from the target tissue towards a periphery of the one or more apertures.
[0039] The receptacle may comprise an inlet, the receptacle adapted to receive the fluid via a fluid inlet conduit in fluid communication with the inlet. The receptacle may comprise an outlet, the receptacle adapted to allow the fluid to exit the receptacle via a fluid outlet conduit in fluid communication with the outlet. The inlet and the outlet may be arranged substantially adjacent one another. The inlet and the outlet may be located at a tail portion of the receptacle. The apparatus may comprise a pressure spreading device configured to mitigate a pressure applied to the patient by the fluid inlet conduit and/or the fluid outlet conduit. The pressure spreading device may comprise an indicator of an orientation of the receptacle. The pressure spreading device may have a substantially flat surface at an operatively patient facing side.
[0040] The carrier layer may be configured to operatively define the one or more apertures by having one or more pre-cut apertures. The one or more pre-cut apertures may be chamfered at an operatively permeable layer facing side of the carrier layer. The carrier layer may be configured to operatively define the one or more apertures at a perforated region provided in the carrier layer.
[0041] The carrier layer may be configured to operatively define a plurality of apertures. The carrier layer may be configured to be disposed between the permeable layer and the tissue area such that the at least one section deforms into each of the plurality of apertures to supply molecules within the fluid to the target tissue. The permeable layer may have a plurality of sections configured to permit molecules within the fluid to pass through the permeable layer and to be deformable. The carrier layer may be configured to be disposed between the permeable layer and the tissue area such that each section of the plurality of sections deforms into at least one aperture of the plurality of apertures to supply molecules within the fluid to the target tissue.
[0042] The apparatus may comprise a plurality of permeable layers, each permeable layer of the plurality of permeable layers having at least one section configured to permit molecules within the fluid to pass through the permeable layer and to be deformable. The at least one section of each of the plurality of permeable layers may deform into at least one aperture of the plurality of apertures and supply molecules within the fluid to the target tissue. The apparatus may comprise a plurality of receptacles adapted to receive the fluid, each receptacle of the plurality of receptacles comprising an operatively tissue area facing first wall portion, the first wall portion having a permeable layer of the plurality of permeable layers.
[0043] The apparatus may comprise a plurality of carrier layers, each carrier layer of the plurality of carrier layers configured to operatively define one or more apertures. The plurality of carrier layers may be configured to be disposable between the permeable layer and the tissue area in a layered manner so as to align the one or more apertures of the plurality of carrier layers between the target tissue and the at least one section of the permeable layer such that the at least one section deforms into the one or more apertures of the plurality of carrier layers and supplies molecules within the fluid to the target tissue. Each carrier layer of the plurality of carrier layers may be configured to be disposed between the permeable layer and the tissue area such that the at least one section deforms into the one or more apertures of each carrier layer of the plurality of carrier layers and supply molecules within the fluid to the target tissue. The apparatus may comprise a plurality of permeable layers, each permeable layer of the plurality of permeable layers having at least one section configured to permit the fluid to pass through the permeable layer, the at least one section configured to be deformable, and wherein each carrier layer of the plurality of carrier layers is configured to be disposable between at least one permeable layer of the plurality of permeable layers and the tissue area such that the at least one section of the at least one permeable layer deforms into the one or more apertures of the carrier layer and supplies the fluid to the target tissue.
[0044] The first wall portion and the second wall portion may each have a permeable layer, the permeable layer of each of the first wall portion and the second wall portion having at least one section configured to permit the fluid to pass through the permeable layer.
[0045] According to an aspect of the disclosure, a method of dressing a tissue area of a patient, the method comprising: applying a carrier layer defining one or more apertures to the tissue area; applying a permeable layer to the carrier layer so as to position the permeable layer over the one or more apertures of the carrier layer, the permeable layer having at least one section configured to permit molecules within a fluid to pass through the permeable layer to supply the molecules to the tissue area.
[0046] The section may comprise the entirety of the permeable layer. The section of the permeable layer may be adapted to deform under pressure imparted by the fluid on the permeable layer. [0047] Applying the permeable layer to the carrier layer may comprise and/or may be followed by deforming the section of the permeable layer, under pressure imparted by the fluid on the permeable layer towards the tissue area, into the one or more apertures of the carrier layer. Deforming the section of the permeable layer may be preceded by supplying the fluid at a side of the permeable layer opposite a side of the permeable layer facing the carrier layer.
[0048] Applying the carrier layer to the tissue area may be preceded by causing the carrier layer to define the one or more apertures. Causing the carrier layer to define the one or more apertures may comprise causing the carrier layer to define the one or more apertures such that the one or more apertures correspond to a shape and/or a location and/or a geometry of target tissue within the tissue area. The one or more apertures may be chamfered at an operatively permeable layer facing side of the carrier layer. The carrier layer may define a plurality of apertures. The carrier layer may be absorbent.
[0049] The fluid may comprise a therapeutic fluid. The therapeutic fluid may comprise oxygen and/or carbon dioxide and/or carbon monoxide, and/or nitric oxide.
[0050] The section may be configured to permit the molecules within the fluid to pass through the permeable layer by diffusion alone or by a combination of diffusion and pore flow.
[0051] The permeable layer may be non-destructively removable from the carrier layer subsequent to applying the permeable layer to the carrier layer. Applying the permeable layer to the carrier layer may be followed by removing the permeable layer from the carrier layer and applying a further permeable layer to the carrier layer so as to position the further permeable layer over the one or more apertures of the carrier layer, a section of the further permeable layer configured to permit molecules of a fluid to pass through the further permeable layer to supply the molecules of the fluid to the tissue area. [0052] A receptacle adapted to receive the fluid may comprise an operatively tissue area facing first wall portion having the permeable layer, the section of the permeable layer deforming under pressure imparted by the fluid on the permeable layer towards the tissue area through inflation of the receptacle by the fluid. The receptacle may be formed from the first wall portion and an opposing second wall portion. The first wall portion and the second wall portion may be non-porous.
[0053] Deforming the section of the permeable layer may be preceded by connecting an inlet of the receptacle to a fluid source. Connecting the inlet of the receptacle to a fluid source may be followed by at least partially inflating the receptacle through an activation of the fluid source. The fluid source may be connected to the inlet of the receptacle by an inlet conduit. The receptacle may be adapted to allow the fluid to exit the receptacle via a fluid outlet conduit in fluid communication with an outlet of the receptacle. The outlet conduit may comprise a pressure relief (for example a pressure relief valve.)
[0054] Applying a permeable layer to the carrier layer may be followed by positioning a cover over the receptacle and the tissue area. The cover may operatively constrain deformation of the receptacle away from the tissue area during inflation of the receptacle.
[0055] According to an aspect of the disclosure, a kit of parts for supplying fluid to target tissue within a tissue area of a patient, the kit comprising: a receptacle adapted to receive the fluid, the receptacle comprising an operatively tissue area facing first wall portion, the first wall portion having a permeable layer with at least one section configured to permit molecules within the fluid to pass through the permeable layer and to be deformable; a carrier layer configured for application between the tissue area and the first wall portion of the receptacle, the carrier layer operatively defining one or more apertures into which the section of the permeable layer operatively deforms to supply molecules within the fluid to the target tissue. [0056] The receptacle may be formed from the first wall portion and an opposing second wall portion.
[0057] The one or more apertures may be defined in the carrier layer by forming the one or more apertures from a perforated region of the carrier layer. The one or more apertures may be pre-cut into the carrier layer. The kit may comprise a cutter configured for cutting the carrier layer to define the one or more apertures such that the one or more apertures correspond to a shape and/or a location and/or a geometry of the target tissue.
[0058] The carrier layer may comprise an absorbent material and/or a nonabsorbent material. The absorbent material may be a foam material. The carrier layer may be compressible.
[0059] The at least one section may operatively deform into the one or more apertures under pressure imparted by the fluid on the permeable layer towards the tissue area through inflation of the receptacle by the fluid.
[0060] The kit may comprise a cover configured to hold the receptacle onto the tissue area, the cover operatively constraining deformation of the receptacle away from the tissue area during inflation of the receptacle. The kit may comprise a fluid source connectable to an inlet of the receptacle. The kit may comprise an outlet conduit connectable to an outlet of the receptacle, the outlet conduit comprising a pressure relief valve.
[0061] According to an aspect of the disclosure, a tissue care dressing for a tissue area of a patient, the tissue care dressing comprising: a receptacle having an inlet and an outlet, the receptacle adapted to receive a fluid via the inlet and from which the fluid can exit via the outlet, the receptacle formed from an operatively tissue area facing first wall portion and an opposing second wall portion and defining a fluid flow path from the inlet to the outlet, the fluid flow path comprising: a first chamber in fluid flow connection with the inlet, and a second chamber in fluid flow connection with the first chamber and the outlet, the second chamber partitioned from the first chamber by a juncture between the first wall portion and the second wall portion.
[0062] The juncture may be formed by a bond between an inner surface of the first wall portion and an inner surface of the second wall portion.
[0063] At least one of the first chamber and the second chamber may be configured to be positionable at the tissue area, the first wall portion of the at least one of the first chamber and the second chamber having a permeable layer with at least one section configured to permit molecules within the fluid to pass through the permeable layer. The at least one section may be deformable under pressure imparted by the fluid on the first wall portion. The at least one section of the at least one of the first chamber and the second chamber may comprise a plurality of microstructures arranged at an operatively tissue area facing surface of the first wall portion.
[0064] The inlet may be substantially adjacent the outlet. The inlet and the outlet may be disposed at a tail portion of the receptacle. The receptacle may be adapted to receive the fluid via a fluid inlet conduit in fluid communication with the inlet and from which the fluid can exit via a fluid outlet conduit in fluid communication with the outlet. The tissue care dressing may comprise a pressure spreading device configured to mitigate a pressure applied to the patient by the fluid inlet conduit and/or the fluid outlet conduit. The pressure spreading device may have a substantially flat surface at an operatively patient facing side thereof.
[0065] The tissue care dressing may comprise an indicator of an orientation of the receptacle. The pressure spreading device may comprise the indicator.
[0066] The second wall portion may comprise one or more ridges extending a distance along the fluid flow path at an inner surface of the second wall portion. [0067] At least one of the first chamber and the second chamber may have a generally elongate shape or curved shape or rectangular shape or square shape or oval shape or round shape.
[0068] One of the first chamber and the second chamber may be configured to be positionable at the tissue area, the first wall portion of the one of the first chamber and the second chamber having a larger surface area relative to the surface area of the first wall portion of the other of the first chamber and the second chamber. The other of the first chamber and the second chamber may comprise a conduit between the inlet or the outlet for the fluid to or from the one of the first chamber and the second chamber.
[0069] According to an aspect of the disclosure, an apparatus for supplying fluid to various target tissue within a tissue area of a patient, the apparatus comprising a plurality of permeable layers, each permeable layer of the plurality of permeable layers configured to supply a fluid to a target tissue of the various target tissue through an aperture of a carrier layer or plurality of carrier layers operatively disposed between the permeable layer and the target tissue.
[0070] The plurality of permeable layers may be applied to the carrier layer or plurality of carrier layers to be separately disposed about the tissue area.
[0071] Each permeable layer of the plurality of permeable layers may be deformable into the aperture of the carrier layer. The permeable layer may have a convex shape operatively disposed towards the tissue area.
[0072] Each permeable layer of the plurality of permeable layers may be an operatively tissue area facing first wall portion of a receptacle adapted to receive the fluid. The receptacle may receive the fluid via an inlet in fluid flow connection with a manifold connected to a fluid source. Brief Description of Drawings
[0073] One or more embodiments of the present disclosure will now be described by way of specific example(s) with reference to the accompanying drawings, in which:
[0074] Fig. l is a cross-sectional schematic view of an embodiment of an apparatus for supplying fluid to a tissue area;
[0075] Fig. 1 A is a view of an embodiment of an apparatus for supplying fluid to a tissue area;
[0076] Fig. 2 is a cross-sectional schematic view of an embodiment of an apparatus for supplying fluid to a tissue area;
[0077] Fig. 3 is a cross-sectional schematic view of an embodiment of an apparatus for supplying fluid to a tissue area, having a fluid inlet conduit and first and second fluid outlet conduits;
[0078] Fig. 3 A is a cross-sectional schematic view of an embodiment of an apparatus for supplying fluid to a tissue area, having a fluid inlet conduit, first and second fluid outlet conduits, and first and second films forming a cover;
[0079] Fig. 4 is a cross-sectional schematic view of an embodiment of an apparatus for supplying fluid to a tissue area, having multiple receptacles;
[0080] Fig. 5 is a cross-sectional schematic view of an embodiment of an apparatus for supplying fluid to a tissue area, having multiple receptacles and a manifold;
[0081] Fig. 6 is a cross-sectional schematic view of another embodiment of an apparatus for supplying fluid to a tissue area, having multiple receptacles and a manifold; [0082] Fig. 7 is a cross-sectional schematic view of a further embodiment of an apparatus for supplying fluid to a tissue area;
[0083] Fig. 8 is a cross-sectional schematic view of an embodiment of an apparatus for supplying fluid to a tissue area, having a pressure relief valve;
[0084] Fig. 9 is a schematic plan view of an embodiment of the apparatus including a through-hole in the receptacle;
[0085] Fig. 10 is a schematic plan view of an embodiment of the apparatus including a plurality of through-holes in the receptacle;
[0086] Fig. 11 is a schematic plan view of an apparatus having multiple receptacles;
[0087] Fig. 12 is a cross-sectional schematic view of a further embodiment of the apparatus including fasteners;
[0088] Fig. 13 is a cross-sectional schematic view of a further embodiment of the apparatus including an absorbent material layer;
[0089] Fig. 14a and Fig. 14b are a schematic plan view and schematic cross- sectional view of an embodiment of the apparatus having combined fluid conduits;
[0090] Fig. 15a and Fig. 15b are a schematic plan view and schematic cross- sectional view of another embodiment of the apparatus having combined fluid conduits;
[0091] Fig. 16a and Fig. 16b are a schematic plan view and schematic cross- sectional view of a further embodiment of the apparatus having combined fluid conduits; [0092] Fig. 17a and Fig. 17b are a schematic plan view and schematic cross- sectional view of a still further embodiment of the apparatus having combined fluid conduits;
[0093] Fig. 18 is a schematic cross-sectional view of another apparatus for supplying fluid to a tissue area having a receptacle;
[0094] Fig. 19 is a schematic cross-sectional view of the apparatus of Fig. 18, including a dressing;
[0095] Fig. 20 is a schematic cross-sectional view of another apparatus for supplying fluid to a tissue area having a receptacle;
[0096] Fig. 20A is a view of another apparatus for supplying fluid to a tissue area having a receptacle;
[0097] Fig. 21 is a schematic cross-sectional view of the apparatus of Fig. 20, including a dressing;
[0098] Fig. 21 A is a view of a pressure spreading device, fluid inlet conduit and first fluid outlet conduit of an emboduiment of the apparatus, protruding from a cover wrapped around a model of a leg of a patient;
[0099] Fig. 2 IB is a view of a receptacle, fluid inlet conduit and first fluid outlet conduit of an embodiment of the apparatus in situ on a wound on a model of a leg of a patient;
[0100] Fig 21C is an enlarged view of a receptacle of an embodiment of the apparatus in situ on a wound on a model of a leg of a patient;
[0101] Fig. 22 is a schematic cross-sectional view of another apparatus for supplying fluid to a tissue area having multiple receptacles; [0102] Fig. 23 is a schematic cross-sectional view of the apparatus of Fig. 22, including a dressing;
[0103] Fig. 24 is a schematic cross-sectional view of another apparatus for supplying fluid to a tissue, including a pressure relief valve;
[0104] Fig. 25 is a schematic cross-sectional view of the apparatus of Fig. 24, including a dressing;
[0105] Fig. 26 is a schematic plan view of a receptacle according to an embodiment of the apparatus;
[0106] Fig. 27 is a schematic cross-sectional view through the line A- A of Fig. 26;
[0107] Fig. 28 is a schematic cross-sectional view through the line B-B of Fig. 26 in i) an inflated configuration and ii) a configuration in which the receptacle is not inflated;
[0108] Fig. 28 A is a view of a receptacle in i) an inflated configuration and ii) a configuration in which the receptacle is not inflated;
[0109] Fig. 29 is a schematic cross-sectional view through the line B-B of Fig. 26 with a) first rough surface and b) a first rough surface and a second rough surface, in accordance with an embodiment;
[0110] Fig. 30 is a close-up view of an example embodiment of the first rough surface of Fig. 29a and Fig. 29b, and Fig 63a and Fig 63b;
[0111] Fig. 31 is a schematic cross sectional view of an inner surface of a receptacle with a) a plurality of ridges and b) a second wall portion pressed onto the ridge of a first wall portion of a receptacle according to an embodiment; [0112] Fig. 32 is a schematic cross sectional view of the embodiment of Fig. 31, with i) overlapping ridges at a first wall portion and a second wall portion and ii) non-overlapping ridges at the first wall portion and the second wall portion;
[0113] Fig. 33 is a partial schematic cross-sectional representation of a ridge according to the embodiment of Fig. 31 adjoining a first and/or second wall portion with a) a small fillet radius; b) a medium fillet radius; c) a large fillet radius; and d) an overhanging comer;
[0114] Fig. 34 is a schematic plan view of a receptacle according to an embodiment showing embodiments of ridge configurations: a) ridges extend through tail portion; b) ridges extend through tail portion and head portion; c) non-straight ridges;
[0115] Fig. 35 is a schematic cross-sectional view of a further receptacle according to an embodiment of the apparatus;
[0116] Fig. 35 A is a schematic schematic cross-sectional view of a further receptacle according to an embodiment of the apparatus in a (i) unfolded configuration and (ii) folded configuration;
[0117] Fig. 35B is a schematic schematic cross-sectional view of a further receptacle according to an embodiment of the apparatus in a (i) unfolded configuration and (ii) folded configuration;
[0118] Fig. 36 is a schematic cross-sectional view of an embodiment of the apparatus with a pressure relief valve at a fluid outlet port;
[0119] Fig. 37 is an embodiment of a receptacle with a pressure relief valve at a fluid outlet port;
[0120] Fig. 38 is an embodiment of a receptacle having a thicker material layer; [0121] Fig. 39 is an embodiment of a receptacle having a plurality of apertures in an upper layer;
[0122] Fig. 40 is a schematic cross-sectional view of a further embodiment of the apparatus;
[0123] Fig. 41 is a schematic plan view of the embodiment of Fig. 40;
[0124] Fig. 42 is an enlarged schematic view of an opening of an internal flow guide of the embodiment of Figs. 40 and 41;
[0125] Fig. 43 i) to iv) are example embodiments of cross-sectional shapes of a surround of the opening of Figs. 40-42;
[0126] Fig. 43A and Fig. 43B are views of a receptacle showing overlap of an opening surround and ridges, Fig 43C is a cross-sectional view of the opening surround and ridges at arrows A-A of Fig. 43B;
[0127] Fig. 43D is a schematic plan view of a circulation opening and opening surround of an internal flow guide of the embodiment of Figs. 40 and 41;
[0128] Fig. 43E is a schematic plan view of the circulation opening and opening surround of an internal flow guide of Fig. 43D including ridges;
[0129] Fig. 43F is a schematic plan view of another circulation opening and opening surround of an internal flow guide of the embodiment of Figs. 40 and 41;
[0130] Fig. 44 a) is a schematic cross-sectional view of the embodiment of Fig. 40 showing the attachment of the fluid inlet and outlet conduits to the receptacle;
[0131] Fig. 44 b) is an enlarged detail view of the attachment of the fluid inlet and outlet conduits to the receptacle; [0132] Fig. 45 is schematic cross-sectional view of a further embodiment of the apparatus;
[0133] Fig. 46 is a further schematic plan view of the embodiment of the apparatus of Fig. 45;
[0134] Fig. 47 is a schematic plan view of a further embodiment of the apparatus;
[0135] Fig. 48 is a further cross-sectional side view of the embodiment of the apparatus of Fig. 47;
[0136] Fig. 49 is a schematic cross-sectional view of a further embodiment of the apparatus;
[0137] Fig. 50 a) is a schematic cross-sectional view of a further embodiment of the apparatus in which the fluid inlet and outlet conduits are disposed side by side;
[0138] Fig. 50 b) is a further schematic cross sectional view of the embodiment of the apparatus of Fig. 50 a), looking in the direction shown at line A- A in Fig. 50 a);
[0139] Fig 51 a) and b) is a schematic diagram of example embodiments of internal ridges of the embodiments of Figs. 41 to 50;
[0140] Fig. 52 is a schematic cross-sectional view of a further embodiment of the apparatus;
[0141] Fig. 53 is a schematic cross-sectional view of the tail portion and pressure spreading device of a receptacle and fluid inlet and outlet conduits of an embodiment of the apparatus; [0142] Fig. 54 is another schematic view of the tail portion and pressure spreading device of a receptacle and fluid inlet and outlet conduits of an embodiment of the apparatus;
[0143] Fig. 55 is an exploded view of a pressure spreading device and tail portion of a receptacle, of an embodiment of the apparatus;
[0144] Fig. 56 is a partial section view of the pressure spreading device and tail portion of Fig. 55, including a cavity in the pressure spreading device, inlet conduit channel and outlet conduit channel;
[0145] Fig. 57 is a partial section view of the pressure spreading device and tail portion of Fig. 55, including a cavity in the pressure spreading device, inlet conduit channel and outlet conduit channel;
[0146] Fig. 58 is a cross-section view of the pressure spreading device of Fig. 55, showing a conduit locating feature of the inlet conduit channel;
[0147] Figs. 59(a)-(d) are schematic plan views of alternative receptacle shapes;
[0148] Figs. 60 (a)-(d) are schematic plan views of alternative receptacle shapes that have a tail portion and a pressure spreading device;
[0149] Fig. 61 is a schematic representation of an embodiment of the apparatus, including an optional regulator and optional calibrated leak orifice upstream of the fluid inlet;
[0150] Fig. 62 is a schematic partial representation of a variation of the embodiment of the apparatus of Fig. 61, including a conduit connector and holder. [0151] Fig. 63 is a schematic cross-sectional view through the line B-B of Fig. 26 with a) first rough surface or b) a first rough surface and a second rough surface, in accordance with variations of an embodiment;
[0152] Fig. 64 is a partial section view of the pressure spreading device and tail portion of Fig. 55, including a trench in the inlet conduit channel and outlet conduit channel, and a channel at least partially surrounding the inlet conduit channel and outlet conduit channel;
[0153] Fig. 65 is a cross-sectional schematic side representation of an apparatus for supplying fluid to target tissue within a tissue area of a patient;
[0154] Fig. 66 is a side view of an embodiment of an apparatus for supplying fluid to target tissue within a tissue area of a patient, (a) through (e) showing increasing pressure imparted on a permeable layer of a receptacle of the apparatus by fluid in an interior of the receptacle;
[0155] Fig. 67 is a side view embodiment of an apparatus for supplying fluid to target tissue within a tissue area of a patient, with an aperture of a carrier layer of the apparatus having a chamfered edge;
[0156] Fig. 68 is a side view of an embodiment of an apparatus for supplying fluid to target tissue within a tissue area of a patient;
[0157] Fig. 69 is a cross-sectional schematic side representation of a variation of an apparatus for supplying fluid to target tissue within a tissue area of a patient;
[0158] Fig. 70 is a side view of an embodiment of the apparatus of Fig. 69, comprising a plurality of receptacles for supplying fluid to target tissue within the tissue area of a patient; [0159] Fig. 71 is a side view of an embodiment of an apparatus for supplying fluid to target tissue within a tissue area of a patient, comprising a receptacle formed from a first wall portion and a second wall portion having the same structural features;
[0160] Fig. 72 is a top view of an embodiment of a tissue care dressing;
[0161] Fig. 73 is a top view of a variation of the embodiment of the tissue care dressing of Fig. 72;
[0162] Fig. 74 is a perspective view of a variation of the tissue care dressing of Fig. 73 with a receptacle in an inflated position and comprising a pressure spreading device;
[0163] Fig. 75 is a schematic cross sectional view of the embodiment of the tissue care dressing of Fig. 74 with the receptacle in an inflated position, looking in the direction shown at line B-B in Fig. 74;
[0164] Fig. 76 is a side view of the embodiment of the tissue care dressing of Fig. 74 in an uninflated position of the receptacle;
[0165] Fig. 77 is a top view of a variation of the embodiment of the tissue care dressing of Fig. 73 comprising an indicator; and
[0166] Fig. 78 is a schematic flow diagram of a method of dressing a tissue area of a patient.
Description of Embodiments
[0167] Figure 1 shows an embodiment of an apparatus for supplying fluid to a tissue area. Throughout this disclosure, it will be appreciated that a tissue area may include target tissue that is to be treated and an area of tissue surrounding the target tissue. Target tissue may include one or more of healthy tissue, a wound or a part of a wound, healed wound tissue, scar tissue, muscle, bone and the like. It will be appreciated that there may be multiple tissue areas of a patient, and tissue areas of a patient can be in close proximity with one another or disposed at completely different parts of the patient. The apparatus may supply fluid to tissue on an external surface of the patient (e.g. skin) or it may supply fluid to tissue on an internal surface of the patient (e.g. it may supply fluid to an intestinal wall or to the wall of an internal organ during surgery). One example of the tissue that the apparatus may be applied to is a wound. The embodiments described herein are described with reference to a wound. However, it will be appreciated that they are, in general, applicable to other tissue areas as described above.
[0168] The apparatus 100 includes a receptacle 10 that is positioned at a wound area 20, for example a chronic wound as may be found on a lower limb of a diabetic patient. The wound area 20 includes the wound 22 and an area of healthy skin 24 that surrounds the wound 22. The wound area 20 is also referred to as the tissue area throughout this specification. The apparatus further includes a cover 30 that is positionable over the receptacle to form a compartment 35 that is substantially bounded by the cover 30, the receptacle 10, and the wound area 20. In some embodiments of the apparatus described in this disclosure, the compartment may also be bounded by additional components of the apparatus that may be present and still be substantially bounded by the cover 30, the receptacle 10 and the wound area 20. For example, in some embodiments of the disclosure described herein, the compartment may be further bounded by one or more fluid inlet conduits and/or fluid outlet conduits as will be described herein.
[0169] The receptacle 10 consists of an inflatable, hollow bag that is fluidly connectable to a fluid source 40 for inflating the receptacle 10 with a fluid. The receptacle 10 may be connected to a fluid inlet conduit 50 for delivery of the fluid from the fluid source 40 to the receptacle 10. The connection of the fluid source 40 to the fluid inlet conduit 50 is shown schematically in the Figures and may not be shown directly. It will be appreciated that one or more additional conduits (not shown) may be included in the connection between the fluid inlet conduit 50 and the fluid source 40. The receptacle 10 may be for single use on a single patient. It may be used continuously at the wound for up to several days (e.g. 7 days or 10 days), and may be changed as and when a dressing, for example a bandage, is changed.
[0170] In each of the embodiments described in this disclosure, the fluid may comprise a gas and/or a liquid. For example, the fluid may comprise oxygen gas, carbon dioxide gas, carbon monoxide gas, nitric oxide gas, ambient air, aerosols and gases at different humidity levels and/or other therapeutic gases that may be beneficial in treating the wound and/or assisting the wound to heal. The fluid may comprise combinations of any of the aforesaid gases. The fluid may also comprise a liquid, for example it may comprise water, water with molecularly dispersed substances, or saline solution. The fluid source 40 may be a gas source such as a wall source, oxygen or carbon dioxide or carbon monoxide, nitric oxide bottle, oxygen or carbon dioxide or carbon monoxide, nitric oxide concentrator, oxygen or carbon dioxide or carbon monoxide, nitric oxide pump or the like, suitable to meet a predetermined concentration and/or pressure and/or flow rate of oxygen or other therapeutic fluid as will be described further below. The fluid source 40 may comprise a flow and/or pressure regulator 76 (shown in Figure 61) for controlling a flow rate and/or pressure of fluid issuing from the fluid source 40. The fluid source 40 is reusable, as is the flow and/or pressure regulator 76. The pressure regulator 76 may be integrated into a housing of the fluid source 40 or provided separate to the fluid source 40.
[0171] In some embodiments, the fluid source 40 may comprise at least one filter 73 (shown in Figure 61) to remove contaminants from the fluid before it is delivered to the receptacle 10. The filter 73 may be integrated into a housing of the fluid source 40 or provided separate to the fluid source 40. The filter 73 may be an inline filter. The filter 73 may be positioned upstream and/or downstream of the flow and/or pressure regulator 76. Some embodiments may not include the filter 73. [0172] The receptacle 10, and each of the receptacles 110, 210, 210A, 310, 410, 510, 610 and 710 described in this disclosure, may be formed of one or more walls 15 of a flexible material. For example, it may be formed from a single wall or two or more walls attached together via heat sealing or otherwise. The receptacle 10 may contain oxygen gas, however other therapeutic fluids, for example carbon dioxide gas or carbon monoxide gas nitric oxide gas, or ambient air may also be used as described herein. The one or more walls 15 of the receptacle 10 has at least one section that is made from a material that is adapted to allow molecules within the fluid in the receptacle 10 to diffuse to outside of the receptacle 10. In some embodiments, the entire receptacle 10 may be formed of the material that allows molecules within the fluid in the receptacle to diffuse through it, whereas in other embodiments the receptacle 10 (other than the at least one section) may be made of a material of a different thickness to the material of the at least one section, or it may be made of a different material. The material section(s) may have a thin wall. The material may have a thickness of between approximately 10 micrometres and 150 micrometres, for example between approximately 20 micrometres and 140 micrometres, or between approximately 30 micrometres and 130 micrometres, or between approximately 35 micrometres and 100 micrometres, or between approximately 60 micrometres and 105 micrometres, or between approximately 40 micrometres and 80 micrometres, or between approximately 40 micrometres to 70 micrometres, or between approximately 30 micrometres to 60 micrometres, or between approximately 20 micrometres to 60 micrometres, or between approximately 45 micrometres and 55 micrometres. In some embodiments, the wall thickness is approximately 60 micrometres. In some embodiments, the wall thickness is approximately 50 micrometres. It will be appreciated by the skilled person that the wall thicknesses and/or layer thicknesses disclosed herein and throughout the specification may refer to the the thickness of the relevant wall or layer in a non-inflated state of the receptacle. When fluid is present in the receptacle and/or the receptacle is inflated, the thickness of one or more walls and/or layers may decrease. For example, the thickness may decrease as a result of stretching of the walls and/or layers.
[0173] The thinness of the material allows the wall 15 of the receptacle 10 to be flexible. This flexibility may help to maximise the surface contact between the receptacle 10 and the wound area, by allowing the wall of the receptacle 10 to conform to the wound surface, regardless of the wound topology. The material section(s) may be made of a stretchable material (that may deform elastically). The material section(s) may stretch in response to the amount of fluid in the receptacle. The stretchable material may help to maximise the surface contact between the receptacle 10 and the wound area, by allowing the wall of the receptacle 10 to conform to the wound surface, regardless of the wound topology.
[0174] Figure 65 shows a cross-sectional schematic side representation of an apparatus 500 for supplying fluid to target tissue 522 within a tissue area 525 of a patient. The target tissue 522 within the tissue area 525 is indicated by dashed line for ease of reference only, and target tissue 522 need not be distinct from the tissue area 525 and can be any target tissue or various target tissue within the tissue area 525 and having any shape and/or size and/or geometry. For example, where the tissue area 525 includes a wound of the patient, target tissue 522 may be the whole wound or any part or parts of the wound and/or healthy tissue around the wound and/or healed wound tissue and/or scar tissue and/or muscle and/or bone and the like. By way of non-limiting example, target tissue 522 can be selected as a part or parts of the tissue area 525 to which the supply of fluid is to be targeted, for example to promote healing, such as an area or areas of the wound that is slower to heal than the remainder of the wound or an area or areas of the wound which is deepened. It will be appreciated that the tissue area 525 need however not be a wound, a part of a wound or include a wound, and can be or include healthy tissue, healed wound tissue, scar tissue, muscle, bone and the like. [0175] The apparatus 500 includes a permeable layer 505 having at least one section 520 permitting molecules within the fluid to pass through the permeable layer 505 (generally in the direction indicated by arrows X) and deformable, for example, under pressure operatively imparted by the fluid on the permeable layer 505 towards the tissue area 525. It will be appreciated that the section 520 may make up the whole of the permeable layer 505 or any part thereof. The section 520 may permit molecules within the fluid to pass through the permeable layer 505 by diffusion and/or pore flow, for example as further discussed herein with reference to receptacles 10, 110, 210, 210A, 310, 410, 510, 610 and 710. The section 520 may further be flexible and/or stretchable such that it is deformable. By way of example, the section 520 can comprise the entirety of the permeable layer 505 as a non-porous membrane, a non-limiting example of which is flexible liquid silicone rubber as discussed further herein below, and thereby the section 520 permits molecules within the fluid to pass through the permeable layer 505 by diffusion alone while also being deformable.
[0176] The apparatus 500 is shown to further comprise a carrier layer 530 which is configured to define an aperture 535 such that, when applied to the tissue area 525, the carrier layer 530 is disposed between the permeable layer 505 and the tissue area 525 so as to position the aperture 535 between any target tissue 522 and the permeable layer 505. In this manner, by supplying fluid at a side of the permeable layer 505 opposite a side facing the carrier layer 530 as shown in Figure 65, the section 520 can deform into the aperture 535 and supply fluid to the target tissue 522. The aperture 535 may, for example, be any hole, slit, gap, opening or the like made, formed or otherwise defined through the carrier layer 530. It will be appreciated that the aperture 535 can be made, formed or otherwise defined in the carrier layer 530 to correspond to a shape and/or size and/or geometry of any intended target tissue 522. Conversly, the shape and/or size and/or geometry of the aperture 535 may act to define the target tissue 522 when the carrier layer 530 is applied to the tissue area 525. The size of the aperture 535 may be selected to ensure that it is smaller than the surface of the permeable layer 505. This can allow for the above described deformation of the section 520.
[0177] It will be appreciated that, where the section 520 makes up the whole of the permeable layer 505, only a part of the section 520 which is provided over the aperture 535 may necessarily deform into the aperture 535 when the permeable layer 505 is applied to the carrier layer 530. Accordingly, deformation of the section 520 with reference to apparatus 500 is intended to include reference to deformation of any part of the section 520 or the whole of the section 520.
[0178] Figure 66 shows an example embodiment of the apparatus 500. In accordance with this example embodiment, the apparatus 500 includes a receptacle 510 formed from a first wall portion 515a and an opposing second wall portion 515b. The receptacle 510 may, by way of non-limiting example, have the same features and structure as a receptacle 610 as shown in Figures 72 through 77 and discussed further herein, which can be formed from joining a first wall portion 615a and a second wall portion 615b as separate walls at a seam 665 or from a first wall portion 615a and a second wall portion 615b as a single wall. The receptacle 510 is applied so as to position the receptacle 510 at the tissue area 525 with the first wall portion 515a facing the tissue area 525. The first wall portion 515a in this embodiment has the permeable layer 505 comprising substantially the entirety of the first wall portion 515a. The first wall portion 515a may therefore be a membrane as described herein, for example with reference to receptacles 10, 110, 210, 210A, 310, 410, 610 and 710 with at least one section 520 permitting molecules within the fluid to pass through the first wall portion 515a from an interior of the receptacle 510.
[0179] In this example embodiment, the section 520 comprises substantially the entirety of the permeable layer 505 and thereby also substantially the first wall portion 515a. Accordingly, the section 520 is deformable under pressure imparted on the first wall portion 515a by the fluid contained in the interior of the receptacle 510. [0180] The apparatus 500 includes the carrier layer 530 to support or carry the first wall portion 515a thereon, and thereby the permeable layer 505, when the receptacle 510 is applied so as to be positioned at the tissue area 525. The carrier layer 530 may further provide cushioning between the tissue area and at least a part of the permeable layer 505. For example, the carrier layer 530 can be or can include in part a compressible material, for example a compressible foam material. The carrier layer 530 can be or can include an absorbent material and/or non-absorbent material as further described herein. The carrier layer 530 may still further be configured to adhere to at least a part of the tissue area 525, for example the carrier layer 530 can comprise adhesive at a tissue area 525 side thereof. This example embodiment will be described further with reference to the carrier layer 530 as a compressible foam material. The foam material may be adhesive backed, such as an adhesive backed absorbent foam, for example an adhesive backed absorbent foam rubber which allows the carrier layer 530 to be adhered to the tissue area 525. The carrier layer 530 need however not be adhesive backed and can, instead or in addition to comprising an adhesive backing, be affixed to the patient at or about the tissue area 525, for example by adhesive, such as adhesive tape.
[0181] As noted in accordance with this example embodiment, the carrier layer 530 is configured to define the aperture 535 such that, when applied to the tissue area 525, the carrier layer 530 is disposed between the first wall portion 515a of the receptacle 510 and the tissue area 525, thereby the aperture 535 is positioned between target tissue 522 and the section 520 of the permeable layer 505. The aperture 535 can be defined in the carrier layer 530 prior to or in the course of applying the carrier layer 530 to the tissue area 525. For example, the carrier layer 530 can have a perforated region (not shown) which allows tearing out the perforated region to define the aperture 535 in the carrier layer 530. The aperture 535 can also be pre-cut into the carrier layer 530, for example during manufacturing, or manually using a cutter, prior to or in the course of applying the carrier layer 530 to the tissue area 525. It will be appreciated that there are several ways in which the carrier layer 530 can be caused to define the aperture 535, whether in the course of its application to the tissue area 525 or prior thereto.
[0182] When the carrier layer 530 and the the receptacle 510 are positioned at the tissue area 525 as shown in Figure 66(a), the interior of the receptacle 510 receives the fluid from a fluid source 40, for example as described with reference to receptacle 10, or may already contain the fluid. It will be appreciated that, when the receptacle 510 receives the fluid, the fluid may inflate or partially inflate the receptacle 510, but this need not necessarily occur. Introducing the fluid into the interior of the receptacle 510 in this regard can be performed in a similar manner as described herein with reference to receptacles 10, 110, 210, 210A, 310, 410, 610 or 710.
[0183] The fluid in the receptacle 510 imparts pressure on the permeable layer 505 towards the tissue area 525, which can cause at least the part of the section 520 disposed over the aperture 535 to deform into the aperture 535. Figures 66(a) through (e) show in sequence how the section 520 deforms to take a substantially convex shape towards the tissue area 525 as the receptacle 510 is inflated from an uninflated or partially inflated position of the receptacle 510, and as the fluid in the interior of the receptacle 510 imparts more and more pressure on the permeable layer 505 and thereby the section 520. Consequently, the deformation of the section 520 in this manner can be proportional to the pressure imparted on the permeable layer 505 by the fluid contained in the interior of the receptacle 510. To facilitate this deformation, the receptacle 510 can be configured for inflation biased towards deforming the section 520. For example, the second wall portion 515b may have a thickness that is greater than the thickness of the first wall portion 515a and thereby the section 520, similar to that as described with reference to receptacle 10 above, rendering the section 520 more susceptible to deformation under pressure imparted by the fluid on the interior of the receptacle 510. For example, the section 520 can have a thickness of between approximately 20pm to 90pm, or between approximately 50pm to 70pm, between approximately 40pm to 70pm, or between approximately 45pm to 65 pm, or between approximately 50pm to 60pm. The section 520 can have a thickness of approximately 55pm. Correspondingly, the second wall portion 515b may have a thickness of between approximately 100pm to 300pm, or between approximately 100pm to 250pm, or between approximately 150pm to 250pm or between approximately 175pm to 225pm. The second wall portion 515b may have a thickness of approximately 200pm. In some embodiments, the second wall portion 515b may have a wall thickness of approximately 160pm.
[0184] The first wall portion 515a, thereby also the permeable layer 505 and the section 520, may further or alternatively be formed of a material that is flexible and/or stretchable, such as liquid silicone rubber as discussed further herein. The permeable layer 505 and/or the section 520 may still further or alternatively have a convex shape disposed towards the tissue area 525 when the receptacle 510 is applied to the carrier layer 530 in an uninflated postion of the receptacle 510. The first wall portion 515a may yet further or alternatively have a greater surface area relative to the second wall portion 515b in an uninflated position of the receptacle 510, causing the first wall portion 515a to be biased towards the tissue area 525 when the receptacle 510 is applied, which can aid in the deformation of the section 520.
[0185] As exemplified in Figure 67, the aperture 535 can also be chamfered 540 at a side of the carrier layer 530 facing the first wall portion 515a in order to facilitate and/or accommodate deformation of the section 520. In addition to chamfering or alternatively, where the carrier layer 530 is compressible, the edge of the aperture 535 may also become sloped during deformation of the section 520, as the section 520 presses against the carrier layer 530 causing the edge of the aperture 535 to conform to the shape of the deformation of the section 520.
[0186] As represented in Figure 78, it will be appreciated that the apparatus 500 thereby allows for applying a carrier layer 530 defining one or more apertures 535 to a tissue area 525, and thereafter applying a permable layer 505, per the above example as a first wall portion 515a of a receptacle 510, to the carrier layer 530 so as to position the permeable layer 505 over the one or more apertures 535 of the carrier layer 530. Thereafter, supplying fluid at a side of the permeable layer 505 opposite a side facing the carrier layer 530, or per the above example by introducing the fluid into the interior of the receptacle 510, enables supplying molecules within the fluid to target tissue, over which the one or more apertures 535 are disposed, through a section 520 of the permeable layer 505. As such, and per the aforementioned example embodiment, when the receptacle 510 is applied to the carrier layer 530 at the tissue area 525 in the manner described above with reference to Figure 66, the aperture 535 allows the receptacle 510 to supply fluid to the target tissue 522 through at least the part of the section 520 which is disposed over the aperture 535. As such, target tissue 522 may be a part of the tissue area 525 with which the aperture 535 is specifically aligned during application of the carrier layer 535, or it may merely be any part of the tissue area 525 over which the aperture 535 is disposed when the carrier layer 530 is applied to the tissue area 525. The apparatus 500 accordingly allows the supply of molecules within the fluid to be targeted towards any such target tissue 522. It will be appreciated that the carrier layer 530 need not be the only layer disposed between the first wall portion 515a of the receptacle 510 and the tissue area 525, and a further layer or layers can also be disposed between the first wall portion 515a and the tissue area 525 and even the target tissue 522 without impinging on the functioning of the apparatus 500, such as a medical gauze layer, padding layer, suitable plastic wrap, porous layer or absorbent layer which may further permit molecules within the fluid to pass therethrough.
[0187] It will further be appreciated that neither deformation of the section 520 nor contact between the section 520 and the target tissue 522 is required in order for the apparatus 500 to supply molecules within the fluid to the target tissue 522. As the section 520 allows molecules within the fluid to pass through the permeable layer 505, once a fluid is supplied to the receptacle 510 as applied at the tissue area 525, molecules within the fluid can in turn be supplied to the target tissue 522 through the section 520 and the aperture 535, whether the section 520 is undeformed, partially deformed or deformed to the extent that it contacts the target tissue 522. As further described herein, permeability in the present context includes reference to diffusion and/or pore-flow. Accordingly, supply of the fluid in this manner may occur by diffusion and/or pore flow through the section 520. In one example, where the first wall portion 515a and the second wall portion 515b of the receptacle 510 are non-porous, molecules within the fluid can pass through the section 520 by diffusion alone.
[0188] The first wall portion 515a having the permeable layer can be configured to be non-destructively removable from the carrier layer 530 subsequent to it being applied thereto. This allows removing the receptacle 510 from the tissue area 525 and thereby also from the carrier layer 530 after the supply of fluid to the target tissue 522 without necessitating removal of the carrier layer 530 from the tissue area 525, which may act to reduce trauma to the tissue area 525. Accordingly, once a receptacle 510 is removed, a further receptacle, for example a receptacle similar to receptacle 510, the same receptacle 510 or any receptacle 10, 110, 210, 210A, 310, 410, 610, 710 as disclosed herein, can again be applied to the same carrier layer 530 so as to be positioned at the tissue area 525 and the carrier layer 530 to further supply a fluid to the target tissue 522 in a similar manner as described above. This allows, for example, for the target tissue 522 to be inspected and/or for a different fluid to be supplied to the same target tissue 522 and/or for a damaged receptacle to be replaced without requiring removal of the carrier layer 530.
[0189] The carrier layer 530 may also be configured to adhere to the permeable layer 505, for example to at least a part of the first wall portion 515a. For example, the carrier layer 530 can comprise adhesive at a first wall portion 515a side thereof to assist in retaining the receptacle 510 in position at the tissue area 525. It will be understood that this may, for example, assist in allowing the section 520 to deform into the aperture 520.
[0190] As used in this specification, the terms ‘diffuse’ and ‘diffusion’ refer to the process of molecular diffusion. Molecular diffusion is a process by which molecules within a fluid can pass from an upstream side to a downstream side of a material (e.g. a polymer film). Molecular diffusion involves three stages: 1) sorption - the molecules within the fluid on the upstream side of the material are adsorbed onto the upstream surface of the material and then absorbed into the material; 2) diffusion - the molecules diffuse through the material. The direction of diffusion is dependent on a concentration gradient of the molecules within the material. The diffusion stage may be facilitated by the opening and closing of free-volume elements in the material; 3) desorption - the molecules may be desorbed from the downstream surface of the material into the fluid on the downstream side of the material. If the fluid into which the molecules desorb is a gas, then the molecules may be in a gas phase, or dispersed in the gas, after desorption. If the fluid into which the molecules desorb is a liquid, then the molecules may be in a liquid phase, or dispersed in the liquid, after desorption. The molecules will not remain in a liquid phase or a gas phase throughout the diffusion stage. Instead, during this stage, the molecules are considered to be molecularly dispersed in the material. The number of molecules that pass from the upstream side to the downstream side per unit time via molecular diffusion may be a function of, for example: the partial pressures on the upstream and downstream sides, the concentrations on the upstream and downstream sides, the thickness of the material, and the area of the material through which the molecular diffusion can occur.
[0191] As used in this specification, the term ‘pore’ refers to pores through which fluid molecules may move from an upstream side towards a downstream side of a material (e.g. a porous foam). The movement of molecules through pores, from an upstream side towards a downstream side of a material, is known as pore flow. For molecules to pass completely through a material via pore flow alone, there must be one or more pores that provide a continuous pathway from the upstream side to the downstream side. When molecules move from the upstream side to the downstream side of a material via pore flow, they may remain in a particular phase (e.g. liquid or gas) throughout. [0192] The material may be a membrane that is adapted to allow molecules within the fluid to diffuse through the membrane. The membrane may be hydrophobic. Alternatively the material can be treated so that it repels water, for example with a hydrophobic coating or other hydrophobic material. In some embodiments, the membrane is substantially pore-free. Accordingly, in those embodiments the membrane material may have no visible discontinuities or pores that are visible with an optical or electron microscope, for example a scanning electron microscope such as a Jeol IT300, at a resolution on the order of 1 micrometre. Transport of fluid through the membrane does not substantially take place via porosity of the membrane. The diffusion transport mechanism provides a more even distribution of fluid molecules diffusing from the receptacle to the wound area when compared with materials having micropores or porous membranes. This is because, some of the pores may become blocked, by exudate for example, causing an uneven distribution of molecules across the membrane. The substantially pore-free membrane helps to prevent wound exudate from clogging or entering the receptacle 10. However, transport by porosity may occasionally take place, for example, due to the possibility of manufacturing defects occurring in the membrane. The membrane is substantially impermeable to bulk transport (also referred to herein as bulk flow) of fluid. That is, the molecules within the fluid cannot pass from one side of the membrane to the other side of the membrane without becoming molecularly diffused, and therefore cannot pass through the membrane in the fluid form in which they enter it e.g. gas or liquid form. The membrane being impermeable to bulk transport (or bulk flow) of fluid further helps to prevent exudate from entering the receptacle 10.
However in some examples, water vapour molecules may pass through the permeable layer 505 from the interior of the receptacle 10, 110, 210, 210A, 310, 410, 510, 610, 710 towards the tissue area 525 or from the tissue area 525 toward the interior of the receptacle 10, 110, 210, 210A, 310, 410, 510, 610, 710, depending on the humidity levels of the fluid provided and the environment of the tissue area 525. [0193] Suitable materials for the membrane include any liquid silicone rubber, such as any one of, or a combination including, a liquid silicone rubber having a 70 Shore A hardness elastomer (Silopren® LSR 4070 silicone from Momentive) or a 40 Shore A hardness elastomer (Silopren® LSR 4840 silicone from Momentive); pre-formed silicone sheet or film; silicone hydrogel; multilayer, blown, LLDPE/CaCO3 films, for example resin LLDP/CaCO3 from Reifenhauser (BF110, BF106); materials having silicone coatings; high consistency rubber silicone (HCR); KEG-2000-60-A/B (Shore A hardness of approximately 60) or KEG-2000-40-A/B (Shore A hardness of approximately 40) from Shin Etsu; and a copolymer that comprises polyethylene and polyethylene oxide).
[0194] In some embodiments, the membrane is made of a liquid silicone rubber having a 60 Shore A hardness that forms sheets having a thickness of 60 micrometres or of 50 micrometres. In some embodiments, the membrane is made of a liquid silicone rubber having a 40 Shore A hardness that forms sheets having a thickness of 60 micrometres or of 50 micrometres. These materials have been found to have suitable durability and suitable ability to hold their shape. The fluid inlet conduit 50 may also be made of this material. In this case, the fluid inlet conduit 50 may be integrally formed with the receptacle 10 or it may be connected to it via a seal. Alternatively, the fluid inlet conduit 50 may be made of soft, pliable material such as silicone tubing, for example Versilic® silicone tubing.
[0195] In this context, and with reference to the apparatus 500 as shown in Figures 65 and 66, it will be appreciated that supply of molecules within the fluid in this manner can be targeted at any target tissue 522 within a tissue area 525. For example, where the fluid is a therapeutic gas or liquid and/or comprises therapeutic molecules, the carrier layer 530 can be caused to define an aperture 535 corresponding with the shape and/or location and/or geometry of any target tissue 522, as may be required, to effectively target the target tissue 522 for treatment by a supply of therapeutic molecules within the fluid, for example, through a membrane as a permeable layer 505.
[0196] Figure 68 shows a further example embodiment of the apparatus 500 similar to that of Figure 66 and like features are given like reference numbers. However, in this example embodiment of Figure 68, a plurality of carrier layers
530.1 through 530. n define a plurality of apertures 535.1 through 535. n. It will be appreciated that this need not be a plurality of carrier layers 530.1 through 530. n and may also be a single carrier layer 530 defining the plurality of apertures
535.1 through 535. n without impinging on the operation of the apparatus. The plurality of apertures 535.1 through 535. n correspond to target tissue 522, whether the target tissue 522 is a particular part or parts of the tissue area 525 with which the apertures 535.1 through 535. n are to be aligned, or merely the part or parts of the tissue area 525 over which the apertures 535.1 through 535. n are incidentally disposed when the carrier layers 530.1 through 530. n are applied to the tissue area 525.
[0197] In this embodiment the carrier layers 530.1 through 530. n are disposed between the section 520, which can comprise a part or substantially the entirety of the first wall portion 515a as a permeable layer 505, and the tissue area 525 so that the section 520 of the receptacle 510 can deform into each of the plurality of apertures 535.1 through 535. n to supply fluid to the target tissue 522. It will be appreciated that the receptacle 510 can alternatively comprise the first wall portion 515a as a permeable layer 505 which has a plurality of different sections 520, each of which allows molecules within the fluid to pass through the permeable layer 505 and each of which is deformable. In such a variation, the receptacle 510 can be applied to the carrier layers 530.1 through 530. n positioned at the tissue area 525 so as to substantially align the plurality of apertures 535.1 through 535. n with the plurality of sections 520. In this manner, each section of the plurality of sections 520 may deform into an aperture of the plurality of apertures 535.1 through 535. n and supply molecules within the fluid to target tissue 522. [0198] In accordance with the variations of this example embodiment of the apparatus 500, the supply of molecules within the fluid can be targeted at any number of parts of a given tissue area 525, which may be advantageous where the tissue area 525 has a large surface area. For example, various target tissue 522 across a large tissue area 525 can be targeted for treatment where the fluid is a therapeutic fluid and/or has therapeutic molecules therewithin.
[0199] It will be appreciated that the carrier layer 530 in any embodiment of the apparatus 500 described herein need not be a continuous carrier layer 530 and, as shown in Figure 68, can be a plurality of carrier layers 530.1 through 530. n applied to the tissue area, for example in a substantially side-by-side configuration. As such, the plurality of carrier layers 530.1 through 530. n may collectively define the apertures 535.1 through 535. n. Each of the plurality of carrier layers 530.1 through 530. n can therefore be applied so as to be disposed between the permeable layer 505 and, in this example embodiment constituting the first wall portion 515. a of the receptacle 510, the tissue area 525 such that the section 520 allows the supply of molecules within the fluid to target tissue 522 through the apertures 535.1 through 535. n.
[0200] Figure 69 shows a cross-sectional schematic side representation of an apparatus 500 similar to that of Figure 65 and like features are given like reference numbers, but with the apparatus 500 comprising a plurality of permeable layers 505.1 through 505. n. It will be appreciated that the the permeable layers 505.1 through 505. n may be disposed about the tissue area 525 to be separate from one another in various different configurations, denoted by the break shown in chained lines, as may be required for any particular tissue area 525. By way of non-limiting example, the permeable layers 505.1 through 505. n can be disposed side-by-side at a tissue area 525. In the example configuration where the permeable layers 505.1 through 505. n are disposed side-by-side at a tissue area 525, the permeable layers 505.1 through 505. n may also overlap to any extent. [0201] In this manner, supplying fluid at a side of each of the permeable layers
505.1 through 505. n opposite a side facing a carrier layer 530, as shown in Figure 69, allows the section 520 of each of the permeable layers 505.1 through 505. n to supply molecules within the fluid to target tissue 522 through an aperture 535 of a carrier layer 530.
[0202] It will again be appreciated that in any embodiment of the apparatus 500 described herein, the apparatus 500 need not necessarily comprise only a single carrier layer 530 and, as shown in Figure 69, can rather comprise a plurality of carrier layers 530.1 through 530. n, each carrier layer 530 of the plurality of carrier layers 530.1 through 530. n defining an aperture 535 or apertures 535.1 through 535. n. The carrier layers 530.1 through 530. n can then be applied to the tissue area 525 in a layered manner so as to align the aperture 535 or apertures
535.1 through 535. n of the carrier layers 530.1 through 530. n. In such an embodiment, the section 520 of the permeable layer 505 or plurality of permeable layers 505.1 through 505. n can allow the supply of fluid to target tissue 522 through the apertures 535.1 through 535. n of the plurality of carrier layers 530.1 through 530.n.
[0203] Figure 70 shows an example embodiment of the apparatus 500 of Figure 69, which includes a plurality of the receptacles 510.1 through 510.n disposed side-by-side at a tissue area 525 and each of which comprise a first wall portion 515a as a permeable layer 505 of the plurality of permeable layers 505.1 through 505. n. It will be appreciated that the receptacles 510.1 through 5 lO.n need not be disposed side-by-side at the tissue area 525 and can be disposed about the tissue area 525 as may be required. The apparatus 500 is further shown to comprise a carrier layer 530 defining a plurality of apertures 535.1 through 535. n. As in all the previous embodiments of the apparatus 500, the carrier layer 530 can be caused to define the plurality of apertures 535.1 through 535. n either before or in the course of applying the carrier layer 530 to the tissue area 525. [0204] Each of the receptacles 510.1 through 5 lO.n is adapted to receive a fluid and to be applied to the carrier layer 530 so as to be positioned at the tissue area 525 with its first wall portion 515a facing the tissue area 525. In this manner, each of the receptacles 510.1 through 510.n enables the supply of molecules within a fluid to target tissue 522 within the tissue area 525 in a similar manner as described herein with reference to Figure 66, through the plurality of apertures 535.1 through 535. n.
[0205] It will be appreciated that each of the receptacles 510.1 through 5 lO.n can comprise a part or substantially the entirety of its first wall portion 515a, thereby its permeable layer 505, as a section 520 allowing molecules within the fluid to pass therethrough. The section 520 of each of the receptacles 510.1 through 5 lO.n can also be deformable. The receptacles 510.1 through 5 lO.n may further, and in addition to these features, include features similar to those described herein after with reference to receptacles 10.
[0206] The carrier layer 530 is applied to the tissue area 525, after which the receptacles 510.1 through 5 lO.n can be applied to the carrier layer 530 so that the carrier layer 530 is disposed between the tissue area 525 and each of the a first wall portions 515a of the receptacles 510.1 through 5 lO.n as shown in Figure 70.
[0207] In an embodiment where a receptacle 510 comprises substantially the entirety of its first wall portion 515a as an above described section 520, this can alleviate the need to position a particular part of the first wall portion 515a over an aperture 535, rather only requiring any part of the first wall portion 515a over an aperture 535. In the present example embodiment, this may enable any part of a first wall portion 515a of any one of the receptacles 510.1 through 5 lO.n to be positioned over any aperture 535 of the plurality of apertures 535.1 through 535. n without impinging on the function of the apparatus 500. It will be appreciated that each of the receptacles 510.1 through 5 lO.n and apertures 535.1 through 535. n may have a different size and/or shape and/or geometry, thereby enabling supply of fluid to target tissue 522 of various sizes, shapes and/or geometries. Therefore, when fluid is received in the interior of each of the receptacles 510.1 through 510.n, for example by a manifold 80 and/or fluid inlet conduits 50 as described with reference to receptacles 10 herein below, the receptacles 510.1 through 510.n enable the supply of molecules within the fluid to any target tissue 522 within a tissue area 525 through their respective sections 520 and the apertures 535.1 through 535. n of the carrier layer 530 or plurality of carrier layers 530.1 through 530.n.
[0208] Figure 71 shows yet another example embodiment of the apparatus 500 of Figure 69, wherein the plurality of permeable layers 505.1 through 505. n are defined by a first wall portion 715a and an opposing second wall portion 715b of a receptacle 710 respectively. In this example embodiment, the first wall portion 715a and the second wall portion 715b are flexible, rendering the receptacle 710 suitably flexible so as to be manipulated during application of the receptacle 710 to a carrier layer 530 and/or positionable substantially within a cavity as a tissue area 525 as shown in Figure 71. Either or both the first wall portion 715a and the second wall portion 715b may have substantially the same features as described herein with reference to a first wall portion 515a according to any embodiment of the receptacle 510. By non-limiting example, both the first wall portion 715a and the second wall portion 715b may have microstructures 60 on an outer surface thereof. Additionally or alternatively, one of the first wall portion 715a and the second wall portion 715b, or both the first wall portion 715a and second wall portion 715b, may have ridges 96 on an inner surface thereof, as described herein.
[0209] It will be appreciated that the first wall portion 715a and the second wall portion 715b need not be separate walls joined together and can comprise portions of a single wall. It will be further appreciated that a receptacle 510, 610, 710 in accordance with any embodiment discussed herein and which comprises a first wall portion 515a, 615a, 715a and a second wall portion 515b, 615b, 715b as the same flexible wall or separate flexible walls joined together, may be rendered suitably flexible so as to be manipulated during application of the receptacle 510, 610, 710 to the carrier layer and/or positionable substantially within a cavity as a tissue area 525.
[0210] In this context, at least one carrier layer 530 defining an aperture 535 or a plurality of apertures 535.1 through 535. n as shown in Figure 71 can be applied, for example, to a cavity of the tissue area 525, after which the receptacle 710 is applied to the carrier layer 530 so as to be positioned at least partly within the cavity as shown in Figure 71. In the example embodiment where the first wall portion 715a and second wall portion 715b are permeable layers 505.1 through 505. n, each having a section 520 as exemplified in Figure 71, the section 520 of each of the first wall portion 715a and second wall portion 715b is thereby able to deform into an aperture 535 of the apertures 535.1 through 535. n and supply molecules within the fluid to target tissue 522 within a cavity of the tissue area 525 when fluid is received in the interior of the receptacle 710.
[0211] In a variation of a receptacle 510, 610, 710 as described herein and which comprises the first wall portion 515a, 615a, 715a and the second wall portion 515b, 615b, 715b as a single wall, it will be appreciated that the single wall may be a permeable layer 505. By way of non-limiting example, in such a variation of the receptacle 510, 610, 710 the permeable layer 505 can accordingly have a plurality of sections as a section 520 of the first wall portion 515a, 615a, 715a and a section 520 of the second wall portion 515b, 615b, 715b. The plurality of sections 520 of a permeable layer 505 need not however comprise a section 520 of both the first wall portion 515a, 615a, 715a the second wall portion 515b, 615b, 715b, and may also be a plurality of sections 520 provided at one of the first wall portion 515a, 615a, 715a and the second wall portion 515b, 615b, 715b.
[0212] The fluid supply to the receptacle 10, or any one of the other receptacles 110, 210, 210A, 310, 410, 510, 610 or 710 described in this disclosure, may be continuous or it may be intermittent, i.e. supplied periodically. The fluid may have a concentration of up to 100%, for example 99% or 95% or 90% and/or a pressure of between about 6 mmHg and 50 mmHg above atmospheric pressure, for example between about 10 mmHg to 40 mmHg or about 20 mmHg to 30 mmHg.
[0213] The receptacle 10, or any of the receptacles 110, 210, 210A, 310, 410, 510, 610 or 710 described in this disclosure, may come in various sizes according to the size of a tissue area. When inflated it may have any reasonable shape, for example a spheroid, ovoid, cuboid or cylindrical shape. The one or more walls include a tissue facing portion that faces the tissue of the patient in use. As seen in Figure 1, the receptacle 10 has a flattened ovoid cross-sectional shape, such that the tissue facing portion of the one or more walls provides a substantial tissue-facing surface, which in this example is a wound-facing surface 12 for contacting the wound when the receptacle is at least partially inflated. The wound facing surface 12 of the receptacle 10 is made of the membrane adapted to allow molecules to diffuse from the receptacle to the wound 22. The wound facing surface 12 of the receptacle 10 is pressed against the wound surface and forces exudate to move outwards to the periphery of the wound 22. This displacement of exudate from the wound is due to the pressure that the receptacle 10 applies to the wound 22. The wound 22 ‘experiences’ the highest pressure from the receptacle 10 in the radial centre and the lowest pressure from the receptacle 10 at the radial extreme due to the shape of the receptacle 10. This pressure gradient can force exudate to move outwards. Forcing the exudate to move outwards may help to prevent or mitigate pooling of exudate between the wound facing surface 12 of the receptacle 10 and the wound 22. Preventing or mitigating this pooling may be beneficial as it may help to prevent exudate from impeding the movement of molecules from the inside of the receptacle 10 to the wound 22. Whilst exudate is forced outwards from the wound 22, the wound 22 may remain moist. Maintaining a moist environment within and around a wound can be important as a dry environment within and around the wound may be detrimental to the healing process. The receptacle configuration of Figure 1 also provides a substantially even distribution of fluid to the wound 22 as a result of the substantial area of the wound facing surface 12. The diffusion of the fluid molecules through the membrane adapted to allow molecules to diffuse from the receptacle 10 to the wound 22 further provides for a substantially even concentration of fluid being applied across the wound 22.
[0214] With reference to the various example embodiments of the apparatus 500 as described herein with reference to Figure 65 through Figure 71, and as exemplified in Figures 66(c) through (e), it will be appreciated that the extent of the deformation of a section 520 of a permeable layer 505 can be such that the section 520 can contact the target tissue 522 through an aperture 535 or apertures 535.1 through 535. n. It will be appreciated that this contact may act to improve the supply of molecules within the fluid through the section 520 to the target tissue 522. Contact between the section 520 and target tissue 522 can, for example, be further facilitated by selecting an appropriate shape and/or size of the receptacle 510, as a larger receptacle 510 and/or certain shapes may be capable of a greater degree of distension. This contact between the section 520 and target tissue 522 can still further be facilitated by considering a number of factors, including but not limited to, thickness of the carrier layer 530, material selection of the section 520, thickness of the section 520, the size of the target tissue 522, the material selection of the carrier layer 530 and the compressibility of the material of the carrier layer 530. For example, a thicker carrier layer 530 provides increased cushioning between the permeable layer 505 and the tissue area and/or absorptive properties when compared with a thinner carrier layer 530. However, with a thicker carrier layer 530 more pressure is required to facilitate contact between between the section 520 and the target tissue 522. Alternatively, a thinner carrier layer 530 may allow contact between the section 520 and the target tissue 522, but may provide reduced cushioning between the permeable layer 505 and the tissue area and/or absorptive properties. In one example, the carrier layer 530 may be between 2mm and 5mm thick. In this context, and in a similar manner as described with reference to receptacle 10, where exudate is present at the tissue area 525, contact between the section 520 and the target tissue 522 can force exudate to move outwards towards the periphery of the aperture 535 or apertures 535.1 through 535. n. Advantageously, where exudate is forced towards the the periphery of the aperture 535 or apertures 535.1 through 535. n, this can mitigate against exudate pooling at the target tissue 522 and forming a barrier between the section 520 and target tissue 522 which may hinder supply of fluid to the target tissue 522.
[0215] In an embodiment where the carrier layer comprises an absorbent material, exudate can also be absorbed by the carrier layer 530 and this absorbtion of exudate by the carrier layer 530 can occur substantially concurrently with the supply of fluid to the target tissue 522.
[0216] Where the apparatus 500 comprises a carrier layer 530, contact between a section 520 and the target tissue 522 need however not occur. Fluid can be delivered to the target tissue 522 through the aperture 535 via the section 520 without contacting the target tissue 522. In an example having an absorptive carrier layer 530, the carrier layer 530 can be configured to wick exudate from the target tissue 522 and thereby reduce or mitigate against pooling of exudate at the target tissue 522. The carrier layer 530 can also be configured to wick exudate in addition to the section 520 contacting the target tissue 522, thereby further facilitating movement of exudate outwards towards the periphery of the aperture 535 or apertures 535.1 through 535. n for absorbtion by the carrier layer 530. Exudate can also, or additionally be drawn away by way of negative pressure applied to a compartment 35 defined by a cover 30 as described further herein below.
[0217] Still further, and with reference to the embodiment of the apparatus 500 shown in Figure 67, an edge of an aperture 535 or apertures 535.1 through 535. n of a carrier layer 530 can be chamfered 540 at a side of the carrier layer 530 facing the permeable layer 505 (as the first wall portion 515a in the example of Figure 67) in order to facilitate and/or accommodate deformation of the section 520. In addition to being chamfered or alternatively, where the carrier layer 530 is compressible, the edge of the aperture 535 may also become sloped during deformation of the section 520, as the section 520 presses against the carrier layer 530 causing the edge of the aperture 535 or apertures 535.1 through 535. n to conform to the shape of the deformation of the section 520. It will be appreciated that the chamfer 540 and/or sloping of the edge of the aperture 535 can act to allow the section 520 to deform so that at least a part thereof takes up substantially the whole of an aperture 535, reducing exudate pooling in any void of the aperture 535. Pooling of exudate may be detrimental to the supply of fluid to the target tissue 522 and/or may compromise tissue exposed to the pooled exudate.
[0218] In the embodiment of Figure 2, the receptacle 10 is shown in use, at least partially inflated, and has an undulating surface when at least partially inflated that may conform particularly well to complex, three-dimensional wound surfaces such that a larger proportion of the wound 22 is contacted by the woundfacing surface 12 of the membrane. The undulating surface may also help facilitate exudate flow away from the wound 22. This embodiment is described with reference to a wound. However, it will be appreciated that it is, in general, applicable to other tissue areas as described elsewhere in this disclosure.
[0219] In some embodiments, the receptacle 10, or any one of the receptacles 110, 210, 210A, 310, 410, 510, 610 or 710 described in this disclosure, may function as a fluid reservoir in which a volume of fluid may be stored. This can be beneficial if the fluid supply to the receptacle 10 is interrupted, due, for example, to a disconnection of the fluid source 40 from the fluid inlet conduit 50 or a malfunction of the fluid source 40. In some embodiments, the receptacle 10 is filled with fluid to ensure a fluid supply to the wound 22 in the event of disruption of the fluid supply from the fluid source 40. The filling of the receptacle 10 may be carried out by a clinician prior to positioning the receptacle 10 at the wound area 20 of the patient or during use of the apparatus.
Alternatively, the receptacles 10 may be pre-filled with the fluid during manufacture of the apparatus, for example at the site of manufacture.
[0220] In some embodiments, for example for some wound geometries, various methods and configurations may be used to improve contact between the receptacle 10, or any one of the receptacles 110, 210, 210A, 310, 410, 510, 610 or 710 described in this disclosure, and the wound 22. In a first method, a material (such as an absorbent foam) may be placed over the receptacle 10 after the receptacle 10 has been placed on the wound 22, and prior to any cover 30 being applied. The material may be rolled or folded so as to press the receptacle 10 into the wound 22 when the cover 30 is applied. The cover 30 may, for example, comprise a bandage as is discussed later. In a second method, the receptacle 10 may be inflated prior to the cover 30 being placed over the receptacle 10. This may ensure that the receptacle 10 contacts the wound 22 such that when the cover 30 is attached, the receptacle 10 is pushed into contact with the wound 22.
[0221] As shown in Figure 1, embodiments of the receptacle 10 include a plurality of structures, for example microstructures 60, arranged on the wound facing surface 12 of the receptacle 10. Whilst the microstructures 60 are shown on only a portion of the receptacle 10, they may cover one or more other portions of the one or more walls 15 of the receptacle 10, or of any of the receptacles 110, 210, 210A, 310, 410, 510, 610, 710 described in this disclosure. In an embodiment, the microstructures may be present on each of the one or more walls 15 of the receptacle 10. A benefit of the receptacle 10 having microstructures 60 that may cover one or more other portions of the one or more walls 15 of the receptacle 10 is that the receptacle 10 (or any of the receptacles 110, 210, 210A, 310, 410, 510, 610, 710) can be applied to the wound 22 in any orientation and the microstructures will contact the wound 22.
[0222] Whilst Figure 1 shows a schematic representation of the microstructures 60, Figure 1 A shows a view of the receptacle 10 having a plurality of microstructures 60 on a wall 15 of the receptacle. The microstructures 60 are part of the receptacle 10 and whilst the microstructures are shown arranged on the receptacle 10 of the embodiment of Figure 1, they may be included in any of the embodiments of the receptacle(s) described and illustrated in this disclosure. The microstructures are structures of microscale dimensions that are configured to contact the wound area 20 of the patient. The microstructures 60 may be made of the same material as the membrane adapted to allow molecules to diffuse through it and from the receptacle 10 to the wound 22. The microstructures 60 are positioned on and protrude from the wound facing surface 12. The microstructures may exert forces on the wound. These forces may result in microstresses that stretch the underlying cells and cause them to take on the same signalling pathways as those affected by growth factors. This can encourage cell growth. The molecules within the fluid in the receptacle 10 may diffuse through the membrane of the receptacle 10 and into the wound 22, and/or through the membrane of the receptacle, through the microstructures 60, and into the wound 22.
[0223] The microstructures 60 may be of a semi-spherical, spherical, pyramidal, conical, domed or frustoconical shape, or have a trapezoidal, semi-circular or parabolic shape in profile, or may be formed as small dimples in the surface of the membrane. Any comers or edges of the microstructures 60 may be rounded as sharp edges can cause damage to cells. The microstructures 60 may be formed as elongate structures having e.g. a semi-circular, parabolic, domed or trapezoidal cross-sectional profile as described above, or they may comprise discrete structures, each having e.g. a pyramidal or semi-spherical or parabolic, domed or conical or frustoconical shape. In some embodiments the microstructures 60 are configured in arrays. The microstructures 60 may have a base dimension, e.g. a width or a diameter of between approximately 100 to 400 micrometres, for example between approximately 250 to 350 micrometres, or between approximately 280 to 330 micrometres. The microstructures 60 may be spaced from one another at a distance of between about 0.5mm to 3mm between the bases of adjacent microstructures 60. The microstructures 60 may have a height dimension of between approximately 100 to 200 micrometres, for example between approximately 125 to 175 micrometres. In some embodiments, the microstructures may have a base dimension of approximately 310 micrometres and a height dimension of approximately 150 micrometres. The cells typically have a height dimension of between approximately 7 micrometres and 15 micrometres, for example 10 micrometres. It will be appreciated by the skilled person that the microstructures 60 illustrated in Fig. 1 are not to scale. Whilst the features of the microstructures 60 are described with reference to the receptacle 10, it will be apparent that one or more of the features may also be applied to any of the other receptacles 110, 210, 210A, 310, 410, 510, 610 or 710 described in this disclosure.
[0224] The microstructures 60 can be used in combination with a rough surface 312, 314, on the outer surface of wall 315, as further described below.
[0225] The cover 30 is configured to at least partially enclose the receptacle 10 to form a compartment 35 substantially bounded by the cover 30, the receptacle 10 and the wound area 20. In some embodiments, for example as shown in Fig. 1, the cover 30 is positionable over the receptacle 10 to fully enclose the receptacle 10 to form the compartment 35. The cover 30 may also be applied to any of the receptacles 110, 210, 210A, 310, 410, 510, 610 or 710 described in this disclosure.
[0226] In embodiments of the receptacle 510 or receptacles 510.1 through 510.n, it will be appreciated that positioning a cover 30 as described with reference to receptacle 10 over the receptacle 510, the carrier layer 530 and the tissue area 525 can act to hold the receptacle 510 or receptacles 510.1 through 510.n in place over the tissue area 525. Further, the cover 30 can constrain deformation of the receptacle 510 or receptacles 510.1 through 510.n away from the tissue area 525 as fluid enters the interior of the receptacle 510 or during inflation of the receptacle 510. Positioning the cover 30 in this manner can thereby facilitate deformation of a section 520 into an aperture 535 or apertures 535.1 through 535. n.
[0227] In some embodiments, the cover 30 consists of a wall or walls configured to enclose the receptacle 10 and to seal to the healthy skin 24 adjacent the wound 22. A seal 32 for this purpose may comprise an adhesive in the form of an adhesive bead or strip at a sealing surface of the cover 30 or it may be a suction seal. The cover 30 may include a layer of absorbent material 75, seen in Figure 13, such that any exudate from the wound that reaches the cover is absorbed into the layer of absorbent material 75. The absorbent material 75 may be a fibrous fabric. The absorbent material 75 may form part of the cover 30, or it may be provided as a separate layer for use with the cover 30. For example, the absorbent material 75 may be wrapped around a limb or other body part of the patient that has the wound. The cover 30 may be placed over the absorbent material 75. The absorbent material 75 forms part of the cover 30 such that the compartment substantially bounded by the cover 30, the receptacle 10 and the wound area 20 includes the absorbent material 75. The absorbent material 75 may allow exudate to evaporate to the ambient environment. Alternatively, the cover 30 may be impermeable to the bulk flow of fluid. This arrangement is in contrast to some known solutions in which the absorbent material 75 is provided directly over the wound for collecting exudate. In these known solutions, the exudate may saturate and ‘clog’ the absorbent material 75. If this occurs, it may impede movement of molecules from the inside of the receptacle to the wound surface, or lead to inconsistent and/or unevenly distributed application of the molecules to the wound surface. In addition to this, there is also a chance that pieces of the absorbent material 75 may end up in the wound (which may increase the chance of infection). Alternatively, as the wound heals, tissue can grow into the voids of the absorbent (e.g. foam) material. This may make it painful to remove the absorbent material. An advantage of the absorbent material 75 forming part of the cover 30 or being provided for use with the cover 30 is that it avoids these issues, as it allows for absorption of the exudate into the absorbent material 75 away from the wound 22 and away from the receptacle 10. Even if exudate saturates or clogs the absorbent material 75, the movement of molecules from the inside of the receptacle 10 to the wound 22 will not be impeded by the absorbent material.
[0228] The cover 30 may be separate to the receptacle 10 or it may be combined with (i.e. connected to) the receptacle 10 to form a single dressing that can be placed at the wound area 20. [0229] With reference to the embodiment of Figure 3, the cover 30 includes a first opening 34 through which the fluid inlet conduit 50 passes to enter the compartment 35 to provide fluid to the receptacle 10. The cover 30 further includes a second opening 36 via which fluid in the receptacle 10 may exit the receptacle 10. The second opening 36 receives a first fluid outlet conduit 52. The first fluid outlet conduit 52 is integral with or connected to the receptacle 10 and passes through the second opening 36. The cover 30 further includes a third opening 38 through which fluid in the compartment 35 may exit the compartment 35. A second fluid outlet conduit 54 is connected at the third opening 38 of the cover 30 for transporting fluid out of the compartment 35. The first and second fluid outlet conduits 52, 54 may be made from soft, pliable material such as silicone tubing, for example Versilic® silicone tubing. The fluid inlet conduit 50 and the fluid outlet conduits 52, 54 may be for single use on a single patient and may be changed after up to several days (e.g. 7 days or 10 days) continuous use on a patient. In this embodiment, as described elsewhere in this disclosure, the compartment 35, that is substantially bounded by the cover 30, the receptacle 10 and the wound area 20, is further bounded by the fluid inlet conduit 50 and the first fluid outlet conduit 52.
[0230] In this embodiment, the at least one section of the wall 15 of the receptacle 10 may allow molecules within the fluid to diffuse from the receptacle 10 to the wound 22, or the fluid to pass from the receptacle 10 to the wound 22 via pore flow, or alternatively it may allow molecules within the fluid to both diffuse from the receptacle 10 to the wound 22 and also to allow the fluid to pass from the receptacle 10 to the wound 22 via pore flow. The receptacle 10 may include a plurality of the microstructures 60 arranged on the wound facing surface 12 of the receptacle 10. The fluid may comprise a gas, such as oxygen gas or carbon dioxide gas or carbon monoxide gas or nitric oxide gas or ambient air. The fluid may also comprise a combination of the aforesaid gases.
[0231] The provision of the fluid inlet conduit 50 and the first fluid outlet conduit 52 in fluid communication with the receptacle 10 allows for circulation of fluid through the receptacle 10. Fluid enters the receptacle 10 via the fluid inlet conduit 50. Fluid exits the receptacle 10 via the first fluid outlet conduit 52. Fresh fluid can be cycled into and out of the receptacle 10 as shown schematically in Figure 3, either constantly or periodically. As the fluid is cycled out of the receptacle 10, it is flushed out, for example to the atmosphere, and not returned to the receptacle 10. This applies to all instances of fluid cycling through the receptacle 10 disclosed in this specification. The cycling enables a fluid concentration, for example an oxygen gas concentration, within the receptacle 10 to be maintained at a desired level, even if nitrogen and/or other fluid molecules enter the receptacle 10 through the membrane of the receptacle 10. The cycling also enables the fluid, from which molecules diffuse through the wall 15 of the receptacle 10, or which passes through the wall 15 via pore flow, to be replenished. The fluid concentration may be precisely controlled via a controller, for example a controller of the fluid source 40. Additionally, other fluids, including drugs could be cycled through the receptacle 10 and applied to the wound 22 via diffusion through the wound facing surface 12. As will be appreciated, the cycling may be applied to any one of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610 or 710 described in this disclosure that have a fluid inlet conduit 50 and a first fluid outlet conduit 52.
[0232] The apparatus may include a negative pressure source 45 for drawing fluid out of the compartment 35. Negative pressure refers to a pressure below that of the ambient atmosphere around the patient. The pressure in the compartment 35 may be altered to be between approximately 50mmHg to 150mmHg or between approximately 80mmHg to 125mmHg or between 90mmHg to 1 lOmmHg below atmospheric pressure. The negative pressure source may be a pump. The second fluid outlet conduit 54 may connect the compartment 35 to the negative pressure source 45 at the third opening 38 of the cover 30. The connection of the negative pressure source 45 to the second fluid outlet conduit 54 is shown schematically in the Figures and may not be shown directly. It will be appreciated that one or more additional conduits (not shown) may be included in the connection between the second fluid outlet conduit 54 and the negative pressure source 45.
[0233] In use, the receptacle 10 is positioned on the wound 22 and may be held in place by the cover 30 operating as a negative pressure dressing. The cover 30 seals to the healthy skin 24 of the patient surrounding the wound 22 and, as the negative pressure source 45 draws fluid from the compartment 35, forms a negative pressure compartment enclosing the receptacle 10. The fluid inlet conduit 50 and/or the second fluid outlet conduit 54 may extend through the cover 30 or under an outer edge of the cover 30.
[0234] The cover 30 may comprise at least one film. The film may comprise an adhesive on one surface of the film. The adhesive may be at an edge of the film, or may cover the entire surface of the film. The adhesive may be arranged around a perimeter, or at least part of the perimeter of the film. The film may be a polyurethane film.
[0235] In embodiments where the fluid inlet conduit 50, the first fluid outlet conduit 52 and/or the second fluid outlet conduit 54 extend under an outer edge of the cover 30, the cover 30 may form a seal around each conduit 50, 52, and/or 54 and with the healthy skin 24 of the patient. A slit or cut-out may be made in the outer edge of the cover 30 for each of the first fluid inlet conduit 50, the first fluid outlet conduit 52, and/or the second fluid outlet conduit 54 to allow the cover 30 to wrap around each conduit 50, 52, and 54 and form a seal between the cover 30, each of the first fluid inlet conduit 50, the first fluid outlet conduit 52, and/or the second fluid outlet conduit 54, and the healthy skin 24.
[0236] In some embodiments, the cover 30 may comprise two films with adhesive . The adhesive may extend over substantially the entire surface of each of the two films, or it may extend over only a part of the two films. The adhesive may be arranged in a pattern over the surfaces of the two films. The two films with adhesive form a seal with the healthy skin 24 and with each other. The two films with adhesive may be adhered to each other at an overlapping portion. In an embodiment, the two films may have adhesive around the edges and in the overlapping portions. At least one of the fluid inlet conduit 50, the first fluid outlet conduit 52 and the second fluid outlet conduit 54 may extend through the overlapping section between the two films. The two films form a seal around each of the fluid inlet conduit 50, the first fluid outlet conduit 52 and the second fluid outlet conduit 54 that extends through the overlapping section between the two films.
[0237] In one embodiment shown in Figure 3A, a first film 30A of the cover 30 may be placed on the healthy skin 24 adjacent the wound 22 and folded back on itself, such that the adhesive surface both adheres to the healthy skin 24 and the folded portion faces upwards away from the healthy skin 24. Then, the receptacle 10 may be placed on the wound 22 with the fluid inlet conduit 50, the first fluid outlet conduit 52 and/or the second fluid outlet conduit 54 positioned onto the upwards facing adhesive surface of the first film 30A. An absorbent material (not shown) may optionally be placed over the receptacle 10, the wound 22 and/or the healthy skin 24. Then, a second film 30B of the cover 30 may be placed over the receptacle 10 and the absorbent material if present, surrounding the wound 22. The second film 30B may create a seal with the healthy skin 24 and with the upward facing adhesive surface of the first film 30 A. In the embodiment of Figure 3 A, the fluid inlet conduit 50 and the first fluid outlet conduit 52 will extend through the overlapping portion between the first film 30A and the second film 30B, whilst the second fluid outlet conduit 54 extends through a separate opening in the second film 30B. In an alternative configuration of the two films that is not shown, the fluid inlet conduit 50, the first fluid outlet conduit 52 and the second fluid outlet conduit 54 will all extend through the overlapping portion between the first film 30A and the second film 30B.As shown in the embodiment of Figure 3, fluid may be cycled through the receptacle 10 at the same time as a negative pressure is applied to the compartment 35. The negative pressure is applied to the compartment 35 by the negative pressure source 45, via the second fluid conduit 54 connected to the cover 30 at the third opening 38. The fluid in the receptacle 10 may diffuse through the membrane or pass through it via pore flow at the wound facing surface 12 of the receptacle 10 as the negative pressure is applied to the compartment 35.
[0238] This embodiment is described with reference to a wound. However, it will be appreciated that it is, in general, applicable to other tissue areas as described elsewhere in this disclosure.
[0239] Refering now to the embodiments of the apparatus 500 as discussed herein above, and wherein the apparatus 500 includes a cover 30 which acts to form a compartment 35 together with a negative pressure source to apply a negative pressure to the compartment 35. In such an example embodiment, it will be appreciated that the carrier layer 530 can comprise an absorbent and/or nonabsorbent material. The application of negative pressure would allow for drawing fluid, including exudate, from the compartment 35 in the absence of or in addition to exudate being wicked and/or absorbed by the carrier layer 530. In such a configuration of the apparatus 500, the carrier layer 530 may therefore comprise a material which allows exudate to pass from a tissue area 525 facing side thereof to a permeable layer 505 facing side thereof, thereby allowing exudate to be drawn from the compartment 35 across the tissue area 525. Exudate may additionally or alternatively be drawn through an aperture 535 or apertures 535.1 through 535. n of the carrier layer 530.
[0240] In the embodiments of Figures 1 and 2, the cover 30 includes only the first opening 34 and the third opening 38. In these embodiments, fluid is supplied into the receptacle 10 via the fluid inlet conduit 50 and exits the receptacle only via diffusion through the membrane adapted to allow molecules within the fluid to diffuse from the wound facing surface 12 of the receptacle 10.
Simultaneously, a negative pressure may be applied to the compartment 35 via the second fluid outlet conduit 54 connected to the cover 30 at the third opening 38. In these embodiments, the compartment 35 substantially bounded by the cover 30, the receptacle 10 and the tissue area is further bounded by the fluid inlet conduit 50. This arrangement of the apparatus 100 is advantageous over prior solutions that allow a therapeutic fluid (e.g. oxygen) and negative pressure to be applied to a wound simultaneously. Many of these existing solutions rely on an arrangement that, when sealed to the heathy skin surrounding a wound, defines a single compartment (a compartment bounded by the inside of the bandage and the wound area). Oxygen is pumped into the compartment while the fluid within the compartment is removed (by a negative pressure pump) to generate the negative pressure environment. One issue with these existing, single-compartment arrangements is that the negative pressure tends to draw oxygen out of the wound environment before it has a chance to contact the wound. Furthermore, as the negative pressure draws exudate from the wound and into the compartment, this exudate may impede the movement of molecules from the inside of the receptacle to the wound surface. The dual compartment arrangement of the apparatus 100 allows negative pressure to be applied to the wound 22 and exudate to be removed into the compartment 35 and through the second fluid outlet conduit 54 without significantly affecting the movement of molecules from the receptacle 10, through the membrane, to the surface of the wound 22. The receptacle 10 of this embodiment may include a plurality of the microstructures 60 arranged on the wound facing surface 12 of the receptacle 10.
[0241] In some embodiments, shown in Figures 14 to 17, two or more of the fluid inlet conduit 50, the first fluid outlet conduit 52 and the second fluid outlet conduit 54 may be combined into a single conduit that passes through only a single opening 39 in the cover 30. For example, in Figure 14a and Figure 14b, the fluid inlet conduit 50 and the second fluid outlet conduit 54 may be arranged coaxially. Figure 14a shows the coaxial arrangement of the fluid inlet conduit 50 and the second fluid outlet conduit 54 in plan view. Figure 14b shows the coaxial arrangement of the conduits 50, 54 in use of the apparatus 100. Figure 15a and Figure 15b show another arrangement in which the fluid inlet conduit 50 and the second fluid outlet conduit 54 may be arranged adjacent one another so as to pass through the single opening 39 in the cover 30. In the arrangement of Figure 16a and Figure 16b, the apparatus includes the fluid inlet conduit 50, the first fluid outlet conduit 52 and the second fluid outlet conduit 54, arranged adjacent one another as a combined conduit that passes through the single opening 39. In Figures 17a and 17b, the fluid inlet conduit 50, first fluid outlet conduit 52 and second fluid outlet conduit 54 are arranged coaxially. These arrangements may improve the seal between the apparatus 100 and the skin of the patient or other tissue surface, due to multiple conduits passing through a single opening in the cover rather than through multiple openings. This is because multiple openings may compromise the seal in comparison with a single opening. Whilst a single opening may compromise the seal to some extent, multiple openings will compromise the seal to a greater extent. The single opening 39 provides a larger cover surface area for sealing against the tissue of the patient than would be the case with the first, second and third openings 34, 36, 38.
[0242] In the embodiments of Figures 1 to 6 and also Figure 8 and Figures 12 to 17, the cover 30 and the receptacle 10 do not share any common walls; they are separate components and the walls of the receptacle 10 and the cover 30 are independent of one another. The cover 30 may be connected to the receptacle 10 via the fluid inlet conduit 50, at the first opening 34. The cover 30 may also be connected to the receptacle 10 via the first fluid outlet conduit 52 at the second opening 36. These one or two connection points may be the only points of connection between the receptacle 10 and the cover 30. This minimal connection between the receptacle 10 and the cover 30 enables the receptacle 10 to be movable within the compartment 35 while also allowing exudate to move out of the wound 22, which may help the receptacle 10 to conform to wounds having a complex geometry and/or topology. Alternatively, the fluid inlet conduit 50, first fluid outlet conduit 52 and/or the second fluid outlet conduit 54 may not be connected to the cover 30 but may protrude from a gap in the cover 30. In each of these embodiments, the receptacle(s) 10 may include a plurality of the microstructures 60 arranged on the wound facing surface 12 of the receptacle(s) 10. [0243] In some embodiments of the apparatus 100, the cover 30 may be formed from wrapping a dressing, for example a compression bandage around a body part, for example a limb, of the patient and over the receptacle 10. The compression bandage holds the receptacle 10 in place on the wound 22 and can absorb exudate and/or allow evaporation of exudate. The compression bandage material allows the bulk transport of gases, however it will be appreciated that it may be wrapped about the patient forming enough layers that it provides a substantial barrier to the bulk flow of gases. The fluid, for example oxygen, is supplied to the receptacle 10 at a positive pressure for effective oxygen delivery, even when used under a compression bandage that may compress the receptacle 10 against the wound 22. As the receptacle 10 is impermeable to the bulk flow of fluid, a positive pressure can be maintained in the receptacle 10 even as it is positioned within a negative pressure compartment. This means that the apparatus 100 can be used to simultaneously deliver topical oxygen therapy and negative pressure therapy. The fluid inlet conduit 50, first fluid outlet conduit 52 and/or the second fluid outlet conduit 54 may not be connected to the compression bandage but may protrude from a gap in the wrapped layers. In a variation of this embodiment, the dressing may be an adhesive dressing that adheres to the healthy skin 24 of the patient over the receptacle 10. This embodiment may or may not utilise the negative pressure source 45 to form a negative pressure compartment. Whilst this embodiment is described with reference to a wound, it will be appreciated that it is, in general, applicable to other tissue areas as described elsewhere in this disclosure. In this embodiment, the compartment 35 substantially bounded by the cover 30, the receptacle 10 and the tissue area is further bounded by one or more of the fluid inlet conduit 50 and the first fluid outlet conduit 52. Whilst this embodiment of the cover 30 is described with reference to the receptacle 10, it will be appreciated that it may be applicable to any of the other receptacles 110, 210, 210A, 310, 410, 510, 610 or 710 described in this disclosure.
[0244] Figure 4 shows a further embodiment of the apparatus 100 that includes a plurality of the receptacles 10 positioned at the wound area 20. The plurality of receptacles 10 may be distributed over the wound 22 as is also shown schematically in the plan view of Figure 11. In the embodiments of Figure 4 and Figure 11, the at least one section of the wall 15 of each of the plurality of receptacles 10 may allow molecules within the fluid to diffuse from the plurality of receptacles 10 (also referred to herein as multiple receptacles 10) to the wound 22, or to pass from the multiple receptacles 10 to the wound 22 via pore flow, or to allow molecules within the fluid to diffuse from the multiple receptacles 10 to the wound 22 and also to pass from the multiple receptacles 10 to the wound 22 via pore flow. The fluid may comprise a gas, such as oxygen gas or carbon dioxide gas or carbon monoxide gas or nitric oxide gas or ambient air. The fluid may also comprise a combination of the aforesaid gases. The plurality of receptacles 10 may equally be a plurality of any of the receptacles 110, 210, 210A, 310, 410, 510, 610 or 710 described in this disclosure.
[0245] Multiple receptacles 10 can provide additional conformability to the wound for complex and/or varying wound topologies. For example, if a wound is small or deep, multiple receptacles 10 may be more easily manipulated to optimise delivery of therapeutic fluid and/or negative pressure therapy. Accordingly, if a wound is deep and/or has an irregular surface, it may be possible to achieve greater surface area contact between the section(s) of the wall(s) 15 through which the molecules can diffuse or pass via pore flow and the wound by using multiple receptacles 10, relative to the contact that could be achieved using one receptacle 10. A large amount of surface area contact can be beneficial as it can result in a more even distribution of therapeutic molecules to the wound. Multiple receptacles 10 can also be used to treat a large wound.
[0246] Multiple receptacles 10 may also allow for more localised wound healing. For example, if some parts of a wound heal faster than others, one or more of the receptacles 10 can be positioned to promote healing of a wound region that is less healed rather than remaining at the more healed parts. Each receptacle 10 is moveable within the compartment 35 independently of any of the other receptacles 10. Each receptacle 10 may include a plurality of the microstructures 60 arranged on the wound facing surface 12 of the receptacle 10.
[0247] As shown in Figure 4, each of the receptacles 10 has its own fluid inlet conduit 50 associated with it. In the embodiment of Figure 4, each of the fluid inlet conduits passes through a separate respective first opening 34 in the cover 30, for connection to a respective separate fluid supply or fluid source. This arrangement allows different fluids to be provided in different receptacles for variable, customisable control of fluid molecule delivery over the wound area 20. It will be appreciated that any reasonable number of multiple receptacles 10 and fluid inlet conduits 50 may be positioned at the wound area 20 and that the number of receptacles is not limited to the number shown in Figure 4. For example, the number of receptacles 10 may depend on the surface area of the wound 22. Examples include from two, three, four and all numbers of receptacles that may be required to treat the tissue area concerned. Whilst this embodiment is described with reference to a wound, it will be appreciated that it is, in general, applicable to other tissue areas as described elsewhere in this disclosure. In this embodiment, the compartment 35 substantially bounded by the cover 30, the receptacle 10 and the tissue area is further bounded by the each of the fluid inlet conduits 50.
[0248] In the embodiments of Figure 5 and Figure 6, the fluid inlet conduits 50 are connected together in fluid communication with one another via a manifold 80, the manifold being supplied with fluid via a single fluid supply conduit 85. The manifold 80 joins together the three fluid inlet conduits 50 shown in Figure 5 inside the compartment 35. The manifold 80 joins together the three fluid inlet conduits 50 shown in Figure 6 outside the compartment 35. The Figure 5 arrangement may improve sealing of the cover 30 against the skin when compared with the embodiment of Figure 6, as it requires fewer openings in the cover 30. It will be appreciated that any reasonable number of multiple receptacles 10 and fluid inlet conduits 50 may be joined together at the manifold 80 and that the number of receptacles is not limited to the number shown in Figure 5 and Figure 6. For example, the number of receptacles 10 may depend on the surface area of the wound 22. Examples include from two, three, four and all numbers of receptacles that may be required to treat the tissue area concerned. The single fluid supply conduit 85 passes through the first opening 34 in the cover 30 for receiving fluid therein from a single fluid source 40. The manifold 80 may include a valve (not shown) on each fluid inlet conduit 50 for individual control of fluid flow through the respective fluid inlet conduits 50. Although not shown in Figure 5, respective first fluid outlet conduits 52 may be used to cycle fluid through the fluid receptacles 10 and to exit the receptacles 10 via the respective first fluid outlet conduits 52. In these embodiments, the compartment 35 substantially bounded by the cover 30, the receptacles 10 and the tissue area is further bounded by the fluid inlet conduits 50, the manifold 80 and the fluid supply conduit 85, and the respective fluid outlet conduits 52 if present.
[0249] In the embodiment of Figure 6, the manifold 80 joins together the three fluid inlet conduits 50 outside of the compartment 35. In these embodiments, the compartment 35 substantially bounded by the cover 30, the receptacles 10 and the tissue area is further bounded by the fluid inlet conduits 50. It will be appreciated that any reasonable number of receptacles 10 and fluid inlet conduits 50 may be joined together at the manifold 80. The three fluid inlet conduits 50 pass through respective first openings 34 in the cover 30 for receiving fluid therein from a single fluid source 40. The manifold 80 may include a valve (not shown) on each fluid inlet conduit 50 for individual control of fluid flow through the respective fluid inlet conduits 50. Although not shown in Figure 6, respective first fluid outlet conduits 52 may be used to cycle fluid through the receptacles 10. The fluid may enter the receptacles 10 via the fluid supply conduit 85 and the respective fluid inlet conduits 50 and exit the receptacles 10 via the respective first fluid outlet conduits 52.
[0250] It is noted that Figures 5 and 6 are schematic illustrations of the manifold 80, fluid inlet conduits 50 and fluid supply conduit 85. The manifold 80, fluid inlet conduits 50 and fluid supply conduit 85 may be made from soft, pliable material such as silicone tubing, for example Versilic® silicone tubing. They may be formed integrally with the receptacles 10, so that they are conformable and comfortable against the wound 22. This embodiment is described with reference to a wound. However, it will be appreciated that it is, in general, applicable to other tissue areas as described elsewhere in this disclosure.
[0251] Figure 7 shows an apparatus 200 in which the receptacle 210 is not enclosed within the negative pressure compartment 35. The receptacle 210 may be formed from two sheets of material, for example a wound facing sheet 212 and a cover sheet 230 that are pressed and sealed together at the edges of the receptacle 210. The excess pressed material around the receptacle 210 provides the functionality of the cover 30 of previous embodiments and includes the seal 32 for sealing to the healthy skin 24 of the patient around the wound 22 or other tissue area. The two sheets of material 212, 230 that are pressed and sealed together may be made of the same material. For example, the wound facing sheet 212 and the cover sheet 230 may both be made from the membrane that allows molecules to pass through it. Alternatively, the two sheets that are pressed and sealed together may be made of different material. For example, the wound facing sheet 212 may be made from the membrane that allows molecules to pass through it. The membrane may allow molecules within the fluid to diffuse from the receptacle 210 to the wound 22 or to pass through the membrane via pore flow, or it may allow molecules within the fluid to both diffuse from the receptacle 210 to the wound 22 and to pass from the receptacle 210 to the wound 22 via pore flow. The cover sheet 230 may not allow molecules within the fluid to pass through it. Alternatively, the cover sheet 230 may allow molecules within the fluid to pass through via diffusion or via pore flow, or it may allow molecules within the fluid to both diffuse from the receptacle 210 to the wound 22 and to pass from the receptacle 210 to the wound 22 via pore flow. If the cover sheet 230 is made from the membrane that allows molecules to pass through, then molecules may be able to move from the compartment 35 to the outside of the cover sheet 230. The apparatus 200 may further comprise a negative pressure compartment 35 substantially bounded by the cover sheet 230, the wound facing sheet 212 of the receptacle 10 and the wound area 20. In this construction, the negative pressure compartment 35 is substantially bounded by the cover 230, the wound facing surface 212 of the receptacle 210 and the wound area 20. In this embodiment, the fluid may enter the receptacle 210 via the fluid inlet conduit 50 and, although not shown in Figure 7, it may also be cycled through the receptacle 210 and exit the receptacle 210 via the first fluid outlet 52. The negative pressure compartment 35 is formed by connecting the third opening 38 in the cover sheet 230 to the negative pressure source 45. Alternatively, a cover 30 could be added, for example glued, onto the receptacle 210, over the cover sheet 230, after the receptacle has been formed. The addition of the cover 30 allows a negative pressure compartment 35 to be formed as described in relation to the embodiment of Figure 1 above. The addition of the cover 30 may also allow the wound facing sheet 212 and the cover sheet 230 of the receptacle 210 to be made from the same material, and for a cover 30 made from material that is impermeable to bulk flow of fluid to be glued or otherwise added over the top of the receptacle 210. The cover 30 may have all of the features of the cover 30 described earlier in this disclosure. For example, it may include an absorbent layer such as the absorbent material 75 described in Figure 13. Alternatively, this embodiment may be used without a negative pressure compartment, in which case the first fluid outlet conduit 54 and the negative pressure source 45 need not be included. The receptacle 210 may include a plurality of the microstructures 60 arranged on the wound facing sheet 212 of the receptacle 210. The fluid may comprise a gas, such as oxygen gas or carbon dioxide gas or carbon monoxide gas or nitric oxide gas or ambient air. The fluid may also comprise a combination of the aforesaid gases. The apparatus 200 may require less material to manufacture than the apparatus 100.
[0252] If a fluid source 40 (e.g. a pump) or its associated controller malfunctions, the pressure within the associated oxygen compartment(s) may increase to an undesirable level. This could cause the receptacle(s) 10, 110, 210, or any of the other receptacles 210A, 310, 410, 510, 610, 710 described in this disclosure, to rupture. In some embodiments, the apparatus 100 includes a pressure regulator, for example a pressure relief valve 70, that can be configured to open to relieve pressure if the pressure within the receptacle(s) 10 exceeds a threshold value. As seen in Figure 8, the pressure relief valve 70 may be connected to the fluid inlet conduit 50 either at a wall of the fluid inlet conduit 50 or at a wall of a branch line 72 extending from and in fluid communication with the fluid inlet conduit 50. The pressure relief valve 70 may be positioned outside of the compartment 35 formed by the cover 30 as shown in Figure 8, or inside the compartment 35 formed by the cover 30 (not shown). In the latter embodiment, the cover 30 may include a vent to atmosphere, for example an outlet port, a negative pressure port or may be a permeable cover 30 such as a compression bandage, such that gas released from the pressure relief valve 70 on the fluid inlet conduit 50 inlet may be vented from underneath the cover 30 to prevent the compartment 35 formed by the cover 30 from bursting.
[0253] When open, the pressure relief valve 70 may exhaust fluid to the ambient environment (if positioned outside of the cover 30), or exhaust fluid into the compartment formed by the cover 30 (if positioned inside of the compartment 35). In this embodiment, the compartment 35 substantially bounded by the cover 30, the receptacle 10 and the tissue area is further bounded by the fluid inlet conduit 50, branch line 72 if present and the pressure relief valve 70, if present inside the cover 30. As shown in Figure 8 and also in Figure 61, a calibrated leak orifice 74 may be included upstream of the fluid inlet conduit 50 and downstream of the fluid source 40. A calibrated leak orifice is a mechanical device that may be calibrated to produce a specific flow rate in response to a certain pressure. The receptacle 10 of the embodiment of Figure 8 is supplied with fluid from a fluid source 40 configured to supply fluid into the fluid inlet conduit 50. The calibrated leak orifice 74 may be used in addition to or in place of the fluid source regulator 76 (shown in Figure 61) to control the flow rate of fluid passing from the fluid source 40 and into the fluid inlet conduit 50. The calibrated leak orifice 74 may be reusable or it may be for single use on a single patient. It may be integrated into a housing of the fluid source 40 or provided separate to the fluid source 40. [0254] In an alternative embodiment, the pressure relief valve 70 or other pressure regulator is not present at the fluid inlet conduit 50, however a calibrated leak orifice 74 may be disposed on the fluid inlet conduit 50, between the fluid source 40 and the receptacle 10.
[0255] Any of the pressure relief valve 170 or other pressure regulator or calibrated leak orifice 74 may be present at any of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610 or 710 decribed in this disclosure.
[0256] At least one filter 73 (shown in Figure 61) may optionally be included upstream of the fluid inlet conduit 50 and downstream of the fluid source 40. The filter 73 may be integrated into a housing of the fluid source 40 or it may be provided separately. The filter 73 may remove contaminants from the fluid before it is delivered to the receptacle 10. The filter 73 may be an inline filter. The filter 73 may be positioned upstream (as shown in Figure 61) and/or downstream of the calibrated leak orifice 74.
[0257] As shown in Figure 62, the fluid inlet conduit 50 is connected to a fluid source conduit 79 with a conduit connector 77. The first fluid outlet conduit 52 may also be connected to the pressure relief valve 70 with a further conduit connector (not seen in Figure 62). The conduit connectors 77 may be any type of appropriate connector, for example barb connectors, double-ended barb connectors, luer-type connectors, or other connectors that click into place. Each conduit connector 77 may be held by a holder 78. A holder 78 may hold multiple conduit connectors 77 or each connector 77 may be held in a separate holder 78. Each holder 78 may be attachable to the limb, torso, neck or other part or portion of the body. The holder 78 may be attachable to the patient by, for example a strap with hook and loop or an attachment comprising adhesive, or a clip that attaches to the clothing or belt of a patient, or a strap with a buckle fastening. A single connector 77 may have two connection points such that the fluid inlet conduit 50 and the first fluid outlet connector 52 are connected to the holder 78 at a multi-conduit connector 77, as shown in Figure 62. [0258] In the embodiment of Figures 7 and 8, the at least one section of the wall 15 of the receptacle 10 may allow molecules within the fluid to diffuse from the receptacle 10 to the wound 22 or to pass from the receptacle 10 to the wound 22 via pore flow, or it may allow molecules within the fluid to both diffuse from the receptacle 10 to the wound 22 and to pass from the receptacle 10 to the wound 22 via pore flow. The fluid may comprise a gas, such as oxygen gas or carbon dioxide gas or carbon monoxide gas or nitric oxide gas or ambient air. The fluid may also comprise a combination of the aforesaid gases.
[0259] Figures 9 and 10 show embodiments of the apparatus 100 in which the receptacle 10 has a substantially annular or doughnut shape in plan view so as to include a through-hole 25. In use of the apparatus 100, the through-hole 25 provides an additional path for exudate to flow away from the wound surface. It provides additional areas of fluid communication between the wound 22 and the cover 30 or the absorbent material 75 (seen in Figure 13) of the cover 30. The through hole 25 may therefore help to facilitate the flow of exudate away from the wound 22, particularly when the compartment 35 is subject to a negative pressure to form a negative pressure compartment. In the embodiment of Figure 10, the receptacle 10 includes multiple through-holes 25, providing multiple additional paths for exudate to flow from the wound surface, which may further increase the flow of exudate away from the wound 22. These embodiments are described with reference to a wound, and its effect may be most advantageous when used at a wound. However, it will be appreciated that it is, in general, applicable to other tissue areas as described elsewhere in this disclosure. The receptacle 10 may include a plurality of the microstructures 60 arranged on the wound facing surface 12 (not shown in the plan views of Figures 9 and 10) of the receptacle 10.
[0260] The one or more receptacles 10 are movable by a clinician when being positioned on the wound area 20 on the patient and also in situ, in response to patient movement. However, in some circumstances it may be required to secure the receptacles in place. The apparatus 100 may further include one or more fasteners 80 for securing the receptacle(s) 10 in place at the wound area 20 once they are positioned. The fastener 80 may comprise adhesive, such as adhesive tape as schematically shown in Figure 12 and may be used to secure the receptacle 10 and/or one or more of the fluid inlet conduit 50 and the first fluid outlet conduit 52 (seen in Figure 3), 54 to the healthy skin 24 of the patient or to the cover 30. Securing the receptacle 10 and/or one or more the fluid inlet conduit 50, the first fluid outlet conduit 52, and the second fluid outlet conduit 54 in place may reduce movement of the components within the wound area 20, including the wound 22.
[0261] Figures 18 to 25 show embodiments of the apparatus 300 that do not include a negative pressure compartment. Whilst shown and described with reference to the receptacle 10, it may apply to any of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 described in this disclosure. These embodiments are described with reference to a wound. However, it will be appreciated that they are, in general, applicable to other tissue areas as described elsewhere in this disclosure. The components of these embodiments are as described in respect of the apparatus 100, 200 and like components are given like reference numbers. In each of these embodiments, as with the other embodiments disclosed herein, the fluid may comprise a gas, such as oxygen gas or carbon dioxide gas or carbon monoxide gas or nitric oxide gas or ambient air. The fluid may also comprise a combination of the aforesaid gases. In its simplest form as shown in Figure 18, the apparatus 300 has a receptacle 10 and a fluid inlet conduit 50 through which fluid is introduced into the receptacle 10 from a fluid source 40. The receptacle 10 is formed of one or more walls 15 having at least one section made of the membrane adapted to allow molecules within the fluid to diffuse from the receptacle 10 to the wound area 20. The receptacle 10 is placed in contact with the wound 22, with the wound facing surface 12 of the receptacle 10 facing the wound 22. A schematic representation of a receptacle having a fluid inlet conduit 50 is shown in Figure 26. In the embodiment of Figure 19, an optional cover 30 in the form of a bandage may be wrapped around the body part containing the wound 22 such that it is wrapped over the receptacle 10 to provide pressure to the receptacle 10 and press it into contact with the wound 22. The cover 30 contacts the healthy skin 24 of the patient that surrounds the wound at the wound area 20. An optional seal 32, for example an adhesive seal, may be used to fasten the cover 30 to the healthy skin 24 to keep the cover 30 in place. Where the bandage is used as the cover 30, the fluid inlet conduit 50 may pass through the first opening 34 that is formed in between adjacent wrappings of the bandage. In this embodiment, the compartment 35 substantially bounded by the cover 30 in the form of the bandage, the receptacle 10 and the tissue area may be further bounded by the fluid inlet conduit 50.
[0262] Figure 20 shows an embodiment that is very similar to that of Figure 18, with the addition of the first fluid outlet conduit 52. Accordingly, the fluid that enters the receptacle 10 through the fluid inlet conduit 50 may cycle through the receptacle 10 and exit the receptacle 10 through the first fluid outlet conduit 52. A view of a receptacle 10 having a fluid inlet conduit 50 and a first fluid outlet conduit 52 is shown in Figure 20A. In Figure 21, as with the embodiment of Figure 19, the optional cover 30 in the form of a bandage may be wrapped around the body part of the patient having the wound 22 and around the receptacle 10 placed on the wound 22. An optional seal 32, which may be an adhesive seal, may be used to fasten the cover 30 to the healthy skin 24 to keep the cover 30 in place. Where the cover 30 in the form of a bandage is used, the fluid inlet conduit 50 and the first fluid outlet conduit 52 may pass through the first opening 34 and the second opening 36 that is formed in between adjacent wrappings of the bandage. Alternatively, the fluid inlet conduit 50 and the first fluid outlet conduit 52 may pass through the bandage as coaxial conduits or adjacent conduits as in the embodiment of Figures 14 to 17, or they may be substantially adjacent conduits as described in relation to Figures 40, 41, 45-50 and 52 elsewhere in this disclosure. In this embodiment, the compartment 35 substantially bounded by the cover 30, the receptacle 10 and the tissue area may be further bounded by the fluid inlet conduit 50 and the first fluid outlet conduit 52. [0263] Figure 22 shows an arrangement that has multiple receptacles 10, in this case three receptacles. As with the apparatus 100, the number of receptacles 10 shown in Figure 22 is non-limiting and any reasonable number of receptacles 10 may be used depending on the area of the wound surface. Each receptacle 10 has a respective fluid inlet conduit 50 that is supplied with the fluid from the fluid source 40. The receptacles 10 are independent of one another and may be placed on the wound 22 where fluid is required. The receptacles 10 may be moved from time to time to treat other parts of the wound 22, for example a part that is not healing as quickly. Figure 23 shows this arrangement with the optional cover 30 in the form of a bandage wrapped around the body part of the patient having the wound 22 and around the receptacles 10. The optional seal 32, which may be an adhesive seal, may be used to fasten the cover 30 to the healthy skin 24 to keep the cover 30 in place. Where the cover 30 in the form of a bandage is used, the respective fluid inlet conduits 50 may pass through respective first openings 34 that are formed in between adjacent wrappings of the bandage. In some embodiments, the respective fluid inlet conduits 50 may pass through a single first opening 34. In this embodiment, the compartment 35 substantially bounded by the cover 30, the receptacle 10 and the tissue area may be further bounded by the fluid inlet conduits 50.
[0264] In the embodiments of Figures 22 and 23, the at least one section of the wall 15 of the receptacle 10 may allow molecules within the fluid to diffuse from the receptacles 10 to the wound 22 or to pass from the receptacles 10 to the wound 22 via pore flow, or it may allow molecules within the fluid to both diffuse from the receptacle 10 to the wound 22 and to pass from the receptacle 10 to the wound 22 via pore flow.
[0265] Figures 24 and 25 show variations of the arrangements of Figures 18 and 19 that include a pressure relief valve 70 either in the fluid inlet conduit 50 or in a branch line 72 of the fluid inlet conduit 50 as shown in Figures 24 and 25. In the embodiments of Figures 24 and 25, the at least one section of the wall 15 of the receptacle 10 may allow molecules within the fluid to diffuse from the receptacle 10 to the wound 22 or to pass from the receptacle 10 to the wound 22 via pore flow, or it may allow molecules within the fluid to both diffuse from the receptacle 10 to the wound 22 and to pass from the receptacle 10 to the wound 22 via pore flow. The arrangements are otherwise identical to the arrangements of Figures 18 and 19. In the embodiment of Figure 25, the compartment 35 substantially bounded by the cover 30, the receptacle 10 and the tissue area may be further bounded by the fluid inlet conduit 50. In a further embodiment, the branch line 72 and pressure relief valve 70 may be present inside the cover 30. The cover 30 may include a vent to atmosphere, for example an outlet port, or the cover 30 may be a permeable cover 30 such as a compression bandage, such that gas released from the pressure relief valve 70 on the fluid inlet conduit 50 inlet may be vented from underneath the cover 30 to prevent the compartment 35 formed by the cover 30 from bursting. In this embodiment, the compartment 35 substantially bounded by the cover 30, the receptacle 10 and the tissue area may be further bounded by the fluid inlet conduit 50
[0266] In each of the embodiments of Figures 18 to 25, the receptacle(s) may include a plurality of microstructures 60 arranged on the wound facing surface 12 of the receptacle 10, or on any other portion of the wall 15 as shown in Figure 1A.
[0267] As discussed elsewhere in this disclosure, some of the dressings that cover the receptacle(s) 10 may press the receptacle 10 against the wound 22 and the healthy skin 24 around the wound 22. Such dressings may also press some length of the fluid inlet conduit 50 or first fluid outlet conduit 52 connected to the receptacle 10 against the healthy skin 24 around the wound 22 and even the wound 22 itself, depending on the size and position of the receptacle 10 relative to the wound 22. When the outer diameter of the conduits 50, 52 is small, for example 5 mm or less, the patient may find it uncomfortable to have the conduit 50, 52 pressed against them in this way. Furthermore, when the apparatus 100, 200, 300 is removed, the patient may be left with a temporary yet uncomfortable indentation in the shape of the conduit 50, 52. Figure 26 shows a schematic plan view of a variation of a receptacle 110 that is similar to the receptacle 10 in that it has a generally circular shaped head portion 93 that is placed over the wound 22 and further includes an additional tail portion 90 that is formed integrally with and extends from the generally circular shaped head portion 93. Alternatively, the tail portion and the head portion 93 may be formed as two separate components and joined together. The tail portion 90 has a generally elongate rectangular shape when viewed in plan view and it is inflatable with the circular head portion 93 of the receptacle 110. The tail portion 90 may be longer than it is wide. The tail portion 90 may have a width that is less than the width of the head portion 93. In an alternate embodiment, the tail portion 90 may be wider that is long. It may have a shape, when viewed in plan view, that is rectangular, square, elliptical or any other suitable shape. The fluid inlet conduit 50 connects to a distal end wall 92 of the tail portion 90 that is furthest from the head portion 93 such that it is in fluid communication with the tail portion 90. The fluid inlet conduit 50 is configured to supply fluid to the head portion 93 via the tail portion 90.
[0268] The tail portion 90 may extend beyond the wound 22 such that the interface between the fluid inlet conduit 50 and the receptacle 110 is spaced apart from the wound surface, reducing the likelihood of the fluid inlet conduit 50 being pressed into the wound 22 or other tissue site of the patient by the cover 30 in the form of a bandage or other dressing. Furthermore, the tail portion 90 may extend beyond the wound 22 such that the interface between the fluid inlet conduit 50 and the receptacle 110 is beyond the pressing force of the bandage 30 or other dressing, reducing the likelihood of the fluid inlet conduit 50 being pressed into the tissue of the patient by the bandage 30 or other dressing. In cases where the pressing force includes a portion of the tail portion 90 having the fluid inlet conduit 50, the pressing force may press the tail portion 90 against the patient rather than the fluid inlet conduit 50. This will be more comfortable for the patient. Whilst not shown in Figure 26, a first fluid outlet conduit 52 may also protrude into the distal edge 92 of the tail portion 90. In embodiments that include a first fluid outlet conduit 52, see for example the embodiments of Figures 40 to 54 described later in this disclosure, the tail portion 90 allows the conduits 50, 52 to terminate distally from the wound 22 so that ends of the conduits 50, 52 will not impact the wound 22; that is, the application of a cover 30 in the form of a bandage or other dressing over the receptacle 110 will not press the conduits 50, 52 into the wound. In some cases, the tail portion 90 may lie over a portion of the wound 22 that is not covered by the head portion 93, particularly where the wound 22 is large and/or of an irregular shape. The cover 30 in the form of a bandage or other dressing may therefore be wrapped over the tail portion 90 rather than directly over the tissue or a wound of the patient,. Furthermore, tissue bordering the wound 22 may also be compromised or at a different stage of healing and may be sensitive and/or easily damaged. Wrapping the cover 30 over the tail portion 90 rather than directly over the wound or the tissue in these cases may help to reduce patient discomfort. The user of the receptacle 10 may also find it more straight forward to seal a negative pressure dressing or cover 30 to an upper surface of the tail portion 90 rather than over the top of multiple, separate conduits. The receptacle 110 may be inflatable. In some embodiments, the receptacle 110 is a bag. The receptacle 110 may comprise one or more walls 115 and is adapted to receive a fluid. The one or more walls of the tail portion 90 may be formed from the same material as the one or more walls of the head portion 93. As such, the one or more walls 115 of the head portion 93 and the tail portion 90 of the receptacle 110 may have the same properties as the one or more walls 15 described in this disclosure, and may be flexible and conformable such that they can conform to the wound topology. The wall 115 of the tail portion 90 may be formed continuously with the wall 115 of the head portion 93; that is, they may be the same wall 115. Alternatively, the wall 115 of the tail portion 90 may not be formed continuously with the wall 115 of the head portion 93; that is, they may not be the same wall 115. The one or more walls 115 of the head portion 93 and the tail portion 90 may comprise at least one section adapted to allow molecules within the fluid to move from inside of the receptacle 110 to the tissue area. The one or more walls 115 of the head portion 93 and the tail portion 90 may be adapted to allow the molecules to move through the wall via diffusion. The one or more walls 115 may be substantially pore-free such that molecules do not move through the wall via pore flow. The one or more walls 115 may be substantially impermeable to bulk transport of fluid. However, in some embodiments, the one or more walls 115 that comprise the tail portion 90 of the receptacle 110 may or may not be adapted to allow the molecules to move through the wall via diffusion. The head portion 93 and the tail portion 90 may be formed as separate components that may be pneumatically connected. The tail portion 90 may be inflatable. Alternatively, the tail portion 90 may not be inflatable. The tail portion 90 may be made of a different material to the head portion 93, for example it may be made of a foam. The tail portion 90 may comprise of a foam having a coating that is impermeable to bulk transport of fluid and/or diffusion. Alternatively, it may be made of a material that is adapted to substantially prevent molecules within the fluid from passing through it. The receptacle 110 may include a plurality of microstructures 60 arranged on a wound facing surface 12 of the receptacle 110. The tail portion 90 of the receptacle 110 may include a plurality of the microstructures 60. However, an alternative embodiment of the tail portion 90 of the receptacle 110 may not include the plurality of microstructures 60. Embodiments of the tail portion 90 may provide a bridge between the head portion 93 of the receptacle 110 and the ends of the fluid inlet conduit 50 and first fluid outlet conduit 52 to which the fluid source 40 is connected. For the receptacle 110, 210, 210A, 310, 410, 510, 610, 710 and all embodiments of the receptacle described in this disclosure that may include a tail portion 90, the tail portion 90 allows fluid supplied into the fluid inlet conduit 50 to be transported to the head portion 93 for treatment at the wound 22. All other features of the receptacle 110 are the same as for the receptacle 10. The fluid may comprise a gas, such as oxygen gas or carbon dioxide gas or carbon monoxide gas or nitric oxide gas or ambient air. The fluid may also comprise a combination of the aforesaid gases.
[0269] Whilst the disclosure of the features of the tail portion 90 are described with reference to the receptacle 110, one or more of the features may apply to any of the receptacles 10, 210, 210A, 310, 410, 510, 610 or 710 described in this disclosure.
[0270] Furthermore, as shown in Figures 26 and 27, the fluid inlet conduit 50 is encapsulated in a pressure spreading device 95 that is adjacent the receptacle 110. The pressure spreading device 95 is a silicone component that is moulded with the fluid inlet conduit 50 so as to surround it, as shown in the cross-sectional view of Figure 27. The pressure spreading device 95 spreads the load of the fluid inlet conduit 50 over a greater portion of the healthy skin 24 of the patient adjacent the wound 22 to reduce indentation during and after use of the receptacle 110.
[0271] The fluid inlet conduit 50 may be bonded to the pressure spreading device 95. The pressure spreading device 95 may encapsulate at least a portion of the fluid inlet conduit 50 between the fluid delivery device and a fluid source. The pressure spreading device 95 may be shaped to reduce a pressure exerted on the patient by the fluid inlet conduit 50. In some embodiments, the pressure spreading device 95 may have a width that is greater than an external diameter of the fluid inlet conduit 50. For example, the width may be about 2 to 10 times greater than the external diameter, or about 3 to 9 times greater than the external diameter, or about 4 to 8 times greater than the external diameter, or about 5 to 7 times greater than the external diameter of the fluid inlet conduit 50.
[0272] Whist some embodiments of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 may have a tail portion 90 and a pressure spreading device 95, some embodiments of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 may have a tail portion 90 and no pressure spreading device 95, or they may have a pressure spreading device 95 and no tail portion 90.
[0273] The tail portion 90 and the pressure spreading device 95 may be formed integrally with one another or they may comprise separate components. The tail portion 90 and the pressure spreading device 95 may be bonded together. The pressure spreading device 95 and the receptacle 110 may be made from the same material. The pressure spreading device 95 may have a generally elliptical crosssection. In some embodiments, it may have a cross-section that is shaped like a convex lens as shown in Figure 27. The fluid inlet conduit 50 may be bonded to the pressure spreading device 95.
[0274] During use of the receptacle 110, fluid passes from the fluid inlet conduit 50, into the tail portion 90, through the tail portion 90, and into the head portion 93. This flow of fluid is intended to at least partially inflate both the tail portion 90 and the head portion 93 in order to press the outside of the receptacle 110 to the target tissue, which helps to maximise the surface contact between the receptacle 110 and the wound 22 for delivery of molecules within the fluid to the target tissue, including the wound 22. Inflation of the receptacle 110 is schematically shown in the cross-sectional view of Figure 28(i) and in the view of the inflated receptacle 110 of Figure 28A(i). If the receptacle 110 is prevented from at least partially inflating, fluid flow through the receptacle may be impaired or even prevented, reducing or preventing the delivery of molecules within the fluid to the wound 22. For example, if the receptacle 110 is made of a smooth silicone material, one or more sections of the inner surface(s) of the one or more walls 115 of the receptacle 110 may adhere together such that the receptacle is unable to inflate. A non-inflated receptacle 110 is shown schematically in Figure 28(ii), and in the view of Figure 28A(ii).
[0275] In order to reduce the adherence together of the one or more sections of the inner surface(s) of the wall(s) 115 of the receptacle 110, surface contact between the one or more sections may be reduced. In some embodiments of the receptacle 110, the surface contact may be reduced by roughening the one or more sections of the inner surface(s) of the wall(s) 115. Figure 29 shows a cross- sectional view of an embodiment of a receptacle 310 in which an inner surface of one or more sections of the wall(s) 315. i.e. a non-wound contacting surface, is roughened to form a rough surface. In Figure 29a, an inner surface of a wall 315 has a roughened section forming a first rough surface 311. As shown in Figure 29b, multiple sections of the wall(s) 315 can be roughened; the inner surface of the wall 315 has a first roughened section forming a first rough surface 311 and a second roughened section forming a second rough surface 313. However, the wall(s) 315 may have further roughened sections forming further rough surfaces. Whilst Figure 29(a) and Figure 29(b) show roughening of a central section of the inner surface of the wall(s) 315, the roughening may be applied over other sections of the the wall(s) 315 or even over the the entirety of the inner surface of the wall(s) 315. In Figure 29b, the first rough surface 311 and the second rough surface 313 are opposite one another, however they may also be on sections of the inner surface of the wall(s) 315 that are not opposite one another. A close-up view of a cross-section of the rough surface 311 of the wall 315 is shown in Figure 30, however the features are equally applicable to the rough surface 313. The rough surface 311 has a rough texture. The roughness causes random variation in the topology of the surface.
[0276] The rough surface 311 may be irregular; it may vary in height (D) and it may include a plurality of raised and/or recessed elements that vary in width (W) as shown in Figure 30. In some cases the elements are added or raised elements from a common baseline within the wall 315. In some cases the elements are recessed from a common baseline within the wall 315. In some cases the elements are both raised and recessed from a common baseline within the wall 315. For example, the common baseline may be the level of a smooth section of the wall 315 i.e. a section that is not roughened. For example, the height (D) of the elements may be between about 0.2 micrometres to 200 micrometres, or between about 0.2 micrometres and 150 micrometres, or between about 0.2 micrometres and 100 micrometres, or between about 0.3 micrometres and 50 micrometres, or between about 0.5 micrometres and 10 micrometres, from the common baseline. The width (W) of the elements may be between about 0.2 micrometres to 200 micrometres, or between about 0.2 micrometres and 150 micrometres, or between about 0.2 micrometres and 100 micrometres, or between about 0.3 micrometres and 50 micrometres, or between about 0.5 micrometres and 10 micrometres, relative to the common baseline. In some cases, the height (D) of the rough surface may be measured from a low point to a high point thereof. For example, the height (D) of the rough surface may be between about 0.2 micrometres to 400 micrometres, or between about 0.2 micrometres and 300 micrometres, or between about 0.2 micrometres and 200 micrometres, or between about 0.4 micrometres and 200 micrometres, or between about 0.6 micrometres and 100 micrometres, or between about 1.0 micrometres and 20 micrometres, from a low point to a high point thereof.
[0277] As a result of the rough surface 311, there is less surface contact between the opposing inner surfaces of the wall(s) 315, so a lower likelihood of the inner surfaces of the wall(s) 315 adhering together to prevent inflation of the receptacle 310.
[0278] The outer surface of the wall 315 can be roughened to provide a rough surface 312. This may reduce the surface contact and thus the adherence between the outer surface of the wall 315 and contaminants such as dirt or dust that may be present in the manufacturing space. This can improve the cleanliness of the receptacle 310 due to reduced adherence between the outer surface of the wall 315 and the contaminants. This makes the receptacle 310 easier to clean and to keep clean. At least a portion of the rough surface 312 may be present on a section of the outer surface of the wall 315 configured for contacting the tissue, i.e. a wound or tissue contacting section of the surface that in use is intended to contact the tissue of the patient. Alternatively or additionally, at least a portion of the rough surface 312 may be present on a section of the outer surface of the wall 315 configured not to contact the tissue, such as a section of the surface opposing the wound or tissue contacting section of the surface, or a section of the surface adjacent the wound or tissue contacting section of the surface.
[0279] Figure 63 shows a cross-sectional view of an embodiment of a receptacle 310 in which one or more sections of an outer surface of the wall(s) 315. e.g. a wound or tissue contacting section of the surface, or a section of the surface opposing or adjacent the wound or tissue contacting section of the surface, is roughened to form a rough surface 312. In Figure 63a, an outer surface of a wall 315 has a roughened section forming a first rough surface 312. As shown in Figure 63b, multiple sections of the wall(s) 315 can be roughened; the outer surface of the wall 315 has a first roughened section forming a first rough surface 312 and a second roughened section forming a second rough surface 314. However, the wall(s) 315 may have further roughened sections forming further rough surfaces. Whilst Figure 63(a) and Figure 63(b) show roughening of a central section of the outer surface of the wall(s) 315, the roughening may be applied over other sections of the the wall(s) 315 or even over the entirety of the outer surface of the wall(s) 315. The roughened surface can be applied at least partially to the head portion 93 and/or tail portion 90. In Figure 63b, the first rough surface 312 and the second rough surface 314 are opposite one another, however they may also be on sections of the outer surface of the wall(s) 315 that are not opposite one another, for example the sections may be adjacent one another. A close-up view of a cross-section of the rough surface 311 of the wall 315 is shown in Figure 30 as described above, however the features are equally applicable to the rough surfaces 312, 314.
[0280] The rough surface on the outer surface of the wall(s) 315 may be used instead of or in addition to the rough surface on the inner surface of the wall 315.
[0281] Whilst the rough surface is described with respect to the receptacle 310, it will be apparent that it may be applied to any of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610 or 710 described in this disclosure. Accordingly, the rough surface may be combined with one or more features of the receptacles 110, 210, 210A, 310, 410, 510, 610 and 710.
[0282] If the receptacle 110 or 310, or any one of the receptacles 10, 210, 210A, 410, 510, 610, 710 described in this disclosure, is covered with a cover in the form of a dressing, (e.g. a compression dressing), the pressure from the dressing may also press walls of the receptacle 10, 110, 210, 210A, 310, 410, 510, 610, 710 together in such a way as to block the flow of fluid through the tail portion 90. Patient movement or position may also cause this kind of blockage if, for example, a patient rolls on top of the receptacle 10, 110, 210, 210A, 310, 410, 510, 610, 710. Such a blockage may stop fluid getting to the head portion 93. If this occurs, the patient will not receive therapy. To reduce the chance of such a blockage, a feature can be incorporated to help maintain a flow path along the tail portion 90, regardless of the pressure applied, such as by dressings, patient movement or patient position.
[0283] Figure 31a shows a cross sectional view, such as at line B-B of Figure 26 of an embodiment of the inside surface of a wall 415 of a receptacle 410. The inner surface of the wall 415 includes one or more small, soft, protruding ridges
96. When two portions of the one or more walls 415 are pressed together, the wall 415 opposing the ridge 96 drapes over the ridge 96, leaving gaps 97 on either side of it as shown in Figure 3 lb. The gaps 97 will generally remain even when tight dressings are applied over the receptacle 410 in use or regardless of patient movement. The ridges 96 are also shown in the views of the receptacle 415 of Figure 28 A.
[0284] The gaps 97 are formed due to the shape of the corner between each ridge 96 and the section of wall 415 from which it protrudes. The corners may be sharp such that it is substantially non-filleted, or it may have a fillet 98 that is small as shown in Figure 33a. For a substantially non-filleted comer, the corner may have a fillet that is so small as to be negligible, within the bounds of manufacturing capabilities. If the size of the fillet 98 is small in comparison with the height of the ridge 96, the likelihood that an opposing section of wall 415, pressed against the section with the ridges 96, will be able to deform in such a way that it fills that gaps 97, is reduced. For example, the fillet radius may be not more than about 30%, for example not more than about 25% or not more than about 20% or not more than about 10 % of the height of the ridge 96.
[0285] The importance of the sharp comers and fillets 98 is illustrated by the four alternatives shown in Figure 33a-c. Each of the alternatives shows the gap
97, between a first wall portion of the wall 415 and a second wall portion which can be an opposing wall portion of the wall 415 or another wall 415, on one side of a ridge 96. In Figure 33a, the fillet 98 is very small, so the comer is very sharp. Therefore, in this alternative, it is unlikely that the opposing wall would deform in such a way as to fill the gaps 97 when pressed onto the ridge 96. In Figure 33b, the fillet 98 is larger, so the corner is less sharp. Although this geometry may still result in gaps 97 being present when the opposing wall 415 presses down on the ridge 96, the gaps 97 would not be as large as they could be if the fillet 98 was smaller. In this case, fluid flow through the receptacle 410 would be more restricted in Figure 33b than in Figure 33a. In Figure 33c, the fillet 98 is large. In this alternative, it is possible that the opposing wall 415 would deform to fill the gaps 97. This would likely result in a blockage within the receptacle 410, which would compromise the therapy. The illustrative examples of the fillets 98 are shown in Figure 33 a-c as having a concave fillet shape. However, the fillets 98 may also be convex or mitre shaped. Alternatively, as shown in Figure 33d, the ridge 96 may overhang the comer to produce a sharp corner. In this embodiment, the corner may be substantially non-filleted, within the bounds of manufacturing capabilities.
[0286] The one or more ridges 96 may extend through the tail portion 490 of the receptacle 410, as far along the tail portion 490 as is necessary to maintain an open flow path inside the receptacle 410. For example, a plurality of the ridges 96 may extend through the entire tail portion 490 as shown in Figure 34a. Figure 34a shows three ridges 96. However, it will be appreciated that any appropriate number of ridges 96 may be included inside the tail portion 490. The ridges 96 may extend across some proportion of the head portion 493 as shown in Figure 34b. The ridges 96 may be straight as in the examples of Figure 34a and Figure 34b. The one or more ridges 96 may comprise two or more ridges arranged substantially parallel to one another as in the examples of Figure 34a and Figure 34b. Alternatively, the ridges 96 may be non-straight, for example they may have a longitudinal form that is a regular or irregular curve 96a, or zigzag 96b as illustrated in the example of Figure 34c. The ridges 96, 96a, 96b maintain a flow path between the entry point of the fluid conduit 50 to the tail portion 490 and the head portion 493. Figure 28 A shows views of an embodiment of the receptacle 110 showing the ridges 96, in both an inflated configuration of the receptacle 110 (Figure 28A(i)) and a non-inflated configuration (Figure 28A(ii)). Whilst the ridges 96 are shown for the receptacle 110, it will be apparent that the ridges apply also to any of the receptacles 10, 110, 210, 210A, 310, 310, 410, 510, 610, 710 described in this disclosure.
[0287] The ridges 96 may be formed of a soft, yielding material such as silicone. The yielding material is not rigid and may give way under pressure. It will deform to an extent under pressure but will regain its original configuration once the pressure is removed. The extent to which the ridges 96 may yield is a balance of the requirements for softer, more yielding ridges to help reduce indentation on the patient tissue while maintaining enough rigidity to maintain the flow path and prevent blockage. The one or more walls 415 of the receptacle 410 may include the first wall portion and the second wall portion opposite the first wall portion. The ridges 96 may be formed integrally with the first wall portion and/or the second wall portion respectively of the receptacle 410. The ridge 96 may have a rounded tip as shown in Figure 3 lb. A height of each ridge 96 may be similar to the height of one of the microstructures 60 described elsewhere in this disclosure. Each ridge 96 may have a height of between approximately 50 to 500 micrometres, for example 75 to 250 micrometres, for example 100 to 200 micrometres, for example between approximately 125 to 175 micrometres. An embodiment of the ridge 96 has a height of 150 micrometres. The height of the ridge 96 is a balance of the requirement for a taller ridge to help maintain a sufficient gap 97 and thereby prevent blockage of the flow path, whilst avoiding an overly tall ridge that may cause indentation in the patient tissue and which may render the ridge 96 susceptible to buckling. A width of each ridge 96 may be similar to the base diameter of the one of the microstructures 60. Each ridge 96 may have a width of between approximately 50 to 500 micrometres, for example 100 to 400 micrometres, for example between approximately 250 to 350 micrometres, or between approximately 280 to 330 micrometres. The ridge 96 increases the thickness of the wall 415 at the particular location of the ridge 96, which may affect the ability of molecules within the fluid to diffuse through the wall 415 at that location. Thus, whilst a larger number of ridges 96 may be included in the receptacle 110 to maintain a fluid flow path in the event the receptacle 110 is crushed, the number of ridges 96 should be balanced with the requirement that the molecules within the fluid can diffuse through the wall 415.
[0288] The thickness of the wall portion opposing the first wall portion or second wall portion of the wall 415 having the ridge 96 formed therewith is also a factor in the size of the gap 97 that is formed as the opposing first wall portion or second wall portion of the wall 415 is pressed onto the ridge 96. A thicker wall portion is less likely to deform into the gap 97, whereas a thinner wall portion is more flexible and thus more likely to deform and fill a gap 97. A thinner wall portion 415 may also have higher rates of diffusion across the wall than a thicker wall portion 415. The wall(s) 415 of the receptacle 410 may be the same material and thickness as those described in respect of receptacle 10 and may be flexible and conformable such that they can conform to the wound topology. Hence, it is important to balance these desirable properties of the first wall portion or second wall portion of the wall(s) 415 with the likelihood of blockage and choose the dimensions of the ridge 96 accordingly e.g. decrease fillet size or increase ridge height to ensure a suitable gap 97 is always present. For example, a thickness dimension of the first wall portion and/or the second wall portion may be less than or approximately equal to a height dimension of the ridge 96. Alternatively, the thickness dimension of the first wall portion and/or the second wall portion may be greater than a height dimension of the ridge 96.
[0289] The first wall portion and/or the second wall portion of the wall(s) 415 may have a wall thickness of between about 10 micrometres and 150 micrometres, or between about 20 micrometres and 140 micrometres, or between about 30 micrometres and 130 micrometres, or between about 35 micrometres and 100 micrometres, or between about 60 micrometres and about 105 micrometres, or between about 40 micrometres and 80 micrometres, or between about 40 micrometres to 70 micrometres, or between about 30 micrometres to 60 micrometres, or between about 45 micrometres and 55 micrometres. In an embodiment, the first wall portion and/or the second wall portion may have a wall thickness of approximately 60 micrometres. In another embodiment, the first wall portion and/or the second wall portion may have a wall thickness of approximately 50 micrometres.
[0290] In the embodiment of Figure 32, ridges 96 are provided on each of an opposing first wall portion and second wall portion of the wall(s) 415. In Figure 32(i), the ridges 96 are directly opposed when the surfaces are pressed together. In Figure 32(ii), the ridges 96 on opposing inner surfaces of the first wall portion and second wall portion of the wall(s) 415 are offset from one another when the surfaces are pressed together and are not directly opposed. Either embodiment may be used, however the use of non-opposing ridges may be less likely to indent the patient’s tissue when the receptacle 410 is pressed onto the wound 22 and/or surrounding tissue.
[0291] Whilst the features of the ridges 96 and thickness of the walls are described with respect to the receptacle 410, it will be apparent one or more of the features may also be applied to any of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610 or 710 described in this disclosure. For example, the ridges 96 may be used in combination with the rough surface 311, 313 of the receptacle 310 to mitigate indentation of the patient tissue in conjunction with reducing adherence of the inner surfaces of the receptacle 310 to one another. One or more ridges 96 extending through the tail portion 90 into the head portion 93 of the receptacles 110, 310 may contribute to the prevention of the inner surfaces adhering together.
[0292] Figure 35 shows a further variation of the receptacle 210 that is formed to have an elongated tubular shape through which fluid may be cycled. The receptacle 210 has a fluid inlet conduit 50 at one end of the elongate tube shape, for admission of fluid into the receptacle 210. It also has a first fluid outlet conduit 52 through which fluid may exit the receptacle 210 as with other embodiments of the receptacle 210. All other features of the receptacle 210 are the same as for the receptacle 10. This embodiment of the receptacle 210 may be particularly suitable for use on wounds or other tissue surfaces of a certain shape, for example elongate and/or narrow wound or other tissue area shapes. The receptacle 210 may include a plurality of microstructures 60 arranged on the wound facing surface 12 of the receptacle 10. The fluid may comprise a gas, such as oxygen gas or carbon dioxide gas or carbon monoxide gas or nitric oxide gas or ambient air. The fluid may also comprise a combination of the aforesaid gases.
[0293] A variation of the embodiment of Figure 35 is shown in Figure 35A and Figure 35B. As shown in Figure 35A(i), the receptacle 210A is formed to have an elongated tubular shape through which fluid may be cycled. The receptacle 210A has a fluid inlet conduit 50 at one end of the elongate tube shape, for admission of fluid into the receptacle 210A. It also has a first fluid outlet conduit 52 at an opposite end of the receptacle 210A to the fluid inlet conduit 50 through which fluid may exit the receptacle 210A as with other embodiments of the receptacle 210. All other features of the receptacle 210A are the same as for the receptacle 10. The elongate tube shape of the receptacle 210A allows a user to fold the receptacle 210A along its length as shown in Figure 35 A(ii), such that the fluid inlet condit 50 is positioned close to the first fluid outlet conduit 52 when in use on a patient. This arrangement means that fluid entering the receptacle 210A at the fluid inlet conduit 50 must pass along the length of the receptacle 210A to reach the first fluid outlet conduit 52, which may prolong the residence time that the fluid spends inside the receptacle 210A. The receptacle 210A may include one or more ridges extending from the fluid inlet conduit 50 to the first fluid outlet conduit 52, as described in respect of the embodiments of Figures 3 la to Figure 34. The ridges 96 may at least partially maintain open a fluid flow path from the fluid inlet 50, through the receptacle 210A to the first fluid outlet 52 when the receptacle 210A is folded. As shown in Figure 35B, the receptacle 210A may include a tail portion 90 and/or pressure spreading device 95 at the fluid inlet conduit end of the receptacle 210A and/or the first fluid outlet conduit end of the receptacle 210A. [0294] Figures 72 through 77 show variations of an embodiment of a tissue care dressing 600 which comprise a receptacle 610 that is formed from a first wall portion 615a and an opposing second wall portion 615b. The first wall portion 615a and the second wall portion 615b may be of a single wall, in accordance with which the receptacle 610 may, for example, be an inflatable bag. The first wall portion 615a and the second wall portion 615b may further be two separate walls attached together via heat sealing or joined otherwise at a seam 665.
[0295] The receptacle 610 has an inlet 620 and an outlet 630 which is substantially adjacent to the inlet 620. The inlet 620 and the outlet 630 of the receptacle 610 may be located at or near a tail portion 90 of the tissue care dressing 600. The receptacle 610 is adapted to receive a fluid via the inlet 620, and for the fluid to exit the receptacle via the outlet 630, such as to the ambient environment. The fluid may further pass through a pressure relief valve 70, for example as described with reference to Figure 8 herein above, before exiting to the ambient emvironment. As described herein with reference to receptacles 10, 110, 210, 210 A, 310, 410, 510 and 710, the receptacle 610 can be adapted to receive the fluid via a fluid inlet conduit 50 in fluid communication with the inlet 620. Similarly, the fluid can exit the receptacle via a fluid outlet conduit 52 in fluid communication with the outlet 630. The fluid inlet conduit 50 and the fluid outlet conduit 52 may be arranged to be disposed substantially adjacent one another, as described in respect of the embodiments of Figures 40, 41, 45-50 and 52 below. This embodiment of the receptacle 610 will be further described with reference to its application at a tissue area of a patient so that the first wall portion 615a faces the tissue area. It will however be appreciated that the first wall portion 615a and the second wall portion 615b can be configured to be substantially similar, as described herein above with reference to receptacle 710, and therefore reference to the first wall portion 615a herein is not necessarily indicative of a specific side of the receptacle 610 across all intended embodiments within the scope of this disclosure. [0296] The first wall portion 615a and the second wall portion 615b are formed so as to define a fluid flow path from the inlet 620 to the outlet 630, this fluid flow path generally indicated by reference FP in Figure 72. It is to be appreciated that the inlet 620 and the outlet 630 may be interchangeable such that the direction of fluid flow along the fluid flow path FP through the receptacle 610 can be in either direction as may be required. The embodiment of the receptacle 610 is however further described herein with reference to the configuration of the inlet 620 and outlet 630 as shown in Figures 72 and 73.
[0297] The fluid flow path FP is defined through a first chamber 640 in fluid flow connection with the inlet 620, and a second chamber 650 in fluid flow connection with the first chamber 640 and the outlet 630. The first chamber 640 and the second chamber 650 are provided at a head portion 93 of the receptacle 610, with the second chamber 650 being partitioned from the first chamber 640 by a juncture 660 between the first wall portion 615a and the second wall portion 615b. For example, this juncture 660 can be formed by a bond between an inner surface of the first wall portion 615a and an inner surface of the second wall portion 615b as shown schematically in Figure 75. This allows the formation of the fluid flow path substantially through the head portion 93 of the receptacle 610.
[0298] In this embodiment, the first chamber 640 is configured to be positionable at the tissue area, for example it may be shaped and/or sized to conform with a shape and/or size and/or geometry of the tissue area or a part thereof, with the first wall portion 615a thereof as a permeable layer 505 as described with reference to Figure 65 herein and with at least one section 520, as shown in Figure 74, allowing molecules within the fluid to pass through the permeable layer and deformable under pressure imparted by fluid in the interior of the receptacle 610 on the first wall portion 615a. It will be appreciated that the first chamber 640 and/or the second chamber 650 can take any appropriate shape, non-limiting examples of which include generally elongate shapes, curved shapes, rectangular shapes, square shapes, oval shapes and round shapes, and can further be any appropriate size, for example as may be required as a result of the size of the tissue area 525. A potential benefit of a larger first chamber 640 and/or the second chamber 650 may further be the ease with which the receptacle 610 can be secured to the tissue area 525, such as by adhesive tape. The chamber, in this example the first chamber 640, which is configured to be positionable at the tissue area preferably has a first wall portion 615a which has a larger surface area than the first wall portion 615a of the other chamber, in this example the second chamber 650. It will be appreciated that the larger surface area can facilitate correctly positioning of the receptacle 610 at the tissue area. Correspondingly, the chamber having a first wall portion with a smaller surface area, in this example the second chamber 650, may then allow for a relatively smaller chamber which can act as a conduit, shown by example in Figures 72 and 73 as having a generally curved shape about the first chamber 640, for conveying the fluid to or from the relatively larger chamber towards the inlet 620 or the outlet 630, dependant on the direction of fluid flow as discussed herein above with reference to the configuration of the inlet 620 and the outlet 630 of the receptacle 610. With further reference to Figure 75 and as described below, a larger surface area may allow a greater extent of deformation of the first wall portion 615a, such that the first wall portion 615a is more likely to contact the tissue area 525 of the patient.
[0299] The receptacle 610 may further be applied to a carrier layer 530 as described with reference to receptacle 510, 710 and shown in Figures 65 through 71, the section 520 thereby may supply molecules within the fluid to target tissue 522 within the tissue area 525 through an aperture 535 or apertures 535.1 through 535. n of the carrier layer 530 or carrier layers 530.1 through 530. n. It will be appreciated that in such an example embodiment, the carrier layer 530 or carrier layers 530.1 through 530. n may provide cushioning between the receptacle 610 and the tissue area 525. By way of non-limiting example, a carrier layer 530 may provide cushioning between the tissue area 525 and at least a part of the first chamber 640 and/or the second chamber 650 where a part or the whole of the first chamber 640 is applied over an aperture 530 or apertures 530.1 through 530. n of the carrier layer 530. The carrier layer 530 in such an example may further, and if present, provide cushioning between the fluid inlet conduit 50 and fluid outlet conduit 52, a seam 665, juncture 660, a pressure relief valve 7 and/or any part or surface of the receptacle which is not required to contact target tissue 522 within the tissue area 525.
[0300] Figures 72 through 74, 76 and 77 show the tissue care dressing 600 comprising a pressure spreading device 95 disposed at the tail portion 90. It will be appreciated that a pressure spreading device 95 is optional, but may improve patient comfort as it can be configured to mitigate a pressure applied to the patient by the fluid inlet conduit 50 and/or the fluid outlet conduit 52, such as described further herein with reference to receptacle 110. To further advance patient comfort during use of the tissue care dressing 600, the pressure spreading device 95 can be provided with a substantially flat surface 680 at an operatively patient facing side thereof.
[0301] Figures 73, 74 and 77 show the second wall portion 615b comprising a plurality of ridges 96 which extend along the fluid flow path at an inner surface of the second wall portion 615b. It will be appreciated that these ridges 96 may alternatively or in addtion be provided at an inner surface of the first wall portion 615a. These ridges 96 can be similar to the ridges 96 further described herein with reference to receptacles 10, 110, 210, 210A, 310, 410, 510 and 710. Figure 74 further shows the first wall portion 615a, and thereby the section 520 of the permeable layer 505 of the first chamber 640, comprising a plurality of microstructures 60 arranged at an operatively tissue facing surface of the first wall portion 615a. These microstructures 60 can be similar to the microstructures 60 further described herein with reference to receptacles 10, 110, 210, 210A, 310, 410, 510 and 710.
[0302] As discussed above, the first wall portion 615a and the second wall portion 615b can be configured to be substantially similar, and this may allow for the tissue care dressing 600 to be applied to a patient with any one or both of the first wall portion 615a and the second wall portion 615b facing the tissue area of the patient. However, as shown in Figure 74, the first wall portion 615a may be specifically configured to comprise microstructures 60 intended to contact the tissue area. Figure 75 shows the second wall portion 615b may be configured to have a greater thickness than the first wall portion 615a, which thicker second wall portion 615b may also comprise ridges 96 at its inner surface. In such instances, the tissue care dressing 600 is necessarily to be applied to a patient in a particular orientation. To facilitate ease of its application in this regard, the tissue care dressing 600 can comprise an indicator 690 of an orientation of the receptacle 610. In a simple form, and as shown in Figure 77, the indicator may comprise the word for example, “up” or “top”, or alternatively a graphical indicator, printed, moulded or otherwise provided on the tissue care dressing 600 to indicate, either directly or by implication, a surface of the receptacle 610 which is intended to face away from the patient. It will be appreciated that this indicator 690 can be provided anywhere on the tissue care dressing 600, for example at the tail portion 90 or head portion 93 of the receptacle 610 itself or on the pressure spreading device 95, should the tissue care dressing 600 include one, and can take various other forms in addition to those described herein above, non-limiting examples of which include colouring, labels and haptic indicators such as textures, patterns and the like.
[0303] In addition to the features described above with reference to receptacle 610, it will be appreciated that the second wall portion 615b can be configured to mitigate against or prevent fluid to pass therethrough. This may act to advance the passage of molecules within the fluid through the section 520 and/or mitigate against fluids in the environment passing through the second wall portion 615b into the interior of the receptacle 610. For example, the second wall portion 615b can have a thickness as described herein relative the first wall portion 615a and with reference to the second wall portion 515b and/or be of a material which does not allow bulk flow fluid to pass therethrough, and thereby the second wall portion 615b can also substantially prevent diffusion and/or pore flow therethrough. [0304] For some wounds, such as wounds with complex shapes or tunneling wounds, it may be more effective to insert a receptacle into the wound rather than place it on the wound. Insertion of the receptacle may result in a greater surface contact between the one or more walls of the receptacle and the patient tissue. This may assist both fluid delivery to the wound and exudate management. To insert the receptacle into the wound, the user may fold, twist, scrunch or otherwise manipulate the receptacle so that it can be inserted into the wound. In this event, the ridges 96 help to maintain open the fluid flow path from the fluid inlet conduit 50 to the first fluid outlet conduit 52. The receptacle 210A is an example of a receptacle that is easily folded or otherwise manipulated for insertion into a wound, however other receptacles 10, 110, 210, 310, 410, 510, 610, 710 described in this disclosure may also be user manipulated for this purpose. In some examples, adhesive, such as tape, can be used to hold the manipulated receptacle in place. A larger receptacle 10, 110, 210, 310, 410, 510, 610, 710 which is formed from one or more walls 15, 115, 515, 615, 715 may further allow for the receptacle 10, 110, 210, 310, 410, 510, 610, 710 to better conform to complex tissue areas due to less constraint by any outer seams formed in the joining of the walls 15, 115, 515, 615, 715, and/or less constraint caused by an adhesive holding the receptacle in place, when compared with a smaller receptacle. Thereby the total deformation of the receptacle 10, 110, 210, 310, 410, 510, 610, 710 will be greater than that for a smaller receptacle. Thus, the receptacle 10, 110, 210, 310, 410, 510, 610, 710 may have improved contact with a tissue area when compared to a smaller receptacle 10, 110, 210, 310, 410, 510, 610, 710 as it is better able to conform to the shape and/or geometry of the tissue area while aso allowing a greater degree of manipulation to conform to the tissue area during positioning of the receptacle 10, 110, 210, 310, 410, 510, 610, 710.
[0305] In all embodiments of an apparatus 100, 200, 300, 500, 1100, 1200, 1300 as described herein and/or the receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 the fluid source 40 may be controlled to maintain a set pressure in the receptacle 10, 110, 210, 210A, 310, 410, 510, 610, 710. That is, the controller may compensate over time for loss of fluid from the receptacle 10, 110, 210, 210A, 310, 410, 510, 610, 710 due to e.g. fluid diffusion out of the receptacle 10, 110, 210, 210A, 310, 410, 510, 610, 710 via the wound facing surface 12 to the wound 22. As such, the section of the wall 15 or the entire wall 15 that is made of the membrane experiences an even pressure, which results in an even pressure of fluid applied at the wound 22.
[0306] Figures 36 to 39 show further embodiments of the apparatus 100 having a pressure regulator associated with the fluid outlet 53. However, the features of the apparatus of any one of the embodiments of Figures 1 to 35 A may feature also in the embodiment of Figs. 36 to 39. The embodiments of Figures 36 to 39 may assist in achieving a substantially consistent concentration of the fluid within the receptacle 10, for example an oxygen concentration within the receptacle 10, by facilitating the cycling of the fluid through the receptacle 10.
[0307] In the embodiment of Figure 36, the fluid inlet conduit 50 has a fluid inlet 55 that is positioned at an end of the fluid inlet conduit 50 that is distal from the receptacle 10. The first fluid outlet conduit 52 of the receptacle 10 has a fluid outlet 53 that is positioned at an end of the first fluid outlet conduit 52 that is distal from the receptacle 10. The fluid inlet 55 and the fluid outlet 53 each provide fluid communication with the receptacle 10, via the fluid inlet conduit 50 and the first fluid outlet conduit 52, respectively, and may comprise a port, connector, or other fitting. A fluid flow path through the receptacle 10 may be defined by the one or more walls of the receptacle 10, the fluid inlet 55 and the fluid outlet 53. A boundary of the fluid flow path through the receptacle 10 may be independent of the tissue of the patient. That is, the tissue of the patient does not form part of the fluid flow path through the receptacle 10. Whether the wall 15 of the receptacle 10 allows molecules within the fluid inside the receptacle 10 to diffuse through the wall 15 to the wound 22, or to pass from the receptacle 10 to the wound 22 via pore flow, the wall 15 is present between the fluid and the wound 22 as the fluid is delivered to the receptacle 10. [0308] A pressure regulator in the form of a pressure relief valve 170 is associated with, that is, disposed at the fluid outlet 53. The pressure regulator is disposed in fluid communication with the fluid outlet 53 and thus also with the receptacle 10. The pressure regulator, for example the pressure relief valve 170, may be operable to relieve pressure within the fluid outlet 53 and/or the receptacle 10. The pressure relief valve 170 may be positioned in spaced relation from, that is, at a distance away from the receptacle 10, e.g. at the fluid outlet 53 that allows the pressure relief valve 170 to be moved relative to the receptacle 10. For example, the first fluid outlet conduit 52 may have a length, at the distal end of which is the fluid outlet 53. The pressure relief valve 170 may be positioned on the first fluid outlet conduit 52 at the fluid outlet 53, distally from the receptacle 10, which allows it to be positioned outside of any cover 30 As such, the fluid inlet conduit 50 or the first fluid outlet conduit, with the fluid outlet 53 and the pressure relief valve 170, can be moved for ease of wrapping a bandage or other dressing over the receptacle 10. The arrangement allows a cover 30 in the form of a bandage or other dressing to be wrapped over the receptacle 10 without having to also wrap the bandage around the additional bulk of a pressure relief valve 170 or other pressure regulator. As shown in Fig. 36, the pressure relief valve 170 is placed outside of the cover 30. Alternatively, for embodiments in which no negative pressure source 45 and no cover 30 is present, the pressure relief valve 170 may be placed close to, or even in contact with, the receptacle 10. In such an embodiment, the first fluid outlet conduit 52 may be omitted. In such an embodiment, the pressure relief valve 170 may be integral with or connected to the receptacle 10. In some embodiments, a cover 30 in the form of a bandage or other dressing may be wrapped over the receptacle 10 and the pressure relief valve 170. In one embodiment, the cover 30 may comprise a compression bandage wrapped over the receptacle 10, and an outer dressing wrapped over the compression bandage. In this embodiment, the pressure relief valve 170 may be placed outside of the compression bandage and under the outer dressing.
[0309] During use of the apparatus 100, the receptacle 10 may be maintained at a positive pressure (e.g. the receptacle 10 may be inflated) to encourage molecules within the fluid inside the receptacle 10 to diffuse through the membrane of the receptacle 10 to the wound 22 by generating a pressure gradient across the membrane. The apparatus 100 may be set up so that a constant, low flow of fluid enters the receptacle 10 via the fluid inlet conduit 50. The constant fluid flow, along with the pressure regulator on the fluid outlet 53, maintains a positive pressure within the receptacle 10. However, the constant fluid flow in through the fluid inlet 55 also means that there must be a regular fluid flow out through the fluid outlet 53 as the rate of diffusion through the membrane is not high enough to empty the receptacle 10 of all of the fluid entering the receptacle 10 at the fluid inlet 55. The regular fluid flow out through the fluid outlet 53 may not necessarily be constant due to operation of the pressure relief valve 170. Furthermore, in the initial stages of use of the receptacle 10 or at low fluid flow rates, there may be no need for the pressure relief valve 170 to open, such that no fluid flows out through the fluid outlet 53 unless a threshold pressure within the receptacle 10 is reached that causes the pressure relief valve 170 to open. At a steady state, the constant or regular flow of fluid in and out of the receptacle 10 cycles the fluid through the receptacle 10 so that the fluid, e.g. oxygen, within the receptacle 10 is maintained at a high concentration. If there was no cycling of the fluid, the fluid in the receptacle 10 could be diluted by other fluids, e.g. nitrogen, that may diffuse in to the receptacle 10 through the membrane from the outside.
[0310] The pressure regulator on the fluid outlet 53 is important to the cycling process, as it allows cycling of the fluid to be achieved in a controlled manner. In particular, the pressure regulator may be configured to ensure cycling does not occur at too high a rate that may lead to wasted fluid, e.g. oxygen, in addition to maintaining a positive pressure within the receptacle 10 as described above. The pressure relief valve 170 is configurable to relieve pressure within the receptacle 10 when the pressure within the receptacle 10 reaches a threshold value. In some embodiments, the pressure relief valve 170 may be configurable to adjust the pressure threshold value. The pressure threshold value may be an upper pressure bound, above which the pressure relief valve is to open. By having an upper pressure bound threshold, cycling of the fluid through the receptacle 10 may only occur if the upper bound is exceeded, therefore a positive pressure may be maintained within the receptacle, providing a pressure gradient between the receptacle 10 and the wound 22. This pressure gradient may aid with diffusion of molecules within the fluid across the membrane from a high pressure side (within the receptacle 10) to a low pressure side outside of the receptacle 10, e.g. at the wound 22. That is, if the pressure gradient results in a high partial pressure of fluid, e.g. oxygen, within the receptacle 10 and a low partial pressure of fluid, e.g. oxygen, at the wound 22, the pressure gradient may drive diffusion of molecules within the oxygen across the membrane to the wound 22. In contrast, a high partial pressure of nitrogen outside of the receptacle 10 and a low partial pressure of nitrogen within the receptacle 10 may cause nitrogen to diffuse into the receptacle 10 as discussed above, hence cycling of fluid through the receptacle 10 helps to maintain a high concentration of oxygen within the receptacle 10. The purpose of the cycling is to regularly refresh the fluid within the receptacle 10 with fluid of a high oxygen concentration by cycling out fluid already within the receptacle 10 including any other fluids such as nitrogen, so that more of the high oxygen concentration fluid reaches the wound 22.
[0311] The pressure relief valve 170 may comprise any suitable type of valve such as a spring-loaded check valve with a disc, a spring-loaded check valve with a ball, a diaphragm valve, a lift valve, a butterfly valve or a duckbill valve. Each of these valve types may be set to permit fluid to pass through the pressure relief valve 170 and out of the fluid outlet 53 when a threshold fluid pressure is reached upstream of the pressure relief valve 170.
[0312] The pressure relief valve 170 may be selectively actuable to an at least partially open position to permit fluid to pass therethrough, and is configured, when in the at least partially open position, to vent the fluid passing there through to the atmosphere, via the fluid outlet 53. In some embodiments, the pressure relief valve 170 may be either open or closed, however the pressure relief valve 170 valve may also include at least one partially open position between the open and closed positions. The open position may correspond to a threshold fluid pressure at which the pressure relief valve 170 opens. Where used, the at least one partially open position may correspond to at least one other threshold fluid pressure at which the pressure relief valve 170 partially opens.
[0313] The pressure relief valve 170 may be passively actuated, or it may be actively actuated. Where the pressure relief valve 170 is actively actuated, a sensor, for example a pressure sensor or a flow sensor, may be disposed to sense a parameter of the fluid from which a fluid pressure can be determined. A controller is disposed in communication with the sensor. The fluid pressure may be provided to the controller. The controller may be configured to control the pressure relief valve 170 such that if the pressure sensor detects a fluid pressure that is greater than or equal to one of the threshold fluid pressures, the pressure relief valve 170 will open to the open position or to the at least one partially open position.
[0314] Fig. 37 shows a variation of the embodiment of Fig. 36 in which the cover 30 is not present such that there is no compartment 35. The pressure relief valve 170 is positioned at the fluid outlet 53 of the first fluid outlet conduit 52, in fluid communication with the receptacle 10 as in the embodiment of Figure 36.
[0315] Figure 38 shows a variation of the embodiment of Figure 37 in which a wall 15 has a first layer and a second layer. The second layer of the wall 15 of the receptacle 10 faces away from the wound 22 and is made of a material having a thickness that is greater than a thickness of a first layer of the wall 15 that faces toward the wound 22. The thicker material may reduce the loss of fluid through areas of the wall 15 that do not face the wound 22 and may result in an increase in efficiency of the apparatus 100. The first layer of the wall 15 of the receptacle 10 may have the wall thickness as described above for the receptacle 10; that is between about 10 micrometres and about 150 micrometres, for example between approximately 20 micrometres and 140 micrometres, or between approximately 20 micrometres and 90 micrometres, or between approximately 30 micrometres and 130 micrometres, or between approximately 35 micrometres and 100 micrometres, or between approximately 40 micrometres and 80 micrometres, or between approximately 40 micrometres to 70 micrometres, or between approximately 50 micrometres to 70 micrometres, or between approximately 30 micrometres to 60 micrometres, or between approximately 20 to 60 micrometres, or between approximately 45 micrometres and 55 micrometres. In some embodiments, the first layer of the wall 15 may have a wall thickness of approximately 60 micrometres. In some embodiments, the first layer of the wall 15 may have a wall thickness of approximately 50 micrometres. The second layer of the wall 15 may have a wall thickness of between about 75 micrometres and about 1 mm, for example between approximately 80 micrometres and 800 micrometres, or between approximately 85 micrometres and 600 micrometres, or between approximately 90 micrometres and 400 micrometres, or between approximately 95 micrometres and 300 micrometres, or between approximately 100 micrometres and 200 micrometres, or between approximately 125 micrometres and 175 micrometres, or between approximately 100 micrometres and 250 micrometres. In some embodiments, the wall thickness is approximately 160 micrometres. In some embodiments, the wall thickness is approximately 150 micrometres. The wall thickness may be greater than 1 mm provided that the second layer remains flexible such that the apparatus 100 inflates and conforms to the underlying patient tissue at the wound 22. It will be apparent to the skilled person that the thicker material of the second layer of the wall 15 may be used with any one of the embodiments of the receptacle 10, 110, 210 310, 410, 510, 610, 710 disclosed herein and this disclosure extends also to those embodiments.
[0316] Whilst the pressure regulator of Figure 36 to Figure 38 is described in the form of a pressure relief valve 170, the pressure regulator may take other forms to achieve a positive pressure within the receptacle 10. Whilst the pressure regulator is described here with respect to the receptacle 10, it will be apparent to the skilled person that tthe following applies to all embodiments of the disclosure that include a pressure regulator for regulating fluid pressure within the receptacle 110, 10, including where a pressure regulator is used with the receptacles 210, 210A, 310, 410, 510, 610, 710. The pressure regulator, including the pressure relief valve 170, may be passively and/or mechanically actuable to permit fluid to pass therethrough, i.e. the pressure regulator is not powered. Alternative pressure regulators to the pressure relief valve 170 may include, for example, that the first fluid outlet conduit 52 may have a small internal diameter and/or a long length that would generate a large resistance to fluid flow exiting the receptacle 10 and a resultant positive pressure in the receptacle 10. In practice, the length and the internal diameter of the first fluid outlet conduit 52 will be determined based on the target fluid pressure in the receptacle 10. The skilled person in the art would know to vary the length and/or the internal diameter in order to achieve a target pressure. Similarly, a series of baffles or changes of direction of the first fluid outlet conduit 52 may be used to form a tortuous section of flow path within the first fluid outlet conduit 52 to generate a large resistance to fluid flow, resulting in a positive pressure in the receptacle 10. The tortuous section could be formed in a block of material or by manipulating the shape of the first fluid outlet conduit 52. A further alternative is to utilise a Tesla valve in the flow outlet conduit 52 to generate a large resistance to fluid flow within the first fluid outlet conduit 52.
[0317] A calibrated leak orifice similar to the calibrated leak orifice 74 seen in Figure 8 may be used at the fluid outlet 53 to permit a specified leak, which may result in a positive pressure in the receptacle 10. The calibrated leak orifice may be calibrated to provide a leak out of the receptacle 10 that is small enough to maintain a positive pressure within the receptacle 10, but large enough to reduce the chance of pressure within the receptacle 10 becoming undesirably high.
[0318] Fig. 39 shows an embodiment of a receptacle 10 in which cycling of fluid within the receptacle 10 may be achieved by incorporating at least one aperture 120 in the second layer of the wall 15, that are configured to permit fluid within the receptacle 10 to pass therethrough to exit the receptacle 10. The at least one aperture 120 may comprise a plurality of apertures. The size and/or number of the at least one aperture 120 may be tailored to allow cycling of fluid from within the receptacle 10 to the atmosphere whilst providing enough resistance to fluid flow to achieve a positive pressure in the receptacle 10. The at least one aperture 120 may also help to prevent the pressure within the receptacle 10 from becoming too high and to relieve pressure within the receptacle 10 during use of the apparatus. The at least one aperture 120 may be used where the apparatus does not include a compartment 35. The at least one aperture 120 functions most effectively in the absence of a negative pressure compartment. In this embodiment, the at least one aperture 120 may be used instead of the first fluid outlet conduit 52.
[0319] The at least one aperture 120 may have a border of thicker material to prevent tearing and to maintain the integrity of the material of the second layer surrounding the at least one aperture 120. The border of thicker material may comprise a ring of raised material surrounding the at least one aperture 120 and the border of thicker material may be of any reasonable cross-sectional shape, for example a semi-oval shape, or a rounded rectangular shape or a semi-octagonal shape. The border of thicker material surrounding the at least one aperture 120 may improve the structural integrity of the material of the second layer surrounding the at least one aperture 120 and help to prevent any tear in the at least one aperture 120 from propagating beyond the border.
[0320] Whilst the pressure relief valve 170 or other pressure regulator or calibrated leak orifice or the at least one aperture 120 are described with reference to the receptacle 10, any of them may apply also to any of the receptacles 110, 210, 210A, 310, 410, 510, 610, 710 described in this disclosure.
[0321] Figures 40 to 44 show an embodiment of a receptacle that is similar to the receptacle 110 of Figure 26, and like features are given like reference numbers. The receptacle 110 has a longitudinal axis X-X that extends through the head portion 93 and the tail portion 90 of the receptacle 110. In the embodiment of the receptacle 110 shown in Figure 40 and Figure 41, an internal flow guide 140 in the form of an internal wall. The internal wall extends along the longitudinal axis X-X to form two compartments, one either side of the internal wall. The compartments are arranged in a layered or stacked configuration with a first wall portion of the wall 115 (a lower portion of the wall as viewed in Figure 40) and a second wall portion of the wall 115 (an upper portion of the wall as viewed in Figure 40) of the receptacle 110. That is, the internal flow guide 140 has a first flow guide surface 142 that is configured to face the wound 22 and/or healthy skin 24 surrounding the wound 22 during use, and a second flow guide surface 144 that opposes the first flow guide surface 142 and faces away from the wound 22 and/or healthy skin 24 surrounding the wound during use. Accordingly, a layered or stacked configuration of the compartments refers to a first compartment formed between the first wall portion and the first flow guide surface 142 of the internal flow guide 140 and a second compartment formed between the second flow guide surface 144 and the second wall portion of the wall 115. Whilst the internal flow guide 140 of Figure 40 extends along the longitudinal axis X-X, in an alternative embodiment it may extend parallel to the longitudinal axis X-X so as to be offset from it. In such an embodiment, the internal flow guide 140 divides the receptacle 110 into two compartments of different sizes. The first wall portion and the second wall portion of the wall 115 are flexible such that, prior to use, the internal flow guide 140 may lie substantially parallel with the first wall portion and the second wall portion of the wall 115 of the receptacle 110, however, in use, of the receptacle 110, the first wall portion and the second wall portion of the wall 115 may be contorted or bent to accommodate a complex wound shape or to fit onto a contoured part of the body, for example, a heel or knee. The internal flow guide 140 extends across the full lateral extent of the receptacle and may be sealed at its periphery to the one or more walls 115 of the receptacle 110. The internal flow guide 140 has a circulation opening 145 towards an end of the internal flow guide 140 that is positioned in the head portion 93 of the receptacle 110. The circulation opening 145 provides a fluid pathway through the receptacle 110 and between the two compartments, as will be described further.
[0322] As best seen in Figure 44, the receptacle 110 has a fluid inlet conduit 50 and a first fluid outlet conduit 52, each of which passes through the pressure spreading device 95 and through which fluid respectively enters and exits the receptacle 110. However, in embodiments of the receptacle 10, 110 that do not include a pressure spreading device 95, the fluid inlet conduit 50 and the first fluid outlet conduit 52 pass directly into the one or more walls 15, 115 of the receptacle 10. In Figure 40, the fluid inlet conduit 50 is shown beneath the first fluid outlet conduit 52, however the converse arrangement may also be used where the fluid inlet conduit 50 is above the first fluid outlet conduit 52. The fluid inlet conduit 50 and the first fluid outlet conduit 52 may also be disposed side by side, as will be described with respect to Figure 50(a) and 50(b). The fluid outlet 53 has a pressure regulator such as a pressure relief valve 170 disposed on it for relieving pressure inside the receptacle 110.
[0323] The one or more walls 115, the fluid inlet 55, the fluid outlet 53 and the internal flow guide 140 are configured to define a fluid flow path through the receptacle 110 that extends from the fluid inlet 55, past at least a portion of the internal flow guide 140, and out of the fluid outlet 53. In use of the apparatus 1100, fluid enters the receptacle 110 via the fluid inlet 55 of the fluid inlet conduit 50, and flows along the part of the fluid flow path defined by the major portion of the first flow guide surface 142 that lies upstream of the circulation opening 145 and the first wall portion of the wall 115, through the circulation opening 145 and along the part of the fluid flow path defined by the major part of the second flow guide surface 144 and out of the fluid outlet 53 of the first fluid outlet conduit 52 via the pressure relief valve 170 (or other pressure regulator as described above). As such, the internal flow guide 140 may prolong a residence time in which fluid entering the fluid inlet 55 spends within the receptacle 110 prior to exiting the receptacle 110 through the fluid outlet 53, relative to a receptacle 110 that does not include an internal flow guide 140. The internal flow guide 140 effectively divides the receptacle 110 into first and second compartments that are fluidly connected by the circulation opening 145. The internal flow guide 140 may permit molecules within the fluid within the receptacle 110 to pass through it and may be made of the same material as the one or more walls 115 of the receptacle 110. However, the internal flow guide 140 may be made of a different material and that material may not allow molecules within the fluid within the receptacle 110 to pass through it.
[0324] In the embodiment of Figure 40 and Figure 41, the fluid inlet conduit 50 and the first fluid outlet conduit 52 are disposed at the same end of the receptacle 110. This arrangement is advantageous in that it facilitates ease of handling a dressing, for example a bandage, and the fluid inlet conduit 50, first fluid outlet conduit 52, and any further tubes that are connected to them, during application of the dressing over a wound 22. In particular, the fluid inlet conduit 50 and the first fluid outlet conduit 52 may be handled in one hand as the receptacle 110 is applied onto the wound 22, leaving the other hand free to apply a dressing or to wind the bandage over the receptacle 110 and the fluid inlet conduit 50 and first fluid outlet conduit 52, and around a limb or other body part having the wound 22. The user must take care when applying the dressing not to trap the fluid inlet conduit 50 and the first fluid outlet conduit 52 such that they dig into the healthy skin 24 surrounding the wound 22 and cause discomfort to the patient. As a result of the fluid inlet conduit 50 and the first fluid outlet conduit 52 being disposed at the same end of the receptacle 110, the fluid inlet conduit 50 and the first fluid outlet conduit 52 can be managed together, minimising the possibility of causing such discomfort. This aspect of the receptacle 110 applies also to the embodiment of the receptacle 10 shown in Figure 16b, described above, in which the fluid inlet conduit 50, first fluid outlet conduit 52 and the second fluid outlet conduit 54 are arranged adjacent one another at the same section of the receptacle 10. The arrangement also encourages an even dispersal of fluid through the receptacle 110, as fluid must travel from the fluid inlet 55 of the fluid inlet conduit 50, along a majority of the length of the receptacle 110, through the circulation opening 145 and back along the majority of the length of the receptacle 110 before it may exit the fluid outlet 53 and via the first fluid outlet conduit 52.
[0325] It is noted that whilst the above description refers to the first flow guide surface 142 being configured to face the wound 22 and/or healthy tissue skin 24 surrounding the wound 22 during use, and the second flow guide surface 144 opposing the first flow guide surface 142 and facing away from the wound 22 and/or healthy skin 24 surrounding the wound during use, the description simply refers to the orientation of the receptacle as it is shown in Figure 40. In practice, the receptacle 110 may equally be used in an orientation in which the the first flow guide surface 142 is configured to face away from the wound 22 and/or healthy tissue skin 24 surrounding the wound 22 during use, and the second flow guide surface 144 opposing the first flow guide surface 142 faces the wound 22 and/or healthy skin 24 surrounding the wound. The one or more walls 115 of the receptacle 110 may also have the same properties regardless of orientation of the receptacle 110. The receptacle 110 may accordingly be used in either orientation in use, making the receptacle 110 user friendly. Furthermore, whilst the features of the internal flow guide 140 are described with reference to the receptacle 10, it will be apparent that one or more of the features of the internal flow guide 140 may appy to any of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 described in this disclosure.
[0326] The circulation opening 145 of the internal flow guide 140 is shown in plan view in Figure 41. In Figure 41 it has an oval shape, however it may have any reasonable shape such as a circle, rectangle or slit. For example, in Figures 43 A to 43C, the circulation opening 145 is shaped as a slot. It may have a width dimension that is sufficiently large to allow fluid to pass through it across a significant portion of the interior width of the receptacle 110, across the plurality of ridges 96. A width dimension of the circulation opening 145 may be between 5% and 95% of an interior width of the receptacle 110 when not inflated. In an example, the width of the circulation opening 145 may be between 15% and 85% or between 25% and 75% or between 30% and 60% of the interior width of the receptacle 110 when not inflated. The circulation opening 145 may be positioned at an end of the receptacle 110 that is distal from the fluid inlet conduit 50 and the first fluid outlet conduit 52 as shown in Figure 41. The circulation opening 145 may be surrounded by an opening surround 148, as seen in Figure 42. Figure 42 is an enlarged plan view of the circulation opening 145 and its opening surround 148. The opening surround 148 may comprise a ring of raised material, such as a rib. The raised material may rise from one of the first flow guide surface 142 or the second flow guide surface 144 or both of the first flow guide surface 142 and the second flow guide surface 144. The ring of raised material may have any reasonable cross-sectional shape. Examples of possible cross-sectional shapes of the ring of raised material are shown in Figure 43. In Figure 43(i), the ring of raised material of the opening surround 148 has a shallow semi -oval cross- sectional shape. In Figure 43 (ii), the ring of raised material of the opening surround 148 has a deeper ovoid cross-sectional shape. In Figure 43 (iii), the ring of raised material of the opening surround 148 has a rounded rectangular cross- sectional shape. The rounded rectangular cross-sectional shape is easy to manufacture and does not have any sharp comers that may cause discomfort to the patient. In Figure 43(iv), the ring of raised material of the opening surround 148 has a semi-octagonal cross-sectional shape. A variation of this embodiment may have rounded comers rather than the sharp comers shown in Figure 43 (iv). The opening surround 148 may improve the structural integrity of the material surrounding the circulation opening 145 and help to prevent any tear in the internal flow guide 140 at the circulation opening 145 from propagating too far and substantially increasing the size of the circulation opening 145.
[0327] Figure 43 A to Figure 43 C illustrate how the ridges 96 of the first wall portion and/or the second wall portion of the wall 115 may overlap the opening surround 148. The ridges 96 may alternatively or additionally be present on the first flow guide surface 142 and/or the second flow guide surface 144 of the internal flow guide 140. The overlapping of the ridges 96 with the opening surround 148 helps to maintain the fluid flow path inside the receptacle 10, 110, 210, 210A, 310, 410, 510, 610 and fluid may flow along the side of the ridges 96 as described above and over the opening surround 148 into the circulation opening 145. In Figure 43A and Figure 43B, the ridges 96 are shown on the second wall portion of the wall 115. The microstructures 60 are also visible on the second wall portion of the wall 115. The opening surround 148 on the second flow guide surface 144 of the internal flow guide 140 is shown overlapping with some of the ridges 96. Figure 43C is a view of the circulation opening 145, opening surround 148 and ridge 96 of Figure 43B and illustrates clearly how the ridge 96 overlaps the opening surround 148 at two points, either side of the circulation opening 145.
[0328] The opening surround 148 may have one or more gaps or discontinuities 149 as shown in Figure 43D to Figure 43F. The gaps 149 in the opening surround
148 may assist fluid within the receptacle 10,110, 210, 210A, 310, 410, 510, 610, 710 to flow past the opening surround 148 and through the circulation opening 145. The opening surround 148 may include a plurality of the gaps 149. The gaps 149 may be evenly spaced around the opening surround 148 as shown in Figures 43D and 43E or they may be unevenly spaced. At least some of the gaps
149 may be aligned with one another across the circulation opening 145.
[0329] As shown by way of example in Figure 43E, some of the ridges 96 of the first wall portion and/or the second wall portion of the wall 115 may terminate at the gaps 149 or at the opening surround 148. Alternatively, some of the ridges 96 may terminate at the circulation opening 145. Some of the ridges 96 may pass through the gaps 149 and continue to the opposite side of the circulation opening 145 and/or may pass through a gap 149 on the opposite side of the opening surround 148. Ridges 96 that pass through gaps 149 in the opening surround 148 may be less prone to creating a pressure point on the tissue of the patient in use. The ridges 96 in the vicinity of any one circulation opening 145 may include a mix of termination points as shown in the example of Figure 43E.
[0330] Figure 43F shows an embodiment of an an opening surround 148 that comprises only sections at the extremities of the circulation opening 145, where the corners are sharp. The sections of the opening surround 148 assist in preventing tears in the material of the internal flow guide 140 at the sharp corners of the circulation opening 145 from propagating through the internal flow guide 140. In this embodiment, one or more of the ridges 96 may extend over the circulation opening 145. [0331] The internal flow guide 140 may include more than one of the circulation openings 145. Having more than one circulation opening 145 can be beneficial in the event that one of the circulation openings 145 becomes blocked, fluid is still able to pass through another circulation opening 145 to reach the fluid outlet 53. The internal flow guide 140 may include a section that is porous such that it provides a flow path through which fluid may flow. The porous section may be distal from the fluid inlet conduit 50.
[0332] Figures 44a and 44b show how the fluid inlet conduit 50 and the first fluid outlet conduit 52 attach to the tail portion 90 of the receptacle 110. As shown in Figures 40 to 43, the fluid inlet conduit 50 and the first fluid outlet conduit 52 are encapsulated in the pressure spreading device 95 and extend into the tail portion 90 of the receptacle. Figures 44a and 44b show further detail of the termination of the fluid inlet conduit 50 and the first fluid outlet conduit 52 at the tail portion 90. The ends of the fluid inlet conduit 50 and the first fluid outlet conduit 52 respectively pass through the first wall portion and the second wall portion of the wall 115 of the receptacle 110 and into the interior of the receptacle 110. In particular, the ends of the fluid inlet conduit 50 and the first fluid outlet conduit 52 are integrally formed, for example moulded, into the first wall portion and the second wall portion of the at least one wall 115 of the receptacle 110 such that an outlet 57 of the fluid inlet conduit 50 and an inlet 58 of the first fluid outlet conduit 52 are disposed inside the tail portion 90 of the receptacle 110. The outlet 57 and the inlet 58 may take the form of a port, or an end of a fluid inlet conduit or first fluid outlet conduit that protrudes into the tail portion 90 of the receptacle 110. Alternatively, the outlet 57 and the inlet 58 may each comprise of an opening that allows delivery of the fluid from the fluid inlet conduit 50 to the receptacle 110, or from the receptacle 110 to the first fluid outlet conduit 52, by maintaining fluid communication between the receptacle 110 and the respective one of the fluid inlet conduit 50 and the first fluid outlet conduit 52. In use, fluid is supplied to the receptacle 110 via the outlet 57 of the fluid inlet conduit 50 and fluid exits the receptacle 110 through the inlet 58 of the first fluid outlet conduit 52. This attachment of the fluid inlet conduit 50 and the first fluid outlet conduit 52 to the receptacle 110 may apply to all embodiments of the receptacle 110 disclosed herein. For embodiments of the receptacle 10, 110, 210, 210A, 310, 410, 510, 610, 710 that may not include a pressure spreading device 95, the fluid inlet conduit 50 and the first fluid outlet conduit 52 may be integrally formed with and pass directly through the first wall portion and the second wall portion of the one or more walls 15 such that their ends extend into the interior of the receptacle 10, 110, 210, 210A, 310, 410, 510, 610, 710. For example, they may be moulded into the one or more walls 15. Alternatively, the fluid inlet conduit 50 and the first fluid outlet conduit 52 may terminate within the pressure spreading device 95 and do not pass through the one or more walls 15 and into the receptacle 10.
[0333] A pressure regulator such as a pressure relief valve 170 may be added to the fluid inlet 55 of the fluid inlet conduit 50, either in addition to or instead of at the fluid outlet 53. The embodiment of the apparatus of Figures 40 to 44 may be used with or without the cover 30, which if used may form a compartment 35 which can be a negative pressure compartment or it may comprise a bandage or compression bandage.
[0334] Figure 45 and Figure 46 show a variation of the embodiment of Figures 41 to 44 in which the circulation opening 145 is replaced with an opening that takes the form of a larger circulation opening or gap 145A. In this embodiment, the internal flow guide 140A does not extend the entire longitudinal axis X-X of the receptacle 110, but extends through the tail portion 90 and part way into the head portion 93 where it terminates. The circulation gap 145A spans the distance between an end 141 A of the internal flow guide 140A and the wall 115 of the receptacle 110 at the head portion 93 of the receptacle 110. This embodiment has the benefit of ease of manufacture. The internal flow guide 140 A has a first flow guide surface 142A that is configured to face the wound 22 and/or healthy skin 24 surrounding the wound 22 during use, and a second flow guide surface 144 A that opposes the first flow guide surface 142 A and faces away from the wound 22 and/or healthy tissue skin 24 surrounding the wound 22 during use. Prior to use, the internal flow guide 140A may lie substantially parallel with the first wall portion and the second wall portion of the wall 115 of the receptacle 110. However in use of the receptacle 110, the first wall portion and the second wall portion of the wall 115 is flexible and may be contorted or bent to accommodate a complex wound shape or to fit onto a contoured part of the body, for example a heel or a knee.
[0335] The internal flow guide 140A effectively divides the receptacle 110 into first and second compartments that are fluidly connected by the circulation gap 145A. In use of the apparatus 1200, fluid enters the receptacle 110 via the fluid inlet 55 of the fluid inlet conduit 50, and flows along the part of the fluid flow path defined by the first flow guide surface 142 A that lies upstream of the circulation gap 145 A and the first wall portion of the wall 115, through the circulation gap 145 A and along the part of the fluid flow path defined by the part of the second flow guide surface 144A and out of the fluid outlet 53 of the first fluid outlet conduit 52 via the pressure relief valve 170 (or other pressure regulator as described above).
[0336] The fluid inlet conduit 50 and the first fluid outlet conduit 52 are disposed at the same end of the receptacle 110. This arrangement is advantageous in that it facilitates ease of handling a dressing, for example a bandage, and the fluid inlet conduit 50, fluid outlet conduit 52, and any further tubes that are connected to them, during application of the dressing over the wound, as in the embodiment of Figure 41. The arrangement also encourages an even dispersal of fluid through the receptacle 110, as fluid must travel from the fluid inlet 55 of the fluid inlet conduit 50, along a majority of the length of the receptacle 110, through the circulation gap 145A and back along the majority of the length of the receptacle 110 before it may exit the fluid outlet 53 via the first fluid outlet conduit 52. Whilst the features of the internal flow guide 140A are described with reference to the receptacle 110, it will be apparent that one or more of the features of the internal flow guide 140 A may apply to any of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 described in this disclosure.
[0337] A further variation of the embodiment of Figures 40 to 44 is shown in Figures 47 and 48. Figure 47 shows a plan view of a receptacle 110 that has a longitudinal axis X-X that extends through the head portion 93 and the tail portion 90 of the receptacle 110. Figure 48 is a cross-sectional side view of the receptacle 110. In the embodiment of the receptacle 110 shown in Figure 47 and Figure 48, an internal flow guide 140B (best seen in Figure 47) in the form of an internal wall extends along the longitudinal axis X-X so as to extend between the first wall portion and the second wall portion of the wall 115 of the receptacle 110. The internal flow guide 140B is arranged to form side by side compartments within the receptacle 110 rather than upper and lower compartments and bisects the first wall portion and the second wall portion of the wall 115 at its upper and lower bounds, respectively. That is, the internal flow guide 140B has an upper edge that adjoins the second wall portion of the wall 115 of the receptacle 110 and a lower edge that adjoins a first wall portion of the wall 115 of the receptacle 110 during use. The internal flow guide 140B has a first flow guide surface 142B and a second flow guide surface 144B that opposes the first flow guide surface 142B. Accordingly, a portion of the first wall portion of the wall 115 of the receptacle 110 that faces and may come into contact with the tissue of the patient during use is a tissue facing portion of the first wall portion of the wall 115, and is disposed adjacent both the first flow guide surface 142B and the second flow guide surface 144B such that fluid flowing through the receptacle 110 passes the first wall portion of the wall 115 as it passes the first flow guide surface 142B and also the second flow guide surface 144B. The internal flow guide 140B may bisect the first wall portion of the wall 115 into two equal portions, or alternatively the internal flow guide 140B may be disposed parallel to the longitudinal axis X-X so that it is offset from it and thus divides the first wall portion of the wall 115 into two compartments, wherein the compartments are different sizes. The internal flow guide 140B may also be disposed at an angle to the longitudinal axis X-X such that the two compartments are not symmetrical about the longitudinal axis X-X.
[0338] The internal flow guide 140B has a circulation opening 145B that is the same as the circulation opening 145. The circulation opening 145B is positioned towards an end of the internal flow guide 140B that is positioned in the head portion 93 of the receptacle 110. The circulation opening 145B provides a fluid pathway through the receptacle 110 in the same manner as the circulation opening 145.
[0339] The receptacle 110 has a fluid inlet conduit 50 and a first fluid outlet conduit 52, each of which passes through the pressure spreading device 95 and through which fluid respectively enters and exits the receptacle 110. In Figure 47, the fluid inlet conduit 50 is shown adjacent the first fluid outlet conduit 52 such that they lie side by side. The first fluid outlet conduit 52 may have a pressure regulator such as pressure relief valve 170 disposed on it for relieving pressure inside the receptacle 110.
[0340] The internal flow guide 140B effectively divides the receptacle 110 into first and second compartments that are disposed side by side and that are fluidly connected by the circulation opening 145B. In use of the apparatus 1300, fluid enters the receptacle 110 via the fluid inlet 55 of the fluid inlet conduit 50, and flows along the part of the fluid flow path defined by the first flow guide surface 142B that lies upstream of the circulation opening 145B and the first wall portion and second wall portion of the wall 115 of the receptacle 110, through the circulation opening 145B and along the part of the fluid flow path defined by the major part of the second flow guide surface 144B and the first wall portion and the second wall portion of the wall 115 out of the fluid outlet 53 of the first fluid outlet conduit 52 via the pressure relief valve 170 (or other pressure regulator as described above). Whilst the features of the internal flow guide 140B are described with reference to the receptacle 110, it will be apparent that one or more of the features of the internal flow guide 140B may apply to any of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 described in this disclosure.
[0341] In use of the receptacle 110 according to the embodiments of Figure 47 and Figure 48, the fluid flow path extends past the first wall portion of the wall 115 of the receptacle 110 both upon entering the receptacle 110 and when exiting it, which may result in prolonging a period of time that the fluid within the receptacle 110 spends adjacent the membrane of the wall 115 receptacle 110.
[0342] In each of the embodiments of the receptacle 110 shown in Figures 40 to
48, the internal flow guide 140, 140 A, MOB prevents fluid entering the receptacle 110 from simply exiting through the fluid outlet 53 before it has travelled over a significant portion of the internal wall area, thereby allowing fluid to diffuse through a significant portion of the membrane of the wall 115 to more of the wound area 20. However, it is also envisaged that the receptacle 110 may have no internal flow guide 140, 140 A, MOB as shown in the embodiment of Figure
49. The fluid inlet conduit 50 and the first fluid outlet conduit 52 are disposed at the same end of the receptacle 110. This arrangement allows ease of handling the fluid inlet conduit 50 and the first fluid outlet conduit 52 and of applying a dressing over the fluid inlet conduit 50, the first fluid outlet conduit 52, and any further tubes that are connected to them, as with the embodiments of Figures 40 to 48. A pressure regulator such as a pressure relief valve 170 is disposed at the fluid outlet 53 for relieving pressure within the receptacle 110 as has been described in relation to the embodiments of Figures 36 to 39.
[0343] Figure 50(a) and Figure 50(b) show an example of a receptacle 110 that is similar to that of the embodiment of Figures 40 to 44, and which has an internal flow guide 140 configured in a layered or stacked configuration. However, in the embodiment of Figure 50 (a) and (b), the fluid inlet conduit 50 and the first fluid outlet conduit 52 are arranged in a side by side configuration such that the outlet 57 of the fluid inlet conduit 50 and the inlet 58 of the first fluid outlet conduit 52 lie side by side within the interior of the receptacle 110 and/or within the pressure spreading device 95. The internal flow guide 140 separates the outlet 57 from the inlet 58. As shown in Figure 50 (b), this is achieved by positioning the internal flow guide 140 to lie underneath the inlet 58 of the fluid inlet conduit 52 and over the outlet 57 of the first fluid outlet conduit 50. However, it may also be achieved by positioning the internal flow guide 140 to lie over the inlet 58 and underneath the outlet 57. The side by side arrangement of the fluid inlet conduit 50 and the first fluid outlet conduit 52 spreads the forces applied by the fluid inlet conduit 50 and the first fluid outlet conduit 52 on the tissue of the patient over a larger area of tissue than if they are arranged one on top of the other, and thus reduces the pressure applied to one portion of the tissue. As a result, the overall pressure experienced by the patient from the fluid inlet conduit 50 and the first fluid outlet conduit 52 is reduced as it is spread over a wider area, which may result in a more comfortable experience for the patient. Whilst the features of the internal flow guide 140 are described with reference to the receptacle 110, it will be apparent that one or more of the features of the internal flow guide 140 may apply to any of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 described in this disclosure.
[0344] In any one of the embodiments shown in Figures 40 to 49, the receptacle 110 may include a plurality of ridges as described in relation to Figures 31 to 34 above. The disclosure in relation to the embodiments described in relation to Figures 31 to 34 applies also to the embodiments of Figures 41 to 49. Figure 51(a) and Figure 51(b) each show a cross sectional view through the head portion 93, such as at line A-A of Figure 41, of an embodiment of the inside surface of at least one wall 115 of a receptacle 110. As shown in Figure 51(a) and 51(b), the receptacle 110 includes the internal flow guide 140 of the embodiment of Figures 40 to 44, however it may equally be the internal flow guide 140A of Figures 45 and 46 or the internal flow guide 140B of the embodiments of Figures 47 and 48. The inner surface of the wall 115 includes one or more small, soft, protruding ridges 196. The ridges 196 have the same properties as the ridges 96 described in relation to Figures 31 to 34 above and the same disclosure applies. [0345] The ridges 196 may be positioned on opposing inner surfaces of the first wall portion and second wall portion of of the one or more walls 115 as shown in Figure 51(a), such that when they are pressed together, the internal flow guide 140 opposing the ridge 196 drapes over the ridge 196, leaving gaps on either side of it in the manner described above in relation to Figure 3 lb. Alternatively, the ridges 196 may be positioned on the first flow guide surface 142 and the second flow guide surface 144 of the internal flow guide 140 as shown in Figure 51(b). As the first wall portion and the second wall portion of the one or more walls 115 are pressed together, they will drape over the ridge 196 on the internal flow guide 140, leaving gaps either side of it. The gaps will generally remain even when tight dressings are applied over the receptacle 110 in use or regardless of patient movement. Whilst not shown in Figure 51, a further alternative configuration is for the ridges 196 to be positioned on an inner surface of the first wall portion of the one or more walls 115 and on the first flow guide surface 142. A yet further alternative configuration is for the ridges 196 to be positioned on an inner surface of the second wall portion of the one or more walls 115 and on the second flow guide surface 144.
[0346] The ridges 196 may be offset from one another on opposing first wall portion and second wall portion of the one or more walls 115 as shown in Figure 51(a) or on opposing first flow guide surfaces 142, and second flow guide surface 144 as shown in Figure 51(b). However, other arrangements of the ridges 196 may also be used. Each ridge 196 may have a height of between approximately 50 to 500 micrometres, for example 75 to 250 micrometres, for example 100 to 200 micrometres, for example between approximately 125 to 175 micrometres. An embodiment of the ridge has a height of 150 micrometres. The height of the ridge 196 is a balance of the requirement for a taller ridge to help maintain a sufficient gap and thereby prevent blockage of the flow path, whilst avoiding an overly tall ridge that may cause indentation to the tissue of the patient and which may render the ridge susceptible to buckling. Each ridge 196 may have a width of between approximately 50 to 500 micrometres, for example 100 to 400 micrometres, for example between approximately 250 to 350 micrometres, or between approximately 280 to 330 micrometres. Whilst the features of the ridges 196 are described with reference to the receptacle 110, it will be apparent that one or more of the features of the ridges 196 may apply to any of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 described in this disclosure.
[0347] Figure 52 shows an embodiment of the receptacle 110 that is similar to the embodiment of Figure 40. In particular, the receptacle 110 includes an internal flow guide 140C that is configured in the same way as the internal flow guide 140 and has a first flow guide surface 142C and an opposing second flow guide surface 144C. However, in the embodiment of Figure 52, the circulation opening 145C has a pressure regulator such as a pressure relief valve 170C disposed in it, such that fluid flowing through the flow path inside the receptacle 110 must pass through the pressure relief valve 170C before it can exit the receptacle 110 through the fluid outlet 53. Accordingly, there may be no pressure relief valve or other form of pressure regulator at the fluid outlet 53. The pressure relief valve 170C may be used instead of (or in addition to) the pressure relief valve 170 also in the embodiment of Figures 47 and 48 in which the internal flow guide 140B is arranged to form side by side compartments within the receptacle rather the upper and lower compartments. An alternative pressure regulation device, such as any of the pressure regulators disclosed herein, may be used instead of the pressure relief valve 170C to achieve the same effect. Whilst the features of the internal flow guide 140C are described with reference to the receptacle 110, it will be apparent that one or more of the features of the internal flow guide 140C may apply to any of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 described in this disclosure.
[0348] The internal flow guides 140, MOB and 140C may each be roughened on either or both of the first flow guide surface 142, 142A, 142B, 142C, and the second flow guide surface 144, 144A, 144B, 144C. The surface roughening may take the same form as is described in relation to the embodiment of the receptacle 310 shown in Figure 29 and Figure 30. The roughened surface(s) of the internal flow guide 140, MOB, 140C may be in addition to, or instead of, roughening of the internal surface of the receptacle 110 in the manner described in relation to the embodiment of the receptacle 310 shown in Figure 29 and Figure 30.
[0349] In each of the embodiments shown in Figs. 40, 41, 45 to 50 and 52, the fluid inlet conduit 50 and the first fluid outlet conduit 52 can be encapsulated in the pressure spreading device 95 of the receptacle 110 so as to extend therefrom in the same direction, as further illustrated in Figure 52. The fluid inlet conduit 50 and the first fluid outlet conduit 52 may be arranged to be disposed substantially adjacent one another. “Substantially adjacent” may include that the fluid inlet conduit 50 and the first fluid outlet conduit 52 are disposed such that they may be joined together, but need not be joined together, or that a space between the fluid inlet conduit 50 and the first fluid outlet conduit 52 may be such that a user of the receptacle 110 can apply a bandage or other dressing over the receptacle 110 at the wound 22 with the one hand as explained earlier in this disclosure, whilst handling both of the fluid inlet conduit 50 and the first fluid outlet conduit 52 with the other hand. For example, in some embodiments, a space between the fluid inlet conduit 50 and the first fluid outlet conduit 52 may be between approximately 0 mm to 20 mm, or between approximately 1 mm to 15 mm, or between approximately 1.5 mm to 10 mm, or between approximately 2 mm to 7 mm, or between approximately 2.5 mm to 5 mm, or between approximately 3 mm to 4 mm. In an example of a lower leg wound, the user may typically wrap the dressing over the receptacle 10 from the ankle to the knee in one direction. Arranging the fluid inlet conduit 50 and the first fluid outlet conduit 52 substantially adjacent one another may help to prevent the possibility of one conduit becoming trapped beneath the compression dressing as the leg is being wrapped up, which could cause a pressure injury to the patient. In some embodiments, the space between the fluid inlet conduit 50 and the first fluid outlet conduit 52 may be large, e.g. greater than about 20 mm as long as the fluid inlet conduit 50 and first fluid outlet conduit 52 can be handled with one hand to allow the dressing to be applied in this manner. [0350] Furthermore, at least an end portion 50A, 52A (shown in Figure 53) of each of the fluid inlet conduit 50 and the first fluid outlet conduit 52 that are closest to the pressure spreading device 95 may be arranged to protrude from the pressure spreading device 95 in a direction substantially aligned with the longitudinal axis of the receptacle 110, prior to use, as shown in Figure 53. The end portions 50A, 52A of the fluid inlet conduit 50 and the first fluid outlet conduit 52 may be arranged substantially parallel with one another. The fluid inlet conduit 50 and the first fluid outlet conduit 52 may be at least partially adjoined so as to extend from the receptacle 110 in a common direction. In the embodiment of Figures 26 and 27, the fluid inlet conduit 50 is encapsulated in a pressure spreading device 95 that is attached to the receptacle 110. As an alternative to encapsulating the end portions 50A, 52A of the fluid inlet conduit 50 and the first fluid outlet conduit 52 in the pressure spreading device 95, the fluid inlet conduit 50 and the first fluid outlet conduit 52 may be at least partially adjoined or held together with tape, ties, glue, and/or clips (not shown). Such devices could be used to hold the fluid inlet conduit 50 and the first fluid outlet conduit 52 together at the end portions 50A, 52A that are closest to the receptacle 110, or over most of their length, or anything in between. However, in some embodiments, the end portions 50A, 52A of the fluid inlet conduit 50 and the first fluid outlet conduit 52 need not be held together.
[0351] At least partially adjoining or holding together the end portions 50A, 52A of the fluid inlet conduit 50 and the first fluid outlet conduit 52 may also allow application of a bandage or other dressing over the receptacle 110 and the fluid inlet conduit 50 and the first fluid outlet conduit 52 as described above, as the end portions 50A, 52A protrude from the pressure spreading device 95 parallel with one another. The end portions 50A, 52A of the fluid inlet conduit 50 and first fluid outlet conduit 52 may be arranged to protrude from the pressure spreading device 95 such that there is a relatively small vertical distance between the end portions 50A, 52A of the fluid inlet conduit 50 and first fluid outlet conduit 52, and a lowermost surface of the receptacle 110. This in turn means that the end portions 50A, 52A are disposed in close spaced relation from the tissue of the patient during use. In this context, “in close spaced relation” may include that the end portions 50A, 52A lie close to the tissue of the patient during use of the receptacle 110 so as to be almost but not quite touching the tissue, as illustrated by the arrows 56 in Fig. 54. This may also allow easier application of a bandage or other dressing over the receptacle 110 and the fluid inlet conduit 50 and the first fluid outlet conduit 52, in the manner described above. In an alternative embodiment, the end portions 50A, 52A of the fluid inlet conduit 50 and first fluid outlet conduit 52 may be arranged to protrude from the pressure spreading device 95 so as to be disposed in contact with the tissue of the patient during use. This disclosure may apply to any of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610 described in this disclosure having a pressure spreading device 95, a fluid inlet conduit 50 and a first fluid outlet conduit 52.
[0352] Referring to the embodiment of the receptacle 110 shown in Figures 55 to 58, the pressure spreading device 95 attaches to the the tail portion 90, and the fluid inlet conduit 50 and the first fluid outlet conduit 52 may terminate within the pressure spreading device 95. This arrangement may help to prevent pressure injuries in use of the receptacle 110 from the fluid inlet conduit 50 and the first fluid outlet conduit 52 protruding into the tail portion 90 and creating a pressure point on the tissue of the patient.
[0353] As shown in the embodiment of Figures 55 to Figure 57, the pressure spreading device 95 has an upper portion 95 A and a lower portion 95B that together form the pressure spreading device 95. The upper portion 95 A and the lower portion 95B are the same as one another, however as best seen in Figure 55, one is flipped relative to the other to form the pressure spreading device 95. An exterior surface of the upper portion 95 A and the lower portion 95B are smooth, as seen for the upper portion 95A in Figure 55. For example, the pressure spreading device 95 may be made of a smooth silicone material for contact with the tissue of the patient. The smooth exterior surface of the pressure spreading device 95 may assist with patient comfort as it contacts the tissue of the patient. The lower portion 95B and the upper portion 95 A of the pressure spreading device 95 house a first cavity 180 and a second cavity 181 therein that in use enable fluid communication between the fluid inlet conduit 50 and the first fluid outlet conduit 52 and the tail portion 90, as will be described further below. The lower portion 95B of the pressure spreading device 95 has a fluid inlet conduit channel 98 integrally formed therein. The upper portion 95 A of the pressure spreading device 95 has a first fluid outlet conduit channel 99 integrally formed therein. The fluid inlet conduit channel 98 and the first fluid outlet conduit channel 99 serve to guide the positioning of the fluid inlet conduit 50 and the first fluid outlet conduit 52 (not shown) inside the pressure spreading device 95. Consistent positioning of the fluid inlet conduit 50 and the first fluid outlet conduit 52 helps to achieve consistency of flow path length between receptacles 110 and, therefore, consistency of flow characteristics for each receptacle 110.
[0354] As seen in Figure 55 and Figure 57, the lower portion 95B of the pressure spreading device 95 may include the first cavity 180 that extends from the fluid inlet conduit channel 98 to the tail portion 90 of the receptacle 110, to enable fluid communication from the fluid inlet conduit 50 into the tail portion 90 of the receptacle 110. The upper portion 95 A of the pressure spreading device 95 includes the second cavity 181, seen in Figure 56, that extends from the tail portion 90 of the receptacle 110 to the first fluid outlet conduit channel 99 to enable fluid communication from the tail portion 90 of the receptacle 110 to the first fluid outlet conduit 52. The first cavity 180 is formed integrally within the lower portion 95B of the pressure spreading device 95. The second cavity 181 is formed integrally within the upper portion 95 A of the pressure spreading device 95.
[0355] The pressure spreading device 95 includes an internal flow guide 140 in the form of an internal wall, best seen in Figure 55. The internal flow guide 140 includes a portion of the fluid inlet conduit channel 98 on one side thereof and a portion of the first fluid outlet conduit channel 99 on an opposing side thereof. The first cavity 180 and the second cavity 181 are separated by the internal flow guide 140 within the pressure spreading device 95, as are the fluid inlet conduit channel 98 and the first fluid outlet conduit channel 99. In use, fluid may pass from the first cavity 180 into the tail portion 90 of the receptacle 110, into the head portion 93 of the receptacle 110 and through the circulation opening 145 (seen in Figure 55) of the internal flow guide 140, as is described in respect of the embodiment of Figure 50 above. Once fluid passes through the circulation opening 145, it passes back through the head portion 93, into the tail portion 90 and into the second cavity 181 of the pressure spreading device 95.
[0356] The first cavity 180 and the second cavity 181 each have a shape that gradually expands from a narrow end 182 at the respective fluid inlet conduit channel 98 or the first fluid outlet conduit channel 99 to the tail portion 90. With reference to Figure 55, the shape of the first cavity 180 may assist in distributing fluid entering the first cavity 180 across the width of the tail portion 90, encouraging the fluid to reach each of the plurality of ridges 96 in the tail portion 90. To further assist the fluid entering the first cavity 180 to reach each of the plurality of ridges 96, the internal flow guide 140 may also have a series of cavity ridges 97 on the first flow guide surface 142 that faces the first cavity 180 (not seen in Figures 55 to 58). In Figure 57, three cavity ridges 97 are schematically shown for ease of explanation. The cavity ridges 97 on the first flow guide surface 142 (the underside of the internal flow guide 140) help to maintain a fluid flow path from the fluid inlet conduit 50 to the tail portion 90 even if the first cavity 180 is crushed during use. Similarly, the series of cavity ridges 97 on the second flow guide surface 144 of the internal flow guide 140 (the upper surface of the internal flow guide 140, seen in Figure 55) help to maintain a fluid flow path from the tail portion 90 to the first fluid outlet conduit 52 even if the second cavity 181 is crushed during use. In Figure 56, three cavity ridges 97 are shown on the second flow guide surface 144. The cavity ridges 97 are arranged to taper towards each other at the narrow end 182 of the first cavity 180 of the fluid inlet conduit 50 and at the narrow end 182 of the second cavity 181 of the first fluid outlet conduit 52 , as shown in Figure 55 and also in Figures 56 and 57, following the shape of the respective cavity in which they are positioned. The cavity ridges 97 may be formed on the upper portion 95A and/or lower portion 95B of the pressure spreading device 95 instead of, or in addition to, those formed on the internal flow guide 140. The ridges 96 and the cavity ridges 97 are positioned so as to be offset from one another, to avoid creating pressure points that may lead to patient discomfort. However, the cavity ridges 97 continue into the tail portion 90 beyond the starting point of the ridges 96. This longitudinal overlap of the ridges 96 and the cavity ridges 97 helps to maintain a fluid flow path between the first cavity 180 and the tail portion 90 and the tail portion 90 and the second cavity 181 even if the first cavity 180 and/or the second cavity 181 is crushed.
[0357] In an alternative embodiment, the ridges 96 of the tail portion 90 of the receptacle 110 may extend into the first cavity 180 and the second cavity 181, terminating towards the narrow end 182 of the respective first cavity 180 or second cavity 181. In this embodiment, the cavity ridges 97 are not required.
[0358] Each of the fluid inlet conduit channel 98 and the first fluid outlet conduit channel 99 may have a conduit locating feature 101, shown in Figure 58. The conduit locating feature 101 is in the form of a stop. For example, the conduit locating feature 101 may be formed as an inwardly directed ring or partial ring that prevents the fluid inlet conduit 50 or first fluid outlet conduit 52 from being over inserted into the respective one of the fluid inlet conduit channel 98 and the first fluid outlet conduit channel 99. The fluid inlet conduit 50 or the first fluid outlet conduit 52 is positioned in the fluid inlet conduit channel 98 or the first fluid outlet conduit channel 99 so that its end contacts the conduit locating feature 101. In this way, the conduit locating feature 101 facilitates appropriate termination of the fluid inlet conduit 50 and the first fluid outlet conduit 52 at or near the narrow end 182 of the respective first cavity 180 or second cavity 181, preventing over insertion of the fluid inlet conduit 50 or the first fluid outlet conduit 52 which may cause additional pressure points on the tissue of the patient, increasing patient discomfort.
[0359] In an alternative embodiment, the conduit locating feature 101 may be omitted. In another alternative embodiment, the fluid inlet conduit 50 and the first fluid outlet conduit 52 may be configured to terminate in the respective one of the fluid inlet conduit channel 98 and the first fluid outlet conduit channel 99 prior to reaching the first cavity 180 or the second cavity 181, for example at the start of the fluid inlet conduit channel 98 and the first fluid outlet conduit channel 99 or part way along the respective channel. In such embodiments, the conduit locating feature 101 may be omitted, or it could be positioned at an appropriate point along the fluid inlet conduit channel 98 and/or the first fluid outlet channel 99. In a still further embodiment, the fluid inlet conduit 50 and the first fluid outlet conduit 52 may be configured to terminate in the first cavity 180 or the second cavity 181.
[0360] One way of manufacturing the embodiment of the receptacle 110 shown in Figure 55 may be to bond the upper portion 95A, lower portion 95B and internal flow guide 140 together, for example using an adhesive material. In this embodiment, each of the fluid inlet conduit channel 98 and/or the first fluid outlet conduit channel 99 may have at least one recessed feature configured to facilitate improved adhesion between features of the pressure spreader device 95. For example, a trench 102 is shown recessed from the fluid inlet conduit channel 98 and/or the first fluid outlet conduit channel 99 in Figure 64. Adhesive material may be received into or flow into the trench 102 and provides improved adhesion between the fluid inlet conduit 50 and the fluid inlet conduit channel 98, and/or the first fluid outlet conduit 52 and the first fluid outlet conduit channel 99. The trench 102 may reduce occlusion of the fluid inlet conduit 50 and/or the first fluid outlet conduit 52 by the adhesive, by providing a space to allow adhesive to flow around the fluid inlet conduit 50 and/or the first fluid outlet conduit 52. The trench 102 may additionally or alternatively reduce occlusion of the fluid inlet conduit channel 98 and/or the first fluid outlet conduit channel 99.
[0361] The at least one recessed feature may additionally or alternatively comprise at least one channel 103. The channel 103 may be provided in combination with the trench 102, or may be included separately, without the trench 102. The channel 103 at least partially surrounds or extends alongside at least a portion of the fluid inlet conduit channel 98 and/or the first fluid outlet conduit channel 99. Similarly to the trench 102, the channel 103 provides a space for adhesive to be received in or to flow therein, thereby guiding it to the desired location(s) surrounding or extending alongside at least a portion of the fluid inlet conduit channel 98 and the first fluid outlet conduit channel 99. This allows better adhesion between the lower portion 95B and the upper portion 95 A, while reducing the likelihood of occluding the fluid inlet conduit 50 and/or the first fluid outlet conduit 52 or of occluding the fluid inlet conduit channel 98 and/or the first fluid outlet conduit channel 99.
[0362] As described in Figure 55 to Figure 57, the pressure spreading device 95 has an upper portion 95 A and a lower portion 95B that together form the pressure spreading device 95. The upper portion 95 A and the lower portion 95B are the same as one another, however as best seen in Figure 55, one is flipped relative to the other to form the pressure spreading device 95. As such, although Figure 64 shows a lower portion 95B having a trench 102 and/or a channel 103, the trench 102 and/or channel 103 may also be included on an upper portion 95 A of the pressure spreading device 95.
[0363] It will be appreciated that any of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610 or 710 that have a pressure spreading device 95 and a tail portion 90 may have one or more of the features of the first cavity 180, second cavity 181, fluid inlet conduit channel 98, fluid outlet conduit channel 99, conduit locating feature 101, trench 102 or channel 103 described above.
[0364] The receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 disclosed herein may have a shape that is different to those disclosed in the accompanying Figures and/or the specification. Examples of possible alternative receptacle shapes are shown in Figure 59 and Figure 60, however other shapes are also possible. Figure 59(a) shows a receptacle 10 having a generally elongate rectangular shape. Figure 59(b) shows a receptacle 10 having a generally square shape, with the fluid inlet conduit 50 and the first fluid outlet conduit 52 both extending from or near a mid-point of one side of the receptacle 10. Figure 59(c) shows a receptacle 10 having a generally oval shape with the fluid inlet conduit 50 and the first fluid outlet conduit 52 both extending from a mid-point of an elongate side of the receptacle 10. Figure 59(d) shows another receptacle 10 having a generally oval shape, with the fluid inlet conduit 50 and the first fluid outlet conduit 52 both extending from one end of the receptacle 10. It will be appreciated that the positions of the fluid inlet conduit 50 and the first fluid outlet conduit 52 relative to the receptacle 10 may also be changed from the positions shown in Figure 59 without departing from the scope of the disclosure, as illustrated by the examples of the oval shaped receptacles of Figure 59(c) and Figure 59(d).
[0365] Each of the possible alternate shapes of the receptacle 10 may include a tail portion 90 and/or a pressure spreading device 95 as shown in Figure 60(a) to (d). Whilst the embodiments shown in Figures Figure 60(a) to (d) have both a tail portion 90 and a pressure spreading device 95, they may alternatively have a tail portion 90 but not a pressure spreading device 95, or they may have a pressure spreading device 95 but not a tail portion 90. The tail portion 90 and/or pressure spreading device 95 may extend from or near a mid-point of an elongate side of the receptacle 10 as shown in the embodiments of Figure 60(a) and Figure 60(b) or they may extend from one end of the receptacle 10 as shown in Figure 60(c) and Figure 60(d). Whilst the receptacles 10 shown in Figure 60 have a sharp corner or squared transition between the tail portion 90 and the head portion 93, they may alternatively have a rounded or gradual transition between the tail portion 90 and the head portion 93 to avoid a sharp corner at the transition.
[0366] The flow rate of fluid entering the receptacles 10, 110, 210, 310, 410, 510, 610, 710 from the fluid source 40 may be between approximately >0 mL/min to 20 mL/min, or between approximately 5 mL/min to 15 mL/min, or between approximately 7 to 13 mL/min, or between approximately 9 mL/min to 11 mL/min. In an embodiment, the flow rate of fluid entering the receptacle may be approximately 10 mL/min. For each of the embodiments of the receptacle 10, 110, 210, 210A, 310, 410, 510, 610, 710 described in this disclosure, the amount of fluid leaving the interior of the receptacle 10, 110, 210, 210 A, 310, 410, 510, 610, 710 as a result of molecules within the fluid passing through the one or more walls of the receptacle 10, 110, 210, 210A, 310, 410, 510, 610, 710 (e.g. via diffusion) may be approximately 0.5 to 2.5 mL/hr/cm2, or 1 to 2 mL/hr/cm2, or 1.2 to 1.6 mL/hr/cm2, or 1.5 mL/hr/cm2, as measured using a measuring system. In some embodiments, the amount of fluid leaving the interior of the receptacle 10, 110, 210, 210A, 310, 410, 510, 610, 710 as a result of the molecules within the fluid passing through the one or more walls of the receptacle 10, 110, 210, 210A, 310, 410, 510, 610, 710 (e.g. via diffusion) may be below about 0.5 mL/hr/cm2, as measured using the measuring system.
[0367] The measuring system includes a jig into which a receptacle, e.g. receptacle 10, is placed. The jig allows diffused fluid molecules to escape from the interior of the receptacle 10. The fluid inlet 55 of the receptacle 10 is fluidly connected to the fluid source 40 via an inlet line. An inlet flow meter is fluidly connected to the inlet line between the fluid source 40 and the fluid inlet 55. An outlet flow meter is fluidly connected to the fluid outlet 53 of the receptacle 10. The measurements are taken as follows. To measure the amount of fluid leaving the interior of the receptacle 10, the volumetric flow rate (standardised for temperature and pressure) at the fluid inlet 55 of the receptacle 10 is measured with the inlet flow meter and the volumetric flow rate at the fluid outlet 53 of the receptacle 10 (standardised for temperature and pressure) is measured with the outlet flow meter. The operator must wait until the system has reached equilibrium before taking this data. A difference between the inlet flow rate and the outlet flow rate is calculated. The value obtained corresponds to the amount of fluid leaving the interior of the receptacle 10 as a result of the molecules within the fluid passing through the one or more walls 15 of the receptacle (e.g. via diffusion). The measuring system is leak tested before the measurements are taken to ensure the difference in the two flow meters 507, 511 is not due to a leak but to the molecules within the fluid passing through the one or more walls 15 of the receptacle 10 (e.g. via diffusion).
[0368] The apparatus disclosed herein may be provided in various kit forms. For example, where the cover 30 is in the form of a compression bandage, the kit may comprise one or more receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 and the compression bandage. Where the apparatus comprises a carrier layer 530, for example a foam material, the kit may comprise one or more receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 and the carrier layer 530. Where the apparatus comprises a carrier layer 530, the kit may comprise a cutter so as to cause the carrier layer 530 to define one or more apertures in the course of applying the carrier layer 530 or prior thereto. In addition, where the apparatus comprises a carrier layer, the kit may comprise a plastic layer, such as a transparent plastic wrap, which can be applied to the carrier layer and/or the tissue area, the transparent plastic layer comprising tracing lines to guide the forming of an aperture or apertures in the carrier layer 530. The kit may further comprise a fluid source 40, for example a portable oxygen source such as an oxygen bottle. Another kit may include one or more receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 and instructions to a user to apply a compression bandage for use with the one or more receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710. A further kit may include one or more receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 and a fluid source 40, for example a portable oxygen source such as an oxygen bottle. The receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 may be supplied with one or more of the fluid inlet conduit 50, the first fluid outlet conduit 52 and one or more of the pressure relief valves 70, 170 or other pressure regulator.
[0369] Where the cover 30 is in the form of an adhesive dressing, the kit may comprise one or more of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 and the adhesive dressing. The kit may further comprise a fluid source 40, for example a portable oxygen source such as an oxygen bottle. In one form, the kit may comprise one or more of the receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710. In each of the kits, the receptacles 10, 110, 210, 210A, 310, 410, 510, 610, 710 may be supplied with one or more of the fluid inlet conduit 50 and the pressure relief valve 70, the first fluid outlet conduit 52 and the pressure relief valve 170 or other pressure regulator. A further kit may include a sealing cover 30 and a negative pressure source 45, for example a diaphragm or peristaltic pump. A canister (not shown) may also be supplied for attachment to the pump 45 for exudate collection.
[0370] It will be appreciated by the skilled person that the features and aspects of the various receptacles of the apparatus described herein are generally described in a form prior to use on a patient, unless stated otherwise. It will further be appreciated by the skilled person that the apparatus described herein may sometimes be used with an additional layer between the receptacle and the wound, for example a gauze layer. Reference to a tissue facing layer, wound facing surface, tissue facing surface of the receptacle or to applying the receptacle at the tissue or wound site, or placing the receptacle in contact with the wound or tissue, includes the possibility of using the apparatus with such an additional layer as well as use directly on the wound or tissue.
[0371] It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the above-described embodiments, without departing from the broad general scope of the present disclosure, including the following clauses. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.

Claims

1. A tissue care dressing, comprising a receptacle having at least one wall, the at least one wall having an outer surface, wherein at least a section of the outer surface comprises a rough surface.
2. The tissue care dressing of claim 1, wherein the rough surface is configured to present a reduced surface area of the outer surface available for contact with contaminants.
3. The tissue care dressing of claim 1 or 2, wherein the rough surface is configured for hindering the adherence of contaminants to the outer surface.
4. The tissue care dressing of any one of claims 1 to 3, wherein the rough surface is present on multiple sections of the outer surface.
5. The tissue care dressing of any one of claims 1 to 4, wherein at least a portion of the rough surface is present on a section of the outer surface configured for contacting the tissue.
6. The tissue care dressing of any one of claims 1 to 5, wherein at least a portion of the rough surface is present on a section of the outer surface configured not to contact the tissue.
7. The tissue care dressing of any one of claims 1 to 6, wherein the rough surface is configured to present a substantially random variation in the topology of the at least a section of the outer surface.
8. The tissue care dressing of any one of the preceding claims, wherein the rough surface is irregular.
9. The tissue care dressing of claim 8, wherein the rough surface has a height of between about 0.2 micrometres to 400 micrometres from a low point to a high point thereof.
10. The tissue care dressing of any one of claims 1 to 8, wherein the rough surface has a plurality of raised or recessed elements that vary in height.
11. The tissue care dressing of claim 10, wherein the height of the elements is between about 0.2 micrometres to 200 micrometres
12. The tissue care dressing of claim 11, wherein the height of the elements is measured from a common baseline.
13. The tissue care dressing of any one of the preceding claims, wherein the rough surface has a plurality of raised and/or recessed elements that vary in width.
14. The tissue care dressing of claim 13, wherein the width is between about 0.2 micrometers to 200 micrometers.
15. The tissue care dressing of any one of the preceding claims, wherein the receptacle has a head portion and a tail portion.
16. The tissue care dressing of claim 15, wherein the rough surface is present on at least a portion of the head portion and/or at least a portion of the tail portion.
17. The tissue care dressing of claim 15 or 16, wherein the rough surface is present on substantially the entirety of the head portion and/or the tail portion.
18. The tissue care dressing of any one of the preceding claims, wherein the at least one wall has an inner surface, and at least a section of the inner surface comprises a rough surface.
19. The tissue care dressing of any one of the preceding claims, wherein the at least one wall of the receptacle is flexible.
20. The tissue care dressing of any one of the preceding claims, wherein the receptacle is inflatable.
21. The tissue care dressing of any one of the preceding claims, wherein the receptacle is configurable to press against the tissue of a patient.
22. The tissue care dressing of any one of the preceding claims, wherein the receptacle is configured for receiving a fluid therein.
23. The tissue care dressing of claim 22, configured to deliver the fluid to tissue of a patient through the at least one wall of the receptacle.
24. The tissue care dressing of claim 23, wherein the at least one wall comprises at least one section adapted to allow the fluid to pass from the receptacle to the tissue by pore flow.
25. The tissue care dressing of claim 23, wherein the at least one wall comprises at least one section adapted to allow molecules within the fluid to diffuse from the receptacle to the tissue.
26. The tissue care dressing of any one of claims 22 to 25, wherein the fluid is oxygen.
27. The tissue care dressing of any one of the preceding claims, wherein at least a section of the outer surface includes a plurality of microstructures.
28. The tissue care dressing of claim 27, wherein the microstructures are configured for encouraging cell growth.
29. The tissue care dressing of any one of the preceding claims, further comprising a cover positionable over the receptacle to form a compartment substantially bounded by the cover, the receptacle and the tissue.
30. An apparatus for supplying fluid to target tissue within a tissue area of a patient, the apparatus comprising: a permeable layer having at least one section configured to permit molecules within the fluid to pass through the permeable layer and to be deformable; and a carrier layer configured to operatively define one or more apertures and to be disposable between the permeable layer and the tissue area so as to position the one or more apertures between the target tissue and the permeable layer such that the at least one section deforms into the one or more apertures and supplies molecules within the fluid to the target tissue.
31. The apparatus of claim 30, wherein the at least one section comprises substantially the entirety of the permeable layer.
32. The apparatus of claim 30 or 31, wherein the at least one section is deformable under pressure operatively imparted by the fluid on the permeable layer towards the tissue area.
33. The apparatus of claim 32, comprising a receptacle adapted to receive the fluid, the receptacle comprising an operatively tissue area facing first wall portion, the first wall portion having the permeable layer.
34. The apparatus of claim 33, wherein the permeable layer comprises substantially the entirety of the first wall portion.
35. The apparatus of claim 33 or 34, wherein the at least one section deforms under pressure operatively imparted by the fluid on the permeable layer towards the tissue area through inflation of the receptacle by the fluid.
36. The apparatus of claim 35, wherein the receptacle is formed from the first wall portion and an opposing second wall portion.
37. The apparatus of claim 36, wherein the receptacle is configured for inflation biased towards deforming the at least one section.
38. The apparatus of claims 37, wherein at least a part of the at least one section has a substantially convex shape in an inflated position of the receptacle.
39. The apparatus of any one of claims 36 to 38, wherein the second wall portion has a thickness that is greater than a thickness of the at least one section of the permeable layer.
40. The apparatus of any one of claims 36 to 39, wherein the first wall portion and the second wall portion are non-porous.
41. The apparatus of any one of claims 36 to 40, wherein the receptacle is formed by joining the first wall portion and the second wall portion at a seam.
42. The apparatus of claim 37 or 38, wherein configuration of the receptacle for inflation biased towards deforming the at least one section comprises the first wall portion having a greater surface area relative to the second wall portion in an uninflated position of the receptacle.
43. The apparatus of claim 42, wherein the first wall portion has a convex shape operatively disposed towards the tissue area in the uninflated position.
44. The apparatus of claim 42, wherein the at least one section has a convex shape operatively disposed towards the tissue area in the uninflated position.
45. The apparatus of any one of claims 30 to 44, wherein the at least one section of the permeable layer has a thickness of between approximately 40pm to 70pm, or between approximately 45pm to 65pm, or between approximately 50pm to 60pm.
46. The apparatus of claim 45, wherein the at least one section of the permeable layer has a thickness of approximately 55pm.
47. The apparatus of any one of claims 36 to 44, wherein the second wall portion has a thickness of between approximately 100pm to 300pm, or between approximately 150pm to 250pm or between approximately 175pm to 225pm.
48. The apparatus of claim 47, wherein the second wall portion has a thickness of approximately 200pm.
49. The apparatus of any one of claims 35 to 44, comprising a cover configured to hold the receptacle onto the tissue area.
50. The apparatus of claim 49, wherein the cover constrains deformation of the receptacle away from the tissue area during inflation of the receptacle.
51. The apparatus of any one of claims 30 to 50, wherein the at least one section is configured to permit molecules within the fluid to pass through the permeable layer by diffusion alone or by a combination of diffusion and pore flow.
52. The apparatus of claim 51, wherein the supply of the molecules within the fluid to the target tissue comprises the molecules within the fluid operably diffusing through the at least one section of the permeable layer towards the target tissue.
53. The apparatus of any one of claims 30 to 39, wherein the at least one section is configured to permit molecules within the fluid to pass through the permeable layer by pore flow.
54. The apparatus of any one of claims 30 to 53, wherein the carrier layer is configured to enable the one or more apertures to correspond to a shape and/or a location and/or geometry of the target tissue.
55. The apparatus of any one of claims 30 to 54, wherein the fluid is a therapeutic fluid.
56. The apparatus of claim 55, wherein the therapeutic fluid is oxygen and/or carbon dioxide and/or carbon monoxide, and/or nitric oxide.
57. The apparatus of any one of claims 54 to 56, enabling targeting of treatment towards the target tissue.
58. The apparatus of any one of claims 30 to 46, wherein deformation of the at least one section into the one or more apertures is proportional to the pressure imparted on the permeable layer by the fluid.
59. The apparatus of any one of claims 35 to 44, wherein deformation of the at least one section into the one or more apertures is proportional to the pressure imparted on the permeable layer by the fluid contained in an interior of the receptacle.
60. The apparatus of any one of claims 35 to 44, wherein the receptacle is configured to receive a fluid comprising therapeutic molecules, the at least one section configured to permit the therapeutic molecules within the fluid to pass through the permeable layer from an interior of the receptacle.
61. The apparatus of any one of claims 36 to 44, wherein a surface of the second wall portion disposed towards an interior of the receptacle comprises at least one ridge.
62. The apparatus of any one of claims 30 to 61, wherein the permeable layer is flexible.
63. The apparatus of any one of claims 30 to 62, wherein the permeable layer is stretchable.
64. The apparatus of any one of claims 30 to 63, wherein the at least one section comprises a plurality of microstructures arranged on an operatively tissue area facing surface of the permeable layer.
65. The apparatus of any one of claims 30 to 64, wherein the carrier layer comprises an absorbent material and/or a non-absorbent material.
66. The apparatus of claim 65, wherein the carrier layer is an absorbent material.
67. The apparatus of claim 66, wherein the absorbent material is a foam material.
68. The apparatus of any one of claims 30 to 65, wherein the carrier layer comprises a plurality of absorbent material sections.
69. The apparatus of any one of claims 65 to 68, wherein the carrier layer material allows absorption of exudate from the target tissue.
70. The apparatus of any one of claims 65 to 69, wherein the carrier layer is configured to wick exudate from the target tissue.
71. The apparatus of claim 69, wherein supply of the molecules within the fluid to the target tissue and absorption of exudate by the carrier layer material occurs substantially concurrently.
72. The apparatus of any one of claims 30 to 71, wherein the at least one section deforms into the one or more apertures to contact the target tissue.
73. The apparatus of claim 72, wherein the at least one section contacting the target tissue displaces exudate from the target tissue towards a periphery of the one or more apertures.
74. The apparatus of any one of claims 33 to 44, wherein the apparatus comprises an indicator of an orientation of the receptacle.
75. The apparatus of any one of claims 33 to 44, wherein the receptacle comprises an inlet, the receptacle adapted to receive the fluid via a fluid inlet conduit in fluid communication with the inlet.
76. The apparatus of claim 75, wherein the receptacle comprises an outlet, the receptacle adapted to allow the fluid to exit the receptacle via a fluid outlet conduit in fluid communication with the outlet.
77. The apparatus of claim 76, wherein the inlet and the outlet are arranged substantially adjacent one another.
78. The apparatus of claim 77, wherein the inlet and the outlet are located at a tail portion of the receptacle.
79. The apparatus of any one of claims 76 to 78, comprising a pressure spreading device configured to mitigate a pressure applied to the patient by the fluid inlet conduit and/or the fluid outlet conduit.
80. The apparatus of claim 79, wherein the pressure spreading device comprises an indicator of an orientation of the receptacle.
81. The apparatus of claim 79 or 80, wherein the pressure spreading device has a substantially flat surface at an operatively patient facing side.
82. The apparatus of any one of claims 76 to 81, wherein the outlet conduit comprises a pressure relief valve.
83. The apparatus of any one of claims 30 to 82, wherein the carrier layer is configured to operatively define the one or more apertures by having one or more precut apertures.
84. The apparatus of claim 83, wherein the one or more pre-cut apertures are chamfered at an operatively permeable layer facing side of the carrier layer.
85. The apparatus of any one of claims 30 to 82, wherein the carrier layer is configured to operatively define the one or more apertures at a perforated region provided in the carrier layer.
86. The apparatus of claim 30, wherein the carrier layer is configured to operatively define a plurality of apertures.
87. The apparatus of claim 86, wherein the carrier layer is configured to be disposed between the permeable layer and the tissue area such that the at least one section deforms into each of the plurality of apertures to supply molecules within the fluid to the target tissue.
88. The apparatus of claim 86, wherein the permeable layer has a plurality of sections configured to permit molecules within the fluid to pass through the permeable layer and to be deformable.
89. The apparatus of claim 88, wherein the carrier layer is configured to be disposed between the permeable layer and the tissue area such that each section of the plurality of sections deforms into at least one aperture of the plurality of apertures to supply molecules within the fluid to the target tissue.
90. The apparatus of claim 86, comprising a plurality of permeable layers, each permeable layer of the plurality of permeable layers having at least one section configured to permit molecules within the fluid to pass through the permeable layer and to be deformable.
91. The apparatus of claim 90, wherein the at least one section of each of the plurality of permeable layers deforms into at least one aperture of the plurality of apertures and supplies molecules within the fluid to the target tissue.
92. The apparatus of claim 91, comprising a plurality of receptacles adapted to receive the fluid, each receptacle of the plurality of receptacles comprising an operatively tissue area facing first wall portion, the first wall portion having a permeable layer of the plurality of permeable layers.
93. The apparatus of claim 30, comprising a plurality of carrier layers, each carrier layer of the plurality of carrier layers configured to operatively define one or more apertures.
94. The apparatus of claim 93, wherein the plurality of carrier layers are configured to be disposable between the permeable layer and the tissue area in a layered manner so as to align the one or more apertures of the plurality of carrier layers between the target tissue and the at least one section of the permeable layer such that the at least one section deforms into the one or more apertures of the plurality of carrier layers and supplies molecules within the fluid to the target tissue.
95. The apparatus of claim 93, wherein each carrier layer of the plurality of carrier layers is configured to be disposed between the permeable layer and the tissue area such that the at least one section deforms into the one or more apertures of each carrier layer of the plurality of carrier layers and supply molecules within the fluid to the target tissue.
96. The apparatus of claim 93, comprising a plurality of permeable layers, each permeable layer of the plurality of permeable layers having at least one section configured to permit the fluid to pass through the permeable layer, the at least one section configured to be deformable, and wherein each carrier layer of the plurality of carrier layers is configured to be disposable between at least one permeable layer of the plurality of permeable layers and the tissue area such that the at least one section of the at least one permeable layer deforms into the one or more apertures of the carrier layer and supplies the fluid to the target tissue.
97. The apparatus of any one of claims 30 to 91, wherein the carrier layer is configured to adhere to at least a part of the tissue area and/or at least a part of the permeable layer.
98. The apparatus of any one of claims 30 to 91, wherein the carrier layer is affixable to the patient at or about the tissue area by adhesive tape.
99. The apparatus of any of claims 30 to 91, wherein the carrier layer provides cushioning between the tissue area and at least a part of the permeable layer.
100. The apparatus of claim 36, wherein the first wall portion and the second wall portion each has a permeable layer, the permeable layer of each of the first wall portion and the second wall portion having at least one section configured to permit the fluid to pass through the permeable layer.
101. The apparatus of claim 36 or 100, wherein the tissue area comprises a cavity and the receptacle is substantially flexible so as to at least in part be positionable within the cavity.
102. A method of dressing a tissue area of a patient, the method comprising: applying a carrier layer defining one or more apertures to the tissue area; applying a permeable layer to the carrier layer so as to position the permeable layer over the one or more apertures of the carrier layer, the permeable layer having at least one section configured to permit molecules within a fluid to pass through the permeable layer to supply the molecules to the tissue area.
103. The method of claim 102, wherein the section comprises the entirety of the permeable layer.
104. The method of claim 102 or 103, wherein the section of the permeable layer is adapted to deform under pressure imparted by the fluid on the permeable layer.
105. The method of claim 104, wherein applying the permeable layer to the carrier layer comprises and/or is followed by deforming the section of the permeable layer, under pressure imparted by the fluid on the permeable layer towards the tissue area, into the one or more apertures of the carrier layer.
106. The method of claim 105, wherein deforming the section of the permeable layer is preceded by supplying the fluid at a side of the permeable layer opposite a side of the permeable layer facing the carrier layer.
107. The method of any one of claims 102 to 106, wherein applying the carrier layer to the tissue area is preceded by causing the carrier layer to define the one or more apertures.
108. The method of claim 107, wherein causing the carrier layer to define the one or more apertures comprises causing the carrier layer to define the one or more apertures such that the one or more apertures correspond to a shape and/or a location and/or a geometry of target tissue within the tissue area.
109. The method of any one of claims 102 to 108, wherein the one or more apertures are chamfered at an operatively permeable layer facing side of the carrier layer.
110. The method of any one of claims 102 to 109, wherein the carrier layer defines a plurality of apertures.
111. The method of any one of claims 102 to 110, wherein the fluid comprises a therapeutic fluid.
112. The method of claim 111, wherein the therapeutic fluid comprises oxygen and/or carbon dioxide and/or carbon monoxide, and/or nitric oxide.
113. The method of any one of claims 102 to 112, wherein the section is configured to permit the molecules within the fluid to pass through the permeable layer by diffusion alone or by a combination of diffusion and pore flow.
114. The method of any one of claims 102 to 113, wherein the carrier layer is absorbent.
115. The method of any one of claims 102 to 114, wherein the permeable layer is non-destructively removable from the carrier layer subsequent to applying the permeable layer to the carrier layer.
116. The method of claim 115, wherein applying the permeable layer to the carrier layer is followed by removing the permeable layer from the carrier layer and applying a further permeable layer to the carrier layer so as to position the further permeable layer over the one or more apertures of the carrier layer, asection of the further permeable layer configured to permit molecules of a fluid to pass through the further permeable layer to supply the molecules of the fluid to the tissue area.
117. The method of claim 105, wherein a receptacle adapted to receive the fluid comprises an operatively tissue area facing first wall portion having the permeable layer, the section of the permeable layer deforming under pressure imparted by the fluid on the permeable layer towards the tissue area through inflation of the receptacle by the fluid.
118. The method of claim 117, wherein the receptacle is formed from the first wall portion and an opposing second wall portion.
119. The method of claim 118, wherein the first wall portion and the second wall portion are non-porous.
120. The method of any one of claims 117 to 119, wherein deforming the section of the permeable layer is preceded by connecting an inlet of the receptacle to a fluid source.
121. The method of claim 120, wherein connecting the inlet of the receptacle to a fluid source is followed by at least partially inflating the receptacle through an activation of the fluid source.
122. The method of claim 121, wherein applying a permeable layer to the carrier layer is followed by positioning a cover over the receptacle and the tissue area.
123. The method of claim 122, wherein the cover operatively constrains deformation of the receptacle away from the tissue area during inflation of the receptacle.
124. The method of any one of claims 120 to 123, wherein the fluid source is connected to the inlet of the receptacle by an inlet conduit.
125. The method of claim 124, wherein the receptacle is adapted to allow the fluid to exit the receptacle via a fluid outlet conduit in fluid communication with an outlet of the receptacle.
126. The method of claim 125, wherein the outlet conduit comprises a pressure relief valve.
127. A kit of parts for supplying fluid to target tissue within a tissue area of a patient, the kit comprising: a receptacle adapted to receive the fluid, the receptacle comprising an operatively tissue area facing first wall portion, the first wall portion having a permeable layer with at least one section configured to permit molecules within the fluid to pass through the permeable layer and to be deformable; a carrier layer configured for application between the tissue area and the first wall portion of the receptacle, the carrier layer operatively defining one or more apertures into which the section of the permeable layer operatively deforms to supply molecules within the fluid to the target tissue.
128. The kit of claim 127, wherein the receptacle is formed from the first wall portion and an opposing second wall portion.
129. The kit of claim 127 or 128, wherein the one or more apertures are defined in the carrier layer by forming the one or more apertures from a perforated region of the carrier layer.
130. The kit of claim 127 or 128, wherein the one or more apertures are pre-cut into the carrier layer.
131. The kit of claim 127 or 128, comprising a cutter configured for cutting the carrier layer to define the one or more apertures such that the one or more apertures correspond to a shape and/or a location and/or a geometry of the target tissue.
132. The kit of any one of claims 127 to 131, wherein the carrier layer comprises an absorbent material and/or a non-absorbent material.
133. The kit of claim 132, wherein the absorbent material is a foam material.
134. The kit of any one of claims 127 to 133, wherein the carrier layer is compressible.
135. The kit of any one of claims 127 to 134, wherein the at least one section operatively deforms into the one or more apertures under pressure imparted by the fluid on the permeable layer towards the tissue area through inflation of the receptacle by the fluid.
136. The kit of claim 135, comprising a cover configured to hold the receptacle onto the tissue area, the cover operatively constraining deformation of the receptacle away from the tissue area during inflation of the receptacle.
137. The kit of any one of claims 127 to 136, comprising a fluid source connectable to an inlet of the receptacle.
138. The kit of claim 137, comprising an outlet conduit connectable to an outlet of the receptacle, the outlet conduit comprising a pressure relief valve.
139. A tissue care dressing for a tissue area of a patient, the tissue care dressing comprising: a receptacle having an inlet and an outlet, the receptacle adapted to receive a fluid via the inlet and from which the fluid can exit via the outlet, the receptacle formed from an operatively tissue area facing first wall portion and an opposing second wall portion and defining a fluid flow path from the inlet to the outlet, the fluid flow path comprising: a first chamber in fluid flow connection with the inlet, and a second chamber in fluid flow connection with the first chamber and the outlet, the second chamber partitioned from the first chamber by a juncture between the first wall portion and the second wall portion.
140. The tissue care dressing of claim 139, wherein the juncture is formed by a bond between an inner surface of the first wall portion and an inner surface of the second wall portion.
141. The tissue care dressing of claim 139 or 140, wherein at least one of the first chamber and the second chamber is configured to be positionable at the tissue area, the first wall portion of the at least one of the first chamber and the second chamber having a permeable layer with at least one section configured to permit molecules within the fluid to pass through the permeable layer.
142. The tissue care dressing of claim 141, wherein the at least one section is deformable under pressure imparted by the fluid on the first wall portion.
143. The tissue care dressing of any one of claims 139 to 142, wherein the inlet is substantially adjacent the outlet.
144. The tissue care dressing of claim 143, wherein the inlet and the outlet are disposed at a tail portion of the receptacle.
145. The tissue care dressing of claim 143 or 144, comprising an indicator of an orientation of the receptacle.
146. The tissue care dressing of claim 145, wherein the receptacle is adapted to receive the fluid via a fluid inlet conduit in fluid communication with the inlet and from which the fluid can exit via a fluid outlet conduit in fluid communication with the outlet.
147. The tissue care dressing of claim 146, comprising a pressure spreading device configured to mitigate a pressure applied to the patient by the fluid inlet conduit and/or the fluid outlet conduit.
148. The tissue care dressing of claim 147, wherein the pressure spreading device comprises the indicator.
149. The tissue care dressing of claim 147 or 148, wherein the pressure spreading device has a substantially flat surface at an operatively patient facing side thereof.
150. The tissue care dressing of any one of claims 139 to 149, wherein the second wall portion comprises one or more ridges extending a distance along the fluid flow path at an inner surface of the second wall portion.
151. The tissue care dressing of claim 141, wherein the at least one section of the at least one of the first chamber and the second chamber comprises a plurality of microstructures arranged at an operatively tissue area facing surface of the first wall portion.
152. The tissue care dressing of any one of claims 139 to 151, wherein at least one of the first chamber and the second chamber has a generally elongate shape or curved shape or rectangular shape or square shape or oval shape or round shape.
153. The tissue care dressing of 141, wherein one of the first chamber and the second chamber is configured to be positionable at the tissue area, the first wall portion of the one of the first chamber and the second chamber having a larger surface area relative to the surface area of the first wall portion of the other of the first chamber and the second chamber.
154. The tissue care dressing of 153, wherein the other of the first chamber and the second chamber comprises a conduit between the inlet or the outlet for the fluid to or from the one of the first chamber and the second chamber.
155. An apparatus for supplying fluid to various target tissue within a tissue area of a patient, the apparatus comprising a plurality of permeable layers, each permeable layer of the plurality of permeable layers configured to supply a fluid to a target tissue of the various target tissue through an aperture of a carrier layer or plurality of carrier layers operatively disposed between the permeable layer and the target tissue.
156. The apparatus of claim 155, wherein the plurality of permeable layers are applied to the carrier layer or plurality of carrier layers to be separately disposed about the tissue area.
157. The apparatus of claim 155, wherein each permeable layer of the plurality of permeable layers is deformable into the aperture of the carrier layer.
158. The apparatus of claim 156, wherein the permeable layer has a convex shape operatively disposed towards the tissue area.
159. The apparatus of any one of claims 155 to 158, wherein each permeable layer of the plurality of permeable layers is an operatively tissue area facing first wall portion of a receptacle adapted to receive the fluid.
160. The apparatus of claim 159, wherein the receptacle receives the fluid via an inlet in fluid flow connection with a manifold connected to a fluid source.
EP24756440.4A 2023-02-16 2024-02-16 Apparatus for supplying fluid to a tissue area Pending EP4665286A1 (en)

Applications Claiming Priority (3)

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AU2023900374A AU2023900374A0 (en) 2023-02-16 Apparatus for supplying fluid to a tissue area
AU2023901902A AU2023901902A0 (en) 2023-06-16 Apparatus for supplying fluid to a tissue area
PCT/IB2024/051461 WO2024171120A1 (en) 2023-02-16 2024-02-16 "apparatus for supplying fluid to a tissue area"

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CN120981211A (en) 2025-11-18
WO2024171120A1 (en) 2024-08-22

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