WO2018060412A1 - Negative pressure wound treatment apparatuses and methods with integrated electronics - Google Patents

Negative pressure wound treatment apparatuses and methods with integrated electronics Download PDF

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Publication number
WO2018060412A1
WO2018060412A1 PCT/EP2017/074755 EP2017074755W WO2018060412A1 WO 2018060412 A1 WO2018060412 A1 WO 2018060412A1 EP 2017074755 W EP2017074755 W EP 2017074755W WO 2018060412 A1 WO2018060412 A1 WO 2018060412A1
Authority
WO
WIPO (PCT)
Prior art keywords
wound
area
layer
negative pressure
wound dressing
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP2017/074755
Other languages
English (en)
French (fr)
Inventor
Victoria Beadle
Mark Hesketh
William KELBIE
Damyn Musgrave
Joseph William Robinson
Daniel STEWARD
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.)
Smith and Nephew PLC
Original Assignee
Smith and Nephew PLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Smith and Nephew PLC filed Critical Smith and Nephew PLC
Priority to EP17777257.1A priority Critical patent/EP3519000B1/en
Priority to AU2017336305A priority patent/AU2017336305B2/en
Priority to US16/338,386 priority patent/US12447260B2/en
Priority to JP2019516606A priority patent/JP2019528957A/ja
Publication of WO2018060412A1 publication Critical patent/WO2018060412A1/en
Anticipated expiration legal-status Critical
Priority to US18/893,837 priority patent/US20250082512A1/en
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/96—Suction control thereof
    • A61M1/962—Suction control thereof having pumping means on the suction site, e.g. miniature pump on dressing or dressing capable of exerting suction
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/05—Bandages or dressings; Absorbent pads specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
    • A61M1/96—Suction control thereof
    • A61M1/964—Suction control thereof having venting means on or near the dressing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/84—Accessories, not otherwise provided for, for absorbent pads
    • A61F2013/8476—Accessories, not otherwise provided for, for absorbent pads with various devices or method
    • A61F2013/8479—Accessories, not otherwise provided for, for absorbent pads with various devices or method including electric or magnetic devices
    • A61F2013/8482—Accessories, not otherwise provided for, for absorbent pads with various devices or method including electric or magnetic devices including numeric control, e.g. using computer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/15—Absorbent pads, e.g. sanitary towels, swabs or tampons for external or internal application to the body; Supporting or fastening means therefor; Tampon applicators
    • A61F13/84—Accessories, not otherwise provided for, for absorbent pads
    • A61F2013/8494—Accessories, not otherwise provided for, for absorbent pads including pumping devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71—Suction drainage systems
    • A61M1/78—Means for preventing overflow or contamination of the pumping systems
    • A61M1/784—Means for preventing overflow or contamination of the pumping systems by filtering, sterilising or disinfecting the exhaust air, e.g. swellable filter valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/587—Lighting arrangements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/75—General characteristics of the apparatus with filters
    • A61M2205/7518—General characteristics of the apparatus with filters bacterial

Definitions

  • Embodiments described herein relate to apparatuses, systems, and methods the treatment of wounds, for example using dressings in combination with negative pressure wound therapy.
  • Negative pressure wound therapy systems currently known in the art commonly involve placing a cover that is impermeable or semi-permeable to fluids over the wound, using various means to seal the cover to the tissue of the patient surrounding the wound, and connecting a source of negative pressure (such as a vacuum pump) to the cover in a manner so that negative pressure is created and maintained under the cover.
  • a source of negative pressure such as a vacuum pump
  • wound dressings are known for aiding in NPWT systems. These different types of wound dressings include many different types of materials and layers, for example, gauze, pads, foam pads or multi-layer wound dressings.
  • a multi-layer wound dressing is the PICO dressing, available from Smith & Nephew, which includes a superabsorbent layer beneath a backing layer to provide a canister-less system for treating a wound with NPWT.
  • the wound dressing may be sealed to a suction port providing connection to a length of tubing, which may be used to pump fluid out of the dressing and/or to transmit negative pressure from a pump to the wound dressing.
  • the wound dressing apparatus of the preceding paragraph or in other embodiments can include one or more of the following features.
  • the electronic components can comprise one or more of a power source, a flexible circuit board, a sensor, a switch, and/or a light or LED indicator.
  • the wound dressing apparatus can further comprise a negative pressure source inlet protection mechanism and a negative pressure source outlet or exhaust.
  • the negative pressure source outlet or exhaust can comprise an antibacterial membrane and/or a non- return valve.
  • the cover layer can comprise an aperture over the outlet or exhaust.
  • the negative pressure source inlet protection mechanism can comprise a hydrophobic material configured to prevent fluid from entering the negative pressure source.
  • the electronics cassette can comprise one or more slits, grooves or recesses in the casing, wherein the slits, grooves or recesses are configured to provide one or more hinge points in the casing and increase flexibility of the electronics cassette.
  • the spacer layer can extend within both the first area and the second area and the electronics cassette is provided over the spacer layer.
  • the negative pressure source and/or electronic components can be encapsulated in a hydrophobic coating.
  • a wound dressing apparatus can comprise a wound contact layer configured to be positioned in contact with a wound, a first area over the wound contact layer can comprise a spacer layer and an absorbent layer over the spacer layer, a second area over the wound contact layer comprising an electronics unit, the electronics unit comprising a negative pressure source and/or electronic components, wherein the first area is positioned adjacent to the second area, wherein the second area can comprise a cradle configured to allow fluid communication between the first area and second area, wherein the cradle can comprise recesses configured to receive a portion of the electronics unit, and a cover layer configured to cover and form a seal over the wound contact layer, the first area, and the second area.
  • the wound dressing apparatus of the preceding paragraph or in other embodiments can include one or more of the following features.
  • the cradle can comprise a hydrophilic material.
  • the wound dressing apparatus wherein at least a portion of the second area can overlap a portion of the first area.
  • the cradle can comprise a recess configured to receive a portion of the absorbent layer.
  • the electronic components can comprise one or more of a power source, a flexible circuit board, a sensor, a switch, and/or a light or LED indicator.
  • the wound dressing apparatus can further comprise a negative pressure source inlet protection mechanism and a negative pressure source outlet or exhaust.
  • the negative pressure source outlet or exhaust can comprise an antibacterial membrane and/or a non-return valve.
  • the cover layer can comprise an aperture over the outlet or exhaust.
  • the negative pressure source inlet protection mechanism can comprise a hydrophobic material configured to prevent fluid from entering the negative pressure source.
  • the negative pressure source and/or electronic components can be encapsulated in a hydrophobic
  • a wound dressing apparatus can comprise a wound contact layer comprising a proximal wound-facing face and a distal face, wherein the wound-facing face is configured to be positioned in contact with a wound, a spacer layer comprising a proximal wound-facing face and a distal face, the spacer layer positioned over the distal face of the wound contact layer, a first area over the spacer layer comprising an absorbent layer, a second area over the spacer layer comprising an electronics unit, the electronics unit comprising a negative pressure source and/or electronic components, wherein the first area is positioned adjacent to the second area, wherein the second area over the spacer layer comprises a cradle configured to allow fluid communication between the first area and second area, wherein the cradle comprises recesses configured to receive the electronics unit, and a cover layer configured to cover and form a seal over the wound contact layer, the spacer layer, the first area, and the second area.
  • the wound dressing apparatus of the preceding paragraph or in other embodiments can include one or more of the following features.
  • the cradle can comprise a hydrophilic material.
  • the electronic components can comprise one or more of a power source, a flexible circuit board, a sensor, a switch, and/or a light or LED indicator.
  • the wound dressing apparatus can further comprise a negative pressure source inlet protection mechanism and a negative pressure source outlet or exhaust.
  • the negative pressure source outlet or exhaust can comprise an antibacterial membrane and/or a non-return valve.
  • the cover layer can comprise an aperture over the outlet or exhaust.
  • the negative pressure source inlet protection mechanism can comprise a hydrophobic material configured to prevent fluid from entering the negative pressure source.
  • a wound dressing apparatus can comprise a wound contact layer comprising a proximal wound-facing face and a distal face, wherein the proximal wound-facing face is configured to be positioned in contact with a wound, a spacer layer comprising a proximal wound-facing face and a distal face, the spacer layer positioned over the distal face of the wound contact layer, an absorbent layer comprising a proximal wound-facing face and a distal face, the absorbent layer positioned on the distal face of the spacer layer, an electronics unit comprising a negative pressure source and/or electronic components, a cradle positioned on the distal face of the absorbent layer and configured to allow fluid communication between the absorbent layer and the electronics unit, wherein the cradle comprises recesses configured to receive the electronics unit, and a cover layer configured to cover and form a seal over the wound contact layer, the spacer layer, the absorbent layer, the cradle and electronics unit.
  • the wound dressing apparatus of the preceding paragraph or in other embodiments can include one or more of the following features.
  • the cradle can comprise a hydrophilic material.
  • the electronic components can comprise one or more of a power source, a flexible circuit board, a sensor, a switch, and/or a light or LED indicator.
  • the wound dressing apparatus can further comprise a negative pressure source inlet protection mechanism and a negative pressure source outlet or exhaust.
  • the negative pressure source outlet or exhaust can comprise an antibacterial membrane and/or a non-return valve.
  • the cover layer can comprise an aperture over the outlet or exhaust.
  • the negative pressure source inlet protection mechanism can comprise a hydrophobic material configured to prevent fluid from entering the negative pressure source.
  • a wound dressing apparatus can comprise a wound contact layer comprising a proximal wound-facing face and a distal face, wherein the wound-facing face is configured to be positioned in contact with a wound, a first area over the distal face of the wound contact layer comprising a spacer layer, and an absorbent layer over the spacer layer, a second area over the distal face of the wound contact layer comprising an electronics unit, the electronics unit comprising a negative pressure source and/or electronic components, wherein the first area is positioned adjacent to the second area, wherein the second area comprises a cradle positioned directly on the wound contact layer, wherein the cradle is configured to allow fluid communication between the first area and second area, and wherein the cradle comprises recesses configured to receive the electronics unit, and a cover layer configured to cover and form a seal over the wound contact layer, the first area, and the second area.
  • the wound dressing apparatus of the preceding paragraph or in other embodiments can include one or more of the following features.
  • the cradle can comprise a hydrophilic material.
  • the electronic components can comprise one or more of a power source, a flexible circuit board, a sensor, a switch, and/or a light or LED indicator.
  • the wound dressing apparatus can further comprise a negative pressure source inlet protection mechanism and a negative pressure source outlet or exhaust.
  • the negative pressure source outlet or exhaust can comprise an antibacterial membrane and/or a non- return valve.
  • the cover layer can comprise an aperture over the outlet or exhaust.
  • the negative pressure source inlet protection mechanism can comprise a hydrophobic material configured to prevent fluid from entering the negative pressure source.
  • FIGS 2, 3A-3D, and 4A-4B illustrate embodiments of the electronics unit 67 that can be incorporated into a wound dressing
  • FIGS 5A-5E illustrate embodiments of components of the electronics cassette
  • Figures 6A-6D illustrate an embodiment of the flexible circuit board for use in the electronics cassette
  • Figures 7A-7D illustrate embodiments of electronic cassettes with two pump exhausts in various configurations and shapes
  • Figures 8A-8C illustrates embodiments of electronic cassettes with one pump exhaust in various shapes
  • FIGS 9A-9D illustrate various embodiments of the electronic cassette with various configurations for components on the electronic cassettes
  • Figure 10 illustrates an embodiment of the electronics cassette
  • Figure 17 illustrates an embodiment of on/off switch for use with a wound dressing with integrated electronics
  • Figure 18 illustrates an embodiment of a wound dressing incorporating an electronics unit within the dressing
  • Figure 19A illustrates an embodiment of the electronics unit
  • Figure 19B illustrates an embodiment of the cradle that can be within, adjacent to, and/or above the absorbent dressing material
  • Figure 19C illustrates an embodiment of the electronics unit incorporated into the cradle
  • Figures 22A-22C illustrate another embodiment of a wound dressing incorporating an electronics unit and cradle in the wound dressing
  • Figure 23 illustrates an absorbent layer provided over the entire length of the spacer layer
  • Figures 25A-25B illustrate embodiments of an assembled wound dressing with the dressing layers enclosed between a wound contact layer and a cover layer;
  • Figure 26 illustrates an embodiment of an assembled wound dressing.
  • Embodiments disclosed herein relate to apparatuses and methods of treating a wound with reduced pressure, including a source of negative pressure and wound dressing components and apparatuses.
  • the apparatuses and components comprising the wound overlay and packing materials, if any, are sometimes collectively referred to herein as dressings.
  • wound is to be broadly construed and encompasses open and closed wounds in which skin is torn, cut or punctured or where trauma causes a contusion, or any other superficial or other conditions or imperfections on the skin of a patient or otherwise that benefit from reduced pressure treatment.
  • a wound is thus broadly defined as any damaged region of tissue where fluid may or may not be produced.
  • wounds include, but are not limited to, abdominal wounds or other large or incisional wounds, either as a result of surgery, trauma, sterniotomies, fasciotomies, or other conditions, dehisced wounds, acute wounds, chronic wounds, subacute and dehisced wounds, traumatic wounds, flaps and skin grafts, lacerations, abrasions, contusions, bums, diabetic ulcers, pressure ulcers, stoma, surgical wounds, trauma and venous ulcers or the like.
  • reduced or negative pressure levels represent pressure levels relative to normal ambient atmospheric pressure, which can correspond to 760 mmHg (or 1 atm, 29.93 inHg, 101.325 kPa, 14.696 psi, etc.).
  • a negative pressure value of -X mmHg reflects absolute pressure that is X mmHg below 760 mmHg or, in other words, an absolute pressure of (760-X) mmHg.
  • negative pressure that is "less” or "smaller” than X mmHg corresponds to pressure that is closer to atmospheric pressure (e.g. ,-40 mmHg is less than -60 mmHg).
  • Negative pressure that is "more” or “greater” than -X mmHg corresponds to pressure that is further from atmospheric pressure (e.g., -80 mmHg is more than -60 mmHg).
  • local ambient atmospheric pressure is used as a reference point, and such local atmospheric pressure may not necessarily be, for example, 760 mmHg.
  • the negative pressure range for some embodiments of the present disclosure can be approximately -80 mmHg, or between about -20 mmHg and -200 mmHg. Note that these pressures are relative to normal ambient atmospheric pressure, which can be 760 mmHg. Thus, -200 mmHg would be about 560 mmHg in practical terms.
  • the pressure range can be between about -40 mmHg and -150 mmHg.
  • a pressure range of up to -75 mmHg, up to -80 mmHg or over -80 mmHg can be used.
  • a pressure range of below -75 mmHg can be used.
  • a pressure range of over approximately -100 mmHg, or even -150 mmHg can be supplied by the negative pressure apparatus.
  • increased wound contraction can lead to increased tissue expansion in the surrounding wound tissue.
  • This effect may be increased by varying the force applied to the tissue, for example by varying the negative pressure applied to the wound over time, possibly in conjunction with increased tensile forces applied to the wound via embodiments of the wound closure devices.
  • negative pressure may be varied over time for example using a sinusoidal wave, square wave, and/or in synchronization with one or more patient physiological indices (e.g., heartbeat). Examples of such applications where additional disclosure relating to the preceding may be found include U.S. Patent No. 8,235,955, titled "Wound treatment apparatus and method," issued on August 7, 2012; and U.S. Patent No. 7,753,894, titled "Wound cleansing apparatus with stress,” issued July 13, 2010. The disclosures of both of these patents are hereby incorporated by reference in their entirety.
  • the electronics unit 67 includes one or more slits, grooves or recesses 71 in the unit between the pump and the two batteries.
  • the slits, grooves or recesses 71 can allow for the electronics unit 67 to be flexible and conform to the shape of the wound.
  • the unit 67 can have two parallel slits, grooves or recesses 71 forming three segments of the electronics unit 67.
  • the slits, grooves or recesses 71 of the unit 67 create hinge points or gaps that allows for flexibility of the electronics unit at that hinge point.
  • the pump exhaust 64, switch 65, and indicators 66 are shown on the top surface surrounded by the electronics unit 67.
  • FIG. 5B and 5E illustrates embodiments of a top view of the electronics cassette 62 or 82.
  • the pump exhaust 64, switch 65, and indicators 66 are shown on the top surface surrounded by the casing 73 or 83.
  • one embodiment of the electronics cassette 62 or 82 has two hinge points, slits, grooves or recesses 81 on the top or upper surface of the cassette to separate the cassette into three regions or panels, for example one to contain one battery, one to contain the pump and one to contain another battery.
  • the hinge points, slits, grooves or recesses can be on the top surface, bottom surface, or on both the top and bottom surfaces of the cassette.
  • Figure 17 illustrates an embodiment of on/off switch that can be used with a wound dressing with integrated electronics and with electronic units and cassettes described herein.
  • Figure 18 illustrates an embodiment of a wound dressing incorporating an electronics unit 67 within the dressing.
  • the wound dressing can include a wound contact layer 104.
  • the dressing can also include a spacer layer 105 which may be made of a 3D material above the wound contact layer.
  • the electronics sub assembly or electronics unit 67 can be embedded in an absorbent pad 102 towards one end of the dressing, as depicted in Figure 18.
  • Figure 18 illustrates dressing layers with an electronics area A and an absorbent area B.
  • the electronics area A can include the electronics unit 67.
  • the absorbent area B can include the absorbent material 102 and can be positioned over the wound area to absorb fluid from the wound within the absorbent material or pad 102.
  • the electronics unit 67 can be positioned in a hole in the absorbent pad 102 and can be surrounded by the absorbent pad as illustrated in Figure 18 with the absorbent pad 102 on each side of the electronics unit 67.
  • the presence of the electronics unit since it is entirely non-absorbent, could physically inhibit the migration of wound exudate through the absorbent pad from area A to area B, the main body of the pad, and would thus result in pooling of wound exudate in area A. This can be deleterious to the patient, resulting in maceration of the skin and other potentially harmful effects.
  • a construct can be used that acts like a support mechanism or cradle for the electronics sub assembly.
  • Figure 19A illustrates an embodiment of the electronics unit 67.
  • the electronics unit 67 can be coated and/or include a pump inlet and outlet protection mechanism to protect the pump from the fluid environment of the dressing as described herein.
  • Figure 19B illustrates an embodiment of the material of the cradle 501 that can be within, adjacent to, and/or above the absorbent dressing material 502.
  • the cradle 501 is positioned adjacent to the dressing material 502 as illustrated in Figures 19B and 19C.
  • Figure 19C illustrates an embodiment of the electronics unit 67 incorporated into the cradle 501 and adjacent to an absorbent pad 502.
  • the cradle can include recesses, cutouts, or slots 503 and 504 within the cradle material 501 for receiving components of the electronics unit 67 as illustrated in Figure 19B.
  • the electronics unit 67 can be fit into the recesses 503 and 504 of the cradle material 501.
  • the cradle can include one or more recess 503 shaped to receive the batteries and a recess 504 shaped to receive the pump with the pump inlet and pump outlet mechanisms of the electronics unit as illustrated in Figure 19B.
  • the top of the electronics unit can be flush with or can have a similar height profile as the electronics cradle material.
  • the cradle can be a soft or patient compatible material to minimize the discomfort of a patient when the wound dressing with integrated electronics are in contact with the wound or skin.
  • the cradle can include an absorbent or wicking material that allows the flow of fluid through the casing.
  • the absorbent components and electronics components can be overlapping but offset.
  • a portion of the electronics area can overlap the absorbent area, for example overlapping the superabsorber layer, but the electronics area is not completely over the absorbent area. Therefore, a portion of the electronics area can be offset from the absorbent area and only provided over the cushioning transmission or spacer layers 605.
  • the dressing layer and electronic components can be enclosed in a wound contact layer (not shown) positioned below the lower most layer and a cover layer (not shown) positioned above the absorbent layer and electronics.
  • the wound contact layer and cover layer can be sealed at a perimeter enclosing the dressing components.
  • Figure 21 C illustrates an embodiment of an electronics unit 704 and a cradle 705 shown removed from the wound dressing layers.
  • the cradle 705 include recesses, cutout, or slots 706 within the cradle.
  • the recesses 706 are shaped to fit portions of the electronics unit.
  • the recesses 706 can be shaped in a complementary shape that matches the shape of portions of the underside of the electronics unit 704 similar to the electronics unit 67 shown and described with reference to Figures 2, 3A-3D, and 4A-4B.
  • the recesses 706 can be the shape of the batteries and pump assembly as shown in Figures 21C- 2 IE.
  • Figures 22A-22C illustrate another embodiment of a wound dressing incorporating an electronics unit 804 and cradle 805 in the wound dressing.
  • the dressing layers described with reference to Figures 22A-22C can incorporate an electronics unit within an electronics cassette as described with reference to Figures 5A-5E, 7A-7D, 8A-8C, 9A-9D, and 10 herein.
  • the electronics cassette can be used instead of the electronics cradle described with reference to Figures 22A- 22C.
  • FIG 22A illustrates an embodiment of a wound dressing including a spacer layer 801 , absorbent layer 802, and cradle 805.
  • the wound dressing layers can include an absorbent area 860 and an electronics area 861.
  • the electronics area 861 can include the electronics unit 804.
  • the absorbent area 860 can include the absorbent material 802 and can be positioned over the wound area to absorb fluid from the wound within the absorbent material or pad 802.
  • the absorbent layer 802 as shown in Figures 22A-22C can be positioned above the spacer layer 801 in the absorbent area 860 and the electronics area 861 and spans the length of the dressing.
  • the cradle 805 can be positioned above the absorbent layer 802 in the electronics area 861.
  • Figure 22A illustrates the recesses 806 in the cradle 805 similar to the recesses described herein with reference to Figures 21A-21F.
  • Figures 22B and 22C illustrate the electronics unit 804 positioned within the recesses 806 of the cradle.
  • Figure 23 illustrates an absorbent layer 902 provided over the entire length of the spacer layer 901.
  • the wound dressing layers can include an absorbent area 960 and an electronics area 961.
  • the electronics area 961 can include the electronics unit.
  • the absorbent area 960 can include the absorbent material 902 and can be positioned over the wound area to absorb fluid from the wound within the absorbent material or pad 902.
  • the absorbent layer has one recess, cutout, or slot 907 in the portion of the absorbent layer 902 located in the electronics area 961.
  • the spacer layer 901 is visible in the recess 907 of the absorbent layer 902.
  • the absorbent material 902 spans the length of the dressing and can include a single aperture 907 in the absorbent material 902.
  • the electronics cradle or electronics cassette described herein can be positioned within the single aperture 907 in the absorbent material or absorbent layer 902 of the dressing.
  • an electronic unit can be positioned within the electronics cradle or electronics cassette as described herein.
  • the dressing layers and components shown in Figure 23 can be enclosed in a wound contact layer (not shown) positioned below the spacer layer 901 and a cover layer (not shown) positioned above the absorbent layer 902 and electronics cradle or cassette.
  • the wound contact layer and cover layer can be sealed at a perimeter enclosing the dressing components.
  • Figure 24 illustrates an embodiment of a wound dressing incorporating an electronics unit resting in a cradle 1005.
  • the dressing layers described with reference to Figure 24 can incorporate an electronics unit within an electronics cassette as described with reference to Figures 5A-5E, 7A-7D, 8A-8C, 9A-9D, and 10 herein.
  • the electronics cassette can be used instead of the electronics cradle described with reference to Figure 24.
  • the wound dressing layers can include an absorbent area 1060 and an electronics area 1061.
  • the electronics area 1061 can include the electronics unit 1004 and electronics cradle 1005.
  • the absorbent area 1060 can include the absorbent material 1002 and can be positioned over the wound area to absorb fluid from the wound within the absorbent material or pad 1002.
  • Figure 24 illustrates a spacer layer 1001 and an absorbent layer 1002 positioned adjacent to a cradle 1005 and electronics unit 1004.
  • the dressing configuration illustrated in Figure 24 is similar to the dressing described with reference to Figures 21A-21F.
  • the spacer layer 1001 as shown in Figure 24 does not extend the entire length of the dressing. Instead, the spacer layer 1001 only extends to an edge of the cradle 1005 and the cradle is positioned to be in direct contact with an underlying wound contact layer 1006.
  • FIGs 25A-25B illustrate embodiments of an assembled wound dressing with the dressing layers enclosed between a wound contact layer (not shown) and a cover layer 11 10.
  • the wound dressing layers can include an absorbent area 1160 and an electronics area 1 161.
  • the electronics area 1 161 can include the electronics unit 1104 and electronics cradle 1105.
  • the absorbent area 1160 can include the absorbent material 1102 and can be positioned over the wound area to absorb fluid from the wound within the absorbent material or pad 1102.
  • the wound dressing can include a spacer layer 1101 as illustrated in Figure 25 A.
  • FIG. 25A-25B illustrates an embodiment of an assembled wound dressing similar to the dressing shown in Figures 25A-25B. However, the wound dressing of Figure 26 includes an additional masking or obscuring layer 1208 positioned above the dressing layers and below the cover layer 1210. As illustrated in Figure 26, the wound dressing layers can include an absorbent area 1260 and an electronics area 1261. In some embodiments, the electronics area 1261 can include the electronics unit 1204.
  • the masking or obscuring layer can span the entire length of the absorbent area 1260 and electronics area 1261. In some embodiments, the masking or obscuring layer can have a larger perimeter than the spacer layer, absorbent layer, and electronics unit, cradle, or cassette and can overborder the absorbent material and electronics unit, cradle, or cassette as shown in Figure 26.
  • the absorbent components and electronics components can be overlapping but offset.
  • a portion of the electronics area can overlap the absorbent area, for example overlapping the superabsorber layer, but the electronics area is not completely over the absorbent area. Therefore, a portion of the electronics area can be offset from the absorbent area and only provided over the cushioning spacer layers.
  • Conditional language such as “can,” “could,” “might,” or “may,” unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain embodiments include, while other embodiments do not include, certain features, elements, or steps. Thus, such conditional language is not generally intended to imply that features, elements, or steps are in any way required for one or more embodiments or that one or more embodiments necessarily include logic for deciding, with or without user input or prompting, whether these features, elements, or steps are included or are to be performed in any particular embodiment.
  • the terms “comprising,” “including,” “having,” and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth.
  • the term “or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or” means one, some, or all of the elements in the list.
  • the term “and/or” in reference to a list of two or more items covers all of the following interpretations of the word: any one of the items in the list, all of the items in the list, and any combination of the items in the list.
  • the term “each,” as used herein, in addition to having its ordinary meaning, can mean any subset of a set of elements to which the term “each” is applied.
  • the words “herein,” “above,” “below,” and words of similar import when used in this application, refer to this application as a whole and not to any particular portions of this application.
  • the terms “generally parallel” and “substantially parallel” refer to a value, amount, or characteristic that departs from exactly parallel by less than or equal to 15 degrees, 10 degrees, 5 degrees, 3 degrees, 1 degree, or 0.1 degree.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • External Artificial Organs (AREA)
PCT/EP2017/074755 2016-09-30 2017-09-29 Negative pressure wound treatment apparatuses and methods with integrated electronics Ceased WO2018060412A1 (en)

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EP17777257.1A EP3519000B1 (en) 2016-09-30 2017-09-29 Negative pressure wound treatment apparatuses and methods with integrated electronics
AU2017336305A AU2017336305B2 (en) 2016-09-30 2017-09-29 Negative pressure wound treatment apparatuses and methods with integrated electronics
US16/338,386 US12447260B2 (en) 2016-09-30 2017-09-29 Negative pressure wound treatment apparatuses and methods with integrated electronics
JP2019516606A JP2019528957A (ja) 2016-09-30 2017-09-29 一体化された電子機器を備えた陰圧創傷治療装置及び方法
US18/893,837 US20250082512A1 (en) 2016-09-30 2024-09-23 Negative pressure wound treatment apparatuses and methods with integrated electronics

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US201662402382P 2016-09-30 2016-09-30
US201662402298P 2016-09-30 2016-09-30
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