WO2021014297A1 - Pansement absorbant à pression négative avec bordure adhésive de retenue - Google Patents

Pansement absorbant à pression négative avec bordure adhésive de retenue Download PDF

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Publication number
WO2021014297A1
WO2021014297A1 PCT/IB2020/056711 IB2020056711W WO2021014297A1 WO 2021014297 A1 WO2021014297 A1 WO 2021014297A1 IB 2020056711 W IB2020056711 W IB 2020056711W WO 2021014297 A1 WO2021014297 A1 WO 2021014297A1
Authority
WO
WIPO (PCT)
Prior art keywords
border
dressing
adhesive border
silicone adhesive
coupled
Prior art date
Application number
PCT/IB2020/056711
Other languages
English (en)
Inventor
Christopher Brian Locke
Original Assignee
Kci Licensing, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Kci Licensing, Inc. filed Critical Kci Licensing, Inc.
Publication of WO2021014297A1 publication Critical patent/WO2021014297A1/fr

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
    • A61F13/0246Adhesive bandages or dressings characterised by the skin-adhering layer
    • A61F13/025Adhesive bandages or dressings characterised by the skin-adhering layer having a special distribution arrangement of the adhesive
    • 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
    • A61F13/02Adhesive bandages or dressings
    • A61F13/0246Adhesive bandages or dressings characterised by the skin-adhering layer
    • A61F13/0253Adhesive bandages or dressings characterised by the skin-adhering layer characterized by the adhesive material
    • 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
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L15/00Chemical aspects of, or use of materials for, bandages, dressings or absorbent pads
    • A61L15/16Bandages, dressings or absorbent pads for physiological fluids such as urine or blood, e.g. sanitary towels, tampons
    • A61L15/42Use of materials characterised by their function or physical properties
    • A61L15/58Adhesives

Definitions

  • the present disclosure relates generally to the field of wound therapy, and more particularly to dressings for use in negative pressure wound therapy.
  • Negative pressure wound therapy is a type of wound therapy that involves applying negative pressure (relative to atmospheric pressure) to a wound bed to promote wound healing.
  • a dressing is sealed over a wound bed and air is pumped out of the dressing to create a negative pressure at the wound bed.
  • wound exudate and other fluid is pumped out of the dressing and collected by a therapy system.
  • air is pumped out of the dressing while the dressing is used to absorb fluid from the wound.
  • the dressing may include a silicone adhesive that is suitable for creating a substantially air-tight seal between the dressing and the patient’s skin.
  • a silicone adhesive that is suitable for creating a substantially air-tight seal between the dressing and the patient’s skin.
  • the dressing includes a dressing core, a first border coupled to the dressing core and including a silicone adhesive border that surrounds the dressing core, a second border coupled to the first border and including an acrylic adhesive border that at least partially surrounds the silicone adhesive border.
  • the silicone adhesive border is configured to seal the dressing to skin of a patient surrounding a wound bed and the acrylic adhesive border is configured to reinforce a coupling between the silicone adhesive border and the skin of the patient by adhering to the skin.
  • the dressing may include a tube coupled to the dressing core and configured to be coupled to a pump configured to operate to establish a negative pressure at the dressing core when the silicone adhesive border is sealed to the skin.
  • the dressing core may include a wound contact film, a manifolding foam, and an absorbent material.
  • the dressing includes a first release liner coupled to the dressing and removable to expose the silicone adhesive border and a second release liner coupled to the dressing and removable to expose the acrylic adhesive border.
  • the first release liner can include a first material configured to release from the silicone adhesive border
  • the second the second release liner can include a second material configured to release from the acrylic adhesive border.
  • the second material is different from the first material.
  • the second release liner may be configured to be removed from the acrylic adhesive border in two or four sections.
  • the acrylic adhesive border includes a light-deactivated adhesive.
  • the silicone adhesive border radially extends from the dressing core by approximately 20 to 25 millimeters and the acrylic adhesive border radially extends from the silicone adhesive border by approximately 10 to 20 millimeters.
  • the second border comprises a top support layer removeably coupled to the second border.
  • the wound therapy system includes a pump, a tube coupled to the pump, a dressing core coupled to the tube, a first border coupled to the dressing core and including a silicone adhesive border that surrounds the dressing core, a second border coupled to the first border and including an acrylic adhesive border that at least partially surrounds the silicone adhesive border.
  • the silicone adhesive border is configured to establish a seal between the first border and a patient.
  • the acrylic adhesive border may be configured to adhere to the patient.
  • the acrylic adhesive border can reinforce a bond between the silicone adhesive border and the patient.
  • the dressing core includes a wound contact film, a manifolding film, and an absorbent material.
  • the pump is operable to remove air from the manifolding foam via the tube.
  • the wound therapy system includes a first release liner coupled to dressing and removable to expose the silicone adhesive border and a second release liner coupled to the dressing and removable to expose the acrylic adhesive border.
  • the first liner can include a first material configured to release from the silicone adhesive border and the second release liner can include a second material configured to release from the acrylic adhesive border. The second material is different from the first material.
  • FIG. 1 is a cross-sectional diagram of a negative pressure wound therapy (NPWT) system with an absorbent dressing, according to an exemplary embodiment.
  • NGWT negative pressure wound therapy
  • FIG. 2 in an exploded cross-sectional side view of the dressing of FIG. 1, according to an exemplary embodiment.
  • FIG. 3 is an exploded perspective view of the dressing of FIG. 1, according to an exemplary embodiment.
  • FIG. 4 is a bottom view of the dressing of FIG. 1, according to an exemplary embodiment.
  • FIGS. 1-4 a negative pressure wound therapy (NPWT) system 100 and a dressing 104 for use therewith are shown, according to exemplary embodiments.
  • the NPWT system 100 includes a pump 102 pneumatically communicable with a dressing 104 via tube 106.
  • FIG. 1 shows a cross-sectional side-view of the NPWT system 100 in which the dressing 104 is sealed over a wound bed.
  • the wound bed is a tissue wound of a patient, for example a laceration, bum, sore, trauma wound, chronic wound, etc.
  • FIG. 2 shows an exploded, cross-sectional, side view of the NPWT system 100 before the dressing 104 is sealed over the wound bed.
  • the dressing 104 provides a silicone adhesive that facilitates an initial seal between the dressing 104 and the patient in addition to an acrylic adhesive that reinforces the bond between the dressing 104 and the patient and facilitates long term (e.g., approximately 7 days) fixation of the dressing 104 to the patient.
  • this dual-adhesive dressing design is configured to be highly-intuitive and easy-to-use for a caregiver.
  • the dressing 104 allows a negative pressure to be maintained at the wound bed while absorbing fluid from the wound bed.
  • the dressing 104 is shown to include a drape 112, a dressing core 120, a first border 121, and a second border 122.
  • the drape 112 is configured to provide a barrier between the ambient environment and the dressing core 120 and wound bed.
  • the drape 112 may include a material that substantially prevents leaking of air therethrough to facilitate creation and maintenance of a negative pressure at the dressing core 120 (i.e., in a volume between the drape 112 and the wound bed).
  • the drape 112 may also include a material with a high moisture vapor transfer rate to facilitate evaporation of fluid from the dressing core 120 to the ambient air through the drape 112.
  • the first border 121 is configured to provide a substantially air-tight seal between the drape 112 and the patient’s skin around the wound bed
  • the second border 122 is configured to adhere to the skin to retain the dressing 104 in a substantially-fixed location on the patient (i.e., to reinforce the bond between the first border 121 and the skin).
  • the first border 121 and the second border 122 are described in further detail below.
  • the dressing core 120 is configured to facilitate communication of negative pressure across the wound bed while also absorbing fluid from the wound bed.
  • Various dressing cores 120 are possible in various embodiments.
  • the dressing core 120 may be the same as or similar to that included with the absorbent negative pressure dressing sold under the trade name PICO by Smith and Nephew.
  • the dressing core 120 includes a manifold layer 110, a wound contact layer 114, and an absorbent 116.
  • the dressing core 120 may have a rectangular shape, a circular shape, an elliptical shape, a pentagonal shape, an octagonal shape, etc.
  • the wound contact layer 114 provides an interface between the dressing 104 and a wound.
  • the wound contact layer 114 is configured to prevent ingrowth of the wound bed to the dressing and to facilitate removal of the dressing 104 while minimizing damage to the healing tissue of the wound bed.
  • the wound contact layer 114 includes a film, for example a silicone film.
  • the wound contact layer 114 may be perforated, fenestrated, or otherwise formed to allow for the flow of air and fluid therethrough.
  • the manifold layer 110 is configured to allow airflow therethrough to facilitate the distribution of negative pressure across the wound bed.
  • the manifold layer 110 may include an open-celled foam, for example a foam material marketed as GRANUFOAMTMby ACELITYTM.
  • the manifold layer 110 is also configured to allow fluid to flow therethrough, for example from the wound bed to the absorbent 116.
  • the absorbent 116 (e.g., absorbent deposits, absorbent layer) is configured to absorb fluid, for example wound exudate from the wound bed.
  • the absorbent 116 may include a superabsorbent material.
  • the absorbent 116 is formed as a superabsorbent laminate positioned between the drape 112 and the manifold layer 110, with channels extending therethrough to allow airflow therethrough.
  • the absorbent 116 is printed or deposited in a pattern on a non-wound-facing surface of the manifold layer 110 (i.e., adjacent the drape 112). It should be understood that various configurations of the dressing core 120 are contemplated by the present disclosure.
  • connection assembly 108 is configured to couple the dressing 104 to a tube 106, which is coupled to a pump 102.
  • the connection assembly 108 is configured to allow airflow between the manifold layer 110 and the pump 102, while restricting the flow of fluid therethrough.
  • the connection assembly 108 may include a filter or membrane that allows airflow therethrough while preventing the flow of fluid therethrough.
  • the pump 102 is operable to pump air out of the dressing 104 via the tube 106 to create and maintain a negative pressure at the wound bed.
  • the pump 102 is electrically powered (e.g., battery powered) and the NPWT system 100 includes power systems and control circuitry to power and control operation of the pump 102.
  • the NPWT system 100 may include one or more pressure sensors or various other sensors that collect data used to control the pump 102 to maintain a negative pressure at the wound bed.
  • the pump 102 is manually-powered, such that a user may manipulate the pump 102 to draw air out of the dressing 104 as desired by the user.
  • the pump 102 may be spring-loaded to gradually pull air from the dressing 104 for a duration of time following a compression of the pump 102 by the user.
  • the NPWT system 100 is thereby configured to provide a negative pressure at the wound bed while also facilitating absorption of fluid from the wound bed by the dressing 104.
  • the first border 121 is configured to provide a substantially airtight seal between the drape 112 and the skin.
  • the first border 121 includes a silicone adhesive border that surrounds the dressing core 120. That is, the first border 121 includes a patient-facing surface that includes a silicone adhesive and surrounds the dressing core 120.
  • the silicone adhesive can seal the first border 121 to a patient’s skin.
  • the first border 121 extends radially from the wound contact layer 114 of the dressing core 120 by a breadth in the range of approximately 20 millimeters to 25 millimeters.
  • the first border 121 is formed as an integral part of the drape 112, such that the drape 112 extends beyond the dressing core 120 to provide the patient-facing surface which is coated with the silicone adhesive.
  • the first border 121 is formed as a separate piece of material which is coupled to the drape 112 and/or the dressing core 120 (e.g., adhered to the wound contact layer 114).
  • the second border 122 is coupled to the first border 121 and includes an acrylic adhesive border that at least partially surrounds the silicone adhesive border.
  • the second border 122 has an inner portion that defines (borders, surrounds, delineates) a central opening 300.
  • the central opening 300 is shaped and sized to be aligned with and placed over the dressing core 120 such that the inner portion of the second border 122 overlaps the first border 121 and can be coupled to the first border 121. That is, as shown in FIG. 1, the inner portion of the second border 122 is configured to be adhered to the non-patient facing surface of the first border 121.
  • the second border 122 also includes an outer portion that extends radially from the inner portion such that the outer portion extends radially from the first border 121 when the second border 122 is coupled to the first border 121.
  • the second border 122 may extend from the first border 121 with a breadth in a range of approximately 10 millimeters to 20 millimeters.
  • the outer portion includes an acrylic adhesive on a patient-facing surface to form the acrylic adhesive border.
  • the acrylic adhesive is configured to adhere to the patient and substantially fix the dressing 104 in position on the patient.
  • the acrylic adhesive border is configured to adhere to the patient for a duration of at least seven days.
  • the acrylic adhesive is a light-deactivated adhesive that is configured to release (i.e., lose the ability to adhere) when exposed to a particular wavelength of light (e.g., ultraviolet light).
  • a particular wavelength of light e.g., ultraviolet light
  • the acrylic adhesive border may adhere to the patient until a caregiver applies light of the corresponding wavelength to deactivate the adhesive.
  • a light-deactivated adhesive marketed as Adhelight by Lumina may be included with the second border 122.
  • the dressing 104 is manufactured with the second border 122 coupled to the first border 121 during the manufacturing process.
  • the second border 122 is manufactured and distributed as a separate piece from the first border 121, the drape 113, the dressing core 120.
  • the second border 122 is configured to allow a user to couple the second border 122 to the first border 121 when applying the dressing.
  • the dressing 104 can include release liners that cover the adhesive surfaces and the wound contact layer 114 until the dressing 104 is applied to the wound by a user (caregiver, patient, etc.).
  • the dressing 104 includes a first release liner 200 configured to cover and release from the first border 121 (i.e., the silicone adhesive border) and a second release liner 208 configured to cover and release from the second border 122 (i.e., the acrylic border).
  • the first release liner 200 includes a first material suitable to allowing the first release liner 200 to be easily removed from a silicone adhesive
  • the second release liner 208 includes a second material suitable to allowing the second release liner 208 to be easily removed from an acrylic adhesive.
  • the first material may be different from the second material.
  • the first release liner 200 includes a central release liner 202 positioned to cover and release from the wound contact layer 114 and longitudinally-central portions of the first border 121, a first end release liner 204 configured to cover and release from a first end of the first border 121 and a portion of the wound contact layer 114 proximate the first end, a second end release liner 206 configured to cover and release from a second end of the first border 121 and a portion of the wound contact layer 114 proximate the second end.
  • the central release liner 202, the first end release liner 204, and the second end release liner 206 includes folds 210 at which the release liners 202-206 fold away from the wound contact layer 114 and the first border 121.
  • the folds 210 provide a gripping area for a user to grab and pull on the release liners 202-206 to facilitate removal of the release liners 202-206 from the first border and the wound contact layer 114.
  • the second release liner 208 is shaped to cover the outer portion of the second border 122, i.e., the portion that extends beyond the first border 121.
  • the second release liner 208 surrounds and is aligned with the first release liner 200 such that a patient-facing side of the dressing is substantially covered by the combination of the first release liner 200 and the second release liner 208.
  • the second release liner 208 may be formed as one piece, in two portions, in three portions, in four portions, etc. In the example of FIG. 4, the second release liner 208 is formed in four portions.
  • Each portion includes a tab 400 that can extend away from the second border 122 and is configured to be gripped by a user to facilitate the user in removing the second release liner 208 from the second border 122.
  • a top support layer 212 is included with the dressing 104 and is removeably coupled to the second border 122.
  • the top support layer 212 is at least partially rigid and provides structure support to the second border 122, which is made of a flexible material configured to conform to a patient’s anatomy.
  • the top support layer 212 can thereby protect the second border 122 from being folded, curled, deformed, etc. during distribution and storage of the dressing 104.
  • the top support layer 212 can then be removed from the dressing 104 (i.e., from the second border 122) during application of the dressing 104 to a patient.
  • a user may first remove the first release liner 200 to expose the silicone adhesive border and the wound contact layer 114.
  • the wound contact layer 114 and the dressing core 120 can be aligned with a wound and the silicone adhesive border can be sealed to the patient around the wound.
  • the tube 106 can then be used to connect the dressing core 120 to the pump 102, and the pump 102 operated to test whether the seal is satisfactorily established between the silicone adhesive border and the patient.
  • the first border 121 is configured to be shifted in location relative to the patient several times to facilitate a caregiver in achieving a desired location of the dressing 104 relative to the wound.
  • a user can remove the second release liner 208 to expose the acrylic adhesive border of the second border 122.
  • the user also removes the support layer 210 at this step.
  • the acrylic adhesive can then be positioned against the patient around the first border 121 to couple the second border 122 in a substantially-fixed position on the patient.
  • the silicone adhesive may provide a sufficient bond between the dressing 104 and the patient over the timespan of the dressing being applied that a caregiver may be inclined to believe that further retention structures are not necessary.
  • the silicone adhesive may not provide sufficient retention over longer time spans.
  • the dressing 104 described herein advantageously includes the second border 122 as an integral part of the dressing 104, which may substantially prevent users from mistakenly omitting the acrylic adhesive.
  • the second release liner 208 includes brightly-colored tabs or other visual indications configured to substantially prevent a user from failing to remove the second release liner 208. The dressing 104 is thereby configured to reduce the risk of improper application of the dressing 104.

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

Abstract

La présente invention concerne un pansement qui comprend un centre de pansement, une première bordure accouplée au centre de pansement et comprenant une bordure adhésive en silicone qui entoure le centre de pansement, une seconde bordure accouplée à la première bordure et comprenant une bordure adhésive en acrylique qui entoure au moins partiellement la bordure adhésive en silicone.
PCT/IB2020/056711 2019-07-19 2020-07-16 Pansement absorbant à pression négative avec bordure adhésive de retenue WO2021014297A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962876223P 2019-07-19 2019-07-19
US62/876,223 2019-07-19

Publications (1)

Publication Number Publication Date
WO2021014297A1 true WO2021014297A1 (fr) 2021-01-28

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ID=71784348

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2020/056711 WO2021014297A1 (fr) 2019-07-19 2020-07-16 Pansement absorbant à pression négative avec bordure adhésive de retenue

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WO (1) WO2021014297A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12064319B2 (en) 2019-10-11 2024-08-20 T.J.Smith And Nephew, Limited Apparatuses and methods for negative pressure wound therapy with switchable fluid management

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100204667A1 (en) * 2009-01-06 2010-08-12 Medline Ind. Wound Dressing
US20100292626A1 (en) * 2006-10-13 2010-11-18 Coloplast A/S Wound Dressing
GB2531344A (en) * 2014-10-17 2016-04-20 Brightwake Ltd Composite wound dressing
GB2568101A (en) * 2017-11-06 2019-05-08 Brightwake Ltd Antimicrobial dressing

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100292626A1 (en) * 2006-10-13 2010-11-18 Coloplast A/S Wound Dressing
US20100204667A1 (en) * 2009-01-06 2010-08-12 Medline Ind. Wound Dressing
GB2531344A (en) * 2014-10-17 2016-04-20 Brightwake Ltd Composite wound dressing
GB2568101A (en) * 2017-11-06 2019-05-08 Brightwake Ltd Antimicrobial dressing

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12064319B2 (en) 2019-10-11 2024-08-20 T.J.Smith And Nephew, Limited Apparatuses and methods for negative pressure wound therapy with switchable fluid management

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