EP3700481A1 - Dispositif pour fournir un pansement pour la peau ou des plaies - Google Patents

Dispositif pour fournir un pansement pour la peau ou des plaies

Info

Publication number
EP3700481A1
EP3700481A1 EP18799461.1A EP18799461A EP3700481A1 EP 3700481 A1 EP3700481 A1 EP 3700481A1 EP 18799461 A EP18799461 A EP 18799461A EP 3700481 A1 EP3700481 A1 EP 3700481A1
Authority
EP
European Patent Office
Prior art keywords
chambers
liquids
skin
wound dressing
drug carrier
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.)
Withdrawn
Application number
EP18799461.1A
Other languages
German (de)
English (en)
Inventor
Michael Wiehl
Peter KEITEL
Dirk Kaiser
Mark-Andre Freyberg
Stephan BRUCKMANN
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.)
Derma Tools Biotech GmbH
Original Assignee
Derma Tools Biotech GmbH
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 Derma Tools Biotech GmbH filed Critical Derma Tools Biotech GmbH
Publication of EP3700481A1 publication Critical patent/EP3700481A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/00051—Accessories for dressings
    • A61F13/00063—Accessories for dressings comprising medicaments or additives, e.g. odor control, PH control, debriding, antimicrobic
    • 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
    • A61F13/00051—Accessories for dressings
    • A61F13/00072—Packaging of dressings
    • 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
    • A61F15/00—Auxiliary appliances for wound dressings; Dispensing containers for dressings or bandages
    • A61F15/001—Packages or dispensers for bandages, cotton balls, drapes, dressings, gauze, gowns, sheets, sponges, swabsticks or towels
    • A61F15/002—Packages or dispensers for bandages, cotton balls, drapes, dressings, gauze, gowns, sheets, sponges, swabsticks or towels dispensers for web or tape like bandages

Definitions

  • the present invention relates to a device for providing a skin or wound dressing, a wound treatment set and a method for providing a skin or wound dressing.
  • Wound plaster which can be easily and reliably removed from the packaging, are disclosed inter alia in WO 01/02270 A1 and WO 2014 / 070589A1.
  • WO 01/02270 A1 and WO 2014 / 070589A1.
  • standard patches are presented as a wound dressing in which they are stored in a special packaging, which is a simple
  • the device should be as simple and inexpensive to produce.
  • the device should be able to be mass produced.
  • the device should be provided in the form of a disposable article.
  • the device should not only be used by professional nurses but also by untrained persons, such as patients, so that, for example, a self-care of wounds is possible.
  • a risk to the patient should be excluded as possible.
  • the effort and the requirements of the motor skill in the operation of the device should be kept relatively low.
  • the operation should be as intuitive as possible, so that a malfunction should be excluded as possible.
  • the device for providing a skin or wound dressing with respect to the dosage should be easily adapted to specifications, so that, for example, relatively high dosages can be applied. Moreover, it was therefore an object of the present invention a generic
  • the device should provide a skin or wound dressing with a predetermined dosage, so that the skin or wound dressing has a drug concentration that is as constant as possible.
  • the dosage should be able to be designed so that no liquid active substance drips out of the wound dressing or areas of the skin or wound dressing are equipped on application without active ingredient.
  • the device should serve to provide a skin or wound dressing can be distributed in a total of 2 ml of liquid to an area of about 10 cm 2 .
  • the skin or wound dressing to be provided should not be subject to any great restriction in size.
  • relatively large and relatively small editions should be able to be provided.
  • the device and the resulting skin or wound dressing should have a low bacterial count, both of which should be as sterile as possible. Furthermore, the device should have a high acceptance, for example, the device should show a high perceived value and the skin or wound dressing in the usual color scheme in the field, namely white, can be configured.
  • the subject of the present invention is accordingly an apparatus for providing a skin or wound dressing, comprising an active ingredient, which is characterized in that the apparatus comprises at least two chambers for the storage of at least two liquids, which are manifest by mechanical action, so that after opening the chambers, the liquids are miscible and can be converted into a drug carrier.
  • the present invention in particular causes a
  • the applicable drug can not be readily stored for a long period of time, but can be obtained by mixing two components that are stable as such.
  • a device according to the invention for providing a skin or wound dressing makes it possible to safely and reliably apply a liquid active substance with limited durability.
  • the device preferably relatively easy and inexpensive to produce.
  • a device according to the invention can be produced in a mass production.
  • a device according to the invention is provided in the form of a disposable article.
  • the device for providing a skin or wound dressing can be handled safely and easily.
  • the device may not only be used by professional caregivers but also by untrained persons,
  • patients are used so that, for example, a
  • the device for providing a skin or wound dressing with respect to the dosage can be easily adapted to specifications, so that
  • the present invention provides a generic device that can be used even with relatively small amounts of liquid.
  • the device provides a skin or wound dressing with a predetermined dosage, so that the skin or wound dressing preferably has a substantially constant drug concentration.
  • the dosage is designed so that no liquid active substance drips out of the wound dressing or areas of the skin or wound dressing on application without
  • Active ingredient are equipped. Furthermore, it is preferably ensured by the configuration of the device that only completely mixed volumes of liquid come into contact with the wound dressing. Furthermore, the skin or wound dressing to be provided is not subject to any great restriction in size. Thus, relatively large and relatively small editions can be provided.
  • the device and the skin or wound dressing obtainable therefrom have a low bacterial count, both of which can be kept sterile. Furthermore, the device can be designed so that a high acceptance is achieved by the users and in particular corresponds to usual standards. Thus, the device can show a high perceived value and the skin or wound dressing in the color scheme customary in the present field, namely white, be designed.
  • the device of the present invention comprises at least two chambers for storing at least two liquids.
  • the device may in this case have more than two chambers, wherein in these chambers exactly two different liquids are housed or more than two liquids.
  • the number of chambers corresponds to the number of different liquids.
  • the liquids are miscible and in one
  • the liquids outside the active substance carrier can flow together, preferably by opening the two chambers, a mixing region is created or a mixing region is present, into which the liquids can be transferred, and the liquids subsequently from the mixing region can be converted into the drug carrier.
  • the opening of the two chambers takes place in a first step and, in a second step separated therefrom, the resulting mixture is transferred into the active substance carrier by establishing a flow connection between the mixing region and the space in which active substance carrier is provided.
  • the at least two chambers for storing two liquids are manifested by mechanical action.
  • the type of mechanical action as such is not critical, so that it can be effected by a rotational movement or a linear movement. Therefore, a pulling device or a depressible component, such as a button or the like may be provided to effect said movements.
  • the rotational movement or the linear movement is provided with a force conversion, so that over a longer path of movement, a higher force acting on the chambers is affected.
  • a thread may be provided, via which a linear movement for opening the chambers is effected.
  • the device can in this case be designed so that a simple and safe operation is guaranteed.
  • the device can in this case be designed so that a simple and safe operation is guaranteed.
  • only one or two controls are provided, on their actuation, the device
  • the chambers are connected to the two liquids by a first opening step, and in a subsequent opening step the space in which the mixed liquids are present is connected to the space in which the active substance carrier is provided.
  • These two opening steps can be effected by the operation of a control element or by the operation of two control elements.
  • these separately present elements are preferably arranged so that the control element, by which the two liquid chambers are connected or brought into fluid communication with each other, must be operated first. This can be achieved in that, for example, the second operating element can only be operated after the first operating element has been triggered.
  • the second operating element by the first
  • the two chambers for the storage of two liquids by a pressure apparently, wherein the liberated liquids are preferably transferred under the influence of this pressure in the drug carrier.
  • This pressure can be via a direct action on a component, which preferably flexible is designed to be generated.
  • the pressure may be effected via a force conversion, for example via a thread provided in a cover, wherein the rotation of the cover reduces the volume below it. The one by the volume reduction
  • resulting pressure preferably causes the opening of the chambers.
  • an elastic element may be provided, through which a part of the device is under tension.
  • the energy contained in the voltage can be released by releasing a fuse, wherein the energy released causes an opening of the chambers.
  • Elastic elements are well known in the art, these elements preferably in the form of rubber-containing plastic strips or in the form of elastomers, which may be designed in particular as a film, are used.
  • a projection a chamber wall can be separated, wherein the projection is preferably provided with a sharp edge or a tip to facilitate the opening of this wall.
  • a sealed area provided between the chambers may be made mechanically permeable by, for example, lifting.
  • a sealed area is formed by parts of the devices forming the chambers, the parts being designed to prevent unwanted mass transfer.
  • the parts of the device which form the chambers may be made of corresponding materials or comprise these materials.
  • one or more seals may be used, which is or are provided between the chambers.
  • the parts of the device that form the chambers may have a corresponding shape that includes, for example, sealing lips or the like.
  • Chamber preferably a predetermined breaking point, which, depending on the nature of
  • Chamber material for example, as a thin area or as an apparent weld (Peelnaht) can be configured.
  • a securing mechanism must be solved. This securing mechanism is preferably by a predetermined breaking point, a
  • the device according to the invention comprises at least one active substance carrier.
  • the device preferably has at least one chamber or a space in which the drug carrier is provided.
  • the space or the chamber is preferably designed so that the active substance carrier with the
  • Liquids preferably the mixing liquid can be wetted without the liquid can escape from the device. Accordingly, for the removal of the drug carrier provided with active ingredient or the skin or
  • the device has a housing or a chamber, which encloses or the drug carrier.
  • the device has an outer packaging.
  • liquids are preferably over the
  • the top has the largest area of the three-dimensional drug carrier.
  • the two chambers and the drug carrier are arranged in at least two different levels.
  • the two chambers and the drug carrier are arranged in at least two different levels.
  • the two chambers are arranged in a plane and the
  • Active substance carrier is arranged below this level.
  • this preferably comprises at least one lid, which with an intermediate piece the
  • the at least two separate chambers for storage of two liquids or these chambers are formed in the lid or in the intermediate piece.
  • the at least two separate chambers for storing two liquids are preferably annular arranged, one liquid in an inner region and the second
  • Liquid is disposed in an outer region.
  • the intermediate piece has a plurality of openings, preferably designed like a sieve.
  • the intermediate piece may comprise an impermeable inner region or may be of a sieve-like design over the entire inner surface.
  • the intermediate piece has at least one, preferably at least two projections which are formed such that the at least two separate chambers for the storage of two liquids by a movement thereof in the direction of the projections are apparent, wherein the movement in the direction of Projections by a rotary motion or a linear movement can be effected.
  • a sealed area is formed, for example, at least one seal is provided or the parts of the lid and the intermediate piece are made of appropriate materials or have a sealing shape, such as sealing lips , wherein the parts are mechanically movable.
  • two areas, preferably annularly arranged walls are provided in the lid, which are formed such that, together with further areas of the lid and the intermediate piece, at least two separate chambers for the storage of two liquids are formed.
  • the regions of the chambers formed by the intermediate piece and the regions formed by the cover in particular the annularly arranged walls, at least one seal which is evident by a movement of the cover, wherein the Opening the seal can be effected by a rotational movement or a linear movement, preferably a rotary movement, wherein preferably the lid is raised with respect to the intermediate piece.
  • the seal can also be formed by an appropriate choice of material and / or shape.
  • the drug carrier is arranged below the intermediate piece, wherein the drug carrier is held by an apparent bottom piece.
  • the bottom piece is liquid impermeable.
  • the bottom piece preferably has a grip area which is not covered by the active substance carrier.
  • the device has a housing, in which the two chambers are introduced, wherein a pull tab is connected to the two chambers, via which the two chambers can be pulled out of the housing.
  • the device has a housing, in which the two chambers and the drug carrier are introduced, wherein a lid is provided, which is connected via a rotation axis with the housing, wherein by opening the lid, a pressure can be generated in the chambers through which the chambers are apparent.
  • the two chambers for the storage of two liquids and the drug carrier are arranged in three different planes.
  • the active substance carrier is preferably arranged between the two chambers for the storage of two liquids.
  • one of the chambers is arranged between a further chamber for storage of a liquid and the active substance carrier.
  • the device comprises at least one elastic element, wherein by releasing a fuse, a movement, preferably a folding mechanism is triggered, whereby the opening of the chambers for storage of two liquids facilitates, preferably effected.
  • a part of the device is under
  • An embodiment of the present device with at least one elastic element preferably comprises at least two plastic layers which differ in their impact strength, their stiffness and / or their hardness.
  • a further embodiment of the present device with at least one elastic element is preferably characterized in that the two Chambers for the storage of two liquids are formed by at least two plastic layers, which are fixedly connected on two opposite sides and a side through which the chambers are connectable, separated by a bent edge.
  • the drug carrier is contained in a third chamber which is formed by at least two plastic layers which are fixedly connected on two opposite sides and a side, by a bending edge of is separated at least one other chamber, as
  • Mixing chamber can be formed.
  • the device comprises three plastic layers which differ in their mechanical properties, the device preferably being at least one flexible one
  • Plastic layer A, at least one elastomer-containing layer B and a rigid plastic layer C has.
  • the flexible plastic layer A and the elastomer-containing layer B are firmly connected to each other, for example, these layers A and B are preferably flat welded, glued or coextruded.
  • the flexible plastic layer A and the rigid plastic layer C have a similar area and the elastomer-containing layer B has a smaller area than the flexible plastic layer A or the rigid plastic layer C.
  • a surface is generally similar when the
  • the length denotes the greatest extent over the largest surface of a body, in this case the flat layer, the width the second largest extent over the largest surface of the planar layer and the thickness the smallest extent for the determination of the
  • the flexible plastic layer A and the rigid plastic layer C are connected to each other at the edge, for example
  • Plastic layer A and the rigid plastic layer C is formed.
  • chambers are formed in the cavity, which are detachably separated by a bent edge, wherein preferably in a chamber, the first liquid, in a second chamber, the second liquid and in a third chamber of the drug carriers are provided.
  • the chamber in which the first liquid is provided, and the chamber in which the second liquid is provided is separated by a bent edge, so that the chamber in which the drug carrier is provided, only one chamber adjacent, which comprises a liquid.
  • Plastic layer C the chambers preferably by pressure against each other, which is given in particular at the bending edge.
  • pressure can be effective after opening the chambers with the two liquids and the chamber with the active substance carrier that the
  • This pressure is preferably based on the restoring forces that can be provided by the combination of a flexible plastic layer and a rigid plastic layer.
  • a planar arrangement of the components of the device is formed after opening the chambers.
  • the stress generated due to the strength of the rigid plastic layer in the production of the structure is preferably released in this case, so that the original flat shape is restored and the liquid is pressed into the drug carrier.
  • This effect which can also be referred to as a memory effect, is based on the molecular properties of the polymers and the manufacturing and / or
  • the two chambers and the drug carrier are arranged in a plane.
  • the Device in this embodiment, a housing in which the two chambers and the drug carrier are introduced, wherein a pull tab is connected to the two chambers, through which the two chambers can be pulled out of the housing.
  • the present device for providing a skin or wound dressing comprises at least two chambers for the storage of two liquids. These chambers may be very similar or different, with preferred embodiments of the liquid storage chambers previously and subsequently described in the drawings, so that reference will be made thereto in general.
  • the at least two separate chambers are made of a plastic, which preferably have at least one section of a flexible plastic, particularly preferably of a plastic film.
  • the plastic from which the at least two separate chambers or parts of these chambers are made is hydrophobic.
  • a hydrophobic plastic preferably has a surface energy of at most 90 mN / m, more preferably at most 65 mN / m, and especially preferably at most 50 mN / m. It can preferably be provided that the plastic preferably has a surface energy in the range from 10 to 90 mN / m, more preferably in the range from 14 to 65 mN / m and especially preferably in the range from 18 to 50 mN / m.
  • all parts of the device which come into contact with the two liquids or their mixture are particularly preferably made from a hydrophobic plastic, the surface energies previously set forth for the chamber material likewise being valid for these plastics.
  • the nature of the plastic parts that come into contact with the two liquids or their mixture depends on the specific configuration of the device, which, for example, include the intermediate layer or the bottom piece, which are set out above and below.
  • the surface energy is determined by the method of Ownes-Wendt-Rabel & Kaelble.
  • test series are carried out with the standard Busscher series, in which the test liquids used were water [SFT 72.1 mN / m], formamide [SFT 56.9 mN / m, diiodomethane [SFT 50.0 mN / m] and alpha Bromonaphthalene [SFT 44.4 mN / m] can be used.
  • the measurement is carried out at 20 ° C.
  • the two chambers each have a volume in the range of 0.1 to 10 ml, preferably 0.3 to 5 ml and more preferably in the range 0.5 to 2 ml.
  • the two liquids in the chambers are sterile.
  • the present device has at least one active substance carrier.
  • the drug carrier is intended to be wetted with a mixed fluid.
  • the active substance carrier preferably represents a fabric, particularly preferably a woven fabric, knitted fabric, knitted fabric, braided fabric, stitchbonded fabric, nonwoven fabric or felt, particularly preferably a nonwoven fabric.
  • Drug carrier is not critical as such, so this can be chosen based on the requirements. Therefore, conventional materials can be used in the medical field, which can be selected based on the liquid with which the drug carrier is wetted.
  • the liquid preferably shows a good compatibility with the material. This allows a uniform and good dosage of the active ingredient on the skin or the wound be ensured. If, for example, the liquid has a high polarity, in particular water, the active substance carrier is preferably hydrophilic.
  • the drug carrier can be prepared include, in particular, polyacrylates and polysaccharides, for example
  • Cellulose or cellulose derivatives particular preference being given to using cellulose or cellulose derivatives, for example viscose, the hydrophilicity of which has been adapted to the needs by chemical modification.
  • a hydrophilic active substance carrier preferably has a surface energy of at least 55 mN / m, more preferably at least 63 mN / m, and especially preferably at least 70 mN / m. It can preferably be provided that the hydrophilic active substance carrier preferably has a surface energy in the range from 55 to 150 mN / m, more preferably in the range from 63 to 120 mN / m and especially preferably in the range from 70 to 90 mN / m.
  • the materials are preferably inversely chosen with regard to polarity, so that the plastics which come into contact with the liquids, for example the material from which the chambers are made, and optionally the material from the the intermediate piece or the bottom piece was obtained, are made hydrophilic and the drug carrier is made of a material which is hydrophobic.
  • the surface energies set out above apply accordingly.
  • the fibers from which the previously set forth fabrics, preferably nonwovens, have been made are not subject to any particular limitation and may be embodied inter alia as microfibers and / or hydrofibres.
  • the active substance carrier may comprise a further active ingredient before opening the device, which preferably has a high shelf life.
  • the other active ingredient may include, for example, antibiotics (eg, fusidic acid, sulfonamides, gentamycin), honey, antiseptics (eg, chlorhexidine, polyhexanide), analgesics (eg, ibuprofen, lidocaine), collagen, hyaluronic acid.
  • the active ingredient carrier is free of a further active ingredient.
  • the drug carrier is dry before opening the device, so that a high fluid intake is given.
  • the drug carrier is sterile before opening the device.
  • the dimensions of the drug carrier can be adapted to the requirements, so that the drug carrier, for example, a thickness in the range of 0.5 to 20 mm, preferably in the range of 1 to 10 mm, a length in the range of 0.5 to 20 mm, preferably in the range of 1 to 10 cm and a width in the range of 0.5 to 20 mm, preferably in the range of 1 to 10 cm.
  • the area is preferably in the range of 1 to 100 cm 2 .
  • the device can also be designed so that larger or smaller wound dressings are obtained. However, this generally adversely affects the handling of the device. Furthermore, very large wound dressings are relatively rare for the
  • the amount of liquid contained in chambers can be adapted to the particular needs and the size of the drug carrier.
  • the active ingredient carrier is preferably moistened by the liquids.
  • the amount of liquid is preferably kept within a range that does not cause the release of drops of skin or skin comprising an active ingredient
  • the separate Chambers in total contain an amount of liquid which corresponds to a moisture content of the drug carrier in the range of 0.05 ml / cm 2 to 0.8 ml / cm 2 , more preferably in the range of 0.1 ml / cm 2 to 0.4 ml / cm 2, and more preferably in the range of 0.15 ml / cm 2 to 0.3 ml / cm 2 .
  • At least two fluids are contained in the at least two chambers, which are mixed by opening the device and transferred to the drug carrier.
  • a mixed liquid containing the active ingredient is formed.
  • the active ingredient as such or the mixed liquid has a reduced shelf life compared to the original liquids. Therefore, the present device is useful for all liquid active ingredients, which have a reduced storage life compared to a storage form in two separate liquids.
  • Liquids preferably the two liquids stored in the chambers comprise water.
  • Some agents are relatively unstable at a pH where the drug is used, but are readily storable at a higher or lower pH. In a preferred embodiment it can be provided that the two
  • Liquids in the chambers have a different pH, wherein the first liquid preferably has a pH of at least 9, preferably at least 10 and more preferably at least 1 1 and the second liquid preferably has a pH of at most 4, preferably at most 3 and especially preferably at most 2.
  • the dosage of the active ingredient can be adapted to the needs of the patient, preferably by the amount of fluid contained in the Active substance carrier is transferred, the concentration of active ingredient in the liquid and / or the size of the active ingredient carrier can take place.
  • the dosage of active ingredient in the resulting skin or wound dressing is preferably selected such that a change of the skin or wound dressing within a period of 6 to 48 hours, particularly preferably within a period of 12 to 36 Hours and especially preferably within a period of 18 to 30 hours.
  • Device essentially made of medically acceptable and inexpensive plastics, wherein the respective components can be prepared by appropriate methods.
  • a housing a lid, a
  • the two chambers for storing two liquids can be formed by a sheet, preferably one or more films, which can be obtained by blow molding or extrusion.
  • the present device provides an active ingredient skin or
  • the pad can be configured, for example, as a compress or gauze.
  • the skin or wound dressing may be used alone or in combination with other components used for skin or wound treatment. These include, for example, alginates, hydrogels, hydrocolloids. Furthermore, the skin or wound dressing in combination with another
  • Carrier component for example, a foam can be used.
  • these components may be antibiotics (eg fusidic acid, sulfonamides,
  • Another object of the present invention is a wound treatment set comprising a device according to the invention for providing a skin or wound dressing, a wound spacer, a cover sheet and a
  • Wound spacers are known in the art and prevent a wound dressing from sticking to the wound, resulting in a change to a wound dressing
  • Wound spacers may, for example, be configured as silicone mesh, which are available, inter alia, from Mölnlycke Health Care (product "Mepilex").
  • Cover films e.g., product "Opsite” by Smith & Nephew
  • the bandage fixation is used to attach and secure the previously described parts of the wound treatment set.
  • this can be effected by conventional bandages, in particular roll bandages, gauze bandages or linen bandages, or hoses.
  • Yet another object of the present invention is a method for providing a skin or wound dressing, comprising an active ingredient, in which a device according to the invention is opened and a wound dressing provided with an active substance is removed.
  • the method may be performed by operating one or two controls as set forth above.
  • Figure 1 is a schematic longitudinal sectional view of a first
  • Figure 2 is a schematic cross-sectional view of a first
  • Figure 3 is a schematic longitudinal sectional view of a second
  • FIG. 4 shows a schematic exploded view of a third embodiment of a device according to the invention for providing a skin or wound dressing
  • Figure 5 is a schematic exploded view of a fourth
  • Figure 6 is a schematic exploded view of a fifth
  • Figure 7 shows the intermediate piece and the lid of the fifth
  • Figure 8 is a schematic plan view of a sixth
  • Figure 9 is a schematic plan view of a sixth
  • Figure 10 is a schematic representation of the manufacturing stages of a sixth
  • Figure 1 1 is a schematic cross-sectional view of a seventh
  • FIG. 1 shows a schematic longitudinal section of a first embodiment
  • FIG. 1 a shows the storable state of the device
  • FIG. 1 b shows the state in which the two fluids are mixed
  • FIG. 1 c describes the state of the device in which a skin - Is provided or wound dressing with an active ingredient, which can be removed from the device.
  • the device for providing a skin or wound dressing 10 which is shown in FIG. 1a, comprises at least two chambers for the storage of two
  • Liquids 12, 14 and a drug carrier 16 are formed in a lid 20 which encloses the two liquids together with an intermediate piece 22.
  • the intermediate piece 22 and the cover 20 presently have at least two predetermined breaking points 24, 26, wherein the first
  • Predetermined breaking point 24 is provided between the two chambers 12, 14 formed by the cover 20 and the intermediate piece 22.
  • the second predetermined breaking point 26 is provided between one of the chambers 12, 14 and the space 28, in which the drug carrier 16 is included.
  • the first predetermined breaking point 24 When a pressure is exerted on the cover in the region of the first chamber 12, the first predetermined breaking point 24 is deliberately opened so that the two chambers 12, 14 are connected to a mixing region 30.
  • This half-opened state is shown in FIG. 1 b, wherein in this state the drug carrier 16 is not yet moistened with a liquid.
  • the predetermined breaking point 26 is closed in this case, so that this predetermined breaking point at the beginning of the pressure application of the opening initially withstands.
  • the second predetermined breaking point 26 is opened so that the state shown in FIG. 1 c is reached.
  • the mixed liquid which is contained in the mixing region 30, is transferred into the active substance carrier 16.
  • Figure 2 shows a schematic cross-sectional view of the illustrated in Figure 1 first embodiment of a device according to the invention. It can be seen that the two chambers 12, 14 have a smaller diameter than that
  • FIGS. 1 and 2 the first embodiment illustrated in FIGS. 1 and 2 is illustrated conceptually in order to explain the principles of the present invention in more detail. Of course, the expert can implement this concept quite easily, for example, the chambers 12, 14 in the form of a
  • Foil assembly are performed, wherein the two predetermined breaking points 24, 26 are performed by different stable releasable seams. Furthermore, the pressure can be applied via a screw-in cover, as in the second
  • FIG. 3 shows, in a schematic longitudinal section, a second embodiment of a skin or wound dressing according to the invention, FIG. 3a indicating the storable state of the device, FIG. 3b the state in which the two liquids are mixed and FIG. 3c describes the state of the device a skin or wound dressing with an active substance is provided which can be removed from the device.
  • the device for providing a skin or wound pad 40 which is shown in Figure 3a, comprises at least two chambers for the storage of two
  • Liquids 42, 44 and a drug carrier 46 are formed in a lid 50 which, together with a release film 52 enclosing the two liquids.
  • a release film 52 enclosing the two liquids.
  • an intermediate piece 54 with two projections 56, 58 is provided below the release film.
  • the area between the separating film 52 and the intermediate piece 54 may in the present case be regarded as a mixing region 62.
  • the intermediate piece 54 below the intermediate piece 54, a space is formed in cooperation with a removable bottom piece 60, in which the active substance carrier 46 is introduced.
  • the bottom piece 60 forms in the present case with the intermediate piece 54 a housing.
  • FIGS. 3b and 3c illustrate the opening of the device shown in FIG. 3a.
  • the two projections 56, 58 are pressed by the release film 52, so that the two chambers 42, 44 opened and the two liquids are passed into the mixing region 62.
  • the liquids stored in the cans 42, 44 are conducted out of the mixing region 62 into the active substance carrier 46, so that an active substance-comprising skin or wound dressing is obtained.
  • the gas previously contained in the active substance carrier as well as in the mixing region is guided into the region between cover 50 and separating film 52, so that the liquids originally stored in the chambers 42, 44 are pressed relatively completely into the active substance carrier 46.
  • the bottom piece 60 can be removed and the skin or wound dressing (drug carrier 46 wetted with the active ingredient) removed from the device.
  • FIG. 4 shows a schematic exploded view of a third embodiment of a device 61 according to the invention.
  • the third embodiment corresponds conceptually to the embodiment shown in FIG. 3, so that reference will be made thereto in detail and like reference numerals denote like components.
  • the third embodiment comprises two chambers 42, 44 formed by the cover 50 and the separating film 52, a threaded intermediate piece 54 through which the cover 50 can be moved in the direction of the projections 56, 58 provided in the intermediate piece 54, around the chambers 42, 44 open and the two
  • the formation of the two chambers 42, 44 is represented by corresponding sections on the release film 52.
  • the projections 56, 58 are provided in spatial proximity, so that the mixture of liquids can already arise during the outflow from the chambers.
  • the third embodiment comprises a distribution film 64 which is provided between the intermediate piece 54 and the release film 52 and leads to the improvement of the mixture of both liquids.
  • the intermediate piece 54 of the drug carrier 46 is provided below the intermediate piece 54 of the drug carrier 46 , which is held by a bottom piece 60, which can be fastened to the intermediate piece 54, for example, welded or glued.
  • the bottom piece 60 forms in the present case with the intermediate piece 54 a housing.
  • the bottom piece 60 has a grip area 66 which is not covered by the active substance carrier. After opening the Device, the bottom piece 60 can be detached from the intermediate piece 54, so that the provided with active skin or wound dressing is easily removed.
  • the lid 50 is connected via an easily breakable fuse 68 with the
  • FIG. 5 shows a schematic exploded view of a fourth embodiment of a device according to the invention.
  • the fourth embodiment corresponds conceptually to the embodiment shown in FIG. 3, so that reference will be made thereto in detail and like reference numerals denote like components.
  • the third embodiment comprises two chambers formed by the cover 70 and the separating film, not shown in Figure 5, an intermediate piece 74 with a
  • Thread through which the cover 70 in the direction of the intermediate piece 74 provided projections 76 a, 76 b, 76 c, 76 d, 76 e, 76 f can be moved to open the chambers and the two liquids 78, 80 release.
  • a plurality of projections 76 a, 76 b, 76 c, 76 d, 76 e, 76 f are provided, so that the openable film after opening has a plurality of cuts, which is a very complete transfer of the two liquids effected in the intermediate piece 74.
  • the intermediate piece 74 differs in that the intermediate piece 74 has a radially arranged sieve-like region, wherein an impermeable inner region is present.
  • the projections 76 a, 76 b, 76 c, 76 d, 76 e, 76 f are arranged in the fourth embodiment on the radially arranged sieve-like region, so that the mixture of the two liquids in the radially arranged sieve-like region.
  • This embodiment is particularly active
  • this embodiment can be used in active ingredients that have a high
  • the bottom piece 60 forms in the present case with the intermediate piece 74 a housing.
  • the bottom piece 60 may have a handle portion that is not covered by the drug carrier.
  • the lid 70 is connected via an easily breakable fuse with the intermediate piece 74 in order to avoid accidental opening of the device.
  • FIG. 6 shows a schematic exploded view of a fifth embodiment
  • Embodiment of a device according to the invention is similar to the embodiment shown in FIG. 3, so that reference will be made to them in detail and like reference numerals denote like components.
  • the device for providing a skin or wound dressing 90 which is shown in FIG. 6, comprises at least two chambers for the storage of two
  • Liquids and a drug carrier 46 Liquids and a drug carrier 46.
  • the two chambers are formed in a lid 92 which, together with the intermediate piece 94, the two liquids 96, 98 encloses.
  • annular walls are provided in the lid 92 in FIG. 6, which are provided with seals 120, 122 and 122a.
  • the seals 120, 122 and 122a are between the
  • a corresponding thread is provided in the intermediate piece 94 and in the lid 92, which is presently formed by helical or wave-like molds 104 and 106, which convert a rotational movement into a linear movement.
  • Intermediate piece 94 may in the present case be regarded as a mixing region 108.
  • the intermediate piece 94 has a radially arranged sieve-like region 1 10, wherein an impermeable inner region 1 1 1 is provided, which forms a first chamber together with the lid.
  • the second chamber is formed via an annular wall 1 12 together with the lid.
  • the annular wall 1 12 has a radially encircling slope 1 13, so that the liquid provided in the second chamber easily after opening in the radially arranged sieve-like area 1 10 runs. Below the intermediate piece 94 is in
  • a space is formed in which the active substance carrier 46 is introduced.
  • the bottom piece 60 forms in the present case with the intermediate piece 94 a housing.
  • the intermediate piece 94 three recesses 1 14a, 1 14b, 1 14c, which prevent unintentional opening of the device.
  • the lid 92 tongues are provided as counterparts in FIG.
  • Figure 7 shows a representation of the intermediate piece (Figure 7a) and the lid ( Figure 7b). the fifth shown in a schematic exploded view
  • FIG. 7 a shows a plan view of the intermediate piece 94.
  • Spacer 94 has a radially arranged sieve-like portion 1 10, wherein an impermeable inner region 1 1 1 is present, which forms a first chamber together with the lid.
  • the second chamber is formed via an annular wall 1 12 together with the lid.
  • the annular wall 1 12 has a radially encircling slope, so that the liquid provided in the second chamber after opening easily into the radially arranged sieve-like area 1 10 runs.
  • three recesses 1 14a, 1 14b, 1 14c are set forth in Figure 7a, which prevent unintentional opening of the device.
  • FIG. 7b shows the inner region of the cover 92. Shown are, in particular, the annular walls 116, 118, which form seals with seals 120, 122, 122a, which together with the regions of the intermediate piece set out above form two chambers.
  • the chambers can be filled via openings provided in the lid 100 and 102.
  • the lid has three tongues 124a, 124b, 124c which, together with the recesses in the intermediate piece set out above, prevent inadvertent opening of the device.
  • FIG. 8 illustrates a sixth in a schematic overview
  • Embodiment of a device according to the invention 130 In this sixth embodiment of the device shown in storable state, the drug carrier 136 is provided between the at least two chambers for storage of the two liquids, wherein due to the representation herein, only the chamber 132 is shown.
  • the chambers are formed by different polymer films, which are formed into cavities.
  • the sixth embodiment is provided with an elastic member through which a part of the storable device for providing a skin or wound dressing is under tension. The stress can be described by a molecular memory effect, which causes the plastic to return to its original shape. By loosening a fuse in this case the opening of the chambers for the storage of two
  • Liquids facilitates, preferably effected.
  • FIG. 9 shows the state of the sixth embodiment in which the two liquids are mixed.
  • the chambers are first connected, in which the liquids are stored.
  • the unfolding for connecting the two fluid-containing chambers and / or the unfolding for connecting the mixing chamber 138 with the the drug carrier 136 comprehensive cavity are characterized by the elastic
  • Element supported preferably effected.
  • by loosening a weld or other securing element due to the voltage causes a Aufklappvorgang, by which the chambers are connected to each other.
  • FIG. 10 shows a schematic representation of the production steps of the sixth embodiment of a device according to the invention for providing a skin or wound dressing.
  • FIG. 10a shows that initially a flexible polymer film 140 is connected to an elastomer film 142.
  • The can preferably be done by surface bonding.
  • the elastomeric film 142 has a smaller area than the flexible one
  • Polymer film 140 at three edges with the rigid polymer film 144 connected This can be done for example via heated laser welding. This creates a closed on three sides, elongated cavity. Via a pipette 150, the first liquid is subsequently introduced into this cavity, as shown in FIG. 10c. Subsequently, the filled area is bent and separated with a clamp 152, so that a first chamber 132 is formed, in which the first liquid is contained. Subsequently, as shown in Figure 10d, the second liquid is filled in the remaining area of the cavity.
  • the filled with a second liquid portion is bent and secured with a clip 152, so that a second chamber 134 is formed. In the remaining area of the cavity is then the
  • Drug carrier 136 inserted, as shown in Figure 10e.
  • Active substance carrier 136 is arranged between the chambers 132, 134 with the liquids. Subsequently, a fuse can be attached, which prevents unintentional opening of the device. After attaching the fuse, the clips can generally be removed.
  • the sixth embodiment comprises a flexible polymeric film 140, an elastic member in the form of an elastomeric film 142 and a rigid polymeric film 144. These polymeric films 140, 142 and 144 are bonded to form two chambers 132, 134 in which the two liquids are stored, and a cavity in which the drug carrier 136 is incorporated.
  • the chambers are only by
  • Figure 1 1 describes a schematic cross-sectional view of a seventh
  • Figure 1 1 b the state in which the two liquids are mixed
  • Figure 1 1 c describes the state of the device in which a skin or wound dressing is provided with an active ingredient, which can be removed from the device.
  • Wound dressing comprises at least two chambers for storage of two
  • Liquids 162, 164 and a mixing chamber 168 wherein the drug carrier is disposed below the chambers 162, 164 and the mixing chamber 168.
  • the two chambers 162, 164 are connected to a pulling device 170, so that a pulling movement for opening two predetermined breaking points 172, 174 leads.
  • the pulling device can be secured by a fuse, for example, an easily detachable predetermined breaking point, which can connect the pulling device 170 with the housing 171.
  • the liquids flow into the mixing chamber 178 and from there into the drug carrier 176, as shown in FIG. 11b.
  • the skin or wound dressing provided with active substance can be removed, as shown in FIG. 11c.

Abstract

La présente invention concerne un dispositif permettant de fournir un pansement pour la peau ou des plaies, qui comporte un principe actif, ledit dispositif comprenant au moins deux chambres pour stocker deux liquides, qui peuvent s'ouvrir par action mécanique, de sorte qu'après ouverture des chambres, les liquides peuvent être mélangés et transférés dans un support de principe actif. La présente invention concerne en outre un ensemble de traitement de plaie ainsi qu'un procédé pour préparer un pansement pour la peau ou des plaies.
EP18799461.1A 2017-10-27 2018-10-25 Dispositif pour fournir un pansement pour la peau ou des plaies Withdrawn EP3700481A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102017125281.9A DE102017125281A1 (de) 2017-10-27 2017-10-27 Vorrichtung zur Bereitstellung einer Haut- oder Wundauflage
PCT/EP2018/079299 WO2019081647A1 (fr) 2017-10-27 2018-10-25 Dispositif pour fournir un pansement pour la peau ou des plaies

Publications (1)

Publication Number Publication Date
EP3700481A1 true EP3700481A1 (fr) 2020-09-02

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EP18799461.1A Withdrawn EP3700481A1 (fr) 2017-10-27 2018-10-25 Dispositif pour fournir un pansement pour la peau ou des plaies

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US (1) US20200323691A1 (fr)
EP (1) EP3700481A1 (fr)
DE (1) DE102017125281A1 (fr)
WO (1) WO2019081647A1 (fr)

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CN117281729B (zh) * 2023-11-24 2024-01-30 临沂康利医疗器械有限公司 一种液体伤口敷料储存装置

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DE102017125281A1 (de) 2019-05-02
WO2019081647A1 (fr) 2019-05-02
US20200323691A1 (en) 2020-10-15

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