Patent Application
20200323691
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.
Skin or wound dressings which can serve to administer medication have been known for a long time. For example, plaster patch-type systems for medication are described in the documents DE 19733981 A1, EP 2793869 B1, EP 1928436 B1, DE 19503336 A1, DE 19712699 A1 and U.S. Pat. No. 8,784,874. The application forms described therein, frequently relate to medicines which can be easily and safely stored, whereby a mixture of the substances is not necessary in order to achieve a certain effect. The embodiment in U.S. Pat. No. 8,784,874 describes a system where the same or different medications are applied on the surface of various areas, which are then mixed before use by folding. For the presentation of liquid medications which are contained on a skin or wound dressing, the embodiments described therein are not generally suited. This is particularly the case when the active substance itself only has a limited shelf life, however its stability increases after two components have been mixed. Furthermore, the shelf life of various medications can be considerably increased by variations of the pH-value. For the application of the medication, however, there must be certainty that a tolerable pH-value has been adjusted.
Wound plasters which can be removed from the packaging simply and reliably are, among others, disclosed in WO 01/02270 A1 and WO 2014/070589A1. Here, though, only standard plasters as wound dressings are described, whereby they must be stored in a special packaging which can be simply removed. Furthermore, multi-chamber bags are known from the current state of the art, which serve to store various liquids, whose mixtures can be used for example in dialysis treatment, as infusion solutions or for parenteral nutrition. These bags are described, among others, in EP 2167011 B1 and WO 95/26177 A1. However such multi-chamber bags are used for the mixtures of large volumes of liquids, whereby these bags are generally used in the course of inpatient or at least outpatient treatment.
Considering the state of the art, it is therefore object of the present invention to provide a device for providing a skin or wound dressing, via which a liquid active substance, with a limited shelf life, can be safely and reliably administered. Also, the device should ideally be simple to manufacture at low cost.
In particular, the device should be able to be mass produced, and also made available in the form of a disposable item.
Moreover, the provision of a generic device which can be handled easily and safely is a purpose of the present invention. In particular, the device should not only be suitable for use by professional care givers, but also by untrained persons, for example patients, so that they can take care of their own wounds. In this regard, any hazard for the patient should be excluded. Furthermore, the force required and the demands on motor skills when operating the device should be kept relatively low. Here, the handling should be as intuitive as possible so that incorrect handling is excluded as far as possible.
Additionally, the device for provision of a skin or wound dressing should be easily adaptable to dosing requirements, so that, for example, relatively large dosages can be administered. Furthermore, it was also a purpose of the present invention to make a class-specific device available which can also be used for the application of relatively low volumes of liquid. What's more, the device should provide a skin or wound dressing with a predefined active substance dosage, so that it contains a preferably constant active substance concentration. Preferably, the dosing must be carried out so that no liquid active substance can drip out of the wound dressing, or there are areas of skin or wound dressing that are not covered with active substance upon application. For example, the device should provide a skin or wound dressing where a total of 2 ml of liquid are distributed over a surface of ca. 10 cm2.
Furthermore, the skin or wound dressing to be provided should not be subject to any particular restriction regarding its size. It should be possible to provide relatively large and relatively small dressings.
Moreover, the device, and the resulting skin or wound dressing, should have a low microbial count, whereby both should be as sterile as possible. Furthermore, the device should show a high rate of acceptance, for example the device should have a high perceived value and the skin or wound dressing should be able to be designed in the color scheme usual in the present field, namely white.
These as well as further objects which are not explicitly mentioned, but which can be easily deduced or derived from the contexts introductorily discussed are solved by a device for providing a skin or wound dressing, containing an active substance, having all the features of patent claim 1.
The subject matter of the present invention is accordingly a device for providing a skin or wound dressing, including an active substance, which is characterized by the device containing at least two chambers for storing at least two liquids, which can be opened by mechanical action, so that after opening the chambers, the liquids are miscible and can be transferred to an active substance carrier.
In particular, the present invention permits the safe and reliable provision of an active substance-containing skin or wound dressing, whose applicable active substance cannot be easily stored over a long period, but which can be preserved by mixing two components which are, as such, stable.
In particular, a device, according to the invention, for providing a skin or wound dressing enables the safe and reliable application of a liquid active substance with a limited shelf life. Here, a device is preferably relative simple and inexpensive to manufacture. Furthermore, a device, according to the invention, can be mass produced. Preferably, a device, according to the invention, can be provided in the form of a disposable item.
Moreover, the device for providing a skin or wound dressing can be handled simply and safely. In particular, the device can not only be used by professional care givers, but also by untrained persons, for example patients, so that a self-treatment of wounds is enabled. In particular, the handling of the preferred embodiments of the present device is so arranged that, when used according to instructions, a hazard for patients is excluded. Furthermore, the force required and the demands on motor skills when handling the device can generally be kept very low. Here, the handling of the preferred embodiments is very intuitive, so that incorrect use can be almost excluded. This ensures proper use, so that an unwanted release of the components stored in the device can only occur in the event of intent or deliberate action.
Furthermore, the device for the provision of a skin or wound dressing can be easily adapted to fulfill dosing requirements, so that relatively high or low dosages can be applied, according to the requirements of the patient. Furthermore, the present invention makes a class-specific device available which can also be used with low volumes of liquid. Furthermore the device provides a skin and wound dressing with a specified dosage, so that the skin or wound dressing preferably demonstrates an almost constant active substance concentration. Preferably, the dosage is adjusted so that no liquid active substance drips out, or leaves areas of the skin or wound dressing without active substance cover. Furthermore, due to the design of the device, it is preferably ensured that only completely mixed liquid volumes come into contact with the wound dressing.
Furthermore, the skin or wound dressing to be provided is not subject to any particular restriction regarding its size. This means that relatively large and relatively small dressings can be provided.
Moreover, the device and the skin or wound dressing provided through it, have a low microbial count, whereby both can be kept sterile. Furthermore, the device can be designed in such a way that a high level of acceptance is achieved among users and, in particular, that it meets the usual standards. The device can thus be designed to give a high perceived value and the skin or wound dressing can be designed in the color scheme customary in the present field, namely white.
The device of the present invention contains at least two chambers for the storage of at least two liquids. Here, the device can have more than two chambers, whereby in these chambers exactly two different liquids are stored, or more than two liquids. Preferably, the number of individual chambers corresponds with the number of different liquids.
After opening of the chambers, the liquids are miscible and transferrable to an active substance carrier. Accordingly, after opening, the chambers are in flow connection with the active substance carrier.
In a special configuration it may be provided that after opening the chambers the liquids are mergeable outside the active substance carrier, preferably by creating by a mixing area upon opening the two chambers, or a mixing area is present, into which the liquids are transferrable and the liquids are subsequently transferrable from the mixing area into the active substance carrier. Preferably, the opening of the two chambers takes place in a first step, and in a separated second step, the mixture obtained is transferred into the active substance carrier by establishing a flow connection between the mixing area and the space in which the active substance carrier is provided.
The minimum of two chambers for the storage of two liquids are openable mechanically. Here, the type of mechanical action is not important, so that this can be carried out with a turning movement or by a linear movement. Therefore, a pulling device or a push-in component, e.g. a knob or the like, may be provided to achieve the movements mentioned.
In particular, it may be provided that the turning or linear movement is provided with a force conversion so that a higher force is applied to the chambers over a longer ovement path. For example, a thread can be provided to effect a linear movement to open the chambers.
In particular, the device can be designed in such a way as to ensure simple and safe operation. Preferably, only one or two control elements are provided. The actuation of these the device mixes the components and transfers them to the active substance carrier. In a preferred embodiment, first of all the chambers with the two liquids are connected 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 achieved by actuating one control element or by actuating two control elements. When two control elements are actuated, these separately present elements are preferably arranged in such a way that the control element by which the chambers with two liquids are connected to each other or brought into flow connection must be operated first. This can be achieved, for example, by ensuring that the second control element can only be operated after the first control element has been triggered. Preferably, the second control element is covered by the first control element.
In using such a design, in particular, a simple and safe operation of the device can be achieved, so that untrained persons, or persons with impaired motor skills, can obtain a skin or wound dressing with an active substance, safely and reliably.
Preferably, the two chambers for storing two liquids are openable by pressure, whereby the released liquids are transferrable to the active substance carrier, preferably with the aid of this pressure. This pressure can be generated by direct pressure on a structural element, which is preferably flexible. In a preferable embodiment, the pressure can be achieved by force conversion, for example using a thread in a lid, whereby the turning of the lid reduces the volume below it. The pressure created by the volume reduction opens the chambers.
In a further preferred embodiment, an elastic element can be used which puts part of the device under tension. The energy contained in the tension can be released by loosening a safety holder, which in turn, opens the chambers. Elastic elements are widely known in professional circles, and these elements are preferably used in the form of rubber-containing plastic strips or in the form of elastomers, which may be in the form of films.
Preferably the at least two separate chambers for storing two liquids are openable by a turning movement or linear movement, whereby the chambers are opened mechanically by a protruding edge, a sealed area or by a predetermined breaking point, for example an openable weld seam. For example, a chamber wall can be separated using a protruding edge, preferably the protruding edge is equipped with a sharp edge or point, to facilitate opening this wall. Also, a sealed off area between the chambers can be made mechanically permeable by lifting it. A sealed off area makes up part of the device where the chambers are formed, whereby the parts are so designed to prevent an unintentional substance transfer. Here, the parts of the device which form the chamber are manufactured from corresponding materials, or comprise these materials. Furthermore, one or more seals can be used, which is or are provided between the chambers. Furthermore, the parts of the device forming the chambers can have an appropriate shape, for example comprising sealing lips or similar. In a further embodiment, the chamber preferably has a predetermined breaking point which, depending on the type of chamber material, can be designed, for example, as a thin area or as an openable welding seam (peeling strip).
In addition, it may be provided that a safeguarding mechanism must be released to effect the turning movement or the linear movement. This safeguarding mechanism is preferably provided by a predetermined breaking point, a weld or a seal, the integrity of which indicates the proper condition of the device.
The device according to the present invention includes at least one active substance carrier. Accordingly, the device preferably comprises at least one chamber or a space where the active substance carrier is provided. Here, the space or the chamber is preferably so designed that the active substance carrier can be moistened with the liquids, preferably the mixture thereof, without the liquid leaking from the device. Accordingly, in order to remove the active substance carrier comprising active substance, or rather the skin or wound dressing itself, an additional operation step is necessary. Furthermore, it is possible that the device contains a chamber or casing which encloses the active substance carrier.
In a special embodiment, it is possible that the device has an outer packaging.
In a further embodiment, the liquids are preferably introduceable over the surface of the upper side of the active substance carrier. The upper side has the largest surface area of the three-dimensional active substance carrier.
Furthermore, it may be provided that the two chambers and the active substance carrier are arranged on at least two different levels. In a special embodiment, the two chambers are arranged on one level and the active substance carrier is situated below this level.
In a specific embodiment of the present device, it includes preferably at least one lid which, with an intermediate piece, which encloses the two separate chambers for storing two liquids, or which forms these chambers in the lid or the intermediate piece. In a special embodiment, there are at least two separate chambers for storing two liquids, preferably arranged in a ring, whereby one liquid is in an inner area and the second liquid is situated in the outer area.
Furthermore, it may be provided that the intermediate piece has several openings, preferably is of sieve-like design. Here, the intermediate piece may comprise an impervious inner area or be designed in a sieve-like manner over the entire inner surface.
Also it can be provided that the intermediate piece has a least one, preferably two protrusions, which are formed in such a way that the at least two separate chambers for the storage of two liquids, by moving them in the direction of the protrusions, are openable, whereby the movement in the direction of the protrusions can be a turning movement or a linear movement.
In a further special embodiment of the present device, it can be provided that between the intermediate piece and the lid, a sealed area is formed, whereby for example at least one seal is provided, the parts of the lid and the intermediate piece are made of appropriate materials, or exhibit a sealing shape, such as sealing lips, whereby the parts are mechanically moveable. Preferably two sections, preferably annularly arranged walls, are provided in the lid, which are designed in such a way that, together with other sections of the lid and the intermediate piece, at least two separate chambers are formed for storing two liquids. Here, preferably between the sections of the chambers, which are formed by the intermediate piece, and the sections which are formed by the lid, in particular the walls, arranged in a ring form, at least one seal is provided which is openable by movement of the lid, whereby the opening of the seal can be achieved either by a turning movement or a linear movement, preferably by a turning movement, whereby the lid is lifted in relation to the intermediate piece. Here the seal can also be formed by an appropriate material choice and/or an appropriate shape.
Preferably, the active substance carrier is located below the intermediate piece, whereby the active substance carrier is held by an openable bottom piece. Preferably, the bottom piece is impervious to liquids. Moreover, the bottom piece provides a grip portion which is not covered by the active substance carrier.
In a further embodiment, it can be provided that the device has a casing in which the two chambers are situated, whereby a pull strap is connected to the two chambers and via which, the two chambers can be pulled out of the casing.
In yet another embodiment, it may be provided that the device has a casing in which the two chambers and the active substance carrier are inserted, whereby a lid is provided which is connected to the casing via a turning axis, wherein by opening the lid a pressure is creatable in the chambers by which the chambers are openable.
Furthermore, it may be provided that the two chambers for storage of two liquids and the active substance carrier are arranged on three different levels. Preferably, the active substance carrier is located between the two chambers for storing two liquids. In a further embodiment, one of the chambers is located between a further chamber for storing liquid and the active substance carrier.
In a preferable embodiment, it may be provided that the device includes at least one elastic element, whereby through release of a safety holder, a movement is initiated, preferably a flap mechanism, which facilitates, preferably effects, the opening of the chambers for storing two liquids. In this embodiment, part of the device is under tension, whereby this tension is caused by the elastic element. An embodiment of the present device with at least one elastic element includes preferably at least two plastic layers, which differ with regard to their impact strength, stiffness and/or hardness.
A further embodiment of the present device with at least one elastic element is preferably characterized in that the two chambers for storing two liquids are formed from at least two plastic layers which are firmly connected on two opposite sides and one side, via which the chambers are connectable, is separated by a break-off edge.
Furthermore, in an embodiment of the present device with at least one elastic element it may be provided that the active substance carrier is contained in a third chamber, which is formed by at least two plastic layers which are firmly connected on two opposite sides, and on one side is separated by a break-off edge from at least one further chamber which chamber is formable as a mixing chamber.
In a further embodiment, it may be provided that the device includes three plastic layers, which differ in their mechanical properties, whereby the device preferably has at least one flexible plastic layer A, at least one elastomer containing layer B, and a stiff plastic layer C.
Preferably, the flexible plastic layer A and the elastomer containing layer B are firmly connected together, for example, these layers A and B are preferably two-dimensional welded or glued together or co-extruded.
Furthermore, it may be provided that the flexible plastic layer A and the stiff plastic layer C have a similar area, and that the elastomer containing layer B has a smaller area than the flexible plastic layer A or the stiff plastic layer C. An area is generally similar when the relationship of the areas lies in the range of 1.5:1 to 1:1.5, preferably in the range of 1.2:1 to 1:1.2 and especially preferably in the range of 1.1:1 to 1:1.1, and the length and breadth relationships are also in the range of 1.5:1 to 1:1.5, preferably in the range of 1.2:1 to 1:1.2 and especially preferably in the range of 1.1:1 to 1:1.1. In the case of a flat object, the length represents the largest dimension over the largest surface of an object, the present case of the even layer, the width is the second largest expansion over the largest surface of the flat layer and the thickness, the smallest expansion, for determining the volume of an object.
Furthermore, it may be provided that the flexible plastic layer A and the stiff plastic layer C are connected at the edges, for example welded or glued, so that a cavity is formed between the flexible plastic layer A and the stiff plastic layer C. Preferably, chambers are formed in the cavity which are detachably separated by a kink edge, whereby preferably in one chamber the first liquid is provided and in a second chamber the second liquid is provided, and then in a third chamber, the active substance carrier is provided. In particular, it may be provided that the chamber in which the first liquid is placed, and the chamber in which the second liquid is placed, are separated by a kink edge, so that the chamber with the active substance carrier is only adjacent to one chamber which contains one liquid.
In this embodiment, the elastomer containing layer B in combination with the flexible plastic layer A and the stiff plastic layer C seal off the chambers from each other, preferably by pressure which is particularly present at the kink edge.
With special embodiments of the previously described device with at least one elastic element, after opening the chambers with the two liquids and the chamber with the active substance carrier, pressure can cause the mixed liquid to be actively transferred to the active substance carrier. This pressure is based preferably on the restoring forces which can be provided through the combination of a flexible plastic layer and a stiff plastic layer. In a preferred embodiment, after the opening of the chambers, a planar arrangement of the components of the device is formed. The tension created during the manufacture of the structure due to the strength of the stiff plastic layer is preferably released so that the original flat shape is restored and the liquid is pressed into the active substance carrier. This effect, which can also be called memory effect, is based on the molecular properties of the polymers as well as the manufacturing and/or processing methods of the plastic layers.
In a further embodiment, it may be provided that the two chambers and the active substance carrier are arranged on one level. Preferably, in this embodiment, the device is enclosed in a casing, which contains the two chambers and the active substance carrier, whereby a pull strap is connected with the two chambers, via which the two chambers can be removed from the casing.
The present device for the provision of a skin or wound dressing contains at least two chambers for storing two liquids. These chambers can be very similar or also have different shapes, whereby preferred shapes of the chambers for storing liquids are previously described and are again subsequently described in the drawings, so that this is generally referred to. It can therefore be provided that at least two separate chambers are made from one plastic material, whereby these have preferably at least one part made of a flexible plastic, especially preferred manufactured from a plastic film.
In a special embodiment, the plastic from which the at least two separate chambers, or parts of these chambers, are manufactured is hydrophobic. A hydrophobic plastic exhibits preferably a surface energy of maximum 90 mN/m, specially preferred maximum 65 mN/m and very specially preferred, a maximum of 50 mN/m. Preferably, it may be provided that the plastic exhibits a surface energy in the range of 10 to 90 mN/m, specially preferred in the range of 14 to 65 mN/m and very specially preferred in the range of 18 to 50 mN/m.
As well as the chambers for storing at least two liquids, specially preferred are all parts of the device made of hydrophobic plastic which come into contact with the two liquids or their mixture, whereby the previously detailed surface energies for the chamber materials also apply to these plastics. The nature of the plastic parts which come into contact with the two liquids or their mixture depends on the actual design of the device, whereby the intermediate layer or the bottom piece belong here, as previously and subsequently described.
The surface energy is determined according to the method of Ownes-Wendt-Rabel & Kaelble. For this, the measurement series are carried out with the standard series according to Busscher, whereby the test fluids used are 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]. The measurement is carried out at 20° C. The surface energy can be determined with a contact angle measuring system G40 from the Krüss company, Hamburg, whereby the performance is described in the user manual of the contact angle measuring system G40, 1993. With regard to calculation methods, reference is made to A. W. Neumann, Über die Messmethodik zur Bestimmung grenzflächenenergetischer Größen (concerning measurement methods for the determination of interfacial energetic values), Part I, Zeitschrift für Phys. Chem. (Journal of Phys. Chem.), Bd. 41, P. 339-352 (1964), and A. W. Neumann, Über die Messmethodik zur Bestimmung grenzflächenenergetischer Größen, Part II, Zeitschrift für Phys. Chem., Bd. 43, P. 71-83 (1964).
Furthermore, it may be provided that the two chambers each have a volume in the range of 0.1 to 10 ml, preferably 0.3 to 5 ml and specially preferred in the range of 0.5 to 2 ml.
Also, it may be provided that the two liquids in the chambers are sterile.
As well as the at least two chambers for storing two liquids, the present device exhibits at least one active substance carrier. The active substance carrier is provided for it to be moistened with a liquid mixture. Accordingly, the active substance carrier is preferably a fabric, particularly preferably a woven fabric, knitted fabric, crotcheted fabric, braided fabric, stitch-bonded fabric, non-woven or felt, particularly preferably a non-woven. The material out of which the active substance carrier is made is not a critical factor, therefore this can be chosen according to requirements. Therefore, the materials which are commonly used in the medical field can be applied, and these will be selected as most appropriate for the liquid with which the active substance carrier is moistened. Here, the liquid preferably demonstrates good compatibility with the material. In this way, an even and adequate dosage of the active substance on the skin or the wound can be ensured. In case the liquid for example has a high polarity, as in particular water, the active substance carrier is preferably hydrophilic.
Among the preferred materials out of which the active substance carrier can be manufactured are, in particular, polyacrylates and polysaccharides, for example cellulose or cellulose derivatives, whereby particularly preferred cellulose or cellulose derivatives, such as for example viscose, are used, whose hydrophily is adapted to the requirements by chemical modification.
A hydrophilic active substance carrier preferably exhibits a surface energy of at least 55 mN/m, particularly preferred at least 63 mN/m and very particularly preferred at least 70 mN/m. Preference may be given to a hydrophilic active substance carrier which has a surface energy in the range of 55 to 150 mN/m, particularly preferred in the range of 63 to 120 mN/m, and very particularly preferred in the range of 70 to 90 mN/m.
The previously defined configurations with regard to the hydrophobicity of the plastics with which the liquids come into contact, such as, for example, the materials out of which the chambers are made, and, where applicable, the material used for the intermediate piece or the bottom piece, as well as the hydrophily of the material from which the active substance carrier was obtained, apply in particular to hydrophilic liquids, preferably for aqueous media, in which the active substance is, or active substances are dissolved or dispersed.
For hydrophobic liquids, for example oils containing active substance, the materials are selected preferably inverse with regard to polarity, so that the plastics which come into contact with the liquids, such as, for example, the material out of which the chambers are manufactured, and, where applicable, the material used for the intermediate piece or the bottom piece, are hydrophilic, and the active substance carrier is made of a material which is hydrophobic. The previously presented surface energies apply accordingly.
Through this design of the hydrophobicity and/or the hydrophily of the materials, preferably a capillary effect is achieved, which leads to a good moistening of the active substance carrier and to a targeted and relatively complete transfer of the liquids from the chambers into the active substance carrier.
The fibers from which the above-mentioned fabrics, preferably non-wovens, are made, are not subject to any particular limitation and can be present, inter alia, as microfibers and/or hydrofibers.
Before opening the device, the active substance carrier can include a further active substance, which preferably has a high storage capability. The further active substance can, for example, be an antibiotic (e.g. fusidic acid, sulfonamides, gentamycin), honey, antiseptics (e.g. chlorhexidine, polyhexanide), analgesics (e.g. ibuprofen, lidocaine), collagen or hyaluronic acid. In a particular embodiment, the active substance carrier is free of a further active substance. Moreover, before the device is opened, the active substance carrier is dry so that a high liquid absorption take takes place. In a further embodiment, the active substance carrier is sterile before opening the device.
The dimensions of the active substance carrier can be adapted to the requirements, so that the thickness of the active substance carrier, for example, lies in the range of 0.5 to 20 mm, preferably in the range of 1 to 10 mm, the length lies in the range of 0.5 to 20 mm, preferably in the range of 1 to 10 cm, and the breadth lies in the range of 0.5 to 20 mm, preferably in the range of 1 to 10 cm. The surface area lies in the range of preferably 1 to 100 cm2. The device can still be so equipped that larger or smaller wound dressings can be obtained. However, here, generally, the ease of handling the device is impaired. Moreover, very large wound dressings are relatively seldom requirements for patients who self-medicate, so that the manufacture of such devices is generally uneconomical.
The volume of liquid contained in the chambers can be adapted to the individual requirements and the size of the active substance carrier.
The active substance carrier is preferably moistened by the liquids. Here, the volume of liquid is preferably kept in an range, which does not lead to a release of drops from the skin or wound dressing comprising an active substance. Preferably, it may be provided that the separate chambers contain a total volume of liquid which leads to a oistening of the active substance carrier in the range of 0.05 ml/cm2 to 0.8 ml/cm2, particularly preferably in the range of 0.1 ml/cm2 to 0.4 ml/cm2 and very particularly preferably in a range of 0.15 ml/cm2 to 0.3 ml/cm2.
The not less than two liquids are contained in the minimum of two chambers, and the liquids are mixed when the device is opened and transferred to the active substance carrier. By mixing the minimum of two liquids, a mixture is obtained which contains the active substance. The active substance as such, or rather the liquid mixture, has a shorter shelf-life in comparison with that of the original liquids. Therefore, the present device is appropriate for all liquid active substances, which have a shorter shelf life, in comparison with that of a storage as two separate liquids.
Preferably, it may be provided that one of the liquids stored in the chambers, preferably the two liquids stored in the chambers, include water.
Some active substances are relatively unstable at the pH value at which the active substance is used, however at a lower or higher pH value they have good storage stability. In a preferred embodiment, it may be provided that the two liquids in the chamber exhibit different pH values, whereby the first liquid preferably has a pH value of at least 9, more preferably at least 10 and especially preferably at least 11, and the second liquid preferably has a pH value of a maximum of 4, more preferably a maximum of 3 and specially preferably a maximum of 2.
Examples of such active substances are described in the documents WO 00/48940 A1, WO 2005/049483 A2 and EP 1687238 B1, whereby these documents, in particular the wound treatment agents described therein, for disclosure purposes, are inserted by reference to these publications.
The dosage of the active substance can be adapted to the requirements of the patient, whereby this can be carried out preferably via the volume of liquid which is transferred to the active substance carrier, the concentration of active substance in the liquid and/or the size of the active substance carrier.
During a wound treatment, it may be provided that the dosage of active substance in the wound or skin dressing obtained is preferably chosen so that a change of the skin or wound dressing takes place within a time period of 6 to 48 hours, especially preferably within a time period of 12 to 36 hours and very especially preferably within a time period of 18 to 30. This can prevent destruction of the fibrils formed during the healing process without reducing the healing process or increasing other complications due to the wound fluid formed during healing process.
In a preferred embodiment, the components of the present device are essentially made up of medically harmless and cost-efficient plastics, whereby the individual components can be manufactured with corresponding methods. So, for example the components of the device previously and subsequently described here—a casing, a lid, an intermediate piece and/or a bottom piece—can be injection molded. Furthermore, the two chambers for storing two liquids are formed as a flat structure, preferably one or more films, which can be obtained by blow molding or extrusion.
The present device makes available a skin or wound dressing containing an active substance, whereby this can be present in all forms. The dressing can be made available, for example, as a compress or as a gauze.
Furthermore, the skin or wound dressing can be used alone or in combination with further components which are used for skin or wound treatment. Among these are, for example, alginates, hydrogels, hydrocolloids. Moreover, the skin or wound dressing can be used in combination with a further carrier component, for example with a foam component. Here, further substances, which promote the regeneration process or serve the well-being of the patient, can be made available. These components can include, for example, antibiotic (e.g. fusidic acid, sulfonamides, gentamycin), honey, antiseptics (e.g. chlorhexidine, polyhexanide), analgesics (e.g. ibuprofen, lidocaine), collagen or hyaluronic acid.
A further embodiment of the present invention is a wound treatment set containing a device, according to the invention, for the provision of a skin or wound dressing, a wound spacer, a cover film and a bandage fixation.
Wound spacers are known from the state of the art and prevent a wound dressing sticking to the wound, as this reduces wound healing when the dressing is changed. Wound spacers can, for example, be made as a silcone net, which, among others, can be obtained from Mölnlycke Health Care (product “Mepilex”).
Cover films (e.g., product “Opsite” from Smith & Nephew) prevent the active substance from leaking out upwards from the moist skin or wound dressing and thus not being available for wound healing. Accordingly, such films are generally waterproof, in case the active substance is an aqueous solution. Moreover these cover films are generally flexible so that they can be adapted to the specific requirements.
The dressing fixation serves to attach and safeguard the previously described components of the wound treatment set. For example, this can be carried out using the normal bandages, in particular roll bandages, linen bandages or gauze bandages, or bandage sleeves.
Another subject of the present invention is a method for providing a skin or wound dressing, including an active substance, in which a device according to the invention is opened, and a wound dressing containing an active substance is removed.
In a preferred embodiment of the present invention, the method can be carried out by operating one or two control elements, as has been described previously.
Hereinafter, using 9 figures, preferred embodiments of the present invention are described by way of example, without thereby limiting the invention.
Shown are:
The device for making available a skin or wound dressing 10, which is shown in
By applying pressure on the lid in the location of the first chamber 12, the first predetermined breaking point 24 will be specifically targeted and opened, so that the two chambers 12, 14 are connected to a mixing area 30. This half-opened condition is shown in
If pressure is further applied, the second predetermined breaking point 26 will open, so that the condition shown in
It should be noted that the first embodiment, shown in
The device for providing a skin or wound dressing 40, which is shown in
In
The liquids stored in the chambers 42, 44 are conducted out of the mixing area 62 into the active substance carrier 46, so that a skin or wound dressing, including an active substance, is obtained. The gas previously contained in the active substance carrier and in the mixing area is conducted into the space between the lid 50 and the separating film 52, so that the liquids originally stored in the chambers 42, 44 are relatively completely pressed into the active substance carrier 46.
After the liquids stored in the chambers 42, 44 have been transferred relatively completely into the active substance carrier 46, the bottom piece 60 can be removed and the skin or wound dressing (with an active substance carrier 46, moistened with active substance) can be taken out of the device.
Moreover, the lid 50 is connected via an easily removable securing mechanism 68 with the intermediate piece 54, in order to prevent the device being opened unintentionally.
In comparison with the third embodiment, shown previously in
Below the intermediate piece 74, the active substance carrier 46 is located and it is held by a bottom piece 60 which is attachable to the intermediate piece 74 by gluing or welding, for example. The bottom piece 60, together with the intermediate piece 74, forms a casing. As previously shown, the bottom piece 60 can have a grip portion, which is not covered by the active substance carrier. After opening the device, the bottom piece 60 can be detached from the intermediate piece 74, so that the skin or wound dressing containing active substance can be easily taken out.
Moreover, it can be provided that the lid 70 is connected via an easily removable securing mechanism 68 with the intermediate piece 74, in order to prevent the device being opened unintentionally.
The device for providing a skin or wound dressing 90, which is shown in
Furthermore, intermediate piece 94 has three recesses 114a, 114b, 114c, which prevent an unintentional opening of the device. The counterparts for tongues, not shown in
In
Furthermore, three recesses 114a, 114b, 114c, are shown in
Moreover, the lid exhibits three tongues 124a, 124b, 124c, which, together with the previously described recesses in the intermediate piece, prevent an unintentional opening of the device.
In
After the cavity has been filled, the area filled with second liquid is also bent off and closed with a clamp 152, so that a second chamber 134 is created. Subsequently, the active substance carrier 136 is placed in the remaining space of the cavity, as shown in
Subsequently, the cavity is closed and a strap is attached with which this closure can be easily opened, as shown in
The sixth embodiment comprises a flexible polymer film 140, an elastic element in the form of an elastomeric film 142 and a stiff polymer film 144. These polymer films 140, 142 and 144 are connected in such a way that two chambers 132, 134 are created, in which the two liquids are stored, as well as a cavity into which the active substance carrier 136 is placed.
In a preferred embodiment, the chambers are merely separated by clamping pressure, which, after the securing element has been released, leads first to an opening of the chambers forming a mixing area, and subsequently to an opening of the connection between the mixing area and the cavity.
The device shown in
After the predetermined breaking points 172, 174 have been opened the liquids flow into the mixing chamber 178 and from there to the active substance carrier 176, as shown in
After the pulling mechanism 170 has been pulled out completely, the active substance containing skin or wound dressing can be taken out, as shown in
The features of the invention disclosed in the previous description, as well as in the claims, Figures and execution examples, can, both individually or in any form of combination, be essential for the realization of the invention in its various embodiments.
| Number | Date | Country | Kind |
|---|---|---|---|
| 10 2017 125 281.9 | Oct 2017 | DE | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2018/079299 | 10/25/2018 | WO | 00 |
