Wound treatment order

Description

[0001] The invention relates to a wound treatment arrangement according to the preamble of patent claim 1.

[0002] Such wound treatment devices are used particularly in the context of superficial, intra-abdominal, intrathoracic, and / or intracorporeal negative pressure therapy. Within the context of this negative pressure therapy, the drainage device can be positioned between the wound and an occlusive film covering. In the wound space thus formed, containing the drainage device, a negative pressure can be generated using a drainage tube connected via an opening in the occlusive film covering and / or a drainage tube attached to the drainage device and / or an open-pore drainage material in fluid-conducting contact with the surface of the drainage device. Under the influence of the negative pressure, the wound is cleaned, with wound secretions being suctioned away, interstitial edema being reduced, and blood circulation being improved.

[0003] WO 2014 / 044400 A1 discloses a wound treatment device according to the preamble of patent claim 1. WO 2007 / 051599 discloses an absorbent body for application to human or animal skin surfaces, comprising a mixture of highly osmotically active substances and comparatively weak or osmotically inactive substances. EP 2567681 A1 discloses a wound dressing for the abdominal region. DE 102014216139 A1 discloses a wound dressing kit for treating wound cavities. US 2018 / 0353344 A1 discloses methods for producing multilayer wound materials for use in negative pressure therapy.

[0004] However, it has been shown that the use of known wound treatment devices of the type described above in negative pressure therapy leads to unsatisfactory healing results in some cases. In view of these problems in the prior art, the object of the invention is to provide a wound treatment device that can promote satisfactory therapeutic success.

[0005] According to the invention, this object is achieved by the further development of the known wound treatment arrangements specified in the characterizing part of patent claim 1.

[0006] The invention is based on the realization that negative pressure therapy, even when treating a single wound, can place different demands on the drainage device, failure to meet these demands can lead to unsatisfactory healing results. Furthermore, the invention is based on the realization that different wounds can place different demands on the drainage device during negative pressure therapy, and these demands can also change during the course of the negative pressure therapy itself.

[0007] The inventive refinement of known wound treatment devices with a drainage device having a multi-layer composite structure allows different material properties to be combined in the drainage device, which are therapeutically useful in negative pressure therapy and eliminates the disadvantages of a drainage device that possesses only one of the properties. The invention can be used in particular in superficial, intra-abdominal, intrathoracic, and / or intracorporeal negative pressure therapy. The drainage device provided according to the invention with a multi-layer composite structure enables differentiated negative pressure therapy and eliminates disadvantages associated with the use of individual materials.

[0008] In preferred embodiments of the invention, the drainage device has only two drainage layers, so that the boundary layer facing away from the boundary surfaces is formed between the two drainage layers, which are connected to one another in a fluid-conducting manner. The connection of the drainage layers can be achieved by gluing, welding, sewing, laser welding, or using other joining techniques. It is essential that the connection of the drainage layers maintains fluid-conducting contact between the drainage layers. The fluid-conducting contact between the drainage layers can be achieved by the open-pore fluid-conducting properties of the drainage layering and the surface of the drainage layers. The fluid-conducting contact between the layers can also be established by separate fluid-conducting connections, openings in the surface of the layers, or fluid-conducting communicating channels.

[0009] According to the invention, the first drainage layer comprises an open-pored foam, in particular polyurethane foam. The term "open-pored" encompasses a structure in which at least some pores of the foam are connected to one another in a fluid-conducting manner. To achieve a satisfactory drainage effect, it has proven useful if the average pore size of the open-pored foam is 200 µm or more and / or 800 µm or less. The thickness of the first drainage layer in a thickness direction extending perpendicular to the first outer boundary surface can be 1 mm or more, in particular 2 mm or more, particularly preferably 10 mm or more and / or 30 mm or less. The total thickness of the drainage device is preferably 1.5 mm or more, preferably 5 mm or more, in particular 15 mm or more and / or 50 mm or less, preferably 40 mm or less, in particular 35 mm or less.

[0010] The first outer boundary surface formed by the open-pore foam, in particular polyurethane foam, has the properties of a sponge, in particular a polyurethane sponge. A drainage unit equipped in the surface can, after applying negative pressure, use this first boundary surface to achieve wound debridement, high adhesion to tissue, granulation of wound surfaces, increased blood flow, and an erosive suction pattern corresponding to the sponge surface in the suction-exerting contact between the wound surface and a body tissue in suction-exerting contact during negative pressure therapy.

[0011] According to the invention, the second drainage layer of the multilayer composite structure used as a drainage device within the scope of the invention comprises a single-layer or multi-layer drainage film, wherein the second outer boundary surface comprises a film layer penetrated by a plurality of perforation openings.

[0012] Within the scope of the invention, the use of embodiments is also conceived in which the second drainage layer consists of a single-layer perforated film. According to the invention, however, it has proven particularly expedient if the second drainage layer has at least two film layers, between which a drainage space is formed and each of which has a plurality of perforation openings that open into the drainage space. In this embodiment of the invention, the second outer boundary surface is formed by a first perforated film layer, while the boundary layer to the adjacent drainage layer is formed by the second film layer facing away from the second boundary surface, which second film layer is also perforated and ensures a fluid-conducting connection with the adjacent drainage layer, in particular the first drainage layer.

[0013] Suitable multi-layer drainage films are specified in WO 2010 / 124844. Similar to the drainage films described in this document, the second drainage layer of a drainage device of a wound treatment arrangement according to the invention can also be designed such that at least one perforation of a film layer extends through a channel, starting from this film layer in the direction of the opposite inner boundary surface of the other film layer, and forms a channel opening into the drainage space, the channel wall of which is preferably formed integrally with the film layer. The cross-sectional area of ​​the channel can decrease in a plane extending perpendicular to the depth direction, starting from the first film layer in the direction of the opposite other boundary surface, in particular to maintain a capillary effect that promotes the entry of body fluid into the drainage space.

[0014] Within the scope of the invention, embodiments are also conceived in which at least one film layer has a plurality of perforation openings, preferably arranged in a grid, the distance between adjacent openings being 15 mm or less, preferably 5 mm or less, in particular 3 mm or less. The openings of the openings arranged in one film layer in a projection along the depth direction can be arranged between the openings of the perforation openings arranged in the other film layer. The individual film layers can be connected to one another via point-shaped fastening areas, preferably designed in a grid arrangement. These fastening areas can be formed by a material bridge connecting the opposing boundary surfaces of the film layers.

[0015] With regard to the desired drainage effect of the second drainage layer, it has proven particularly advantageous if at least one perforation opening has an area of ​​0.01 mm² or more and / or 1 mm² or less in a plane extending parallel to the second outer boundary surface. The second outer boundary surface formed by the drainage film has the properties of a film. When negative pressure is applied, it develops a flat drainage effect, creates only slight adhesion to the wound and body tissue and is therefore particularly suitable for application to surface-sensitive organs such as the intestines, peritoneum, pleura and vessels. When negative pressure is applied, a suction pattern corresponding to the pattern of the perforation openings is created on the wound surface and in tissue in suction contact.

[0016] Depending on the specific wound situation, negative pressure therapy can be performed using a drainage device with a multi-layer composite structure within the scope of the invention, according to the specific therapeutic requirements and individually tailored treatment. Depending on the required properties of the wound surface, the treatment determines which of the boundary surfaces of the multi-layer composite structure should have direct suction contact with the wound. For example, if a wound is to be debrided, the first outer boundary surface of the multi-layer composite structure is brought into contact with the wound. This surface, when used with a coarse-pore polyurethane foam, is characterized by highly debriding and adhesive properties.Once the wound has been largely conditioned and cleaned, the second outer boundary surface, which, when using an open-pore double-layer drainage film, has a suction-exerting but less adhesive and debriding surface, is brought into contact with the wound.

[0017] In superficial therapy using a wound treatment device according to the invention, the wound is closed with an occlusion film over the inserted drainage device. Suction can then be applied to the wound, for example, using a suction adapter. Alternatively or additionally, the wound can also be closed with a film that is open-pored on one side. The wound can also be closed with a transparent negative pressure dressing or a negative pressure plaster, which is fluidically connected to a negative pressure-generating system.

[0018] Preferably, during abdominal therapy, the second outer boundary surface, i.e., the film side of the drainage device in the form of a multilayer composite structure, is placed on the intra-abdominal organs. Due to the reduced adhesion to the tissue, the risk of iatrogenic tissue injury is reduced. The drainage device used in the invention, in the form of a multilayer composite structure, can also be rolled or folded, for example, to more specifically drain an intra-abdominal region.

[0019] In a preferred embodiment of the invention, the drainage device is cuttable and / or divisible. For this purpose, it can be perforated so that division can be achieved, possibly by pulling, to obtain predetermined shapes and / or sizes. Strips, rectangles, round, elliptical, and / or spiral shapes can be obtained. This can facilitate placement depending on the spatial conditions. To exert suction, the individual parts can be brought into direct contact. Additionally or alternatively, suction can be exerted via bridging elements, such as open-pore film elements, polyurethane foams, drains, or the like.

[0020] For intrathoracic application, the second outer boundary surface, i.e., the film side of the drainage device, is placed on the pulmonary tract. The first outer boundary surface, i.e., the outer boundary surface formed by the open-pore foam, can be placed on the chest wall side, which, for example, leads to debridement of the pleura.

[0021] Within the scope of the invention, it is also conceivable to place two similar outer boundary surfaces of drainage devices in the form of multi-layer composite structures or to fold the drainage device. This makes it possible to construct a drainage device in which either only one polyurethane foam boundary surface or one film boundary surface is provided on the outside, depending on the local requirements of the wound to be treated. Perforation of the drainage device can also be useful in this context for the purpose of facilitating separation.

[0022] According to the invention, the second drainage layer is penetrated by at least one perforation hole through which the adjacent drainage layer, in particular the first drainage layer, is accessible. This embodiment of the invention creates a surface area on the second outer boundary surface in the region of the perforation hole(s) that has the properties of the other drainage layer, in particular the layer formed from an open-pore foam, in particular polyurethane foam. If a negative pressure is applied to this side, i.e. to the drainage layer formed by the open-pore foam, a suction effect on the wound is created in the region of the second outer boundary surface, i.e. in the region of the second drainage layer equipped with the perforations, which suction effect corresponds to the first drainage layer. This exerts different surface-mediated suction effects on the wound.The absorption behavior and the applied suction strength can thus be irregular on the surface facing the wound. This can also result in an irregular suction effect on the wound, whereby a stronger suction can be applied to the wound in the area of ​​the perforation holes than in the film sections remaining between the perforations. These properties allow for island-like wound cleansing in the area of ​​the perforation holes. It has been shown that this can exert a stronger granulation stimulus on the wound surface, leading to the increased formation of granulation tissue.

[0023] The perforation of a boundary surface, as shown above, can be implemented in any material combination of the layered structure of the drainage unit. A polyurethane foam can also be provided with perforations, and the second, closed drainage layer can be made of foil. This design has the advantage that the varying thickness of the foam can exert an additional granulation stimulus on a wound.

[0024] As can be seen from the above explanation of the last-described embodiment of the invention, by forming the perforation holes, different requirements for wound healing in the area of ​​only one wound can be met if it is ensured that where debridement is required, the polyurethane foam is effective through the perforation holes, while where adhesion is to be avoided, the perforation film comes into contact with the wound.

[0025] According to the invention, at least one perforation hole has an opening area in a plane extending parallel to the second boundary surface of 10 mm 2 or more, in particular 25 mm 2 or more and / or 1,000 mm 2 or less, in particular 400 mm 2 or less. The second drainage layer can have two or more perforation holes with different opening areas and / or shapes. The perforation holes can be circular, elliptical, and / or polygonal. They can also have other configurations. The perforation holes can be formed in a regular grid structure, in an irregular structure, of constant size, or of different sizes.In order to provide an irregular suction in the area of ​​the wound surface, it has proven to be expedient if the second drainage layer has a plurality of perforation holes and the mutually facing edges of at least two perforation holes, in particular all perforation holes, have a distance of 1 mm or more, preferably 5 mm or more, wherein the distance can expediently be 100 mm or less, in particular 50 mm or less.

[0026] As can be seen from the above explanation of superficial negative pressure therapy, a wound treatment device according to the invention can have an occlusion film for creating a closed wound space containing the drainage device. The occlusion film can be applied independently of the drainage device, so that the variability of the wound care device according to the invention is not impaired. The occlusion of the wound space can also be achieved with a film that is open-pored on one side. The wound treatment device according to the invention, as can be seen from the above explanation, is expediently used in the context of negative pressure therapy. Accordingly, the wound care device according to the invention preferably has a suction device for generating a negative pressure in the region of at least one outer boundary surface of the drainage device.The suction device may comprise a drainage hose fluidically connected to the drainage device, in particular the first drainage layer, which is also connected to a vacuum source, such as a pump or a vacuum reservoir. Suction can also be provided with another drainage device through direct surface contact.

[0027] For some applications, it has proven advantageous for the drainage device to be wound along a winding axis running parallel to an outer boundary surface. In its basic form, however, the drainage device of wound care arrangements according to the invention expediently has a web-like configuration, whereby the drainage device can be rectangular with a side length of 1 to 50 cm.

[0028] In some embodiments, it has further proven to be expedient if the second drainage layer projects beyond the first drainage layer in the region of its edge, at least in sections, in a direction running parallel to the second outer boundary surface.

[0029] As can be seen from the above explanation of wound care arrangements according to the invention, the invention also relates to the use of a drainage device with a multi-layer composite structure for producing a wound treatment arrangement according to the invention. For this purpose, the first drainage layer can be connected to a drainage tube and / or the drainage device can be combined with a drainage tube, an occlusive film, a film with open pores on one side, and / or a vacuum source to form a kit.

[0030] The invention is explained below with reference to the drawing, to which reference is expressly made with regard to all details essential to the invention and not further detailed in the description. The drawing shows: Fig. 1 shows a side view of a drainage device suitable for producing a wound care arrangement according to a first embodiment of the invention, Fig. 2 shows a side view of a drainage device suitable for producing a wound care arrangement according to a second embodiment of the invention, Fig. 3 shows a perspective view of a drainage device suitable for producing a wound care arrangement according to the invention according to a third embodiment of the invention, Fig. 4 shows a drainage device suitable for producing a wound care arrangement according to the invention according to a fourth embodiment of the invention, Fig. 5 shows a sectional view of the drainage device according toFig. 4 , Fig. 6 a perspective view of a drainage device suitable for producing a wound care arrangement according to the invention according to a fifth embodiment of the invention, Fig. 7 a sectional view of the drainage device according to Fig. 6 , Fig. 8 a further sectional view of the drainage device according to Fig. 6 , and Fig. 9 a drainage device suitable for producing a wound care arrangement according to the invention according to a sixth embodiment of the invention.

[0031] The Fig. 1The drainage device shown is designed in the form of a two-layer basic structure. It has a first drainage layer 10 formed by an open-pore polyurethane foam and a second drainage layer 20 formed by an open-pore film. The second drainage layer 20 can be designed as a double-layer open-pore film, as described in WO 2010 / 124844. It can also be designed as a single-layer. The first drainage layer 10 is connected to the second drainage layer 20 in a fluid-conducting manner. Thus, by applying a negative pressure to the first drainage layer 10, a suction or negative pressure can be generated in the region of the outer boundary surface 22 of the second drainage layer 20 facing away from the first drainage layer 10, just as by applying a negative pressure in the region of the second drainage layer 20, a negative pressure or suction can be generated in the region of the boundary surface 12 of the first drainage layer 10 facing away from the second drainage layer.

[0032] The Fig. 2 The embodiment shown differs from that shown in Fig. 1 illustrated embodiment essentially in that the edges of the second drainage layer 20 project beyond the edges of the first drainage layer 10. This ensures that the boundary surface 24 of the second drainage layer 20 facing away from the second boundary surface 22 is exposed in the region of the projecting edges and is not covered by the first drainage layer 10.

[0033] The Fig. 3 The embodiment of the invention shown differs essentially from that shown in the Figures 1 and 2In the embodiments explained, the second drainage layer 20 is penetrated by perforation holes 26 through which the first drainage layer 10 is accessible. This ensures that, in the region of the perforation holes 26, direct contact is created between the first drainage layer 10 and a wound on which the second drainage layer 20 rests, and a suction pattern corresponding to the perforation holes can be created in the region of the wound. If the first drainage layer 10 is formed in the form of an open-pore polyurethane foam, polyurethane foam islands are created in the region of the perforation holes 26, with which, on the one hand, debridement and, on the other hand, an increased suction effect can be achieved.

[0034] The Fig. 4 The embodiment of the invention shown differs essentially from that shown in the Fig. 3explained embodiment that perforation holes 26, 26', 26" of different sizes are provided in the second drainage layer 20. This contributes to the creation of a desired suction pattern in the area of ​​the wound.

[0035] As is particularly evident in Fig. 5 As can be seen, between the perforation holes 26, in the area of ​​which the polyurethane foam of the first drainage layer 10 is accessible, there are film-like areas 21 of the second drainage layer 20, which form the second outer boundary surface 22 of the drainage device and can be applied to the wound.

[0036] In the Figures 6 to 8In the embodiment of the invention shown, the drainage device designed as a multi-layer composite structure is wound up into a multi-layer roll via a winding axis running parallel to an outer boundary surface of the drainage layers, wherein the second outer boundary surface 22 formed by the drainage film forms the outside of the roll.

[0037] The Fig. 9 The embodiment of the invention shown essentially corresponds to that described in Figures 6 to 8 explained embodiment, wherein the roll of this embodiment is designed such that the first outer boundary surface of the drainage device formed by the open-pore polyurethane foam forms the outside of the roll.

[0038] The invention is not limited to the embodiments explained with reference to the drawings. Rather, embodiments are also conceived in which the second drainage layer is formed by a single-layer film. The perforation holes can be elliptical, oval, or polygonal, as opposed to circular. A drainage tube can be assigned to the drainage device, which can be connected to the second drainage layer via a port and / or inserted into the first drainage layer. Two, three, or more lines can also be provided to establish a fluid-conducting connection between the drainage device and a vacuum source. An occlusion film can be assigned to the drainage device to create a wound space containing the drainage device.Additional open-pore drainage elements, such as PU foam, a film, a film drain, a drainage tube, or the like, can also be associated with the drainage device. Within the scope of the invention, the drainage device can be designed to be freely customizable by being cuttable. This allows the surgeon to easily produce drainage devices with the required shape, with the drainage properties being achieved by positioning the multilayer composite structure in the desired manner.

[0039] Furthermore, the drainage device of a wound care arrangement according to the invention can also be fluidly connected to drainage tubes or other fluid-conducting drains, via which rinsing fluids and / or medications can be supplied to the drainage device.

[0040] In a corresponding embodiment of the invention, the drainage device can be used to both supply and suck out liquids.

Claims

1. Wound treatment arrangement having a drainage device designed for draining fluids from a human or animal body, in particular from a wound, wherein the drainage device has a multilayer composite structure having two boundary surfaces which are opposite one another, are at least partially fluid-permeable, in particular run approximately parallel to one another, of which one is formed at least partially by a first outer boundary surface, facing away from a boundary layer between two adjacent drainage layers, of a first drainage layer having a first surface finish, and the other is formed at least partially by a second outer boundary surface, facing away from a boundary layer between two adjacent drainage layers, of a second drainage layer having a second surface finish which differs from the first surface finish, wherein the drainage layers are preferably connected to one another in a fluid-conducting manner, the first drainage layer has an open-pore foam, in particular polyurethane foam, and the second drainage layer has a single-layer or multilayer drainage film, wherein the second outer boundary surface is formed by a film layer which is penetrated by a plurality of perforation openings, characterized in that the second drainage layer is penetrated by at least one perforation hole through which the adjacent drainage layer, in particular the first drainage layer, is accessible, and at least one perforation hole has an opening area in a plane extending parallel to the second boundary surface of 10 mm2 or more, in particular 25 mm2 or more and / or 1000 mm2 or less, in particular 400 mm2 or less.

2. Wound treatment arrangement according to Claim 1, characterized in that the mean pore size of the open-pore foam is 200 µm or more and / or 800 µm or less.

3. Wound treatment arrangement according to one of the preceding claims, characterized in that the thickness of the first drainage layer in a thickness direction extending perpendicularly to the first outer boundary surface is 10 mm or more and / or 30 mm or less.

4. Wound treatment arrangement according to one of the preceding claims, characterized in that the second drainage layer has two film layers, between which a drainage space is formed and each of which has a plurality of perforation openings which open into the drainage space.

5. Wound treatment arrangement according to one of the preceding claims, characterized in that the perforation openings have an area of 0.01 mm2 or more and / or 1 mm2 or less in a plane extending parallel to the second outer boundary surface.

6. Wound treatment arrangement according to one of the preceding claims, characterized in that the second drainage layer has at least two perforation holes with different opening areas and / or opening shapes.

7. Wound treatment arrangement according to one of the preceding claims, characterized in that the second drainage layer has a plurality of perforation holes and the mutually facing edges of at least two perforation holes, in particular of all the perforation holes, have a spacing of 1 mm or more, preferably 5 mm or more.

8. Wound treatment arrangement according to one of the preceding claims, characterized by an occlusion film for producing a closed wound space containing the drainage device.

9. Wound treatment arrangement according to one of the preceding claims, characterized by a suction device for generating a negative pressure in the region of at least one outer boundary surface of the drainage device.

10. Wound treatment arrangement according to Claim 9, characterized in that the suction device has a drainage hose which is connected in a fluid-conducting manner to the drainage device, in particular to the first drainage layer, and which is connected on the other side to a negative pressure source.

11. Wound treatment arrangement according to one of the preceding claims, characterized in that the drainage device is wound up with respect to a winding axis running parallel to an outer boundary surface.

12. Wound treatment arrangement according to one of the preceding claims, characterized in that the second drainage layer projects beyond the first drainage layer in the region of its edge at least in sections in a direction running parallel to the second outer boundary surface.

13. Use of a drainage device with a multilayer composite structure for producing a wound treatment arrangement according to one of the preceding claims.