EP2582337A2

EP2582337A2 - Device for wound treatment and wound covering plaster

Info

Publication number: EP2582337A2
Application number: EP11819159.2A
Authority: EP
Inventors: Norbert Neubauer
Original assignee: Iskia & Co KG GmbH
Current assignee: Simex Medizintechnik GmbH
Priority date: 2010-06-16
Filing date: 2011-06-15
Publication date: 2013-04-24
Also published as: US9199013B2; DE112011102047A5; US20130090616A1; WO2012041296A2; WO2012041296A3

Abstract

The invention relates to a device for wound treatment, which advantageously can be used in particular in various methods for the vacuum wound treatment of surface wounds. The object of the invention is to specify a device for vacuum wound treatment which can be used multimodally, even when commercially conventional vacuum pumps are used, and permits adequate ventilation of the wound when the negative pressure required in the wound area is reached, without complicated control means for the vacuum pump being necessary. Said object is achieved in that part of a conventional wound covering plaster (2), which completely covers the wound area in an airtight manner with respect to the outside, is provided with at least one opening (21) located over the wound area, on which a stack (1) of layers is provided, which comprises at least a filter disk (11), at least one paper-like disk (12) which is open to vapor diffusion but at the same time watertight, and at least one further flexible film (14), likewise having an opening (141) which is arranged in the wound plaster (2) in a manner corresponding to the opening (21). Said flexible film (14) covers and seals off all the aforementioned layer pack constituents with the wound plaster (2) directly or indirectly at the sides and in the border area (15) in a sealing manner, wherein the at least one watertight disk (12) is arranged in such a way that it seals off said layer stack (1) on the side facing the outside air.

Description

Device for wound treatment and wound dressing

The invention relates to a device for wound treatment and a wound covering plaster made according thereto, which can be advantageously used in particular in various methods of vacuum wound treatment of surface wounds.

It is a common task in medicine to suck out wound fluids. In particular, it is deep, big and in the process

in particular of infected surface wounds the hitherto customary practice of inserting into the wound a wound dressing which does not grow together with the tissue. On this wound dressing, the physician brings a first layer of gauze, in which then by hand, a drainage tube, partially wound several times, is inserted and this covered again with a second layer of gauze and then the entire wound site is covered with a plaster. The end of the

Drainage tube is then subjected to a negative pressure, whereby the wound fluid can be sucked off. In addition to the long duration of time required to lay the above described means, this approach also requires considerable skill of the medical practitioner, because during wound care, all separately inserted device components are to be fixed, which often can not be accomplished by one person alone.

Another type of dressings, especially for the

Vacuum wound treatment have been developed, for example, in

DE 601 18 546 T2. The wound dressing described there requires, on the one hand, a relatively high manufacturing outlay and, on the other hand, is not readily adaptable to different wound sizes. In order to carry out a vacuum treatment, this solution requires, on the other hand, other relatively complicated supplementary supports and, as a rule, bell-shaped seals of the wound, to which an external vacuum connection is attached.

Such, the skin surface far superior designs significantly restrict the freedom of movement of the patient and also generate unpleasant additional pressure loads. Outlined above treatment of such wounds

Negative pressure is a procedure that has been practiced for many years, which positively influences the healing of deep and large wounds by permanent wound irritation. This type of vacuum wound treatment is described in detail, for example, in DE 694 25 8B1 T3, DE 692 29 940 T2 and DE 692 24 847 T3, which is why reference should here be made to this only.

In addition, there are a variety of other solutions, which should be listed here only as an example, because they concern more distant technical solutions. That's how it is

No. 6,695,824 B2 discloses a wound dressing covering for outer flat wounds which consists of two layers, wherein the first layer is applied directly to the wound and the second layer has an outwardly acting moisture barrier. Between the said layers a plurality of hose-like supply lines are provided which provide a moisture supply to the wound

guarantee. For use in the context of a wound treatment of deep, poorly healing wounds with the aid of the technique of vacuum wound treatment is mentioned above

Wound dressing cover, however, not designed And also not suitable, because a vacuum-tight lead out of the sometimes multiple hoses from the wound area is virtually impossible. The same is true for a variety of devices

Suction of wound secretions from body cavities, such. As described in EP 1 764 127 A1.

Furthermore, in WO 2008/131895 A1 a flat drainage

described the above-mentioned sealing problem by a laterally under the wound covering the wound plaster

brought out flat drain tail corrects.

DE 698 25 767 T2 and DE 698 33 579 T2 disclose suction heads for wound treatment and a combination with a surgical drape in such a way that a port with adhesive plaster and suction tube is glued to a film adhering to the wound. The disadvantage here is the hard port, the application of a vacuum presses on the wound and causes pain. Other

Applications also use such ports, which differ only in other shapes and materials as well as different extraction channels

differ. Again, the hard port is a disadvantage to the patient. Furthermore, the use of hard ports for small wounds with respect to air circulation in the wound area unsuitable because a small adhesive surface is not sufficiently ventilated beyond the wound area. This obstructs the aspiration of the wound secretion. Only by a special pump, by the

Suction hose allows ventilation of the wound, the suction process of wound secretion can be maintained. Such special pumps with special additional ventilation of the

Wound area are, for example, in WO 2008/039314 A1,

US 2007/0219532 A1 and US 7,857,806 B2. Although they solve the problem of continuous or discontinuous wound ventilation, while maintaining a

required negative pressure in the Vakuumwundbehandlung, but require their cost-intensive purchase. Also, for example, the need for a second additional ventilation connection in the wound area is complex and inconvenient.

The present invention has for its object to provide a multivalent usable device for vacuum wound treatment, which allows sufficient ventilation of the wound even when using commercially conventional vacuum pumps on reaching the required negative pressure in the wound area without it consuming

Control means for the vacuum pump requires as well as a subsequently manufactured Wundabdeckpflaster.

The object is achieved by the characterizing features of the first and eleventh claim. Advantageous embodiments are the subject of the dependent claims.

The essence of the invention consists in that a part of a conventional wound cover plaster, which covers the wound surface completely airtight to the outside, is provided with at least one opening lying above the wound surface, on which a layer stack is provided is, at least from a filter disc, in particular

Bacteria filter disc, at least one vapor diffusion-open, but at the same time watertight paper-like disc and at least one further, also provided with an opening which is preferably arranged corresponding to the opening in the wound film, provided flexible film which directly or indirectly sealing all of the aforementioned Schichtpaketbestandteile with the wound film in the boundary region includes and closes, wherein the arrangement of at least one waterproof disc always takes place so that it is provided on the side facing the outside air layer stack final.

By choosing the porosity of the filter disk, for which a variety of available on the market, and defined eligibility of the diameter of the respective passage openings can be adapted to the vacuum treatment method used and to the

used adjustable vacuum pumps defined adjust adjustable throttle effects of the proposed device. If the proposed device is already integrated into a wound cover, additional steps for the surgeon's attachment are unnecessary. If the device is offered separately on a carrier foil, the surgeon only has to bring in an opening in the wound cover whose diameter is slightly larger than the opening of the opening of the proposed device to be placed on it, in order not to change the throttle effect predefined by it. This is easy to do even for an inexperienced surgeon. The main advantage of the proposed device is that no

Changes to the already in use

Vacuum pump technology and the already proven

Vacuum pumping must be made. Here, however, a targeted and time-staggered throttle effect in a broad

Vacuum range is specifiable adjustable. Due to the fact that ventilation of the wound via the pump itself is eliminated, the risk of germ infections by the pumping paths is no longer present.

If filters, in particular bacteria filters, are to be used in the device according to the invention which are sensitive to moisture, not only the side facing the outside air is mentioned

Schichtstapeis finally with a waterproof disc or provided with a moisture-repellent layer disc, but also the wound-facing side of the device according to the invention provided with such a final layer.

The invention will be described below with reference to specific

Embodiments will be explained in more detail. Hs show schematically:

Fig. 1 is a plan view of a possible embodiment, which makes it clear that all subsequent figures are to represent vertical not to scale cuts along a plane X-X;

Fig. 2 shows a first embodiment in which the

Device according to the invention is provided directly on a Wundabdeckpflaster;

Fig. 3 shows a second embodiment in which the

Device according to the invention is arranged directly on a separate carrier film which is mounted over an opening in Wundabdeckpflaster;

4 shows an exemplary embodiment consisting of a layer stack analogous to the example according to FIG. 3;

5 shows an exemplary fourth embodiment in which the layer stacks provided according to the present invention are applied in a split manner on both surfaces of a wound cover plaster or a carrier foil;

Fig. 6 by way of example a possible StufenkegeIstumpfartige

Training the discs used, which is providable in all the above embodiments and

7 shows a simple realization form of the invention as well as the simplest realization form of a wound cover plaster manufactured according to the present invention.

FIG. 1 shows, on the basis of a plan view of the example according to FIG. 2, how the sectional images according to FIGS. 2 to 6 are to be understood, namely as a vertical section along a plane X-X.

FIG. 2 shows a first possible embodiment in which a wound covering plaster 2 is initially applied over a wound W shown schematically, as usual in the prior art is. This wound cover plaster 2 hermetically seals the wound. Vacuum hoses, fillings of the wound W with gauze, drainage means, etc. are not shown here and in the following for reasons of clarity. According to the present invention is in the

Wundabdeckpflaster 2 introduced in this example an opening 21, on which a filter disc 11, in particular formed by a bacterial filter with about 10 mm diameter, is arranged, on which also a vapor diffusion-open but also waterproof paper-like disc 12 {preferred consisting of Tyvek ^® )

is provided. The filter 11, the disc 12 are laterally outwardly and in the surface area by means of a sealing film 14 includes and fixed to the wound cover plaster 2 connected. This can be done by gluing or sizing, depending on what material is used for the wound dressing and the film. In the film 14, corresponding to the opening 21 in

Wundabdeckpflaster 2 also an air inlet opening 141st

intended. In this example, the openings 21 and 141 are formed in the same diameter a and b.

FIG. 3 shows an embodiment of FIG. 2 which is otherwise identical with regard to the device components filter 11, disk 12 and film 14, but here the components mentioned are initially provided on a separate carrier film 3, whose

Wundabdeckpflaster 2 facing surface has an adhesive coating. After the surgeon has introduced an opening 21 into a previously closed wound covering plaster 2, he fixes the device 1 according to the invention with the aid of said adhesive layer over the opening 21 such that the opening 31 in the carrier foil 3 corresponds to the opening 21 in the wound cover plaster 2. It can be seen in this example that the opening 21 should always be designed to be larger than the Drosseletquerschnitt with determining opening 31 in the support film 3, whose smaller diameter is designated in Fig. 3 with d, so before by the filter material, its thickness and

Permeability, the thickness of other package constituents etc.

fixed throttle characteristics are not adversely affected. FIG. 4 shows, by way of example only, that the proposed layer package 1, if the throttle cross section specifications make it necessary, can also consist of several filter disks 11 of the same or different properties and of a plurality of disks 12. Even with such a construction, as shown in Fig. 4, the

Total height h of the applied device in the example only 1.3 mm. In the case of the relatively small diameters of the individual slices of the layer pact, a substantially flexible connection and fixation on the wound cover plaster 2 is therefore already possible

which, unlike prior art measures, does not affect the patient, e.g. additional pressure pain, as usual according to the prior art, no longer occur here.

In a fourth exemplary embodiment according to FIG. 5, the possibility is shown of dividing said layer packages and applying them to both sides of a wound cover plaster 2 or a carrier foil 3. Such an embodiment is within the scope of the invention. With particular reference to this figure, it should be understood that e.g. In the case of intensely weeping wounds, it may be advantageous to first provide a moist-repellent disc 12 on the wound side. This protects the filter 11 and prevents its possible clogging, even if the flow direction of the device takes place by suction of outside air in the direction of the wound. Within the overall layer package, the provision of discs 12 is not necessarily required, but in any case such a disc should move the device in the direction

Final outdoor air cover, which is the patient too

problemtos a shower allowed.

Figure 6 outlined with reference to only two discs 11, 12 an advantageous embodiment in which the diameter of the filter discs 1 1 and the discs 12 are tapered stepwise designed such that a Stufenkegelstumpfartiges structure with the smallest diameter is formed on the respective outer side adjacent disc. Of course, the smallest disc diameter is still larger than the opening above it. Such Design Simplifies in the manufacture of the attachment of the flexible film 14, which conforms more easily to the provided stack.

Within the scope of extensive experiments it has been found that it is advantageous to provide the wound-facing opening with an approximately half the opening diameter as the opening facing the outside air. Thus, the diameter of the opening facing the outside air was from 6 mm to 1 mm with a simultaneous decreasing determination of diameters of the wound facing the opening of 3 mm to 0.5 mm in their positive

Application tested.

Finally, a simplest implementation of the invention should be mentioned, if the user of the solution according to the invention wants to dispense with the effect of the proposed disc 12. Here is a one side provided with an adhesive layer carrier film 3, in which an opening 31 predetermined diameter

is introduced, get used. Directly above the opening 31, only one filter disk 11 is glued in this example. This is placed on the front side directly above an opening 21 in the wound cover plaster 2, pressed and the carrier sheet 3 is connected directly to the wound covering plaster via the remaining adhesive layer surrounding the filter disc, not shown in FIG. As described above, a plurality of filters 11 and / or

water-repellent discs 12 even with such

Embodiment are used, they are initially against each other at the edge to fix before they are in the composite with the carrier film 3 on the provided with an opening 21st

Wundabdeckpflaster 2 are connected airtight in the remaining peripheral area. This composite thus produced then realizes the function of the film 14 described for the other exemplary embodiments.

Without a separate presentation, reference should be made to a further possibility within the scope of the invention, namely that of the opening 141 facing the outside air, at least one further detachable adhesive patch with a further opening smaller diameter than that of the opening 141 in the film 14 is assigned. Should the surgeon find that ventilation of the wound occurs too late when using his vacuum pump, then he can only pull off this separate patch with a smaller opening and thus increases the air inlet cross section.

The above statement of diameters for the openings provided does not limit the invention to circular cross sections of these openings. Any other contours are possible, so they follow the other requirements of the invention. Also, the provision of several separate openings in one of the described

Devices as well as the attachment of several such device on large Wundabdeckpflasterflächen is within the scope of the invention.

In conclusion, let's briefly look at the impact of the proposed

Device to be received during operation. When a vacuum is applied, the wound filling in the wound W, which is not shown here in more detail, is compressed. Secretion flows out of the wound W via suction hoses (also not shown) as long as there is air circulation in the wound. According to the state of the art, in particular for small wounds, air circulation is only possible if the wound is ventilated via the pump. If a pump is used without wound ventilation, this will happen after a short time

Inadmissible and painful negative pressure that the pump

is switched off automatically. This already applies

Wound diameters of the order of 50-70 mm too. One would now, without being able to continue to pump out wound secretion, wait until a ventilation of the wound through the

Wound cover plaster itself is done. Even more harmful would be the

Ventilation via the suction hoses, as these are germinated.

If, however, the device according to the invention is used, venting of the wound takes place after 12 to 15 seconds

ensures that, depending on the method used

Vacuum wound treatment, never a negative pressure of 200 mbar is exceeded even for a short time. The device according to the invention can be produced inexpensively and can be used in all known vacuum wound treatment methods (also for pumps at intervals).

LIST OF REFERENCES

1 layer stack

11 - Filter disc

12 - waterproof paper-like disc

14 - flexible film

141 - opening in the flexible film 14

15 - boundary area

2 wound plaster

21 - opening in the wound cover plaster

3 carrier film

31 - opening in the carrier foil

a, b, d - different opening diameters h total height of the layer stack 1

W - wound

X X - cutting plane

Claims

claims

1. Device for wound treatment, in particular

Vacuum wound treatment, characterized in that a part of a conventional wound cover plaster (2), the

Wound surface completely hermetically covered to the outside, with at least one overlying the wound surface opening (21) is provided on which a layer stack (1), at least one filter disc (11), at least one vapor diffusion open, but at the same time waterproof paper-like disc ( 12) and at least one further, likewise with an opening (141) which is arranged corresponding to the opening (21) in the wound plaster (2), provided with flexible film (14), all of which

Layer package constituents with the wound plaster (2) directly and indirectly laterally and in the boundary region (15) sealingly closes and closes, the arrangement of at least one

waterproof disc (12) always takes place so that it is made on the side facing the outside air layer stack (1) final.

2. Device according to claim 1, characterized in that said layer stack (1) is part of a

Wound cover plaster (2) itself is.

3. A device according to claim 1, characterized in that said layer stack (1) component of a separately on the Wundabdeckpflaster over the opening (21) sealing

can be applied and provided with an opening (31) carrier film (3).

4. Apparatus according to claim 2 or 3, characterized in that said layer stack (1), in particular with multiple provision of the individual stack constituents (11, 12), divided on both sides of an opening (21) in the wound plaster (2) or an opening (31). in a fixable on the wound plaster

Carrier film (3) is arranged.

5. Device according to one of the preceding claims, characterized in that the corresponding openings (21, 141, 31) with different diameters (a, b, d) can be fixed.

6. The device according to claim 5, characterized in that the opening (21) of the Wundabdeckpflasters (2), respectively, the wound facing the opening (31) of the carrier film (3) in the order of magnitude is set half too large in diameter, such as the outside air facing opening (141).

7. Device according to one of claims 1 to 4, characterized

in that the diameters of the filter discs (11) and of the discs (12) are tapered stepwise in such a way that a step-truncated cone-like structure with the smallest diameter is formed on the disc lying against the respective outer side.

8. Device according to one of the preceding claims, characterized in that the porosity of the filter disc (s) (11), their number and the variable definition of

Opening diameter (141, 21, 31) and their number

according to the used

Vacuum treatment process are set variably adjustable.

9. Apparatus according to claim 1 or 8, characterized in that the outer air-facing opening (141) is associated with at least one further releasable adhesive patch with a further opening smaller diameter than that of the opening (141) in the film (14).

10. The device according to claim 1, characterized in that over an opening (31) of a carrier film (3) directly one

Filter disc (11) is glued, which frontally placed directly above an opening (21) in Wundabdeckpflaster (2) and the carrier film (3) over a surrounding the filter disc

Adhesive layer is directly connected to the Wundabdeckpflaster.

11. Wundabdeckpflaster, characterized in that over a defined opening diameter defined in the opening (31) of a carrier film (3) directly at least one filter disc (11) is glued with a larger diameter than the opening diameter of the opening (31), wherein the at least one filter disc (11) frontally placed directly above an opening (21) in an otherwise customary Wundabdeckpflaster (2) and the carrier film (3) via a filter disc (11) surrounding adhesive layer directly to the Wundabdeckpflaster (2) in the remaining circumference sbereich airtight connected.