EP1418954A2

EP1418954A2 - Dressing material in addition to treatment solution for use with said dressing material

Info

Publication number: EP1418954A2
Application number: EP02711765A
Authority: EP
Inventors: Thomas Riesinger
Original assignee: Nawa-Heilmittel GmbH; NAWA HEILMITTEL GmbH
Current assignee: NAWA-HEILMITTEL GMBH
Priority date: 2001-01-18
Filing date: 2002-01-09
Publication date: 2004-05-19
Also published as: JP2004535212A; CA2435072A1; JP4408018B2; AU2002231597A1; CN1529621A; US20040076662A1; WO2002056927A2; WO2002056927A3

Abstract

The invention relates to dressing material comprising a plurality of layers which are adjacent to each other and joined together, namely at least one first perforated layer forming a covering on the wound, a second layer which is preferably multi-layered, soft and simultaneously absorbent in addition to a third layer forming in the outer surface of the dressing material facing away from the wound when applied. At least one chamber for distributing a liquid treatment medium is provided in the second layer, inside the series formed by said layers.

Description

Dressing material and treatment solution for use with the

dressing material

The invention relates to a dressing material according to the preamble of claim 1 and to a treatment solution according to the preamble of claim 16.

It is known in principle that the healing of wounds can be improved by a moist environment, in particular media which support wound healing or which contain at least one medicament, for example solutions or gels, can also be used. A currently practiced method is that the dressing material or a layer of this material consisting of an absorbent material is soaked with the relevant solution and then the dressing material is applied to the wound. The handling is cumbersome and especially when treating larger and deeper wounds and when dressings are changed frequently, a specially trained staff is necessary.

The object of the invention is to show a dressing material which, with simplified use, enables an improvement in wound healing. A dressing material according to claim 1 is designed to solve this problem. A treatment medium that can be used with the dressing material is designed according to claim 16.

The dressing material according to the invention has the advantage that, in the case of simple use, it allows wound healing in a moist environment using media which promote wound healing and / or contain medications, in particular solutions, and also significantly increases the time period within which a dressing change must take place. For example, when using the dressing material according to the invention possible to change the dressing only three days after the first care of a wound, ie at a time at which a deep wound has already closed to such an extent that the risk of infections is significantly reduced. This long residence time of the dressing material on the wound also ensures wound rest that is necessary for rapid healing, particularly within the first few days after the wound has been treated. This is possible because the chamber for the treatment medium has at least one connection led out of the dressing material for refilling and / or renewing the treatment medium.

In a preferred embodiment, which is characterized by a particularly inexpensive and effective structure of the dressing material, the chamber is formed by at least one channel which extends in several sections and / or turns over the surface of the dressing material. This channel is then preferably at least one piece of hose.

Developments of the invention are the subject of the dependent claims. The invention is explained in more detail below with reference to the figures using exemplary embodiments. Show it:

1 shows a schematic partial representation of the layer structure of a dressing material according to the invention, the individual layers actually connected to one another in the dressing material being shown separated from one another for the sake of clarity in the manner of an exploded view;

Figure 2 is a simplified schematic representation of a top view of the material of Figure 1;

3 shows a schematic partial representation of the layer structure of a further dressing material according to the invention; 4 - 7 different graphics relating to the time course of wound healing in animal experiments.

The dressing material, generally designated 1 in the figures, which is also particularly suitable for treating open, deep wounds, is essentially designed as a multi-layer flat material, for example with a square or rectangular cut.

In the embodiment shown, the dressing material 1 consists of a first, sterile layer 2 on the outside, which forms the support on the wound and is formed by a perforated flat material, for example perforated film or grid made of a suitable plastic, for example PVC. The single-layer outer layer 2 is followed by a layer 3, which is formed by several layers of a sterile, absorbent and air and moisture-permeable material, for example a coarse fabric or a non-woven material. In the embodiment shown, the layer 3 consists of several layers of sterile gauze, for example four layers. The other surface side or outside of the dressing material 1, which in use is the outer surface of this dressing material facing away from the wound, is formed by a layer 4, which in the embodiment shown is of a single layer, consisting of a flat material or a film, preferably one plastic film. Layer 4 has semipermeable properties, ie it is permeable to air and gases, but not permeable to liquids. On the inner side of layer 4 facing layer 3, a lumen or tube piece 5 is fastened, which extends in a meandering manner almost over the entire area of layer 4 and thus over the entire area of dressing material 1 and forms two ends or connections 6, which are led out laterally from the dressing material 1, namely at the Embodiment shown such that these ends 6 protrude on two opposite peripheral sides 1 'and 1 "of the dressing material.

The tube piece 5, which forms a channel for receiving and distributing a treatment medium, in particular a liquid or aqueous treatment medium, is on its inside the dressing material 1, i.e. between the layers 3 and 4 extending length so that a finely divided outlet of the treatment medium present in the tube piece 5 is possible in the layer 3. For this purpose, the piece of hose 5 is, for example, finely perforated. The projecting ends 6 are preferably each formed by a tube length that does not have this perforation.

The individual layers 2, 3 and 4 with the tube piece 5 arranged between the layers 3 and 4 are connected to one another in a suitable manner, for example along the edge of the dressing material 1 and / or point-wise also within the dressing material 1.

In use, the dressing material 1 is placed on the wound to be treated with the layer 2 and then fixed, for example, at the edge by means of an adhesive tape 7 or in some other way. In order to achieve improved wound healing in a moist environment, a solution suitable for wound treatment is supplied via one end 6, for example via the upper end in FIG. 2, and until such solution emerges at the other end or connection 6 and thus the entire chamber formed by the hose section 5 is filled with this treatment solution. Then both ends 6 are closed, for example with a suitable plug. The treatment solution emerging from the tube piece 5 is finely distributed over the entire dressing material over the layer 3 and thus in particular also over the entire wound area. The solution in Hose section 5 is renewed and replaced several times a day, for example twice a day.

The wound material is optimally kept occlusive and moist by the dressing material according to the invention, so that a significantly improved wound healing is achieved. The particular advantage of the dressing material according to the invention, however, is that a change of the dressing is only necessary after several days, for example only every three days, so that the first change of the dressing material usually takes place at a time when even a deep, open wound has already closed to such an extent that the risk of an additional infection when changing the dressing can be excluded. The large time interval between the application of the dressing material and the first change of this dressing material ensures, in particular, that the wound is calm for the first healing process within the first days after the care of a wound. The dressing material according to the invention thus combines the advantages of wound healing in a moist environment with the advantage of long wound rest, which promotes the healing process, particularly in the first few days.

FIG. 3 shows a further exemplary embodiment of the invention in a schematic representation and in section of a dressing material 1 a, which in turn has a multi-layer construction and also serves to improve wound healing in a moist environment. The dressing material 1 a consists of a lower layer 10 with which this material is placed on a wound. This layer 10, which forms the sterile pad on the wound, is formed from a sterile perforated flat material, for example from a perforated or lattice-like film made from a suitable plastic, for example from PVC or silicone. A layer 11 is provided on the layer 10, which serves as a distribution layer for the treatment liquid and for this purpose is made, for example, from a sterile, soft and absorbent material, for example from gauze or from a nonwoven material (fleece). On the side of the layer 11 facing away from the layer 10 there is a layer 12 which contains the liquid treatment medium in encapsulated form, in such a way that the treatment medium is opened via the layer 11 by opening or breaking the layer 12 or the capsules there distributed to the underside of the dressing material and thus to the wound area. Over the layer 12, a cover layer 13 is provided, which consists of a semi-permeable flat material, ie a flat material which is not or largely impermeable to the liquid treatment medium, but is permeable to air and gases.

As is also shown in FIG. 3, the covering layer 1 3 also covers the dressing material 1 a or the various layers and layers of this dressing material from the side and is skin-compatible at the edge which is at the level of the underside of the layer 10 adhesive order 14 provided. The dressing material 1 a is sterile closed on the side with which it is applied to a wound with a removable cover layer 15. Layer 15 is subtracted in use.

In use, the dressing material, after removal of the cover or protective layer 15, with the then exposed layer 10, is placed on the wound and fixed around the wound with the adhesive layer 14. By breaking the layer 12, the encapsulated treatment liquid is released.

The dressing material 1 a is preferably designed such that when changing a dressing, the layer 10 of the existing dressing is separated from the adjacent layer 11 is and the layer 10 thus remains on the wound, so that the rest of the wound and thus the healing process are not affected by a change of dressing. The fresh dressing material used when changing the dressing then corresponds to the dressing material 1 a, but without the layer 10, ie the formation is made such that in addition to the protective layer 1 5, the layer 10 can also be removed from the dressing material 1 a if necessary.

As a treatment medium, for example, a solution is used which contains zinc and iron in aqueous solution, in addition to distilled water and sulfuric acid per liter of solution 10 - 100 mg Zn and 6.5 - 65 mg Fe, e.g. 1 5 - 45 mg Zn and 10 - 30 mg Fe, the proportion of sulfuric acid being chosen so that a pH value between 2.5 to 3.5, preferably 2.8. In a preferred embodiment, a 95-97% sulfuric acid is used. The distilled water is a double distilled water according to DAB 10. Suitable raw materials are, for example, ZnCl ₂ and FeSO ₄ , namely about 20-209 mg ZnCl ₂ and 32-325 mg FeSO ₄ per liter of solution.

An example of the composition of the treatment solution is given below:

Contains one liter of solution

Aqua bidestillata DAB 10 980g

FeSO ₄ 0.097 g

ZnCI ₂ 0.063g

Remaining sulfuric acid 95 - 97% in a proportion until a pH of 2.8 is reached.

The low pH of the treatment medium not only creates an acidic and therefore optimal wound environment. The acidic environment is particularly also stimulates the metabolism that promotes the healing process. Furthermore, the treatment medium also has a microbacteriostatic effect due to the acid in connection with the iron content, ie it creates a milieu which prevents the growth of germs and bacteria and has a repulsive effect on them, so that inflammation is caused by germs entering a wound and developing there are effectively prevented.

The treatment medium (solution) described above is also particularly suitable in combination with the dressing material 1 or 1 a. for use in skin grafts to supply or cover the transplant site, but also to supply the donor side (e.g. buttocks) where the transplanted skin has been removed.

The treatment medium (solution) described above is also particularly suitable in combination with the dressing material 1 or 1 a. for the treatment of postoperative wounds and thereby decisively improves the healing process, as has been demonstrated by tests on pigs. For this purpose, animal experiments were carried out on pigs using the treatment medium described above and the dressing material 1. In these experiments, compared to wound healing in ambient air, a significantly accelerated healing process (shortening the healing process by about 5 days) and a substantial reduction in scar formation were found.

The above-described treatment medium (solution) is also particularly suitable in conjunction with the dressing material 1 or 1 a and also for the treatment of chronic wounds and burns, as was again found in animal experiments. To demonstrate this, animal tests on pigs were carried out using the one described above Treatment medium with a proportion of 30 mg zinc and 20 mg iron per liter solution (hereinafter 0.003% solution) with a reference solution containing only 10 mg zinc and about 7 mg iron per liter solution (hereinafter 0.001% solution) a comparative solution containing 100 mg zinc and 66 mg iron per liter solution (hereinafter 0.01% solution). In a further comparative series of experiments, the healing process in conventional wound care was examined.

The results of these burn tests, as is generally recognized, are also significant for the effectiveness in the care of chronic wounds, e.g. Pressure ulcers, leg ulcers, wound healing disorders in diabetes mellitus, etc.

The results are shown in the graphics of FIGS. 4, 5, 6 and 7, specifically in FIG. 4 for the 0.001% solution, in FIG. 5 for the 0.01% solution, in FIG. 6 for the 0.003 % Solution and in Figure 7 for a wound only exposed to ambient air. The illustrations show that the best healing results are achieved with the 0.003% solution.

In FIG. 2, 16 also denotes an indicator which, in the embodiment shown, consists of a substrate or strip of a flat material which is provided with an indicator material which is used when the dressing material 1 falls or dries out, ie when the moisture of this dressing material 1 falls below a predetermined value in use, the color changes. The indicator 16 is integrated in the dressing material 1 so that it is visible when the dressing material 1 is applied. In the embodiment shown, the indicator 16 is located below the layer that closes the dressing material on the side facing away from the wound, ie in the dressing material 1 between the layer 4 and the layer 5 and in the dressing material 1 a below the layer 13. Suitable indicator materials which change their color depending on the moisture are known to the person skilled in the art. In principle, an indicator material is also suitable in the invention, which changes color depending on the pH value, since the pH value changes when the dressing material dries out or falls dry.

In addition or instead of the indicator 16, which indicates that the dressing material has fallen dry, an indicator can also be integrated into the dressing material 1 or 1 a, which displays an indication of a possible increased microbial contamination of the dressing material, so that the dressing material can be changed in good time , This indicator is also designed in accordance with the indicator 16 and is preferably provided such that it is visible when the dressing is applied to the patient, and consists of a carrier material which is provided with a substance which changes color when there is an increased microbial load or contamination, for example, again due to a change in the pH value.

In principle, it is of course also possible to provide a corresponding indicator 16 for the moisture of the dressing and / or for the microbial condition of the dressing on the side of the dressing material facing the respective wound.

The invention has been described above using an exemplary embodiment. It goes without saying that numerous changes and modifications are possible without thereby departing from the inventive idea on which the invention is based. LIST OF REFERENCE NUMBERS

1, 1 a dressing material

V, 1 "peripheral edge

2 layers of a sterile, perforated flat material made of plastic, for example made of PVC as a covering on the wound

3 protective layer made of a sterile, soft and absorbent

Material, for example gauze layer made of a semi-permeable material

5 piece of hose

6 hose end or connection

7 adhesive tape 0, 1 1 layer 2 layer 3 cover layer 4 adhesive application 5 cover layer 6 indicator

Claims

claims

1 . Dressing material, consisting of several adjoining and interconnected layers, namely at least one first perforated layer (2, 10) forming an overlay on the wound, consisting of a preferably multilayer soft and at the same time absorbent second layer (3,

1 1) and from a third layer (4, 1 3) forming the outer surface of the dressing material facing away from a wound, characterized in that within the layer sequence formed by the layers at least one chamber (5, 12) dispenses a liquid treatment medium into the second layer (3, 1 1) is provided.

2. Dressing material according to claim 1, characterized in that the at least one chamber (5) has at least one on an outside of the dressing material (1) accessible connection (6) for supplying a treatment medium and on a wall for finely distributed delivery of the treatment medium in the second layer (3) is formed.

3. Dressing material according to claim 1 or 2, characterized in that the at least one chamber (5) is finely perforated on its wall.

4. Dressing material according to one of the preceding claims, characterized in that the at least one chamber (5) is channel-like and extends with a plurality of channel sections and / or turns over the surface of the dressing material (1).

5. dressing material according to claim 4, characterized in that the at least one chamber (5) forms a connection (5) at two ends.

6. dressing material according to one of the preceding claims, characterized in that the at least one chamber is formed by at least one tube piece (5).

7. Dressing material according to one of the preceding claims, characterized in that the at least one chamber (5, 1 2) between the third layer (4, 1 3) forming the outside of the dressing material and a further layer, for example the second layer (3rd , 1 1) is provided.

8. Dressing material according to one of the preceding claims, characterized in that the at least one chamber (5, 1 2) is provided on the side of the second layer facing away from the first layer adjacent to this.

9. dressing material according to one of the preceding claims, characterized in that the at least one chamber (5, 12) in the preferably multi-layered second layer (3, 1 1) is provided.

10.Nerband material according to one of the preceding claims, characterized in that the third layer (4, 1 3) is semipermeable, i.e. allows gas and air to pass through, but blocks liquid.

1 1. Dressing material according to one of the preceding claims, characterized in that the at least one connection (6) on one side of the dressing material (1) is led out of this. Nerband material according to one of the preceding claims, characterized in that the at least one tube piece (5) is fixed to the third layer (4).

Nerband material according to one of the preceding claims, characterized in that the at least one chamber is formed by at least one capsule for receiving the treatment medium, preferably by a layer (12) of several capsules.

Nerband material according to one of the preceding claims, characterized in that the at least one chamber (5, 12) serves to receive a treatment solution which, in addition to water and acid, preferably contains sulfuric acid per liter of solution: 10-100 mg zinc (Zn) 6, 5 - 65 mg iron (Fe)

for example

15-45 mg zinc

10 - 30 mg iron, the proportion of acid being chosen so that a pH of about 2.5 to 3.5, preferably 2.8, is reached.

Nerband material according to one of the preceding claims, characterized by at least one indicator (16) for optically displaying the moisture status and / or the microbial load status of the dressing material.

16. Treatment solution for use with the dressing material according to any one of the preceding claims, in particular for promoting the acceptance of a graft, in particular of transplanted skin through the tissue at a transplant site, characterized by an aqueous solution, preferably per liter of solution in addition to water and acid Sulfuric acid contains:

10 - 100 mg zinc (Zn) 6.5 - 65 mg iron (Fe)

for example 1 5 - 45 mg zinc 10 - 30 mg iron,

the proportion of acid being chosen so that a pH of about 2.5 to 3.5, preferably 2.8, is reached.

1 7. treatment solution according to claim 1 5, characterized by the use of 95-97% sulfuric acid.

18. Treatment solution according to one of the preceding claims, characterized by the use of ZnCl ₂ as a zinc component, preferably in an amount of

10 - 100 mg per liter of solution, for example 46 - 80 mg per liter of solution.

19. Treatment solution according to one of the preceding claims, characterized by the use of FeS0 ₄ as an iron component, preferably in an amount of 32 - 325 mg per liter of solution, for example 80 - 1 14 mg per liter of solution.

20. Treatment solution according to one of the preceding claims, characterized in that it contains about 30 mg of zinc and 20 mg of iron per liter of solution, preferably prepared using about 63 mg of ZnCl ₂ and about

97 mg FeS0 ₄ .

21. Treatment solution according to one of the preceding claims, characterized in that the aqueous solution contains, in addition to zinc and iron, only distilled water and acid, preferably sulfuric acid.