EP2187999A1

EP2187999A1 - Tube-fixing plaster

Info

Publication number: EP2187999A1
Application number: EP08785014A
Authority: EP
Inventors: Axel Eckstein; Regina Merkle; Bernd Becht
Original assignee: Paul Hartmann AG
Current assignee: Paul Hartmann AG
Priority date: 2007-08-17
Filing date: 2008-07-24
Publication date: 2010-05-26
Also published as: JP5415419B2; US20100163052A1; WO2009024240A1; US8888748B2; DE102007038993B4; DE102007038993A1; JP2010536401A

Abstract

The present invention relates to a fixing plaster (10) for fixing tubes, hoses or catheters, in particular a tube-fixing plaster (10) for fixing endotracheal tubes in a particularly user-friendly form.

Description

Title: Tubus Fixierpflaster

description

The present invention relates to a fixation plaster for the fixation of tubes, tubes or probes, in particular a Tubusfixierpflaster for fixing endotracheal tubes in a particularly user-friendly form.

Fixation patches are known in emergency medicine or surgery for a long time. These fixation plasters are used, in particular, as a tube fixation plaster, for example during the endotracheal intubation of a tube into the trachea of a patient during a surgical procedure on the patient. This tube may include one or more tubes that are inserted through the mouth into the trachea of the patient, whereby the tube ensures ventilation and / or anesthesia during the operation. It is essential that the tube is fixed in place during the entire surgical procedure, so that it does not slip.

Such fixation patches are known in the patent literature. For example, DE-3924599-A1 describes a fixation plaster for the fixation of endotracheal tubes. The fixation plaster consists of a plaster, which has four sections, each separately for

Fixation on the skin or for fixation on the tube or the tube are suitable.

Furthermore, a holder for endotracheal tubes is described in DE-8500022-U1, which consists of a plaster, the fixation via separate fixing strips is centered on the holder. Furthermore, DE-20302211-U1 discloses a tube fixation plaster for oral endotracheal tubes which has a base plate and four fixation reins connected to the base plate.

The object of the present invention is to provide an alternative fixation plaster which, on the one hand, offers a high degree of application safety in use and, on the other hand, ensures high flexibility and high wearing comfort during use and at the same time is cost-effective to manufacture.

This object is achieved by a fixation patch according to claim 1. Accordingly, a fixation patch according to the invention consists of a multilayer carrier material which comprises a first carrier layer, at least one second carrier layer and an adhesive layer for Comprising fixation on the skin of a patient and having a moisture vapor transmission rate (MVTR) of at least 300 g / m ² / 24h, the fixation patch consisting of a base element and two fixation strips connected to the base element and a side length ratio of length to width of 5: 1 to 10: 1. In particular, the fixation patch has a side length ratio of length to width of 6: 1 to 9: 1 and most preferably of 7: 1 to 9: 1.

According to the present invention, this fixation patch has fixation strips which each have at least one free end and an end connected to the base element and passing into the base element. Thus, these fixing strips do not form separate from the fixing patch, separate elements and no elements that may be solvable from the base element. Rather, it is the case that the fixing strips together with the basic element form a unit which can not be separated into partial regions.

This fixation patch has significant advantages over known fixation patches. Thus, by the use of a multilayer carrier material, a fixation plaster can be provided, which has an increased wearing comfort, while at the same time the required application security is given. In addition, a fixing plaster is provided by the adjustment of the aspect ratio and by the connection of the fixing strips with the base element that ensures a very secure fixation. By adjusting the water vapor permeability, a fixing plaster is provided, which has a good breathability. Conventional patches are usually occlusively adjusted, whereby neither a water vapor permeability nor an air permeability is provided. By adjusting the water vapor permeability, a skin-friendly and secure fixation plaster is thus provided, which adheres particularly well to the skin of a patient.

In a second preferred embodiment of the invention it is provided that the fixing strips are arranged parallel to each other. It is particularly advantageous if the two fixing strips are the same length. In this connection, or independently thereof, the fixation patch has fixation strips which have substantially the same length as the base element. In particular, the length of the fixing strips deviates by at most 15%, in particular by at most 10%, from the length of the base element (based on the length of the base element).

By subdividing the fixing plaster according to the invention into a base element and Only two fixing strips, especially with the given size ratios, the user is given a Fixierpflaster to the hand, which allows a very flexible application. If, for example, an endotracheal tube is to be fixed, then the fixation plaster with the base element on the right or left side of the mouth, ie, at the side of the corner of the mouth, is determined by means of the adhesive layer, wherein the choice of the side can be freely selected. The first fixation strip can then be used to further fix the fixation plaster above or below the upper or lower lip. A secure fixation of the tube in the corner of the mouth of the patient can take place with the second fixation strip, wherein this fixation strip can be wound around the intubated tube at least once and the free end of the strip can be fixed on the base element or the first fixation strip. A fixation in the corner of the mouth is safer compared to a fixation in the middle of the mouth, as a free access to the oral cavity remains. If deemed necessary, with the aid of a second patch according to the invention, an additional fixation can be carried out in the same way, wherein the base element of the second fixation plaster is applied to the same side of the mouth. The longitudinal axes of the basic elements of the first and second fixing plaster can in this case occupy an angle of more than 5 ° to each other. Thus, these basic elements and the fixing strips are not parallel, whereby the anatomy of a patient can be better considered in the application. Here, the fixing strips are used in mirror image to each other, ie, that the first fixing of the second Fixierpflasters is set below the lower lip, if the first fixation of the first Fixierpflasters is set above the upper lip. With the second fixation then the additional fixation of the tube is done by one or more times wrapping and fixing on the base element or the first fixing strip. Thus, the two first fixing strips can be fixed above and below the upper and lower lips, with the two second fixing strips arranged between the first fixing strips enclosing the tube. As a result, a very secure fixation of the tube in the corner of the mouth of the patient can be achieved.

According to a further preferred embodiment of the fixing plaster it is provided that the fixing plaster has a length of at least 150 mm and at most 250 mm and in particular at least 170 mm and at most 230 mm. Thus, a fixation plaster can be provided that ensures a secure fixation of tubes, probes or tubes on the skin of a patient. Furthermore, the longitudinal extension of the base element and the fixing strips can be adjusted in a ratio that on the one hand a fixation on the skin and on the other hand by means of the second Fixierstreifens a winding of the tube is guaranteed. In connection or independent of the longitudinal extension, it can be provided according to a further preferred embodiment of the fixing plaster that the fixing plaster has a width of at least 20 mm and at most 40 mm and in particular at least 22 mm and at most 30 mm. In particular, the width of the first fixing strip deviates by at most 15%, in particular by at most 10%, from the width of the second fixing strip (relative to the width of the wider fixing strip). In particular, the fixing strips have substantially the same width. Thus, a fixation patch can be provided, the fixation strips have a width that ensures a wrinkle-free winding of the tubes and tubes and a wrinkle-free setting on the skin of the patient.

Thus, a Tubusfixierpflaster, in particular a Endotrachealtubusfixierpflaster for fixing a tube in a corner of a patient's mouth consisting of a multilayer substrate comprising a first carrier layer, at least a second carrier layer and an adhesive layer for fixation on the skin of a patient, the Tubusfixierpflaster from a Basic element and two connected to the base fixing strips, and the Tubusfixierpflaster has a aspect ratio of length to width of 5: 1 to 10: 1, subject of the present invention. In particular, the tube fixation patch has a side length ratio of length to width of 6: 1 to 9: 1 and most preferably of 7: 1 to 9: 1.

According to a particularly preferred embodiment of the present invention, it is provided that the second carrier layer consists of a non-woven fabric, which is in particular mounted between the first carrier layer and the adhesive layer for fixing on the skin of a patient. Particularly preferred as the second carrier layer is a hydrophobic nonwoven fabric. This fiber fleece has the advantage that it is particularly kind to the skin and ensures a particularly good fixation of Tubusfixierpflasters. If, on the other hand, hydrophilic nonwoven fabrics are used, these liquids absorb them. The inclusion of liquids in the present case, however, is not desirable, as a result, a worse fixation is achieved. Further preferred nonwoven fabrics used are non-woven fabrics which consist of polyester fibers, polyethylene fibers, polypropylene fibers, polyamide fibers, viscose fibers or mixtures thereof. Very particularly preferred is a nonwoven fabric which consists of hydrophobic polyester fibers. In particular, a woven fabric, in particular a plain weave fabric, may be used as the first backing layer, wherein furthermore preferably this first backing layer and the second backing layer are permanently joined by means of a pressure-sensitive adhesive. This fabric has a high tensile strength compared to the nonwoven fabric and in particular is less extensible. In particular, the tissue is a hydrophobic tissue. Particularly preferably, the fabric consists of a viscose yarn, polyester yarn, polyamide yarn, polyacrylonitrile yarn or mixtures of these yarns. Most preferably, a fabric of a hydrophobic viscose yarn can be used.

By using a multilayer carrier material which has a tissue as the first carrier layer and a nonwoven fabric as the second carrier layer, a particularly skin-friendly fixation plaster can thus be made available which, moreover, is less expansible and thus particularly safe. Thus, in particular, a fixation patch is the subject of the invention, which consists of a multilayer carrier material which has a

Elongation at break in the longitudinal extent of the fixation patch of at most 30%, in particular at most 25% and most particularly at most 20%, wherein for stretching a force of at least 30 N / cm is used (measured according to DIN EN 1940/1941 at a width of 25 mm) ,

Thus, a multi-layered carrier material can be provided, on the one hand a high tensile strength and on the other hand is particularly kind to the skin. Such a multilayer textile support material of a fabric and a nonwoven fabric has the advantage over films or other support materials that it has a good water vapor permeability and low elongation.

In the following, the invention will be explained in more detail with reference to drawings. In the drawings show:

FIG. 1: An endotracheal tube fixation plaster in top view

Figure 2 Endotrachealtubusfixierpflaster according to Figure 1 in cross section

FIG. 1 shows an endotracheal tube fixation plaster (10) in plan view. This fixation patch has a base element (11) and a first fixation strip (13) for fastening the patch to the skin of a patient and a second fixation strip (14) for fixing a tube. The primitive and the fuser strips are off manufactured the same carrier material (20). The first fixing strip is separated from the second fixing strip by a cut (12) in the carrier material (20), wherein the fixing strips are parallel to one another and have the same length.

The fixing plaster (10) has an overall length A with a = 200 mm and a total width B with b = 25 mm, wherein the ends (10a, 10b) are rounded. Thus, the aspect ratio of the length to the width of the patch is 8: 1. The base element (11) has a length C with c = 110 mm and a width D which corresponds to the total width B of the fixing plaster. Each fixing strip (13, 14) has a length F with f = 90 mm and a width E with e = 12.5 mm.

The fixing plaster is made of a carrier material (20) comprising a laminate of a first carrier layer (15) and a second carrier layer (17), wherein these two carrier layers are permanently connected to each other, that is, the two layers are not separated can, without one of the two layers is destroyed (see Figure 2, cross section of the fixation plaster (10) along the section line A - A). In particular, these two layers are inextricably linked together even in the intended use. The first carrier layer (15) is made of a non-stretchable fabric which is laminated to the second carrier layer (17) by means of a third layer (16) consisting of a zinc oxide-containing synthetic rubber adhesive. The second carrier layer (17) is made of a non-woven fabric. On the nonwoven fabric, a transparent synthetic rubber adhesive (18) is applied, which fixes the fixing plaster on the skin of a patient in the intended state of the fixation plaster. This transparent adhesive is covered with a two-part release paper for protection against contamination before use (not shown here).

The fabric of the first carrier layer (15) consists of 100% of viscose yarn with a yarn count of 165 dtex (DIN 53 812 T1). The basis weight is 115 g / m ² (measured according to DIN 53 352). The thread density in the warp direction is 33 threads / cm and in the weft direction 29 threads / cm (according to DIN 53 853). The air permeability is a maximum of 400 l / dm ² / min measured according to DIN EN ISO 9237. The maximum tensile force in the warp direction is a maximum of 16% and in firing direction a maximum of 35% (according to DIN 53 857). This fabric can be obtained from Slezan AS, CZ-738 15 Frydek-Mistek (Czech Republic).

The zinc oxide-containing synthetic rubber has a softening point of about 113 ° C. (measured to DIN 52 011) and a melt viscosity of 17,700 +/- 3,000 mPas (measured according to Ph. Eur. 1997 - Method 2.2.10). The transparent synthetic rubber has a softening point of about 106 ⁰ C (measured according to DIN 52 011) and a melt viscosity of 15,000 +/- 3,000 mPas (according to Ph. Eur. 1997 - Method 2.2.10). Both pressure-sensitive adhesives can be obtained from Collano, CH-6203 Sempach-Station (Switzerland).

The fiber fleece (17) is a skin-friendly needle nonwoven fabric made of polyester fibers with a basis weight of about 45 g / m ² (EDANA 40.3-90) and a density of 0.67 g / cm ³ (EDANA 30.05.99). The maximum elongation of this fiber fleece is approximately 46% in the longitudinal direction and a maximum of approximately 170% in the transverse direction according to EN 29073/3. This needle-punched nonwoven can be obtained from the company Ahlstrom, 1-10121 Turin (Italy).

The Endotrachealtubusfixierpflaster (10) has a basis weight of 340 g / m ² . The water vapor transmission rate (MVTR) is 383 g / m ² / 24h measured according to the German Pharmacopoeia, 10th edition, 1992 (DAB 10). The bond strength (180 ° peel angle) is 5.5 N / 25 mm measured according to DIN EN 1939.

The Endotrachealtubusfixierpflaster has a width of 25 mm elongation at break in the longitudinal extent of 19% and a breaking load of 30 N / cm (measured according to DIN EN 1940/1941).

This fixation patch is particularly skin-friendly due to the nonwoven fabric used and has a good water vapor permeability. In addition, the adhesive used is insensitive to moisture, i. it does not lose its adhesive power when in contact with sweat or saliva. The set sizes ensure a particularly user-friendly fixation plaster.

Claims

claims

1. Fixierpflaster (10) for fixing tubes, tubes or probes consisting of a multilayer carrier material (20), a first carrier layer (15), at least a second carrier layer (17) and an adhesive layer (18) for fixation on the skin of a Patients and having a water vapor transmission rate (MVTR) of at least 300 g / m ² / 24h, wherein the fixing plaster consists of a base member (11) and two fixing strips (13, 14) connected to the base member and a side length ratio of the length to the width of 5 : 1 to 10: 1.

2. Fixierpflaster according to claim 1, characterized in that the fixing patch has a side length ratio of the length to the width of 6: 1 to 9: 1 and in particular 7: 1 to 9: 1.

3. Fixierpflaster according to at least one of the preceding claims, characterized in that the fixing plaster has a width of at least 20 mm and at most 40 mm, in particular at least 22 mm and at most 30 mm.

4. Fixierpflaster according to at least one of the preceding claims, characterized in that the fixing patch has a length of at least 150 mm and at most 250 mm, in particular at least 170 mm and at most 230 mm.

5. Fixing plaster according to at least one of the preceding claims, characterized in that the first carrier layer (15) consists of a tissue.

6. fixation patch according to at least one of the preceding claims, characterized in that the second carrier layer (17) consists of a non-woven fabric, in particular between the first carrier layer (15) and the adhesive layer (18) is attached to the fixation on the skin of a patient.

7. Fixierpflaster according to at least one of the preceding claims, characterized in that the first carrier layer and the second carrier layer are permanently connected by means of a pressure-sensitive adhesive (16).

8. Fixierpflaster according to at least one of the preceding claims, characterized in that the fixing strips (13, 14) have the same length.

9. Fixierpflaster according to at least one of the preceding claims, characterized in that the fixing strips (13, 14) are arranged in parallel.

10. Fixierpflaster according to at least one of the preceding claims, characterized in that the fixing strips (13, 14) have substantially the same length as the base element (11).

11. Use of a Fixierpflasters (10) according to at least one of the preceding claims as Endotrachealtubusfixierpflaster.