WO2013054420A1

WO2013054420A1 - Catheter fastening patch

Info

Publication number: WO2013054420A1
Application number: PCT/JP2011/073574
Authority: WO
Inventors: 智範猪飼; 藤澤　博充; 一樹磯部
Original assignee: ニチバン株式会社
Priority date: 2011-10-13
Filing date: 2011-10-13
Publication date: 2013-04-18
Also published as: JP5918777B2; JPWO2013054420A1

Abstract

In order to obtain a catheter fastening patch capable of covering a punctuate part of a catheter to keep the punctuate part hygienic and reliably fastening a tube of the catheter, in a main body (1) capable of covering a punctuate part of a catheter, a notch part (2) which extends from one side peripheral edge to the central part of the main body and through which a tube and the like of the catheter can be inserted is provided. An auxiliary piece (5) is provided at the other side edge of the main body (1) with a cutting-plane line (4) interposed therebetween, and an adhesive layer is formed on one surface of each of the main body (1) and the auxiliary piece (5). The adhesive layer of the auxiliary piece (5) and part of the adhesive layer of the main body (1) adjacent thereto across the cutting-plane line (4) are covered with auxiliary release paper (13) and the remaining adhesive layer of the main body is covered with main body release paper, thereby forming a catheter fastening patch (15). When the main body release paper is peeled off, the main body is integrally supported by the auxiliary release paper (13).

Description

Catheter fixation patch

The present invention relates to an improvement of a catheter fixing patch for stably holding a catheter puncture portion and the like.

Conventionally, a puncture portion into which a catheter has been inserted is covered with a dressing formed of a flexible plastic film, so that the state of the puncture portion is stably maintained and is prevented from being contaminated by bacteria from the outside. In this dressing, an adhesive layer is provided on one side of a flexible plastic film reinforced with a carrier film, and this adhesive layer is covered with release paper. The release paper is peeled off and attached to the puncture site with the adhesive layer. After that, the carrier film is peeled off. In such dressing, since the carrier film is used as a support for the adhesive material, it is usually a rigid material or a sufficient thickness. For this reason, the puncture portion of the catheter cannot be sufficiently fixed by this, and there is a high risk of causing liquid leakage, and it is often difficult to stick to the puncture portion in use.

Therefore, a surgical tape or the like is separately prepared separately from the dressing and the catheter tube is fixed. However, there is a disadvantage that the operation is complicated.
For this reason, an adhesive layer is provided on the back side of the release paper in which an adhesive layer is provided on one side of a flexible plastic film reinforced with a carrier film and covered with the release paper. And what is trying to fix tube more reliably is proposed by peeling this and making it locate under the tube of the catheter in a puncture part, and making it slip. (Patent Document 1)

JP 2010-207300 A

The present invention is intended to obtain an improved catheter fixing patch that can be used hygienically while covering the puncture portion of the catheter and is capable of securely fixing the catheter tube and is easy to use.

According to the present invention, a notch portion is provided in a body that can cover the puncture portion of the catheter, extending from one side periphery toward the center portion and allowing insertion of catheter tubes. An auxiliary piece is provided on the other side edge of the main body via a cutting line, and an adhesive layer is formed on one surface of the main body and the auxiliary piece. Cover the adhesive layer of the auxiliary piece and a part of the adhesive layer of the main body adjacent to the cutting line with the auxiliary release paper, and cover the remaining adhesive layer of the main body with the main body release paper, thereby fixing the catheter fixing patch. And
This auxiliary piece can be provided on one of the other side edges of the main body or all of the other side edges, or these can be provided symmetrically.

In the catheter fixing patch of the present invention, the auxiliary release paper is still attached to a part of the adhesive layer of the main body when the main body release paper is peeled off and attached to the puncture portion of the catheter. Therefore, when the auxiliary piece covered with the auxiliary release paper is used as the gripping piece, the main body can be maintained in a stretched state, and the main body can be easily stuck on the puncture portion of the catheter in such a state. Since a cutting line is interposed between the main body and the auxiliary piece, the auxiliary piece can be separated from the main body by peeling off the auxiliary release paper from the main body. By peeling the auxiliary piece from this auxiliary release paper and sticking it to the catheter tube, the tube can be fixed to the skin surface, and even if the patient moves, the tube will come out and come off more reliably. Can be prevented.

It is a top view which shows the Example of this invention. It is sectional drawing which expands and shows what is shown in FIG. It is a bottom view of what is shown in FIG. FIG. 2 is an explanatory diagram showing an example of how to use what is shown in FIG. 1 in order from (A) to (G). It is a top view which shows the other Example of this invention. It is sectional drawing which expands and shows what is shown in FIG. It is a bottom view of what is shown in FIG. It is a top view which shows the other example of this invention. It is a bottom view of what is shown in FIG. It is a top view which shows the further another example of this invention. It is a bottom view of what is shown in FIG.

The main body 1 has a size capable of covering the catheter puncture portion, and is usually formed of a flexible, durable, comfortable touch nonwoven fabric, a plastic film, an appropriate composite thereof, or the like. For example, in addition to various nonwoven fabrics, as plastic films, polyolefin plastics such as polyethylene and ethylene-vinyl acetate copolymers, styrene elastomers such as styrene-isoprene-styrene copolymers, styrene-butadiene-styrene copolymers, etc. An olefin elastomer such as ethylene-propylene rubber can be preferably used. These may be used alone or in combination by appropriately laminating a plurality of them.

As will be described later, since an auxiliary piece may be affixed to the main body 1 in order to improve the fixing force to the catheter during use, a silicone peeling treatment or the like is performed on the surface opposite to the adhesive layer 10. Those not present are preferred.
One of the preferred embodiments used for the main body 1 is that the base material is a non-woven fabric, and the non-woven fabric is generally highly moisture-permeable compared to a plastic film, so that the skin around the puncture site is excessive. It is possible not to be in a wet state.

The main body 1 is provided with a notch 2 extending from the peripheral edge of one side toward the center, and the notch 2 is provided with a catheter tube 33 extending from the puncture portion 32 of the skin surface 31 as described later. Can be inserted. In the case shown in FIG. 1, the circular hole 3 is formed at the terminal end of the notch 2, and the tube 33 is inserted well. In general, the longer the notch 2 is, the more the ability to fix the catheter tube can be improved. However, as will be described later, when the window hole portion 6 is provided in the main body 1 so that the puncture portion 32 can be seen, the length of the cutout portion 2 is preferably about 1/3 to 1/2 of the entire patch.

A connector part of the catheter may be disposed around the circular hole part 3. Therefore, the peripheral edge of the cutout portion 2 and the circular hole portion 3 on the surface of the main body 1 may be provided with a layer such as a thick hydrocolloid or urethane foam, hydrogel, or the like. This is preferable because the connector portion can suppress the generation of ulcers by applying stress such as compression or friction to the skin. In particular, when the disposed material is a hydrocolloid, it is more preferable because it has the ability to absorb blood leaked from the puncture site.
Although the composition of the hydrocolloid is not particularly limited, for example, a material obtained by dispersing a water-absorbing substance such as CMC in a thermoplastic elastomer such as a styrene / isoprene copolymer can be used. The thickness of such a hydrocolloid layer is about 20 to 3000 μm, preferably about 200 μm.

An auxiliary piece 5 is provided on the other side edge of the notch 2 via a cutting line 4. The auxiliary piece 5 may be formed integrally with the main body 1 described above and can be separated from the main body 1 by the cutting line 4. The auxiliary piece 5 shown in the drawing is formed with a recess 17 that can correspond to the catheter tube 33 as will be described later. Usually, the base material of the auxiliary piece 5 is often the same base material as that of the main body 1, but a different base material can be used or a different color can be used.
As the form of the cutting line 4, it is possible to form a cutting line that can be easily separated by a straight or curved deep embossing or a perforation or seam that completely penetrates the main body 1. However, in order to quickly separate the auxiliary piece from the main body 1 after the main body 1 is affixed to the skin at the puncture site and the catheter is fixed, the main body 1 and the auxiliary piece 5 are preferably in a completely separated state. . The cutting line 4 may be wide so that the main body 1 and the auxiliary piece 5 are slightly separated.

In the case shown in FIG. 1, a window hole portion 6 is formed in the central portion of the main body 1, and the window hole portion 6 is soft and rich in stretchability of the window hole 7 formed by punching the main body 1, It is covered with a transparent plastic film 8. If the puncture portion 32 of the catheter is positioned in the window hole portion 6, the state of the puncture portion 32 with the catheter fixed from the outside can be seen through. The window hole portion 6 can have an arbitrary size so that the puncture site can be clearly seen.

As the plastic film 8 covering the window hole 7, a suitable film such as a urethane film having the above-described properties, preferably waterproof and capable of transmitting water vapor, for example, can be used. In the figure, the plastic film 8 is formed on the upper surface side of the main body 1, and an adhesive layer 9 is formed on the skin side of the plastic film.
The plastic film 8 can also be formed on the skin side of the lower surface of the main body 1. When formed on the lower surface side of the main body 1, if the main body 1 is formed of a non-woven fabric, there may be inconveniences such as turning off the non-woven fabric of the main body from the periphery of the window hole 7 during use. For this reason, the plastic film 8 is preferably formed on the upper surface side of the main body 1 as described above.

The plastic film 8 having the pressure-sensitive adhesive layer 9 is formed larger than at least the window hole 6 formed in the main body 1 and adhered to the main body 1. It is preferable that the plastic film 8 be strongly bonded to the peripheral portion of the window hole 7 by heat sealing to the main body 1. As another embodiment, the main body 1 and, if necessary, the auxiliary piece 5 can be made of a transparent plastic material without forming the window hole 6.

The adhesive layers 10 and 11 are formed on one surface of the main body 1 and the auxiliary piece 5. Since the

adhesive layers

9, 10, and 11 are affixed to the skin surface 31 such as an affected area, it is preferable to use an adhesive that is less irritating to the skin. If it is such an adhesive, the composition is not particularly limited. For example, natural rubber-based, synthetic rubber-based (styrene / isoprene copolymer, polyisobutylene, etc.), acrylic-based, urethane-based, silicone-based, etc. An adhesive is mentioned. The same pressure-sensitive adhesive may be used for the pressure-sensitive

adhesive layers

9, 10, and 11, or different types may be used in combination, or a foamed pressure-sensitive adhesive layer may be used.

The pressure-sensitive adhesive layer 10 formed on the main body 1 has a function of covering the puncture portion 32 of the catheter and fixing it to the skin. Therefore, the pressure-sensitive adhesive layer 10 is preferably a rubber-based or acrylic pressure-sensitive adhesive having a relatively strong adhesive force. The auxiliary piece 5 is preferably bonded to the main body 1 or the like and has a strong adhesive force for fixing the catheter. For example, a rubber or acrylic adhesive may be used.
On the other hand, in the adhesive layer 9 formed on the skin side of the plastic film 8 used for the window hole portion 6 of the main body, blood leaks to the outside of the patch even when blood oozes from the puncture portion by a needle removal or the like. It is preferable to use a highly moisture-permeable pressure-sensitive adhesive in order to prevent the puncture from coming out, and to prevent whitening of the skin. For example, an acrylic adhesive, a urethane adhesive, a silicone adhesive, etc. are mentioned.

As the acrylic pressure-sensitive adhesive, for example, an acrylic pressure-sensitive adhesive mainly composed of 2-ethylhexyl acrylate, butyl acrylate, ethyl acrylate or the like is used. The thickness of the pressure-sensitive adhesive layer may be the same for the pressure-sensitive

adhesive layers

9, 10, and 11, or may be different.
Usually, the thickness of the pressure-sensitive adhesive layers 10 and 11 of the main body 1 and the auxiliary piece 5 is about 10 to 40 μm, preferably about 18 to 26 μm. The thickness of the pressure-sensitive adhesive layer 9 of the plastic film 8 is about 5 to 40 μm, preferably about 10 to 20 μm.

The surface of the pressure-sensitive adhesive layer 11 of the auxiliary piece 5 is covered with the auxiliary release paper 13, and this auxiliary release paper 13 covers a part of the pressure-sensitive adhesive layer 10 of the adjacent main body 1 beyond the cutting line 4. It is like that. The auxiliary release paper 13 is folded back on the pressure-sensitive adhesive layer 10 side of the main body 1, and a hand can be inserted between the auxiliary release papers 13 to hold the auxiliary piece 5.
The remaining part of the pressure-sensitive adhesive layer 10 of the main body 1 that is not covered with the auxiliary release paper 13 is covered with the main body release paper 12 including the pressure-sensitive adhesive layer 9 of the window hole 6. In the drawing, the auxiliary release paper 13 is further covered so as to cover the entire catheter fixing patch 15.
The adhesive layer 10 of the main body on the side of the cutout portion 2 is inserted with folded

release papers

14 and 14, and this portion becomes a handle in use.

A general method can be used as a method of manufacturing the patch. For example, an adhesive is applied to a non-woven fabric of a substrate and covered with release paper to produce an adhesive roll with release paper. A sticking material in which the main body 1 having the window hole 7 and the auxiliary piece 5 are integrated with this adhesive roll is cut out by a reciprocating machine. The window hole 7 is covered with a plastic film 8 having a larger pressure-sensitive adhesive layer 9 and heat sealed to the surface of the main body 1. Next, after applying the release paper in the final form, the cutting line 4 is formed so that the main body 1 and the auxiliary piece 5 can be separated, and the outer shape including the cutout portion 2 and the circular hole portion 3 is completely removed together with the release paper. It can be produced by removing.

When this patch 15 is used for the catheter puncture portion 32 protruding from the skin surface 31 (FIG. 4A), when the main body release paper 12 is peeled off, the adhesive layer 9 of the main body 1 including the window hole portion 6 is removed. , 10 are exposed. Since the auxiliary release paper 13 side and the folded release paper 14 side can be grasped by hand, the main body 1 can be maintained in the expanded state, and the window hole portion 6 is positioned at the position of the puncture portion 32 of the catheter. It can be affixed to the skin surface 31 of the affected area. Then, holding the folded release paper 14, the catheter tube 33 is inserted into the cutout portion 2 of the main body 1 and positioned in the circular hole portion 3 (FIGS. 4B and 4C).

Next, the folded

release papers

14 and 14 are peeled off, the main body 1 is attached to the skin surface 31, and the tube 33 is held by the notch 2 (FIG. 4 (D)). In this case, as shown in FIG. 1, by providing two release papers 14 on both sides of the notch 2 of the main body 1, the catheter tube can be fixed by peeling one sheet at a time. Therefore, it is less likely to be re-applied than other embodiments in which one release paper is peeled off at a time, which is preferable because it can be reliably attached.

Since the auxiliary release paper 13 is bonded to the auxiliary piece 5 and also to a part of the main body 1 adjacent to the cutting line 4, the auxiliary piece 5 is cut along the cutting line when the bonding with the main body 1 is peeled off. 4 to separate from the main body 1 (FIG. 4E).
The auxiliary piece 5 separated from the main body 1 is peeled off the auxiliary release paper 13 (FIG. 4F), and the concave piece 17 is formed in the tube 33 extending from the circular hole portion 3 to the auxiliary piece 5. Affix to the main body 1 so as to be addressed. As a result, the tube 33 in the vicinity of the puncture unit 32 is firmly bonded and fixed (FIG. 4G), and the fixing force to the tube 33 in the vicinity of the puncture unit 32 is improved and the needle is pulled out from the puncture unit 32. It can be sufficiently prevented. In some cases, the auxiliary piece 5 may be bonded and fixed to the tube 33 in a portion away from the main body 1.

The non-adhesive part 18 can be formed on the auxiliary piece 5 attached to the auxiliary release paper 13 by applying an appropriate width tape to the adhesive layer 11 or by not providing an adhesive layer. In what is shown in FIG. 1, the non-adhesion part 18 which stuck the tape to the part adjacent to the cutting line 4 is provided. Since the non-adhesive portion 18 is a clue when the auxiliary piece 5 is peeled off from the auxiliary release paper 13, even when a surgical glove is fitted, the auxiliary piece 5 can be easily peeled off and applied to the skin surface. It can be carried out. In particular, when the non-adhesive portion 18 is formed with a width of about 5 to 8 mm, the adhesive is used during a series of operations from fixing the puncture site of the catheter to fixing the catheter tube using the auxiliary piece 5. Avoid wearing gloves as much as possible. Also, when peeling off the auxiliary piece fixing the catheter, the non-adhesive portion can be easily pinched with a finger, which is useful.

Thus, the main body 1 and the auxiliary piece 5 of the patch 15 attached to the skin surface 31 can reliably maintain the fixed state of the puncture portion 32 of the catheter and the tube 33 extending therefrom, and from the window hole portion 6. The state of the puncture unit 32 can be observed. Furthermore, since it is not necessary to prepare a separate surgical tape or the like to fix the catheter tube, the operability during use can be improved as compared with a conventional adhesive material.

The auxiliary piece 5 may be attached on the auxiliary release paper 13 as a plurality of pieces adjacent to the main body 1 or at intervals. Moreover, when there are a plurality of auxiliary pieces 5, a concave portion that can correspond to each tube of the catheter may be formed. For example, the auxiliary piece 5 can be affixed on the auxiliary release paper 13 in the form of a plurality of tapes.
When using such a device, for example, after puncturing the catheter, one of the plurality of auxiliary pieces 5 is peeled off, and the tube 33 near the puncture portion 32 of the catheter is first fixed, and then the window hole of the main body 1 of the patch material is used. Attaching to the skin so that the puncture part 32 can be seen from the part 6. Thereafter, the folded release paper 14 is peeled off to fix the tube, and then the remaining auxiliary piece 5 is further peeled off from the auxiliary release paper 13 and used to fix the appropriate portion of the tube to the skin.

The plurality of auxiliary pieces is usually about 1 to 4 pieces. Moreover, although the shape of the auxiliary | assistant piece 5 is usually made into a rectangular shape, the corner | angular part of a rectangular shape can be cut off roundly and can be made into other appropriate shapes. Since the catheter may branch from the puncture portion into a plurality of tubes, each tube can be fixed by providing a plurality of auxiliary pieces.
In addition, by writing information such as a name and date on one or a plurality of auxiliary pieces, it is possible to know the replacement time of the patch. For this reason, it is preferable that appropriate information is printed in advance on the base material of the auxiliary piece or processed so that characters can be written with oil-based ink or the like. As described above, since the main body 1 and the auxiliary piece 5 are arranged on the same surface side on the release paper, the visibility to the auxiliary piece is good, and there is little problem of forgetting to attach it.
If the auxiliary release paper 13 holding a plurality of auxiliary pieces 5 is appropriately divided into a plurality of pieces, the auxiliary pieces are bonded to the skin and the catheter tube without touching the adhesive layer of the auxiliary pieces. can do.

5 to 7 show another embodiment of the present invention. A cutout 2 having a circular hole 3 as an end from one side of the main body 1 is provided. Two

auxiliary pieces

5 and 5 are provided so as to face each other, and both of the two

auxiliary pieces

5 and 5 are formed in the same manner as the auxiliary piece 5 shown in FIGS.

When this is used, the auxiliary piece 5 is held by hand, the main body release paper 12 is removed, the main body 1 is maintained in the expanded state by the

auxiliary pieces

5 and 5 located on both sides, and the window hole portion 6 is made to correspond to the puncture portion 32. Thus, the tube 33 can be inserted into the circular hole portion 3 from the notch portion 2 and attached to the skin surface 31. Since the two

auxiliary pieces

5 and 5 are provided, the tube 33 can be fixed at two places.

FIGS. 8 and 9 show another embodiment of the present invention. The

auxiliary pieces

5 and 5 provided on both sides of the main body 1 shown in FIGS. It is covered with a sheet of release paper 21. The sheet of release paper 21 includes a main body release paper 22 that covers most of the main body 1, and two auxiliary pieces 5 that respectively cover the whole of the main body 1 and a part of the main body 1 adjacent to the cutting line 4. It is formed by a sheet of

auxiliary release paper

23, 23. The

auxiliary release papers

23 and 23 are constituted by

inner release papers

24 and 24 and

outer release papers

25 and 25.

The main body release paper 22 constituting the release paper 21, the

auxiliary release papers

23 and 23 including the

inner release papers

24 and 24 and the

outer release papers

25 and 25 are each separated by a separation line 26. The separation line 26 can be formed by a discontinuous cut line or a cut line that can be easily separated.
Further, since the release paper 21 is formed larger than the main body 1 and the

auxiliary pieces

5 and 5 opposed to both sides thereof as described above, unlike the one shown in FIGS. The auxiliary piece 5 can be easily peeled off from the auxiliary release paper 23 without forming the.

When this patch is used, the body release paper 22 is picked and peeled off, and the skin 1 is held in a stretched state with the

auxiliary pieces

5 and 5 with the

auxiliary release papers

23 and 23 attached. It can be attached to the surface 31. Then, the auxiliary piece 5 is separated from the main body 1, the outer release paper 25 of the auxiliary release paper 23 is peeled off, the concave portion 17 is attached to the tube 33, and the inner release paper 24 is further peeled off to fix the tube. be able to.

10 and 11 are different from each other in that the

auxiliary release papers

23 and 23 are divided into

upper release papers

27 and 27 and

lower release papers

28 and 28 by a separation line 26. The configuration is the same as that shown in FIGS.
The auxiliary piece 5 can be used by peeling off the upper release paper 27 and the lower release paper 28 of the auxiliary release paper 23 that has been peeled off from the main body, and the other points are as shown in FIGS. It can be used in the same way.
Moreover, in the above-mentioned various things, it can also be set as the patch which does not form the notch part 2 and the circular hole part 3 in the main body depending on the case.

DESCRIPTION OF SYMBOLS 1 Main body 2 Notch part 3 Circular hole part 4 Cutting line 5 Auxiliary piece 6

Window hole part

9,10,11 Adhesive layer 12 Main body release paper 13 Auxiliary release paper 14 Notch side release paper 15 Adhesive material 17 Supplementary piece of auxiliary piece Concave part 18 Non-adhesive part of auxiliary piece 26 Separation line 31 Skin surface 32 Puncture part 33 Tube

Claims

A main body that covers the catheter puncture portion; a cutout portion that extends from one side edge of the main body toward the center portion and into which catheter tubes can be inserted; and is provided on the other side edge of the main body via a cutting line Auxiliary piece is provided, an adhesive layer is formed on one surface of the main body and the auxiliary piece, and a part of the adhesive layer of the auxiliary piece and the adhesive layer of the main body adjacent to the cutting line is crossed to the auxiliary release paper. A catheter fixing patch that is covered with, and the remaining adhesive layer of the main body is covered with a main body release paper.
The catheter fixing patch according to claim 1, wherein when the main body release paper is peeled off, the main body is integrally supported by the auxiliary release paper.
The catheter according to claim 1 or 2, wherein a central portion of the main body has a window hole portion through which the catheter puncture portion can be seen through, and the window hole of the window hole portion is covered with a transparent flexible film. Fixing patch.
The catheter fixing patch according to any one of claims 1 to 3, wherein the auxiliary piece is formed with a concave portion corresponding to a catheter tube at a central portion of one side edge parallel to the cutting line.
The catheter fixing patch according to any one of claims 1 to 4, wherein one or more auxiliary pieces are formed on the main body.
The auxiliary piece according to any one of claims 1 to 5, wherein one or a plurality of auxiliary pieces are formed adjacent to or spaced from the main body, and each of the auxiliary pieces forms a recess that can correspond to a catheter tube. Catheter fixing patch.
The main body release paper and the auxiliary release paper are formed of a single release paper, and are formed larger than the main body and the auxiliary piece, and the main body release paper and the auxiliary release paper are divided by discontinuous cut lines. 7. The catheter fixing patch according to any one of items 1 to 6.