JP5017615B2 - Catheter fixture - Google Patents

Description

The present invention relates to a catheter fixing tool for fixing a catheter (hereinafter simply referred to as a catheter) such as a tube, cannula, drain or the like to be inserted into the body, and a skin patch for fixing the catheter.
More specifically, the present invention relates to a catheter fixing tool for fixing a catheter line portion (a tubular portion other than a catheter puncture portion) to the skin and a catheter fixing skin patch.
In addition, the fixture of the present invention can be suitably used in medical fields for medical materials other than catheters, fixation of instruments to the skin, protection of skin and wounds, treatment, and the like.

  In the medical field, catheters are placed in the body for the purpose of drug administration, nutrition management, body fluid discharge, monitoring, and the like. This type of catheter may be left for several hours to several days for its intended treatment, but during that period, the catheter should not be dropped from the patient or inserted excessively into the interior. The catheter must be securely fixed and held at a specific position on the skin.

  For fixing the catheter, a so-called film dressing made of a thin plastic film adapted to the catheter is widely used at the puncture portion. When fixing the line part other than the puncture part of the catheter, apply an adhesive tape to the skin in advance, place the catheter on the adhesive tape, and then apply another adhesive tape from above to fix it. Has been done. This is because if the catheter is directly fixed to the skin, the fixing position of the catheter is likely to be shifted, and there is a risk that skin damage may occur due to friction or the like.

  In general, the line part of the catheter is fixed by a medical worker by cutting a roll-shaped adhesive tape into an appropriate size, and preparing a tape for skin application and a tape for catheter application, respectively. Affix to the catheter and fix the catheter. In addition, in order to solve such trouble of cutting and fixing complexity, a catheter fixing tool in which a tape for skin application and a tape for catheter application are prepared in advance has also been proposed (for example, Patent Documents). 1 and 2).

  However, these conventional adhesive tapes used for fixing are often set to have a high adhesive force because of the need to securely fix the catheter. The adhesive used is often the same. Therefore, when these adhesive tapes are removed from the skin, peeling strength is given to the skin due to the strength of the adhesive force. In the case of long-term hospitalization, hemodialysis, and the like, when these adhesive tapes are repeatedly applied and peeled off, there is a problem that skin damage occurs due to repeated peeling stimulation.

Japanese Patent Laid-Open No. 9-192166 JP 2002-35133 A

  The present invention has been made in view of the above-described problems, and an object of the present invention is to fix a catheter at a specific position on the skin, and to fix the catheter to the skin and to fix the catheter. It is to provide a skin patch for use.

  In order to solve the above-described problems, according to the present invention, in a catheter fixture comprising a skin patch attached to the skin and a catheter patch for fixing a catheter on the skin patch, the skin patch Is provided at the center of the upper surface of the base material, a base material having a top surface and a bottom surface, a pressure-sensitive adhesive layer covering the bottom surface of the base material, a pressure-sensitive adhesive protective layer covering the surface of the pressure-sensitive adhesive layer. A catheter fixing part, and the catheter patch includes a base material having an upper surface and a bottom surface, and an adhesive layer covering the bottom surface of the base material, and the catheter to be fixed by the adhesive layer of the catheter patch is skinned It is fixable to the catheter fixing part of a patch, The adhesive layer area of the said skin patch is formed more widely than the adhesive layer area of the said catheter patch, and the adhesive force F1 with respect to the stainless steel plate of the said skin patch , And it is smaller than the adhesive force F2 against the catheter fixing portion of the catheter patch body.

In the catheter fixture of the present invention, the F2 / F1 ratio is preferably in the range of 1.2 to 10.0. Moreover, it is preferable to provide the easily peelable part which can peel a catheter sticking body with the adhesive force lower than the adhesive force F2 with respect to the catheter fixing part of a catheter sticking body in the circumference | surroundings or edge part of the said catheter fixing part. Furthermore, it is preferable that the ratio F2 / F3 of the adhesive force F2 with respect to the catheter fixing part of the catheter patch and the adhesive force F3 with respect to the easily peelable part of the catheter patch is in the range of 1.2 to 20.0.
In the catheter fixture of the present invention, it is preferable that the catheter fixing part and the easy peeling part are formed in different forms on the same plane on the upper surface of the base material of the skin patch. Furthermore, it is preferable that the catheter fixing part is formed in a film form and the easy peeling part is formed in a fiber form. Moreover, it is preferable that the adhesive force F1 with respect to the stainless steel plate of the said skin sticking body is the range of 0.1-1.8N / 25mm.
Furthermore, it is preferable that the adhesive layer of the skin patch contains a silicone adhesive. Moreover, it is preferable that the adhesive layer of the said skin patch contains a gel adhesive or a hydrocolloid adhesive.

  Further, the present invention provides a skin patch for fixing the catheter to the skin in advance when the catheter is fixed to the skin, and the skin patch for fixing the catheter thereon, wherein the skin patch includes a base material having a top surface and a bottom surface; A pressure-sensitive adhesive layer covering the bottom surface of the substrate, a pressure-sensitive adhesive protective layer covering the surface of the pressure-sensitive adhesive layer, a catheter fixing portion provided in the center of the top surface of the base material, And an adhesive force F4 of the skin patch to the catheter fixing portion is greater than an adhesive force F5 of the skin patch to the easy peel portion.

In the catheter fixing skin patch of the present invention, the ratio F4 / F5 of the adhesive force F4 to the catheter fixing part of the skin patch and the adhesive force F5 to the easily peelable part of the skin patch is 1.2 to 20. A range of 0 is preferable. Moreover, it is preferable that the said catheter fixing | fixed part and an easily peelable part are formed in the form which differs on the same plane in the base-material upper surface of a skin patch. Furthermore, it is preferable that the catheter fixing part is formed in a film form and the easy peeling part is formed in a fiber form. Moreover, it is preferable that the adhesive force F1 with respect to the stainless steel plate of the said skin sticking body is the range of 0.1-1.8N / 25mm.
Moreover, it is preferable that the adhesive layer of the skin patch contains a silicone adhesive. Furthermore, it is preferable that the adhesive layer of the skin patch contains a gel adhesive or a hydrocolloid adhesive.

ADVANTAGE OF THE INVENTION According to this invention, a catheter can be fixed reliably, and when removing from a skin, a catheter fixing tool with little irritation | stimulation to skin and a skin patch for catheter fixation can be provided.
Further, by providing the catheter fixing part and the easy peeling part on the upper surface of the base material of the skin patch, the position adjustment or exchange of the catheter can be easily performed.

An embodiment of the present invention will be described below based on FIGS. The common parts of each embodiment will be described with the same numbers.
1 to 4, an embodiment of the “catheter fixing tool” of the present invention will be described. The “skin patch” in the “catheter fixing tool” is the “skin fixing patch for catheter fixing” of the present invention. It can be used as an embodiment.

FIG. 1: shows the block diagram of embodiment which concerns on the catheter fixture of this invention, a) A figure is a perspective view, b) A figure is sectional drawing which follows the bb line of a) figure.
The catheter fixture 1 of the present invention comprises a skin patch 10 to be affixed to the skin, and a catheter patch 20 for fixing the catheter on the skin patch 10 after fixing the catheter on the skin patch 10.

The skin patch 10 of the present invention comprises a substrate 11 having an upper surface and a bottom surface, an adhesive layer 12 that covers the bottom surface of the substrate, and an adhesive protective layer 13 that covers and peels the surface of the adhesive layer. I have.
The base material 11 of the skin patch 10 in the embodiment of FIG. 1 is a laminated base material in which a non-woven fabric and a film are laminated, and the non-woven fabric is positioned on the top surface of the base material and the film is positioned on the bottom surface of the base material. . A catheter fixing portion 14 in which a nonwoven fabric is formed into a film shape by heat melting is formed at the center of the upper surface of the base material 11, and the non-woven fabric is not heat-melted at the edge of the catheter fixing portion 14 in a fibrous form. The easily peelable portion 15 is formed.
Thus, by forming the catheter fixing part 14 and the easy peeling part 15 in different forms on the same plane on the upper surface of the base material of the skin patch 10, the catheter fixing function and the catheter patch 20 can be easily peeled off. Can be satisfied at the same time. That is, in the embodiment of FIG. 1, the catheter fixing part 14 is formed in a film shape, so that the catheter patch 20 is firmly adhered as compared to the fibrous easy-release part 15, and the catheter is placed on the skin patch. When the skin patch 20 needs to be peeled off, a simple peeling operation can be performed with the end of the skin patch stuck to the easy peeling portion 15 as a trigger.
In the embodiment of FIG. 1, a laminated base material of a nonwoven fabric and a film is used as the base material 11, but an embodiment in which the nonwoven fabric is a single base material is also possible.

  The catheter patch 20 includes a base material 21 having an upper surface and a bottom surface, and an adhesive layer 22 covering the bottom surface of the base material, and a catheter to be fixed by the adhesive layer 22 is a catheter fixing portion 14 of the skin patch. It can be fixed to. Although not shown in the embodiment of FIG. 1, an adhesive protective layer that covers the surface of the adhesive layer 22 and can be peeled off may be provided on the catheter patch 20.

Next, the actual use state of the catheter fixture of the present invention will be described with reference to FIG. The catheter fixture shown in FIG. 2 is similar to the embodiment of FIG.
FIG. 2 is a view showing a state where the central venous catheter 40 is placed under the clavicle. A puncture portion 41 of the catheter is fixed by a film dressing 42, and a ring-shaped absorption pad 43 is provided around the puncture portion 41. Has been. The line portion of the catheter 40 is looped at an appropriate place and fixed on the skin by the catheter fixture 1. In order to fix the line portion of the catheter, first, the skin patch 10 from which the adhesive protective layer has been peeled off is stuck on the skin, and then the catheter is placed on the catheter fixing portion 14 of the skin patch 10. At this time, in order to improve the fixation of the catheter, the catheter is placed so as to cross almost the center of the catheter fixing portion 14. Then, the catheter patch 20 is stuck on the catheter fixing portion 14 so that the catheter surface is wound around the catheter. At this time, the catheter patch 20 is pasted so that the end of the catheter patch 20 is positioned at the easy peeling portion 15 of the skin patch. Here, since the easy peeling part 15 has a lower adhesive force to the catheter patch 20 than the catheter fixing part 14, the easy peel part 15 and the end of the catheter patch 20 are easily peeled, The operation of removing the catheter and adjusting the position becomes simple.

Next, an embodiment of a catheter fixture different from the embodiment of FIG. 1 will be described based on FIG. a) The figure is a front view, b) The figure is sectional drawing which follows the bb line of a) figure.
In the embodiment of FIG. 3, the “catheter patch” can be the same as that of the embodiment of FIG.
The embodiment of FIG. 3 is different from the embodiment of FIG. 1 in the overall shape of the skin patch 10 and the configuration of the substrate 11. That is, the skin patch 10 in the embodiment of FIG. 3 has a substantially rectangular overall shape, and the base material 11 is a laminated base material in which a nonwoven fabric and a film are laminated. The central part of the base material is installed only in the part and has a structure in which the film is exposed.
In the embodiment of FIG. 3, the film portion of the base material 11 becomes the catheter fixing portion 14, and the nonwoven fabric portion provided on the edge of the catheter fixing portion 14 becomes the easy peeling portion 15.

Next, an embodiment of the catheter fixture different from the embodiment of FIGS. 1 and 3 will be described based on FIG.
In the embodiment of FIG. 4, the “catheter patch” can be the same as that of the embodiment of FIG.
The embodiment of FIG. 4 is a tape-like skin patch 10, which is in the form of a roll in this embodiment. The base material 11 of the skin patch 10 in the embodiment of FIG. 4 is a laminated base material in which a non-woven fabric and a film are laminated, and the non-woven fabric is positioned on the top surface of the base material and the film is positioned on the bottom surface of the base material. . In addition, a catheter fixing portion 14 in which the nonwoven fabric is formed into a film shape by heat melting is continuously formed in the longitudinal direction at the center of the upper surface of the base material 11, and the nonwoven fabric is heated at the edge of the catheter fixing portion 14. The easy peeling part 15 made into a fibrous form without melting is continuously formed in the longitudinal direction.
As described above, when the skin patch 10 has a continuous shape in the longitudinal direction, the skin patch 10 having a specific size, shape, or the like is required depending on the use situation of the catheter. The body 10 can be easily obtained at any time.

The overall shape of the skin patch and catheter patch of the present invention can be a circle, an ellipse, a polygon such as a triangle, a square, a rectangle, a rhombus, a star, or the like, and a combination of these shapes as appropriate. You can also The skin patch of the present invention may be produced continuously in the longitudinal direction and in a roll form.
Further, the catheter fixture of the present invention may be configured in a state in which the skin patch and the catheter patch are separated from each other as separate members in a state before use, and the catheter is placed on the upper surface of the substrate of the skin patch. A part of the patch may be combined and previously integrated.

(Relationship between skin patch and catheter patch)
The catheter fixing tool of the present invention is such that the adhesive layer area of the skin patch is wider than the adhesive layer area of the catheter patch, and further the adhesive force F1 of the skin patch to the stainless steel plate is applied to the catheter fixing part of the catheter patch. It is preferable to form it so that it may become smaller than the adhesive force F2. Further, the catheter fixture of the present invention is preferably formed so that the ratio of F2 / F1 is in the range of 1.2 to 10.0, and is formed in the range of 1.5 to 10.0. More preferably.
By setting the adhesive layer area, F1, and F2 of the skin patch and catheter patch as described above, the catheter can be securely adhered and fixed on the skin patch by the catheter patch. Since the body also exhibits a sufficient adhesive force as a whole, there is no fear that the catheter fixture itself peels from the skin, and further, when the skin patch is peeled from the skin, it is possible to suppress peeling stimulus.
The adhesive force F1 of the skin patch to the stainless steel plate is preferably in the range of 0.1 to 1.8 N / 25 mm in order to show an appropriate adhesive force when applied to the skin and not give a peeling stimulus. More preferably, the range is 0.5 to 1.8 N / 25 mm.
The adhesive force F2 of the catheter patch to the catheter fixing part is preferably in the range of 1.8 to 15.0 N / 25 mm in order to securely fix the catheter to the catheter fixing part, and 2.0 to 15.0 N More preferably, the range is / 25 mm.

(About skin patch)
In the skin patch of the present invention, a catheter fixing part is provided at the center of the upper surface of the base material.
The catheter fixing part is a part where the adhesive layer of the catheter patch of the present invention or other patch can be firmly adhered and the catheter can be firmly adhered and fixed.
Moreover, it is preferable that the skin patch of this invention provides an easily peelable part in the circumference | surroundings or edge part of a catheter fixing part. In the case where the easy peeling portion is provided around the catheter fixing portion, it is preferably provided in a frame shape, but may be configured such that a part of the frame is missing. When providing an easily peelable part in the edge part of a catheter fixing part, it is preferable to provide in two edge parts which a catheter fixing part opposes, but you may provide in an edge part other than that. The easy peeling portion is a portion to which an adhesive body such as a catheter patch is difficult to adhere as compared with the catheter fixing portion, and the catheter patch can be peeled with an adhesive force lower than the adhesive force F2 to the catheter fixing portion of the catheter patch. Part.
Here, the relationship between the catheter fixing part and the easy peeling part in the skin patch is such that the ratio F2 / F3 of the adhesive force F2 to the catheter fixing part of the catheter patch and the adhesive force F3 to the easy peeling part of the catheter patch is: The range is preferably 1.2 to 20.0, and more preferably 2.0 to 15.0.
Further, the catheter fixing skin patch of the present invention is preferably formed so that the adhesive force F4 to the catheter fixing part of the skin patch is larger than the adhesive force F5 to the easy peeling part of the skin patch. At that time, the ratio F4 / F5 of the adhesive force F4 to the catheter fixing part of the skin patch and the adhesive force F5 to the easily peelable part of the skin patch should be in the range of 1.2 to 20.0. Is preferred.
The adhesive force F3 to the easily peelable portion of the catheter patch is preferably in the range of 0.01 to 5.0 N / 25 mm, and more preferably in the range of 0.1 to 5.0 N / 25 mm.
The adhesive force F4 to the catheter fixing part of the skin patch is preferably in the range of 0.1 to 15.0 N / 25 mm, and more preferably in the range of 0.5 to 15.0 N / 25 mm.
The adhesive force F5 with respect to the easily peelable portion of the skin patch is preferably 0.01 to 5.0 N / 25 mm, and more preferably 0.1 to 5.0 N / 25 mm.
By setting F2 and F3, and F4 and F5 within the above relationship and adhesive force range, the catheter can be reliably fixed, and further, the presence of an easily peelable part forms a trigger for the patch to fix the catheter. Therefore, the removal of the catheter and the position adjustment operation are simplified.

(About the form of catheter fixing part and easy peeling part)
The catheter fixing part and the easy peeling part in the skin patch are preferably formed in different forms on the same plane on the upper surface of the substrate of the skin patch. By forming the catheter fixing part and the easy peeling part on the same plane, stable fixation becomes possible when the catheter is placed on the upper surface of the base material of the skin patch.
Moreover, by forming the catheter fixing part and the easy peeling part in different forms, it is possible to easily form a region where the adhesive layer is difficult to peel and a region where the pressure sensitive adhesive layer is easy to peel. Examples of the method for making the catheter fixing part and the easy peeling part different from each other include a method of disposing different materials in the two regions, a method of performing different surface treatments in the two regions such as hot melt processing and embossing, and the like. .
As for the form of the catheter fixing part and the easy peeling part, it is preferable that the catheter fixing part is formed in a film form and the easy peeling part is formed in a fiber form. As a method for forming the catheter fixing portion in a film shape and the easily peelable portion in a fibrous form, a method of processing the central portion of a base material made of thermoplastic fibers into a film shape by heat melting (implementation of FIG. 1 or FIG. 4) Mode), a method of laminating a fibrous base material around the upper surface or edge of the film-like base material (embodiment of FIG. 3), and applying a pressure-sensitive adhesive to the central part of the fibrous base material to form a film-like adhesive Examples thereof include a method for forming an agent layer.
Among them, a method of processing a fiber base material into a film by heat melting is preferable, and a known heat processing method such as heat sealing, impulse sealing, ultrasonic sealing (ultrasonic welding), high frequency sealing (high frequency welding) can be used. Further, when a film-like pressure-sensitive adhesive layer is formed on the catheter fixing portion, the catheter can be temporarily fixed, and the positioning becomes simple.
By forming the catheter fixing part in the form of a film, the contact area between the catheter fixing part having a smooth surface and the adhesive layer such as a catheter patch is maximized in a short time, and the catheter has high fixability immediately after application. Is obtained.
On the other hand, by making the easily peelable portion into a fibrous form, the contact area between the easily peelable portion and the pressure-sensitive adhesive layer such as the catheter patch can be reduced due to the unevenness of the fiber surface, and the catheter patch etc. is peeled off. A chance can be formed.
From the viewpoint of catheter fixation reliability and ease of peeling of the catheter patch, on the upper surface of the base material of the skin patch, the ratio of the area of the catheter fixing part is 40 to 95%, and the ratio of the area of the easy peel part is 5 to 60. % Is preferred.

(About the base material of the skin patch)
The base material used for the skin patch of the present invention may be a fiber, film, foam or the like, and a laminated base material appropriately combining these may be used.
Especially, since it is preferable to form a catheter fixing | fixed part in a film-like form and an easily peelable part in a fiber-like form, fibrous form, film form, or these laminated base materials are preferable.

(Fibrous base material of skin patch)
As the fibrous base material used for the skin patch, a nonwoven fabric, a knitted fabric, a woven fabric, a net, or the like can be used. Among them, a nonwoven fabric made of a thermoplastic resin that is easy to form a uniform film layer when melted by heat is preferable.
The fibrous base material used for the skin patch includes polyesters such as polyethylene terephthalate and polybutylene terephthalate; polyurethanes; polyolefins such as polyethylene and polypropylene; ethylene / vinyl acetate copolymer (EVA) and ethylene / ethyl acrylate Polymer (EEA), ethylene / methyl acrylate copolymer (EMA), ethylene / methyl methacrylate copolymer (EMMA), ethylene / methacrylic acid polymer (EMAA), ethylene / acrylic acid copolymer (EAA), etc. Examples thereof include olefin copolymers; polyamides such as nylon 6 and nylon 66; polystyrene; thermoplastic resins such as silicone. These materials may be used alone or in combination of two or more. Among them, a polyester elastomer and a polyurethane elastomer having moisture permeability and stretchability are preferable, and a polyester elastomer is particularly preferable.
Preferably the weight per unit area of the fibrous substrate used in the skin patch body is 10 to 150 g / m ^2, and still more preferably from 10 to 100 g / m ^2. When the weight per unit area is lower than 10 g / m ² , the strength of the base material is not sufficient, and there is a possibility that it will be broken by repeated peeling operations during use. On the other hand, if the weight per unit area is higher than 150 g / m ² , it becomes bulky and uncomfortable when applied to the skin, the followability to a curved surface part is deteriorated, and melting by heat may be difficult. is there.
In the present invention, the thickness of the fibrous base material is preferably 15 to 1,000 μm, more preferably 15 to 400 μm.

(About the film-like substrate of the skin patch)
A known plastic film can be used as the film-like substrate used for the skin patch, and the same material as the thermoplastic resin that can be used as the material for the fibrous substrate can be used. Of these, a polyester elastomer and a polyurethane elastomer having moisture permeability are preferable. These materials may be used alone or in combination of two or more. Further, the laminated film may be a single layer or two or more layers.
Preferably the weight per unit area of the film base material used in the skin patch body is 5 to 150 g / m ^2, and still more preferably from 5 to 100 g / m ^2.
The thickness of the film-like substrate used for the skin patch is preferably 15 to 1,000 μm, more preferably 15 to 150 μm.

(About the adhesive layer of the skin patch)
As the adhesive layer of the skin patch formed on the bottom side of the substrate, various pressure-sensitive adhesives can be used, for example, silicone-based, acrylic-based, urethane-based, vinyl ether-based, natural rubber-based, synthetic rubber-based, etc. A silicone pressure-sensitive adhesive with little peeling irritation from the skin is preferable.
Moreover, the adhesive layer of a skin patch can also reduce the peeling irritation | stimulation from skin by containing a gel adhesive. The gel adhesive may be a hydrogel adhesive containing water or an organogel adhesive containing an organic solvent, and a silicone gel adhesive or an acrylic gel adhesive is preferred.
In addition, when these so-called hydrocolloid adhesives are used, in which hydrophilic polymer compounds such as carboxymethylcellulose, karaya gum, pectin, and gelatin are added to these pressure-sensitive adhesives, they absorb sweat and exudates from the catheter puncture site. This can reduce irritation and rash caused by stuffiness.
In the adhesive layer of the skin patch, other adjusters such as drugs, powders, water-absorbing polymers, pH adjusters, preservatives, antibacterial agents, and coloring agents are appropriately blended so long as the object of the present invention is not impaired. can do.

(About the method of forming the adhesive layer of the skin patch)
As a coating pattern of the adhesive layer of the skin patch, the surface of the base material may be partially covered, or the entire surface may be covered, and an arbitrary pattern such as a lattice shape, a net shape, a granular shape, an arabesque pattern, etc. Can be selected. The coating method is not particularly limited, and the coating pattern and thickness can be controlled using a known coating method such as comma direct, knife coater, or gravure direct.
The thickness of the adhesive layer of the skin patch is preferably 10 to 1,000 μm, more preferably 10 to 500 μm. Further, preferably in the range of 10~1,000g / m ² in terms of the coating weight of the adhesive layer, more preferably in the range of 10 to 500 g / m ^2. When the thickness of the pressure-sensitive adhesive layer and the coating weight are within this range, it exhibits an appropriate adhesive force when applied to the skin, is excellent in followability to the skin, and can obtain good moisture permeability.

(About adhesive protective layer of skin patch)
As the adhesive protective layer of the skin patch, known release papers and release films can be used, and the surface of the paper or film subjected to silicone resin treatment or fluorine resin treatment can be used. Moreover, you may provide unevenness, such as embossing, in these peeling films.

(Characteristics of skin patch)
The skin patch of the present invention preferably has a moisture permeability of 250 g / m ² · 24 hours or more, and has a moisture permeability of 500 g / m ² · 24 hours or more in order to reduce skin troubles at the time of application. Is more preferable.
Moreover, it is preferable that the skin patch of the present invention has a bending resistance of 10 to 40 mm / 20 mm, and more preferably 15 to 35 mm / 20 mm. When the bending resistance is in this range, it is easy to handle before sticking to the skin, and there is little discomfort after sticking to the skin.

(About catheter patch)
The catheter patch should be formed so that its area is smaller than that of the skin patch from the viewpoint of easy attachment and detachment, and its longitudinal width should be the same as or less than the longitudinal width of the skin patch. Is preferred.
As conditions for the base material, the pressure-sensitive adhesive layer, and the like used for the catheter patch, the same materials as those for the above-mentioned skin patch can be used as long as the relationship between the adhesive forces of F1 to F3 is satisfied.
If necessary, the pressure-sensitive adhesive layer of the catheter patch may be provided with a pressure-sensitive adhesive protective layer that covers the surface and can be peeled off.

  EXAMPLES Hereinafter, although this invention is demonstrated further in detail based on an Example, this invention is not limited to these. Moreover, each characteristic of the patch was evaluated by the following method.

[F1 to F5 adhesive strength]
These adhesive strengths are measured according to JIS Z 0237-2000 “180 degree peeling adhesive strength”. However, as the adherend, a SUS304 plate is used for the measurement of F1, and the test pieces that are adherends are fixed to the SUS304 plate for the measurement of F2 to F5. The adhesive force is an average value in a section of 20 to 80% of the peeled displacement.

Specifically, it is as follows.
1) Adhesive force F1 of a skin patch to a stainless steel plate
Let SUS304 be an adherend, and let F1 (N / 25 mm) be the adhesive force when the “skin patch” is attached to and peeled off from the adherend by the above method.
2) Adhesive force F2 to the catheter fixing part of the catheter patch
An adherend is obtained by adhering and fixing the “catheter fixing part” to SUS304, and the adhesive force when the “catheter patch” is attached to the adherend and peeled by the above method is F2 (N / 25 mm).
3) Adhesive force F3 to the easily peelable part of the catheter patch
An adherend is obtained by adhering and fixing an “easy peeling portion” to SUS304, and the adhesive force when attaching and peeling the “catheter patch” on the adherend by the above method is F3 (N / 25 mm).
4) Adhesive force F4 to the catheter fixing part of the skin patch
An adherend is obtained by adhering and fixing the “catheter fixing part” to SUS304, and the adhesive force when attaching and peeling the “skin patch” to the adherend by the above method is F4 (N / 25 mm).
5) Adhesive strength F5 to easily peelable part of skin patch
An adherend is obtained by adhering and fixing an “easy peeling part” to SUS304, and the adhesive force when attaching and peeling the “skin patch” to the adherend by the above method is F5 (N / 25 mm).

[Moisture permeability]
The moisture permeability (g / m ² · 24 hours) of the skin patch when measured according to JIS L 1099-1993 A-2 “Water Method” is measured. In the measurement, the adhesive layer of the patch is placed facing the water side of the moisture permeable cup. The higher this number, the better the moisture permeability

[Flexibility of skin patch]
In accordance with JIS L 1096 “Bending / softness A method (45 ° cantilever method)”, the bending / softness of the patch is measured. Specifically, it is as follows.
Five test pieces of 20 mm × about 150 mm are collected from the skin patch, the pressure-sensitive adhesive protective layer is peeled off, and talc is applied to the surface of the pressure-sensitive adhesive layer to remove the adhesiveness. The test piece is placed on a smooth horizontal surface having a 45-degree slope at one end as shown in FIG. 5 with the short side of the test piece aligned with the scale base line. Next, the test piece is gently slid in the direction of the slope, and when the center point of one end of the test piece is in contact with the slope A, the position of the other end is read by a scale. The bending resistance is indicated by the length (mm) of the movement of the test piece, and the average value is calculated by measuring the front and back of the five sheets.

[Evaluation of actual use]
1) Peeling stimulation of skin patch Attaching the skin patch to the forearm and peeling stimulus when peeling the skin patch 4 hours after sticking: ○: Almost no stimulation, △: Slightly stimulated, X: Stimulated Evaluation is made in three stages.
2) Fixation of catheter With respect to the displacement of the catheter when the catheter is fixed on the skin patch with a catheter patch and a predetermined tensile force is applied to the catheter, ○: almost no displacement, Δ: small displacement X: Evaluated in three stages: large displacement.

[Example 1]
[Skin patch]
95 parts by weight of a mixture obtained by mixing two liquids of a two-component silicone mainly composed of a vinyl group-substituted polydimethylsiloxane, an organohydrogenpolysiloxane and a platinum catalyst (manufactured by Dow Corning, trade name “DOW CORNING 7-9800”); Then, 5 parts by weight of silicone obtained from a dehydration condensation reaction of silicone rubber and silicone resin (product name “DOW CORNING MD7-4502”, manufactured by Dow Corning) was mixed to obtain an adhesive (this mixing) In this case, the silicone subjected to dehydration condensation reaction was diluted with ethyl acetate to a solid content of about 62%).
The obtained pressure-sensitive adhesive was coated on a condensation reaction type silicone release paper and cured by heating at 110 ° C. for 3 minutes to form a silicone pressure-sensitive adhesive layer having a thickness of 85 μm.
Next, this pressure-sensitive adhesive layer is transferred to the film side of a laminated base material of a polyester elastomer film composed of a polyether / polyester block copolymer and a polyester elastomer nonwoven fabric composed of a polyether / polyester block copolymer. A patch was obtained. In addition, the weight per unit area of the film used for this laminated base material is 20 g / m ² and the thickness is 20 μm, the weight per unit area of the nonwoven fabric is 50 g / m ² , and the thickness is 200 μm. .
Thereafter, both edges of the patch were left, a mold heated to 200 ° C. was pressed at the center for 3 seconds to heat-melt the polyester elastomer nonwoven fabric, and the patch was then applied to the skin patch of the embodiment of FIG. Punched into the same shape as the body. As a result, a skin patch having a catheter fixing part having a film-like form by heat melting at the center part and an easy peeling part having a fibrous form at the edge part thereof was obtained.
[Catheter patch]
An aqueous emulsion pressure-sensitive adhesive containing an acrylic polymer obtained by emulsion copolymerization of a monomer mixture mainly composed of 2-ethylhexyl acrylate, butyl acrylate, and acrylic acid is coated on a condensation reaction type silicone release paper. And cured at 110 ° C. for 3 minutes to form an acrylic pressure-sensitive adhesive layer having a thickness of 50 μm.
Next, this pressure-sensitive adhesive layer was transferred to a polyester non-woven fabric (weight per unit area 44 g / m ² , thickness 380 μm) to obtain a catheter patch having the same shape as the catheter patch of the embodiment of FIG.

[Example 2]
[Skin patch]
70 parts by weight of a mixture obtained by mixing two liquids of a two-component type silicone mainly composed of vinyl group-substituted polydimethylsiloxane, organohydrogenpolysiloxane and platinum catalyst (trade name “DOW CORNING 7-9800” manufactured by Dow Corning) In addition, 30 parts by weight of silicone obtained from a dehydration condensation reaction of silicone rubber and silicone resin (Dow Corning, trade name “DOW CORNING MD7-4502”) was mixed to obtain a pressure-sensitive adhesive (this mixing) In this case, the silicone subjected to dehydration condensation reaction was diluted with ethyl acetate to a solid content of about 62%).
The obtained pressure-sensitive adhesive was coated on a condensation reaction type silicone release paper and cured by heating at 110 ° C. for 3 minutes to form a silicone pressure-sensitive adhesive layer having a thickness of 70 μm.
Thereafter, a skin patch was obtained in the same manner as in Example 1.
[Catheter patch]
A catheter patch was obtained in the same manner as in Example 1.

Example 3
[Skin patch]
Hydrogenated styrene-butadiene rubber (HSBR) (made by Nippon Synthetic Rubber, molecular weight: about 300,000) 20 parts by weight, liquid styrene-ethylene / propylene rubber (made by Kuraray, molecular weight: about 20,000), 70 parts by weight, liquid polybutene ( Shin Nippon Petrochemical Co., Ltd. molecular weight: 2900) 10 parts by weight is charged into a pressure kneader and mixed until sufficiently uniform. Next, 60 parts by weight of carboxymethylcellulose-Na (manufactured by Daicel) as a hydrophilic polymer compound and 8 parts by weight of ceramide were added and mixed under pressure to obtain a hydrocolloid pressure-sensitive adhesive.
The hydrocolloid adhesive was rolled to a thickness of 350 μm and transferred to a polyurethane film (weight per unit area: 15 g / m ² , thickness: 15 μm) to prepare a patch.
Thereafter, a polyester non-woven fabric (weight per unit area: 44 g / m ² , thickness: 380 μm) is bonded to both edges of the patch as an easily peelable portion, and the patch is then attached to the skin of the embodiment of FIG. Punched into the same shape as the patch. As a result, a skin patch comprising a catheter fixing part having a film-like form at the center part and an easy peeling part having a fibrous form at the edge part thereof was obtained.
[Catheter patch]
A catheter patch was obtained in the same manner as in Example 1.

[Comparative Example 1]
[Skin patch]
An aqueous emulsion pressure-sensitive adhesive containing an acrylic polymer obtained by emulsion copolymerization of a monomer mixture mainly composed of 2-ethylhexyl acrylate, butyl acrylate, and acrylic acid is coated on a condensation reaction type silicone release paper. And cured at 110 ° C. for 3 minutes to form an acrylic pressure-sensitive adhesive layer having a thickness of 50 μm.
Thereafter, this pressure-sensitive adhesive layer is transferred to a polyester non-woven fabric (weight per unit area is 44 g / m ² , thickness 380 μm), then punched out, and the skin patch having the same shape as the skin patch of the embodiment of FIG. Got the body.
[Catheter patch]
A catheter patch was obtained in the same manner as in Example 1.

[Comparative Example 2]
[Skin patch]
A catheter patch was obtained in the same manner as in Example 1 except that the polyester elastomer nonwoven fabric was not melted using a heated mold.
[Catheter patch]
A patch similar to the skin patch of Comparative Example 2 was used as a catheter patch. However, the shape was the same as that of the catheter patch of the embodiment of FIG.

Each characteristic of the obtained Example and the comparative example is shown in FIG. About the Example of this invention, the following can be said including the result of FIG.
In the catheter fixing tool according to the example of the present invention, the patch easily adheres to the catheter fixing portion of the skin patch, and the catheter can be fixed securely. It was difficult for the patch to stick to the easy peeling portion, and the easy peeling portion was used as a trigger for peeling, and the peeling operation of the patch stuck there could be easily performed. In addition, the skin patches of the examples of the present invention showed relatively low adhesive strength and did not give irritation when peeled from the skin, but because the skin patches as a whole have sufficient adhesive strength, Even when the catheter patch was peeled from the catheter fixing part, the skin patch was not peeled from the skin.

The figure of embodiment of this invention. The figure which concerns on the use condition of embodiment of FIG. 1 of this invention. The figure of other embodiments of the present invention. The figure of other embodiments of the present invention. The figure which shows the measuring method of bending resistance. The figure which shows the evaluation result of the Example of this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Catheter fixing tool 10 Skin patch 11 Base material 12 Adhesive layer 13 Adhesive protective layer 14 Catheter fixing part 15 Easily peelable part 20 Catheter patch 21 Base material 22 Adhesive layer 40 Catheter

Claims (9)

In a catheter fixture comprising a skin patch to be affixed to the skin and a catheter patch for fixing the catheter on the skin patch,
The skin patch includes a base material having a top surface and a bottom surface, a pressure-sensitive adhesive layer covering the bottom surface of the base material, a pressure-sensitive adhesive protective layer covering the surface of the pressure-sensitive adhesive layer, and a center portion of the base material top surface A catheter fixing portion provided in the
The catheter patch includes a base material having an upper surface and a bottom surface, and an adhesive layer that covers the bottom surface of the base material, and a catheter to be fixed by the adhesive layer of the catheter patch is attached to the catheter fixing portion of the skin patch. Can be fixed,
The adhesive layer area of the skin patch is formed wider than the adhesive layer area of the catheter patch, and the adhesive force F1 of the skin patch to the stainless steel plate is the adhesive force F2 to the catheter fixing part of the catheter patch. A catheter fixture characterized by being smaller.   The catheter fixture according to claim 1, wherein the ratio of F2 / F1 is in the range of 1.2 to 10.0.   3. An easily peelable portion capable of peeling the catheter patch with an adhesive force lower than an adhesive force F2 with respect to the catheter fixing portion of the catheter patch is provided around or on the edge of the catheter anchor. Catheter fixing tool.   The ratio F2 / F3 of the adhesive force F2 to the catheter fixing part of the catheter patch and the adhesive force F3 to the easily peelable part of the catheter patch is in the range of 1.2 to 20.0. 4. The catheter fixture according to 3.   The catheter fixing tool according to claim 3 or 4, wherein the catheter fixing part and the easy peeling part are formed in different forms on the same plane on the upper surface of the base material of the skin patch.   The catheter fixture according to any one of claims 3 to 5, wherein the catheter fixing part is formed in a film form, and the easy peeling part is formed in a fibrous form.   The catheter fixture according to any one of claims 1 to 6, wherein the adhesive force F1 of the skin patch to the stainless steel plate is in the range of 0.1 to 1.8 N / 25 mm.   The catheter fixture according to any one of claims 1 to 7, wherein the adhesive layer of the skin patch contains a silicone adhesive. The catheter fixture according to any one of claims 1 to 8, wherein the adhesive layer of the skin patch comprises a gel adhesive or a hydrocolloid adhesive.

Images