JP3696922B2 - Catheter installation aid - Google Patents

Description

[0001]
[Industrial application fields]
The present invention relates to an auxiliary tool for attaching to a living body surface of a catheter outside the living body at a puncture portion of the catheter to the living body.
[0002]
[Prior art]
In many cases, a catheter to be inserted into a living body is mainly inserted into a blood vessel by puncturing a living body surface such as skin. In such a case, an external force acts on the puncture part of the living body by an operation on the catheter outside the living body. Therefore, it is necessary to prevent this and fix the catheter, and at the same time, prevent bacterial infection from the puncture part of the living body. There is.
Conventionally, an adhesive film dressing is applied to the puncture portion of the catheter to the living body so as to cover a wide area including the puncture portion, and the catheter is attached and fixed to the surface of the living body. Prevents intrusion.
[0003]
[Problems to be solved by the invention]
However, external forces in various directions repeatedly and strongly act on the puncture portion due to mechanical operations on the catheter in vitro or administration of a drug into the catheter. In particular, a multi-function catheter having a plurality of lumens inside and having various working functions at the distal end has a larger outer diameter and higher rigidity. Even if this force is applied, a large force acts on the puncture portion, like the lever lever.
Therefore, if the puncture part is simply held down with an adhesive film dressing as in the prior art, there is a problem that the adhesive film dressing easily floats or peels off due to the movement of the catheter, and that part becomes a bacterial infection route. .
[0004]
The object of the present invention is to attach and fix the catheter to the puncture portion of the living body with good workability, and even if a strong external force acts on the catheter and the catheter moves in the puncture portion of the catheter, It is providing the catheter attachment auxiliary tool which can suppress the float and peeling from the biological body surface of an adhesive film dressing.
[0005]
[Means for Solving the Problems]
That is, the present invention is as follows.
(1) Auxiliary tool used when attaching the catheter to a living body surface by adhering the adhesive film dressing to the living body surface in the vicinity of the puncturing section so as to cover the puncturing section of the catheter to the living body,
A pair of film base materials are laminated and bonded to each other in a region sharing a part of these outlines so that they can be opened and closed with each other. It consists of a laminate of a pair of film base materials that have an adhesive function and the other film base material is used for holding a catheter.
The laminated body of the pair of film bases is positioned such that the adhesive portion is in the direction closest to the puncture portion of the catheter to the living body and is in contact with or near the puncture portion of the catheter to the living body. So as to be placed on the surface of the living body and stick the outer surface in the stacking direction of one film substrate to the surface of the living body, while the outer surface in the stacking direction of the other film substrate is Place the catheter going out of the body,
Adhesive film dressing is adhered to the surface so as to cover the catheter placed on the outer surface in the laminating direction of the other film base, and further, the catheter and the periphery of the puncture part are covered so as to cover the catheter of the puncture part. A catheter attachment assisting device characterized in that the catheter is attached to a living body by adhering to the surface of the living body.
(2) One film substrate of the pair of film substrates further has a separator that covers the adhesive function, and the adhesive function is due to the adhesive layer provided on the film substrate. The catheter attachment aid according to (1) above.
(3) The catheter attachment aid according to (1) or (2), wherein the other film base of the pair of film bases has an adhesive function on an outer surface in the stacking direction.
(4) As described in any one of (1) to (3) above, the other film base of the pair of film bases further has a peelable reinforcing layer on the outer surface in the stacking direction. Catheter installation aid.
(5) The external shape of the pair of film bases is a congruent rectangle or square, and these layers are formed so that the external shapes thereof coincide with each other. The catheter attachment aid according to any one of the above (1) to (4), wherein a part of one side of the outer shape or the whole of one side is a rectangle or a square sharing one side.
(6) The separator has two parallel linear cut portions for being divided into three, and the two straight lines of the cut portions are from both ends of the one side of the outer shape of the film base. The catheter attachment aid according to the above (5), which is formed perpendicularly to the one side at an equal distance.
(7) It further has two parallel straight cutting sections for dividing the entire catheter attachment aid into three parts, and the straight lines of the two cutting sections are both of the separator. The catheter attachment aid according to the above (6), which is formed at a position parallel to the straight line of the cutting part and sandwiched between two straight lines of the cutting part of the separator .
[0006]
[Action]
In order to explain the action of the catheter attachment aid of the present invention, its use state will be described first.
FIG. 4 is a diagram schematically showing an example of the usage state. As shown in the figure, the catheter attachment auxiliary tool A of the present invention has a pair of film bases 1 and 2 such that a part of each of the regions can be opened and closed with each other like an operation of opening and closing a book. An adhesive function to the surface of a living body is imparted to the outer surface of the film substrate 1 in the stacking direction.
First, one of the film substrates 1 is bonded to the living body surface (skin) B. The orientation of the catheter attachment aid A at that time is set so that the region e is closest to the puncture portion. Further, the position is the position where the end of the region e is in contact with or near the puncture portion. The catheter attachment aid may be attached to the skin before or after insertion of the catheter into the body.
Next, the catheter C coming out of the living body from the puncture portion is fixed to the upper surface of the film base 2 of the catheter attachment aid using a part of the existing adhesive film dressing D. At that time, care is taken not to impair the opening and closing of the pair of film substrates 1 and 2. The remaining part of the adhesive film dressing D covers the catheter C of the puncture unit, and is adhered to the living body surface around the puncture unit so as not to form a bacterial infection route.
[0007]
By being used as described above, even if the catheter C moves in the direction shown by the thick arrow in FIG. 4, the pair of film base materials of the catheter attachment aid A performs an opening / closing operation using the region e as a hinge, Follow the movement of the catheter. Due to the operation of this catheter attachment aid, the adhesive film dressing is hardly affected by the force in the direction of peeling off the adhesion to the film substrate 2 and the adhesion to the living body surface. Therefore, the occurrence of floating or peeling is suppressed over the entire surface of the adhesive film dressing.
[0008]
【Example】
Hereinafter, the present invention will be described in more detail with reference to examples.
FIG. 1 is a view schematically showing an embodiment of a catheter attachment aid according to the present invention, and is a view of the lamination of film base materials as viewed from the side. FIG. 2 is a view of the catheter attachment aid of FIG. As shown in FIG. 1, the catheter attachment aid of the present invention has a pair of film bases 1 and 2 laminated and bonded to each other in a partial region e of the joint surface so that they can be opened and closed. Is. Furthermore, one film base material 1 has an adhesive function that can be attached to the surface of the living body on the outer surface 1a in the laminating direction. In this embodiment, the adhesive function is provided by the adhesive layer 6 being provided. Is applied and has a separator 7 on the adhesive layer. In this embodiment, the pressure-sensitive adhesive layer 4 is further provided on the outer surface 2a in the stacking direction of the other film base 2, and the peelable reinforcing layer 5 is provided on the surface 2a on the pressure-sensitive adhesive layer 4. ing.
[0009]
The one film substrate is a film to be attached to the surface of a living body, and the material may be any material as long as it does not cause rejection on the surface of the living body, particularly human skin. It is preferable that it has nature. Such materials include polymers such as acrylic polymers, polyethylene, ethylene-vinyl acetate copolymers, polyurethanes, polyether polyesters, polyether polyamide block copolymers, and nylon derivatives. Among them, polymers such as acrylic polymers, polyurethanes, polyether polyesters, and nylon derivatives are excellent in water vapor permeability when processed as a film, hardly disturb the breathing of the skin, and suppress the skin whitening phenomenon. It is particularly preferable because it can be applied and because it has transparency, it can be applied while looking at the application location. Moreover, this film base material may consist of only one of the above materials, or may be a laminate film obtained by laminating a plurality of films made of any material.
The thickness of the film substrate is preferably 10 μm to 75 μm, more preferably 15 μm to 45 μm, from the viewpoint that it can reduce a sense of incongruity when pasted on the skin and is excellent in water vapor permeability.
[0010]
The other film substrate is a movable part that opens and closes using the bonded region e as a hinge and follows the movement of the catheter. Many catheters to which the present invention is applied are mainly flexible, and it is preferable that the film substrate has flexibility so that it can be bent together with the catheter. As such a material, in addition to the material used for the above one film substrate, a polyolefin film such as polyethylene or polypropylene, a polyester film, a polytetrafluoroethylene film, a polyvinyl chloride film, a laminate of these films and a nonwoven fabric Examples include films and porous bodies of these plastic films.
Moreover, this film base material may be made of a single material or a laminate film as in the case of the one film base material.
The thickness of the film substrate is preferably 10 μm to 75 μm, more preferably 15 μm to 45 μm, from the viewpoint of excellent catheter retention.
[0011]
The pair of film base materials are superposed and bonded to each other in a partial region of the joint surface, and are configured so that they can be opened and closed.
The method for adhering a pair of film base materials is not particularly limited, and examples thereof include a method using a pressure-sensitive adhesive or an adhesive, a method using welding with heat or high frequency, a method using mechanical bonding, and the like. In this embodiment, as shown in FIG. 1, the adhesive layer 3 is interposed and bonded.
In the case of interposing an adhesive layer, the adhesive layer is composed of an adhesive only layer, a layer in which the base material is impregnated with the adhesive, and an adhesive layer on both sides of the base material such as a double-sided adhesive tape. Examples of such a layer may be mentioned.
[0012]
The outer shape of the pair of film bases is not limited, but is preferably rectangular or square from the viewpoints of easy production, low production loss, and use of an existing adhesive film dressing. However, the rounded corners are arbitrary. Moreover, it is preferable that it is a mutually congruent shape. Furthermore, it is preferable to laminate them so that their outer shapes match.
[0013]
The region where the pair of film base materials are bonded to each other is preferably provided in contact with the outline of the film base material in order to seal the puncture portion more preferably.
As shown in FIG. 2, if the outer shape of the pair of film bases is a congruent rectangle or square and the pair of film bases are superposed on each other so that the outer shapes coincide with each other, they are bonded. The shape of the region e is preferably a rectangle or a square having a part of one side 8 of the outer shape of the film substrate or the whole side 8 as one side. In particular, as shown in FIG. 2, by making the region e a quadrangle that shares the entire side 8 as one side, the sealing performance against the puncture portion is further improved.
[0014]
An adhesive function for adhering the catheter attachment aid to the living body surface is provided on the outer side in the stacking direction of the one film base. The pressure-sensitive adhesive function may be any as long as it adheres favorably to the surface of the living body, but it is a preferable aspect to provide a pressure-sensitive adhesive layer on the film substrate.
The pressure-sensitive adhesive layer may be a layer composed only of a pressure-sensitive adhesive or may have a base material in the layer like a double-sided pressure-sensitive adhesive tape. The pressure-sensitive adhesive is not particularly limited, but a pressure-sensitive adhesive that has strong adhesive strength, good adhesion to the skin, and does not cause eczema or the like on the skin is preferable. For example, acrylic adhesives, rubber adhesives, silicone adhesives, liquid-absorbing hydrocolloid adhesives, and the like can be given.
As a method of providing the pressure-sensitive adhesive layer on the film substrate, a known method may be used. For example, a method of coating the pressure-sensitive adhesive composition on the film, a film formed of a pre-formed pressure-sensitive adhesive composition as a film The method of providing on top etc. is mentioned.
The thickness of the pressure-sensitive adhesive layer is 10 μm to 100 μm, preferably 15 μm to 60 μm. In addition, when using a hydrocolloid type adhesive, in order to maintain skin adhesiveness, it is preferable that the upper limit of thickness shall be about 1.5 mm.
[0015]
On the pressure-sensitive adhesive layer, a separator is preferably laminated and provided as in this example. By providing the separator, the adhesiveness of the pressure-sensitive adhesive layer is protected and the handleability is further improved until the catheter attachment aid of the present invention is used.
Examples of the base material of the separator include plastic films (for example, polyethylene, polypropylene, polyester, and laminated composites thereof), paper (for example, high-quality paper, kraft paper, and the like). In addition, the surface of the substrate is subjected to a silicone resin treatment, a fluororesin treatment, or the like as a release treatment for obtaining good release properties from the pressure-sensitive adhesive layer.
[0016]
The separator is preferably provided with a cutting portion that can divide the separator into two or more. As a result, the separator can be easily peeled off, and in the affixing operation of the catheter attachment aid, the separator part that has not been peeled can be held by hand, and contamination of the adhesive layer from the hand can be prevented.
In particular, as shown in FIG. 2, if the outer shapes of a pair of film bases are congruent rectangles or squares and the pair of film bases are stacked so that the outer shapes match, the film base In a preferred embodiment, two parallel straight cut portions 9 and 10 are formed at the same distance from both ends of one side 8 of the outer shape of the outer shape, and the parallel cut portions 9 and 10 are formed in parallel, and the cut portion divides the separator into three. Due to such an aspect of the cutting portion, in the attaching operation of the catheter attachment aid, first, the divided separator 12 is peeled off, the remaining separators 11 and 13 on both sides are held with both hands, and the exposed adhesive layer is removed from the living body. The work can be carried out by a procedure of sticking to the surface, and then peeling the separators 11 and 13 and sticking the entire surface. Therefore, it is easy, quick and accurate.
As long as the cutting part can easily divide the separator at the cutting part, the cutting part may be completely cut in advance or may be a weak part that is not cut, and is not particularly limited. For example, a broken line-like cut, a curved line, or a straight cut may be used.
[0017]
The outer surface in the laminating direction of the other film substrate is a surface to which an existing adhesive film dressing is applied in order to fix the catheter, and it does not matter whether or not it has an adhesive function, but has an adhesive function. This is a more preferable embodiment. Accordingly, when the adhesive film dressing is bonded to this surface, the adhesive surfaces are brought into close contact with each other, so that the bonding can be performed more firmly.
As shown in FIG. 1, this adhesive function is imparted by providing an adhesive layer 4 on the outer surface 2a of the other film substrate 2 in the laminating direction as shown in FIG. This is a preferred embodiment.
Moreover, the aspect which does not form the adhesion function provided on this other film base material, especially an adhesive layer in the outer periphery part of this film base material is mentioned. That is, in the upper surface of the other film substrate, the pressure-sensitive adhesive layer is not formed in a region having a desired width from the outline, and the pressure-sensitive adhesive layer is provided only in the central region. Accordingly, when the adhesive film dressing is bonded to this surface, the adhesive layer is not exposed even if the position of the adhesive film dressing is slightly displaced.
[0018]
It is preferable to provide a peelable reinforcing layer on the outside in the stacking direction of the other film substrate. The reinforcing layer is peeled off after the catheter mounting aid is attached to the surface of the living body. This improves the handleability of the catheter attachment aid when not in use, and allows the outside of the film substrate in the stacking direction to be kept sterile until just before use.
Further, by using a transparent material for the reinforcing layer, it can be applied while looking at the application location.
The material of the reinforcing layer is not limited, and examples thereof include polyolefin films such as polyethylene and polypropylene, polyester films, polyvinyl chloride films, polyvinylidene chloride films, and acrylic films.
The thickness of the reinforcing layer is 10 μm to 80 μm, preferably 20 μm to 50 μm.
Methods for providing the reinforcing layer so as to be peelable from the film substrate include physical adsorption methods of the reinforcing layer and the film substrate, surface treatment methods such as corona treatment of the reinforcing layer surface, and thermocompression treatment methods. Is mentioned.
[0019]
In the case of the embodiment shown in FIG. 2 described above, there is further exemplified an embodiment in which two parallel linear cutting scheduled portions for dividing the entire catheter attachment aid into three parts are provided. . That is, as in the embodiment schematically shown in FIG. 3, even when the catheter attachment aid is formed by further laminating other layers, the two parallel linear cuts that can be divided into three parts as a whole. This is a mode in which the scheduled portions 14 and 15 are provided. Both straight lines of the two scheduled cutting parts are formed in parallel to the straight line of the cut part of the separator and at a position sandwiched between the two straight lines of the cut part of the separator. In addition, this cutting scheduled portion is a weak portion that is not cut even if it is a perforation as long as it can be used to easily divide the entire catheter mounting aid at that portion. There may be, and it does not restrict | limit in particular. FIG. 3 shows a form of perforations, and broken lines indicating the scheduled cutting portions 14 and 15 are holes that completely penetrate the laminated body to the back surface.
By providing this cutting-scheduled portion, in the affixing operation of the catheter attachment aid, first, the divided separator 12 is peeled off, the remaining separators 11 and 13 on both sides are held with both hands, and the exposed adhesive layer is removed. It is possible to perform an operation of attaching the catheter attachment aid to the surface of the living body, then dividing the catheter attachment aid at the portions to be cut 14 and 15, and discarding the portions on both sides that are not attached to the surface of the living body. Therefore, since the part touched by the hand is completely removed, the pasting operation is easy, quick, accurate, and cleaner.
[0020]
The film base, pressure-sensitive adhesive, separator, and reinforcing layer used in the present invention may contain known additives such as antibacterial agents, anti-aging agents, stabilizers, fillers, cross-linking agents, and pigments as necessary. it can.
[0021]
The catheter attachment aid of the present invention may be individually packaged in a sterilization bag, or may be sterilized by radiation or the like.
[0022]
[Performance confirmation experiment]
In this experiment, the workability of the catheter mounting aid according to the present invention was actually manufactured and applied to the mounting and fixing of the catheter, thereby confirming the workability and the state after the catheter was mounted.
[0023]
The structure of the catheter mounting aid produced for this experiment is as shown in the above embodiment and FIG. 1, and the specific specifications of each part are as follows. However, the outer shape of each part is a rectangle having an outer shape of 60 mm × 100 mm except for the shape of the region of the adhesive layer 3.
Reinforcing layer 5; thickness 40 μm, material polypropylene film.
Film base 2; thickness 25 μm, material polyether polyester.
Adhesive layer 3; shape of region 30 mm × 100 mm, thickness 50 μm, material acrylic pressure-sensitive adhesive.
Film substrate 1; thickness 25 μm, material polyether polyester.
Adhesive layer 6; thickness 20 μm, material acrylic adhesive.
Separator 7: Thickness 100 μm, material treated with silicone on the surface of fine paper. Moreover, as shown in FIG. 2, the cutting parts 9 and 10 are provided.
The external shape of the catheter to be attached was φ3 mm.
[0024]
As shown below, the catheter attachment auxiliary tool having the above specifications was applied to attachment when the catheter was punctured and inserted from the skin of a human body.
First, of the three divided separators, the central separator is peeled to expose the adhesive layer, positioned with both hands, applied to the skin in the vicinity of the puncture part, the remaining separator is peeled off, and one film substrate is entirely exposed. Affixed to the skin. Here, it was set as the direction where the adhesive bond layer which adhere | attaches a pair of film base material is the closest to a puncture part. After attaching the catheter attachment aid to the skin, the reinforcing layer was peeled off, and the catheter was placed on the aid of the present invention as described above. Furthermore, the existing adhesive film dressing was applied so as not to protrude from the other film substrate and to completely cover the puncture portion of the catheter to the living body, and the attachment of the catheter was completed.
[0025]
From the above experiment, it was confirmed that the catheter could be easily attached with good sealing performance. Moreover, when the circumference | surroundings of the puncture part immediately after attachment were confirmed, it sealed well and the space | gap which became an infection path | route of a sexual bacterium was not formed.
After the attachment, the catheter was moved by various operations, and force was applied to the puncture portion. However, the catheter attachment aid according to the present invention performed an opening / closing operation and satisfactorily followed the movement of the catheter. This reduced the lifting and peeling of the adhesive film dressing due to catheter movement.
[0026]
【The invention's effect】
According to the present invention, the catheter can be attached and fixed to the puncture portion of the living body with good workability. Further, even when a strong external force acts on the catheter and the catheter moves at the puncture portion of the catheter to the living body, the adhesive film dressing can be prevented from floating or peeling off from the living body surface.
[Brief description of the drawings]
FIG. 1 is a diagram schematically showing an embodiment of a catheter attachment aid according to the present invention.
2 is a view of the catheter attachment aid of FIG. 1 as viewed from the direction of arrow X. FIG.
FIG. 3 is a view schematically showing another embodiment of the catheter attachment aid of the present invention.
FIG. 4 is a view schematically showing a use state of the catheter attachment aid of the present invention.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 One film base material 1a The outer surface 2 of the one film base material in the lamination direction 2 The other film base material 2a The outer surface of the other film base material in the lamination direction 5 Removable reinforcing layer 6 Adhesive layer 7 Separator e Area to bond a pair of film bases so that they can be opened and closed

Claims (7)

Adhesive film dressing is attached to the living body surface near the puncture part so as to cover the puncture part of the catheter to the living body, and is an auxiliary tool used when attaching the catheter to the living body surface,
A pair of film base materials are laminated and bonded to each other in a region sharing a part of these outlines so that they can be opened and closed with each other. It consists of a laminate of a pair of film base materials that have an adhesive function and the other film base material is used for holding a catheter.
The laminated body of the pair of film bases is positioned so that the adhesive portion is in the direction closest to the puncture portion of the catheter to the living body and is in contact with or near the puncture portion of the catheter to the living body. So as to be disposed on the surface of the living body and stick the outer surface in the stacking direction of one film substrate to the surface of the living body, while the outer surface in the stacking direction of the other film substrate is Place the catheter going out of the body,
Adhesive film dressing is adhered to the surface so as to cover the catheter placed on the outer surface in the laminating direction of the other film substrate, and further, the catheter and the periphery of the puncture portion are covered so as to cover the catheter of the puncture portion. A catheter attachment assisting device characterized in that the catheter is attached to a living body by adhering to the surface of the living body.   The one film base material of the pair of film base materials further has a separator that covers the adhesive function, and the adhesive function is due to an adhesive layer provided on the film base material. The catheter mounting aid as described.   The catheter attachment aid according to claim 1 or 2, wherein the other film base of the pair of film bases has an adhesive function on an outer surface in the laminating direction.   The catheter attachment auxiliary tool according to any one of claims 1 to 3, wherein the other film base material of the pair of film base materials further has a detachable reinforcing layer on the outer surface in the laminating direction.   The outer shapes of the pair of film bases are congruent rectangles or squares, and these layers are stacked so that the outer shapes match, and the shape of the region to be bonded is one side of the outer shape of the film base The catheter attachment aid according to any one of claims 1 to 4, which is a rectangle or a square sharing a part or all of one side as one side.   The separator has two parallel straight cut portions to be divided into three, and the two straight lines of the cut portions have an equal distance from both ends of the one side of the outer shape of the film substrate. The catheter attachment aid according to claim 5, wherein the catheter attachment aid is formed at a position perpendicular to the one side.   The catheter attachment assisting tool further includes two parallel straight cutting portions for dividing the catheter into three parts, and both of the two cutting portions are straight lines of the separator cutting portion. The catheter attachment aid according to claim 6, which is formed at a position parallel to the straight line and sandwiched between the two straight lines of the cut portion of the separator.

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