JP2582655Y2 - Catheter holder - Google Patents

Description

[Detailed description of the invention]

[0001]

[Industrial application field] The present invention is intended to pierce the skin of a patient,
The present invention relates to a catheter holder for holding a catheter inserted by incision or the like in that state.

[0002]

2. Description of the Related Art When a catheter is inserted into a patient's skin from a distal end portion and is left in the body for a long period of time, a pathogen invades the body through the outer wall of the catheter from the insertion portion. In some cases, serious complications such as sepsis are often caused. In addition, the catheter may be accidentally detached from the insertion site due to the operation of the patient having the catheter placed therein.
Heretofore, there have been proposed several methods for securely fixing the catheter to an appropriate position and preventing pathogen invasion.

[0003] As a method of preventing the invasion of pathogens,
(1) A method of including an antimicrobial substance in or on the base material of the catheter, (2) A cuff is attached to the portion of the catheter to be buried in the body, and the surrounding tissue is developed in the cuff to provide a barrier against pathogens. (3)
There is a method of suppressing a pathogen invading along the catheter by covering the catheter insertion portion with a catheter holder formed of a material having antibacterial properties.

[0004] As a method of fixing the catheter,
(4) sew the catheter directly to the skin with a suture, (5)
There is a method of covering the entire catheter insertion section with an adhesive film, (6) fixing the catheter by developing tissue in the cuff attached to the catheter in (2), (7) using a catheter holder, and the like. .

[0005]

An invention is, however, a method of inhibiting the invasion of pathogens, methods of Ru is contained antibacterial substances to the catheter base material, such as (1) above, when the indwelling catheter in the body, the catheter The action of the antibacterial substance contained in the lipstick was too strong, and sometimes inflammation was caused. The method of attaching the cuff according to the above (2) has no effect until the tissue is sufficiently developed in the cuff, and furthermore, there is a trouble that a cuff burial site must be formed when inserting a catheter. there were. In this respect, the method (3) using the catheter holder has relatively few problems,
As shown in FIGS.
Because the fixed surface to the surface was flat, depending on the shape of the body surface
Poor adhesion to the skin surface of the catheter insertion site ,
A sufficient effect was not obtained.

[0006] In the method of fixing the catheter, the method of sewing directly to the skin in the above (4) has a risk of damaging or closing the catheter. In the method (5) of covering the entire insertion portion with the adhesive film, it is difficult to control the exudate such as blood from the catheter insertion portion. The method of attaching the cuff of the above (6) is described in the above (2).
As before, until the tissue is fully developed in the cuff,
There was also uncertainty regarding catheter fixation. In this respect, the method (7) using the catheter holder has relatively few problems.
Order to hold at right angles a catheter for insertion into a not necessarily perpendicular direction with respect如rather skin surface shown in 0 to the skin surface, there is a problem that it takes an excessive stress to the catheter.

[0007] Therefore, the present invention improves the above-mentioned drawbacks, improves the adhesion to the skin surface , enables reliable fixation to the skin, and prevents the invasion of pathogens into the body. It is an object of the present invention to provide a catheter holder in which excessive stress is not applied.

[0008]

SUMMARY OF THE INVENTION The present invention achieves the above object and provides a catheter holder comprising a disc-shaped portion for fixing to a skin surface and a cylindrical portion for inserting and fixing a catheter. (1) the disc-shaped portion and the cylindrical portion are formed of an organic polymer elastomer containing an antibacterial substance; and (2) the disc-shaped portion has a curved surface whose lower surface is convex downward. And (3) the cylindrical portion communicates with the through hole of the disc-shaped portion,
In addition, it is characterized by being erected obliquely with respect to the disc-shaped portion.

[0009]

The holding device of the present invention is formed of an organic polymer elastomer, and the cylindrical portion is set up obliquely with respect to the disk-shaped portion, so that excessive stress is applied to the catheter placed in the patient's body. It can be fixed without hanging and its movement can be prevented. Also, the disc-shaped part is formed of an organic polymer elastomer which also contains an antibacterial substance.
In addition, since the lower surface is a curved surface that is convex downward, it will be in close contact with the skin surface regardless of the shape of the body surface, and since the antibacterial substance works effectively, it is caused by pathogens that pass through the outer wall of the catheter. Infection can be prevented.

[0010]

DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, each of the catheter holders according to the present invention will be described.
Embodiments will be described in detail with reference to the drawings . 1 to 4 showing a first embodiment of the catheter holder of the present invention, reference numeral 1 denotes a catheter holder, and this catheter holder 1 is made of an organic polymer elastomer, and is used for inserting and fixing a catheter 7 therethrough. It comprises a cylindrical portion 2 and a disk-shaped portion 3 which is in close contact with the skin surface and covers the catheter insertion site.

[0011] Then, the diameter of the through hole (lumen) for inserting the catheter of the cylindrical portion 2, since it is desirable substantially equal to the outer diameter of the catheter, in this invention to use the organic polymer elastomers, multi It may be slightly larger or smaller ,
Further, the length is not particularly limited. A groove 4 is formed on the outer periphery of the cylindrical portion 2. After a catheter is inserted into the through-hole of the cylindrical portion 2, a thread is strongly wound from the outer periphery of the groove 4 so that The position of the catheter can be fixed. Further, a cutout 5 for attaching and detaching the catheter is formed on the side edge of the cylindrical portion 2 and the disc-shaped portion 3 as shown in FIG.

The disc-shaped portion 3 has a through-hole extending from the upper surface to the lower surface, and the cylindrical portion 2 is inclined on the disc-shaped portion 3 so as to communicate with the through-hole of the cylindrical portion 2. It is erected in. The angle between the cylindrical portion 2 and the disk portion 3 is 0 with respect to the disk portion 3 so that the catheter is not bent.
It is desirable that the angle be in the range of 85 to 85 degrees, preferably 5 to 60 degrees. In FIG. 4, the angle is 30 degrees. The disk-shaped portion 3 has a downwardly convex curved surface for tightly fixing to the skin 8, whereby the disk-shaped portion 3 is involved in the shape of the body surface.
When firmly fixed on the skin, it adheres to the skin,
It is possible to prevent invasion of pathogenic bacteria from the circumference immediately adjacent to the insertion portion. A small hole 6 for threading for fixing on the skin is formed in the disc-shaped portion 3.

5 and 6 showing another embodiment, FIG.
The disk-shaped part 3 is formed in an elliptical shape, and is substantially the same as the first embodiment except that the angle formed by the cylindrical part 2 and the disk-shaped part 3 is 45 °.

7 and 8 showing another embodiment, except that there is no small hole 6 and the adhesive is applied to the convex curved surface portion of the disc-shaped portion 3 which is in contact with the skin. Example 1
It is almost the same as In addition, in the figure which illustrated each said Example , although the catheter detachment | separation cut 5 was provided,
It is not necessary.

The cylindrical portion 2 and the disc-shaped portion 3 are formed of an organic polymer elastomer. The organic polymer elastomer has rubber-like elasticity at around normal temperature and is, for example, a natural rubber. , Butadiene, isoprene, pentadiene, hexadiene, heptadiene, polymers of diene monomers such as chloroprene or copolymers thereof,
Examples include butylene-ethylene-styrene copolymer, ethylene-vinyl acetate copolymer, silicone rubber such as organopolysiloxane, polyurethane, and soft polyvinyl chloride.

The organic polymer elastomer contains an antibacterial substance. The antibacterial substance is a substance having an antibacterial action, such as erythromycin, oxytetracycline, tetracycline, chloramphenicol, and the like. Fusidic acid, micamycin, kanamycin, gettamycin, fradiomycin, gramicidin, streptomycin, polymyxin, colistin, antibiotics such as bacitracin, biguanide compounds such as chlorhexidine, benzethonium, benzalkonium, lauryl sulfate, alkyl polyaminoethyl glycine, fatty acids and the like Compounds with surface activity, phenol,
Hexachlorophene, phenol derivatives such as resorcinol, boric acid, boric acid compounds such as borax, iodine, iodoform, iodine compounds such as povidone-iodine, gold, silver,
Metals such as copper and mercury; metal compounds such as thimerosal and methylobromine; antibacterial dye compounds such as acrinol and methylrosaniline; and sulfa agents such as mafenide acetate, sulfadiazine, sulfisomidine and sulfamethoxazole. These antibacterials include sodium salts,
Potassium, magnesium, calcium, hydrochloride,
Salt compounds such as sulfates and gluconates may be used.

As a method of manufacturing the catheter holder of the present invention, an organic polymer elastomer is melted or dissolved by heat or a solvent, and an antibacterial substance is added to the melted or melted material.
The mixture is mixed at a ratio of 1 to 80% by weight, preferably 0.01 to 50% by weight, and formed into a required shape. As a molding method, a method generally used for molding an elastomer may be used, and for example, an injection molding method, a dipping method, or the like is used.

The method of using the catheter holder of the present invention can be, for example, as follows. The catheter 7 is inserted into the through-hole (lumen) of the cylindrical portion 2 of the catheter holder 1, or if the cylindrical portion 2 has a catheter detachment cut 5, the cut 5 is opened and inserted.
The catheter 7 is inserted into the distal end portion of the catheter 7 or the like to reach a predetermined location of the patient and is left there. Alternatively, after the distal end of the catheter 7 is placed at a predetermined position in the body of the patient by puncturing or the like, the catheter detachment cut 5 of the catheter holder 1 is opened to cover the outer periphery of the catheter 7. Next, the catheter holder 1 is moved to bring the disc-shaped portion 3 into close contact with the skin 8 of the patient, and a thread is strongly wound around the groove 4 of the cylindrical portion 2 so that the catheter 7 is moved to the cylindrical portion of the catheter holder 1. Fix to 2. Thereafter, the disc-shaped portion 3 of the catheter holder 1 and the skin 8 are sutured and fixed by passing the thread through the small hole 6. A catheter that can be used for the catheter holder of the present invention is a medical tube inserted into the body for drainage of body fluid, circulation of body fluid, infusion or drainage of ring fluid or perfusate, or examination or the like, Anything is acceptable.

Specific Example 1 Chlorohexidine hydrochloride was added to ethylene-vinyl acetate copolymer at a ratio of 10% by weight and kneaded at 85 ° C.
Injection molding was performed into the shapes shown in FIGS. The diameter of the cylindrical part was 3 cm, and the inner diameter of the cylinder was 1.5 mm so that a polyurethane catheter (outer diameter 1.5 mm) could be inserted.

After cutting the hair on the back of a rabbit weighing about 2.5 kg, the above-mentioned polyurethane catheter was subcutaneously applied to the tip of the rabbit from the tip.
The catheter was inserted and placed to a length of 5 cm, the above-mentioned catheter holder was attached to the catheter, and was brought into close contact with the skin at the catheter insertion site, the groove 4 was tied with a suture, and the catheter was fixed to the holder. Furthermore, the holder was sutured and fixed to the skin so as not to separate from the skin. At this time, it was observed that the catheter was held straight without applying excessive stress to the insertion direction, and that the holder was in close contact with the skin. On the holder, the bacterial solution of Staphylococcus aureus (10 ⁸
Per ml) was placed thereon, fixed with tape on top of it, and allowed to stand for 10 days. The skin was incised and the catheter was taken out. The catheter placed in the rabbit body on the distal side from the holder was taken out and cultured on a brain heart infusion agar medium, but no colony was detected.

As a comparative example, the contact surface with the skin is flat,
9 and 1 with the catheter held at right angles to the skin
The holder shown in No. 0 was molded using an ethylene-vinyl acetate copolymer containing chlorhexidine hydrochloride, and the same experiment as above was performed. Since the catheter inserted subcutaneously at an angle of about 30 ° was forcibly held at a right angle, the removed catheter was curved near the insertion portion. In addition, the holder was floating from the skin in some places, and the adhesion was not so good. When this catheter was cultured, colonies due to invasion of bacteria were detected from the indwelling portion of the catheter.

Example 2 Chlorohexidine hydrochloride was added to the ethylene-vinyl acetate copolymer at a ratio of 10% by weight and kneaded at 85 ° C.
Injection molding was performed into the shapes shown in FIGS. This catheter holder had no small holes for fixing the holder, but was coated with a polyolefin-based adhesive 9 for skin adhesion on a portion excluding a radius of 5 mm from the center of the disk. The diameter of the disc-shaped part of this catheter holder is 3 cm, and the inner diameter of the cylindrical part is
1.5 mm. When used in the same manner as in Example 1, similar effects were obtained.

[0023]

As is apparent from the foregoing description of the invention] The catheter retainer of this invention is, without applying excessive stress to the catheter which is indwelling in the patient, rather than Rubakari can be reliably fixed Since the movement of the holder can be prevented and the disc-shaped part of the holder is in close contact with the skin, the antibacterial substance contained in the holder works effectively, thus preventing infection by pathogens through the outer wall of the catheter. Excellent effects can be achieved.

[Brief description of the drawings]

FIG. 1 is a perspective view showing an embodiment of a catheter holder according to the present invention.

FIG. 2 is a plan view of the catheter holder shown in FIG.

FIG. 3 is a bottom view of the catheter holder shown in FIG.

FIG. 4 is a cross-sectional view taken along line A-A 'shown in FIG.

FIG. 5 is a side view showing another embodiment of the catheter holder of the present invention.

6 is a plan view of the catheter holder shown in FIG.

FIG. 7 is a plan view showing another embodiment of the catheter holder of the present invention.

FIG. 8 is a bottom view of the catheter holder shown in FIG.

FIG. 9 is a side view showing a conventional catheter holder.

FIG. 10 is a plan view of the catheter holder shown in FIG.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Catheter holder 2 Cylindrical part 3 Disk-shaped part 4 Groove part 5 Cut line for catheter insertion / removal 6 Small hole 7 Catheter 8 Skin 9 Adhesive

────────────────────────────────────────────────── ─── Continued on the front page (72) Inventor Masanao Koyama 23, Uji Kozakura, Uji City, Kyoto Unitika, Central Research Laboratory, Inc. (56) References JP-A-2-299665 (JP, A) JP-A-60-100973 (JP, A) JP-A-4-193181 (JP, A) JP-A-64-9656 (JP, U) JP-A-58-108846 (JP, U) (58) Fields investigated (Int. Cl. ⁶⁾ , DB name) A61M 25/02

Claims (1)

(57) [Scope of request for utility model registration] 1. A catheter holder comprising a disc-shaped portion for fixing to a skin surface and a cylindrical portion for inserting and fixing a catheter, wherein: (1) the disc-shaped portion and the cylindrical portion are: (2) The disc-shaped portion has a curved surface whose lower surface is convex downward, and has a through-hole extending from the upper surface to the lower surface. ) The cylindrical portion communicates with a through hole of the disc-shaped portion;
And a catheter holder which is erected obliquely with respect to the disc-shaped portion.