JPS59118166A - Medical needle and medical instrument having same - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION 10. Background of the Invention (Technical Field) The present invention relates to a medical needle and a medical instrument having the same.

(Prior Art and its Problems) A medical needle is known in which the hub and protector of the medical needle are integrally molded to ensure tamper-proofness, hygiene, etc. (see U.S. Pat. No. 3,523,530). ). In such medical needles, when the hub and protector are integrally molded, a thin fragile part is simultaneously formed between them, and when in use, the camera is exposed by twisting this thin fragile part. There is. By the way, although integrally molding the hub and protector in this way seems very reasonable, many problems have been pointed out as described below. Not only does it require advanced technology to mold an overall thin and long hub/protector composite, but it is even more difficult to simultaneously form small thin-walled fragile parts, which inevitably means that the thin-walled parts and the parts to be formed are relatively thick. There is a tendency for it to become fleshy, which not only increases the force required for twisting and cutting, but also tends to increase the variation among finished products. Furthermore, the manufacturing mold must be precise, resulting in high costs. Furthermore, due to the fact that they are integrally molded, the hub and protector are made of the same material, and while the hub portion where the hollow needles are implanted is strong, the protector portion that is continuous with this is hollow and relatively It is thin and easily deforms. In order to prevent this, there is a problem associated with integral molding that the protector portion must be made relatively thick. Since medical needles are generally connected to tubes made of vinyl chloride resin, the materials for the hub and protector are necessarily limited, resulting in the problems described above.

1. Purpose of the Invention Accordingly, the purpose of the present invention is to provide a material that can be manufactured relatively easily, has a homogeneous thin-walled fragile part for cutting, and can be easily broken and removed with a constant force to expose the hollow needle. The purpose of the present invention is to provide an inexpensive medical needle and a medical device equipped with the same.

Another object of the present invention is to provide a medical needle configured such that a protector portion that covers a hollow needle portion exposed from a hub does not deform and damage the hollow needle portion, and a medical instrument equipped with the same. I'm trying.

10 Specific Structure of the Invention According to the first aspect of the invention, there is a hollow needle having a pointed end, a proximal end of the hollow needle is supported, and a tube is connected to the hollow needle at the other end. It consists of a hub that can be connected and lowered, and a hollow body whose distal end is closed and whose proximal end is open, and the distal end side of the hub is attached at the open end of the hollow body so as to seal the hollow needle portion exposed from the knob 1. and a protector made of a molded body fixed to the /
A medical needle is provided in which a thin fragile portion is formed on the X-jib at a portion other than the portion to which the protector is fixed.

According to a second aspect of the present invention, the hollow needle has a container for containing a liquid and has a pointed end, and the hollow needle has a proximal end side supported and a tube attached to the other end of the hollow needle. a hub that can be connected to communicate with the hub; and a hollow body having a closed distal end and an open proximal end, the distal end of the hub at the open end of the hollow body so as to seal the hollow needle portion exposed from the hub. a medical needle comprising a protector made of a molded body fixed to the side thereof, and a thin fragile part formed on the hub except for the part fixed to the protector;
A medical device is provided, the tube having one end connected to the proximal end of the hub so as to communicate with the hollow needle, and the other end communicating with the container.

Preferably, the tube and the blood collection container and the tube and the protector are fixed using a solvent or an adhesive that dissolves the constituent materials of both.

The adhesive is preferably a vinyl chloride polymer base resin blended with a plasticizer, and the composition of the adhesive is preferably such that the amount of plasticizer blended is 50 to 350 parts by weight based on 100 parts by weight of the paste resin. Preferably, the enlivening agent is phthalate esters, trimellitate esters, aliphatic polybasic acid esters, phosphoric acid esters, citric acid esters or butylphthalyl butyl glycolate.

Preferably, at least the fixed portions of the hub and the protector are made of the same material. The protector includes at least a first layer having a fixing portion to the hub, and a second inner layer thereof, the first layer protruding more proximally than the second layer, and the It is preferable that the protector portion to be slid on is formed only by the first layer, and the second layer is made of an olefin plastic selected from polyethylene, polypropylene, and polybutylene, and is particularly preferably made of polypropylene. It is.

Hereinafter, preferred embodiments of the present invention shown in the drawings will be described in detail.

FIG. 1 shows a medical needle 1 of the present invention in partial cross section. A hollow needle 3 with a pointed end 2 is fixed to a knob 5 with an adhesive 4 (e.g., epoxy resin), and a connecting tube (not shown) is connected to the proximal end of the hub 5. An annular recess 6 is formed to allow communication between the tube and the hollow needle 3. In this way, the hollow needle portion exposed from the hub 3 is hermetically covered by the protector No. 7. Conventionally, this envelopment has been performed using an integrally molded knob and protector composite, but as mentioned above, there were various problems, so in the present invention, the hub and protector are formed as separate molded bodies. The exposed portion of the hollow needle is hermetically encapsulated by bonding these together.

Generally, the connecting tube is made of vinyl chloride resin. Therefore, the hub is made of PVC (vinyl chloride resin). Furthermore, it is best that this hub and protector are made of PVC.

However, if the protector is made of PVC, it will have the same strength problem as conventional integrally molded products, and the only way to solve this problem will be to increase the thickness, which will lead to an unnecessary increase in cost. Of course, the protector may be composed of a single layer of PVC, but preferably the protector is composed of multiple layers. A two-layer molded protector, which is a preferred embodiment, is shown in FIG.

The protector 7 shown in FIG. 1 has an outer layer 8 for adhesion to the hub 5 and an inner reinforcing layer 9, and the end thereof is closed. The outer layer 8 is formed so as to protrude from the reinforcing inner layer 9 by an adhesive portion 10 . Correspondingly, a first step 11 and a second step 12 are formed at the tip of the hub 5, and the outer layer 8 and inner layer 9 are aligned as shown in FIG. 1, respectively.

By the way, the hub 5 and the protector 7 are tightly fixed in a sealed state between the first step part 11 of the hub and the protruding part 10 of the outer layer 8. It is preferable that the two members be bonded using a solvent or adhesive that can dissolve the material (for example, PVC) constituting the two members. Typical solvents include organic solvents such as tetrahydrofuran (THF). As the adhesive, it is preferable to use a vinyl chloride polymer base resin described below.

Note that the inner layer 9 is of course not bonded to the knob 5 because it is twisted or cut and heated, and the inner layer 9 is made of olefin such as polyethylene, polypropylene, polybutylene, etc. to give the protector strength. Plastics are preferred, with polypropylene being the most preferred.

The vinyl chloride polymer base resin blended with a plasticizer used in the present invention refers to fine powder of a vinyl chloride polymer with a particle size of 0.02 to 20 μm, preferably 0.1 to 10 μm, mixed uniformly with a plasticizer. [It is made by dispersing and suspending this. In addition to homopolymers of vinyl chloride, imitative powdered vinyl chloride polymers include copolymers of vinyl chloride and comonomers such as vinylidene chloride, vinyl acetate, and vinyl alcohol. The amount of
It's morchi. The average degree of polymerization of these homopolymers and copolymers is 900-1200. Preferably 960~
It is 1130.

The base resin is made by dispersing and suspending such a finely powdered vinyl chloride polymer in a plasticizer, and its solid content is 25 to 50% by weight, preferably 30 to 50% by weight. Examples of plasticizers that make the vinyl chloride polymer y-era cloudy include di-2-ethylhexyl phthalate, di-n-octyl phthalate, diisooctyl phthalate,
Phthalate esters such as dioctyl azelate, didecyl phthalate, diisodecyl phthalate, octyldecyl phthalate, butylbenzyl phthalate, trimellitic acid esters such as tributyl trimellitate, trioctyl trimellitate, dioctyl adipate, dioctyl azelate, Aliphatic polybasic acid esters such as dioctifresebacate, tricresyl phosphate, tricylenyl phosphate, monooctyl diphenyl phosphate, monobutyl dixylenyl phosphate, t1''
Phosphate esters such as octyl bosphate, butyl acetyl citrate, trioctyl acetyl citrate, butylphthalyl butyl 1-nocholate, etc.

The adhesive used in the present invention further contains 50 to 350 parts by weight, preferably 150 to 20050 to 200 parts by weight, or about 200 parts by weight of a plasticizer based on 100 parts by weight of such base resin. The amount of plasticizer used is as follows: 15 parts of plasticizer per 100 parts of base resin.
If the amount is less than 0 parts by weight, the viscosity suitability of the adhesive solution used will be insufficient, and if it exceeds 350 parts by weight, the adhesive strength will be insufficient.

A blend of such a vinyl chloride polymer base resin and a plasticizer may be used as necessary. Metal soaps with ethylhexoic acid, dibutyltin dilaurate,
Organic tins such as dibutyltin dimaleate and dibutyltin mercaptide can be blended as stabilizers.

In the medical needle 10 of the present invention having the hub and protector bonded together as described above, a twisting mechanism is formed as described below. A ring-shaped cut portion is formed on the outer periphery of the hub 5 to provide a thin weakened portion 13 between the bonded portion between the hub 5 and the protector 7 and the bonded portion between the annular recess 6 of the hub 5 and the tube. The hub 5 and the hollow needle 3 are bonded together with an adhesive such as epoxy resin, and a portion of the adhesive passes through the hollow needle 3 and permeates into the through hole 14 of the hub. For this reason, if the thin-walled fragile portion 13 is formed on the hub portion close to the bonded portion between the hub 5 and the hollow needle 3, separation at the thin-walled fragile portion 13 may be difficult or impossible due to infiltration and solidification of the adhesive. There is a fear. Therefore, T
When the hollow needle 3 and the hub 5 are bonded together using an adhesive, it is preferable to form the thin-walled fragile portion 13 on a portion of the hub as far away as possible from this bonding position. And thin-walled weak part 1
3 on the relatively distal side of the knob 1, that is, in a position close to the adhesive part between the /X button 5 and the protector 7, the protruding base end of the hollow button 3 and the base end of the hub 50 It is preferable to apply an adhesive 4' between the parts.

The thin-walled fragile portion 13 formed on the hub 51 may be formed during the molding of the hub 5, or may be formed during subsequent processing, but it will not be damaged during distribution and storage and can be easily twisted and cut during use. It is necessary to form the wall to be thick enough to allow this. When the hub is made of PvC, the thickness of the thin fragile part is approximately 0.5mm.
It was confirmed that by cutting the material, it is easy to manufacture and a homogeneous product can be obtained, and both the breakage resistance during distribution and storage and the ease of twisting and cutting during use are guaranteed.

If the hub 5 and protector 7 are fixed together by adhesive, it is not necessary to manufacture them to precise dimensions compared to the case where they are tightly fitted, and even if there is a slight dimensional difference (tolerance), There is no problem since it is filled with adhesive.

FIG. 2 shows another example of the construction of the medical needle 1 of the present invention. In this example, the protector 7 is similar to that of FIG.
The outer layer 8 has an outer layer 8 which is an adhesive layer with the hub 5, and an inner reinforcing layer 9 thereof, and the outer layer 8 extends to the lower right of the protruding portion 15 than the inner layer 9 so that it can be bonded to the hub 5.

The hub 5 also has a protruding portion 16 corresponding to the protruding portion 15, and both protruding portions 15 and 16 are fixed as described above. At this time, the hollow needle 3 and the hub 5 are fixed with the adhesive 4 at the proximal end of the protruding portion 16.

In this example as well, the hub 5 is bonded to the outer layer 8 of the protector 7, as in the case shown in FIG. 1, and since they are made of the same material, the adhesion is excellent.

The thin-walled fragile portion 13 is formed on the outer periphery of the hub 5 and is connected to the hub 5 and the protruding portion 1.
It is formed in a part other than the adhesive part with 5. The dimensions and shape are the same as those described for the example of FIG.

The medical needle 1 described above is used by being connected to various blood collection containers. As a representative example of this, an example connected to a blood bag is shown in an exaggerated manner in FIG. In FIG. 3, 17 is a blood bag, and 18 is a connecting tube. The connecting tube 18, the mW bag 15, and the hub 5 of the medical needle 1 can be bonded together in the same manner as described for bonding the hub 5 of the medical needle 1 and the protector 7. especially,
Preferably, vinyl chloride polymer based resins are used.

In addition to vinyl chloride homopolymers, vinyl chloride resins used to make blood collection containers such as blood bags and connecting tubes include copolymers of vinyl chloride, vinyl acetate, vinyl alcohol, etc., and vinyl chloride. In the case of this copolymer, the amount of monomer bonded to vinyl chloride is 15 moles/L/% or less, preferably 3 to 7 moles.

(6) Specific Effects of the Invention The medical needle of the present invention and the medical instrument having the same are used by being connected to a water sampling container as shown in FIG. During use, by placing each finger on the ribs 17 and 18 formed on the hub 5 and the protector 7 and applying twisting force in opposite directions, the parts on the hub 5 excluding the part where the protector 7 is fixed , T, that is, the ring-shaped thin-walled fragile part 13 formed between the fixed part between the hub 5 and the protector 7 and the connecting part between the hub 5 and the tube is twisted, and a part of the hub 5 and the protector 7 are twisted. is separated from the hub 5, and the hollow needle 3 is exposed by removal of this separated portion. This state is shown in FIG. The tip of the hollow needle 3 is punctured into the patient and blood is collected in a conventional manner. The collected blood is collected from the hollow needle 3 through the tube 16 into the blood collection container 15.

The torsional force applied in this manner may be a certain small amount because the pre-formed thin-walled fragile portion 13 is sufficiently thin and is uniform throughout the product.

Further, when the protector 7 has at least a two-layer structure, it has sufficient deformation resistance, so that the hollow needle will not be damaged during twisting or storage.

(6) Effects of the Invention The medical needle according to the present invention and the medical instrument having the same have many advantages over conventional needles as described below.

(1) The hub and protector are not integrally molded, but have a structure in which each separate member is glued together. Especially when a vinyl chloride polymer-based resin is used to bond the two, no solvent is used, so excess solvent may be used for medical purposes. There is no need to worry about it getting mixed into the equipment, and since no solvent is used, there is no deterioration of the material or the occurrence of cracks, and the working environment for joining will not deteriorate.

(2) When the hub and protector are integrally molded, there is no need for precision in the mold for manufacturing the hub, and there is no problem in manufacturing the characteristic thin-walled fragile portion. In addition, the thin-walled fragile part can be made sufficiently thinner than when the hub and protector are integrally molded, which means that no damage occurs during distribution, and all products are easy to twist and cut during use. It can be obtained homogeneously throughout.

(3) Since the protector has at least a two-layer structure, sufficient reinforcing strength can be provided, so that the protector is not deformed (therefore, the hollow needles are not damaged during storage or twisting).

(4) Since the protector and the hub are bonded to each other using the same material, good and firm bonding can be achieved.

(5) Even when the protector has a multilayer structure, the thin fragile portion is made of a material that can be easily twisted and cut, and is formed on the hub portion that is not affected by the epoxy adhesive, so twisting and cutting can be easily done.

(6) When the connecting portion of the medical device having the medical needle of the present invention is connected using the vinyl chloride polymer base resin described above, the same effect as described in (1) can be obtained.

[Brief explanation of the drawing]

FIG. 1 is a partial vertical cross-sectional view of a medical needle of the present invention, FIG. 2 is a partial vertical cross-sectional view of another configuration example of the medical needle of the present invention, and FIG. 3 is a medical needle having a medical needle of the present invention. FIG. 4 is a partial cross-sectional view of the medical needle of the present invention with the hub and protector separated by twisting. Explanation of symbols 1. Medical needle of the present invention, 2. Point, 3. Hollow needle, 4. Adhesive, 5. Hub, 6. Annular recess, 7..・Protector, 8...Outer layer, 9...Inner layer, 10...Protruding portion, 11...First step portion, 12...
・Second stage part, 13... Thin-walled fragile part, 14... Through hole, 15.16... Projecting part, 17... Collapse bag,
18...Tube, 19.20...Rib Patent Applicant Terumo Corporation Representative Patent Attorney Minoru Watanabe (1,゛

Claims (1)

[Scope of Claims] (1) A hollow needle with a pointed end, and a hub that supports the proximal end of the hollow needle and can connect a tube to the other end so as to communicate with the hollow needle. , consisting of a hollow body with a distal end closed and a proximal end open, and a molded body fixed to the distal end side of the hub at the open end of the hollow body so as to seal the hollow needle portion exposed from the hub. 1. A medical needle, comprising: a protector, and a thin fragile portion is formed in a portion of the hub other than a portion to which the protector is fixed. (2) At least the fixed portions of the hub and the protector are made of the same material.
This medical needle is described here. 0) The protector has at least a first layer having a fixing portion to the hub, and a second inner layer thereof, and
Claim 1 or 2, wherein the layer protrudes more proximally than the second layer, and the protector portion fixed to the hub is composed of only the first layer. needle. (4) The second layer is made of polyethylene, polypropylene,
The medical needle according to claim 3, which is made of an olefin plastic selected from polybutylene. (5) The medical needle according to claim 3, wherein the second layer is made of polypropylene. (6) The medical needle according to any one of claims 1 to 5, wherein the hub and the protector are fixed to each other using a solvent or adhesive that can dissolve the constituent materials of both. (7) The medical needle according to claim 6, wherein the adhesive is a vinyl chloride polymer-based resin containing a plasticizer. (8) The medical needle according to claim 7, wherein the composition of the adhesive is such that the amount of plasticizer blended is 50 to 350 parts by weight based on 100 parts by weight of the base resin. (9) Claim 7, wherein the plasticizer is phthalic acid esters, trimellitic acid esters, aliphatic polybasic acid esters, phosphoric acid esters, citric acid esters, or butylphthalyl butyl glycolate. Section or 8th
Medical needles listed in section. αO) A hollow needle having a container containing a liquid and having a pointed end, supporting the proximal end of the hollow needle, and connecting a tube to the other end so as to communicate with the hollow needle. A molding comprising a hub and a hollow body having a closed tip and an open base end, the open end of the hollow body being fixed to the distal end side of the hub so as to seal the hollow needle portion exposed from the hub. a medical needle comprising a protector made of a body, and a thin fragile portion formed on the hub except for a portion to which the protector is fixed; A medical device characterized by having a tube connected to the container and having the other end communicating with the container. α1) At least the fixed portion of the hub and the protector are made of the same material. A medical device according to claim 10. (a) The protector has at least a first layer having a fixing portion to the knob 1, and a second inner layer thereof, the first layer protruding more proximally than the second layer, and 12. The medical instrument according to claim 10, wherein the protector portion fixed to the hub is composed of only the first layer. α3) The second layer is made of polyethylene, polypropylene,
13. The medical device according to claim 12, which is made of an olefin plastic selected from polybutylene. α4) The medical device according to claim 12, wherein the second layer is made of polypropylene. 1. The tube and the blood collection container, and the hub and the protector are fixed to each other using a solvent or an adhesive that dissolves the constituent materials of both of them. medical equipment. α6) The medical device according to claim 15, wherein the adhesive is a vinyl chloride polymer paste resin mixed with a plasticizer. 17. The medical device according to claim 16, wherein the composition of the adhesive includes 50 to 350 parts by weight of the plasticizer based on 100 parts by weight of the paste resin. Claim 16, wherein the plasticizer of 0 is phthalate esters, trimellitic acid esters, aliphatic polybasic acid esters, phosphoric acid esters, citric acid esters, or butylphthalyl butyl glycolate. or the medical device according to item 17.