JPH0117381B2 - - Google Patents

Description

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 a hub and a protector of the medical needle are integrally molded to ensure tamper-proof properties, hygiene, etc. (see US 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 the two, and when in use, the cannula 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 and protector composite, but it is even more difficult to simultaneously form small thin-walled fragile parts, which inevitably means that the parts that should be thin-walled 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. In addition, the manufacturing mold must be precise,
This results in high costs. Furthermore,
Due to the integral molding, the hub and protector are made of the same material, and while the hub portion where the hollow needle is implanted is strong, the protector portion that is continuous with it is hollow and relatively thin. Easy to deform. To prevent this, there is a problem associated with integral molding that the protector portion must be made relatively thick. Generally, medical needles are connected to a tube made of vinyl chloride resin.
The materials for the hub and protector are also necessarily limited, resulting in the problems described above.

OBJECTS OF THE INVENTION Therefore, an object of the present invention is to manufacture a needle that is relatively easy to manufacture, has a homogeneous thin-walled fragile part for cutting, and can be easily broken and removed with a constant force to expose a hollow needle. The purpose is to provide inexpensive medical needles and medical instruments equipped with the same.

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

Specific Structure of the Invention According to the first aspect of the present invention, a hollow needle having a pointed end is supported, and a tube is provided at the other end to communicate with the hollow needle. It consists of a hub that can be connected, and a hollow body whose distal end is closed and whose proximal end is open, and the open end of the hollow body is fixed to the distal end side of the hub so as to seal the hollow needle portion exposed from the hub. a protector made of a molded body, the protector having at least a first layer having a fixing portion to the hub, and a second layer made of a material having higher rigidity than the first layer as an inner layer thereof, The first layer protrudes more proximally than the second layer, and is fixed to the hub at the protruding first layer portion, the hub is made of a material with low rigidity, and the hub is fixed to the protector at a portion on the hub. A medical needle is provided in which a thin-walled fragile portion is formed in a portion other than the portion.

According to a second aspect of the present invention, the hollow needle has a container for storing a liquid and has a pointed end, and the hollow needle has a proximal end side supported and a tube at the other end. 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 a part fixed to the protector, and one end of the needle communicates with the hollow needle. and a tube connected to the proximal end of the hub and having the other end communicatively connected to the container.

It is preferable that the tube and the blood collection container and the hub and the protector be fixed to each other using a solvent or an adhesive that can dissolve the constituent materials of both. The adhesive is a vinyl chloride polymer paste 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 per 100 parts by weight of the paste resin. Preferably, the plasticizer is phthalate esters, trimellitic acid 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 second layer is made of polyethylene, polypropylene,
It is preferably constructed from an olefinic plastic selected from polybutylene, particularly polypropylene.

The present invention will now be described in detail with reference to preferred embodiments shown in the drawings.

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 coated with an adhesive 4.
An annular recess 6 that is fixed to the base end of the hub 5 with (for example, epoxy resin) and to which a connection tube (not shown) can be connected.
is formed, and is configured to communicate between the tube and the hollow needle 3. In this way, the hollow needle portion exposed from the hub 5 is hermetically covered by the protector 7. Conventionally, this encapsulation was performed using an integrally molded hub and protector composite, but
As mentioned above, there have been various problems, and in the present invention, the hub and protector are formed as separate molded bodies, and these are adhered to seal the exposed portion of the hollow needle.

Generally, the connecting tube is made of vinyl chloride resin. Therefore, the hub is made of PVC (vinyl chloride resin). Furthermore, the protector that should be bonded to this hub should be made of PVC.
However, if the protector is made of PVC, there will be strength problems similar to those of conventional integrally molded products, and the only way to solve this problem is to make it thicker.
This results in unnecessary high costs. For this reason, it is preferable that the protector be composed of a multilayer body. 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 that is an adhesive layer with the hub 5 and a reinforcing layer 9 as an inner layer thereof.
The ends are occluded. 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 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 paste resin described below.

Note that the inner layer 9 is of course not bonded to the hub 5 because it is twisted or separated, and its constituent material is preferably an olefin plastic such as polyethylene, polypropylene, or polybutylene in order to impart strength to the protector. However, polypropylene is most preferred.

The vinyl chloride polymer paste resin blended with a plasticizer used in the present invention has a particle size of 0.02~
It is made by uniformly dispersing and suspending vinyl chloride polymer fine powder of 20 μm, preferably 0.1 to 10 μm, in a plasticizer. Finely powdered vinyl chloride polymers include homopolymers of vinyl chloride as well as copolymers of vinyl chloride and comonomers such as vinylidene chloride, vinyl acetate, and vinyl alcohol. The amount of is 30 mol% or less, preferably 3 to 7 mol%. The average degree of polymerization of these homopolymers and copolymers is from 900 to 1200, preferably from 960 to
It is 1130.

Paste 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.
It is 50% by weight. Plasticizers for suspending such vinyl chloride polymers include di-2-ethylhexyl phthalate, di-n-octyl phthalate,
Phthalate esters such as diisooctyl phthalate, diheptyl phthalate, didecyl phthalate, diisodecyl phthalate, octyldecyl phthalate, butylbenzyl phthalate, trimellitic acid esters such as tributyl trimellitate, trioctyl trimellitate, dioctyl adipate, Aliphatic polybasic acid esters such as dioctyl azelate and dioctyl sebacate, tricresyl phosphate, tricylenyl phosphate,
Phosphate esters such as monooctyl diphenyl phosphate, monobutyl dixylenyl phosphate, trioctyl phosphate, citric acid esters such as tributyl acetyl citrate, trioctyl acetyl citrate, tributyl citrate, butylphthalyl Butyl glycolate, etc.

The adhesive used in the present invention may be present in an amount of 50 to 350 parts by weight, preferably 150 to 200 parts by weight, most preferably about 200 parts by weight, based on 100 parts by weight of such paste resin.
It is made by further blending parts by weight of a plasticizer, and the plasticizers used are those mentioned above. In other words, if the amount of plasticizer is less than 50 parts by weight based on 100 parts by weight of the paste resin, the viscosity suitability of the adhesive solution used will be insufficient, while if it exceeds 350 parts by weight, the adhesive strength will be insufficient. It is.

Such a blend of vinyl chloride polymer paste resin and plasticizer may optionally contain metals such as lead, cadmium, barium, zinc, and calcium, and stearic acid, lauric acid, ricinoleic acid, naphthenic acid, and 2-ethylhexoic acid. Metallic stabilizers such as dibutyltin dilaurate, dibutyltin dimaleate, dibutyltin mercaptide, and other organic tins can be blended as stabilizers.

In the medical needle 1 of the present invention in which the hub and protector as described above are bonded together, the 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 fragile 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 near the adhesive portion between the hub 5 and the hollow needle 3, the thin-walled fragile portion 13
It may become difficult or impossible to separate the Therefore, when the hollow needle 3 and the hub 5 are bonded together using the adhesive shown at 4 in FIG. 1, it is preferable to form the thin-walled fragile portion 13 on the hub portion as far away as possible from the bonding position. For this reason, the thin-walled fragile portion 13 is provided at a relatively distal side of the hub, that is, at a position close to the bonding portion between the hub 5 and the protector 7, and is bonded between the proximal end of the hollow needle 3 and the proximal end of the hub 5. It is preferable to apply agent 4. The thin-walled fragile portion 13 formed on the hub 5 may be formed during molding of the hub 5, or may be formed during subsequent processing, but should be made so that it will not be damaged during distribution and storage and can be easily twisted and cut during use. It needs to be formed thickly. When the hub is made of PVC, the wall thickness of the thin-walled fragile part is approximately
If it is 0.5mm, it will be easy to manufacture and can be made homogeneous.
It was confirmed that both breakage resistance during distribution and storage and ease of twisting and cutting during use were 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 configuration of the medical needle 1 of the present invention. In this example, the protector 7 has an outer layer 8 which is an adhesive layer with the hub 5 and a reinforcing layer 9 as an inner layer, similar to the one in FIG. It has a protruding portion 15. The hub 5 also has a protruding part 16 corresponding to the protruding part 15, and both protruding parts 15 and 1
6 is fixed as described above. 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 bonding properties are good. The thin-walled fragile portion 13 is located on the outer periphery of the hub 5.
It is formed in a portion other than the adhesive portion between the hub 5 and the protruding portion 15. 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 typical example, 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 connection tube. Connection tube 18 and blood bag 1
5 and the hub 5 of the medical needle 1 can be bonded in the same manner as described in the case of bonding the hub 5 of the medical needle 1 and the protector 7. especially,
Preferably, a vinyl chloride polymer paste resin is used.

In addition, the vinyl chloride resin that makes up blood collection containers such as blood bags and connection tubes include:
In addition to homopolymers of vinyl chloride, there are copolymers of vinylidene chloride, vinyl acetate, vinyl alcohol, etc. with vinyl chloride, and in the case of these copolymers, the amount of monomers bonded with vinyl chloride is preferably 15 mol% or less, preferably It is 3 to 7 mol%.

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 blood collection 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 , that is, a ring-shaped thin-walled fragile portion 13 formed between the fixed portion between the hub 5 and the protector 7 and the connecting portion between the hub 5 and the tube.
is twisted, a portion of the hub 5 and the protector 7 are separated from the hub 5, and the hollow needle 3 is exposed by removing 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 uniform throughout the product.
Furthermore, since the protector 7 has at least two layers, it has sufficient deformation resistance, and the hollow needle will not be damaged during twisting or storage.

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 vinyl chloride polymer paste resin is used to bond the two, no solvent is used, so excess solvent may be There is no need to mix it into the equipment, and since no solvent is used, there is no deterioration of the material or occurrence of cracks, and there is no deterioration of the working environment for joining.

(2) When the hub and protector are integrally molded, the precision of the manufacturing mold etc. is not required, and the manufacturing of the characteristic thin-walled fragile portion becomes less of a problem.
Furthermore, 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 ease of twisting and cutting during use is ensured for all products. Obtained homogeneously.

(3) Since the protector has at least a two-layer structure, sufficient reinforcing strength can be provided, so that the hollow needle will not be damaged during storage or twisting due to deformation of the protector.

(4) Since the protector and the hub are bonded together using the same material, the bonding can be done well and firmly.

(5) The protector has a multi-layer structure, and the thin fragile part is made of a material that is easy to twist and cut, and is formed on the hub part that is not affected by the epoxy adhesive, so twisting can be easily done.

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

[Brief explanation of drawings]

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...
Tip, 3... Hollow needle, 4... Adhesive, 5... Hub, 6... Annular recess, 7... Protector, 8...
Outer layer, 9...Inner layer, 10...Protruding portion, 11...
1st stage part, 12...2nd stage part, 13...thin-walled weak part, 14...through hole, 15, 16...protruding part,
17...Blood bag, 18...Tube, 19,
20...Rib.

Claims (1)

[Scope of Claims] 1. A hollow needle having a pointed end, 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, and a distal end thereof. and a protector made of 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. , the protector has at least a first layer having a fixing portion to the hub, and a second layer made of a material having higher rigidity than the first layer as an inner layer thereof, and the first layer is more rigid than the second layer. protrudes toward the proximal end, and is fixed to the hub at this protruding first layer portion;
The medical needle is characterized in that the hub is made of a material with low rigidity, and a thin fragile part is formed on the hub except for the part where it is fixed to the protector. 2. The medical needle according to claim 1, wherein at least the fixed portions of the hub and the protector are made of the same material. 3. The medical needle according to claim 1 or 2, wherein the second layer is made of an olefin plastic selected from polyethylene, polypropylene, and polybutylene. 4. The medical needle according to claim 1 or 2, wherein the second layer is made of polypropylene. 5. The medical needle according to any one of claims 1 to 4, wherein the hub and the protector are fixed to each other using a solvent or adhesive that can dissolve the constituent materials of both. 6. The medical needle according to claim 5, wherein the adhesive is a vinyl chloride polymer paste resin mixed with a plasticizer. 7. The medical needle according to claim 6, 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 paste resin. 8 The plasticizer is phthalic acid ester, trimellitic acid ester, aliphatic polybasic acid ester,
The medical needle according to claim 6 or 7, which is a phosphoric acid ester, a citric acid ester, or a butylphthalyl butyl glycolate. 9 A hollow needle that has a container for containing a liquid and has a pointed end, and a hub that supports the proximal end of this hollow needle and can connect a tube to the other end so as to communicate with the hollow needle. and a protector 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. The protector has at least a first layer having a fixing portion to the hub, and a second layer made of a material having higher rigidity than the first layer as an inner layer thereof, and the first layer The protruding first layer portion protrudes toward the proximal end side, and is fixed to the hub at this protruding first layer portion, and the hub is made of a material with low rigidity, and the portion of the hub other than the portion where it is fixed to the protector is thin and fragile. A medical needle comprising: a 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. utensils. 10. The medical instrument according to claim 9, wherein at least the fixed portions of the hub and the protector are made of the same material. 11. Claim 9, wherein the second layer is made of an olefin plastic selected from polyethylene, polypropylene, and polybutylene.
The medical device according to item 1 or item 10. 12. The medical device according to claim 9 or 10, wherein the second layer is made of polypropylene. 13. The method according to any one of claims 9 to 12, wherein the tube and the blood collection container and the hub and the protector are fixed using a solvent or an adhesive that can dissolve the constituent materials of both. Medical equipment. 14. The medical device according to claim 13, wherein the adhesive is a vinyl chloride polymer paste resin mixed with a plasticizer. 15 The composition of the adhesive is paste resin 100
15. The medical device according to claim 14, wherein the amount of plasticizer blended is 50 to 350 parts by weight. 16. Claim 14 or 1, wherein the plasticizer is phthalic acid esters, trimellitic acid esters, aliphatic polybasic acid esters, phosphoric acid esters, citric acid esters, or butylphthalyl butyl glycolate. The medical device according to item 15.