JPH04180774A - Introducing needle of medical treating implement - Google Patents

Abstract

PURPOSE:To facilitate the division and removal from a catheter, etc., by constituting a hollow tubular body made of a synthetic resin to allow the insertion of a bar-shaped medical treating implement of the same material and forming brittle parts melted and adhered at the time of molding over the entire length in the longitudinal direction of the tubular body or the entire length in the longitudinal direction exclusive of the tip part. CONSTITUTION:This needle consists of the hollow tubular body which is opened at both ends and allows the insertion of the bar-shaped medical treating implement, such as catheter 5. The brittle parts 12a, 12b molded to have the tear strength lower than the tear strength in other arc parts are formed at two opposite points in a part of the arc constituting the tubular body, i.e., in a diametral direction over the entire length in the longitudinal direction of the tubular body or the entire length in the longitudinal direction exclusive of the tip part. The brittle parts 12a, 12b are the parts to be melted and adhered at the time of the extrusion molding of the hollow tubular body. If the brittle parts are melted and adhered in such a manner, these parts have the tear strength smaller than the tear strength in the other parts and the brittle parts suitable for tearing are formed. The easy division and removal of the introducing needle 11 for the medical treating implement from the catheter 5, etc., is assured in this way.

Description

DETAILED DESCRIPTION OF THE INVENTION (Field of Application of Industry-I-) The present invention relates to a synthetic resin introduction needle used when introducing and indwelling a rod-shaped medical device such as a catheter or kite wire into a blood vessel or the like.

(Prior art and invention or problem to be solved) Conventionally,
For example, when introducing and indwelling a catheter into a blood vessel, a synthetic resin introduction tube is used. That is, as shown in FIG. 8, the introduction needle 1 is inserted into the inner needle 3 of the syringe 2 so that the tip of the inner needle 3 protrudes.
Then, as shown in FIG. 9, the inner needle 3 is inserted into the tube 1111 until the tip of the introduction tube 11 is inserted into the blood vessel 4. Next, as shown in the figure, the inner needle 3 is removed from the blood vessel 4 while the introduction needle 1 is kept in that state. With the opening side of Jg secured inside the blood vessel 4, insert the desired catheter 5 into the introduction needle l as shown in Figure 1O, and insert its tip into the blood vessel 4. Insert into. After the catheter 5 is indwelled at a predetermined position within the blood vessel 4 in this manner, it is desirable to remove the unnecessary introduction needle 1 from the blood vessel 4 and also from the catheter 5. This is because it is not sanitary to leave the unnecessary introduction needle I removed from the blood vessel 4.

3゜However, it also interferes with subsequent operations.
Withdrawing the introducer needle I from the catheter 5 is not possible due to the presence of an enlarged part, such as the connector 6 of the catheter, for example.

Therefore, several proposals have been made for removing the introduction needle 1 that is no longer needed from the catheter 5. For example, a method has been proposed in which a slit is previously formed along the length of the introducer needle and the unnecessary introducer 4 is removed from the catheter through this slit. However, with this method, the strength of the introduction needle decreases, making it difficult to operate, and when introducing the catheter into the blood vessel, the slit enlarges, causing blood leakage, and the penetration resistance increases, causing pain to the patient. There is.

In addition, Japanese Patent Application Laid-Open No. 56-11069 discloses that a pair of filaments are formed at radially opposite locations of the introduction needle using a plastic different from the sample plastic, and the introduction needle that is no longer used is inserted into the threads. 13 has also been proposed in which it is divided into two by tearing it from the striatum. but,
In this case, the filament is likely to crack during post-processing such as cutting the introduction needle and processing the tip, or when handling it as a product.
This causes problems such as unusability or blood leakage.

The present invention has been made in view of the above circumstances, and there is no risk of inadvertent peeling or splitting during post-processing or handling as a product, and it is easy to separate and remove the catheter from the catheter when it is no longer used. We aim to provide a needle for easy introduction of medical devices.
It is considered to be I-like.

(Step f for solving the problem) That is, this invention is a medical device introduction ε1 for introducing a rod-shaped medical device into a living body formed by extrusion molding.
It is made of a synthetic resin hollow tube into which the rod-shaped medical device H1 can be inserted, and is made of the same material, and the entire longitudinal length of the tube described in 01j or the entire longitudinal length excluding the tip is molded. The present invention provides a medical device introducer 1 characterized in that it has at least one weakened section that is sometimes melt-bonded. .

Furthermore, the present invention relates to the above-mentioned medical device introduction date;
To provide a tube body whose tip end is tapered so as to come into close contact with an inner hole 1 inserted therein, and whose base part has a wide shape.

Furthermore, the present invention provides the above-mentioned medical device introducing needle, in which the weakened portions are provided in pairs so as to face each other in the radial direction.

Furthermore, in the medical device introduction needle, the hollow tube body is made of a polymer selected from polypropylene, fluororesin, hydrogenated polyethylene, and a blend polymer of polyolefin resin and ethylene/vinyl acetate copolymer. Provide something that is unique.

The present invention will be specifically explained based on figures showing examples thereof.

FIG. 1 is a perspective view of a medical device introduction needle 11 according to the present invention, which consists of a hollow tube body between both ends 1-1 into which a rod-shaped medical device such as a catheter can be inserted, and whose tip is an inner needle (not shown). )
It is tapered so as to fit closely into the body, and the base forms a cylindrical body with an enlarged base.

As shown in Fig. 2, this hollow tube has a part of the circular arc constituting the tube, that is, two diametrically opposed points extending over the entire length of the tube or the entire length excluding the tip. Fragile parts 12a and 12b are formed so that their tear strength is smaller than that of other circular arc parts. The fragile portions 12a and 12b are portions that are melted and bonded during extrusion molding of the hollow tube.

When melted and bonded in this way, the tear strength of that part is lower than that of other parts, forming a weakened part suitable for tearing.

A method of using the medical device introduction needle of the present invention will be explained.

First, the introducer needle 11 is inserted into the syringe 2 as shown in FIG. 8 in the same manner as shown in FIGS. 8 to 10, and then the inner needle is inserted into a blood vessel etc. is removed, the introduction side 11 is secured in a blood vessel, etc., and then a catheter or the like is inserted into this introduction 311), and the catheter or the like is introduced into the blood vessel -9.

Next, when removing this unnecessary introduction needle 11 from a catheter or the like, as shown in FIG.
The introduction needle 11 can be easily removed from the catheter 5 by tearing off the catheter 5b and then tearing the whole body through this proximal end.

In addition, in the example described in Jl, the case where a catheter is introduced as the "medical device introduction side" has been explained, but it is of course applicable to the case where not only catheters but all kinds of rod-shaped medical devices are introduced into the human body. .

Further, the fragile tearing portion mentioned above is not limited to two strips as in Example θ), but may be provided with one strip, three or more strips.

Next, the manufacturing method of the medical device introduction side of the present invention will be explained.

The medical device introduction side of the present invention can be manufactured using, for example, an extrusion molding machine 13 as shown in FIGS. 1 and 5. FIG. 4 is a front view of the die of the molding machine 13, and FIG. 5 is a sectional view thereof. This molding machine 13 has a die 14
A pair of baffle plates 15a and 15b for suppressing the flow of molding resin are provided near the discharge portion of the inner mold 16 so as to protrude from the circumferential surface of the tip end of the inner mold 16 so as to face in opposite directions. Once the resin flow is substantially divided by this baffle plate, it joins again, adheres, and is extruded from the die discharge.
The molded portions that have passed through the baffle plates 15a and 15b, that is, the melted and bonded portions, become the weakened portions 12a and 12b.

The positions, heights, etc. of the baffle plates 15a, 15b can be appropriately determined depending on the type and composition of the synthetic resin used, but in general, the position and height of the baffle plates 15a, 151) and the tip of the die 14 are determined as appropriate. Let distance 1 be 0 to 5111111,
The distance 11 between one end of the baffle plates 15a, 15b and the inner wall of the outer mold 17 is h with respect to the interval II of the resin passage 18:
If; 0 to 1/2: 1, preferably 0 to 115
: 1, a weakened portion 12t''+12+) having the desired draw strength can be obtained.

Under such conditions, the baffle plates 15a and 15b are
4 using an extrusion molding machine installed near the discharge part.

When molding the bone that constitutes the medical device introduction needle.

j into the die 14 by a screw (not shown),
ll, the softened resin left by one person is baffle plate 15a, 15b
The die 14 is once effectively divided into two parts by
11 at or near the discharge of the die 14]
: They are glued together and formed into a tube shape.

At first glance, the tube formed in this way appears to form a smooth and continuous arc, but it gets in the way.
.

Weld line at +5b passing part, that is, weak B1112
a.

]2b is formed. These weak parts 12a and 12b have a bonding force between their two sides that is significantly smaller than a bonding force between the synthetic resins of the other circular arc parts, so they can be ruptured by applying external stress, for example, as shown in FIG. It can be torn apart easily.

The tear strength of this fragile portion 12 a+ 121) can be adjusted by adjusting the position, height, and IIJ of the baffle plate 1511 + + 513.
(length, thickness) etc. or by adjusting the
This can be carried out as desired by adjusting the blending of the resins listed below.

In addition, the material of the tubular body constituting the medical device introduction needle described in 1. may include thermoplastic resins such as polypropylene, fluororesin, hydrogenated polyethylene, blended polymers of polyolefin resin and ethylene/vinyl acetate copolymer, etc.
Select as appropriate.

In addition, as a method for forming the weak parts 12a and 12b,
As shown in FIGS. 4 and 5, the baffle plate 15 a+
Although the case where an extruder with l 5 b protruding from the inner mold is used has been described, the present invention is not limited to this, and any other arbitrary molding means may be employed. For example, as shown in FIGS. 6 and 7, baffle plates 15a and 15b similar to those described with reference to FIGS. 4 and 5 may be formed to face the outer mold of the die 14. All reference numbers and symbols are the same as in Figs. 4 and 5), and although not shown, similar baffle plates are provided protruding from both the outer mold and the inner mold so as to face each other. Good too. In either case, the position of the baffle board (
I, ), height ([1), size, etc., can be adjusted and selected in the same way as in Figures 4 and 5.1.Example 1 Length 22 mm, 11J0,5 is placed in a pair of books. As shown in Fig. 7, the baffle plate is placed in contact with the inner wall of the outer die of the extrusion molding machine, and its tip is placed 0.5 mm in front of the die outlet 1.1 (i.e., Fig. 7, "1,'"-0,5mm) was provided. Polypropylene was then used to obtain a catheterization layer that was compatible with a 16G internal needle. Even if this was melt-processed to make the tip tapered so that it would fit tightly onto the 16G inner needle (
In this case, due to this melt processing, the weld line during the forming of the processed tip almost disappears)) There were no problems such as cracking near the tip 4. Furthermore, when the inner needle was pierced into the blood vessel of a mongrel dog. There was no curling or cracking of the tip, and when we tried to split it at the time of removal, it was easy to split it.

Comparative Example 1 A baffle plate similar to that of Example 1 was placed 61I in front of the L of the die outlet.
A catheter introduction 41 was obtained by extrusion molding in the same manner as in Example 1 except that the portion 111 was reached. However, in this case, the catheterization layer did not substantially form a weakened region and could not be torn.

Comparative Example 2 A baffle plate similar to that in Example 1 was provided protruding from the inner wall of the outer mold with an inner diameter of 511IllI. However, in this case, lj' of the baffle plate was
The thickness is the outer diameter of the inner mold of 4 + nm and the outer diameter of 0.6 ohm.
The position of the tip of the tire was set at 0.5 mm in front of -f of the tire leaf. When a catheter needle was molded using this extrusion molding machine in the same manner as in the example, no fragile portion was formed and it could not be torn.

(Effects of the Invention) As detailed below, the medical device introduction needle according to the present invention has the following effects:
It is useful because it avoids undesired cracking during handling and has a fragile part that is suitable for tearing. Also, misfire 1! Introduction 1 of medical devices related to IJ is that there is no need to provide slits after molding as in the past, or to provide striae made of different synthetic 1+ltf fat during molding, and molding can be performed using a single plastic composition. It is easy to perform post-processing such as tip processing, so it is easy to manufacture and the manufacturing cost is low.
fj), which is advantageous.

[Brief explanation of the drawing]

FIG. 1 is a perspective view of a medical device introduction needle according to the present invention, and FIG.
λ1 is a cross-sectional view taken along the line TI-TI in FIG. 1, FIG. 3 is a perspective view of the state where the introduction layer in FIG. 1 is torn, and FIG. Figure 5 is a sectional view of the manufacturing apparatus of Figure 4, and Figure 6 is a front view of another manufacturing apparatus for the introduction layer of the present invention.
Figure 7 is a sectional view of the manufacturing equipment in Figure 6, and Figures 8 to 1.
Figure 0 is a schematic diagram for explaining the usage pattern of the medical device introduction needle.

Claims (4)

[Claims] (1) A medical device introduction needle for introducing a rod-shaped medical device into a living body formed by extrusion molding, which is made of a synthetic resin hollow tube into which the rod-shaped medical device can be inserted, and is made of the same material. A medical device introduction needle characterized in that the tube has at least one weakened section melt-bonded during molding over the entire longitudinal length of the tubular body or the entire longitudinal length excluding the tip. (2) The medical device introduction needle according to claim 1, wherein the distal end of the tubular body is processed so as to come into close contact with an inner needle inserted therein, and the base has a widened shape. (3) The medical device introduction needle according to claim 1, wherein a pair of the weakened portions are provided so as to face each other in the radial direction. (4) The medical device according to claim 1, wherein the hollow tube body is made of a polymer selected from polypropylene, fluororesin, hydrogenated polyethylene, and a blend polymer of polyolefin resin and ethylene/vinyl acetate copolymer. Introducing needle.