JP2002011013A - Device for pull-out testing of eyeless needle and testing method of the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a device for pull-out testing of an eyeless needle which can perform a pull out test of a plurality of eyeless needles within short time, and to provide a testing method of the same. SOLUTION: The testing device comprises a holding means 13 holding a plurality of surgical eyeless needles which has a blind hole 1b arranged at its base end part 1c to which a surgical suture is inserted and fixed by clamping, by means of holding either needles or surgical needles collectively, a supporting table 12 supporting the holding means 13 sliding freely, and a weight adding means 18 adding weight to the holding means. The test is carried out by holding and pulling the eyeless needle 1 piece by piece by a needle holder and by adding a prescribed weight.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a test for pulling out a suture of a medical eyeless needle in which a suture is caulked and fixed at a base end portion.

[0002]

2. Description of the Related Art A medical suture needle used in a surgical operation has a through hole (elastic hole) for inserting a suture into a proximal end thereof.
And an eyeless needle without a hole.

[0003] The eyed needle is obtained by flattening the base end of a suture needle by press working, forming a hole in the flat part by press working, and forming a threading groove from the base end face of the needle to the hole. The hole is an elastic hole having a spring property. A suture thread is inserted into the hole of the bobbin for use.

[0004] The other eyeless needle has a configuration as shown in FIG. In FIG. 1, a base end face 1a is provided at one end of the eyeless needle 1. A blind hole is formed in the base end face 1a by a processing method such as a laser processing method, an electron beam processing method, an electric discharge processing method, and a drilling method. I have. The blind hole 1b
Is formed to have a size of about 1/2 of the thickness of the base end 1c of the eyeless needle 1. A sharp needle tip 1d is formed at the tip of the eyeless needle 1, and a plurality of cutting blades 1e are formed continuously with the needle tip 1d.

As the eyeless needle 1, there are a suture needle with a blade in which the cross section of the blade portion is formed in a polygonal shape as shown in FIG. 3, and a round needle (not shown) in which the cross section is formed in a substantially circular shape. These suture needles are selected and used in accordance with the living tissue to be sutured and the suture site.

Many different types of sutures 2 are provided, such as thickness, material (nylon, silk, etc.), monofilament or multifilament, and the like. Then, an appropriate type of suture is selected and used according to a living tissue to be sutured and a suture site. Suture 2
Is inserted into the blind hole 1b at its tip, and
The eyeless needle 1 is fixed to the base 1c by crushing and swaging b. The eyeless needle has an advantage that a thread having a length necessary for suturing is fixed from the beginning, and the trouble of inserting a thread into a hole unlike an eyed needle is unnecessary.

[0007] During a suturing operation, it is required that a suture thread attached to a suturing needle does not come off due to thread breakage and thread breakage. In the case of an eyed needle, the suture thread penetrates the boring hole, so two threads are lined up from both sides of the boring hole, but the thread separates unless tension is applied to only one of the bobbins. There is no.

However, in the case of an eyeless needle, the connection between the needle and the thread depends on the contact friction between the needle and the thread at the swaged portion. May be separated from the On the other hand, if the caulking is too strong, the yarn may be partially broken by the caulking, the strength may be reduced, and the yarn may be broken while passing through the living tissue. For this reason, for the eyeless needle, the allowable thread pull-out force is set in advance according to the size of the suture used, and a pull-out test is performed to check whether the allowable thread pull-out force is satisfied.

The conventional pull-out test is performed using the apparatus shown in FIG. The eyeless needle 1 to which the suture thread 2 is attached is attached to the locking portion 3a at the tip of the spring scale 3.
FIG. 4B is a diagram of the locking portion. A groove 3b thicker than the suture thread 2 and thinner than the eyeless needle 1 is formed in the locking portion 3a. The suture thread 2 is inserted into the groove 3b, and the base end surface 1a of the eyeless needle 1 is brought into contact with the locking portion 3a to apply a predetermined tensile force to the suture thread 2. The tensile force can be known by reading the scale 3c of the spring balance 3. That is, a test is performed to determine whether or not a thread pullout occurs when the scale of the spring balance 3 reaches a predetermined value.

[0010]

However, in the above-mentioned apparatus, the eyeless needles 1 must be set one by one and tested by applying a tensile force, and the operation is complicated and time-consuming.
This has caused a rise in the manufacturing cost of the suture needle.

An object of the present invention is to provide an eyeless needle pull-out test apparatus and method capable of performing a pull-out test of a plurality of eyeless needles in a short time.

[0012]

SUMMARY OF THE INVENTION In order to achieve the above object, an eyeless needle pull-out test apparatus according to the present invention comprises a plurality of blind holes which are formed by inserting a suture into a blind hole formed at a base end side and caulking the same. It is characterized in that it has a gripping means for collectively gripping either the needle or the suture of the medical eyeless needle, and a load applying means for applying a load to the gripping means.

The grip means may be configured to grip the sutures of the plurality of eyeless needles, or a support table may be provided between the grip means and the load applying means for supporting the grip means slidably in a horizontal direction. The gripping means may be configured to have upper and lower plate members, a holding body sandwiched between the front ends of the plate members, and an elastic body that presses the front end of the plate member to the holding body,
The holding body may be made of a soft elastic material, or the holding means may be slidably attached to a table.

Further, the holding means has left and right (or vertical) plate members, a holding member sandwiched between the ends of the plate members, and an elastic member for pressing the tip of the plate member against the holding member. With the configuration, the load applying means can be directly connected to the end of the gripping means. In this case, the sum of the weight of the gripping means and the load applied by the load applying means is the load acting on the caulked portion. In contrast to this configuration, the configuration in which the support table is provided can perform a test by pulling in the horizontal direction, and thus has an advantage that the burden on the operator can be reduced.

The eyeless needle pull-out test method of the present invention for achieving the above object is a suture pull-out test method using the medical eyeless needle pull-out test apparatus, wherein It is characterized in that tension is applied to each thread of the medical eyeless needle and the pull-out force of the suture is inspected.

[0016]

Embodiments of the present invention will be described below with reference to the drawings. FIG. 1 is a diagram showing a configuration of an eyeless needle pull-out test device (hereinafter abbreviated as “test device”) according to the present invention. The test apparatus 10 shown in FIG.
It comprises a slidable support base 12 fixed on the upper side and a gripping means 13 fixed on a movable portion 12b of the support base 12.

The holding means 13 comprises upper and lower plate members 14 and 15
And a holding body 16 sandwiched between these tips, and an elastic body 17 for applying a pressing force to the holding body 16. The test apparatus 10 further includes the gripping means 13
Has a weight 18 as a load applying means for urging one side.

As the support table 12, a ball slide unit is used. The fixed part 12a of the support base 12 is fixed to the table 11, and the movable part 12b is fixed to the gripping means 13. The use of the ball slide unit as the support base 12 minimizes the coefficient of friction between the gripping means 13 and the table 11 so that when the load of the weight 18 is applied to the gripping means, the load is reduced by friction. Is set to a level that can be ignored. Here, it is sufficient that the friction coefficient is small. For example, it can be easily understood that a unit using a roller, a needle roller, or the like as the rolling element may be used. The gripping means 13 can move left and right in FIG. 1 by sliding the movable part 12b of the support base 12 on the fixed part 12a, but at least the left part of the figure is provided by a stopper (not shown) provided on the movable part 12b or the fixed part 12a. The amount of movement in the direction is finite.

The upper and lower plate members 14, 15 have projections 14a, 15a, respectively, which are connected by a pin 19. Therefore, the upper plate member 15 is rotatable about the pin 19 as a fulcrum. Since the elastic body 17 provided at one end (rear end) is made of a compressed coil spring, the rear ends of the upper and lower plate members 14, 15 are separated from each other as shown by arrows. To the holding body 16
Is pressed between the tips of the upper and lower plate members 14 and 15.

The holding body 16 holds the sutures 2 of the plurality of eyeless needles 1 together between the upper and lower plate members 14 and 15 under pressure. Since the suture 2 is held by the frictional force between the holding body 16 and the upper and lower plate members 14 and 15, the holding body 1
As 6, a material having a large friction coefficient is used. It is also important that the suture 2 is not damaged even if the suture 2 is sandwiched by a strong force. For this purpose, the holding body 16 of the embodiment uses a hollow, thick cylindrical member made of rubber. Holder 1
The diameter of 6 is preferably as large as possible so that the curl does not remain when the wound suture 2 is removed. Also,
Rubber sheets 14b, 15b are also attached to the upper and lower plate members 14, 15 in order to improve the frictional force and protect the sutures 2.

In the embodiment, a coil spring is used as the elastic body 17, but another spring such as a leaf spring may be used, and the upper and lower plate members 14, 15 clamp the holder 16 by an air cylinder or the like. May be.

A bracket 20 is fixed to the left end of the table 11 with a thumb screw 20b, and a pulley 20a is rotatably attached to the bracket 20. Then, the rope 21 tied to the locking portion 14c provided on the lower surface of the lower plate member 14 is wound around the pulley 20a and
1 hangs down. A loop 21a is formed at the tip of the rope 21, and a hook of the weight 18 is hooked on the loop 21a. That is, as long as the rope 21 is not loosened, the weight of the weight 18 is always added to the gripping means 13.

Next, a method of a yarn pull-out test will be described. Rubber sheet 14 at the tip of upper and lower plate members 14 and 15
Remove the holding body 16 sandwiched between b and 15b. Then, the sutures 2 of the plurality of eyeless needles 1 are wound around the holding body 16 in a half-circle or two-circle manner, and sandwiched between the tips of the upper and lower plate members 14 and 15 as shown in FIG.

Next, an allowable thread pull-out force determined from the thread size of the suture 2 is obtained, and the weight 18 having the obtained weight is hooked on the loop 21 a at the tip of the rope 21. Whether the weight 18 has reached the floor and the rope 21 is loose,
Moves to the left in FIG. 1 and is stopped by a stopper (not shown).

One of the plurality of eyeless needles 1 is firmly grasped by a needle holder, and is slowly pulled to the right in FIG. So that it joins thread 2. Even if the load of the weight 18 is applied, if the suture 2 does not come off or is not cut, it is a passed product.
It can be determined that the product is defective.

When the test for one eyeless needle 1 is completed, the next eyeless needle is gripped by the needle holder, and the same operation is repeated. The number of eyeless needles gripped by the gripping means 13 can be inspected continuously one after another, and the inspection can be performed very efficiently. Instead of using the needle holder, the load may be applied by pinching and pulling with a human finger.

When gripping with a needle holder or the like, gripping the base end 1c of the eyeless needle 1 reinforces the caulked portion, and there is a possibility that accurate inspection cannot be performed.
The part other than the caulked part must be grasped.

FIG. 2 is a view showing another embodiment of the test apparatus of the present invention. This test apparatus 10 'is characterized in that the load applying means is not a weight 18, but a spring balance 25. The measuring method is the same as that of the apparatus shown in FIG. 1, but a predetermined load is applied while pulling the eyeless needle 1 and checking the scale of the spring balance 25. In the case of the weight 18 in FIG. 1, the load applied to the suture 2 is constant even if the length of pulling the eyeless needle 1 changes, but in the embodiment of FIG. 2, a load proportional to the pulling length is applied. become. Therefore, the work of changing the load according to the size of the suture can be omitted. It is also suitable for performing a test for determining the cutting load of the suture 2.

In another embodiment, the holding means is arranged vertically without providing a support, the load applying means is connected to the lower or upper part of the holding means, and the needle is pulled upward or downward. A configuration of pulling is also conceivable. When the load applying means is connected to the lower portion of the gripping means, a weight, a spring, a fluid cylinder, or the like can be used as the load applying means. When the load applying means is connected to the upper part of the gripping means, a spring or a cylinder can be used.

As described above, the load applying means may be the weight 18 or the spring balance 25, and furthermore, a cylinder using hydraulic pressure or pneumatic pressure can be used. When a spring or a cylinder is used, a desired load can be applied regardless of the position of the holding unit 13 in any of the upper, lower, left and right directions.

In the above embodiment, the eyeless needle 1 is pulled by grasping the suture 2 of the eyeless needle 1. On the other hand, the plurality of eyeless needles 1 are grasped by the grasping means to hold the suture 2 together. You may pull it one by one.

[0032]

As described above, the medical eyeless needle pull-out test apparatus of the present invention comprises a plurality of medical eyeless needles in which a suture is inserted into a blind hole formed on the base end side and caulked and fixed. And a load applying means for applying a load to the gripping means, so that a plurality of eyeless needles are successively subjected to a thread pull-out force test. And an efficient inspection became possible.

[Brief description of the drawings]

FIG. 1 is a diagram showing the configuration of a medical eyeless needle pull-out test apparatus of the present invention.

FIG. 2 is a diagram showing a main part of another embodiment of the test apparatus of the present invention.

FIG. 3 is a perspective view showing an eyeless needle.

FIG. 4 is a view showing a configuration of a conventional medical eyeless needle pull-out test apparatus.

[Explanation of symbols]

 DESCRIPTION OF SYMBOLS 1 Eyeless needle 1a Base end face 1b Blind hole 2 Suture thread 12 Support stand 13 Gripping means 18, 25 Load applying means

Claims (2)

[Claims] 1. A gripping means for collectively gripping any one of a plurality of medical eyeless needles or sutures secured by caulking and inserting a suture into a blind hole formed in a base end portion, and the grip. And a load applying means for applying a load to the means. 2. A suture pull-out test method using the medical eyeless needle pull-out test device according to claim 1, wherein tension is applied to each of the plurality of medical eyeless needles to pull out the suture. A pull-out test method for a medical eyeless needle, wherein the force is inspected.