JPH0636804B2 - Needle suture, caulking pattern for manufacturing the same, and manufacturing method - Google Patents

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a suture thread with a needle to which a needle is previously attached at the end, a caulking die for manufacturing the same, and a manufacturing method.

[0002]

2. Description of the Related Art Conventionally, as a suture thread used in a surgical operation, there is known a suture thread which is commercially available in a sterilized state in which an eyeless needle for operation is previously attached to its end. According to this suture with needle, the outer diameter of the needle and the thickness of the thread are almost the same, so there is less damage to the tissue to be operated, and the work of the nurse who attaches the suture to the needle in the operating room is reduced. Such a suture with a needle is being widely used because it has the advantage of significantly shortening the operation time and the operation time.

However, the work of manufacturing such a suture with a needle, that is, the work of connecting and fixing a surgical needle to the end portion of the suture requires very fine and high precision, and is considerable. Requires skill. Therefore, there is a strong demand for mechanization of the manufacturing operation of the suture thread with a needle.

As a means thereof, for example, Japanese Examined Patent Publication No. 56-43.
In Japanese Patent Publication No. 420, the caulking portion of the eyeless needle into which the end portion of the suture is inserted is crimped with an upper die and a lower die having a substantially semicircular concave portion corresponding to the caulking portion to flatten the caulking portion. ,
Then, by swaging the swaged portion by 90 ° as well, the cross-sectional shape of the swaged portion is made substantially circular, and the needle is connected to the end portion of the suture with the cross-sectional area being smaller than that before the swaging. It is shown to be fixed. Further, Japanese Patent Publication No. 1-34625 discloses a caulking portion of an eyeless needle, which has a tapered shape that becomes thinner from the needle tip side toward the needle base side.

More recently, for example, Japanese Patent Publication No. 58-395.
As shown in Japanese Patent Publication No. 44-44, by finely adjusting the fixing strength of the needle with respect to the suture thread, it is possible to easily pull the needle out of the suture thread by hand or with a needle holder after the suture is completed. Possible sutures have also been provided. The use of such sutures will further reduce the burden of surgical work. In this method, the work of connecting and fixing the needle and the suture is completed with a single swaging operation, and the shape of the finally obtained swaging part is flattened in one direction compared to other parts. It is in a state.

[0006]

DISCLOSURE OF THE INVENTION Problems to be Solved by the Invention
In the suture thread disclosed in Japanese Patent No. 544, since the shape of the caulking portion is a flat shape that bulges in one direction more than other portions, the caulking portion is caught on the tissue during the suturing operation, and the tissue May be damaged.

On the other hand, as shown in Japanese Patent Publication No. 56-43420 and Japanese Patent Publication No. 1-34625 , if the caulking portion has a substantially circular cross section smaller than the cross sectional area of other portions, The inconvenience of damaging the tissue as described above can be prevented, but in order to obtain the crimped portion having such a shape, the crimping work is performed twice or more in the directions different from each other by approximately 90 ° as described above. However, there is a disadvantage that the reduction of manufacturing time is prevented. Moreover, in such a method requiring a plurality of times of crimping, as the number of times of crimping is large, the pull-out strength (that is, the load required to pull out the needle from the suture) of the needle-attached suture obtained as a product becomes more uneven. So
As shown in Japanese Patent Publication No. 58-39544, it is very difficult to finely adjust the fixing strength of the needle with respect to the suture thread, and it is extremely difficult to stably manufacture the above-mentioned needle-withdrawable suture thread. .

In view of the above circumstances, the present invention is a suture thread with a needle, which can be reliably manufactured by one swaging operation, without any fear of damage to the tissue, etc., a swaging pattern for manufacturing the suture thread, and a manufacturing method thereof. The purpose is to provide.

[0009]

The present invention comprises a needle having a crimped portion provided with an axial insertion hole, and a suture thread whose end is inserted into the insertion hole. In the suture with a needle in which the needle and the suture are connected and fixed by crimping the caulking portion with the end portion of the suture inserted, the cross-sectional shape of the caulking portion is continuous over the entire circumference. And has a recess at one location, and the cross-sectional area of the caulked portion is smaller than the cross-sectional area of the portion adjacent thereto (Claim 1). here,
More preferably, the pull-out strength of the needle is adjusted by crimping the crimped portion so that the needle can be pulled out from the suture thread (claim 2).

Further, the present invention is a crimping type for manufacturing the suture thread with a needle, which comprises an upper die and a lower die, and an upper end of the lower die has a substantially U-shaped recess opening upward. The upper die is formed with a substantially V-shaped convex portion having an angle that can be inserted into the concave portion from above in the lower end portion (claim 3). In this caulking die, it is more preferable that a tapered guide surface is formed that extends outward from both upper ends of the substantially U-shaped recess of the lower die (claim 4).

Further, the present invention is a method for manufacturing a suture thread with a needle using the above-mentioned crimping die for manufacturing, wherein the end portion of the suture thread is inserted into an axial insertion hole provided in the crimping portion of the needle, The caulking portion is fitted into the concave portion of the lower die, and the central portion of the caulking portion is pressed from above by the convex portion of the upper die (claim 5). In this method, the pull-out strength of the needle with respect to the suture can be adjusted by the distance between the upper mold and the lower mold when the upper mold and the lower mold are closest to each other (claim 6).

[0012]

According to the crimping die of the third aspect and the method of the fifth aspect, the caulking portion of the needle is fitted in the substantially U-shaped concave portion provided in the lower die, whereby the caulking portion is moved in the left-right direction. About, it will not be able to swell in the same direction,
In this state, the center of the caulking portion is pressed from above by a convex portion of the upper die, so that the caulking portion has a recess at one location by one caulking operation without enlarging the cross-sectional shape of the caulking portion. The suture with needle described can be obtained.
The crimped portion of this suture with needle has a smaller cross-sectional area than the portion adjacent thereto and there is no sharply pointed portion on the peripheral surface, so there is no risk of damaging the tissue during suturing.
Moreover, since a part of the crimped portion is formed with a recess that bites into the suture thread, it is possible to obtain sufficient fixing strength even with one crimping operation. The needle can be pulled out from the suture by adjusting the pull-out strength of the needle-attached suture with respect to the suture (claim 2).

Further, since the caulking operation is performed only once, the needle pull-out strength of the suture with a needle obtained as a product can be adjusted by adjusting the compressive force of the caulking portion by the upper die and the lower die during the caulking. Then, it can be realized only by the distance between the upper mold and the lower mold when the two molds are closest to each other (claim 6).

According to another aspect of the present invention, the caulking die is provided with tapered guide surfaces extending outward from both upper ends of the substantially U-shaped recess of the lower die (claim 4). The crimped portion will be smoothly guided into the recess.

[0015]

DESCRIPTION OF THE PREFERRED EMBODIMENTS An embodiment of the present invention will be described with reference to the drawings.

In FIG. 2, 10 is a suture thread before the needle is attached, and 20 is an eyeless needle made of stainless steel or the like. The eyeless needle 20 has a proximal end (an end opposite to the distal end). ) Is a caulking portion 22 having a circular cross section with an insertion hole 21 in the axial direction. The caulking portion 22 is caulked with a lower die 30 and an upper die 40.

As shown in FIG. 1, the upper end portion of the lower mold 30 is substantially U-shaped surrounded by a semicircular portion 31 and straight portions 32 extending upward from both upper ends of the semicircular portion 31. A concave portion 33 is formed, and a tapered guide surface 34 that extends from the upper end of the linear portion 32 to both outer sides is formed above the concave portion 33. The diameter of the semicircular portion 31 is set to be equal to or slightly larger than the diameter of the crimped portion 22, and the dimension ε of the linear portion 32 is set to a minute dimension as described later. Has been done.

To obtain the shape of the upper end of the lower mold 30,
First, by forming a complete U-shaped concave portion on the upper end portion and gradually cutting off both corner portions 35 (indicated by a chain double-dashed line in FIG. 1) to leave only the linear portion 32 having the above dimension ε. Good.

On the other hand, a V-shaped convex portion 41 forming an acute angle is formed at the lower end of the upper mold 40. The angle of the convex portion 41 is such that the convex portion 41 is inside the concave portion 33. It is set small so that it can be inserted from above. Also,
In this embodiment, the lowermost end of the convex portion 41 is chamfered to form a flat surface 42 having a minute width.

Next, a method of manufacturing a suture thread with a needle using this crimping type, that is, a method of connecting and fixing the needle to the suture thread 10 will be described.

First, the end portion of the suture thread 10 is inserted into the insertion hole 21 provided in the caulking portion 22 of the eyeless needle 20, and in this state, the caulking portion 22 is fitted into the recess 33 of the lower die 30. As a result, as shown in FIG. 3A, the caulking portion 22 is constrained in the left-right direction in the region substantially contacting the semicircular portion 31 and the straight portion 32 shown in FIG. Is in a regulated state.

In this state, the upper die 40 is lowered, and the convex portion 41 presses the central portion of the crimped portion 22 from above. By this one swaging operation, the swaging portion 22 is deformed into a shape having a cross section having a recess 23 at one location as shown in FIGS. 3 (b) and 4, and the eyeless needle 20 causes the suture 10 to end. It is connected and fixed to the section.

According to such a method, the eyeless needle 20 can be fixed to the end portion of the suture thread 10 by one swaging operation, so that the manufacturing time can be greatly shortened. Moreover, since the swelling in the left and right direction of the caulking portion 22 fitted in the recess 33 is restricted during the caulking operation, the caulking portion 22 is not required to be swung twice or more as in the conventional case. The cross-sectional area of 22 is always smaller than the cross-sectional area of the portion 24 (FIG. 4) adjacent thereto.
More specifically, as shown in FIG. 4, the lateral dimension d ₁ of the caulking portion 22 is substantially equal to the diameter D of the other portion 24 adjacent to the caulking portion 22, and As shown in FIG. 5, the vertical dimension d ₂ of the crimped portion 22 is smaller than the diameter D of the adjacent portion 24. Therefore, according to the suture thread with the needle, there is no possibility that the caulked portion 22 damages the tissue during suturing.

In order to obtain such an effect, the lower mold 30
The concave portion 33 is substantially U-shaped, that is, a semicircular portion 31 having a complete semicircular shape and a linear portion 32 extending upward from both upper ends of the semicircular portion 31 (this may not be strictly a straight line). Is important.

Further, according to this method, since the caulking operation is performed only once, variations in the needle pull-out strength of the suture with needle obtained when caulking under the same conditions are reduced. Therefore, the needle pull-out strength is adjusted by adjusting the compression force by the lower mold 30 and the upper mold 40 at the time of crimping.
In other words, the two molds 3 when the two molds 30 and 40 are brought closest to each other
This can be performed only by the distance between 0 and 40, and the needle-withdrawable suture can be easily manufactured.

The pull-out strength range required for a suture thread with a completely fixed needle and a suture thread capable of withdrawing a needle is defined by the USP (USP) standard, and in principle,
Adjustment based on this may be performed. The following Table 1 shows the lower limit (minimum value) of the average value of the pull-out strengths required for sutures having various sizes of completely fixed needles, and the lower limit of each value, and Table 2 shows the needles. It shows the allowable range of the needle pull-out strength for a pullable suture.

[0027]

[Table 1]

[0028]

[Table 2]

Since the permissible range shown in Table 2 is very wide, in practice, for example, in the case of an absorbable polyglycolic acid suture, the needle pull-out strength may be set within the range shown in Table 3 below. desirable. In addition, the "withdrawable strength allowable range" in the table means the range in which all the measured values must be satisfied in order to allow the needle to be pulled out with the hand or the needle holder. "Intensity average value" means a range that this average value should satisfy when a large number of measured values are plotted and the average value is taken.

[0030]

[Table 3]

Next, the present invention and the prior art will be compared based on experimental data. In the experiment described below, U
SP3-0 polyglycolic acid suture thread is used.

The following Table 4 shows the case where the caulking die of the present invention is used to perform the caulking with a force that allows the needle to be withdrawn, the caulking die to be used until the needle cannot be withdrawn, and the conventional caulking die (top 2) until it becomes impossible to pull out the needle due to the semi-circular recess provided in the mold and lower mold.
It shows each measured value and the average value when performing crimping twice.

[0033]

[Table 4]

As shown in this table, according to the caulking die and method of the present invention, even when aiming at the strength at which the needle can be pulled out,
Further, it is found that even when the caulking is performed until the needle cannot be withdrawn, a stable needle withdrawal value can be obtained by one caulking operation. Moreover, when performing the crimping until the needle cannot be pulled out, it is almost the same as the suture with a needle obtained by performing the crimping operation twice in the conventional crimping type, although the crimping operation is performed only once. An equivalent needle pull-out value can be obtained. It is considered that this is because a part of the crimped portion 22 has a recess 23 that bites into the suture thread 10.

The following Table 5 shows measured values and average values of the cross-sectional areas of the caulking portion 22 when caulking is performed with a force that enables needle withdrawal by the caulking die of the present application and the conventional caulking die. is there.

[0036]

[Table 5]

As is clear from this table, according to the caulking type of the present invention, the caulking is performed by a single caulking operation, and the caulking strength is adjusted so that the needle can be pulled out, but the conventional caulking is performed. The cross-sectional area can be made smaller than in the case of using a mold, and it is possible to more reliably prevent damage to the tissue during suturing.

A suture with needle having a caulking portion shape similar to that of the suture with needle of the present invention is disclosed in US Pat. No. 25,815.
No. 64 is shown in the specification and drawings. The needle-attached suture has a caulked portion whose cross-sectional shape is slightly like a heart shape.

However, this needle-attached suture is completely different in manufacturing method from the needle-attached suture shown in each of the above figures, and the eyeless needle 20 shown in each of the above figures is
The caulking portion 22 is a so-called drilled needle that is continuous over the entire circumference, whereas the above-mentioned U.S. Pat. There are differences. That is, in the above-mentioned channel needle, there is a risk of damaging the tissue at the corners of the notch, and moreover, as compared with the eyeless needle 20 in which the caulking portion 22 is continuous over the entire circumference,
The bending strength and the needle pull-out strength of the crimped portion 22 (that is, the needle holding portion), particularly, the bending strength is significantly reduced.
The following Table 6 shows, as a reference material, the measurement results obtained by comparing the commercially available polypropylene suture with a channel needle (USP3-0) and the polypropylene suture with an eyeless needle according to the present invention (USP3-0). deep.

[0040]

[Table 6]

The present invention is not limited to the above embodiments, but the following modes can be adopted as examples.

(1) In the above-mentioned embodiment, the tapered guide surface 34 is formed above the linear portion 32, but the linear portion 3 having the above-mentioned dimension ε without the guide surface 34 is shown.
Even if all the portions above 2 are removed, the above effect can be obtained. However, by providing the guide surface 34 as described above, when the caulking portion 22 is fitted into the concave portion 33, the caulking portion 22 can be guided by the guide surface 34 into the concave portion 33. The setting work of 22 is further facilitated.

(2) The smaller the dimension ε of the linear portion 32, the smaller the force required to pull out the crimped portion 22 from the recess 33 after crimping, and the easier the taking-out work is. Therefore, it is desirable to set this dimension ε as small as possible while ensuring at least the swelling of the caulking portion 22 in the left-right direction.

[0044]

As described above, according to the caulking die and the manufacturing method of the present invention, a needle having a recess at one position can be provided by one caulking operation without enlarging the cross-sectional shape of the caulking portion of the eyeless needle. Sutures can be obtained. Since the crimped portion of the suture with needle has a smaller cross-sectional area than the portion adjacent thereto and does not have a sharply pointed portion, there is no risk of damaging the tissue during suturing. Moreover, since the caulking portion digs into the suture thread in the recess, a sufficient fixing strength can be obtained even with a single caulking operation.

Further, according to the caulking die and the manufacturing method, the caulking operation is performed only once. Therefore, the needle pull-out strength of the suture with a needle obtained as a product can be adjusted by the upper die and the lower die at the time of caulking. Adjusting the compression force of the caulking part,
In other words, it can be realized only by the distance between the upper mold and the lower mold when they are closest to each other, and the needle-pullable suture can be easily manufactured. Further, according to the caulking type, which has tapered guide surfaces extending outward from both upper ends of the substantially U-shaped recess of the lower die, the caulking portion can be smoothly guided by the guide surfaces. There is an effect that it can be fitted into the recess of the lower mold.

[Brief description of drawings]

FIG. 1 is a front view of a caulking die for manufacturing a suture with a needle according to an embodiment of the present invention.

FIG. 2 is a perspective view of an eyeless needle and a suture, and a caulking die for manufacturing, before manufacturing the suture with a needle.

FIG. 3A is a cross-sectional front view showing a state in which the caulking portion of the eyeless needle is set in the lower die of the manufacturing caulking die,
(B) is a cross-sectional front view showing a state in which the caulking portion is crimped by an upper mold.

FIG. 4 is a perspective view showing a main part of a suture thread with a needle obtained by the crimping mold.

FIG. 5 is a side view showing a main part of the suture thread with a needle.

[Explanation of symbols]

 10 Suture Thread 20 Airless Needle 21 Insertion Hole 22 Caulking Part 23 Recess 24 Part Adjacent to Caulking Part 30 Lower Mold 33 Recess 34 Guide Surface 40 Upper Mold 41 Convex Part

Claims (6)

[Claims] 1. A needle having a crimped portion provided with an axial insertion hole, and a suture thread having an end portion inserted into the insertion hole, wherein the end portion of the suture thread is inserted into the insertion hole. In a suture with a needle in which a needle and a suture are connected and fixed by crimping the caulked portion in a closed state, the cross-sectional shape of the caulked portion is continuous over the entire circumference and has a depression at one place. A suture thread with a needle, which is shaped and has a cross-sectional area smaller than that of a portion adjacent to the crimped portion. 2. The withdrawal strength of the needle with respect to the suture thread is adjusted by caulking the caulking portion so that the needle can be withdrawn from the suture thread.
A suture with a needle as described. 3. An upper mold and a lower mold, wherein a substantially U-shaped recess opening upward is formed at an upper end of the lower mold, and a lower end of the upper mold can be inserted into the recess from above. V with an angle
A crimping type for manufacturing a suture with a needle, which is formed with a letter-shaped convex portion. 4. The crimping die for manufacturing a needle-attached suture according to claim 3, wherein a tapered guide surface that extends outward from both upper ends of the substantially U-shaped recess of the lower die is formed. A crimping type for manufacturing a characteristic suture with a needle. 5. An end portion of a suture is inserted into an axial insertion hole provided in a caulking portion of a needle, and the caulking portion is formed with a substantially U-shaped recess opening upward at an upper end portion thereof. It is fitted in the recess of the lower mold, and the central portion of the caulking portion is set to the lower end portion by approximately V
A method for manufacturing a suture thread with a needle, comprising pressing from above by the convex portion of an upper mold having a character-shaped convex portion formed thereon. 6. The method for manufacturing a suture thread with a needle according to claim 5, wherein the pull-out strength of the needle with respect to the suture thread is adjusted by the distance between the upper mold and the lower mold when the upper mold and the lower mold are closest to each other. A method for producing a characteristic suture with a needle.