WO2012029689A1 - Silicone-coated suture needle and production method for same - Google Patents

Abstract

[Problem] To provide a silicone-coated suture needle wherein the time required for silicone coating (including drying time) is reduced, and a production method for same. [Solution] To support on a horizontal plane a plurality of suture needles (10) comprising: a shaft (15) with a prescribed cross-sectional shape; and a tapered section (14) that continues from the shaft (15) and gradually narrows towards a sharp needle tip (13); to spray liquid silicone on the tapered section (14) from one side of the supported suture needles(10) and coat the needles to the other side of the tapered section (14); and to dry same at room temperature. Then, once this coating has occurred a plurality of times, to heat-dry the silicone.

Description

Suture needle coated with silicone and its manufacturing method

The present invention relates to a suture needle used in a surgical operation, and more particularly to a suture needle in which silicone is applied to the suture needle and a method for manufacturing the suture needle.

There are various types of medical suturing needles depending on the application. Among them, typical examples include a square needle and a round needle. The square needle is generally used for suturing hard tissues such as skin and muscle, and has a sharply sharpened tip, a polygonal cone-shaped taper portion, and a trunk portion having a predetermined cross-sectional shape formed on the base end side thereof. The predetermined ridgeline in the taper portion becomes a cutting edge to cut open the structure. The cross-sectional shape of the body portion includes a polygonal shape such as a triangle, a quadrangle, etc., and a circular shape or an oval shape.

The round needle has a distal end, a conical tapered portion, and a body portion formed on the proximal end side and having a predetermined cross-sectional shape. The cross-sectional shape of the conical taper portion and the body portion is usually circular, but there are an oval shape having two substantially parallel planes, a shape having four planes, and a drum shape. However, it is not used as a cutting blade with a sharp ridgeline like a square needle.

The round needle pierces the tissue at the tip of the needle and then expands this hole at the taper. However, since there is no cutting edge like a square needle, the tissue is not cut off. Therefore, it is possible to prevent the biological tissue of the perforated part from being in close contact with the surface of the thread and leaking body fluid from the sutured part. Because of these characteristics, round needles are mainly used for sutures of blood vessels and soft tissues.

Medical suturing needles are usually manufactured as follows. First, a wire having a predetermined thickness is cut into a predetermined length. Next, an engaging portion with a suture is formed at one end of the material. Examples of the engaging portion include a blind hole drilled in the axial direction and a bullet hole. Next, in the case of a square needle, the material is pressed into a predetermined cross-sectional shape to form a body portion, and then a cutting edge is formed by grinding to form a tapered portion and a tip. In the case of a round needle, the tip portion is ground with a grindstone or the like to form a tapered portion and a tip. Then, after rough buffing or grinding with a fine grindstone or the like, the grinding strip is removed by fine buffing or electrolytic polishing to finish it into a mirror surface, bent into a predetermined shape, heat-treated, and surface-treated.

By the way, regarding the sharpness of the needle, that is, the reduction of the piercing resistance, the level required by the user has become very high. Even if the cutting edge (edge) in the pyramidal taper portion such as a triangular suture needle is a square needle that advances while opening the tissue, if the frictional resistance between the living tissue and the surface of the needle increases, the piercing resistance is increased. Because of this, research is being conducted daily to reduce piercing resistance as much as possible. And it is difficult to reduce especially piercing resistance with the round needle without a cutting blade.

In response to this problem, conventionally, the needle surface has been mirror-finished to reduce the piercing resistance. That is, a mirror surface is obtained by performing a buffing finishing method, an electrolytic polishing finishing method, a chemical polishing finishing method, or the like as a finishing surface treatment in the above manufacturing process.

The buffing finish is made by rotating cotton cloth with fine abrasive grains, felt, etc., against the material to be polished, and polishing with the abrasive grains. The needle tip and barrel can be mirror finished. it can.

Electrolytic polishing is a method in which a suture needle is immersed in an electrolytic solution, electrolyzed by electricity, and the surface is dissolved. Unlike the electrolytic polishing finishing method, the chemical polishing finishing method is a method in which the surface of the needle is dissolved by an acid without forcing a current to flow. Even in this case, the finish-polished surface is mirror-like.

However, the above finishing method has a smooth mirror surface as far as it is seen with the naked eye, but it is not a mirror surface when viewed microscopically. For example, in the case of buffing, there are many streaky irregularities due to abrasive grains.

In addition, even in the case of electropolishing, it can be confirmed by microscopic observation that shallow crater-like irregularities are formed by the gas generated during electrolysis adhering to the surface. In the case of chemical polishing, in addition to crater-like irregularities by the same gas as electrolytic polishing, shallow irregularities are formed on the surface of the needle by crystal grains that are easily polished for each crystal grain of the material and crystal grains that are not polished. ing.

In this way, there is a limit to reducing the piercing resistance only with the mirror finish. On the other hand, silicone is also coated on the taper portion.

Patent Document 1 describes that by using a silicone treatment material containing an aminoalkylsiloxane and at least one other siloxane copolymerizable therewith, it is possible to reduce the piercing resistance as compared with a normal silicone coating.

Patent Document 2 proposes a suture needle in which an uneven surface is formed along the axial direction in a part of a tapered portion at the tip of a round needle and silicone is coated thereon. The rugged surface creates a fine gap between the suture needle and the living tissue, and the puncture resistance can be lowered by reducing the contact area with the living tissue.

In Patent Document 3, silicone having high adhesion to the metal forming the suturing needle is applied in stripes or spots with an appropriate interval to form irregularities on the surface of the suturing needle. Proposal of high silicone applied. When the silicone applied in stripes or spots contacts the living tissue, the contact area can be reduced and the penetration resistance can be reduced.

JP-A-4-317644 JP-A-11-70113 JP 2009-160006

The conventional silicone application method is a method in which a suture needle is immersed in a silicone liquid, and silicone is applied to the entire suture needle. However, since it is not necessary to apply to the whole suture needle, there was a lot of waste of silicone. In general, the puncture resistance of a suture needle tends to increase as the number of punctures increases, and there has been a demand for the appearance of a suture needle with little increase in puncture resistance even when the number of punctures increases.

The present invention has been made in view of such circumstances, and an object of the present invention is to provide a suture needle coated with silicone that can reduce the amount of silicone used even when the number of times of piercing increases, and a method for manufacturing the same. It is said.

In order to achieve the above object, a suture needle coated with silicone according to the present invention has a trunk portion having a predetermined cross-sectional shape, and a suture portion that continues to the trunk portion and has a tapered portion that gradually narrows toward the tip. The needle is sprayed with liquid silicone from one side of the suture needle to apply silicone to the other side of the tapered portion, and the silicone adheres to at least a part of the body. It is characterized by having a portion that does not.
It can be set as the structure by which the silicone was apply | coated to the front-end | tip of the said suture needle, or it can be set as the structure in which the part which the said silicone does not adhere includes the part adjacent to the said taper part of the said trunk | drum.

In order to achieve the above object, a method for producing a suture needle coated with silicone according to the present invention includes a trunk portion having a predetermined cross-sectional shape, a tapered portion that gradually narrows toward the tip, following the trunk portion, And a step of spraying liquid silicone from one side of the supported suture needle to apply the silicone to the other side of the tapered portion.

The step of supporting the suturing needle is a step of placing the suturing needle on a flat placement surface and supporting the suturing needle with the body portion, and a portion narrower than the body portion of the tapered portion is placed as described above. It is configured to be a process of supporting to float from the surface, or a process of spraying and applying the liquid silicone is performed a plurality of times, and a process of heating and drying the silicone is performed after each spraying process. In addition, it may be configured such that the step of heating and drying the silicone is performed only after the last spraying.

In conventional spray application, silicone is applied from one side of the suture needle, and then silicone is applied from the other side. In addition, the entire length of the suture needle is the target for application. On the other hand, according to the present invention, the silicone is sprayed and applied from one side of the suture needle, and it is not necessary to apply the entire length of the suture needle, so the application time is shortened and the waste of the silicone is reduced. Can do. In addition, silicone is firmly applied to the entire circumference of the tip portion that affects the sharpness, and even if the number of times of piercing increases, an increase in piercing resistance can be suppressed.

In particular, in the case of an eyeless suture needle, if silicone enters a blind hole formed along the axis from the proximal end surface of the suture needle for suture, the fixing force of the suture is reduced. Therefore, conventionally, water has been put into the blind hole to prevent silicone from entering. However, in the case of a thin and small suture needle, it is difficult for water to enter the blind hole, and it is difficult to prevent silicone from entering. On the other hand, in the present invention, silicone can be applied only to a necessary portion of the suture needle, and there is also an effect that the silicone can be easily applied by spraying while avoiding the blind hole.

It is a perspective view of the suturing needle of the present invention. It is a top view which shows the state which arranged the suture needle side by side on the mounting base. It is a figure which shows the state of the A, B, C cross section of FIG. It is a figure which shows the state which sprayed the silicone liquid, (a) shows the spraying state in (a) or (b) of FIG. (B) is a figure which shows the spray state in FIG.3 (c). It is a figure which shows the structure of the coating device of silicone. It is a graph which shows the change of the puncture resistance of a suture needle with respect to the puncture frequency.

Embodiments of the present invention will be described below with reference to the accompanying drawings.
FIG. 1 is a perspective view of the suture needle of the present invention. The suturing needle 10 is an eyeless suturing needle and is manufactured by a conventionally known method.

As shown in FIG. 1, the suture needle 10 has a proximal end surface 11a at one end of the proximal end portion 11, and this proximal end surface 11a is processed by a laser machining method, an electron beam machining method, an electrical discharge machining method, drilling, or the like. A blind hole 12 is formed by the method. Further, a sharp needle tip 13 is formed at the distal end of the suture needle 10, and a taper portion 14 whose diameter gradually increases from the needle tip 13 is formed.

The proximal end 11 side of the tapered portion 14 is a body portion 15 having the same outer diameter as that of the proximal end portion 11. The base end portion 11 is substantially linear, but the trunk portion 15 is different in that it is curved. In addition, the base end portion 11 has a circular cross-sectional shape, but the cross-sectional shape of the body portion 15 is not limited to a circle, and an oval shape having two substantially parallel planes, one having four planes, There are also things.

The suture needle of the present invention is not limited to the eyeless suture needle as shown in FIG. 1, but may be an eyed suture needle or a round needle, and may be a square needle such as a triangular needle. Further, the tip may be blunt.

Many different types of sutures 20 are provided, such as thickness, material (nylon, silk, etc.), monofilament or multifilament, and the like. An appropriate type of suture is selected and used according to the living tissue to be sutured and the suture site. The distal end of the suture 20 is inserted into the blind hole 12 at the proximal end, and is fixed to the proximal end of the suture needle 10 by crushing and crimping the blind hole 12 with a press or the like. The suture needle 10 has an advantage that a thread of a length necessary for the suture is fixed from the beginning, and the trouble of inserting the thread into the hole like an idle needle is unnecessary.

FIG. 2 shows a state in which a plurality of the suture needles 10 shown in FIG. 1 are placed side by side on the placement table 21. In this way, the suture needles 10 are arranged on the mounting table 21 and the silicone solution is sprayed from above the mounting table 21.

FIG. 3 is a diagram showing states of cross sections A, B, and C in FIG. 2A is a cross section in the vicinity of the distal end of the suturing needle 10, and B in FIG. 2 is a cross section in the middle of the tapered portion 14. As shown in FIG. 3C, the suture needle 10 is supported by the upper surface of the mounting table 21, that is, the mounting surface 21a, by the base end portion 11 and the trunk portion 15, and therefore has a diameter larger than these. As shown in FIGS. 3 (a) and 3 (b), the thin taper portion has each cross-section floating in the air.

FIG. 4 is a view showing a state in which the silicone liquid is sprayed, and (a) shows the sprayed state in (a) or (b) of FIG. (B) is a figure which shows the spray state in FIG.3 (c).

As shown in FIG. 4A, when the diameter of the cross section of the suture needle 10 is narrower than the base end portion 11, the suture needle 10 floats in a space away from the placement surface 21a of the placement table 21. On the other hand, the sprayed silicone becomes small particles 30 and floats near the suture needle. Some of the silicone particles 30 slowly descend toward the mounting surface 21a, some descend slightly faster, and some drift in the air while moving up and down. Then, the particles 30 approaching the taper portion 14, the body portion 15, the base end portion 11, and the like of the suture needle 10 adhere to the portions and form the silicone layer 31.

The portion thinner than the base end portion 11 of the taper portion 14 has a gap between the placement surface 21a as shown in FIG. 4A, so that the silicone particles 30 are formed on the upper surface and both side surfaces of the suture needle 10. Of course, it also adheres to the lower surface, and eventually, the silicone layer 31 is firmly formed over the entire circumference of the suture needle 10.

On the other hand, as shown in FIG. 4 (b), since the lower portion of the body portion 15 and the base end portion 11 is in contact with the placement surface 21a, silicone particles 30 adhere to the upper side and both side surfaces. Silicone does not adhere to the lower side.

In such a spraying method of the silicone liquid, since the silicone particles 30 are small and adhere evenly, they are dried in a short time even at room temperature.

When dried, spray and apply silicone again from above and dry at room temperature. This process is repeated, and when a plurality of layers (here, four layers) of silicone layers 31 are formed, the layers are heated to 180 ° C. and dried for 8 hours. When this heat drying is completed, the suture needle 10 is completed. The completed suture needle 10 has portions where silicone is not applied on both sides with the line contact portion in contact with the placement surface 21a of the trunk portion 15 as the center. The portion where the silicone is not applied starts from a portion adjacent to the taper portion 14 of the trunk portion 15 and extends over the entire range where the silicone of the trunk portion 15 is applied.

In the present invention, since it is applied by spraying, drying is fast, so after the last spray coating is applied, it is only necessary to heat and dry once, replacing the heat drying conventionally performed for each coating with short-time room temperature drying. Can do. Therefore, the time required for heat drying can be greatly shortened. Furthermore, since the drying is fast, the concentration of silicone can be made higher than that by dip coating, and a thick silicone can be uniformly applied. In the case of immersion, when the concentration of silicone is 1% or more, it is not preferable to employ it because it takes a long time to dry, but in the case of spraying, it is preferable to employ a concentration of 1% or more.

FIG. 5 is a diagram showing a configuration of a suture needle manufacturing apparatus to which the silicone of the present invention is applied. The manufacturing apparatus includes a belt conveyor 35 serving as a transport device, a nozzle 36 serving as a silicone spraying device provided in the middle of the transport path of the belt conveyor 35, a mounting table 21 transported to the belt conveyor 35, and a belt conveyor 35. And a drying furnace 37 provided at the end of the.

A large number of suture needles 10 are placed on the placement surface 21a of the placement table 21 as shown in FIG. When the mounting table 21 is conveyed and reaches below the nozzle 36, silicone is sprayed from the nozzle and applied. The applied silicone is dried at room temperature until the mounting table 21 moves on the belt conveyor 35 and reaches the next nozzle 36, and is applied by spraying with the next nozzle 36. In this way, spraying → drying → spraying → drying is repeated four times and applied to the final end of the belt conveyor 35 and sent to the drying furnace 37 where it is heated and dried at 180 ° C. for 8 hours. . The drying furnace 37 is not limited to being provided at the end of the belt conveyor 35, and may be installed at a location away from the belt conveyor 35.

In the embodiment of the present invention, silicone is applied four times by spraying, but the number of times is not particularly limited. However, since the thickness of the silicone film is small at one time, it is desirable to repeat it several times.

In the present invention, since it suffices to apply silicone only to the tapered portion 14 of the suturing needle 10, it is not necessary to spray silicone over a wide range such as over the entire length of the suturing needle. Further, even in the tapered portion 14, there is a possibility that silicone is not applied to the entire circumference where the diameter is close to the body portion 15. However, in the case of a round needle as in this embodiment, the piercing resistance of the suture needle 10 peaks at the tip of the suture needle 10 and a position slightly approaching from the tip, so that the length of the tapered portion 14 from the tip is the same. It suffices that silicone is applied to the entire circumference of up to about a half. Even in the case of a square needle, a peak occurs near the position of the maximum diameter of the tapered portion 14. Therefore, even if silicone is not applied to the body portion 15 and the base end portion 11 at all, the piercing resistance does not increase.

In the above embodiment, a round needle having a round cross-sectional shape has been described, but the same effect can be obtained with a square suture needle such as a triangular needle. That is, in the case of a triangular needle, a tapered triangular pyramid is formed from the pointed tip of the needle to reach the trunk. Therefore, the silicone may be applied to the triangular pyramid portion by spraying. Even with a square suture needle, when coating is performed by dipping, the coating in the vicinity of the edge including the tip becomes thin, so that application by spraying is effective.

FIG. 6 is a graph showing changes in the piercing resistance of the suture needle with respect to the number of piercings. All the needles from the present invention to Comparative Example 3 are round needles and have a 0.24 mm outer diameter. The piercing material was measured using an artificial leather pole bear having a thickness of 0.45 mm, and the average value of five was described. The unit of piercing resistance is N (Newton), and the method of applying silicone is as follows.

[Invention] As in the above-described embodiment, a suture needle was placed on the placing table 21, and sprayed with 2.0% silicone by spraying from above and dried at room temperature for a short time. The painting place is the entire tapered portion including the tip of the suture needle and one side surface side. The number of coatings was 4, and after the final spray coating, the coating was heated to 180 ° C. and heat-dried for 8 hours.

[Comparative Example 1] Instead of spray coating, the entire suture needle was dipped in a 0.8% concentration silicone liquid. The number of paintings is four times. After each immersion, it was heat-dried 4 times at 180 ° C. for 8 hours.

[Comparative Example 2] Instead of spray coating, the entire suture needle was immersed in a 0.8% concentration silicone liquid. The number of coatings was 4, and after each dipping, it was heat-dried 3 times at 180 ° C for 1 hour, and after the last dipping coating, it was heat-dried at 180 ° C for 8 hours.
[Comparative Example 3] It was a commercial product of another company, and the application condition of silicone was unknown.

Referring to the graph of FIG. 6, in Comparative Example 2 and Comparative Example 3, the piercing resistance increases as the number of piercings increases. However, it can be seen that the piercing resistance does not increase between the present invention and Comparative Example 1 even when the piercing frequency is increased. In the present invention and Comparative Example 1, the number of coatings is four, but in the present invention, spray coating is performed from one side, whereas Comparative Example 1 is immersion coating. From the above, it can be seen that according to the present invention, it is possible to produce a product having the same performance in a shorter time than a conventional product. Moreover, since the thing of this invention is spray coating, the quantity of silicone decreases and waste is also reduced. Furthermore, since the present invention is spray coating and the concentration is high, thick silicone can be applied, so that the result that the piercing resistance does not increase even when the piercing frequency is increased is obtained. It is done.

Tables 1 and 2 show, as another experimental example, the outer diameters of the needles were 0.14 mm, 0.18 mm, 0.24 mm (above Table 1), 0.28 mm, 0.33 mm, 0.38 mm (above Table 2 shows the experimental results of comparison and examination on how sharpness and sharpness durability change between spray coating and immersion coating.

As the piercing material, a pole bear having a thickness of 0.45 mm was used if the outer diameter was 0.28 mm or less, and a pole bear having a thickness of 1.10 mm was used if the outer diameter was 0.33 mm or more.

[Invention]
Like the said Example, the suturing needle was mounted on the mounting base 21, and the 2.0% density | concentration silicone was sprayed and painted by spraying from the upper direction. The painting place is the whole taper part including a front-end | tip and the middle of a trunk | drum. The number of paintings is four times. After the first and third sprays, they were heat-dried at 180 ° C. for 4 hours, and after the second and fourth sprays, they were heat-dried at 180 ° C. for 8 hours. At each outer diameter, the piercing resistance (average value of five) from the first piercing to the tenth piercing was measured. The unit of piercing resistance is N (Newton).

[Comparative Example]
As a comparative example, painting was performed by immersing a suture needle in a 0.8% concentration silicone liquid. The number of paintings is four times. After the first and third immersions, heat drying was performed at 180 ° C. for 1 hour, and after the second and fourth times, heat drying was performed at 180 ° C. for 8 hours. At each outer diameter, the piercing resistance (average value of five) from the first piercing to the tenth piercing was measured.

As a result of the experiment, it was found that the average value of the piercing resistance from the first piercing to the tenth piercing was smaller in the spray type of the present invention in all the outer diameters from 0.14 mm to 0.38 mm. . When the average value of the immersion type puncture resistance was divided by the average value of the spray type puncture resistance and the sharpness was compared, it was over 2.0 when the outer diameter was 0.14 mm. It was found that a significant advantage appears. From the experimental results, it has been found that the present invention has a special effect particularly when applied to a small-sized suture needle.

In addition, for both the spray type and the immersion type, a value obtained by dividing the puncture resistance of the 10th puncture by the puncture resistance of the 1st puncture (referred to as “the puncture resistance increase rate”) was obtained. In all of the diameters from 0.14 mm to 0.38 mm, the value of the spray type was lower. This proves the result of FIG. 6 that the increase in piercing resistance is small and the sharpness durability is good even after ten piercings.

Furthermore, when the value obtained by dividing the immersion type puncture resistance increase rate by the spray type puncture resistance increase rate was obtained and the sharpness durability was compared, it exceeded 2.0 when the outer diameter was 0.14 mm and 0.18 mm. It was. That is, the present invention was found to be particularly effective with a small-sized suture needle.

Summarizing the above experiments, it was found that advantageous results were obtained when the spray method of the present invention was used in both sharpness and sharpness durability. In addition, it is recognized that the effect is particularly high in a small-sized suture needle. As described above, the small-sized suture needle also takes into consideration that water for preventing silicone from entering the blind hole is difficult to enter. It was found that it is optimal to adopt the spray type of the present invention for a small-sized suture needle. In particular, with a suture needle having an outer diameter of 0.28 mm or less, it was found that the sharpness durability was 1.59 times better when compared with the case of the conventional immersion type, and it was found that it can be particularly preferably applied.

DESCRIPTION OF SYMBOLS 10 Suture needle 11 Base end part 11a Base end surface 12 Blind hole 13 Needle tip 14 Taper part 15 Trunk part 20 Suture thread 21 Mounting stand 21a Mounting surface 30 Silicone particle 31 Silicone layer 35 Belt conveyor (conveyance device)
36 nozzle (spraying device)
37 Drying furnace

Claims (3)

1. A suturing needle having a trunk portion having a predetermined cross-sectional shape, and a tapered portion that gradually narrows toward the tip, following the trunk portion,
   The suturing needle is sprayed with liquid silicone from one side surface of the suturing needle and applied with silicone to the other side surface of the tapered portion, and has at least a portion where the silicone does not adhere to a part of the body portion. A suture needle coated with silicone.
2. The silicone-applied suture needle according to claim 1, wherein silicone is applied to the tip of the suture needle.
3. A step of supporting a suture needle having a trunk portion having a predetermined cross-sectional shape and a tapered portion that gradually narrows toward the distal end following the barrel portion; and a liquid state from one side of the supported suture needle And a step of spraying the silicone to the other side surface of the tapered portion, and a method of manufacturing a suture needle coated with silicone.

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