WO2016190504A1 - Suture comprising ultra-high-molecular-weight polyethylene fiber - Google Patents

Abstract

The present invention relates to a suture manufactured by twisting together an ultra-high-molecular-weight polyethylene (UHMWPE) fiber and a different type of colored fiber, and relates to a suture having remarkably improved distinctiveness and having excellent tensile strength and knot strength and improved knot stability by optimizing the mixing amount of the UHMWPE fiber, and the twisting angle and twisting interval of the fibers.

Description

Sutures containing ultra high molecular weight polyethylene fibers

The present invention relates to a suture comprising ultra high molecular weight polyethylene fibers, and more specifically, to a suture made by twisting ultra high molecular weight polyethylene fibers (Fiber) and heterogeneous colored fibers (Fiber) to improve the discrimination ability and physical properties of the suture. It is about a suture that can satisfy together.

Generally, sutures used in surgery include biodegradable sutures that are broken down and absorbed in vivo, and non-degradable sutures that do not break down in vivo, which are mainly twisted into multifilaments or composed of monofilaments, sometimes twisted It may also consist of a twisted structure.

Non-degradable sutures made from materials such as silk, polypropylene, polyester, nylon or ultra high molecular weight polyethylene (UHMWPE) are biocompatible In addition to showing excellent physical properties are mainly used for imaging, vascular, orthopedic surgery.

For example, orthopedic surgeons use suture anchors to reattach damaged soft tissues (tendons, ligaments, muscles) to bones. The suture screw is composed of an anchor fixing to the bone and a suture connecting the soft tissue, wherein the suture uses ultra-high molecular weight polyethylene (UHWMPE) having a high strength.

The ultra high molecular weight polyethylene is a high-density polyethylene having a weight average molecular weight of about 1 million or more, and is suitable for living beings, has excellent wear resistance, and exhibits high tensile strength.

On the other hand, the suture is advantageous to have a good discrimination ability so that the doctor can easily locate and suture the suture in the blood during surgery.

However, natural materials or synthetically obtained suture materials are basically colorless. Especially, because of their excellent physical properties, ultra-high molecular weight polyethylene widely used as suture materials is difficult to dye due to high crystallinity.

In the case of arthroscopic procedures in which the surgical site is not seen directly by the eye but indirectly confirmed by the screen through the camera, it is difficult to distinguish the sutures of several strands due to the deterioration of the identification of the sutures as described above. It acts as a factor.

In order to solve this problem, European Patent No. 2,158,344 discloses a method of manufacturing a super high molecular weight polyethylene suture having a light blue yarn by spinning blue yarn by adding a blue dye during the gel spinning process, and twisting the yarn. have.

However, due to the physicochemical properties of the ultra high molecular weight polyethylene, the dyeable color is not only limited to blue but also has a problem that the dyed dye is not peeled off or the identification is still improved.

On the other hand, EP 1,293,218 discloses a method for producing a suture by twisting together ultra-high molecular weight polyethylene and multifilaments or monofilaments of other dyed materials.

However, the method has a possibility of reducing the strength of the produced suture due to other materials used with ultra high molecular weight polyethylene, as well as twisted structure of the yarn to distinguish the color of the braided with white ultra high molecular weight polyethylene (UHMWPE) Is very simple, and when the narrow field of view of the arthroscopy and the strong light are illuminated, the color is not easily distinguished from white.

The present invention has been made to solve the above-mentioned problems, and an object thereof is to provide an improved suture.

Another object of the present invention is to provide a suture excellent in knot strength and linear strength.

Another object of the present invention is to provide a suture excellent in knot stability.

Suture of the present invention for achieving the above object is characterized by being produced by twisting ultra-high molecular weight polyethylene (UHMWPE) fibers and colored fibers (Fiber).

In addition, the suture of the present invention is characterized in that the colored fibers are naturally derived fibers or synthetic fibers.

In addition, the suture of the present invention is the natural fiber is silk (Silk) or cotton (Cotton), the synthetic fiber is polypropylene (Polypropylene), nylon (Nylon), polytetrafluoroethylene (PTFE, Polytetrafluoroethylene), polyethylene tere Phthalate (PET, polyethylene terephthalate), polybutylene terephthalate (PBT), carbon fiber, polyglycolic acid (PGA), polylactic acid (PLA), polyglyco-lactic acid ( PGLA), polydioxanone (PDO), polycaprolactone (PCL) or polyglyco-co-caprolactone (PGCL).

In addition, the suture of the present invention contains the ultra-high molecular weight polyethylene (UHMWPE) fibers 35% by weight to 90% by weight based on the total suture, the twist interval (PPI) of the suture is 40 to 60 times per inch of suture length; And the twist angle of the suture is characterized in that 25 ° ~ 45 °.

In addition, the suture of the present invention, when the suture is USP 2-0, the linear strength (N) 100 or more and the knot strength (N) 50 or more, when the suture is USP 0, the linear strength (N) 120 or more and Knot strength (N) 55 or more, when the suture is USP 1, the linear strength (N) 150 or more and knot strength (N) 80 or more, when the suture is USP 2, the linear strength (N) 200 or more and Knot strength (N) 100 or more, the suture is USP 3 & 4, the linear strength (N) 250 or more and the knot strength (N) 130 or more, if the suture is USP 5, the linear strength (N) 300 or more and Knot strength (N) 160 or more, the suture is USP 6, the linear strength (N) 320 or more and knot strength (N) 180 or more, the suture is USP 7, the linear strength (N) 340 or more and The knot strength (N) is characterized in that more than 200.

Suture according to the present invention has the advantage that recognizability is significantly improved by twisting colorless ultra high molecular weight polyethylene (UHMWPE) fibers and colored fibers (Fiber).

In addition, the suture according to the present invention has the effect of providing a suture with improved knot stability as well as excellent linear strength and knot strength by optimizing the blending amount of the ultra high molecular weight polyethylene (UHMWPE) fibers, the twist angle and the twist interval of the fibers. .

1 is a view showing the structure of the suture according to the present invention.

2 is a view showing the twist angle and the pitch of the suture.

Figure 3a is a photograph of the suture according to the present invention.

Figure 3b is a photograph of the suture according to the prior art.

Hereinafter, preferred embodiments of the present invention will be described in detail so that those skilled in the art can easily implement. Embodiment of the present invention can be modified in various other forms, the scope of the present invention is not limited to the embodiments described below.

Hereinafter, the suture of the present invention will be described in detail.

The suture of the present invention is made by twisting ultra-high molecular weight polyethylene (UHMWPE) fibers and colored fibers (Fiber), the suture twist interval (PPI) of the suture length 40 ~ 60 per inch and twist angle 25 ° ~ 45 ° In this case, when the suture is USP 2-0 (suture diameter 0.330 ~ 0.369 mm), the linear strength (N) 100 or more and the knot strength (N) 50 or more, the suture is USP 0 (suture diameter 0.380 ~ 0.429 mm) ), The straight strength (N) 120 or more and the knot strength (N) 55 or more, and when the suture is USP 1 (suture diameter 0.450 to 0.549 mm), the linear strength (N) 150 or more and the knot strength (N) 80 or more, when the suture is USP 2 (suture diameter 0.550 ~ 0.649 mm), the straight strength (N) 200 or more and the knot strength (N) 100 or more, the suture is USP 3 & 4 (suture diameter 0.650 ~ 0.749 mm) ), The linear strength (N) 250 or more and the knot strength (N) 130 or more, the suture is USP 5 (suture diameter 0.750 to 0.849 mm), the linear strength (N) 300 or more and knot strength (N) 160 or more, and when the suture is USP 6 (suture diameter 0.850 to 0.949 mm), the linear strength (N) 320 or more and the knot When the strength (N) is 180 or more, and the suture is USP 7 (suture diameter 0.950 to 1.499 mm), it is characterized in that the linear strength (N) 340 or more and knot strength (N) 200 or more.

Here, the preferred linear strength and the knot strength for each kind of the suture are different because the strength required depends on the diameter of the suture.

The ultra high molecular weight polyethylene (UHMWPE) fibers can be produced by a known method, and can also be obtained commercially as Spectra® or Dyneema® grades.

Known methods include spinning into a fiber yarn from a solution of ultra high molecular weight polyethylene; Cooling the obtained fiber yarn to form gel fiber yarn; Removing the spinning solvent from the gel fiber yarns; And drawing the fiber yarn in one or more drawing steps before, during or after removing the spinning solvent.

Herein, ultra high molecular weight polyethylene (UHMWPE) fibers in the present invention do not impart any color. That is, conventionally, blue pigments (copper phthalocyanine pigments, CI Pigment Blue 15, [Phthalocyaninati (2-)] copper) were added to ultra-high molecular weight polyethylene (UHMWPE) without color during gel spinning process for the purpose of enhancing suture identification. Although there are cases where blue yarns are spun, there is still a problem that it is difficult to distinguish and dyeing is not easy due to the high crystallinity of the ultra high molecular weight polyethylene (UHMWPE) yarn itself.

Therefore, the present invention does not impart any color to the ultra high molecular weight polyethylene (UHMWPE) fibers, while providing a suture significantly recognizable compared to the conventional suture by giving a color only to the fiber to be braided together with the ultra high molecular weight polyethylene (UHMWPE) fibers. Can be.

Fibers braided together with the ultra high molecular weight polyethylene (UHMWPE) fibers are not particularly limited as long as they are easy to impart color, and are preferably natural fibers or synthetic fibers.

The naturally occurring fiber is preferably silk or cotton, and the synthetic fiber is polypropylene, nylon, polytetrafluoroethylene (PTFE, polytetrafluoroethylene), polyethylene terephthalate (PET). polyglycolic acid (PGA), polylactic acid (PLA), including non-absorbable synthetic fibers such as polyethylene terephthalate (PET), polybutylene terephthalate (PBT), and carbon fiber And absorbent synthetic fibers such as polyglyco-lactic acid (PGLA), polydioxanone (PDO), polycaprolactone (PCL), polyglyco-ca-lacrolactone (PGCL).

Looking at the structure of the suture according to the present invention with reference to the accompanying Figures 1 and 2, consisting of a core of the core (Core) and several strands (Sheath) surrounding the core (Core), the core and the sheath blading To manufacture a suture.

Here, the fiber corresponding to the core is ultra high molecular weight polyethylene (UHMWPE) or heterogeneous colored fibers.

That is, when the ultra high molecular weight polyethylene (UHMWPE) is used as the core, the ultra high molecular weight polyethylene (UHMWPE) and heterogeneous colored fibers are arranged as sheaths, and conversely, heterogeneous colored fibers. In the case of Core, ultra high molecular weight polyethylene (UHMWPE) and heterogeneous colored fibers become sheath.

On the other hand, the ultra-high molecular weight polyethylene (UHMWPE) fibers used as a core (Core) or sheath (Sheath) in the present invention is preferably included in more than 35% by weight to 90% by weight based on the total suture. When the content of the ultra high molecular weight polyethylene (UHMWPE) fiber is less than 35% by weight, even if the degree of twisting to be described later can not be obtained sufficient physical properties to the suture, if it exceeds 90% by weight the suture of the suture is too low It is preferable to use it in the said range since a problem arises, such as being soft and smooth and a knot stability falls rapidly.

On the other hand, if the amount of ultra high molecular weight polyethylene (UHMWPE) contained in a certain length in a suture made of only ultra high molecular weight polyethylene (UHMWPE) is assumed to be 100, it is twisted together with heterogeneous colored fibers to improve the suture's discrimination ability. The semi-suture helps doctors easily determine the direction of suture movement during surgery, especially arthroscopy, but the content of ultra high molecular weight polyethylene (UHMWPE) is inevitably reduced, resulting in deterioration of physical properties such as straight strength and knot strength. Can be.

That is, the suture refers to a thread used to sew wounds or torn areas, and the physical properties required as the sutures require a knot stability that is excellent in strength in addition to the discriminating power and that the knot is not easily released. In orthopedic surgery, injured soft tissues (tendons, ligaments, muscles, etc.) are attached to bones, and a minimal incision is made to shorten the recovery time, followed by arthroscopy. At this time, suture screws are used to reattach the soft tissues. You will use (Suture Anchor). The Suture Anchor consists of an anchor part that is anchored to the bone and a suture part that is used to pull the soft tissue part. Therefore, in order to attach and fix the soft tissue such as muscle to the bone, a corresponding strength must be obtained. need.

Therefore, in order to secure the strength and knot stability of the suture described above, it is very important to select the optimal condition of the degree of twist. In other words, if the degree of twisting is not appropriate, too stiff or loose and knot stability is insufficient, the suture can not fully exhibit its function.

In particular, in the case of producing a suture by twisting ultra-high molecular weight polyethylene (UHMWPE) and the color of heterogeneous (異種) fibers can be said that the role of the twisting condition is more important.

Here, in general, when twisting a suture, the degree of twisting can be expressed by the pitch per inch (PPI) and the twist angle, and the twist angle is the number of twists per inch of the suture length, and the twist angle is represented by 0 to 90 degrees. .

In the present invention, in order to cope with the above problems that may occur in the production of the suture twisted ultra-high molecular weight polyethylene (UHMWPE) and heterogeneous colored fibers, twist interval 40 ~ 60 PPI, twist angle 25 ° ~ 45 ° It is characterized by that.

When the twisting interval is less than 40 PPI, the linear strength and the knot strength are too low to reach the strength required by the suture. When the twisting interval is greater than 60 PPI, the suture is too stiff and the flexibility is difficult to handle when used.

In addition, even when the twist angle is less than 25 ° twisted too poorly, straightness and knot strength is lowered, if it exceeds 45 ° twisted too tightly, the flexibility of the suture is inferior.

Therefore, in providing the suture of the present invention by blading ultra high molecular weight polyethylene (UHMWPE) and heterogeneous colored fibers, the twisting interval is 40 ~ in order to secure the strength and knot stability required as the suture with excellent discrimination 60 PPI, twist angle is preferably adjusted to 25 ° ~ 45 °.

Hereinafter, preferred examples are provided to aid in understanding the present invention. However, the following examples are merely provided to more easily understand the present invention, and the contents of the present invention are not limited thereto.

How to measure

1. Straight line strong measuring method

Two clamps are attached to the sutures of the following Examples and Comparative Examples, one of which was moved at a constant speed of 300 mm / min. At this time, the length of the suture between the two clamps is 200mm, the force when the suture is cut was measured.

2. Knot strength measurement

Two clamps are attached to the sutures of the following Examples and Comparative Examples, one of which was moved at a constant speed of 250 mm / min. At this time, the length of the suture between the two clamps was 200mm, the knot was tied in a simple knot method so that the knot was positioned at the midpoint between the clamps and the force was measured when the suture was cut.

3. Knot stability

Tie a knot with Surgeon's knot around the rubber tube and cut the suture opposite the knot. Position the knot at the midpoint of the clamp and secure the two cut ends to the two clamps. While moving the moving clamp, measure the force when the suture is cut and consider the knot stability if the knot is released during the measurement.

Examples 1-5

Ultra high molecular weight polyethylene (UHMWPE) and polyethylene terephthalate (PET) were selected as suture materials as heterogeneous fibers. The heterogeneous fibers were dyed with blue or green dyes when spinning to improve the susceptibility of sutures. Among them, ultra high molecular weight polyethylene (UHMWPE) or polyethylene terephthalate (PET) is used as a core and ultra high molecular weight polyethylene (UHMWPE) as a sheath, and polyethylene terephthalate (PET, polyethylene terephthalate) is selectively added.

The suture was prepared while adjusting the ultra high molecular weight polyethylene (UHMWPE) blending ratio to 35 to 90% by weight, while adjusting the twist angle to 30 ° to 45 ° and the twist interval of 45 to 60 PPI. On the other hand in the Example was used a suture having a USP 2 size corresponding to a diameter of 0.550 ~ 0.649 mm.

Comparative Examples 1 to 5

Ultra-high molecular weight polyethylene (UHMWPE) and polyethylene terephthalate (PET) heterogeneous (異種) fibers, which are the same as the above examples, were used, but sutures were prepared by varying the compounding ratio, twist angle, and twist interval of ultra high molecular weight polyethylene (UHMWPE). .

Experimental Example

The linear strength, the knot strength and the knot stability were measured for the sutures prepared in Examples 1 to 4 and Comparative Examples 1 to 4, and the results are shown in Table 1 and FIGS. 3A and 3B.

division	UHMWPE content (% by weight)	Twist angle (°)	Twisting interval (PPI)	Linear strength (N)	Knot Strength (N)	Knot Stability
Example 1	40	30	45	200	109	O
Example 2	40	30	54	238	118	O
Example 3	60	30	54	229	113	O
Example 4	70	30	54	240	125	O
Example 5	90	30	54	250	131	O
Comparative Example 1	100	30	54	276	145	X
Comparative Example 2	40	15	25	263	87	X
Comparative Example 3	40	20	35	226	87	X
Comparative Example 4	40	35	68	219	92	O
Comparative Example 5	30	30	54	108	47	O

As can be seen in Table 1, in Examples 1 to 5, the ultra high molecular weight polyethylene content of 40% by weight to 90% by weight, twist angle of 30 ° twist interval 45PPI to 54PPI, linear strength of 200 N or more and knot strength It can be seen that not only the strength obtained as 100 N or more, but also sufficient strength as a suture was obtained, and there was no problem in knot stability at all.

On the other hand, Comparative Example 1, which is 100% of ultra high molecular weight polyethylene (UHMWPE) without mixing heterogeneous colored fibers, corresponds to colorlessness, and not only sutures are identified, but also knot stability is poor, causing slippage.

Meanwhile, from Comparative Examples 2 and 3, the content of ultra high molecular weight polyethylene falls within the preferred range of the present invention, but the twist angle is 15 ° and the twist interval is 25PPI (Comparative Example 2), the twist angle is 20 ° and the twist interval is 35PPI (Comparative Example 3) As a result, when the twist angle and the twist interval are too low, it can be seen that problems occur in knot strength and knot stability.

In addition, when the twist interval is too high as 68PPI, it can be seen from Comparative Example 4 that the knot strength is less than 100 N and is also unsuitable as a suture.

The twist angle and the twist interval correspond to the preferred range of the present invention, but in Comparative Example 5 in which the ultra high molecular weight polyethylene (UHMWPE) content is too low, it can be seen that the linear strength and the knot strength cannot be used as the suture.

On the other hand, as can be seen in Figures 3a and 3b, compared to the suture according to the prior art by lowering the content of ultra-high molecular weight polyethylene according to the second embodiment of the present invention by using a combination of heterogeneous colored fibers also distinguishable remarkably It can be seen that it is elevated.

Claims (5)

1. Suture made by twisting ultra high molecular weight polyethylene (UHMWPE) fibers and colored fibers (Fiber).
2. The suture of claim 1, wherein the colored fibers are naturally derived fibers or synthetic fibers.
3. The method of claim 2, wherein the naturally derived fibers are silk or cotton, and the synthetic fibers are polypropylene, nylon, polytetrafluoroethylene (PTFE, polytetrafluoroethylene), and polyethylene tere. Phthalate (PET, polyethylene terephthalate), polybutylene terephthalate (PBT), carbon fiber, polyglycolic acid (PGA), polylactic acid (PLA), polyglyco-lactic acid ( PGLA), polydioxanone (PDO), polycaprolactone (PCL) or polyglyco-co-caprolactone (PGCL).
4. According to claim 1, wherein the ultra-high molecular weight polyethylene (UHMWPE) fibers are contained in 35% to 90% by weight of the total suture, the twist interval (PPI) of the suture is 40 to 60 times per inch of suture length; And the twist angle of the suture is 25 ° ~ 45 °.
5. The method of claim 4, wherein when the suture is USP 2-0, the linear strength (N) 100 or more and the knot strength (N) 50 or more,

   When the suture is USP 0, the linear strength (N) 120 or more and the knot strength (N) 55 or more,

   When the suture is USP 1, the linear strength (N) 150 or more and the knot strength (N) 80 or more,

   When the suture is USP 2, the linear strength (N) 200 or more and the knot strength (N) 100 or more,

   When the suture is USP 3 & 4, the linear strength (N) 250 or more and the knot strength (N) 130 or more,

   When the suture is USP 5, the linear strength (N) 300 or more and the knot strength (N) 160 or more,

   When the suture is USP 6, the linear strength (N) 320 or more and the knot strength (N) 180 or more,

   When the suture is USP 7, the suture is characterized in that the linear strength (N) 340 or more and knot strength (N) 200 or more.

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