JPS61502379A - composite surgical suture - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed description of the invention] composite surgical suture Crying Man May Industrial applications The present invention is an improved method with very strong knot strength. The present invention relates to surgical sutures and methods of manufacturing the same. More specifically, depending on the nodule strength, The United States Pharmacopeia, Multiplexes available over a range of suture sizes classified as Concerning surgical sutures.

Brief description of prior art Surgical sutures generally fall into two classes: (1) natural or are synthetic absorbable sutures and (2) remain in the body for a long time or are removed as the wound heals. , are broadly classified into non-water absorbent sutures.

For the patient, the implanted suture is harmless. If available, use the thinnest sutures, whether absorbable or non-absorbable. This allows the nodule to be directly related to the minimum body size and the size of the nodule portion, in other words. The larger the nodule, the greater the risk of interfering with wound healing. It is based on this idea.

Indeed, this is why the original United States Pharmacopoeia standards required non-absorbable sutures to be 10.910.810.710.610.510.410.310,210,0 ．． This was the reason why it was classified into 17 sizes: 1.2.3.4.5.6.7. Furthermore, Several types of 1-nize are used that are not in the US Pharmacopoeia. mid-1920s and 19 Considering that silk was the most frequently used non-absorbable suture in the 1930s, The above sizes were simply classified based on Mid.

The sizes of these 17 species could be classified by visual measurement. If more detailed Even if a proper classification is required, the raw materials from the pumps will vary, and the Therefore, such a precise classification would not have been possible. This classification was previously It was quite useful. It is true that it is not possible to "normalize" the number of sizes. stomach. There are countless sizes. J: For finer sizes, use the following Reese as a substitute. It has sufficient knot break strength. Unfortunately, it was not possible to combine the sizes into one.

BACKGROUND ART Postoperative hernias have traditionally been a major problem in surgical operations.

The tension of scar tissue is clearly inferior when compared to that of normal tissue. Herni For many years, scars have been occurring from post-surgery scars. If it supports scars If sutures are developed that leave a non-absorbable suture system, surgical complications may be reduced. Post-operative hernias, a symptom of this disease, will be reduced or perhaps eliminated.

Composite sutures with reinforced cores are known in the art. however However, a suture having the above-mentioned desired characteristics has not yet been obtained.

Therefore, it is an object of the present invention to provide an external body with much less foreign matter remaining in the body and with strong knot strength. Our objective is to provide medical sutures.

Another object of the present invention is to provide sutures classified according to the United States Pharmacopoeia standard due to their knotting strength. It can be used for a range of surgical suture threads in various sizes, and only a few types can be used for all sizes of the classification. The object of the present invention is to provide a surgical suture thread that is finer than the conventional one and can be used as a substitute for the surgical suture thread.

The purpose of the present invention is to provide non-absorbable sutures for nabotting scars, leaving no residue behind. An object of the present invention is to provide a composite suture that reduces or eliminates complications of postoperative hernia.

The object of the present invention is to have strong knot strength and adjust its surface properties to meet the desired properties. An object of the present invention is to provide a method for manufacturing a surgical suture thread that can be adjusted.

An object of the present invention is to provide a composite suture that can be used with a needle having the same outer diameter as the composite suture. It's there.

The object of the present invention is to create a composite suture with lateral strength, i.e., during knotting, abrasion, The objective is to provide a composite suture that is stable against torsion and/or fibrillation. .

Composition of the invention An intended object of the present invention is to have a knot strength of at least 7 g/denier and to and a synthetic polymer elongated core coated with a fibrogenic surgical material. , accomplished by sterile surgical sutures. U.S. pharmacy made using the coated core Surgical sutures of specific sizes in the United States Pharmacopoeia are made of the suture materials listed above. Demonstrates knot strength comparable to surgical sutures two sizes larger.

The long core of the suture of the present invention has straight tensile strength (straightr) t enacity) of at least 15 g/denier, preferably 70 g/denier or more and the knot strength is at least 7 Q/denier, preferably 30 g/denier. Fiber-forming synthetic polymers of denier or higher, such as polyamides, polyols, etc. Manufactured from resin and polyester. As used herein, "knot strength" The opening indicates the nodule failure strength and is classified as a denier unit. Invention suture If the synthetic polymer constituting the yarn core does not satisfy the above knot strength characteristics, such a core Sutures using .

Synthetic polymeric materials suitable for use as suture cores of the present invention include fiber-forming Examples include aromatic polyamides, and the bonds that extend the chain from the aromatic core of the polyamides are substantially coaxial or parallel and oriented in opposite directions. Here, it becomes "aromatic nucleus" The term refers to aromatic rings connected in a chain and divalent fused aromatic groups. Preferred polymer - per amide bond, up to two aromatic rings, e.g. Fused rings (e.g. 4,4'-biphenylene) or fused rings (e.g. '1,5-naphenyl) carbocyclic polyamides containing talin). From these aromatic rings The emerging chain extension bonds are para-oriented and/or substantially coaxial or parallel and [formula In the figure, R and R' represent phenylene (M) in which the chain extending bonds are substantially coaxial. , and may have a substituent on R and the aromatic nucleus. ) Examples include polyamides characterized by

Furthermore, it is particularly preferable to have a substituent on the aromatic nucleus of the general formula.

] Polyamides characterized by a repeating unit represented by the following can also be exemplified.

As mentioned above, the aromatic nucleus of the polymer of the present invention may have a substituent. These places Substituents do not react during the polymerization reaction, for example, during polymer processing such as heat treatment of molded fibers. Preferably, those that do not react also. Such reactivity is undesirable. why If so, the reactivity of such substituents promotes crosslinking of the polymer, while the doped And/or there is a possibility that the fiber properties will not be affected. Preferred non-reactivity Substituents include names halogens (e.g. Examples include methoxy group and ethoxy group), cyano group, acedel group and nitro group. Wear. Other suitable substituents that do not participate in the polymerization reaction are well known in the art. , the dope and/or fiber properties of the invention may be impaired by factors such as steric hindrance. Unless otherwise specified, they are included in the present invention. Usually, 2 or less per aromatic ring, more preferably 2 or less per aromatic ring. Alternatively, it is preferred that one or less suitable substituents are present. However, if the substituent For example, if it is a relatively small group such as a methyl group, there may be more than two substituents. It's okay.

Homopolymers and copolymers that may have substituents on aromatic rings are covered by the present invention. Particularly suitable for dopes and fibers. Among copolymers, especially random copolymers - is preferred. The term "random" here means that the copolymer is composed of two or more different types. It does not indicate that it consists of a molecule containing many units in an irregular arrangement. That Yu As a knit, AB type (for example, p-aminobenzoyl chloride hydro chloride), AA type (e.g. p-phenylenediamine or 2,6-dichloro -p-phenylene diamine), or BB type (e.g. terephthaloyl or 4, (4'-bibenzoyl chloride) or a mixture thereof. However, always Chemistry for high polymer production! 6 requirements shall be met. different thailand The relative number of each unit in the group on each molecule or on different parts of the same molecule However, they do not have to be the same.

One or more of these polymers can be used in the fibers of the present invention. That is, a single ij\mopolymer, single copolymer or homopolymer and/or copolymer Blends are preferably used.

The above-mentioned polymer chain essentially consists of an amide bond (-COL-IN-) and the above-mentioned aromatic The polymers useful for making the cores of the present invention, which meet the above requirements, are It may contain up to about 10% (on a molar basis) of non-containing units. Cough unit 1~ For example, an aromatic polyamide forming unit whose chain extension bond is Coaxial or parallel but not facing each other, e.g. meta-oriented, or other than amides Examples include bonds such as urea or ester groups.

Suitable aromatic polyamides include poly(p-benzamide), poly(p-phenylene), Nylene terephthalamide), poly(2-chloro-p-phenylene terephthal) amide), poly('2,6-dichloro-p-phenylene 2,6-natsutarua) (mid), poly(p-phenylene p, p'-biphenyldicarboxy mid) , poly(p,p'-phenylenebenzamide), poly(1,5-nanodylene) terephthalamide), e.g. copoly(p,p'-diaminobenzanilide) Ordered aromatic copolyamides such as terephthalamide and copoly(p-benzamide/m-benzamide>(9515)) An example is random copolyamide, and there are many others.

Usually, these aromatic polyamides have an intrinsic viscosity, which is greater than 1.0. is preferred. The intrinsic viscosity (ηinh) is the formula %formula%)) [In the formula, (ηre!) indicates relative viscosity, and C is dissolved in 100 mf2 of solvent. The concentration of 015g of polymer is shown. ]. Aromatic polyamide as above For example, ``Kevlar'' series (DuPont Corp. An example of this is what is known as ``Made by Shonen.'' These are straight tensile strength about 18=250/denier and the knot strength is at least about 70/denier. Ru. Further examples of polyamides such as those described above and methods for producing the same are disclosed in U.S. Pat. No. 3,063.96. No. 6, No. 3,600,350, No. 3.671゜542 and No. 3,819,5 It is described in No. 87.

In addition to the above, synthetic polymers suitable for use as suture cores of the present invention include: High strength polio, such as polyethylene, gives a straight tensile strength of about 25 ml. An example is refin. These polyolefin fibers have complete chain elongation and high knots. (1) By improving the conventional cooling stretching method, solidified crystalline points can be produced. Ultradrawing of lyolefin material L/, (2) Lander The chain is elongated in a molten state (molten state or solution state), and then crystallized in the elongated state. Manufactured by oxidation. Polyolefins with these properties and their The manufacturing method is "high modulus fiber" [Keller, I-()(eller, A. >, written by 3arham, P.J., Plastics and Rubber International (p1astic s and Rubber international), February, Volume 6, No. 1 (1981)).

The core of the surgical suture of the present invention has a monofilament or multifilament structure. Either of these is fine. The latter is usually preferred. This is because the stitches that will continue to be applied The coating of doubling material is generally stronger than the core of multifilamen 1. This is because it exhibits adhesive properties. The coating of liquefied suture material is Penetrates into the core of the filament, fills the gap and coats the core, thereby Let the coating settle. Multificimen 1 ~ The core is a braid s), twisted polyfilament, yarn, etc.

Additionally, suture materials in the form of multi- or monofilament yarns may be used. Initially present as a core, around it is a high-strength material that will eventually become the core in the finished suture. Even if the yarn braid is twisted together, the suture material can also be Plied, twisted, braided or co-mingled with high tenacity yarns It is also possible to have an L/2 configuration. Synthesis used in the core of the composite suture of the present invention Polymers have high axial strength but lack the necessary transverse strength easy to abrasion, kink and/or fibrillation when knotting, Therefore, it is generally not suitable for use as a suture material. Unexpectedly, the present invention Accordingly, by covering the core with suture material, stabilization, i.e. and thus provide strong lateral resistance to It has been found that the synthetic polymer fibers mentioned above can be preferably used as suture threads. Served.

Absorbable and non-absorbable suture materials are used to cover the core. Any film-forming material commonly used in making doubling yarns can be used. Generally, this These suture materials have a straight tensile strength of about 4-10 g/denier when drawn into fibers. Indicates strength. Non-absorbable suture materials include silk (fibroin), polyester, etc. Polyolefins such as tyrene and polypropylene, e.g. polyethylene tereph Examples include polyester such as talate and nylon.

Absorbent materials useful as core coatings include collagen and synthetic absorbent materials. I can list the fees. Synthetic absorbent materials include polylactide and polyglyco Lido and copolymers of lactide and glycolide and the above lactide or glycolide and the reaction described in U.S. Pat. No. 3,636,952 and U.S. Pat. For example, a copolymer with a polypropylene compound and the like can be exemplified. In this specification, the synthetic absorbent The polymers are simply referred to as pomopolymers and copolymers of lactide and glycolide. Sometimes.

The amount of suture material coated on the core depends on the composition of the core, the monofilament or multifilament, number of blades or twists and stiffness tic +htness), straight tensile strength and knot strength of the core, used for coating depending on the type of suture material used and its properties (e.g., molten liquid, solution, or solid). change. In general, if the -teink is a non-absorbable suture material, The coating comprises about 5% to about 101% of the coated core. On the other hand, Cautin If the suture material is an absorbable suture, it will make up about 5% to 90% by weight of the coated core. Ru.

When coating, use coating methods well known in the coating field as appropriate. Can be used. For example, coatings can include solution coating, melt coating ( It can be applied to the core by extraction coating, etc.

For example, in melt coating, a tensioned, uncoated core is coated with suture material. The diameter of the desired suture is smaller than the upper limit of the diameter specification. V1 is passed through an extrusion die having an orifice followed by a coating. Excess coating material is removed by heating above the melting point of the coating material. to form a composite thread.

Solution coating involves dissolving the suture material in a suitable solvent and Pass the wick slowly through the coating solution. The treated wick was subsequently heated The solvent is evaporated by passing it through a tube oven and increasing the temperature. Fuse and solidify the suture material.

If the core to be coated is made of Multificimen 1, the preferred coating method is First of all, either solution coating or melt coating is mentioned. It will be done. In the latter, the wick to be coated is kept under suitable tension and the liquefied coating material The material penetrates into the interstices of the core and forms a foundation that helps the core coating material settle.

The impregnated core may be coated with the same suture material by any conventional coating method. How many phrases should I use for the second layer?

In typical extrusion coating methods, the core is coated in a conventional wire coating extrusion. Pass through the cross-head die of the exit device. Coating material pellets are extruded It is introduced into the plasticizing zone of the machine, where it is plasticized and becomes a melt, which is then transferred to the extruder. It is extruded through an annular die and coated on the core.

Which of the above two coding methods to adopt depends on the core used. It will depend on the type. For example, aromatic polyamide cores have a high melting point, so they Suitable for coating or extrusion coating. On the other hand, high strength polyethylene The core material has a low melting point (e.g. about 145°C) compared to aromatic polyamides. , must be treated differently. Mononu is made of high-strength polyethylene. The main coating method for multifilament cores is solution coating.

According to a preferred embodiment of the invention, the core to be coated is made of aromatic polyamide. (Details below) A pre-coating process and a final coating process are carried out. It will be done.

Impregnation/pre-coating process The impregnation/pre-coating operation according to the present invention can be applied to matilfila consisting of suture material. Men 1 to core and tensile strength of 18Ω/denier or more, knot strength of 7q/denier or more It is carried out using threads made of a plurality of synthetic polymer fibers.

The thread may be fabricated in a conventional manner, e.g., with a plurality of synthetic polymers around a core of suture material. By twisting or braiding the fibers Manufactured. The thread, i.e. the coated core, is passed through a suitable oven. to a temperature higher than the melting point of the multifilament core material. Passing through oven The suture material is melted and under automatic and/or artificial tension, polyfilament leach through the synthetic polymer portion and onto its surface. during the melting period Fills the gap between the filament core and coats the surface of the thread. Sufficient coating material must be used. Excess melted code The tinging material is 1-rimmed. In some cases, coated core mixed yarns are The yarn is heated under tension with little or no stretching. The suture will be in good condition when it is lowered. Through this process, assimilation coating Create the basic structure of the core.

The impregnated and coated core is passed through a heated die to remove the coating mass from the core. and smooth the outer surface of the thread. Stretching may also be carried out during the smoothing operation.

However, as mentioned above, the best suture results when no or minimal stretching is performed. Yarn is obtained. The threads are worked around until a smooth, solid surface is obtained. Pass through a hot oven or smoothing die. Advantageously, especially when smoothing out lumps. In addition to removing the excess surface coating, the surface of the excess material is To obtain a sufficiently smooth undercoat structure to fill in the undulations of the thread surface. Can be done. If the smoothing process is not carried out, the surface coating will be similar to the ring of the thread. Even if you leave the outline as it is and apply further coating, the outline will still remain. cormorant.

The temperature inside the heating oven depends on the coating material used and the coating on the core. The ratio of materials, the speed at which the core is passed through the oven, the heating and/or flattening under drawing conditions. It varies depending on whether smoothing is performed or not. Coating material temperature as mentioned above above the melting point of the coating material, i.e. to the extent that the coating material oozes through the thread. to raise it. When the exuded coating material is cooled, gelatin forms on the surface of the twisted yarn. It becomes a solid mass. To thin the coating, spillage of coating material occurs. If heated to excessively high temperatures such as , which tends to make it impossible to obtain a solid case structure, should be avoided.

Generally, when the impregnation/precoating operation is carried out under stretching conditions, the coating The stretching material spreads throughout the thread at a lower temperature than without stretching. oozes to the surface. However, the core is highly stretched during the impregnation/precoating operation. Once in condition, the next finish coating step according to a preferred embodiment of the invention It must be noted that the ability to undergo stretching is reduced or eliminated. Is this so? According to a preferred embodiment of the present invention, in the final coating step, the Precoated threads are further heat treated under high elongation conditions and examine finished suture properties such as breakon (latiOn). Arrange.

The optimal melt temperature for the impregnation/precoating operation depends primarily on the suture coat used. Depends on the cutting material. The temperature of the smoothing die is also lower than the melting point of the coating material. is also high and lower than the melting point of the core. Usually it is an impregnation/pre-coating process. temperature, preferably about 5-15% below the impregnation/pre-coating step temperature. ℃low.

Part 71: Coating stage According to a preferred practical IM aspect of the invention, in the final step, the smoothed impregnation/print A composite suture structure is obtained by melt extruding the coating material onto the coating thread. It will be done. A variety of conventional extrusion equipment can be used for this purpose. smooth pleco The coated thread is guided into an extrusion coating die for impregnation/pre-coating. Coated with the same type of coating material used in the process. Up) Impregnated/pre-coated thread is coated on its surface. It is essential that there are no ups and downs, and this must be kept in mind. extrusion code Increasing the heating temperature and other conditions being equal will result in a larger diameter finished suture. can be obtained, but extrusion is carried out at a temperature similar to that of the impregnation/pre-coating step. Now. This is due to the fact that increasing the temperature reduces the melt viscosity and increases the viscosity of the polymer under a given force. This is because the flow increases.

The following examples are provided to illustrate the novel composite suture and method of making the same according to the present invention. It is described here. The following drawings are referred to in the description of the embodiments, in which the first The figure is a schematic diagram of the apparatus used in the impregnation/pre-coating step according to the invention, Figure 2 shows an extruded coat of impregnated and precoated suture using the apparatus shown in Figure 1. 3 is an enlarged cross-sectional view of the extrusion die shown in FIG. 2. As you can see from the drawings, it is a normal New England bat blader la (N ew England Butt braidermachine) (4) of 30 to 50 denier with a straight tensile strength of about 7.5 g per denier. Product name: "Kevlar" manufactured by Dupont eNemours (Key + ar) Straight tensile strength of approximately 4C]/Denny It is knitted around a continuous single core of 40 denier polypropylene. like this The rawbraid formed is wound on the reel 2 and Feed roll (body (Godat))> 6, guide 8 and sent to a heated 10 cm long tube oven. Pushing without feeding The lumen of the coating die helps with this and is shown in Figure 1. specified heating zone ■. Tension roll (body (Godat) > 1 3, without stretching the rope blade, i.e. at a stretching ratio (SR>171). Pull through. Heating zone ■ is maintained at 230°C. Even under such conditions In the process, all the polypropylene is melted into the blade gap, and then the blade Covers the surface completely. No solidified polypropylene core remains.

When the blade comes out of the heating zone ■, the large amount of excess polypropylene eluted is removed manually. Next, the blade passes through the insulator 15 and reaches the heating zone ■ . The zone trims and smoothes the knots formed on the blade, Q, 2mm diameter. A smoothing die 17 is included. The heating zone ■ is approximately 220℃ due to smoothing treatment. will be maintained. The smoothed blade is removed from the heating zone by a tension roll (Bolt Godat> 19 pulls him and hands him a receiving ring 21. Bu The speed at which the radar passes through both heating zones ■ and ■ is approximately 1 to 1.8 m/min. Ru. Pre-coated blades have a preferred smoothness impregnated/pre-coated blade. It is passed through the smoothing die 17 three times to obtain a smoothing code.

As shown in Figure 2, smooth impregnated/pre-coated The reel 31 of the blade is passed through a tensioner 33, and is connected to a feed roll (body (G odat)) 35. The feed roll guides the blade 37 to an extrusion coating die apparatus indicated at 39.

The polypropylene chips are melted in the heated reservoir 41 maintained at 260'C, The bolt is J Two extrusion coating dies are fed.

In particular, as can be seen from FIG. 49, housing a spinneret 57 having an outlet 52 It is equipped with a holder indicated by 47. Lumen member 49 is connected to annular chamber 53 It is arranged in the boulder 47 so as to form a . Gasket 55 is inserted into the holder. One end of the member 49 is sealed, and the other end of the member 49 is attached to a plate 60 with a slot. Therefore, it is supported. The lumen member has an inlet 59 and an outlet 61. Exit A hollow needle 63 is arranged between 61 and the spinneret outlet 52. Impregnation/pull The reccoquit thread 65 is continuously connected to the lumen member 49 and the hollow needle 5. 9, passes through outlet 52 and is coated with melt as it exits the die.

The coating die is maintained at a coating temperature of 235°C.

The coated filament is then drawn to a pull roll 48 which applies tension. The tension is It decreases with the pull roll 50 being slower than the pull roll 48. Yarn speed is 1.43 m/min, and the total stretching ratio (SR) is 1.02. The processed suture is finally It is wound around the receiving wheel 51.

The finished product has a 510 diameter "Kevlar" core that occupies approximately 90% of the cross section. , knot break strength) is approximately 3.2 bonds It is a processed composite suture.

Knot breaking strength of 3.2 lbs is USI of 2.0 length monofilament suture. ) is equivalent to the standard. Composite sutures made in this way are 510.410 or It can be used as a 310 suture.

Example■ Produced in Example ■ using a polyethylene terephthalate core instead of a polypropylene core. The process is repeated, and in the extrusion coating die device 39, the polyethylene film is coated. Extrusion coating with phthalate is performed. The resulting product stands for cross-section It has a 510 diameter Kevlar core that accounts for 90% of the total, and is made of polyethylene terephthalate. coated and has a knot breaking strength of approximately 3.5 pounds, which is greater than 210 size sutures. Exceeds USP standards. Therefore, the composite suture can It can be used as suture threads 510, 410, 310 and 210.

Example■ Dissolve fibroin (silk) in a 62% zinc chloride aqueous solution and prepare a 5-20M concentration of fibroin (silk). Obtain a broin solution. The obtained solution was kept at approximately the boiling point temperature and Blur''' yarn is passed through the solution at a constant speed to impregnate and coat the A-noon.

The impregnated coated yarn was placed in a tubular oven maintained at heating temperatures reaching 130'C. Pass it through a bun to dry. The heat treatment evaporates the solution and forms a continuous fibroin. Form a film. The composite suture is washed with cold water to remove residual zinc chloride. .

The resulting composite suture was a size 510" Kevlar containing approximately 5% by weight fibroin. It has a core and has a knot breaking strength of approximately 3.5 pounds, which is greater than size 210 silk. It is equivalent to 1 ply yarn. In other words, silk-coated “Kevlar” composite sutures are 510, 410. Can be used in place of 310 and 210 silk.

size 510 high strength fully extended chain (fullChain-eXte nded) Polyethylene multifilament yarn with straight l tensile strength Yarn with a knot strength of 50 g/denier and a knot strength of 15 g/denier was Hexafluoroisopropanol 31% by weight via a 10% solution of phthalate into a solvent mixture of methylene chloride containing Remove solution.

Dry the coated core in air and add polyethylene terephthalate to the final composite suture. Repeat the process to form a coating containing 10% by weight. Wash the composite yarn with water and dry again. The resulting composite suture has a size of 510,410.310.21 0 and Ilo.

Example■ Polypropylene chip with polyglycol 1 (PGA) instead of polypropylene core Example 1 is repeated using PGA resin instead.

1q Kevlar/polyglycolic acid composite yarn has a weight of 1550-1700 grams. It has a minimum nodule failure strength in the range of Commercially available size 310 non-absorbable suture “° Prolene has a nodule strength of 1550-1650 grams. do. This means that the size 310" Kevlar Pa/Polyglycol 1 suture is After absorbing glyfuric acid, it will retain the nodule breaking strength of 310 "Prosyn". It means. “Kevlar”/polyglycolic acid suture produced in this way The threads are sizes 310, 410 and 510.

Uses 610 size “Kevlar” reinforced core with non-reinforced PGA coating. If the core and white are sized 410 and 51 based on the knot strength of “Prosyn” Provides a knot strength between 0 but above the USP specification for 410.

In this way, the ``Kevlar'' composite yarn with 610 cores coated with PGA is It can be used as size 610.510 and also as size 410.

Sai1 reinforced core reinforced core and PGA non-supportive ve):]-A strength of 610 is obtained for ting. Therefore, PGA coating 7 10 core "Kevlar" is available in sizes 610 and 710.

High strength with straight tensile breaking strength of 50Q/denier and knot strength approximately 1/3 of that. When using extended chain polyethylene, the diameter A size 510 core of reinforced high strength polyethylene of approximately 0.140 mm has at least 2 10 shows the knotting force of sutures. Therefore, polyglycolic acid coated high strength polyester Ethylene core 510 is available in absorbent and non-absorbent sizes 2101310.410.510. Can be substituted for astringent composite sutures.

Non-supporting PG with a diameter of approximately 0.90mm using high-strength polyethylene The A-coated 610 size reinforced core is size 4 based on Prosyn's knot strength. Provides a knot strength well suited to 10, 510 and 6/○.

High strength of non-reinforced polyglycolic acid coating with a diameter of about 0.060-0.065mm Polyethylene 710 size reinforced core is based on the knot strength of Prosyn, size 5 10.Provides knot strength well matched to 610 and 710.

As a material, use a material with higher strength or a material with increased knotting force of the above material. If so, it can fit a wider range of sizes with the same thin reinforced core as above. .

As a product, a needle is attached to one end of the composite suture of the present invention, and the suture is placed in a sterile container. Can be packed. The suture is glass-tied so that it is stable for long periods of time without conditioning fluid. Dry packed in tubes or plastic envelopes. adjustment ng) Fluids may be used to maintain sterility or prevent lead from rusting. As a needle, tissue damage Eyeless needles are preferred because they cause less harm. The composite suture of the present invention can be shaped into a convenient length. can be connected to an eyeless needle and wound on a spool if necessary, e.g. It can be packed into an envelope-like container. Sterilization of sutures is performed by This is done using tyrene, oxide or other conventional gaseous disinfectants. Or suture is sealed in an envelope and exposed to heat and radiation such as X-rays, gamma rays, electrons, and neutrons. Sterilized and weighs 1q.

Another advantage of the composite suture of the present invention is that the diameter of the needle to be applied can be reduced. . According to this feature, one end of the composite thread is coated or coated with suture material. remove the removed part by an appropriate method, such as by dissolving it with a solvent, leaving the core behind. This exposes the core. Furthermore, compared to those used for sutures of the same outer diameter, e.g. The core is bonded by draw swaging a small outer diameter needle. Below The examples below illustrate this feature.

Example Vl Composite material with an outer diameter of approximately 0.012 inch manufactured by WIA using the general method of Example (■) Place 1/8 inch end of suture in boiling xylene until polypropylene coating softens. Soak.

The polypropylene coating is then manually removed to expose the 510" Kevlar fiber core.

A 0.014 inch diameter needle is swaged into the core and a 0.012 inch diameter needle is swaged into the core. Equipped with a needle having a cross-sectional area approximately 2/3 of the cross-sectional area of the needle required for the suture thread. Obtain appropriate sutures.

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Claims (1)

[Claims] (1) have a knot strength of at least 7 g per denier; mand) Synthetic port covered with fiberformed surgical suture material Rimmer elongated wick, said coated wick outside of specific USP grade sizes. When configured into a medical suture, at least two steps larger of the suture material Sterile surgical with knot strength represented by P grade size surgical sutures for sutures. (2) The sterilization according to claim 1, wherein the synthetic polymer is an aromatic polyamide. Surgical suture. 3. The aromatic polyamide is poly(P-phenylene terephthalamide) A sterile surgical suture according to item 1. (4) A claim in which the aromatic polyamide is poly(1,4-benzamide). A sterile surgical suture according to paragraph 1. (5) The synthetic polymer has a straight tensile strength of about 30 to 50 g/denier. The sterile surgical suture of claim 1, which is a chain polyethylene. (6) The sterile method according to claim 1, wherein the surgical suture material is hibroin. Medical sutures. (7) The sterility of claim 1, wherein the surgical suture material is polyester. Surgical suture. (8) Claim 1, wherein the polyester is polyethylene terephthalate. Sterile surgical sutures as described. (9) the surgical suture material has a straight tensile strength of about 4 to 10 g/denier; The sterile surgical suture of claim 1, which is a polyolefin. (10) The sterilization according to claim 1, wherein the polyolefin is polyethylene. Surgical suture. (11) The method according to claim 1, wherein the polyolefin is polypropylene. Fungal surgical suture. (12) The sterilization according to claim 1, wherein the surgical suture material is collagen. Surgical suture. (13) The surgical suture material is an absorbable synthetic polymer capable of forming a film. A sterile surgical suture according to claim 1. (14) The absorbable synthetic polymer is lactide and glycolide with film-forming ability. The claimed invention is selected from the group consisting of homopolymers and copolymers of The sterile surgical suture of paragraph 13. (15) A claim in which the absorbent synthetic polymer is a glycolide homopolymer. 15. The sterile surgical suture of paragraph 14. (16) Claim No. 1, wherein the absorbent synthetic polymer is a lactide homopolymer. The sterile surgical suture according to item 14. (17) Aseptic surgery according to claim 1, wherein the core has a monofilament structure. for sutures. (18) Aseptic surgery according to claim 2, wherein the core has a monofilament structure. for sutures. (19) The aromatic polyamide is poly(p-phenylene terephthalamide). 19. The sterile surgical suture of claim 18. (20) The synthetic polymer fiber having a large number of cores is made into a twisted yarn or a braided string. A sterile surgical suture according to claim 1, which is a sterile surgical suture. (21) The synthetic polymer fiber having a large number of cores is made into a twisted yarn or a braided string. A sterile surgical suture according to claim 2, which is a sterile surgical suture. (22) The aromatic polyamide is poly(p-phenylene terephthalamide). 21. The sterile surgical suture of claim 20. (23) The coating of the suture material capable of forming a film is applied to 5 to 1 portions of the suture. The sterile surgical suture of claim 1, wherein the sterile surgical suture is 0% by weight. (24) The coating of the film-forming suture material 14. The sterile surgical suture of claim 13, wherein the sterile surgical suture is 90% by weight. (25) knot strength that can be used across a range of USP suture grade sizes; a method of manufacturing a surgical suture having a knot of at least 7 g/denier; A long core made of synthetic polymer with knot strength has the ability to form fibers and films. coated with surgical suture material, and the coated core is coated with a specific USP grade. When configured into a rad-sized surgical suture, a small amount of the surgical suture material A knot created by a USP grade surgical suture that is at least two steps larger. A method comprising providing knot strength. (26) Claim No. 1, wherein the coating is performed by solution coating. The method according to item 25. (27) Claim No. 1, wherein the coating is performed by melt coating. The method according to item 25. (28) Numerous synthetic polymers in the form of coatings with knot strengths of at least 7 g/denier - at least one meltable surgical suture material in the form of fibers and cores, fibers; The surgical suture material fibers are placed under tension on the thread of the bar. The fibers are heated to a temperature sufficient to melt and liquefy, leaving behind the fibers to form a liquefied surgical stitch. Coat the covered portion by filling the gap and the surface of the covered portion with doubling material. - Apply a coating to form the core of the finished composite suture, and smooth the coating. A method according to claim 25. (29) By passing the heated thread through a heated smoothing die, 29. The method of claim 28, wherein said smoothing is performed. (30) the surgical suture material is selected from polyolefin and polyester; 29. The method according to claim 28. (31) Straight tensile strength is at least 18 g/denier, knot strength is at least Numerous synthetic polymer fibers in the form of 7g/denier coatings and cores. tensioning a thread of at least one fusible surgical suture material fiber; Under conditions, the surgical suture fibers melt sufficiently leaving the coating fibers intact. and heat it to a temperature where it liquefies, and fill the gaps in the covered area with liquefied surgical suture material. Coating the covered part by filling the surface and finishing with composite suture The core of the yarn is smoothed, and the smoothed coating is coated with a similar outer layer. 26. The method of claim 25, wherein the medical suture material is melt extruded. (32) the surgical suture material is selected from polyolefin and polyester; 32. The method according to claim 31. (33) Claim 25, wherein the coating is performed by a solution coating method. The method described in. (34) have a nodule strength of at least 7 g/denier, with a lateral strength on the nodule; A long core of synthetic polymer that is insufficient to prevent abrasion, fibrillation, or torsion. , strengthens the lateral strength of the core and prevents wear, fibrillation or torsion on the nodules. coated with sufficient film and fiber-formed suture material to provide resistance to When the coated core is processed into a surgical suture of a specific USP standard size, to have a knotting force equivalent to at least two USP standard size surgical sutures. How to do it. (35) The sterile surgical suture according to claim 1, wherein a needle is attached to the core. (36) Claim 35, wherein the synthetic polymer is an aromatic polyamide. sterile surgical sutures. (37) The aromatic polyamide is poly(p-phenylene terephthalamide). 36. The sterile surgical suture of claim 35. (38) A claim in which the aromatic polyamide is poly(1,4-benzamide). 36. A sterile surgical suture according to paragraph 35. (39) The synthetic polymer has a straight tensile strength of about 30 to 50 g/denier. 36. The sterile surgical suture of claim 35, which is fully chain extended polyethylene. .