DE2162900A1 - Sterile absorbable surgical sutures - Google Patents

Description

Sterile absorbable surgical sutures

The invention relates to improved absorbable surgical suture, particularly in the form of braided, its tensile strength was 15 days after implantation in living animal tissue or about 50 and 21 days after implantation for about 20 fi ihre3 original value. The suturing material according to the invention consists of a copolymer obtained by reacting not less than 10 mol percent and not more than 15 mol percent L (-) - laetide with not less than 85 mol percent and not more than 90 mol percent glycolide.

The most widely used absorbable surgical sutures consists of catgut monofilaments (from cattle or Collagen obtained from sheep intestines). Collagen sutures are also made by extrusion from acid swollen Collagen fibrils obtained from bovine tendons, in a drainage bath, with filaments forming, which are then used for the purpose of further orientation of the collagen fibrils

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stretched and combined into a strand. The manufacture of surgical sutures from regenerated collagen, is described in U.S. Patents 3,114,373 and 3,114,593.

Absorbable suturing material can also be used according to the USA patent 3,297,033 from polyglycolic acid ester. Such suturing material made from the homopolymer of a glycolic acid ester however, it has the disadvantage that it retains its tensile strength after implantation; in the animal body too loses quickly and in this respect is less favorable than tanned catgut.

W According to the US Patent 3 422 181. can filaments from homopolymers of polyglycolic their Hesorptionsgeschwindigkeit be with regard to in vivo significantly improved by them, which vary for periods reverse to! Temperature ranging from about 5 hours to 5 minutes, at about 50 treated up to 190 ° 0. Table I of the referenced patent relates to braided sutures made from heat treated monofilaments. According to Table I of the cited patent, this sewing material has a tensile strength (straight) of 3-923 kg / cm and a knot strength of 2660 kg / cm. Fifteen days after implantation in rabbits, the tensile strength of this suture is still 2

k ' 545 kg / cm or $ 13.9 of the original tensile strength.

Another disadvantage of the polyglycolide sutures described in U.S. Patent 3,297,033 is that the color of extruded threads varies from whitish to light brownish. Such · light colors are for surgical sutures because of the so-called "chameleon effect" undesirable. if If the suturing material is inserted into an operating cavity, e3 quickly turns red and the surgeon can use ea bloody surroundings cannot be easily distinguished. Numerous methods are known for dyeing textile thread; after

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Current regulations of the United States Food & Drug Administration permit absorbable surgical sutures However, they can only be colored with those dyes that are approved as non-toxic by this authority. The problem The dyeing of polyglycolic acid sutures is made even more difficult by the fact that this suturing material is present from moisture, especially at elevated temperatures, such as those often used when dyeing textiles, easily hydrolyzed and thereby loses tensile strength.

Dr. I.L. Lichtenstein (Jcur. A. Med. Assoc, Volume 24 (1970), Page 760) has indicated that it is important that surgical sutures in the final stages of the healing process have a high percentage of their original tensile strength retains. It has now been found that a reaction of at least 85 mol percent, but not more than 90 mole percent, glycolide with not less than 10 mole percent but not more than 15 mole percent, L (-) - lactide in the presence copolymer obtained from tin (II) caprylate as a catalyst can be processed by extrusion, braiding, heat treatment and sterilization into a sewing material, which thereby indicates that it retains its tensile strength to an improved extent 15 or 21 days after implantation. Furthermore, this suturing material can be converted into _ color the monomer mixture in the mass before polymerisation, without the high degree of retention of tensile strength suffering.

This benefit of maintaining a large part of the original tensile strength 15 to 21 days after implantation in living tissue appears for the above-described copolymers of L (-) - lactide and glycolide, if they, after extruded, pre-stretched using the processes described below, braided, heat treated and sterilized to be characteristic.

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To further explain the invention, reference is made to the drawings. . ,

Fig. 1 shows an apparatus for extrusion and Yerstrekken of the copolymers of L (-) - lactide and glycolide.

2 shows the decrease in tensile strength in the form of a diagram of braided suturing material made from the copolymer of L (-) - lactide and glycolide after implantation in the animal body.

. The curve of Figure 3 shows the molecular weight distribution in a braided suture according to the invention \ from the copolymer of L (-) - Iiactid and glycolide.

FIG. 4 is a thermogram of the braided suturing material illustrated by FIG. 3 made from the copolymer of L (-) - lactide and glycolide.

5 shows the decrease in tensile strength in the form of a diagram of the braided suturing material from the copolymer of L (-) .- lactide and glycolide according to Fig. 3 and 4 according to the Implantation in the animal body.

The one here for the production of surgical suturing material. Copolymer of L (-) - lactide and glycolide written "is a copolymer obtained by reacting not less than 10, but not more than 15 mol percent L (-) - lactide with not less aiii 85, but not more than 90 mol percent Glycolide maintains. "■

Dan : 'Aiv polymerization used L (-) - laotide and glycolide Goll (j] i pure and dry noin. The reaction is carried out in ojnom ■ dry vessels under dry nitrogen; Tin-oaprylate. Swool-Uf.äs · - ßiβ j] »Heroes of about 50,000: 1 Mq 150,000; 1. To control

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The molecular weight can be a small amount of glycolic acid to add. The ratio of monomers to glycolic acid is in the range from 400: 1 to 2000: 1. '

In order to bring about the polymerization, the mixture is made of L (-) - lactide and glycolide heated to about 200 ° C for 5 hours, until a sample of the polymer has an inherent one determined at 0.1 percent concentration in hexafluoroisopropanol at 25 ° C Has viscosity of about 1.4.

If the copolymer is to be used for the production of colored surgical sutures, 0.1 to ₁ % by weight of j1-hydroxy-4-p-toluidino-anthrachi non ("D&G Violet") is added to the reaction flask before polymerization

No. 2) too. This dye becomes uniform in the monomer mixture distributed and has hardly any adverse influence on the Polyroerisatxonsreaktxon. After the polymerization can the colored polymer in the air to form a multifilament Yarn are extruded, which can be stretched before braiding and heat-sensitive. After braiding it will Yarn braid, in turn, stretched and heat-treated and then sterilized.

• The equipment used to extrude the copolymer is shown in FIG. The extruder "'10 has one in the. vertical plane supported hopper 11 which opens into a cylinder 12 at its lower end. By doing Cylinder 12 is a screw 14, which is a little smaller Has diameter than the cylinder 12, rotatably mounted and is driven by a control motor 16 via the shaft 18.

The finely divided copolymer 20 to be extruded is through the side arm 21 under dry nitrogen into the Hopper is poured and moisture comes out of the extruder kept away by a steady stream of dry nitrogen flowing through opening 22 into the hopper

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flows in and flows out through the opening 24.

The C © polymer powder flows from the bottom of the hopper into the extrusion cylinder, where it is melted, and from the screw 14 through the bore 26 into the chamber of a gear pump 28 is driven. The gear pump is set in rotation by a variable speed motor (not shown) and guides the melted copolyroerisate at a controlled speed through a bore JO of the extrusion mold 32 to »Immediately In front of the extrusion mold there is a filter made of classified fine Se.n.dpartchen, which are on a sieve.

w The extrusion mold has several openings. Preferably each extrusion orifice has an entry angle of 20 °. At this entry angle a streamlined flow is obtained, which ensures the uniformity of the extruded material.

When the extrusion press is in operation, the temperatures of the screw (zone 1), the metering pump (zone 2) and the extrusion mold (zone 3) are constantly controlled by three electrical heating devices controlled, which surround the screw, the metering pump and the extrusion mold. In addition, the one from the snail 14 and the metering pump 28 exerted on the copolymer melt Pressure constantly monitored.

When the copolymers are extruded, the dried copolymer powder is poured into the hopper 11 and flows under the action of gravity into the extrusion cylinder 12. The screw 14 conveys the polymer through zone 1, where it is melted, and presses the polymer melt at pressures 210 kg / cm, through the opening 26 into the gear pump 28, which meters the volume of the polymer melt flowing through the extrusion mold 32. When passing through the metering pump (zone 2) and the extrusion mold (zone 3), the temperature of the copolymer

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melt controlled.

During normal operation, the screw (zone 1) is kept at around 244 - 3 ° C, the metering pump (zone 2) between 202 and 220 ° C and the extrusion mold (zone 3) between 202 and 230 ° C. After leaving the extrusion mold, the extruded threads 33 are stretched approximately 200 times and cooled to room temperature in the air. The stretching takes place in the first 10 to 13 cm under the extrusion mold.

The multi-filament yarn runs around an idle roller 35, over a Roll 36 and is wrapped around the gaIettes 37 and 38, to prevent slippage caused by fluctuations in the draw between the extrusion die and the idle roller 35 could be caused. The yarn coming from godet 37 is then wound onto drum 40.

The yarn 33 can, as mentioned above, both before and after stretched and heat-treated with braiding. The braided Suturing material can be sterilized without reducing its tensile strength by exposing it to the action exposed to a humid atmosphere of freon and ethylene oxide.

The following examples, in which all amounts relate to weight unless otherwise specified, describe the production of braided copolymer Iiähmaterial, which 15 days after implantation in the animal body for at least 50 i ° and 21 days after Implantation still has at least 20 % of its original tensile strength.

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Example 1 °

Production of a copolymer from 10 mol percent L (-) - lactide and 90 mol percent glycolide (1023-86)

One equipped with a paddle stirrer, stirrer motor and gas outlet 1 liter stainless steel reaction vessel is placed under vacuum heated to 110 ° C to the inner surfaces of the vessel to get rid of moisture.

Using dry glass devices, a mixture of 80.6 g (0.56 mol; 12.2 percent by weight) of pure L (-) - Iiactide (P. 97-99 ° C; specific rotation at least 282 °) and 580 g (5.0 mol; 87.8% by weight) of pure glycolide (m.p. 82.5-84.5 ° O). This mixture of 10 mole percent L (-) - lactide and 90 mole percent. Glycolide is transferred to the reaction vessel under dry nitrogen. The reaction mixture is by means of a dry injection syringe made of glass with 0.34 ml of 0 »33- molar catalyst solution of 13.41 g of tin (II) caprylate in 100 ml toluene (1.1 Xio""^ mole) was added. The molar ratio of monomers to catalyst is 50,000: 1. . Then added 0.5283 g (6.95 x 10 ^"5 mole) of glycolic acid to the molar ratio of monomers to glycolic acid is 800: 1.

The reaction vessel is closed and the toluene under High vacuum (0.1-0.2 mm Hg) driven off. Then the vessel will purged with dry nitrogen by evacuating and filling with nitrogen twice in a row. The container is then filled with dry nitrogen again until the pressure in the vessel is about 0.07 atm The outlet valve closes. '

The vessel and its contents are placed in a silicone bath preheated to 200 ° C used and heated to this temperature with stirring for one hour and 20 minutes. Then the stirrer is over the The liquid level is raised and the contents of the vessel are heated to 200 ° 0 for a further four hours. The vessel is cooled and

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the polymer mass discharged. The polymer is cooled with solid carbon dioxide, cut into quarters with a hand saw, in a Cumberland mill with solid carbon dioxide Grind and 48 hours at 25 ° C and 0.1 mm Hg in a vacuum dried. The yield of copolymer (product '1023-86) is 617 g. This product has a hardness of 92-94, a "softening temperature in the range of 193-196 ° C, a sticking point fc of 199 ° C, a draw point of 207 ° C and one Melting point (flow point) of 218-219 ° C The inherent viscosity of the copolymer, determined on a 0.1 percent Solution in Hexafluorxsoprcpanol at 25 ° 0, is 1.55

The polymerization described in this example is still repeated four times, heating to 200 ° C for 1 hour each time with stirring and a further 4 hours without stirring on the keeps the same temperature. The following results are obtained:

- ' Product 1023-88

Yield, g 621

Hardness ο ^'92 ~ ⁹⁴

Softening Point, C 193-196

Glue dot, ⁰ C 197-199

Draw point, ⁰ C ■ 206-207

Melting point, ⁰ C 218-219

inherent viscosity 1.55

" Product 1023-92

Yield, g 618

Hardness 92-94

Softening Point, C 194-197

Glue dot, ⁰ O 193-199

Stretching point, oq 207

Melting point, OC 219

inherent viscosity 1.54

' Product 1023-93

Yield, g 616

Hardness 92-94

Softening Point, C 193-197

Glue point, 198-199 ° C

Stretching point, ° c _Λ 207-208

Melting point, ⁰ C- '219-220

inherent viscosity 1.49

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Product 1023-94 ■ '. : ^ '/ \ "· \ - Χ' ^: '\' \

Yield, g 620: "

Hardness «92-94

Softening point, ^U C 194-197:

Glue dot, ⁰ C 199 -T

Stern point, ⁰ C 207-208,

Melting point, ⁰ C. 218-219

inherent viscosity 1.49

The above five products (1023-86, 88, 92, 93 and 94) will be in a Cumberland mill with solid carbon dioxide on grain sizes ground below 4.75 mm. The mixture becomes: mi ^ dem. Metals removed from magnets and thoroughly dried in a vacuum oven. The combined product (1023-101) weighs 2883 g; and has the following physical characteristics:

Softening Point, ⁰ C 190-195

Glue dot, ⁰ G 196-197; : '-?'

Stretching point, ⁰ G 207-208

. Melting point, ⁰ C 217-2t9

inherent viscosity -. '. ■ 1.57

The melt index of a sample of the combined product becomes according to ASTM test standard D 1238-652 with an extrusion plastometer the Pirma Tinius Olsen Testing Machine Co., Saston Eöad, Willow Grove, Pennb / lvania 19090, V.St.A., determined. At 235 ° C is the melt index using a weight of 3800 g and an opening of 0.635 mm 0.7 (g / 10.join at 900 see).

Example 2 ;

Extrusion of the copolymer from L (-) - lactide and glycolide (T038-53, 56)

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The polymer mixture described in Example 1 (1023-101) is extruded under dry nitrogen with the extruder shown in FIG. 1 to form an 8-ply yarn Pilter made of sand with grain sizes below 0.59 mm and bad? ; 0.297 mm is on a sieve with a mesh width of 0.25 mm between the dosing pump and the extrusion mold 32 * The extrusion mold has eight iron openings, each 0.63 mm Diameter. . .

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The extruder screw generates a pressure of

105 kg / cm s and the metering pump works so that the pressure on the extrusion mold in the range from 21 "to 210 kg / cm remain. The extrusion speed is 30 g / h.

During extrusion, the feed section of the screw (zone 1) is set to 245 ° C, the metering pump (zone 2) to 205 ° C and the extrusion mold (zone 3) kept at 210 ° C. The 8-ply yarn is on the bobbin 40 at a speed of Wound up 21.3 m / min.

The yarn thus obtained is drawn by drawing on one. 52 Up to 54 ° C heated galette 3 to 3.5 times oriented. The take-up speed of the oriented yarn is 160 m / min. The tensile strength of this oriented yarn is 3 »5 g / den. The oriented yarn is then heat treated, by placing the bobbin with the yarn in a 113 ° G oven for 20 minutes. After heat treatment has the yarn has a tensile strength of 5.1 to 5.3 g / den.

Example 3 Braiding a copolymer yarn (P-240A 1Q45-9S)

The 8-ply yarn described in Example 2 (total denier .59-12 denier) is applied to the bobbins of a 16-bobbin braiding machine with a 3-ply core. The braid is made with a braiding density of 51-3 25 ₅ 4 mm each, and a surgical suturing material is obtained in the form of a 2/0 thread braid. The braided yarn (medium diameter

ser 0.368 mm) has a tensile strength of 5.53 kg (5200 kg / em) and a Khoten strength (mean diameter 0.371 mm) of 3.54 kg (3283 kg / cm). The yarn braid is stretched by winding it onto a tensioning device, which is then stretched 20 io , so that you get a braid stretched 1.2 times * The tensioning device with the stretched braid is still in place Heat treated in an oven at 105 ° C for 24 hours. One for stretching

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and heat-treating the copolymer mesh using a suitable device is in U.S. Patent Application Serial No. 846 412 of July 31, 1969 ". ■ ·

Example 4

Sterilizing and Packaging Surgical Sutures (1045-132, 134B; 1039-99)

The twisted and heat-treated yarn braid according to Example 3 is cut into lengths suitable for use as surgical suturing material and sterilized with ethylene oxide in open, ventilated packs by placing it on the braided suturing material for 6 hours at a relative humidity of 70 io and a temperature of 38 ° C, an atomic \ gas atmosphere of Freon and ethylene oxide (500 mg ethylene oxide per liter of gas) can act.

The packs of sterilized braided sutures are sealed to keep the material sterile until use. The sterile packaged suture (0.328 mm diameter) has a tensile strength (straight) of 5.17 kg (6123 kg / cm) and a knot strength (0.333 mm diameter) of 3.26 kg (3733 kg / cm ² ).

The rate of absorption of this product (remain- ' the percentage of tensile strength 5 days after implantation

»In rats) is carried out on ten samples with five different test animals certainly. The percentage remaining is also shown Tensile strength determined 10, 15 and 21 days after implantation. The mean values from ten yarn breaks each, determined with the Instron tensile tester at a shoe speed of 25.4 mm / min on 12.7 mm samples, are in the Table below and summarized in Pig. 2 shown.

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Q 5 10 15 21 Tensile strength (straight), kg 5.17 4.54 3.87 2.98 1.05

remaining tensile strength, fo 100 87.8 75 57.8 20, J

Example 5 .

Production of a copolymer from L (-) - lactide and glycolide with an i-hydroxy-4-p-tOluidino-anthraquinone content of 0.1 percent by weight -. (1023-74;.

One equipped with a paddle stirrer, stirrer motor and gas outlet Tetes 1 liter stainless steel reaction vessel is placed under Vacuum heated to 110 ° C to cover the inner surfaces of the jar to get rid of moisture.

Specific rotation at least, using dry -Glasgeräten In a glove box under dry nitrogen, a mixture of 80.6 g (0.56 moles; 12.2 percent by weight) lactide (m.p. 97-99 ° C - pure L (-) 282 °) and 580 g (5.0 mol; 87.8 percent by weight) of pure glycolide (M.p. 82.5 to 84.5 ° C). This mixture of 10 mol percent L (-) - lactide and 90 mol percent glycolide is transferred into the reaction vessel under dry nitrogen. 0.34 ml of a 0.33 molar catalyst solution of 13.41 g of tin (II) caprylate in 100 ml of toluene (1.11 10 " ⁴ " mol) are added to the reaction mixture using a dry glass syringe . The molar ratio of monomers to catalyst is 50,000: 1. Then added 0.5283 g (6.95 χ 10 ~ ⁵ mole) of glycolic acid and 0.6611 g (0.1 weight percent) of 1-hydroxy-4-ptoluidino-anthraquinone. The molar ratio of monomers to glycolic acid is 800: 1. .

The reaction vessel is closed and 'the toluene under High vacuum (0.1-0.2 mm Hg) driven off. Then the vessel becomes purged with dry nitrogen by evacuating and filling with nitrogen twice in a row. The container is then filled with dry nitrogen again until the

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The pressure in the vessel is about 0.07 atmospheres, whereupon the outlet valve is opened closes.

The vessel and its contents are placed in a silicone bath preheated to 200 ° C used and heated to this temperature for one hour and 20 minutes with stirring. Then the stirrer is over the The liquid level is raised and the contents of the vessel are heated to 200 ° C for a further 4 hours and 18 minutes. The vessel becomes cooled and discharged the polymer mass. The polymer is "cooled with solid carbon dioxide", with the handsaw in Quarter cut, milled in a Cumberland mill with solid carbon dioxide and 48 hours at 25 ° C and 0.1 mm: Hg dried in vacuum. The yield of copolymer (product 1023-74) is 620 g. The copolymer obtained in this way has a hardness of 92-94 ° C. and a softening temperature in the range from 196-199 ° C, an adhesive point of 200-202 ° C, a stretching point of 206-207 ° C and a melting point (pour point) of 217 C The inherent viscosity of the copolymer, determined at 25 ° C on a 0.1 percent solution in hexafluoroisopropanol, is 1.43.

The polymerization described in this example is repeated four times, each time one hour with stirring heated to 200 ° C and a further 4 hours without stirring to the same temperature. The following results are obtained:

Product 1023-76

Yield, g 618

, Hardness 92-94

Softening point, ⁰ C '195-198

Glue dot, C, 199-200

Draw point, ⁰ C. 2Ό6

Melting point, ⁰ C 217-219

inherent viscosity 1.35

Product 1023-79

Yield, g 615

Hardness 92-94

Softening Point, C 195-198

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Product 1023-79

Glue point, _n ° C 199-201

Stretching point, ^Ü C 205-206

Melting point, C 217-219

inherent viscosity 1.46

Product 1023-81

Yield, g 621

Hardness 92-94

Softening Point, C 195-198

Glue dot, ⁰ C 200

Draw point, ⁰ C 206-207

Melting point, ⁰ G 215-218

inherent viscosity 1.57

Product 1023-83

Yield, g * 621

Hardness 92-94

Softening Point, C 195-198

Glue dot, ⁰ C 200

Draw point, ⁰ C 205-206

Melting point, ⁰ C 215-216

inherent viscosity 1.29

The above five products (1023-74. 76, 79, 81 and 83) are cut to grain sizes in a Cumberland mill with solid carbon dioxide ground less than 4.75 mm. The mixture (1023-85) is freed of metal with the magnet and thoroughly dried in a vacuum oven. The combined product weighs g and has the following physical characteristics:

Softening Point, ⁰ O 190-197

Glue dot, ⁰ C 200-202

Draw point, ⁰ C 205-206

Melting point, ⁰ C 217-218

inherent viscosity 1.41

The melt index of a sample of the combined product, determined according to Example 1, is 1.2.

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Example 6

Extrusion of the copolymer prepared according to Example 5 (1038-49, 55; 2661-130957-61)

The copolymer mixture prepared according to Example 5 (1023-85) is extruded according to Example 2 to form an 8-ply yarn.

The screw of the extruder generates a pressure of 105 kg / cm ² , and the metering pump works so that the pressure on the extrusion die remains in the range of 14 Ms 193 kg / cm and the extrusion speed is 30 g / h.

During extrusion, the feed section of the screw) (zone 1) is set to 245 - 2 ° C, the metering pump (zone 2) is on 202-207 ° 0 and the extrusion mold (zone 3) to 203-211 ° C held. The 8-ply yarn is wound onto the bobbin 40 at a speed of 21.3 m / min.

The yarn obtained in this way is oriented 3> 5 times by drawing on a godet heated to 52 ° C. The take-up speed of the oriented yarn is 160 m / min. The oriented yarn is then heat treated by placing the bobbin of yarn in a 113 ° 0 oven for 20 minutes. After the heat treatment, the yarn has a titer of 56-4 to and a tensile strength from 5.2 to 0.8 g / den. . ■.

Example 7 r

Braiding of the copolymer yarn produced according to Example 6 (P-259A - 1045 p. 96, 96A) -

The 8-ply yarn produced according to Example 6 (total denier 56-4 denier) is applied to the bobbins of a 16-bobbin braiding machine with a 3-ply core. The braid is made with a braiding density of 51-3 per 25.4 mm , and 320 m of surgical suturing material is obtained in the form of a 2/0 thread braid. The yarn braid (middle

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Diameter 0.348 mm) has a tensile strength of 4.72 kg (4956 kg / cm) and a knot strength (mean diameter 0.343 mm) of 3.13 kg (3388 kg / cm ² ).

The yarn braid is drawn by winding it up on a tensioning device, which is then stretched 20 fo , so that a braid that is 1.2 times drawn is obtained. The tensioning device with the stretched braid still in place is heat-treated in an oven at 105 ° C. for 24 hours. After the heat treatment, the braid (diameter 0.318 mm) has a tensile strength (straight) of 4.67 kg (5905 kg / cm) ) and a dry knot strength (diameter 0.310 mm) of 2.82 kg (3733 kg / cm ² ).

Example 8

Sterilizing and packaging the surgical suturing material obtained according to Example 7 (1045-132, 134A; 1039-99)

-The yarn braid stretched and heat-treated according to Example 7 is cut into lengths suitable for use as surgical suturing material and sterilized with ethylene oxide in open, ventilated packs by leaving the braided suturing material for 6 hours at a relative humidity of 70 ° C. and a temperature of 38 ° C allows an atmosphere of freon and ethylene oxide (500 mg ethylene oxide per liter of gas) to act.

The packs of sterilized braided sutures are sealed to allow the material to be used remains sterile. The sterile packaged suturing material has a tensile strength (straight) of 4.54 kg and a dry knot strength of 2.97 kg. .

The rate of absorption of this product (percentage of tensile strength remaining 5 days after implantation in Rats) is determined on ten samples with five different test animals. The percentage remaining train

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strength determined 10, 15 and 21 days after implantation. The mean values from ten yarn breaks, determined with the Instron tensile tester at a shoe speed of 25.4 mm / min on 12.7 mm samples are in the The table below is summarized and shown in FIG. 2. .

Days after implantation 0 5 10 15 21

Tensile strength (straight), kg 4.54 3.99 3.40 2.49 * 1.35

Remaining tensile strength, 100 pounds 88 75 55 29.7

* Average of nine yarn breaks.

Samples of the sterile braid are hydrolyzed in methanolic potassium hydroxide. The resulting glycolate and lactate are esterified with methanol and the methyl esters are simultaneously determined by gas chromatography with a thermal conductivity detector (Hewlett Packard 5750 or a similar device). The mean glycolide content (six samples) is 91.1 percent by weight with a normal deviation of 1.3 ^; . The mean lactide content of the braid (six samples) is 10.0 percent by weight with a normal deviation of 0.33

Example 9

Production of a copolymer from L (-) - lactide and glycolide mii? a content of 1-hydroxy-4-p-toluidino-annthraquinone Ύθη 0.3 percent by weight (1023-110) - -

A 1 liter stainless steel reaction vessel equipped with a paddle stirrer, stirrer motor and gas outlet is placed under Vacuum heated to 110 ° C to remove moisture from the inner walls of the vessel. Using dry Glass tanning is a mixture of 80.6 g (0.56 mol; 12.2 percent by weight) in the glove box under dry nitrogen pure L (-) - lactide (m.p. 97-99 ° C; specific rotation at least 282 °) and 580 g (5.0 mol; 87.8 percent by weight)

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made of pure glycolide. This mixture of 10 mol percent L (-) - lactide and 90 mol percent glycolide is transferred into the reaction vessel under nitrogen. The reaction mixture is mixed with 0.34 ml of a 0.33 molar catalyst solution of 13.4-1 g of tin (II) caprylate in 100 ml of toluene (1.11 x 10 " ⁴ " mol) using a dry glass syringe. offset. The molar ratio of monomers to catalyst is 50,000: 1. Then 0.5283 g (6.95 ^× 1 ° ~ ^{5 mol} ) of glycolic acid and 1.9834 g (0.3 percent by weight) of 1-hydroxy-4- p-toluidino-anthraquinone to. The molar ratio of monomers to glycolic acid "is 800: 1. .

The reaction vessel is closed and the toluene in a high vacuum (0.1-0.2 mm Hg) aborted. The vessel is rinsed with dry nitrogen by rinsing it twice in a row evacuated and filled with dry nitrogen. Then the vessel is filled again with dry nitrogen "bis the pressure in the vessel is about 0.07 atm, whereupon the outlet valve is closed. The vessel with its contents is in a Silicone bath preheated to 200 ° C is used and the contents of the vessel heated to this temperature for one hour while stirring. Then the stirrer is raised above the liquid level and the contents are heated to 200 ° C. for a further 4 hours without stirring. After the vessel has cooled, the copolymerized material is discharged. The copolymer is intensely purple in color and the yield (product 1023-110) is 626 g. The copolymer is cooled with solid carbon dioxide and cut with the handsaw into quarters, which together with solid carbon dioxide in the Gumberland mill to grain sizes below 4.75 mm be ground, whereupon the product is freed from metal with the magnet. The milled copolymer is 48 hours dried at 25 ° C and 0.1 mm Hg in vacuo. The thus obtained Copolymer has a hardness of 92-94, a softening point in the range of 190-195 ° C, an adhesive point of 197 ° C, a stretching point of 206 ° C and a melting point of • 219 ° C.

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The inherent viscosity of this colored copolymer is correct at 25 ° C. on an ι
isopropanol, is 1.41.

is correct at 25 C in a 0.1 percent solution in hexafluoro-

The melt index of the colored copolymer, determined according to Example 1, is 1.84.

Example 10

Extrusion of the copolymer prepared according to Example 9 (1038-54, 57) . - -_

The copolymer (1023-110) prepared according to Example 9 is with the one in Pig. 1 shown screw extruder into a | 8-ply extruded yarn. Between the metering pump 28 and The extrusion mold .32 rests on a sieve of 0.25 mm mesh size of classified sand with grain sizes below 0.59 mm and above 0.297 mm. The extrusion mold has eight openings each 0.635 mm in diameter. . .

The screw of the extruder generates a pressure of 105 kg / cm, and the metering pump works so that the pressure at the extrusion opening is in the range of 56 to 207 kg / cm ² and the extrusion rate is 30 g / h.

During extrusion, the temperature of the feed section of the screw (zone 1) is kept at 241-245 ° C, that of the metering pump (Zone 2) to 205 ° C and that of the extrusion mold (Zone 3) to 204-207 ° C. The 8-ply yarn is set to c.ia Coil 40. wound at a speed of 21.3 m / min.

The yarn so obtained is oriented by running it on a Galette heated to 52 ° C. stretched 3.5 times. The winding speed of the oriented yarn is 160 m / min. The oriented yarn is then heat treated by placing the bobbin of yarn in an oven at 113 ° C for 20 minutes is introduced. Subject of heat treatment is the tensile

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ΕΤΗ 354 - ■ '. ■

tenacity of the yarn (51 - 1 denier) 5.8 ± 0.7 g / denier.

Example 11

Braiding the after. Example 10 produced copolymer yarn (P-244A; 1045-1HB), ' '

The 8-filamentary yarn prepared according to Example 10 (total denier 51-1 s) is applied to the clapper of a 16-Spuligen braiding machine applied with 3 times the core. The braid is made with a braid density of 51 - 3 per 25.4 mm, and a surgical suturing material is obtained in the form of a braided thread of size 2/0.

2 ser 0.340 mm) has a tensile strength of 4.76 kg (5200 kg / em) and a knot strength (mean diameter 0.335 mm) of 3.05; kg (3452 kg / cm). The yarn braid is stretched, by winding it on a jig, which is then stretched $ 20 so that it is stretched 1.2 times Braid received. Die-jig with the braid While still in place, it is then heat-treated in an oven at 105 ° C. for 24 hours. After heat treatment the braid (mean diameter 0.282 mm) has a tensile strength (straight) of 4.63 kg (7410 kg / cm) and a dry knot strength of 2.90 kg (4478 kg / cm).

B is ρ ie 1 12.

Sterilizing and packaging the mowing material produced according to Example 11 (1045-98, 132, 134C)

The drawn according to Example 11 and heat-treated Garngeflecht is cut into appropriate for use as a surgical suture lengths and in open or ventilated, sterilized packs Ithylenoxid by 6 hours at 70 io relative humidity and 38 ° C to the action of an atmosphere of Iraion and Ethylene oxide (500 mg ethylene oxide per liter of gas) is exposed.

The packs with the sterilized thread mesh are closed, so that the material is sterile until it is used

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209 827/09 51

remain. The sterile packaged suturing material has tensile strength (straight) of 5.05 kg and a dry knot strength of 2.78 kg.

The rate of absorption of this product (remaining Percentage of tensile strength 5 days after implantation in Rats) is carried out on ten samples with five different test animals certainly. The percentage remaining tensile strength is also determined 10, 15 and 21 days after implantation. The mean values from every ten yarn breaks, determined with the Instron tensile tester with a slide block distance of 25.4 mm / min on 12.7 mm samples, are shown in the following Table summarized and in Pig. 2 shown.

Days after implantation

JL 'J ι - 10 15 21st Tensile Strength (Straight), kg 5.05 4, 13th 3.66 * 2.62 1.48 Remaining tensile strength
ability, £ 100 81 , 6 72.4 51.8 29.2 * Mean of nine
Yarn breaks. Example 13 Rate of absorption of a sterile braided
Suturing material made from the homopolymer of glycolic acid

. A box with 3 dozen individually wrapped sewing material- ■ spotted, size 00 (size 2/0), manufactured by Davis & Geck, Cyanamid of Great Britain Ltd., London, England, (trade name "Dexon") is numbered 7002-51 identified as Lot No. 6384. The sewing material, approximately 152 cm long and 0.328 mm in diameter, has a tensile strength (straight) of 4.39 kg (5216 kg / cm) and a dry knot strength (0.328 mm diameter) of 3.15 kg (3712 kg / cm ² ).

The rate of resorption of this product (percentage of tensile strength remaining 5 days after implantation in hat-

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th) is determined by dividing eight samples into eight different ones Experimental animals are implanted. Likewise, the percentage remaining tensile strength 10, 15 and 21 days after implantation certainly. The mean values of eight yarn breaks determined with the Instron tensile tester on one Sliding jaw spacing of 25.4 mm / min on 12.7 mm specimens are in in the table below and in! ig. 2 shown. ■

Days after implantation 0 5 10 15 21 Tensile strength (straight), kg 4.73 4.38 3.00 1.80 0.33 Remaining tensile strength -

speed, i> 100 92.3 63.2 37.9 6.88

Like Pig. 2 shows is that described in Examples 1 to 12, braided sewing material made from a co-polymer from 10 mole percent! (-) - lactide and 90 mole percent glycolide polyglycolic acid braided sutures for the percentage remaining 15 and 21 days after implantation Far superior to the original tensile strength.

Example 14

Preparation of a copolymers of l (-) ^ I <aetid and glycolide having a content of 1,4-bis (p-toluidino) anthraquinone of 0.1 weight percent (1014-120-6, 121, 139; 145) ■

Following the procedure of Example 5, a green-colored copolymer is obtained prepared by adding 0.1 percent by weight to the reaction mixture of 10 mol percent L (-) - lactide and 90 mol percent glycolide 1,4-bis (p-toluidino) anthraquinone (D&C Green No. 6) clogs. The copolymer obtained in this way has an inherent viscosity of 1.41 and a melt viscosity (determined according to example 1) of 0.9.

The green-colored polymer can be extruded into a yarn, stretched, braided, heat treated, sterilized and packaged as surgical sutures.

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Likewise, one can dye the surgical Jiahmaterial according to of the invention -use any non-toxic dye, which retains its color and color strength under the conditions of the polymerization and does not affect the polymerization reaction. .

Many of the regulations in the Federal Food, Drug, and Cosmetic Act "of 1938 as dyes listed for foods, drugs and cosmetics cannot be used because they interfere with the copolymerization by using copolymers of L (-) - lactide and glycolide of low molecular weight obtained that have low inherent viscosity and low tensile strength. Other non-toxic ^ see dyes themselves suffer under the conditions of .Polymerization and then do not produce the desired bright color.

Example 15 ■

Production of a copolymer from L (-) - lactide and glycolide

One equipped with a paddle stirrer, stirrer motor and gas outlet 1 liter stainless steel reaction vessel is heated to 110 ° C under yakuum to remove the inner walls of To free moisture.

In dry glass devices under dry nitrogen im "Glove box a mixture of 80.6 g (0.56 mol; 12.2 percent by weight) of pure L (-) - lactide (m.p. 97-99 ° C; specific Rotation at least 282 °) and 580 g (5.0 mol; 87.8 percent by weight) pure glycolide (m.p. 82.5-84-, 25 ° C). This mixture of 10 mol percent L (~) -lactide and 90 mol percent Glycolide is poured into the realization vessel under dry nitrogen convicted. The reaction mixture is filled with 0.34 ml of a 0.33 molar catalyst solution from 13.41 g of tin (II) caprylate in 100 ml of toluene (1.11 χ ίΟ "^ mol). The molar ratio

- 24 -;

2 0 0 ■; ■? 1 I 0 9 5 1.

nis of monomers to catalyst "is 50. 000:.. 1 are then added 0.5283 g (6.95 χ 10 ~ ⁵ mol) to Glykoleäure The molar ratio of monomers to glycolic acid" is 800: 1.

The reaction vessel is closed and the toluene under High vacuum (0.1-0.2 mm Hg) -drained. "The vessel is with purged dry nitrogen by applying it twice in a row evacuated and filled with dry nitrogen. Then the vessel will come back with. filled with dry nitrogen, "up the pressure in the vessel is 0.07 atm, whereupon the outlet valve is closed. ·.

Now the vessel with its contents is preheated to 200 ° 0 Silicone bath used and the contents of the vessel 1 hour heated to this temperature with stirring. Then there is a stirrer Raised above the liquid level and heating continued at 200 ° C for 4 hours. The vessel is cooled and the polymer mass discharged. The polymer is cooled with solid carbon dioxide, with the hand saw in "Quarter cut, in a Ciimberland mill with firm Grind carbon dioxide and 72 hours at 25 ° G and 0.1 mm. Ed dried in vacuum. The yield of copolymer (polymer 1078-21B) is 545.9 g or $ 82.9. The product has an adhesive point of 210 ° C, a draw point of 214 ° C and a melting point, (pour point) of 234 ° CV The inherent The viscosity of the copolymer, determined at 25 ° C. on a 0.1 percent solution in hexafluoroisopropanol, is 1.54.

The melt index of a sample of the product, determined according to the example 1, is 0.36 (g / 10 min at 900 see).

Example 16

Extrusion of the polymer prepared according to Example 15 (1038-153) _.

The polymer prepared according to Example 15 (1078-21-B2) is under dry nitrogen with the help of a screw

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Extruder extruded into an 8-ply yarn. Between the metering pump and the extrusion mold, a filter made of classified sand rests on a sieve with a mesh size of 0.177 mm Grain sizes of less than 0.42 mm and more than 0.25 mm. the The extrusion mold has eight openings, each 0.635 mm in diameter.

The extruder screw generates a pressure of 140 kg /, cm, and the metering pump works so that the pressure on the extrusion mold is in the range of 10.5 to 7 kg / cm. At the The feed section of the screw of the extruder is extruded to 245 ° C, the metering pump to 210 ° C and the Extrusion mold kept at 215 ° C. The 8-ply yarn is wound up at a speed of 21.3 m / min.

The yarn obtained in this way is oriented by placing it on a 57 ° C-heated galette is stretched 4.5 times. The oriented yarn is then heat treated by using the bobbin the yarn is heated in an oven held at 105 ° C for 45 minutes. The tensile strength after heat treatment (54.8 denier) is 4.8 g / denier.

Example 17

Pike the copolymer yarn prepared according to Example 16 (P-331) '

The 8-ply yarn (54.8 denier) produced according to Example 16 is applied to the bobbins of a 16-bobbin braiding machine with a 3-ply core. The braid is made with a braid density of 51 - 3 per 25.4 mm, and a surgical suturing material is obtained in the form of a thread braid of size 2/0 (mean diameter 0.345 mm) with a tensile strength of 6.26 kg (6678 kg / cm) and a knot strength of 3.86 kg (4113 kg / cm ² ). The yarn braid is stretched hot by winding it onto a tensioning device, which is expanded by 10 $> in an oven slightly above room temperature, so that it is 1.1 times longer

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stretched braid receives. The jig with the The stretched braid in place is then heat-treated for 24 hours at 105 ° G in the oven in an inert atmosphere.

Example 18

Sterilizing and packaging the braid produced according to Example 17 (1O95-39A)

The yarn braid drawn and heat-treated according to Example 17 is cut into lengths suitable for use as surgical suturing material and sterilized in open, ventilated packs with ethylene oxide by exposing it to the action of an atmosphere for 3 hours at 25 ° G and 100% relative humidity. which contains 1000 mg of ethylene oxide per liter. The sterilization process is repeated by exposing the product to the action of the gas atmosphere for a further 3 hours at 25 ° C. under the same conditions. Then the paclnmgen are degassed for 16 hours at 40 ° G under vacuum (0.5 liiiii Hg) and then closed. The sterile, packaged suturing material (diameter 0.335 mm) has a knot strength of 3.67 kg (4155 kg / cm), determined with the oblique oenen tester ύοώ. Scott (model no, ΙΓ-4), according to the "United States Pharmacopoeia" , Volume XVII, page 921. The tensile strength (straight) of the sterile suturing material (diameter 0.335 mm), determined with the Scott Schrägebenen tester, is 5.81 kg (6580 kg / cm ² ).

The. Rate of absorption of this product (percent tensile strength remaining 7, 14, 21 and 28 days, respectively, after implantation in rats) is determined by implanting ten samples in five different test animals. The mean values from ten yarn fragments, determined with the Instron tensile strength tester at a sliding block speed of 25.4 mm / min on 12.7 mm samples are listed below and in Pig. 5 shown.

-? 7 2CPr? 7/0 95 1

■ Days after implantation 0 _7_ 14 21 28

Tensile strength (straight), kg 5.76 4.85 3.75 2.41 0.98

Remaining tensile strength, fo , 100 84.32 65.09 41.88 17.06

A representative sample of the braided suture material is examined by gel filtration chromatography _t for information on the molecular weight and molecular weight distribution of the copolymers to be obtained. Pig. Fig. 3 is a graph showing the chain length distribution values thus obtained. It is noted that the ratio of the weight average molecular weight to the number average molecular weight is 72,000: 33,000, or about 2.1.

A representative sample of the sterile braided sutures of this example is taken on the differential scanning calorimeter (DUPONT Instruments Model No. 500) examined. The thermograms are shown in FIG. From curve A it can be seen that the freezing temperature of the heat-treated, braided sewing material (No. 10) is 55 Q. The one with 12 designated melting point is 205 C. After melting the copolymer suturing material is cooled, whereupon one second thermogram (curve B). The freezing temperature (No. 14) of this chilled material is 43 ° G. Die Crystallization temperature (No. 16) is 112 ° C and the Melting point (No. 18) 205 ° C,. ".-..

Example 19

Production of a copolymer from L (~) -lactide and glycolide (1078-16A and 1Q78-16B) , '. '

A 1 liter stainless steel reaction vessel equipped with a paddle stirrer, stirrer motor and gas outlet is placed under Vacuum heated to 110 ° C to remove moisture from the inner walls. ·

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ΕΤΗ 354 <& .21 6290Q

A mixture of 126.7 g (0.88 mol; 17.93 percent by weight) of pure L (-) - lactide and 580 g (5.0 mol; 82.07 percent by weight) of pure is placed in a glove box under dry nitrogen in dry glass devices Glycolide (P. 82.5-84.5 ° C) produced. This mixture of 15 mol percent L (-) - lactide and 85 mol percent glycolide is transferred to the reaction vessel under dry nitrogen. The reaction mixture is mixed with 0.36 ml of a 0.33 molar catalyst solution of 13.41 g of tin (II) caprylate in 100 ml of toluene (1.18 × 10 "^ mol) using a dry glass injection needle. The molar ratio ^: of monomers to catalyst is 50,000: 1. Then added 0.5586 g (7.35 x 10 ~ ⁵ mol) to glycolic acid. The molar ratio of monomers to glycolic acid is 800: 1.

The reaction vessel is closed and the toluene in a high vacuum (0.1-0.2 mm Hg) aborted. Then the vessel is flushed with dry nitrogen by making it twice in a row evacuated and filled with dry nitrogen. The vessel is then filled again with dry nitrogen until the pressure in the vessel is 0.07 atm, whereupon the outlet valve is opened closes.

The vessel and its contents are placed in a silicone bath preheated to 200 ° C used and the contents heated to 193 to 200 ° C for 55 minutes with stirring. Then the stirrer is over the The liquid level of the reaction mixture was raised and the mixture was heated to 200 ° 0 for a further 4 hours and 5 minutes. The "reaction vessel is removed from the silicone bath and Let it cool down overnight. Then the reaction vessel with contents cooled with solid carbon dioxide and the polymer discharged from the reaction vessel, cut into quarters with the hand saw, together with solid carbon dioxide in a Cumberland mill and grind at 25 ° 0 and 0.1 mm Hg dried in vacuum. The polymer yield obtained in this way (product 1078-12) is 5t2.4 g. This product has a Hardness of 90-91, a sticking point of 195 ° C, a stretching point of 205 ° G and a melting point (pour point) of 225 ° C.

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209 827/0951

The inherent viscosity of the copolymer is determined by 25 ° C on a 0.1 percent solution in hexafluoroisopropanol, is 1.51.

The Schmel ζ this example index of a sample of the vacuum dried product, as determined by the method of Example 1 at 2J5 C with a weight of 3800 g and an opening of 0.635 mm, is 0.33 (g / 10 min at 900 lake ). -

Example 20

Extrusion of the copolymer produced according to Example 19 - sate (1038-143; 1095-12-B) .

The copolymer prepared according to Example 19 is under dry nitrogen with the screw extruder shown in Example 1 to form a 12-thread yarn. Between the metering pump and the extrusion mold 32 rests a filter with a mesh size of 0.14-9 mm classified sand with grain sizes between 0.177 and 0.149 mm. The extrusion mold has twelve openings, each 0.508 mm in diameter.

The extruder screw exerts a pressure of 105 kg / cm off, and the metering pump works so that the pressure on the Extrusion mold in the range of 53 to 140 kg / cm ^ - lies.

In extrusion, the feed section of the screw becomes the Extrusion press (zone 1) to 245 ° C, the metering pump (zone 2) 220 ° C and the extrusion mold (zone 3) kept at 230 ° C. The 12-ply yarn is wound onto the bobbin 40.

The yarn obtained in this way is oriented by stretching it 4.5 times on a godet heated to 54 ° C. The tensile strength of this oriented yarn (40-5 s) is 4.0 g / den.

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Example 21

Braiding of the yarn produced according to Example 20 (braid 299A; 1095-12-B) '

The 12-ply yarn (total denier 4O ^ 5 den) is put on the clapper a 16-spool braiding machine with a triple core. The braid is made with a braid density of 49 - 3 per 25.4 mm, and nan is given a surgical one Sewing material in the form of a 2/0 thread mesh. The yarn braid (mean diameter 0.330 mm) has a

ο tensile strength of 3.95 kg (4570 kg / cm) and a knot strength

capacity of 2.40 kg (2810 kg / cm). The twine v. ^It is stretched by winding it on a jig, which is then stretched $ 15 to make a braid stretched 1.15 times. The tensioning device with the stretched braid on it is then heat-treated in an oven at 105 ° C. for 24 hours.

Example 22

Sterilizing and packaging the sewing material produced according to Example 21 (1095-12-B, ERF 71-61, P-299A)

The drawn according to Example 21 and wärmebehanc'elte Garngeflecht is cut into suitable lengths for surgical suture material and sterilized in open or ventilated packs Ithylenoxid by 6 hours at 25 ° C and a relative humidity of 70 i <> the action of an atmosphere of Freon and ethylene oxide (500 mg ethylene oxide per liter of gas) is exposed. The packages are degassed for 1 hour at 40 ° G under vacuum (0.5 mm Hg) and then sealed to keep the sutures sterile until use.

The sterile, packaged suturing material (mean diameter 0.291 mm) has a tensile strength (straight), as determined by the Scott Inclined Cane Tester, Model IP-4, of 4.65 kg (7080 kg / cm) and a dry knot strength of 2.90 kg (4400 kg / cm ² ).

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The rate of absorption of this product (the 7 days percentage of tensile strength remaining after implantation in rats) is determined by implanting 12 specimens in determined twelve different test animals. In the same way, the percentage remaining tensile strength becomes 14, 21 and 28 days after implantation. The mean values from twelve yarn breaks determined with the Instron tensile strength meter at a sliding jaw speed of 25.4 mm / min on 12.7 mm specimens, result from the following Tabel.

Days after implantation 0 7 14 21 28

* Tensile strength (straight), kg 4.38 3.48 2.59 1.69 0.64

Remaining Tensile Strength, $ 100 -79.5 59.1 '38.1 14.6

Samples of the sterile braid are hydrolyzed in methanolic potassium hydroxide. The resulting glycolate and Lactate are esterified with methanol and the methyl esters at the same time by gas chromatography with a thermal conductivity detector (Hewlett Packard 5750 or equivalent). The mean glycolide content of six samples is 86.8 percent by weight with a normal deviation of 1.4. The mean Lautidgehalü of the six analyzed samples of the braid is 14.7 percent by weight with a normal deviation of 0.2.

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BATH ORIGINAL

Claims (8)

December 17, I97I EtMcon, Inc. ETII 554 Godfather spray t. Sterile, absorbable surgical suturing material in the form of a thread structure, which consists essentially of a carbon polymer of £ (-) - lactide and glycol, in which the proportion of L (-) - lactide units is at least 10, but not more than 15 percent by weight is, characterized, that the - (/ © polymerisat gate of the extrusion has an inherent Ylscosltät determined on a 0.1 percent solution in hexafluoroisopropanol at 25 ° C of at least about 1.4 and the surgical suturing material after sterilization a knot strengthens of not having a tensile strength (straight) of not less than about 5625 kg / cm, less than about 5515 kg / cm and, 15 days after the implantation in animal tissue still about 50% "and 21 days after implantation for at least 20 < fi has its original value. 2. Surgical suturing material according to claim 1, characterized in that that by coloring it in bulk with a dark -toxic dye brightly colored 1st. 3. Surgical suturing material according to claim 2, characterized in that that the copolymer in its mass with about 0.1 to 0.5 percent by weight of i-hydroxy-4-p-toluidino-anthrachlnone is colored «. 4. Surgical suturing material according to claim 2, characterized in that that the copolymer is colored in its mass with about 0.1 percent by weight of 1,4-bis (p-toluidino) anthraquinone is. - 53 - 209827/0951 5. Combination of surgical needle and suture material, characterized in that the surgical suture material is a yarn braid according to claim 1 or 3. 6. Sterile packaged combination of surgical needle and Suturing material, characterized in that the surgical suturing material is a thread mesh according to claim 1 or 3 is. 7 · Procedure for closing wounds in living tissue by suturing the and edges with sterile, absorbable surgical suturing material, characterized in that the surgical suturing material is a braid according to Claim 1 or 3 used. 8. A method of retaining living tissue in the desired relative position of the tissue sites to one another Healing process by fixing the tissue with the help of a sterile absorbable surgical suturing material that is attached to It remains in place in the tissue until it is removed from the tissue has been absorbed during the healing process, characterized in that it is used as a surgical suturing material Yarn braid according to claim 1, 3 or 4 is used. - 34 20 9 827/0951