DE2246215A1 - SURGICAL SUTURE - Google Patents

Description

PATENT ADVOCATE DR. HANS-GUNTHER EGGERT ₁ DIPLOMA CHEMIST

5 COLOGNE SI, "OBERLÄNDER UFER 90 2 24 Ό 4 | Q

Cologne, September 20, 1972 Eg / Ax

Ethicon, Inc., Somerville, New Jersey, / USA "

Surgical sutures

The invention relates to improved surgical sutures, particularly sutures having improved Knot strength.

Braided parliamentary yarns have been used as sutures due to Their excellent flexibility and good handling properties are widely used in surgery found. These braiding yarns are smooth and easy to tie into a secure knot. Braiding yarn made from Multifilament yarns or fiber yarns exist, but have inherently a deterioration in potential Tensile strength. This is due to the bending of the threads from the straight or parallel, which is required in braids Direction. The manufacture of sutures in the form of braiding yarn is extremely slow due to the mechanical limitations of the braiding machine design.

. The sutures according to the invention have flexibility and handling properties that are similar to those of loose yarns come close, and are easily tied into knots of significantly increased strength. Because the knot strength of braiding yarn generally only about $ 50 the straight tensile strength, determines the knot strength

309813/0912

-S-

the actual holding of such a seam. It is an important advantage of the sutures according to the Invention that they have a much higher Khoten strength have as sutures in the form of braiding yarn of the appropriate size.

The surgical sutures according to the invention are made using a central core Filament yarn produced that has been impregnated with an adhesive binder. The core yarn becomes helical wound with filament yarn. The composite material is hot stretched, whereby the binder tightly unites the outer convolutions with itself and with the central core. It is also possible to have the central core made of filament yarn (without using the adhesive binder) in a helical shape to wrap with filament yarn and apply the binding agent to the suture and thereby the outer To firmly unite turns with itself and with the central core.

Wrapped yarns are not new in themselves. Spandex yarns wound with nylon are used to make elastomeric Stretch yarns used for bathing suits. These threads would however, are not suitable as surgical sutures as it would be difficult for the surgeon to control the tension an elastic suture to regulate the constriction or strangulation as well as necrosis or death of the sutured Tissue.

The sutures according to the invention differ from the wrapped yarns of the prior art in that that they are not elastic. Preferably, the core and the helical wrap made of threads are the same Composition made. The wrapped sutures described here are also characterized by a significantly increased knot strength.

The core yarn of the wound suture material can be a filament

309813/0912

yarn made from collagen, nylon, polyesters, polypropylene, silk or be cotton. Preferred as polyester for the manufacture of absorbable, wound sutures are the homopolymers and copolymers of L (-) - lactide and the homopolymers and copolymers of glycolide. The wrapping yarn can be a pilament yarn be made of collagen, nylon, polyester, polypropylene, silk or cotton. Also here are used for the production of absorbable sutures yarns made from homopolymers and copolymers of L (-) - lactide and glycolide for the helical winding around the core is preferred.

The invention is hereinafter described in connection with Illustrations showing a preferred embodiment of the Show the invention as an example, explained in detail. Here is

Fig. 1 is a perspective view of a Umwindungsmas chine,

Pig. 2 is an enlarged, partially shown in section View of a hollow spindle on which a bobbin with wrapping yarn is placed,

Fig. 3 is a plan view taken along line 3-3 of Fig. 2;

4 is an enlarged perspective view of a wound filament yarn and FIG

Fig. 5 is a cross section of a wrapped yarn along the line Line 5-5 from Flg. 4th

In the preferred method of making the flexible wrapped sutures according to the invention, a H.H. ARNOLD wrapping machine used (manufacturer H.H. Arnold, Rockland, Massachusetts, U.S.A.), which is shown schematically in Figures 1, 2 and 3.

The machine shown in Figs. 1 to 3 and the stages the manufacture of the wrapped sutures according to

309813/0912

Invention will now be described. The Umwlhäungsmaschine 10 is provided with a hollow spindle 12, the is rotatably mounted on the carrier 14. The hollow spindle is provided with a coil carrier or a coil platform 16 wedged, the lower end of which is designed as a pulley 18 is. A belt 19 is used to drive the belt pulley, which rotates the bobbin carrier and the hollow spindle.

The wrapping yarn is supplied from a bobbin 20, which with a central transverse bore 21 for receiving the hollow spindle is provided. The coil rests on the platform 16. A protrusion 22 extending upward from the coil platform protrudes, engages in a recess 24 in the lower surface 25 of the coil.

The wrapping machine is also equipped with a round cover plate 26, which is approximately the same diameter as the coil. This cover plate is with a concentric Cylinder that protrudes above and below the cover plate when the machine is put together. As Fig. 2 shows the lower part of this cylinder extends. Deter to under the cover plate in the central bore of the coil and in the hollow spindle 12. A projection 52 on the The underside of the cover plate engages in a recess 33 in the upper flange of the spool.

A flyer 34 rotates freely around the cylinder 28. It is mounted on a bearing surface 35 which extends over the cover plate 26 protrudes. The tension under which the flyer brings the wrapping yarn during the twist is regulated by weights 36, which can be pushed over the cylinder 28. After the desired number of weights has been applied, a guide 38 is fastened to the upper end of the cylinder 28 with a locking screw 40.

In operation, the core yarn 41 to be wound is of a (not shown) delivery reel fed to a delivery roll 42, from which it passes through the hollow spindle 12 and the

309813/0912

BATH ORIGINAL

Cylinder 28 runs up to take-off roller 44. The core yarn is once around the delivery roll and the take-off disk wound to ensure that the core yarn is kept under tension while the wrap yarn is in the "wrapping zone" (between delivery roll and take-off disk) is wrapped around the core yarn.

As the core thread runs through the bobbin, the Spool with its cover plate, the cylinder and the guide rotated at a speed that depends on the number of revolutions depends on the pulley that turns the spool carrier and the hollow spindle. The amount of covering yarn 4j5 that is wound around the core depends on the speed at which the core yarn runs through the wrapping zone.

The machine is preferably operated so that the take-off disk rotates about 2% faster than the supply roll to keep the core yarn under tension. The flyer is loaded with a number of flyer weights (until shortly before the wrapping yarn breaks) in order to keep the wrapping yarn under high tension. Under these working conditions, the machine delivers a compact material with good intrinsic strength. In order to achieve the best appearance and the best handling properties of the end product, the core yarn is twisted before being wrapped with the wrapping yarn 4 ^.

The wound yarn from the take-off disk 44 is wound onto a bobbin 45 and can be used until later treatment with a suitable resin, wax or other suitable equipment to prevent fraying, Improvement of the abrasion resistance and binding properties

JiO ten be stored. It is also possible for the wrapped yarn to be fed directly into a finishing bath after it has left the wrapping machine.

If the core yarn has not been coated with a resin binder before being wrapped with the cover yarn, then

309813/0912

as already mentioned, the wrapped yarn with a resin or wax or other suitable equipment treated to prevent fraying and increase abrasion resistance. This can be done by the wound suture material directly into a solution of the desired treatment resin and then passed through a drying oven to remove the solvent, such as this is known and common in the textile sector.

The invention is further illustrated by the following examples explained. These examples describe the manufacture of wrapped sutures of various sizes that all have excellent grip and flexibility and excellent knot strength.

example 1 Wrapped polyester sutures, size 3/0 «

A 3/0 braided polyester suture is made using the machine illustrated in FIGS. 1-3. The suture is made using a core made of 2 plied without twist ^/ Polyester filament yarns of 220 den each with 50 filaments. It is a light-colored filament yarn of high tensile strength that has been entangled or entwined to achieve a twist-free cohesion is (Rotoset Industrial DACRON, type 52, manufacturer

EGG. du Pont de Nemours ft Company, Wilmington, Delaware).

Before winding, the core yarn is coated with an adhesive binder by passing it through a solution containing 7 parts of a linear saturated polyester with a melting point of 138 ^° C. (manufacturer: Industrial Chemicals Division, Eastman Chemical Products, Inc., Kingsport, Tenri., Trade name "XFA-1") and contains 93 parts of methylene chloride. After application, the core yarn is fed through a steel nozzle to remove excess glue and create a smooth surface. The entrance of this

309813/0912

The nozzle has a diameter of 0.457 mm and its outlet has a diameter of 0.305 mm. The core yarn is then dried with air in countercurrent at room temperature and wound onto a drum. The pressure applied in this manner to the "core yarn coating makes 6.3 wt -.% Of the core yarn from unbeschichteteri.

The bobbin 20 of the winding machine is wound with a light-colored filament yarn of normal tear strength, which has a denier of 40 and consists of 27 filaments (Rotoset Industrial DACRON type 56, manufacturer EI du Pont de Nemours & Company). The flyer (E16) is loaded with five weights (total weight 50 g), and the winding machine is operated at a spindle speed of 10,000 rpm, with 2756 t / m of the winding yarn · (S twist) being obtained.

The resin binder in the core of the wound yarn is activated, by hot stretching the wound suture between two godets by $ 2. The receiving galette has a diameter of 15 * 6 cm and a temperature of 221 ° C. The wound suture is heated around it 15 times Galette wound. The dwell time ^ on the godet at 221 ° C is about 15 seconds.

After the binder resin present in the core has been activated is to firmly connect the helical wrapping of the wrapping filament yarn to the core, that will wound sutures cooled to room temperature under minimal tension, wound on a drum on which cut to the correct length and sterilized by irradiation with cobalt 60. The physical properties the sterile wound suture thus obtained are the same as those of a braided suture Size compared in Table I.

309813/0912
BATH ORIGINAL

-β

Physical Properties

Wrapped QrCBe 3/0 polyester sutures

Braided polyester sutures GrOBa 3/0

Diameter, n 244

Tear strength without knots, kg 3 * 5 ^ (straight pull)

True tensile strength without knots (intrinsic straight _o pull), kg / cnr

Knot strength, kg 2.54

True knot strength, kg / cm 5400 (Intrinsic Knot Pull)

241 3.81

19.5 4290

The values in Table I show that the wrapped polyester sutures made in the flat catfish has more than $ 25 more knot strength than one Braided polyester sutures of smooth size.

Example 2 Wrapped polyester sutures, QrOBe 2.

A wrapped polyester suture material of size 2 is used with the In Flg. 1 to 3 shown device manufactured. The core consists of nine twist-free polyester filament yarns with a titer of 220 den are made up of 50 filaments each. This

Yarn is a light-colored, highly tear-resistant multi-filament yarn;

that has been entangled or entwined without twisting in order to achieve a firm cohesion (Rotoset Industrial DACRON type 52, manufacturer E.I. du Pont de Nemours ft Company),

The bobbin 20 of the winding machine is made of light-colored yarn of normal tear strength, which has a titer of 70 den and consists of 34 filaments (manufacturer I.I. du Pont de Nemours ft Company). The Flyer (E20) is loaded with six weights (total weight 60 g). The turning machine runs at a spindle speed of 8500 rpm, with 2560 turns / m (Z-twist) being obtained for the wrapping yarn.

309813/0912

BAD ORIQINAi.

The wrapped yarn is then coated by modifying it with a solution of 14.25 parts of a linear saturated polyester (trade name VITEL PE-207, made by Good Year Tire & Rubber Company, Akron, Ohio) and 0.75 parts of a vulcanizing agent Isocyanate (trade name RC-805, manufacturer EI du Pont de Nemours & Company) is performed in 75 parts of methyl ethyl ketone. After coating, the wound suture material is passed through a 2.74 m long horizontal drying tube (dwell time approx. 45 seconds). The suture material is dried in the tube by means of countercurrent warm air. At the entrance to the drying tube, the air has a temperature of 197 ° C. The temperature of the exiting air is 6O ⁰ C. After leaving the drying tube, the enwound suture material is cooled under minimal tension to room temperature and then wound onto a drum, cut to the proper length and sterilized by irradiation with cobalt 60th The physical properties of the sterile, wrapped suture made in this manner are compared with those of a braided suture of the same size in Table II.

Table II

Physical Properties

Wrapped
coated
Polyester sutures
Size 2

Braided polyester sutures Size 2

Diameter, yes tensile strength without knots, (straight pull) True tensile strength without knots (intrinsic straight pull), kg / cm ²

35 knot strength, kg true knot strength, (Intrinsic knot pull)

kg / cm ^c

550
15.69

6610
9.07
3830

540 9.62

4260 5.17 2735

109813/0912

The values in Table II show that the In described Mannered Coated Wrapped Polyester Sutures a knot strength that is more than 30 # higher has as a braided polyester suture of the same size.

Example III Wrapped Nylon Sutures

Using a wrapped nylon suture / Wira of a nylon core yarn of 210 den, 3 ^ filaments, type 380, with 28 turns / m (S-direction) (manufacturer E.I. du Pont de Nemours A Company). Before winding, this core yarn is twisted with 236 twists / m in the Z direction twisted. The coil 20 of the winding machine is with a single winding yarn of 30 denier, 26 filaments, 20 turns / m (Z-direction) (semi-matt nylon yarn type with normal tear strength, manufacturer E.I. du Pont de Nemours A Company). The flyer (E17) is loaded with a weight (5 g). The bobbin and the spindle are rotated at 10,000 rpm, while the core yarn from the take-off disk at such a linear speed it is taken up that a suture material is obtained, the entangling yarn of which has 33 ^ 7 turns / m (Z-direction).

Strands of the suture thus produced are colored by immersing them in an aqueous bath consisting of a solution of 0.3 parts of Dft C Green No. 5 dye in 600 parts of glacial acetic acid and 500 parts of water. The temperature of the bath is 100 ^° C. and the residence time in the liquor is 20 minutes.

The suture is then coated by it at room temperature by a solution of 17.5 parts of nylon 6 (manufacturer Allied Chemical Plastics Division, Morristown, N.J., trade designation "PLASKON 8202) in 82.5 parts of trifluoroethanol. On exit the coated seam-

309813/0912

materim through a steel nozzle (μ input 505 diameter, exit 152 u in diameter) and then under tension by a 1/22 m long vertical drying tube. The approximate residence time in the drying tube is 11 seconds, the temperature at the lower end of the tube about 75 ° C and the temperature at the top of about 150 ⁰ C. The weight of the coating resin which is applied in this step is, lk% of the weight of the circled Suture material before coating. The finished suture is placed on the in. Example 1 described manner wound and sterilized. The physical properties of the sterile wrapped suture obtained are compared with those of a braided suture of the same size in Table III.

Table III

Physical Properties Coiled Black Ge

Nylon thread braided nylon size 4/0 thread size 4/0

Diameter, u 195 190.5

Tear strength without knots, kg 1.63 1.63 (straight pull)

True tensile strength without knots _{or the like}

(Intrinsic Straight Pull), kg / cur 5575 5720 Knot strength, kg · ■ 1.27 1.04 True knot strength wedge
(Intrinsic knot pull)

True knot strength, kg / cm ² 4338 367Ο

The values in Table III show that the coated nylon wrapped suture has a knot strength equal to is about 78 # of the straight (knot-free) tensile strength. In contrast, the knot strength of a braided suture is about $ 64 that of the straight (knot-free) Tensile strenght.

309813/0912

Example IV Wrapped nylon seam material

A 1/0 size wound nylon suture is made using a core made up of three light-colored Nylon yarns of high tensile strength, titer 260 denier each, 17 filaments each, type 38O, with 39 twists / m (Z-direction) exists (manufacturer E.I. du Pont de Nemours ft Company). The three core yarns are twisted with 236 twists / m in the Z-direction twisted together. The bobbin 20 of the winding milling machine is made with a single nylon thread of 70 denier, 3 ^ filaments, 20 'turns / m in S-direction, type 38O, wound. Of the Flyer (E20) is loaded with 5 weights (50 g). The coil and the spindle are rotated at 10,000 rpm while the Core yarn is taken up by the haul-off disk at a linear rate such that a suture is wrapped is obtained whose wrapping yarn has 1772 turns / m in the Z direction.

The wrapped suture is then coated by passing it through a solution of 17 * 3 parts of nylon 6 (manufactured by Allied Chemical Company Plastics Division, Morristown, NJ, trade name PLASKON 8202) in 82.7 parts of trifluoroethanol at room temperature. Upon exit from the coating solution, the suture through a StahldUse (u input 762 diameter, 457 M Auegang diameter) is guided. It then runs under tension through a 1.22 m long vertical drying tube. The approximate residence time in the drying tube is 11 seconds, the temperature at the bottom of the tube about 75 ^° C. and the temperature at the top of the tube about 130 ^° C. The weight of the coating resin applied in this stage is $ 11.2 of the weight of the wrapped one Sutures before coating. The finished suture is wound up in the manner described in Example 1 and sterilized. The physical properties of the sterile, wrapped suture are compared to those of a braided suture of the same size in Table IV.

309813/0912

Table IV

Physical Properties Coiled Black Ge

Nylon yarn braided nylon size 1/0 yarn, size 1/0

Diameter, / U 351 386

Tear strength without knots, kg 4.99 5.22 True tensile strength without

Node (intrinsic straight

Pull), kg / cm ² 5168 4450

Khoten firmness, kg 4.17 3.36

True knot strength
(Intrinsic knot pull)

True knot strength, kg / cm ² 4324 2880

The values in Table IV show that the coated nylon wrapped suture has a knot strength equal to is about $ 83 knotless tensile strength. In contrast, braided nylon sutures have one Knot strength of about $ 65 of the knot-free tensile strength. The setting properties of this suture can be improved by adding a coating of tetrafluoroethylene is applied as in U.S. Patent 3,527,650 described.

Example 5

Wrapped suture material made of L (-) - lactide and glycolide in a ratio of 65 1 35, size 2/0.

A resorbable, wound suture of size 2/0 is made from a copolymer of 65 mol- # L (-) - lactide, 35 moles- # glycolide using the methods shown in Figures 1-3 apparatus shown. The preparation of the copolymer of 65 mol- #.!, (-) - lactide and 35 mol- # Glycolide, which is useful in the experiment described herein, is shown in Example XVIII of U.S. Patent Application Serial No. 36 797 (May 13, 1970). The suture is made using a core consisting of 9 yarns from this copolymer (66 den, 34 filaments, 236 turns / m) that have been ply twisted free.

303813/0912

A single 34-ply 66 denier yarn is used for wrapping, the same as that described above Copolymer and has 1417 turns / m.

The Flyer (E12) is loaded with three 5 g weights (total weight 15 g). The wrapping machine comes with a Speed of 8500 rpm operated, the core yarn helically is wrapped with 1575 turns / m (Z-direction).

The wound suture is coated by passing it through a bath consisting of a solution of 10 parts of poly-DL-lactide (homopolymer) in 90 parts of toluene. It is dried by passing it through a 2.74 m long horizontal drying tube. The approximate residence time of the suture in this tube is 40 seconds. During this time, it is dried at room temperature using countercurrent air. The weight of the coating resin applied at this stage is $ 9.03 the weight of the wrapped suture prior to coating. The finished suture is wound in the manner described in Example 1 onto a drum, annealed for 3 days at 65 ⁰ C and sterilized. The physical properties of the obtained sterile entwined suture which are compared with a braided ^w ahtmaterials the same size and composition in Table V.

Table V

Physical Properties

Coated Braided Wrapped Sutures Sutures Size 2/0 Size 2/0

Diameter, ix Tear Strength Without Knots, kg True Tensile Strength} Without Knots, kg / cm ^

Knot Strength, kg True Knot Strength, kg / cm (Intrinsic Knot Pull)

310 330 ?, 13 4.04 2826 47IO 1.5 2.17 1980 2540

3 0 9 8 13/0912

The values in Table V show that the wrapped suture has a knot strength that is about "J0% of its straight (knot-free) tensile strength. In contrast, the braided suture has a knot strength of only about 3/4 % of its straight tensile strength.

Example VI Wrapped suture made of polyglycolide, size 2/0.

In the manner described in Example 5, an absorbable Suture material of size 2/0 is produced, but with a filament yarn as the core yarn and wraparound yarn from a glycolide homopolymer is used. The wrapped Suture material is coated by passing it through a solution of 10 parts of DL-lactide homopolymer in 90 parts Toluene is performed. It is dried, tempered and sterilized in the manner described in Example 5. The finished suture has excellent flexibility and knot strength.

The products according to the invention are advantageous surgical sutures. To improve their setting properties they can optionally be treated with lubricants or coated with other resins, as in U.S. Patent 3,527,650. Naturally can with the wound sutures, their core and umwlndungsgarn from a resorbable polymer or copolymer of L (-) - LaetiJi or glycolide, the proportions of L {-) - lactide and glycolide im Polymer are changed so that the desired absorption properties are achieved in vivo. the Speed of absorption and the retention of tensile strength of these absorbable wrapped sutures can also be done by changing the composition of the copolymer of the binder resin that forms the outer wrapping connects with itself and the central core.

309,813 / 0912

Claims (9)

Claims 1. Sterile, non-absorbable surgical suture material, consisting of a filament yarn as the inner core and a helically wound outer filament cover yarn, with the abutting edges of the outer filament yarn are connected to each other and to the central core yarn with a binder. 2. Suture material according to claim 1, characterized in that the core yarn and the wrapping yarn are the same Have composition. 3. suture material according to claim 1 and 2, characterized in that, that the core yarn and the wrapping yarn are made of nylon. 4. Suture material according to claim 1 and 2, characterized in that the core yarn and the wrapping yarn from one Are made of polyester. 5. Suture material according to claim 1 and 2, characterized in that the core yarn and the wrapping yarn are filament yarns are made of a polyglycolide. 6. suture material according to claim 1 and 2, characterized in that the core yarn and the wrapping yarn from one Polymer of L (-) - lactide consist. 7 suture material according to claim 1 and 2, characterized in that that the core yarn and the wrapping yarn are filament yarns made from a copolymer of 65 mol- # L (-) - lactide and 55 moles # are glycolide. 8. Suture material according to claim 7, characterized in that it contains a polyester as a binder. 9. suture according to claim 1 to 8, characterized in that its knot strength is at least 75 # of the straight (knot-free) tensile strength of the suture material. 309813/0912 Blank page