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Publication numberUS3187752 A
Publication typeGrant
Publication dateJun 8, 1965
Filing dateApr 27, 1962
Priority dateApr 27, 1962
Publication numberUS 3187752 A, US 3187752A, US-A-3187752, US3187752 A, US3187752A
InventorsGlick Arthur
Original AssigneeAmerican Cyanamid Co
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Non-absorbable silicone coated sutures and method of making
US 3187752 A
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Description  (OCR text may contain errors)

June 8, 1965 A. GLICK 3,187,752

NON-ABSORBABLE SILICONE COATED SUTURES AND METHOD OF MAKING Filed April 27, 1962 j z INVEI qTOR.

ARTHUR GL ICK BY M Wmm United States Patent 0 3,187,752 NUN-ABSORBABLE SILICGNE COATED SUTURES AND METHGD 0F MAKDIG Arthur Gliclr, Danbury, Count, assignor to American 1(Iqyanamid Company, Stamford, Conn., a corporation of ame Filed Apr. 27, 1962, Ser. No. 199,604 26 Claims. (Cl. 128--335.5)

This application is a continuation-in-part of application Serial Number 767,502, filed October 16, 1958 and now abandoned.

This invention relates to a non-absorbable densely constructed suture built up of a plurality of filaments 113V, ing a serum-proof, moisture-resistant coating on the surface of the individual filaments, which coating contains a silicone resin.

As used in this specification the term suture is intended to include both sutures, as are used for the sewing of tissues, and ligatures as used for tying off blood vessels, etc. Different portions of one strand may be used for both purposes in the same operation depending upon the needs of the surgeon at the particular moment.

In surgical practice; and for present purposes, this includes both human and animal surgery, two classes of sutures are commonly used. One is the absorbable suture which is absorbed by the tissues and accordingly loses its identity, such sutures usually being of catgut, etc.; and the other form is a non-absorbable suture which in most instances is permitted to remain as such pen strong and should maintain their strength and integrity for prolonged periods while in contact with body tissues and fluids. It is desirable that such sutures be inert, causing a minimum of tissue irritation, and that the diffusion of fluids through the suture by capillarity be at a minimum. 1

It has been customary to use silk sutures built up as by braiding, Weaving, twisting or spinning, hereafter called coordinate configuration, of from a plurality of individual silk filaments. Synthetic polymers may be used instead of natural silk. These filaments present a construction in which there are fine interstices which by capillary action cause fluids to travel along the length of the suture. This may permit migration of pathogenic organisms.

Accordingly, such sutures have been coated with waxes, such as beeswax, or beeswax mixed with ethyl cellulose, which material reduces the capillarity of the suture and improves the handling characteristics of the suture.

There is some evidence that under some conditions these waxes cause granuloma formation, and have other undesirable side ellects.

Additionally the coating material should be inert to all body fluids and heat stable to permit heat sterilization of the suture. It is desirable that the coating be economical and readily applied.

In addition to the physiological properties of inertness the characteristics of handling and of strength of a suture are extremely important. It is desirable that a suture be sufiiciently still that it can be easily handled and yet readily formable to a new position. After being bent to a new position, it should maintain this new set position. Many fibrous materials have a plastic memory, and after being bent to a new position slowly on standing tend to go back to their former shape. A suture should not have plastic memory but should when once set maintain that new position.

Additionally the suture should be easy to tie in a knot and should be resistant to knot-slippage under strain and the knot should remain secure and not slip or untie itself on standing. Additionally, a suture should have what is known as throwability. That is, the surgeon should be able to pick up the suture and throw it to a new position, which position is then retained. It is desirable at' times to place a suture in a given location or throw it in a given direction with the knowledge that the suture will stay there until-positively moved.

In the past a great deal of the handling characteristics have been imparted to a limp suture by the coating material. Beeswax or beeswax mixed with ethyl cellulose used as a coating is responsible for the desirable handling characteristics.

If some other coating material is used with the same filament construction, the sutures may not have satisfactory handling characteristics.

it has now been found that by braiding a suture with a tighter and more dense construction using fewer picks, i.e. cross-overs per inch, and by dry stretching the braided filaments, a suture can be formed which has inherently stiffer qualities and improved handleability.

Silk is the usual material used for non-absorbable sutures. Synthetic filaments such as nylon, polypropylene, Or-lon, polyacrylonitrile, Dacron, a stretched oriented polyester of ethylene glycol and terephthalic acid, etc., or cotton, or linen are sometimes used. Occasionally such materials as stainless steel or horsehair are used. All such materials can be advantageously coated with polymeric silicones, in accordance with this invention, and are braided or spun or formed more tightly for coating with silicones than with conventional coating materials.

Polymeric silicones are applied to this denser suture; such polymeric silicones readily coat the individual filaments increasing the resistance to aqueous fluids thus a reducing capillarity. Furthermore, such silicones applied'as a coating are heat stable. In at least some instances the coating may be applied in a partially polymerized state and the silicone further polymerized in position on the suture. Fortunately and fortuitously, polymerization catalysts are decomposed by heat sterilization procedures or heat curing so that even if toxic catalysts are used as a component of the silicone coating, the final product is completely inert.

The particular silicone resins themselves are not a part of this invention and standard commercial resins may be used. It is not necessary that the material be applied as a liquid, as some of these silicone resin forming materials, such as the General Electric Drifilrns, are volatile and may be applied in the gaseousphase. These materials are among the volatile silicone compounds such as alkyl silicone halides. A material such as dimethyl silicone dichloride is comparatively volatile and may be applied either direct or by allowing an ethereal solution thereof to evaporate and the vapors contact the suture material.

Frequently, it is more convenient to use a liquid preparation. Such preparations are solvent dispersions of silicone resins, that is partially olymerized products which will polymerize to a silicone film. For purposes of convenience it is normally easier to purchase the material under trade-names rather than making it, or obtain it to a performance specification. Materials which are sold commercially such as the Dow-Corning silicone DC DC 804 or General Electrics 9980 give highly satisfactory and useful films. To those skilled in the art of silicone compounding it is comparatively simple to select a heat-curable or potentially heat-curable silicone resin, which either from its inherentcharacteristics, or

s eaves :3 the addition of a polymerizing catalyst, will set up or cure. As a final check to insure the complete removal oi all halide to silicone linkages, ammonia fumes may be used. Usually sufiicient moisture is present to insure the hydrolysis of the halogen, but ammonia fumes insure a neutral product. I desired, silicone containing resins may be used in which the silicone atoms are linked through nitrogen, from ammonia, rather than through oxygen as in the silicones, such resins at times being referred to as silamines.

Methods for preparation of silicone resins are well known. Patent No. 2,306,222 to W. I. Patnode, Method of Rendering Materials Water Repellant, discloses the use of a vapor of an alkyl silicone halide for making glass vapor-proof. The same types of materials as therein described may be used to water-proof and treat sutures. The patent to Safford, No. 2,424,853, and the patent to Tanis, No. 2,408,822, additionally describe siliceous halides and their conversion to resins. There are several methods of preparing such silicone resins, among others are the reaction of Grignard type reagents with a silicone tetrahalide. From the standpoint of costs silicone tetrachloride is normally used and the Grignard may be either alkyl or aryl or a mixture thereof. The amounts of alkyl and aryl groups used affect the brittleness and rate of cure of the resin formed. Normally the product of the reaction of the Grignard reagent with silicone tetrachloride is allowed to react with moisture, allowed to partially polymerize, and the partially polymerized materials are dissolved in a suitable solvent whereby additional polymerization is either inhibi ed or substantially slowed down; The higher the ratio of lower alkyls, the more rapid the materials will cure and the more brittle will be the film. The more highly branched the chains formed in the resin, which are necessarily formed by the polymerization of the silicone types containing more halide atoms per silicone molecule, the more brittle and polymerized are the resins.

The organo-silicones sometimes referred to as organopolysiloxanes, more particularly the hydrocarbon substituted polysiloxanes are particularly suitable for suture coating. The patent to Wright et al., No. 2,389,477, entitled Polysiloxane Resins gives considerable information'or" this type of resin. Certain of the resins which are described in the patent to Hyde, No. 2,386,466, Insulated Conductor and Insulation Therefor, it diluted with body fluids. in neural surgery, suture materials frequently deleteriouslyaifect regeneration of nerve fibers. Silicone coated silk is the first material known to have been successfully used in suturing nerve fibers which permits the regeneration of the nerves in the spinal column.

Usually silk is braided loose enough for a beeswax coating to impregnate the silk, reduce capillarity, and impart desirable handling qualities. The new silicone coating may not inherently have enough body to give the desired handling qualities. Rather than use a more highly polymrized' silicone resin, which is stiller, it is preferred to use a denser silk construction, with more silk filaments in a given cross-section. This gives a greater strength, and a thinner silicone coating gives a proper inertness to the suture and at the same time prevents capillarity.

One standard test for capillarity is to boil two 3 to 4 inch lengths of the suture in distilled water in a glass container for three successive 20-minute periods, changing the water each time. After the third boiling, the test sutures are allowed to stand for at least 8 hours in an atmosphere having a relative humidity of 65% 12% at a temperature of 2lil C. The segment of suture is tied to a piece of white silk thread with a square knot, the ends cut close, and suspended by the white silk thread so that the suture dips into a 0.5% aqueous solution of methylene blue, with the knot %-inch above the dye solution. After standing for 24 hours, the white silk is inspected for evidence of dye carried up the suture by capillary action. It the white silk is free from dye color, the suture is non-capillary, and passes the test. Both of the duplicate samples should pass.

Sutures of this invention pass this test for capillarity. Sutures which pass this test'are non-capillary in tissues of man and animals.

For preventing slippage at knots in the suture, a coating forming ahardened, but flexible silicone film ispreferred, using a silicone having a higher ratio of with a solvent may be used in accordance with the instant invention. The patent to Hyde, No. 2,371,050, Organo- Silicone Polymers and Method of Making Them, de-

scribes certain additional methods of preparing such resins. It is not necessary that the resins be prepared from halogen containing compounds as, for example, methods such as set forth by Strain et al. in Patent No. 2,394,642, Silicic Acid Esters, describes a difierent form of silicone containing resin. The patent to Iler, No. 2,395,550, Modified Alkyd Resins, describes still further modifications of silicone containing resins in which the silicone linkages are different than those classified as organo-polysiloxanes.

It is not intended that a treatise be here included on the production of such resins, as such resins are the invention of others and are adequately described in the patent literature, as well aselsewhere. The texts Introduction to the Chemistry of the Silicones, Eugene G.

,closes some of the silicones which may be used, and other medical usages for such silicones.

The silicone acts as a protectivc'layer on the surface of the filaments, and prevents dyes or the surface characteristics of the filaments, suchas silk, from interacting aryl groups. For instance, a polysiloxane having from about 72% to 67% methyl substituents and from 28% to 33% phenyl groups cures to a non-slipping finish that gives excellent knot retention. Usually the suture breaks before the knot slips. Also such polysiloxanes are sufficiently adhesive that spun sutures of silk or other filaments do not unravel, or broom, and can bethreaded into needles. 7

The silk construction itself rather than the coating can beused to give the handling qualities.

Whereas the number of ends, and total denier, varies with size, it is desirable that a maximum size, and

strength be obtained within the overall limits of suture diameter. For the standard United States Pharmacopeia sizes (United States Pharmacopeia Convention, Inc., Distributed by Mack Publishing Co., Easton, Penn., elsewhere abbreviated U.S.P.) this is:

U.S.P. Picks per Denier U.S.P. size diameter, inch of raw inches, max. silk used The picks per inch are the number of threads, running in one direction, per lineal inch of suture.

The silk is braided using a smaller number of picks than conventional, and with a larger core size. The braided'silk is washedto degurn, then dyed, if desired, in skeins in accordance with conventional practice. The silk is dried, and then dry stretched from. about 6% to about 11% of its length. This stretching tightens the braid, and gives a more dense, more handleable silk. At least some of the stretching may be accomplished while the silk is wet.

The raw silk used has a total of about 378 denier.

white felt.

After stretching the silk suture ,is passed through a solvent bath containing the polymeric silicone. Such solvents as xylene, toluene, benzene, gasoline, or other non-toxic volatile hydrocarbon solvents may be used. In addition to the silicone, beeswax, ethyl cellulose or a low molecular weight polyethylene may be dissolved and used as part of the coating. For the silicone rubbers, a catalyst is usually used to accelerate the curing rate. The standard organic peroxides, of which benzoyl peroxide is the most frequently used, are suitable catalysts, 2% to by weight of the polymer gives good results. The heat which sets the resin decomposes residual peroxides to give non-toxic products. For the hardened, flexible films, having a higher percentage of phenyl groups, heat alone can cure the silicone. Organo metallic driers such as zinc octoate, or iron stearate accelerates the cure. Nontoxic salts of metals with fatty acids are effective.

A 2% to 50% solids bath gives a satisfactory coating.

A 5% to solids concentration in the bath results in easier operating control. A 20% concentration is usually preferred. While an adequate pick up with a single coating bath is obtainable, more uniform distribution and coating can be obtained by using two or more baths, with heat curing between coatings. A cure temperature of at least 150 C. for 30 seconds gives a cure, al-

though longer times at lower temperatures, or a longer cure with less catalysts, etc. in accordance with standard practice in the silicone art may be used.

A total weight of coat of 2% to 20% by Weight of the fiber gives good characteristics. This percentage is called the pick up.

The sutures are shown in the attached drawings:

FIGURE 1 is a cross-section of a silicone coated suture.

FIGURE 2 shows a portion of an eight carrier on a 16 capacity carrier braider formed braid.

FIGURE 3 shows a portion of a sixteen carrier braid.

EXAMPLE 1 A silk suture is braided, using 8 carriers,'on a sixteen carrier braider, with 3 ends of 13 to 15 denier silk per carrier, and a core of 3 ends of 13 to 15 denier silk, and picks per inch, giving the skipped braid of FIGURE 2. (The denier is the weight in grams of 9000 meters of the strand.) The braided suture is washed to degum, then dried, while looped in skeins. The dry silk is stretched 9% of its length, which gives improved stifiness; and increases the density.

A silicone rubber sold as Silastic 9711 by Dow- Corning is milled into sheets of about /s-inch thick, and thereto while milling additionally is added 8.46% by weight of the rubberof a silicone fluid containing by weight benzoyl peroxide (Luperco ASF). After milling for an additional 5 minutes, the sheets are cut into small pieces and soaked overnight in xylene. The swollen silicone is stirred to a cream-like consistency, then diluted to 20% solids, and stirred until uniform.

The braided silk is immersed in a trough of the silicone solution at room temperature, then wiped over a piece of The coated silk is passed through a three stage heating tunnel, so that the silk is heated for one minute each at 100 C., 125 C., and 150 C. The silk is spooled after air cooling.

This coating procedure is repeated. In the double c'oa'ting, the'silk is found to have picked up 15% by weight of the silicone coating.

The finished suture gauges 0.0077 inch in diameter and is a 4-0 suture.

A conventional braiding of a 4-0 suture gives about 60 to 70 picks per inch, and uses 8 carriers with 2 ends of 20-22 denier each, and no core.- Such a silk suture has a total denier of about 336, and if coated with bees wax in accordance with conventional practice gauges .0083 inch.

length as to heat the silk suture for two minutes.

Other characteristics for comparison are:

Silk Silk With With New Old Silicone Beeswax Picks per i nch 40 60 Gauge:

Raw int-he 0076 0081 sterilized d0 0077 0083 Straight pull sterilized pounds 3. 17 2. 68 Knot pull sterilized do 2. 04 1.80 Pliaoility to bend, raw mgs 117 102 Stifinessinches self support Horizontal (sterile) inches 2. 94 4. 75 Vertical (sterile) do 4. 00 5.13 Apparent density as braided gms./cc- 1.127 0.927

The increase in strength after sterilization both straight and over a knot shows the new silicone construction to have marked advantages. 7

The suture is sterilized either by conventional autoclaving procedures, or by ethylene oxide gas, in accordance with commercial practice in the industry.

The individual silk filaments of the braid are shown at 10, the filaments of the core are shown at 11, and the suture has a silicone coating 12. FIGURE 2 shows the construction of a 000 suture, otherwise the same as above.

EXAMPLE 2 The coating of the suture of Example 1 is repeated using a 15% solids solution of a dimethy silicone polymer of the general formula (CH SiO) with 5% by weight of the polymer of benzoyl peroxide as catalyst. After two coatings, a readily handleable suture is obtained.

EXAMPLE 3 A multi-filament 4-0 sized silk suture braided as in Example 1 is washed and dyed black in accordance with conventional procedures. The suture is then dry stretched. An alkyl polysiloxane sold by General Electric as Drifilm 88 is diluted with toluene to form a 10% silicone solids solution. The silk suture is immersed in the toluene solution of the silicone resin at 50 C., then drawn through a curing tunnel at a temperature of C., and of such The suture may be heated longer, so as to sterilize thesuture at this time after which it is sterilely packed and handled until used by the surgeon; or after the two-minute heating, the suture may be reeled and packaged using clean but not sterile techniques and finally sterilized by dry heat after packaging and prior to sale, or just prior to use by the surgeon.

EXAMPLE 4 the coated silk is heated to 130 C. for three minutes. i

The silk suture may be sterilized by heating, as desired, but before use. About 12% by weight of the silk of the silicone remains in the coating.

EXAMPLE 5 The silicone rubber sold as Dow-Corning Silastic 9711 is milled with 4.2% of benzoyl peroxide for five minutes, out into small pieces, covered with xylene, and soaked overnight. The swollen material is stirred with additional xylene to obtain a 20% solids concentration.

Braided silk prepared as described in Example 1 is passed through the silicone in xylene, wiped with a piece of white felt, then cured for one minute each at temperatures of 100 C., 125 C., and 150 C. The silk picks up about A multi-filament size 3-0 braided polyester suturewas .coated in two passes with a silicone rubber bath containing 17% silicone solids dispersed in xylene. The coating and curing procedure was as described in Example 5. The suture picked up 2.9% by weight of silicone solids. The polyester suture iwas non-capillary.

EXAMPLE 7 A multi-filament 241 silk suture was braided using 16 carriers each containing 3 end denier silk; a core of 14 ends 20-22 denier silk; a pick count of and a total denier of 966. The construction is of the type shown in FIGURE 3. The braided suture was coated with a methyl phenyl polysiloxane which contains about 72% methyl groups and 28% phenyl groups. The coating bath con tained 35% silicone solids in xylol. The excess coating was wiped off with apiece of sponge rubber and the coating was cured for one minute each at temperatures of 100-C., 125 C., and 150 C. The silk picked up 7% by weight of silicone solids for one coat. A second coat under the same conditions yielded a total pick up of 12%. The silk at both coating levels Wasnon-capillary, had good bond and showed good resistance to brooming. Surgeons knots tied in the silk broke before slipping.

EXAMPLE 8 A multi-filament spun, or twisted, 3-0 silk suture was coated with a methyl-phenyl polysiloxane, processed and cured as in Example 7. The spun and twisted silk had a silicone pick up that ranged from 7% for a single coat to 12% for a double coat. The silk did not broom or bush and the filaments were bonded together, so that a needle could be readily threaded.

EXAMPLE 9 A multi-filament size 3-0 braided nylon suture was coated in two passes in a silicone rubber bath containing 17% silicone solids dispersed in xylene. and curing procedure was that described in Example 5. The nylon suture picked up 4.5% by weight of silicone solids and was non-capillary. Good results were obtained when used in surgery.

EXAMPLE 10 A multi-filament braided 3-0 suture was coated with a bath containing 30% solids of a silicone resin commercially sold as Dow-Corning 804. This resin is a comparatively short chain silicone resin containing both phenyl and methyl substitutents on the silicone atoms. Added to this bath was a plasticizer amounting to 20% of the weight of the silicone solids. The silk was immersed in this bath, the excess silicone wiped off with sponge rubber and the silicone was cured in a tunnel for one minute each at temperatures of 100 C., 125 C., and 150 C. The silk for a single coat had a silicone pick up of 7% of the weight of the silk. Silk with two coats had a pick up of 12% silicone resin- Silk coated in this resin bath and the added plasticizer had good hand, was'non-capillary and did not broom; Plasticizers' used' were alkyl aryl phosphates, phthalates, sebacates, citrates, epoxies and. polymeric dimethyl siloxanes;

The coating The polysiloxanes containing larger proportions of.

aryl groups require larger amountsof plasticizers. The

pick up can be readily varied by the pressure on the wipers. A slower. cure at a lower temperature gives a good coating. A more rapid cure is generally preferred, as the cure most conveniently takes place in a tunnel, and if a slower cure is used the tunnel must be longer for a given production rate and hence. is more expensive.

I claim:

1. A surgical suture comprising a plurality of individual silk filaments, the external silk filaments being in braided configuration, having a tight braid, with high density, having approximately the following construction: U.S.P. size 6-0; picks per inch 40; denier of raw silk used 112; and a coating on each silk filament of a non-toxic physiologically inert polymeric silicone, said silicone being present in an amount at least sufficient to impart noncapillarity and not more than 20% of the weight of the uncoated filaments.

2. A surgical suture comprising a plurality of individual silk filaments, the external silk filaments being in braided configuration, having a tight braid, with high density, having approximately the following construction: U.S.P. size 5-0; picks per inch 40; denier of raw silk used 252; and a coating on each silk filament of a non-toxic physiologically inert polymeric silicone, said silicone being present in an amount at least sufiicient to impart noncapillarity and not more than 20% of the weight of the uncoated filaments.

3. A surgical suture comprising a plurality of individual silk filaments, the external silk filaments being in braided configuration, having a tight braid, with high density, havingapproximately the following construction: U.S.P. size 4-0; picks per inch 40; denier of raw silk used 378; and a coating on each silk filament of a non-toxic physiologically inert polymeric silicone, said silicone being present in an amount at least sufiicient to impart noncapillary and not more than 20% of the weight of the uncoated filaments.

4. A surgical suture comprising a plurality of individual silk filaments, the external silk filaments being in braided configuration, having a tight braid, with high density, having approximately the following construction: U.S.P. size 3-0; picks per inch 40; denier. of. raw silk used 630; and a coating on each silk filament of a non-toxic physiologically inert polymeric silicone, said silicone being present in an amount at least sufiicient to impart noncapillarity and not more than 20% of the weight of the uncoated filaments.

5. A surgical suture comprising a plurality of individual silk filaments, the external silk filaments being in braided configuration, having a tight braid, with high density, having approximately the following construction: U.S.P. size 00; picks per inch 50; denier of raw silk used 966; and a coating on each silk filament of a non-toxic physiologically inert polymeric silicone, said silicone being present in an amount at least suificient to impart noncapillarity and not more than 20% of the weight of the uncoated filaments.

6. A surgical suture comprising a plurality of individual silk filaments, the external silk filaments being in braided configuration, having ;a tight braid, with high density, having approximately the following construction: U.S.P. size 0; picks per inch 50; denier of raw silk used 1560; and a coating on each silk filament of a non-toxic physiologically inert polymeric silicone, said silicone being present in an amount at least sufiicient to impart noncapillarity and not more than 20% of the Weight of the uncoated filaments.

7. The method of making surgical sutures comprising braiding a plurality of filaments of silk into a hard dense core, washing the gum from the braided silk, drying the braided silk, dry stretching the braided silk about 6. to 11% of its length, immersing the braided silk in a xylene solution of a polymerizable silicone, wiping the braided silk suture, whereby there is a silicone pick up of about to by weight, and drying and polymerizing said silicone.

8. The method of making surgical Sutures comprising braiding a plurality of filaments of silk into a hard dense core, washing the gum from the braided silk, drying the braided silk, dry stretching the braided silk about 6 to 11% of its length, immersing the braided silk in a solution of a polymerizable silicone rubber containing a catalyst, wiping the braided silk suture, whereby there is a silicone pick up of about 10% to 20% by weight, and drying and polymerizing said silicone by heat, of at least about 150 C. for at least about seconds, thereby also decomposing the catalyst.

9. The method of making surgical sutures comprising braiding a plurality of filaments of silk into a hard dense core, washing the gum from the braided silk, drying the braided silk, dry stretching the braided silk about 6 to 11% of its length, immersing the braided silk in nontoxic volatile hydrocarbon solvent solution of a polymerizable silicone rubber containing a catalyst, wiping the braided silk suture, drying and polymerizing said silicone, re-immersing in said solution, re-wiping the suture, whereby there is a total silicone pick up of about 10% to 20% by weight, and drying and polymerizing said silicone by heat, of at least about 150 C. for at least about 30 seconds, thereby also decomposing the catalyst.

10. A surgical suture comprising a plurality of individual silk filaments, the external silk filaments being in braided configuration, having a tight braid, with high density, having approximately the following construction: U.S.P. size 6-0; picks per inch denier of raw silk used 112; and a coating on each silk filament of a nontoxic physiologically inert polymeric silicone, said coating Weighing from 10% to 20% of the weight of the silk filaments.

11. A surgical suture comprising a plurality of individual silk filaments, the external silk filaments being in braided configuration, having a tight braid, with high density, having approximately the following construction: U.S.P. size 5-0; picks per inch 40; denier of raw silk used 252; and a coating on each silk filament of a nontoxic physiologically inert polymeric silicone, said coating weighing from 10% to 20% of the weight of the silk filaments.

12. A surgical suture comprising a plurality of individual silk filaments, the external silk filaments being in braided configuration, having a tight braid, with high density, having approximately the following construction: U.S.P. size 4-0; picks per inch 40; denier of raw silk used 378; and a coating on each silk filament of a nontoxic physiologically inert polymeric silicone, said coating weighing from 10% to 20% of the weight of the silk filaments.

13. A surgical suture comprising a plurality of individual silk filaments, the external silk filaments being in braided configuration, having a tight braid, with high density, having approximately the following construction: U.S.P. size 3-0; picks per inch 40; denier of raw silk used 630; and a coating on each silk filament of a nontoxic physiologically inert polymeric silicone, said coating weighing from 10% to 20% of the weight of the silk filaments.

14. A surgical suture comprising a plurality of individual silk filaments, the external silk filaments being in braided configuration, having a tight braid, with high density, having approximately the following construction: U.S.P. size 00; picks per inch denier of raw silk used 966; and a coating on each silk filament of a nontoxic physiologically inert polymeric silicone, said coating weighing from 10% to 20% of the weight of the silk filaments.

15. A surgical suture comprising a plurality of individual silk filaments, the external silk filaments being in braided configuration, having a tight braid, with high density, having approximately the following construction:

10 U.S.P. size 0; picks per inch 50; denier of raw silk used 1560; and a coating on each silk filament of a non-toxic physiologically inert polymeric silicone, said coating weighing from 10% to 20% of the weight of the silk filaments. V

16. A surgical suture comprising a plurality of individual filaments in coordinate configuration, the filaments being bonded together to hold the filaments in a unitary strand, and hence non-brooming, having a coating on each filament of a non-toxic, physiologically inert, polymeric silicone, whereby the suture is non-capillary and is inert towards livingtissue, the Weight of said silicone being from 10% to 20% of the weight of the uncoated filaments.

17. A surgical suture comprising a plurality of individual filaments selected from the group consisting of silk, nylon, polypropylene and stretched oriented polyester, the external filaments being in braided configuration, having a tight braid, and low pick count, with high density, thereby imparting surgically handleable char acteristics to the uncoated suture, and a coating on each filament of a non-toxic physiologically inert polymeric silicone, whereby the suture is non-capillary and is inert towards living tissue, the weight of said silicone being from 10% to 20% of the weight of the uncoated filaments.

18. A surgical suture comprising a plurality of individual silk filaments, the external silk filaments being in braided configuration, having a tight braid, and low pick count, with high density, thereby imparting surgically handleable characteristics to the uncoated suture, and a coating on each silk filament of a non-toxic physiologically inert polymeric silicone, whereby the suture is noncapillary and is inert towards living tissue, the weight of said silicone being from 10 %to 20% of the weight of the uncoated filaments.

19. A surgical suture comprising a plurality of individual silk filaments in coordinate configuration, each filament having thereon a coating of a polymethyl-polyphenyl siloxane, at least the final polymerization being in situ, the weight of said silicone being from 10% to 20% of the Weight of the uncoated filaments, whereby the suture is non-capillary and is inert towards living tissue, and the siloxane coating causes the filaments to adhere to each other, and thereby be free from brooming, and which suture, when tied in a surgeons knot, breaks rather than slips, on pulling in tension.

20. The method of making surgical sutures comprising braiding a plurality of filaments of silk into a hard dense core, washing the gum from the braided silik, drying the braided silk, dry stretching the braided silk about 6 to 11% of its length, immersing the braided silk in a xlyene solution of a polymeriza-ble silicone, wiping the braided silk suture, whereby there is a silicone pick up of an amount sufi'icient to render the finished suture non-capillary and not more than 20% of the weight of the uncoated -filaments,.and drying and polymerizing said silicone.

21. The method of making surgical sutures comprising braiding a plurality of filaments of silk into a hard dense core, washing the gum from the braided silk, drying the braided silk, dry stretching the braided silk about 6 to 11% of its length, immersing the braided silk in a solution of a polymerizable silicone rubber containing a catalyst, wiping the braided silk suture, whereby there is a silicone pick up of an amount sufiicient to render the finished suture non-capillary and not more than 20% of the weight of the uncoated filaments, and drying and polymerizing said silicone by heat, of at least about C. for at least about 30 seconds, thereby also decomposing the catalyst.

22. The method of making surgical sutures comprising braiding a plurality of filaments of silk into a hard dense core, washing the gum from the braided silk, drying the braided silk, dry stretching the braided silk about 6 to 11% of its length, immersing the braided silk in non-toxic sues #52 l. volatile hydrocarbon solvent solution ofa polymerizable silicone rubber containing a catalyst, Wiping the braided silk suture, drying and polymerizing said silicone, reimmersing in said solution, re-wiping the suture, whereby there is a total silicone pick up of an amount sufficient silicone, said silicone being present in an amount at least sufiicient to impart non-capillarity and not more than 20% of the Weight of the uncoated filaments, and the suture is inert towards living tissue.

24. A surgical suture comprising a plurality of individual filaments selected from the group consisting of silk,

nylon, polypropylene and stretched oriented polyester,

the external filaments being in braided configuration, having a tight braid, and low pick count, with high density, thereby imparting surgically handlea-ble characteristics to the uncoated suture, and a coating on each filament of a non-toxic physiologically inert polymeric silicone, said silicone being present in an amount at least sufiicient to impart non-capillarity and not more than 20% of the weight of the uncoat-e filaments, and the suture is inert towards living tissue.

25. A surgical suture comprising a plurality of individual silk filaments, the external silk filaments being in braided configuration, having a tight braid, and low pick count, with high density, thereby imparting surgically handleable characteristics to the uncoated suture,.and a coating on each silk filament of a non-toxic physiologically inert polymeric silicone, said silicone being present in.

an amount at least suificient to impart non-capillarity and not more than 20% of the weight of the uncoated filaments, and the suture is inert towards living tissue.

26. A surgical suture comprising a plurality of individual silk filaments in coordinate configuration, each filament havingthereon a coating of a polymethyl-polyphenyl siloxane, at least the final polymerization being in situ, the weight of said silicone being an amount sufficient to render the finished suture non-capillary and not more than 20% of the weight ofthe uncoated filaments, and said suture is inert towards living tissue, and the siloxane coating causes the filaments to adhere to each other, and thereby be free from brooming, and which suture when when tied in a surgeons knot, breaks rather than slips, on pulling in tention.

References Cited by the Examiner UNITED STATES PATENTS 2,193,188 3/40 Bradley 128-6355 2,588,365 3/52 Dennett.

2,698,817 1/55 G'uenther 28--80 2,734,506 2/56 Nichols et al. l28-335.5 2,737,075 3/ 56 Poirier et al 872 3,035,476 5/62 Fogden 87-9 V FOREIGN PATENTS 876,208 8/61 Great Britain. 1,110,824 7/61 Germany.

RlCHARD A. GAUDET, Primary Examiner. JORDAN FRANKLIN, Examiner.

Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US2193188 *Jun 16, 1938Mar 12, 1940American Cyanamid CoNoncapillary silk suture and method of preparing the same
US2583365 *Jan 19, 1948Jan 22, 1952Eddy Floyd LDispenser for pastelike substance having a vaned rotary extruding element
US2698817 *Feb 28, 1951Jan 4, 1955Coats & ClarkSewing thread and method for producing same
US2734506 *Dec 14, 1953Feb 14, 1956 Silk sutures and ligatures
US2737075 *Sep 5, 1952Mar 6, 1956Homer J PelchatCord structure
US3035476 *Feb 23, 1961May 22, 1962Samson Cordage WorksBraided cord
DE1110824B *Sep 9, 1958Jul 13, 1961Dr Med Hansheinrich GrunertVerfahren zur Herstellung resorbierbarer Formkoerper aus menschlicher Plazenta fuer verschiedene chirurgische Zwecke
GB876208A * Title not available
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US3307971 *Sep 30, 1963Mar 7, 1967Sutures IncMethods of altering the surface characteristics of solid resin surfaces and articlesproduced thereby
US3322125 *Apr 4, 1966May 30, 1967Sutures IncSutures and method of making same
US3371069 *Mar 17, 1964Feb 27, 1968Ajinomoto KkFilaments and surgical sutures of polyl-glutamic acid partly esterified with lower alkanols and process therefor
US3390681 *Apr 4, 1966Jul 2, 1968Sutures IncPolyester suture having improved knotting characteristics
US3423235 *Nov 23, 1964Jan 21, 1969Dow CorningOrganosiloxane-containing finishes for organic fibers
US3424164 *May 20, 1966Jan 28, 1969Ethicon IncSilk suture
US3527556 *Dec 8, 1966Sep 8, 1970American Cyanamid CoDyeing polyester sutures with indigo and the coating of the dyed sutures
US3541196 *Jul 26, 1967Nov 17, 1970Phillips Petroleum CoMethod for forming silicone composition coated polyolefin articles
US3565077 *May 6, 1968Feb 23, 1971American Cyanamid CoDensified absorbably polyglycolic acid suture braid, and method for preparing same
US3729007 *Dec 21, 1970Apr 24, 1973Sutramed SarlResorbable surgical suture
US4461298 *Jul 26, 1982Jul 24, 1984Ethicon, Inc.Composite sutures of silk and hydrophobic thermoplastic elastomers
US4546769 *Feb 14, 1984Oct 15, 1985Institute Fur Textilund FaserforschungSuture thread
US4712553 *May 30, 1985Dec 15, 1987Cordis CorporationSutures having a porous surface
US4851009 *Jun 15, 1988Jul 25, 1989Corvita CorporationCrack prevention of implanted prostheses
US4880002 *Dec 9, 1987Nov 14, 1989Corvita CorporationPolyurethanes, polycarbonates
US4959069 *Oct 20, 1989Sep 25, 1990Ethicon, Inc.Braided surgical sutures
US5019093 *Mar 9, 1990May 28, 1991United States Surgical CorporationBraided suture
US5059213 *Mar 26, 1990Oct 22, 1991United States Surgical CorporationSpiroid braided suture
US5075126 *Jun 24, 1989Dec 24, 1991Heidi StrohProtecting against allergic reactions
US5084065 *Jul 10, 1989Jan 28, 1992Corvita CorporationReinforced graft assembly
US5133738 *Aug 21, 1990Jul 28, 1992United States Surgical CorporationCombined surgical needle-spiroid braided suture device
US5181923 *Aug 17, 1990Jan 26, 1993United States Surgical CorporationBraid with coating to reduce drag on tissues
US5222978 *Aug 16, 1990Jun 29, 1993United States Surgical CorporationPackaged synthetic absorbable surgical elements
US5226912 *Aug 21, 1990Jul 13, 1993United States Surgical CorporationCombined surgical needle-braided suture device
US5261886 *Dec 4, 1991Nov 16, 1993United States Surgical CorporationCabled core and braided suture made therefrom
US5275618 *Nov 13, 1991Jan 4, 1994United States Surgical CorporationJet entangled suture yarn and method for making same
US5306289 *Feb 26, 1991Apr 26, 1994United States Surgical CorporationBraided suture of improved characteristics
US5314446 *Feb 19, 1992May 24, 1994Ethicon, Inc.Sterilized heterogeneous braids
US5318575 *Feb 3, 1992Jun 7, 1994United States Surgical CorporationMethod of using a surgical repair suture product
US5359831 *Jun 18, 1993Nov 1, 1994United States Surgical CorporationMolded suture retainer
US5366081 *Jul 10, 1992Nov 22, 1994United States Surgical CorporationPackaged synthetic absorbable surgical elements
US5370031 *Apr 15, 1993Dec 6, 1994United States Surgical CorporationBraider apparatus with improved bobbin holder
US5383387 *Jun 4, 1993Jan 24, 1995United States Surgical CorporationApparatus and method for producing braided suture products
US5383903 *Aug 20, 1992Jan 24, 1995United States Surgical CorporationDimethylsiloxane-alkylene oxide copolymer coatings for filaments
US5423821 *Jan 18, 1994Jun 13, 1995Pasque; Michael K.Sternal closure device
US5423859 *Feb 1, 1993Jun 13, 1995United States Surgical CorporationJet entangled suture yarn and method for making same
US5456697 *Aug 23, 1993Oct 10, 1995United States Surgical CorporationCabled core and braided suture made therefrom
US5468252 *Jun 22, 1993Nov 21, 1995United States Surgical CorporationFilled suture
US5520084 *Jan 13, 1995May 28, 1996United States Surgical CorporationApparatus and method for producing braided suture products
US5662682 *Jan 15, 1993Sep 2, 1997United States Surgical CorporationSpiroid braided suture
US5876421 *Mar 25, 1997Mar 2, 1999Torgerson; Robert D.Residual xylene removal from sutures
US6558409Sep 28, 2001May 6, 2003Tyco Healthcare Group LpPlasma treated surgical needles and methods for their manufacture
US7294357Sep 28, 2001Nov 13, 2007Tyco Healthcare Group LpPlasma coated sutures
US7736293Jul 22, 2005Jun 15, 2010Biocompatibles Uk LimitedImplants for use in brachytherapy and other radiation therapy that resist migration and rotation
US7736294Oct 28, 2005Jun 15, 2010Biocompatibles Uk LimitedDelivery system and method for interstitial radiation therapy using seed strands with custom end spacing
US7736295Nov 15, 2005Jun 15, 2010Biocompatibles Uk LimitedDelivery system and method for interstitial radiation therapy using custom end spacing
US7806908Jan 2, 2008Oct 5, 2010Quill Medical, Inc.Barbed tissue connector
US7857829May 11, 2007Dec 28, 2010Quill Medical, Inc.Suture method
US7862583 *May 27, 2004Jan 4, 2011Ethicon Endo-Surgery, Inc.Fusible suture and method for suturing therewith
US7874974Oct 28, 2005Jan 25, 2011Biocompatibles Uk LimitedDelivery system and method for interstitial radiation therapy
US7874976Sep 7, 2006Jan 25, 2011Biocompatibles Uk LimitedEchogenic strands and spacers therein
US7878964 *Sep 7, 2006Feb 1, 2011Biocompatibles Uk LimitedEchogenic spacers and strands
US7901705Feb 28, 2007Mar 8, 2011Tyco Healthcare Group LpAntimicrobial releasing polymers
US7913365Mar 27, 2007Mar 29, 2011Quill Medical, Inc.Method of forming barbs on a suture and apparatus for performing same
US7923439Oct 5, 2009Apr 12, 2011Tyco Healthcare Group LpHydroxamate compositions
US7942803Jan 21, 2010May 17, 2011Biocompatibles Uk LimitedDelivery system and method for interstitial radiation therapy
US7972261Jul 20, 2006Jul 5, 2011Biocompatibles Uk LimitedDevices to resist migration and rotation of implants used in brachytherapy and other radiation therapy
US7985172Apr 27, 2007Jul 26, 2011Biocompatibles Uk LimitedAfter-loader devices and kits
US7988611Nov 3, 2006Aug 2, 2011Biocompatibles Uk LimitedAfter-loader for positioning implants for needle delivery in brachytherapy and other radiation therapy
US7996967Aug 4, 2010Aug 16, 2011Quill Medical, Inc.System for variable-angle cutting of a suture to create tissue retainers of a desired shape and size
US7996968Aug 4, 2010Aug 16, 2011Quill Medical, Inc.Automated method for cutting tissue retainers on a suture
US8011072Aug 4, 2010Sep 6, 2011Quill Medical, Inc.Method for variable-angle cutting of a suture to create tissue retainers of a desired shape and size
US8012172Mar 8, 2006Sep 6, 2011Arthrex, Inc.High strength suture with coating and colored trace
US8015678Aug 4, 2010Sep 13, 2011Quill Medical, Inc.Method for cutting a suture to create tissue retainers of a desired shape and size
US8020263Aug 4, 2010Sep 20, 2011Quill Medical, Inc.Automated system for cutting tissue retainers on a suture
US8021291Jan 21, 2009Sep 20, 2011Biocompatibles Uk LimitedMarkers for use in brachytherapy and other radiation therapy that resist migration and rotation
US8028387Aug 4, 2010Oct 4, 2011Quill Medical, Inc.System for supporting and cutting suture thread to create tissue retainers thereon
US8028388Aug 4, 2010Oct 4, 2011Quill Medical, Inc.System for cutting a suture to create tissue retainers of a desired shape and size
US8032996May 13, 2004Oct 11, 2011Quill Medical, Inc.Apparatus for forming barbs on a suture
US8066627Jun 16, 2006Nov 29, 2011Biocompatibles Uk LimitedDelivery system and method for interstitial radiation therapy using strands constructed with extruded strand housings
US8083770May 13, 2008Dec 27, 2011Quill Medical, Inc.Suture anchor and method
US8114007Dec 15, 2008Feb 14, 2012Biocompatibles Uk LimitedImplants for use in brachytherapy and other radiation therapy that resist migration and rotation
US8187159Feb 26, 2009May 29, 2012Biocompatibles, UKTherapeutic member including a rail used in brachytherapy and other radiation therapy
US8192345Jan 21, 2009Jun 5, 2012Biocompatibles, UKCartridge for use with brachytherapy applicator
US8246652Aug 4, 2010Aug 21, 2012Ethicon, Inc.Suture with a pointed end and an anchor end and with equally spaced yieldable tissue grasping barbs located at successive axial locations
US8268958Mar 30, 2011Sep 18, 2012Tyco Healthcare Group IpPhospholipid copolymers
US8273104Jul 11, 2006Sep 25, 2012Tyco Healthcare Group LpAntimicrobial sutures and methods of making them
US8419736Mar 10, 2010Apr 16, 2013Synthes Usa, LlcSternal reconstruction system
US8470294Jun 25, 2010Jun 25, 2013Microspherix LlcFlexible and/or elastic brachytherapy seed or strand
US8615856Jan 30, 2009Dec 31, 2013Ethicon, Inc.Apparatus and method for forming self-retaining sutures
US8641732Feb 25, 2009Feb 4, 2014Ethicon, Inc.Self-retaining suture with variable dimension filament and method
US8652170Aug 4, 2010Feb 18, 2014Ethicon, Inc.Double ended barbed suture with an intermediate body
US8663277 *Jun 29, 2005Mar 4, 2014Ethicon, Inc.Braided barbed suture
US8679158Aug 4, 2010Mar 25, 2014Ethicon, Inc.Multiple suture thread configuration with an intermediate connector
US8690914Aug 4, 2010Apr 8, 2014Ethicon, Inc.Suture with an intermediate barbed body
US8715320Sep 17, 2012May 6, 2014Ethicon, Inc.Braided barbed suture
US8721664Mar 12, 2013May 13, 2014Ethicon, Inc.Suture methods and devices
US8721681Jun 30, 2009May 13, 2014Ethicon, Inc.Barbed suture in combination with surgical needle
US8734485Aug 4, 2010May 27, 2014Ethicon, Inc.Sutures with barbs that overlap and cover projections
US8734486Aug 4, 2010May 27, 2014Ethicon, Inc.Multiple suture thread configuration with an intermediate connector
US8747437Aug 4, 2010Jun 10, 2014Ethicon, Inc.Continuous stitch wound closure utilizing one-way suture
US8764776Aug 4, 2010Jul 1, 2014Ethicon, Inc.Anastomosis method using self-retaining sutures
US8764796Feb 10, 2006Jul 1, 2014Ethicon, Inc.Suture method
US20110082499 *Sep 24, 2010Apr 7, 2011Tyco Healthcare Group LpCoatings that enhance resistance to abrasion
US20110082500 *Sep 24, 2010Apr 7, 2011Tyco Healthcare Group LpCoatings that enhance resistance to abrasion
US20130211430 *Feb 10, 2012Aug 15, 2013Novus Scientific Pte. Ltd.Multifilaments with time-dependent characteristics, and medical products made from such multifilaments
CN101296661BJun 21, 2006Jul 6, 2011伊西康公司Braided barbed suture
EP0002090A1 *Nov 13, 1978May 30, 1979CarboMedics, Inc.Multifibre suture
EP0472260A1 Mar 1, 1991Feb 26, 1992United States Surgical CorporationBraided suture of improved characteristics
EP1743660A2Jun 20, 2006Jan 17, 2007Tyco Healthcare Group LpAntimicrobial sutures and methods of making them
EP1946705A2Sep 10, 2004Jul 23, 2008Tyco Healthcare Group LpMethod for treating a section of a suture and forming a suture tip for attachment to a needle
EP2028208A1Aug 14, 2008Feb 25, 2009Tyco Healthcare Group LPPhospholipid copolymers
EP2055323A2Oct 27, 2008May 6, 2009Tyco Healthcare Group LPFilament-reinforced composite fiber
EP2110146A2Apr 14, 2009Oct 21, 2009Tyco Healthcare Group LPPoly(trimethylene) terephthalate filaments and articles made therefrom
EP2143449A1Apr 5, 2007Jan 13, 2010Tyco Healthcare Group LpYarns containing thermoplastic elastomer copolymer and polyolefin filaments
EP2158925A2Jun 20, 2006Mar 3, 2010Tyco Healthcare Group Lpantimicrobial sutures and methods of making them
EP2161041A2Aug 6, 2009Mar 10, 2010Tyco Healthcare Group LPYarns containing thermoplastic elastomer copolymer and polyolefin filaments
EP2177226A1Oct 14, 2009Apr 21, 2010Tyco Healthcare Group LPHydroxamate compositions
EP2177554A2Oct 14, 2009Apr 21, 2010Tyco Healthcare Group LPHydroxamate-initiated polymers
EP2255716A1Aug 27, 2002Dec 1, 2010Tyco Healthcare Group, LPPlasma coated sutures
EP2258410A2Jun 2, 2010Dec 8, 2010Tyco Healthcare Group LPNovel biomaterial drug delivery and surface modification compositions
EP2399505A1Aug 27, 2002Dec 28, 2011Tyco Healthcare Group LPPlasma coates sutures
EP2489357A1Sep 20, 2007Aug 22, 2012Tyco Healthcare Group, LPNovel Triclosan Salts
EP2564859A1Oct 14, 2009Mar 6, 2013Covidien LPHydroxamate compositions
WO1992010137A1 *Dec 4, 1991Jun 6, 1992United States Surgical CorpCabled core and braided suture made therefrom
WO1996041581A1Jun 12, 1995Dec 27, 1996Michael K PasqueSternal closure device
Classifications
U.S. Classification606/231, 427/2.31, 273/DIG.290
International ClassificationA61L17/14, A61B17/06
Cooperative ClassificationY10S273/29, A61L17/145, A61B17/06166
European ClassificationA61L17/14C, A61B17/06S