Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L17/00—Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
  • A61L17/14—Post-treatment to improve physical properties
  • A61L17/145—Coating

Definitions

• Tnis invention relates to improved surgical sutures having extremely high knot strength and to methods for their preparation. More particularly, the invention is directed to composite surgical sutures having a knot strength that enables them to be used over a range of suture sizes classified by the United States Pharmacopeia ( USP ) .
• USP United States Pharmacopeia
• Surgical sutures are generally divided into two broad classes: (1) absorbable sutures, either natural or synthetic, which are absorbed by the body and (2) non-absorbable sutures, which remain in the body for prolonged periods of time or are removed when the wound heals.
• a further long term problem in surgery is post-operative hernia. It is a truism that scar tissue never achieves the tensile strength of normal tissue. Hernias have occurred many years post-operably through the scar. If a suture were developed which would leave as a residue a nonabsorbable suture to support that scar tissue, it would undoubtedly decrease and most likely eliminate the post-operative hernia as a complication.
• Another object of the invention is to provide a surgical suture having a knot strength that renders it useful over a range of surgical sizes within the USP classification of graded suture sizes, and thus having the ability to replace the USP graded scale of sizes with just a few finer sutures whose strength would cover the entire range.
• a further object of the invention is to provide a composite suture which leaves a residue of nonabsorbabie suture to support scar tissue and, therefore, decreases or eliminates post-operative hernia as a complication.
• Another object of the invention is to provide a method of preparing surgical sutures having extremely high knot strength whose surface characteristics can be tailored to meet desired properties.
• a further object of the invention is to provide composite sutures capable of using needles which more closely approximate the outer diameter of the suture.
• a further object of the invention is to provide a composite suture having lateral strength, that is, a suture stabilized against abrasion, kinking and/or fibrillation during knotting.
• a sterile, surgical suture having an elongated core of a synthetic polymer having a knot tenacity of at least 7 grams/denier coated with a film and fiber-forming surgical material, said coated core, when constructed into a surgical suture of a particular USP grade size, having a knot strength exhibited by surgical sutures of said suture material at least two USP grade sizes larger.
• the elongated core of trie sutures of the invention can be formed of any fioer-forming synthetic polymer, such as a polyamide, polyolefin, polyester and the like , having a straight pull tenacity of at least 15 grams/denier, preferably up to 70 or more grams/denier and a knot tenacity of at least 7 grams/denier, preferably up to 30 or more grams/- denier.
• fioer-forming synthetic polymer such as a polyamide, polyolefin, polyester and the like , having a straight pull tenacity of at least 15 grams/denier, preferably up to 70 or more grams/denier and a knot tenacity of at least 7 grams/denier, preferably up to 30 or more grams/- denier.
• knot break strength divided by the denier.
• aromatic polyamides in which the chain extending bonds from each aromatic nucleus are essentially coaxial or parallel and oppositely directed.
• aromatic nucleus is used herein to include individual enchained aromatic rings and fused-ring aromatic divalent radicals.
• the preferred polymers include carbocyclic aromatic polyamides containing up to 2 aromatic rings, including enchained non-fused rings (e.g. 4, 4'-biphenylene) or fused rings (e.g. 1, 5-na ⁇ hthalene) per amide linkage.
• the chainextending bonds from these aromatic rings are paraoriented and/or essentially coaxial or parallel and oppositely directed.
• highly preferred polyamides are characterized by recurring units of the formula:
• R and R' are selected from the group of: 1,4-phenylene, and
• 4,4'-biphenylene and R and R' are selected from the group of:
• R and R' may be the same or different and may contain substituents on the aromatic nuclei.
• R" is selected from the group of:
• R" may contain substituents on the aromatic nuclei.
• the aromatic nuclei of the polymers of this invention may bear substituents.
• substituents should be non-reactive during the polymerization and preferably also should be non-reactive (e.g. thermally) during subsequent processing of the polymer, e.g., heat treating of a shaped fiber thereof. Such reactivity is undesirable in that it may cause cross linking of the polymer and may adversely effect the dope and/or fiber properties.
• the preferred non-reactive substituents may be names halogens (e.g., methoxy and ethoxy), cyano, acetyl, and nitro.
• Random copolymers are preferred copolymers.
• random is meant that the conolymer consists of molecules containing large numbers of units comprised of two or more different types in irregular sequence.
• the units may be of AB (e.g., from p-aminobenzoyl chloride hydrochloride), AA (e.g., from p-phenylenediamine or 2,6-dichloro-p-phenylene diamine ), or BB (e.g., from terephthaloyl or 4,4'-bibenzoyl chloride) type or mixtures of these, provided always that the requirements of stoichiometry for high polymer formation are met. It is not necessary that the relative numbers of the different types of the unit be the same in different molecules or even in different portions of a single molecule.
• One or more of these polymers may suitably be used in the fibers of this invention, i.e., a single homopolymer; a single copolymer; or homopolymer and/or copolymer olends are suitable herein.
• the polymers useful for preparing the core of this invention may also comprise up to about 10 percent (mole basis) of units not conforming to the above-cited description, e.g., aromatic polyamide-forming units whose chain extending bonds are other than coaxial or parallel and oppositely directed, e.g., they may be metaoriented, or of linkages other than amide, e.g., urea or ester groups.
• aromatic polyamides may be named poly(p-benzamide); poly(p-phenylene terephthalamide); poly(2-chloro-p- ⁇ henylene terephthalamide); poly(2,6-dichloro- ⁇ -phenylene 2,6-naphthal ⁇ mide); poly(p-phenylene p; ⁇ '-biphenyldicarboxamide); poly(p,p'-phenylene benzamide); poly(1,5-naphthylene terephthalamide); ordered aromatic copolyamides such as e.g., copoly(p,p'-diarninobenzanilide terephthalamide), and random copolyamides such as, e.g., copoly(p-benzamide/m-benzamide) (95/5); and many others.
• aromatic copolyamides such as e.g., copoly(p,p'-diarninobenzanilide terephthalamide), and random copolyamides such as,
• aromatic polyamides generally have an inherent viscosity and prefereably greater than 1.0.
• Exemplary of such aromatic polyamides are those known as the "Kevlar" series, products of the DuPont corporation, which generally have a straight pull tenacity of about 18 to 25 grams per denier and a knot tenacity of at least about 7 grams per denier. Further examples of such aromatic polyamides and their methods of preparation can be found, for instance, in U.S. Patent Wos. 3,063,966, 3,600,350, 3,671,542 and 3,819,587 all incorporated herein by reference.
• a synthetic polymer suitable for use as the core of the suture of tne invention are high strength oolyolefins such as polyethylene which provides fioers having a straight pull tenacity of about 25-50 grams/denier and a knot tenacity of about 7 to 17 grams/denier.
• These polyolefin fibers are characterized by full chain extension and high crystallization and can be prepared: (1) by ultradrawing of the solidified crystalline polyolefin material that is, by further development of the traditional cold drawing process, and (2) by extending the chains in random state (melt or solution) and inducing them to crystallize in the extended form subsequently.
• Polyolefins having these characteristics and their method of preparation are described in Keller, A. and Barham, P.J. "High Modulus Fibres", Plastics and Rubber International, February, Volume 6, No. 1 (1981), herein incorporated by reference.
• the core of the surgical suture of the invention can be either a monofilament or of multifilament construction.
• the latter is ordinarily preferred since the coating of suture material subsequently applied generally exhibits stronger adhesion to multifilament cores.
• the liquified suture material coating tends to penetrate and fill the interstices of a multifilament core as well as coating the core, thereby anchoring the coating thereto.
• Mul tifilament cores can take the form of braids, twisted polyfilaments, yarns and the like.* It should be noted that while the synthetic polymer materials contemplated for use as the core of the composite sutures of the invention, have high axial strength, they are not ordinarily suitable for use as sutures since they do not possess the necessary lateral strength and, therefore, tend to abrade, kink and/or fibrillate during knotting. Coating of the core with ⁇ suture material pursuant to the present invention has been found to unexpectedly stabilize, i.e. provide lateral strength resistance against such action thereby rendering suitable for use as sutures these synthetic polymer fibers normally unsuitable for such use.
• the surgical suture material used to coat the core can be any film-forming material commonly used in the construction of absorbable and nonabsorbable sutures. In general these suture materials when drawn into fibers exhibit straight tensile strengths of about 4 to 10 grams /denier.
• non-absorbable type suture materials are silk (fibroin), polyolefins, such as polyethylene and polypropylene, polyesters such as polyethylene terephthalate and nylon.
• the suture material in the form of multi or monofilament yarn may also be present initially as a core around which the high strength yarn which eventually becomes the core in the finished suture is braided or twisted or it may be formed into a plied, twisted, braided or co-mingled construction with the high strength yarn.
• the core include collagen and the synthetic absorbable materials such as polylactide, polyglycolide and copolymers of lactide and glycolide with each other and with other reactive monomers such as those described, for instance, in U.S. Patent Nos. 3,636,952 and 2,683,136, which patents are herewith incorporated by reference.
• Such synthetic absorbable polymers are sometimes referred to herein as simply homopolymers and copolymers of l ⁇ ctide and glycolide.
• the amount of suture material coated onto the core will vary depending upon the constructon of the core, whether monofilament or multifilament, the number and tightness of braid or twist, the particular tensile strength and knot tenacity of the core, the particular suture material used as the coating and its nature, e.g. melt, solution or solid.
• the coating when the coating is a nonabsorbable suture material, the coating will constitute about 5 to about 10% by weight of the coated core.
• the coating when the coating is an absorbable suture material, the coating may constitute about 5 to 90% by weight of the coated core.
• the coatings can be applied by a variety of suitable techniques well known in the coating art.
• the coatings can be applied to the core by solution coating, melt coating, extrusion coating and the like.
• melt coating for example, the uncoated core under tension is slowly passed through ⁇ melt of the suture material and then through a die having an orifice smaller than the upper diameter specification for the suture size desired, heated above the melting point of the coating materials, to trim off excess coating material and shape the composite. Multiple coatings may be applied if necessary.
• the suture material is dissolved in a suitable solvent and the core is slowly passed through the coating solution thus formed.
• the treated core is then passed continuously through a tubular oven heated to an elevated temperature to evaporate the solvent and coalesce and solidify the suture material that remains.
• a preferred coating technique when the core being coated is of multifilament construction comprises initially either solution coating or melt coating the multifi lament core while the latter is held under a suitaole tension and allowing the liquified coating material to penetrate or infiltrate the interstices of the core, thereby forming roots which help anchor the coating of the core.
• a second layer of tne same suture material may then be applied to the impregnated core by any of the conventional coating methods.
• the core is passed through the cross-head die of a conventional wire coating extrusion apparatus.
• Pellets of the coating material are introduced into the plastification zone of the extruder wherein they are plasticized into ⁇ melt which is forced through the annular die of the extruder and onto the core.
• Aromatic polyamide cores lend themselves to melt or extrusion coating because of their high melting points.
• the high strength polyethylene cores have relatively low melting points, e.g. about 145°C, and must be treated differently. With them, solution coating of the monoor multi-filament cores is the chief method.
• the core being coated is an aromatic polyamide
• it is subjected to both a precoating stage and finish coating stage, each of which will be discussed below in more detail.
• the impregnation/precoating operation of the invention can be conducted using a thread composed of a core made up of multifilaments of a suture material and a plurality of fibers of a synthetic polymer having a tenacity of at least 18 grams/- denier and knot tenacity of at least 7 grams/- denier.
• the thread can be formed in the usual manner as by twisting, braiding, etc., a plurality of the synthetic polymer fibers around the suture material core.
• the thread that is, the covered core is then heated to temperatures above the melting point of the multifilament core material passing it through any suitable oven during which passage the suture material melts and under the tension developed and/or applied exudes upward through the polyfilamentous synthetic polymer component and onto its surface.
• the amount of coating employed should be sufficient to not only fill all the interstices of the multifilament core component during the melting period but to also coat the surface of the yarn or thread component. Any excess coating material which may have melted out is trimmed off. While the heating of the covered core mixed yarns can be effected with or without stretching of the thread in some instances, a better final suture is obtained when the yarn is maintained under tension with little or no stretch applied at this stage. It is at this stage that the basic solid coated core structure is developed.
• the impregnated and coated core is then passed through a heated dye which trims coating nubs from the core and otherwise smooths the external surface of the thread. Stretch may also be applied during the smoothing operation, but again, best results are obtained with no or minimum stretch.
• the thread may oe passed through the heating oven or smoothing die as many times as is necessary to obtain a smooth, nub-free surface.
• in smoothing down the nubs not only should excess surface coating be removed, but some of it should be used to fill the ups and down of the thread's surface in order to obtain a sufficiently smooth undercoat structure. If this is not done, the coating remaining on the surface follows the contours of the thread and any subsequently applied coating will follow these contours.
• the temperatures employed in the heating oven will vary depending on the coating employed, the proportions of coating material to core, the speed at which the core is passed through the oven and whether the heating ⁇ nd/or smoothing is conducted under stretch conditions. As aforementioned, the temperature should be raised above the melting point to a level at which the coating material exudes through the thread as a gelatinous mass wnich can then be seen on the surface of the thread when it cools. Excessively high temperatures which thin the coating material to a point where it runs off should be avoided as they tend to exude too much coating material and fail to produce a solid case structure.
• the optimum melting temperatures employed in the impregnation/precoating operation will depend primarily upon which suture coating material is employed.
• the smoothing die temperature will also be above the melting point of the coating material and below the melting point of the core. Usually it will conform closely to the temperature employed in the impregnation/precoating stage preferably about 5 to 15 degrees below that used in the irapregnat ion/precoating stage.
• the final stage in obtaining the composite suture structure is to melt extrude coating material onto the smoothed impregnated/precoated thread.
• Any of the conventional extrusion apparatuses can be employed for this purpose.
• the smooth precoated thread is simply fed through the extrusion coating die and coated with additional coating material of the same type as used in the impregnation/ precoating stage.
• additional coating material of the same type as used in the impregnation/ precoating stage.
• the smooth impregnated/ precoated thread subjected to the coating stage be essentially free of an undulating surface.
• the extrusion temperatures employed in the impregnation/ precoating stage although it has been found that the higher the extrusion coating temperature, other conditions being equal, the greater the finished suture diameter. This is due to decreased melt viscosity with increased temperature which results in increased polymer flow under a given applied force.
• Fig. 1 is a schematic drawing of an apparatus useful in the impregnation/precoating stage of the present invention
• Fig. 2 is a schematic drawing of an apparatus useful in the extrusion coating of the suture impregnated and precoated by use of the apparatus of Fig. 1
• Fig. 3 is a cross-section of the extrusion die in Fig. 2 on a larger scale.
• a draw roll (Godet) 13 pulls the raw braid through the oven without stretch, that is, at a stretch ratio (SR) of 1:1.
• the Heated Zone I is maintained at ⁇ temperature of 230°C. Under these conditions all the polypropylene melts and is entirely distributed throughout the braid interstices and onto the surface of the braid. No solid polypropylene core residue remains.
• Heated Zone II contains a smoothing die 17 having a 0.2 mm diameter that trims and smooths down nubs that are formed on the braid. Heated Zone II is maintained at a temperature of about 220°C for the smoothing operation.
• the smoothed braid is pulled through Heated Zone II by a draw roll (Godet) 19 and onto receiving reel 21. The speed at which the braid passes through both Heated Zone I and II is approximately 1-1.8 M/min.
• the precoated braid is passed through the smoothing die 17 three times so as to obtain an impregnated/precoated braid of the desired smoothness.
• reel 31 of smooth impregnated/precoated braid prepared as above is passed through a tensioner 33, to feed roll (Godet) 35 which feeds the braid through guide 37 into extrusion coating die apparatus indicated generally as 39.
• Polypropylene chips are melted in heated reservoir 41 maintained at a temperature of 260°C and the melt is forced by means of extruding weights 43 applied at a force of 0.233 kg to a piston 45 into and through the extrusion coating die.
• the extruding coating apparatus is comprised of a holder indicated generally as 47 which houses a hollow lumen member 49 a spinneret 57 having an outlet 52.
• the lumen member 49 essentially positioned within the holder 47 so as to provide an annular chamber 53.
• a gasket 55 seals one end of the member 49 within the holder while the other end is supported by slotted plate 60.
• the lumen member contains an inlet 59 and an outlet 61. Between outlet 61 and outlet 52 of the spinneret 57 is positioned a hollow needle 63.
• the impregnated/ precoated thread 65 passes consecutively through lumen member 49, hollow needle 59, outlet 52 and is coated with melt as it emerged from the die.
• the coating die is maintained at a coating temperature of 235°C.
• the coated filament is then taken up on draw roll 48 which applies stretch. Tension is let down on draw roll 50 which is run more slowly than draw roll 48. The yarn velocity is 1.43 M/min. and the total stretch ratio (SR) is 1.02. The finished suture is finally wound around receiving reel 51.
• the composite suture prepared can be used as a 5/0, 4/0, or 3/0 suture.
• Example I Tiie process of Example I is repeated substituting a polyethylene terephthalate core for polypropylene core and extrusion coating in extrusion coating die apparatus 39 with polyethylene terephthalate.
• the result is a composite suture having a 5/0 diameter "Kevl ⁇ r" core accounting for approximately 90% of the cross-sectional volume coated with polyethylene terephthalate exhibiting a knot break strength of about 3.5 pounds which is a knot brek strength above the USP limits for a 2/0 size suture. Therefore, the composite suture prepared could be used for sizes 5/0, 4/0, 3/0 and 2/0 according to the physician's wishes.
• Fibroin (silk) is dissolved in ⁇ aqueous solution of 62% zinc chloride to give a solution having fibroin weight % concentrations in the range of 5-20%.
• the resulting solution is maintained at approximately its boiling point and "Kevlar" yarn of Example I is pulled through the solution at a constant rate as to fully impregnate and coat the yarn.
• the impregnated and coated yarn is then dried by passing it through a tubular oven maintained at heating temperatures up to 130°C. The heat treatment evaporates the solvent and helps to form a continuous fibroin film.
• the composite suture is then washed with cold water to remove residual zinc chloride.
• the resulting composite suture with a size 5/0 "Kevl ⁇ r” core containing approximately 5% by weight fibroin exhibits a knot break strength of approximately 3.5 pounds which is equivalent to a silk suture of size 2.0.
• the silkcoated "Kevlar” composite suture could be used instead of silk in the following sizes: 5/0, 4/0, 3/0 and 2/0.
• a size 5/0 high strength fully chain-extended polyethylene multifi lament yarn having a straight pull tenacity of 50 grams/denier and a knot tenacity of 15 grams/denier is pulled through a 10% solution of polyethylene terephthalate in a solvent mixture of methylene chloride containing 31% by weight hexafluoroisopropanol and then passed through a die to trim off excess solution.
• the coated core is dried in air and the process repeated to build up the coating to ⁇ final composite suture containing 10% oy weight polyethylene terephthalate.
• the composite is washed with water and dried again.
• the resulting composite suture could be used for sizes 5/0, 4/0, 3/0, 2/0 and 1/0.
• Example I is repeated substituting a polyglycolic acid (PGA) core for the polypropylene core and PGA resin for the polypropylene chips.
• the resulting "Kevlar”/polyglycolic acid composite has ⁇ minimum knot break strength in the range of 1550-1700 grams. Since commercial non-absorbable "Prolene" sutures of size 3/0 has ⁇ knot strength of 1550-1650 grams, this means that a size 3/0 "Kevlar”/ ⁇ olyglycolic acid suture will retain the knot break strength of 3/0 "Prolene” after absorption of all the polyglycolic acid. Thus, the "Kevlar”/polyglycolic acid suture prepared could be used for sized 3/0, 4/0 and 5/0.
• a 5/0 size reinforcing high strength polyethylene core of about 0.140 mm in diameter will impart at least the knot strength of a 2/0 suture to the composite.
• a PGA-coated high strength polyethylene 5/0 core can be used to make sizes 2/0, 3/0, 4/0 and 5/0 absorbable, nonabsorbable composite sutures.
• needles may be attached to one end of the composite sutures of the invention and the sutures may be packed in sterile containers.
• the sutures may be dry packed in glass tubes or plastic envelopes. Conditioning fluid may be used to assure maintenance of sterility or as a rust preventing medium for the needle. Eyeless needles are preferred since they cause less tissue damage.
• the composite sutures of the present invention are formed at convenient lengths, attached to eyeless needle, wound on reels if desired, and placed in containers such as plastic envelopes.
• the sutures may then be sterilized with ethylene oxide or other conventional gaseous sterilizing agents in accordance with known practices.
• the sutures may be sealed in the envelopes and then sterilized by using heat and radiation including x-rays, gamma rays, electrons, neutrons, etc.
• Another advantage offered by the composite sutures of the invention is that .needles of smaller diameter can be attached thereto.
• the outside cover or coating of suture material at the end of the composite suture is removed by any suitable means as, for instance, by dissolving the cover using a solvent which solubilizes the cover but not the core.
• the core at the end of the suture is thereby exposed and onto the core is attached as, for instance, by swagging a needle of smaller outer diamter than would be used with a suture of the same outer diameter.
• Example VI The end of a composite suture prepared according to the general procedure of Example I and having an outer diameter of approximately 0.012 inch is dipped one-eighth inch into boiling xylene until the polypropylene cover softens. The polypropylene cover is then manually scrapped off to expose the 5/0 "Kevlar" core. A 0.014 inch diameter needle is swagged onto the core to provide a suture with ⁇ needle having a cross-sectional area reduced approximately two-thirds that of needles required for sutures having a 0.012 inch diameter.

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• 1984
  • 1984-06-14 EP EP19840902563 patent/EP0182784A1/de not_active Withdrawn
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  • 1984-06-14 JP JP50249584A patent/JPS61502379A/ja active Pending

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