US3630205A - Polypropylene monofilament sutures - Google Patents

Polypropylene monofilament sutures Download PDF

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US3630205A
US3630205A US3630205DA US3630205A US 3630205 A US3630205 A US 3630205A US 3630205D A US3630205D A US 3630205DA US 3630205 A US3630205 A US 3630205A
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polypropylene
monofilament
stretched
creel
length
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Gregory J Listner
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Ethicon Inc
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Ethicon Inc
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    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166—Sutures
    • D—TEXTILES; PAPER
    • D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
    • D01F—CHEMICAL FEATURES IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS; APPARATUS SPECIALLY ADAPTED FOR THE MANUFACTURE OF CARBON FILAMENTS
    • D01F6/00—Monocomponent artificial filaments or the like of synthetic polymers; Manufacture thereof
    • D01F6/02—Monocomponent artificial filaments or the like of synthetic polymers; Manufacture thereof from homopolymers obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • D01F6/04—Monocomponent artificial filaments or the like of synthetic polymers; Manufacture thereof from homopolymers obtained by reactions only involving carbon-to-carbon unsaturated bonds from polyolefins
    • D01F6/06—Monocomponent artificial filaments or the like of synthetic polymers; Manufacture thereof from homopolymers obtained by reactions only involving carbon-to-carbon unsaturated bonds from polyolefins from polypropylene
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L23/00—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
    • C08L23/02—Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers not modified by chemical after-treatment
    • C08L23/10—Homopolymers or copolymers of propene
    • C08L23/12—Polypropene
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S264/00—Plastic and nonmetallic article shaping or treating: processes
    • Y10S264/73—Processes of stretching
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T442/00—Fabric [woven, knitted, or nonwoven textile or cloth, etc.]
    • Y10T442/60—Nonwoven fabric [i.e., nonwoven strand or fiber material]
    • Y10T442/682—Needled nonwoven fabric
    • Y10T442/684—Containing at least two chemically different strand or fiber materials
    • Y10T442/688—Containing polymeric strand or fiber material

Definitions

  • Mmler ABSTRACT A flexible, uniform monofilament of isotatic [54] :PNOFILAMENT SUTURES polypropylene having an improved hand and an ultimate elonrawmg gation greater than 35 percent is prepared by extruding [52] U.S.Cl 128/3355, isolatic polypropylene having a weight average molecular 161/150, 161/161 weight between 299,000 and 316,000 to form a monofila- [51] 1nt.Cl A611 17/00 ment. Stretching said mo fi a 300 to about [50] Field ofSearch 128/3355; times its original length.
  • SHEET 5 or 5 ATTORNEY 1 POLYPROPYLENE MONOFILAMENT SUTURES BACKGROUND OF THE INVENTION are of the second type; i.e. they are nonabsorbable in the human body.
  • the strongest polypropylene monofilaments can generally be made from resins of high molecular weight and high crystallinity.
  • the processing conditions along with the resin physical properties determine the final filament properties, and it is known that to obtain the tenacity that is required of a surgical suture, the extruded polypropylene monofilament must be stretched to alignthe polymer molecules.
  • a stiff suture that has poor handling characteristics is inelastic and will break upon stretching.
  • the polypropylene sutures of the prior art were characterized by an ultimate elongation (the percent increase in the length of the monofilament when stretched at room temperature to the breaking point) of less than 25 percent.
  • the flexible polypropylene monofilaments of the present invention are characterized by an ultimate elongation of 35 to about 63 percent.
  • the extruded polypropylene monofilament may be drawn at conventional temperatures, i.e., between about 260 and 325 F. At about 330 F., the monofilament is approaching the molten stage, and breakage can be a problem.
  • the tenacity of the monofilament is somewhat higher if the drawing is effected at the low temperature (in the-neighborhood of 260 F.).
  • a product, the tensile strength of which is suitable for suture use (tenacity 3.3 to 8.5 grams per denier), may be obtained with a draw ratio of about 6.6:] at 260-325 F.
  • the preferred drawing temperature for practicing the present invention is 300 F.
  • the relaxing of shrinking of the monofilament is also carried out at an elevated temperature, which may be within the range of the drawing temperature, i.e., 260 to 325 F. Again, it is preferred to shrink the monofilament at a temperature of 300 F.
  • Monofilaments that have not contracted to 91 percent of the stretched length have an ultimate elongation of about 25 percent, a Young's Modulus greater than about 6X10" and are lacking in flexibility as determined on the Gurley'tester.
  • F ilaments that have contracted more than 76 percent of the stretchedlength have an excellent hand but may be deficient in tensile strength.
  • the preferred amount of shrinkage that results in a polypropylene suture of good hand and tensile strength is about 82-85 percent.
  • a stiff or wiry suture is difficult for the surgeon to handle and tie down.
  • a flexible suture by contrast has a "dead quality and may be characterized by the surgeon as throwable.”
  • the hand of the monofilament suture can be related to certain physical characteristics that will enable one to predict its acceptability to the surgeon independent of such subjective parameters as throwability, deadness, flexibility, or hand.
  • One instrument that has been specifically designed to measure the stifi'ness or flexibility of textile materials is the Gurley tester.
  • Gurley stiffness of a monofilament suture as measured by this instrument is a measure of the desirability of a suture from the standpoint of its handling characteristics.
  • FIGS. la and lb illustrate apparatus for extruding and drawing polypropylene monofilament in accordance with the invention.
  • FIG. 2 is a perspective view of two godets that draw and orient the polypropylene monofilament.
  • FIG. 3 is a perspective view of the godets shown in FIG. 2 and illustrates the simultaneous drawing of four polypropylene monofilaments.
  • FIG. 4 is a perspective view of a creel.
  • FIG. 5 is an enlarged view partially in section of the lower left leg of the creel as viewed from the right in FIG. 4, showing the creel in an extended position.
  • FIG. 6 is a sectional view of the leg of the creel illustrated in FIG. 5, showing the creel in a modified position.
  • FIG. 7 is a sectional view of the leg of the creel illustrated in FIG. 5, showing the creel in a retracted position.
  • FIG. 8 is a sectional view of the leg of the creel on the line 8-8 of FIG. 5.
  • FIG. 9 is a perspective view of a Gurley stifiness tester.
  • FIG. 10 is a perspective view of a jig designed to be used with the Gurley tester.
  • FIG. 11 is a sectional view on the Line ll 11 of FIG. 10.
  • FIG. 12 is a reproduction of a stress-strain curve, obtained by applying stress at a constant rate to a polypropylene strand that has been produced in accordance with the present invention.
  • the preferred method for preparing the flexible polypropylene sutures of the present invention utilizes as the raw material pellets of isotatic polypropylene having a weight average molecular weight of from about 299,000 to about 316,000 and a number average molecular weight of from about 78,400 to about 82,100.
  • the computed ratio of MN,,JMW, is 3.84.
  • Polypropylene of this grade is available in both powder and pellet form. Pellets, the maximum diameter of which do not exceed one-fourth inch, may be used in the process to be described.
  • the extruder that is used to form the polypropylene monofilament has a cylindrical barrel 11 supported in a horizontal plane and terminating at one end at an adapter section 12 which leads to an extrusion die 14.
  • a longitudinal screw 16 is mounted for rotation within the barrel 11 and is driven by the sprocket gear 18 positioned at the end of the extruder that is remote from the die through the chain 19 and a variable speed motor not shown.
  • Polypropylene pellets flow by gravity from the hopper 21 into the cylindrical barrel of the extruder and are moved by the screw 16 in the direction of the die.
  • the temperature of the extruder is controlled by three electrical heating units 22, 23, and 24, which surround the barrel 11 and the die 14.
  • a cooling jacket 25 surround that end of the extruder barrel that is most remote from the die and removes heat from that end of the screw 16 that lies beneath the hopper.
  • the die 14 is constructed with a long land length and may have one or more orifices.
  • the die orifice has an entrance angle of 20. With this entrance angle, streamlined flow is obtained insuring uniform extrudate.
  • Polypropylene pellets are placed in the hopper 21 and flow by gravity into the barrel 12 of the extruder which is at that point maintained at room temperature or below by water flowing through the cooling jacket 25.
  • the screw 16 conveys the polypropylene pellets through the feeding zone 22 into the metering zone 23 of the extruder wherein the polypropylene pellets are compressed and metered.
  • the melted polypropylene then passes through the die 14, the temperature of which is controlled by a heating jacket 24, and into a quenching bath 27, which may be a water bath.
  • the feeding zone 22 is maintained at about 430F., the metering zone 23 between 400 and 450 F., the die 14 between 400 and 450 F., and the quenching bath at about 75 to 85 F.
  • the extruded monofilament 28 is solidified as it moves downwardly into the quench bath.
  • the monofilament passes around the idler 30, over the roller 32, and is wrapped around the godets 33 and 34 to prevent the slipping that might otherwise occur as a result of stretching the monofilament to orient the same and increase its tensile strength.
  • the monofilament from the godet 33 is stretched and oriented by passing it through the heating chamber 36 and around the godets 38 and 39 which rotate at a higher peripheral velocity than the godets 33 and 34, thereby stretching the monofilament from six or seven times its original length and orienting the monofilament.
  • the manner of wrapping the polypropylene monofilament around the godets 38 and 39 is shown in FIGS. 2 and 3.
  • FIG. 3 illustrates the arrangement of four monofilaments extruded simultaneously through a die having four orifices.
  • the temperature of the monofilament as it passes through the chamber 36 is maintained at about 260 to 325 F.
  • the stretched and oriented monofilament from the godet 38 passes over the guides 40 and the reciprocating guide 41 and is collected on spool 42.
  • the spools of polypropylene monofilament may be stored for further processing.
  • the monofilament is permitted to shrink.
  • This step may be carried out by a discontinuous process whereby a fixed length of polypropylene monofilament is heated to about 300 F. and permitted to shrink to between 92 and 75 percent of its original length.
  • the discontinuous finishing process is illustrated in FIGS. 4 through 8.
  • the polypropylene monofilament is transferred from spool 42 to a creel 43 by rotating the creel on its axle 44, power being supplied by the motor 46 through the pulleys 47 and 48 and the belt 49.
  • the creel 43 may be conveniently constructed of channel iron with two-leg sections 50 and 52 that are welded at one end to a crossbar 53. The opposite ends of these leg sections slidably receive channel sections 54 and 55, which are welded to a crossbar 57. The position of the crossbar 57 is fixed with respect to the opposite crossbar 53 by the stay bolts 58 and 59 which pass through the channel section 54 and the leg section 50. Similar bolts 58 and 59' pass through the channel section 55 and the leg section 52.
  • the long dimension of the creel measures 50% inches when extended as shown in FIG. 4.
  • a retention strip 56 is fastened to the crossbar 53 of the creel by bolts 51, thereby compressing the polypropylene monofilaments between the retention strip and the end of the creel.
  • a second retention strip 56' is bolted to the opposite crossbar 57 of the creel thereby preventing the polypropylene from shifting during the heat-shrinking step.
  • the channel sections 54 and 55 are then telescoped into the legs 50 and 52 a distance corresponding to the desired amount of shrinkage and the stay bolts replaced.
  • the creel is then placed in an oven maintained at 300 F. and rotated at 5-20 r.p.m. to insure uniform heating. At this temperature, the polypropylene that is wrapped on the creel shrinks causing the channel sections 54 and 55 of the creel to telescope into the leg sections 50 and 52 as indicated by FIG. 6.
  • the creel is removed from the oven after 10 minutes and is permitted to cool to room temperature.
  • the position of the end 57 of the creel after the heatshrinking step is shown in FIG. 7. As indicated above, the creel in its extended position (FIG.
  • each 505a-inch length of polypropylene amounts to 8% inches (from 50% inches to 42 inches in increments that permit shrinking of the monofilament from 91 to 75.6 percent.
  • polypropylene sutures size 2 through 7/0
  • polypropylene sutures size 2 through 7/0
  • polypropylene sutures size 2 through 7/0
  • isotatic polypropylene having a weight average molecular weight of between about 294,000 and about 316,000 and a number average molecular weight of between about 78,400 and about 82,100.
  • copper phthalocyanine dye To this resin is added 0.5 percent by weight of copper phthalocyanine dye, which imparts a dark blue color to the resin and the monofilaments extruded therefrom.
  • Heat stabilizers and other processing compounds known in the art may be added to improve the resistance to oxidation during the extrusion and processing steps.
  • Compounds commonly used for this purpose are tertiary butyl-o-cresol (IONOL) together with dilauryl thio-propionate in amounts of about 0.25 percent each.
  • the tensile strength and percent elongation at break reported in examples I through XIII are determined by A.S.T.M. method D225666T using a constant rate of extension tester, namely a table model INSTRON universal testing instrument manufactured by the Instron Corporation of Canton, Massachusetts. This test method is described in the 1966 Book of A.S.T.M. Standards, part 24 (published in Aug. of 1966 by the American Society for Testing Material, I916 Race Street, Philadelphia, Pennsylvania). The 20 seconds to break is approximated by using a 1-inch sample (or gauge length) with the INSTRON Tester crosshead speed set at 1 inch per minute.
  • knot strength is determined by the test method described in the US. Pharmacopeia, Vol. XVII, page 921.
  • Young's Modulus is detennined on a Table Model lN- STRON instrument using line contact jaw faces to minimize slippage. A 10.0-inch sample is elongated at the rate of 5.0
  • the Gurley stiffness is measured with a motor-operated Gurley Stiffness Tester (Model 4171) manufactured by W. and L.. E. Gurley of Troy, New York.
  • This instrument illustrated in FIG. 9, consists of a balanced pendulum or pointer 60, which is center pivoted and which can be variously weighted below itscenter with a removable weight 61.
  • the pointer moves parallel to a sine scale 62 graduated in both directions.
  • 10-inch polypropylene monofilament strands a total of at least 20 inches, are required per sample.
  • the strands used should be relatively straight.
  • the 10, 2-inch strands 63 are inserted in the jig illustrated in FIGS. and 11.
  • the jig is constructed with 10 parallel holes drilled on )-inch centers.
  • the polypropylene strands are inserted so that at least I inch of each strand protrudes beyond the bending bar 64, and a locking pin 65 is inserted to clamp the monofilaments in the jig.
  • a razor blade is used to shave closely the strand tips which extend from the back of the jig, and all 10 strands are cut 1 inch from the edge of the bending bar 64 on the opposite side of the clamp.
  • the jig is placed on the motor-driven arm 68 of the Gurley instrument so that the clamp-bending bar lies one-half inch above the edge 70 of the swinging pendulum.
  • the motor-driven arm 68 presses the monofilaments 63 against the edge 70 of the pendulum, the pointer is deflected until the sample scrapes past the pendulum and may be read on the scale 62.
  • the resistance of the pendulum and thus the sensitivity of the machine to materials of different stiffness can be adjusted in two ways: by changing the distance from the fulcrum 67 of the weight 61 and by changing the weight itself.
  • the machine is operated for one or two cycles to adjust the weight-distance combination if necessary. This adjustment should be made so that the average reading will fall between 2.0 and 7.0 Gurley units. (A cycle is defined as a left plus a right swing of the pointer 60. A Gurley unit is the unit reading marked on the sine scale). After the necessary adjustments are made, the machine is operated for 10 cycles without recording the results. After each half cycle, the oscillation of the pendulum is stopped before continuing. The readings of cycles 11 through 15 are recorded and averaged. The stiffness of the polypropylene monofilament sample may then be calculated by use of the following formula:
  • Gurley stiffness (mg) 0.0002 RWD, where R test reading in Gurley units W counterweight (g.) D distance of counterweight from fulcrum (inches)
  • the present invention will be further illustrated by the following examples which describe the manufacture of polypropylene sutures of different sizes, all of which have a Youngs Modulus below 6 l0 p.s.i. and an elongation at break.of at least 35 percent.
  • the area compensator on the lNSTRON Tester is set for the correct diameter of the suture (to give readout in p.s.i.) and the strand is elongated at a constant rate to 122.5 percent of the original length (preset on the lNSTRON).
  • the lNSTRON machine is operated at a crosshead speed of 5 inches per minute and a chart speed of 20 inches per minute.
  • Youngs Modulus (p.s.i. X 10 is the initial modulus as determined from the slope of the curve A of FIG. 12. Young's Modulus is the ratio of applied stress to strain in the elastic region and measures the elastic component of a suture's resistance to stress. This value is related to the flexibility of a suture.
  • Plastic flow (p.s.i. X 10) is the viscoelastic modulus as determined from the slope of the curve B of FIG. 12. It measures the plastic component of a sutures resistance to stress and is related to the "give a suture exhibits under a force in excess of the yield stress.
  • the yield stress (p.s.i. X 10) is the first point of inflection in the stress-strain curve or the point of intersection C of the slopes A and B of FIG. 12. Yield Stress measures the force required to initiate viscoelastic flow and is related to the straightenability of a suture.
  • Typical pliability data as determined from the stress-strain curves of the polypropylene sutures of the present invention is summarized in table I. The date is obtained after aging the sample for 1 month.
  • a size 7/0 polypropylene suture, diameter 2.6 mils, is prepared by the general procedure described above.
  • the die orifice measures 20 mils in diameter, and the flow rate of the polypropylene through the die orifice is 0.06 pounds per hour.
  • the temperature of the feed zone is maintained at 430 F., and the temperature of the die and extruder barrel is maintained at 450 F.
  • the ratio of the rate of takeup of the godet 33 to the linear rate of extrusion (draw ratio) is 5.9.
  • the water bath is maintained at 75-84 F.
  • the heating chamber is 7 feet in length and is maintained at 285 F., as measured with a pyrometer.
  • the polypropylene monofilament enters the chamber at the linear rate of 50 feet per minute andjis taken up on the godet 38 at the linear rate of 330 feet per minute (stretched 6.6 times its original length).
  • the propylene monofilament after hot stretching is collected on the takeup spool 42 and transferred to the creel 43 illustrated in FIGS. 4-8.
  • the tension strips are applied to either end of the creel and the distance between the crossbars 53 and 57 is adjusted by the stay bolts 58, 59, 58' and 59 to permit the desired amount of shrinkage.
  • the creel is then heated in an oven at 285 F. and rotated at 10 r.p.m. for 10 minutes; during which time the monofilament shrinks to 5% times its original length (from 50% to 42 inches or 83.5 percent).
  • polypropylene from the same extrusion batch (stretched 6.6 times its original length) is removed from the takeup spool 42, placed on the creel, and heated in an oven at 300 F. for 10 minutes with no relaxation.
  • the length of the monofilament is 52% inches prior to and after the 10 minutes heat treatment at 300 F.
  • the following table shows the differences in the physical properties of polypropylene monofilament that has been (1) hot stretched 6.6 X while maintaining the temperature at 285 F.; (2) hot stretched 6.6 X its original length while maintaining the temperature at 285 F. and then annealing for l minutes at 300 F. without relaxation; and (3) hot stretched 6.6 X its original length while maintaining the temperature at 285 F. and the annealing for 10 minutes at 300 F. while relaxing to 5.5 X its original length (83.5 percent of its hot stretched length).
  • the data is obtained after aging the samples for 1 month.
  • a size 5/0 polypropylene suture, diameter 4.9 mils. is prepared by the general procedure described above.
  • the die orifice measures mils in diameter, and the flow rate of the polypropylene through the die orifice is 0.09 pounds per hour.
  • the temperature of the feed zone is maintained at 430 F.. and the temperature of the die and extruder barrel is maintained at 450 F.
  • the ratio of the rate of takeup of the godet 33 to the linear rate of extrusion (draw ratio) is 2.32.
  • the water bath is maintained at 75-84 F.
  • the heating chamber is 7 feet in length and is maintained at 285 F. as measured with a pyrometer.
  • the polypropylene monofilament enters the chamber at the linear rate of 30 feet per minute and is taken up on the godet 38 at the linear rate of 198 feet per minute (stretched 6.6 times its original length).
  • the polypropylene monofilament after hot stretching is collected on the takeup spool 42 and transferred to the creel 43 illustrated in FIGS. 4-8.
  • the tension strips are applied to either end of the creel and the distance between the crossbars $3 and 57 is adjusted by the stay bolts 58, 59, 58' and 59' to permit the desired amount of shrinkage.
  • the creel is then heated in an oven at 285 F. and rotated at 10 r.p.m. for ID minutes; during which time the monofilament shrinks to 5 V2 its original length (from 50% to 42 inches or 83.5 percent).
  • propylene from the same extrusion batch (stretched 6.6 times its original length) is removed from the takeup spool 42, placed on the creel, and heated in an oven at 300 F. for l0 minutes with no relaxation.
  • the length of the monofilament is 52% inches prior to and after the 10- minute heat treatment at 300 F.
  • the physical properties of the product so obtained are summarized in the following table. The data is obtained after aging the samples for l month.
  • EXAMPLE IV A size 4/0 polypropylene suture, diameter 6.9 mils, is prepared by the general procedure described above. The die orifice measures 34 mils in diameter, and the flow rate of the polypropylene through the die orifice is 0.24 pounds per hour.
  • the heating chamber is 7 feet in length and is maintained at 295 F. as measured with a pyrometer.
  • the polypropylene monofilament enters the chamber at the linear rate of 40 feet per minute and is taken up on the godet 38 at the linear rate of 264 feet per minute (stretched 6.6 times its original length).
  • the polypropylene monofilament after hot stretching is collected on the takeup spool 42 and transferred to the creel 43 illustrated in FIGS. 4-8.
  • the tension strips are applied to either end of the creel and the distance between the crossbnrs 53 and 57 is adjusted by the stay bolts 58. 59. 58 and 59' to permit the desired amount of shrinkage.
  • the creel is then heated in an oven at 300 and rotated at l0 r.p.m. for 10 minutes; during which time the monofilament shrinks to 5% times its original length (from 50% to 42 inches or 83.5 percent).
  • polypropylene from the same extrusion batch (stretched 6.6 times its original length) is removed from the takeup spool 42, placed on the creel, and heated in an oven at 300 F. and rotated at l0 r.p.m. for l0 minutes with no relaxation.
  • the length of the monofilament is 52% inches prior to and after the lO-minutc heat treatment at 300 F.
  • the difl'erence in the physical properties of polypropylene monofilament that has been drawn, annealed without relaxation and heat relaxed to 83.5 percent of its original length is summarized in the following table. The data is obtained after aging the sample for 1 month.
  • the temperature f the f d long is maintain; at 430 [and the temperature of the die and extruder barrel is maintained at 430 F.
  • the ratio of the rate of takeup of the godet 33 to the linear rate of extrusion (draw ratio) is 2.26.
  • the water bath is maintained at 75-84 F.
  • the heating chamber is 7 feet in length and is maintained at 260 F. as measured with a pyrometer.
  • the polypropylene monofilaments enters the chamber at the linear rate of 25 feet per minute and is taken up on the godet 38 at the linear rate of 165 feet per minute (stretched 6.6 times its original length).
  • the polypropylene monofilament after hot stretching is collected on the takeup spool 42 and transferred to the creel 43 illustrated in FIGS. 4-8.
  • the tension strips are applied to either end of the creel and the distance between the crossbars 53 and 57 is adjusted by the stay bolts 58, 59, 58' and 59' to permit the desired amount of shrinkage.
  • the creel is then heated in an oven at 300 F. and rotated at 10 r.p.m. for 10 minutes; during which time the monofilament shrinks to 5% times its original length (from 50% to 42 inches or 83.5 percent).
  • polypropylene from the same extrusion batch (stretched 6.6 times its original length) is removed from the takeup spool 42, placed on the creel, and heated in an oven at 300 F. and rotated at 10 r.p.m. for 10 minutes with no relaxation.
  • the length of the monofilament is 52% inches prior to and after the l-minute heat treatment at 300 F.
  • the difference in the physical properties of polypropylene monofilament that has been drawn, annealed without relaxation and heat relaxed to 83.5 percent of its original length is summarized in the following table. The data is obtained after aging the samples for 1 month.
  • a size 2/0 polypropylene suture, diameter 1 1.1 mils, is prepared by the general procedure described above.
  • the die orifice measures 54 mils in diameter, and the flow rate of the polypropylene through the die orifice is 0.60 pounds per hour.
  • the temperature of the feed zone is maintained at 430 F., and the temperatures of the die and extruder barrel is maintained at 430 F.
  • the ratio of the rate of takeup of the godet 33 to the linear rate of extrusion (draw ratio) is 3:33.
  • the water bath is maintained at 75-84 F.
  • the heating chamber is to 7 feet in length and is maintained at 230 F. as measured with a pyrometer.
  • the polypropylene monofilament enters the chamber at the linear rate of 38 feet per minute and is taken up on the godet 38 at the linear rate of 250 feet per minute (stretched 6.6 times its original length).
  • the polypropylene monofilament after hot stretching is collected on the takeup spool 42 and transferred to the creel 43 illustrated in FIGS. 4-8.
  • the tension strips are applied to either end of the creel and the distance between the crossbars 53 and 57 is adjusted by the stay bolts 58, 59, 58' and 59' to permit the desired amount of shrinkage.
  • the creel is then heated in an oven at 300 F. and rotated at 10 r.p.m. for 10 minutes; during which time the monofilament shrinks to 5 A its original length (from 50% to 42 inches or 83.5 percent).
  • polypropylene from the same extrusion batch (stretched 6.6 times its original length) is removed from the takeup spool 42, placed on the creel, and heated in an oven at 300 F. and rotated at 10 r.p.m. for 10 minutes with no relaxation.
  • the length of the monofilament is 52% inches prior to and after the IO-minute heat treatment at 300 F.
  • the difference in the physical properties of polypropylene monofilament that has been drawnannealed withoutrelaxation and heat relaxed to 83.5 percent of its original length is summarized in the following table. The data is obtained after aging the samples for 1 month.
  • a size of 0 polypropylene suture, diameter 13.8 mil, is prepared by the general procedure described above.
  • the die orifice measures 54 mils in diameter, and the flow rate of the polypropylene through the die orifice is 0.59 pounds per hour.
  • the temperature of the feed zone is maintained at 430 F., and the temperature of the die and extruder barrel is maintained at 430 F.
  • the ratio of the rate of takeup of the godet 33 to the linear rate of extrusion (draw ratio) is 2.22.
  • the water bath is maintained at -84 F.
  • the heating chamber is 7 feet in length and is maintained at 240 F. as measured with a pyrometer.
  • the polypropylene monofilament enters the chamber at the linear rate of 25 feet per minute and is taken up on the godet 38 at the linear rate of feet per minute (stretched 6.6 times its original length).
  • the polypropylene monofilament after hot stretching is collected on the takeup spool 42 and transferred to the creed 43 illustrated in FIGS. 4-8.
  • the tension strips are applied to either end of the creel and the distance between the crossbars 53 and 57 is adjusted by the stay bolts 58, 59, 58' and 59' to permit the desired amount of shrinkage.
  • the creel is then heated in an oven at 300 F. and rotated at 10 r.p.m. for 10 minutes; during which time the monofilament shrinks to 5% times its original length (from 50% to 42 inches or 83.5 percent.).
  • polypropylene from the same extrusion batch (stretched 6.6 times its original length) is removed from the takeup spool 42, placed on the creel, and heated in an oven at 300 F. and rotated at 10 r.p.m. for 10 minutes with no relaxation.
  • the length of the monofilament is 52% inches prior to and after the 10-minute heat treatment at 300 F.
  • the difference in the physical properties of polypropylene monofilament that has been drawn annealed without relaxation and heat relaxed to 83.5 percent of its original length is summarized in the following table. The data is obtained after aging the samples for 1 month.
  • EXAMPLE VIII A size 1 polypropylene suture, diameter 16.1 mil, is prepared by the general procedure described above.
  • the die orifice measures 54 mils in diameter, and the flow rate of the polypropylene through the die orifice is 0.80 pounds per hour.
  • the temperature of the feed zone is maintained at 430 F., and the temperature of the die and extruder barrel is maintained at TABLE VII p yp pylene stretched (3) Polypropylene stretched (1) Poly- 6.621 and 6.611 and propylene annealed at relaxed to 83. 5% stretched 300 F. for of stretched 6.6:1 10 min. length Lot number 107947 107947 107947 Diameter, mils 13. 8 14.0 14.8 i.D en
  • the heating chamber is 7 feet in length and is maintained at 255 F. as measured with a pyrometer.
  • the polypropylene monofilament enters the chamber at the linear rate of 23 feet per minute and is taken up on the godet 38 at the linear rate of 152 feet per minute (stretched 6.6 times its original length).
  • the polypropylene monofilament after hot stretching is collected on the takeup spool 42 and transferred to the creel 43 illustrated in FIGS. 4-8.
  • the tension strips are applied to either end of the creel and the distance between the crossbars 53 and 57 is adjusted by the stay bolts 58, 59, 58' and 59 to permit the desired amount of shrinkage.
  • the creel is then heated in an oven at 300 F. and rotated at r.p.m. for 10 minutes; during which time the monofilament shrinks to 5% times its original length (from 50% to 42 inches or 83.5 percent).
  • polypropylene from the same extrusion batch (stretched 6.6 times its original length) is removed from the takeup spool 42, placed on the creel, and heated in an oven at 300 F. and rotated at 10 r.p.m. for 10 minutes with no relaxation.
  • the length of the monofilament is 52% inches prior to and after the lO-minute heat treatment at 300 F.
  • the difference in the physical properties of polypropylene monofrlament that has been drawn annealed without relaxation and heat relaxed to 83.5 percent of its original length is summarized in the following table. The data is obtained after aging the samples for 1 month.
  • a size 2 polypropylene suture, diameter 19.4 mils is prepared by the general procedure described above.
  • the die orifice measures 64 mils in diameter, and the flow rate of the polypropylene through the die orifice is 1.1 pounds per hour.
  • the temperature of the feed zone is maintained at 430 F and the temperature of the die and extruder barrel is maintained at 430 F.
  • the ratio of the rate of takeup of the godet 33 to the linear rate of extrusion (draw ratio) is 1.70.
  • the water bath is maintained at 75-84 F.
  • the heating chamber is 7 feet in length and is maintained at 230 F. as measured with a pyrometer.
  • the polypropylene monofilament enters the chamber at the linear rate of 26 feet per minute and is taken up on the godet 38 at the linear rate of 168 feet per minute (stretched 6.6 times its original length).
  • the polypropylene monofilament after hot stretching is collected on the takeup spool 42 and transferred to the creel 43 illustrated in FIGS. 4-8.
  • the tension strips are applied to either end of the creel and the distance between the crossbars 53 and S7 is adjusted by the stay bolts 58, 59, 58' and 59' to permit the desired amount of shrinkage.
  • the creel is heated in an oven at 300 F. and rotated at l0 r.p.m. for 10 minutes; during which time the monofilament shrinks to 5% times its original length (from 50% to 42 inches or 8.35 percent).
  • polypropylene from the same extrusion batch (stretched 6.6 times its original length) is removed from the takeup spool 42, placed on the creel, and heated in an oven at 300 F. and rotated at 10 r.p.m. for 10 minutes with no relaxation.
  • the length of the monofilament is 52% inches prior to and after the 10-minute heat treatment at 300 F.
  • the difference in the physical properties of polypropylene monofilament that has been drawn, annealed without relaxation and heat relaxed to 83.5 percent of its original length is summarized in the following table. The data is obtained after aging the samples for 1 month.
  • a size 3/0 polypropylene suture, diameter 9.14 mils, is prepared by the general procedure described in example V. Instead of stretching the polypropylene monofilament 6.6 times, however, it is stretched 6.0 times its original length in a heating chamber maintained at 260 F.
  • the polypropylene monofilament after hot stretching is collected on the takeup spool 42 and transferred to the creel 43 illustrated in FIGS. 4-8.
  • the tension strips are applied to either end of the creel and the distance between the crossbars 53 and 57 is adjusted by the stay bolts 58, 59, 58 and S9 to permit the desired amount of shrinkage.
  • the creel is then heated in an oven at 300 F. and rotated at 10 r.p.m. for 10 minutes; during which time the monofilament shrinks to 5% times its original length (91.6 percent).
  • polypropylene from the same extrusion batch (stretched 6.0 times its original length) is removed from the takeup spool 42, placed on the creel and heated in an oven at 300 F. and rotated at 10 r.p.m. for l0 minutes with no relaxation.
  • the length of the monoiilament is 52% inches prior to and after the lO-minute heat treatment at 300 F.
  • polypropylene from the same extrusion batch (stretched 7.0 times its original length) is removed from the takeup spool 42, placed on the creel and heated in an oven at 300 F. and rotated at 10 r.p.m. for 10 minutes with no relaxation.
  • the length of the monofilament is 52% inches prior to and after the 10-minute heat treatment at 300 F.
  • a size 0 polypropylene suture, diameter 13.9 mils, is prepared by the general procedure described above in example VII.
  • the die orifice measures 54 mils in diameter, and the flow rate of the polypropylene through the die orifice is 0.59 pounds per hour.
  • the temperature of the feed zone is maintained at 430 F., and the temperature of the die and extruder barrel is maintained at 430 F.
  • the ratio of the rate of takeup of the godet 33 to the linear rate of extrusion (draw ratio) is 2.22.
  • the water bath is maintained at 7S-84 F.
  • the heating chamber is 7 feet in length and is maintained at 240 F. as measured with a pyrometer.
  • the polypropylene monofilament enters the chamber at the linear rate of 25 feet per minute and is taken up on the godet 38 at the linear rate of 165 feet per minute (stretched 6.6 times its original length).
  • the polypropylene monofilament after hot stretching is collected on the takeup spool 42 and transferred to the creel 43 illustrated in FIGS. 4-8.
  • the tension strips are applied to either end of the creel and the distance between the crossbars 53 and 57 is adjusted by the stay bolts 58, 59., 58' and 59' to pennit the desired amount of shrinkage.
  • the creel is then heated in an oven at 300 F. and rotated at 10 r.p.m. for l0 minutes; during which time the monofilament shrinks to 6.0 times its stretched length.
  • polypropylene from the same extrusion batch (stretched 6.6 times its original length) is removed from the takeup spool 42, placed on the creel, and heated in an oven at 300 F. and rotated at l0 r.p.m. for 10 minutes with no relaxation.
  • the length of the monofilament is 52% inches prior to and after the 10-minute heat treatment at 300 F.
  • the difference in the physical properties of polypropylene monofilament that has been drawn, annealed without relaxation and heat relaxed to 9l percent of its stretched length is summarized in the following table.
  • the data obtained after aging the sample for 1 week is as follows.
  • An isotactic polypropylene monofilament suture the diameter of which is in the range of from about 0.002 to about 0.020 inches, said isotactic polypropylene having the following characteristics:
  • a needled surgical suture comprising an isotactic about 294.000 to about 3l6,000
  • polypropylene suture attached to a surgical needle, said needle and said suture being sterile, said isotactic polypropylene having approximately the following characteristics:
US3630205D 1969-07-31 1969-07-31 Polypropylene monofilament sutures Expired - Lifetime US3630205A (en)

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CA (1) CA968244A (de)
DE (1) DE2037813C3 (de)
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NO (1) NO133310C (de)
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WO1986000020A1 (en) * 1984-06-14 1986-01-03 Bioresearch Inc. Composite surgical sutures
EP0176183A1 (de) * 1984-07-30 1986-04-02 Pfizer Hospital Products Group, Inc. Hartelastische, chirurgische Nahtmaterialien
US4621638A (en) * 1984-07-30 1986-11-11 Pfizer Hospital Products Group, Inc. Hard elastic sutures
US4911165A (en) * 1983-01-12 1990-03-27 Ethicon, Inc. Pliabilized polypropylene surgical filaments
US4932404A (en) * 1980-10-29 1990-06-12 Unitaka, Ltd. Chitin fibers and process for the production of the same
US5007922A (en) * 1989-11-13 1991-04-16 Ethicon, Inc. Method of making a surgical suture
AU625405B2 (en) * 1989-09-01 1992-07-09 Ethicon Inc. Thermal treatment of thermoplastic filaments
WO1992012673A1 (en) * 1991-01-18 1992-08-06 Eaton Alexander M Adjustable sutures and methods of making and using same
EP0526759A1 (de) * 1991-07-12 1993-02-10 United States Surgical Corporation Monofilamentnahtmaterialien aus Polypropylen und Verfahren zu seiner Herstellung
US5222978A (en) * 1987-08-26 1993-06-29 United States Surgical Corporation Packaged synthetic absorbable surgical elements
US5225485A (en) * 1992-03-03 1993-07-06 United States Surgical Corporation Polyetherimide ester suture and its method of manufacture and method of use
US5269807A (en) * 1992-08-27 1993-12-14 United States Surgical Corporation Suture fabricated from syndiotactic polypropylene
US5284489A (en) * 1992-08-19 1994-02-08 United States Surgical Corporation Filament fabricated from a blend of ionomer resin and nonionic thermoplastic resin
US5287634A (en) * 1992-02-07 1994-02-22 United States Surgical Corporation Removal of vaporizable components from polymeric products
US5294395A (en) * 1989-09-01 1994-03-15 Ethicon, Inc. Thermal treatment of theraplastic filaments for the preparation of surgical sutures
US5294389A (en) * 1991-06-14 1994-03-15 United States Surgical Corporation Dynamic treatment of suture strand
EP0588302A1 (de) * 1992-09-14 1994-03-23 United States Surgical Corporation Ionomerisches Nahtmaterial, seine Herstellung und Anwendungsverfahren
US5359831A (en) * 1989-08-01 1994-11-01 United States Surgical Corporation Molded suture retainer
US5366081A (en) * 1987-08-26 1994-11-22 United States Surgical Corporation Packaged synthetic absorbable surgical elements
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US5494620A (en) * 1993-11-24 1996-02-27 United States Surgical Corporation Method of manufacturing a monofilament suture
EP0726078A1 (de) * 1995-02-10 1996-08-14 Ethicon, Inc. Inlinie-Glühen von Nähten
US5626811A (en) * 1993-12-09 1997-05-06 United States Surgical Corporation Process of making a monofilament
EP0786259A2 (de) 1996-01-19 1997-07-30 United States Surgical Corporation Absorbierbare polymer Mischungen und chirurgische Gegenstände daraus
US5871502A (en) * 1996-04-08 1999-02-16 Ethicon, Inc. Process for manufacturing a polypropylene monofilament suture
US6063105A (en) * 1996-06-18 2000-05-16 United States Surgical Medical devices fabricated from elastomeric alpha-olefins
US6093200A (en) * 1994-02-10 2000-07-25 United States Surgical Composite bioabsorbable materials and surgical articles made therefrom
US6287499B1 (en) 1998-10-09 2001-09-11 United States Surgical Corporation Process of making bioabsorbable block copolymer filaments
US6387363B1 (en) 1992-12-31 2002-05-14 United States Surgical Corporation Biocompatible medical devices
US20020177876A1 (en) * 2001-03-26 2002-11-28 Tyco Healthcare Group Lp Polyolefin sutures having improved processing and handling characteristics
US6613254B1 (en) 1999-10-19 2003-09-02 Ethicon, Inc. Method for making extruded, oriented fiber
US20040092964A1 (en) * 1999-03-04 2004-05-13 Modesitt D. Bruce Articulating suturing device and method
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US20060212072A1 (en) * 2005-03-16 2006-09-21 Cuevas Brian J Polyolefin sutures having enhanced durability
US20060241693A1 (en) * 2005-04-26 2006-10-26 Peregrina Carlos A Plastic mono-filamentary thermo-contractible surgical thread
US20070016251A1 (en) * 2005-07-13 2007-01-18 Mark Roby Monofilament sutures made from a composition containing ultra high molecular weight polyethylene
US7462188B2 (en) 2003-09-26 2008-12-09 Abbott Laboratories Device and method for suturing intracardiac defects
US20100292730A1 (en) * 2002-10-04 2010-11-18 John Kennedy Process of making bioabsorbable filaments
US7837696B2 (en) 1999-03-04 2010-11-23 Abbott Laboratories Articulating suturing device and method
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US7842048B2 (en) 2006-08-18 2010-11-30 Abbott Laboratories Articulating suture device and method
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US8048108B2 (en) 2005-08-24 2011-11-01 Abbott Vascular Inc. Vascular closure methods and apparatuses
US8083754B2 (en) 2005-08-08 2011-12-27 Abbott Laboratories Vascular suturing device with needle capture
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US20120109195A1 (en) * 2009-05-08 2012-05-03 Itv Denkendorf Produktservice Gmbh Elastomeric thread having anchoring structures for anchoring in biological tissues
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US4932404A (en) * 1980-10-29 1990-06-12 Unitaka, Ltd. Chitin fibers and process for the production of the same
US4470941A (en) * 1982-06-02 1984-09-11 Bioresearch Inc. Preparation of composite surgical sutures
US4911165A (en) * 1983-01-12 1990-03-27 Ethicon, Inc. Pliabilized polypropylene surgical filaments
US4557264A (en) * 1984-04-09 1985-12-10 Ethicon Inc. Surgical filament from polypropylene blended with polyethylene
WO1986000020A1 (en) * 1984-06-14 1986-01-03 Bioresearch Inc. Composite surgical sutures
EP0176183A1 (de) * 1984-07-30 1986-04-02 Pfizer Hospital Products Group, Inc. Hartelastische, chirurgische Nahtmaterialien
US4621638A (en) * 1984-07-30 1986-11-11 Pfizer Hospital Products Group, Inc. Hard elastic sutures
US5222978A (en) * 1987-08-26 1993-06-29 United States Surgical Corporation Packaged synthetic absorbable surgical elements
US5366081A (en) * 1987-08-26 1994-11-22 United States Surgical Corporation Packaged synthetic absorbable surgical elements
US5468252A (en) * 1987-08-26 1995-11-21 United States Surgical Corporation Packaged synthetic absorbable surgical elements
US5359831A (en) * 1989-08-01 1994-11-01 United States Surgical Corporation Molded suture retainer
AU625405B2 (en) * 1989-09-01 1992-07-09 Ethicon Inc. Thermal treatment of thermoplastic filaments
US5451461A (en) * 1989-09-01 1995-09-19 Ethicon, Inc. Thermal treatment of thermoplastic filaments for the preparation of surgical sutures
US5294395A (en) * 1989-09-01 1994-03-15 Ethicon, Inc. Thermal treatment of theraplastic filaments for the preparation of surgical sutures
AU635980B2 (en) * 1989-11-13 1993-04-08 Ethicon Inc. Surgical suture
US5007922A (en) * 1989-11-13 1991-04-16 Ethicon, Inc. Method of making a surgical suture
WO1992012673A1 (en) * 1991-01-18 1992-08-06 Eaton Alexander M Adjustable sutures and methods of making and using same
US5234006A (en) * 1991-01-18 1993-08-10 Eaton Alexander M Adjustable sutures and method of using the same
US5294389A (en) * 1991-06-14 1994-03-15 United States Surgical Corporation Dynamic treatment of suture strand
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US5217485A (en) * 1991-07-12 1993-06-08 United States Surgical Corporation Polypropylene monofilament suture and process for its manufacture
US5287634A (en) * 1992-02-07 1994-02-22 United States Surgical Corporation Removal of vaporizable components from polymeric products
US5225485A (en) * 1992-03-03 1993-07-06 United States Surgical Corporation Polyetherimide ester suture and its method of manufacture and method of use
US5480411A (en) * 1992-03-03 1996-01-02 United States Surgical Corporation Method of suturing using a polyetherimide ester suture
US5284489A (en) * 1992-08-19 1994-02-08 United States Surgical Corporation Filament fabricated from a blend of ionomer resin and nonionic thermoplastic resin
EP0585814A1 (de) * 1992-08-27 1994-03-09 United States Surgical Corporation Chirurgisches Nahtmaterial aus syndiotaktischem Polypropylen und Verfahren zu seiner Herstellung
US5269807A (en) * 1992-08-27 1993-12-14 United States Surgical Corporation Suture fabricated from syndiotactic polypropylene
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US5549907A (en) * 1992-09-14 1996-08-27 United States Surgical Corporation Ionomeric suture and its method of manufacture
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US5494620A (en) * 1993-11-24 1996-02-27 United States Surgical Corporation Method of manufacturing a monofilament suture
US5626811A (en) * 1993-12-09 1997-05-06 United States Surgical Corporation Process of making a monofilament
US6093200A (en) * 1994-02-10 2000-07-25 United States Surgical Composite bioabsorbable materials and surgical articles made therefrom
EP0726078A1 (de) * 1995-02-10 1996-08-14 Ethicon, Inc. Inlinie-Glühen von Nähten
EP0786259A2 (de) 1996-01-19 1997-07-30 United States Surgical Corporation Absorbierbare polymer Mischungen und chirurgische Gegenstände daraus
US5871502A (en) * 1996-04-08 1999-02-16 Ethicon, Inc. Process for manufacturing a polypropylene monofilament suture
US6063105A (en) * 1996-06-18 2000-05-16 United States Surgical Medical devices fabricated from elastomeric alpha-olefins
US6287499B1 (en) 1998-10-09 2001-09-11 United States Surgical Corporation Process of making bioabsorbable block copolymer filaments
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US6613254B1 (en) 1999-10-19 2003-09-02 Ethicon, Inc. Method for making extruded, oriented fiber
US20020177876A1 (en) * 2001-03-26 2002-11-28 Tyco Healthcare Group Lp Polyolefin sutures having improved processing and handling characteristics
US8262963B2 (en) 2002-10-04 2012-09-11 Tyco Healthcare Group Lp Process of making bioabsorbable filaments
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DE2037813B2 (de) 1979-03-22
NL7011148A (de) 1971-02-02
DK155869B (da) 1989-05-29
NL167596C (nl) 1982-01-18
NO133310C (de) 1976-04-12
DK155869C (da) 1989-10-30
FR2055680A5 (de) 1971-05-07
CA968244A (en) 1975-05-27
GB1305420A (de) 1973-01-31
DE2037813C3 (de) 1979-11-15
ZA705280B (en) 1972-03-29
FI53923C (fi) 1978-09-11
SE382387B (sv) 1976-02-02
NO133310B (de) 1976-01-05
FI53923B (fi) 1978-05-31
DE2037813A1 (de) 1971-02-18
NL167596B (nl) 1981-08-17
JPS5314649B1 (de) 1978-05-19

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