CN102286793A - Process of making bioabsorbable filaments - Google Patents
Process of making bioabsorbable filaments Download PDFInfo
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- CN102286793A CN102286793A CN2011101598413A CN201110159841A CN102286793A CN 102286793 A CN102286793 A CN 102286793A CN 2011101598413 A CN2011101598413 A CN 2011101598413A CN 201110159841 A CN201110159841 A CN 201110159841A CN 102286793 A CN102286793 A CN 102286793A
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Abstract
Methods for making bioabsorbable copolymer filaments are provided herein. The methods include drying the polymer pellets to be extruded, melt extrusion of copolymer components, stretching the filaments in one or more draw steps and permitting the drawn filaments to relax. The copolymer preferably contains units derived from glycolide or glycolic acid and units derived from an alkylene carbonate, such as, for example, trimethylene carbonate.
Description
The cross reference of related application
The application is that the sequence number of submitting on April 1st, 2005 is 10/530, the further part application of 076 U. S. application also requires the priority of this U. S. application, this U. S. application is to be the national phase application that the international application of PCT/US2003/031360 is submitted to according to 35U.S.C. § 371 in the sequence number that on October 2nd, 2003 submitted to, the sequence number that this international application requires to submit on October 4th, 2002 is 60/416,087 U.S. Provisional Application No., mode is by reference incorporated these applications full content separately into the application.
Technical field
The disclosure relates to the method for preparing the copolymer fibril, and described copolymer fibril is used to prepare the surgical article as suture.More specifically, the disclosure relates to the fibril by the copolymer of glycolide that is used to prepare surgical sutures and propylene carbonate (trimethylene carbonate).
Background technology
Preparation is applicable to that the method for the monofilament of surgical sutures generally includes the following step: extrude at least a bio-absorbable or examples of non-bioabsorbable polymer so that fibril to be provided, stretch or elongate the fibril that solidifies realizing molecularly oriented, and the fibril of drawn is annealed to alleviate internal stress.Referring to for example sequence number is 3,092,891,3,106,442,3,630,205,4,911,165,5,217, and 485 United States Patent (USP) and sequence number are that 1,588,081 british patent specification and sequence number are 415,783 european patent application.
It is desirable to, a kind of bio-absorbable suture is provided, it has good flexibility and processing characteristics, keeps other required characteristics simultaneously, keeps (knot retention) and required absorption characteristic as knot strength, knotting.
Summary of the invention
The application provides the method that is used to prepare bio-absorbable copolymer fibril.This method comprises: the polymer beads that drying will be extruded, melt is extruded copolymer component, elongates fibril and make the fibril of drawn lax in one or more stretching step.Described copolymer can contain the unit that is derived from glycolide or glycolic acid and be derived from the unit of alkylene carbonate (as propylene carbonate).Described copolymer also can contain the material that Medicine and Surgery can be used.
In some embodiments, the method that is prepared monofilament suture by the block copolymer that comprises glycolide and propylene carbonate has been described.For example, described by comprising about 50 and prepare the certain methods of monofilament suture to the glycolide of about 80 percentage by weights and about 20 block copolymers to the propylene carbonate of about 50 percentage by weights, this method comprises the following steps: a) to extrude described copolymer so that the monofilament of fusion to be provided; B) monofilament to described fusion quenches so that the monofilament of curing to be provided; C) by temperature be maintained at about 25 ℃ to about 40 ℃ first baking ovens with about 2: 1 to recently the stretch monofilament of described curing of about 15: 1 stretching; D) by temperature be maintained at about 30 ℃ to about 150 ℃ second baking ovens with about 1.1: 1 to about 5: 1 stretching described monofilament that recently stretches; E) by temperature be maintained at about 125 ℃ to about 165 ℃ the 3rd baking ovens with about 0.5: 1 to about 0.8: 1 stretching described monofilament that recently stretches; And f) described monofilament is annealed.
In some embodiments, described by comprising about 60 and prepare the method for monofilament suture to the glycolide of about 70 percentage by weights and about 30 block copolymers to the propylene carbonate of about 40 percentage by weights, described method comprises the following steps: a) to extrude described copolymer so that the monofilament of fusion to be provided at about 170 ℃ to about 240 ℃ temperature; B) temperature for about 10 ℃ to about 80 ℃ hardening bath the monofilament to described fusion quench so that the monofilament of curing to be provided; C) by temperature be maintained at about 25 ℃ to about 40 ℃ first baking ovens with about 3: 1 to recently the stretch monofilament of described curing of about 12: 1 stretching; D) by temperature be maintained at about 30 ℃ to about 150 ℃ second baking ovens with about 1.25: 1 to about 1.50: 1 stretching described monofilament that recently stretches; E) by temperature be maintained at about 125 ℃ to about 165 ℃ the 3rd baking ovens with about 0.55: 1 to about 0.9: 1 stretching described monofilament that recently stretches; And f) described monofilament is annealed to the temperature of about 150 ℃ of variations at about 100 ℃.
In some other embodiment, also described by the method that is mainly prepared monofilament suture by best about 50 block copolymers that constitute to the propylene carbonate of about 50 percentage by weights to the glycolide of about 80 percentage by weights and about 20, described method comprises: a) extrude described copolymer so that the monofilament of fusion to be provided; B) monofilament to described fusion quenches so that the monofilament of curing to be provided; C) by temperature be maintained at about 25 ℃ to about 40 ℃ first baking ovens with about 2: 1 to recently the stretch monofilament of described curing of about 15: 1 stretching; D) by temperature be maintained at about 30 ℃ to about 150 ℃ second baking ovens with about 1.1: 1 to about 5: 1 stretching described monofilament that recently stretches; E) by temperature be maintained at about 120 ℃ to about 165 ℃ the 3rd baking ovens with about 0.5: 1 to about 0.9: 1 stretching described monofilament that recently stretches; And f) described monofilament is annealed.
Description of drawings
Describe different embodiments with reference to the accompanying drawings at this, wherein:
Fig. 1 has shown and is applicable to and implements the described method of the application to form the schematic representation of apparatus of fibril.
Fig. 2 has shown according to suture with needle of the present disclosure.
The specific embodiment
According to the disclosure, provide the monofilament that is suitable for use as suture.This monofilament can be by containing the oxyacetate unit and being derived from the bio-absorbable copolymer of the unit of alkylene carbonate (as, propylene carbonate for example).
Glycolide-propylene carbonate the copolymer that can be used to prepare fibril of the present invention is well known by persons skilled in the art.Be 4,048,256,4,243 for example at sequence number, 775,4,300,565,4,429,080 and 4,438, the copolymer and their method of preparation that are fit to are disclosed in 253 the United States Patent (USP), in this mode by reference complete the application that incorporates into of disclosure with these patents.In some embodiments, described fibril can be by comprising about 50 to the glycolide of about 80 percentage by weights and the about 20 block copolymer preparations to the propylene carbonate of about 50 percentage by weights.In other embodiments, described fibril can be by comprising about 60 to the glycolide of about 70 percentage by weights and the about 30 block copolymer preparations to the propylene carbonate of about 40 percentage by weights.The component of particularly suitable is to be used for preparing the commercially available MAXON that gets
The glycolide of suture-propylene carbonate copolymer.
Fig. 1 schematically illustrates the monofilament suture preparation process applicable to the preparation suture.Extruder unit 10 is that known or conventional type and being equipped with is used for regulating the controller of cylinder 11 in the temperature of its zones of different (for example along the length of the cylinder temperature in three continuum A, B and the progressive rising of C).By feed hopper 12 resin particle or powder are added extruder.Before or after resin is put into feed hopper to its drying.Can adopt any known technology dry resin.In some embodiments, can come dry resin by resin until reaching required dew point by flowing into nitrogen.Can use 5 to 20 scfm (scfm), be the flow velocity in 8 to the 15scfm scopes in some embodiments.Be lower than-60 ℃ dew point approximately, being lower than approximately in some embodiments ,-40 ℃ dew point is preferred dried level.
The resin transfer that electronic measuring pump 13 will be extruded through melt with constant speed is to spinning pack 14, and the spinning head 15 in the aperture by having one or more required diameters is to provide the monofilament of fusion then.The throughput of polymer depends on the size and the spinning head number of openings of the suture that is extruded, but usually can be at about 1cc to the scope of about 500cc.In some embodiments, throughput can be at about 11cc to the scope of about 306cc.Throughput can change according to the quantity of nib in suture diameter and the spinning head.The minimizing of throughput has reduced the internal stress of the monofilament that is applied to fusion in orientation process.Then, the monofilament 16 of fusion enters the hardening bath 17 that for example contains water, and monofilament solidifies there.Monofilament 16 expose from spinning head 15 back to its enter hardening bath 17 the position the distance of process, that is, the air gap can be different, and advantageously, can for about 0.25cm to about 100cm, be extremely about 20cm of about 0.5cm in some embodiments.If desired, can provide chimney-like tube cover (chimney) (not shown) or guard shield to prevent that to isolate monofilament 16 it from contacting with air-flow, otherwise air-flow may influence the cooling of monofilament in unpredictable mode.Usually, the temperature of the cylinder a-quadrant of extruder can be maintained at about 170 ℃ to 220 ℃, the temperature in B zone is maintained at about 180 ℃ to 230 ℃ and the temperature in C zone is maintained at about 190 ℃ to about 240 ℃.In some embodiments, the temperature of the cylinder a-quadrant of extruder can be maintained at about 185 ℃ to 205 ℃, the temperature in B zone is maintained at about 190 ℃ to 210 ℃ and the temperature in C zone is maintained at about 195 ℃ to about 215 ℃.Other temperature parameter can comprise: metering pump part 13 is about 180 ℃ to about 230 ℃, and spinning pack 14 is about 180 ℃ to about 230 ℃, and spinning head 15 is about 180 ℃ to about 230 ℃.The temperature of hardening bath 17 can be maintained at about 10 ℃ to about 80 ℃, and in some embodiments, be about 20 ℃ to about 30 ℃.
Monofilament 16 can pass through hardening bath 17 around the dummy roll 19 of driven roller 18 and top.Not necessarily, when monofilament when hardening bath 17 is removed, the wiper (not shown) can be removed unnecessary water from monofilament.When leaving hardening bath 17, monofilament 16 is wound on first godet roller 21 that mip rolls 22 is housed to prevent otherwise the slippage that may be caused by follow-up elongation operation; The godet roller 101,102,103 of first roller part of in the first roller part 100, reeling then and 104 or any other suitable godet roller arrange.Stretch with similar to following scope first and recently to elongate the monofilament 16 that passes through from the first roller part 100 to influence its orientation: for example described scope is about 2: 1 to about 15: 1; Be about 3: 1 to about 12: 1 in some embodiments; And be about 5: 1 to about 7: 1 in some embodiments.Monofilament 16 at first relies on to rotate than godet roller 101,102, the 103 and 104 higher speed of first godet roller 21 and first roller part with the second roller part godet roller 105,106,107 of second godet roller 24 that required first draw ratio is provided and the second roller part 200 and 108 or any other suitable combination of godet roller and being stretched by first heating region 23 (for example, hydrothermal solution stretch bath or hot gas Convective Heating chamber).The temperature of first heating region 23 can about 20 ℃ to about 90 ℃ scope, and in some embodiments, can about 25 ℃ to about 40 ℃ scope.
First draw ratio described herein can change by any the speed in the first roller part godet roller 101,102,103 and 104 that changes first godet roller 21 and the first roller part 100.For example, in some embodiments, the speed of first godet roller 21 can be maintained at about 2 meters/minute or " mpm " (G
1) and the speed of second godet roller 24 can be maintained at about 10mpm (G
2) so that about 5: 1 (G to be provided
2/ G
1) first draw ratio.In some embodiments, the speed that can set second godet roller 24 at about 5mpm to the velocity interval of about 15mpm (in some embodiments about 9mpm extremely about 10mpm) and can not change.In these embodiments, the speed of first godet roller 21 can be at about 1mpm to the scope of about 5mpm, and in some embodiments, can be at about 1.5mpm extremely in the scope of about 2.5mpm.
Even the minor alteration of the speed of first godet roller 21 also may change several tensile propertys of monofilament, that is, and knotting-pull strength, percentage elongation, modulus and external intensity.For example, the increment that the speed of first godet roller 21 reduces reaches knotting drawing value, elongation values and the external intensity level that about 0.1mpm can reduce monofilament, but can increase the modulus value of monofilament.On the contrary, the increment that the speed of first godet roller 21 increases reaches knotting drawing value, elongation values and the external intensity level that about 0.1mpm can improve monofilament, but can reduce the modulus value of monofilament.
Return Fig. 1, monofilament 16 can be carried out second and stretch behind the godet roller 105,106,107 and 108 by second roller part.Particularly, can recently elongate the monofilament 16 that passes through from the second roller part 200 to influence its further orientation with the stretching similar to following scope: described scope for example is about 1.1: 1 to about 5: 1; Be about 1.2: 1 to about 3: 1 in some embodiments; Be about 1.25: 1 to about 1.5: 1 in some other embodiment.Monofilament 16 can pass through second heating region 25 (for example, hydrothermal solution stretch bath or hot gas Convective Heating chamber) and rely on to rotate than godet roller 105,106, the 107 and 108 higher speed of second godet roller 24 and second roller part with the 3rd roller part godet roller 109,110,111 of the 3rd godet roller 26 that required draw ratio is provided and the 3rd roller part 300 and 112 or any other suitable combination of godet roller and being stretched.Advantageously, the temperature of second heating region 25 can about 30 ℃ to about 150 ℃ scope, in some embodiments, can about 110 ℃ to about 120 ℃ scope.
Second draw ratio described here can change by the speed of any in the 3rd roller part godet roller 109,110,111 and 112 that changes the 3rd godet roller 26 and the 3rd roller part 300.For example, in some embodiments, the speed of the 3rd godet roller 26 can be maintained at about 13.5mpm (G
3) and the speed of second godet roller 24 can be maintained at about 9.5mpm (G
2) so that about 1.42: 1 (G to be provided
3/ G
2) second draw ratio.In some embodiments, can set the speed of second godet roller 24 and to the velocity interval of about 15mpm (in some embodiments about 9mpm extremely about 10mpm), can not change at about 5mpm.In these embodiments, the speed of the 3rd godet roller 26 can be at about 5.5mpm to the scope of about 25mpm, and in some embodiments, can be at about 13mpm extremely in the scope of about 16mpm.
Even the minor alteration of the speed of the 3rd godet roller 26 also can change the external intensity of monofilament.For example, the increment that reduces of the speed of the 3rd godet roller 26 reaches the external tension values that about 0.2mpm can reduce monofilament.On the contrary, the increment of the speed of the 3rd godet roller 26 increase reaches the external tension values that about 0.1mpm can improve monofilament.In some embodiments, knotting drawing value, elongation values and modulus then can not be subjected to the influence of minor alteration like this of the speed of the 3rd godet roller 26.
After second stretched, monofilament 16 can carry out the 3rd stretching after the godet roller 109,110,111 and 112 by the 3rd roller part.Particularly, can recently make the monofilament that passes through from the 3rd roller part 300 16 lax to eliminate material contingent " creep " and to increase the tensile elongation of monofilament with the stretching similar to following scope: for example, described scope be about 0.5: 1 to about 0.9: 1; Be about 0.55: 1 to about 0.8: 1 in some embodiments.Monofilament 16 can pass through the 3rd heating region 27 (for example, hydrothermal solution stretch bath or hot gas Convective Heating chamber) and rely on to rotate than godet roller 109,110, the 111 and 112 lower speed of the 3rd godet roller 26 and the 3rd roller part with the 4th roller part godet roller 113,114,115 of the 4th godet roller 28 that required draw ratio is provided and the 4th roller part 400 and 116 or any other suitable combination of godet roller and being stretched.Advantageously, the temperature of the 3rd heating region 27 can about 125 ℃ to about 165 ℃ scope, in some embodiments, can about 128 ℃ to about 150 ℃ scope.Further, in other embodiments, the temperature of the 3rd heating region 27 can advantageously be maintained at about 130 ℃.
The 3rd draw ratio described here can change by the speed of any in the 4th roller part godet roller 113,114,115 and 116 that changes the 4th godet roller 28 and the 4th roller part 400.For example, in some embodiments, the speed of the 4th godet roller 28 can be maintained at about 9.9mpm (G
4) and the speed of the 3rd godet roller 26 can be maintained at about 13.5mpm (G
3) so that about 0.73: 1 (G to be provided
4/ G
3) the 3rd draw ratio.In some embodiments, the speed of the 4th godet roller 28 and to the velocity interval of about 15mpm (in some embodiments about 8mpm extremely about 10mpm), can not change at about 3mpm.
The speed that can change the 4th godet roller 28 is to change the tensile properties of monofilament.For example, the increment that the speed of the 4th godet roller 28 reduces reaches knotting-drawing value, the elongation values that about 0.1mpm can improve monofilament, but can reduce the modulus value of monofilament.On the contrary, the increment that the speed of the 4th godet roller 28 increases reaches knotting-drawing value, the elongation values that about 0.1mpm can reduce monofilament, but can improve the modulus value of monofilament.
The total drawing ratio of monofilament 16 can be at about 5: 1 to about 10: 1 scope; In some embodiments can be to about 8.5: 1 scope at about 6.5: 1; And in other embodiments can be at about 7: 1 to about 8: 1 scope.In embodiment, the rate of extension of actinobacillus device (draw rate payoff) can be at about 5 meters/minute (mpm) to about 70 meters/minute scope; In some embodiments, the rate of extension of actinobacillus device can be at about 8mpm to the scope of about 60mpm.
Can will be suitable for spraying silk and the parameter according to the monofilament of disclosure preparation of stretching is summarised among the following table I-III any.Some parameters can be according to being changed by the size of the monofilament of spray silk and stretching.For example, Table I, II and III represent respectively and are suitable for forming the parameter that is of a size of 0,1 and 2/0 fibril, and various fibrils are by making according to glycolide of the present disclosure-propylene carbonate copolymer.
Table 1
| The extruder overview | Fibril size 0 |
| The charging cooling | Open |
| The cylinder temperature, ℃, regional A | 195(190-200) |
| The cylinder temperature, ℃, area B | 200(195-205) |
| The cylinder temperature, ℃, zone C | 200(195-205) |
| The anchor clamps temperature, ℃ | 200(195-205) |
| Connector temperature, ℃ | 200(195-205) |
| Parts (block) temperature, ℃ | 200(195-205) |
| Die temperature, ℃ | 200(195-205) |
| Auxiliary die temperature, ℃ | 225(220-230) |
| The cylinder melt temperature, ℃ | Only monitoring |
| The pump melt temperature, ℃ | Only monitoring |
| The die orifice melt temperature, ℃ | Only monitoring |
| Cylinder pressure, pound/square inch | Only monitoring |
| Fore pump pressure, pound/square inch | 350-2000 |
| Die orifice pressure, pound/square inch | Only monitoring |
| Extruder screw, rev/min | Automatically |
| Pump, rev/min | Only monitoring |
| The hardening bath temperature, ℃ | 22 |
| Air gap (cm) | 1 |
| Pump (cc/rev) 0.297 pump (only) | |
| Resin viscosity 1.13-1.68dl/g | |
| Resin dew point≤-60 ℃ | |
| Die orifice screens 20 μ | |
| Stretching condition | |
| Actuating speed, mpm | 0 |
| The roller degree of depth, cm | (37-48) |
| First godet roller, mpm | 1.85(1.8-1.9) |
| Second godet roller, mpm | 9.5 |
| The 3rd godet roller, mpm | 13.5(13.4-13.6) |
| The 4th godet roller, mpm | 9.9 |
| First oven temperature, ℃ | 30 |
| Second oven temperature, ℃ | 115 |
| The 3rd oven temperature, ℃ | 130 |
| Draw ratio #1 | 5.14∶1(5.0∶1-5.28∶1) |
| Draw ratio #2 | 1.42∶1(1.41∶1-1.43∶1) |
| Draw ratio #3 | 0.733∶1(0.728∶1-0.739∶1) |
| Total drawing ratio | 7.30(7.05∶1-7.56∶1) |
| Purge time | 3 hours |
Table 2
| The extruder overview | Fibril size 1 |
| The charging cooling | Open |
| The cylinder temperature, ℃, regional A | 200(190-200) |
| The cylinder temperature, ℃, area B | 205(195-205) |
| The cylinder temperature, ℃, zone C | 205(195-205) |
| The anchor clamps temperature, ℃ | 205(195-205) |
| Connector temperature, ℃ | 205(195-205) |
| Part temperatures, ℃ | 205(195-205) |
| Die temperature, ℃ | 208(206-210) |
| Auxiliary die temperature, ℃ | 226(221-230) |
| The cylinder melt temperature, ℃ | Only monitoring |
| The pump melt temperature, ℃ | Only monitoring |
| The die orifice melt temperature, ℃ | Only monitoring |
| Cylinder pressure, pound/square inch | Only monitoring |
| Fore pump pressure, pound/square inch | 350-2000 |
| Die orifice pressure, pound/square inch | Only monitoring |
| Extruder screw, rev/min | Automatically |
| Pump, rev/min | Only monitoring |
| The hardening bath temperature, ℃ | 22 |
| Air gap (cm) | 1 |
| Pump (cc/rev) 0.297 pump (only) | |
| Resin viscosity 1.13-1.68dl/g | |
| Resin dew point≤-60 ℃ | |
| Die orifice screens 20 μ | |
| Stretching condition | |
| Actuating speed, mpm | 0 |
| The roller degree of depth, cm | (37-48) |
| First godet roller, mpm | 1.85(1.8-1.9) |
| Second godet roller, mpm | 9.5 |
| The 3rd godet roller, mpm | 13.5(13.4-13.6) |
| The 4th godet roller, mpm | 9.6(9.5-10.0) |
| First oven temperature, ℃ | 30 |
| Second oven temperature, ℃ | 115 |
| The 3rd oven temperature, ℃ | 130 |
| Draw ratio #1 | 5.14∶1(5.0∶1-5.28∶1) |
| Draw ratio #2 | 1.42∶1(1.41∶1-1.43∶1) |
| Draw ratio #3 | 0.711∶1(0.699∶1-0.746∶1) |
| Total drawing ratio | 7.30(7.05∶1-7.56∶1) |
| Purge time | 2 hours |
Table 3
| The extruder overview | Fibril size 2/0 |
| The charging cooling | Open |
| The cylinder temperature, ℃, regional A | 195(190-200) |
| The cylinder temperature, ℃, area B | 200(195-205) |
| The cylinder temperature, ℃, zone C | 200(195-205) |
| The anchor clamps temperature, ℃ | 200(195-205) |
| Connector temperature, ℃ | 200(195-205) |
| Part temperatures, ℃ | 200(195-205) |
| Die temperature, ℃ | 200(195-205) |
| Auxiliary die temperature, ℃ | 220(220-230) |
| The cylinder melt temperature, ℃ | Only monitoring |
| The pump melt temperature, ℃ | Only monitoring |
| The die orifice melt temperature, ℃ | Only monitoring |
| Cylinder pressure, pound/square inch | Only monitoring |
| Fore pump pressure, pound/square inch | 350-2000 |
| Die orifice pressure, pound/square inch | Only monitoring |
| Extruder screw, rev/min | Automatically |
| Pump, rev/min | Only monitoring |
| The hardening bath temperature, ℃ | 22 |
| Air gap (cm) | 1 |
| Pump (cc/rev) 0.297 pump (only) | |
| Resin viscosity 1.13-1.68dl/g | |
| Resin dew point≤-60 ℃ | |
| Die orifice screens 20 μ | |
| Stretching condition | |
| Actuating speed, mpm | 0 |
| The roller degree of depth, cm | (37-48) |
| First godet roller, mpm | 1.75(1.7-1.8) |
| Second godet roller, mpm | 10 |
| The 3rd godet roller, mpm | 13.2(13.1-13.3) |
| The 4th godet roller, mpm | 9.2(9.1-9.5) |
| First oven temperature, ℃ | 30 |
| Second oven temperature, ℃ | 115 |
| The 3rd oven temperature, ℃ | 130 |
| Draw ratio #1 | 5.85∶1(5.56∶1-5.88∶1) |
| Draw ratio #2 | 1.32∶1(1.31∶1-1.33∶1) |
| Draw ratio #3 | 0.697∶1(0.684∶1-0.725∶1) |
| Total drawing ratio | 7.71(7.28∶1-7.84∶1) |
| Purge time | 4.2 hour |
In other embodiments, but off line is carried out annealing steps, and wherein, monofilament 16 can center on the parent roll winding of single layer, has or do not have vacuum and/or pressure, and temperature range is about 100 ℃ to about 150 ℃; Be about 120 ℃ to about 130 ℃ in some embodiments.Available nitrogen purging parent roll.Sustainable about 9 hours to about 24 hours of annealing steps; Sustainable in some embodiments about 12-18 hour.In these embodiments, increase circulation timei and/or reduce that holocrystallineization, monomer that annealing temperature can realize monofilament 16 are removed and internal stress reduces and need not monofilament 16 is exposed to melting temperature near the material that is used to prepare monofilament 16, that is, and about 185 ℃.At the material of annealing on the reel is that individual layer also disappears except when the possibility that the intersection that monofilament can occur can be by crossover or multi-lay winding the time is twined impression, so output monofilament preferably.
As shown in Figure 2, suture described here, suture 501 can combine with the surgical stitch pin by means commonly known in the art.Make suture with needle by organizing so that thereby wound closure can be sewed up a wound.Can take off sewing needle and suture is tied a knot from suture then.
Further, in the disclosure, incorporate the material that one or more Medicine and Surgery can use (for example, when the time those acceleration or improve the material of agglutination valuably) into also in the scope of the present disclosure to operative repair position particulate application.Therefore, for example suture can be loaded with and can be deposited on the therapeutic agent of repairing the position.Therapeutic agent can be selected because of the ability of its antimicrobial properties, the ability that promotes reparation or reconstruction and/or promotion growth of new tissue.Can use the antimicrobial that slowly is discharged into organization internal by this way, broad-spectrum antibiotic (gentamicin sulphate, erythromycin or the glycopeptide of deriving) for example is to help the clinical and subclinical infection at antagonism tissue repair position.For promoting to repair and/or tissue growth, one or more positive growth factors can be added in the suture, for example, fibroblast growth factor, bone growth factor, EGF, platelet-derived growth factor, macrophage derived growth factor, alveolar source growth factor, monocyte source growth factor, magainin (magainin) etc.Some treatment indications are: glycerine causes that with tissue or kidney plasminogen activator thrombosis, superoxide dismutase are removed the tissue damage free radical, TNF is used for treatment of cancer or colony stimulating factor and interferon, proleulzin or other lymphokine enhance immunity systems.
The example of the kind of the therapeutic agent that can use according to the disclosure comprises: for example, and anti-blocking agent, antimicrobial, analgestic, antipyretic, anesthetic, Anti-epileptics, antihistaminic, antiinflammatory, cardiovascular drug, diagnosticum, sympathetic transmitter releasers, cholinomimetic, antimuscarinic drug, antispastic, hormone, growth factor, muscle relaxant, adrenergic neuron blocking agent, antineoplastic, immunogenic formulation, immunodepressant, gastrointestinal drug, diuretics, steroids, lipid, lipopolysaccharides, polysaccharide, platelet activation medicine, clotting factor and enzyme.In addition, also can use the combination of therapeutic agent.
Can be used as the involved suitable antimicrobial agents in order of therapeutic agent comprises: for example, triclosan is also referred to as 2,4,4 '-three chloro-2 '-dihydroxy diphenyl ethers; Hibitane and salt thereof comprise chlorhexidine acetate, chlorhexidine gluconate, chlorhexidine hydrochloride and sulfuric acid hibitane; Silver and salt thereof comprise silver acetate, silver benzoate, silver carbonate, itrol, silver iodate, silver iodide, actol, laurate silver, silver nitrate, silver oxide, palmitic acid silver, argyrol and flamazine; Polymyxins; Tetracycline; Aminoglycosides, for example tobramycin and gentamicin; Rifampin; Bacitracin; Neomycin; Chloramphenicol; Miconazole; Quinolones, Li such as oxolinic acid, orfloxacin, nalidixic acid, Pefloxacin, Enoxacin and Ciprofloxacin; PCs, for example Oxacillin and avocin; Nonoxynol-9; Fusidinic acid; Cynnematin; And combination.In addition, also can be used as in therapeutic agent is comprised in as the antimicrobial proteins of bovine lactoferrin and lactoferrin B and peptide.
Other examples of therapeutic agent comprise: local anesthetic; Non-steroid anti-inflammatory drug; Parasympathomimetics; Psychotropic drugs; Sedative; Decongestant; Hypnotic sedative agent; Steroids; Sulfa drug; Sympathetic transmitter releasers; Vaccine; Vitamin; Antimalarial; Antimigraine; Anti-Parkinson medicine, for example levodopa; Antispasmodic; Anticholinergic agent (for example, oxybutynin); Pectoral; Bronchodilators; Cardiovascular drug, for example coronary artery expansion medicine and monobel; Alkaloid; Antalgesic; Anesthetic, for example codeine, paracodin, Sauteralgyl, morphine etc.; Non-narcotic (pain relieving) medicine, for example salicylic acid, aspirin, Propoxyphene etc.; Opiate receptor antagonist, for example naltrexone and naloxone; Anticancer; Anticonvulsive drug; Antiemetic; Antihistaminic; Antiinflammatory, for example hormone preparation, hydrocortisone, prednisolone, prednisone, non-hormone preparation, allopurinol, indocin, phenylbutazone etc.; Prostaglandin and cytotoxic drug; Chemotherapeutics, estrogen; Antibacterials; Antibiotic; Antifungal; Antiviral agent; Anticoagulant; Anticonvulsant; Antidepressants; Antihistaminic; And immune formulation.
Other examples that can be comprised in the suitable therapeutic agent in the monofilament comprise: for example, and virus and cell; Peptide, polypeptide and protein and analog thereof, mutein and active fragment; Immunoglobulin (Ig); Antibody; Cell factor (for example, lymphokine, monokine, chemotactic factor (CF)); Clotting factor; Hemopoietic factor; Interleukin (IL-2, IL-3, IL-4, IL-6); Interferon (β-IFN, α-IFN and γ-IFN); Hematopoietin; Nuclease; TNF; Colony stimulating factor (for example, GCSF, GM-CSF, MCSF); Insulin; Antitumor agent and tumor inhibitor; Blood protein, for example fibrin, fibrin ferment, fibrinogen, synthetic fibrin ferment, synthetic fibrin, synthetic fibrinogen; Promoting sexual gland hormone (for example, FSH, LH, CG etc.); Hormone and hormone analogs (for example, growth hormone); Vaccine (for example, tumour, bacterium and viral antigen); Growth hormone-release inhibiting factor; Antigen; The blood clotting factor; Growth factor (for example, nerve growth factor, IGF); BMP; TGF-B; The albumen inhibiting factor; Protein antagonist; Nucleic acid, for example antisense molecule, DNA, RNA, RNAi; Oligonucleotide; Polynucleotide; And ribozyme.
Also designed and to have dyeed to increase the observability of suture to suture of the present disclosure in the art Yezhong.Can use the dyestuff of known suitable adding suture.This class dyestuff includes but not limited to carbon black, bone black, D﹠amp; No. 6, C Green and D﹠amp; No. 2, C Violet (as describing in U.S.'s food, medicine and the used for cosmetic colouring agent handbook (1979) of Daniel M.Marrion).According to the disclosure, this class suture can by in extruding the forward direction resin, add be up to several approximately percentages (being about 0.2% in some embodiments) as D﹠amp; The dyestuff that No. 2, C Violet dyes.
Although comprised many details and example in the above-mentioned explanation, these details and example should not be understood that it is restriction to disclosure scope, and only are the example of its detailed embodiment.Those skilled in the art can be contemplated in disclosure scope and intraparenchymatous many other possible variations.
Claims (24)
1. method for preparing monofilament suture by block copolymer, described block copolymer comprises about 50 glycolide and about 20 propylene carbonate to about 50 percentage by weights to about 80 percentage by weights, and described method comprises: a) extrude described copolymer so that the monofilament of fusion to be provided; B) monofilament to described fusion quenches so that the monofilament of curing to be provided; C) by temperature be maintained at about 25 ℃ to about 40 ℃ first baking ovens with about 2: 1 to recently the stretch monofilament of described curing of about 15: 1 stretching; D) by temperature be maintained at about 30 ℃ to about 150 ℃ second baking ovens with about 1.1: 1 to about 5: 1 stretching described monofilament that recently stretches; E) by temperature be maintained at about 125 ℃ to about 165 ℃ the 3rd baking ovens with about 0.5: 1 to about 0.8: 1 stretching described monofilament that recently stretches; And f) described monofilament is annealed.
2. method according to claim 1, wherein, the described step of extruding copolymer is included in about 170 ℃ and extrudes described copolymer to about 240 ℃ temperature.
3. method according to claim 1, wherein, the described step that the monofilament of fusion is quenched comprise serviceability temperature be about 10 ℃ to about 80 ℃ hardening bath.
4. method according to claim 1, wherein, the described step that the monofilament of fusion is quenched comprise serviceability temperature be about 20 ℃ to about 30 ℃ hardening bath.
5. method according to claim 1 wherein, describedly comprises with about 3: 1 and recently stretching to about 12: 1 stretching by the stretch step of the monofilament that solidifies of first baking oven.
6. method according to claim 1 wherein, describedly comprises with about 5: 1 and recently stretching to about 7: 1 stretching by the stretch step of the monofilament that solidifies of first baking oven.
7. method according to claim 1 wherein, describedly comprises with about 1.2: 1 and recently stretching to about 3: 1 stretching by the stretch step of the monofilament that solidifies of second baking oven.
8. method according to claim 1 wherein, describedly comprises with about 1.25: 1 and recently stretching to about 1.5: 1 stretching by the stretch step of the monofilament that solidifies of second baking oven.
9. method according to claim 1 wherein, describedly comprises with about 0.55: 1 and recently stretching to about 0.75: 1 stretching by the stretch step of the monofilament that solidifies of the 3rd baking oven.
10. method according to claim 1, wherein, total drawing ratio is about 6.5: 1 to about 8.5: 1.
11. method according to claim 1, wherein, total drawing ratio is about 7: 1 to about 8: 1.
12. method according to claim 1, wherein, the rate of extension of actinobacillus device can about 5 meters/minute to about 70 meters/minute scope.
13. method according to claim 1 wherein, describedly comprises by temperature and is maintained at about 128 ℃ to the 3rd about 150 ℃ baking oven described monofilament that stretches by the stretch step of the monofilament that solidifies of the 3rd baking oven.
14. method according to claim 1, wherein, the described step that monofilament is annealed comprises makes described monofilament experience about 100 ℃ of temperature to about 180 ℃ of variations.
15. method according to claim 1, wherein, the described step that monofilament is annealed comprises makes described monofilament experience about 110 ℃ of temperature to about 150 ℃ of variations.
16. method according to claim 1, wherein, described annealing steps continues about 9 hours to about 24 hours.
17. method according to claim 1, wherein, described monofilament suture further comprises the material that at least a Medicine and Surgery can be used.
18. method according to claim 1, wherein, described at least a Medicine and Surgery can with material comprise positive growth factor.
19. method according to claim 1, wherein, described at least a Medicine and Surgery can with material comprise antimicrobial.
20. method for preparing monofilament suture by block copolymer, described block copolymer comprises about 60 glycolide and about 30 propylene carbonate to about 40 percentage by weights to about 70 percentage by weights, and described method comprises: a) extrude described copolymer so that the monofilament of fusion to be provided at about 170 ℃ to about 240 ℃ temperature; B) temperature for about 10 ℃ to about 80 ℃ hardening bath the monofilament to described fusion quench so that the monofilament of curing to be provided; C) by temperature be maintained at about 25 ℃ to about 40 ℃ first baking ovens with about 3: 1 to recently the stretch monofilament of described curing of about 12: 1 stretching; D) by temperature be maintained at about 30 ℃ to about 150 ℃ second baking ovens with about 1.25: 1 to about 1.50: 1 stretching described monofilament that recently stretches; E) by temperature be maintained at about 125 ℃ to about 165 ℃ the 3rd baking ovens with about 0.55: 1 to about 0.9: 1 stretching described monofilament that recently stretches; And f) described monofilament is annealed to the temperature of about 150 ℃ of variations at about 100 ℃.
21. the method for a fixing organization, this method comprises: suture with needle is provided, and wherein, described suture is prepared by method according to claim 1; Make this suture with needle by tissue; And fix this tissue.
22. method for preparing monofilament suture by block copolymer, described block copolymer mainly is made of about 50 glycolide and about 20 propylene carbonate to about 50 percentage by weights to about 80 percentage by weights, and described method comprises: a) extrude described copolymer so that the monofilament of fusion to be provided; B) monofilament to described fusion quenches so that the monofilament of curing to be provided; C) by temperature be maintained at about 25 ℃ to about 40 ℃ first baking ovens with about 2: 1 to recently the stretch monofilament of described curing of about 15: 1 stretching; D) by temperature be maintained at about 30 ℃ to about 150 ℃ second baking ovens with about 1.1: 1 to about 5: 1 stretching described monofilament that recently stretches; E) by temperature be maintained at about 120 ℃ to about 165 ℃ the 3rd baking ovens with about 0.5: 1 to about 0.9: 1 stretching described monofilament that recently stretches; And f) described monofilament is annealed.
23. method according to claim 20, wherein, described block copolymer comprises the propylene carbonate of about 65 weight % to the glycolide of about 67 weight % and about 33 weight % to about 35 weight %.
24. method according to claim 22, wherein, described block copolymer comprises the propylene carbonate of about 65 weight % to the glycolide of about 67 weight % and about 33 weight % to about 35 weight %.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US12/817,782 | 2010-06-17 | ||
| US12/817,782 US8262963B2 (en) | 2002-10-04 | 2010-06-17 | Process of making bioabsorbable filaments |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN102286793A true CN102286793A (en) | 2011-12-21 |
Family
ID=45327281
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2011101598413A Pending CN102286793A (en) | 2010-06-17 | 2011-06-08 | Process of making bioabsorbable filaments |
Country Status (4)
| Country | Link |
|---|---|
| JP (1) | JP2012000451A (en) |
| CN (1) | CN102286793A (en) |
| AU (1) | AU2011202342A1 (en) |
| CA (1) | CA2740386A1 (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107207345A (en) * | 2014-12-17 | 2017-09-26 | 埃泰克斯服务股份有限公司 | Improved polypropylene fibre, the method for manufacturing the fiber and its purposes for being used to produce fiber cement products |
| CN112969565A (en) * | 2018-11-08 | 2021-06-15 | 爱惜康股份有限公司 | Novel extrusion process for making absorbent suture fibers |
| CN113679875A (en) * | 2021-08-31 | 2021-11-23 | 长春圣博玛生物材料有限公司 | Absorbable medical operation line and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4243775A (en) * | 1978-11-13 | 1981-01-06 | American Cyanamid Company | Synthetic polyester surgical articles |
| US6005019A (en) * | 1993-07-21 | 1999-12-21 | United States Surgical Corporation | Plasticizers for fibers used to form surgical devices |
| US20020177876A1 (en) * | 2001-03-26 | 2002-11-28 | Tyco Healthcare Group Lp | Polyolefin sutures having improved processing and handling characteristics |
| US20060125142A1 (en) * | 2002-10-04 | 2006-06-15 | John Kennedy | Process of making bioabsorbable filaments |
| CN101050575A (en) * | 2006-04-06 | 2007-10-10 | Tyco医疗健康集团 | Yarns containing thermoplastic elastomer copolymer and polyolefin filaments |
-
2011
- 2011-05-16 CA CA2740386A patent/CA2740386A1/en not_active Abandoned
- 2011-05-19 AU AU2011202342A patent/AU2011202342A1/en not_active Abandoned
- 2011-05-31 JP JP2011122560A patent/JP2012000451A/en not_active Withdrawn
- 2011-06-08 CN CN2011101598413A patent/CN102286793A/en active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4243775A (en) * | 1978-11-13 | 1981-01-06 | American Cyanamid Company | Synthetic polyester surgical articles |
| US6005019A (en) * | 1993-07-21 | 1999-12-21 | United States Surgical Corporation | Plasticizers for fibers used to form surgical devices |
| US20020177876A1 (en) * | 2001-03-26 | 2002-11-28 | Tyco Healthcare Group Lp | Polyolefin sutures having improved processing and handling characteristics |
| US20060125142A1 (en) * | 2002-10-04 | 2006-06-15 | John Kennedy | Process of making bioabsorbable filaments |
| CN101050575A (en) * | 2006-04-06 | 2007-10-10 | Tyco医疗健康集团 | Yarns containing thermoplastic elastomer copolymer and polyolefin filaments |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107207345A (en) * | 2014-12-17 | 2017-09-26 | 埃泰克斯服务股份有限公司 | Improved polypropylene fibre, the method for manufacturing the fiber and its purposes for being used to produce fiber cement products |
| CN112969565A (en) * | 2018-11-08 | 2021-06-15 | 爱惜康股份有限公司 | Novel extrusion process for making absorbent suture fibers |
| CN112969565B (en) * | 2018-11-08 | 2023-10-27 | 爱惜康股份有限公司 | Novel extrusion process for making absorbent suture fibers |
| CN113679875A (en) * | 2021-08-31 | 2021-11-23 | 长春圣博玛生物材料有限公司 | Absorbable medical operation line and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| JP2012000451A (en) | 2012-01-05 |
| AU2011202342A1 (en) | 2012-01-19 |
| CA2740386A1 (en) | 2011-12-17 |
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