EP1310585A1 - Dispositif et procede de fonte et de centrifugation - Google Patents

Dispositif et procede de fonte et de centrifugation Download PDF

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Publication number
EP1310585A1
EP1310585A1 EP02718587A EP02718587A EP1310585A1 EP 1310585 A1 EP1310585 A1 EP 1310585A1 EP 02718587 A EP02718587 A EP 02718587A EP 02718587 A EP02718587 A EP 02718587A EP 1310585 A1 EP1310585 A1 EP 1310585A1
Authority
EP
European Patent Office
Prior art keywords
polymer material
cylinder
biodegradable polymer
melt spinning
screw
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP02718587A
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German (de)
English (en)
Other versions
EP1310585B1 (fr
EP1310585A4 (fr
Inventor
Keiji KABUSHIKIKAISHA IGAKI IRYO SEKKEI IGAKI
Hideki Yamane
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Igaki Iryo Sekkei KK
Original Assignee
Igaki Iryo Sekkei KK
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Publication date
Application filed by Igaki Iryo Sekkei KK filed Critical Igaki Iryo Sekkei KK
Publication of EP1310585A1 publication Critical patent/EP1310585A1/fr
Publication of EP1310585A4 publication Critical patent/EP1310585A4/fr
Application granted granted Critical
Publication of EP1310585B1 publication Critical patent/EP1310585B1/fr
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Expired - Lifetime legal-status Critical Current

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Classifications

    • D—TEXTILES; PAPER
    • D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
    • D01D—MECHANICAL METHODS OR APPARATUS IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS
    • D01D1/00—Treatment of filament-forming or like material
    • D01D1/04—Melting filament-forming substances
    • D—TEXTILES; PAPER
    • D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
    • D01D—MECHANICAL METHODS OR APPARATUS IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS
    • D01D1/00—Treatment of filament-forming or like material
    • D01D1/06—Feeding liquid to the spinning head
    • D—TEXTILES; PAPER
    • D01—NATURAL OR MAN-MADE THREADS OR FIBRES; SPINNING
    • D01D—MECHANICAL METHODS OR APPARATUS IN THE MANUFACTURE OF ARTIFICIAL FILAMENTS, THREADS, FIBRES, BRISTLES OR RIBBONS
    • D01D5/00—Formation of filaments, threads, or the like
    • D01D5/08—Melt spinning methods

Definitions

  • This invention relates to a method and an apparatus for melt spinning a medical material implanted in a living body, for example, a strand of a biodegradable polymer material which forms a stent implanted in the vascular vessel of a living body.
  • the percutaneous transluminal angioplasty is performed by inserting a balloon mounted in the vicinity of the distal end of a catheter into the stenosed lesion and inflating this balloon to expand the stenosed lesion to keep the blood flowing.
  • the conventional practice is to implant a tubular stent on the site where the PTA has been performed.
  • This stent is inserted in a contracted state into the blood vessel, subsequently dilated and implanted in this state in the blood vessel to support the blood vessel from its inside to prevent re-stenosis from occurring in the blood vessel.
  • the metallic stent formed of such as stainless steel or a Ti-Ni based alloy, is now in use.
  • the principal objective in implanting a stent in the blood vessel in PTA is to prevent acute coronary occlusion and to decrease the frequency of re-stenosis. It has been reported that, since the acute coronary occlusion and re-stenosis are the phenomenon which occurs during a predetermined time period, so that only transient therapy is needed. Consequently, the stent is required to maintain the function of supporting the blood vessel from inside for a predetermined time period, while it is more desirable that the stent is not left in the living body as a foreign substance.
  • the metallic stent is implanted in the blood vessel, it is left permanently, so that, when re-stenosis occurs on the stent site, the stent frequently proves an obstruction to the operation of re-angioplasty. Moreover, the operation of coronary-artery bypass graft is difficult to perform on the site of implanted stent. Thus, implanting the permanently persisting metallic stent offers various inconveniences to re-treatment.
  • the present inventors have proposed a stent comprised of a knitting obtained on knitting a strand of the biodegradable polymer material into a tubular form (JP Patent 2842943), and a stent obtained by bending a strand of a biodegradable polymer in a zigzag shape and wrapping it in a tubular form under a non-woven non-knitted condition.
  • the strand formed of a biodegradable polymer With the use of the strand formed of a biodegradable polymer, it is possible to form a stent which exhibits mechanical characteristics sufficient to support the vessel in the inflated state for certain time duration and disappears after lapse of the preset time.
  • the stent formed of the strand of the biodegradable polymer can readily be flexed and deformed, it can readily be delivered through the sinuous blood vessel so as to be implanted on the target site.
  • the biodegradable polymer material differs in its degradation and absorption characteristics, and hence in its mechanical properties, depending on the molecular weight.
  • the molecular weight of the biodegradable polymer material such as polylactic acid (PLA)
  • PLA polylactic acid
  • the degree that the molecular weight is lowered changes depending on the degree of thermal decomposition.
  • the melt spinning heating time of the same biodegradable polymer material is non-uniform, then the average molecular weight of the spun strand becomes non-uniform. If the strand is non-uniform in its average molecular weight, its degradation and absorption characteristics or mechanical properties undergo localized variations.
  • a stent is formed and implanted in the vascular vessel, such as a blood vessel, the stent in its entirety cannot be degraded or absorbed evenly. Moreover, there is a fear that the stent formed using this sort of the strand cannot support the inner wall of the vascular vessel, such as blood vessels, with a uniform force, because the strand itself exhibits strength variations.
  • the present invention provides a melt spinning apparatus for melt spinning a strand of a biodegradable polymer material, forming a stent implanted in a living body.
  • This comprises a vertically mounted cylinder, supplied with the biodegradable polymer material, a screw mounted in the cylinder coaxially, rotationally driven by a rotational driving unit and having at least one turn of a helical groove on its peripheral surface, and a nozzle mounted to the distal end of the cylinder and having a discharge opening coaxially with the cylinder.
  • the biodegradable polymer material supplied into the cylinder and melted by rotation of the screw is emitted vertically from a discharge opening in the nozzle for spinning the strand.
  • the molten biodegradable polymer material is fed by a screw in the vertical direction and emitted from a nozzle for spinning a strand, so that the strand has a uniform molecular weight distribution is spun as stagnation or non-uniform eddying currents of the biodegradable polymer material melted in the cylinder or the nozzle may be prevented from being produced.
  • the present melt spinning apparatus there is provided a plural number of heating units placed in juxtaposition along the axial direction of the cylinder, on the outer sides of the cylinder forming the melt mechanism for melting the biodegradable polymer material, for controlling the molten state of the biodegradable polymer material injected into the cylinder.
  • the heating units are able to perform temperature control independently of one another.
  • the nozzle for discharging the molten biodegradable polymer material is kept at a constant temperature by the heating units. By controlling the nozzle temperature, the temperature of the molten biodegradable polymer material discharged from the nozzle can be made constant.
  • the biodegradable polymer material is melted by a melt mechanism including a screw which is provided in a vertically mounted cylinder coaxially and on the peripheral surface of which at least one turn of the helical groove is formed.
  • the screw is rotated by a rotational driving mechanism.
  • the molten biodegradable polymer material is emitted in the vertical direction through a discharge opening in a nozzle provided coaxially with the cylinder for spinning the strand.
  • a spun filament having a uniform molecular weight distribution may be produced.
  • melt spinning apparatus and method for melt spinning the biodegradable polymer material using the melt spinning apparatus are now explained in detail.
  • the melt spinning apparatus according to the present invention is of a vertical type in which a melt spinning unit is mounted vertically, as shown in Fig.1.
  • the melt spinning apparatus shown in Fig.1, includes a base plate 2, mounted horizontally on a mounting surface, and the melt spinning unit 1 is supported by member 3a by a support pillar 3 mounted upright on the base plate 2.
  • the melt spinning unit 1 includes: a melt mechanism 4 which is supported by and parallel to the upstanding support pillar 3, a discharging unit 5 for discharging the polymer material melted by the melt mechanism 4, a supplying unit 6 for supplying the polymer material to the melt mechanism 4, and a rotational driving mechanism 7 for rotationally driving a screw 16 forming the melt mechanism 4.
  • the melt mechanism 4 which is in the melt spinning unit 1, includes a cylinder 8, as shown in Fig.2.
  • the screw 16 is provided within and coaxially of the cylinder 8. The screw 16 pressurizes the polymer material, injected into the cylinder 8 and extrudes the pressurized material towards the distal end of the cylinder 8 while melting it.
  • heating units 9 On the outer periphery of the cylinder 8, there is a plural number of heating units 9 in juxtaposition along the axial direction of the cylinder 8. These heating units 9 are controlled independently of one another to enable the multi-stage control of the temperature axially of the cylinder 8.
  • the connecting member 21 is ring-shaped and has at its center portion a flow resistance plate 22 including a plural number of through-holes 22a matching the axial direction of the screw 16, as shown in Fig.3.
  • the molten polymer material, supplied from the distal end of the cylinder 8, by rotating the screw 16, is pressurized by the flow resistance when traversing the flow resistance plate 22.
  • the pressurized polymer material is discharged towards the discharging unit 5 from the distal end of the cylinder 8.
  • the diameter or the number of the through-holes 22a provided on the flow resistance plate 22 is changed depending on the amount or supply rate of the molten polymer material supplied from the distal end of cylinder 8, on rotation of screw 16, or on the viscous resistance of the polymer material.
  • the flow resistance plate 22 may be of any shape provided that it affords the flow resistance to the polymer material supplied melted from the distal end of the cylinder 8 on rotation of the screw 16 to pressurize the polymer material.
  • the discharging unit 5, mounted by the connecting member 21 at the distal end of the cylinder 8, includes a sprue bush 11, connected to the distal end of cylinder 8, and a nozzle 10 mounted to the distal end of the sprue bush 11, as shown in Fig.4.
  • the nozzle 10 is secured to the distal end of the sprue bush 11 by a mounting member 12. Meanwhile, the nozzle 10 and the mounting member 12 can be the same.
  • a flow passage 11a is in the center co-axially of the cylinder 8, as shown in Fig.4. That is, the flow passage 11a and the cylinder 8 are placed vertically with a common axis P1.
  • the flow passage 11a is tapered moderately from the vertically placed cylinder 8 towards the nozzle 10 so that the polymer material supplied melted from the cylinder 8 may be supplied in succession by predetermined amounts per unit time to the nozzle 10 without producing stagnation or eddying currents.
  • the nozzle 10 includes a discharge opening 10a for discharging the polymer material supplied melted from the sprue bush 11, as shown in Fig.4.
  • the discharge opening 10a operates for controlling the diameter of the spun strand and is formed by an optimum diameter depending on the thickness of the spun strand.
  • the discharge opening 10a is also formed to be coaxial with the flow passage 11a. That is, the discharge opening 10a and the flow passage 11a are set upright coaxially as the cylinder 8.
  • plural different nozzles with different diameters R 1 at the discharge opening 10a may be provided and exchanged from time to time to spin the strand with different thicknesses.
  • heating unit 13 for controlling the temperature of the discharging unit 5.
  • This heating unit 13 controls the temperature of the discharging unit 5 to control the temperature of the polymer material discharged from the nozzle 10.
  • the supplying unit 6 for supplying the molten polymer material to the melt mechanism 4 includes a hopper 14 for loading the polymer material into the cylinder 8 and a mounting unit 6a for mounting the unit 6 to the cylinder 8, as shown in Fig.5.
  • a temperature controller 15 for controlling the temperature of the supplying unit 6. This temperature controller 15 keeps the polymer material, loaded into the hopper 14, at a constant temperature, and is comprised of a heating/cooling means.
  • the melt mechanism 4 includes the screw 16, having a helically extending groove 17 on its peripheral surface, is mounted coaxially within the cylinder 8.
  • the screw 16 is rotationally driven by the rotational driving mechanism 7 at the proximal end where the screw is connected.
  • the screw 16 is driven rotationally, the polymer material, loaded into the cylinder 8 and melted by the heating units 9, is fed to the distal end of the cylinder 8.
  • the helical groove of the screw used in the routine melt spinning apparatus is formed to a pitch subsequently equivalent to the screw diameter.
  • the helical groove 17 of the screw 16 used in the melt spinning apparatus according to the present invention has a pitch Tp equal to one-half the diameter Sr of the screw 16.
  • the melt spinning apparatus of the present invention may be provided with a supply controlling mechanism 18, between the melt mechanism 4 and the discharging unit 5, for controlling the supply quantity of the polymer material in molten state, which is supplied to the discharging unit 5.
  • This supply controlling mechanism 18 may be configured as shown for example in Fig.7.
  • the supply controlling mechanism 18, shown in Fig.7 includes a pressure detection means 19 for measuring the pressure of the polymer material extruded from the melt mechanism 4 and circulated in the molten state through a flow passage 18a, and a set of gears 20 for feeding the melted polymer material to the discharging unit 5.
  • This supply controlling mechanism 18 detects the pressure of the polymer material flowing through the flow passage 18a by the pressure detection means 19.
  • the rotation of the set of gears 20 is controlled by this detection output to keep the pressure of the polymer material flowing through the flow passage 18a constant.
  • This detection output By controlling the pressure of the polymer material flowing through the flow passage 18a at a constant magnitude, a preset constant quantity of the polymer material can be supplied to the discharging unit 5.
  • a heating unit 23 is on the outer periphery of the portion of the supply controlling mechanism 18, which controls the temperature of the polymer material flowing through the flow passage 18a at a preset temperature.
  • the present invention melt-spins the strand, formed of a biodegradable polymer material used for forming a stent implanted in the living body.
  • the melt spun polymer material used herein, is the biodegradable polymer material.
  • the biodegradable polymer material may be enumerated by polylactic acid (PLA), polyglycolic acid (PGA), polyglactin (polyglycolic acid-polylactic acid copolymer), polydioxanone, polyglyconate (trimethylene carbonate-glycoid copolymer) and a polylactic acid- ⁇ -caprolactone copolymer.
  • a pellet-like polymer material Pp is charged into a hopper 14 of the supplying unit 6.
  • the polymer material, loaded into the hopper 14, is supplied to the cylinder 8 of the melt mechanism 4.
  • the polymer material In order for the polymer material, loaded into the hopper 14, to be quickly supplied into the helical groove 17 formed in the screw 16 rotating in the cylinder 8, the polymer material needs to be in solid state. That is, the polymer material, supplied into the cylinder 8, needs to be controlled to a temperature not higher than its melting point (Tm) or softening point. For shortening the melt time in the melt mechanism 4, the polymer material, supplied to the cylinder 8, needs to be melted immediately.
  • the temperature controller 15, provided in the supplying unit 6, sets the temperature of the polymer material, charged into the hopper 14, to a temperature at which the polymer material can be melted immediately as it maintains its solid state.
  • the polymer material supplied into the cylinder 8 through the hopper 14, is introduced into the helical groove 17 of the screw 16, rotated by the rotational driving mechanism 7, so as to be extruded towards the distal end of the cylinder 8, as it is heated by the heating units 9 provided on the outer periphery of the cylinder 8.
  • the temperature of the polymer material is controlled to be lower than its thermal decomposition temperature so as not to cause transmutation of the polymer material.
  • the polymer material thus controlled to a temperature not higher than its thermal decomposition temperature, is positively extruded from the distal end of the cylinder 8 as it is kept in molten state without undergoing transmutation.
  • the polymer material extruded at the distal end of the cylinder 8 while in its molten state, is afforded with flow resistance by the flow resistance plate 22, in such a manner that it is evenly pressurized by the through-holes 22a.
  • the polymer materia, thus pressurized, is supplied to the discharging unit 5.
  • the polymer material can be supplied to the discharging unit 5 as the molecular weight distribution is maintained to be constant.
  • the melt spinning apparatus has the supply controlling mechanism 18 between the melt mechanism 4 and the discharging unit 5, the molten polymer material, extruded from the cylinder 8 of the melt mechanism 4, is maintained at a constant pressure by the supply controlling mechanism 18, so that it is controlled in flow rate at the discharging unit 5 and is reliably supplied to the discharging unit 5 at a constant flow rate.
  • the polymer material supplied to the supply controlling mechanism 18 is heated by the heating unit 23 provided on the outer periphery of the supply controlling mechanism 18 and hence is delivered to the discharging unit 5, reliably in its molten state.
  • the heating unit 23 maintains the heating temperature at less than the thermal decomposition temperature so as not to cause transmutation of the polymer material.
  • a monofilament strand may be spun because the sole discharge opening 10a is formed through the nozzle 10 for extending in the vertical direction.
  • the melt spinning method and apparatus of the present invention it is possible to prevent stagnation or nonuniform eddying currents of the biodegradable polymer material in order to spin the strand into a uniform average molecular weight. That is, the strand of the biodegradable polymer material may be spun which is uniform mechanical properties and degradation and absorption characteristics. This spun strand can be used to the utmost advantage for forming a stent inserted into the vascular vessel of the living body.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Textile Engineering (AREA)
  • Spinning Methods And Devices For Manufacturing Artificial Fibers (AREA)
  • Inorganic Fibers (AREA)
  • Inks, Pencil-Leads, Or Crayons (AREA)
  • Materials For Medical Uses (AREA)
EP02718587A 2001-04-18 2002-04-15 Dispositif et procede de fonte et de centrifugation Expired - Lifetime EP1310585B1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2001119964 2001-04-18
JP2001119964 2001-04-18
PCT/JP2002/003738 WO2002086203A1 (fr) 2001-04-18 2002-04-15 Dispositif et procede de fonte et de centrifugation

Publications (3)

Publication Number Publication Date
EP1310585A1 true EP1310585A1 (fr) 2003-05-14
EP1310585A4 EP1310585A4 (fr) 2006-07-12
EP1310585B1 EP1310585B1 (fr) 2007-10-10

Family

ID=18970088

Family Applications (1)

Application Number Title Priority Date Filing Date
EP02718587A Expired - Lifetime EP1310585B1 (fr) 2001-04-18 2002-04-15 Dispositif et procede de fonte et de centrifugation

Country Status (13)

Country Link
US (1) US20030173702A1 (fr)
EP (1) EP1310585B1 (fr)
JP (1) JP3898131B2 (fr)
KR (1) KR100780401B1 (fr)
CN (1) CN1461361A (fr)
AT (1) ATE375411T1 (fr)
AU (1) AU2002249597B2 (fr)
CA (1) CA2412825C (fr)
DE (1) DE60222848T2 (fr)
DK (1) DK1310585T3 (fr)
ES (1) ES2295334T3 (fr)
PT (1) PT1310585E (fr)
WO (1) WO2002086203A1 (fr)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7794494B2 (en) 2002-10-11 2010-09-14 Boston Scientific Scimed, Inc. Implantable medical devices
CA2532548A1 (fr) * 2003-07-18 2005-02-03 Boston Scientific Limited Dispositifs medicaux
DE102010012845A1 (de) * 2010-03-25 2011-09-29 Carl Freudenberg Kg Durch Rotationsspinnverfahren hergestellte Mehrkomponentenfasern
KR102242444B1 (ko) * 2019-06-11 2021-04-21 울산대학교 산학협력단 다공성 보형물 생성 방법 및 장치
KR102168655B1 (ko) * 2019-11-06 2020-10-21 한국섬유개발연구원 생분해성 이종소재 복합 시스-코어 필라멘트 제조방법 및 이를 통해 제조된 생분해성 이종소재 복합 시스-코어 필라멘트
CN111647958B (zh) * 2020-05-29 2022-04-15 中鸿纳米纤维技术丹阳有限公司 一种聚乙醇酸喷丝组件

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB683510A (en) * 1950-11-23 1952-11-26 Dow Chemical Co Method of making crinkled artificial fibres

Family Cites Families (9)

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Publication number Priority date Publication date Assignee Title
US3344218A (en) * 1967-09-26 Retreatment of synthetic fibres
JPS4414711Y1 (fr) * 1964-04-14 1969-06-23
DE2431871C3 (de) 1974-07-03 1978-10-12 Akzo Gmbh, 5600 Wuppertal Verfahren und Düsenplatte zur Herstellung einer elastischen Mattenbahn
US3737506A (en) * 1970-04-03 1973-06-05 Viscose Suisse Soc D Process and apparatus for continuous extrusion of highly-viscous melts
US4347207A (en) * 1981-01-27 1982-08-31 Kling-Tecs, Inc. Method of extruding polypropylene yarn
US4950735A (en) * 1988-07-26 1990-08-21 Sharpoint L.P. Biodegradable polyamides
US5166278A (en) * 1990-04-17 1992-11-24 E. I. Du Pont De Nemours And Company Process for modifying polyamide dyeability using co-fed polyamide flake
AU650700B2 (en) * 1991-03-08 1994-06-30 Keiji Igaki Luminal stent, holding structure therefor and device for attaching luminal stent
US6719935B2 (en) * 2001-01-05 2004-04-13 Howmedica Osteonics Corp. Process for forming bioabsorbable implants

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB683510A (en) * 1950-11-23 1952-11-26 Dow Chemical Co Method of making crinkled artificial fibres

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO02086203A1 *

Also Published As

Publication number Publication date
ES2295334T3 (es) 2008-04-16
KR100780401B1 (ko) 2007-11-28
EP1310585B1 (fr) 2007-10-10
DE60222848D1 (de) 2007-11-22
CA2412825C (fr) 2010-09-14
WO2002086203A1 (fr) 2002-10-31
EP1310585A4 (fr) 2006-07-12
DK1310585T3 (da) 2008-01-02
AU2002249597B2 (en) 2007-02-15
PT1310585E (pt) 2007-10-25
KR20030011898A (ko) 2003-02-11
JPWO2002086203A1 (ja) 2004-08-12
JP3898131B2 (ja) 2007-03-28
CN1461361A (zh) 2003-12-10
ATE375411T1 (de) 2007-10-15
CA2412825A1 (fr) 2002-12-13
US20030173702A1 (en) 2003-09-18
DE60222848T2 (de) 2008-07-17

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