EP2347819A1 - Dispositif de mélange et procédé de fabrication de pâtes de ciment osseux à base de polyméthyle-méthacrylate - Google Patents

Dispositif de mélange et procédé de fabrication de pâtes de ciment osseux à base de polyméthyle-méthacrylate Download PDF

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Publication number
EP2347819A1
EP2347819A1 EP11000207A EP11000207A EP2347819A1 EP 2347819 A1 EP2347819 A1 EP 2347819A1 EP 11000207 A EP11000207 A EP 11000207A EP 11000207 A EP11000207 A EP 11000207A EP 2347819 A1 EP2347819 A1 EP 2347819A1
Authority
EP
European Patent Office
Prior art keywords
cement
opening
shaft
hollow body
tubular hollow
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
EP11000207A
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German (de)
English (en)
Other versions
EP2347819B1 (fr
Inventor
Sebastian Dr. Vogt
Hubert Dr. Büchner
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.)
Heraeus Medical GmbH
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Heraeus Medical GmbH
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Heraeus Medical GmbH filed Critical Heraeus Medical GmbH
Publication of EP2347819A1 publication Critical patent/EP2347819A1/fr
Application granted granted Critical
Publication of EP2347819B1 publication Critical patent/EP2347819B1/fr
Not-in-force legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F27/00—Mixers with rotary stirring devices in fixed receptacles; Kneaders
    • B01F27/05—Stirrers
    • B01F27/11—Stirrers characterised by the configuration of the stirrers
    • B01F27/112—Stirrers characterised by the configuration of the stirrers with arms, paddles, vanes or blades
    • B01F27/1125—Stirrers characterised by the configuration of the stirrers with arms, paddles, vanes or blades with vanes or blades extending parallel or oblique to the stirrer axis
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F27/00—Mixers with rotary stirring devices in fixed receptacles; Kneaders
    • B01F27/05—Stirrers
    • B01F27/11—Stirrers characterised by the configuration of the stirrers
    • B01F27/114—Helically shaped stirrers, i.e. stirrers comprising a helically shaped band or helically shaped band sections
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/75—Discharge mechanisms
    • B01F35/754—Discharge mechanisms characterised by the means for discharging the components from the mixer
    • B01F35/75455—Discharge mechanisms characterised by the means for discharging the components from the mixer using a rotary discharge means, e.g. a screw beneath the receptacle
    • B01F35/754551—Discharge mechanisms characterised by the means for discharging the components from the mixer using a rotary discharge means, e.g. a screw beneath the receptacle using helical screws
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F2101/00—Mixing characterised by the nature of the mixed materials or by the application field
    • B01F2101/20—Mixing of ingredients for bone cement

Definitions

  • the invention relates to a mixing device and a method for producing paste-like polymethyl methacrylate bone cement pastes.
  • PMMA bone cements have been known for decades and are based on the fundamental work of Sir Charnley ( Charnley, J .: Anchorage of the femoral head prosthesis of the shaft of the femur. J. Bone Joint Surg. 42 (1960) 28-30 ).
  • the basic structure of PMMA bone cements has remained basically the same since then.
  • PMMA bone cements consist of a liquid monomer component and a powder component.
  • the monomer component generally contains (i) the monomer methyl methacrylate and (ii) an activator (for example N, N-dimethyl-p-toluidine) dissolved therein.
  • the powder component comprises (i) one or more polymers based on methyl methacrylate and comonomers such as styrene, methyl acrylate or similar monomers, prepared by polymerization, preferably suspension polymerization, (ii) an x-ray opacifier and (iii) an initiator (e.g. ) Dibenzoyl peroxide.
  • a plastically deformable dough is formed by swelling the polymers of the powder component in the methyl methacrylate of the monomer component.
  • the activator N N-dimethyl-p-toluidine reacts with dibenzoyl peroxide, which decomposes to form radicals.
  • the radicals formed initiate the radical polymerization of the methyl methacrylate.
  • the viscosity of the cement paste increases until the cement paste solidifies and hardens.
  • paste-shaped bone cements An interesting alternative to conventional cements composed of a powder component and a liquid component is paste-shaped bone cements. Such paste-like bone cements are described, for example, in US Pat EP 2052747 and the EP 2052748 described.
  • Two-component paste cements are composed of two storable paste-like components which, when mixed, form a cement paste which cures within a few minutes. These pastes are provided in cartridges or in tubular bags to the medical user. These bone cement pastes contain at least (i) a monomer, (ii) a polymer soluble in this monomer, and (iii) a polymer insoluble in this monomer and / or other fillers.
  • components of redox initiator systems are included in the cement pastes.
  • a powdery cement component A and a liquid monomer component B are mixed.
  • the pulverulent component A comprises a polymer which is soluble in the monomers of the monomer component B, a polymer which is insoluble in the monomers of the monomer component B and / or fillers.
  • the powdery cement component A is mixed with the liquid monomer component B, this swells in the monomer or monomer-soluble polymer, before it dissolves in the monomer / monomer mixture.
  • the viscosity of the mixture increases so much that the mixture forms a paste.
  • the viscosity of the paste is so high that the insoluble polymer and / or the fillers do not sediment.
  • pastes are a common process in the food and adhesives industry, which is carried out with the aid of large-volume mixing vessels. It is usually carried out a mixing of the paste components with conventional wing or Sch Siemensrlochern.
  • the formed pastes are pressed out of the mixing vessels by means of fitted, movable lids by means of presses in suitable packaging such as cartridges, tubular bags and tubes.
  • suitable packaging such as cartridges, tubular bags and tubes.
  • the monomer methylmethacrylate which is mainly contained in bone cement pastes, is a very reactive and volatile liquid.
  • dissolved polymers such as, for example, polymethyl methacrylate
  • polymethyl methacrylate are also contained in the bone cement pastes.
  • cement pastes are in a gel state.
  • the monomer mixtures contained in the Zemen pastes are extremely reactive, especially when the cement paste is in a gel state. Consequently, these systems have a tendency to spontaneous polymerization.
  • Methyl methacrylate releases a reaction enthalpy of -59 kJ / mol in the free-radical polymerization.
  • Usual preparation containers have a capacity of approx. 200 liters. In an approach to paste cement of about 200 kg, containing about 40 weight percent monomer, about 80 kg (corresponding to 800 mol) of methyl methacrylate are included. With an undesirable spontaneous polymerization of this approach, an energy of approximately - 47200 kJ would be released within a few minutes, which can lead to deflagration or explosion. Furthermore, the very expensive preparation container after a spontaneous polymerization of cement paste are no longer used, because the cured bone cement pastes are mechanically very resistant. Therefore, the use of conventional approach containers for Production of bone cement pastes very problematic.
  • the invention is therefore based on the object to provide a device with which it is possible to produce largely degassed polymethyl methacrylate bone cement paste while avoiding large-volume mixing vessels and contained therein large volumes of cement. Furthermore, a process for the preparation of largely degassed polymethyl methacrylate bone cement pastes should be made available, which manages without the use of large-volume mixing containers.
  • the invention thus provides an apparatus for producing polymethyl methacrylate bone cement pastes from a powder cement component A and a liquid monomer component B, comprising a tubular hollow body having an input-side first opening and an output-side second opening, at least one rotatably mounted shaft arranged in axial Direction is arranged in the tubular hollow body, threads which are arranged axially along the outside of the shaft, wherein the shaft has at least one section with threads whose pitch decreases in the direction of the second opening, at least one stirring blade, which is arranged on the shaft, and rigid mixing elements disposed on the inside of the tubular hollow body.
  • the invention provides a process for the preparation of polymethylmethacrylate bone cement pastes from a powdery cement component A and a liquid monomer component B using the apparatus described above, comprising the powdery cement component A through the first supply port and the liquid one through the second supply port Monomer component B is introduced into the tubular hollow body, forming a cement mixture C by swelling, and causes axial rotational movements of the shaft, whereby a flow of the cement mixture C generated from the first opening in the direction of the second opening and the cement mixture is pressed out of the opening.
  • the device according to the invention enables the continuous production of largely degassed cement pastes.
  • the device according to the invention makes it possible to produce polymethyl methacrylate bone cement pastes.
  • Polymethyl methacrylate bone cement pastes are pasty compositions containing the polymer polymethylmethacrylate and preferably for the production of bone cement.
  • the polymethyl methacrylate bone cement pastes on the one hand in the presence of suitable initiator systems, for example, be brought directly to polymerization by the action of energy and thus without mixing with other ingredients to produce bone cement.
  • the bone cement can also be made by mixing and curing more than one bone cement paste.
  • These bone cement pastes themselves are produced according to the invention using the device described herein. In this case, at least one pulverulent cement component A and a liquid monomer component B are mixed together.
  • the monomer component B comprises at least one monomer.
  • the monomer may be, for example, a monofunctional methacrylic acid ester.
  • a particularly preferred methacrylic acid ester is methyl methacrylate.
  • the pulverulent cement component A preferably contains a polymer which is soluble in the monomers of the monomer component B and a polymer which is insoluble in the monomers of the monomer component B and / or fillers.
  • the pulverulent cement component A or the monomer component B may contain further constituents, in particular polymerization initiators, polymerization accelerators, pharmaceutical substances, such as antibiotics, radiopaque and / or dyes.
  • the device according to the invention has a tubular hollow body (10).
  • the tubular hollow body (10) has a circular or elliptical cross-section.
  • the tubular hollow body (10) has a different cross section.
  • the cross section may also be formed by two or more than two, for example three, adjacent gyro elements (see FIG. 2 ).
  • the inside of the tubular hollow body (10) preferably comprises an abrasion resistant material or is lined with such an abrasion resistant material, such as a ceramic. This can prevent that the inside of the tubular hollow body (10) is damaged and possibly from the inside of the tubular hollow body (10) dissolved components get into the bone cement paste and affect the quality of the bone cement.
  • the tubular hollow body (10) is preferably arranged vertically and has a first opening (30) and a second opening (20).
  • the first opening (30) defines the tubular hollow body (10) upwardly and the second opening (20) downwardly bounds the tubular hollow body (10).
  • the first opening (30) is the entrance-side opening and the second opening (20) is the exit-side opening.
  • the device according to the invention further comprises at least one rotatably mounted shaft (40), which is arranged in the axial direction in the tubular hollow body (10).
  • the shaft (40) itself is axially rotatable according to the invention.
  • the shaft (40) is connected to a drive capable of causing the shaft (40) to rotate axially.
  • the cross section of the tubular hollow body is formed by two or more than two, for example three, adjacent gyro elements.
  • a shaft (40) is preferably included in each section of the tubular hollow body (10) formed by a circular element.
  • Threads (50) are arranged on the outside of the at least one shaft (40) threads (50) are arranged.
  • Threads (50) are preferably understood to mean all elements which are inclined to an imaginary plane which is perpendicular to the axis of the shaft (40) and are arranged helically around the shaft.
  • the spiral formed by the elements can be continuous (in the sense of a classical thread) or interrupted.
  • the angle of inclination of the elements with respect to the imaginary plane is preferably 1 to 30 and more preferably 5 to 20 degrees.
  • the shaft (40) has at least one section in which the pitch of the threads (50) decreases in the direction of the second opening (20).
  • pitch is understood according to the invention, the distance between adjacent threads on a straight line parallel to the axis of the shaft (40) and along the shaft (40). Accordingly, it may be preferred that the pitch of the threads (50) from the first opening (30) towards the second opening (20) decreases continuously.
  • there is at least one further section in which the pitch of the threads (50) towards the second opening (20) does not decrease.
  • the shaft (40) has a plurality of sections of threads (50) arranged in the axial direction, wherein at least one section decreases the pitch of the threads (50) in the direction of the second opening (20).
  • this section is the section of threads (50) closest to the second opening (20).
  • the device according to the invention further comprises at least one stirring blade (60) which is arranged on the shaft (40). It may be preferred that a plurality of impellers (60) are axially along the shaft (40).
  • the agitator blades (60) are preferably arranged such that, during operation of the device, a flow of material is produced from the inlet-side opening (30) in the direction of the outlet-side opening (20). This can be achieved, for example, in that the agitating vanes (60) are inclined to an imaginary plane that is perpendicular to the axis of the shaft (40).
  • the shape of the impellers (60) and the number of impellers (60) arranged on an imaginary plane perpendicular to the axis of the shaft (40) are not limited.
  • the stirring vanes (60) are rod-shaped. Furthermore, it may be preferred if two, three, four, five or more impellers (60) are located in a plane parallel to the axis of the shaft (40). Preferably, in a plane parallel to the axis of the shaft (40) mounted agitator blades (60) are arranged so that their distance is maximum. Accordingly, the impellers (60) in a plane perpendicular to the axis of the shaft (40) are preferably at an angle of about 180 °, 120 °, 90 °, 72 ° or less.
  • the device according to the invention has rigid mixing elements (70) which are arranged on the inside of the tubular body (10).
  • the rigid mixing elements (70) are preferably integrally connected to the inside of the tubular body (10).
  • the rigid mixing elements (70) are rod-shaped.
  • the rigid mixing elements (70) arranged in a plane perpendicular to the axis of the shaft (40) have a maximum spacing.
  • the rigid mixing elements (70) in a plane perpendicular to the axis of the shaft (40) are preferably at an angle of about 180 °, 120 °, 90 °, 72 ° or less.
  • the stirring vanes (60) and the rigid mixing elements (70) are arranged alternately to one another.
  • at least one impeller (60) is preferably mounted along the shaft (40) adjacent to at least two rigid mixing elements (70) that are not within the same plane perpendicular to the axis of the shaft (40).
  • at least one rigid mixing element (70) is attached to the inside of the tubular hollow body (10) and that at least two stirring vanes (60) which are not within the same plane perpendicular to the axis of the shaft (40). is adjacent.
  • the stirring vanes (60), the mixing elements (70) and the threads (50) are arranged so that a rotational movement of the shaft (40) to a flow of material in the device from the first opening (30) in the direction of second opening (20) leads.
  • the substance is the powdery component A, the liquid monomer component B or a cement mixture C of the powdery component A and the liquid monomer component B.
  • the cement mixture C is preferably pasty.
  • the impellers (60) are oriented so that upon rotation of the shaft (40) the cement mixture C is moved in the direction of the opening (20).
  • the threads (50) are arranged so that upon rotation of the shaft (40) the cement mixture C is moved in the direction of the opening (20).
  • the agitating vanes (60), the mixing elements (70) and the threads (50) are further arranged so that upon rotation of the shaft (40) the agitating vanes (60) shear the cement mixture C on the rigid mixing elements (70) and the threads (50) transport the sheared cement mixture C in the direction of the opening (20) and compact and can press out of the opening (20). During the compression of the cement mixture C trapped air and gas residues are removed.
  • the portion of the shaft (40) having the threads (50) is located downstream of the portion of the shaft (40) having the stirring vanes (60). According to this embodiment, the portion of the shaft (40) having the threads (50) is further toward the output side opening (20) than the portion of the shaft (40) having the stirring vanes (60).
  • the outer diameter of the threads (50) is at most equal to the inner diameter of the tubular hollow body (10).
  • tubular hollow body (10) may be formed as a nozzle tube (80) at the second opening (20) and for a slide (95) to be additionally arranged in the nozzle tube (80) perpendicular to the axis of the nozzle tube (80) is.
  • the first opening (30) is closed with a cap (90) having one or more passages (91) for one or more shafts (40), at least one feed opening (100) for the powder component and at least one feed opening (110) for the monomer liquid and optionally an exhaust port (120) and optionally a gassing opening (130).
  • a tempering jacket (140) is mounted around the tubular hollow body.
  • This tempering jacket (140) can be flowed through with thermostated water or other suitable liquids.
  • the tempering jacket (140) can be avoided during the compression of the cement mixture C unwanted heating of the cement mixture C, which could favor a spontaneous polymerization.
  • a constant temperature of the cement paste C is desirable so that the viscosity and volume of the cement paste remain constant during the subsequent filling process.
  • the pulverulent cement component A is introduced through the first supply opening (100) and the liquid monomer component B is continuously introduced into the hollow body (10) through the second supply opening (110).
  • a cement mixture C is formed by swelling.
  • the cement mixture C Due to the axial rotational movements of the shaft (40), the cement mixture C is moved by the agitator blades (60) in the direction of the rigid mixing elements (70), causing a shear of the cement mixture C.
  • the shearing of the cement mixture C on the rigid mixing elements (70) leads to a rapid swelling of the cement mixture C.
  • the residence time of the cement mixture C in the mixing device can be drastically reduced.
  • the cement mixture C is compressed due to the decreasing pitch of the threads (50) arranged on the shaft (40). During compression, gas bubbles trapped in the cement mixture C are removed. This allows the production of largely degassed cement pastes. Finally, the cement mixture C is pressed out of the opening (20).
  • the inventive method thus enables the continuous production of polymethyl methacrylate bone cement pastes.
  • the mixing of the powdery cement component A with the liquid monomer component B takes place at a temperature in the range of -30 ° C to + 60 ° C.
  • the powdery cement component A with the liquid monomer component B at this temperature within 5 to 20 minutes mixed so that continuously the pasty cement paste C is formed.
  • the mixture is such that dissolution processes and swelling processes in the cement component C occur during the mixing process.
  • the method according to the invention is not a variant of reactive injection molding.

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  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)
  • Mixers Of The Rotary Stirring Type (AREA)
  • Surgical Instruments (AREA)
  • Accessories For Mixers (AREA)
EP11000207A 2010-01-26 2011-01-13 Dispositif de mélange et procédé de fabrication de pâtes de ciment osseux à base de polyméthyle-méthacrylate Not-in-force EP2347819B1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE102010005864A DE102010005864B4 (de) 2010-01-26 2010-01-26 Mischvorrichtung und ein Verfahren zur Herstellung von Polymethylmethacrylat-Knochenzementpasten

Publications (2)

Publication Number Publication Date
EP2347819A1 true EP2347819A1 (fr) 2011-07-27
EP2347819B1 EP2347819B1 (fr) 2012-05-09

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP11000207A Not-in-force EP2347819B1 (fr) 2010-01-26 2011-01-13 Dispositif de mélange et procédé de fabrication de pâtes de ciment osseux à base de polyméthyle-méthacrylate

Country Status (8)

Country Link
US (1) US8960991B2 (fr)
EP (1) EP2347819B1 (fr)
JP (1) JP4959846B2 (fr)
AT (1) ATE556766T1 (fr)
AU (1) AU2011200103B2 (fr)
CA (1) CA2726954C (fr)
DE (1) DE102010005864B4 (fr)
ZA (1) ZA201100588B (fr)

Cited By (4)

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CN109289628A (zh) * 2018-11-01 2019-02-01 徐州永丰磁业有限公司 一种钕铁硼粉末防氧化暂存装置
CN110215863A (zh) * 2019-05-27 2019-09-10 山东消博士消毒科技股份有限公司 一种抗菌皂液一体化制备装置
CN112275199A (zh) * 2020-10-14 2021-01-29 日照德联化工有限公司 一种立体连续轧浆制漆工艺
CN116651448A (zh) * 2023-05-22 2023-08-29 平顶山市拓青科技有限公司 一种钌基载体型加氢催化剂及催化剂水溶液制备方法

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JP6081103B2 (ja) * 2012-08-15 2017-02-15 デンカ株式会社 撹拌装置及び小サイズの平板部材の製造方法
DE102014106873B4 (de) * 2014-05-15 2016-12-08 Heraeus Medical Gmbh Vorrichtung und Verfahren zum Mischen eines Mehrkomponentenzements
DE102015111320B4 (de) * 2015-07-13 2018-10-18 Heraeus Medical Gmbh Vakuummischsystem und Verfahren zum Mischen von Polymethylmethacrylat-Knochenzement
US11845047B2 (en) * 2018-05-15 2023-12-19 Chevron Phillips Chemical Company Lp Systems and methods for improved mixing
CN111234568A (zh) * 2018-11-28 2020-06-05 李文娟 一种干粉型贝壳粉复合涂料的制备方法及其制备设备
CN111939793A (zh) * 2020-06-24 2020-11-17 哈尔滨鼎智瑞光科技有限公司 一种防粘结3d打印机金属胚料混料装置及混料方法
US12171669B2 (en) 2020-10-09 2024-12-24 Spinal Elements, Inc. Systems and methods for filling material
CN113384362B (zh) * 2021-07-23 2023-01-31 山东省日照市人民医院 一种骨科关节置换手术用辅助装置

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CN109289628A (zh) * 2018-11-01 2019-02-01 徐州永丰磁业有限公司 一种钕铁硼粉末防氧化暂存装置
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CN116651448A (zh) * 2023-05-22 2023-08-29 平顶山市拓青科技有限公司 一种钌基载体型加氢催化剂及催化剂水溶液制备方法

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JP4959846B2 (ja) 2012-06-27
CA2726954C (fr) 2013-07-23
AU2011200103B2 (en) 2012-12-06
ATE556766T1 (de) 2012-05-15
JP2011152536A (ja) 2011-08-11
DE102010005864A1 (de) 2011-07-28
AU2011200103A1 (en) 2011-08-11
ZA201100588B (en) 2011-10-26
US20110184083A1 (en) 2011-07-28
CA2726954A1 (fr) 2011-07-26
EP2347819B1 (fr) 2012-05-09
US8960991B2 (en) 2015-02-24

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