EP4079396B1 - Dispositif de fourniture de la pâte de ciment osseux - Google Patents

Dispositif de fourniture de la pâte de ciment osseux Download PDF

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Publication number
EP4079396B1
EP4079396B1 EP21169786.7A EP21169786A EP4079396B1 EP 4079396 B1 EP4079396 B1 EP 4079396B1 EP 21169786 A EP21169786 A EP 21169786A EP 4079396 B1 EP4079396 B1 EP 4079396B1
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EP
European Patent Office
Prior art keywords
interior
container
bone cement
monomer liquid
rear part
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.)
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Application number
EP21169786.7A
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German (de)
English (en)
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EP4079396A1 (fr
Inventor
Sebastian Vogt
Thomas Kluge
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Heraeus Medical GmbH
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Heraeus Medical GmbH
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Priority to EP21169786.7A priority Critical patent/EP4079396B1/fr
Publication of EP4079396A1 publication Critical patent/EP4079396A1/fr
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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00—Other mixers; Mixing plants; Combinations of mixers
    • B01F33/50—Movable or transportable mixing devices or plants
    • B01F33/501—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use
    • B01F33/5011—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use portable during use, e.g. hand-held
    • B01F33/50112—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use portable during use, e.g. hand-held of the syringe or cartridge type
    • 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
    • B01F35/71—Feed mechanisms
    • B01F35/713—Feed mechanisms comprising breaking packages or parts thereof, e.g. piercing or opening sealing elements between compartments or cartridges
    • B01F35/7131—Breaking or perforating packages, containers or vials
    • 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
    • B01F35/71—Feed mechanisms
    • B01F35/716—Feed mechanisms characterised by the relative arrangement of the containers for feeding or mixing the components
    • B01F35/7161—Feed mechanisms characterised by the relative arrangement of the containers for feeding or mixing the components the containers being connected coaxially before contacting the contents
    • 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
    • B01F35/71—Feed mechanisms
    • B01F35/717—Feed mechanisms characterised by the means for feeding the components to the mixer
    • B01F35/7174—Feed mechanisms characterised by the means for feeding the components to the mixer using pistons, plungers or syringes
    • 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
    • B01F35/75425—Discharge mechanisms characterised by the means for discharging the components from the mixer using pistons or plungers
    • B01F35/754251—Discharge mechanisms characterised by the means for discharging the components from the mixer using pistons or plungers reciprocating in the mixing receptacle
    • 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 device for providing a bone cement dough from two starting components, comprising a hollow cylindrical cartridge with an interior, wherein a bone cement powder is stored as the first starting component in a front part of the interior and a container containing a monomer liquid is stored as the second starting component in a rear part of the interior, wherein a discharge piston which is axially movable in the interior is arranged between the bone cement powder and the container and a delivery piston which is axially movable in the interior is arranged on the side of the container opposite the discharge piston, the rear part and the front part of the interior being connected to one another in a fluid-conducting manner via a conduit and through
  • the container is to be opened by disintegrating into a large number of container sections, so that the monomer liquid can flow into the rear part of the interior.
  • the invention further relates to a method for providing a bone cement dough from two starting components using such a device.
  • a full prepack system in which the container filled with monomer liquid is stored axially behind the bone cement powder within a cartridge.
  • a discharge piston is arranged between the bone cement powder and the container.
  • a delivery piston which is arranged on a side of the container opposite the discharge piston, is advanced in the direction of the discharge piston, which results in the container being opened by at least partially bursting the container into container sections.
  • the monomer liquid emerging from the container is conveyed into the bone cement powder by continuing to advance the delivery piston, forming the bone cement dough.
  • the container is compressed further and further, sometimes with further fragmentation of the container sections, until maximum compression is achieved.
  • the bone cement dough facing the container sections has a larger proportion of monomer liquid to bone cement powder as the part of the bone cement dough facing away from the container sections and therefore the properties of the bone cement dough change in the course of discharge.
  • the bone cement dough facing the container is "diluted" by the amount of monomer liquid subsequently introduced and has a lower viscosity than the bone cement dough initially discharged from the device.
  • a full prepack system wherein the container filled with monomer liquid is stored axially behind the bone cement powder within a cartridge.
  • a discharge piston is arranged between the bone cement powder and the container.
  • a delivery piston which is arranged on a side of the container opposite the discharge piston, is advanced in the direction of the discharge piston, which results in the container being opened by at least partially bursting the container into container sections.
  • the container is there partially covered by foam, which serves as transport security and shock protection.
  • An object of the present invention is to at least partially overcome one or more of the disadvantages resulting from the prior art.
  • the invention is based on the aim of providing devices which can provide a bone cement dough simply, safely, quickly and with a constant mixing ratio of bone cement powder and monomer liquid.
  • the device should enable the monomer liquid to be conveyed as completely as possible into the bone cement powder, so that as little monomer liquid as possible remains between the container sections.
  • the device is intended to provide the bone cement without mechanical mixing of the starting components.
  • the device should also be designed in such a way that the user does not have to carry out any assembly steps.
  • the device should be able to provide the bone cement without an externally applied vacuum.
  • the device should be able to discharge the bone cement provided.
  • the device should be able to discharge the provided bone cement without any modifications.
  • the device should be able to provide and discharge the bone cement without any modifications and without external equipment, such as hoses, vacuum sources or squeezing devices.
  • the device should be able to be operated with as few steps as possible in order to minimize sources of error by the user.
  • the large number of particles of the displacement agent are spherical, in particular spherical or ovoid.
  • This embodiment is a third embodiment of the invention, which preferably depends on the second embodiment of the invention.
  • the particles of the displacement agent are made of silicone rubber, natural rubber, polyurethane-polyester rubber, polybutadiene-styrene rubber or mixtures of these substances.
  • This embodiment is a fourth embodiment of the invention, which preferably depends on the second or third embodiment of the invention.
  • the particles of the displacement agent have a diameter in a range from 1 mm to 3.5 mm, preferably in a range from 1.3 mm to 3.0 mm, more preferably in a range from 1.5 mm to 2.5 mm, on.
  • This embodiment is a fifth embodiment of the invention, which preferably depends on the second, third or fourth embodiments of the invention.
  • the displacement agent comprises propane-1,2,3-triol as a liquid and silicon dioxide as a solid.
  • This embodiment is a seventh embodiment of the invention, which preferably depends on the sixth embodiment of the invention.
  • the silicon dioxide comprises fumed silicon dioxide, precipitated silicon dioxide or a mixture of fumed and precipitated silicon dioxide.
  • This embodiment is an eighth embodiment of the invention, which preferably depends on the seventh embodiment of the invention.
  • the displacement agent occupies a displacement agent volume which corresponds to at least a total volume of the container sections.
  • This embodiment is a ninth embodiment of the invention, which preferably depends on one of the previous embodiments of the invention.
  • the displacement means is at least partially arranged between the container and the delivery piston.
  • This embodiment is a tenth embodiment of the invention, which preferably depends on one of the previous embodiments of the invention.
  • the displacement means is at least partially arranged radially around the container.
  • This embodiment is an eleventh embodiment of the invention, which preferably depends on one of the previous embodiments of the invention.
  • the displacing agent is essentially insoluble in the monomer liquid at room temperature, i.e. in the range from 15°C to 30°C.
  • This embodiment is a twelfth embodiment of the invention, which preferably depends on the first, second or sixth embodiments of the invention.
  • the device is inserted into a discharge device to advance the delivery piston.
  • This embodiment is a fourteenth embodiment of the invention, which preferably depends on the fourteenth embodiment of the invention.
  • the monomer liquid is distributed in the bone cement powder using a hydrophilic additive.
  • This embodiment is one fifteenth embodiment of the invention, which preferably depends on the fourteenth or fifteenth embodiment of the invention.
  • range information also includes the values mentioned as limits.
  • a specification of the type "in the range from X to Y" with respect to a quantity A therefore means that A can take on the values X, Y and values between X and Y.
  • One-sided limited areas of the type "up to Y" for a size A mean correspondingly as a value Y and smaller than Y.
  • a volume-stable displacement means is arranged in the rear part of the interior, which is designed to enclose the container sections while displacing the monomer liquid between the container sections as the delivery piston progresses in the direction of the discharge piston to convey the monomer liquid from the rear part via the conduit to the front part of the interior.
  • the displacement means thus fills an intermediate space between the container sections, which after opening the container and possible further fragmentation of the container sections into smaller container sections is filled with the monomer liquid and / or a gas, such as air or nitrogen, and displaces the monomer liquid present there. Since the rear part of the interior is closed in a fluid-tight manner by the delivery piston on a side opposite the line means, the monomer liquid is fed into the bone cement powder via the line means with continued advancement of the delivery piston, and thus also with continued filling of the space between the container sections by the displacement agent front part of the interior promoted.
  • the device thus ensures almost complete mixing of bone cement powder and monomer liquid, which allows bone cement dough with a consistent bone cement dough composition to be prepared easily, quickly and safely.
  • the device has a hollow cylindrical cartridge.
  • a hollow cylindrical cartridge is to be understood as meaning a tube-like container which has an interior and a cartridge wall surrounding the interior.
  • the cross section of the cartridge can take any shape. Due to the simple production and the safer use of the device, the cross section, and preferably also the cross section of the interior, is circular. This allows easy handling for the user and, due to the absence of edges, reduces the risk of moving parts becoming wedged within the device.
  • the cartridge can consist of a wide variety of materials or combinations of materials.
  • the device can be made of plastic.
  • the plastic is preferably a transparent plastic, since in this way the user can visually check that the device is functioning properly during use.
  • a discharge piston that is axially movable in the interior is arranged between the bone cement powder and the container.
  • the discharge piston serves to spatially separate the container and bone cement powder, so that neither bone cement powder is transferred from the front part of the interior to the rear part of the interior, nor the container or container sections after opening the container, from the rear part of the interior to the front part of the interior can reach.
  • the latter in particular prevents bone cement dough interspersed with container sections, which could pose health risks for the patient and impair proper discharge of the bone cement dough from the device.
  • the discharge piston continues to serve to discharge the provided bone cement dough from the device.
  • the discharge piston can be moved from its original position towards a discharge opening of the device.
  • the discharge opening is preferably located on a side of the bone cement powder that is axially opposite the discharge piston.
  • the device has a delivery piston that is axially movable in the interior.
  • the delivery piston is arranged on the side of the container axially opposite the discharge piston within the device.
  • the container By propelling, that is, by a relative movement of the delivery piston in the direction of the discharge piston, which shortens the distance between the delivery piston and the discharge piston within the interior, the container opens. Opening of the container occurs when the distance between the delivery piston and the discharge piston is reduced such that the container is subjected to a resulting force that is greater than the structural integrity of the container.
  • the container breaks down into a large number, that is to say at least two, of container sections, so that a monomer liquid can escape from the interior of the container into the rear part of the interior of the cartridge.
  • a continued advancement of the delivery piston in the direction of the discharge piston leads, in particular with the cooperation of the displacement means, to the monomer liquid being conveyed from the rear part of the interior of the device via the line means into the front part of the interior of the device.
  • a container containing a monomer liquid is stored within the rear part of the interior of the device.
  • a container is understood to mean a storage option that can store the monomer liquid in a hermetically sealed and sterile manner and can be destroyed by manual force.
  • Examples of containers containing the monomer liquid are Glass ampoules, plastic ampoules and plastic bags. Glass ampoules are preferred due to their ability to be easily sterilized and easily opened by manual force.
  • the device has a conduit through which the rear part and the front part of the interior are connected in a fluid-conducting manner.
  • Fluid-conducting means that the rear part and the front part of the interior are connected so that they are permeable to liquids, in particular the monomer liquid, and to gases.
  • the conduit is preferably equipped with a filter medium, in particular one Pore disk, for example made of sintered polypropylene particles, made of cellulose felt or made of cardboard, can be arranged, which makes the conduit impermeable to solids.
  • At least one passage is provided as a line means in the discharge piston and/or between the discharge piston and the inner wall of the interior, through which the rear part and the front part of the interior are connected to one another in a fluid-conducting manner.
  • a filter that is impermeable to the bone cement powder and permeable to the monomer liquid and gases for example a pore disk, for example made of sintered polypropylene particles, made of cellulose felt or made of cardboard, can be arranged in or at one or both ends of the at least one feedthrough.
  • the line means is one or more lines which is or are arranged on the outside of the cartridge or in the cartridge wall and which connects or connects the rear part and the front part of the interior through passages in the cartridge wall or through openings.
  • the discharge piston is bypassed in this variant.
  • the monomer liquid within the interior of the cartridge can be transferred via the conduit from the rear part of the interior to the front part of the interior, in which the bone cement powder is located.
  • a variant of the device is designed so that continued advancement of the delivery piston in the direction of the discharge piston after the monomer liquid has been conveyed from the rear part of the interior into the front part of the interior causes the discharge piston to advance in the direction of the discharge opening of the device.
  • the bone cement dough provided by mixing bone cement powder and monomer liquid can be discharged from the device through the discharge opening become. This ensures in a simple manner that the bone cement dough can be expelled from the cartridge with the same drive that is also used to open the container and to convey the monomer liquid, namely with the unidirectionally driven delivery piston.
  • a locking means can be arranged on the discharge piston, so that the discharge piston can lock between the front part and the rear part of the interior with the cartridge, in particular with the cartridge wall, this locking by the forces occurring when the container is opened and a pressure exerted on the monomer liquid by the delivery piston, or by the delivery piston and displacement means, when the monomer liquid is conveyed into the front part of the interior cannot be released, but by direct pressure from the delivery piston or delivery piston , displacement means and any container sections located in between, pressure acting on the discharge piston can be released.
  • the locking means ensures that the container can first be opened by advancing the delivery piston and the monomer liquid flowing out from it is released with the delivery piston, or with the delivery piston in interaction with the displacement means, then into the front part of the interior of the cartridge, i.e. into the bone cement powder , can be pressed, with the discharge piston maintaining its original position relative to the cartridge and the interior. Only after the monomer liquid has largely been pressed into the bone cement powder, and thus the bone cement dough is in the front part of the interior of the cartridge, can the bone cement dough then be pressed out of the front part of the cartridge using the discharge piston.
  • the force to release the detent is therefore greater than the force required to open the container and convey the monomer liquid via the conduit into the front part of the interior.
  • the container When opened, the container breaks down into a large number of container sections, allowing the monomer liquid to flow into the rear part of the interior of the cartridge.
  • the opening occurs by advancing the delivery piston in the direction of the discharge piston.
  • the container sections created when the container is opened can in turn break into a large number of smaller container sections.
  • the delivery piston has been moved far enough in the direction of the discharge piston, the monomer liquid begins to be delivered from the rear part of the interior via the conduit into the front part of the interior with the formation of the bone cement dough.
  • a complete advancement of the delivery piston, so that delivery piston and discharge piston touch each other directly, can be prevented due to the container sections, especially if the opposite sides of the discharge piston and delivery piston are designed to be flat.
  • the container sections can break down into smaller and smaller container sections as the delivery piston and discharge piston move closer together, but there will always be a gap between the backs of the container sections, which is filled with the monomer liquid and/or gas present in the interior.
  • a volume-stable displacement means is arranged in the rear part of the interior.
  • a volume-stable displacement agent is to be understood as meaning a plastically and/or elastically deformable material.
  • the displacement agent comprises in particular a solid and/or a flowable substance with a higher viscosity than the monomer liquid.
  • a material is to be regarded as volume-stable if it is under the pressure conditions of up to 0.5 kN/cm 2 that arise when using the device, in particular when opening the container, when conveying the monomer liquid and, preferably, when discharging the bone cement dough provided the device causes no or only an insignificant change in volume of the displacement agent. Gases, for example, are not stable in volume when pressure is applied.
  • the displacement means is suitable for enclosing the container sections under the pressure conditions acting when conveying the monomer liquid from the rear part of the interior into the front part of the interior in such a way that monomer liquid present in the space between the container sections is conveyed through the line means into the front part of the interior in order to be available for the formation of the bone cement dough without being conveyed into the front part of the interior.
  • the displacement agent can contain at least a portion of a solid and/or the displacement agent has such a high viscosity that conveying into the front part of the interior through the conduit, in particular through a conduit equipped with a filter agent, such as a pore disk, is impossible the pressure conditions used are omitted.
  • the displacement agent fills the space between the container sections as completely as possible, so that the monomer liquid is displaced as completely as possible from the space.
  • the displacing agent is essentially insoluble in the monomer liquid, in particular in methyl methacrylate, at room temperature (15 to 30 ° C).
  • the displacing agent is soluble with a maximum of 10 g in 1 liter of methyl methacrylate with a contact time with the methyl methacrylate of 120 seconds.
  • the displacing agent does not dissolve at all in the monomer liquid, especially in methyl methacrylate.
  • the displacing agent comprises a hard fat and/or a wax with a melting point of at least 40° C. or a plurality of particles with a Shore A hardness of less than or equal to 80 or a paste containing a powdery solid and a liquid.
  • the displacement agent comprises a hard fat and/or a wax with a melting point of at least 40 ° C.
  • the displacement agent can therefore be a hard fat (adpes solidus, for example the hard fat CAS 67701-26-2 ) with a melting point of at least 40 °C, a wax with a melting point of at least 40 °C or a mixture of a hard fat with a melting point of at least 40 °C and a wax with a melting point of at least 40 °C.
  • paraffins such as Fischer-Tropsch waxes (CAS 8002-74-2 ), amide waxes ( CAS 110-30-5 ) or waxy fatty acid esters of natural origin, such as beeswax ( CAS 18012-89-3 ), understood.
  • the waxes can be used in their pure form or using plasticizers, for example from the group of fatty acid isopropyl esters or liquid paraffins.
  • the hard fats can be used in pure form or with the addition of other compounds, such as glycerol tripalmate, glycerol trilaurate or glycerol tristearate. By adding glycerol trifatty acid esters that melt above 40 °C, the melting point of the hard fat can be increased.
  • the displacement agent comprises a large number of particles with a Shore A hardness of less than or equal to 80, preferably less than or equal to 50, more preferably less than or equal to 30.
  • Shore A hardness of a given material is known to those skilled in the art.
  • Such particles can penetrate into the space between the container sections and are soft enough that when the delivery piston is advanced in the direction of the discharge piston prevailing pressure conditions, an elastic and/or plastic deformation of the particles takes place, so that the particles compact while displacing the cavity between the individual particles.
  • This allows the monomer liquid to be displaced as completely as possible from the space between the container sections while conveying the monomer liquid via the conduit into the front part of the interior.
  • the container sections are surrounded as completely as possible, since the particles “nestle” to them.
  • the particles can have different shapes. Due to the better flowability and the associated better penetration into the space between the container sections, a spherical particle shape is preferred.
  • the particles can have a spherical or ovoid particle shape.
  • the particles can comprise different materials or consist of different materials as long as they have a Shore A hardness of less than or equal to 80, preferably less than or equal to 50, more preferably less than or equal to 30.
  • the particles are made of silicone rubber, natural rubber, polybutadiene-styrene rubber and/or polyurethane-polyester rubber.
  • the particles can consist entirely or at least partially of the materials mentioned. If the particles only partially consist of the materials mentioned, it is preferred that the materials mentioned are arranged on a surface of the particles, so that the aforementioned compression of the particles can take place when the delivery piston is advanced in the direction of the discharge piston.
  • the particles can have different diameters.
  • the particles have a diameter in a range from 1 to 3.5 mm, preferably from 1.2 to 3.0 mm, more preferably from 1.5 to 2.5 mm.
  • the diameter of the particles refers to the D50 value. Particles with these diameters allow easy introduction into the space between the container sections. In addition, such particles can be compacted well by the pressure conditions prevailing when the delivery piston is advanced in the direction of the discharge piston in order to achieve the most complete displacement of the monomer liquid from the space between the container sections.
  • the displacement agent comprises a paste containing a powdery solid and a liquid.
  • the powdery solid comprises the above-described particles with a Shore A hardness of less than or equal to 80, preferably less than or equal to 50, more preferably less than or equal to 30, or consists of these particles.
  • the powdery solid comprises a material which has a greater hardness than the particles described above.
  • the powdery solid preferably has solid particles with a diameter in a range from 1 to 3.5 mm, preferably from 1.2 to 3.0 mm, more preferably from 1.5 to 2.5 mm.
  • the diameter of the particles refers to the D50 value. Solid particles with these diameters allow the paste to be easily introduced into the space between the container sections.
  • liquids of organic or inorganic nature can be used as liquid.
  • organic liquids include alcohols, particularly polyalcohols such as glycerin, hydrocarbons and aromatic solvents.
  • inorganic liquids include water and aqueous solutions.
  • the paste comprises propane-1,2,3-triol (glycerin) as a liquid and silicon dioxide as a powdery solid.
  • the paste consists of silicon dioxide and propane-1,2,3-triol.
  • the silicon dioxide can have different shapes and/or properties.
  • the silicon dioxide comprises or consists of fumed silicon dioxide (fumed silica), precipitated silicon dioxide or a mixture of fumed and precipitated silicon dioxide.
  • the displacement agent can occupy different volume proportions of the interior, in particular the rear part of the interior.
  • the displacement agent occupies a displacement agent volume which corresponds to at least a total volume of the container sections.
  • the total volume of the container sections corresponds to the volumes of all container sections into which the container collapses when the delivery piston is opened or advanced.
  • the total volume of the container sections therefore corresponds to a volume which, through the wall of the container, or through the walls of the container sections, itself, i.e. does not correspond to the space enclosed by the container.
  • the displacement agent preferably has a displacement agent volume which corresponds to at least 1.5 times, more preferably at least 2 times, most preferably at least 2.5 times the total volume of the container sections.
  • the displacement agent volume does not correspond to more than 6 times the total volume of the container sections.
  • the displacement means can be arranged at different locations within the rear part of the interior of the cartridge.
  • the displacement means is at least partially arranged between the container and the delivery piston.
  • the displacement means is at least partially arranged between the container and the delivery piston.
  • at least 10% by volume, preferably at least 25% by volume, more preferably at least 50% by volume of the displacement agent can be arranged between the container and the delivery piston.
  • An advantage here is that such an arrangement allows the displacement means to be easily pushed into the container sections as the delivery piston continues to advance in the direction of the discharge piston, since the displacement means is already pushed in the direction of the container due to its spatial arrangement.
  • the displacement means arranged in this way allows the monomer liquid to be displaced in a targeted manner in the direction of the line means.
  • the displacement means is at least partially arranged radially around the container.
  • the displacement means thereby exerts a stabilizing, holding effect on the container, so that it can be stored safely and with a reduced risk of accidental breakage within the rear part of the interior of the cartridge.
  • the displacement means extends around the entire radial circumference of the container and thus surrounds the container in a sleeve-like manner.
  • the displacement means does not extend completely around the entire radial circumference of the container, but rather only surrounds the container, for example, on 50% of the radial circumference.
  • the displacement element can extend over the entire length of the container or only over one or more partial lengths of the container.
  • the delivery piston has a receptacle which is open in the direction of the container and in which the displacement means is arranged.
  • the container is partially inserted into the receptacle with an axial end pointing in the direction of the delivery piston, so that the displacement means at least partially encloses this axial end of the container.
  • the container is radially surrounded by the displacement means at least at this axial end and is therefore spatially fixed.
  • the container is only inserted into the receptacle to such an extent that displacement means is also arranged between the container and the delivery piston.
  • no displacement means is arranged between the container and the discharge piston within the rear part of the interior of the cartridge, so that the monomer liquid does not have to be conveyed through or past the displacement means through the line means into the front part of the interior of the cartridge. This allows the monomer liquid to be pumped into the bone cement powder with as little effort as possible by the user of the device.
  • the container sections when the container sections created when the container is opened are pushed together, the container sections, or at least one or more of the initial container sections, can be further fragmented into further, smaller container sections. Regardless of this further fragmentation, a space will always remain between the container sections, in which at least part of the monomer liquid remains. If the container sections cannot be pushed together any further by further advancing the delivery piston in the direction of the discharge piston, the displacement means stored in the rear part of the interior is introduced into the space between the container sections at this point at the latest. The displacement means will accommodate the container sections by enclosing them and thereby displace the monomer liquid remaining in the gap from the gap.
  • the displacement means is preferably designed in such a way that it essentially cannot absorb the monomer liquid. Since the rear part of the interior is closed at one axial end by the delivery piston, the only path left for the monomer liquid is through the conduit into the front part of the interior. There it comes into contact with the bone cement powder to form the bone cement dough.
  • the delivery piston can be advanced into the cartridge in the direction of the discharge piston in different ways.
  • a user of the device can advance the delivery piston manually, in particular by applying force to a rod or axle.
  • the cartridge and the delivery piston together form a thread, via which the delivery piston can be screwed into the cartridge in the direction of the discharge piston.
  • the cartridge preferably has an internal thread and the delivery piston has an external thread, which interact positively and/or non-positively to enable the delivery piston to be advanced.
  • the delivery piston is advanced using a mechanical aid.
  • One embodiment of the method is characterized in that to advance the delivery piston, the device is inserted into a discharge device, in particular a discharge gun for bone cement dough.
  • a discharge device in particular a discharge gun for bone cement dough.
  • Dispensing guns for bone cement dough are known to those skilled in the art.
  • the formation of the bone cement dough from the two starting components begins. This is preferably done with the two starting components mixed as evenly as possible in order to obtain a bone cement dough that is as homogeneous as possible.
  • the two components can be mixed in different ways. In one embodiment of the method, the mixing takes place with the active participation of the user of the device, for example by shaking the device or by actuating a mixing element in the front part of the interior, in particular a stirrer.
  • One embodiment of the method is characterized in that the monomer liquid is distributed in the bone cement powder with the aid of a hydrophilic additive.
  • the device according to the invention is characterized in that it provides a bone cement dough from two starting components.
  • a bone cement dough is a substance that is suitable in the field of medical technology to create a stable connection between artificial joints, such as hip and knee joints, and bone material. Hardening turns a bone cement dough into a bone cement.
  • These are preferred Bone cements include polymethyl methacrylate bone cements (PMMA bone cements). PMMA bone cements have long been used in medical applications and go back to the work of Sir Charnley (cf. Charnley, J. Anchorage of the femoral head prosthesis of the shaft of the femur. J. Bone Joint Surg. 1960; 42, 28-30 .).
  • PMMA bone cements can be produced from a bone cement powder as the first starting component and a monomer liquid as the second starting component. If the composition is suitable, the two starting components can be stored separately from one another. When the two starting components come into contact, a plastically deformable bone cement dough is created due to the swelling of the polymer components of the bone cement powder. Polymerization of the monomer is initiated by radicals. As the polymerization of the monomer progresses, the viscosity of the bone cement dough increases until it hardens completely.
  • a bone cement powder is understood to mean a powder which comprises at least one particulate polymethyl methacrylate and/or one particulate polymethyl methacrylate copolymer. Examples of copolymers are styrene and/or methyl acrylate.
  • the bone cement powder may additionally comprise a hydrophilic additive which supports the distribution of the monomer liquid within the bone cement powder.
  • the bone cement powder can additionally comprise an initiator, which initiates the polymerization.
  • the bone cement powder can additionally comprise an X-ray opaque.
  • the bone cement powder can additionally comprise pharmaceutically active substances, such as antibiotics.
  • the bone cement powder preferably comprises, as a hydrophilic additive, at least one particulate polymethyl methacrylate and/or a particulate polymethyl methacrylate copolymer, an initiator and an X-ray opaque or consists of these components. More preferably, the bone cement powder comprises at least one particulate polymethyl methacrylate and/or a particulate polymethyl methacrylate copolymer, an initiator, an X-ray opaque and a hydrophilic additive or consists of these components.
  • the bone cement powder comprises or consists of at least one particulate polymethyl methacrylate and/or a particulate polymethyl methacrylate copolymer, an initiator, a radiopaque, a hydrophilic additive and an antibiotic.
  • the particle size of the particulate polymethyl methacrylate and/or the particulate polymethyl methacrylate copolymer of the bone cement powder can correspond to the sieve fraction of less than 150 ⁇ m, preferably less than 100 ⁇ m.
  • the hydrophilic additive can be designed to be particulate and/or fibrous.
  • the hydrophilic additive can be slightly soluble, preferably insoluble, in methyl methacrylate.
  • the hydrophilic additive can have an absorption capacity of at least 0.6 g of methyl methacrylate per gram of hydrophilic additive.
  • the hydrophilic additive can have a chemical substance with at least one OH group. It can preferably be provided that the hydrophilic additive has covalently bonded OH groups on its surface. Examples of such preferred hydrophilic additives can be additives selected from the group comprising cellulose, oxycellulose, starch, titanium dioxide and silicon dioxide, with fumed silicon dioxide being particularly preferred.
  • the particle size of the hydrophilic additive of the sieve fraction can correspond to less than 100 ⁇ m, preferably less than 50 ⁇ m and most preferably less than 10 ⁇ m.
  • the hydrophilic additive can be contained in an amount of 0.1 to 2.5% by weight based on the total weight of the bone cement powder.
  • the initiator can contain dibenzoyl peroxide or consist of dibenzoyl peroxide.
  • a radiopaque is understood to mean a substance which allows the bone cement to be made visible on x-ray diagnostic images.
  • radiopaques may include barium sulfate, zirconia and calcium carbonate.
  • the pharmaceutically active substance can comprise one or more antibiotics and optionally added co-factors for the one or more antibiotics.
  • the pharmaceutically active substance preferably consists of one or more antibiotics and optionally added co-factors for the one or more antibiotics.
  • antibiotics include gentamicin, clindamycin and vancomycin.
  • the monomer liquid can comprise the monomer methyl methacrylate or consist of methyl methacrylate.
  • the monomer liquid comprises, in addition to the monomer, an activator dissolved therein, such as N,N-dimethyl-p-toluidine, or consists of methyl methacrylate and N,N-dimethyl-p-toluidine.
  • an activator dissolved therein such as N,N-dimethyl-p-toluidine, or consists of methyl methacrylate and N,N-dimethyl-p-toluidine.
  • FIG. 1 shows a schematic cross section of an exemplary embodiment of a device 100 for providing a bone cement dough in an initial state.
  • the device 100 is in one piece, but is made up of several components.
  • the device 100 is constructed like a tube and includes a hollow cylindrical cartridge 200 with an interior 210.
  • a bone cement powder 400 as a first starting component
  • a container 300 in the form of a glass ampoule containing a monomer liquid 350 stored as the second starting component of the bone cement dough.
  • the bone cement powder 400 contains particulate polymethyl methacrylate as the main component and a hydrophilic additive with which the monomer liquid 350 can be distributed in the bone cement powder 400.
  • the front part 220 and the rear part 230 of the interior 210 are separated by a discharge piston 250 that is movable axially in the interior 210.
  • the discharge piston 250 is designed to be impermeable to solids, so that no bone cement powder 400 comes from the front Part 210 into the rear part 230 of the interior 210 and the container 300 cannot get from the rear part 230 to the front part 220 of the interior 210.
  • the discharge piston 250 has a line means 260 in the form of several passages through which there is a fluid-conducting connection between the front part 220 and the rear part 230.
  • the line means 260 is formed as part of the discharge piston 250 in the embodiment of the device 100 shown. In further embodiments, not shown, the line means 260 can be formed separately from the discharge piston 250, for example as a tubular line outside the cartridge.
  • the conduit 260 is closed by a pore disk 265 that is impermeable to solids and highly viscous liquids, such as hard fats, waxes, pastes or bone cement doughs, but which allows the monomer liquid 350 to be conveyed easily from the rear part 230 into the front part 220 of the interior 210.
  • the pore disk 265 is arranged on the end of the conduit 260 facing the front part 220 of the interior 210.
  • the pore disk 265, or other means is arranged on the end of the conduit 260 facing the rear part 230 or at both ends of the conduit 260.
  • a delivery piston 270 which is axially movable within the interior 210 is arranged.
  • the delivery piston 270 closes a back of the interior 210 of the cartridge 200.
  • two radially circumferential sealing rings 255 made of rubber are provided on the discharge piston 250, with which the discharge piston 250 is sealed against the wall of the interior 210 .
  • two radially circumferential sealing rings 275 are provided on the delivery piston 270, with which the monomer liquid 350 is prevented from escaping past the delivery piston 270 and out of the device 100.
  • the sealing effect of the sealing rings 275 on the delivery piston 270 must be sufficient, even if the delivery piston 270 exerts such great pressure on the monomer liquid 350 that it flows through the conduit 270 and the pore disk 265 from the rear part 230 into the front part 220 of the interior 210 is pressed in.
  • the device also has a discharge opening 280, which delimits the area of the front part 220 of the interior 210 of the cartridge 200 facing away from the discharge piston 250.
  • the discharge opening 280 is closed by a closure cap 281 with a stopper 285, so that no bone cement powder 400 can escape from the cartridge 200.
  • a displacement means 500 is stored within the rear part 230 of the interior 210.
  • the displacement means 500 is arranged within a receptacle 271 of the delivery piston 270 in the initial state of the device 100.
  • the displacement means 500 arranged in this way surrounds a part of the container 300, in particular a container head 310 in the form of a glass ampoule head, both axially in the direction of the delivery piston 270 and radially.
  • the container 300 is thereby fixed within the rear part 230 of the interior 210 by means of the discharge piston 250 and the displacement means 500 in such a way that the risk of accidental opening of the container 300, for example due to a shaking movement of the device 100, is reduced.
  • the type of arrangement shown is particularly suitable for displacement means 500, which are present as a compact, plastically deformable body, for example in the form of a hard fat, as a wax or in a pasty form.
  • the device 100 is inserted into a discharge device 700 (not shown completely).
  • the discharge device comprises an internal thread 710, which interacts positively and/or non-positively with an external thread 110 of the device 100 and thus connects the device 100 and the discharge device 700 to one another, and a plunger 720.
  • the device 100 and the discharge device 700 are not via a thread, but via a different type of connection can be connected in a positive and/or non-positive manner, in particular via a bayonet lock or a plug connection.
  • the delivery piston 270 can be advanced axially in the interior 210 in the direction of the discharge piston 250 by means of the plunger 720 in the direction of the discharge piston 250.
  • Figure 2 shows the device Figure 1 , where compared to Figure 1 the delivery piston 270 is advanced in the direction of the discharge piston 250 by means of the plunger 720 of the discharge device 700 until contact between the container 300 and the delivery piston 270 has come about.
  • the container 300 in particular the container head 310, was further received into the receptacle 271 of the delivery piston 270, while at the same time part of the displacement means 500 was pushed out of the receptacle 271.
  • the position of the discharge piston 250 is compared to Figure 1 essentially unchanged. In the state of the device 100 shown, the distance between the delivery piston 270 and the discharge piston 250 essentially corresponds to the length of the container 300.
  • Figure 3 shows the device 100 from the Figures 1 and 2 , where compared to Figure 2 the delivery piston 270 is advanced further in the direction of the discharge piston 250 by means of the plunger 720 of the discharge device 700.
  • the structural integrity of the container 300 was destroyed, causing it to break down into a large number of container sections 300a and the monomer liquid 350 to leak from the interior of the container 300 into the rear part 230 of the interior 210.
  • Some of the container sections 300a are at least partially enclosed by the displacement means 500, so that no monomer liquid 350 can be found between them.
  • Monomer liquid 350 can be found between other container sections 300a that are not enclosed by the displacement means 500.
  • the monomer liquid is arranged between the displacement means 500 and the discharge piston 250 within the rear part 230 of the interior 210.
  • Figure 4 shows the device 100 from the Figures 1 to 3 , where compared to Figure 3 the delivery piston 270 is advanced further in the direction of the discharge piston 250. Due to the resulting reduced distance from delivery piston 270 to discharge piston 250, the in Figure 3 The container sections 300a shown at least partially burst into further, smaller container sections 300a.
  • the displacement means 500 encloses in comparison to Figure 3 a larger proportion of container sections 300a, whereby the monomer liquid 350 was displaced between these container sections 300a.
  • the delivery piston 270 is pushed so far into the cartridge 200 that the monomer liquid 260 has penetrated into the conduit 260.
  • Figure 5 shows the device 100 from the Figures 1 to 4 , where compared to Figure 4 the delivery piston 270 is advanced further in the direction of the discharge piston 250.
  • the container sections 300a are essentially completely enclosed by the displacement means 500 and the monomer liquid 350 is removed from the Figures 1 to 4 essentially completely conveyed via the conduit 260 from the rear part 230 into the front part 220 of the interior 210, whereby the bone cement powder 400 from the Figures 1 to 4 and the monomer liquid 350, a bone cement dough 450 was formed and provided in the front part 220 of the interior 210.
  • the bone cement powder 400 has an additive with which it is possible to introduce the monomer liquid 350 onto a base area of the front part 220 of the interior 210 and still achieve a complete distribution of the monomer liquid 350 in the bone cement powder 400.
  • the pore disk 260 prevents the displacing agent 500 from being conveyed into the bone cement dough 450 Forming the bone cement dough 450 from monomer liquid 350 and bone cement powder 400, the volume of the original bone cement powder 400 increased due to swelling of the bone cement powder 400, as a result of which the plug 285 was partially expelled from the closure cap 281.
  • Figure 6 shows the device 100 from the Figures 1 to 5 , where compared to Figure 5 the delivery piston 270 together with the discharge piston 250 was advanced in the direction of the discharge opening 281 of the device 100. The advancement resulted in the bone cement dough 450 being partially discharged from the device 100.
  • the closure cap 281 is made of the Figures 1 to 5 replaced by a discharge snorkel 730 (only partially shown).
  • the bone cement dough is dispensed without a discharge snorkel 730, for example by simply removing the stopper 285 or the stopper 285 and the closure cap 281 from the Figures 1 to 5 discharged from the device 100.
  • Figure 7 shows a method 600 for providing a bone cement dough 450 from two starting components using the device 100 according to Figures 1 to 6 comprising method steps 610 to 630 and optionally 640.
  • a step 610 the delivery piston 270 is pushed into the cartridge 200 in the direction of the discharge piston 250. If the distance between the delivery piston 270 and the discharge piston 250 decreases below a length of the container 300, it breaks into at least two container sections 300a, so that the monomer liquid 350 can flow out into the rear part 230 of the interior 210.
  • the discharge piston 250 remains essentially in the same position within the interior 210.
  • a step 620 continued advancement of the delivery piston 270 in the direction of the discharge piston 250 results in a compression of the initial container sections 300a.
  • the compression can cause the initial container sections 300a to break down into smaller container sections 300a depending on the distance between the delivery piston 270 and the discharge piston 250.
  • the monomer liquid 350 begins to be pumped via the line means 260 into the front part 220 of the interior 210 while the bone cement dough 450 begins to form.
  • a step 630 the monomer liquid between the container sections 300a is displaced by the displacement means 500 while the delivery piston 270 continues to advance in the direction of the discharge piston 250.
  • the delivery piston 270 moves the displacement means 500 under pressure into a space between the container sections 300a, so that the displacement means 500 encloses the container sections 300a as much as possible and the monomer liquid 350 from the space between the container sections 300a via the line means 260 into the front part 220 of the interior 210 is funded.
  • the displacement means 500 has a volume which can, if possible, fill the entire space between the container sections 300a, so that as much as possible of the monomer liquid 350 can be conveyed into the front part 220 of the interior and is available there to form the bone cement dough.
  • the bone cement dough 450 is discharged from the device 100 through a discharge opening 280 in the front part 220 of the interior 210 by continued advancement 610 of the delivery piston 270.
  • the delivery piston 270 overcomes a force holding the discharge piston 250, so that the delivery piston 270 and the discharge piston 250 are moved together in the direction of the discharge opening 280 within the interior 210 and the bone cement dough 450 is discharged.
  • the container 300 is opened, the monomer liquid 350 is conveyed as completely as possible into the front part 220 of the interior 210 with the cooperation of the displacement agent 500 and optionally the bone cement dough 450 provided thereby is discharged with a unidirectional linear movement of the delivery piston 270 in the interior 210 of the cartridge 200.
  • the device 100 is preferably held during steps 610 to 630 so that the discharge piston 250 is arranged spatially above the delivery piston 270.
  • Gas present there such as air or a protective gas, in particular nitrogen or argon, is first conveyed from the rear part 230 of the interior 210 via the line means 260 into the front part 220 of the interior 210 before the monomer liquid 350 is conveyed sets in. In this way, gas inclusions in the bone cement powder 400 are displaced by the monomer liquid 350 and no further gas is introduced after the formation of the bone cement dough 450 has begun.
  • the advancement 610 of the delivery piston 270 can be done by manual force exerted by a user of the device 100.
  • the device 100 is inserted into a discharge device 700 and the delivery piston 270 is advanced by actuating the discharge device 700, for example a discharge gun. This makes it easier for the user to use the device 100.

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  • Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Prostheses (AREA)

Claims (15)

  1. Dispositif (100) permettant la fourniture d'une pâte de ciment osseux (450) à partir de deux composants de départ, comprenant
    une cartouche (200) en forme de cylindre creux comportant un espace intérieur (210), dans lequel, dans une partie avant (220) de l'espace intérieur (210), une poudre de ciment osseux (400) est stockée en tant que premier composant de départ et, dans une partie arrière (230) de l'espace intérieur (210), un récipient (300) contenant un liquide monomère (350) est stocké en tant que second composant de départ,
    dans lequel un piston d'évacuation (250) mobile axialement dans l'espace intérieur (210) est disposé entre la poudre de ciment osseux (400) et le récipient (300) et un piston de transport (270) mobile axialement dans l'espace intérieur (210) est disposé sur le côté du récipient (300) opposé au piston d'évacuation (250), dans lequel la partie arrière (230) et la partie avant (220) de l'espace intérieur (210) sont reliées l'une à l'autre d'une manière conductrice de fluide par l'intermédiaire d'un moyen de conduite (260) et, par une avancée du piston de transport (270) en direction du piston d'évacuation (250), le récipient (300) doit être ouvert par division en une pluralité de portions de récipient (300a), de sorte que le liquide monomère (350) peut s'écouler dans la partie arrière (230) de l'espace intérieur (210), dans lequel un agent de refoulement (500) de volume stable est disposé dans la partie arrière (230) de l'espace intérieur (210), lequel agent de refoulement est conçu, au fur et à mesure de l'avancée du piston de transport (270) en direction du piston d'évacuation (250), pour entourer les portions de récipient (300a) en refoulant le liquide monomère entre les portions de récipient (300a) afin de transporter le liquide monomère (350) à partir de la partie arrière (230) dans la partie avant (220) de l'espace intérieur (210) par l'intermédiaire du moyen de conduite (260),
    caractérisé en ce que
    l'agent de refoulement (500) comprend une graisse dure et/ou une cire comportant un point de fusion d'au moins 40 °C.
  2. Dispositif (100) permettant la fourniture d'une pâte de ciment osseux (450) à partir de deux composants de départ, comprenant
    une cartouche (200) en forme de cylindre creux comportant un espace intérieur (210), dans lequel, dans une partie avant (220) de l'espace intérieur (210), une poudre de ciment osseux (400) est stockée en tant que premier composant de départ et, dans une partie arrière (230) de l'espace intérieur (210), un récipient (300) contenant un liquide monomère (350) est stocké en tant que second composant de départ,
    dans lequel un piston d'évacuation (250) mobile axialement dans l'espace intérieur (210) est disposé entre la poudre de ciment osseux (400) et le récipient (300) et un piston de transport (270) mobile axialement dans l'espace intérieur (210) est disposé sur le côté du récipient (300) opposé au piston d'évacuation (250), dans lequel la partie arrière (230) et la partie avant (220) de l'espace intérieur (210) sont reliées l'une à l'autre d'une manière conductrice de fluide par l'intermédiaire d'un moyen de conduite (260) et, par une avancée du piston de transport (270) en direction du piston d'évacuation (250), le récipient (300) doit être ouvert par division en une pluralité de portions de récipient (300a), de sorte que le liquide monomère (350) peut s'écouler dans la partie arrière (230) de l'espace intérieur (210), dans lequel un agent de refoulement (500) de volume stable est disposé dans la partie arrière (230) de l'espace intérieur (210), lequel agent de refoulement est conçu, au fur et à mesure de l'avancée du piston de transport (270) en direction du piston d'évacuation (250), pour entourer les portions de récipient (300a) en refoulant le liquide monomère entre les portions de récipient (300a) afin de transporter le liquide monomère (350) à partir de la partie arrière (230) dans la partie avant (220) de l'espace intérieur (210) par l'intermédiaire du moyen de conduite (260),
    caractérisé en ce que
    l'agent de refoulement (500) comprend une pluralité de particules comportant une dureté Shore A inférieure ou égale à 80.
  3. Dispositif (100) selon la revendication 2, dans lequel les particules sont formées de manière sphérique, en particulier en forme de billes ou de manière ovoïde.
  4. Dispositif (100) selon la revendication 2 ou 3, dans lequel les particules sont réalisées à partir de caoutchouc de silicone, de caoutchouc naturel, de caoutchouc polybutadiène-styrène et/ou de caoutchouc polyuréthane-polyester.
  5. Dispositif (100) selon l'une des revendications 2 à 4, dans lequel les particules présentent un diamètre dans une plage allant de 1 à 3,5 mm.
  6. Dispositif (100) permettant la fourniture d'une pâte de ciment osseux (450) à partir de deux composants de départ, comprenant
    une cartouche (200) en forme de cylindre creux comportant un espace intérieur (210), dans lequel, dans une partie avant (220) de l'espace intérieur (210), une poudre de ciment osseux (400) est stockée en tant que premier composant de départ et, dans une partie arrière (230) de l'espace intérieur (210), un récipient (300) contenant un liquide monomère (350) est stocké en tant que second composant de départ, dans lequel un piston d'évacuation (250) mobile axialement dans l'espace intérieur (210) est disposé entre la poudre de ciment osseux (400) et le récipient (300) et un piston de transport (270) mobile axialement dans l'espace intérieur (210) est disposé sur le côté du récipient (300) opposé au piston d'évacuation (250), dans lequel la partie arrière (230) et la partie avant (220) de l'espace intérieur (210) sont reliées l'une à l'autre d'une manière conductrice de fluide par l'intermédiaire d'un moyen de conduite (260) et, par une avancée du piston de transport (270) en direction du piston d'évacuation (250), le récipient (300) doit être ouvert par division en une pluralité de portions de récipient (300a), de sorte que le liquide monomère (350) peut s'écouler dans la partie arrière (230) de l'espace intérieur (210), dans lequel un agent de refoulement (500) de volume stable est disposé dans la partie arrière (230) de l'espace intérieur (210), lequel agent de refoulement est conçu, au fur et à mesure de l'avancée du piston de transport (270) en direction du piston d'évacuation (250), pour entourer les portions de récipient (300a) en refoulant le liquide monomère entre les portions de récipient (300a) afin de transporter le liquide monomère (350) à partir de la partie arrière (230) dans la partie avant (220) de l'espace intérieur (210) par l'intermédiaire du moyen de conduite (260),
    caractérisé en ce que
    l'agent de refoulement (500) comprend une pâte contenant une matière solide pulvérulente et un liquide.
  7. Dispositif (100) selon la revendication 6, dans lequel le liquide comprend du propane-1,2,3-triol et la matière solide comprend du dioxyde de silicium.
  8. Dispositif (100) selon la revendication 7, dans lequel le dioxyde de silicium comprend du dioxyde de silicium pyrogéné et/ou du dioxyde de silicium précipité.
  9. Dispositif (100) selon l'une des revendications précédentes, dans lequel l'agent de refoulement (500) occupe un volume d'agent de refoulement qui correspond au moins à un volume total des portions de récipient (300a).
  10. Dispositif (100) selon l'une des revendications précédentes, dans lequel l'agent de refoulement (500) est disposé au moins en partie entre le récipient (300) et le piston de transport (270).
  11. Dispositif (100) selon l'une des revendications précédentes, dans lequel l'agent de refoulement (500) est disposé au moins en partie radialement autour du récipient (300).
  12. Dispositif (100) selon la revendication 1, 2 ou 6, dans lequel l'agent de refoulement (500) est sensiblement insoluble dans le liquide monomère (350) à température ambiante.
  13. Procédé (600) permettant la fourniture d'une pâte de ciment osseux (450) à partir de deux composants de départ au moyen d'un dispositif (100) selon l'une des revendications précédentes, comprenant les étapes suivantes :
    a. avancée (610) du piston de transport (270) en direction du piston d'évacuation (250) avec division du récipient (300) en une pluralité de portions de récipient (300a),
    b. poussée (620) des portions de récipient (300a) les unes contre les autres par poursuite de l'avancée (610) du piston de transport (270),
    c. refoulement (630) du liquide monomère (350) entre les portions de récipient (300a) au moyen de l'agent de refoulement (500) avec transport du liquide monomère (350) dans la partie avant (220) de l'espace intérieur (210) pour la formation de la pâte de ciment osseux (450).
  14. Procédé (600) selon la revendication 13, dans lequel, pour l'avancée (610) du piston de transport (270), le dispositif (100) est inséré dans un appareil d'évacuation (700).
  15. Procédé (600) selon la revendication 13 ou 14, dans lequel le liquide monomère (350) est réparti dans la poudre de ciment osseux (400) à l'aide d'un additif hydrophile.
EP21169786.7A 2021-04-22 2021-04-22 Dispositif de fourniture de la pâte de ciment osseux Active EP4079396B1 (fr)

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DE102009031178B3 (de) 2009-06-29 2010-09-16 Heraeus Medical Gmbh Vorrichtung zum Mischen und Austragen von Knochenzement
DE102016121607B4 (de) 2016-11-11 2019-05-16 Heraeus Medical Gmbh Vorrichtung und Verfahren zum Lagern und Mischen eines Knochenzements
DE102017110732B4 (de) * 2017-05-17 2021-01-28 Heraeus Medical Gmbh Vorrichtung zum Herstellen eines Knochenzementteigs und zum Austragen des gemischten Knochenzementteigs sowie Verfahren zur Herstellung eines Knochenzementteigs

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