EP4079396A1 - 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
EP4079396A1
EP4079396A1 EP21169786.7A EP21169786A EP4079396A1 EP 4079396 A1 EP4079396 A1 EP 4079396A1 EP 21169786 A EP21169786 A EP 21169786A EP 4079396 A1 EP4079396 A1 EP 4079396A1
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EP
European Patent Office
Prior art keywords
container
bone cement
interior
monomer liquid
discharge
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
EP21169786.7A
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German (de)
English (en)
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EP4079396B1 (fr
Inventor
Sebastian Vogt
Thomas Kluge
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
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Filing date
Publication date
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Priority to EP21169786.7A priority Critical patent/EP4079396B1/fr
Publication of EP4079396A1 publication Critical patent/EP4079396A1/fr
Application granted granted Critical
Publication of EP4079396B1 publication Critical patent/EP4079396B1/fr
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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
    • 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 preparing a bone cement paste from two starting components, comprising a hollow-cylindrical cartridge with an interior space, a bone cement powder as the first starting component being stored in a front part of the interior space and a container containing a monomer liquid as the second starting component being stored in a rear part of the interior space.
  • a discharge piston that is movable axially in the interior space and on the side of the container opposite the discharge piston is a delivery piston that is movable axially in the interior space, with the rear part and the front part of the interior space being connected to one another in a fluid-conducting manner via a line and by Advancing the feed piston in the direction of the discharge piston, the container can be opened by breaking it up 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 preparing a bone cement dough from two starting components by means of 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 plunger 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, as a result of which the container is 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 with the formation of the bone cement dough by the continued advancement of the conveying plunger.
  • the container is compressed further and further, sometimes with further fragmentation of the container sections, until a maximum compression is reached.
  • the bone cement paste facing the container sections has a larger proportion of monomer liquid compared to bone cement powder as the part of the bone cement paste facing away from the container sections and therefore the properties of the bone cement paste change in the course of the discharge.
  • the bone cement paste facing the container is "diluted" by the subsequently introduced amount of monomer liquid and has a lower viscosity than the bone cement paste initially discharged from the device.
  • the invention is based on the aim of providing devices which can provide a bone cement paste 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 externally applied vacuum.
  • the device should be able to discharge the bone cement provided.
  • the device should be able to discharge the bone cement provided without any modification measures.
  • the device should be able to provide and discharge the bone cement without conversion measures and without external equipment such as hoses, vacuum sources or squeezing devices.
  • the device should be able to be operated with as few work steps as possible in order to minimize sources of error by the user.
  • Another object of the invention is to provide a method with which bone cement can be provided from two starting components, by means of which at least some of the objects already described are at least partially achieved.
  • a first embodiment of the invention is a device for preparing a bone cement paste from two starting components, comprising a hollow-cylindrical cartridge with an interior space, a bone cement powder as the first starting component being stored in a front part of the interior space and a container containing a monomer liquid as the second starting component being stored in a rear part of the interior space, wherein between the bone cement powder and the container is a discharge piston that is movable axially in the interior space and on the side of the container opposite the discharge piston is a delivery piston that is movable axially in the interior space, with the rear part and the front part of the interior space being connected to one another in a fluid-conducting manner via a line and by advancing the delivery plunger in the direction of the discharge plunger, the container can be opened by breaking it up into a large number of container sections, so that the monomer liquid can flow into the rear part of the interior, characterized in that a volume-stable displacement means is arranged in the rear part of the interior, which is designed to
  • the displacer is substantially insoluble in the monomer liquid at room temperature, that is, in the range of 15°C to 30°C.
  • This embodiment is a second embodiment of the invention, which preferably depends on the first embodiment of the invention.
  • the displacing agent comprises a hard fat and/or a wax with a melting point of at least 40°C.
  • This embodiment is a third embodiment of the invention, which preferably depends on the first or the second embodiment of the invention.
  • the displacement means comprises a large number, meaning at least two, 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.
  • This embodiment is a fourth embodiment of the Invention, which preferably depends on the first or second embodiment of the invention.
  • the multiplicity of particles of the displacement agent are spherical, in particular spherical or ovoid, in shape.
  • This embodiment is a fifth embodiment of the invention, which preferably depends on the fourth 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 sixth embodiment of the invention, which preferably depends on the fourth or fifth 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 2.5mm, on.
  • This embodiment is a seventh embodiment of the invention, which preferably depends on the fourth, fifth or sixth embodiment of the invention.
  • the displacement means comprises a paste containing a powdered solid and a liquid.
  • This embodiment is an eighth embodiment of the invention, which preferably depends on the first or second embodiment 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 ninth embodiment of the invention, which preferably depends on the eighth 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 a tenth embodiment of the invention, which preferably depends on the ninth embodiment of the invention.
  • the displacement medium occupies a displacement medium volume which corresponds at least to a total volume of the container sections.
  • This embodiment is an eleventh embodiment of the Invention, which preferably depends on one of the preceding embodiments of the invention.
  • the displacement means is arranged at least partially between the container and the delivery piston.
  • This embodiment is a twelfth embodiment of the invention, which preferably depends on any of the preceding embodiments of the invention.
  • the displacement means is arranged at least partially radially around the container.
  • This embodiment is a thirteenth embodiment of the invention, which preferably depends on any of the preceding embodiments of the invention.
  • the device is used in a discharge device to advance the delivery plunger.
  • This embodiment is a fifteenth embodiment of the invention, which preferably depends on the fourteenth embodiment of the invention.
  • the monomer liquid is distributed in the bone cement powder with the aid of a hydrophilic additive.
  • This embodiment is a sixteenth embodiment of the invention, which preferably depends on the fourteenth or fifteenth embodiment of the invention.
  • range specifications also include the values specified as limits.
  • An indication of the type "in the range from X to Y" in relation to a quantity A therefore means that A can take on the values X, Y and values between X and Y.
  • Unilaterally delimited areas of the type "up to Y" for a size A mean correspondingly as a value Y and smaller than Y.
  • a first object of the invention relates to a device for preparing a bone cement dough from two starting components, comprising a hollow-cylindrical cartridge with an interior space, a bone cement powder as the first starting component being stored in a front part of the interior space and a container containing a monomer liquid as the second starting component being stored in a rear part of the interior space, wherein between the bone cement powder and the container is a discharge piston that is movable axially in the interior space and on the side of the container opposite the discharge piston is a delivery piston that is movable axially in the interior space, with the rear part and the front part of the interior space being connected to one another in a fluid-conducting manner via a line and by Advancing the feed piston in the direction of the discharge piston, the container can be opened by breaking it up into a large number of container sections, so that the monomer liquid can flow into the rear part of the interior.
  • the invention provides that a volume-stable displacement means is arranged in the rear part of the interior, which is designed to enclose the container sections with progressive advancement of the delivery piston in the direction of the discharge piston, with displacement of the monomer liquid between the container sections to convey the monomer liquid from the rear part to the front part of the inner space via the conduit means.
  • the displacement agent thus fills an intermediate space between the container sections, which is filled with the monomer liquid and/or a gas, such as air or nitrogen, after the container has been opened and the container sections have been further fragmented into smaller container sections, and displaces the monomer liquid present there. Since the rear part of the interior space is sealed in a fluid-tight manner by the delivery plunger on the side opposite the line means, the monomer liquid is pumped via the line means into the bone cement powder in the bone cement powder in the promoted front part of the interior.
  • the device thus ensures an almost complete mixing of bone cement powder and monomer liquid, which means that bone cement dough can be provided easily, quickly and reliably with a constant Bone cement dough composition allowed.
  • 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 space and a cartridge wall surrounding the interior space.
  • the cross section of the cartridge can take on 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 good handling for the user and, due to the absence of edges, reduces a 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.
  • the discharge piston Arranged between the bone cement powder and the container is a discharge piston that can be moved axially in the interior.
  • the discharge piston is used for the spatial separation of container and bone cement powder, so that neither bone cement powder 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. In particular, the latter prevents a bone cement paste interspersed with container sections, which pose health risks for the patient and could impair proper discharge of the bone cement paste from the device.
  • the discharge plunger is also used to discharge the prepared bone cement dough from the device. For this purpose, the discharge plunger can be moved from its original position in the direction of 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 plunger.
  • the device has a delivery piston that can be moved axially in the interior space.
  • the delivery piston is arranged on the side of the container axially opposite the discharge piston within the device.
  • Propulsion that is to say a relative movement of the delivery plunger in the direction of the discharge plunger, which shortens the distance between the delivery plunger and the discharge plunger within the interior space, causes the container to open. Opening of the container occurs when the distance between the delivery piston and the discharge piston is reduced in such a way that the container is subjected to a resultant force that is greater than the structural integrity of the container.
  • the container breaks up into a large number, that is to say into 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 monomer liquid can escape from the interior of the container into the rear part of the interior of the cartridge.
  • a container containing a monomer liquid is understood to mean a storage option which can store the monomer liquid in a hermetically sealed and sterile manner and which 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 the good sterilizability and good openability by manual force.
  • the device has a line means by which the rear part and the front part of the interior are fluidly connected. 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 line means is preferably equipped with a filter means, in particular one Porous disc, for example made of sintered polypropylene particles, cellulose felt or cardboard, be arranged, which designed the line means impermeable to solids.
  • At least one passage is provided as a conduit in the discharge piston and/or between the discharge piston and the inner wall of the interior space, through which the rear part and the front part of the interior space are fluidly connected to one another.
  • a filter 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, cellulose felt or cardboard, can be arranged in or at one or both ends of the at least one passage.
  • 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 the rear part and the front part of the interior space through passages in the cartridge wall or through openings.
  • the discharge piston is bypassed in this variant.
  • the monomer liquid inside 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 such that continued advancement of the delivery piston in the direction of the discharge piston after the monomer liquid has been delivered from the rear part of the interior space to the front part of the interior space causes the discharge piston to be advanced 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 will. This achieves 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 deliver the monomer liquid, namely with the unidirectionally driven delivery piston.
  • a latching means can be arranged on the discharge piston, so that the discharge piston can latch between the front part and the rear part of the interior space with the cartridge, in particular with the cartridge wall, with this latching cannot be released by the forces occurring when the container is opened and by a pressure exerted on the monomer liquid by the delivery plunger, or by the delivery plunger and displacement means, when delivering the monomer liquid into the front part of the interior, but by direct pressure from the delivery plunger or delivery plungers , Displacement means and any container sections located in between, the pressure acting on the discharge piston can be released.
  • the locking means ensures that the container can first be opened by advancing the delivery plunger and the monomer liquid running out of it with the delivery plunger, or with the delivery plunger in interaction with the displacement means, can then flow into the front part of the interior of the cartridge, i.e. into the bone cement powder , Can be pressed, with the discharge piston holding its original position relative to the cartridge and the interior. Only after the monomer liquid has been largely pressed into the bone cement powder, and thus the bone cement dough is present 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 with the discharge piston. The force required to release the latch 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 the container is opened, it breaks up into a large number of container sections, as a result of which the monomer liquid can flow into the rear part of the interior of the cartridge. It is opened by pushing the delivery plunger forward in the direction of the discharge plunger. With continued advancement, the container sections created when the container is opened can in turn break into a large number of smaller container sections. If the feed plunger has been pushed far enough in the direction of the discharge plunger, the monomer liquid begins to be conveyed from the rear part of the interior space via the line means into the front part of the interior to form the bone cement dough. A complete advance of the delivery piston, so that delivery piston and discharge piston touch each other directly, can be prevented due to the container sections, in particular if the opposite sides of the discharge piston and delivery piston are configured flat.
  • a volume-stable displacement means is arranged in the rear part of the interior space.
  • a volume-stable displacement means is to be understood as meaning a plastically and/or elastically deformable material.
  • the displacement agent comprises 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 falls under the pressure conditions of up to 0.5 kN/cm 2 occurring 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 comes to no or only an insignificant change in volume of the displacement medium. Gases, for example, are not volume-stable 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 is in order to be available there for the formation of the bone cement dough without being conveyed into the front part of the interior.
  • the displacement medium can contain at least a proportion of a solid and/or the displacement medium has such a high viscosity that conveying into the front part of the interior space through the line means, in particular through a line means equipped with a filter means, such as a porous disk, for example the pressure conditions used.
  • the displacement means fills the space between the container sections as completely as possible, so that the monomer liquid is displaced from the space as completely as possible.
  • the displacer be substantially insoluble in the monomer liquid, particularly methyl methacrylate, at room temperature (15 to 30°C).
  • the displacement agent is soluble with a maximum of 10 g in 1 liter of methyl methacrylate at a contact time with the methyl methacrylate of 120 seconds.
  • the displacer does not dissolve at all in the monomer liquid, particularly methyl methacrylate.
  • the displacement means can comprise different materials or consist of different materials.
  • the displacement means has such a plastic deformability that allows the container sections to flow around or to be enclosed under the pressure conditions used in the device, the displacement means can be designed as a plastically deformable, compact body.
  • 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 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 hard fat with a melting point of at least 40 °C and a wax with a melting point of at least 40 °C.
  • a wax is defined as 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), Roger that.
  • the waxes can be used in pure form or with the use of 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.
  • the melting point of the hard fat can be increased by adding glycerol trifatty acid esters that melt at more than 40 °C.
  • the displacement means comprises a material that does not deform sufficiently under the given pressure conditions to form a compact body around the container sections
  • the displacement means is not present as a compact body, but as a large number of particles, which are loose or bound together, for example by means of a liquid wetting the particles, ie in pasty form.
  • the displacement means 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. Determining the Shore A hardness of a given material is well 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, an elastic and/or plastic deformation of the particles takes place in the prevailing pressure conditions, so that the particles displace the cavity between the individual particles condense. 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. In addition, the container sections are surrounded as completely as possible, since the particles "snuggle up" to them.
  • the particles can have different shapes.
  • a spherical particle shape is preferred because of the better flowability and associated better penetration into the space between the container sections.
  • 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.
  • An embodiment of the device is characterized in that 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 preferable for the materials mentioned to be arranged on a surface of the particles, so that the particles can be compacted as mentioned above when the delivery piston is advanced in the direction of the discharge piston.
  • the particles can have different diameters.
  • An embodiment of the device is characterized in that 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 means the D50 value. Particles with these diameters allow easy insertion into the space between the container sections. In addition, such particles can be well compressed by the pressure conditions prevailing when the delivery plunger is advanced in the direction of the discharge plunger, in order to achieve the most complete possible displacement of the monomer liquid from the space between the container sections.
  • the displacement means comprises a paste containing a powdered solid and a liquid.
  • a 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 powdered solid comprises a material which is harder than the particles described above.
  • the pulverulent 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 means the D50 value. Solid particles with these diameters allow the paste to be easily introduced into the space between the container sections.
  • a large number of different liquids of an organic or inorganic nature can be used as the liquid. Examples of organic liquids include alcohols, particularly polyalcohols such as glycerin, hydrocarbons and aromatic solvents. Examples of inorganic liquids include water and aqueous solutions.
  • the paste comprises propane-1,2,3-triol (glycerol) as the liquid and silicon dioxide as the powdered solid.
  • the paste consists of silicon dioxide and propane-1,2,3-triol.
  • the silicon dioxide can have different shapes and/or properties.
  • An embodiment of the device is characterized in that the silicon dioxide comprises or consists of fumed silicon dioxide, precipitated silicon dioxide or a mixture of fumed and precipitated silicon dioxide.
  • the silicon dioxide comprises or consists of fumed silicon dioxide, precipitated silicon dioxide or a mixture of fumed and precipitated silicon dioxide.
  • the displacement means can occupy different volume fractions of the interior space, in particular of the rear part of the interior space.
  • An embodiment of the device is characterized in that the displacement means occupies a volume of displacement means which corresponds at least to 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 breaks up when the delivery plunger is opened or pushed forward.
  • the total volume of the container sections therefore corresponds to a volume which corresponds to the wall of the container or the walls of the container sections per se, ie not to the space enclosed by the container.
  • the displacement medium preferably has a displacement medium 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 container sections can be surrounded as completely as possible by the displacement means and thus the monomer liquid can be conveyed as completely as possible from the space between the tank sections into the front part of the interior. So that the interior of the cartridge and thus the device itself does not have to be designed too large and thus too unwieldy, it is preferred that the volume of the displacement medium 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.
  • An embodiment of the device is characterized in that the displacement means is arranged at least partially between the container and the delivery piston. For example, at least 10% by volume, preferably at least 25% by volume, more preferably at least 50% by volume of the displacement medium can be arranged between the container and the delivery piston.
  • the displacement means is arranged at least partially between the container and the delivery piston. For example, at least 10% by volume, preferably at least 25% by volume, more preferably at least 50% by volume of the displacement medium can be arranged between the container and the delivery piston.
  • An embodiment of the device is characterized in that the displacement means is arranged at least partially radially around the container.
  • the displacement means extends around the entire radial circumference of the container and thus surrounds the container like a collar.
  • the displacement means does not extend completely around the entire radial circumference of the container, but only surrounds the container, for example over 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 that is open in the direction of the container and in which the displacement means is arranged.
  • the container is preferably partially inserted into the receptacle with an axial end pointing in the direction of the delivery plunger, so that the displacement means at least partially encloses this axial end of the container.
  • the container is surrounded radially by the displacement means and is thus spatially fixed.
  • the container is preferably 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 conveyed into the bone cement powder with as little effort as possible by the user of the device.
  • pushing together the container sections created when the container is opened can lead to further fragmentation of the container sections, or at least one or more of the initial container sections, into further, smaller container sections. Irrespective of this further fragmentation, there will always remain a space 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 advancement of the delivery piston in the direction of the discharge piston, the displacement agent 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 intermediate space from the intermediate space.
  • 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 space is closed at one axial end by the delivery plunger, only the monomer liquid remains the path 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 plunger can be advanced in different ways in the direction of the discharge plunger into the cartridge.
  • a user of the device can advance the delivery piston manually, in particular by applying force to a rod or axis.
  • the cartridge and the delivery plunger together form a thread, via which the delivery plunger can be screwed into the cartridge in the direction of the discharge plunger.
  • the cartridge preferably has an internal thread and the delivery piston has an external thread, which interact in a form-fitting and/or non-positive manner in order to enable the delivery piston to be advanced.
  • the delivery plunger is advanced using a mechanical aid.
  • One embodiment of the method is characterized in that the device is inserted into a discharge device, in particular a discharge gun for bone cement dough, in order to advance the delivery plunger.
  • a discharge device in particular a discharge gun for bone cement dough
  • Discharge 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 preferably takes place with the two starting components being mixed as uniformly as possible in order to obtain a bone cement dough which is as homogeneous as possible.
  • the mixing of the two components can be done 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.
  • An 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.
  • Bone cement dough is understood to be a substance that is suitable in the field of medical technology for creating a stable connection between artificial joints, such as hip and knee joints, and bone material. Hardening turns bone cement dough into bone cement.
  • These bone cements are preferably 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.
  • the two starting components can be stored separately from one another.
  • the swelling of the polymer components of the bone cement powder results in a plastically deformable bone cement dough.
  • polymerization of the monomer is initiated by free radicals.
  • 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.
  • the bone cement powder can additionally include 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 polymerisation.
  • the bone cement powder can additionally include an X-ray opaque material.
  • the bone cement powder can additionally include pharmaceutically active substances such as antibiotics.
  • the bone cement powder preferably comprises at least one particulate polymethyl methacrylate and/or one particulate polymethyl methacrylate copolymer, an initiator and an X-ray opaque material as a hydrophilic additive, 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 material 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 particulate and/or fibrous.
  • the hydrophilic additive can be sparingly 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 pyrogenic 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.
  • an X-ray opaque is a substance that allows the bone cement to be made visible on X-ray diagnostic images. Examples of radiopacifiers can include barium sulfate, zirconia, and calcium carbonate.
  • the pharmaceutically active substance can comprise one or more antibiotics and optionally added cofactors for the one or more antibiotics.
  • the pharmaceutically active substance preferably consists of one or more antibiotics and optionally added cofactors for the one or more antibiotics.
  • 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.
  • FIG 1 shows a schematic cross section of an exemplary embodiment of a device 100 for preparing 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 has a tubular structure and includes a hollow-cylindrical cartridge 200 with an interior 210.
  • a bone cement powder 400 as a first starting component
  • a rear part 230 of the interior 210 is 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 paste.
  • the main component of the bone cement powder 400 is particulate polymethyl methacrylate and also 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 space 210 are separated by a discharge piston 250 that can move axially in the interior space 210 .
  • the discharge piston 250 is designed to be impermeable to solids, so that no bone cement powder 400 from the front Part 210 can not get into the rear part 230 of the interior 210 and the container 300 from the rear part 230 in the front part 220 of the interior 210.
  • the discharge plunger 250 has a conduit 260 in the form of a plurality of passages through which there is a fluid-conducting connection between the front part 220 and the rear part 230 .
  • the conduit means 260 is formed as part of the discharge plunger 250 .
  • the line means 260 can be formed separately from the discharge plunger 250, for example as a tubular line outside the cartridge.
  • the conduit 260 is sealed by a porous disc 265 for solids and highly viscous liquids, such as hard fats, waxes, pastes or bone cement dough, which, however, allows the monomer liquid 350 to be conveyed from the rear part 230 to the front part 220 of the interior space 210 without any problems.
  • the porous disk 265 is arranged on the end of the conduit 260 facing the front part 220 of the interior space 210 .
  • the porous disc 265 or other type of means is arranged on the end of the conduit means 260 facing the rear part 230 or on both ends of the conduit means 260 .
  • An advantage of a porous disc arranged as shown is that the bone cement dough forming at the front part 220 of the interior space 210 cannot clog the conduit means 260 .
  • the delivery plunger 270 closes off a rear side 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 space 210 .
  • two radially circumferential sealing rings 275 are provided on the delivery plunger 270, with which an escape of the monomer liquid 350 past the delivery plunger 270 and out of the device 100 is avoided.
  • the sealing effect of the sealing rings 275 on the delivery plunger 270 must be sufficient, even if the delivery plunger 270 exerts such great pressure on the monomer liquid 350 that it flows through the conduit 270 and the porous disc 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 which faces away from the discharge plunger 250 .
  • the discharge opening 280 is closed by a sealing cap 281 with a plug 285 , so that no bone cement powder 400 can escape from the cartridge 200 .
  • a displacement means 500 is mounted within the rear part 230 of the interior space 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 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 plunger 270 and radially.
  • the container 300 is thus 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 accidentally opening the container 300, for example due to a shaking-like 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 paste-like form.
  • the device 100 is inserted into a discharge device 700 (not fully shown).
  • the discharge device comprises an internal thread 710, which interacts positively and/or non-positively with an external thread 110 of device 100 and thus connects device 100 and discharge device 700 to one another, and a plunger 720.
  • Device 100 and discharge device 700 are not in further, non-illustrated embodiments via a thread, but via a different type of connection in a form-fitting and/or force-fitting manner, in particular via a bayonet catch or a plug-in connection.
  • the delivery plunger 270 can be advanced axially in the interior space 210 in the direction of the discharge plunger 250 by means of the ram 720 in the direction of the discharge plunger 250 .
  • figure 2 shows the device figure 1 , where compared to figure 1 the delivery plunger 270 is advanced by means of the plunger 720 of the discharge device 700 in the direction of the delivery plunger 250 until the container 300 and delivery plunger 270 come into contact.
  • the container 300 in particular the container head 310 , was further accommodated in 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.
  • the distance between the delivery plunger 270 and the discharge plunger 250 essentially corresponds to the length of the container 300 in the state of the device 100 shown.
  • figure 3 shows the device 100 of FIGS figures 1 and 2 , where compared to figure 2 the delivery plunger 270 is driven further in the direction of the discharge plunger 250 by means of the plunger 720 of the discharge device 700 .
  • the structural integrity of the container 300 was destroyed by the advancement of the delivery piston 270, as a result of which it disintegrated into a plurality of container sections 300a and the monomer liquid 350 escaped from the interior of the container 300 into the rear part 230 of the inner space 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. Between other container sections 300a not enclosed by the displacement means 500, monomer liquid 350 can be found.
  • the monomer liquid is arranged between the displacement means 500 and the discharge piston 250 within the rear part 230 of the inner space 210 .
  • figure 4 shows the device 100 of FIGS Figures 1 to 3 , where compared to figure 3 the delivery piston 270 is driven 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 shown container sections 300a at least partially burst into further, smaller container sections 300a.
  • the displacement means 500 encloses compared to figure 3 a greater proportion of tank sections 300a, thereby displacing the monomer liquid 350 between these tank sections 300a.
  • the delivery plunger 270 has been inserted so far into the cartridge 200 that the monomer liquid 260 has penetrated into the conduit 260 .
  • figure 5 shows the device 100 of FIGS Figures 1 to 4 , where compared to figure 4 the delivery piston 270 is driven further in the direction of the discharge piston 250.
  • the container sections 300a are essentially completely surrounded by the displacement means 500 and the monomer liquid 350 from the Figures 1 to 4 been funded substantially completely via the line means 260 from the rear part 230 in 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 formed and provided a bone cement dough 450 in the front part 220 of the inner space 210 .
  • the bone cement powder 400 has an additive with which it is possible to introduce the monomer liquid 350 at a base area of the front part 220 of the interior space 210 and still achieve complete distribution of the monomer liquid 350 in the bone cement powder 400 .
  • the porous disc 260 prevents the displacement agent 500 from being conveyed into the bone cement dough 450.
  • figure 6 shows the device 100 of FIGS Figures 1 to 5 , where compared to figure 5 the delivery plunger 270 together with the discharge plunger 250 has been advanced in the direction of the discharge opening 281 of the device 100 .
  • the bone cement dough 450 has been partially discharged from the device 100 as a result of the driving forward.
  • the cap 281 is made of the Figures 1 to 5 replaced by a 730 discharge snorkel (only partially shown).
  • the bone cement dough without discharge snorkel 730 for example by simply removing the plug 285 or the plug 285 and the 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 by means of the device 100 according to FIGS Figures 1 to 6 comprising the method steps 610 to 630 and optionally 640.
  • a step 610 the delivery plunger 270 is pushed into the cartridge 200 in the direction of the discharge plunger 250 . If the distance between the delivery plunger 270 and the discharge plunger 250 falls below the length of the container 300, it breaks up into at least two container sections 300a, so that the monomer liquid 350 can flow out into the rear part 230 of the interior space 210.
  • the discharge piston 250 essentially remains in the same position within the interior space 210.
  • a step 620 continued advancement of the delivery plunger 270 toward the discharge plunger 250 compresses the initial container sections 300a.
  • the initial container sections 300a can disintegrate 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 conduit 260 into the front part 220 of the interior space 210 with the beginning formation of the bone cement dough 450 .
  • a step 630 the monomer liquid between the container sections 300a is displaced by the displacement means 500 while the delivery plunger 270 continues to be advanced in the direction of the discharge plunger 250.
  • the delivery piston 270 brings the displacement means 500 under pressure into an intermediate space between the container sections 300a, so that the displacement means 500 encloses the container sections 300a as far as possible and the monomer liquid 350 from the intermediate space between the container sections 300a via the line means 260 into the front part 220 of the interior 210 is promoted.
  • the displacement means 500 has a volume which can if possible fill the entire space between the container sections 300a, so that if possible the entire monomer liquid 350 can be conveyed into the front part 220 of the interior and is available there for forming 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 space 210 by the continued forward drive 610 of the delivery piston 270 .
  • the delivery plunger 270 overcomes a force holding the discharge plunger 250 so that the delivery plunger 270 and the discharge plunger 250 are moved together in the direction of the discharge opening 280 within the interior space 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 space 210 with the cooperation of the displacement means 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 space 210 of the cartridge 200
  • the device 100 is preferably held during steps 610 to 630 in such a way that the discharge piston 250 is spatially arranged above the delivery piston 270 .
  • gas present there such as air or an inert gas, in particular nitrogen or argon, is first conveyed via the line 260 into the front part 220 of the interior space 210, before the monomer liquid 350 uses.
  • gas inclusions in the bone cement powder 400 are displaced by the monomer liquid 350 and no further gas is introduced once the bone cement dough 450 has started to form.
  • the advancement 610 of the delivery plunger 270 can take place through the manual application of force by a user of the device 100 .
  • the device 100 is inserted into a discharge device 700 for the propulsion 610 and the delivery plunger 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)
EP21169786.7A 2021-04-22 2021-04-22 Dispositif de fourniture de la pâte de ciment osseux Active EP4079396B1 (fr)

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EP21169786.7A EP4079396B1 (fr) 2021-04-22 2021-04-22 Dispositif de fourniture de la pâte de ciment osseux

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US4671263A (en) 1984-07-11 1987-06-09 Klaus Draenert Device and process for mixing and applying bone cement
DE3640279A1 (de) 1985-12-23 1987-06-25 Mit Ab Geraet zum mischen von knochenzement im vakuum
US4973168A (en) 1989-01-13 1990-11-27 Chan Kwan Ho Vacuum mixing/bone cement cartridge and kit
US5344232A (en) 1991-09-30 1994-09-06 Stryker Corporation Bone cement mixing and loading apparatus
WO1994026403A1 (fr) 1993-05-10 1994-11-24 Cemvac System Ab Procede et dispositif permettant d'introduire des constituants d'un ciment pour les os dans un recipient ou ils doivent etre melanges
EP0692229A1 (fr) 1994-07-16 1996-01-17 MERCK PATENT GmbH Dispositif pour mélanger et appliquer un ciment osseux
US5586821A (en) 1995-10-10 1996-12-24 Zimmer, Inc. Bone cement preparation kit
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EP0796653A2 (fr) 1996-02-21 1997-09-24 Kwan-Ho Chan Dispositif et procédé pour le malaxage d'un ciment pour os
US5997544A (en) 1997-05-02 1999-12-07 Merck Patent Gesellschaft Mit Beschrankter Haftung Process and device for producing sterile-packed bone cement
WO1999067015A1 (fr) 1997-05-21 1999-12-29 Nikomed Aps Appareil pour la preparation de ciment osseux
US6033105A (en) 1996-11-15 2000-03-07 Barker; Donald Integrated bone cement mixing and dispensing system
EP1005901A2 (fr) 1995-11-13 2000-06-07 Cemvac System Aktiebolag Procédé et dispositif pour mélanger des composants pour un ciment osseux dans un récipient de mélange
EP1020167A2 (fr) 1999-01-14 2000-07-19 Bristol-Myers Squibb Company Dispositif et procédé pour mélanger et appliquer du ciment osseux
DE69812726T2 (de) 1998-12-14 2004-02-05 Ao Research Institute Methode und vorrichtung zur herstellung von knochenzement
EP1886647A1 (fr) 2006-08-11 2008-02-13 Biomet Cementing Technologies AB Dispositif de mélangeur de ciment osseux
DE102009031178B3 (de) 2009-06-29 2010-09-16 Heraeus Medical Gmbh Vorrichtung zum Mischen und Austragen von Knochenzement
EP3320870A1 (fr) 2016-11-11 2018-05-16 Heraeus Medical GmbH Dispositif et procédé de stockage et de mélange d'un ciment osseux
EP3403716A1 (fr) * 2017-05-17 2018-11-21 Heraeus Medical GmbH Applicateur de ciment osseux doté du cylindre creux au niveau du piston de distribution

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DE3640279A1 (de) 1985-12-23 1987-06-25 Mit Ab Geraet zum mischen von knochenzement im vakuum
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DE102009031178B3 (de) 2009-06-29 2010-09-16 Heraeus Medical Gmbh Vorrichtung zum Mischen und Austragen von Knochenzement
EP3320870A1 (fr) 2016-11-11 2018-05-16 Heraeus Medical GmbH Dispositif et procédé de stockage et de mélange d'un ciment osseux
EP3403716A1 (fr) * 2017-05-17 2018-11-21 Heraeus Medical GmbH Applicateur de ciment osseux doté du cylindre creux au niveau du piston de distribution

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