WO2013113970A1 - Device for the dosing and injection of bone cement - Google Patents
Device for the dosing and injection of bone cement Download PDFInfo
- Publication number
- WO2013113970A1 WO2013113970A1 PCT/ES2013/070055 ES2013070055W WO2013113970A1 WO 2013113970 A1 WO2013113970 A1 WO 2013113970A1 ES 2013070055 W ES2013070055 W ES 2013070055W WO 2013113970 A1 WO2013113970 A1 WO 2013113970A1
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- WO
- WIPO (PCT)
- Prior art keywords
- injection
- slotted head
- pusher
- bone cements
- dosing
- Prior art date
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
- A61B17/8802—Equipment for handling bone cement or other fluid fillers
- A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
- A61B17/8822—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum
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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
- B01F27/00—Mixers with rotary stirring devices in fixed receptacles; Kneaders
- B01F27/05—Stirrers
- B01F27/11—Stirrers characterised by the configuration of the stirrers
- B01F27/114—Helically shaped stirrers, i.e. stirrers comprising a helically shaped band or helically shaped band sections
- B01F27/1143—Helically shaped stirrers, i.e. stirrers comprising a helically shaped band or helically shaped band sections screw-shaped, e.g. worms
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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
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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
- B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
- B01F35/10—Maintenance of mixers
- B01F35/12—Maintenance of mixers using mechanical means
- B01F35/123—Maintenance of mixers using mechanical means using scrapers for cleaning mixers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
- A61B17/8802—Equipment for handling bone cement or other fluid fillers
- A61B17/8833—Osteosynthesis tools specially adapted for handling bone cement or fluid fillers; Means for supplying bone cement or fluid fillers to introducing tools, e.g. cartridge handling means
- A61B2017/8838—Osteosynthesis tools specially adapted for handling bone cement or fluid fillers; Means for supplying bone cement or fluid fillers to introducing tools, e.g. cartridge handling means for mixing bone cement or fluid fillers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/3159—Dose expelling manners
- A61M5/31593—Multi-dose, i.e. individually set dose repeatedly administered from the same medicament reservoir
Definitions
- the present invention relates to a device for dosing and injecting bone cements, comprising a plunger containing a slotted head, which, through a pusher, forces a propeller to rotate on itself as the head It descends through the piston body.
- This device allows the constant agitation of the cement during the injection process, guaranteeing homogeneity and improving injectability.
- Current devices for the injection of bone cements are based on the injection of cement from a plunger mechanism that forces the rectilinear movement of the pusher that forces the cement to move longitudinally and be introduced, after a conical reduction of the plunger, into the cannula or needle that directs it to the cavity of the bone to be filled.
- the progressive separation or elimination of the liquid phase into the cannula during the injection together with the compaction of the powder phase inside the plunger causes a drastic decrease in the injectability of the material and a significant increase in the manual pressure required to continue the injection of the same by the surgeon, a situation that disables the clinical procedure, since in addition the partial volume of injected cement does not ensure the mechanical or biomechanical stability properties of the implant due to having, injected cement, a liquid / powder ratio greater than that of the densified cement inside the plunger that has not yet been injected.
- the paste in the low pressure zone that is, near the inlet of the cannula, is enriched in the liquid phase.
- these described effects are dynamic, the size of the area that is emptied of liquid, wet dust, increases during the injection, reaching the injection tip or end of travel of the device and blocking it.
- some authors have proposed to influence aspects of the design of the material such as reducing the particle size of the ceramic powder phase, using more spherical particles, increasing the viscosity of the liquid phase by incorporating additives, or increasing the liquid to powder ratio of the cement.
- none of these options is completely viable since it presupposes that the design factor is the material and that, therefore, any modification on the cement is valid in order to achieve, for example, a certain optimum value of injectability.
- the final objective of this patent is to focus the injection system as a real design factor, understanding both the surgical technique and the in vivo setting and hardening properties of the biocement as optimal.
- the present patent ensures by means of the new system design of Injection that the biocement remains homogeneous, without phase separation, during the entire ex vivo injection process, that is, during the emptying of the cement from inside the syringe into the cannula and by continuity into the bone cavity a try.
- the present invention implements a device for dosing and injecting bone cements, in a helical advance movement, which allows the vertical translation and the transverse rotational translation of the cement in a continuous way avoiding the densification of the cement during the injection process. This reduces pressure filtration problems, facilitating their injection and maintaining the injectability properties of the cement and reducing the clinical manual pressure required by the surgeon during the entire injection procedure.
- the dosing and injection device for bone cements comprises a plunger or syringe body containing a slotted head, both of the same cross section, animated by a longitudinal translation movement as a result of the thrust experienced by the pusher, which forces a propeller to rotate on itself as the pusher descends through the syringe body.
- the rotational movement caused by the propeller guarantees the agitation and mixing of the ceramic biocement maintaining its homogeneity and density, facilitating the entry of flow into the injection cannula and eliminating pressure filtration problems, with the consequent reduction of the injection pressure required
- This helical agitation system offered by the propeller guarantees the homogeneity of the biphasic mixture of the material and avoids pressure filtration problems during dosing.
- the dosage and injection device described herein can be used for a plurality of injections or could be designed for single use, as will be described later.
- Figure 1 shows an exploded view of the device for dosing and injection of bone cements of the invention, in this case, body (4) and slotted head (2) with oval cross section.
- Figure 2 - shows a view of the device of the invention, in three injection phases, where the displacement of the slotted head (2) towards the injection tip can be seen, while the part (3) remains inside the hollow body of the pusher (1).
- Figure 3.- shows a view of the slotted head (2) of the device of the invention, where the negative grooving of the helical blades of the piece (3) can be seen. It could have some type of flange (5) or means of attachment for the pusher (1), when the return of said slotted head is desired (2) to the original position and re-inject.
- Figure 4.- shows a perspective view of the slotted head (2), with a flange (5) or connecting means for the pusher (1), representing in a broken line the spiral grooved interior, negative of the helical blades of the piece (3).
- Figure 5.- shows a plan view of the slotted head (2).
- the proposed invention concerns a device for dosing and injection of bone cements, which has advantages over those existing in the state of the art.
- the device described here is capable of maintaining continuous agitation of the bone cement during the dosing and injection process, guaranteeing the homogeneity of the cement and its liquid-powder ratio, avoiding the problems of pressure filtration during its dosing, thus as reducing your pressure during the entire clinical injection procedure.
- the described dosing and injection device comprises elements known in the state of the art, such as the hollow body (4) of the device, which has clamping fins (41) and ends at the end point in a small cylinder (42) conical. This small conical cylinder (42) is the one that contacts the injection cannulas.
- the device will be provided with means to couple an external mixing system.
- a pusher (1) provided with a support tongue (1 1) is arranged, to easily push with the finger.
- one of the important features of the device of the invention lies in a piece (3) included inside the body (4), along its entire length, with helical blades that act as a bone cement agitator when they are in motion.
- This rotational or rotational movement of the piece (3) is achieved thanks to the performance of a slotted head (2), of the same cross section as the body (4).
- the slotted head (2) is pressed by the pusher (1), rotating the helical blades of the piece (3) as it descends through the body (4).
- the slotted head (2) is a small piece in relation to the body (4), which has to slide without turning inside the body (4). Therefore, both pieces must have the same cross-section, this cross-section being any, preferably oval, although they could also be of circular section whenever the rotation of the slotted head (2) inside the hollow body (4) is avoided. Therefore, in a preferred embodiment of the invention, to prevent the internal rotation of said slotted head (2) inside the body (4) and thus rotate the helical blades of the part (3), both said slotted head ( 2) as the body (4) will be of non-circular cross-section, being able to adopt any other cross-section other than this one, that is, they could be of triangular, quadrangular, pentagonal, hexagonal, etc. cross-section.
- both the slotted head (2) and the hollow body (4) could have a circular cross-section, provided there are means that prevent the rotation of said slotted head (2), such as for example, longitudinal guides inside the body (4) with the corresponding housings in the slotted head (2), for sliding without turning the slotted head (2).
- the pusher (1) must be a hollow element, which allows the slotted head to be displaced (2), but which also allows the piece (3) to pass inside as it advances and pushes the head grooved (2), of so that when the pusher (1) reaches the end of the body (4), the part (3) would be completely hidden inside the pusher (1).
- the slotted head (2) contains the negative of the helical blades of the piece (3). That is, the space arranged inside the slotted head (2) is coincident with the cross section of the piece (3) with the helical blades. In this way, the helical blades are forced to rotate by the action of the pusher (1) on the slotted head (2). Therefore, the function of the slotted head (2) is very important, because on the one hand, it pushes the cement inside the body (4), and on the other hand, it forces the rotation of the helical blades of the piece (3) to guarantee agitation and dosage.
- the dosing and injection device can be used both for a plurality of injections with a slotted head return system (2), or it could be used for a single injection through a retention system.
- the pusher (1) and the slotted head (2) are joined by any means of connection, preferably removable, as a tab (5).
- a retention system could be placed as a clipping means or any other similar, appropriate, once the slotted head (2) reaches the end of the body travel (4) prevents it from returning to its initial position, thus avoiding a new injection.
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- Chemical Kinetics & Catalysis (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Engineering & Computer Science (AREA)
- Heart & Thoracic Surgery (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biomedical Technology (AREA)
- Mechanical Engineering (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Materials For Medical Uses (AREA)
- Prostheses (AREA)
Description
DISPOSITIVO DE DOSIFICACION E INYECCION DE CEMENTOS OSEOS DOSAGE DEVICE AND INJECTION OF OSE CEMENTS
Objeto de la invención La presente invención trata de un dispositivo de dosificación e inyección de cementos óseos, que comprende un émbolo que contiene un cabezal ranurado, que a través de un empujador, obliga a una hélice a girar sobre sí misma a medida que el cabezal desciende por el cuerpo del émbolo. Este dispositivo permite la agitación constante del cemento durante el proceso de inyección, garantizando la homogeneidad y mejorando la inyectabilidad. OBJECT OF THE INVENTION The present invention relates to a device for dosing and injecting bone cements, comprising a plunger containing a slotted head, which, through a pusher, forces a propeller to rotate on itself as the head It descends through the piston body. This device allows the constant agitation of the cement during the injection process, guaranteeing homogeneity and improving injectability.
Antecedentes de la invención Background of the invention
En la actualidad existen una gran variedad de formas y mecanismos que se han integrado en distintos dispositivos biomédicos con el fin de facilitar la inyección de biocementos poliméricos en una cavidad ósea. Sin embargo, con la introducción reciente en la práctica clínica de los biocementos cerámicos bioactivos para ciertas aplicaciones, se ha visto que los actuales sistemas de inyección de cementos poliméricos necesitan optimizarse en base a las nuevas propiedades de los biocementos cerámicos. Por este motivo, la comunidad clínica está reclamando actualmente nuevos conceptos y diseños de sistemas de inyección para cirugía ósea de mínima invasión específicamente diseñados y optimizados para los nuevos biocementos cerámicos. Los dispositivos actuales para la inyección de cementos óseos se basan en la inyección del cemento a partir de un mecanismo de émbolo que fuerza el desplazamiento rectilíneo del empujador que obliga al cemento a desplazarse longitudinalmente y a introducirse, después de una reducción cónica del émbolo, en la cánula o aguja que lo dirige hacia la cavidad del hueso a rellenar. There are currently a wide variety of forms and mechanisms that have been integrated into different biomedical devices in order to facilitate the injection of polymeric biocements into a bone cavity. However, with the recent introduction into the clinical practice of bioactive ceramic biocements for certain applications, it has been found that current polymeric cement injection systems need to be optimized based on the new properties of ceramic biocements. For this reason, the clinical community is currently demanding new concepts and designs of injection systems for minimally invasive bone surgery specifically designed and optimized for new ceramic biocements. Current devices for the injection of bone cements are based on the injection of cement from a plunger mechanism that forces the rectilinear movement of the pusher that forces the cement to move longitudinally and be introduced, after a conical reduction of the plunger, into the cannula or needle that directs it to the cavity of the bone to be filled.
El movimiento seguido por el empujador comprime y desplaza el cemento en su misma dirección sin que éste se vea agitado durante su traslación, y lo fuerza a pasar a través de una reducción de sección en la parte final del émbolo que lo dirige hacia la cánula. Con este procedimiento y en estas situaciones se tienen problemas de falta de llenado completo y homogéneo de la cavidad ósea como consecuencia de la densificación progresiva del cemento en el interior del émbolo que se produce por un efecto de filtrado por presión de la fase líquida a través de las partículas sólidas de la fase en polvo que causa heterogeneidad en la composición de la parte de cemento inyectada respecto de la que reside todavía en el émbolo. La separación o eliminación progresiva de la fase líquida hacia la cánula durante la inyección junto con la compactación de la fase en polvo dentro del émbolo provoca una disminución drástica de la inyectabilidad del material y un aumento importante de la presión manual requerida para continuar con la inyección del mismo por parte del cirujano, situación que inhabilita el procedimiento clínico, ya que además el volumen parcial de cemento inyectado no asegura las propiedades mecánicas ni de estabilidad biomecánica del implante por poseer, el cemento inyectado, una relación líquido/polvo mayor que la del cemento densificado en el interior del émbolo que todavía no ha sido inyectado. The movement followed by the pusher compresses and displaces the cement in its same direction without it being agitated during its translation, and forces it to pass through a section reduction in the final part of the plunger that directs it towards the cannula. With this procedure and in these situations there are problems of lack of complete and homogeneous filling of the bone cavity as a result of the progressive densification of the cement inside the plunger that is produced by a pressure filtration effect of the liquid phase through of the solid particles of the powder phase that causes heterogeneity in the composition of the injected cement part with respect to the one still residing in the plunger. The progressive separation or elimination of the liquid phase into the cannula during the injection together with the compaction of the powder phase inside the plunger causes a drastic decrease in the injectability of the material and a significant increase in the manual pressure required to continue the injection of the same by the surgeon, a situation that disables the clinical procedure, since in addition the partial volume of injected cement does not ensure the mechanical or biomechanical stability properties of the implant due to having, injected cement, a liquid / powder ratio greater than that of the densified cement inside the plunger that has not yet been injected.
De este modo, la práctica clínica ha reportado en muchas ocasiones que los dispositivos de inyección actuales, que son válidos en biocementos poliméricos, producen efectos no deseados cuando se aplican a biocementos cerámicos. Entre estos efectos destaca principalmente el problema observado de filtrado por presión o separación de fases que se produce durante la inyección del cemento en una cavidad ósea, y que afecta tanto a la homogeneidad de la pasta como a su inyectabilidad o capacidad de ser extrudida, limitando la capacidad de llenado y de restauración biomecánica de la cavidad ósea y aumentando drásticamente la presión de extrusión hasta valores no asequibles en la técnica quirúrgica del médico. Thus, clinical practice has reported on many occasions that current injection devices, which are valid in polymeric biocements, produce unwanted effects when applied to ceramic biocements. Among these effects, the observed problem of pressure filtration or phase separation that occurs during the injection of cement into a bone cavity, which affects both the homogeneity of the paste and its injectability or ability to be extruded, is limited the capacity of filling and biomechanical restoration of the bone cavity and drastically increasing the extrusion pressure to values not available in the surgical technique of the doctor.
Ante esta situación se hace evidente que propiedades reológicas del biocemento tales como su inyectabilidad, su cohesión y su viscosidad, se convierten en factores limitantes del proceso de inyección. A modo de ejemplo, si consideramos la inyectabilidad, cuando una pasta o mezcla bifásica de polvo cerámico fino y fase líquida se somete a un gradiente de presión, el líquido puede fluir más rápido que la fase sólida provocando cambios locales en la composición del cemento o pasta. En estos casos, la pasta que se encuentra más cerca de la región de más alta presión, es decir, cerca de la cabeza del empujador de la jeringa, puede haber sido tan vaciada de fase líquida que la mezcla bifásica en esta zona ya no se comporta como una pasta sino como un polvo húmedo. Por el contrario, la pasta en la zona de baja presión, es decir, cercana a la entrada de la cánula, se enriquece en fase líquida. Como estos efectos descritos son dinámicos, el tamaño de la zona que se vacía de líquido, polvo húmedo, aumenta durante la inyección, alcanzando la punta de inyección o final de recorrido del dispositivo y bloqueándola. Para evitar estos efectos que dañan en última instancia a las propiedades del cemento, algunos autores han propuesto incidir sobre aspectos de diseño del material tales como disminuir el tamaño de partícula de la fase en polvo cerámica, utilizar partículas más esféricas, aumentar la viscosidad de la fase líquida mediante la incorporación de aditivos, o aumentar la relación líquido a polvo del cemento. Sin embargo, ninguna de estas opciones es totalmente viable ya que presupone que el factor de diseño es el material y que, por tanto, cualquier modificación sobre el cemento es válida con tal de conseguir, por ejemplo, un cierto valor óptimo de inyectabilidad. Given this situation, it becomes clear that the rheological properties of the biocement, such as its injectability, its cohesion and its viscosity, become limiting factors of the injection process. As an example, if we consider Injectability, when a paste or biphasic mixture of fine ceramic powder and liquid phase is subjected to a pressure gradient, the liquid can flow faster than the solid phase causing local changes in the composition of the cement or paste. In these cases, the paste that is closer to the region of higher pressure, that is, near the head of the syringe pusher, may have been so emptied of liquid phase that the biphasic mixture in this area is no longer It behaves like a paste but like a wet powder. On the contrary, the paste in the low pressure zone, that is, near the inlet of the cannula, is enriched in the liquid phase. As these described effects are dynamic, the size of the area that is emptied of liquid, wet dust, increases during the injection, reaching the injection tip or end of travel of the device and blocking it. To avoid these effects that ultimately damage the properties of the cement, some authors have proposed to influence aspects of the design of the material such as reducing the particle size of the ceramic powder phase, using more spherical particles, increasing the viscosity of the liquid phase by incorporating additives, or increasing the liquid to powder ratio of the cement. However, none of these options is completely viable since it presupposes that the design factor is the material and that, therefore, any modification on the cement is valid in order to achieve, for example, a certain optimum value of injectability.
Sin embargo, esta aproximación sólo asegura que la pasta sea inyectable a través de una determinada geometría de jeringa y técnica quirúrgica, pasando por alto que todas las modificaciones realizadas a la pasta de cemento afectan en última instancia a sus propiedades de fraguado y de endurecimiento y, en definitiva, a la estabilidad biomecánica del material una vez implantado en la cavidad ósea. However, this approach only ensures that the paste is injectable through a specific syringe geometry and surgical technique, ignoring that all modifications made to the cement paste ultimately affect its setting and hardening properties and , in short, to the biomechanical stability of the material once implanted in the bone cavity.
Por este motivo, el objetivo final de esta patente es centrar como factor real de diseño al sistema de inyección, entendiendo como óptimas tanto la técnica quirúrgica como las propiedades de fraguado y de endurecimiento in vivo del biocemento. En este sentido, la presente patente asegura mediante el nuevo diseño de sistema de inyección que el biocemento se mantenga homogéneo, sin separación de fases, durante todo el proceso de inyección ex vivo, es decir, durante el vaciado del cemento desde el interior de la jeringa hacia la cánula y por continuidad hacia el interior de la cavidad ósea a tratar. For this reason, the final objective of this patent is to focus the injection system as a real design factor, understanding both the surgical technique and the in vivo setting and hardening properties of the biocement as optimal. In this sense, the present patent ensures by means of the new system design of Injection that the biocement remains homogeneous, without phase separation, during the entire ex vivo injection process, that is, during the emptying of the cement from inside the syringe into the cannula and by continuity into the bone cavity a try.
Descripción de la invención Description of the invention
La presente invención implementa un dispositivo de dosificación e inyección de cementos óseos, en movimiento de avance helicoidal, que permite la traslación vertical y la rotacional transversal del cemento de forma continua evitando la densificación del cemento durante el proceso de inyección. De este modo se reducen problemas de filtrado por presión, facilitando su inyección y manteniendo las propiedades de inyectabilidad del cemento y reducir la presión manual clínica requerida por el cirujano durante todo el procedimiento de inyección. The present invention implements a device for dosing and injecting bone cements, in a helical advance movement, which allows the vertical translation and the transverse rotational translation of the cement in a continuous way avoiding the densification of the cement during the injection process. This reduces pressure filtration problems, facilitating their injection and maintaining the injectability properties of the cement and reducing the clinical manual pressure required by the surgeon during the entire injection procedure.
El dispositivo de dosificación e inyección de cementos óseos comprende un émbolo o cuerpo de jeringuilla que contiene un cabezal ranurado, ambos de la misma sección transversal, animado por un movimiento de traslación longitudinal como consecuencia del empuje experimentado por el empujador, que obliga a una hélice a girar sobre sí misma a medida que el empujador desciende por el cuerpo de la jeringuilla. The dosing and injection device for bone cements comprises a plunger or syringe body containing a slotted head, both of the same cross section, animated by a longitudinal translation movement as a result of the thrust experienced by the pusher, which forces a propeller to rotate on itself as the pusher descends through the syringe body.
Se ha de impedir el giro del cabezal ranurado en el interior del cuerpo del dispositivo, para lo cual, o bien el cuerpo y el cabezal ranurado disponen de sección no circular, o bien disponen de sección circular con medios que eviten el giro del cabezal, como podrían ser unas guías longitudinales en el interior del cuerpo. It is necessary to prevent the rotation of the slotted head inside the body of the device, for which, either the body and the slotted head have a non-circular section, or they have a circular section with means that prevent the rotation of the head, such as longitudinal guides inside the body.
El movimiento de rotación provocado por la hélice garantiza la agitación y mezcla del biocemento cerámico manteniendo su homogeneidad y densidad, facilitando la entrada de flujo a la cánula de inyección y eliminando los problemas de filtrado por presión, con la consecuente reducción de la presión de inyección requerida. The rotational movement caused by the propeller guarantees the agitation and mixing of the ceramic biocement maintaining its homogeneity and density, facilitating the entry of flow into the injection cannula and eliminating pressure filtration problems, with the consequent reduction of the injection pressure required
Este sistema de agitación helicoidal ofrecido por la hélice garantiza la homogeneidad de la mezcla bifásica del material y evita los problemas de filtrado por presión durante su dosificación. This helical agitation system offered by the propeller guarantees the homogeneity of the biphasic mixture of the material and avoids pressure filtration problems during dosing.
El dispositivo de dosificación e inyección que aquí se describe puede utilizarse para una pluralidad de inyecciones o bien podría diseñarse de un solo uso, según se describirá más adelante. The dosage and injection device described herein can be used for a plurality of injections or could be designed for single use, as will be described later.
Descripción de los dibujos Description of the drawings
Para completar la descripción que se está realizando y con objeto de ayudar a una mejor comprensión de las características del invento, de acuerdo con un ejemplo preferente de la realización práctica del mismo, se acompaña como parte integrante de dicha descripción, un juego de dibujos en donde con carácter ilustrativo y no limitativo, se ha representado lo siguiente: To complete the description that is being made and in order to help a better understanding of the characteristics of the invention, according to a preferred example of the practical realization thereof, a set of drawings is accompanied as an integral part of said description. where for illustrative and non-limiting purposes, the following has been represented:
La Figura 1 .- muestra una vista en despiece del dispositivo de dosificación e inyección de cementos óseos de la invención, en este caso, cuerpo (4) y cabezal ranurado (2) con sección transversal ovalada. Figure 1 .- shows an exploded view of the device for dosing and injection of bone cements of the invention, in this case, body (4) and slotted head (2) with oval cross section.
La Figura 2 - muestra una vista del dispositivo de la invención, en tres fases de inyección, donde se aprecia el desplazamiento del cabezal ranurado (2) hacia la punta de inyección, mientras la pieza (3) va quedando en el interior del cuerpo hueco del empujador (1 ). Figure 2 - shows a view of the device of the invention, in three injection phases, where the displacement of the slotted head (2) towards the injection tip can be seen, while the part (3) remains inside the hollow body of the pusher (1).
La Figura 3.- muestra una vista del cabezal ranurado (2) del dispositivo de la invención, donde se aprecia el ranurado, negativo de las aspas helicoidales de la pieza (3). Podría disponer de algún tipo de pestaña (5) o medio de unión para el empujador (1 ), cuando se desee el regreso de dicho cabezal ranurado (2) a la posición original y volver a inyectar. Figure 3.- shows a view of the slotted head (2) of the device of the invention, where the negative grooving of the helical blades of the piece (3) can be seen. It could have some type of flange (5) or means of attachment for the pusher (1), when the return of said slotted head is desired (2) to the original position and re-inject.
La Figura 4.- muestra una vista en perspectiva del cabezal ranurado (2), con una pestaña (5) o medio de unión para el empujador (1 ), representando en línea discontinua el interior ranurado en espiral, negativo de las aspas helicoidales de la pieza (3). Figure 4.- shows a perspective view of the slotted head (2), with a flange (5) or connecting means for the pusher (1), representing in a broken line the spiral grooved interior, negative of the helical blades of the piece (3).
La Figura 5.- muestra una vista en planta del cabezal ranurado (2). Realización preferente de la invención Figure 5.- shows a plan view of the slotted head (2). Preferred Embodiment of the Invention
La invención propuesta trata de un dispositivo de dosificación e inyección de cementos óseos, que presenta ventajas respecto a los existentes en el estado de la técnica. El dispositivo que aquí se describe es capaz de mantener una agitación continua del cemento óseo durante el proceso de dosificación e inyección del mismo, garantizando la homogeneidad del cemento y su relación líquido-polvo, evitando los problemas de filtrado por presión durante su dosificación, así como reduciendo su presión durante todo el procedimiento clínico de inyección. El dispositivo de dosificación e inyección descrito comprende elementos conocidos en el estado de la técnica, como son el cuerpo (4) hueco del dispositivo, que posee unas aletas de sujeción (41 ) y termina en la punta final en un pequeño cilindro (42) cónico. Este pequeño cilindro (42) cónico es el que se pone en contacto con las cánulas de inyección. Además, el dispositivo irá provisto de medios para acoplar un sistema externo de mezcla. The proposed invention concerns a device for dosing and injection of bone cements, which has advantages over those existing in the state of the art. The device described here is capable of maintaining continuous agitation of the bone cement during the dosing and injection process, guaranteeing the homogeneity of the cement and its liquid-powder ratio, avoiding the problems of pressure filtration during its dosing, thus as reducing your pressure during the entire clinical injection procedure. The described dosing and injection device comprises elements known in the state of the art, such as the hollow body (4) of the device, which has clamping fins (41) and ends at the end point in a small cylinder (42) conical. This small conical cylinder (42) is the one that contacts the injection cannulas. In addition, the device will be provided with means to couple an external mixing system.
Para deslizarse en el interior de dicho cuerpo (4) hueco y con el fin de deslizar el cemento óseo hacia la punta final, se dispone un empujador (1 ) provisto de una lengüeta de apoyo (1 1 ), para empujar con facilidad con el dedo. To slide inside said hollow body (4) and in order to slide the bone cement towards the end point, a pusher (1) provided with a support tongue (1 1) is arranged, to easily push with the finger.
Así, una de las características importantes del dispositivo de la invención radica en una pieza (3) incluida en el interior del cuerpo (4), a lo largo de toda su longitud, con unas aspas helicoidales que actúan como agitador del cemento óseo cuando se encuentran en movimiento. Este movimiento de giro o rotacional de la pieza (3) se consigue gracias a la actuación de un cabezal ranurado (2), de la misma sección transversal que el cuerpo (4). El cabezal ranurado (2) es presionado por el empujador (1 ), haciendo girar las aspas helicoidales de la pieza (3) a medida que desciende por el cuerpo (4). Thus, one of the important features of the device of the invention It lies in a piece (3) included inside the body (4), along its entire length, with helical blades that act as a bone cement agitator when they are in motion. This rotational or rotational movement of the piece (3) is achieved thanks to the performance of a slotted head (2), of the same cross section as the body (4). The slotted head (2) is pressed by the pusher (1), rotating the helical blades of the piece (3) as it descends through the body (4).
El cabezal ranurado (2) es una pieza pequeña en relación al cuerpo (4), que tiene que deslizarse sin girar dentro del cuerpo (4). Por eso, ambas piezas han de tener la misma sección transversal, siendo esta sección transversal cualquiera, preferentemente ovalada, aunque podrían ser también de sección circular siempre que se evite el giro del cabezal ranurado (2) dentro del cuerpo (4) hueco. Por tanto, en una realización preferente de la invención, para evitar el giro interno de dicho cabezal ranurado (2) en el interior del cuerpo (4) y así hacer girar las aspas helicoidales de la pieza (3), tanto dicho cabezal ranurado (2) como el cuerpo (4) serán de sección transversal no circular, pudiendo adoptar cualquier otra sección transversal diferente a ésta, esto es, podrían ser de sección transversal triangular, cuadrangular, pentagonal, hexagonal, etc. , pero preferentemente serán de sección ovalada. La propia configuración no circular del dispositivo impide el giro del cabezal ranurado (2) en el interior del cuerpo (4). Por otro lado, en otra realización preferente de la invención, tanto el cabezal ranurado (2) como el cuerpo (4) hueco podrían poseer sección transversal circular, siempre y cuando existan medios que impidan el giro de dicho cabezal ranurado (2), como por ejemplo unas guías longitudinales en el interior del cuerpo (4) con los alojamiento correspondientes en el cabezal ranurado (2), para el deslizamiento sin giro del cabezal ranurado (2). The slotted head (2) is a small piece in relation to the body (4), which has to slide without turning inside the body (4). Therefore, both pieces must have the same cross-section, this cross-section being any, preferably oval, although they could also be of circular section whenever the rotation of the slotted head (2) inside the hollow body (4) is avoided. Therefore, in a preferred embodiment of the invention, to prevent the internal rotation of said slotted head (2) inside the body (4) and thus rotate the helical blades of the part (3), both said slotted head ( 2) as the body (4) will be of non-circular cross-section, being able to adopt any other cross-section other than this one, that is, they could be of triangular, quadrangular, pentagonal, hexagonal, etc. cross-section. , but preferably they will be oval. The non-circular configuration of the device prevents rotation of the slotted head (2) inside the body (4). On the other hand, in another preferred embodiment of the invention, both the slotted head (2) and the hollow body (4) could have a circular cross-section, provided there are means that prevent the rotation of said slotted head (2), such as for example, longitudinal guides inside the body (4) with the corresponding housings in the slotted head (2), for sliding without turning the slotted head (2).
Al mismo tiempo, el empujador (1 ) ha de ser un elemento hueco, que permita desplazar el cabezal ranurado (2), pero que además permita el paso en su interior de la pieza (3) a medida que va avanzando y empujando al cabezal ranurado (2), de modo que cuando el empujador (1 ) llega al final del cuerpo (4), la pieza (3) quedaría escondida por completo dentro del empujador (1 ). At the same time, the pusher (1) must be a hollow element, which allows the slotted head to be displaced (2), but which also allows the piece (3) to pass inside as it advances and pushes the head grooved (2), of so that when the pusher (1) reaches the end of the body (4), the part (3) would be completely hidden inside the pusher (1).
De este modo, la acción conjunta del empujador (1 ) y el cabezal ranurado (2) que se desliza sin girar en el interior del cuerpo (4), hacen que la pieza (3), gracias a su geometría, mantenga un movimiento rotativo. La geometría de las aspas helicoidales se adapta a la forma interior del cuerpo donde se encuentra alojada. In this way, the joint action of the pusher (1) and the slotted head (2) that slides without turning inside the body (4), make the piece (3), thanks to its geometry, maintain a rotational movement . The geometry of the helical blades adapts to the internal shape of the body where it is housed.
El cabezal ranurado (2) contiene el negativo de las aspas helicoidales de la pieza (3). Es decir, el espacio dispuesto en el interior del cabezal ranurado (2) es coincidente con la sección transversal de la pieza (3) con las aspas helicoidales. De este modo, las aspas helicoidales son obligadas a rotar por la acción del empujador (1 ) sobre el cabezal ranurado (2). Por tanto, la función del cabezal ranurado (2) es muy importante, pues por un lado, empuja el cemento del interior del cuerpo (4), y por otro lado, fuerza la rotación de las aspas helicoidales de la pieza (3) para garantizar la agitación y dosificación. The slotted head (2) contains the negative of the helical blades of the piece (3). That is, the space arranged inside the slotted head (2) is coincident with the cross section of the piece (3) with the helical blades. In this way, the helical blades are forced to rotate by the action of the pusher (1) on the slotted head (2). Therefore, the function of the slotted head (2) is very important, because on the one hand, it pushes the cement inside the body (4), and on the other hand, it forces the rotation of the helical blades of the piece (3) to guarantee agitation and dosage.
Por último, el dispositivo de dosificación e inyección puede ser utilizado tanto para una pluralidad de inyecciones con un sistema de retorno del cabezal ranurado (2), o podría utilizarse para una única inyección a través de un sistema de retención. Para garantizar el retorno y la pluralidad de inyecciones del cabezal ranurado (2) a su posición inicial una vez se termina la inyección, el empujador (1 ) y el cabezal ranurado (2) se encuentran unidos por cualquier medio de unión, preferentemente desmontable, como una pestaña (5). En el caso de que se desee utilizar un dispositivo de dosificación e inyección de una única aplicación, podría colocarse un sistema de retención como un medio de clipaje o cualquier otro similar apropiado, que una vez que el cabezal ranurado (2) llegue al final del recorrido del cuerpo (4) impida que vuelva a colocarse en su posición inicial, evitando de este modo una nueva inyección. Finally, the dosing and injection device can be used both for a plurality of injections with a slotted head return system (2), or it could be used for a single injection through a retention system. To guarantee the return and the plurality of injections of the slotted head (2) to its initial position once the injection is finished, the pusher (1) and the slotted head (2) are joined by any means of connection, preferably removable, as a tab (5). In the case that it is desired to use a dosing and injection device of a single application, a retention system could be placed as a clipping means or any other similar, appropriate, once the slotted head (2) reaches the end of the body travel (4) prevents it from returning to its initial position, thus avoiding a new injection.
Claims
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| ES201230145A ES2421545B1 (en) | 2012-02-01 | 2012-02-01 | BODY CEMENT DOSAGE AND INJECTION DEVICE |
| ESP201230145 | 2012-02-01 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2013113970A1 true WO2013113970A1 (en) | 2013-08-08 |
Family
ID=48904449
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/ES2013/070055 Ceased WO2013113970A1 (en) | 2012-02-01 | 2013-02-01 | Device for the dosing and injection of bone cement |
Country Status (2)
| Country | Link |
|---|---|
| ES (1) | ES2421545B1 (en) |
| WO (1) | WO2013113970A1 (en) |
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105944861A (en) * | 2016-07-06 | 2016-09-21 | 冀中能源邯郸矿业集团有限公司 | Super high-water material slurry mixing nozzle |
| ITUA20162703A1 (en) * | 2016-04-19 | 2017-10-19 | Nicola Rossi | CARTRIDGE AND CONNECTED MIXING AND DELIVERY DEVICE |
| US9987767B1 (en) * | 2013-03-11 | 2018-06-05 | Galomb, Inc. | Material stripping apparatus for external mixing element |
| US11241541B2 (en) | 2017-08-21 | 2022-02-08 | Miraki Innovation Think Tank Llc | Cold slurry syringe |
| US11324673B2 (en) | 2016-11-18 | 2022-05-10 | Miraki Innovation Think Tank Llc | Cosmetic appearance of skin |
| US11439532B2 (en) | 2017-04-05 | 2022-09-13 | Miraki Innovation Think Tank Llc | Point of delivery cold slurry generation |
| US11446178B2 (en) | 2017-04-05 | 2022-09-20 | Miraki Innovation Think Tank Llc | Cold slurry containment |
| US11890225B2 (en) | 2016-11-02 | 2024-02-06 | Miraki Innovation Think Tank Llc | Devices and methods for slurry generation |
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|---|---|---|---|---|
| US5842786A (en) * | 1997-03-07 | 1998-12-01 | Solomon; Alan | Method and device for mixing medical compositions |
| US6431743B1 (en) * | 1999-10-06 | 2002-08-13 | Ngk Spark Plug Co., Ltd. | Method of preparing and extruding a chemical agent using a kneader and chemical-agent extrusion assisting tool |
| US20060256646A1 (en) * | 2003-06-25 | 2006-11-16 | Bidoia S.A.S. Di Gianfranco Bidoia E. C. | Mixing and distribution device for fixing paste, particularly for multicomponent bone cement |
| US20110004156A1 (en) * | 2008-02-28 | 2011-01-06 | Medmix Systems Ag | Single chamber device for drawing in and dispensing components |
-
2012
- 2012-02-01 ES ES201230145A patent/ES2421545B1/en active Active
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- 2013-02-01 WO PCT/ES2013/070055 patent/WO2013113970A1/en not_active Ceased
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5842786A (en) * | 1997-03-07 | 1998-12-01 | Solomon; Alan | Method and device for mixing medical compositions |
| US6431743B1 (en) * | 1999-10-06 | 2002-08-13 | Ngk Spark Plug Co., Ltd. | Method of preparing and extruding a chemical agent using a kneader and chemical-agent extrusion assisting tool |
| US20060256646A1 (en) * | 2003-06-25 | 2006-11-16 | Bidoia S.A.S. Di Gianfranco Bidoia E. C. | Mixing and distribution device for fixing paste, particularly for multicomponent bone cement |
| US20110004156A1 (en) * | 2008-02-28 | 2011-01-06 | Medmix Systems Ag | Single chamber device for drawing in and dispensing components |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9987767B1 (en) * | 2013-03-11 | 2018-06-05 | Galomb, Inc. | Material stripping apparatus for external mixing element |
| ITUA20162703A1 (en) * | 2016-04-19 | 2017-10-19 | Nicola Rossi | CARTRIDGE AND CONNECTED MIXING AND DELIVERY DEVICE |
| CN105944861A (en) * | 2016-07-06 | 2016-09-21 | 冀中能源邯郸矿业集团有限公司 | Super high-water material slurry mixing nozzle |
| US11890225B2 (en) | 2016-11-02 | 2024-02-06 | Miraki Innovation Think Tank Llc | Devices and methods for slurry generation |
| US11324673B2 (en) | 2016-11-18 | 2022-05-10 | Miraki Innovation Think Tank Llc | Cosmetic appearance of skin |
| US11439532B2 (en) | 2017-04-05 | 2022-09-13 | Miraki Innovation Think Tank Llc | Point of delivery cold slurry generation |
| US11446178B2 (en) | 2017-04-05 | 2022-09-20 | Miraki Innovation Think Tank Llc | Cold slurry containment |
| US11241541B2 (en) | 2017-08-21 | 2022-02-08 | Miraki Innovation Think Tank Llc | Cold slurry syringe |
Also Published As
| Publication number | Publication date |
|---|---|
| ES2421545B1 (en) | 2014-06-25 |
| ES2421545A1 (en) | 2013-09-03 |
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