WO2013117795A1 - Dosing device for injecting bone cement - Google Patents

Dosing device for injecting bone cement Download PDF

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Publication number
WO2013117795A1
WO2013117795A1 PCT/ES2013/070076 ES2013070076W WO2013117795A1 WO 2013117795 A1 WO2013117795 A1 WO 2013117795A1 ES 2013070076 W ES2013070076 W ES 2013070076W WO 2013117795 A1 WO2013117795 A1 WO 2013117795A1
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WO
WIPO (PCT)
Prior art keywords
spring
cement
plunger
injection
coils
Prior art date
Application number
PCT/ES2013/070076
Other languages
Spanish (es)
French (fr)
Inventor
Sergio GÓMEZ GONZÁLEZ
Enrique FERNÁNDEZ AGUADO
Maria Daniela VLAD
Miguel Ángel GÓMEZ GONZÁLEZ
Leonel Christopher ECHENIQUE SULCA
Original Assignee
Universitat Politècnica De Catalunya
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
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Publication of WO2013117795A1 publication Critical patent/WO2013117795A1/en

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Classifications

    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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, setting implements or the like
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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, setting implements or the like
    • 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
    • A61B17/8825—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by syringe details
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F25/00—Flow mixers; Mixers for falling materials, e.g. solid particles
    • B01F25/40—Static mixers
    • B01F25/44—Mixers in which the components are pressed through slits
    • B01F25/441—Mixers in which the components are pressed through slits characterised by the configuration of the surfaces forming the slits
    • B01F25/4415—Mixers in which the components are pressed through slits characterised by the configuration of the surfaces forming the slits the slits being formed between the helical windings of a spring-like construction or by deforming a spring
    • 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
    • B01F35/56—General build-up of the mixers
    • B01F35/562—General build-up of the mixers the mixer or mixing elements being collapsible, i.e. when discharging the products
    • 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
    • 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
    • A61M2005/3114—Filling or refilling
    • A61M2005/3115—Filling or refilling spring-assisted

Definitions

  • the present invention concerns a dosing device for injection of bone cements, plunger type, comprising a main body containing a compressible conical spring of fine section and length equal to the body, which through a pusher, forces the spring to compress complete form until adopting a flat spiral shape without the turns coming to touch.
  • This device allows the constant agitation of the cement contained inside the body due to the shear produced by the windings of the spring in its displacement in compression during the injection.
  • This device guarantees the homogeneity of the cement, improving its injectability and avoiding the problems of pressure filtration and syringe blockage that are observed during the filling of bone cavities for this type of materials in standard injection processes.
  • 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 liquid can flow faster than the solid phase causing local changes in the composition of the cement or pasta.
  • 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.
  • the paste in the low pressure zone that is, near the inlet of the cannula, is enriched in the liquid phase.
  • 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 through the new design of injection system 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 to be treated.
  • the present invention implements a dosing device for injection of bone cements that facilitates their mixing and homogenization by the shear effect produced by the conical spring turns during their compression as a result of the movement of the pusher or piston in vertical movement in the inside the hollow syringe body.
  • the approach of the turns during the compression of the conical spring allows the Homogeneous shearing and mixing of cement without phase separation or unwanted effects of pressure filtering.
  • the effect achieved is an improvement in the injectability of the cement or the ability to inject it without modifying its properties. This also reduces the manual pressure required by the surgeon during the entire injection procedure, facilitating the surgical technique.
  • the dosing device for injection of bone cements comprises a plunger or syringe body containing, within it, a conical spring of any section, in an extended position, and at least the same length as the inner piston body.
  • the push made on it by the piston in its longitudinal translation movement allows the spring to be compressed to maximum compression, when all the turns take the form of a spiral, in the same plane, without the turns coming into contact with each other.
  • This system of mixing or shear agitation offered by the conical propeller of any section guarantees the homogeneity of the cement-based cement-like materials, such as bone cements of calcium phosphates and / or calcium sulfates, or others, and prevents known problems of pressure filtration of this type of biphasic mixtures during dosing and filling of bone cavities.
  • the dosing and injection device described herein can be used for a plurality of injections or could be designed for single use, for example, taking into account the spring recovery constant or using known anchoring systems between the pusher, or plunger , and the main body in maximum compression position.
  • Figure 1 shows an exploded view of the dosing device for injection of bone cements of the invention, in this case, the piston (1) and the conical spring of any profile (2) and the syringe body (3) in the initial state, without compression of the conical spring.
  • Figure 2.- shows an exploded view of the dosing device for injection of bone cements of the invention, in this case, the piston (1) and the conical spring of any profile (2) and the syringe body (3) in final state, after compression of the conical spring.
  • Figure 3.- shows a view of the compression conical spring in its initial position.
  • Figure 4.- shows a view of the conical compression spring in its final position of maximum compression.
  • the proposed invention concerns a dosing device for 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 piston (1), the conical spring of any profile (2) and the hollow syringe body (3).
  • the conical spring is in intimate contact with the plunger and with the distal part of the inside of the syringe, where the conical propeller rests, preferably in the part with smaller diameter.
  • the device will be provided with means to couple an external mixing system.
  • the conical propeller or spring (2) In order for the conical propeller or spring (2) to mix the cement by shear, it must be placed inside the syringe body (3) and also must be concentrically subjected to the compression exerted by the plunger (1).
  • one of the important features of the device of the invention lies in the spring (2) included inside the syringe body (3), along its entire length, where the conical turns of the propeller are collected from Telescopic shape due to the effect of compression.
  • the relative translational movement of the plunger on the syringe is achieved by the pressure exerted by the surgeon from the thrust of the plunger (1) preventing the mechanical recovery constant of the spring from producing stresses. excessive progressive.
  • the spring (2) when compressed by the action of the piston (1) as it descends through the interior of the body (3) causes the telescopic withdrawal of the conical helix turns, allowing to adopt:
  • the dosing and injection device can be used both for a plurality of injections if the recovery constant of the spring (2) is considered, and for a single injection if a material for the spring (2) is selected with absence of elastic recovery or active anchoring systems are designed between the plunger (1) and the syringe body (3) in maximum compression position.

Abstract

The invention relates to a dosing device for injecting bone cement, which comprises a plunger (1), a compressible cone spring (2) and a syringe body (3) in which the spring (2) and the cement are housed. The longitudinal displacement of the plunger (1) causes the cone spring (2) to be compressed and the progressive approach of the coils thereof facilitates the injectability and the thrust of the bone cement along the inside of the syringe body (3). The compression of the cone spring (2) facilitates the homogeneous mixing of the cement in the interior of the body (3) because of the shear effect which the coils of the spring produce when said coils approach each other during compression, which extends until all the coils attain the same minimal height and are located in the same plane. In this way, a continuous agitation of the product to be injected is maintained, ensuring the homogeneity thereof and preventing the problems of filtering under pressure.

Description

DISPOSITIVO DOSIFICADOR PARA INYECCIÓN DE CEMENTOS ÓSEOS  DOSING DEVICE FOR BONE CEMENT INJECTION
Objeto de la invención Object of the invention
La presente invención trata de un dispositivo dosificador para inyección de cementos óseos, tipo émbolo, que comprende un cuerpo principal que contiene un resorte cónico compresible de sección fina y longitud igual al cuerpo, que a través de un empujador, obliga al resorte a comprimirse de forma completa hasta adoptar una forma de espiral plana sin que las espiras lleguen a tocarse. Este dispositivo permite la agitación constante del cemento contenido en el interior del cuerpo debido a la cizalla que producen las espiras del resorte en su desplazamiento en compresión durante la inyección. Este dispositivo garantiza la homogeneidad del cemento, mejorando su inyectabilidad y evitando los problemas de filtrado por presión y bloqueo de la jeringa que se observan durante el rellenado de cavidades óseas para este tipo de materiales en procesos de inyección estándar. The present invention concerns a dosing device for injection of bone cements, plunger type, comprising a main body containing a compressible conical spring of fine section and length equal to the body, which through a pusher, forces the spring to compress complete form until adopting a flat spiral shape without the turns coming to touch. This device allows the constant agitation of the cement contained inside the body due to the shear produced by the windings of the spring in its displacement in compression during the injection. This device guarantees the homogeneity of the cement, improving its injectability and avoiding the problems of pressure filtration and syringe blockage that are observed during the filling of bone cavities for this type of materials in standard injection processes.
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 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
HOJA DE REEMPLAZO (Regla 26) optimizados para los nuevos biocementos cerámicos. REPLACEMENT SHEET (Rule 26) optimized for new ceramic biocements.
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. 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 the 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. 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. Thus, clinical practice has reported on many occasions that current injection devices, which are valid in biocements polymeric, 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. 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 pasta. 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.
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. 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 cement, some authors have proposed influencing aspects of material design 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 ratio to cement powder 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 through the new design of injection system 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 to be treated.
Descripción de la invención La presente invención implementa un dispositivo dosificador para inyección de cementos óseos que facilita su mezcla y homogeneización por el efecto de cizalla que producen las espiras del resorte cónico durante su compresión como consecuencia del desplazamiento del empujador o émbolo en movimiento vertical en el interior del cuerpo de jeringuilla hueco. El acercamiento de las espiras durante la compresión del resorte cónico permite el cizallado y mezclado homogéneo del cemento sin que se produzca separación de fases o efectos no deseados de filtrado por presión. El efecto que se consigue es una mejora de la inyectabilidad del cemento o capacidad de inyectarlo sin modificar sus propiedades. De este modo también se reduce la presión manual requerida por el cirujano durante todo el procedimiento de inyección, facilitando la técnica quirúrgica. DESCRIPTION OF THE INVENTION The present invention implements a dosing device for injection of bone cements that facilitates their mixing and homogenization by the shear effect produced by the conical spring turns during their compression as a result of the movement of the pusher or piston in vertical movement in the inside the hollow syringe body. The approach of the turns during the compression of the conical spring allows the Homogeneous shearing and mixing of cement without phase separation or unwanted effects of pressure filtering. The effect achieved is an improvement in the injectability of the cement or the ability to inject it without modifying its properties. This also reduces the manual pressure required by the surgeon during the entire injection procedure, facilitating the surgical technique.
El dispositivo dosificador para inyección de cementos óseos comprende un émbolo o cuerpo de jeringuilla que contiene, dentro del mismo, un resorte cónico de sección cualquiera, en posición extendida, y al menos de la misma longitud que el cuerpo del émbolo interior. El empuje efectuado sobre el mismo por parte el émbolo en su movimiento de traslación longitudinal permite comprimir el resorte hasta compresión máxima, cuando todas las espiras adoptan la forma de una espiral, en un mismo plano, sin que las espiras lleguen a tocarse entre ellas. The dosing device for injection of bone cements comprises a plunger or syringe body containing, within it, a conical spring of any section, in an extended position, and at least the same length as the inner piston body. The push made on it by the piston in its longitudinal translation movement allows the spring to be compressed to maximum compression, when all the turns take the form of a spiral, in the same plane, without the turns coming into contact with each other.
A medida que la hélice cónica se comprime todas las espiras se sitúan en planos más cercanos entre sí facilitando el cizallado y el mezclado homogéneo del cemento. La compresión máxima del resorte cónico junta todas las espiras haciendo que la altura máxima coincida con la altura de la sección, cualquiera, de la propia hélice cónica. As the conical helix is compressed all turns are placed in planes closer to each other facilitating shearing and homogeneous mixing of the cement. The maximum compression of the conical spring brings together all the turns making the maximum height coincide with the height of the section, either, of the conical propeller itself.
Este sistema de mezcla o agitación por cizalla ofrecido por la hélice cónica de sección cualquiera garantiza la homogeneidad de los materiales tipo cemento de base cerámica, como son los cementos óseos de fosfatos de calcio y/o sulfatos de calcio, u otros, y evita los problemas conocidos de filtrado por presión de este tipo de mezclas bifásicas durante su dosificación y llenado de cavidades óseas. 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, por ejemplo, teniendo en cuenta la constante de recuperación del resorte o utilizando sistemas de anclaje conocidos entre el empujador, o émbolo, y el cuerpo principal en posición de compresión máxima. This system of mixing or shear agitation offered by the conical propeller of any section guarantees the homogeneity of the cement-based cement-like materials, such as bone cements of calcium phosphates and / or calcium sulfates, or others, and prevents known problems of pressure filtration of this type of biphasic mixtures during dosing and filling of bone cavities. The dosing and injection device described herein can be used for a plurality of injections or could be designed for single use, for example, taking into account the spring recovery constant or using known anchoring systems between the pusher, or plunger , and the main body in maximum compression position.
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: La Figura 1.- muestra una vista en despiece del dispositivo dosificador para inyección de cementos óseos de la invención, en este caso, el émbolo (1 ) y el resorte cónico de perfil cualquiera (2) y el cuerpo de la jeringuilla (3) en estado inicial, sin la compresión del resorte cónico. La Figura 2.- muestra una vista en despiece del dispositivo dosificador para inyección de cementos óseos de la invención, en este caso, el émbolo (1 ) y el resorte cónico de perfil cualquiera (2) y el cuerpo de la jeringuilla (3) en estado final, después de la compresión del resorte cónico. 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: Figure 1 shows an exploded view of the dosing device for injection of bone cements of the invention, in this case, the piston (1) and the conical spring of any profile (2) and the syringe body (3) in the initial state, without compression of the conical spring. Figure 2.- shows an exploded view of the dosing device for injection of bone cements of the invention, in this case, the piston (1) and the conical spring of any profile (2) and the syringe body (3) in final state, after compression of the conical spring.
La Figura 3.- muestra una vista del resorte cónico a compresión en su posición inicial. Figure 3.- shows a view of the compression conical spring in its initial position.
La Figura 4.- muestra una vista del resorte cónico a compresión en su posición final de máxima compresión. Realización preferente de la invención Figure 4.- shows a view of the conical compression spring in its final position of maximum compression. Preferred Embodiment of the Invention
La invención propuesta trata de un dispositivo dosificador para 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. The proposed invention concerns a dosing device for 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.
El dispositivo de dosificación e inyección descrito comprende elementos conocidos en el estado de la técnica, como son el émbolo (1 ), el resorte cónico de perfil cualquiera (2) y el cuerpo de la jeringuilla (3) hueco. El resorte cónico está en contacto íntimo con el émbolo y con la parte distal del interior de la jeringuilla, dónde se apoya la hélice cónica, preferentemente en la parte con menor diámetro. Además, el dispositivo irá provisto de medios para acoplar un sistema externo de mezcla. Para que la hélice o resorte cónico (2) mezcle el cemento por cizalla, éste debe situarse en el interior del cuerpo de la jeringuilla (3) y además debe estar sometido de forma concéntrica a la compresión ejercida por el émbolo (1 ). The described dosing and injection device comprises elements known in the state of the art, such as the piston (1), the conical spring of any profile (2) and the hollow syringe body (3). The conical spring is in intimate contact with the plunger and with the distal part of the inside of the syringe, where the conical propeller rests, preferably in the part with smaller diameter. In addition, the device will be provided with means to couple an external mixing system. In order for the conical propeller or spring (2) to mix the cement by shear, it must be placed inside the syringe body (3) and also must be concentrically subjected to the compression exerted by the plunger (1).
Así, una de las características importantes del dispositivo de la invención radica en el resorte (2) incluido en el interior del cuerpo de la jeringuilla (3), a lo largo de toda su longitud, donde las espiras cónicas de la hélice van recogiéndose de forma telescópica por el efecto de su compresión. El movimiento de translación relativo del émbolo sobre la jeringa se consigue por la presión ejercida por el cirujano a partir del empuje del émbolo (1 ) evitando que la constante de recuperación mecánica del resorte produzca esfuerzos excesivos progresivos. Thus, one of the important features of the device of the invention lies in the spring (2) included inside the syringe body (3), along its entire length, where the conical turns of the propeller are collected from Telescopic shape due to the effect of compression. The relative translational movement of the plunger on the syringe is achieved by the pressure exerted by the surgeon from the thrust of the plunger (1) preventing the mechanical recovery constant of the spring from producing stresses. excessive progressive.
El resorte (2), al ser comprimido por la acción del émbolo (1 ) a medida que desciende por el interior del cuerpo (3) provoca el recogimiento telescópico de las espiras de la hélice cónica, permitiendo adoptar: The spring (2), when compressed by the action of the piston (1) as it descends through the interior of the body (3) causes the telescopic withdrawal of the conical helix turns, allowing to adopt:
• una posición inicial extendida del resorte (2); y  • an extended initial position of the spring (2); Y
• una posición final de compresión máxima, donde el resorte (2) forma una espiral plana sin que ninguna de sus espiras se toquen, dejando un espacio entre ellas suficiente para facilitar el cizallado, mezclado y paso del cemento a su través durante el proceso de inyección y llenado de una cavidad ósea.  • a final maximum compression position, where the spring (2) forms a flat spiral without any of its turns touching each other, leaving enough space between them to facilitate the shearing, mixing and passage of cement through it during the process of injection and filling of a bone cavity.
Por último, el dispositivo de dosificación e inyección puede ser utilizado tanto para una pluralidad de inyecciones si se considera la constante de recuperación del resorte (2), como para una única inyección si se selecciona un material para el resorte (2) con ausencia de recuperación elástica o se diseñan sistemas de anclaje activos entre el émbolo (1 ) y el cuerpo de la jeringuilla (3) en posición de compresión máxima. Finally, the dosing and injection device can be used both for a plurality of injections if the recovery constant of the spring (2) is considered, and for a single injection if a material for the spring (2) is selected with absence of elastic recovery or active anchoring systems are designed between the plunger (1) and the syringe body (3) in maximum compression position.

Claims

REIVINDICACIONES
1.- Dispositivo dosificador para inyección de cementos óseos, que comprende un émbolo (1 ) y un cuerpo de jeringuilla hueco (3), provisto de medios para acoplar un sistema externo de mezcla, caracterizado porque en el interior del cuerpo (3), y a lo largo de toda su longitud, se dispone de un resorte (2) compresible con espiras, en forma de hélice cónica, en contacto íntimo con el émbolo (1 ) y con la parte distal del interior del cuerpo (3), sometido de forma concéntrica a la compresión ejercida por el émbolo (1 ), que al ser comprimido por la acción del émbolo (1 ) a medida que desciende por el interior del cuerpo (3) provoca el recogimiento telescópico de las espiras de la hélice cónica, permitiendo adoptar: 1.- Dosing device for injection of bone cements, comprising a plunger (1) and a hollow syringe body (3), provided with means for coupling an external mixing system, characterized in that inside the body (3), and along its entire length, there is a spring (2) compressible with turns, in the form of a conical helix, in intimate contact with the plunger (1) and with the distal part inside the body (3), subjected to Concentric shape to the compression exerted by the piston (1), which when compressed by the action of the piston (1) as it descends through the interior of the body (3) causes the telescopic withdrawal of the conical helix turns, allowing adopt:
• una posición inicial extendida del resorte (2); y  • an extended initial position of the spring (2); Y
· una posición final de compresión máxima, donde el resorte (2) forma una espiral plana sin que ninguna de sus espiras se toquen, dejando un espacio entre ellas.  · A final maximum compression position, where the spring (2) forms a flat spiral without any of its turns touching each other, leaving a space between them.
PCT/ES2013/070076 2012-02-10 2013-02-11 Dosing device for injecting bone cement WO2013117795A1 (en)

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