WO2010076427A1 - Holding and bone synthesis device for a broken bone, made of a shape memory alloy - Google Patents
Holding and bone synthesis device for a broken bone, made of a shape memory alloy Download PDFInfo
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- WO2010076427A1 WO2010076427A1 PCT/FR2009/001447 FR2009001447W WO2010076427A1 WO 2010076427 A1 WO2010076427 A1 WO 2010076427A1 FR 2009001447 W FR2009001447 W FR 2009001447W WO 2010076427 A1 WO2010076427 A1 WO 2010076427A1
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- bone
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- synthesis according
- main axis
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- 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
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/82—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin for bone cerclage
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00867—Material properties shape memory effect
Definitions
- the present invention relates to a device for maintaining a bone having undergone a discontinuity, and / or a fracture and is in the form of two or more fragments, following a fracture, by immobilization then carrying out a bone synthesis.
- a bone immobilization and synthesis device particularly in the form of a staple plate, made of a shape memory alloy, which may be provided with one or more layers of biocompatible coating, which will can be positioned and maintained on the fragments of a fractured bone, using a temperature close to that of the body, to stabilize the fracture pending consolidation, its removal being ensured by the application of a temperature close to Room temperature.
- the various immobilization devices must be fixed directly on the invoiced bone fragments in order to bring them together and to hold them together and to ensure anatomical reconstitution, for consolidation.
- This attachment is generally performed by means of screws or other fastener, which require the perforation of the bone, prior to their introduction, to ensure optimal retention of the fragments.
- WO 97/13469 discloses a device for connecting two bone areas, consisting of a plate having screw insertion holes. This device is made of a shape memory alloy so as to adapt to the morphology of the bone.
- WO 02/083014 discloses a system for attaching two bone fragments separated by a fracture, which consists of a screw provided with two helical perforators. The latter fit into each of the two bone fragments so as to bring them together for their joint and thus reduce the fracture.
- WO 01/60269 discloses a fixation device for fractured bone made of a shape memory alloy. This device is in the form of a clamp in the shape of "C", which does not require the perforation of the bone for its implementation.
- FR 2,694,696 discloses a clip made of a shape memory alloy. It is in the form of a cross-shaped wave on which are arranged two perpendicular arms. These are inserted into the bone, on both sides of the fracture. The deformation of the crosspiece will allow a closer to two bone fragments for repair.
- the risk due to the presence of screws is the breaking of the screws in the bone, which forces the surgeon to perform a second operation to reduce the bone and recover the broken screw by digging around the screw, which is a significant inconvenience for the patient, and can create an area of bone fragility during the filling of the bone, that is to say for one to two months.
- the present invention intends to remedy these various disadvantages of the prior art by proposing a device for immobilization and bone synthesis, in particular a staple plate, intended to reduce fractures effectively, while not requiring prior perforation of the bone. bones, as no screws or other inserts are necessary to maintain this device on the bone
- the subject of the present invention is an immobilization and bone synthesis device for maintaining a bone having undergone a discontinuity and / or rupture and having one or more fragments following a fracture, carried out in a shape memory alloy, characterized in that it consists of a main axis disposed at the bone fragments to be welded and fixed together, and at least one fastening element comprising at least a pair of arms disposed substantially in a plane perpendicular to the main axis, surrounding the bone in the locked position automatically obtained by the heat of the body when said device is subjected to a temperature between 25 and 40 ° C, and retracting bone when said device is subjected to a temperature between -5 and 20 ° C,
- FIG. 1 is a representation of a staple plate according to a first example
- FIG. 2 represents a second embodiment of the staple plate according to the invention
- - Figure 3 is a representation of a staple plate according to a third embodiment
- Figure 4 is a fourth embodiment of the staple plate according to the invention
- Figure 5 is a representation of a second embodiment of a staple plate.
- the bone immobilization and synthesis device is preferably in the form of a staple plate having a main axis 1 disposed on the bone fragments to be welded or repaired.
- the length as well as the width of the main axis 1 will be a function of the dimensions of the bone, but also of the number of bone fragments that it is desired to weld, as well as of the type of fracture or repair desired.
- the main axis 1 of the immobilization device and bone synthesis is provided with at least one attachment element 2, allowing the maintenance of the bone immobilization and synthesis device on the bone fragments to be welded together.
- the attachment element 2 is preferably in the form of a pair of arms 2a disposed substantially in a plane perpendicular to the main axis 1.
- the arms 2a are arranged in pairs, on either side of the main axis 1, so as to increase their rigidity and promote the retention of the immobilizer, as it can be seen in Figures 1 to 4.
- the number of arms 2a will depend on the length and diameter of the bone to be repaired, as well as the desired type of maintenance.
- the length of the arms 2a may be the same, as shown in Figure 3, or may vary ( Figures 1, 2 and 4).
- the number of arms 2a on either side of the main axis 1 may be heterogeneous, that is to say that one side of the main axis has more arms 2a than the other (variant no shown).
- the arms 2a can also be offset relative to each other, according to the morphology of the fractured bone, which thus promotes the maintenance of the immobilization element and bone synthesis.
- the dimensions, the number and the positioning of the arms 2a will depend on the type of bone to be repaired as well as its dimensions, the type of fracture, and the type of support desired.
- the attachment element 2 may also be arranged in the continuity of the main axis 1 (variant not shown). According to another variant embodiment of the bone immobilization and synthesis device, represented in FIG. 5, the attachment element 2 has a shape in a circular arc 2b, which has the effect of ensuring a better bone approximation. .
- the main axis 1 has a curvilinear shape, such as an "S" shape, the attachment elements of which form an integral part of the axis 1.
- the main axis can be bent before it is placed on the bone. Bending of the main axis of the holding device is carried out at room temperature using a bender, which allows the surgeon to have a plate matching the shape of the bone. If necessary, the surgeon can slightly straighten the plate by heating the holding device at a temperature greater than or equal to 50 ° C. This heat treatment makes it possible to bring the main axis back to its initial position.
- the setting up of the maintenance is achieved by blocking the arms around the bone, enabled by the application of a temperature of the order of 40 0 C, at the arms only. This allows the main axis to keep its curved shape, particularly adapted to the shape of the bone.
- the device for immobilization and bone synthesis according to the invention is made of a shape memory alloy.
- a temperature between 25 and 40 0 C 1 preferably 4O 0 C that is to say close to body temperature.
- This temperature can be obtained by means of a source of heat or naturally, that is to say the temperature of the human body.
- the application of this temperature will give the locking device its locking form.
- the main axis has the determined shape in which it has been shaped using the bender at room temperature.
- the removal of the bone immobilization and synthesis device is effected by the application of a temperature below 20 0 C, more particularly of the order of -5 to 20 ° C. At this temperature the device becomes malleable and can be deformed to facilitate its removal or insertion on a bone.
- the shape-memory alloy constituting the bone immobilization and synthesis device according to the invention consists of nickel and titanium, in respective proportions of 50 to 60% for the first element, and 40 to 50% for the first element. titanium.
- the preferred proportions are respectively 55% and 45% for nickel and titanium.
- the shape memory alloy may be provided with a coating consisting of one or more fully biocompatible materials in the form of superposed, homogeneous or heterogeneous layers depending on the desired properties of the immobilization and bone synthesis element.
- the materials used for coating the immobilization device and bone synthesis memory alloy shape are chosen for their biocompatibility, stability, low or no toxicity in the human body.
- the preferred coatings are titanium, nickel carbide, titanium carbide, titanium nitride, aluminum oxide, molybdenum disulfide, nickel carbonitride, nickel ternary, titanium and aluminum, chromium nitride, diamond carbon, gold, silver, platinum, hydroxyapatite, ceramic and zirconia.
- the device for immobilization and bone synthesis may consist of a single layer of coating, consisting of one of the previously mentioned materials. It can also be provided with two or more layers of the same material or different materials, these layers being superimposed.
- the proportions of nickel and titanium may vary depending on the application of the immobilizing element and bone synthesis, whose malleability properties are a function of the quantity of these elements, as well as the type of coating chosen, and the number of superimposed layers, as well as their homogeneity or heterogeneity.
- the bone immobilization and synthesis device has an initial form allowing its storage when not in use and which will allow its positioning on the discontinuous bone fragments that are to be repaired. It is arranged so that the main axis 1 covers all bone fragments that must be consolidated.
- the bone immobilization and synthesis device is subjected to a precise temperature, which will give it its locking configuration, by deformation of the initial shape.
- the temperature for configuring the immobilization and bone synthesis element in the locked position is of the order of 20 to 35) ° C, or even 40 ° C, that is to say close to the ambient temperature or body. It is thus brought directly by the human body. No additional tools, such as scalpel, are necessary, which avoids the risk of injury, burns and necrosis of tissue around the fracture.
- the attachment element 2 of the bone immobilization and synthesis device then articulates around the bone fragments, so as to partially enclose them.
- the bone immobilization and synthesis device then plays its role of maintaining all the bone fragments together, via the main axis 1 which rests on the discontinuous bone, so as to bring the different bone fragments closer to join them.
- the main axis has a curvilinear shape
- the provision of a temperature of the order of 20 to 40 0 C allows its placement on both the bone fragments and around it in the same way as if the device had latching elements.
- the bone immobilization and synthesis device becomes hard, and no longer malleable, which will allow optimal retention of fractured bone fragments, with a view to their consolidation to ensure good continuity.
- a temperature below that of the body preferably close to room temperature, that is to say less than 20 0 C, but which may however vary from -5 at
- the bone memory alloy immobilization and synthesis device is applied to the bone memory alloy immobilization and synthesis device.
- the appropriate temperature can be obtained by means of physiological saline, by way of non-limiting example.
- the fastening element becomes malleable, then retracts and detaches from the bone. The surgeon can then extract the bone immobilization and synthesis device according to the invention using a clamp.
- immobilization device and bone synthesis is neither invasive nor aggressive for the bone, since it does not require the perforation of the bone for insertion.
- one or more attachment elements may be inserted into the bone to improve the maintenance of the immobilizer.
- the immobilization and bone synthesis device is made of a shape-memory alloy that can be provided with a coating, it is very well tolerated by the body because it does not release any residue of nickel or titanium, constituents of the alloy.
- the fact that the coating is completely biocompatible avoids the inconvenience of the presence of a foreign body in the body, with the risk of allergies or other that may result.
- the element of immobilization and bone synthesis according to the invention is intended to reduce all types of fractures of a bone having undergone a discontinuity.
- These bones may be the femur, tibia, humerus, fibula, radius, ulna, metatarsals, metacarpals, phalanges P1, P2 fingers as non-limiting examples.
- the dimensions of the immobilization element and bone synthesis will depend on the bone to be repaired. Thus, the longer the bone, the longer the main axis will be extended; in the same way, its width, its diameter, and its thickness can vary so as to be well inserted on the fragments of bone so as to bring them closer as possible.
- the dimensions of the arms can be more or less important so that, in its locking position, they marry the best shape of the bone, without being invasive to the surrounding muscles.
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Abstract
The invention relates to an immobilisation and bone synthesis device for supporting a bone having suffered from discontinuity and/or breakage and including one or more fragments after a fracture, and which is made of a shape memory alloy, characterised in that the device comprises a main shaft (1) arranged at the bone fragments for bone resumption therebetween, and at least one attachment element (2) surrounding the bone in a locking position resulting when said device is subjected to a temperature of 20 to 40°C, and retracting from the bone when the device is subjected to a temperature of -5 to 20°C.
Description
DISPOSITIF DE MAINTIEN ET DE SYNTHESE OSSEUSE D'UN OS FRACTURE REALISE EN UN ALLIAGE A MEMOIRE DE FORME DEVICE FOR MAINTAINING AND SYNTHETIC BONE OF A FRACTURE BONE MADE OF A MEMORY MEMORY ALLOY
La présente invention concerne un dispositif destiné à maintenir un os ayant subi une discontinuité, et/ou une rupture et se présentant sous la forme de deux ou plusieurs fragments, suite à une fracture, par immobilisation puis réalisation d'une synthèse osseuse.The present invention relates to a device for maintaining a bone having undergone a discontinuity, and / or a fracture and is in the form of two or more fragments, following a fracture, by immobilization then carrying out a bone synthesis.
Elle concerne plus particulièrement un dispositif d'immobilisation et de synthèse osseuse, se présentant particulièrement sous la forme d'une plaque agrafe, réalisé en un alliage à mémoire de forme, pouvant être muni d'une ou plusieurs couches de revêtement biocompatible, qui va pouvoir être positionné et maintenu sur les fragments d'un os fracturé, en utilisant une température proche de celle du corps, en vue de stabiliser la fracture en attente de sa consolidation, son retrait étant assuré par l'application d'une température proche de la température ambiante.It relates more particularly to a bone immobilization and synthesis device, particularly in the form of a staple plate, made of a shape memory alloy, which may be provided with one or more layers of biocompatible coating, which will can be positioned and maintained on the fragments of a fractured bone, using a temperature close to that of the body, to stabilize the fracture pending consolidation, its removal being ensured by the application of a temperature close to Room temperature.
Lors de la stabilisation et l'immobilisation interne de certains types de fractures, les divers dispositifs d'immobilisation doivent être fixés directement sur les fragments d'os facturés afin de les rapprocher et de les maintenir ensemble et d'en assurer une reconstitution anatomique, en vue de leur consolidation. Cette fixation est généralement réalisée au moyen de vis ou autre élément de fixation, qui nécessitent la perforation de l'os, préalablement à leur mise en place, afin d'assurer un maintien optimal des fragments.During the stabilization and internal immobilization of certain types of fractures, the various immobilization devices must be fixed directly on the invoiced bone fragments in order to bring them together and to hold them together and to ensure anatomical reconstitution, for consolidation. This attachment is generally performed by means of screws or other fastener, which require the perforation of the bone, prior to their introduction, to ensure optimal retention of the fragments.
Divers dispositifs permettant de maintenir ensemble les deux parties d'un os fracturé afin de le réparer ont déjà été décrits dans l'art antérieur. Ainsi, le document WO 97/13469 décrit un dispositif de connexion de deux zones d'os, constitué d'une plaque ayant des orifices d'insertion de vis. Ce dispositif est réalisé en un alliage à mémoire de forme de manière à s'adapter à la morphologie de l'os.Various devices for holding together the two parts of a fractured bone to repair it have already been described in the prior art. Thus, WO 97/13469 discloses a device for connecting two bone areas, consisting of a plate having screw insertion holes. This device is made of a shape memory alloy so as to adapt to the morphology of the bone.
Le document WO 02/083014 décrit un système d'attache de deux fragments d'os séparés par une fracture, qui est constitué d'une vis munie de deux perforateurs hélicoïdaux. Ces derniers s'insèrent dans chacun des deux fragments d'os de manière à les rapprocher en vue de leur jointure et réduire ainsi la fracture.
Le document WO 01/60269 décrit un dispositif de fixation pour un os ayant subi une fracture, réalisé en un alliage à mémoire de forme. Ce dispositif se présente sous la forme d'un clamp en forme de « C », qui ne nécessite pas la perforation de l'os pour sa mise en place. Le document FR 2 694 696 décrit une agrafe réalisée en un alliage à mémoire de forme. Elle se présente sous la forme d'une traverse de forme ondulée sur laquelle sont disposés deux bras perpendiculaires. Ces derniers sont insérés dans l'os, de part et d'autre de la fracture. La déformation de la traverse va permettre un de rapprocher des deux fragments d'os en vue de leur réparation.WO 02/083014 discloses a system for attaching two bone fragments separated by a fracture, which consists of a screw provided with two helical perforators. The latter fit into each of the two bone fragments so as to bring them together for their joint and thus reduce the fracture. WO 01/60269 discloses a fixation device for fractured bone made of a shape memory alloy. This device is in the form of a clamp in the shape of "C", which does not require the perforation of the bone for its implementation. FR 2,694,696 discloses a clip made of a shape memory alloy. It is in the form of a cross-shaped wave on which are arranged two perpendicular arms. These are inserted into the bone, on both sides of the fracture. The deformation of the crosspiece will allow a closer to two bone fragments for repair.
Même s'ils permettent de réduire efficacement les fractures, ces dispositifs présentent l'inconvénient majeur d'être fortement invasifs et douloureux, puisqu'ils nécessitent la perforation préalable de l'os, afin d'y insérer les vis indispensables à leur maintien. Par ailleurs, la présence des têtes de vis à la surface de l'os entraîne souvent un recouvrement par le cal osseux, ce qui complique fortement le retrait du dispositif d'immobilisation, et peut ainsi compliquer le processus de cicatrisation et de réparation de l'os fracturé.Although they can effectively reduce fractures, these devices have the major disadvantage of being highly invasive and painful, since they require the prior perforation of the bone, in order to insert the screws essential for their maintenance. Moreover, the presence of the screw heads on the surface of the bone often leads to recovery by bone callus, which greatly complicates the removal of the immobilizer, and can thus complicate the process of healing and repair of the bone. fractured bone.
Le risque dû à la présence de vis est la cassure de ces dernières dans l'os, ce qui oblige le chirurgien à effectuer une seconde opération afin de réduire l'os et récupérer la vis cassée par creusement autour de la vis, ce qui constitue un désagrément non négligeable pour le patient, et peut créer une zone de fragilité osseuse durant le comblement de l'os, c'est-à-dire pendant un à deux mois. La présente invention entend remédier à ces divers inconvénients de l'art antérieur en proposant un dispositif d'immobilisation et de synthèse osseuse, en particulier une plaque agrafe, destiné à réduire efficacement les fractures, tout en ne nécessitant pas une perforation préalable de l'os, dans la mesure où aucune vis ou autre élément rapporté n'est indispensable pour le maintien de ce dispositif sur l'osThe risk due to the presence of screws is the breaking of the screws in the bone, which forces the surgeon to perform a second operation to reduce the bone and recover the broken screw by digging around the screw, which is a significant inconvenience for the patient, and can create an area of bone fragility during the filling of the bone, that is to say for one to two months. The present invention intends to remedy these various disadvantages of the prior art by proposing a device for immobilization and bone synthesis, in particular a staple plate, intended to reduce fractures effectively, while not requiring prior perforation of the bone. bones, as no screws or other inserts are necessary to maintain this device on the bone
A cet effet, la présente invention a pour objet un dispositif d'immobilisation et de synthèse osseuse pour maintenir un os ayant subi une discontinuité et/ou une rupture et présentant un ou plusieurs fragments suite à une fracture, réalisé
en un alliage à mémoire de forme, caractérisé en ce qu'il est constitué d'un axe principal disposé au niveau des fragments d'os à souder et à fixer entre eux, et d'au moins un élément d'accrochage comportant au moins une paire de bras disposés sensiblement dans un plan perpendiculaire à l'axe principal, entourant l'os en position de verrouillage obtenue automatiquement par la chaleur du corps quand ledit dispositif est soumis à une température comprise entre 25 et 40 °C, et se rétractant de l'os quand ledit dispositif est soumis à une température comprise entre -5 et 2O0C,For this purpose, the subject of the present invention is an immobilization and bone synthesis device for maintaining a bone having undergone a discontinuity and / or rupture and having one or more fragments following a fracture, carried out in a shape memory alloy, characterized in that it consists of a main axis disposed at the bone fragments to be welded and fixed together, and at least one fastening element comprising at least a pair of arms disposed substantially in a plane perpendicular to the main axis, surrounding the bone in the locked position automatically obtained by the heat of the body when said device is subjected to a temperature between 25 and 40 ° C, and retracting bone when said device is subjected to a temperature between -5 and 20 ° C,
On comprendra mieux l'invention en référence aux dessins annexés sur lesquels : la figure 1 est une représentation d'une plaque agrafe selon un premier exemple ; la figure 2 représente un second exemple de réalisation de la plaque agrafe selon l'invention ; - la figure 3 est une représentation d'une plaque agrafe selon un troisième exemple de réalisation ; la figure 4 est un quatrième exemple de réalisation de la plaque agrafe selon l'invention ; la figure 5 est une représentation d'une seconde variante de réalisation d'une plaque agrafe.The invention will be better understood with reference to the accompanying drawings, in which: FIG. 1 is a representation of a staple plate according to a first example; FIG. 2 represents a second embodiment of the staple plate according to the invention; - Figure 3 is a representation of a staple plate according to a third embodiment; Figure 4 is a fourth embodiment of the staple plate according to the invention; Figure 5 is a representation of a second embodiment of a staple plate.
Le dispositif d'immobilisation et de synthèse osseuse se présente préférentiellement sous la forme d'une plaque agrafe, ayant un axe principal 1 , disposé sur les fragments d'os à souder ou à réparer. La longueur ainsi que la largeur de l'axe principal 1 seront fonction des dimensions de l'os, mais aussi du nombre de fragments d'os que l'on souhaite souder, ainsi que du type de fracture ou de réparation souhaitées.The bone immobilization and synthesis device is preferably in the form of a staple plate having a main axis 1 disposed on the bone fragments to be welded or repaired. The length as well as the width of the main axis 1 will be a function of the dimensions of the bone, but also of the number of bone fragments that it is desired to weld, as well as of the type of fracture or repair desired.
L'axe principal 1 du dispositif d'immobilisation et de synthèse osseuse est muni d'au moins un élément d'accrochage 2, permettant le maintien du dispositif d'immobilisation et de synthèse osseuse sur les fragments d'os à souder entre eux.The main axis 1 of the immobilization device and bone synthesis is provided with at least one attachment element 2, allowing the maintenance of the bone immobilization and synthesis device on the bone fragments to be welded together.
L'élément d'accrochage 2 se présente préférentiellement sous la forme d'une paire de bras 2a, disposée sensiblement dans un plan perpendiculaire par rapport à l'axe principal 1.
Selon une variante préférée de réalisation du dispositif d'immobilisation, les bras 2a sont disposés par paire, de part et d'autre de l'axe principal 1 , de manière à augmenter leur rigidité et favoriser le maintien du dispositif d'immobilisation, comme on peut le voir sur les figures 1 à 4. Le nombre de bras 2a sera fonction de la longueur et du diamètre de l'os à réparer, ainsi que du type de maintien souhaité.The attachment element 2 is preferably in the form of a pair of arms 2a disposed substantially in a plane perpendicular to the main axis 1. According to a preferred embodiment of the immobilizer, the arms 2a are arranged in pairs, on either side of the main axis 1, so as to increase their rigidity and promote the retention of the immobilizer, as it can be seen in Figures 1 to 4. The number of arms 2a will depend on the length and diameter of the bone to be repaired, as well as the desired type of maintenance.
La longueur des bras 2a peut être identique, tel que représenté sur la figure 3, ou peut varier (figures 1 , 2 et 4).The length of the arms 2a may be the same, as shown in Figure 3, or may vary (Figures 1, 2 and 4).
Le nombre de bras 2a de part et d'autre de l'axe principal 1 peut être hétérogène, c'est-à-dire qu'un des côtés de l'axe principal comporte plus de bras 2a que l'autre (variante non représentée).The number of arms 2a on either side of the main axis 1 may be heterogeneous, that is to say that one side of the main axis has more arms 2a than the other (variant no shown).
Les bras 2a peuvent également être décalés les uns par rapport aux autres, selon la morphologie de l'os fracturé, ce qui favorise ainsi le maintien de l'élément d'immobilisation et de synthèse osseuse. Les dimensions, le nombre et le positionnement des bras 2a seront fonction du type d'os à réparer ainsi que de ses dimensions, du type de fracture, et du type de maintien souhaité.The arms 2a can also be offset relative to each other, according to the morphology of the fractured bone, which thus promotes the maintenance of the immobilization element and bone synthesis. The dimensions, the number and the positioning of the arms 2a will depend on the type of bone to be repaired as well as its dimensions, the type of fracture, and the type of support desired.
L'élément d'accrochage 2 peut également être disposé dans la continuité de l'axe principal 1 (variante non représentée). Selon une autre variante de réalisation du dispositif d'immobilisation et de synthèse osseuse, représentée sur la figure 5, l'élément d'accrochage 2 présente une forme en arc de cercle 2b, ce qui a pour effet d'assurer un meilleur rapprochement osseux.The attachment element 2 may also be arranged in the continuity of the main axis 1 (variant not shown). According to another variant embodiment of the bone immobilization and synthesis device, represented in FIG. 5, the attachment element 2 has a shape in a circular arc 2b, which has the effect of ensuring a better bone approximation. .
Selon une troisième variante de réalisation (non représentée), l'axe principal 1 présente une forme curviligne, telle qu'une forme en « S », dont les éléments d'accrochage font partie intégrante de l'axe 1.According to a third variant embodiment (not shown), the main axis 1 has a curvilinear shape, such as an "S" shape, the attachment elements of which form an integral part of the axis 1.
L'axe principal peut être préalablement cintré avant sa mise en place sur l'os. Le cintrage de l'axe principal du dispositif de maintien est réalisé à la température ambiante à l'aide d'une cintreuse, ce qui permet au chirurgien de disposer d'une plaque épousant la forme de l'os. En cas de besoin, le chirurgien peut légèrement redresser la plaque par un chauffage du dispositif de maintien à une température supérieure ou égale à 5O0C. Ce traitement thermique permet de ramener l'axe principal dans sa position initiale. La mise en place du dispositif de
maintien est réalisée par blocage des bras autour de l'os, permis par l'application d'une température de l'ordre de 40 0C, au niveau des bras uniquement. Ceci permet ainsi à l'axe principal de garder sa forme cintrée, particulièrement adaptée à la forme de l'os. Le dispositif d'immobilisation et de synthèse osseuse selon l'invention est réalisé en un alliage à mémoire de forme. Il présente ainsi la particularité de pouvoir être mis en place au moyen de l'application d'une température comprise entre 25 et 400C1 préférentiellement 4O0C, c'est-à-dire proche de la température corporelle. Cette température peut être obtenue au moyen d'une source de chaleur ou naturellement, c'est-à-dire la température du corps humain. L'application de cette température va conférer au dispositif d'immobilisation sa forme de verrouillage. Dans la forme de verrouillage, l'axe principal présente la forme déterminée dans laquelle il a été façonné à l'aide de la cintreuse à température ambiante Le retrait du dispositif d'immobilisation et de synthèse osseuse est effectué par l'application d'une température inférieure à 200C, plus particulièrement de l'ordre de -5 à 20°C. A cette température le dispositif devient malléable et peut être déformé pour faciliter son retrait ou son insertion sur un os.The main axis can be bent before it is placed on the bone. Bending of the main axis of the holding device is carried out at room temperature using a bender, which allows the surgeon to have a plate matching the shape of the bone. If necessary, the surgeon can slightly straighten the plate by heating the holding device at a temperature greater than or equal to 50 ° C. This heat treatment makes it possible to bring the main axis back to its initial position. The setting up of the maintenance is achieved by blocking the arms around the bone, enabled by the application of a temperature of the order of 40 0 C, at the arms only. This allows the main axis to keep its curved shape, particularly adapted to the shape of the bone. The device for immobilization and bone synthesis according to the invention is made of a shape memory alloy. It thus has the characteristic of being set up by means of the application of a temperature between 25 and 40 0 C 1 preferably 4O 0 C, that is to say close to body temperature. This temperature can be obtained by means of a source of heat or naturally, that is to say the temperature of the human body. The application of this temperature will give the locking device its locking form. In the locking form, the main axis has the determined shape in which it has been shaped using the bender at room temperature. The removal of the bone immobilization and synthesis device is effected by the application of a temperature below 20 0 C, more particularly of the order of -5 to 20 ° C. At this temperature the device becomes malleable and can be deformed to facilitate its removal or insertion on a bone.
L'alliage à mémoire de forme constitutif du dispositif d'immobilisation et de synthèse osseuse selon l'invention est constitué de nickel et de titane, dans des proportions respectives de 50 à 60% pour le premier élément, et 40 à 50% pour le titane. Les proportions préférées sont respectivement de 55% et 45% pour le nickel et le titane.The shape-memory alloy constituting the bone immobilization and synthesis device according to the invention consists of nickel and titanium, in respective proportions of 50 to 60% for the first element, and 40 to 50% for the first element. titanium. The preferred proportions are respectively 55% and 45% for nickel and titanium.
L'alliage à mémoire de forme peut être muni d'un revêtement constitué d'un ou plusieurs matériaux totalement biocompatibles sous forme de couches superposées, homogènes ou hétérogènes en fonction des propriétés souhaitées de l'élément d'immobilisation et de synthèse osseuse.The shape memory alloy may be provided with a coating consisting of one or more fully biocompatible materials in the form of superposed, homogeneous or heterogeneous layers depending on the desired properties of the immobilization and bone synthesis element.
Les matériaux utilisés pour le revêtement du dispositif d'immobilisation et de synthèse osseuse en alliage à mémoire de forme sont choisis pour leur biocompatibilité, leur stabilité, leur faible voire non toxicité dans l'organisme humain.The materials used for coating the immobilization device and bone synthesis memory alloy shape are chosen for their biocompatibility, stability, low or no toxicity in the human body.
Les revêtements préférés sont le titane, le carbure de nickel, le carbure de titane, le nitrure de titane, l'oxyde d'aluminium, le bisulfure de molybdène, le
carbonitrure de nickel, le ternaire de nickel, titane et aluminium, le nitrure de chrome, le carbone diamant, l'or, l'argent, le platine, l'hydroxyapatite, la céramique et le zircone.The preferred coatings are titanium, nickel carbide, titanium carbide, titanium nitride, aluminum oxide, molybdenum disulfide, nickel carbonitride, nickel ternary, titanium and aluminum, chromium nitride, diamond carbon, gold, silver, platinum, hydroxyapatite, ceramic and zirconia.
Le dispositif d'immobilisation et de synthèse osseuse peut être constitué d'une seule couche de revêtement, constituée d'un des matériaux précédemment mentionnés. Il peut également être muni de deux couches ou plus du même matériau ou de différents matériaux, ces couches étant superposées.The device for immobilization and bone synthesis may consist of a single layer of coating, consisting of one of the previously mentioned materials. It can also be provided with two or more layers of the same material or different materials, these layers being superimposed.
Les proportions de nickel et de titane peuvent varier en fonction de l'application de l'élément d'immobilisation et de synthèse osseuse, dont les propriétés de malléabilité sont fonction de la quantité de ces éléments, ainsi que du type de revêtement choisi, et du nombre de couches superposées, ainsi que de leur homogénéité ou hétérogénéité.The proportions of nickel and titanium may vary depending on the application of the immobilizing element and bone synthesis, whose malleability properties are a function of the quantity of these elements, as well as the type of coating chosen, and the number of superimposed layers, as well as their homogeneity or heterogeneity.
Le dispositif d'immobilisation et de synthèse osseuse présente une forme initiale permettant son stockage lorsqu'il n'est pas utilisé et qui va permettre son positionnement sur les fragments d'os discontinus que l'on souhaite réparer. Il est disposé de manière à ce que l'axe principal 1 recouvre tous les fragments d'os qui doivent être consolidés.The bone immobilization and synthesis device has an initial form allowing its storage when not in use and which will allow its positioning on the discontinuous bone fragments that are to be repaired. It is arranged so that the main axis 1 covers all bone fragments that must be consolidated.
Pour sa mise en place, le dispositif d'immobilisation et de synthèse osseuse est soumis à une température précise, qui va lui conférer sa configuration de verrouillage, par déformation de la forme initiale.For its implementation, the bone immobilization and synthesis device is subjected to a precise temperature, which will give it its locking configuration, by deformation of the initial shape.
La température permettant de configurer l'élément d'immobilisation et de synthèse osseuse en position de verrouillage est de l'ordre de 20 à 35)° C, voire 40°C, c'est-à-dire proche de la température ambiante ou corporelle. Elle est ainsi apportée directement par le corps humain. Aucun outillage supplémentaire, du type bistouri, n'est nécessaire, ce qui évite ainsi les risques de blessures, brûlures et nécroses des tissus alentours de la fracture.The temperature for configuring the immobilization and bone synthesis element in the locked position is of the order of 20 to 35) ° C, or even 40 ° C, that is to say close to the ambient temperature or body. It is thus brought directly by the human body. No additional tools, such as scalpel, are necessary, which avoids the risk of injury, burns and necrosis of tissue around the fracture.
L'élément d'accrochage 2 du dispositif d'immobilisation et de synthèse osseuse s'articule alors autour des fragments d'os, de manière à les enserrer partiellement. Le dispositif d'immobilisation et de synthèse osseuse joue alors son rôle de maintien de l'ensemble des fragments d'os entre eux, par l'intermédiaire de l'axe principal 1 qui s'appuie sur l'os discontinu, de manière à rapprocher les différents fragments d'os en vue de leur jointure.
Dans le cas où l'axe principal a une forme curviligne, l'apport d'une température de l'ordre de 20 à 400C permet sa mise en place à la fois sur les fragments d'os et autour de celui-ci, de la même manière que si le dispositif présentait des éléments d'accrochage. Une fois mis en place et verrouillé, le dispositif d'immobilisation et de synthèse osseuse devient dur, et non plus malléable, ce qui va permettre un maintien optimal des fragments d'os fracturés, en vue de leur consolidation afin de leur assurer une bonne continuité.The attachment element 2 of the bone immobilization and synthesis device then articulates around the bone fragments, so as to partially enclose them. The bone immobilization and synthesis device then plays its role of maintaining all the bone fragments together, via the main axis 1 which rests on the discontinuous bone, so as to bring the different bone fragments closer to join them. In the case where the main axis has a curvilinear shape, the provision of a temperature of the order of 20 to 40 0 C allows its placement on both the bone fragments and around it in the same way as if the device had latching elements. Once set up and locked, the bone immobilization and synthesis device becomes hard, and no longer malleable, which will allow optimal retention of fractured bone fragments, with a view to their consolidation to ensure good continuity.
Lors du retrait du dispositif d'immobilisation et de synthèse osseuse, une température inférieure à celle du corps, de préférence proche de la température ambiante, c'est-à-dire inférieure à 200C, mais qui peut cependant varier de -5 àWhen removing the immobilization and bone synthesis device, a temperature below that of the body, preferably close to room temperature, that is to say less than 20 0 C, but which may however vary from -5 at
2O0C, de préférence de 0 à 200C, est appliquée sur le dispositif d'immobilisation et de synthèse osseuse en alliage à mémoire de forme. La température adéquate peut être obtenue au moyen de sérum physiologique, à titre d'exemple non limitatif. L'élément d'accrochage devient malléable, se rétracte alors et se détache de l'os. Le chirurgien peut alors extraire le dispositif d'immobilisation et de synthèse osseuse selon l'invention à l'aide d'une pince.20 ° C., preferably from 0 ° to 20 ° C., is applied to the bone memory alloy immobilization and synthesis device. The appropriate temperature can be obtained by means of physiological saline, by way of non-limiting example. The fastening element becomes malleable, then retracts and detaches from the bone. The surgeon can then extract the bone immobilization and synthesis device according to the invention using a clamp.
La mise en place du dispositif d'immobilisation et de synthèse osseuse selon l'invention n'est ni invasive ni agressive pour l'os, puisqu'elle ne nécessite pas la perforation de l'os pour son insertion.The establishment of immobilization device and bone synthesis according to the invention is neither invasive nor aggressive for the bone, since it does not require the perforation of the bone for insertion.
De ce fait, l'importance de l'exposition osseuse est réduite, le temps et la difficulté d'intervention sont plus courts donc le risque infectieux est diminué, représentant ainsi un confort important pour le patient.As a result, the importance of the bone exposure is reduced, the time and the difficulty of intervention are shorter so the risk of infection is reduced, thus representing an important comfort for the patient.
Cependant, dans certains cas de fracture, un ou plusieurs éléments d'accrochage pourront être insérés dans l'os afin d'améliorer le maintien du dispositif d'immobilisation.However, in some cases of fracture, one or more attachment elements may be inserted into the bone to improve the maintenance of the immobilizer.
De plus, comme le dispositif d'immobilisation et de synthèse osseuse est réalisé en un alliage à mémoire de forme pouvant être muni d'un revêtement, il est très bien toléré par l'organisme, car il ne relargue aucun résidu de nickel ou de titane, constitutifs de l'alliage. Le fait que le revêtement soit totalement biocompatible évite les désagréments de la présence d'un corps étranger dans l'organisme, avec les risques d'allergies ou autres que cela peut entraîner.
L'élément d'immobilisation et de synthèse osseuse selon l'invention est destiné à réduire tous types de fractures d'un os ayant subi une discontinuité.In addition, since the immobilization and bone synthesis device is made of a shape-memory alloy that can be provided with a coating, it is very well tolerated by the body because it does not release any residue of nickel or titanium, constituents of the alloy. The fact that the coating is completely biocompatible avoids the inconvenience of the presence of a foreign body in the body, with the risk of allergies or other that may result. The element of immobilization and bone synthesis according to the invention is intended to reduce all types of fractures of a bone having undergone a discontinuity.
Ces os peuvent être le fémur, le tibia, l'humérus, le péroné, le radius, le cubitus, les métatarsiens, les métacarpiens, les phalanges P1 , P2 des doigts à titre d'exemples non limitatifs.These bones may be the femur, tibia, humerus, fibula, radius, ulna, metatarsals, metacarpals, phalanges P1, P2 fingers as non-limiting examples.
Les dimensions de l'élément d'immobilisation et de synthèse osseuse seront fonction de l'os à réparer. Ainsi plus l'os sera long, plus l'axe principal sera allongé ; de la même manière, sa largeur, son diamètre, et son épaisseur peuvent varier de manière à bien s'insérer sur les fragments d'os de manière à les rapprocher le plus possible. Les dimensions des bras peuvent être plus ou moins importantes de manière à ce que, lors de sa position de verrouillage, ils épousent au mieux la forme de l'os, sans être invasifs pour les muscles alentours.The dimensions of the immobilization element and bone synthesis will depend on the bone to be repaired. Thus, the longer the bone, the longer the main axis will be extended; in the same way, its width, its diameter, and its thickness can vary so as to be well inserted on the fragments of bone so as to bring them closer as possible. The dimensions of the arms can be more or less important so that, in its locking position, they marry the best shape of the bone, without being invasive to the surrounding muscles.
De plus, le fait de soumettre l'élément d'immobilisation et de synthèse osseuse à des températures non agressives, c'est-à-dire aux alentours de 20 àIn addition, subjecting the immobilization and bone synthesis element to non-aggressive temperatures, that is to say around 20 to
4O0C pour son verrouillage et de -5 à 2O0C pour son retrait, n'impose pas à l'organisme de choc thermique, et ne risque pas d'endommager les tissus environnants.
40 ° C for its locking and -5 to 20 ° C for removal, does not impose the body heat shock, and does not risk damaging the surrounding tissue.
Claims
1. Dispositif d'immobilisation et de synthèse osseuse pour maintenir un os ayant subi une discontinuité et/ou une rupture et présentant un ou plusieurs fragments suite à une fracture, réalisé en un alliage à mémoire de forme, caractérisé en ce qu'il est constitué d'un axe principal (1) disposé au niveau des fragments d'os à souder et à fixer entre eux, et d'au moins un élément d'accrochage (2) comportant au moins une paire de bras (2a) disposés sensiblement dans un plan perpendiculaire à l'axe principal (1) de part et d'autre de l'axe principal (1), entourant l'os en position de verrouillage obtenue quand ledit dispositif est soumis à une température comprise entre 20 et 350C, et se rétractant de l'os quand ledit dispositif est soumis à une température comprise entre 0 et 2O0C.A bone immobilization and synthesis device for maintaining a bone having undergone a discontinuity and / or rupture and having one or more fragments following a fracture, made of a shape-memory alloy, characterized in that it is consisting of a main axis (1) disposed at the level of the bone fragments to be welded and fixed together, and at least one attachment element (2) comprising at least one pair of arms (2a) arranged substantially in a plane perpendicular to the main axis (1) on either side of the main axis (1), surrounding the bone in the locked position obtained when said device is subjected to a temperature of between 20 and 35 ° C. C, and retracting from the bone when said device is subjected to a temperature of between 0 and 20 ° C.
2. Dispositif d'immobilisation et de synthèse osseuse selon la revendication 1 , caractérisé en ce que l'axe principal est déformable par cintrage à température ambiante et à l'aide d'une cintreuse, de sorte à obtenir une forme plus proche de celle de l'os, et est redressé dans sa position initiale par chauffage à une température supérieure ou égale à 500C.2. Device for immobilization and bone synthesis according to claim 1, characterized in that the main axis is deformable by bending at room temperature and using a bender, so as to obtain a form closer to that of the bone, and is straightened in its initial position by heating at a temperature greater than or equal to 50 ° C.
3. Dispositif d'immobilisation et de synthèse osseuse selon la revendication 1 ou 2, caractérisé en ce que les bras (2a) sont distribués de manière hétérogène de part et d'autre de l'axe principal 1.3. Device for immobilization and bone synthesis according to claim 1 or 2, characterized in that the arms (2a) are distributed in a heterogeneous manner on either side of the main axis 1.
4. Dispositif d'immobilisation et de synthèse osseuse selon l'une des revendications 1 à 3, caractérisé en que les bras (2a) disposés de part et d'autre de l'axe principal 1 sont décalés les uns par rapport aux autres.4. Device for immobilization and bone synthesis according to one of claims 1 to 3, characterized in that the arms (2a) disposed on either side of the main axis 1 are offset with respect to each other.
5. Dispositif d'immobilisation et de synthèse osseuse selon l'une des revendications précédentes, caractérisé en ce que la longueur des bras 2a est hétérogène.5. Device for immobilization and bone synthesis according to one of the preceding claims, characterized in that the length of the arms 2a is heterogeneous.
6. Dispositif d'immobilisation et de synthèse osseuse selon la revendication 1 , caractérisé en ce que l'élément d'accrochage (2) est disposé dans la continuité de l'axe principal 1.6. Device for immobilization and bone synthesis according to claim 1, characterized in that the hooking element (2) is arranged in the continuity of the main axis 1.
7. Dispositif d'immobilisation et de synthèse osseuse selon la revendication 1 , caractérisé en ce que l'axe principal (1) a une forme curviligne intégrant l'élément d'accrochage (2). 7. Device for immobilization and bone synthesis according to claim 1, characterized in that the main axis (1) has a curvilinear shape incorporating the fastening element (2).
8. Dispositif d'immobilisation et de synthèse osseuse selon la revendication 1 , caractérisé en ce que l'élément d'accrochage (2) présente une forme arrondie.8. Device for immobilization and bone synthesis according to claim 1, characterized in that the fastening element (2) has a rounded shape.
9. Dispositif d'immobilisation et de synthèse osseuse selon l'une des revendications précédentes, caractérisé en ce que l'alliage à mémoire de forme qui le constitue est réalisé avec 50 à 60% de nickel, et 40 à 50% de titane, préférentiellement respectivement 55% et 45%, ledit alliage étant en outre muni d'un revêtement constitué d'un ou plusieurs matériaux totalement biocompatibles sous forme de couches superposées homogènes ou hétérogènes.9. Device for immobilization and bone synthesis according to one of the preceding claims, characterized in that the shape memory alloy which constitutes it is made with 50 to 60% nickel, and 40 to 50% titanium, preferably 55% and 45% respectively, said alloy being further provided with a coating consisting of one or more completely biocompatible materials in the form of homogeneous or heterogeneous superposed layers.
10. Dispositif d'immobilisation et de synthèse osseuse selon la revendication précédente, caractérisé en ce que le revêtement constitutif de l'alliage à mémoire de forme est choisi parmi les matériaux suivants :10. Device for immobilization and bone synthesis according to the preceding claim, characterized in that the constituent coating of the shape memory alloy is selected from the following materials:
- titane,- titanium,
- carbure de nickel,- nickel carbide,
- carbure de titane,- titanium carbide,
- nitrure de titane,- titanium nitride,
- oxyde d'aluminium,- aluminum oxide,
- bisulfure de molybdène,- molybdenum disulfide,
- carbonitrure de nickel,- nickel carbonitride,
- ternaire de nickel, titane et aluminium,- ternary nickel, titanium and aluminum,
- nitrure de chrome,- chromium nitride,
- carbone diamant, - or,- diamond carbon, - gold,
- argent,- money,
- platine,- platinum,
- hydroxyapatite,hydroxyapatite,
- zircone,- zirconia,
- céramique.- ceramic.
11. Dispositif d'immobilisation et de synthèse osseuse selon la revendication précédente, caractérisé en ce que la première couche du revêtement est du titane ou un de ses alliages. 11. Device for immobilization and bone synthesis according to the preceding claim, characterized in that the first layer of the coating is titanium or one of its alloys.
12. Dispositif d'immobilisation et de synthèse osseuse selon l'une des revendications précédentes, dans lequel la position de verrouillage est obtenue quand ledit dispositif est soumis à une température comprise entre 20 et 400C, et le dispositif se rétractant de l'os quand ledit dispositif est soumis à une température comprise entre -5 et 2O0C.12. Device for immobilization and bone synthesis according to one of the preceding claims, wherein the locking position is obtained when said device is subjected to a temperature between 20 and 40 0 C, and the device retracting the os when said device is subjected to a temperature of between -5 and 20 ° C.
13. Dispositif d'immobilisation et de synthèse osseuse selon l'une des revendications précédentes, caractérisé en ce qu'il présente une forme initiale, permettant son stockage lorsqu'il se trouve à une température inférieure à celle du corps. 13. Device for immobilization and bone synthesis according to one of the preceding claims, characterized in that it has an initial shape, allowing its storage when it is at a temperature below that of the body.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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FR0807151 | 2008-12-19 | ||
FR0807151A FR2940042A1 (en) | 2008-12-19 | 2008-12-19 | DEVICE FOR MAINTAINING AND SYNTHETIC BONE OF A FRACTURE BONE MADE OF A MEMORY MEMORY ALLOY |
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WO2010076427A1 true WO2010076427A1 (en) | 2010-07-08 |
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ID=40918571
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PCT/FR2009/001447 WO2010076427A1 (en) | 2008-12-19 | 2009-12-18 | Holding and bone synthesis device for a broken bone, made of a shape memory alloy |
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WO (1) | WO2010076427A1 (en) |
Cited By (1)
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CN107174323A (en) * | 2017-05-09 | 2017-09-19 | 兰州西脉记忆合金股份有限公司 | A kind of memory alloy wire twin beams contains two pairs of sternum fixers for encircling arm |
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WO1997013469A1 (en) | 1994-04-07 | 1997-04-17 | Anson Medical Limited | Connection device e.g. for bone parts |
WO2001060269A1 (en) | 2000-02-16 | 2001-08-23 | Shinhan Metals Co., Ltd. | Device for the fixation of broken bones |
WO2002083014A1 (en) | 2001-04-16 | 2002-10-24 | The Cleveland Clinic Foundation | Apparatus for attaching fractured sections of bone |
US6969391B1 (en) * | 1999-04-21 | 2005-11-29 | Romolo Igino Gazzani | Semi-rigid compressive clamp for use in sternotomy, and forceps for its application |
WO2008022261A2 (en) * | 2006-08-18 | 2008-02-21 | Intelifuse, Inc. | Shape-transforming implant device |
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2008
- 2008-12-19 FR FR0807151A patent/FR2940042A1/en active Pending
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FR2694696A1 (en) | 1992-08-14 | 1994-02-18 | Memometal Ind | Shape-memory alloy clip for bone fractures - is made from nickel@-titanium@ alloy, and is in form of staple with two branches having contact zones and connection piece |
WO1997013469A1 (en) | 1994-04-07 | 1997-04-17 | Anson Medical Limited | Connection device e.g. for bone parts |
US6969391B1 (en) * | 1999-04-21 | 2005-11-29 | Romolo Igino Gazzani | Semi-rigid compressive clamp for use in sternotomy, and forceps for its application |
WO2001060269A1 (en) | 2000-02-16 | 2001-08-23 | Shinhan Metals Co., Ltd. | Device for the fixation of broken bones |
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CN107174323A (en) * | 2017-05-09 | 2017-09-19 | 兰州西脉记忆合金股份有限公司 | A kind of memory alloy wire twin beams contains two pairs of sternum fixers for encircling arm |
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