WO2018024617A1 - Deployable implant - Google Patents

Deployable implant Download PDF

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Publication number
WO2018024617A1
WO2018024617A1 PCT/EP2017/069096 EP2017069096W WO2018024617A1 WO 2018024617 A1 WO2018024617 A1 WO 2018024617A1 EP 2017069096 W EP2017069096 W EP 2017069096W WO 2018024617 A1 WO2018024617 A1 WO 2018024617A1
Authority
WO
WIPO (PCT)
Prior art keywords
rod
anchoring means
implant
male element
cavity
Prior art date
Application number
PCT/EP2017/069096
Other languages
French (fr)
Inventor
David François FISCHER LOKOU
Original Assignee
Spine Arch Brevet
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.)
Filing date
Publication date
Application filed by Spine Arch Brevet filed Critical Spine Arch Brevet
Publication of WO2018024617A1 publication Critical patent/WO2018024617A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/88Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8875Screwdrivers, spanners or wrenches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/844Fasteners therefor or fasteners being internal fixation devices with expandable anchors or anchors having movable parts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • A61B17/864Pins or screws or threaded wires; nuts therefor hollow, e.g. with socket or cannulated
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86Pins or screws or threaded wires; nuts therefor
    • A61B17/8685Pins or screws or threaded wires; nuts therefor comprising multiple separate parts

Definitions

  • the present invention relates to a novel implant for medical use for fixing at least two adjacent bone elements quickly, reliably and minimally invasive.
  • the present invention also describes a method of attaching at least two adjacent bone elements implementing this new implant. This method is particularly suitable for the joining of at least two vertebrae for performing arthrodesis; said implant being of curved shape which makes it particularly suitable for spine surgery.
  • bone problems generate or are part of the clinical picture of many pathologies.
  • trauma associated with accidents, shocks and falls may also cause bone problems requiring surgery.
  • the possibility of fixing bone elements together in order to stabilize or correct a given position is therefore an important medical issue. Indeed, in the field of spine surgery in particular the fact of being able to join bone elements in order to stabilize given areas and / or to release compressed nerve bundles is often the only way to relieve patients.
  • the techniques used to date have several drawbacks, including the complexity of the devices to be implanted, the transepicular approach for the fixation screws of these devices which is relatively invasive and generates side effects (hemorrhages, nerve damage, etc.). the need for follow-up involving imaging techniques performance, ie all of the risk factors, technical factors and costs that must be taken into consideration.
  • the curved implant is one of these solutions, and has however never been proposed to date. Indeed, the implant according to the invention has the advantage of allowing the establishment of a solid attachment requiring a single access path.
  • the curved shape makes it possible to work access ways offering working angles that are not suitable for the rectilinear screws known from the prior art.
  • Another advantage of the invention is to strengthen the attachment of the implant by adding lateral anchoring means in the bone, and particularly rigid means that deploy laterally outside the implant.
  • the present invention proposes a simple surgical implant which makes it possible to achieve the fixation of at least two adjacent bone elements, for example two adjacent vertebrae, without risk of false journey, without particular technical difficulty and without expensive technical assistance other than a simple apparatus. of fluoroscopy.
  • the implants according to the present invention are not positioned in the vertebral pedicles but allow to directly fasten the vertebral bodies together. The device is immediately stronger than pedicle screws commonly used in the prior art.
  • the present invention therefore also proposes a new method of fixing at least two adjacent bone elements, for example two adjacent vertebrae, without the risk of false path and without particular technical difficulty for a surgeon.
  • This method also saves considerable time in the case of the stabilization of more than two adjacent bone elements such as several vertebral stages.
  • this new surgical implant is placed directly in the bone element, without staples or nails, so an arthrodesis operation for example can be performed closed rachis between the nerve bundles and without damaging the nerves.
  • patient is meant a human being or an animal whose symptoms or pathology require the intervention of a surgeon for the joining of at least two bone elements between them.
  • a patient is an individual who has had a vertebral fracture or scoliosis, a vertebral collapse, etc. the proposed method of relieving pain of said patient being the realization of an arthrodesis, that is to say the bone fusion between two vertebrae.
  • bone element is meant anatomical bone elements requiring stabilization or repair surgery but also any implant that replaces for all or part of an anatomical bone element, for example an implant made of metal or alloy of metal, ceramic, polymer, or any other biocompatible material.
  • the subject of the invention is a surgical implant for fixing at least two adjacent bone elements of a patient, consisting of a rod intended to be inserted into a borehole made in the at least two elements. adjacent bone, said implant being characterized in that the stem is curved and hollow so as to form a cavity substantially along the axis of the rod and open at its distal end, said rod comprising at least one deployable anchoring means capable of protruding between a retracted position and a deployed position outside the rod once the latter is placed in the bore so as to immobilize said implant.
  • rod is meant a solid element, preferably of cylindrical shape and which constitutes the body of the implant according to the invention.
  • curve is meant a shape describing or comprising a flat arc or three-dimensional portion, not necessarily regular.
  • the stem may be of regular or mixed curved shape. When it is regular, the stem has a regular arc of curvature, that is to say that it corresponds to a regular circular arc over its entire length. We will then speak of “curvature” or "regular arc of curvature”. When it is mixed the stem has a straight part and at least a curved part without the stem necessarily presents symmetry.
  • the composite rod may have two, three or more curved portions.
  • “Hollow” means that the rod comprises over all or part of its length a bore in the longitudinal direction so as to form a cavity, said cavity being open on one end of the rod (so as to introduce an ancillary for example by this open end).
  • the cavity is open at the so-called “rear” or “distal” end of the stem, the other end, called “before” or “proximal” being full and may have a pointed shape intended to facilitate the penetration of the stem within the bone elements.
  • deploymentable anchoring means means any means known to those skilled in the art that can move from a position called “retracted”, that is to say not hinder in any way whatsoever insertion or withdrawal by sliding of the rod within the hole provided for this purpose to a so-called “extended” position, that is to say projecting outwardly of the rod so as to come s anchor in the bone and immobilize the implant.
  • said deployable anchoring means can easily move from the retracted position to the deployed position, and vice versa, so as to insert or remove the rod at the convenience of the surgeon for example.
  • the "retracted" position means inside the cavity of the stem.
  • the anchoring means may consist of a protuberance, a stop, a hook, a ring, a relief, an impression, a fin, or any equivalent means.
  • the deployable anchoring means consists of a rigid element such as, for example, a rigid fin capable of being deployed towards the outside of the rod.
  • the present invention relates to an implant which as described above is characterized in that said at least one deployable anchoring means consists of at least one fin.
  • said at least one fin is integral with the rod by one of its hinge sides with the body of the rod.
  • said at least one fin may have a chamfer or a rounded in its upper distal portion which comes into contact with the bone or any general shape favoring the passage from the extended position to the retracted position by pressing the bone on the wing when the rod is removed.
  • said at least one deployable anchoring means consists of a rigid element such as, for example, a rigid pin capable of being deployed towards the outside of the rod.
  • the implant may comprise several deployable anchoring means arranged on all or part of the rod. It is understood that depending on the nature of the bone elements to be sealed, the arrangement of said deployable anchoring means may be adapted according to the general knowledge of the skilled person.
  • the rod according to the invention may comprise two sets of deployable anchoring means, each series may comprise at least two means arranged near the distal end of the stem for the first and near the proximal end of the rod for the second. In this way, the means of anchoring once deployed will be anchored in bone without any contact with the intervertebral space.
  • the stop of said at least one deployable anchoring means which comes into contact with the bone can be sharp or slightly sharp so as to enter the bone without damaging it.
  • the surgical implant according to the invention is particularly suitable when said bone elements are vertebrae.
  • the shape of the rod determines the shape of the implant, so in a particular embodiment the rod is curved and the surgical implant once it is in place is also curved.
  • the stem is curved in different planes.
  • the shape of the surgical implant is mixed, that is to say that it has one or more straight portions and one or more curved portion (s).
  • the implant according to the invention is therefore not necessarily regular.
  • the curvature of the implant according to the invention is therefore not necessarily regular.
  • the implant according to the invention will comprise at least one regularly curved portion preferably of developed length between 20 and 180 mm describing an arc of radius typically between 60 and 150 mm.
  • the stem is of curved shape in a plane, with a developed length of 70 mm describing an arc of 44.6 ° and of constant constant radius. at 90mm.
  • the rod is made of metal or a metal-based alloy.
  • the rod is made of materials different biocompatible so as to have according to its sections properties, including flexibility different.
  • different surface treatments of the rod may be envisaged to ensure the biocompatibility, the cutting edge, the spring effect, the sliding or, on the contrary, the adhesion of one or other of these elements.
  • the biocompatible materials constituting the deployable anchoring means may be identical to those used for the rod.
  • the present invention therefore relates to an implant as described above which is characterized in that the rod constituting it is made of one or more biocompatible materials which are flexible.
  • the rod constituting it is made of one or more biocompatible materials which are flexible.
  • the rod is made of a rigid material, the surgeon must drill into the bone elements to assemble which curvature is identical to that of the rod.
  • the rod is made of a solid but flexible material, the rod is capable of adapting to any curvature of the drilling performed by the surgeon according to predefined parameters.
  • the rod is made of one or more flexible biocompatible material (s).
  • the rod may in particular have a nail shape.
  • the implant according to the invention is characterized in that only some of the portions of the rod are flexible.
  • the flexible portions may be provided to be positioned outside the bone elements to be assembled, for example two vertebrae, so as to form a kind of hinge and maintain some flexibility in the implant.
  • this surgical implant makes it particularly adaptable to the morphology of the adjacent bone elements to be fixed between them. Indeed, it is easy to manufacture "custom-made" surgical implants of substantially curved shape, having a symmetry or not with respect to said curve, etc. All forms are permitted in the present invention depending on the area to be implanted. For implantation at the vertebral level, for example, a curved surgical implant will be preferred in order to adapt to the morphology of the vertebrae and to their articulation. The curvature is then determined according to the morphology of the bone elements to be joined. The curvature of the implant according to the invention will not necessarily be flat and may present twists. The curvature of the implant according to the invention is not necessarily regular.
  • the stem typically has a diameter of between 4 and 8 mm, preferably around 6 mm.
  • the establishment of the surgical implant therefore requires drilling of equal or slightly greater size, such as for example between 5 and 10 mm in diameter.
  • the deployable anchoring means are arranged, in their retracted position, within a cavity made for this purpose in the rod. Thus, during the establishment of the rod, they do not hinder the establishment of the rod.
  • An alternative embodiment may be that for example said deployable anchoring means is "plated" against the outer wall of the rod (which may include an imprint for this purpose). Any other equivalent embodiment will of course have to be considered to be within the scope of the present invention.
  • transition from the "retracted” position to the "deployed” position, and vice versa can be achieved by any technique known to those skilled in the art.
  • any technique making it possible to apply pressure to the deployable anchoring means can be envisaged, said pressure then pushing the deployable anchoring means so that they deploy from the "retracted” position into the cavity from the rod to the "extended” position then forming a projection outside the rod.
  • a fluid under pressure such as pressurized air
  • a movable male element capable of sliding in the cavity of the rod so that the head of said movable male member abuts against the deployable anchoring means and thus of push them to deploy to the outside of the rod for example in the manner of a screw in ankle.
  • the implant further comprises an insertable movable male element within the cavity of the stem, after it has been inserted into the bone elements to be stabilized so that the head of said movable male element comes from abut against the deployable anchoring means and thus push them to project outwardly of the rod.
  • this male element mobile may be left in place and participate in the rigidity of the implant or may be removed.
  • this mobile male element can be considered as an integral part of the implant according to the invention.
  • this movable male element may be considered as not forming an integral part of the implant according to the invention but as constituting an independent ancillary. Accordingly, although the description below applies more particularly to the second alternative, it is to be understood that the invention is directed to both the integrated embodiment in which the implant comprises a rod forming the body of the implant and a movable male element, but also the "kit of part" mode which comprises an implant consisting of the rod and an independent ancillary consisting of said movable male element, the assembly forming a kit according to the invention.
  • the present invention therefore also relates to an assembly or kit which comprises an implant as described above and an ancillary comprising a hollow body with a proximal end adapted to be fixed on the distal end of the rod and a male element mobile slidable within said hollow body and capable of sliding in the cavity of the rod so that the head of said movable male member abuts against the deployable anchoring means and thus allows to push them to make them protrude outside the stem.
  • said movable male element consists of two portions, a distal portion intended to be removed after implant placement and a proximal portion intended to remain in place within the cavity of the stem in order to maintain pressure. on the means anchor so as to keep them in the "deployed” position.
  • the removal of the proximal portion of the movable male member will cause a passage from the "deployed" position to the "retracted” position of the anchoring means, thereby allowing removal of the implant by a simple traction of the surgeon.
  • an assembly or kit which comprises an implant as described above and an ancillary as described above comprising a movable male element consisting of two portions, a distal portion to be removed after implant placement and a proximal portion to remain in place within the stem cavity to maintain pressure on the anchoring means to maintain them in the "deployed" position.
  • an ancillary type "syringe” consisting of i) a rigid body or semi rigid with an end adapted to come cooperate with the distal end of the rod and the other end being open and ii) a movable male member slidable within said body in the manner of a piston, said movable male member may comprise two portions.
  • the invention also provides a method of attaching at least two adjacent bone elements, implementing
  • the surgical implant according to the invention consisting of:
  • the present invention relates to a method of fixing at least two adjacent vertebrae which implements a surgical implant as described above, said method consisting in: - practicing with the aid of a drilling tool having the characteristics defined by the surgeon according to the vertebrae to be joined, then
  • the present invention relates to a method of fixing at least two adjacent vertebrae which implements a surgical implant as described above, said method consisting in: practicing with the aid of a tool drilling a drill having the characteristics defined by the surgeon according to the vertebrae to be joined, and then
  • an ancillary device as described above comprising i) a rigid or semi-rigid hollow body with an end adapted to cooperate with the distal end of the stem and the another end being open and ii) a movable male element sliding inside said body in the manner of a piston applying a pressure on the movable male element so that the latter is inserted into the cavity made for this purpose in the rod, slides along the rod so as to abut on said at least one deployable anchoring means thus applying a pressure on this last so that it can move from the "retracted" position to the "deployed” position.
  • an ancillary device as described above comprising i) a rigid or semi-rigid hollow body with an end adapted to cooperate with the distal end of the stem and the another end being open and ii) a movable male element sliding inside said body in the manner of a piston applying a pressure on the movable male element so that the latter is inserted into the cavity made for this purpose in the rod, slides along the rod so as to
  • the present invention relates to a method of fixing at least two adjacent vertebrae which implements a surgical implant as described above, said method consisting in:
  • an ancillary device as described above comprising i) a rigid or semi-rigid hollow body with an end adapted to cooperate with the distal end of the stem and the another end being open and ii) a movable male element consisting of a distal portion and a proximal portion detachable and sliding within said body in the manner of a piston
  • a drilling and laying tool which uses the rod forming the surgical implant. having a pointed distal end as a drill head. In this embodiment there is no prior drilling step when the method according to the invention is applied.
  • the rod of the implant according to the invention can be inserted as a nail by simple percussion or any other thrust on its outer end, without it being necessary to print any rotational movement.
  • the rod of the implant according to the invention can even be inserted in this way in a borehole or housing having a certain curvature, which is strictly impossible for a traditional rigid screw. If the drilling has a constant radius of curvature and lying in a single plane, that is to say without torsion, the rod of the implant according to the invention may be rigid but must have the same radius of curvature as said drilling. If the bending radius of curvature is not constant or if it has one or more twists the stem of the surgical implant according to the invention must necessarily have a certain flexibility.
  • Figure 2 shows a longitudinal sectional view of the rod (4) constituting the surgical implant with the deployable anchoring means (8) in the "deployed”position
  • 3 shows a view of the implant in a conventional embodiment with the rod (4) at the moment when it will be inserted in the borehole (5) made in two vertebrae adjacent (2; 3) with the deployable anchoring means (8) in the retracted position.
  • an ancillary device consisting of a rigid hollow body (11) whose proximal end (12) is positioned at the open distal end (7) of the rod (4) and a movable male element (13) in two portions (13 ';13'') in the high position;
  • Figure 4 shows the rod (4) forming the implant placed in the borehole (5) with the ancillary in place, the movable male element (13) still in the high position.
  • the arrow shown in this figure illustrates the pressure that will be exerted by the surgeon on said movable male element (13); 5 represents the implant anchored within the adjacent bone elements (2; 3) with the movable male element (13) completely inserted into the cavity (6) of the rod (4) thus projecting the means of anchoring (8) to the outside of the rod (4) as represented by the arrows.
  • FIG. 1 shows a rod (4) of curved shape with a regular curvature arc.
  • FIG. 1 a surgical implant according to the invention consisting of a rod (4) curved and hollow so as to form therein a cavity (6) open at its distal end (7). .
  • the proximal end is solid and is in the form of a tip.
  • the rod (4) shown comprises in this embodiment 4 deployable anchoring means (8) consisting of fins shown in the retracted position inside the cavity (6).
  • Figure 2 illustrates the implant according to the invention comprising said 4 deployable anchoring means (8) shown in the deployed position.
  • the fins constituting the deployable anchoring means (8) protrude towards the outside of the rod (4) so as to be anchored directly within the bone material constituting the elements. to join.
  • the fins (8) have a base stop of a length (X) greater than the length (Y) of the stop which comes into contact with the bone.
  • Figure 3 shows an embodiment of the implant according to the invention. It is shown the stem (4) curved and hollow with within it a cavity (6) in which are folded the fins (8) forming anchoring means deployable.
  • the rod (4) is shown while it will be inserted into the bore (5) made for this purpose by the surgeon within the two bone elements (2; 3) to be secured.
  • the rod (4) is shown as being introduced and pushed into the bore (5) via an ancillary.
  • an ancillary is in no way limiting and should be considered as a form of the invention.
  • the ancillary comprises a rigid or semi-rigid hollow body (11) forming a tube, with a proximal end (12) adapted to cooperate with the distal end (7) of the rod (4) and the other end being open from to receive a movable male element (13) slidable within the cavity formed by said hollow body (11), in the manner of a piston.
  • the male element mobile (13) consists of a distal portion (13 ') to be removed which constitutes the portion thereof and a proximal portion (13'') intended to remain inserted within the cavity (6) of the stem (4).
  • the distal portion (13 ') is shown hatched with spaced lines while the proximal portion (13'') is shown hatched with narrow lines.
  • the hollow body (11) is shown in white section (no filling).
  • the proximal end (12) is adapted to engage or "clip" on the distal end (7) of the shaft (4).
  • the proximal end (12) has a diameter slightly greater than the diameter of the distal end (7) of the rod (4) so as to be able to position itself by covering around said distal end ( 7) of the rod (4).
  • the surgeon can set up the ancillary once the rod (4) installed in the borehole (5) or use the ancillary as a tool to push the rod (4) and thus insert it completely into the drilling (5).
  • a combination of these two uses may of course be made by manual insertion of the rod (4) and subsequent push with the ancillary.
  • Figure 4 shows the rod (4) once positioned within the two vertebral bodies (2; 3) to be secured.
  • the rod (4) is completely inserted into the bore (5) and only the ancillary positioned at the distal end (7) of the rod (4) is outside the vertebrae .
  • the movable male element (13) is in the upper position, that is to say engaged within the rigid body (11) forming the ancillary but not extending beyond the proximal end (12) .
  • the movable male element (13) is in no way engaged within the cavity (6) of the rod (4).
  • the proximal portion (13 '') is completely inserted within the hollow body (11) while the distal portion (13 ') is not.
  • the surgeon will only have to apply pressure to the movable male member (13) as shown by the arrow.
  • Such a pressure will have the effect of introducing the proximal portion (13 '') of the movable male element (13) into the cavity (6) of the rod (4) while the distal portion (13 ') is inserted into the hollow body (11).
  • the end of the proximal portion (13 '') will thus abut on the fins (8) which are retracted within the same cavity (6).
  • the fins (8) will be propelled outwardly of the rod (4) so as to be anchored directly in the bone material forming the vertebrae (2; 3).
  • the wings (8) forming anchoring means retracted within the rod (4) and arranged to be positioned at the central bone portion forming each vertebra.
  • no fin is disposed at the intervertebral junction.
  • Figure 5 shows the surgical implant in its final position within two vertebral bodies (2; 3) in our example.
  • the fins (8) are deployed (as illustrated by the arrows in the drawing) so as to be securely anchored in the vertebrae.
  • the pedicles of the vertebrae are not affected by the placement of the surgical implant, which avoids any problem of false path and / or nerve or vascular injury. All that remains is for the surgeon to remove the ancillary device with the distal portion (13 ') of the movable male element (13).
  • the proximal portion (13 '') will be disengaged from the distal portion (13 '), the proximal portion (13'') remaining inserted into the stem (4) so as to maintain pressure on the fins (8).
  • the surgeon can easily remove the implant using the ancillary.
  • the latter will be returned to position at the open distal end (7) of the rod (4) so as to allow the distal portion (13 ') of the movable male element (13) to become solid with the proximal portion (13 '') of the movable male element (13) remained in place within the cavity (6) of the rod (4).
  • the surgeon will then only have to remove the movable male element (13) in its entirety. This will have the effect of removing the pressure exerted by the proximal portion (13 ") on the fins (8) and thus allow them to return to the retracted position in order to remove the implant.
  • the surgeon When the surgeon deems it applicable according to the bone elements to be assembled and the material constituting the rod (4), it may be envisaged to use a drilling and laying tool which uses the stem (4) of the surgical implant presenting a pointed distal end as a drill head. In this embodiment there is no prior drilling step when the method according to the invention is applied.
  • This method is particularly suitable for the fixation of several adjacent vertebrae in a patient presenting a lumbar problem requiring the intervention of a surgeon because it avoids the insertion of pedicle screws according to the techniques currently used, which is less invasive and greatly limits the side effects related to the vertebral fixation operation.
  • the operation can be considered spine closed under fluoroscopic control, passing between the nerve bundles and without damaging the nerves.
  • a borehole (5) is made with a first drilling tool.
  • a tool of pose which one can not consist of the ancillary, is used in order to place the stem (4) since the cortex through the soft part of the first vertebral body and finally to the second vertebral body to fix.
  • the fins (8) forming deployable anchoring means are deployed by any technique known to those skilled in the art.
  • the present invention also relates to kits or kits containing the equipment necessary for the implementation of the method described above.
  • the present invention relates to kits or kits containing a surgical implant in one of the embodiments detailed above.
  • the present invention relates to kits or kits containing a surgical implant in one of the embodiments detailed above and an ancillary in one of the embodiments detailed above.
  • the kit or kit includes a curved surgical implant and an ancillary kit.
  • kits or kits comprising a surgical implant in one of the embodiments detailed above, an ancillary in one of the embodiments detailed above, and a drilling tool and / or a tool for laying the rod (4) independent of the ancillary.

Abstract

The present invention relates to a novel medical implant for the fixation of at least two adjacent bone elements in a manner that is quick, reliable and not very invasive. This implant consists of a curved hollow rod comprising at least one deployable anchoring means allowing said implant to be immobilised. The present invention also describes a method for the fixation of at least two adjacent bone elements implementing this novel implant. This method is particularly suitable for solidly connecting at least two vertebrae in order to perform an arthrodesis, said implant then being curved, making it particularly suitable for spinal surgery.

Description

IMPLANT DEPLOYABLE  DEPLOYABLE IMPLANT
La présente invention a pour objet un nouvel implant à usage médical permettant la fixation d' au moins deux éléments osseux adjacents de manière rapide, fiable et peu invasive. La présente invention décrit également une méthode de fixation d'au moins deux éléments osseux adjacents mettant en œuvre ce nouvel implant. Cette méthode est particulièrement adaptée pour la solidarisation d'au moins deux vertèbres en vue de la réalisation d'une arthrodèse ; ledit implant étant de forme courbe ce qui le rend particulièrement bien adapté à la chirurgie du rachis. The present invention relates to a novel implant for medical use for fixing at least two adjacent bone elements quickly, reliably and minimally invasive. The present invention also describes a method of attaching at least two adjacent bone elements implementing this new implant. This method is particularly suitable for the joining of at least two vertebrae for performing arthrodesis; said implant being of curved shape which makes it particularly suitable for spine surgery.
Eu égards au vieillissement de la population et également au rythme de vie de la population d'actifs, les problèmes osseux génèrent ou font partie du tableau clinique de nombreuses pathologies. Par ailleurs les traumatismes liés à des accidents, chocs et chutes, peuvent également engendrer des problèmes au niveau osseux nécessitant une intervention chirurgicale. La possibilité de fixation d'éléments osseux entre eux afin de stabiliser ou de corriger une position donnée est donc un enjeu médical important. En effet, dans le domaine de la chirurgie du rachis en particulier le fait de pouvoir solidariser des éléments osseux afin de stabiliser des zones données et/ou de libérer des faisceaux nerveux comprimés est souvent la seule façon de soulager les patients. In view of the aging of the population and also the pace of life of the active population, bone problems generate or are part of the clinical picture of many pathologies. In addition, trauma associated with accidents, shocks and falls may also cause bone problems requiring surgery. The possibility of fixing bone elements together in order to stabilize or correct a given position is therefore an important medical issue. Indeed, in the field of spine surgery in particular the fact of being able to join bone elements in order to stabilize given areas and / or to release compressed nerve bundles is often the only way to relieve patients.
Dans le domaine de la chirurgie orthopédique on utilise communément des plaques et des vis afin de stabiliser des zones osseuses adjacentes ou de leur conférer une position donnée. Les matériaux utilisés sont bien évidemment solides et de nombreuses contraintes mécaniques sont imposées par le matériau et le matériel. Pour permettre plus d'adaptation et autoriser plus de possibilités aux chirurgiens, différents dispositifs ont été mis en œuvre afin de permettre une meilleure réponse chirurgicale pour chaque patient : vis chirurgicales en combinaison selon différents angles, plaques fixes, plaques articulées, cages, etc. Dans le domaine particulier de la chirurgie du rachis, les chirurgiens utilisent en général des vis pédiculaires également appelées vis tulipes pour solidariser les vertèbres. Ces vis à usage médical sont des vis droites qui permettent 1 ' arthrodèse, c'est-à-dire la fusion osseuse entre au moins deux vertèbres. Cette technique est communément utilisée en cas de fracture, de scoliose, d'instabilité et de douleurs importantes. Même si cette technique est très couramment pratiquée, la mise en place de vis pédiculaires demeure une procédure difficile qui est réservée aux chirurgiens spécialisés et est susceptible d'entraîner de faux trajets. Dans les cas de faux trajets, une ou plusieurs vis n'étant pas correctement placées, elle peuvent blesser les racines nerveuses ou présenter un défaut de solidité. Pour pallier cette éventualité de faux trajet, plusieurs systèmes sophistiqués d'aide au guidage sont utilisés par les chirurgiens comme "la navigation" comprenant des repérages infra-rouge couplés à un scanner per opératoire. Ces systèmes de navigation permettent de diminuer le risque d'erreur de trajectoire. Cependant le risque d'erreur reste important car les arthrodèses pratiquées à ce jour nécessitent au minimum quatre vis pédiculaires et plus souvent six à huit vis pédiculaires . In the field of orthopedic surgery, plates and screws are commonly used to stabilize adjacent bone areas or to give them a given position. The materials used are obviously solid and many mechanical stresses are imposed by the material and the material. To allow more adaptation and allow more opportunities for surgeons, different devices were implemented to allow a better surgical response for each patient: surgical screws in combination at different angles, fixed plates, articulated plates, cages, etc. In the particular field of spine surgery, surgeons generally use pedicle screws also called tulip screws to secure the vertebrae. These screws for medical use are straight screws which allow the arthrodesis, that is to say the bone fusion between at least two vertebrae. This technique is commonly used in cases of fracture, scoliosis, instability and severe pain. Although this technique is very commonly practiced, the placement of pedicle screws remains a difficult procedure that is reserved for specialized surgeons and is likely to lead to false trips. In cases of false paths, one or more screws are not properly placed, they can hurt the nerve roots or have a lack of strength. To overcome this possibility of false path, several sophisticated guidance systems are used by surgeons as "navigation" including infra-red locations coupled to an intraoperative scan. These navigation systems can reduce the risk of trajectory error. However the risk of error remains important because the arthrodesis performed to date require at least four pedicle screws and more often six to eight pedicle screws.
Ainsi les techniques utilisées à ce jour présentent plusieurs inconvénients dont la complexité des dispositifs à implanter, l'abord transpédiculaire pour les vis de fixation de ces dispositifs qui est relativement invasif et générateur d'effets secondaires (hémorragies, lésions nerveuses, etc.), la nécessité d'un suivi impliquant des techniques d'imagerie performantes, soit autant de facteurs de risques, de technicité et de coûts qui sont à prendre en considération. Thus, the techniques used to date have several drawbacks, including the complexity of the devices to be implanted, the transepicular approach for the fixation screws of these devices which is relatively invasive and generates side effects (hemorrhages, nerve damage, etc.). the need for follow-up involving imaging techniques performance, ie all of the risk factors, technical factors and costs that must be taken into consideration.
La présence de nerfs, vaisseaux sanguins et autres tissus qui doivent nécessairement être préservés à l'occasion des chirurgies osseuses impose des voies d'accès et des abords limités au chirurgien. Les erreurs de trajectoires sont d' autant plus nombreuses que la ou les voies d' accès sont malaisées ou exiguës. Dans certains cas compte tenu de la configuration spatiale des éléments osseux à solidariser les techniques connues de l'art antérieur n'offrent aucune solution. Il existe donc un réel besoin de solutions techniques nouvelles ouvrant de nouvelles possibilités de fixation d'éléments osseux dans des configurations spécifiques . Selon une première caractéristique de l'invention, l'implant courbe est l'une de ces solutions, et n'a cependant jamais été proposé à ce jour. En effet, l'implant selon l'invention présente l'avantage de permettre la mise en place d'une fixation solide nécessitant une seule voie d'accès. La forme courbe permet quant à elle de travailler des voies d'accès offrant des angles de travail qui ne conviennent pas aux vis rectilignes connues de l'art antérieur. The presence of nerves, blood vessels and other tissues that must necessarily be preserved during bone surgeries requires limited access and access for the surgeon. The errors of trajectories are all the more numerous as the access way (s) are difficult or cramped. In certain cases, given the spatial configuration of the bone elements to be joined together the techniques known from the prior art offer no solution. There is therefore a real need for new technical solutions opening new possibilities for fixing bone elements in specific configurations. According to a first characteristic of the invention, the curved implant is one of these solutions, and has however never been proposed to date. Indeed, the implant according to the invention has the advantage of allowing the establishment of a solid attachment requiring a single access path. The curved shape makes it possible to work access ways offering working angles that are not suitable for the rectilinear screws known from the prior art.
Un autre avantage de l'invention vise à renforcer la fixation de l'implant en lui ajoutant des moyens latéraux d'ancrage dans l'os, et tout particulièrement des moyens rigides qui se déploient latéralement à l'extérieur de 1 ' implant . Another advantage of the invention is to strengthen the attachment of the implant by adding lateral anchoring means in the bone, and particularly rigid means that deploy laterally outside the implant.
La présente invention propose un implant chirurgical simple qui permet de réaliser la fixation d'au moins deux éléments osseux adjacents, par exemple deux vertèbres adjacentes, sans risque de faux trajet, sans difficulté technique particulière et sans aide technique coûteuse autre qu'un simple appareil de radioscopie. Dans le cas de la chirurgie du rachis, contrairement à la technique mettant en œuvre des vis pédiculaires , les implants selon la présente invention ne sont pas positionnés dans les pédicules vertébraux mais permettent de solidariser directement les corps vertébraux entre eux. Le dispositif est d'emblée plus solide que les vis pédiculaires couramment utilisées dans l'art antérieur. D'autre part les corps vertébraux étant volumineux, de l'ordre de 4 x 5 x 3 cm, le risque d'un trajet extracorporéal est très limité par rapport aux pédicules vertébraux qui font 1 x 0,8 cm et sont assez difficiles à identifier même avec des techniques d'imagerie performantes. The present invention proposes a simple surgical implant which makes it possible to achieve the fixation of at least two adjacent bone elements, for example two adjacent vertebrae, without risk of false journey, without particular technical difficulty and without expensive technical assistance other than a simple apparatus. of fluoroscopy. In the case of surgery of the spine, unlike the technique using pedicle screws, the implants according to the present invention are not positioned in the vertebral pedicles but allow to directly fasten the vertebral bodies together. The device is immediately stronger than pedicle screws commonly used in the prior art. On the other hand the vertebral bodies being bulky, of the order of 4 x 5 x 3 cm, the risk of an extracorporeal journey is very limited compared to the vertebral pedicles which are 1 x 0.8 cm and are quite difficult to identify even with powerful imaging techniques.
La présente invention propose donc également une nouvelle méthode de fixation d'au moins deux éléments osseux adjacents, par exemple deux vertèbres adjacentes, sans risque de faux trajet et sans difficulté technique particulière pour un chirurgien. Cette méthode permet également un gain de temps considérable dans le cas de la stabilisation de plus de deux éléments osseux adjacents tels plusieurs étages vertébraux. De plus ce nouvel implant chirurgical est placé directement dans l'élément osseux, sans agrafes ni clous, ainsi une opération d' arthrodèse par exemple peut être réalisée rachis fermé entre les faisceaux nerveux et sans léser les nerfs. The present invention therefore also proposes a new method of fixing at least two adjacent bone elements, for example two adjacent vertebrae, without the risk of false path and without particular technical difficulty for a surgeon. This method also saves considerable time in the case of the stabilization of more than two adjacent bone elements such as several vertebral stages. Moreover this new surgical implant is placed directly in the bone element, without staples or nails, so an arthrodesis operation for example can be performed closed rachis between the nerve bundles and without damaging the nerves.
Dans la présente invention, les termes entre guillemets sont utilisés pour décrire le nouvel implant chirurgical, la nouvelle méthode de fixation le mettant en œuvre et les éléments le constituant. Ils sont utilisés au pluriel comme au singulier . In the present invention, the terms in quotation marks are used to describe the new surgical implant, the new method of fixation and its constituent elements. They are used in the plural as in the singular.
Par « patient » on entend un être humain ou un animal dont les symptômes ou la pathologie nécessitent l'intervention d'un chirurgien pour la solidarisation d'au moins deux éléments osseux entre eux. Par exemple un patient est un individu ayant subi une fracture de vertèbre ou présentant une scoliose, un tassement vertébral etc. la méthode proposée pour soulager les douleurs dudit patient étant la réalisation d'une arthrodèse, c'est-à-dire la fusion osseuse entre deux vertèbres. By "patient" is meant a human being or an animal whose symptoms or pathology require the intervention of a surgeon for the joining of at least two bone elements between them. For example, a patient is an individual who has had a vertebral fracture or scoliosis, a vertebral collapse, etc. the proposed method of relieving pain of said patient being the realization of an arthrodesis, that is to say the bone fusion between two vertebrae.
Par « élément osseux » on entend des éléments osseux anatomiques nécessitant une intervention chirurgicale de stabilisation ou de réparation mais également tout implant qui remplace pour tout ou partie un élément osseux anatomique par exemple un implant en métal ou alliage de métal, céramique, polymère, ou tout autre matériau biocompatible. By "bone element" is meant anatomical bone elements requiring stabilization or repair surgery but also any implant that replaces for all or part of an anatomical bone element, for example an implant made of metal or alloy of metal, ceramic, polymer, or any other biocompatible material.
Selon une forme de réalisation, l'invention a pour objet un implant chirurgical pour la fixation d'au moins deux éléments osseux adjacents d'un patient, constitué d'une tige destinée à être insérée dans un forage pratiqué dans les aux moins deux éléments osseux adjacents, ledit implant étant caractérisé en ce que la tige est courbe et creuse de manière à former une cavité suivant sensiblement l'axe de la tige et ouverte au niveau de son extrémité distale, ladite tige comprenant au moins un moyen d' ancrage déployable apte à saillir entre une position rétractée et une position déployée à l'extérieur de la tige une fois cette dernière mise en place au sein du forage de manière à venir immobiliser ledit implant .  According to one embodiment, the subject of the invention is a surgical implant for fixing at least two adjacent bone elements of a patient, consisting of a rod intended to be inserted into a borehole made in the at least two elements. adjacent bone, said implant being characterized in that the stem is curved and hollow so as to form a cavity substantially along the axis of the rod and open at its distal end, said rod comprising at least one deployable anchoring means capable of protruding between a retracted position and a deployed position outside the rod once the latter is placed in the bore so as to immobilize said implant.
Par « tige », on entend un élément solide, préférentiellement de forme cylindrique et qui constitue le corps de l'implant selon l'invention. Par « courbe » on entend une forme décrivant ou comprenant une portion en arc plan ou en trois dimensions, non nécessairement régulier. La tige peut être de forme courbe régulière ou mixte. Lorsqu'elle est régulière, la tige présente un arc de courbure régulier, c' est-a-dire qu'elle correspond à un arc de cercle régulier sur toute sa longueur. On parlera alors de « courbure » ou « d' arc de courbure » régulier. Lorsqu'elle est mixte la tige présente une partie droite et au moins une partie courbe sans que la tige ne présente obligatoirement de symétrie. Dans certaines formes de réalisations, la tige mixte peut présenter deux, trois ou plus de parties courbes. On parlera alors de « courbure » ou « d'arc de courbure » mixte. Par « creuse », on entend que la tige comprend sur toute ou partie de sa longueur un forage dans le sens longitudinal de manière à former une cavité, ladite cavité étant ouverte sur l'une des extrémités de la tige (de manière à pouvoir introduire un ancillaire par exemple par cette extrémité ouverte) . Selon un mode de réalisation particulier, la cavité est ouverte au niveau de l'extrémité dite « arrière » ou « distale » de la tige, l'autre extrémité, dite « avant » ou « proximale » étant pleine et pouvant présenter une forme pointue destinée à faciliter la pénétration de la tige au sein des éléments osseux. By "rod" is meant a solid element, preferably of cylindrical shape and which constitutes the body of the implant according to the invention. By "curve" is meant a shape describing or comprising a flat arc or three-dimensional portion, not necessarily regular. The stem may be of regular or mixed curved shape. When it is regular, the stem has a regular arc of curvature, that is to say that it corresponds to a regular circular arc over its entire length. We will then speak of "curvature" or "regular arc of curvature". When it is mixed the stem has a straight part and at least a curved part without the stem necessarily presents symmetry. In some embodiments, the composite rod may have two, three or more curved portions. We will then speak of "curvature" or "mixed arc of curvature". "Hollow" means that the rod comprises over all or part of its length a bore in the longitudinal direction so as to form a cavity, said cavity being open on one end of the rod (so as to introduce an ancillary for example by this open end). According to a particular embodiment, the cavity is open at the so-called "rear" or "distal" end of the stem, the other end, called "before" or "proximal" being full and may have a pointed shape intended to facilitate the penetration of the stem within the bone elements.
Par « moyen d'ancrage déployable», on entend tout moyen connu de l'Homme de l'Art pouvant passer d'une position dite « rétractée », c'est-à-dire ne venant pas entraver de quelque manière que ce soit l'insertion ou le retrait par glissement de la tige au sein de l'orifice prévu à cet effet à une position dite « déployée », c'est-à-dire faisant saillie vers l'extérieur de la tige de manière à venir s'ancrer dans l'os et ainsi immobiliser l'implant. By "deployable anchoring means" means any means known to those skilled in the art that can move from a position called "retracted", that is to say not hinder in any way whatsoever insertion or withdrawal by sliding of the rod within the hole provided for this purpose to a so-called "extended" position, that is to say projecting outwardly of the rod so as to come s anchor in the bone and immobilize the implant.
Selon une forme préférée, ledit moyen d'ancrage déployable pourra facilement passer de la position rétractée à la position déployée, et inversement, de manière à pouvoir insérer ou retirer la tige à la convenance du chirurgien par exemple. Selon un mode de réalisation préféré, la position « rétractée » signifie à l'intérieur de la cavité de la tige. A titre d'exemple non limitatif, le moyen d'ancrage peut consister en une protubérance, une butée, un crochet, un anneau, un relief, une empreinte, une ailette, ou tout moyen équivalent . Selon une forme particulière de l'invention, le moyen d'ancrage déployable consiste en un élément rigide comme, par exemple, une ailette rigide capable de se déployer vers l'extérieur de la tige. En d'autres termes, la présente invention a pour objet un implant qui tel que décrit plus haut qui se caractérise en ce que ledit au moins un moyen d' ancrage déployable consiste en au moins une ailette . In a preferred form, said deployable anchoring means can easily move from the retracted position to the deployed position, and vice versa, so as to insert or remove the rod at the convenience of the surgeon for example. According to a preferred embodiment, the "retracted" position means inside the cavity of the stem. By way of non-limiting example, the anchoring means may consist of a protuberance, a stop, a hook, a ring, a relief, an impression, a fin, or any equivalent means. According to one particular form of the invention, the deployable anchoring means consists of a rigid element such as, for example, a rigid fin capable of being deployed towards the outside of the rod. In other words, the present invention relates to an implant which as described above is characterized in that said at least one deployable anchoring means consists of at least one fin.
Selon une forme préférée de l'invention ladite au moins une ailette est venue de matière avec la tige par un de ses côtés formant charnière avec le corps de la tige. According to a preferred form of the invention, said at least one fin is integral with the rod by one of its hinge sides with the body of the rod.
Toujours selon une forme préférée, ladite au moins une ailette pourra présenter un chanfrein ou un arrondi dans sa partie distale supérieure qui vient au contact de l'os ou toute forme générale favorisant le passage de la position déployée à la position rétractée par appui de l'os sur l'ailette lorsque la tige est retirée. Still according to a preferred form, said at least one fin may have a chamfer or a rounded in its upper distal portion which comes into contact with the bone or any general shape favoring the passage from the extended position to the retracted position by pressing the bone on the wing when the rod is removed.
Selon une autre forme préférée de l'invention ledit au moins un moyen d'ancrage déployable consiste en un élément rigide comme, par exemple, un picot rigide capable de se déployer vers l'extérieur de la tige. Selon une forme de réalisation, l'implant peut comprendre plusieurs moyens d'ancrage déployables disposés sur tout ou partie de la tige. Il est entendu que selon la nature des éléments osseux à sceller, la disposition desdits moyens d'ancrage déployables pourra être adaptée selon les connaissances générales de l'Homme de l'Art. A titre d'exemple, dans le cas d'une utilisation pour solidariser deux vertèbres, la tige selon l'invention peut comprendre deux séries de moyens d'ancrage déployables, chaque série pouvant comprendre au moins deux moyens disposés proche de l'extrémité distale de la tige pour la première et proche de l'extrémité proximale de la tige pour la seconde. De la sorte, les moyens d'ancrage une fois déployés viendront s'ancrer dans la matière osseuse sans aucun contact avec l'espace intervertébral. According to another preferred form of the invention, said at least one deployable anchoring means consists of a rigid element such as, for example, a rigid pin capable of being deployed towards the outside of the rod. According to one embodiment, the implant may comprise several deployable anchoring means arranged on all or part of the rod. It is understood that depending on the nature of the bone elements to be sealed, the arrangement of said deployable anchoring means may be adapted according to the general knowledge of the skilled person. For example, in the case of a use for securing two vertebrae, the rod according to the invention may comprise two sets of deployable anchoring means, each series may comprise at least two means arranged near the distal end of the stem for the first and near the proximal end of the rod for the second. In this way, the means of anchoring once deployed will be anchored in bone without any contact with the intervertebral space.
Selon une forme préférée, l'arrête dudit au moins un moyen d'ancrage déployable qui vient au contact de l'os peut être tranchante ou légèrement affûtée de manière à pouvoir entrer dans la matière osseuse sans la détériorer. According to a preferred form, the stop of said at least one deployable anchoring means which comes into contact with the bone can be sharp or slightly sharp so as to enter the bone without damaging it.
L'implant chirurgical selon l'invention est particulièrement adapté lorsque lesdits éléments osseux sont des vertèbres . La forme de la tige détermine la forme de l'implant, ainsi dans un mode de réalisation particulier la tige est courbe et l'implant chirurgical une fois celui-ci mis en place est lui aussi courbe. Dans un mode de réalisation spécifique la tige est courbée dans différents plans. Selon une autre caractéristique additionnelle la forme de l'implant chirurgical est mixte, c'est-à-dire qu'elle présente une ou plusieurs portion droite et une ou plusieurs portion (s) courbe ( s ) . The surgical implant according to the invention is particularly suitable when said bone elements are vertebrae. The shape of the rod determines the shape of the implant, so in a particular embodiment the rod is curved and the surgical implant once it is in place is also curved. In a specific embodiment, the stem is curved in different planes. According to another additional characteristic, the shape of the surgical implant is mixed, that is to say that it has one or more straight portions and one or more curved portion (s).
La courbure de l'implant selon l'invention n'est donc pas nécessairement régulière. La courbure de l'implant selon l'invention n'est donc pas nécessairement régulière. Selon une forme particulière de l'invention, l'implant selon l'invention comprendra au moins une partie courbe régulière préférentiellement de longueur développée comprise entre 20 et 180 mm décrivant un arc de rayon typiquement compris entre 60 et 150 mm. Selon une forme plus préférentielle de l'invention parfaitement adaptée à la solidarisation de deux vertèbres chez un patient adulte la tige est de forme courbe dans un plan, de longueur développée de 70 mm décrivant un arc de 44, 6° et de rayon constant égal à 90mm. Selon une caractéristique additionnelle la tige est réalisée en métal ou en un alliage à base de métal. Dans un autre mode de réalisation la tige est réalisée en des matériaux biocompatibles différents de manière à présenter selon ses tronçons des propriétés, notamment de flexibilité différentes. Bien entendu dans des modes de réalisation spécifiques il peut être envisagé différents traitements de surface de la tige pour assurer la biocompatibilité, le tranchant, l'effet ressort, le coulissement ou au contraire l'adhérence de tel ou tel de ces éléments. The curvature of the implant according to the invention is therefore not necessarily regular. The curvature of the implant according to the invention is therefore not necessarily regular. According to one particular form of the invention, the implant according to the invention will comprise at least one regularly curved portion preferably of developed length between 20 and 180 mm describing an arc of radius typically between 60 and 150 mm. According to a more preferred form of the invention perfectly adapted to the joining of two vertebrae in an adult patient, the stem is of curved shape in a plane, with a developed length of 70 mm describing an arc of 44.6 ° and of constant constant radius. at 90mm. According to an additional feature the rod is made of metal or a metal-based alloy. In another embodiment the rod is made of materials different biocompatible so as to have according to its sections properties, including flexibility different. Of course, in specific embodiments, different surface treatments of the rod may be envisaged to ensure the biocompatibility, the cutting edge, the spring effect, the sliding or, on the contrary, the adhesion of one or other of these elements.
Les matériaux biocompatibles constituant les moyens d'ancrage déployables peuvent être identiques à ceux utilisés pour la tige. The biocompatible materials constituting the deployable anchoring means may be identical to those used for the rod.
La présente invention a donc pour objet un implant tel que décrit plus haut qui est caractérisé en ce que la tige le constituant est réalisée en un ou plusieurs matériaux biocompatibles qui sont flexibles . Lorsque la tige est réalisée dans un matériau rigide, le chirurgien doit pratiquer un forage au sein des éléments osseux à assembler dont la courbure est identique à celle de la tige. Lorsque la tige est réalisée dans un matériau solide mais flexible, la tige est susceptible de s'adapter à toute courbure du forage réalisé par le chirurgien selon des paramètres prédéfinis. Ainsi selon une caractéristique additionnelle la tige est réalisée dans un ou plusieurs matériaux biocompatible ( s ) flexible (s). La tige peut notamment avoir une forme de clou. Selon une forme d'exécution particulière, l'implant selon l'invention est caractérisé en ce que uniquement certaines des portions de la tige sont flexibles . The present invention therefore relates to an implant as described above which is characterized in that the rod constituting it is made of one or more biocompatible materials which are flexible. When the rod is made of a rigid material, the surgeon must drill into the bone elements to assemble which curvature is identical to that of the rod. When the rod is made of a solid but flexible material, the rod is capable of adapting to any curvature of the drilling performed by the surgeon according to predefined parameters. Thus, according to an additional characteristic, the rod is made of one or more flexible biocompatible material (s). The rod may in particular have a nail shape. According to a particular embodiment, the implant according to the invention is characterized in that only some of the portions of the rod are flexible.
D'une manière générale, quelle que soit la forme de l'implant selon l'invention, il pourra être envisagé de ne réaliser que certaines portions de la tige en un matériau flexible. Par exemple, les parties flexibles pourront être prévues pour être positionnées à l'extérieur des éléments osseux à assembler, par exemple deux vertèbres, de manière à former une sorte de charnière et à conserver une certaine souplesse à l'implant. In general, whatever the shape of the implant according to the invention, it may be envisaged to make only certain portions of the rod of a flexible material. For example, the flexible portions may be provided to be positioned outside the bone elements to be assembled, for example two vertebrae, so as to form a kind of hinge and maintain some flexibility in the implant.
La simplicité de cet implant chirurgical le rend particulièrement adaptable à la morphologie des éléments osseux adjacents à fixer entre eux. En effet il est aisé de fabriquer « sur mesure » des implants chirurgicaux de forme sensiblement courbe, présentant une symétrie ou non par rapport à ladite courbe, etc. Toutes les formes sont autorisées dans la présente invention en fonction de la zone à implanter. Pour une implantation au niveau vertébral, on privilégiera par exemple un implant chirurgical de forme courbe afin de s'adapter à la morphologie des vertèbres et à leur articulation. La courbure est alors déterminée en fonction de la morphologie des éléments osseux à solidariser. La courbure de l'implant selon l'invention ne sera pas nécessairement plane et pourra présenter des torsions. La courbure de l'implant selon l'invention n'est pas nécessairement régulière. The simplicity of this surgical implant makes it particularly adaptable to the morphology of the adjacent bone elements to be fixed between them. Indeed, it is easy to manufacture "custom-made" surgical implants of substantially curved shape, having a symmetry or not with respect to said curve, etc. All forms are permitted in the present invention depending on the area to be implanted. For implantation at the vertebral level, for example, a curved surgical implant will be preferred in order to adapt to the morphology of the vertebrae and to their articulation. The curvature is then determined according to the morphology of the bone elements to be joined. The curvature of the implant according to the invention will not necessarily be flat and may present twists. The curvature of the implant according to the invention is not necessarily regular.
Typiquement, pour un patient adulte, la tige a un diamètre compris entre 4 et 8 mm, préférentiellement aux alentours de 6 mm. La mise en place de l'implant chirurgical nécessite donc un forage de taille égale ou légèrement supérieure, comme par exemple compris entre 5 et 10 mm de diamètre. Typically, for an adult patient, the stem has a diameter of between 4 and 8 mm, preferably around 6 mm. The establishment of the surgical implant therefore requires drilling of equal or slightly greater size, such as for example between 5 and 10 mm in diameter.
Comme indiqué plus haut, selon un mode de réalisation préféré, les moyens d'ancrage déployables sont disposés, dans leur position rétractée, au sein d'une cavité réalisée à cet effet dans la tige. Ainsi, lors de la mise en place de la tige, ces derniers ne viennent pas entraver la mise en place de la tige. Une forme de réalisation alternative peut consister en ce que par exemple lesdits moyens d'ancrage déployables soient « plaqués » contre la paroi externe de la tige (qui peut comprendre une empreinte à cet effet) . Toute autre forme de réalisation équivalente devra bien entendu être considérée comme entrant dans la portée de la présente invention . As indicated above, according to a preferred embodiment, the deployable anchoring means are arranged, in their retracted position, within a cavity made for this purpose in the rod. Thus, during the establishment of the rod, they do not hinder the establishment of the rod. An alternative embodiment may be that for example said deployable anchoring means is "plated" against the outer wall of the rod (which may include an imprint for this purpose). Any other equivalent embodiment will of course have to be considered to be within the scope of the present invention.
Le passage de la position « rétractée » à la position « déployée », et inversement, peut être réalisé par toute technique connue de l'Homme de l'Art. Concrètement, toute technique permettant de venir appliquer une pression sur les moyens d'ancrage déployables peut être envisagée, ladite pression venant alors pousser les moyens d'ancrage déployables de manière à ce qu' ils se déploient de la position «rétractée » dans la cavité de la tige à la position « déployée » formant alors une saillie à l'extérieur de la tige . The transition from the "retracted" position to the "deployed" position, and vice versa, can be achieved by any technique known to those skilled in the art. In concrete terms, any technique making it possible to apply pressure to the deployable anchoring means can be envisaged, said pressure then pushing the deployable anchoring means so that they deploy from the "retracted" position into the cavity from the rod to the "extended" position then forming a projection outside the rod.
Selon une forme de réalisation, il peut être envisagé d'injecter un fluide sous pression, comme de l'air sous pression, au sein de la cavité. According to one embodiment, it may be envisaged to inject a fluid under pressure, such as pressurized air, into the cavity.
Selon d'autres formes de réalisation, il peut être envisagé d'utiliser des mécanismes à ressort ou à élastique. According to other embodiments, it may be envisaged to use spring or elastic mechanisms.
Selon une autre forme de réalisation préférée, il sera utilisé un élément mâle mobile capable de venir glisser au sein de la cavité de la tige de manière à ce que la tête dudit élément mâle mobile vienne buter contre les moyens d'ancrage déployables et ainsi de les pousser pour les déployer vers l'extérieur de la tige par exemple à la manière d'une vis dans une cheville. According to another preferred embodiment, it will be used a movable male element capable of sliding in the cavity of the rod so that the head of said movable male member abuts against the deployable anchoring means and thus of push them to deploy to the outside of the rod for example in the manner of a screw in ankle.
Selon un mode préféré l'implant comprend en outre un élément mâle mobile insérable au sein de la cavité de la tige, après que celle-ci ait été insérée dans les éléments osseux à stabiliser de manière à ce que la tête dudit élément mâle mobile vienne buter contre les moyens d'ancrage déployables et ainsi les pousser pour les faire saillir vers l'extérieur de la tige. Selon le mode de réalisation choisi, et comme cela sera décrit plus en détails par la suite, cet élément mâle mobile peut-être laissé en place et participer à la rigidité de l'implant ou éventuellement être retiré. According to a preferred embodiment the implant further comprises an insertable movable male element within the cavity of the stem, after it has been inserted into the bone elements to be stabilized so that the head of said movable male element comes from abut against the deployable anchoring means and thus push them to project outwardly of the rod. According to the embodiment chosen, and as will be described in more detail later, this male element mobile may be left in place and participate in the rigidity of the implant or may be removed.
Dans une première alternative, cet élément mâle mobile pourra être considéré comme faisant partie intégrante de l'implant selon l'invention. In a first alternative, this mobile male element can be considered as an integral part of the implant according to the invention.
Dans une deuxième alternative, cet élément mâle mobile pourra être considéré comme ne faisant pas partie intégrante de l'implant selon l'invention mais comme constituant un ancillaire indépendant. En conséquence, bien que la description ci-dessous s'applique plus particulièrement à la deuxième alternative, il faut comprendre que l'invention vise à la fois le mode de réalisation intégré dans lequel l'implant comprend une tige formant le corps de l'implant et un élément mâle mobile, mais aussi le mode « kit of part » qui comprend un implant constitué de la tige et un ancillaire indépendant consistant e ledit élément mâle mobile, l'ensemble formant un kit selon 1 ' invention . In a second alternative, this movable male element may be considered as not forming an integral part of the implant according to the invention but as constituting an independent ancillary. Accordingly, although the description below applies more particularly to the second alternative, it is to be understood that the invention is directed to both the integrated embodiment in which the implant comprises a rod forming the body of the implant and a movable male element, but also the "kit of part" mode which comprises an implant consisting of the rod and an independent ancillary consisting of said movable male element, the assembly forming a kit according to the invention.
La présente invention a donc également pour objet un ensemble ou un kit qui comprend un implant tel que décrit plus haut et un ancillaire comprenant un corps creux avec une extrémité proximale adaptée à venir se fixer sur l'extrémité distale de la tige et un élément mâle mobile venant coulisser au sein dudit corps creux et capable de venir glisser au sein de la cavité de la tige de manière à ce que la tête dudit élément mâle mobile vienne buter contre les moyens d' ancrage déployables et ainsi permet de les pousser pour les faire saillir à l'extérieur de la tige. The present invention therefore also relates to an assembly or kit which comprises an implant as described above and an ancillary comprising a hollow body with a proximal end adapted to be fixed on the distal end of the rod and a male element mobile slidable within said hollow body and capable of sliding in the cavity of the rod so that the head of said movable male member abuts against the deployable anchoring means and thus allows to push them to make them protrude outside the stem.
De manière préférée, ledit élément mâle mobile est constitué de deux portions, une portion distale destinée à être retirée après la pose de l'implant et une portion proximale destinée à rester en place au sein de la cavité de la tige afin de maintenir une pression sur les moyens d'ancrage de manière à les maintenir en position « déployée ». Dans cette forme de réalisation, le retrait de la portion proximale de l'élément mâle mobile entraînera un passage de la position « déployée » à la position « rétractée » des moyens d'ancrage, permettant ainsi le retrait de l'implant par une simple traction du chirurgien. Preferably, said movable male element consists of two portions, a distal portion intended to be removed after implant placement and a proximal portion intended to remain in place within the cavity of the stem in order to maintain pressure. on the means anchor so as to keep them in the "deployed" position. In this embodiment, the removal of the proximal portion of the movable male member will cause a passage from the "deployed" position to the "retracted" position of the anchoring means, thereby allowing removal of the implant by a simple traction of the surgeon.
Selon encore une forme d'exécution particulière de l'invention, il est envisagé un ensemble ou kit qui comprend un implant tel que décrit plus haut et un ancillaire tel que décrit plus haut comprenant un élément mâle mobile constitué de deux portions , une portion distale destinée à être retirée après la pose de l'implant et une portion proximale destinée à rester en place au sein de la cavité de la tige afin de maintenir une pression sur les moyens d' ancrage de manière à les maintenir en position « déployée ». According to another particular embodiment of the invention, it is envisaged an assembly or kit which comprises an implant as described above and an ancillary as described above comprising a movable male element consisting of two portions, a distal portion to be removed after implant placement and a proximal portion to remain in place within the stem cavity to maintain pressure on the anchoring means to maintain them in the "deployed" position.
A titre d'exemple non limitatif, comme cela sera illustré plus bas dans les figures, il pourra être utilisé un ancillaire type « seringue » constitué i) d'un corps creux rigide ou semi rigide avec une extrémité adaptée à venir coopérer avec l'extrémité distale de la tige et l'autre extrémité étant ouverte et ii) un élément mâle mobile venant coulisser au sein dudit corps à la manière d'un piston, ledit élément mâle mobile pouvant comprendre deux portions. By way of nonlimiting example, as will be illustrated below in the figures, it may be used an ancillary type "syringe" consisting of i) a rigid body or semi rigid with an end adapted to come cooperate with the distal end of the rod and the other end being open and ii) a movable male member slidable within said body in the manner of a piston, said movable male member may comprise two portions.
L'invention propose également une méthode de fixation d'au moins deux éléments osseux adjacents, mettant en œuvre The invention also provides a method of attaching at least two adjacent bone elements, implementing
l'implant chirurgical selon l'invention, consistant à : the surgical implant according to the invention, consisting of:
- pratiquer un forage présentant les caractéristiques définies par le chirurgien en fonction des éléments osseux à - perform a drill with the characteristics defined by the surgeon according to the bone elements to
solidariser, solidarity,
- insérer la tige dans le forage ainsi pratiqué , puis - insert the rod into the well, then
- déployer ledit au moins un moyen d' ancrage déployable . La présente invention porte selon un mode de réalisation particulier sur un procédé de fixation d'au moins deux vertèbres adjacentes qui met en œuvre un implant chirurgical tel que décrit ci-dessus, ledit procédé consistant à : - pratiquer à l'aide d'un outil de forage un forage présentant les caractéristiques définies par le chirurgien en fonction des vertèbres à solidariser, puis - Deploying said at least one deployable anchoring means. According to a particular embodiment, the present invention relates to a method of fixing at least two adjacent vertebrae which implements a surgical implant as described above, said method consisting in: - practicing with the aid of a drilling tool having the characteristics defined by the surgeon according to the vertebrae to be joined, then
- insérer la tige dans le forage ainsi pratiqué à l'aide d'un outil de pose sous radioscopie médicale, puis - déployer ledit au moins un moyen d' ancrage déployable par application d'une pression sur ledit au moins un moyen d'ancrage de manière à le faire coulisser d'une position « rétractée » à une position « déployée ». inserting the rod into the bore thus made using a medical radioscopic laying tool, then deploying said at least one deployable anchoring means by applying pressure on said at least one anchoring means; so as to slide it from a "retracted" position to a "deployed" position.
Selon un mode plus particulier, la présente invention porte sur un procédé de fixation d' au moins deux vertèbres adjacentes qui met en œuvre un implant chirurgical tel que décrit ci-dessus, ledit procédé consistant à : pratiquer à l'aide d'un outil de forage un forage présentant les caractéristiques définies par le chirurgien en fonction des vertèbres à solidariser, puis  According to a more particular embodiment, the present invention relates to a method of fixing at least two adjacent vertebrae which implements a surgical implant as described above, said method consisting in: practicing with the aid of a tool drilling a drill having the characteristics defined by the surgeon according to the vertebrae to be joined, and then
- insérer la tige dans le forage ainsi pratiqué à l'aide d'un ancillaire tel que décrit plus haut comprenant i) un corps creux rigide ou semi rigide avec une extrémité adaptée à venir coopérer avec l'extrémité distale de la tige et l'autre extrémité étant ouverte et ii) un élément mâle mobile venant coulisser au sein dudit corps à la manière d'un piston appliquer une pression sur l'élément mâle mobile de manière à ce que ce dernier vienne s'insérer au sein de la cavité réalisée à cet effet dans la tige, coulisse le long de la tige de manière à venir buter sur ledit au moins un moyen d'ancrage déployable appliquant ainsi une pression sur ce dernier de manière à ce qu' il puisse passer de la position « rétractée » à la position « déployée ». inserting the rod in the borehole thus made using an ancillary device as described above comprising i) a rigid or semi-rigid hollow body with an end adapted to cooperate with the distal end of the stem and the another end being open and ii) a movable male element sliding inside said body in the manner of a piston applying a pressure on the movable male element so that the latter is inserted into the cavity made for this purpose in the rod, slides along the rod so as to abut on said at least one deployable anchoring means thus applying a pressure on this last so that it can move from the "retracted" position to the "deployed" position.
Selon encore un mode plus particulier, la présente invention porte sur un procédé de fixation d'au moins deux vertèbres adjacentes qui met en œuvre un implant chirurgical tel que décrit ci-dessus , ledit procédé consistant à : According to a still more particular embodiment, the present invention relates to a method of fixing at least two adjacent vertebrae which implements a surgical implant as described above, said method consisting in:
- pratiquer à l'aide d'un outil de forage un forage présentant les caractéristiques définies par le chirurgien en fonction des vertèbres à solidariser, puis - Using a drilling tool, drill a drill with the characteristics defined by the surgeon according to the vertebrae to be joined, then
- insérer la tige dans le forage ainsi pratiqué à l'aide d'un ancillaire tel que décrit plus haut comprenant i) un corps creux rigide ou semi rigide avec une extrémité adaptée à venir coopérer avec l'extrémité distale de la tige et l'autre extrémité étant ouverte et ii) un élément mâle mobile composée d'une portion distale et d'une portion proximale détachables et venant coulisser au sein dudit corps à la manière d'un piston inserting the rod in the borehole thus made using an ancillary device as described above comprising i) a rigid or semi-rigid hollow body with an end adapted to cooperate with the distal end of the stem and the another end being open and ii) a movable male element consisting of a distal portion and a proximal portion detachable and sliding within said body in the manner of a piston
- appliquer une pression sur l'élément mâle mobile de manière à ce que ce dernier vienne s ' insérer au sein de la cavité réalisée à cet effet dans la tige, coulisse le long de la tige de manière à venir buter sur ledit au moins un moyen d' ancrage déployable appliquant ainsi une pression sur ce dernier de manière à ce qu'il puisse passer de la position « rétractée » à la position « déployée » applying a pressure on the movable male element so that the latter comes to fit within the cavity formed for this purpose in the rod, slides along the rod so as to abut on the at least one deployable anchoring means thereby applying pressure thereon so that it can move from the "retracted" position to the "deployed" position
- décrocher la portion distale de l'élément mâle mobile de manière à ce que seule la portion proximale reste au sein de la cavité de la tige afin de faire pression sur ledit au moins un moyen d' ancrage déployable .  - Removing the distal portion of the movable male element so that only the proximal portion remains within the cavity of the rod in order to pressure said at least one deployable anchoring means.
Lorsque le chirurgien le juge applicable en fonction des éléments osseux à assembler et du matériau constituant la tige, il peut être envisagé d'utiliser un outil de forage et de pose qui emploie la tige formant l'implant chirurgical présentant une extrémité distale pointue comme tête de forage. Dans ce mode de réalisation il n'y a pas d'étape de forage préalable lorsque la méthode selon l'invention est appliquée. When the surgeon deems it applicable according to the bone elements to be assembled and the material constituting the stem, it may be envisaged to use a drilling and laying tool which uses the rod forming the surgical implant. having a pointed distal end as a drill head. In this embodiment there is no prior drilling step when the method according to the invention is applied.
On comprendra aisément que la tige de l'implant selon l'invention peut être insérée comme un clou par simple percussion ou toute autre poussée sur son extrémité externe, sans qu' il ne soit nécessaire de lui imprimer un quelconque mouvement de rotation. La tige de l'implant selon l'invention peut même être insérée de la sorte dans un forage ou un logement présentant une certaine courbure, ce qui est rigoureusement impossible pour une vis traditionnelle rigide. Si le forage présente un rayon de courbure constant et se situant dans un seul plan, c'est-à-dire sans torsion, la tige de l'implant selon l'invention pourra être rigide mais devra avoir le même rayon de courbure que ledit forage. Si le rayon de courbure du forage n'est pas constant ou s'il présente une ou plusieurs torsions la tige de l'implant chirurgical selon l'invention devra nécessairement présenter une certaine souplesse . Les caractéristiques de l'invention mentionnées ci-dessus, ainsi que d'autres, apparaîtront plus clairement à la lecture de la description suivante d'un exemple de réalisation, ladite description faisant référence aux figures jointes, parmi lesquelles : la Figure 1 représente une vue en coupe longitudinale de la tige (4) constituant l'implant chirurgical avec les moyens d'ancrage déployables (8) en position « rétractée » ; la Figure 2 représente une vue en coupe longitudinale de la tige (4) constituant l'implant chirurgical avec les moyens d'ancrage déployables (8) en position « déployée» ; la Figure 3 représente une vue de l'implant dans un mode de réalisation classique avec la tige (4) au moment où elle va être insérée dans le forage (5) pratiqué dans deux vertèbres adjacentes (2 ; 3) avec les moyens d'ancrage déployables (8) en position rétractée. Est également représenté un ancillaire constitué d'un corps creux rigide (11) dont l'extrémité proximale (12) vient se positionner au niveau de l'extrémité distale ouverte (7) de la tige (4) et d'un élément mâle mobile (13) en deux portions (13' ; 13'') en position haute; la Figure 4 représente la tige (4) formant l'implant mise en place au sein du forage (5) avec l' ancillaire en place, l'élément mâle mobile (13) toujours en position haute. La flèche représentée sur cette figure illustre la pression qui sera exercée par le chirurgien sur ledit élément mâle mobile (13) ; la Figure 5 représente l'implant ancré au sein des éléments osseux adjacents (2 ; 3) avec l'élément mâle mobile (13) complètement inséré au sein de la cavité (6) de la tige (4) faisant ainsi saillir les moyens d'ancrage déployables (8) vers l'extérieur de la tige (4) comme représenté par les flèches . It will be readily understood that the rod of the implant according to the invention can be inserted as a nail by simple percussion or any other thrust on its outer end, without it being necessary to print any rotational movement. The rod of the implant according to the invention can even be inserted in this way in a borehole or housing having a certain curvature, which is strictly impossible for a traditional rigid screw. If the drilling has a constant radius of curvature and lying in a single plane, that is to say without torsion, the rod of the implant according to the invention may be rigid but must have the same radius of curvature as said drilling. If the bending radius of curvature is not constant or if it has one or more twists the stem of the surgical implant according to the invention must necessarily have a certain flexibility. The features of the invention mentioned above, as well as others, will appear more clearly on reading the following description of an exemplary embodiment, said description referring to the attached figures, among which: FIG. longitudinal sectional view of the rod (4) constituting the surgical implant with the deployable anchoring means (8) in the "retracted"position; Figure 2 shows a longitudinal sectional view of the rod (4) constituting the surgical implant with the deployable anchoring means (8) in the "deployed"position; 3 shows a view of the implant in a conventional embodiment with the rod (4) at the moment when it will be inserted in the borehole (5) made in two vertebrae adjacent (2; 3) with the deployable anchoring means (8) in the retracted position. Also shown is an ancillary device consisting of a rigid hollow body (11) whose proximal end (12) is positioned at the open distal end (7) of the rod (4) and a movable male element (13) in two portions (13 ';13'') in the high position; Figure 4 shows the rod (4) forming the implant placed in the borehole (5) with the ancillary in place, the movable male element (13) still in the high position. The arrow shown in this figure illustrates the pressure that will be exerted by the surgeon on said movable male element (13); 5 represents the implant anchored within the adjacent bone elements (2; 3) with the movable male element (13) completely inserted into the cavity (6) of the rod (4) thus projecting the means of anchoring (8) to the outside of the rod (4) as represented by the arrows.
Cet exemple de mise en place d'un implant selon l'invention décrit la solidarisation de deux vertèbres adjacentes (2 ; 3) grâce à un implant chirurgical tel que décrit ci-dessus. Le mode de réalisation illustré aux figures 1 et 2 fait apparaître une tige (4) de forme courbe avec un arc de courbure régulier. This example of placement of an implant according to the invention describes the joining of two adjacent vertebrae (2; 3) by means of a surgical implant as described above. The embodiment illustrated in Figures 1 and 2 shows a rod (4) of curved shape with a regular curvature arc.
Plus particulièrement, il est représenté à la figure 1 un implant chirurgical selon l'invention constitué d'une tige (4) courbe et creuse de manière à former en son sein une cavité (6) ouverte au niveau de son extrémité distale (7) . Dans ce mode de réalisation, l'extrémité proximale est pleine et se présente sous la forme d'une pointe. La tige (4) représentée comprend dans ce mode de réalisation 4 moyens d'ancrage déployables (8) consistant en des ailettes représentées en position rétractée à l'intérieur de la cavité (6) . La figure 2 illustre l'implant selon l'invention comprenant lesdits 4 moyens d'ancrage déployables (8) représentés en position déployée. Comme cela ressort clairement de cette figure, les ailettes constituant les moyens d'ancrage déployables (8) font saillie vers l'extérieur de la tige (4) de manière à pouvoir venir s'ancrer directement au sein de la matière osseuse constituant les éléments à solidariser. Que ce soit sur cette figure ou sur la figure 1, il est également représenté un mode de réalisation avec l'extrémité distale (7) ouverte de manière à permettre à un fluide ou un ancillaire d'être inséré au sein de la cavité (6) dans laquelle les ailettes (8) sont rétractées et ainsi faire pression sur ces dernière pour les déployer. Selon le mode de réalisation représenté, les ailettes (8) présentent une arrête de base d'une longueur (X) supérieure à la longueur (Y) de l'arrête qui entre en contact avec l'os. More particularly, there is shown in Figure 1 a surgical implant according to the invention consisting of a rod (4) curved and hollow so as to form therein a cavity (6) open at its distal end (7). . In this embodiment, the proximal end is solid and is in the form of a tip. The rod (4) shown comprises in this embodiment 4 deployable anchoring means (8) consisting of fins shown in the retracted position inside the cavity (6). Figure 2 illustrates the implant according to the invention comprising said 4 deployable anchoring means (8) shown in the deployed position. As is clear from this figure, the fins constituting the deployable anchoring means (8) protrude towards the outside of the rod (4) so as to be anchored directly within the bone material constituting the elements. to join. In this figure or in FIG. 1, there is also shown an embodiment with the distal end (7) open so as to allow a fluid or an ancillary to be inserted within the cavity (6). ) in which the fins (8) are retracted and thus press on the latter to deploy them. According to the embodiment shown, the fins (8) have a base stop of a length (X) greater than the length (Y) of the stop which comes into contact with the bone.
La Figure 3 montre une forme de réalisation de l'implant selon l'invention. Il est représenté la tige (4) courbe et creuse avec en son sein une cavité (6) dans laquelle sont repliées les ailettes (8) formant moyen d'ancrage déployable. La tige (4) est représentée alors qu'elle va être insérée dans le forage (5) pratiqué à cet effet par le chirurgien au sein des deux éléments osseux (2 ; 3) à solidariser. Dans ce mode de réalisation, la tige (4) est représentée comme étant introduite et poussée dans le forage (5) via un ancillaire. Comme indiqué plus haut, l'utilisation d'un tel ancillaire n'est aucunement limitative et ne doit être considérée que comme une forme de l'invention. L' ancillaire comprend un corps creux rigide ou semi rigide (11) formant tube, avec une extrémité proximale (12) adaptée à venir coopérer avec l'extrémité distale (7) de la tige (4) et l'autre extrémité étant ouverte de manière à recevoir un élément mâle mobile (13) venant coulisser au sein de la cavité formée par ledit corps creux (11), à la manière d'un piston. L'élément mâle mobile (13) est constitué d'une portion distale (13') destinée à être retirée qui en constitue la partie et d'une portion proximale (13'') destinée à rester insérée au sein de la cavité (6) de la tige (4) . Dans un souci de clarté, la portion distale (13') est représentée hachurée avec des traits espacés alors que la portion proximale (13'') est représentée hachurée avec des traits resserrés. Le corps creux (11) est représenté en coupe en blanc (aucun remplissage) . Selon une forme préférée, l'extrémité proximale (12) est conçue pour venir s'arrimer ou se « clipser » sur l'extrémité distale (7) de la tige (4) . Selon une autre forme de réalisation, l'extrémité proximale (12) présente un diamètre légèrement supérieur au diamètre de l'extrémité distale (7) de la tige (4) de manière à pouvoir venir se positionner par recouvrement autour de ladite extrémité distale (7) de la tige (4) . En pratique, le chirurgien pourra mettre en place l'ancillaire une fois la tige (4) installée dans le forage (5) ou bien utiliser l'ancillaire comme outil pour venir pousser la tige (4) et ainsi l'insérer complètement dans le forage (5) . Une combinaison de ces deux utilisations pourra bien évidemment être faite par insertion manuelle de la tige (4) puis poussée ultérieure avec l'ancillaire. Figure 3 shows an embodiment of the implant according to the invention. It is shown the stem (4) curved and hollow with within it a cavity (6) in which are folded the fins (8) forming anchoring means deployable. The rod (4) is shown while it will be inserted into the bore (5) made for this purpose by the surgeon within the two bone elements (2; 3) to be secured. In this embodiment, the rod (4) is shown as being introduced and pushed into the bore (5) via an ancillary. As indicated above, the use of such an ancillary is in no way limiting and should be considered as a form of the invention. The ancillary comprises a rigid or semi-rigid hollow body (11) forming a tube, with a proximal end (12) adapted to cooperate with the distal end (7) of the rod (4) and the other end being open from to receive a movable male element (13) slidable within the cavity formed by said hollow body (11), in the manner of a piston. The male element mobile (13) consists of a distal portion (13 ') to be removed which constitutes the portion thereof and a proximal portion (13'') intended to remain inserted within the cavity (6) of the stem (4). For the sake of clarity, the distal portion (13 ') is shown hatched with spaced lines while the proximal portion (13'') is shown hatched with narrow lines. The hollow body (11) is shown in white section (no filling). In a preferred form, the proximal end (12) is adapted to engage or "clip" on the distal end (7) of the shaft (4). According to another embodiment, the proximal end (12) has a diameter slightly greater than the diameter of the distal end (7) of the rod (4) so as to be able to position itself by covering around said distal end ( 7) of the rod (4). In practice, the surgeon can set up the ancillary once the rod (4) installed in the borehole (5) or use the ancillary as a tool to push the rod (4) and thus insert it completely into the drilling (5). A combination of these two uses may of course be made by manual insertion of the rod (4) and subsequent push with the ancillary.
La Figure 4 montre la tige (4) une fois positionnée au sein des deux corps vertébraux (2 ; 3) à solidariser. Comme cela ressort de cette figure, la tige (4) est complètement insérée dans le forage (5) et seul l'ancillaire positionné au niveau de l'extrémité distal (7) de la tige (4) est à l'extérieur des vertèbres. A ce stade, l'élément mâle mobile (13) se trouve en position haute, c'est-à-dire engagé au sein du corps rigide (11) formant l'ancillaire mais ne dépassant pas de l'extrémité proximale (12) . Ainsi, à ce stade, l'élément mâle mobile (13) n'est aucunement engagé au sein de la cavité (6) de la tige (4) . Dans le mode représenté, la portion proximale (13'') est complètement insérée au sein du corps creux (11) alors que la portion distale (13') ne l'est pas. Comme cela est également illustré, le chirurgien n'aura plus qu'à appliquer une pression sur l'élément mâle mobile (13) comme cela est représenté par la flèche. Une telle pression aura pour effet d' introduire la portion proximale (13'') de l'élément mâle mobile (13) au sein de la cavité (6) de la tige (4) alors que la portion distale (13') est insérée au sein du corps creux (11) . L'extrémité de la portion proximale (13'') va ainsi venir buter sur les ailettes (8) qui se trouvent rétractées au sein de cette même cavité (6) . Sous cette pression, les ailettes (8) seront propulsées vers l'extérieur de la tige (4) de manière à venir s'ancrer directement dans la matière osseuse formant les vertèbres (2 ; 3) . Dans ce mode de réalisation appliqué à la solidarisation de deux vertèbres, il est illustré les ailettes (8) formant moyen d'ancrage rétractées au sein de la tige (4) et disposées de manière à se trouver positionnées au niveau de la partie osseuse centrale formant chaque vertèbre. De manière préférée, aucune ailette n'est disposée au niveau de la jonction inter- vertèbres. Figure 4 shows the rod (4) once positioned within the two vertebral bodies (2; 3) to be secured. As is apparent from this figure, the rod (4) is completely inserted into the bore (5) and only the ancillary positioned at the distal end (7) of the rod (4) is outside the vertebrae . At this stage, the movable male element (13) is in the upper position, that is to say engaged within the rigid body (11) forming the ancillary but not extending beyond the proximal end (12) . Thus, at this stage, the movable male element (13) is in no way engaged within the cavity (6) of the rod (4). In the shown mode, the proximal portion (13 '') is completely inserted within the hollow body (11) while the distal portion (13 ') is not. As also illustrated, the surgeon will only have to apply pressure to the movable male member (13) as shown by the arrow. Such a pressure will have the effect of introducing the proximal portion (13 '') of the movable male element (13) into the cavity (6) of the rod (4) while the distal portion (13 ') is inserted into the hollow body (11). The end of the proximal portion (13 '') will thus abut on the fins (8) which are retracted within the same cavity (6). Under this pressure, the fins (8) will be propelled outwardly of the rod (4) so as to be anchored directly in the bone material forming the vertebrae (2; 3). In this embodiment applied to the joining of two vertebrae, it is illustrated the wings (8) forming anchoring means retracted within the rod (4) and arranged to be positioned at the central bone portion forming each vertebra. Preferably, no fin is disposed at the intervertebral junction.
La Figure 5 montre l'implant chirurgical dans sa position finale au sein de deux corps vertébraux (2 ; 3) dans notre exemple. Les ailettes (8) sont déployées (comme illustré par les flèches sur le dessin) de manière à être solidement ancrées dans les vertèbres. Les pédicules des vertèbres ne sont pas affectés par la mise en place de l'implant chirurgical, ce qui évite tout problème de faux trajet et/ou de lésion nerveuse ou vasculaire. Il ne reste alors au chirurgien plus qu'à retirer l'ancillaire avec la portion distale (13') de l'élément mâle mobile (13) . Dans ce mode de réalisation, la portion proximale (13'') sera désolidarisée de la portion distale (13'), la portion proximale (13'') restant insérée au sein de la tige (4) de manière à maintenir une pression sur les ailettes (8) . Bien que non représenté, il est aisément compréhensible que le chirurgien pourra facilement retirer l'implant en utilisant 1 ' ancillaire . Ce dernier sera remis en position au niveau de l'extrémité distale ouverte (7) de la tige (4) de manière à permettre à la portion distale (13') de l'élément mâle mobile (13) de venir se solidariser avec la portion proximale (13'') de l'élément mâle mobile (13) restée en place au sein de la cavité (6) de la tige (4) . Le chirurgien n'aura alors plus qu'à retirer l'élément mâle mobile (13) dans son intégralité. Cela aura pour effet de supprimer la pression exercée par la portion proximale (13'') sur les ailettes (8) et ainsi de leur permettre de revenir en position rétractée afin de pouvoir retirer l'implant. Figure 5 shows the surgical implant in its final position within two vertebral bodies (2; 3) in our example. The fins (8) are deployed (as illustrated by the arrows in the drawing) so as to be securely anchored in the vertebrae. The pedicles of the vertebrae are not affected by the placement of the surgical implant, which avoids any problem of false path and / or nerve or vascular injury. All that remains is for the surgeon to remove the ancillary device with the distal portion (13 ') of the movable male element (13). In this embodiment, the proximal portion (13 '') will be disengaged from the distal portion (13 '), the proximal portion (13'') remaining inserted into the stem (4) so as to maintain pressure on the fins (8). Although not represented, it is easily understandable that the surgeon can easily remove the implant using the ancillary. The latter will be returned to position at the open distal end (7) of the rod (4) so as to allow the distal portion (13 ') of the movable male element (13) to become solid with the proximal portion (13 '') of the movable male element (13) remained in place within the cavity (6) of the rod (4). The surgeon will then only have to remove the movable male element (13) in its entirety. This will have the effect of removing the pressure exerted by the proximal portion (13 ") on the fins (8) and thus allow them to return to the retracted position in order to remove the implant.
Lorsque le chirurgien le juge applicable en fonction des éléments osseux à assembler et du matériau constituant la tige (4), il peut être envisagé d'utiliser un outil de forage et de pose qui emploie la tige (4) de l'implant chirurgical présentant une extrémité distale pointue comme tête de forage. Dans ce mode de réalisation il n'y a pas d'étape de forage préalable lorsque la méthode selon l'invention est appliquée. Cette méthode est particulièrement adaptée à la fixation de plusieurs vertèbres adjacentes chez un patient présentant un problème lombaire nécessitant l'intervention d'un chirurgien car elle permet d'éviter l'insertion de vis pédiculaires selon les techniques utilisées actuellement, ce qui est moins invasif et limite grandement les effets secondaires liés à l'opération de fixation des vertèbres. De plus, l'opération peut être envisagée rachis fermé sous contrôle radioscopique, en passant entre les faisceaux nerveux et sans léser les nerfs. Dans un premier temps un forage (5) est réalisé avec un premier outil de forage. Ensuite un outil de pose, pouvant on non consister en l' ancillaire, est employé afin de placer la tige (4) depuis la corticale à travers la partie tendre du premier corps vertébral et enfin vers le second corps vertébral à fixer. Dans un second temps les ailettes (8) formant moyens d' ancrage déployables sont déployées par toute technique connue de l'Homme du Métier. La présente invention porte également sur des trousses ou kits contenant le matériel nécessaire à la mise en œuvre de la méthode décrite ci-dessus. When the surgeon deems it applicable according to the bone elements to be assembled and the material constituting the rod (4), it may be envisaged to use a drilling and laying tool which uses the stem (4) of the surgical implant presenting a pointed distal end as a drill head. In this embodiment there is no prior drilling step when the method according to the invention is applied. This method is particularly suitable for the fixation of several adjacent vertebrae in a patient presenting a lumbar problem requiring the intervention of a surgeon because it avoids the insertion of pedicle screws according to the techniques currently used, which is less invasive and greatly limits the side effects related to the vertebral fixation operation. In addition, the operation can be considered spine closed under fluoroscopic control, passing between the nerve bundles and without damaging the nerves. First, a borehole (5) is made with a first drilling tool. Then a tool of pose, which one can not consist of the ancillary, is used in order to place the stem (4) since the cortex through the soft part of the first vertebral body and finally to the second vertebral body to fix. Secondly, the fins (8) forming deployable anchoring means are deployed by any technique known to those skilled in the art. The present invention also relates to kits or kits containing the equipment necessary for the implementation of the method described above.
Selon une première forme de réalisation, la présente invention porte sur des trousses ou kits contenant un implant chirurgical dans l'un des modes de réalisation détaillés ci- dessus. According to a first embodiment, the present invention relates to kits or kits containing a surgical implant in one of the embodiments detailed above.
Selon une deuxième forme de réalisation, la présente invention porte sur des trousses ou kits contenant un implant chirurgical dans l'un des modes de réalisation détaillés ci- dessus et un ancillaire dans l'un des modes de réalisation détaillés ci-dessus. According to a second embodiment, the present invention relates to kits or kits containing a surgical implant in one of the embodiments detailed above and an ancillary in one of the embodiments detailed above.
Dans un mode de réalisation préféré la trousse ou kit comprend un implant chirurgical de forme courbe et un kit d' ancillaires . In a preferred embodiment the kit or kit includes a curved surgical implant and an ancillary kit.
Selon une troisième forme de réalisation, la présente invention porte sur des trousses ou kits comprenant un implant chirurgical dans l'un des modes de réalisation détaillés ci- dessus, un ancillaire dans l'un des modes de réalisation détaillés ci-dessus, et un outil de forage et/ou un outil de pose de la tige (4) indépendant de 1 ' ancillaire . According to a third embodiment, the present invention relates to kits or kits comprising a surgical implant in one of the embodiments detailed above, an ancillary in one of the embodiments detailed above, and a drilling tool and / or a tool for laying the rod (4) independent of the ancillary.

Claims

REVENDICATIONS
1. Implant chirurgical pour la fixation d' au moins deux éléments osseux adjacents (2 ; 3) d'un patient, constitué d'une tige (4) destinée à être insérée dans un forage (5) pratiqué dans les aux moins deux éléments osseux adjacents (2 ; 3), caractérisé en ce que ladite tige (4) est courbe et creuse de manière à former une cavité (6) suivant sensiblement l'axe de la tige (4) et ouverte au niveau de son extrémité distale (7), ladite tige (4) comprenant au moins un moyen d'ancrage déployable (8) apte à coulisser entre une position rétractée et une position déployée à l'extérieur de la tige (4) une fois cette dernière mise en place au sein du forage (5) de manière à venir immobiliser ledit implant. Surgical implant for fixing at least two adjacent bone elements (2; 3) of a patient, consisting of a rod (4) intended to be inserted into a borehole (5) made in the at least two elements adjacent bone (2; 3), characterized in that said rod (4) is curved and hollow so as to form a cavity (6) substantially along the axis of the rod (4) and open at its distal end ( 7), said rod (4) comprising at least one deployable anchoring means (8) able to slide between a retracted position and a deployed position outside the rod (4) once the latter has been put in place. drilling (5) so as to immobilize said implant.
2. Implant chirurgical selon la revendication 1, caractérisé en ce que ledit au moins un moyen d'ancrage déployable (8) consiste en au moins une ailette. 2. Surgical implant according to claim 1, characterized in that said at least one deployable anchoring means (8) consists of at least one fin.
3. Implant chirurgical selon l'une quelconque des revendications précédentes caractérisé en ce que la tige (4) est réalisée en un ou plusieurs matériaux biocompatibles qui sont flexibles. 3. Surgical implant according to any one of the preceding claims characterized in that the rod (4) is made of one or more biocompatible materials which are flexible.
4. Implant chirurgical selon l'une quelconque des revendications précédentes caractérisé en ce que les portions de la tige (4) positionnées à l'extérieur des éléments osseux (2 ; 3) à assembler sont flexibles. 4. Surgical implant according to any one of the preceding claims characterized in that the portions of the rod (4) positioned outside the bone elements (2; 3) to be assembled are flexible.
5. Implant chirurgical selon l'une quelconque des revendications 1 à 4 caractérisé en qu' il comprend en outre un élément mâle mobile (13) insérable au sein de la cavité (6) de la tige (4) de manière à ce que la tête dudit élément mâle mobile (13) vienne buter contre les moyens d'ancrage déployables (8) et ainsi les pousser pour les faire saillir vers l'extérieur de la tige (4) . 5. Surgical implant according to any one of claims 1 to 4 characterized in that it further comprises a movable male element (13) insertable within the cavity (6) of the rod (4) so that the head of said movable male element (13) abuts against the deployable anchoring means (8) and thus push them to project outwards from the rod (4).
Implant selon la revendication 5, caractérisé en ce que ledit élément mâle mobile (13) est constitué de deux portions, une portion distale (13') destinée à être retirée après la pose de l'implant et une portion proximale (13'') destinée à rester en place au sein de la cavité (6) de la tige (4) afin de maintenir une pression sur les moyens d'ancrage (8) de manière à les maintenir en position « déployée ». Implant according to claim 5, characterized in that said movable male element (13) consists of two portions, a distal portion (13 ') intended to be removed after implant placement and a proximal portion (13' ') intended to remain in place within the cavity (6) of the rod (4) in order to maintain pressure on the anchoring means (8) so as to keep them in the "deployed" position.
Kit comprenant un implant chirurgical selon l'une quelconque des revendications 1 à 6. Kit comprising a surgical implant according to any one of claims 1 to 6.
Kit selon la revendication 7, caractérisé en ce qu'il comprend un ancillaire constitué d'un corps creux (11) avec une extrémité proximale (12) adaptée à venir se fixer sur l'extrémité distale (7) de la tige (4) et d'un élément mâle mobile (13) venant coulisser au sein dudit corps creux (11) et capable de venir glisser au sein de la cavité (6) de la tige (4) de manière à ce que la tête dudit élément mâle mobile (13) vienne buter contre les moyens d'ancrage déployables (8) et ainsi les pousser pour les faire saillir vers l'extérieur de la tige (4) . Kit according to claim 7, characterized in that it comprises an ancillary device consisting of a hollow body (11) with a proximal end (12) adapted to be fixed on the distal end (7) of the stem (4) and a movable male element (13) slidable within said hollow body (11) and able to slide within the cavity (6) of the rod (4) so that the head of said movable male element (13) abuts against the deployable anchoring means (8) and thus push them to project outwardly of the rod (4).
Méthode de fixation d'au moins deux éléments osseux adjacents (2 ; 3) consistant à : A method of attaching at least two adjacent bone members (2; 3) comprising:
- pratiquer un forage (5) présentant les caractéristiques définies par le chirurgien en fonction des éléments osseux (2 ; 3) à solidariser, - Drilling (5) having the characteristics defined by the surgeon according to the bone elements (2; 3) to be joined,
- insérer la tige (4) dans le forage (5) ainsi pratiqué, puis - déployer ledit au moins un moyen d' ancrage déployable (8) . - insert the rod (4) in the borehole (5) thus made, then - Deploying said at least one deployable anchoring means (8).
Procédé de fixation d' au moins deux vertèbres adjacentes (2 ; 3) consistant à : A method of attaching at least two adjacent vertebrae (2; 3) comprising:
- pratiquer à l'aide d'un outil de forage un forage (5) présentant les caractéristiques définies par le chirurgien en fonction des vertèbres (2 ; 3) à solidariser, puis  - Using a drilling tool, drill (5) having the characteristics defined by the surgeon according to the vertebrae (2; 3) to be joined, and then
- insérer la tige (4) dans le forage (5) ainsi pratiqué à l'aide d'un ancillaire comprenant i) un corps creux (11) avec une extrémité proximale (12) adaptée à venir coopérer avec l'extrémité distale (7) de la tige (4) et l'autre extrémité étant ouverte et ii) un élément mâle mobile (13) composée d'une portion distale (13') et d'une portion proximale (13'') détachables et venant coulisser au sein dudit corps creux (11)  inserting the rod (4) in the borehole (5) thus made using an ancillary including i) a hollow body (11) with a proximal end (12) adapted to cooperate with the distal end (7); ) of the rod (4) and the other end being open and ii) a movable male element (13) consisting of a detachable distal portion (13 ') and a proximal portion (13' ') and sliding within said hollow body (11)
- appliquer une pression sur l'élément mâle mobile (13) de manière à ce que ce dernier vienne s'insérer au sein de la cavité (6) réalisée à cet effet dans la tige (4) et coulisse le long de la tige (4) de manière à venir buter sur ledit au moins un moyen d' ancrage déployable (8) appliquant ainsi une pression sur ce dernier de manière à ce qu' il puisse passer de la position « rétractée » à la position « déployée » applying a pressure on the mobile male element (13) so that the latter comes to fit within the cavity (6) formed for this purpose in the rod (4) and slides along the rod ( 4) so as to abut on said at least one deployable anchoring means (8) thereby applying a pressure on the latter so that it can pass from the "retracted" position to the "deployed" position
- décrocher la portion distale (13') de l'élément mâle mobile (13) de manière à ce que seule la portion proximale (13) reste au sein de la cavité (6) de la tige (4) afin de faire pression sur ledit au moins un moyen d'ancrage déployable (8).  - unhooking the distal portion (13 ') of the movable male element (13) so that only the proximal portion (13) remains within the cavity (6) of the rod (4) in order to put pressure on said at least one deployable anchoring means (8).
PCT/EP2017/069096 2016-08-05 2017-07-27 Deployable implant WO2018024617A1 (en)

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