Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
  • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
  • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
  • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
  • A61B17/86—Pins or screws or threaded wires; nuts therefor
  • A61B17/8605—Heads, i.e. proximal ends projecting from bone
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
  • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
  • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
  • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
  • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
  • A61B17/7035—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
  • A61B17/7037—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other wherein pivoting is blocked when the rod is clamped

Definitions

• the present invention relates to the field of vertebral surgery, and more specifically, a pedicle fixation device for vertebral osteosynthesis.
• Vertebral osteosynthesis consists in immobilizing or more generally in binding one to the other of at least two adjoining vertebrae, in order to correct the deformations of the vertebral column. This operation requires, according to the surgical procedure to be performed, the fixation of various types of bone-anchored implants such as pedicle screws associated with connecting rods which are intended to be fixed to the vertebrae, by means of a connecting connector ( clips, hooks, tie rings, caps, connection head, etc.).
• a connecting connector clips, hooks, tie rings, caps, connection head, etc.
• the present invention relates more specifically to a pedicle fixation device applying a multiaxial pedicle screw. STATE OF THE PRIOR ART
• multiaxial type pedicle screws that is to say, allowing, before tightening, an articulation of a connection head, also called “tulip", by relative to a spherical head of the pedicle screw intended to engage with the bone.
• these multiaxial pedicle screws are the most used in vertebral osteosynthesis. Indeed, the multiaxiality facilitates the positioning of a connecting rod cooperating with the pedicle screws through the tulips, especially when these screws are not perfectly aligned and have differences in angulation. The surgical technique is then facilitated and the operation time reduced.
• Such devices are, for example, in particular presented in US-5,554,157, US-5,549,608, US-5,586,984, US-6,280,442, US-6,053,917, US-5,964,760, US -6,010,503, US-5,910,142, US-6,063,089.
• US 2009/0018591 discloses in particular a multiaxial pedicle screw device comprising a threaded section and a spherical head impression for the drive thereof, a removable tulip that locks provisionally on the pedicle screw, and a connecting rod attaching independently to the tulip, this tulip consisting of an outer body of tulip and an inner element of tulip.
• An attachment ring coupled to the tulip is intended to hold the latter on the spherical head thereby blocking any rotational movement.
• this device comprises a cap provided with a plurality of internal protuberances provided to connect by interlocking to the outer body of the tulip so as to compress the tulip and fix the connecting rod engaged therein.
• this device offers the locking of the multiaxialie, it is difficult to implement on the patient during the procedure. Indeed, this type of device is very complex and expensive because of its high number of component parts, and requires successive manipulations that are not intuitive.
• the connecting rod which is housed in the tulip tends to be expelled by the surrounding soft tissues (muscles, ligaments, ...), or hardly remain in place when the deformations are important.
• the establishment of the clamping cap is not always easy, because of a narrow field of view with the risk of interposition of soft tissue in the housing of the tulip.
• the clamping cap can then engage across the tulip, resulting in inefficient clamping of the assembly.
• a multiaxial pedicle fixation device comprising a pedicle screw provided with a head housed in a tulip provided with guide slots for an intervertebral stem.
• the head of the pedicle screw is locked in position by a locking piece inserted in the tulip.
• the intervertebral stem is positioned in the slots, between the locking piece and a cap screwed to the upper end of the tulip.
• the head of the pedicle screw is shaped with concentric sharp edges located opposite a concave bottom portion of the locking piece made of a plastically deformable material.
• the edges of the screw head bite into the soft material of the deformable material of the lower part of the locking piece.
• Such a device proves difficult to disassemble, or to reposition during an intervention.
• the inner surface of the concave lower part of the locking piece is hemispherical, so that it has a greater diameter than the head of the pedicle screw, resulting in a large footprint.
• a pedicle fixation device described in WO 2009/015100, this device comprising a ball-headed pedicle screw housed in a cavity of a tulip, the head being held in position by a locking collar provided with several flexible arms which encircle the spherical head and interpose between the latter and the wall of the cavity.
• the collar is axially movable in the cavity of the tulip, between a position without contact with the wall of the cavity, and a locking position in which the ends of the flexible arms are crushed between the wall of the cavity and the spherical head of the pedicle screw.
• the tulip is provided with slots for guiding an intervertebral stem which rests resting on an upper part of the neck.
• a clamping cap is used to fix the device in position by pressing the rod by means of a pad.
• the device is composed of five parts, rod not included. In addition, it does not allow to hold the rod in position relative to the collar, before the subassembly constituted by the cap and pad is set up and tight.
• WO 2008/124772 is described a pedicle attachment device relatively close to the previous, and having the same disadvantages.
• the invention taken in its various aspects, in particular aims to remedy all or part of the disadvantages of the prior art.
• an object of the invention is to provide a pedicle fixation device for easily blocking in a desired direction the tulip on the spherical head of the multiaxial pedicle screw after anchoring the latter, which allows act directly on the vertebrae to be instrumented.
• Another object of the invention is to provide such a pedicle fixation device which allows to retain the connecting rod in the tulip.
• an object of the invention is to provide such a pedicle fixation device for a durable locking of the assembly in time and easy unlocking when it is necessary.
• An additional objective is to provide such a pedicle fixation device that is simple to implement on a patient.
• a multiaxial pedicle fixation device for vertebral osteosynthesis comprising: a pedicle screw intended to be implanted in the bone part of a vertebra and having a spherical head provided with an impression for the rotational drive of the pedicle screw; a tulip articulated on the spherical head of the pedicle screw, provided with two diametrically opposite lateral slots for receiving a connecting rod; a clamping piece for holding in position the connecting rod engaged in the tulip; and a locking piece interposed between the spherical head of the pedicle screw and the tulip, comprising at least one base formed in a cold compressible material and provided with an elastic deformation capacity to be interposed between the spherical head of the pedicle screw and the tulip and block the tulip in a desirable direction relative to the spherical head of the pedicle screw after implantation of the pedicle screw.
• the capacity of elastic deformation of the base allows the reversibility of the locking of the tulip, exerting pressure on the top thereof, which makes the screw again multiaxial.
• the tulip is preferably made in one piece, so that the device consists of only four pieces, namely the pedicle screw, the tulip, the locking piece and the clamping piece.
• the locking piece is made entirely in a cold compressible material.
• the locking piece is entirely made of a material having an elastic deformation capacity.
• the base or the distal portion thereof being in contact with the spherical head of the screw itself, interposed between the spherical head and the inner surface of the bottom of the tulip, is constituted by a lip progressively thinner towards the distal end of said locking piece.
• the base of the locking piece may have a spherical inner surface.
• the locking piece is made of a material having a hardness coefficient of less than 82 HRB to allow it to deform under the compression action exerted by the clamping means, the deformed locking piece. to lock the tulip on the spherical head of the screw pedicular in one direction, thus locks the multiaxiality of the latter, so that the maneuvers corrections on the vertebrae are facilitated.
• the selected material therefore has a capacity for elastic deformation because of its selected hardness.
• the multiaxiality of the "vis-tulip" assembly is locked and the surgeon can easily and safely operate the maneuvers to instrument the vertebrae.
• the locking piece comprises, in its proximal portion, two diametrically opposed slots, these slots defining two extensions, have a curved profile rising laterally, so as to retain the connecting rod in the tulip simply by pinching and snapping thereby avoiding that said connecting rod is expelled by the surrounding soft tissues.
• the connecting rod is positioned directly in the tulip and held in position by the extensions due to the deformation of the material, which avoids the surgeon manipulation and additional materials.
• the locking piece is produced in a titanium whose hardness coefficient is less than 82 HRB.
• the titanium in which said locking piece is executed has a hardness coefficient of between 50 HRB and 82 HRB.
• the clamping piece consists of a quarter-turn fastener comprising a cylindrical body having an outer face provided with two fins of asymmetrical shape whose distal end is arranged to separate the side walls. of the tulip, and fit into the latter, the cylindrical body comprising an upper face provided with an imprint for driving in rotation of the quarter-turn fastener, by means of a suitable tool.
• the clamping piece is shaped to lock in position simultaneously the tulip on the spherical head of the pedicle screw and the rod of the connection in the tulip.
• the surgeon can lock the entire fixation device in a single gesture, reducing the duration of the operation.
• the fixation remains in place in time without a forced tightening is necessary and once the vertebrae fused, the attachment can be loosened and removed without snapping.
• a multiaxial pedicular fixation device for vertebral osteosynthesis comprising: a pedicle screw intended to be implanted in the bone portion of a vertebra and having a head provided with an impression for the rotational drive of the pedicle screw; a tulip comprising: lateral walls delimiting two diametrically opposite lateral slots for receiving a connecting rod, the side walls having concave side concaving faces, and a bottom forming a lower housing cavity of a lower part of the head of the pedicle screw and a bearing surface for the lower part of the head of the pedicle screw; a locking piece, comprising a base having a concave wall forming an upper cavity arranged facing the lower cavity of the tulip to come into contact with an upper portion of the head of the pedicle screw, the concave wall of the base being shaped to be interposed between the upper part of the spherical head of the pedicle screw and the concave concave faces
• the elastically deformable base of the locking piece is obtained in a locking position of the spherical head of the pedicle screw very simply by wedging the base between the concave recessed faces of the side wall of the tulip and the head of the pedicle screw.
• the surgeon's gesture to obtain this lock is very simple since it suffices to push the locking piece against the head of the lock.
• the pedicle screw holding the tulip in position Conversely, the unlocking is obtained very easily by pressing the tulip, for example by a slight axial shock.
• This locking device is particularly well suited to a pedicle screw whose head is spherical, which makes it possible to very simply perform a multiaxial pivoting of the tulip relative to the head of the pedicle screw in optimal reliability conditions.
• the bearing surface of the lower cavity of the bottom of the tulip is inscribed on a hemispherical geometric envelope having a radius of curvature equal to the radius of the spherical head of the pedicle screw.
• This lower cavity then forms a bowl constituting with the spherical head a pivot connection.
• the concave wall of the locking jig to be inscribed in a hemispherical geometrical envelope having a curvature equal to the radius of the spherical head of the pedicle screw.
• the concave wall of the base of the workpiece is positioned so as to come into contact with an upper part of the head of the pedicle screw along a contact surface including at least one line of circular contact located on a cone of contact centered on the center of the spherical head of the screw small-ttle and having has an opening angle of less than 150 °.
• the contact cone has a nail opening smaller than 120 °, which reinforces the axial component of the resultant of the contact forces between the locking piece and the head of the pedicle screw.
• the locking piece in contact with the head of the pedicle screw is entirely located in a cone centered on the center of the spherical head of the pedicle screw and lower opening angle to 175 ° and preferably less than 170 °.
• the locking piece wraps the head of the pedicle screw on less than one hemisphere, which ensures easy assembly and disassembly.
• this arrangement limits the radial size of the device.
• the recessed faces of the side walls of the tulip are inscribed on the same cylindrical or frustoconical geometric envelope. The cylindrical shape is particularly advantageous since it prevents the resultant of the contact forces between the locking piece and the tulip from having a component in a direction tending to unlock the locking piece.
• a multiaxial pedicle device for vertebral osteosynthesis comprising: a pedicle screw intended to be implanted in the bone portion of a vertebra and having a head provided with a fingerprint for rotating the pedicle screw; a tulip having a reference geometric axis and comprising: lateral walls delimiting two lateral slots located in the same reference geometric plane containing the reference geometric axis, the two lateral slots being diametrically opposed, and a bottom forming a lower cavity of housing a lower portion of the pedicle screw head and a contact and support surface for the lower portion of the pedicle screw head; a locking piece, comprising: a base having a concave wall forming an upper cavity arranged facing the lower cavity of the tulip to come into contact with an upper part of the head of the pedicle screw, and a proximal portion having at least one two extensions delimiting between them two diametrically opposite lateral slots and aligned with the lateral slots of
• the contact surfaces of the extensions have a curved profile, having a concavity preferably complementary to that of the rod.
• the profile of the contact faces may in particular be cylindrical.
• a multiaxial pedicular fixation device for vertebral osteosynthesis comprising: a pedicle screw intended to be implanted in the bone portion of a vertebra and comprising a head provided with an impression for the rotational drive of the pedicle screw; a tulip having a reference geometrical axis and comprising: lateral walls delimiting two lateral slots situated in the same reference geometrical plane containing the reference geometrical axis, the two lateral slots being diametrically opposed, the lateral walls being provided with a clamping interface; and a bottom forming a lower housing cavity of a lower portion of the head of the pedicle screw and a contact and bearing surface for the lower portion of the pedicle screw head; a locking piece, comprising at least one base having a concave wall forming an upper cavity arranged facing the lower cavity of the tulip to come into contact with an upper portion of the head of the pedicle screw; a cylindrical rod engaged in the slots of the tul
• the clamping piece is thus shaped to lock in position simultaneously the tulip on the spherical head of the pedicle screw and the rod of the connection in the tulip.
• the surgeon can lock the entire fixation device in a single gesture, reducing the duration of the operation.
• the fixation remains in place over time without the need for a forced tightening and once the vertebrae have been fused, the fastener can be loosened and removed without snapping.
• the clamping piece is a quarter turn fastener, which allows clamping by a simple screwing gesture with a low angle of rotation, so good ergonomics of use.
• the clamping interface is constituted by thread portions.
• the tulip further comprises a proximal portion having at least two extensions delimiting between them two diametrically opposite lateral slots and aligned with the lateral slots of the tulip in the reference plane, the extensions having faces. contacting one another, the rod engaged in the slot of the tulip being also engaged in the slots of the proximal portion of the locking piece bearing against the contact faces of the extensions following a contact interface having at least one normal perpendicular to the reference axis of the tulip.
• the locking piece is a ring having a central recess, which minimizes the amount of material required for this part, the functional parts of the part being grouped at its periphery.
• the locking piece comprises a force transmission surface for coming into contact with the rod and transmitting to the locking member of the forces exerted on the rod to lock the locking piece.
• This force transmission surface is preferably formed by the bottoms of the slots of the locking piece.
• a pedicle fixation device comprising at least two multiaxial pedicular devices as described above, and a connecting rod adapted to be engaged and locked in the tulips of the teeth.
• two pedaxial multiaxial devices two pedaxial multiaxial devices.
• the connecting rod and the locking piece are shaped in a complementary manner to ensure their attachment by clamping and snapping.
• a pedicle fixation device for vertebral osteosynthesis comprising a pedicle screw having a threaded section intended to be implanted in the bone part of a vertebra and a head.
• spherical device provided with an impression for its drive in rotation and on which is articulated a tulip, this tulip being provided with two diametrically opposite lateral slots for receiving a connecting rod held in position by a clamping means and an interposed locking means between the spherical head of the pedicle screw and the tulip.
• the locking means is constituted by a ring of which at least the base is made of a cold-compressible material, this locking means making it possible to block the tulip in a desirable direction with respect to the spherical head of the screw, as a function of the position of the pedicle screw after anchoring it.
• this ring is made entirely in a cold compressible material.
• the ring or at least the base of the latter is executed in a material with an elastic deformation capacity.
• Figure 1 is an exploded external view of the pedicle fixation device of the invention, illustrating the pedicle screw secured to a tulip, a connecting rod and the clamping means.
• FIG. 2 is an exploded external view of the pedicular fixation device schematizing the pedicle screw, the tulip and the locking means, according to the present invention
• Figure 3 is an axial sectional view illustrating the pedicle attachment device before the establishment of the clamping means.
• Figure 4 is an axial sectional view similar to the previous figure, showing the interposition of the ring between the spherical head and the tulip with the clamping means.
• Figure 5 is a perspective view of the pedicle fixation device which has been shown a single screw, according to the present invention.
• Figure 6 is a top view of the clamping means according to the present invention.
• Figure 7 is an axial sectional view of the fixing device installed on two adjacent vertebrae.
• the term "tulip” adopted by orthopedic surgery professionals and suppliers of orthopedic materials, designates a tulip-shaped connection head that can receive a connecting rod and which is solidariser to a pedicle screw.
• the pedicle fixation device for vertebral osteosynthesis is composed of a bone anchored pedicle screw 10 on the spherical head 12 of which is articulated a tulip 20, a connecting rod 30 and a clamping means 40 for assembling the connecting rod 30 to the screw 10 through said tulip 20.
• the pedicle screw 10 has at least one threaded portion 11 for anchoring thereof in the bony part of a vertebra.
• the threaded section 11 has a double thread.
• the tulip 20 is constituted by a hollow body 28 of generally cylindrical shape comprising, on the one hand, two U-shaped lateral slits 21, diametrically opposed and extending parallel to the axis of said body 28, these slots defining two vertical panels 22 being intended for the reception of a connecting rod 30 of cylindrical shape, and, secondly, a bottom 23 having in its middle an opening 24 in the spherical head 12 is retained in the cavity 25 provided in the bottom 23 of the tulip 20 after the pedicle screw 10 has been inserted into the opening. 24.
• the tulip 20 is thus pivotally mounted on the spherical head 12, multiaxially by the dimensions of the cavity 25 and those of the spherical head 12.
• the upper internal walls 26 of the vertical panels 22 of the tulip 20 delimited by the lateral slots 21, comprise a thread 27 allowing the rotation and the screwing of the clamping means 40 for locking in position of the connecting rod 30 engaged in the tulip 20.
• the clamping means 40 is constituted by a quarter-turn fastener which comprises a cylindrical body 41 comprising on its outer face 42 two fins 43 asymmetrical and diametrically opposite in the form of net segment the height of the net is widened, resulting in retentive clamping in a quarter turn, and loosening also facilitated.
• the cylindrical body 41 has on its upper face 44 and in the middle of said body, an impression 45 for its rotational drive inside the tulip 20 by a suitable tool (not shown), such as a screwdriver or a wrench. Tightening.
• the multiaxial pedicle screw 10 comprises, as can be seen in FIGS. 2 and 3, and according to a characteristic arrangement, a locking element constituted by a locking ring 50 comprising a hollow cylindrical body 51, complementary with the inner wall 26 of the tulip 20 and dimensioned to fit into the latter before and after deformation.
• This ring 50 may be provided already embedded in the tulip 20 or be it before proceeding to the anchoring of the pedicle screw 10 in the bony part of a vertebra.
• the ring 50 can be disencased by exerting an axial pressure on the top of the tulip, which gives the screw its multiaxial character.
• the locking ring 50 has a base or distal portion 52 having a spherical inner surface.
• This base 52 is constituted by an annular lip 57 of approximately triangular section tapering towards the lower opening 53 of said ring 50.
• This annular lip 57 is interposed or is intended to be interposed between the spherical head 12 of the pedicle screw 10 and the tulip 20.
• the base or distal portion of the ring 50 has a spherical internal surface 58.
• This locking ring 50 has in its proximal portion, two opposite lateral slots 55 oriented parallel to its axis, and delimiting two lateral extensions 56 having a curved profile to retain the connecting rod 30.
• the lateral slots 55 of the locking ring 50 coincide with the lateral slots of the tulip 20.
• the connecting rod 30 is thus retained in the ring 50 by a simple pinching and snap-fastening, taking into account the elasticity of the material in which said ring is made, which makes it possible to avoid that said stem is expelled by the surrounding soft tissues.
• At least the base or distal portion 52 of the ring 50 is executed in a cold compressible material.
• the ring 50 is entirely made of a cold compressible material.
• at least the base 52 of the ring 50 is made of a material having an elastic deformation capacity.
• the ring 50 is entirely made of a material with elastic deformation capacity.
• the ring 50 is made of a material having a hardness coefficient of 82 below the Rockwell scale with ball indenter (HRB), which corresponds to a mechanical strength of 530 MPa.
• HRB Rockwell scale with ball indenter
• the material can be elastically deformed by a force F exerted by the quarter-turn fastener 40 of 320 daN.
• the Young's modulus of this material is 110,000 MPa and its elongation capacity is at least 20%. Due to the large elastic deformation capacity of this material, a simple tightening of the quarter-turn fastener 40 makes it possible to create a force F necessary to deform the material elastically.
• the locking ring 50 embedded in the tulip 20 is thus elastically deformable under the clamping force of the quarter-turn fastener 40 in the tulip 20.
• the titanium in which the ring 50 is made is a so-called "soft" or "soft” titanium comprising a hardness coefficient of less than 82 HRB. Preferably, this titanium may have a hardness coefficient of between 50 HRB and 82 HRB.
• This titanium does not exhibit a phenomenon of breaking initiation after deformation and includes all the properties that make the locking ring 50 not harmful to the human body but also that the biological environment does not degrade said ring 50. It will be appreciated that another material having the same features, mechanical characteristics, elastic deformation and biocompatibility could be suitable for forming ring 50.
• the connecting rod 30 can be introduced through the lateral slots 21 which is then held in the operative position by means of the lateral extensions 56 then deformed by said rod. 30.
• the quarter-turn fastener 40 cooperates, through its two fins 43 asymmetrical shaped of segment of thread, with the thread 27 provided in the inner walls 26 of the tulip 20.
• FIGs 5 to 7 show the pedicle fixation device in its locked position.
• two pedicle screws 10 are anchored in the pedicle P or bone part of two adjoining vertebrae VI and V2 with a non-rigid assembly.
• the multiaxiality of the screws being locked, the vertebrae can be instrumented without parasitic movements of the tulip 20 on the spherical head 12 pedicle screws 10.
• the invention also relates to the pedicle fixation device applying at least two multiaxial pedicle screws 10 as described above, and a connecting rod 30 adapted to be engaged and locked in the tulips 20 of these screws.
• the pedicular fixation device comprising at least two multiaxial pedicle screws 10 and a connecting rod 30, the connecting rod 30 and the two locking rings 50 being shaped in a complementary manner to ensure their fastening by pinching and snapping.
• the invention is not limited to the embodiments described by way of example; but it may be implemented in any application covered by the claims.

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• 2010
  • 2010-04-23 FR FR1001743A patent/FR2959113B1/fr not_active Expired - Fee Related
• 2011
  • 2011-02-16 CN CN2011800313462A patent/CN103124534A/zh active Pending
  • 2011-02-16 BR BR112012027136A patent/BR112012027136A2/pt not_active IP Right Cessation
  • 2011-02-16 EP EP11711604A patent/EP2560565A1/de active Pending
  • 2011-02-16 US US13/643,053 patent/US20130123858A1/en not_active Abandoned
  • 2011-02-16 MX MX2012012337A patent/MX2012012337A/es not_active Application Discontinuation
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