WO2013079753A1 - Dispositif pour le traitement d'une pathologie au niveau de la colonne vertébrale - Google Patents

Dispositif pour le traitement d'une pathologie au niveau de la colonne vertébrale Download PDF

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Publication number
WO2013079753A1
WO2013079753A1 PCT/ES2012/070829 ES2012070829W WO2013079753A1 WO 2013079753 A1 WO2013079753 A1 WO 2013079753A1 ES 2012070829 W ES2012070829 W ES 2012070829W WO 2013079753 A1 WO2013079753 A1 WO 2013079753A1
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Prior art keywords
bar
rod
shaped element
shaped
vertebrae
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PCT/ES2012/070829
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English (en)
Spanish (es)
Inventor
Antonio-magin ALONSO ABAJO
Pedro-hector ALONSO ABAJO
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Alonso Abajo Antonio-Magin
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Publication of WO2013079753A1 publication Critical patent/WO2013079753A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/8625—Shanks, i.e. parts contacting bone tissue
    • A61B17/863—Shanks, i.e. parts contacting bone tissue with thread interrupted or changing its form along shank, other than constant taper
    • A—HUMAN NECESSITIES
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    • 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
    • A61B17/7097—Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants
    • A61B17/7098—Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants wherein the implant is permeable or has openings, e.g. fenestrated screw
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    • 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
    • A61B17/8645—Headless screws, e.g. ligament interference screws
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2002/30108—Shapes
    • A61F2002/3011—Cross-sections or two-dimensional shapes
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30476—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism
    • A61F2002/30507—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements locked by an additional locking mechanism using a threaded locking member, e.g. a locking screw or a set screw
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    • A61F2/02—Prostheses implantable into the body
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    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30593—Special structural features of bone or joint prostheses not otherwise provided for hollow
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Definitions

  • the present invention is a device for treating pathologies in the spine. It is within the field of devices used for instrumentation, fixation and prostheses of the spine.
  • the present invention comprises a set of pieces that allow two possibilities that are either to stabilize the vertebral segment in a totally rigid way or to stabilize the vertebral segment allowing limited movement of the vertebral segment. In both cases a percutaneous approach is used.
  • the name of the device (vertebra - intervertebral disc - vertebra or reduced VEDISVER) has its origin in the fact that the device is created with the necessary characteristics to cross two adjacent vertebrae and the intervertebral disc.
  • the spine is a dynamic system composed of rigid elements (vertebrae) and elastic elements (intervertebral discs, ligaments and muscles).
  • the muscles provide movement by acting on the vertebrae, which can be moved harmoniously if the joint elements work correctly and are not damaged.
  • the set formed by two contiguous vertebrae and all ligament elements that hold them together is called the vertebral segment (SV).
  • the intervertebral disc supports 82% of the loads or weights that go down the spine (Panjabi MM. Biomechanical evaluation of spinal fixation devices, Spine, 1988). On the back of the vertebrae are the two posterior joints (apophysis) that transmit the other 18% of the charges, 9% each. (Panjabi MM, 1988).
  • Traumatic fracture, dislocations, herniated discs.
  • Types of surgical procedure on the spine 1.- Open surgery. Wide incisions are made and the part of the spine where the device with direct visualization is implanted is exposed. Using this technique, the device is placed directly. The spine can be accessed by different routes: anterior, anterolateral, posterior and posterolateral.
  • transpedicular fixation systems require introducing four working channels (dilators) and four skin incisions to place the 4 transpedicular screws that are then joined with two bars one on each side.
  • Vertebroplasties, kyphoplasty (introducing cement into a vertebra) or nucleoplasty (puncturing the disc and treating with radiofrequency or injecting some substance into the disc such as ozone, discogel or chymopapain) can be done.
  • Types of devices used to correct instability in a segment of the spine When an item is injured, the rest of the system has a margin of compensation. Small lesions do not affect the whole because they can be compensated, but if the lesions are large, they cannot be compensated and in the movements excessive displacements occur or outside the limits of normal vertebrae.
  • intervertebral disc contributes 82% in the distribution of loads that pass through the intervertebral column (Panjabi MM. Biomechanical evaluation of spinal fixation devices, Spine, 1988), the intervertebral disc is paramount in maintaining vertebral stability.
  • the other method is to stabilize the vertebral segment but so that a very limited movement is possible. This is intended to be achieved through dynamic stabilization systems.
  • both the stabilization of the two vertebrae rigidly and the stabilization of the two vertebrates dynamically are generally performed with three types of surgical instrumentation systems:
  • transpedicular screws are implanted that join with two bars (transpedicular systems).
  • intervertebral disc is removed and, once removed, some intersomatic screws or boxes (interbody systems) are implanted in the disc space. > Or the two previous systems are used at the same time (circumferential system that is only used in rigid systems).
  • transpedicular fixations require in most cases conventional open surgery and have associated the problems of open surgery.
  • a small number of devices are designed to be placed with minimally invasive surgery and in these cases their implantation in the human body requires two 3-4 cm incisions in the back, one on each side of the spine. Although it is called minimally invasive, it is necessary to open and cut muscular and ligamentous structures. Subsequently the tissues that have been cut will have to heal.
  • transpedicular devices that can be placed percutaneously. For placement they need to make four incisions in the back, two on each side of the spine. In addition its placement requires cutting the dorsal fascia and muscle tissue inside to be able to introduce the bars that join the different screws and assemble the system. For these reasons, although surgery is called percutaneous, it is a rather aggressive surgery that requires cutting many tissues.
  • 3 - Circumferential fixation systems It is one more step by which the two systems are added in the same patient; intersomatic and transpedicular. In this case, an intersomatic device and a transpedicular device must be placed, which means a lot of instrumentation and shows that transpedicular systems and intersomatic systems do not solve the problem completely.
  • 4 - Anterior fixation systems with plate There are devices that implant thick metal plates anteriorly or anterolaterally. These plates are attached to the vertebrae by screws. They are usually used in vertebral trauma when the vertebrae are very damaged.
  • the ideal fixation would be a system that totally blocked the movement between the two vertebrae, which at the same time transmitted most of the weight through it and that did not have risk of fatigue fracture. If we can add that it can be introduced percutaneously, we would be faced with the ideal method of fixation. It would work as a circumferential system, although it would be completely different, and would not require aggressive surgery.
  • the system described in this patent is a device that completely immobilizes the vertebral segment in the three axes of the space and that can be implanted by percutaneous surgery that in this case will be very little aggressive compared to all current systems.
  • Dynamic transpedicular systems Another way of partially conserving the movement of the vertebral segment is by using a transpedicular fixation device that contains in the bars that connect the screws a mobile system that allows small movements of the vertebral segment. These devices are called dynamic transpedicular fixation devices and are usually implanted by open surgery. Examples of such devices are patents:
  • the invention relates to a device for the treatment of pathologies in the spine that cause instability between two or more vertebrae of the spine or an alteration of the intervertebral disc, these pathologies being of congenital, traumatic, degenerative, infectious or tumor origin .
  • the proposed device directly fixes the vertebral bodies together with the disc and is totally different from both transpedicular and intersomatic fixation systems that currently exist.
  • the vertebral segment is given more stability than the stability offered by the transpedicular systems and by the current intersomatic systems.
  • the device comprises rod-shaped elements that are introduced through the bodies of the two vertebrae to be stabilized and the disc that joins them, to give rise to a stable fixation to a vertebral segment.
  • the surgical method to place the device is performed with percutaneous surgery, which can be unilateral (making only one incision and entering only on one side of the spine with a single rod-shaped element) or bilateral (making two incisions, entering through both sides of the spine and using two bar-shaped elements).
  • percutaneous surgery which can be unilateral (making only one incision and entering only on one side of the spine with a single rod-shaped element) or bilateral (making two incisions, entering through both sides of the spine and using two bar-shaped elements).
  • the back or side of the vertebra is accessed with an orientation directed towards the center of the disc to be stabilized. Subsequently, the body of that vertebra, the intervertebral disc and the body of the adjacent vertebra are perforated and the device is implanted without the need for open surgery.
  • the first tool used during the percutaneous surgery procedure is a cannulated trocar that allows to reach the center of the disc from one side or from both sides in case of using two rod-shaped elements.
  • a long metal rod 50-60 cm long is passed through the center of the intervertebral disc. This metal rod serves as a guide in the next steps of the surgery.
  • dilators On the metal rod they are superimposed (following through its outer part) dilators of progressively larger diameters, until a dilator with the appropriate diameter to the implant is placed.
  • This last dilator will serve as a working channel and will have a diameter of 6 to 14 mm and a length of 200 to 400 mm.
  • the dilator separates the skin and muscles until it reaches the vertebra. Subsequently, the device will be introduced in the form of a bar through this last dilator that should be hollow.
  • the configuration of the device in the form of a bar that extends longitudinally is that which allows the insertion of this device between vertebrae and that is introduced through the dilator given the tubular configuration of the latter.
  • the rod-shaped device will be positioned so that it crosses the two adjacent vertebrae and the intervertebral disc so that the vertebral segment is stable.
  • the implant will consist of one or several rod-shaped elements that give rise to the device of the invention and which are to be placed between the vertebrae.
  • the rod-shaped elements extend along a longitudinal axis and comprise at one end means of linking with a tool to allow the insertion and manipulation of the device by percutaneous surgery. Using this tool it is possible to push, pull, turn and manipulate the rod-shaped element until it can be positioned in its final position.
  • a tool to allow the insertion and manipulation of the device by percutaneous surgery. Using this tool it is possible to push, pull, turn and manipulate the rod-shaped element until it can be positioned in its final position.
  • particular ways of linking between the tool and the bar-shaped element will be shown.
  • the device presented in this patent may comprise in some of the exemplary embodiments a second rod-shaped element that extends along a longitudinal axis.
  • This second rod-shaped element if used, has one of the means of linking with a tool to allow insertion and manipulation between vertebrae by percutaneous surgery.
  • this second rod-shaped element is introduced through another dilator that has been placed on the other side of the spine by percutaneous surgery. If more than one bar-shaped element is used, it is sometimes possible to couple the two bar-shaped elements.
  • different surface finishes are incorporated to facilitate insertion by an axial movement coinciding with the longitudinal axis of the bar element or by a turning movement using an external thread.
  • the device described in this patent can function as a rigid fixation system or allow a small movement functioning as a dynamic stabilization system or as a mobile prosthesis. If in the central part of the bar-shaped element a joint is placed that allows the appropriate degrees of movement to each vertebral segment, we will have a structure anchored in the two vertebrae and that allows only small movements to be made. In each plane the mobility and the angle of rotation can be limited to between four and ten degrees, depending on the vertebral segment to be fixed.
  • a rod-shaped element that crosses the two vertebrae and the intervertebral disc is placed.
  • Emulating carpentry work it would be similar to what is done with a dowel or spike that joins two pieces of wood. If a second block or spike is placed in a different plane from the previous one, the solidity of the system would be complete unless the block or spike is broken.
  • the basis of the device is similar to that described for joining pieces of wood, but in this case it will fix the vertebral elements and the intervertebral disc.
  • part of the weight will continue to pass through the intervertebral disc from one vertebra to the other with the advantage that the set of vertebrae and the intervertebral disc is fixed and forced to transmit that weight.
  • the advantage of all this is that the section of the bar-shaped element can be reduced without losing load transfer capacity. This is particularly important with the spine in motion since in these situations the weight to be transmitted is multiplied by 3 or 4 times if compared to the rest effort.
  • a rod-shaped element would be used that would be placed either by displacement according to the longitudinal axis of the device or by rotation around the longitudinal axis.
  • larger diameter screws will be used. Therefore, using a 7 mm bar-shaped element, the elements will be fixed more rigidly than if a 5 mm one is used.
  • the fixation will also be greater than in the case of using a threaded rod-shaped element that is introduced by rotation. This is because with the rod-shaped element that has no thread and that has longitudinal striations, a vertebra cannot rotate on it and differently than the other vertebra does, so that the entire vertebral segment will move jointly.
  • Weight damping is achieved by providing the central area with a closed device.
  • this closed device there are numerous options, for example:
  • the functioning ring fibers will perform their work in better conditions because they are subjected to lower loads.
  • the intervertebral disc ring fibers are not going to have to function in situations of extreme elongation because they have limited movement.
  • the disc space will continue to maintain its height and the intervertebral space will not be welded.
  • the intervertebral space is welded in the case of rigid systems and this is not a problem because it is what is sought.
  • the intervertebral space is welded between 10% and 30% of cases in which a mobile prosthesis is placed, and this is a problem, since after years the prosthesis ceases to be mobile, welds and stops working.
  • the bar-shaped device presented in this patent has many medical advantages for patients and also for surgeons when compared to current methods and current devices that are placed by open surgery and minimally invasive surgery. These advantages are mostly given by the fact that this rod-shaped device can be placed using non-aggressive percutaneous surgery. All the following advantages are compared to the current systems where the problems indicated below occur. Among all the advantages of this new system, the following can be named:
  • the surgery can be done in thirty minutes, compared to the current systems that need at least two or three hours. Therefore, a lot of time is saved in the operating room (it is saved in facilities and personnel).
  • Patients can begin to perform normal activity from 48-72 hours of the operation compared to the two to three months they need with current systems. This will be a great advantage for freelancers, for workers and for athletes who can work or compete much sooner. It also does not need to carry an external immobilization system (corset, girdle, etc., which are used in some of the current systems).
  • FIG. 1 It shows in diagram a representative drawing of an anteroposterior X-ray projection of two vertebrae (VI and V2) that are joined by the intervertebral disc (Di ). Crossing both vertebrae and the intervertebral disc shows an example of embodiment of the device (D).
  • FIG. 2 It shows in diagram a representative drawing of a lateral X-ray projection of two vertebrae (VI and V2) and the intervertebral disc that joins them (Di). Crossing the two vertebrae and the intervertebral disc can be seen an example of embodiment of the device (D).
  • FIG. 3 Schematically shows a drawing of the section of two vertebrae (VI and V2) and the intervertebral disc that joins them.
  • Crossing both vertebral bodies and the disc shows an embodiment with two bar-shaped elements (DI and D2).
  • the two rod-shaped elements are coupled in the central part through a central perforation in the device of greater section (DI), so that the device in the form of a bar of smaller section (D2) it crosses the perforation of the device of greater section (DI).
  • the two bar-shaped elements form a cross-shaped structure once placed. In other embodiments, they do not need to be coupled.
  • FIG. 4 Shows an example of realization of a bar-shaped element in perspective.
  • the rod-shaped device has a circular cross-section and a cone trunk shape, with one of the bases having a diameter slightly smaller than the diameter of the other base.
  • This device contains three differentiated parts (4.1, 4.2 and 4.3) with different properties. It also has transverse perforations (4.1.2 and 4.3.2), means of linking with the tool that will be used to introduce the rod-shaped element during the surgical operation (4.3.3 and 4.3.4) and a longitudinal central perforation ( 4.3.5).
  • FIG. 5 Shows in perspective another particular embodiment with cylindrical shape (instead of cone-shaped) and circular section. It is implanted with a rotation displacement around the longitudinal axis. The last thread pitch of the end that attaches to the manipulation tool has a diameter greater than the diameter of the rest of the thread (5.3.6). Threading is discontinuous for prevent the movement of the device inside the vertebrae (5.1.1 and 5.3.1).
  • the element contains three differentiated parts (5.1, 5.2 and 5.3) with different properties. It also has transverse perforations (5.1.2 and 5.3.2), means of linking with the tool that will be used to introduce the rod-shaped element during the surgical operation (5.3.3 and 5.3.4) and a longitudinal central perforation ( 5.3.5).
  • FIG. 6 It shows another example of perspective embodiment of a rod-shaped element with a cylindrical shape but whose highlights are the vertices of a regular hexagon that has been taken as the basis for the embodiment.
  • the projections have a longitudinal direction (6.1.1 and 6.3.1).
  • the rod-shaped device is positioned by a displacement in the direction of the longitudinal axis.
  • the element contains three differentiated parts (6.1, 6.2 and 6.3) with different properties. It also has transverse perforations (6.1.2 and 6.3.2), means of linking with the tool that will be used to introduce the bar-shaped element during the surgical operation (6.3.4) and longitudinal central perforations, one on each side ( 6.1.5 and 6.3.5).
  • FIG. 7 Shows, in perspective, another embodiment of a rod-shaped device that is introduced by a displacement in the direction of the longitudinal axis (pressing inwards).
  • This bar-shaped device has along its outer surface ridges or projections that go in the direction of the longitudinal axis and which are continuous (7.1.1 and 7.3.1).
  • the section of this exemplary embodiment of the rod-shaped device is hexagonal.
  • the element has means of linking with the tool that will be used to introduce the rod-shaped element during the surgical operation (7.3.4) and longitudinal central perforations on both sides (7.1.5 and 7.3.5).
  • FIG. 8 Shows a particular example of embodiment, in perspective, of a cylindrical device.
  • This rod-shaped device has an external thread to be introduced by a rotational movement around the longitudinal axis (8.1.1 and 8.3.1).
  • the particular feature of this exemplary embodiment is that the bar-shaped element has a through hole (8.2.1) in the central area that crosses the bar-shaped element in its entire thickness to thus allow the passage of another device in bar shape of smaller diameter across it.
  • FIG. 9 Shows an exemplary embodiment, in perspective, of a bar-shaped element with a square section at the ends and circular in the middle.
  • This rectangular bar-shaped element is introduced during percutaneous surgery by a displacement along the longitudinal axis of the element.
  • the projections in the longitudinal direction (9.1.1 and 9.3.1) will help to fix the element once it has been introduced.
  • the rod-shaped device is positioned by a displacement in the direction of the longitudinal axis.
  • the element contains three differentiated parts (9.1, 9.2 and 9.3) with different properties. It also has transverse perforations (9.1.2 and 9.3.2) and means of linking with the tool that will be used to introduce the rod-shaped element during the surgical operation (9.3.4).
  • This particular embodiment shows a diagram of the central area of a rod-shaped element that is articulated to allow a Limited movement of the vertebral segment once the device is placed and crosses the two vertebrae and the intervertebral disc.
  • This exemplary embodiment would be used to achieve dynamic stabilization of the vertebral segment and uses a bolt (10.2.2) and bowl (10.2.3) system as a joint.
  • FIG 11. This particular embodiment shows a diagram of the central area of a rod-shaped element that is articulated to allow limited movement of the vertebral segment once the device is placed through the two vertebrae and the intervertebral disc.
  • This embodiment would be used to achieve dynamic stabilization of the vertebral segment and uses a spring system as a joint (11.2.1).
  • This example of realization of the central zone differs from the previous one in that it allows to absorb loads.
  • FIG 12. This particular embodiment shows a diagram of the central area of a rod-shaped element that is articulated to allow limited movement of the vertebral segment once the device is placed through the two vertebrae and the intervertebral disc.
  • This exemplary embodiment would be used to achieve dynamic stabilization of the vertebral segment and uses an internal elastomer to absorb the loads (12.2.1).
  • the device described in this patent has a basic conformation consisting of a rod-shaped element.
  • This bar-shaped element is a continuous element, but for a detailed explanation of the device three different parts or zones of the bar-shaped element are described. These parts of the device will be referred to hereinafter:
  • part one of the rod-shaped device will be inside the body of vertebra one. This part will be the first part of the element introduced during percutaneous surgery.
  • part two of the bar-shaped device will be inside the intervertebral disc. This part will be the central part of the element.
  • part three of the rod-shaped device will be inside the body of vertebra two.
  • This part will be the last part of the element introduced during percutaneous surgery.
  • this part has means of linking with the tool that is used for the insertion of the element.
  • the rod-shaped element will have the appropriate and necessary length to cross the vertebral segment formed by two adjacent vertebrae and the intervertebral disc that joins them.
  • the rod-shaped element will measure 70 to 100 mm in length, but other different measures may be possible depending on the patient.
  • the section of the bar-shaped element may be any section, although it will generally be a circular or polygonal section to facilitate the construction and handling of these bar-shaped elements. This patent will explain two particular models of realization; a circular section model (fig.
  • the diameters of the bar-shaped device section will be appropriate for each patient.
  • bar-shaped elements with a minimum diameter of 3 mm can be placed, while the maximum diameter will be limited by the working channel used.
  • the diameter should be slightly larger than in the case of rigid fixation devices since the bar-shaped elements with a central joint have a greater risk of breakage.
  • Bar-shaped elements can be made of metal alloys. The most appropriate are those of titanium due to osseointegration capacity and magnetic resonance compatibility (RJVIN). Titanium also has other mechanical resistance properties. Bar-shaped elements can also be made of steel and other metal alloys (chrome, cobalt ). Another type of materials that are appropriate are polymers.
  • polyether ether ketone for example, PEEK
  • PEEK polyether ether ketone
  • Other materials that can be used may be ceramics, composites or polyethylenes.
  • the surface of the materials in the areas of contact with the bone may be laser treated in order to provide a rough surface or a porous surface that facilitates the adhesion with the bone.
  • the surface of the parts of the rod-shaped element that are in contact with the bone of the vertebrae can be treated with a layer of osteoconductive and / or osteoinductive material in order to accelerate the integration process of the device with the bone tissue of the vertebrae.
  • These embodiments have a circular section and are introduced into the vertebral segment formed by the vertebrae and the intervertebral disc by means of a rotation movement around the longitudinal axis that bolts the device into the vertebral segment.
  • the bar-shaped element described in this exemplary embodiment is a unique and continuous element, but for a better understanding of the device, the bar element has been divided into the three parts described in the previous section.
  • Each part of the rod-shaped device can have different perforations and interior and exterior surfaces.
  • the vertebra one (VI) and the vertebra (V2) will be indicated, and in the figures shown the vertebra one appears above and the vertebra two below, but this can be the other way around and the vertebra one (VI) it may be below vertebra two (V2) depending on whether it is decided to introduce the rod-shaped element from top to bottom as in the embodiment examples or from bottom to top.
  • Part one (4.1, 5.1 and 8.1). This part, once the device is placed, will be housed in the body of one of the vertebrae (VI) that will be stabilized.
  • the structure of this part presents particularities that are aimed at facilitating the integration of this part with the bone and its fusion with the bone tissue of both the cortex of the vertebra and the spongy.
  • the outer surface has an external thread (4.1.1; 5.1.1 and 8.1.1) that facilitates the insertion of the device by turning the element.
  • the external threading can be continuous as in the case of Figures 4 and 8 of the exemplary embodiments or it can be discontinuous as in the case of Figure 5 where the discontinuous threading forms ridges or projections in a transverse direction to facilitate grip and avoid the movement once bone growth occurs.
  • Part one may have a hole or central perforation (similar to that seen in Figures 6.1.5 and 7.1.5) that extends along the longitudinal axis.
  • This inner perforation can be threaded or smooth.
  • Part one may have perforations (4.1.2, 5.1.2 and 8.1.2), which cross in the transverse direction and communicate with the central perforation (similar to that of Figures 6.1.5 and 7.1.5). These transversal perforations are distributed over the surface and have two purposes:
  • cement can be introduced through the central perforation, and this cement leaves from the central perforation to the outside through the transverse perforations and extends through the body of the vertebra, thus facilitating a solid union of the piece to the bone once the cement has solidified. This is useful in patients with vertebrae with low bone density.
  • this part one can be cylindrical or cone-shaped, with the base continuing with part two slightly larger than the other base to facilitate insertion.
  • this part one of the rod-shaped element will be those necessary to cover the entire vertebral body between two cortices, the average dimensions of part one of the device will be around 40 mm in length and the diameter may be between 3 to 12 mm depending on the patient and the vertebral level to be fixed.
  • This part one of the rod-shaped element has two ends, one free end that once placed will be in contact with the anterior or lateral cortex of the vertebra (VI), and the other end that continues with part two.
  • the free end may be a little thinner or sharp to better pierce during percutaneous surgery. In the case of carrying a central perforation, the free end may have this central part plugged or closed.
  • Part 2 (4.2, 5.2 and 8.2). It is the central part of the bar-shaped element. Once the device is placed in its final position, part two will be inside the intervertebral disc (Di) that joins the two vertebrae, through this intervertebral disc. This part two will continue at each of its ends with parts one and three respectively. This central part presents different embodiments that are what will give the device the different properties and possibilities.
  • this part two of the device is of circular section and lacks projections and perforations although other configurations are possible.
  • the outer surface of this part two of the rod-shaped element does not carry perforations. This prevents bone formation at the disc level.
  • This part can be perforated by means of a longitudinal central perforation or it can be solid to give more robustness to the device.
  • the perforation may cross the entire rod-shaped element along the longitudinal axis, in which case the perforation will also pass through parts one and three, or it may only be partially perforated.
  • part two vary according to the patient and according to the area of the spine, since the length of this part of the device will depend on the height of the intervertebral disc where this part will be located once it has been implanted. Usually, this part two will have a length of about 20 mm and a diameter that will be the same as the diameter of the rest of the rod-shaped element. There are two embodiments of this part two that give new properties to the bar-shaped element:
  • part two of the device has a transverse through hole that crosses it from one side to the other (8.2.1).
  • This transverse through hole can be circular or have any other section. For example, it may have an oval shape with a major axis along the longitudinal axis of the bar-shaped element.
  • This perforation will allow, in some embodiments, to introduce a second rod-shaped element therethrough.
  • This second bar-shaped element will have a smaller section since it can pass through the transverse through-hole of the first bar-shaped element.
  • the two rod-shaped elements can be coupled and, once placed in the patient, obtain a cross-shaped structure that completely fixes the two vertebrae to stabilize.
  • the second rod-shaped element can pass through the first element and these will be coupled. In other embodiments it is not necessary for the second element to pass through the first and both elements could simply cross. If we want the rod-shaped elements to be coupled, we can provide these specific coupling elements.
  • this part two may have a joint (fig.
  • Figures 10, 11 and 12 show only the central part of the bar-shaped element, so to get an idea of the complete element it is necessary to replace in parts 4, 5, 6, 7 and 9, parts 4.2, 5.2 , 6.2,
  • this part two of the device was provided with the articulated mechanism to allow certain movements, this part two would not be perforated longitudinally (as in figure 8), since in the central area of this part the dynamic device would be located.
  • this part two would not be perforated longitudinally (as in figure 8), since in the central area of this part the dynamic device would be located.
  • FIG. 10 shows a spherical joint that allows the movement of flexion-extension, lateral inclination and rotation.
  • the operation will be that of a bolt and the limitation of movement may be given by the bolt clearance.
  • the bolt (10.2.2) would have a spherical outer surface in contact with a bowl (10.2.3) with a spherical inner surface, which would allow the sliding of one over the other.
  • the sliding surfaces between bolt and bowl (10.2.1) may be ceramic coated, including zirconia, to reduce friction.
  • FIG. 11 Another embodiment of part two (fig. 11) allows movement in flexion-extension, lateral inclination, rotation and also has a spring mechanism (11.2.1) that can also be a crossbow that allows compression of 2 -4 mm in the direction of loading thanks to the internal device.
  • the other movements are determined by the clearance between the outer bowl (11.2.2) and the internal pivot (11.2.4).
  • the internal pivot (11.2.4) serves to keep the spring fixed within the mechanism and to allow maximum movement, since when the spring is compressed due to pressure forces, the internal pivot will collide against the external bowl preventing the spring from compress more.
  • Figure 11.2.6 shows a cross section of this part 11.2, this cross section having been made in the place indicated by the dashed line, so that the cross section shows a section of the spring (11.2.1) and the internal pivot (11.2 .4).
  • the figure also shows a pin (1 1.2.3) that is used to fix the position of the device at the time of insertion.
  • This cross section (11.2.5) is made at the height of the internal pin as indicated by the dashed line.
  • This pin can be an accessory screw threaded on one of the sides of the bowl, the rest of its surface being smooth.
  • part three may have a continuous (4.3.1 and 8.3.1) or discontinuous (5.3.1) threading on its outer surface.
  • This part may have transverse perforations (4.3.2, 5.3.2 and 8.3.2).
  • the function of these transverse perforations is to communicate the exterior with the central longitudinal perforation (4.3.5, 5.3.5 and 8.3.5) in the same way and with the same objective that has been exposed in the transversal perforations existing in part one Of the device.
  • This part may have its own characteristics and different from the characteristics of part one. These characteristics of part three can be:
  • the central internal duct can be threaded (4.3.4; 5.3.4 and 8.3.4). This thread serves to thread a rod inside.
  • the rod will serve as a gripping element with the tool used to manipulate the rod-shaped element during its insertion, extraction and manipulation.
  • the last thread pitch (the closest to the central part of the device), may be 0.5-1 mm more in diameter (5.3.6, 8.3.6) than the rest of the threaded to completely avoid the possibility of migration of the device in the direction of the free end of part one, that is to say to prevent the migration of the device inwards.
  • This migration of the device is practically impossible in the general embodiment of the device in the form of a bar, so that if the last thread pitch is of a greater thickness, any possibility of migration of the device is eliminated.
  • Part three can carry on the free end a polymer cap, to prevent the formation of bone tissue on that end.
  • Part three may have a cone trunk shape, with a slightly larger diameter at the base corresponding to the grip area with the manipulation tool, that is to one end.
  • the cone trunk shape of parts one and three is another way to prevent the migration of the device.
  • This embodiment example generally has a polygonal section although it can have any other section.
  • the rod-shaped element is introduced in this case into the vertebrae and through the intervertebral disc by means of an axial displacement movement along the longitudinal axis or, what is the same, by means of an inward pressure movement. Therefore, instead of using a rotating movement, the device is pressed into the intervertebral segment.
  • the bar-shaped element described in this exemplary embodiment is a unique and continuous element, but for a better understanding of the device the bar-shaped element has been divided into three parts that can have different perforations and interior and exterior surfaces, as well As different functions.
  • the bar-shaped elements which are introduced by displacement along the longitudinal axis and not by rotation around the longitudinal axis, consist of three distinct zones as in the embodiments of the previous section; part one, part two and part three.
  • Part one (6.1, 7.1 and 9.1): it can be shaped like a prism, cylinder or trunk of a pyramid or cone with a polygonal or circular base and with the diameter of the base of the free end that can be a little smaller than the diameter of the base from the end that continues with the rest of the bar-shaped element (part two).
  • This part one will have a free end that will be housed inside the first vertebra (VI), while the other end will continue with part two, being also housed inside the vertebra.
  • ridges or projections (6.1.1, 7.1.1 and 9.1.1) that follow the direction of the longitudinal axis.
  • These projections can be continuous (7.1.1) or discontinuous (6.1.1 and 9.1.1). Its purpose is to leave part one inside the vertebral body of the first vertebra (VI) in a fixed position.
  • the longitudinal direction of the ridges or projections is necessary because the insertion of the rod-shaped element is done by displacement along the longitudinal axis of the device.
  • the device will be inserted through the vertebrae and the disc following a conduit with grooves.
  • the conduit will be made at the beginning of the intervention with a cylindrical drill whose diameter is equal to the outside diameter of the element without the ridges.
  • the grooves can be pre-carved with a chisel that has a section the same as the device section. Once the device is placed, part one will remain inside vertebra VI, part two will remain inside the intervertebral disc (Di) and part three it will remain inside the body of the second vertebra (V2), as can be seen in figures one and two.
  • Part one may have a central perforation, along the longitudinal axis, (6.1.5, 7.1.5 and 9.1.5) and transverse perforations (6.1.2, 7.1.2 and 9.1.2), which communicate the outer surface with central drilling
  • transverse perforations serve to allow the growth of bone through it or to allow the introduction of cement into the vertebra if necessary.
  • Part two in the bar-shaped elements that are introduced by longitudinal displacement is similar to part two of the devices that are introduced by rotation or rotation movement. The description is similar since this part two can be manufactured in combination with any of the embodiments of the other two parts.
  • Part three the rod-shaped elements that are introduced by axial displacement or by pressure along the longitudinal axis, can be in the form of a prism, cylinder or pyramid or cone trunk, and may have the base of the end that comes into contact with the manipulation instrument of a section slightly larger than the other base, which is the one that continues with part two of the element. It has on its outer surface ridges or projections oriented along the longitudinal axis (6.3.1, 7.3.1 and 9.3.1). These ridges and projections allow the insertion of the device and stabilize part three with the V2 vertebra.
  • Part three may have a longitudinal central perforation (6.3.5, 7.3.5 and 9.3.5).
  • This perforation can be threaded (6.3.4, 7.3.4, 9.3.4) to allow the grip with a similar thread that the handling tool could carry. You can also carry other types of irregularities other than threading to adapt it to the handling tool.
  • On its outer surface it can have transversal perforations that communicate the exterior with the central perforation. The meaning of these perforations is similar to the perforations in part one.
  • Part three has two ends, one end is continued with part two and the other end is free.
  • the free end has means of linking with the manipulation tool for the insertion of the device.
  • This end can be smooth (6.3.3 and 7.3.3) or it can be crenellated (9.3.3) to achieve greater grip with the insertion tool.
  • Part three may carry at the free end a cover of polymeric material to cover this end. In this way, bone formation on that free end will be avoided and in the unlikely event that the element needs to be removed, this will be possible since the lid of polymeric material can be removed and the element can be removed using the manipulation tool .

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Abstract

Selon l'invention, un dispositif pour le traitement de pathologies de la colonne vertébrale comprend un élément en forme de barre, continu qui s'étend suivant un axe longitudinal et qui compte trois parties différentes. Une première partie traverse le corps de deux vertèbres contiguës et le disque intervertébral qui les sépare et qui reste fixée dans la vertèbre distale, une seconde partie qui est la continuation de la première suivant l'axe longitudinal, qui traverse une vertèbre et un disque intervertébral, et reste fixée dans le disque, ladite seconde partie constituant la zone médiane de l'axe longitudinal du dispositif en forme de barre, une troisième partie qui est la continuation de la seconde suivant l'axe longitudinal du dispositif et qui traverse le corps d'une vertèbre proximale et reste fixée dans celle-ci. Le dispositif permet de traverser deux vertèbres contiguës et le disque intervertébral qui les sépare et engendre une stabilisation complète comme un système rigide ou un système dynamique du segment vertébral. Le dispositif permet son implantation dans la colonne vertébrale au moyen d'un abordage chirurgical percutané.
PCT/ES2012/070829 2011-12-01 2012-11-26 Dispositif pour le traitement d'une pathologie au niveau de la colonne vertébrale WO2013079753A1 (fr)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3017780A1 (fr) * 2014-11-04 2016-05-11 Hyprevention Implant destiné à stabiliser des os non fracturés ou fracturés

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US20080033432A1 (en) * 2005-02-15 2008-02-07 Hatch Medical, L.L.C. Percutaneous spinal stabilization device and method
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EP3017780A1 (fr) * 2014-11-04 2016-05-11 Hyprevention Implant destiné à stabiliser des os non fracturés ou fracturés
WO2016071089A1 (fr) * 2014-11-04 2016-05-12 Hyprevention Implant de stabilisation d'os fracturés ou non fracturés
KR20170093133A (ko) * 2014-11-04 2017-08-14 하이프레방씨옹 골절 또는 비골절 뼈의 안정화용 임플란트
JP2017533759A (ja) * 2014-11-04 2017-11-16 ハイプリヴェンション 骨折骨または非骨折骨を安定させるためのインプラント
US10278748B2 (en) 2014-11-04 2019-05-07 Hyprevention Implant for stabilizing fractured or non-fractured bones, use of an implant and method for stabilizing fractured or non-fractured bones
RU2704237C2 (ru) * 2014-11-04 2019-10-24 Ипревансьон Имплантат для стабилизации сломанных или несломанных костей
AU2015342167B2 (en) * 2014-11-04 2019-12-05 Hyprevention Implant for stabilizing fractured or non-fractured bones
EP4018948A1 (fr) * 2014-11-04 2022-06-29 Hyprevention Implant destiné à stabiliser des os fracturés ou non fracturés
KR102538262B1 (ko) * 2014-11-04 2023-05-30 하이프레방씨옹 골절 또는 비골절 뼈의 안정화용 임플란트

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