• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    An expandable intervertebral implant intended to be implanted in a space between two adjacent vertebrae in order to at least partially supplant an intervertebral disc, said implant being able to expander along three substantially orthogonal axes to each other, in order to respect the lordosis of the patient while having stability and increased reliability.
    公开号:FR3058043A1
    申请号:FR1660473
    申请日:2016-10-27
    公开日:2018-05-04
    发明作者:Pierre Bernard；Herve Chataigner；Craig CHEBUHAR；Alexander Kirgis；Ross Sherban；Samuel Lequette；Emmanuel BOUGERE；Aymeric FRESNEAU
    申请人:LDR Medical SAS；
    IPC主号:
    专利说明:

    (54) INTERSOMATIC EXPANDABLE CAGE.
    (57) expandable intervertebral implant intended to be implanted in a space between two adjacent vertebrae in order to at least partially supplant an intervertebral disc, said implant being able to expand along three axes substantially orthogonal to one another, in order to respect the lordosis of the patient while having increased stability and reliability.
    FR 3 058 043 - A1
    EXPANSIBLE INTERSOMATIC CAGE
    TECHNICAL DOMAIN OF THE REQUEST The request relates to the field of intervertebral cages and in general to the field of implants intended to be implanted between two adjacent vertebrae in order to at least partially supplant an intervertebral disc and more particularly, to expandable vertebral implants intersomatic cage type.
    STATE OF THE PRIOR ART In order to remedy certain pathologies, it is sometimes sought to obtain a fusion of at least two vertebrae, for example when at least one of their adjacent intervertebral discs is injured.
    It is known from the prior art various arthrodesis techniques, based on various types of implants, such as, for example, the interbody cages inserted in place of a disc to promote bone growth, arthrodesis and securing between them two vertebrae.
    Such devices are for example illustrated in the patent application FR1651637 filed in February 2016, which has interbody cages to supplant an intervertebral disc.
    In addition, in order to maximize and improve the stability and the volume of graft contained in such implants, these must cover a volume which is as close as possible to the volume occupied by the injured vertebral disc. Implants of the prior art therefore generally have a very large volume making their implantation quite invasive for the patient.
    One solution, used to reduce the size of the implants during their implantation, has been the use of expandable cages as described for example in document EP1699389. Such cages, once implanted, are deployed by the surgeon in order to cover a volume approaching the volume of an intervertebral disc while having a profile making it possible to follow the lordosis of the spine, thus improving comfort for the patient and the stability of the cage.
    However, this type of expandable cage has a number of drawbacks. In particular, during their expansion, the surgeon must exert excessive pressure on the implant since its expansion takes place simultaneously on two axes orthogonal to each other. In addition, it is more difficult for the surgeon to respect a specific lordosis. Finally, this type of implant rests little or not on the cortical bone of the vertebra, but on a softer part of the bone, which reduces its stability and presents a risk of sinking.
    PRESENTATION OF THE REQUEST The object of the present request is therefore to propose an expandable intervertebral implant of the interbody fusion type, making it possible to overcome at least some of the drawbacks of the prior art, by proposing an alternative implant having stability and reliability. increased, easier expansion for the surgeon, while respecting the patient's lordosis.
    To this end, the application relates to an expandable intervertebral implant intended to be implanted in a space between two adjacent vertebrae (V1 and V2) in order to at least partially supplant an intervertebral disc, characterized in that said implant comprises at least:
    • an elongated body along an axis (X) comprised between a proximal end and a distal end defined as being the end intended to penetrate first into said intervertebral space, • at least one pivot arm mounted pivoting with respect to the longitudinal body, between a folded position and a deployed position:
    o in the folded position, said arm is substantially parallel to the axis (X) and runs along the body, o in the deployed position said arm is not parallel to the axis (X) and deployed away from the body and expands said implant according to an axis (Y), substantially orthogonal to the axis (X), • an actuation means of said arm (21) for the deployed from the folded position to the deployed position.
    According to one feature, said at least one pivot arm can be arranged at the distal end of the elongated body.
    According to one feature, said implant can be provided with one or more pairs of pivot arms, the arms of each of the pairs being able to be arranged on either side of the elongated body.
    According to one feature, said pivot arms of each pair can be arranged in an axial symmetry, along the axis (X).
    According to one feature, said implant can be provided with a means for blocking said pivot arm in its deployed position.
    According to one feature, said means for actuating said pivot arm can be a wedge sliding along an axis substantially parallel or collinear with the axis (X).
    According to a feature, said longitudinal body along an axis (X) may comprise at least two sub-parts substantially or at least partially superimposed on each other and linked together at least near the proximal end by at least one articulation.
    According to a feature, each of said sub-parts may include at least one pivot arm.
    According to one feature, said implant can be provided with means for expanding the body along an axis (Z) substantially orthogonal to the axes (X) and (Y).
    According to one feature, the means for expanding the body along the axis (Z), can separate one from the other the distal ends of the two sub-parts.
    According to a feature, said means for expanding the longitudinal body can be formed by said actuating means of said at least one pivot arm.
    According to one feature, said means for expanding the longitudinal body may include at least one lockable link in a deployed position when said implant is expanded along the axis (Z).
    According to one feature, the longitudinal body can be provided with at least one opening at its proximal end, said opening being at least configured to form at least one passage for:
    • at least one tool cooperating with:
    o said means for actuating said at least one pivot arm, at least from the folded position towards the deployed position, o and optionally, said means for expanding the distal end of the longitudinal body along an axis (Z) substantially orthogonal to the axes (X) and (Y), and / or • at least one anchoring device configured to secure said implant to the adjacent vertebrae (V1 and V2).
    It will be noted that the term "substantially" is regularly used in the present description, in particular concerning a characteristic such as an orientation or a direction, so as to indicate that the characteristic concerned may in fact be slightly different and not be exactly as designated (for example, the expression "substantially perpendicular" should be interpreted as "at least approximately perpendicular" because it may be possible to choose an orientation which is not exactly perpendicular in order to nevertheless be able to fulfill substantially the same function). In addition, terms such as the term "substantially" used in the present application can also be interpreted as defining that the technical characteristic may be "in general" ("generally"), and often "preferably", as indicated, but that other embodiments or configurations may be within the scope of the present invention. Thus, terms such as "substantially", "substantially" or "approximately" may be omitted in the present application but it will be clear to those skilled in the art that the definitions of technical characteristics are not limited, even in the absence such terms.
    BRIEF DESCRIPTION OF THE FIGURES Other characteristics, details and advantages of the subject of the application will emerge on reading the description which follows with reference to the appended figures, which illustrate:
    - Figures 1A to 1 E, schematically represent the concept object of the request and its deployment
    - The sets of figures 2A to 2E, 3A to 3D, 4A to 4C, 5A to 6B, 7A to 7D and 8A to 8D and 9A to 9D, correspond to different 3D representations of the present application.
    - Figures 9A to 9D show alternatives to the embodiment of the present application.
    In particular, Figure 3C is a sectional view of the distal end of the representation of the present application illustrated by the set of Figure 3A to 3D, Figure 4C is a detailed view of the distal end of the representation of the present application illustrated by the set 4A to 4C FIG. 6A is a section of the sub-part 2a of FIG. 6B FIG. 8C is a profile view of the representation of the present application illustrated by the set of FIG. 8A to 8D, without arm extensions 210.
    DETAILED DESCRIPTION OF DIFFERENT MODES FOR CARRYING OUT THE OBJECT OF THE REQUEST [0024] Many combinations can be envisaged without departing from the scope of the request; the person skilled in the art will choose one or the other according to the economic, ergonomic, dimensional or other constraints which he will have to respect.
    In addition, those skilled in the art may possibly be able to use the two other requests filed on the same day as the present request, by the present plaintiff, in order to assess any functional and / or structural characteristics which would not be not, or insufficiently, detailed in the present request. In other words, the entirety of these two other requests (description, claims and figures) can therefore be considered, if necessary (according to the law in force), as being incorporated into this request, by reference or by reference .
    More particularly, Figures 1A to 1E schematically illustrate the concept object of the request, an intervertebral implant in the form of a cage which expands horizontally and vertically so that the volume initially occupied in the intervertebral space is less at the volume occupied in its final position of use. The distribution of the upper and lower zones of contact of the implant with the vertebral plates is then more relevant, that is to say, the supports on the periphery of the plates and the anterior part are maximized because the cortical bone is more dense at these locations, thereby better supporting the load imposed on the vertebrae.
    The sets of Figures 2A to 2E, 3A to 3D, 4A to 4C, 5A to 6B, 7A to 7D and 8A to 8D represent embodiments but not limiting of the present application. The characteristics of these embodiments can be combined with each other without limitation.
    The implant 1 comprises an elongated body 2 along an axis X, comprising a proximal end and a distal end. The distal end is the end through which the cage is introduced into the intervertebral space. Said body 2 is provided with at least one arm 21 mounted on a pivot 22, or by any other means known to those skilled in the art, allowing a “pivot” movement to said arm 21 between a folded position and a deployed position such a hinge, or a flexible material.
    In the folded position, the arm 21 is disposed against the body 2, that is to say can be substantially parallel to the axis X in order to minimize the dimensions of the profile of the implant for its implantation in the patient allowing thus reducing the invasiveness of the surgical intervention.
    In the deployed position, that is to say, the final position of use, the arm 21 is arranged along an axis Y, so as to be substantially perpendicular to the body 2, and in certain mode, said arm 21 can preferably be in abutment against the latter. The deployment of the arm thus allows the implant to occupy a larger space while allowing increased stability and reliability since the surface in contact with the bone of the vertebrae, in particular, the cortical bone is larger.
    The implant 1 may be provided with an actuating means 3 or 5 of said at least one pivot arm from the folded position to the deployed position.
    According to different embodiments, the triggering of the setting in motion of the arm 21 can be done either by traction, or by pressure from the practitioner. In other embodiments, not shown in the figures, a rotational movement can allow the setting in motion of the arm 21.
    In the case where pressure is used to deploy the arm, said actuating means can be produced by means of a wedge 3 which is pushed towards the distal end of the body 2, along a guide 33 having a shape complementary to a portion 32 of the wedge 3. The wedge 3 then comes into abutment against the arm 21 and forces the latter to move in order to assume its deployed position, which preferably may be perpendicular in abutment against the body 2. In order to facilitate deployment, the wedge 3 and the arm 21 can be connected together by a connecting rod 25, thus allowing better transfer of mechanical energy during the deployment of the arm in the final position of use, as shown Figure 4C. In some embodiments, the wedge 3 has at its distal end 31 a shape complementary to the shape of the arm 21 and allows, by form cooperation during the translation of the wedge, to deploy the arm 21 in its deployed position.
    In the case where traction is necessary in order to deploy the arm, in certain embodiments as illustrated by FIGS. 3A to 3D, in particular FIG. 3C, a traction piece 5, for example in the form of a bar, can be used. The latter may be provided with a notch 51 which cooperates with a complementary notch 23 present on the arm on its edge. When the pull-up bar 5 translates in the direction of the proximal end of the body, the notches 51, 23 cooperate together in order to allow the rotation of the arm around the pivot 22, while releasing the pull-up bar 5 from the implant. 1. In order to facilitate deployment, the pull-up bar 5, in certain embodiments can be formed of two sub-elements 5a and 5b which each make it possible to deploy one or more arms of instincts.
    In another embodiment, the traction piece 5 can be connected to the arm 21, and requires by a pivoting movement the deployment of the arm in the deployed position, when the traction piece is translated towards the proximal end of the implant as illustrated for example in Figures 3A to 3D and 6A.
    In one mode, the arm 21 can be made at least in part, of a flexible material, for example nitinol, which can be put under stress in the folded position by at least one pull-up bar 5. When the practitioner removes the drawbar 5, the arm can be released from the stress allowing it to return to its deployed position as shown for example in Figures 7A to 7D. In the set of figures n ° 7, the implant represented comprises several traction bars 5 which pass through an orifice 55 of each arm, thus making it possible to constrain them in their folded position.
    In different embodiments illustrated by the figures of the present application, said body 2 preferably comprises at least one arm 21 in the vicinity of its distal end, that is to say the end which can be the first in contact with the patient during implantation.
    According to another embodiment, the implant comprises an even number of arms 21, for example, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 or even 24 see more . These pairs can be distributed, preferably, symmetrically along the body 2 of the implant. However, an embodiment with an odd number of arms 21 may be entirely possible. In this case, it may be preferable for the arms to be positioned alternately on either side of the body 2 of the implant, such as a zigzag.
    According to another embodiment, said implant can be provided with a locking means making it possible to lock the pivot arm in its deployed position.
    According to one embodiment, said longitudinal body may comprise two sub-parts 2a and 2b arranged one on the other. The two sub-parts are interconnected by at least one articulation 6. Preferably, this articulation is located at the proximal end of the body, that is to say the side closest to the vertebral spines when said implant is implanted. in a patient, in other words the side of the implant opposite to that of implantation.
    Said articulation 6 allows movement of the two sub-parts 2a and 2b and in particular of their respective distal ends along an axis Z substantially orthogonal to the axes X and Y.
    In one embodiment, said articulation 6 can be provided with fins which are deployed according to a movement along the Y axis, when the wedge 3 is set in motion. Such a deployment, illustrated by FIGS. 2A at 2E, enlarges the volume occupied by the implant in the intervertebral space and promotes its stability. In addition, these fins also help better contain the graft and prevent it from migrating on contact with the roots or the hard mother.
    According to another embodiment, the implant 1 has an expansion means 3 of the longitudinal body along an axis Z orthogonal to the axes X and Y. In particular said expansion means 3 or 8 allows the ends distals of subparts 2a and 2b to move away from each other. Such a characteristic makes it possible to respect the lordosis of the spine. In addition, the expansion along the Z axis can be modulated by the surgeon during implantation in order to perfectly correspond to the patient's lordosis.
    To do this, the expansion means can, depending on the embodiments, be:
    • in the form of a link 8 having at least one locking position.
    • in the form of a shim, this shim 3 can be confused with the shim of the means for actuating the arms on a pivot. Said shim, according to the embodiments, slides along the body 2 in at least one guide 33 having a shape complementary to a portion 32 of the shim.
    In addition, when the implant expands along the Y and Z axis, the expansions can be:
    • sequential, a first expansion along the Y axis, then a second expansion along the Z axis or a first expansion along the Z axis, then a second expansion along the Y axis, or • simultaneous, that is i.e. the expansion along the Y axis, being concomitant with the expansion along the Z axis.
    However, without being limiting, a sequential expansion starting with the Y axis may be preferred. Indeed, due to the constraints on the vertebrae and the spine in general, it may be easier to practice an expansion along the Y axis than an expansion along the Z axis.
    The pivoting arms 21 can be provided with flexible extensions 210 as illustrated by the set of figures 8A to 8D, in order to increase the final volume occupied by the implant in the intervertebral space. Such extensions can for example be made of nitinol. In addition, their free ends can be hooked or placed near the proximal end of the implant in order to "circularize" the pivot arms as shown in Figures 8B and 8D. Preferably, such extensions include a structure allowing its extension along an axis collinear with the Z axis, for example a previously compressed mesh, as illustrated in FIG. 8D. Thus, with such structures, the compression forces which are undergone by the implant, are distributed over the whole of it, reinforcing its stability. These flexible extensions also make it possible to close the graft space of the implant and to properly contain the graft which will then be injected into the implant.
    Said longitudinal body may be provided with an opening at its proximal end, in order to let pass a tool actuating said actuation means of said at least one pivot arm from the folded position to the deployed position, and / or, said means for expanding the distal end of the longitudinal body along an axis Z orthogonal to the axes X and Y, and / or letting at least one anchor or anchoring device 7 configured to secure said cage to the vertebrae (V1 and V2) adjacent. In addition, the opening allows the introduction of a graft to promote bone growth and thus strengthen the stability of the implant.
    Figures 9A to 9D show alternative embodiments which include an elongated body composed of two sub-parts 200a and 200b mounted on pivot 400 and able to pivot in the manner of a chisel, a wedge that can be inserted as this is perfectly illustrated in Figure 9D in order to secure the deployment of the cage.
    In some modes, the implants may preferably be provided with openings. These openings can be right through, in order to promote bone growth within them. These openings thus strengthen the anchoring and the stability of the implant.
    It will be readily understood on reading this application that the features of this application, as generally described and illustrated in the figures, can be arranged and designed according to a wide variety of different configurations. Thus, the description of the present request and the accompanying figures are not intended to limit the scope of the request but simply represent selected embodiments.
    Those skilled in the art will understand that the technical characteristics of a given embodiment can in fact be combined with characteristics of another embodiment unless the reverse is explicitly mentioned or that it does not it is obvious that these characteristics are incompatible. In addition, the technical characteristics described in a given embodiment can be isolated from the other characteristics of this mode unless the reverse is explicitly mentioned. In particular, the embodiments described in the present application, although they are detailed with reference to the examples, illustrative and not limiting of the figures, in which the implant can be intended for implantation by posterior route, are not limited. at a certain vertebral level or at a particular approach. It is therefore clear that these characteristics could be adapted to a thoracic, cervical or lumbar implantation, and by the various traditional approaches (anterior, posterior, lateral etc.). The arrangement of the various components of the implant can then be modified to allow such implantation and so that the expansion of the implant is adapted to its position in the spine and respecting the configuration of the latter. For example, in the case of implantation by the anterior route, it can easily be envisaged to have a means for gripping the implant which makes it possible to hold said implant at the distal end, (ie the end opposite to articulation 6), and allow the actuating means to be set in motion, preferably by traction, in order to expand the cage in one or two dimensions.
    It should be obvious to those skilled in the art that the present application allows embodiments in many other specific forms without departing from the field defined by the scope of the appended claims, they must be considered as illustration and the request should not be limited to the details given above.
    权利要求:
    Claims (11)
    [1" id="c-fr-0001]
    Expandable intervertebral implant (1) intended to be implanted in a space between two adjacent vertebrae (V1 and V2) in order to at least partially replace an intervertebral disc, characterized in that said implant comprises:
    • an elongated body (2) along an axis (X) comprised between a proximal end and a distal end defined as being the end intended to penetrate first into said intervertebral space, • at least one pivot arm (21) mounted pivoting screw with respect to the longitudinal body, between a folded position and a deployed position:
    o in the folded position, said arm (21) is substantially parallel to the axis (X) and runs along the body, o in the deployed position said arm (21) is not parallel to the axis (X) and distant from the body in order to expand said implant along an axis (Y), substantially orthogonal to the axis (X), • an actuation means (3, 5) of said arm (21) to rotate it from the folded position to the position deployed.
    Expandable intervertebral implant according to claim 1, characterized in that said at least one pivot arm (21) is disposed at the distal end of the elongated body.
    Expandable intervertebral implant according to claim 1 or 2, characterized in that said implant is provided with one or more pairs of pivot arms (21), the arms of each of the pairs being arranged on either side of the elongated body (2 ).
    Expandable intervertebral implant according to claim 3, characterized in that said pivot arms (21) of each pair are arranged in an axial symmetry, along the axis (X).
    [2" id="c-fr-0002]
    5. Expandable intervertebral implant according to one of claims 1 to 4, characterized in that said implant is provided with a locking means (25) of said pivot arm (21) in its deployed position.
    [3" id="c-fr-0003]
    6. Expandable intervertebral implant according to one of claims 1 to 5, characterized in that said actuating means (3) of said pivot arm is a wedge sliding along an axis substantially parallel or collinear with the axis (X ).
    [4" id="c-fr-0004]
    7. Expandable intervertebral implant according to one of claims 1 to 6, characterized in that said longitudinal body (2) along an axis (X) comprises at least two sub-parts superimposed on each other (2a, 2b ) and linked together at least near the proximal end by at least one articulation (6).
    [5" id="c-fr-0005]
    8. Expandable intervertebral implant according to claim 7, characterized in that each of said sub-parts (2a, 2b) comprises at least one pivot arm (21).
    [6" id="c-fr-0006]
    9. Expandable intervertebral implant according to one of claims 7 to 8, characterized in that said implant is provided with means for expanding (3, 8) the body along an axis (Z) substantially orthogonal to the axes (X) and (Y).
    [7" id="c-fr-0007]
    10. Expandable intervertebral implant according to claim 9, characterized in that the expansion means (3, 8) of the body along the axis (Z), separates from one another the distal ends of the two sub-parts .
    [8" id="c-fr-0008]
    11. Expandable intervertebral implant according to claims 9 or 10, characterized in that said means for expanding the longitudinal body is formed by said actuating means (3) of said at least one pivot arm.
    [9" id="c-fr-0009]
    12. Expandable intervertebral implant according to claims 9 or 10, characterized in that said means for expanding the longitudinal body comprises at least one lockable link (8) in a deployed position when said implant is expanded along the axis (Z).
    [10" id="c-fr-0010]
    13. Expandable intervertebral implant according to one of claims 1 to 12, 5 characterized in that the longitudinal body is provided with at least one opening at its proximal end, said opening being configured to form at least one passage for:
    • at least one tool cooperating with:
    • said actuating means (3,5) of said at least one pivot arm, at
    10 less from the folded position towards the deployed position, • and optionally, said expansion means (3, 8) of the distal end of the longitudinal body along an axis (Z) substantially orthogonal to the axes (X) and (Y) , and or
    [11" id="c-fr-0011]
    15 "at least one anchoring device (7) configured to secure said implant to the adjacent vertebrae (V1 and V2).
    1 C
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    法律状态:
    2018-02-22| PLFP| Fee payment|Year of fee payment: 2 |
    2018-05-04| PLSC| Publication of the preliminary search report|Effective date: 20180504 |
    2018-10-15| PLFP| Fee payment|Year of fee payment: 3 |
    2019-09-20| PLFP| Fee payment|Year of fee payment: 4 |
    2020-09-17| PLFP| Fee payment|Year of fee payment: 5 |
    2021-09-13| PLFP| Fee payment|Year of fee payment: 6 |
    优先权:
    申请号 | 申请日 | 专利标题
    FR1660473|2016-10-27|
    FR1660473A|FR3058043B1|2016-10-27|2016-10-27|EXPANDABLE INTERSOMATIC CAGE|FR1660473A| FR3058043B1|2016-10-27|2016-10-27|EXPANDABLE INTERSOMATIC CAGE|
    PCT/EP2017/077705| WO2018078148A1|2016-10-27|2017-10-27|Expansible intervertebral cage|
    US15/796,735| US10624756B2|2016-10-27|2017-10-27|Expansible intersomatic cage|
    US16/453,337| US11051950B2|2016-10-27|2019-06-26|Expansible intersomatic cage|
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