Trans-iliosacral pelvic fixation implant
Patent Information
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- SPINEART
- Filing Date
- 2023-08-25
- Publication Date
- 2026-07-01
Smart Images
Figure EP2023073405_06032025_PF_FP_ABST
Abstract
Description
DESCRIPTION Title: Trans-iliosacral pelvic fixation implant Scope of the invention
[0001] The invention falls within the general field of spinal surgery, and more particularly relates to fixation systems, and more specifically to surgery via a posterior approach.
[0002] In particular, the invention relates to a pelvic fixation system usable in spinal surgery comprising a first trans-iliosacral element and a second element intended to connect (reversibly or not) the first element to at least one third element, preferably an intervertebral link (e.g. rod), belonging to a posterior spinal stabilization assembly.
[0003] The invention also relates to a pelvic fixation surgical kit comprising this fixation system.
[0004] The invention also relates to a subset comprising the first trans-ilioascratic element and the second or third element of the pelvic fixation system, as well as the first trans-ilioascratic element as such. Technological background of the invention
[0005] As shown in the attached Figures 1 and 2, posterior spinal surgery (spinal osteosynthesis) may involve the placement of suspended constructs, such as those each comprising rods (T) fixed to the vertebrae (V) by means of pedicle screws (V). p ) (of hooks or links under lamaires).
[0006] This assembly (TW) PThe splint is sometimes fixed to the sacrum (S) and / or the iliac wings (A') of the pelvis (Figure 3) for consolidation purposes, controlling the correction of deformities in the frontal and sagittal planes. This setup allows, in particular, the treatment of pathologies such as scoliosis or kyphosis and / or the correction of pelvic obliquity [imbalance of the pelvis in the frontal plane] and / or pelvic tilt (angle between the vertical and a line joining the center of the femoral heads to the center of the sacral plateau).
[0007] We already know of connection systems, from an iliosacral implant, to a posterior spinal osteosynthesis assembly consisting of at least one rod connected to at least one vertebra, by means of anchoring elements of the pedicle screw type or hooks.
[0008] But these known systems are complex and difficult for the surgeon to implement. Objectives of the invention
[0009] The invention aims to achieve at least one of the following objectives, among others:
[0010] One objective of the invention is to provide an improved pelvic fixation system usable in spinal surgery, simple and easy to use.
[0011] One objective of the invention is to provide an improved pelvic fixation system usable in spinal surgery, allowing control of pelvic obliquity and version.
[0012] An objective of the invention is to provide an improved pelvic fixation system comprising a trans-iliosacral screw and usable in spinal surgery, with which the trans-iliosacral screw can be implanted percutaneously.
[0013] One objective of the invention is to provide an improved pelvic fixation system usable in spinal surgery, for which the risks of pull-out are limited or even eliminated.
[0014] One objective of the invention is to provide an improved pelvic fixation system usable in spinal surgery, for which the risks of mobility of the implanted elements are limited, or even eliminated.
[0015] One objective of the invention is to provide an improved pelvic fixation system usable in spinal surgery, for which the risks of pain for the patient are limited or even eliminated.
[0016] One objective of the invention is to provide an improved pelvic fixation system usable in spinal surgery, for which the risks of buttock pain are limited or even eliminated.
[0017] One objective of the invention is to provide an improved pelvic fixation system usable in spinal surgery, for which the risks of poor trajectory are limited, or even eliminated.
[0018] One objective of the invention is to provide an improved pelvic fixation system usable in spinal surgery, in which the implanted elements facilitate bone regrowth and rapid colonization by the recipient's bone.
[0019] An objective of the invention is to provide an improved pelvic fixation system usable in spinal surgery, for which resection of the iliac bone to avoid any prominence is avoided.
[0020] One objective of the invention is to provide an improved pelvic fixation system usable in spinal surgery, capable of being put in place easily and quickly.
[0021] One objective of the invention is to provide an improved pelvic fixation system usable in spinal surgery, which is reliable, robust, easy to manufacture and economical.
[0022] One objective of the invention is to provide a subset of a pelvic fixation system aimed at achieving at least one of the above-mentioned objectives.
[0023] One objective of the invention is to provide a trans-iliosacral element usable in spinal surgery in a pelvic fixation system aimed at achieving at least one of the aforementioned objectives.
[0024] One objective of the invention is to provide a pelvic fixation surgical kit comprising a pelvic fixation system aimed at at least one of the above-mentioned objectives. Brief description of the invention The invention satisfies at least one of the above objectives and relates, according to a first aspect, to a pelvic fixation system usable in spinal surgery comprising: ■ at least one first element intended for trans-iliosacral implantation; ■ at least one second element intended to be implanted in the sacrum; ■ at least one third element, preferably an intervertebral link (e.g., rod), belonging to a posterior spinal stabilization assembly; ■ the first element being intended to be mechanically linked to the second element, itself intended to be securely linked to the third element; characterized in that the first element is intended to be implanted first through the iliac bone and the sacrum; the first element has at least one hole in which the second element is intended to be fixed, once the first element has been implanted.
[0025] This system is remarkable for its simplicity and ease of implantation in spinal surgery, addressing spinal deformities, particularly those involving the pelvis. It is reliable, stable, effective, and comfortable for the patient, minimizing or even eliminating pain. This ease of use also reduces the duration of surgical procedures.
[0026] In a first preferred embodiment, the position of the second element, relative to the first element, is adjustable.
[0027] This position adjustment is understood as an adjustment of the penetration depth of the second element into a hole in the first element and / or as an adjustment of the position of the second element according to the length of the first element, in the case where the latter has several receiving holes for the second element.
[0028] According to the invention, the mechanical connection of the first element with the second element is preferably a screw connection.
[0029] Alternatives to screwing are conceivable, such as, for example, a connection by pin; a connection by serration; a connection by adhesion (wedging, deformation pinching); a connection by keying.
[0030] Screwing and alternatives to screwing can be combined.
[0031] Advantageously, at least one hole in the first element is through-hole. Furthermore, this hole is intended to be at least partially traversed by the second element.
[0032] According to a second embodiment of the system according to the invention, at least one hole in the first element is a non-through blind hole, into which the second element is intended to be inserted.
[0033] In this second embodiment, the mechanical connection of the first element with the seconde the element is a connection made by screwing against a stop.
[0034] To this end, the first element advantageously includes at least one stop intended to cooperate with a part of the second element, when the latter is screwed with the first element.
[0035] The second element has a head by which the second element is intended to be connected securely to the third element, and, in this second embodiment, the connection securely between the second and third elements contributes to locking the position adjustment of the second element relative to the first element.
[0036] Furthermore, the system according to the invention may exhibit at least one of the following notable characteristics: (i) The second element comprises at least one linking part with the first element and at least one connecting part to the third element(s), this connecting part being optionally removable relative to the linking part and in that this connecting part is movable in rotation about at least one axis, preferably several. (ii) According to a first possibility, the first element includes at least one tapped hole to receive the second threaded element and the second element, once screwed into, preferably through the first element, forms a single angle, preferably of the order of 90°, with respect to the first element. (iii) According to a second possibility, the first element includes at least one tapped hole to receive the second threaded element and the second element can be screwed relative to the first, at several angles varying at a minimum of + / -5°, preferably of + / - 45°, relative to a direction perpendicular to the axis of the first element. (iv) The first element comprises several holes (for example successive and / or juxtaposed) offering several possibilities for positioning at least a second element, once the first element has been implanted through the iliac bone and the sacrum. (v) The first element has at least one external thread; this thread preferably comprising at least one part selected from the group of threads comprising - ideally consisting of - a bone thread, an iso thread, a conical thread, a serrated thread, a variable thread, a thread associated with a locking clip, and combinations thereof. (vi) The first element is, preferably, a screw capable of piercing bones. (vii) According to one variant, the first element could be a pin, in particular a prismatic pin, of any shape, for example, circular, triangular, rectangular, hexagonal... (viii) The first element and / or the second element is / are at least partly made up of at least one biocompatible material, possibly at least partly trabecular and / or porous. (ix) This biocompatible material is advantageously made up of at least one metallic material, and better still of titanium. (x) This biocompatible material possesses at least one of the following notable characteristics: (x.c1) The biocompatible material comprises at least one metal or alloy, in an amount corresponding to - in % by mass and in an increasing order of preference -80; 85; 90; 92; 95; 96; 97; 98; 99. (x.c2) The biocompatible material consists of a plurality of filaments, interlaced and partly contiguous, in which the pores, preferably distributed aperiodically, are formed by the space between these filaments and in which the filaments have a cross-section, preferably substantially circular, the largest dimension of which, preferably the diameter, is between, -in pm and in increasing order of preference- 10 and 700; 20 and 600; 50 and 500; 100 and 300. (x.c3) The biocompatible material is porous and its porosity is between, - in % by mass and in ascending order of preference-, 50 and 90; 60 and 80; 65 and 75; 68 and 72. (x.c4) The biocompatible material is porous and the diameter of its pores is between, -in pm and in increasing order of preference-, 500 and 950; 600 and 850; 700 and 800. (x.c5) The biocompatible material is porous and is produced by additive manufacturing (also called three-dimensional printing). (x.c6) The density of the biocompatible material differs between at least two parts of the first and / or second element. (xi) After implantation, the second element is intended to be integral with the first element, so as to resist tensile forces along the axis of the second element, greater than or equal to - in Newtons and in ascending order of preference - 500; 550; 600; 650; 700; 750; according to a tensile test protocol as defined in ASTM F1798. (xii) The hole(s) of the first element has a cross-section whose largest dimension is 6 mm + / - 45%.
[0037] The invention also includes a subassembly comprising the first element of the pelvic fixation system and the second or third element of this system.
[0038] According to a second aspect, the invention relates to a trans-iliosacral element usable in spinal surgery in a pelvic fixation system, in particular the system according to the invention; this system comprising, in addition to at least one trans-iliosacral element forming a first element, at least one second element intended to be implanted in the sacrum, and at least one third element, preferably an intervertebral link (e.g. rod), belonging to a posterior spinal stabilization assembly; the second element being intended to connect the first element to the third element. In this system: the first element is intended to be implanted first through the iliac bone and the sacrum; the first element has at least one hole into which the second element is intended to be fixed, once the first element has been implanted.
[0039] According to a third aspect, the invention relates to a surgical pelvic fixation kit characterized in that it comprises a pelvic fixation system usable in spinal surgery according to the invention and at least a third element, preferably an intervertebral link (e.g. rod), belonging to a posterior spinal stabilization assembly.
[0040] Advantageously, the first element is a screw and the kit includes: a aiming device, preferably a frame, capable of being implemented during the implantation, preferably by screwing, of the first element in the iliac bone and the sacrum, to allow the precise placement of the second element in a hole in the first element; and / or at least a perforator intended to make an opening in the sacrum to receive the second element and allow visualization of the first element introduced, preferably by screwing into the iliac bone and the sacrum and thus ensure the precise placement of the second element in a hole in the first element. Brief description of the drawings
[0041] This description is made with reference to the attached figures illustrating non-exhaustive examples of implementation, and in which: Fig. 1
[0042] [Fig. 1] is a perspective view of a portion, above the sacrum, of a vertebral column showing a stage of posterior stabilization mounting spinal surgery, in which one of the two intervertebral rods T of the mounting is fixed to the vertebrae V, via pedicle screws V p . Fig. 2
[0043] [Fig. 2] is a perspective view of a portion, including the sacrum, of a vertebral column showing a stage of posterior stabilization mounting spinal surgery, in which the two intervertebral rods T of the mounting are fixed to the vertebrae V via V pedicle screws p , after the step shown in Figure 1. Fig. 3
[0044] [Fig. 3] is a perspective view of a pelvis (sacrum S & iliac wings A'). Fig. 4
[0045] [Fig. 4] is a perspective view of the S system yfixation according to the invention in situ, the first element 1 of which is placed through the ilium A' and the sacrum S, the second element 2 of which is placed in the sacrum S and the third element (intervertebral rod 3) is connected to the second element 2, to form a posterior stabilization assembly. Fig. 5
[0046] [Fig. 5] is a perspective view of the first element 1 (VTIS trans-ilio-sacral screw) of the S system y of fixation according to a first embodiment of the invention, traversed by the second element 2 (sacred screw VS) of this system S y . Fig. 6
[0047] [Fig. 6] is a front view of screws 1,2 in Figure 5. Fig. 7
[0048] [Fig. 7] is a lateral elevation view from the right of screws 1,2 in Figure 5. Fig. 8
[0049] [Fig. 8] is a lateral elevation view from the left of screws 1,2 in Figure 5. Fig. 9
[0050] [Fig. 9] is a perspective view from the top of screws 1,2 in Figure 5. Fig. 10
[0051] [Fig. 10] is a partial longitudinal sectional view along the median longitudinal plane of the VTIS 1 corresponding to the section line XX of figure 6. Fig. 11
[0052] [Fig. 11] is a perspective view of an S system y according to the invention according to the second embodiment of the invention comprising a trans-ilio-sacral screw T, whose holes 14' are blind and a sacral screw 2', adapted to cooperate with one of these blind holes 14'. Fig. 12
[0053] [Fig. 12] is another perspective view of a V1 variant of the first embodiment of the S system yof fixation according to the invention. In this variant V1, the first element 1” (trans-ilio-sacral screw VTIS) is vertical (in the representation of the figures), and crossed by the second element 2” (sacral screw VS) which is horizontal (in the representation of the figures). Fig. 13
[0054] [Fig. 13] comprises, respectively, from left to right, a left-hand lateral elevation view of the first 1” element (VTIS screw) of the system shown in Figure 12, a middle longitudinal sectional view of the 1” VTIS screw along section line CC of the left-hand view, and a right-hand sectional view of the system, along the same plane as the view From the middle, this right view shows the VS 2” screw screwed into the VTIS 1” screw, passing through the latter and forming a fixed angle of approximately 90° with it. Fig. 14
[0055] [Fig. 14] includes views of a V2 variant of the first embodiment of the S system yof the fixing according to the invention, according to the same views as in Figure 13, and in which the right-hand view is a CC cross-sectional view of the system S y , according to the same plan as the middle view, this right view showing the screw VS 2* screwed into the screw VTIS 1*, passing through the latter and having an angular displacement D , relative to the axis YY of the screw VTIS 1*, in the cutting plane CC corresponding to the median longitudinal plane of the screw VTIS 1* which includes the axis XX of the screw VS 2*. Fig. 15
[0056] [Fig. 15] is a front view of a 1 ère possibility of deploying a targeting device 30 1 useful for the surgical implantation of an S system y of fixation according to the invention. Fig. 16
[0057] [Fig. 16] is a front perspective view of the sighting device 30 1of figure 15 as it is used in situ (ilium-sacrum-lumbar) during the surgical implantation of an S system y of fixation according to the invention. Fig. 17
[0058] [Fig. 17] is a side perspective view of the sighting device 30 1 of Figure 15, as used in situ (ilium A'-sacrum S- lumbar) during the surgical implantation of an S system y of fixation according to the invention. Fig. 18
[0059] [Fig. 18] is a perspective view from below of the sighting device 30 1 of figure 15 as used in situ (ilium A' - sacrum S- lumbar) during the surgical implantation of an S system y of fixation according to the invention. Fig. 19
[0060] Figure 19 is a front view of a 2 e possibility of using the aiming device 30 2 useful for the surgical implantation of an S systemy of fixation according to the invention. Fig. 20
[0061] [Fig. 20] is a front perspective view of the aiming device 30 2 of Figure 19, as used in situ (ilium A'-sacrum S- lumbar) during the surgical implantation of an S system y of fixation according to the invention. Fig. 21
[0062] [Fig. 21] is a side perspective view of the sighting device 30 2 of figure 19 as used in situ (ilium A'-sacrum S- lumbar) during the surgical implantation of an S system y of fixation according to the invention. Fig. 22
[0063] [Fig. 22] is a perspective view from below of the sighting device 30 2 of figure 19 as used in situ (ilium A'-sacrum S- lumbar) during the surgical implantation of an S system y of fixation according to the invention. Definitions
[0064] The definitions below are given as examples to facilitate the interpretation of this presentation: * any singular can refer to a plural and vice versa. * “approximately”; “about”; “in the order of”: + / - 10% of the relevant unit of measurement in the International System of Units. * “superior / inferior” “top / bottom” “vertical / horizontal” are defined in relation to the figures and the body of the patient receiving the fixation system according to the invention. * “ISO thread”: can refer to an ISO metric thread with a triangular thread (NF ISO 724) or cylindrical profile (NF EN ISO 228-1); or a thread with a conical or cylindrical profile (NF EN 10226-1, EN 10226, ISO 228). Detailed description of the invention
[0065] In the embodiment examples shown in Figures 4 to 15, the S system y The pelvic fixation device according to the invention comprises: ■ a first element consisting of a trans-iliosacral screw 1 (VTIS) which is intended to be implanted first in the patient, by the surgeon, so that this first element passes through an iliac wing A' to come to rest in the sacrum S; ■ a second element 2 formed by a screw attached to the rod 3 and intended to be screwed through the trans-ilio-sacral screw 1, so as to be able to adjust the position of the screw 2 in relation to this trans-ilio-sacral screw 1; ■ and a third element, in this case an intervertebral rod 3, belonging to a posterior spinal stabilization assembly possibly comprising another intervertebral rod, this rod or these two rods being fixed to the vertebrae (V), for example by means of pedicle screws (V p ) as shown in figures 1 & 2.
[0066] In a first embodiment, the first element or trans-ilio-sacral screw 1 comprises a head 10 located at one end of a threaded body 11 (external thread 11 fe ) the other end of which is a point 12 which gives this screw an ability to pierce bones.
[0067] This body 11 has four through, tapped, and adjacent holes 14. The axis of each hole 14 is substantially perpendicular to the axis of the trans-ilio-sacral screw 1. Each hole 14 has a top opening 15 and a bottom opening 16. These four holes 14 provide four possible positions for the (sacral) screw 2 relative to the trans-ilio-sacral screw 1. This arrangement can facilitate the attachment of the system S y fixation according to the invention, in relation to the posterior spinal stabilization assembly.
[0068] The (sacred) screw 2 is essentially composed of a threaded body 21 and a head 22.
[0069] As shown in particular by figures 5, 6, 9, 10, 12, 13 (right view) & 14 (right view), the female internal thread 14 fi The 14 holes are designed to cooperate with the 21 male external thread. fe of the body 21 of the (sacred) screw 2, to generate a mechanical connection by screwing between the first element 1 and the second element 2, which then form a cross-shaped assembly.
[0070] According to a notable feature of the invention, the internal female thread 14 fi The holes 14 are designed to allow the body 21 of the screw 2 to be engaged through both the upper opening 15 and the lower opening 16 of the hole 14. The female internal thread 14 fi extends from the upper opening 15 to the lower opening 16.
[0071] Once assembled and implanted in situ, the two screws 1 and 2 form an inseparable unit: the trans-ilio-sacral screw 1 can no longer rotate or translate. The same applies to screw 2. The latter is first screwed into screw 1, which is implanted through the ilium and into the sacrum. The position of screw 2 (or insertion depth) relative to screw 1 is thus adjustable. This allows the surgeon to correctly position the head 22 of screw 2 relative to the third element of the system, namely the intervertebral rod 3, before fixing them together. The system is thus locked in an optimal position to address the patient's condition.
[0072] In the 1 er In this embodiment, the cross-section of the holes 14 is substantially circular and of constant diameter: for example about 6 mm + / - 1.5 mm, for the thread.
[0073] As shown in Figures 5, 6, 9 & 11, each through hole 14 opens at both ends into an upper 17 and a lower 18, respectively, recess in the trans-ilio-sacral screw 1. Each recess 17, 18 includes a flat 19 parallel to the median longitudinal plane of the screw 1 and from which two rims 19 rise 1 19 2 opposites each inscribed in a diametrical plane of the screw 1 and extending to the threaded outer face of the screw 1. Each upper opening 15 and lower opening 16 of a hole 14 is in the plane of the flat 19.
[0074] The external thread 11 fe of the body 11 of the screw 1 is for example a bone thread and / or an ISO thread.
[0075] The head 10 of the trans-ilio-sacral screw 1 includes on its external face a cavity 10 1 of hexalobe screw in this example embodiment. This head also includes a 10 groove 2(figure 7) extending inwards and connecting the head 10 to the body 11 of the screw 1.
[0076] The head 10 of the trans iliosacral screw 1 can be polyaxial relative to the body 11 of the screw 1, in order to adapt as best as possible to the anatomy of the iliac bone.
[0077] As shown in Figures 5 to 9, the (sacral) screw 2 can be a pedicle screw with a polyaxial head 22. Pedicle screws are commonly used in spinal surgery. This polyaxial head 22 is articulated on a ball joint 21° provided on the head of the threaded body 21 of the screw 2.
[0078] The clearances 17&18, the flat surface 19, the edges 19 1 19 2 , are absent from variants V1 and V2 of figures, respectively, 12 & 13, and, 14.
[0079] For variant V1 of figures 12 & 13, the references used to designate all parts and parts of parts of the S system yThe fixing points according to the invention are the same as those in figures 4 to 10 with the superscript (”).
[0080] As with the 1 er In this embodiment, the cross-section of the 14" holes of the 1" screw in variant V1 of figures 12 & 13 is substantially circular and of constant diameter: for example approximately 6 mm + / - 1.5 mm, for the screw thread
[0081] For variant V2 of Figure 4, the references used to designate all parts and parts of parts of the S system y The fixing points according to the invention are the same as those in figures 4 to 10 with the superscript (*).
[0082] According to variant V2 shown in figure 14, the cross-section of the holes 14* of screw 1* can be oblong, so that the (sacred) screw 2* can have a deflection Angular displacement D in the median longitudinal plane of the VTIS 1 screw with axis YY, including the axis XX of this (sacral) screw 2*, relative to the axis of the VTIS 1* screw. The angular displacement D corresponds to an angle 2a, with a having a value of at least 5°, for example, on the order of 30°, on either side of the perpendicular PP to the axis YY of the screw 1*. This additional degree of freedom relative to the translation of the (sacral) screw 2* with respect to the trans-ilio-sacral screw 1* simplifies the surgeon's task when implanting the S system. y fixation on the patient.
[0083] In a second embodiment shown in Figure 11, the trans-ilio-sacral screw T is formed by a head 10' and a screw body 1 T with a thread 1 T fe, has blind, non-through holes 14'. This screw T is associated in the fastening system according to the invention with a screw 2' (sacred) consisting of a threaded body 2T and a polyaxial head 22', of the type used in pedicle screws such as those described above. The threaded body 2T and the polyaxial head 22' are identical to those bearing internal reference numerals 21 and 22 and described above, except that the threaded body 2T has, firstly, a length corresponding substantially to the depth of the blind, non-through holes 14' in the body of the screw 1 T, and, secondly, an ISO-type thread.
[0084] The internal thread of the 14' non-through blind holes of the trans-ilio-sacral screw T is designed to cooperate with the external thread 21 fe 'of the body 2T of the (sacred) screw 2', to secure the screws T and 2'.
[0085] The bottoms of the non-through blind holes 14' of the trans-ilio-sacral screw T, each form an end stop, intended to come into contact with the free end of the screw body 2T of the screw 2', and thus block the translational stroke of the latter.
[0086] Alternatively, this blocking of the translational travel of screw 2' can be achieved by means of a limit stop located on the neck of the (sacred) screw 2' and designed to contact the body of screw 1 T of screw T. In this alternative, the holes 14' are through holes. However, it is also possible to provide blind, non-through holes 14', the bottoms of which may or may not be stops that could supplement the action of the limit stop on the neck of screw 2'.
[0087] The end-of-stroke block, whatever it may be, determines the position, relative to the trans-ilio-sacral T screw, in which the sacral 2' screw must be brought to ensure the locking of the connection of the second element of the system with the first element.
[0088] This locking of the second element of the fastening system on the invention, with the first element can also be achieved by other means, not shown in the figures, such as conical wedging, or the implementation of a nut / locknut screwed onto the sacred screw.
[0089] According to another possible embodiment, the head 22,22' and the body 21, 2T of the sacred screw 2,2' can be separated and assembled. Thus, the body 21, 2T can initially be screwed together with the body 11 of the screw 1, the head 22,22' being mounted on the head 21°, 21'° of the body 21, 2T of the screw 2 which is fixed to the body 11 of the screw 1.
[0090] According to another possible embodiment, the head 22,22' of the sacral screw 2, 2', 2”, 2*, (for example pedicular) may be uniplanar or monoaxial, that is to say with a blocking of polyaxiality for example in the sagittal plane, or even partially polyaxial.
[0091] The 1,1',1”,1*, trans-ilio-sacral screw and the 2, 2', 2”, 2*, sacral screw can be made of a biocompatible material, in particular a metal such as titanium or a metal alloy such as chromium / cobalt or titanium / aluminum / vanadium (e.g., Ti6Al4V or TA6V). Titanium is particularly preferred.
[0092] It is also advantageous that at least a portion of the constituent material, at least of the first element of the system S yThe material used for fixing according to the invention is porous and trabecular. The porosity is, for example, on the order of 70% by mass. The pores of this material are substantially circular with a diameter between 700 and 800 µm. The pores can be defined by intersecting and partially contiguous filaments, for example with a circular cross-section and a diameter between 100 and 300 µm.
[0093] The 1,1', 1”,1*, trans-ilio-sacral screw and the 2,2', 2”, 2*, sacral screw can be manufactured by conventional machining or by additive manufacturing (also known as three-dimensional printing).
[0094] Additive manufacturing refers to manufacturing processes that add material, most often computer-aided. It is defined by ASTM (American Society for Testing and Materials) as the process of shaping a part by adding material, by stacking successive layers, as opposed to processes that remove material, such as machining. This technology is commonly called three-dimensional printing (3D printing). An example of 3D printing is laser sintering, including selective laser sintering (SLS), direct metal laser sintering (DMLS), and electron beam melting (EBM). An example of EBM is Ti-LIFE Technology from SPINEART®.
[0095] The intervertebral rod 3 is, for example, made of titanium alloy or cobalt-chromium alloy. It may be an intervertebral rod marketed by Spineart® under the name Perla® TL straight Rod.
[0096] The S system y According to the invention, it is designed to allow the surgeon: -> to implant the first element, namely the 1,1',1”,1*, trans-ilio-sacral screw, through the ilium and into the sacrum, ensuring that the axis of the holes 14, 14', 14”, 14*, of the screws 1, 1',1”,1*, is substantially parallel to the horizontal plane; to make a notch in the S1 vertebra using a perforator, to engage a trans-ilio-sacral screw 1,1',1”,1* through the notch, adjusting the orientation of the trans-ilio-sacral screw 1, 1', 1”, 1*, in order to visualize the hole 14, 14', 14”, 14*, or one of the holes for inserting the sacral screw 2, 2', 2”, 2*, through the screw 1, 1', 1 ”, 1*; ->to adjust the depth position of the sacral screw 2, 2', 2”, 2*, relative to the trans-ilio-sacral screw 1, 1', 1”, 1*; to fix the intervertebral rod 3 to the head 22,22' of the sacral screw 2, 2', 2”, 2*, to contribute to blocking the position of the sacral screw 2, 2', 2”, 2* relative to the trans-ilio-sacral screw 1,1',1”,1*.
[0097] According to an advantageous modality, the S system y according to the invention is associated with a sighting device, such as that shown in the attached figures 15 to 22.
[0098] Figure 15 represents a 1 ère possibility of execution of the aiming device 30 1 Figures 16 to 18 illustrate the implementation of the latter for the implantation of the S system. y pelvic fixation according to the invention.
[0099] Figure 19 represents a 2 e possibility of execution of the aiming device 30 2Figures 20 to 22 illustrate the implementation of the latter for the installation of the S system. y pelvic fixation according to the invention.
[0100] The 30mm aiming device 1 30 2 consists of a four-segment frame contained within the same plane, namely: * a longitudinal segment 31 1 31 2 intended, during the implementation of the S system y pelvic fixation according to the invention, to be positioned parallel to the YY axis of the VTIS 1,1',1”,1* screw; * a transverse segment 32 1 0.32 2 , preferably perpendicular to the longitudinal segment 31 1 0.31 2 ; * a segment 33 1 0.33 2 transverse sacred aiming segment, opposite transverse segment 32 1 0.32 2and intended, during the surgical procedure, to be positioned in the axis along which the placement of the sacral screw 2, 2', 2”, 2* must take place; * and a segment 34 1 0.34 2 longitudinal sacroiliac joint, attached to the end of the transverse segment 32 1 0.32 2 opposite to that related to longitudinal segment 31 1 0.31 2 , preferably perpendicular to the transverse segment 32 1 0.32 2 , and intended, during the intervention surgical, to be positioned in the axis along which the VTIS 1,1',1”,1* must be placed.
[0101] Segment 33 1 0.33 2 transverse sacral aiming is, advantageously, a guide tube allowing the passage of a part (in particular the shaft) of a tool intended to contribute to the implantation of the sacral screw 2, 2', 2”, 2*, in the sacrum according to the direction chosen by the surgeon.
[0102] This tool could be, for example, a square point, an osteotome, a tap, or a screwdriver.
[0103] In the 1 ère possibility of execution of the aiming device 30 1 , segment 33 1 0.33 2 The transverse sacred sight is substantially perpendicular to the longitudinal segment 31 1 0.31 2 .
[0104] In the 2 ème possibility of execution of the aiming device 30 2 , segment 33 1 0.33 2 The transverse sacred sight forms an angle A 2 given (Figure 19), less than 90°, with the longitudinal segment 31 1 0.31 2 .
[0105] Segment 33 1 0.33 2 The transverse sacred sight is either fixed or able to pivot relative to the longitudinal segment 31 1 0.31 2 , in the plane of the frame or in a plane parallel to it, so as to be able to give angle A 2different values.
[0106] The position of the longitudinal segment 31 1 0.31 2 is advantageously adjustable and lockable in translation, relative to the transverse segment 32 1 0.32 2 , parallel to the ilio-sacral direction of segment 34 1 0.34 2 longitudinal sacroiliac.
[0107] It is therefore possible to define different lockable positions of this longitudinal segment 31 1 0.31 2 , one of these positions being intended to correspond to the alignment of the axis of tubular segment 33 1 0.33 2 sacred sight with the axis of a hole 14, 14', 14”, 14*, of the VTIS screw 1 ,1',1”,1*.
[0108] Tubular segment 34 1 0.34 2longitudinal sacroiliac is advantageously a guide tube allowing the passage of a part (in particular the stem) of a tool intended to contribute to the implantation of the VTIS 1, 1', 1”, 1* screw, through the ilium and sacrum according to the direction chosen by the surgeon.
[0109] This tool can be, for example, a square point, an osteotome, a tap, or, as shown in the figures, a screwdriver.35 1 35 2 .
[0110] The S system y pelvic fixation according to the invention and the aiming device 30 1 30 2 are designed to allow the surgeon to implant the first element, namely the 1,1',1”,1* trans-iliosacral screw, through the ilium and into the sacrum, ensuring that the axis of the holes 14, 14', 14”, 14*, of the screws 1, T, 1”, 1*, i.e. substantially parallel to the horizontal plane and by implementing the sighting frame 30 and the screwdriver 37, so that the sacral screw 2, 2', 2”, 2*, can be guided into a hole 14, 14', 14”, 14*, of the trans-ilio-sacral screw 1, 1', 1”, 1*; ->to adjust the position of the sacral screw 2, 2', 2”, 2*, relative to the trans-ilio-sacral screw 1, 1', 1”, 1*; -> to fix the intervertebral rod 3 to the head 22, 22', 22”, 22*, of the sacral screw 2, 2', 2”, 2*, to block the translational position of the sacral screw 2, 2', 2”, 2*, relative to the trans-ilio-sacral screw 1, 1', 1”, 1*.
[0111] The S system yThe invention secures the stable, precise, and robust fixation of the pelvic anchor (first and second elements) to the third element, an intervertebral rod of a posterior spinal stabilization assembly. In doing so, the correction of spinal deformity pathologies, particularly those involving the pelvis, is significantly optimized, minimizing pain for the patient and allowing them to recover as quickly as possible to a better state of spinal health.
[0112] The surgical kit for pelvic fixation according to the invention comprises: * the S system y of pelvic fixation described above (and / or the first and second elements and / or the first and third elements); * and: a sighting device, for example a sighting frame, capable of being used when screwing the first element into the iliac bone and the sacrum, to allow the precise placement of the second element into a hole in the first element; and / or at least one perforator intended to make an opening in the sacrum to receive the second element and allow visualization of the first element introduced by screwing into the iliac bone and the sacrum and thus ensure the precise placement of the second element into a hole in the first element.
[0113] The perforator is, for example, a square point or an osteotome.
Claims
Claims
1. System S y pelvic fixation system suitable for spinal surgery, including: ■ at least one first element (1, 1',1”,1*) intended for trans-ilio-sacral implantation; ■ at least one second element (2, 2', 2”, 2*) intended to be implanted in the sacrum; ■ at least one third element (3), preferably an intervertebral link, belonging to a posterior spinal stabilization assembly; ■ the first element (1, 1', 1”, 1*) being intended to be mechanically linked to the second element (2, 2', 2”, 2*), itself intended to be securely linked to the third element (3); characterized in that the first element (1, 1', 1”, 1*) is intended to be implanted first through the iliac bone and the sacrum; the first element (1, 1', 1”, 1*) comprises at least one hole (14, 14', 14”, 14*) in which the second element (2, 2', 2”, 2*) is intended to be fixed, once the first element (1, 1', 1”, 1*) has been implanted.
2. System S y fixing according to claim 1 characterized in that the position of the second element (2, 2', 2”, 2*) relative to the first element (1, 1', 1”, 1*) is adjustable.
3. System S y fixing according to claim 1 or 2, characterized in that the mechanical connection of the first element (1, 1', 1”, 1*) with the second element (2, 2', 2”, 2*) is a screw connection.
4. System S y fixing according to at least one of the preceding claims, characterized in that at least one hole (14, 14', 14”, 14*) of the first element (1, 1', 1”, 1*) is through and in that this hole (14, 14', 14”, 14*) is intended to be crossed at least partially by the second element (2, 2', 2”, 2*).
5. System S y fixing according to at least one of the preceding claims, characterized in that the first element (1, 1', 1”, 1*) comprises at least one hole (14, 14', 14”, 14*) tapped to receive the second element (2, 2', 2”, 2*) threaded and in that the second element (2, 2', 2”, 2*) once screwed into, preferably through the first element (1, 1 1 ”, 1*), forms a single angle, preferably of the order of 90°, relative to the first element (1, 1', 1 ”, 1*).
6. System S yfixing according to at least one of the preceding claims, characterized in that the first element (1, 1', 1", 1*) comprises at least one hole (14, 14', 14", 14*) tapped to receive the second element (2, 2', 2", 2*) threaded and in that the second element (2, 2', 2", 2*) can be screwed relative to the first element (1, 1', 1", 1*), according to several angles varying at least + / -5°, preferably + / - 45°, relative to a direction perpendicular to the axis of the first element (1, 1', 1", 1*).
7. System S y fixing device according to at least one of the preceding claims, characterized in that the first element (1, 1', 1”, 1*) comprises several holes (14, 14', 14”, 14*) offering several possibilities for positioning at least one second element (2, 2', 2”, 2*), once the first element (1, 1', 1”, 1*) has been implanted through the iliac bone and the sacrum.
8. System S yfixing according to at least one of claims 1 to 3, 5 to 7, characterized in that at least one hole (14') of the first element (1, 1', 1”, 1*) is a blind non-through hole (14'), into which the second element (2, 2', 2”, 2*) is intended to be inserted.
9. System S y fixing according to claim 8 characterized in that the mechanical connection of the first element (1, 1', 1”, 1*) with the second element (2, 2', 2”, 2*) is a connection by screwing in abutment.
10. System S y fixing device according to at least one of the preceding claims, characterized in that the first element (1, 1', 1", 1*) is capable of perforating bones.
11. System S yfixing according to at least one of the preceding claims, characterized in that the second element (2, 2', 2”, 2*) comprises at least one connecting part (21, 2T, 21”, 21*) with the first element (1, 1', 1”, 1*) and at least one connecting part (22, 22', 22”, 22*) to the third element(s) (3), this connecting part (22, 22', 22”, 22*) being optionally removable relative to the connecting part and in that this connection part (22, 22', 22”, 22*) is movable in rotation along at least one axis, preferably several.
12. Subset of system S y fixing according to at least one of the preceding claims, characterized in that it is composed of the first element (1, 1', 1”, 1*) of the system S y and the second element (2, 2', 2”, 2*) or the third element of the system S y .
13. Trans-ilio-sacral element usable in spinal surgery in an S systemy pelvic fixation system, in particular according to at least one of claims 1 to 12, this system S y comprising, in addition to at least one trans-ilio-sacral element forming a first element (1, 1', 1”, 1*), at least one second element (2, 2', 2”, 2*) intended to be implanted in the sacrum and at least one third element, preferably an intervertebral link (eg rod), belonging to a posterior spinal stabilization assembly, the second element (2, 2', 2”, 2*) being intended to connect the first element to the third element; characterized in that the first element (1, 1', 1”, 1*) is intended to be implanted first through the iliac bone and the sacrum; the first element (1, 1', 1”, 1*) comprises at least one hole in which the second element (2, 2', 2”, 2*) is intended to be fixed, once the first element (1, 1', 1”, 1*) has been implanted.
14. Surgical pelvic fixation kit characterized in that it comprises: ->the S system y fixing device according to at least one of claims 1 to 11, the subassembly according to claim 12, or the trans-ilio-sacral element according to claim 13; a sighting device (30 1 ,30 2 ), preferably a frame, capable of being implemented during the implantation, preferably by screwing, of the first element (1, 1', 1 ”,1*) in the iliac bone and the sacrum, to allow the precise placement of the second element (2, 2', 2”, 2*) in a hole (14, 14', 14”, 14*) of the first element (1, 1', 1 ”, 1*); and / or at least one perforator intended to make an opening in the sacrum to receive the second element (2, 2', 2”, 2*) and allow the visualization of the first element (1, 1', 1”, 1*) preferably introduced by screwing, into the iliac bone and the sacrum and thus ensure the precise positioning of the second element (2, 2', 2”, 2*) in a hole (14, 14', 14”, 14*) of the first element (1, 1', 1”, 1*).