TRANSPEDICULAR ANCHORING SCREW WITH REINFORCED SECONDARY STABILITY
20220378487 · 2022-12-01
Inventors
Cpc classification
A61B17/7001
HUMAN NECESSITIES
A61B2017/00004
HUMAN NECESSITIES
A61B17/70
HUMAN NECESSITIES
A61B2017/8655
HUMAN NECESSITIES
A61B17/8605
HUMAN NECESSITIES
International classification
Abstract
A transpedicular anchoring screw including a screw body having a first helical thread having:includes a proximal portion, having notched portions inscribed within notched angular sectors and separated by separation portions inscribed within separation angular sectors, where, over a screw pitch, a ratio between the sum of the measurements of the separation angular sectors and the sum of the measurements of the notched angular sectors is between 50% and 150%. The anchoring screw also includes a distal portion, having notched portions inscribed within notched angular sectors and separated by separation distal portions inscribed within separation angular sectors, where, over a screw pitch, a ratio between the sum of the measurements of the separation angular sectors and the sum of the measurements of the notched angular sectors is between 0% and 10%.
Claims
1. A transpedicular anchoring screw, adapted for anchorage in a pedicle of a vertebra, including a screw body extending along a screw axis between a proximal end and a distal end, said screw body having a first thread and a second thread, each of said first thread and second thread being helical-shaped with a same screw pitch, extending between said proximal end and said distal end and having a convex-shaped outer edge, said transpedicular anchoring screw being characterized in that at least said first thread has, from the proximal end towards the distal end, at least: a proximal portion, in which the outer edge of said first thread has a series of notched proximal portions, each defined by a proximal notch formed in said outer edge and inscribed within a notched proximal angular sector, wherein two successive notched proximal portions are separated from each other by a separation proximal portion, in which said outer edge is not notched and is inscribed within a separation proximal angular sector, and wherein, over a length of the first thread corresponding to one screw pitch (PV), a ratio between the sum of the measurements of all of the separation proximal angular sectors and the sum of the measurements of all of the notched proximal angular sectors is comprised between 50% and 150%; and a distal portion, in which the outer edge of said first thread has a series of notched distal portions, each defined by a distal notch formed in said outer edge and inscribed within a notched distal angular sector, wherein two successive notched distal portions are separated by a separation distal portion, in which said outer edge is not notched and is inscribed within a separation distal angular sector, and wherein, over a length of the first thread corresponding to one screw pitch (PV), a ratio between the sum of the measurements of all of the separation distal angular sectors and the sum of the measurements of all of the notched distal angular sectors is comprised between 0% and 10%.
2. The transpedicular anchoring screw according to claim 1, wherein each proximal notch has an identical shape and wherein each separation proximal portion is inscribed within a respective separation proximal angular sector with an identical extent, so that said proximal notches are evenly spaced from each other along said first thread.
3. The transpedicular anchoring screw according to claim 2, wherein each notched proximal portion and each separation proximal portion is inscribed within a respective notched proximal angular sector or separation proximal angular sector with an identical measurement within 5°.
4. The transpedicular anchoring screw according to claim 3, wherein the measurement of each of said notched proximal angular sectors or separation proximal angular sectors is comprised between 30° and 75°.
5. The transpedicular anchoring screw according to any one of claim 1, wherein at least one of the proximal notches is delimited by a single notch edge shaped as a concave circle arc.
6. The transpedicular anchoring screw according to any one of claim 1, wherein at least one of the proximal notches is delimited by a notch edge shaped as a convex circle arc.
7. The transpedicular anchoring screw according to any one of claim 1, wherein the proximal portion and the distal portion are contiguous, one of the separation proximal portions of the proximal portion being contiguous to one of the notched distal portions of the distal portion.
8. The transpedicular anchoring screw according to claim 1, wherein each of the separation distal portions is inscribed within a separation distal angular sector whose measurement is equal to 0°, so that the successive distal notches are contiguous.
9. The transpedicular anchoring screw according to any one of claim 1, wherein at least one of the distal notches is delimited by a single notch edge shaped as a concave circle arc.
10. The transpedicular anchoring screw according to claim 1, wherein each notched distal portion is inscribed within a notched distal angular sector whose measurement is comprised between 50° and 75°.
11. The transpedicular anchoring screw according to claim 1, wherein the notched proximal portions and the separation proximal portions of the proximal portion have a thickness (E1), measured along the screw axis (111), larger than a thickness of the notched distal portions and of the separation distal portions of the distal portion.
12. The transpedicular anchoring screw according to claim 1, wherein the proximal portion and the distal portion of the first thread extend respectively, along the screw axis, over a proximal length and a distal length, said proximal length having an measurement comprised between 0.5 and 1.5 times that of said distal length.
13. The transpedicular anchoring screw according to claim 1, wherein the screw body has a transverse dimension, measured perpendicularly to the screw axis, whose measurement progressively decreases between the proximal end and the distal end.
14. The transpedicular anchoring screw according to claim 1, including a screw head positioned on the proximal end of the screw body, said screw head having a collar delimited by a convex-shaped collar edge and having head notches formed in said collar edge, said collar having a transverse dimension measured perpendicularly to the screw axis, larger than a transverse dimension of the first thread, also measured perpendicularly to the screw axis.
15. The transpedicular anchoring screw according to claim 1, wherein at least one amongst a proximal notch and a distal notch is at least partially filled with a bioresorbable material.
16. The transpedicular anchoring screw according to claim 15, wherein each of the proximal notches and each of the distal notches is at least partially filled with the bioresorbable material.
17. The transpedicular anchoring screw according to claim 15, wherein the bioresorbable material is a polymer, for example a PLA (polyactic acid) type polymer, a PLGA (polyglycolic acid) type polymer or a PLA-PLGA type copolymer.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0115] Other features and advantages of the present disclosure will appear upon reading the detailed description hereinafter of non-limiting examples of implementation, made with reference to the appended figures in which:
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DETAILED DESCRIPTION OF THE DRAWINGS
[0124]
[0125] The transpedicular anchoring screw 1 has a screw body 11 penetrating a pedicle P and a vertebral body CV of the vertebra V, so that said screw body 11 passes through four types of bone structures of the vertebra V, each having different mechanical properties: [0126] a cortical wall PC of the pedicle P, formed of a compact and hard bone, [0127] a central portion PE of the pedicle P, formed of a quite dense spongy bone, [0128] a spongy body CS of the vertebral body CV, formed of barely dense and fragile bone, and [0129] the cortical wall PO of the vertebral body CV, formed of a compact and hard bone.
[0130] The transpedicular anchoring screw 1 also has a screw head 12 projecting from the pedicle P and adapted to cooperate with a surgical implant (not represented), in order to enable fastening of said surgical implant on the vertebra V.
[0131] Finally, the transpedicular anchoring screw 1 has a leading edge 13 anchored in the cortical wall PO of the vertebral body CV.
[0132] Referring to
[0133] More specifically, the screw body 11 of the transpedicular anchoring screw 1 has a profiled shape, with a circular section, extending along a screw axis 111 between a proximal end 112 and a distal end 113 and is provided with a first thread 2 and a second thread 20, both helical shaped and arranged around the screw body 111 between the screw head 12 and the leading edge 13.
[0134] It should be noted that this screw body 11 may be solid. Alternatively, the screw body 11 may be hollow, in other words this screw body 11 may have an inner hole or orifice extending over all or part of its length from its proximal end 112 to its distal end 113. If this inner hole or orifice extends over the entire length and also passes through the screw head 12, it could then be used, for example, for the passage of a wire or a guide.
[0135] The first thread 2 and the second thread 20 have the same screw pitch PV and are moreover “nested” with each other, so that the screw body 11 has, along the screw axis 111, an alternation of the first thread 2 and the second thread 20.
[0136] The first thread 2 has a particular geometry designed to improve the secondary stability of the transpedicular anchoring screw 1 when the latter is implanted in the vertebra V, as illustrated in the previous
[0137] Indeed, the first thread 2 includes an outer edge 21 disposed, over the entire length of the screw body 11 along the screw axis 111, at a constant distance D from said screw body 11: the screw body 11 having a circular shaped section (in a plane orthogonal to the screw axis 111), the outer edge 21 has a circular spiral shape “winding” around the screw body 11 between the screw head 12 and the leading edge 13.
[0138] As shown in
[0141] Thus, the outer edge 21 (generally convex shaped), has in the proximal portion 22 of the first thread 2 a series of proximal notches 3 (generally concave shaped) separated from each other by non-notched proximal portions 221 of the outer edge 21.
[0142] Hence, each proximal notch 3 defines a notched proximal portion 31 of the first thread 2, corresponding to the portion of the first thread 2 comprised between the screw body 11 and said proximal notch 3.
[0143] In other words, each notched proximal portion 31 of the first thread 2 corresponds to the portion of said first thread 2 comprised in a notched proximal angular sector 33 (shown in
[0144] Similarly, each non-notched proximal portion 221 of the outer edge 21 defines a separation proximal portion 32 of the first thread 2, corresponding to the portion of the first thread 2 comprised between the screw body 11 and said non-notched proximal portion 221.
[0145] In other words, each separation proximal portion 32 of the first thread 2 corresponds to the portion of said first thread 2 comprised in a separation proximal angular sector 34 (shown in
[0146] Thus, the first thread 2 has, from the screw head 12 towards the leading edge 13, an alternation of notched proximal portions 31 and separation proximal portions 32, two successive notched proximal portions 31 being separated from each other by a separation proximal portion 32.
[0147] Similarly, the outer edge 21 (generally convex shaped), has in the distal portion 23 of the first thread 2 a series of distal notches 4 (generally concave shaped) separated from each other by non-notched distal portions 231 of the outer edge 21.
[0148] Hence, each distal notch 4 defines a notched distal portion 41 of the first thread 2, corresponding to the portion of the first thread 2 comprised between the screw body 11 and said distal notch 4.
[0149] In other words, each notched distal portion 41 of the first thread 2 corresponds to the portion of said first thread 2 comprised in a notched distal angular sector 43 (shown in
[0150] Similarly, each non-notched distal portion 231 of the outer edge 21 defines a separation distal portion 42 of the first thread 2, corresponding to the portion of the first thread 2 comprised between the screw body 11 and said non-notched distal portion 231.
[0151] In other words, each separation distal portion 42 of the first thread 2 corresponds to the portion of said first thread 2 comprised in a separation distal angular sector 44 (shown in
[0152] Thus, the first thread 2 has, in its distal portion 23, an alternation of notched distal portions 41 and separation distal portions 42, two successive notched distal portions 41 being separated from each other by a separation distal portion 42.
[0153] The presence of the proximal notches 3 and the distal notches 4 allows improving the secondary stability of the transpedicular anchoring screw 1 according to the disclosure.
[0154] Indeed, once implanted in the vertebra V, these proximal notches 3 and these distal notches 4 promote bone regeneration of said vertebra V: some time after the operation of implanting in the vertebra V, these proximal notches 3 and these distal notches 4 are at least partially filled with new bone structures.
[0155] Due to their extended contact with the first thread 2, these new bone structures increase the intensity of the mechanical forces exerted between the vertebra V and the transpedicular anchoring screw 1, thus improving the secondary stability of the transpedicular anchoring screw 1.
[0156] Conversely, the separation proximal portions 32 and the separation distal portions 42 present, upon implantation of the transpedicular anchoring screw 1 in the vertebra V, a large contact surface therewith and therefore contribute to the primary stability of this transpedicular anchoring screw 1.
[0157] Thus, the larger the surface occupied by the proximal 3 and distal 4 notches, the more the transpedicular anchoring screw will have a significant secondary stability, but the increase in the size of these proximal 3 and distal 4 notches results in a reduction of the surface occupied by the separation proximal portions 32 and the separation distal portions 42: the improvement of the secondary stability of the transpedicular anchoring screw 1 by means of the proximal 3 and distal 4 notches is therefore done to the detriment of its primary stability.
[0158] Hence, the particular geometry of the first thread 2 in its proximal portion 22 and in its distal portion 23 addresses the search for an optimization of the size of the surface occupied by the proximal 3 and distal 4 notches with respect to that of the surface occupied by the separation proximal portions 32 and the separation distal portions 42, in order to improve the secondary stability of the transpedicular anchoring screw 1 without deteriorating its primary stability.
[0159] As shown in
[0160] Thus, it is possible to significantly reduce the surface of these separation distal portions 42 without the overall primary stability of the transpedicular anchoring screw 1 being considerably degraded: it is therefore advantageous to increase the size of the distal notches 4 in comparison with that of the separation distal portions 42, in order to significantly increase the secondary stability conferred by the distal portion 23 of the first thread 2. As shown in
[0161] Thus, each separation distal portion 42 is also reduced to a line segment joining this point of contact and the screw body 11: the surface occupied by the separation distal portions 42 is therefore zero.
[0162] Similarly, the measurement of the separation distal angular sectors 44, in which the separation distal portions 42 are inscribed, is zero.
[0163] Conversely, the distal notches 4 are present in a large number and have a large size: the notched distal angular sectors 43, under which the distal notches 4 are viewed and in which the notched distal portions 41 are inscribed, have a measurement equal to 60°.
[0164] Over a length of the first thread 2 corresponding to one screw pitch PV, the first thread 2 thus has six contiguous distal notches (and also six notched distal portions 41). It should be noted that, in the embodiment represented in
[0165] Thus, in the distal portion 23, over this length of the first thread 2 corresponding to one screw pitch PV, a ratio between the sum of the measurements of all of the separation distal angular sectors 44 and the sum of the measurements of all of the notched distal angular sectors 43 is equal to 0 (and is therefore in particular comprised between 0% and 10%): in the distal portion 23 of the first thread 2, the notched distal portions 41 therefore occupy a large surface in comparison with the separation distal portions 42, allowing greatly increasing the secondary stability conferred by this distal portion 23.
[0166] Conversely, as shown in
[0167] It is then impossible to significantly reduce the surface of these separation proximal portions 32 without the overall primary stability of the transpedicular anchoring screw 1 being greatly degraded: it is therefore necessary to limit the size of the proximal notches 3 and to keep a large size of the separation proximal portions 32, in order to slightly increase the secondary stability conferred by the proximal portion 22 of the first thread 2 while preserving a good primary stability.
[0168] As shown in
[0169] In the two embodiments represented in
[0170] Thus, in the proximal portion 22, over this length of the first thread 2 corresponding to one screw pitch PV, a ratio between the sum of the measurements of all of the separation proximal angular sectors 34 and the sum of the measurements of all of the notched proximal angular sectors 33 is equal to 1 (and is therefore in particular comprised between 0% and 150%).
[0171] Over a length of the first thread 2 corresponding to one screw pitch PV, the first thread 2 thus has only three proximal notches 3 (and therefore three notched proximal portions 31).
[0172] It should be noted that, in the embodiment represented in
[0173] Similarly, all separation proximal portions 32 have the same shape and the same size, and the separation proximal angular sectors 34 have the same extent: other embodiments could also be considered.
[0174] The balance between the surface occupied by the separation proximal portions 32 and that one occupied by the notched proximal portions 31 thus allows improving the secondary stability conferred by the proximal portion 22 of the transpedicular anchoring screw 1, while preserving a good primary stability.
[0175] It should be noted that in
[0176] Many embodiments could be considered regarding the particular shape of these proximal 3 and distal 4 notches.
[0177] For example, in the first embodiment represented by
[0180] In the second embodiment represented by
[0181] Similarly, as shown in
[0182] It should be noted that, because the distal notches 4 are contiguous, the first thread 2 has in the distal portion 23 a “star”-like shape, two successive distal notches 4 forming therebetween a radial projection 5 in the form of a point.
[0183] As mentioned before, these radial projections 5 allow creating at their periphery a bone remodeling area which also promotes the secondary stability of the transpedicular anchoring screw 1.
[0184] Moreover, as shown in
[0185] In addition, the screw body 11 has a slightly conical shape and has a transverse dimension (corresponding to the diameter of its circular section), measured perpendicularly to the screw axis 111, whose measurement progressively decreases between the proximal end 112 and the distal end 113.
[0186] Thus, the screw body 11 has a maximum transverse dimension D1 at the proximal end 112 and a minimum transverse dimension D2 at the distal end 113.
[0187] This reduction in the transverse dimension of the screw body and the thickness of the first thread 2 between the proximal portion 22 and the distal portion 23 allows preventing the distal portion 23 from damaging the bone structure of the pedicle P (in which the proximal portion 22 will be ultimately implanted) during the introduction of the transpedicular anchoring screw 1 into the vertebra V.
[0188] In this way, the primary stability of the transpedicular anchoring screw 1 conferred by the proximal portion 22 is not deteriorated by the prior passage of the distal portion 23 in the pedicle P.
[0189] The screw head 12 also has a structure adapted to promote the primary and secondary stability of the transpedicular anchoring screw 1.
[0190] Indeed, this screw head has in particular a collar 7 delimited by a collar edge 71, in which head notches 72 are formed.
[0191] This collar 7 has a transverse dimension D3 with a measurement larger than the maximum transverse dimension D1 of the first thread 2: this collar 7, once implanted in the cortical wall PC of the pedicle P, thus has a large contact surface with the bone structure of this pedicle P and significantly contributes to the primary stability of the transpedicular anchoring screw 1.
[0192] In the same manner as the proximal 3 or distal 4 notches of the first thread 2, the head notches 72 promote bone regeneration of the pedicle P after the implantation of the transpedicular anchoring screw 1 in the latter, thus contributing to the secondary stability of this transpedicular anchoring screw 1.
[0193] It should be noted that the geometry of the head 12 may also be illustrated by
[0194] Of course, many other embodiments concerning the geometry of this flange 7 are possible.
[0195] It should be noted that the screw head 12 also has an end piece 8, intended to project from the pedicle P once the transpedicular anchoring screw 1 has been implanted in the vertebra V, said endpiece 8 being adapted to cooperate with a surgical implant intended to be fastened on said vertebra V by means of the transpedicular anchoring screw 1.
[0196] The primary stability of the transpedicular anchoring screw 1 is also ensured by the presence of the second thread 20.
[0197] Indeed, as shown in
[0198] Hence, this second thread 20 has a very large contact surface with the bone structures of the vertebra V in which the transpedicular anchoring screw 1 is implanted, thereby guaranteeing a very good primary stability to this transpedicular anchoring screw 1.
[0199] Yet, this second thread 20 contributes only marginally to the secondary stability of the transpedicular anchoring screw 1.
[0200]
[0201] In particular, the first thread 2 herein has, in its distal portion 23, a distal sub-portion 232 close to the leading edge 13 in which the outer edge 21 includes no distal notch 4.
[0202] However, the first thread 2 has distal notches 4, identical to those described before and shown in particular in
[0203] Moreover, in this alternative embodiment, the second thread 20 does not extend up the leading edge 13 and thus has a distal portion 23′ shorter than the distal portion 23 of the first thread 2.
[0204] Thus, the transpedicular anchoring screw 1 of
[0205] In addition, due to the absence of distal notches 4 in this tip portion 131, the transpedicular anchoring screw 1 has no radial projection in the form of a point proximate to the leading edge 13, which allows limiting the risk of deterioration of the bone structures that said transpedicular anchoring screw 1 is brought to pass through during the implantation thereof in a vertebra V.
[0206] Finally, the second thread 20 has, in its distal portion 23′, distal notches 4′ having the same shape and the same function as the distal notches 4 formed in the first thread 2 and described before.
[0207] In particular, the geometry and the distribution of these distal notches 4′ may be illustrated by those of the distal notches 4 represented in
[0208] Hence, this second thread 20 also has, in its distal portion 23′, a “star”-like shape allowing maximizing the secondary stability conferred for the transpedicular anchoring screw 1.
[0209] Thus, the overall secondary stability of the transpedicular anchoring screw 1 of
[0210] Moreover, and as in the previous embodiment, the second thread 20 has no proximal notch in its distal portion 22 (whereas the first thread 2 has proximal notches 3 identical to those described before and shown in particular in
[0211] Thus, this alternative embodiment allows facilitating the insertion of the transpedicular anchoring screw 1 into a vertebra V while avoiding deteriorating the latter, while having primary stability and secondary stability substantially equivalent to the previous embodiment.
[0212] As described before, it could also be considered that, in either one of the previously-described embodiments, the proximal notches 3 and the distal notches 4 or 4′ are at least partially filled, before implantation of the transpedicular anchoring screw 1 in the vertebra V, by a bioresorbable material, for example a PLA (polyactic acid) type polymer, a PLGA (polyglycolic acid) type polymer or a PLA-PLGA type copolymer. Preferably, the proximal notches 3 and the distal notches 4 or 4′ are fully filled so that the bioresorbable material confers continuity with the outer edge 21 of the first thread 2, and possibly with the outer edge of the second thread 20 in the case wherein the latter is also provided with notches.
[0213] In this manner, during the introduction of the transpedicular anchoring screw 1 into the vertebra V, any risk of damage to the bone structure of the latter due to the presence of the proximal notches 3 or the distal notches 4 or 4′ is avoided.
[0214] After the operation of implanting the transpedicular anchoring screw 1 in the vertebra V, the bioresorbable material is resorbed and the proximal 3 and distal 4 or 4′ notches are uncovered and could become the site of a bone regeneration contributing, as described hereinabove, to the secondary stability of the transpedicular anchoring screw 1.
[0215] Thus, the transpedicular anchoring screw 1 according to the disclosure has a geometry adapted to the different bone structures of the vertebra V in which it is intended to be implanted, said geometry allowing significantly improving the secondary stability of this transpedicular anchoring screw 1 in comparison with the anchoring screws of the prior art, without degrading its primary stability.