Reusable surgical guide, particularly for hallux valgus osteosynthesis, and method of use thereof

Abstract

A reusable surgical guide for osteosynthesis for inserting wires into bone portions and a method for using the same. The guide includes a grip including a head extending from the end of a base, a blade fixed to the head, a trigger movable in a first slide formed in the head, and a direction element movable in a second slide formed in the base. The trigger includes a guide element for inserting a pull wire, and the direction element includes a means for supporting at least one positioning wire. The method includes: pulling the trigger to move a first bone portion relative to a second bone portion; and inserting a first wire through the support means into the first and second bone portions, with the surgical guide and the pull wire maintaining the relative positions of the bone portions.

Description

[Technical field]

[0001] The present invention relates to the field of surgical guides and methods of use thereof. More specifically, the present disclosure relates to a reusable surgical guide for osteosynthesis of hallux valgus, especially by a minimally invasive or percutaneous approach. A minimally invasive approach should be understood as a procedure that limits the access of the approach to a few centimeters, and a percutaneous approach should be understood as a procedure that limits the access of the approach to a few millimeters. [Background technology]

[0002] It is well known that hallux valgus deformity results from excessive cuneiform-metatarsal movement in metatarsal inversion. This metatarsal inversion becomes prominent during the support phase. Then, the first metatarsal is observed to be deflected inwards, called varus, while the first phalanx, held by the joint capsule and sesamoid line, is deflected outwards, a deflection called eversion.

[0003] There are different surgical techniques that can correct this deformity. All of these surgical techniques include at least four essential steps that contribute to the durability of the correction: the lateral opening step of the sesamoid line, which allows the contracted tissue to be stretched and allows the mobilization of the first phalanx; the osteotomy step of the first metatarsal (scarf, chevron, Bosch, ...), which reduces the angle between the first and second metatarsals and contributes to the excision of the inflamed area; the osteotomy step of the first phalanx, which is necessary to restore the M1 / P1 alignment; and the capsulotomy step, which plays an important role in the maintenance of the correction. It should be noted that in the percutaneous approach, this last step is irrelevant, since the capsule is only perforated by a few millimeters.

[0004] In the context of minimally invasive or percutaneous approach surgery in the correction of hallux valgus, one of the techniques commonly used is called PECA®, which stands for “Percutaneous Chevron-Akin”, and consists of fixing the two bone fragments of the metatarsal bone by means of two screws inserted in parallel.

[0005] In contrast to the "scarf" or "chevron" techniques of hallux valgus correction, this technique differs essentially by increasing the varus of the first metatarsal to effect a translation of the distal fragment, followed by imposition of the DMAA, which stands for "Distal Metatarsal Articular Angle". Thus, the axis of the head is at an acute angle to the axis of the shaft of the first metatarsal.

[0006] During the operation, the position of the first wire, the proximal wire, is the most critical step and also the most complex to perform. In fact, the proper position and orientation of this wire determines the stability of the initial attachment and also the placement of the second wire and the screws that will subsequently perform the osteosynthesis.

[0007] The proximal wire must be placed in the proximal part of the first metatarsal, crossing the two cortical parts of the bone, before terminating in the distal fragment formed during the osteotomy and translation. Due to the variability of human anatomy, the angle of the wire will vary from individual to individual, from osteotomy to osteotomy, and from translation to translation. Thus, the surgeon must adapt the trajectory of the proximal wire to each operation.

[0008] The second, or distal, wire must be inserted parallel to the proximal wire, spaced neither too far nor too small. The two wires are used to guide the screws for the subsequent osteosynthesis, but they must not be so far apart that they reach the distal fragment, nor too close together to prevent screw interference that may cause degradation of the screws during insertion. Alternatively, the distal (inner) wire can be placed first and the proximal (outer) wire placed second.

[0009] Usually, the step of inserting the wires is performed under X-ray fluoroscopy. Therefore, the X-ray images have many potential health hazards for the patient and the radiologist. In addition, the wires are often not parallel, which may result in improper screw positioning and mechanical weakness of the system, thus causing the operation to fail.

[0010] To overcome these drawbacks, several systems allowing the guidance of these wires have already been devised, examples of which are International Publication WO2017 / 040843 and US Patent Application Publication US2020 / 0060698, primarily commercialized by Wright Medical, Inc., with the MICA system, a registered trademark that stands for "Mini-invasive Chevron-Akin".

[0011] This document WO2017 / 040843 describes an instrument and a method for chevron osteotomy, and more specifically an orientation guide with a handle extending substantially along a longitudinal axis. The longitudinal handle defines one or several burr holes extending from a first side of the handle to a second side of the handle. A head is coupled to the distal end of the longitudinal handle. The head defines a number of guide holes sized and designed to receive Kirschner wires therethrough. The system thus consists of a one-piece guide, the distal end of which is inserted into a percutaneous drill previously placed at the same level as the osteotomy site. The surgeon then selects, based on several X-ray images, the most suitable window in the proximal part of the guide to guide his first wire. The same operation is repeated for the second wire.

[0012] Although this type of guide allows the surgeon's assistance in properly guiding his wire, it has the drawbacks of not being intuitive to use, not allowing the angular deflection of the wire required for proper translation of the metatarsal epiphysis, and not systematically preventing the risk of interference during screw insertion. Furthermore, the use of several X-ray images is still required.

[0013] US Patent Application Publication US2020 / 0060698 describes an orientation guide comprising a body defining a first guide hole sized and configured to receive a guide sleeve therethrough. The first guide hole extends through the body on a first axis. An alignment arm extends between a first end and a second end. The first end is coupled to the body. A tip extends from the second end of the alignment arm. A free end of the tip is aligned with the first axis of the first guide hole. The system thus consists of a guide with a guide barrel for a wire. The surgeon inserts the distal end of the guide into the osteotomy site and places a touch probe at the desired exit point of the surgeon's first wire. The operation is again performed based on several x-ray images. The first barrel is placed in the proximal region of the guide, which allows the first wire to be guided. The same operation is repeated for the second wire. This second system allows the marking of the exit point of the first wire in advance, thus guaranteeing the trajectory while minimizing the choice of similar windows and preventing the risk of interference during subsequent screw insertion.

[0014] Nevertheless, its use still requires x-ray imaging, and poor attachment to the metatarsal bone requires the surgeon to use complex movements to hold the guide in the desired position while inserting the wire. Summary of the Invention [Means for solving the problem]

[0015] Therefore, one of the objects of the present invention is to overcome these drawbacks by providing a surgical guide for osteosynthesis of simple and inexpensive design, making it possible to limit the number of X-ray images, simplifying the surgeon's movements during the operation and avoiding the risk of interference during the insertion of the screws.

[0016] To this end, according to the invention, a surgical guide for osteosynthesis is provided for inserting a positioning wire into a bone, characterized in that it comprises a grip with a head extending at one end of a base, a blade extending in a continuous part of the head and fixed to the head, a trigger configured to cooperate with a first slide formed in the head of the grip to be moved relative to the grip along the blade, the trigger comprising a guide element for inserting a pull wire, and an orientation part configured to cooperate with a second slide formed in the base of the grip to be moved relative to the grip, the orientation part comprising means for supporting at least one positioning wire at its distal end.

[0017] In other words, a reusable surgical guide for hallux valgus is provided, which forms an orientation for guiding and inserting a wire along its axis into a bone, said surgical guide comprising a grip with a head extending at the upper end of a base, a trigger arranged to be moved in a first slide formed in the head of the grip and provided at its distal end with a through hole for the insertion of a wire, a blade fixed below the trigger at the distal end of the head of the grip, and a so-called orientation piece arranged to be moved in a second slide formed in the base of the grip, said orientation piece comprising means for supporting at least one wire at its distal end.

[0018] It should be understood that the surgical guide of the present invention, like the surgical guides of the prior art, orients towards one unique point, but the guide of the present invention orients towards an estimated unique point located on the moving distal piece.

[0019] Thus, the instrument according to the invention is suitable for translation performed by the surgeon, thus avoiding undercorrection, overcorrection and the problems associated therewith.

[0020] For example, the guide element is a through hole.

[0021] According to one embodiment, the grip is constituted by two half shells each having a curved head and a prong, the recess of which is directed towards the distal end of the trigger and the lower end of which is open for the passage of a so-called orientation piece, the head and the curved prong being provided with through holes extending in a pair on opposite sides.

[0022] Preferably, the base has an arcuate shape with an arcuate recess directed towards the distal end of the head of said grip.

[0023] The base of the grip comprises a flat surface and two curved parallel prongs, each prong having at least two through holes extending in a pair on opposite sides.

[0024] In some embodiments, the surgical guide comprises a holding part for holding the position of the directing part, the holding part comprising a blocking element configured to cooperate with the directing part to block the movement of the directing part and a blocking element drive element configured to move the blocking element towards or away from the directing part. This allows the position of the directing part to be held, thus limiting the risk of movement of the directing part during the insertion of the at least one positioning wire. Thus, the positioning of the at least one positioning wire becomes more accurate.

[0025] Furthermore, the so-called directing piece has an arc shape.

[0026] The directing piece has an opening extending substantially from the proximal end to the distal end of the directing piece, the opening cooperating with a through hole in the curved prong of the grip to allow passage of the screw.

[0027] In addition, the means for supporting the at least one positioning wire comprises a cylindrical sleeve whose axis of rotation extends in the sagittal plane of the guide in the direction of the distal end of the blade, said cylindrical sleeve forming a sheath configured to receive a barrel for orienting the at least one positioning wire.

[0028] Advantageously, the sheath includes a longitudinal groove, said groove extending in the sagittal plane of said guide.

[0029] According to one variant, the means for supporting at least one positioning wire comprise two substantially parallel cylindrical sleeves whose rotation axes extend in the sagittal plane of the guide in the direction of the distal end of the blade, said cylindrical sleeves forming first and second sheaths, respectively, configured to receive barrels for orienting the first and second wires.

[0030] The trigger is provided with a measurement scale.

[0031] Further, the blade has a general L-shape, with a proximal portion extending parallel to the head of the grip and provided with a longitudinal opening, and a distal portion configured to be supported on the epiphysis of the metatarsal bone.

[0032] According to one variant, the blade has a straight shape, extends parallel to the head of the grip and comprises a proximal part provided with a longitudinal opening.

[0033] Advantageously, the surgical guide according to the invention comprises means for pulling a trigger.

[0034] The means for pulling the trigger comprises a worm screw having a first end cooperating with the trigger and an opposite end having a knob.

[0035] In addition, the surgical guide according to the present invention includes a rack with a lock release button to ensure head translation and retention of correction.

[0036] In some embodiments, the guide element of the trigger is configured to allow pivoting of the pull wire in the sagittal plane of the surgical guide.

[0037] For example, the trigger bore is open to allow for pivoting of the puller wire in the sagittal plane of the surgical guide.

[0038] In some embodiments, the trigger comprises a retaining element intended to retain the pull wire on the trigger.

[0039] For example, the distal end of the trigger may include a threaded member configured to cooperate with a grip for supporting a pull wire to secure the support grip on the trigger.

[0040] The disclosure also relates to a method of operating a surgical guide including positioning a surgical guide adjacent a first bone, the first bone including a cutting surface dividing the first bone into a first bone portion and a second bone portion; inserting a pull wire into the first bone portion and a through hole at a distal end of a trigger; retracting the trigger proximally through a first slide with the pull wire extending through the through hole and into the first bone portion such that the first bone portion is moved relative to the second bone portion; and thereafter inserting the first wire through a support means into the first and second bone portions to secure the first bone portion to the second bone portion, the first wire being inserted with the surgical guide together with the pull wire maintaining the relative positions of the first and second bone portions. [Brief description of the drawings]

[0041] Other advantages and features will become more apparent from the following description of some variants, given as non-limiting examples, of a surgical guide according to the invention, with reference to the attached drawings, in which: [Figure 1] FIG. 1 is a perspective view of a surgical guide according to the present invention. [Diagram 2] FIG. 2 is an exploded perspective view of a surgical guide according to the present invention. [Diagram 3] FIG. 3 is an exploded perspective view of a grip of a surgical guide according to the present invention. [Figure 4] FIG. 4 is an exploded perspective view of an orientation piece that slides within the grip of a surgical guide according to the present invention. [Diagram 5] FIG. 5 is an exploded perspective view of a grip of a surgical guide according to the present invention. [Figure 6] FIG. 6 is a sagittal cross-sectional view of a surgical guide according to the present invention. [Figure 7] FIG. 7 is a side view of a surgical guide according to the present invention in each step of using the surgical guide. [Figure 8] FIG. 8 is a side view of a surgical guide according to the present invention in each step of using the surgical guide. [Figure 9] FIG. 9 is a side view of a surgical guide according to the present invention in each step of using the surgical guide. [Figure 10] FIG. 10 is a side view of a surgical guide according to the present invention in each step of using the surgical guide. [Figure 11] FIG. 11 is a side view of a surgical guide according to the present invention in each step of using the surgical guide. [Figure 12] FIG. 12 is a perspective view of a surgical guide according to the present invention after placement of a first wire in the first metatarsal. [Figure 13] FIG. 13 is a side view of the arrangement of the second wire with a second so-called parallel guide. [Figure 14] FIG. 14 is a side view of a modified example of a surgical guide according to the present invention. [Figure 15] FIG. 15 is a side view of a modified surgical guide according to the present invention in each step of using the surgical guide. [Figure 16]FIG. 16 is a side view of a modified surgical guide according to the present invention in each step of using the surgical guide. [Figure 17] FIG. 17 is a perspective view of a second modified example of a surgical guide according to the present invention. [Figure 18] FIG. 18 is a sagittal cross-sectional view of a second variant of the surgical guide according to the invention shown in FIG. [Figure 19] FIG. 19 is a perspective view of a third modified example of a surgical guide according to the present invention. [Figure 20] FIG. 20 is a sagittal cross-sectional view of the third variant of the surgical guide according to the invention shown in FIG. [Figure 21] FIG. 21 is an exploded perspective view of the third modified example of the surgical guide according to the present invention shown in FIGS. [Figure 22] FIG. 22 is a perspective view of a fourth modified example of the surgical guide. [Diagram 23] FIG. 23 is a perspective view of a fourth modified example of the surgical guide. [Figure 24] FIG. 24 is a cross-sectional view of a fourth modified example of a surgical guide. [Diagram 25] FIG. 25 is a perspective view of a fourth modified example of the surgical guide. [Figure 26] FIG. 26 is a perspective view of a fourth modified example of the surgical guide. [Figure 27] FIG. 27 is a perspective view of a fourth modified example of a surgical guide. [Figure 28A] FIG. 28A is a perspective view of a patient's foot being prepared for osteotomy. [Figure 28B] FIG. 28B is a perspective view of a patient's foot being prepared for osteotomy. [Figure 29A] FIG. 29A shows pre-movement using a pull wire. [Figure 29B] FIG. 29B shows pre-movement using a pull wire. [Figure 29C] FIG. 29C shows pre-movement using a pull wire. [Figure 30A]FIG. 30A illustrates a method of preparing a surgical guide. [Figure 30B] FIG. 30B illustrates a method of preparing a surgical guide. [Figure 30C] FIG. 30C illustrates a method of preparing a surgical guide. [Figure 30D] FIG. 30D illustrates a method of preparing a surgical guide. [Figure 31A] FIG. 31A shows the positioning of the surgical guide relative to the metatarsal bones. [Figure 31B] FIG. 31B shows the positioning of the surgical guide relative to the metatarsal bones. [Figure 32A] FIG. 32A shows the orientation of the surgical guide relative to the metatarsals. [Figure 32B] FIG. 32B shows the orientation of the surgical guide relative to the metatarsals. [Figure 33A] FIG. 33A shows the insertion of the pull wire and placement of the surgical guide. [Figure 33B] FIG. 33B shows the insertion of the pull wire and placement of the surgical guide. [Figure 33C] FIG. 33C shows insertion of the pull wire and placement of the surgical guide. [Figure 34A] FIG. 34A illustrates translation of a first bone portion and a second bone portion using a surgical guide. [Figure 34B] FIG. 34B illustrates translation of the first and second bone parts using a surgical guide. [Diagram 35] FIG. 35 shows the development of the orientation piece. [Figure 36A] FIG. 36A shows the insertion of a positioning wire using a surgical guide. [Figure 36B] FIG. 36B shows the insertion of a positioning wire using a surgical guide. [Figure 37A] FIG. 37A shows removal of the guide after the positioning wire has been placed. [Figure 37B] FIG. 37B shows removal of the guide after the positioning wire has been placed. [Figure 37C] FIG. 37C shows removal of the guide after the positioning wire has been placed. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0042] In the following description of the surgical guide according to the invention, like reference numbers indicate like elements. The various figures are not necessarily drawn to scale. Furthermore, it is quite clear that the surgical guide according to the invention is particularly suitable for osteosynthesis of hallux valgus, but can be applied to osteosynthesis of other parts of the human anatomy without departing from the scope of the invention.

[0043] 1, 2 and 6, a surgical guide 1 according to the invention comprises a grip 2 with a head 3 extending at the upper end of a base 4, a trigger 5 arranged to be moved in a first slide 6 formed in the head 3 of the grip 2 and in this example provided at its distal end with a guide element, a through hole 7 for inserting a wire, not shown in FIGS. 1 and 6, a blade 8 fixed to the distal end of the head 3 of the grip 2 below the trigger 5, the blade 8 having a general L-shaped shape and comprising a proximal part 8a extending parallel to the head 3 of the grip 2 and provided with a longitudinal opening 8b and a distal part 8c arranged to be supported on the epiphysis of a metatarsal bone, and a so-called orientation piece 9 arranged to be moved in a second slide 10 formed in the base 4 of the grip 2 and comprising at least one means 11 for supporting at least one positioning wire at its distal end.

[0044] 1-6, the base 4 of the grip 2 has an arcuate shape with an arcuate recess facing the distal end of the blade 8. The base 4 of the grip 2 comprises a flat surface 12 and two curved parallel branches 13, each of which is provided with at least two through holes 14 extending in a pair on opposite sides. The head 3 has a substantially parallelepiped shape and is screwed onto the flat surface 12 by means of two screws 15 cooperating with two screw holes 16 formed on the flat surface 12.

[0045] Furthermore, the so-called orientation piece 9 has an arc shape with the same radius of curvature as the base 4 of the grip 2. Said orientation piece has an opening 17 that extends substantially from the proximal end to the distal end of the orientation piece 9, said opening 17 cooperating with a hole 14 in the curved branch 13 of the grip 2 to allow the passage of a screw 18.

[0046] It is quite clear that the orientation piece 9 may have a general arc-like shape having a radius of curvature different from that of the base 4 of the grip 2 while the orientation piece 9 and the base 4 are concentric without departing from the scope of the present invention.

[0047] In addition, the support means 11 comprises at least one cylindrical sleeve 19 whose axis of rotation extends in the sagittal plane of the surgical guide in the direction of the distal end of the blade 8, said cylindrical sleeve 19 forming a sheath configured to receive a barrel 20 for orienting a positioning wire. Advantageously, the sheath formed by the cylindrical sleeve 19 comprises, at the proximal end of the support means 11, a longitudinal groove 21 extending in the sagittal plane of said guide so as to allow easy removal of the surgical guide after the positioning wire has been set up, after which the orienting barrel has been previously removed and the positioning wire has passed through said groove 21.

[0048] 7-13, the operation of the surgical guide according to the present invention will now be described.

[0049] The surgeon makes an incision of the skin and the joint capsule of about 5 mm at the level of the bunion. With a percutaneous drill, the surgeon performs an exostoses of the medial side of the metatarsal bone (FIG. 7) in order to reduce the area of ​​arthritis as much as possible. The surgeon then performs an osteotomy of the metatarsal bone epiphysis, thereby separating the head from the shaft. The surgeon inserts the blade 8 into the incision (FIG. 7) so that its distal end is supported against the medial end of the head of the metatarsal bone. During this insertion, a slight translation is already performed. It should be noted that the blade 8 can also be inserted into the incision and then attached to the grip 2, since the blade 8 is easily removable from the grip 2.

[0050] 8, the surgeon then places the trigger 5 in position relative to the blade 8 by pressing the trigger 5 to slide within the first slide 6. Next, referring to FIG 9, the stabilization / pulling wire 22 may be inserted through the hole 7 at the end of the trigger 5 and into the medullary canal of the metatarsal bone.

[0051] 10, once the pull wire 22 is in place, the surgeon can pull the shaft by pulling the trigger 5. Thus, we have discovered the principle of the surgical technique, which consists of increasing the metatarsal varus by translating the head. By holding the metatarsal head while pulling the metatarsal shaft, a correction of the Distal Metatarsal Articular Angle (DMAA) is automatically achieved.

[0052] 11 and 12, by rotating the orientation piece 9, the surgeon selects the entry point of the first positioning wire 23 to be as proximal as possible. The surgeon inserts the first positioning wire 23 and may then insert the second, distal positioning wire 25 if the device is equipped with a double sheath as described in more detail below.

[0053] The surgeon can now remove the orientation barrel 20 used to insert the so-called proximal first positioning wire 23, and then, by rotating the orientation part 9, the surgeon removes the positioning wire 23 passing through the groove 21, thus extracting the surgical guide according to the present invention while leaving the proximal positioning wire 23 behind and stabilizing the affected area.

[0054] 13, the surgeon may be assisted by the parallel guide 24 to insert a second positioning wire 25 substantially parallel to the first proximal positioning wire 23. If the surgeon wishes, the surgeon may insert the first implant before inserting the second positioning wire 25. The surgeon continues with the insertion of the second implant, thereby completely immobilizing the affected area. Finally, the surgeon performs a final osteotomy to remove any bone wedges that may have encroached on the patient's soft tissue and impeded the patient's ambulation.

[0055] With reference to FIG. 14, according to one variant, the surgical guide 1 according to the invention comprises, as before, a grip 2 with a head 3 extending at the upper end of a base 4, a trigger 5 arranged to be moved in a first slide 6 formed in the head 3 of the grip 2 and at its distal end provided with a guide element, in this example a through hole 7 for inserting a pulling wire not represented in FIGS. 1 and 6 and a so-called orientation piece 9 arranged to be moved in a second slide 10 formed in the base 4 of the grip 2, said orientation piece 9 comprising at its distal end a means 11 for supporting at least one positioning wire.

[0056] The base 4 of the grip 2 has an arcuate shape with an arcuate recess directed towards the distal end of the trigger 5 of the grip 2. The base 4 of the grip 2 comprises a flat surface 12 and two curved parallel branches 13, each of which is provided with at least two through holes 14 extending in a pair on opposite sides. The head 3 has a substantially parallelepiped shape and is screwed onto the flat surface 12 by means of two screws 15 cooperating with two screw holes 16 formed on the flat surface 12.

[0057] Furthermore, the so-called orientation piece 9 has an arc shape with the same radius of curvature as the base 4 of the grip 2. Said orientation piece has an opening 17 that extends substantially from the proximal end to the distal end of the orientation piece 9, said opening 17 cooperating with a hole 14 in the curved branch 13 of the grip 2 to allow the passage of a screw 18.

[0058] As before, it is quite clear that the orientation piece 9 can have a general arcuate shape with a different radius of curvature than the radius of curvature of the base 4 of the grip 2 while the orientation piece 9 and the base 4 are concentric without departing from the scope of the present invention.

[0059] This surgical guide differs from the previous one in that it does not include a blade 8, the trigger 5 is provided with measuring scales 26 and the support means 11 comprises two substantially parallel cylindrical sleeves 19 whose rotation axes extend in the sagittal plane of the guide towards the distal end of the trigger 5, said cylindrical sleeves 19 forming first and second sheaths configured to receive barrels 20 for the orientation of the first and second positioning wires, respectively.

[0060] The previously estimated positioning wire exit point is then determined by measuring the depth of the completed osteotomy, which the surgeon may perform using a depth gauge if he or she wishes.

[0061] The operation of this modified surgical guide will now be described with reference to Figures 15 and 16.

[0062] In this embodiment, the surgeon translates the trigger of the inventive instrument rather than translating the epiphysis of the metatarsal bone. The surgeon can then insert the guide positioning wire using the orientation arc and the barrel attached to the arc. Thus, referring to FIG. 15, the use of the inventive instrument is summarized as performing an osteotomy, measuring the depth of the osteotomy using a depth gauge, inserting a tension wire into the medullary canal of the metatarsal bone, and performing the overlay of the inventive surgical guide over the wire. Then, referring to FIG. 16, the measured depth is reported, the screw guide positioning wire 23, 25 is inserted, the surgical guide is removed, the epiphysis is translated, and full insertion of the positioning wire 23, 25 is proceeded.

[0063] It should be noted that, without departing from the scope of the invention, the variants represented in Figures 1 to 13 may comprise a support means 11 comprising two parallel cylindrical sleeves 19 whose axis of rotation extends in the sagittal plane of the guide in the direction of the distal end of the trigger 5, the cylindrical sleeves 19 forming first and second sheaths configured to receive barrels 20 for orienting the first and second positioning wires, respectively.

[0064] 17 and 18, according to a second variant, a surgical guide 1 according to the invention, similar to the one described with reference to FIGS. 1 to 6, comprises a sleeve 2 with a head 3 extending at the upper end of a base 4, a trigger 5 arranged to be moved in a first slide 6 formed in the head 3 of the grip 2 and at its distal end a blade 8 fixed to the distal end of the head 3 of the grip 2 below the trigger 5 and provided with a through hole 7 for the insertion of a pulling wire 22, said blade 8 having a general L-shaped shape and comprising a proximal part 8a extending parallel to the head 3 of the grip 2 and provided with a longitudinal opening 8b, and a distal part 8c arranged to bear against the epiphysis of the metatarsal bone, a so-called orientation piece 9 arranged to be moved in a second slide 10 formed in the base 4 of the grip 2, said orientation piece 9 comprising at its distal end means 11 for supporting at least one positioning wire.

[0065] The base 4 of the grip 2 has an arcuate shape with an arcuate recess directed towards the distal end of the blade 8. The base 4 of the grip 2 comprises two curved parallel branches 13, each of which is provided with at least two through holes 14 extending in a pair on opposite sides. The head 3 has a substantially parallelepiped shape and comprises two parts, each of which bears a curved branch 13 forming the base 4 of the grip 2.

[0066] Furthermore, the orientation piece 9 has an arc shape with the same radius of curvature as the base 4 of the grip 2. The orientation piece 9 has an opening 17 that extends substantially from the proximal end to the distal end of the orientation piece 9, and the opening 17 cooperates with a hole 14 in the curved branch 13 of the grip 2 to allow the passage of a screw 18.

[0067] As before, it is quite clear that the orientation piece 9 can have a general arcuate shape with a different radius of curvature than the radius of curvature of the base 4 of the grip 2 while the orientation piece 9 and the base 4 are concentric without departing from the scope of the present invention.

[0068] In addition, the support means 11 comprises two cylindrical sleeves 19 whose rotation axes extend parallel to each other in the sagittal plane of the surgical guide in the direction of the distal end of the blade 8, said cylindrical sleeves 19 forming first and second sheaths configured to receive barrels for orienting the first and second positioning wires. Advantageously, the sheath formed by the cylindrical sleeves 19 comprises, at the proximal end of the support means 11, a longitudinal groove 21 extending in the sagittal plane of said guide so as to allow easy removal of the surgical guide after the positioning wires have been set up, with the orienting barrels having been previously removed and the positioning wires having passed through said groove 21.

[0069] This surgical guide differs from the previous one in that it includes a means for pulling a trigger 5, the first end of which cooperates with said trigger 5 and which comprises a worm screw 27, the opposite end of which is provided with a knob 28. In this way, once the head translation has been performed by the surgeon, he has free control over the plantar position of the translated epiphysis of the metatarsal bones. With the other hand, the surgeon can insert a positioning wire, so that it is located in the median plane of the head.

[0070] Additionally, a rack with an unlocking button may be used to ensure head translation and correction are maintained.

[0071] 19-21, according to a third variant, the surgical guide 1 according to the invention comprises, similarly to the one described with reference to FIGS. 1-6, a grip 2 with a head 3 extending at the upper end of a base 4, a trigger 5 configured to be moved in a first slide 6 formed in the head 3 of the grip 2 and provided at its distal end with a through hole 7 for inserting a pulling wire, a blade 8 fixed to the distal end of the head 3 of the grip 2 below the trigger 5, and a so-called orientation piece 9 configured to be moved in a second slide 10 formed in the base 4 of the grip 2, said orientation piece 9 comprising at its distal end a means 11 for supporting at least one positioning wire.

[0072] The support means 11 comprises two cylindrical sleeves 19 whose rotation axes extend parallel to each other in the sagittal plane of the surgical guide in the direction of the distal end of the blade 8, said cylindrical sleeves 19 forming first and second sheaths adapted to receive barrels for the orientation of the first and second positioning wires, respectively. Advantageously, the sheath formed by the cylindrical sleeves 19 comprises, at the proximal end of the support means 11, a longitudinal groove 21 extending in the sagittal plane of said guide so as to allow easy removal of the surgical guide after the positioning wires have been set up, with the orientation barrels having been previously removed and the positioning wires having passed through said groove 21.

[0073] As before, this surgical guide includes a means for pulling a trigger 5, the first end of which cooperates with said trigger 5 and which comprises a worm screw 27 with a knob 28 at its opposite end. In this way, once the head translation has been performed by the surgeon, he has free control over the plantar position of the translated epiphysis of the metatarsal bones. With the other hand, the surgeon can insert a positioning wire so that it is located in the median plane of the head.

[0074] Additionally, a rack with an unlocking button may be used to ensure head translation and correction are maintained.

[0075] This surgical guide differs from the previous one in that the grip 2 comprises two half shells 29a and 29b each comprising a head 3 and a curved branch 13 whose recess is directed towards the distal end of the trigger 5 and whose lower end is open for the passage of the orientation piece 9, the flat surface 12 and the curved branch 13 being provided with through holes 14 extending in a pair on opposite sides. The head 3 thus has a substantially parallelepiped shape and is formed by the two half shells 29a and 29b.

[0076] Furthermore, the orientation piece 9 has an arc shape with the same radius of curvature as the base 4 of the grip 2. The orientation piece 9 has an opening 17 that extends substantially from the proximal end to the distal end of the orientation piece 9, and the opening 17 cooperates with a hole 14 in the curved branch 13 of the grip 2 to allow the passage of a screw 18.

[0077] As before, it is quite clear that the orientation piece 9 can have a general arcuate shape with a different radius of curvature than the radius of curvature of the base 4 of the grip 2 while the orientation piece 9 and the base 4 are concentric without departing from the scope of the present invention.

[0078] This surgical guide also differs from the previous ones in that the blade 8 has a generally straight rather than L-shaped shape and therefore only has a proximal portion 8a which extends parallel to the head 3 of the grip 2 and is provided with a longitudinal opening 8b.

[0079] In this third variant, the trigger 5 also comprises measuring graduations 26 .

[0080] A fourth variant of the surgical guide is depicted in FIGS.

[0081] This variant differs from the variants described above in that the surgical guide comprises an assembly 51 for retaining the position of the orientation part 9. This retaining assembly 51 comprises a blocking element 53 configured to cooperate with the orientation part 9 to block the movement of the orientation part 9, in particular its sliding in the slide 10 of the base 4. The retaining assembly 51 further comprises an element 55 for actuating the blocking element 53, which allows the blocking element 53 to be moved so as to allow the blocking or opening of the orientation part 9.

[0082] For example, the blocking element 53 comprises a threaded member 57 fixed to the orientation part 9. For example, the threaded member 57 is integral with the orientation part 9. The blocking element 53 comprises a screw member 59 configured to cooperate with the threaded member 57. The actuation element comprises an actuation handle 61. The actuation element comprises an actuation handle 61. Rotation of the actuation handle 61 in one direction thus allows the orientation part 9 to approach the actuation handle 61, thus holding the orientation part 9 relative to the slide and holding the actuation handle against the outer wall of the base 4 of the grip 2. Movement of the orientation part 9 relative to the slide 10 is thus prevented by friction. Rotation of the actuation handle 61 in the opposite direction allows the orientation part 9 to move away from the actuation handle 61, thus releasing the movement of the orientation part 9.

[0083] The fourth variant also differs from the previous variants in that the surgical guide comprises an element for holding the pull wire 22 on the trigger 5 .

[0084] In the illustrated example, the retaining element is a threaded portion 63 formed on the distal end of the trigger 5. In particular, the outer surface of the distal end of the trigger 5 comprises the threaded portion 63. The threads of the threaded portion 63 and the through hole 7 are substantially concentric. The threaded portion 63 is configured to cooperate with a threaded portion of a support grip 65 of the pull wire 22. Thus, the grip 65 supporting the pull wire 22 can be locked by the trigger 5.

[0085] The fourth variant also differs from the previous variants in that the trigger 5 is provided with a swivel groove 67 for the pull wire 22. This allows the pull wire 22 to be inserted into the swivel groove 67 to more easily reach the inside of the metatarsal bone, as shown in Fig. 26, and then to be straightened by swivel in the sagittal plane of the guide.

[0086] In the example shown, the distal end of the trigger 5, i.e. the threaded portion 63, is provided with a pivot groove 67 for the pull wire 22. Thus, the through hole 7 opens towards the head 3 by means of the pivot groove 67. In this example, the pivot groove 67 allows the pull wire 22 to pivot at an angle of about 60°. When the pull wire 22 is straightened, the distal end of the trigger 5 and the through hole 7 are aligned.

[0087] In this example, the longitudinal groove 8b of the blade 8 is extended at the downwardly bent distal end 8c of the blade 8 to allow for the passage and pivoting of the pull wire 22. This longitudinal groove 8b and the pivot groove 67 are superimposed.

[0088] Elements described with reference to one variation may be combined with elements described in other variations.

[0089] Furthermore, it must be emphasized that, regardless of the embodiment of the surgical guide according to the invention, the latter allows for a precise insertion of the first proximal positioning wire and, furthermore, for the insertion of the second distal wire parallel to the first proximal wire, regardless of the anatomical structure of the first metatarsal, a symmetrical use of the surgical guide according to the invention without the risk of interference between the screws and the avoidance of the use of X-ray images.

[0090] A method of using a surgical guide according to the present disclosure will now be described with reference to Figures 28A-37C. The method will be described herein using the surgical guide shown in Figures 22-27 (fourth variation), however, it will be understood that the method may be practiced with any of the surgical guides disclosed herein.

[0091] Prior to the osteotomy, the outline of the first bone (e.g., first metatarsal) may be drawn with a marking pen. For example, a skin marking pen line is created running parallel to the dorsal surface of the first bone, as shown in Figures 28A and 28B. A 4 mm incision is then made along a portion of the pen line, centered at the level of the osteotomy that was made. This percutaneous incision may be made in the range of about 4 mm to about 5 mm in length. The incision is continued by blunt dissection to the underlying bone.

[0092] An osteotomy may then be performed separating the first bone 70 into a first bone portion 71 and a second bone portion 72. For example, an osteotomy of the metatarsal epiphysis may be performed by separating the head 72 from the shaft 71. A transverse osteotomy or other suitable osteotomy such as a chevron or modified chevron directed osteotomy may be performed.

[0093] After the osteotomy using a burr is performed, the first bone part 71, such as the diaphysis, can be translated medially to increase the first intermetatarsal angle according to the degree of the patient's deformity using the surgical guide 1. Figures 29A-35 show exemplary steps for performing a preliminary movement, in which a surgical guide is prepared and then a movement to correct the metatarsal angle is performed using the surgical guide 1.

[0094] As shown in Figures 29A-C, pre-movement may be performed after osteotomy. As shown in Figure 29A, a pull wire 22 attached to a support handle 65 is inserted along the osteotomy site. When the tip of the pull wire 22 has passed through the medial cortex and is in the medullary canal of the first bone part 71 (e.g., the shaft of the metatarsal), the support handle 65 is rotated to position the pull wire 22 in the longitudinal axis of the metatarsal 70, and then the second bone part 72 (e.g., the head of the metatarsal) is moved laterally, as shown in Figures 29B-C.

[0095] As shown in Figures 30A-30D, the surgical guide can be prepared for use by retracting the orientation piece 9 to a proximal position in the second slide 10 of the base 4 and the trigger 5 to a proximal position in the first slide 6 of the head 3. Then, as shown in Figure 31A, the joint capsule is incised at the level of the osteotomy towards the second bone 72, e.g., the head of the metatarsal, and the blade 8 (e.g., distal part 8c) is inserted through the incision. Then, as shown in Figure 31B, the blade 8 is slid between the joint capsule and the second bone 72 so that the blade 8 abuts the medial end of the second bone 72. This is performed by rotating the surgical guide 1 by approximately 45°-90°, as shown in Figures 31A-31B.

[0096] The surgical guide 1 may be positioned adjacent to the first bone 70. For example, the surgical guide may be positioned such that the blade 8 is in contact with the cut surface of the first bone 70. In particular, the distal part 8c of the blade 8 may be in contact with the second bone part 72, and the base part 8a of the blade 8 may be in contact with the cut surface of the first bone part 71. As an example, FIG. 32A shows the positioning and / or orientation of the surgical guide 1 with respect to the metatarsal 70. In particular, after the surgical guide 1 is rotated, the base part (e.g., the proximal part 8a) of the blade 8 may be positioned such that it is in contact with the cut surface of the first metatarsal (first bone) 70, and preferably positioned as perpendicular as possible to the second metatarsal 75 (the second bone adjacent to the first bone). At the same time, as shown in FIG. 32B, the surgical guide 1 may be oriented as parallel as possible to the back of the first metatarsal 70.

[0097] Once the surgical guide 1 is properly positioned, the trigger 5 can be advanced relative to the distal portion 8c of the blade 8, for example, using the knob 28. The pull wire 22 can then be inserted through the incision to retrieve the medullary shaft of the first bone portion 71, as shown in FIG. 33A. The pull wire 22 is inserted through the surgical guide 1, for example, through a hole 8b in the blade 8. Once the pull wire 22 is in the medullary shaft of the first bone portion 71, the pull wire assembly can be rotated or tilted relative to the surgical guide 1 to accommodate the wire 22 in the pivot groove 67 of the trigger 5, as shown in FIG. 33B. The pull wire handle 65 can be screwed to the element 63 or through hole 7 of the trigger 5 to secure the assembly, although the disclosure is not limited thereto. The pull wire 22 or pull wire handle 65 can be secured to the surgical guide 1 by any suitable means, such as, but not limited to, a flange, clip, clamp, or snap-fit ​​connection. As shown in FIG. 33C, the guide 1 and pull wire handle 65 should be parallel to the back of the first bone 70 (e.g., the first metatarsal), and the surgical handle 65 can be used to orient the first bone 70 and second bone 75, as described below with respect to FIGS. 34A and 34B.

[0098] 33A-33C, the sleeve forming the through hole 7 in the trigger 5 includes a pivot groove 67 extending in a direction substantially parallel to the through hole 7 to allow for easy insertion of the pull wire 22. Alternatively, the pull wire 22 can be inserted directly into the through hole 7 and then inserted into the pith shaft instead of being inserted into the pith shaft and then rotated into the through hole 7 via the pivot groove 67.

[0099] 34A and 34B, once the pull wire 22 is secured in place and the pull wire handle 65 is secured to the trigger 5, the handle 65 can be used to control the orientation of the proximal phalanx and the height of the metatarsal head 72. The trigger 5 can then be retracted by rotation of the knob 28 or other means to effect the desired movement, i.e., the first bone portion 71 is moved relative to the second bone portion 72. In particular, as shown in FIG. 34B, when the trigger 5 is retracted, the first bone portion 71 is attracted (e.g., pulled) by the wire 22 in a medial direction, while the second bone portion 72 is held by the blade 8 (e.g., by abutment of the distal portion 8c of the blade 8) such that the first bone portion 71 is moved relative to the second bone portion 72 for reduction of metatarsal varus and correction of DMAA.

[0100] After appropriate movement, the orientation piece 9 is deployed from the base 4, as shown in FIG. 35. In particular, the orientation piece 9 may be slid proximally through the second slide 10 until the base 4 contacts the skin. The orientation piece 9 may then be locked in place. Using the handles, the orientation of the proximal phalanx and the height of the metatarsal head may be adjusted as needed.

[0101] Once the orientation is properly controlled, the wires can be placed as shown in Figures 36A-36B. The barrel 20 for orientation of the first wire 23, which is the distal (e.g., medial) screw wire, is inserted into the first (distal) cylindrical sleeve 19 of the support means 11. The direction of the distal phalanx and the height of the metatarsal head (second bone portion) 72 are confirmed. Then, an incision is made where the barrel 20 contacts the skin, and the first wire 23 (distal wire) is inserted through the first bone portion 71 into the second bone portion 72 to fix the first bone portion 71 and the second bone portion 72 to each other, as shown in Figure 30A. As shown in Figure 36A, the first wire 23 is inserted into the first bone portion 71 and the second bone portion 72 in a direction perpendicular to the direction of inserting the pull wire 22 into the first bone portion. The first wire 23 is inserted in a state in which the surgical guide 1 and the pulling wire 22 maintain the relative positions of the first bone portion 71 and the second bone portion 72 .

[0102] Without releasing the toe position, the barrel 20 for directing the second wire 25, which is the proximal (e.g., outer) screw wire, is inserted into the second (proximal) cylindrical sleeve 19 of the support means 11. Then, as shown in FIG. 36B, the second wire 25 is inserted through the first bone portion 71 into the second bone portion 72 in a manner similar to that of the first wire 23. The second wire 25 is inserted proximally (outside) the first wire 23 so as to extend substantially parallel to the first wire 23. As with the first wire 23, the second wire 25 is inserted in a direction perpendicular to the direction of insertion of the pulling wire 22, and in a state in which the surgical guide 1 and the pulling wire 22 maintain the relative positions of the first bone portion 71 and the second bone portion 72. Although the figure shows that the distal wire is inserted first and then the proximal wire is inserted, this order is not essential and may be reversed.

[0103] Once both wires 23, 25 have been inserted for fixation of the first bone part 71 and the second bone part 72 (e.g., the shaft and the metatarsal head), the barrel 20 can be removed from the cylindrical sleeve 19 of the support means 11, as shown in Fig. 37A. The orientation piece 9 can then be unlocked and stored in the base 4 through the second slide 10, as shown in Fig. 37B. The longitudinal grooves 21 in the support means 11 allow the support means 11 to be easily separated from the wires 23, 25 which pass through the grooves 21 when storing the orientation piece 9 in the base 4. The tension wire assembly can be removed by removing the tension wires 22 from the medullary shaft of the first bone part 71 and the surgical guide 1, and the surgical guide 1 can then be removed, as shown in Fig. 37C. After the surgical guide 1 is removed, screws can be placed over the first and second screw wires 23, 25 for final fixation of the first 71 and second 72 bone parts.

[0104] Although the method is described for fixation of the metatarsal head 72 and shaft 71, the method and surgical guide disclosed herein may be used to fix any bones together.

[0105] Finally, it is very clear that the examples provided herein are merely specific illustrations without limiting the field of application of the invention.

Claims

1. A reusable surgical guide for osteosynthesis, for inserting a positioning wire into a bone, comprising: The reusable surgical guide comprises: a grip having a head extending at one end of a base; a blade secured to the head and extending through a continuous portion of the head; a trigger configured to cooperate with a first slide formed in the head of the grip to be moved relative to the grip along the blade, the trigger comprising a guide element for inserting a pull wire; an orientation piece configured to cooperate with a second slide formed in the base of the grip to be moved relative to the grip; The directing piece comprises means for supporting at least one positioning wire at its distal end. Surgical guide.

2. The surgical guide of claim 1 , wherein the base has an arcuate shape with an arcuate recess directed toward the distal end of the head of the grip.

3. The grip comprises two half shells, Each of the two half shells comprises: The head and a curved branch having a recess facing the distal end of the trigger and an opposite end opening to allow passage of the orientation piece; The surgical guide according to claim 2 , wherein the head portion and the curved branch portion are provided with a pair of through holes extending to opposite sides.

4. the base of the grip comprises a flat surface and two curved, parallel prongs; The surgical guide according to claim 2 , wherein each branch portion is provided with at least two through holes extending in a pair on opposite sides of each other.

5. a retaining part for retaining a position of the orientation part; The holding part is a blocking element configured to cooperate with the orientation piece to block movement of the orientation piece; The surgical guide of claim 1 , comprising: a blocking element drive element configured to move the blocking element toward or away from the orientation element.

6. The surgical guide of claim 1 , wherein the orientation piece has an arc shape.

7. the directing piece having an opening extending from a proximal end to a distal end of the directing piece; the opening cooperates with a through hole in a curved branch of the grip to allow passage of a screw; The surgical guide of claim 5.

8. The surgical guide of claim 1 , wherein the means for supporting the at least one positioning wire comprises at least one cylindrically shaped sleeve forming a sheath configured to receive a barrel for directing the at least one positioning wire.

9. The surgical guide of claim 8 , wherein the sheath includes a longitudinal groove.

10. 9. The surgical guide of claim 8, wherein the support means comprises two parallel cylindrical sleeves forming a first sheath and a second sheath, respectively, configured to receive barrels for directing the first and second positioning wires.

11. The surgical guide of claim 1 , wherein the blade comprises a longitudinal opening.

12. The surgical guide of claim 1 , further comprising a means for pulling the trigger.

13. said means for pulling said trigger comprises a worm screw; The surgical guide of claim 12 , wherein a first end of the worm screw cooperates with the trigger and an opposite end of the worm screw includes a knob.

14. The surgical guide of claim 12, further comprising a rack with an unlocking button to ensure retention of the head translation and correction.

15. The surgical guide of claim 1 , wherein the guide element of the trigger is configured to allow pivoting of the puller wire in a sagittal plane of the surgical guide.

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