Extracorporeal correction tool

Abstract

[Problem] To provide an extracorporeal correction tool capable of correcting spinal column deformation by an operation from the outside of a body, thereby ensuring a desired correction rate, eliminating the complexity of correction and fixation surgery using a spinal column deformation correction and fixation system, and consequently further reducing the burden on a patient. [Solution] An extracorporeal correction tool 1A includes a first overcorrection means 31 for overcorrecting and holding a plurality of shaft members 25, 25, which are arranged along the cranial-caudal direction in a curved configuration that is convex toward one side in the left-right direction of a patient in accordance with scoliotic deformation of the patient, so as to be arranged along the cranial-caudal direction in a curved configuration that is convex toward the other side in the left-right direction of the patient. As a result, it is possible to ensure a desired correction rate for a scoliosis patient, to eliminate the complexity of correction and fixation surgery using a spinal column deformation correction and fixation system, and consequently to further reduce the burden on the patient.

Description

External orthosis

[0001] The present invention relates to an external orthosis that can correct externally to assist in the correction and fixation when correcting and fixing spinal deformities using a spinal deformity correction and fixation system including vertebral fixing devices respectively fixed to a plurality of vertebrae and rod members connected to the vertebral fixing devices during spinal deformity correction and fixation surgery.

[0002] In a normal state, the spine is generally straight when viewed from the back, and when viewed from the side, the cervical and lumbar vertebrae are anteriorly curved, and the thoracic and sacral vertebrae are posteriorly curved, presenting a substantially S-shaped curve. On the other hand, spinal deformity, which causes abnormalities in the spine, is a disease in which the spine is deformed, and examples include scoliosis, kyphosis, and scolio-kyphosis. Scoliosis is a disease in which the spine curves to the right or left (sideways) while being twisted. Kyphosis is a disease in which the angle of thoracic kyphosis becomes extremely large or the lumbar lordosis is lost and deformed into kyphosis. Furthermore, scolio-kyphosis is a combination of scoliosis and kyphosis.

[0003] In the treatment of such spinal deformities, spinal deformity correction and fixation surgery is widely performed. This spinal deformity correction and fixation surgery is a surgery in which a deformed spine is corrected and fixed to a normal state or a state close to it using a spinal deformity correction and fixation system (an implant, a so-called buried material in the body) described later, and posterior correction and fixation surgery or anterior correction and fixation surgery is applied. In particular, the posterior correction and fixation surgery is performed as follows. That is, in the posterior correction and fixation surgery, the patient is positioned in the prone position on the operating table, and a surgical incision or a minimally invasive percutaneous surgical incision is made in the midline of the patient's back to expose the posterior elements of the spine. Subsequently, a spinal deformity correction and fixation system (for example, see Patent Document 1) is attached to the spine to three-dimensionally correct the spinal deformity and fix it in that state.

[0004] Generally, a spinal deformity correction and fixation system is adopted, for example, one including a plurality of screw members screwed into the vertebral body through the left and right pairs of pedicles of each vertebra of the spine, and a pair of rod members that are connected to the top open groove portions of each screw member, extend along the axial direction of the spine, and are arranged at intervals in the left-right direction of the patient.

[0005] For example, in a posterior corrective fusion surgery for a scoliosis patient, the above-mentioned spinal deformity correction and fusion system is attached to the spine to correct and fix the spinal deformity. First, the screw members are fixed to each of the vertebrae to be corrected. Next, the rod members are engaged with the top open grooves of the screw members. At this time, although the spine is deformed, the rod members extend in a straight line, making it very difficult to engage the rod members with the top open grooves of the screw members. Therefore, the surgeon uses a special surgical instrument to bend the rod members to conform to the scoliotic deformity of the spine. Next, these bent rods are engaged with the top open grooves of the screw members fixed to each vertebra, and the set screws are temporarily fastened to the top open grooves of each screw member to prevent the rod members from coming out.

[0006] Next, the outer surface of the rod member is gripped with a specialized surgical instrument equivalent to pliers (such as a rod gripper), and the instrument is rotated approximately 90°, thereby rotating the rod member approximately 90° around its axis to correct the scoliotic deformation, including the twisting of the spine. In addition, using specialized surgical instruments, the scoliotic deformation of the spine is corrected by applying compressive or tensile loads to multiple screw members, for example, that are arranged along the axial direction of the spine. After these corrective operations, the set screws are tightened to firmly connect the rod member to each screw member, correcting and fixing the spine.

[0007] Japanese Patent Publication No. 2012-213625

[0008] However, in conventional spinal deformity correction and fixation systems, the rod members are bent to conform to the patient's scoliosis and engaged with the top open grooves of each screw member. However, because the spine undergoes scoliosis that includes twisting, even when the rod members are bent, it is extremely difficult to engage them with the top open grooves of each screw member. Moreover, the longer the correction and fixation range of the spinal deformity correction and fixation system, the more difficult it becomes to engage the rod members with the top open grooves of each screw member, resulting in longer surgery times and increased burden on both the surgeon and the patient. Furthermore, adopting such a surgical method makes it difficult to achieve the correction intended by the surgeon, that is, it is not possible to achieve the desired correction rate (correction of scoliosis) intended by the surgeon, and therefore improvement was necessary.

[0009] Furthermore, in conventional spinal deformity correction and fixation systems, the outer surface of the rod member is firmly gripped with a specialized surgical instrument equivalent to pliers, and the rod member is rotated by approximately 90° to correct scoliosis, including spinal torsion. However, when a rod member curved to match the patient's scoliosis is rotated by approximately 90° around its axis, the curvature of the rod member is replaced by the patient's kyphosis and lordosis. However, because this curvature of the rod member does not match the patient's physiological (normal) kyphosis and lordosis, other problems may arise, and appropriate measures are required to correct the kyphosis and / or lordosis as intended by the surgeon.

[0010] Furthermore, in conventional spinal deformity correction and fixation systems, the outer surface of the rod member is firmly gripped with a specialized surgical instrument equivalent to pliers and rotated 90°. This carries the risk of damage to the gripped portion of the rod member's outer surface. Moreover, because the rod member is temporarily fixed to the top open groove of each screw member with a set screw, rotating the rod member may also damage the contact area with the set screw on the rod member's outer surface. As a result, these damaged areas contribute to the fracture of the rod member after it has been implanted in the body.

[0011] The present invention has been made in view of these points, and aims to provide an external corrective device that, when correcting and fixing spinal deformities with a spinal deformity correction and fixation system, can correct the spinal deformity by manipulating it from outside the body, thereby ensuring a desired correction rate, eliminating the complexity of corrective and fixation surgery using a spinal deformity correction and fixation system, and ultimately reducing the burden on the patient, while also minimizing damage to the rod members of the spinal deformity correction and fixation system.

[0012] As a means to solve the above problems, the invention relating to the external corrective device of claim 1 is an external corrective device that assists in correcting and fixing spinal deformities by manipulating the spinal deformity from outside the body when correcting and fixing spinal deformities with a spinal deformity correction and fixing system comprising a vertebral fixation device fixed to each vertebra of the spine and a rod member connected to the vertebral fixation device, and is characterized by comprising a shaft member that is detachably attached to each vertebral fixation device fixed to each vertebra of the spine and extends toward the outside of the patient's body, and an overcorrection means that overcorrects and holds a plurality of shaft members that are arranged along the craniocaudal direction in a convex curve toward one side of the patient's left-right direction in accordance with the patient's scoliosis, so that they are arranged along the craniocaudal direction in a convex curve toward the other side of the patient's left-right direction.

[0013] As a premise, multiple shaft members fixed to each vertebra are arranged along the craniocaudal direction in a convex curve to the left or right of the patient in accordance with the patient's scoliosis. Even when attempting to correct the scoliosis by holding the upper part of each shaft member so that they are aligned in a nearly straight line, a situation arises where the shaft member located furthest from the ideal spine (nearly straight) rotates around the connection point with the vertebral fixation device, causing the vertebra (vertebral body) itself to rotate only around its radial center and not to move (slide) in parallel with the shaft member. As a result, even if each shaft member is aligned and held in an ideal spine (nearly straight), the corrective force is not sufficiently transmitted to each vertebral fixation device, i.e., each vertebra, and each vertebra is not corrected to the ideal spine (nearly straight). Consequently, the desired correction rate cannot be secured, and therefore the complexity of corrective fixation surgery using a spinal deformity correction fixation system cannot be eliminated.

[0014] In view of these circumstances, the invention of claim 1, in particular, allows the overcorrection means to change the arrangement of each shaft member from an initial state in which they are aligned along the craniocaudal direction with a convex curve to one side of the patient's left-right direction, to an overcorrection state in which they are aligned along the craniocaudal direction with a convex curve to the other side of the patient's left-right direction, in accordance with the patient's scoliotic deformity. By overcorrecting, the vertebral fixation device connected to the shaft member can be physically (mechanically) slid (forcibly pulled) towards approximately the center of the patient's left-right direction, and as a result, each vertebra (spine) can be corrected to be approximately straight along the craniocaudal direction, and consequently, the scoliotic deformity of the spine, in particular, can be corrected according to the surgeon's intention (approximately straight along the craniocaudal direction). This makes it possible to secure the desired correction rate and eliminate the complexity of corrective fixation surgery using a spinal deformity correction fixation system.

[0015] The invention relating to the external orthodontic device of claim 2 is characterized in that, in the invention described in claim 1, the overcorrection means comprises an orthodontic holding plate arranged along each of the shaft members, and an orthodontic screw mechanism that pulls each of the shaft members towards the orthodontic holding plate. In the invention of claim 2, since the overcorrection means has a simple configuration comprising an orthodontic holding plate and an orthodontic screw mechanism, assembly play can be minimized, and the orthodontic force from the orthodontic holding plate and the orthodontic screw mechanism can be reliably transmitted to each vertebra of the spine.

[0016] The invention relating to the external orthodontic device of claim 3 is characterized in that, in the invention described in claim 2, the orthodontic retaining plate is configured to be curved in one or the other direction in the left-right direction of the patient when viewed in plan. In the invention of claim 3, overcorrection can be achieved by the curved shape of the orthodontic retaining plate, so the configuration can be simplified and assembly play can be minimized.

[0017] The invention relating to the extracorporeal orthodontic device of claim 4 is characterized in that, in the invention described in claim 2, the orthodontic screw mechanism comprises a support ring supported on the shaft member so as to be movable in the axial direction, a fixing bolt extending from the support ring toward the orthodontic retaining plate and fixing the orthodontic retaining plate, and a spacer arranged around the fixing bolt and adjusting the distance between the support ring and the orthodontic retaining plate. In the invention of claim 4, the degree of overcorrection curvature (the degree to which the patient's hand curves convexly to one side or the other) can be appropriately set during surgery based on the surgeon's intention by changing the length and number of spacers. In short, the degree of overcorrection curvature can be appropriately changed during surgery based on the magnitude of the patient's scoliosis.

[0018] The invention relating to the external orthodontic device of claim 5 is characterized in that, in the invention described in claim 4, the overcorrection means has a counter plate extending in the craniocaudal direction to connect a pair of shaft members located at both ends of the patient in the craniocaudal direction, and the counter plate is positioned on the opposite side of each shaft member from the orthodontic holding plate side. In the invention of claim 5, the counter plate can be used to set a standard for overcorrection in the left-right direction of the patient.

[0019] The invention relating to the external orthodontic device of claim 6 is characterized in that, in the invention described in claim 5, a pusher member is connected to the counter plate to push the vertebral fixation device, which is fixed to the vertebra, toward the orthodontic holding plate. In the invention of claim 6, the vertebral fixation device, which is fixed to the vertebra, can be directly pushed toward the orthodontic holding plate by the pusher member, thereby physically (mechanically) sliding (forcibly pulling) the vertebral fixation device toward approximately the center in the left-right direction of the patient and holding it.

[0020] The invention relating to the external orthodontic device of claim 7 is characterized in that, in the invention described in claim 5, a pusher member is connected to the counter plate to push the shaft member toward the orthodontic holding plate. In the invention of claim 7, the vertebral fixation device connected to the shaft member can be physically (mechanically) slid (forcibly pulled) and held approximately to the center of the patient's left-right direction by the pusher member pushing the shaft member directly toward the orthodontic holding plate.

[0021] The invention relating to the external orthodontic device of claim 8 is characterized in that, in the invention described in claim 6 or 7, the pusher members are connected in multiples to the counter plate. In the invention of claim 8, multiple vertebral fixation devices, which are fixed to each vertebra (each vertebra located far from the left-right center of the patient) that are located approximately at the top of the patient's scoliosis and have a large amount of slide (amount of slide towards the left-right center of the patient), can be slid (forcibly pulled) towards the left-right center of the patient by multiple pusher members and held in place.

[0022] The invention relating to the external orthodontic device of claim 9 is characterized in that, in the invention described in claim 6 or 7, the pusher member is supported so as to be movable along the longitudinal direction of the counter plate. In the invention of claim 9, any shaft member or vertebral fixation device that is aligned along the head-to-tail direction of the patient, that is, aligned along the longitudinal direction of the counter plate, can be directly pushed away from the counter plate.

[0023] The invention relating to the external orthodontic device of claim 10 is characterized in that, in the invention described in claim 5, the orthodontic holding plate and the counter plate are curved to conform to the lordosis and / or kyphosis of the spine. In the invention of claim 10, the orthodontic holding plate and the counter plate can play a supportive role in correcting the lordosis and kyphosis deformities of the patient.

[0024] The invention relating to the external orthodontic device of claim 11 is characterized in that, in the invention described in claim 1, the overcorrection means is positioned in close proximity to the patient's body surface. In the invention of claim 11, the action of the overcorrection means can be sufficiently transmitted to each vertebra together with each vertebral fixation device.

[0025] The invention relating to the external orthodontic device of claim 12 is characterized in that, in the invention described in claim 1, it is further characterized by comprising a clamping means for clamping and holding the upper parts of each shaft member from both sides in the left-right direction of the patient. In the invention of claim 12, the clamping means can hold the upper parts of each shaft member, which are arranged along the craniocaudal direction in a convex curve to one side in the left-right direction of the patient, in accordance with the scoliosis deformation of the patient, so as to gather them approximately in the center in the left-right direction of the patient. The corrective and holding force of the clamping means is such that it gathers the upper parts of each shaft member approximately in the center in the left-right direction of the patient, and does not interfere with the overcorrective action of the spine by the overcorrective means. In this way, the clamping means can play a supportive role against the overcorrective action of the overcorrective means.

[0026] The invention relating to the external orthodontic device of claim 13 is characterized in that, in the invention described in claim 2, the orthodontic holding plate is configured to be bent in a crank shape in a plan view. The invention of claim 13 makes it possible to increase the variations in the curvature of the patient's teeth that is convex in one or the other direction in the left-right direction when overcorrecting.

[0027] The external corrective device according to the present invention allows for the correction and fixation of spinal deformities by manipulating the spinal deformity from outside the body when correcting and fixing spinal deformities with a spinal deformity correction and fixation system. This ensures a desired correction rate, eliminates the complexity of corrective and fixation surgery using the spinal deformity correction and fixation system, and ultimately reduces the burden on the patient, while also minimizing damage to the rod members of the spinal deformity correction and fixation system.

[0028] Figure 1 is a cross-sectional view of a spinal deformity correction and fixation system to which an external orthodontic device according to the first to third embodiments of the present invention is applied. Figure 2 is a perspective view showing a state in which a rod member is fixed to a screw member of a spinal deformity correction and fixation system to which an external orthodontic device according to the first to third embodiments of the present invention is applied. Figure 3 is a perspective view of the screw member shown in Figure 2. Figure 4 is a plan view seen from the rear of a patient, showing a state in which screw members are fixed to each vertebra of the spine of a scoliosis patient. Figure 5 is a plan view seen from the rear of a patient, showing a state in which the scoliotic deformity of the spine is corrected and fixed by the spinal deformity correction and fixation system. Figure 6 is a perspective view of an external orthodontic device according to the first embodiment of the present invention. Figure 7 is a perspective view of an external orthodontic device according to the first embodiment of the present invention. Figure 8 is a perspective view of an external orthodontic device according to the first embodiment of the present invention, which differs from the external orthodontic devices shown in Figures 6 and 7 in the curvature direction of the correction and retention plate. Figure 9(a) is a perspective view of a shaft member used in an external orthopedic device according to the first embodiment of the present invention, (b) is a perspective view of a screw gripping cylinder member constituting the shaft member, (c) is a perspective view of a rod pusher cylinder member constituting the shaft member, and (d) is a perspective view of a pair of screw gripping pieces constituting the shaft member. Figure 10 is a perspective view of the pressing mechanism of the clamping means used in an external orthopedic device according to the first embodiment of the present invention. Figure 11 is a perspective view of the first support ring used in an external orthopedic device according to the first embodiment of the present invention. Figure 12 shows the effect of overcorrection, in which each vertebra of the spine is corrected to be substantially straight, with (a) showing shaft members arranged along the craniocaudal direction in a convex curve toward one side of the patient's left-right direction due to scoliosis, and (b) showing shaft members arranged along the craniocaudal direction in a convex curve toward the other side of the patient's left-right direction due to overcorrection, and each vertebra of the spine being corrected to be substantially straight along the craniocaudal direction, as seen from the rear of the patient. Figure 13 is a perspective view of an external orthopedic device according to a second embodiment of the present invention. Figure 14 is a perspective view of an external orthopedic device according to a second embodiment of the present invention. Figure 15 is a perspective view of a second support ring used in an external orthopedic device according to a second embodiment of the present invention. Figure 16 is a perspective view of a shaft pusher member used in an external orthopedic device according to a second embodiment of the present invention.Figure 17 is a perspective view of a first support ring member according to another embodiment, which is used in an external orthopedic device according to a second embodiment of the present invention. Figure 18 is a perspective view of a shaft pusher member according to another embodiment, which is used in an external orthopedic device according to a second embodiment of the present invention. Figure 19 is a perspective view showing the engagement state between the first support ring member shown in Figure 17 and the shaft pusher member supported on the counter plate, shown in Figure 18. Figure 20 is a perspective view including a screw pusher member used in an external orthopedic device according to a second embodiment of the present invention. Figure 21 is a perspective view of the screw pusher member shown in Figure 20. Figure 22 is a perspective view of an external orthopedic device according to a third embodiment of the present invention.

[0029] The embodiments for carrying out the present invention will be described in detail below with reference to Figures 1 to 22. The external corrective devices 1A to 1C according to the first to third embodiments of the present invention can assist in the correction and fixation by the spinal deformity correction and fixation system 2 by correcting from outside the body, while ensuring a desired correction rate for the patient's scoliosis, and eliminating the complexity of the correction and fixation surgery performed by the spinal deformity correction and fixation system 2. When correcting and fixing spinal deformity with the spinal deformity correction and fixation system 2, a posterior correction and fixation procedure is employed in which the patient is positioned prone on an operating table (not shown), a surgical incision is made in the midline of the patient's back, and the posterior elements of the spine are exposed.

[0030] First, the spinal deformity correction and fixation system 2 will be described. Referring to Figures 1 to 5, the spinal deformity correction and fixation system 2 is an implantable material placed inside the patient's body and comprises a plurality of screw members 3, 3 that are screwed into the vertebral body via a pair of pedicles on the left and right of each vertebra of the spine, and a pair of left and right rod members 5, 5 that are connected to the top open grooves 10, 10 of each screw member 3, 3 and extend along the axial direction of the spine. Note that the screw members 3 correspond to vertebral fixation devices. Figure 4 is a plan view (viewed from the rear of the patient) showing the state in which the screw members 3 of the spinal deformity correction and fixation system 2 are fixed to each vertebra of the spine of a scoliosis patient, and Figure 5 is a plan view (viewed from the rear of the patient) showing the state in which the scoliotic deformity of the spine is corrected and fixed by the spinal deformity correction and fixation system 2.

[0031] Furthermore, the spinal deformity correction and fixation system 2 may also appropriately incorporate other components as needed, such as hook members (not shown) that are fixed to the vertebrae by hooking onto the pedicles, arches, transverse processes, etc. of the vertebrae, and bridging members (not shown) that are positioned to span a pair of left and right rod members 5, 5. Figures 1 and 5 show the spinal deformity correction and fixation system 2, which includes multiple screw members 3, 3 and a pair of rod members 5, 5.

[0032] Referring to Figures 1 and 2, the implantable material, the screw member 3 and the rod member 5, are made of a biocompatible material such as a titanium alloy. The rod member 5 is formed in a circular cross-section. The length of the rod member 5 is appropriately set according to the degree of spinal deformity of the patient, that is, the range of correction for spinal deformity (axial correction range). Referring to Figures 1 to 3, the screw member 3 is screwed into the vertebral body from the posterior side of the spine via the pedicle of each vertebra. The screw member 3 is also generally called a pedicle screw or pedicle screw. The screw member 3 comprises a rod receiving portion 11 having a top-open groove portion 10 for receiving the rod member 5, and a screw portion 12 connected to the rod receiving portion 11 and screwed into the vertebral body via the pedicle of the vertebra.

[0033] The rod receiving portion 11 is formed in a block shape having a pair of flat portions 15, 15 and a pair of arc portions 16, 16 in a plan view. Referring to Figure 4, when the screw member 3 is screwed into the vertebral body via the pedicle of the patient's vertebra, the pair of flat portions 15, 15 are positioned along the head-to-tail direction of the patient, and the pair of arc portions 16, 16 are positioned along the left-to-right direction of the patient. Referring to Figures 1 to 3, the rod receiving portion 11 has a U-shaped top-open groove portion 10 that is open on the side opposite to the screw portion 12, and is formed along the axial direction of the rod member 5 (spine). This top-open groove portion 10 is formed to penetrate the pair of flat portions 15, 15. The rod member 5 is engaged with this top-open groove portion 10.

[0034] In the rod receiving section 11, female threaded sections 17, 17 are formed on the inner wall surfaces of the walls facing each other across the top-open groove section 10. The set screw 20 is screwed into these female threaded sections 17, 17. On the outer circumferential surface of each arc section 16, 16 of the rod receiving section 11, engagement grooves 23, 23 are formed at positions close to the top, running along the circumferential direction. Referring to Figure 3, the screw section 12 is connected to the rod receiving section 11 so as to be able to swing along the direction in which the top-open groove section 10 extends (the direction of the patient's head and tail) relative to the rod receiving section 11 (direction of the arrow in Figure 3). The range of swing of the screw section 12 relative to the rod receiving section 11 is approximately 25° on one side from the center (total swing range: approximately 50°).

[0035] Next, the external orthodontic devices 1A to 1C according to the first to third embodiments of the present invention will be described in detail based on Figures 6 to 22, with reference to Figures 1 to 5 as appropriate. For the sake of convenience of explanation, the screw portion 12 side of the screw member 3 shown in Figure 3 will be referred to as the lower side, and the rod receiving portion 11 side as the upper side, as appropriate. First, the external orthodontic device 1A according to the first embodiment will be described in detail based on Figures 6 to 12, with reference to Figures 1 to 5 as appropriate. The external orthopedic device 1A according to the first embodiment, as shown in Figures 6 to 8, comprises shaft members 25, 25 that are detachably attached to screw members 3 (see Figures 1 to 5) fixed to each vertebra of the spine and extend toward the outside of the patient's body; a clamping means 30 that holds the upper parts of the multiple shaft members 25, 25, which are arranged along the craniocaudal direction in a convex curve toward one side of the patient's left-right direction in accordance with the patient's scoliotic deformation, by clamping them from the left and right sides of the patient; and a first overcorrection means 31 that overcorrects and holds the multiple shaft members 25, 25, which are arranged along the craniocaudal direction in a convex curve toward one side of the patient's left-right direction in accordance with the patient's scoliotic deformation, so that they are arranged along the craniocaudal direction in a convex curve toward the other side of the patient's left-right direction.

[0036] In Figures 6 to 8, four shaft members 25 are shown in the external orthopedic device 1A according to the first embodiment, and in Figures 13, 14, 17, and 19, eleven shaft members 25 are shown in the external orthopedic devices 1B and 1C according to the second and third embodiments. However, these are illustrative examples, and each shaft member 25 is fixed to a screw member 3 that is arranged along the craniocaudal direction corresponding to each vertebra in the corrective fixation range of the spine, and the number of shaft members 25 corresponds appropriately to the number of screw members 3 arranged in the corrective fixation range.

[0037] Referring to Figure 9, the shaft member 25 (see Figure 9(a)) includes a screw gripping cylinder member 34 (see Figure 9(b)) that grips the rod receiving portion 11 (see Figures 1 to 5) of the screw member 3, a pair of screw gripping pieces 35, 35 (see Figure 9(d)) that are rotatably connected in the vertical direction to the outer circumference of the screw gripping cylinder member 34, and a rod pusher cylinder member 36 (see Figure 9(■)) that is axially movable within the screw gripping cylinder member 34 and pushes the rod member 5 (spinal deformity correction and fixation system 2), which is positioned along the head-to-tail direction of the patient within the slits 38, 38 (described later) of the screw gripping cylinder member 34, into the top open groove portion 10 of the screw member 3. At the lower end of the screw gripping cylinder member 34, a pair of elongated vertical slits 38, 38 are formed facing each other, extending from the lower end in a predetermined axial range.

[0038] A rod member 5 (see Figures 1 to 5) of the spinal deformity correction and fixation system 2 is inserted into a pair of slits 38, 38 so as to cross (intersect) each slit 38, 38. A pair of elongated gripping wall portions 40, 40 are formed on the screw gripping cylinder member 34, extending vertically between the pair of slits 38, 38. The lower ends of the pair of gripping wall portions 40, 40 are curved in an arc shape so as to contact and support the outer circumferential surfaces of a pair of arc portions 16, 16 of the rod receiving portion 11 of the screw member 3. A female screw portion (not shown) is formed on the upper inner circumferential surface of the screw gripping cylinder member 34. A stopper portion 46 is provided projecting radially outward from the outer circumferential surface of the screw gripping cylinder member 34, extending circumferentially slightly above the pair of slits 38, 38.

[0039] A pair of gripping wall portions 40, 40 have elongated receiving recesses 41, 41 formed therein, into which a pair of screw gripping pieces 35, 35 are housed. An elongated through hole 42 is formed approximately in the center of the receiving recess 41 in the vertical direction (longitudinal direction). An insertion hole 44 is formed through the lower end of the receiving recess 41 into which the engaging claw portion 49 (described later) of the screw gripping piece 35 is inserted. The screw gripping piece 35 is formed with a wide lower end and is formed in an approximately inverted T shape when viewed from the front. Engaging claw portions 49, 49 are projected from the lower ends of the pair of screw gripping pieces 35, 35 in directions approaching each other. The screw gripping piece 35 is rotatably mounted in the receiving recess 41 of the gripping wall portion 40 around a pivot point 41A. The engaging claw portion 49 of the screw gripping piece 35 is positioned within the insertion hole 44 of the receiving recess 41.

[0040] A pair of screw gripping pieces 35, 35, which are rotatably attached to a pair of gripping wall portions 40, 40, are constantly biased by an elastic member (not shown) in a direction in which their lower ends (engaging claw portions 49, 49) move closer to each other, and their upper ends move further apart from each other. As a result, by pressing the upper ends of the pair of screw gripping pieces 35, 35, the lower ends (engaging claw portions 49, 49) of the pair of screw gripping pieces 35, 35 are moved further apart from each other, while by releasing the pressure on the upper ends of the pair of screw gripping pieces 35, 35, the biasing force of the elastic member causes the lower ends (engaging claw portions 49, 49) of the pair of screw gripping pieces 35, 35 to move closer to each other.

[0041] The rod pusher cylindrical member 36 is composed of a male threaded cylindrical portion 52 having a male threaded portion 52A on its outer circumference, and a rod pusher cylindrical portion 53 connected to the lower end of the male threaded cylindrical portion 52 so as to be rotatable relative to the male threaded cylindrical portion 52. The male threaded portion 52A of the male threaded cylindrical portion 52 of the rod pusher cylindrical member 36 is screwed into a female threaded portion provided on the upper inner circumference of the screw gripping cylindrical member 34. As a result, the rod pusher cylindrical member 36 is supported within the screw gripping cylindrical member 34 so as to be able to move relative to it along the axial direction.

[0042] A pair of rod push portions 55, 55 are formed at the lower end of the rod pusher cylindrical portion 53, spaced apart from each other. An arc-shaped recess 57 is formed on the lower end surface of the rod push portion 55, which contacts the outer circumferential surface of the rod member 5. The rod pusher cylindrical portion 53 is supported so as not to rotate relative to the screw gripping cylinder member 34, such that its pair of rod push portions 55, 55 are located within the slits 38, 38 of the screw gripping cylinder member 34. By rotating the male threaded cylindrical portion 52 of the rod pusher cylindrical member 36, the rod pusher cylindrical portion 53 slides vertically so as to be rotatable relative to the male threaded cylindrical portion 52, but not rotatable relative to the screw gripping cylinder member 34.

[0043] Referring to Figures 6 to 8, the clamping means 30 is positioned above each shaft member 25, 25. The clamping means 30 includes a pair of clamping plates 60, 60 that, in response to the scoliotic deformation of the patient, correct and hold the upper outer surfaces of the multiple shaft members 25, 25, which are arranged along the craniocaudal direction in a convex curve toward one side in the left-right direction of the patient, by clamping them from the left-right direction of the patient, and a pressing mechanism 61 that presses the pair of clamping plates 60, 60 toward each other. The clamping plates 60 are formed in an elongated, substantially rectangular cross-section along the patient's spine. Bolt members 65, 65 extend from both longitudinal ends of one of the pair of clamping plates 60, 60 toward the other clamping plate 60. Through holes 66, 66 are formed at both longitudinal ends of the other clamping plate 60, through which the bolt members 65, 65 from the other clamping plate 60 are inserted.

[0044] On the opposing inner surfaces of the pair of clamping plates 60, 60, thin plate members 68, 68 made of synthetic resin are respectively fixed. In this embodiment, the thin plate members 68 are made of a silicon-based synthetic resin. Then, by the pair of clamping plates 60, 60, as the patient's scoliosis deformation occurs, the upper outer surfaces of the plurality of shaft members 25, 25 arranged along the cranio-caudal direction in a convex bending mode in one direction in the patient's left-right direction are sandwiched from the patient's left-right direction via the thin plate members 68, 68, and each bolt member 65, 65 from one clamping plate 60 is inserted into each insertion hole 66, 66 of the other clamping plate 60 and fixed by each nut member 70, 70.

[0045] Referring to FIGS. 6 to 8 and FIG. 10, the pressing mechanism 61 is disposed at a substantially central portion in the longitudinal direction of the pair of clamping plates 60, 60. The pressing mechanism 61 includes a pair of pressing portions 72A, 72B that support the pair of clamping plates 60, 60 so as to sandwich them, a bolt member 74 connected to the other pressing portion 72B among the pair of pressing portions 72A, 72B, and a main body portion 76 that integrally extends from the one pressing portion 72A toward the other pressing portion 72B side and supports the other pressing portion 72B so as to be movable forward and backward by screwing with the bolt member 74. That is, the other pressing portion 72B is supported by the main body portion 76 so as to be movable forward and backward with respect to the one pressing portion 72A. After arranging the pair of clamping plates 60, 60 so as to be sandwiched from above by the pair of pressing portions 72A, 72B, by rotating the bolt member 74 in the positive direction to bring the other pressing portion 72B closer to the one pressing portion 72A, the pair of clamping plates 60, 60 can be pressed in a direction approaching each other.

[0046] Referring to Figures 6 and 7, the first overcorrection means 31 is positioned close to the patient's body surface (not shown). The first overcorrection means 30 includes a correction holding plate 81 positioned along each shaft member 25, 25, and a correction screw mechanism 85 that pulls each shaft member 25, 25 towards the correction holding plate 81. The correction holding plate 81 is elongated along the patient's head-to-tail direction and restrains and holds each shaft member 25, 25 via the correction screw mechanism 85. The correction holding plate 81 is erected on the sides of each shaft member 25, 25. The correction holding plate 81 is configured to be curved with a predetermined curvature in a convex shape towards one side or the other in the left-to-right direction of the patient, along the patient's head-to-tail direction. The correction holding plate 81 shown in Figures 6 and 7 is configured to be curved with a predetermined curvature in a convex shape towards the other side in the left-to-right direction of the patient, along the patient's head-to-tail direction. The orthodontic retaining plate 81 shown in Figure 8 is constructed to be curved with a predetermined curvature in a convex shape towards one side of the patient's left-right direction, along the head-to-tail direction of the patient.

[0047] Furthermore, the orthodontic retaining plate 81 is configured to be curved along the patient's craniocaudal direction and in a direction that follows the patient's lordosis and / or kyphosis. In this embodiment, referring to Figure 6, the orthodontic retaining plate 81 is curved along the patient's craniocaudal direction and in a direction that follows the patient's kyphosis. A stepped opening 90, which is elongated along the patient's craniocaudal direction and curved in the same way as its outer shape, passes through the orthodontic retaining plate 81. The stepped opening 90 is composed of a narrow opening 91 and a wide opening 92. A step portion 93 is formed between the narrow opening 91 and the wide opening 92. Note that the orthodontic retaining plate 81 shown in Figure 8 employs a simple elongated opening 90 instead of a stepped opening 90.

[0048] Referring to FIGS. 6 to 8 and FIG. 11, the correction screw mechanism 85 is provided corresponding to each shaft member 25. The correction screw mechanism 85 includes a first support ring 96 supported by the shaft member 25 and integrally having a fixing bolt 95, and a tightening nut 99 screwed onto the fixing bolt 95 of the first support ring 96 inserted through the stepped opening 90 of the correction holding plate 81, and the shaft member 25 is attracted to the correction holding plate 81 via the first support ring 96. On the inner peripheral surface of the first support ring 96, a pair of relief grooves 100, 100 are formed to avoid interference with the pair of screw gripping pieces 35, 35 of the shaft member 25.

[0049] On the outer surface of the first support ring 96, the fixing bolt 95 projects outwardly on the extension line connecting the pair of relief grooves 100, 100. The first support ring 96 is supported so as to be axially movable along the outer periphery of the shaft member 25 (screw gripping cylinder member 34). The downward movement of the first support ring 96 is restricted by a stopper portion 46 (see FIGS. 9(a) and (b)) provided on the screw gripping cylinder member 34 of the shaft member 25. When the first support ring 96 is arranged along the outer peripheral surface of the screw gripping cylinder member 34 of the shaft member 25, the first support ring 96 is supported so as not to be relatively rotatable with respect to the screw gripping cylinder member 34 by the engagement between the pair of screw gripping pieces 35, 35 and the pair of relief grooves 100, 100, and the fixing bolt 95 projects toward one of the gripping wall portions 40, 40 (one screw gripping piece 35) of the screw gripping cylinder member 34.

[0050] Next, a first support ring 96 is supported on the outer circumference of each shaft member 25 (screw gripping cylinder member 34) so ​​as to be movable along the axial direction. Then, a straightening and holding plate 81 is placed to the side of each shaft member 25. Next, fixing bolts 95 from each first support ring 96 supported on each shaft member 25 are inserted into the stepped opening 90 of the straightening and holding plate 81. Then, tightening nuts 99 are screwed onto the fixing bolts 95 of each first support ring 96 protruding from the stepped opening 90 of the straightening and holding plate 81 and tightened so that the tightening nuts 99 come into contact with the stepped portion 93 of the stepped opening 90. As a result, each shaft member 25, 25 is attracted to the corrective holding plate 81 by the action of each corrective screw mechanism 85 and aligns along the corrective holding plate 81 (which has a shape that curves to one side or the other in the left-right direction of the patient). Consequently, each shaft member 25, 25 can be overcorrected and held so that it is aligned along the craniocaudal direction in a convex curve to one side or the other in the left-right direction of the patient.

[0051] At the same time, since each first support ring 96 is axially movable relative to the outer circumferential surface of the corresponding shaft member 25, each shaft member 25 can change its height along the curvature of the lordosis and / or kyphosis of the corrective retaining plate 81. However, since each first support ring 96 is axially movable relative to the outer circumferential surface of the corresponding shaft member 25, the height of each shaft member 25 is not determined along the curvature of the lordosis and / or kyphosis of the corrective retaining plate 81. Rather, as will be described later, the height of each shaft member 25 is changed along the curved shape (lordosis and / or kyphosis) of the rod member 5.

[0052] Next, a method will be described in which, when correcting and fixing spinal deformities with the spinal deformity correction and fixation system 2, the spinal deformity is corrected by external manipulation of the spinal deformity using the external corrective device 1A according to the first embodiment, while assisting the correction and fixation by the spinal deformity correction and fixation system 2. First, posterior corrective fixation is employed for patients with spinal deformities, such as scoliosis. The external corrective device 1A according to the first embodiment is used during this posterior corrective fixation. That is, when performing posterior corrective fixation, first, referring to Figure 4, the screw member 3 is screwed into each vertebra to be corrected, i.e., the vertebra within the correction and fixation range (for example, multiple vertebrae from the thoracic vertebrae to the lumbar vertebrae), from the posterior side of the spine via a pair of pedicles on the left and right sides of the vertebra, using a dedicated surgical instrument, such as a screw driver. Then, each screw member 3 has a pair of planar portions 15, 15 arranged along the head-to-tail direction of the patient, while a pair of arcuate portions 16, 16 are arranged along the left-to-right direction of the patient.

[0053] Next, each shaft member 25, 25 is fixed to the rod receiving portion 11 of each screw member 3 (for example, 6 screw members) that are arranged in the craniocaudal direction on one of the left and right pairs of screw members 3, 3 in each vertebra. Specifically, the upper ends of the pair of screw gripping pieces 35, 35 provided on the screw gripping cylinder member 34 of the shaft member 25 are pressed to separate the lower ends of the pair of screw gripping pieces 35, 35 from each other, that is, the lower ends of the pair of screw gripping pieces 35, 35 are moved outward from the insertion holes 44, 44 of the screw gripping cylinder member 34 (a pair of gripping wall portions 40, 40). Subsequently, the lower ends of the pair of gripping wall portions 40, 40 of the screw gripping cylinder member 34, which is the structure of the shaft member 25, and the lower ends of the pair of screw gripping pieces 35, 35 are positioned to sandwich the pair of arc portions 16, 16 of the rod receiving portion 11 of the screw member 3.

[0054] Next, by releasing the pressure on the upper ends of the pair of screw gripping pieces 35, 35, the lower ends of the pair of screw gripping pieces 35, 35 move closer to each other, and the engaging claws 49, 49 at the lower ends move inward from the insertion holes 44, 44 of the pair of gripping wall portions 40, 40 of the screw gripping cylinder member 34. As a result, the engaging claws 49, 49 of the pair of screw gripping pieces 35, 35 engage with the engaging grooves 23, 23 of the rod receiving portion 11 of the screw member 3, thereby fixing the lower end of the shaft member 25 to the rod receiving portion 11 of the screw member 3. As a result, referring to Figures 6 and 12(a), each shaft member 25, 25 extends upward from the patient's body surface and is aligned along the head-to-tail direction in a convex curve toward one side of the patient's left-to-right direction, along with the patient's scoliosis (for example, a convex scoliosis to the right when viewing the spine from behind as shown in Figure 12), and the pair of screw gripping pieces 35, 35 are aligned so as to face the left-to-right direction of the patient.

[0055] Next, as the first overcorrection means 31, the first support rings 96, 96 of the correction screw mechanism 85 are supported on the outer circumference of each shaft member 25, 25 so as to be movable along the axial direction. Then, the first support rings 96, 96 interfere with the stopper portion 46 provided on the outer circumference of the screw gripping cylinder member 34 and remain in that position. Next, the clamping means 30 is positioned above each shaft member 25, 25. Then, the pair of clamping plates 60, 60 of the clamping means 30 clamp the upper outer surfaces of the multiple shaft members 25, 25 that are lined up along the scoliosis deformation from the left and right directions of the patient via the thin-walled plate members 68, 68, and the bolt members 65, 65 from one clamping plate 60 are inserted into the insertion holes 66, 66 of the other clamping plate 60 and fixed with the nut members 70, 70. Subsequently, the pressing mechanism 61 is positioned approximately in the center of the longitudinal direction of the pair of clamping plates 60, 60.

[0056] Then, the pair of clamping plates 60, 60 are positioned to be clamped from above by the pair of pressing parts 72A, 72B, and the bolt member 74 is rotated in the forward direction to bring the pair of pressing parts 72A, 72B closer together, thereby pressing the pair of clamping plates 60, 60 toward each other. At this time, the corrective and holding force of the clamping means 30 is such that it suppresses large positional displacement of the upper parts of each shaft member 25, 25 along the left-right direction of the patient, or in other words, it brings the upper parts of each shaft member 25, 25 to approximately the center in the left-right direction of the patient, and does not interfere with the overcorrective action of the spine by the first overcorrective means 31.

[0057] Next, the first overcorrection means 31 is positioned relative to each shaft member 25, 25 at a location close to the patient's body surface. Specifically, the correction holding plate 81 is positioned to the side of each shaft member 25, 25. Subsequently, the fixing bolts 95 from each first support ring 96, which are pre-supported on each shaft member 25, are inserted into the stepped openings 90 of the correction holding plate 81, and tightening nuts 99 are screwed onto each fixing bolt 95 protruding from the stepped openings 90 to fully tighten them. As a result, as shown in Figure 12(b), each shaft member 25, 25 can be overcorrected and held so that, in accordance with the curvature of the correction holding plate 81, they are aligned along the craniocaudal direction in a convex curve toward the left or right side of the patient (for example, to the left when viewing the spine from behind as shown in Figure 12). As a result, the screw members 3 connected to each shaft member 25 can be physically (mechanically) slid (forcibly pulled) towards approximately the center in the left-right direction of the patient, and each vertebra (spine) can be corrected to be approximately straight along the craniocaudal direction, thereby correcting the spinal column, in particular scoliosis, according to the operator's intentions. When each shaft member 25 is overcorrected by the first overcorrection means 31, that is, in accordance with the curvature of the correction holding plate 81, so that it is aligned along the craniocaudal direction in a convex curve toward the other side in the left-right direction of the patient (for example, to the left when viewing the spine from behind as shown in Figure 12), each shaft member 25 can move relative to each first support ring 96 in the axial direction, so that each vertebra fixed to each screw member 3 can be rotated as appropriate, thereby correcting the twist of each vertebra simultaneously.

[0058] Next, the rod member 5 of the spinal deformity correction and fixation system 2 is bent with a predetermined curvature along the anterior-posterior direction of the patient, specifically convexly towards the posterior side of the patient, using a special surgical instrument, so that the patient's spine is corrected to, for example, an ideal kyphosis. Subsequently, the rod pusher cylinder member 36, which is part of the shaft member 25, is moved as far upward as possible relative to the screw gripping cylinder member 34. Then, the bent rod member 5 is inserted into the pair of slits 38, 38 of the screw gripping cylinder members 34, 34 of each shaft member 25, 25. Next, by rotating the male threaded cylindrical portion 52 of the rod pusher cylindrical member 36 in the forward direction, the rod pusher cylindrical portion 53 slides downward without relative rotation to the screw gripping cylindrical member 34, and the arc-shaped recesses 57, 57 provided on the lower end surfaces of the pair of rod push portions 55, 55 of the rod pusher cylindrical portion 53 capture the rod member 5, engaging the rod member 5 with the top open groove portion 10 of the rod receiving portion 11 of the screw member 3.

[0059] This engagement operation is repeated for each shaft member 25, 25, engaging the rod member 5 into the top open groove 10 of the rod receiving portion 11 of each screw member 3. As a result, each vertebra of the spine moves in the anterior-posterior direction of the patient in accordance with the curved shape of the rod member 5, correcting it to the ideal kyphosis (desired kyphosis). At this time, several of the shaft members 25, 25 move slightly in the vertical direction relative to the clamping means 30 and the first overcorrection means 31. Next, after tightening the nut members 70, 70 of the clamping means 30 and the bolt member 74 of the pressing mechanism 61, the rod pusher cylinder member 36 is kept in a downward-sliding position, and referring to Figures 2, 3 and 10, the set screw 20 is held with a special surgical instrument and driven through the inside of the shaft member 25 (rod pusher cylinder member 36) to reach the female threaded portions 17, 17 of the rod receiving portion 11 of the screw member 3, screw it in, and tighten the rod member 5 to the rod receiving portion 11 of each screw member 3.

[0060] Next, each shaft member 25, 25 is fixed to the rod receiving portion 11, 11 of each screw member 3, 3 (for example, 6 screw members) that are arranged in the craniocaudal direction of the other screw member 3, 3 in each vertebra, and the above-described operation is repeated. After that, the clamping means 30, the first overcorrection means 31 and each shaft member 25, 25 that are fixed to the pair of screw members 3, 3 in each vertebra are removed, and the spinal deformity correction and fixation procedure using the spinal deformity correction and fixation system 2 is completed, referring to Figure 5. In the above description, each shaft member 25, 25 is fixed to the rod receiving portion 11, 11 of each screw member 3, 3 that is aligned in the craniocaudal direction of one of the left and right pairs of screw members 3, 3 in each vertebra, and the rod member 5 is connected to each screw member 3, 3 by performing the overcorrection operation described above. Subsequently, each shaft member 25, 25 is fixed to the rod receiving portion 11, 11 of each screw member 3, 3 that is aligned in the craniocaudal direction of the other of the left and right pairs of screw members 3, 3 in each vertebra, and the rod member 5 is connected to each screw member 3, 3 by performing the overcorrection operation described above. However, each shaft member 25, 25 may be fixed to the rod receiving portion 11, 11 of all screw members 3, 3 in each vertebra, and the overcorrection operation described above may be performed almost simultaneously on the left and right pairs of screw members 3, 3 in each vertebra to connect the rod member 5 to each screw member 3, 3.

[0061] Next, the external orthopedic device 1B according to the second embodiment will be described in detail based on Figures 13 to 21, with reference to Figures 1 to 5, 9 and 11 as appropriate. When describing the external orthopedic device 1B according to the second embodiment, only the differences from the external orthopedic device 1A according to the first embodiment will be described. In the external orthopedic device 1B according to the second embodiment, the second overcorrection means 32 is positioned close to the patient's body surface (not shown), with reference to Figures 13 and 14, and the other configurations are the same as those of the external orthopedic device 1A according to the first embodiment. Note that the clamping means 30 shown in Figures 6 to 8 is not shown in Figures 13, 14 and 17. In the second overcorrection means 32, as with the first overcorrection means 31 of the external orthopedic device 1A according to the first embodiment, a plurality of shaft members 25, 25 arranged along the craniocaudal direction in a convex curve toward one side of the patient's left-right direction in response to the patient's scoliosis deformation are overcorrected and held so that they are arranged along the craniocaudal direction in a convex curve toward the other side of the patient's left-right direction. The second overcorrection means 32 includes a straightening retaining plate 82 arranged along each shaft member 25, 25, a straightening screw mechanism 86 that pulls each shaft member 25, 25 towards the straightening retaining plate 82, and a counter plate 103 arranged on the side of each shaft member 25, 25 opposite to the straightening retaining plate 82.

[0062] Referring to Figure 13, the corrective retaining plate 82 of the second overcorrection means 32 is erected on the sides of each shaft member 25, 25. The corrective retaining plate 82 is formed to be elongated along the head-to-tail direction of the patient. In plan view, the corrective retaining plate 82 extends substantially in a straight line along the head-to-tail direction of the patient and is gently curved in the direction of the patient's kyphosis and lordosis. An elongated opening 94, which is elongated along the head-to-tail direction of the patient and curved in the same way as its outer shape, passes through the corrective retaining plate 82. Next, the corrective screw mechanism 86 of the second overcorrection means 32 will be described, which differs from the corrective screw mechanism 85 provided in the first overcorrection means 31 of the external orthopedic device 1A according to the first embodiment in the following respects. The straightening screw mechanism 86 of the second over-correction means 32 includes, with reference to Figures 11, 13, and 14, a first support ring 96 on which a fixing bolt 95 protrudes outward on an extension line connecting a pair of relief grooves 100, 100, and, with reference to Figures 13 to 15, a second support ring 97 on which a pair of fixing bolts 95 protrude outward in opposite directions on an extension line connecting a pair of relief grooves 100, 100. The second support ring 97 is each supported by a pair of shaft members 25, 25 located at both ends in the head-to-tail direction so as to be movable along the axial direction. The first support ring 96 is each supported by each of the shaft members 25, 25, excluding the pair of shaft members 25, 25 located at both ends in the head-to-tail direction, so as to be movable along the axial direction.

[0063] Referring to Figures 13 and 14, spacers 105, 105 are arranged around the fixing bolts 95, 95 that extend between the first and second support rings 96, 97, which are supported by each shaft member 25, and the straightening retaining plate 82, in order to adjust the distance between the shaft member 25 and the straightening retaining plate 82. The spacers 105 are formed in a cylindrical shape. Normally, when over-straightening, the number of spacers 105, 105 between the shaft member 25 and the straightening retaining plate 82, and the length of the spacers 105 are adjusted so that the distance between the shaft member 25, 25 located at both ends in the head-to-tail direction and the straightening retaining plate 82 is largest, and gradually decreases toward the inside. In this embodiment, the spacers 105, 105 are arranged so that the distance between the shaft member 25, 25 located at both ends in the head-to-tail direction, and adjacent to both ends and located inward, and the straightening retaining plate 82 is largest.

[0064] Furthermore, the spacers 105, 105 can be positioned such that the distance between the shaft members 25, 25 located at both ends in the craniocaudal direction and the corrective retaining plate 82 is maximized, and it is not necessary to place a spacer 105 inside them. With this configuration, each shaft member 25, 25 located inward from both ends in the craniocaudal direction is attracted to the corrective retaining plate 82 according to the operator's intention by the action of each corrective screw mechanism 86, and aligns with the curvature of the patient to one side or the other in the left-right direction, and the degree of this curvature can be freely set. As a result, each shaft member 25, 25 can be overcorrected and held so that it aligns with the craniocaudal direction in a convex curvature to one side or the other in the left-right direction of the patient, according to the operator's intention (see Figure 12).

[0065] Referring to Figures 13, 14, and 20, the counter plate 103 is positioned on the opposite side of each shaft member 25, 25 from the orthodontic retaining plate 82. Similar to the orthodontic retaining plate 82, the counter plate 103 is elongated along the craniocaudal direction of the patient, extends in a substantially straight line in plan view along the craniocaudal direction of the patient, and is gently curved in the direction of the patient's kyphosis and lordosis. The counter plate 103 is elongated along the craniocaudal direction of the patient, and an elongated opening 108 curved in the same way as its outer shape passes through it. Fixing bolts 95, 95 protruding from the second support rings 97, 97, which are supported by a pair of shaft members 25, 25 located at both ends in the craniocaudal direction, are inserted through the elongated opening 108 of the counter plate 103 and fixed with fixing nuts 110, 110. As a result, the counter plate 103 is fixed to a pair of shaft members 25, 25 located at both ends in the head-to-tail direction via second support rings 97, 97 (fixing bolts 110, 110). Referring to Figures 14 and 16, a shaft pusher member 113 is connected to the counter plate 103 to push the shaft members 25 toward the straightening holding plate 82. Multiple shaft pusher members 113 may be connected to the counter plate 103.

[0066] Referring to Figures 14 and 16, the shaft pusher member 113 comprises a clamp portion 117 that abuts against the outer circumferential surface of the first support ring 96, a shaft portion 118 that extends linearly from the clamp portion 117 toward the counter plate 103, and a support body portion 119 that is screwed into the shaft portion 118 and supported by the counter plate 103. The clamp portion 117 is formed in a substantially rectangular parallelepiped shape. The contact surface 117A of the clamp portion 117 with the outer circumferential surface of the first support ring 96 is recessed in an arc shape. The support body portion 119 is formed in a rectangular tubular shape so as to surround the counter plate 103. The support body portion 119 is supported so as to be movable along the longitudinal direction of the counter plate 103. As a result, the shaft pusher member 113 is supported so as to be movable along the longitudinal direction of the counter plate 103. The shaft portion 118 is inserted through the elongated opening 108 of the counter plate 103 and screwed into the support body portion 119. A hexagonal knob portion 120 is formed at the tip of the shaft portion 118 (the end opposite to the clamp portion 117).

[0067] Then, by gripping and rotating the handle portion 120 of the shaft portion 118, the clamp portion 117 can be moved forward or backward due to the screw-fitting of the shaft portion 118 and the support body portion 119. As a result, by gripping and rotating the handle portion 120 of the shaft portion 118, the clamp portion 117 is moved forward, and the contact surface 117A of the clamp portion 117 comes into contact with the corresponding shaft member 25, in particular the outer circumferential surface of the first support ring 96, pushing the shaft member 25 away from the counter plate 103, that is, towards the correction holding plate 82. By pressing the shaft member 25 with this shaft pusher member 113, overcorrection is promoted, which allows the screw member 3 connected to the shaft member 25 to slide physically (mechanically) towards the approximate center in the left-right direction of the patient, while also slightly rotating the shaft member 25 around the connection point with the rod receiving portion 11 of the screw member 3 as a pivot point, and as a result, torsional deformation of the vertebrae can also be corrected. Furthermore, this shaft pusher member 113 can be used when a spacer 105 is not placed between the first support ring 96 and the straightening retaining plate 82, resulting in a gap. Through the aforementioned action of the shaft pusher member 113, the shaft member 25 can be pushed towards the straightening retaining plate 82 via the first support ring 96.

[0068] In the external orthodontic appliance 1B according to the second embodiment, as shown in Figure 17, a recess 102 is formed on the wall surface opposite to the fixing bolt 95 of the ring body 101, as the first support ring 96A according to the other embodiment. Also, as shown in Figures 18 and 19, the shaft pusher member 113A according to the other embodiment comprises a spherical portion 121 that abuts against the recess 102 of the first support ring 101, a shaft portion 118 that extends linearly from the spherical portion 121 toward the counter plate 103, and a support body portion 119A that is screwed with the shaft portion 118 and supported by the counter plate 103. The support body portion 119A is formed in a U-shape that surrounds the counter plate 103 from above. The other structures are the same as those of the shaft pusher member 113 shown in Figure 16, and are omitted from this explanation.

[0069] Then, by gripping and rotating the knob portion 120 of the shaft pusher member 113A, the shaft portion 118 is advanced, and the spherical portion 121 at the tip comes into contact with the recess 102 of the first support ring 96A of the corresponding shaft member 25, pushing the shaft member 25 away from the counter plate 103, that is, towards the straightening holding plate 82. In this way, the engagement between the recess 102 of the first support ring 96A and the spherical portion 121 of the shaft pusher member 113A restricts the relative axial movement between the first support ring 96A and the shaft portion 118 of the shaft pusher member 113A, and the pressure from the shaft pusher member 113A can be reliably transmitted to the shaft member 25 via the first support ring 96A.

[0070] Furthermore, in the external orthodontic device 1B according to the second embodiment, the shaft pusher member 113 connected to the counter plate 103 pushes the outer surface of the first support ring 96 supported by the shaft member 25 toward the orthodontic holding plate 82. However, although not shown in the figures, in other embodiments, the shaft pusher member 113 may be provided with a bent shaft portion 118, and the part of the shaft member 25 below the first support ring 96 near where it grips the screw member 3 may be pushed toward the orthodontic holding plate 82, or the part of the shaft member 25 above the first support ring 96 may be configured to push toward the orthodontic holding plate 82.

[0071] Furthermore, in the external orthodontic device 1B according to the second embodiment, a shaft pusher member 113 is connected to the counter plate 103, but a screw pusher member 114 can also be connected to the counter plate 103, referring to Figures 20 and 21. The screw pusher member 114 captures the rod receiving portion 11 of the screw member 3 and pushes it toward the orthodontic holding plate 82. Specifically, the screw pusher member 114 comprises a clamp portion 117 that abuts against and captures the outer circumferential surface of the arc portion 16 of the rod receiving portion 11 of the screw member 3, a shaft portion 118 extending from the clamp portion 117 toward the counter plate 103, and a support body portion 119 that is screwed into the shaft portion 118 and supported by the counter plate 103.

[0072] Referring to Figures 20 and 21, the clamp portion 117 is formed in a plate shape. The contact surface 117A of the clamp portion 117 with the outer circumferential surface of the arc portion 16 of the screw member 3 is recessed in an arc shape. The shaft portion 118 is formed in an inverted L shape consisting of an upward-sloping shaft portion 122 and a horizontal shaft portion 123. The support body portion 119 is formed in a rectangular tube shape so as to surround the counter plate 103. The support body portion 119 is supported so as to be movable along the longitudinal direction of the counter plate 103. As a result, the screw pusher member 114 is supported so as to be movable along the longitudinal direction of the counter plate 103. The horizontal shaft portion 123 of the shaft portion 118 is inserted through the elongated opening 108 of the counter plate 103 and screwed into the support body portion 119. A hexagonal knob portion 120 is formed at the tip of the horizontal shaft portion 123 (the end opposite to the clamp portion 117).

[0073] Then, by gripping and rotating the handle portion 120 of the horizontal shaft portion 123, the clamp portion 117 can be moved forward or backward due to the screw-fitting of the horizontal shaft portion 123 and the support body portion 119. As a result, by gripping and rotating the handle portion 120 of the horizontal shaft portion 123, the clamp portion 117 is moved forward, and the contact surface 117A of the clamp portion 117 comes into contact with the outer circumferential surface of the arc portion 16 of the rod receiving portion 11 of the corresponding screw member 3, pushing the screw member 3 away from the counter plate 103, that is, towards the correction holding plate 82. This pressure on the screw member 3 by the screw pusher member 114 promotes overcorrection, allowing the screw member 3, which is screwed into the vertebra, to slide directly to approximately the center in the left-right direction of the patient. In addition, multiple screw pusher members 114 can be connected to the counter plate 103, similar to the shaft pusher member 113.

[0074] In Figure 14, one shaft pusher member 113 is connected to the counter plate 103, and in Figure 20, three screw pusher members 114 are connected to the counter plate 103. However, multiple shaft pusher members 113 may be connected to the counter plate 103, and shaft pusher members 113 and screw pusher members 114 may be mixed and connected to the counter plate 103.

[0075] Next, when correcting and fixing spinal deformities with the spinal deformity correction and fixation system 2, a method will be described in which the spinal deformity is corrected by external manipulation using the external corrective device 1B according to the second embodiment, while assisting the correction and fixation by the spinal deformity correction and fixation system 2. First, each shaft member 25, 25 is fixed to the rod receiving portion 11, 11 of each screw member 3, 3, which is arranged in the craniocaudal direction of one of the pair of screw members 3, 3 on the left and right sides of each vertebra. The details of this have been described above, so the explanation will be omitted here. Next, as the second overcorrection means 32, the second support rings 97, 97 are supported on the pair of shaft members 25, 25 located at both ends in the craniocaudal direction of each shaft member 25, 25 so as to be movable along the axial direction, and the first support rings 96, 96 are supported on the remaining shaft member 25, 25 so as to be movable along the axial direction. Then, the first and second support rings 96, 97 interfere with the stopper portion 46 provided on the outer circumferential surface of the screw gripping cylinder member 34 and remain in that position. Next, the counter plates 103 are placed along each of the shaft members 25, 25.

[0076] The counter plate 103 is pre-connected with one or more shaft pusher members 113 and screw pusher members 114, or a combination thereof, as needed. That is, the support bodies 119, 119 of the shaft pusher members 113 (113A) and screw pusher members 114 are supported so as to be movable along the longitudinal direction, surrounding the counter plate 103. Next, one fixing bolt 95, 95 extending from the second support rings 97, 97 located at both ends in the head-to-tail direction is inserted into the elongated opening 108 of the counter plate 103, and fixing nuts 110, 110 are screwed on and tightened. The counter plate 103 then serves as a reference point in the left-to-right direction for the patient during overcorrection. Next, the clamping means 30 is positioned above each shaft member 25, 25. Details of this have been described above, so an explanation is omitted here.

[0077] Next, as the second over-correction means 32, spacers 105, 105 are placed on the fixing bolts 95, 95 (the other fixing bolt 95 in the case of the second support ring 97) extending from the first and second support rings 96, 97 which are pre-supported on each shaft member 25, 25. The method of installing the spacers 105, 105 on the first and second support rings 96, 97 (quantity, length, etc. for each installation location) has been described above, so a detailed explanation is omitted here. Subsequently, the fixing bolts 95, 95 (the other fixing bolt 95 in the case of the second support ring 97) from the first and second support rings 96, 97 are inserted into the elongated openings 94 of the correction holding plate 82, and tightening nuts 99 are screwed onto each fixing bolt 95 protruding from the elongated openings 94 to fully tighten them.

[0078] As a result, each shaft member 25, 25 is attracted to the corrective holding plate 82 via spacers 105, 105 by the action of each corrective screw mechanism 86, and aligns along the convex curvature of the patient's left or right direction, or to the other. Consequently, each shaft member 25, 25 can be overcorrected and held so that it is aligned along the craniocaudal direction with a convex curvature of the patient's left or right direction (see Figure 12(b)). Consequently, the screw members 3 connected to each shaft member 25 can be physically (mechanically) slid (forcibly pulled) towards approximately the center of the patient's left or right direction, and each vertebra (spine) can be corrected to be approximately straight along the craniocaudal direction, thereby correcting the spinal deformity, particularly scoliosis, according to the operator's intentions (see Figure 12(b)).

[0079] At this time, if necessary, the shaft pusher member 113 and the screw pusher member 114 are positioned to face the corresponding shaft member 25 and screw member 3, and the grip portion 120 of the shaft portion 118 (horizontal shaft portion 123) is grasped and rotated. The screwing of the shaft portion 118 (horizontal shaft portion 123) and the support body portion 119 advances the clamp portion 117, causing its contact surface 117A to contact the outer circumferential surface of the first support ring 96 (arc portion 16) of the corresponding shaft member 25 (screw member 3), thereby pushing the shaft member 25 (screw member 3) away from the counter plate 103, i.e., towards the orthodontic holding plate 82. As a result, in particular, the screw member 3 connected to the shaft member 25 can be physically (mechanically) slid (forcibly pulled) approximately to the center in the left-right direction of the patient.

[0080] Next, the rod members 5 of the spinal deformity correction and fixation system 2 are bent along the anterior-posterior direction of the patient at a predetermined curvature using a special surgical instrument, so that the patient's spine is corrected to, for example, an ideal kyphosis. The rod members 5 are then engaged into the top open grooves 10 of the rod receiving portions 11 of each screw member 3 and tightened. As this process has been described above, a detailed explanation is omitted here.

[0081] Next, each shaft member 25, 25 is fixed to the rod receiving portion 11, 11 of the other screw member 3, 3 in the craniocaudal direction of the left and right pair of screw members 3, 3 in each vertebra, and the above-described operation is repeated. After that, the clamping means 30, the second overcorrection means 32, and each shaft member 25, 25, which are fixed to the left and right pair of screw members 3, 3 in each vertebra, are removed, and the spinal deformity correction and fixation procedure using the spinal deformity correction and fixation system 2 is completed.

[0082] In addition, while the external orthodontic devices 1A and 1B according to the first and second embodiments described above were applied to a single curve in which the thoracolumbar spine curves convexly to one side in the left-right direction as a scoliotic deformity of the patient, the external orthodontic devices 1A and 1B according to the second embodiment can also be applied to a double curve in which the thoracic spine curves convexly to one side in the left-right direction as a scoliotic deformity, and the thoracolumbar spine curves convexly to the other side in the left-right direction of the patient. For example, they can also be applied when correcting a double curve in which the thoracic spine curves convexly to the right and the thoracolumbar spine curves convexly to the left (S-shaped in a frontal view of the patient). In other words, in the external orthodontic device 1A according to the first embodiment, the orthodontic holding plate 81 is formed in a plan view in an S-shape, curving convexly to one side and convexly to the other side along the head-to-tail direction of the patient, and overcorrects the spine by aligning each shaft member 25 along the head-to-tail direction with a convex curve to the left in the thoracic spine region and a convex curve to the right in the thoracolumbar spine region. Furthermore, in the external orthodontic device 1B according to the second embodiment, by appropriately adjusting the distance between each shaft member 25 and the orthodontic holding plate 82 (distance due to the arrangement of spacers 105 and the action of shaft pusher members 113) and the distance between each shaft member 25 and the counter plate 103 (distance due to the arrangement of spacers 105 and the action of shaft pusher members 113), the shaft members 25 are over-corrected so that they are arranged along the craniocaudal direction with a convex curve to the left in the thoracic spine range and a convex curve to the right in the thoracolumbar spine range, thereby correcting each vertebra (spine) to be approximately straight along the craniocaudal direction.

[0083] Next, the external orthodontic device 1C according to the third embodiment will be described in detail based on Figure 22, with reference to Figures 1 to 5 and Figure 8 as appropriate. When describing the external orthodontic device 1C according to the third embodiment, only the differences from the external orthodontic device 1B according to the second embodiment will be described. In the external orthodontic device 1C according to the third embodiment, referring to Figure 22, the third overcorrection means 33 is positioned close to the patient's body surface (not shown), and the other configurations are the same as those of the external orthodontic device 1B according to the second embodiment. Note that in Figure 22, the clamping means 30, the shaft pusher member 113, and the screw pusher + member 114 are not shown. The third overcorrection means 33 includes an orthodontic holding plate 83 arranged along each shaft member 25, 25, an orthodontic screw mechanism 87 that pulls each shaft member 25, 25 to the orthodontic holding plate 83, and a counter plate 103 arranged on the opposite side of each shaft member 25, 25 from the orthodontic holding plate 83.

[0084] Referring to Figure 22, the correction retaining plate 83 of the third overcorrection means 33 is formed in a crank shape in a plan view. More specifically, the correction retaining plate 83 is constructed by integrally connecting a pair of reference plate portions 130, 130, which are positioned at a predetermined distance apart from each other along the head-to-tail direction of the patient; a pair of intermediate plate portions 131, 131, which are located inside the pair of reference plate portions 130, 130 and are located away from the pair of reference plate portions 130, 130 along the left-to-right direction of the patient, and a vertex plate portion 132, which is located inside the pair of intermediate plate portions 131, 131 and is located away from the pair of intermediate plate portions 131, 131 along the left-to-right direction of the patient. The reference plate portions 130, intermediate plate portions 131 and vertex plate portion 132 extend linearly along the head-to-tail direction. An elongated opening 134 is formed in the entire longitudinal region of the correction retaining plate 83.

[0085] In the orthodontic screw mechanism 87 provided in the third overcorrection means 33 of the external orthodontic device 1C according to the third embodiment, the spacer 105 used in the orthodontic screw mechanism 86 of the second overcorrection means 32 of the external orthodontic device 1B according to the second embodiment is not used. Furthermore, the counter plate 103 provided in the third overcorrection means 33 of the external orthodontic device 1C according to the third embodiment is the same as the counter plate 103 provided in the second overcorrection means 32 of the external orthodontic device 1B according to the second embodiment.

[0086] Then, the fixing bolts 95, 95 from the first and second support rings 96, 97 supported by each shaft member 25, 25 are inserted into the elongated openings 134 of the straightening and holding plate 83 (a pair of reference plate portions 130, 130, a pair of intermediate plate portions 131, 131, and a top plate portion 132), and the tightening nuts 99, 99 are screwed onto each fixing bolt 95, 95 protruding from the elongated openings 134 to secure them. In this embodiment, the reference plate portion 130 of the straightening and holding plate 83 corresponds to the two shaft members 25, 25 located at the ends aligned along the head-to-tail direction, the intermediate plate portion 131 corresponds to the two shaft members 25, 25 located inside it, and the top plate portion 132 corresponds to the three shaft members 25, 25 located approximately in the center aligned along the head-to-tail direction.

[0087] As a result, each shaft member 25, 25 is overcorrected to align along the craniocaudal direction in a convex curve toward one side or the other in the left-right direction of the patient, following the crank-shaped bending of the corrective holding plate 83 (see Figure 12(b)). Consequently, the screw members 3 connected to each shaft member 25, 25 can be physically (mechanically) slid (forcibly pulled) toward approximately the center in the left-right direction of the patient, allowing each vertebra (spine) to be corrected to be approximately straight along the craniocaudal direction, and thus correcting the spinal deformity, particularly scoliosis, according to the operator's intentions (see Figure 12(b)).

[0088] Furthermore, the method of correcting spinal deformity by external manipulation using the external corrective device 1C according to the third embodiment while assisting the corrective fixation by the spinal deformity correction and fixation system 2 is the same as the method of correcting spinal deformity by external manipulation using the external corrective device 1B according to the second embodiment while assisting the corrective fixation by the spinal deformity correction and fixation system 2 (except for the placement of the spacer 105), so its explanation will be omitted.

[0089] As described above, the external orthodontic devices 1A to 1C according to the first to third embodiments, in particular the first to third overcorrection means 31 to 33, allow for overcorrection and retention of multiple shaft members 25, 25 that are arranged along the craniocaudal direction with a convex curve toward one side of the patient's left-right direction in accordance with the patient's scoliosis deformity, so that they are arranged along the craniocaudal direction with a convex curve toward the other side of the patient's left-right direction. By overcorrecting in this way, the screw members 3 connected to the shaft members 25 can be physically (mechanically) slid (forcibly pulled) toward approximately the center of the patient's left-right direction, allowing each vertebra (spine) to be corrected to be approximately straight along the craniocaudal direction, and consequently, the scoliosis deformity of the spine can be corrected according to the surgeon's intention (see Figure 12).

[0090] As a result, the desired correction rate can be achieved, and the complexity of the correction and fixation surgery using the spinal deformity correction and fixation system 2 can be eliminated, thereby further reducing the burden on the patient. Moreover, since there is no operation of firmly gripping and rotating the outer surface of the rod member 5 of the spinal deformity correction and fixation system 2 with a special surgical instrument equivalent to pliers, the rod member 5 is not damaged, making it very effective.

[0091] Furthermore, the first to third overcorrection means 31 to 33 of the external orthodontic devices 1A to 1C according to the first to third embodiments have a simple configuration, comprising orthodontic holding plates 81 to 83 arranged along each shaft member 25, 25, and orthodontic screw mechanisms 85 to 87 that pull each shaft member 25, 25 to the orthodontic holding plates 81 to 83, respectively. This minimizes assembly play and ensures that the orthodontic force from the orthodontic holding plates 81 to 83 and the orthodontic screw mechanisms 85 to 87 is reliably transmitted to each vertebra of the spine.

[0092] Furthermore, the orthodontic retaining plate 81 used in the first overcorrection means 31 of the external orthodontic device 1A according to the first embodiment is configured to be curved in one or the other direction in the left-right direction of the patient when viewed from above. Since overcorrection can be achieved by the curved shape of the orthodontic retaining plate 81, the configuration can be simplified and assembly play can be minimized.

[0093] Furthermore, the orthodontic screw mechanism 86 employed in the second overcorrection means 32 of the external orthodontic device 1B according to the second embodiment includes spacers 105 arranged around the fixing bolts 95, 95 from the first and second support rings 96, 97, and adjusting the distance between the first and second support rings 96, 97 (each shaft member 25) and the orthodontic holding plate 82. Therefore, during surgery, the degree of overcorrection curvature (the degree to which the patient's hand curves convexly to one side or the other) can be appropriately set according to the surgeon's intention by changing the length and number of spacers 105. In short, during surgery, the degree of overcorrection curvature can be appropriately changed based on the magnitude of the patient's scoliosis.

[0094] Furthermore, the second and third overcorrection means 32 and 33 of the external orthodontic devices 1B and 1C according to the second and third embodiments have a counter plate 103 that extends in the craniocaudal direction to connect a pair of shaft members 25, 25 located at both ends of the patient in the craniocaudal direction. The counter plate 103 allows for setting a reference point for overcorrection in the left-right direction of the patient (the normal configuration of the spine (extending in a straight line in a plan view)). The counter plate 103 also has the function of receiving a reaction force from the overcorrection force caused by the pressing operation of the shaft pusher member 113 (113A) and the screw pusher member 114, which is very effective.

[0095] Furthermore, in the second overcorrection means 32 of the external orthodontic device 1B according to the second embodiment, a shaft pusher member 113 (113A) is connected to the counter plate 103 to push the shaft member 25 toward the orthodontic holding plate 82. By using the shaft pusher member 113 (113A) to push the shaft member 25 away from the counter plate 103, i.e., toward the orthodontic holding plate 82 via the first support ring 96, the screw member 3 connected to the shaft member 25 is physically (mechanically) slid (forcibly pulled) toward approximately the center in the left-right direction of the patient, while the shaft member 25 is also slightly rotated around the connection point with the screw member 3 as a fulcrum, and as a result, torsional deformation of the vertebrae can also be corrected. Note that the first overcorrection means 31 of the external orthodontic device 1A according to the first embodiment may also be equipped with a shaft pusher member 113 (113A) and a screw pusher member 114 together with the counter plate 103.

[0096] Furthermore, in the second overcorrection means 32 of the external orthodontic device 1B according to the second embodiment, a screw pusher member 114 is connected to the counter plate 103 to push the rod receiving portion 11 of the screw member 3 fixed to the vertebra toward the correction holding plate 82. The screw pusher member 114 then pushes the screw member 3 fixed to the vertebra directly toward the counter plate 103, that is, toward the correction holding plate 82, thereby physically (mechanically) sliding (forcibly pulling) the screw member 3 toward approximately the center in the left-right direction of the patient and holding it in place. As a result, each vertebra (spine) can be corrected to be approximately straight along the head-to-tail direction.

[0097] Furthermore, in the second overcorrection means 32 of the external orthodontic device 1B according to the second embodiment, multiple screw pusher members 114, multiple shaft pusher members 113 (113A), and a mixture of shaft pusher members 113 (113A) and screw pusher members 114 can be connected to the counter plate 103. This allows multiple screw members 3, which are located near the apex of the patient's scoliosis and fixed to each vertebra where the amount of sliding towards the left-right center of the patient is large, to be slid and held towards the left-right center of the patient by multiple shaft pusher members 113 (113A) or screw pusher members 114.

[0098] Furthermore, in the second overcorrection means 32 of the external orthodontic device 1B according to the second embodiment, the shaft pusher member 113 (113A) and the screw pusher member 114 are supported so as to be movable along the longitudinal direction of the counter plate 103. This allows any shaft member 25 or screw member 3 aligned along the longitudinal direction of the counter plate 103 to be directly pushed away from the counter plate 103, that is, towards the orthodontic holding plate 82.

[0099] Furthermore, for the correction of lordosis and / or kyphosis in patients, the rod members 5 of the spinal deformity correction and fixation system 2 are first curved to a predetermined curvature using a special surgical instrument so that the patient's spine is corrected to, for example, an ideal lordosis and / or kyphosis, and then set into the rod receiving portions 11, 11 of each screw member 3, 3. As a result, the height of each shaft member 25, 25 from each vertebra differs according to the curved shape of the rod member 5, and each shaft member 25, 25 is arranged so that its top is, for example, gently convex, gently concave, or gently concave-convex.

[0100] Furthermore, the corrective holding plates 82, 83 of the first and second overcorrective means 32 of the external orthodontic devices 1A, 1B according to the first and second embodiments, and the counter plates 103, 103 of the second and third overcorrective means 32, 33 of the external orthodontic devices 1B, 1C according to the second and third embodiments, are curved to conform to the lordosis and / or kyphosis of the spine, so that they can properly hold each shaft member 25, 25 whose tops are arranged in, for example, a gentle convex, a gentle concave, or a gentle concave-concave shape, and the curvature of the corrective holding plates 82, 83 and the counter plate 103 can play a supportive role in correcting the lordosis and / or kyphosis deformity of the patient.

[0101] Furthermore, since the first to third overcorrection means 31 to 33 of the external orthodontic devices 1A to 1C according to the first to third embodiments are positioned close to the patient's body surface, the action of the first to third overcorrection means 31 to 33 can be sufficiently transmitted to each screw member 3 and, consequently, to each vertebra.

[0102] Furthermore, the external orthodontic devices 1A to 1C according to the first to third embodiments are equipped with a clamping means 30 that holds the upper parts of each shaft member 25, 25 by clamping them from both sides in the left-right direction of the patient. The clamping means 30 can hold the upper parts of each shaft member 25, 25, which are arranged along the craniocaudal direction in a convex curve toward one side in the left-right direction of the patient, in accordance with the scoliosis deformation of the patient, so as to gather them approximately in the center in the left-right direction of the patient. In this way, the clamping means 30 can play a supportive role against the overcorrective action of the first to third overcorrective means 31 to 33.

[0103] Furthermore, in the third overcorrection means 33 of the external orthodontic device 1C according to the third embodiment, the orthodontic holding plate 83 is configured to be bent in a crank shape when viewed from above, so that the variations in the curvature of the patient's hand, which is convex in one or the other direction when overcorrecting can be increased.

[0104] 1A, 1B, 1C External orthodontic device, 2 Spinal deformity correction and fixation system, 3 Screw member (vertebral fixation device), 5 Rod member, 25 Shaft member, 30 Clamping means, 31 First overcorrection means, 32 Second overcorrection means, 33 Third overcorrection means, 81 Correction holding plate (first overcorrection means), 82 Correction holding plate (second overcorrection means), 83 Correction holding plate (third overcorrection means), 85 Correction screw mechanism (first overcorrection means), 86 Correction screw mechanism (second overcorrection means), 87 Correction screw mechanism (third overcorrection means), 95 Fixing bolt, 96 First support ring, 97 Second support ring, 103 Counter plate, 105 Spacer, 113, 113A Shaft pusher member (pusher member), 114 Screw pusher member (pusher member)

Claims

1. An external corrective device for correcting and fixing spinal deformities by manipulating the spinal deformity from outside the body, when correcting and fixing spinal deformities using a spinal deformity correction and fixing system comprising a vertebral fixation device fixed to each vertebra of the spine and a rod member connected to the vertebral fixation device, characterized in that it comprises a shaft member that is detachably attached to each vertebral fixation device fixed to each vertebra of the spine and extends outward from the patient's body, and an overcorrection means for overcorrecting and holding a plurality of shaft members that are arranged along the craniocaudal direction in a convex curve toward one side of the patient's left-right direction in accordance with the patient's scoliosis, so that they are arranged along the craniocaudal direction in a convex curve toward the other side of the patient's left-right direction.

2. The extracorporeal orthopedic device according to claim 1, characterized in that the overcorrection means comprises an orthodontic holding plate arranged along each of the shaft members, and an orthodontic screw mechanism that pulls each of the shaft members to the orthodontic holding plate.

3. The external orthodontic device according to claim 2, characterized in that the orthodontic retaining plate is curved in one or the other direction in the left-right direction of the patient when viewed in plan.

4. The external orthopedic device according to claim 2, characterized in that the orthodontic screw mechanism comprises a support ring supported on the shaft member so as to be movable in the axial direction; a fixing bolt extending from the support ring toward the orthodontic retaining plate and fixing the orthodontic retaining plate; and a spacer arranged around the fixing bolt to adjust the distance between the support ring and the orthodontic retaining plate.

5. The extracorporeal orthopedic device according to claim 4, wherein the overcorrection means has a counter plate extending in the craniocaudal direction to connect a pair of shaft members located at both ends of the patient in the craniocaudal direction, and the counter plate is positioned on the opposite side of each shaft member from the orthodontic holding plate side.

6. The external orthopedic device according to claim 5, characterized in that a pusher member is connected to the counter plate to push the vertebral fixation device, which is fixed to the vertebra, toward the orthodontic holding plate.

7. The extracorporeal orthopedic device according to claim 5, characterized in that a pusher member is connected to the counter plate for pushing the shaft member toward the orthodontic holding plate.

8. The extracorporeal orthodontic device according to claim 6 or 7, characterized in that a plurality of the pusher members are connected to the counter plate.

9. The extracorporeal orthopedic device according to claim 6 or 7, characterized in that the pusher member is supported so as to be movable along the longitudinal direction of the counter plate.

10. The external orthopedic device according to claim 5, characterized in that the orthodontic retaining plate and the counter plate are curved to conform to the lordosis and / or kyphosis of the spine.

11. The extracorporeal orthopedic device according to claim 1, characterized in that the overcorrection means is positioned in close proximity to the patient's body surface.

12. The extracorporeal orthopedic device according to claim 1, further comprising a clamping means for holding the upper part of each shaft member from both sides in the left-right direction of the patient.

13. The external orthodontic device according to claim 2, characterized in that the orthodontic retaining plate is bent in a crank shape when viewed from above.

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