External orthosis
The external orthosis enhances spinal deformity correction by providing external assistance through shaft members and a rack and pinion unit, addressing engagement and force application challenges, thus simplifying surgery and reducing patient burden.
Patent Information
- Application Number
- JP2021555107
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2019-11-06
- Filing Date
- 2020-11-05
- Publication Date
- 2025-07-04
- Estimated Expiration
- 2040-11-05
AI Technical Summary
Conventional spinal deformity correction and fixation methods using spinal deformity correction and fixation systems face challenges such as difficulty in engaging rod members with screw and hook members due to scoliosis deformation, increased operation time, risk of rod member damage, and limited corrective force application, leading to prolonged surgery and patient burden.
An external orthosis that assists spinal deformity correction and fixation by providing a pair of shaft members and a horizontal arm member outside the body, allowing for detachable attachment to vertebral fixing devices, enabling telescopic extension, and incorporating a rack and pinion unit for improved operability and force application.
Facilitates easy and effective spinal deformity correction with enhanced force application, reduces surgery complexity and time, and minimizes implant damage, thereby reducing the burden on patients and surgeons.
Smart Images

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Abstract
Description
Technical Field
[0001] The present invention relates to an external corrector capable of correcting, by an operation from outside the body, the correction and fixation when correcting and fixing spinal deformity by a spinal deformity correction and fixation system including a vertebral fixing device respectively fixed to a plurality of vertebrae and a rod member connected to the vertebral fixing device during spinal deformity correction and fixation surgery.
Background Art
[0002] In a normal state, the spine is generally straight when viewed from the rear, and when viewed from the side, the cervical vertebrae and lumbar vertebrae are anteriorly curved, and the thoracic vertebrae and sacral vertebrae are posteriorly curved, presenting a substantially S shape. On the other hand, spinal deformity, which causes an abnormality in the spine, is a disease in which the spine is deformed, and examples thereof include scoliosis, kyphosis, and scoliokyphosis. Scoliosis is a disease in which the spine bends laterally 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, scoliokyphosis 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 for correcting and fixing a deformed spine to a normal state or a state close thereto by a spinal deformity correction and fixation system (an implant, a so-called buried material in the body) described later, and a posterior correction and fixation surgery or an 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 wound or a minimally invasive percutaneous surgical wound is made in the midline of the patient's back to expose the posterior elements of the spine. Subsequently, by attaching a spinal deformity correction and fixation system (see, for example, Patent Document 1) to the spine, the spinal deformity is three-dimensionally corrected and fixed in that state.
[0004] Generally, a spinal deformity correction and fixation system typically includes, for example, a plurality of screw members that are screwed into the vertebral body through a pair of pedicles on each side of each vertebra of the spine, hook members that are hooked onto the pedicles or transverse processes of each vertebra, and a pair of rod members that are connected to, for example, the top-open groove portions of each screw member and each hook member, extend along the axial direction of the spine, and are spaced apart in the left-right direction of the patient.
[0005] For example, in the case of a patient with scoliosis, during the operation of performing posterior correction and fixation by attaching the above-described spinal deformity correction and fixation system to the spine to correct and fix spinal deformity, first, the screw members and the hook members are respectively fixed to a plurality of vertebrae to be corrected. Subsequently, the rod member is engaged with the top-open groove portions of the screw members and the hook members. At this time, although the spine is in a deformed state, since the rod member extends linearly, it is very difficult to engage the rod member with the top-open groove portions of the screw members and the hook members. Therefore, the surgeon uses a dedicated surgical instrument to bend the rod member along the scoliosis deformation of the spine. Subsequently, the bent rod is engaged with the top-open groove portions of the screw members and the hook members fixed to each vertebra, and a set screw is temporarily fixed to the top-open groove portions so that the rod member does not come out of the top-open groove portions of each screw member and each hook member.
[0006] Subsequently, the outer peripheral surface of the rod member is clamped by a dedicated surgical instrument equivalent to pliers (such as a rod gripper), and the surgical instrument is rotated approximately 90°, so that the rod member is rotated approximately 90° around its axis to correct the scoliosis deformation including the torsion of the spine. In addition, using a dedicated surgical instrument, for example, a plurality of screw members arranged along the axial direction of the spine and adjacent screw members arranged along the axial direction of the spine are subjected to compressive loads or tensile loads applied to each other to correct the scoliosis deformation of the spine. After performing such correction operations, the set screws are tightened to firmly connect the rod member to each screw member and each hook member, and correct and fix the spine.
Prior Art Documents
Patent Documents
[0007]
Patent Document 1
Summary of the Invention
Problems to be Solved by the Invention
[0008] However, in the conventional correction and fixation method using a spinal deformity correction and fixation system, the rod member is bent along the scoliosis deformation of the patient and engaged with the top open groove portions of each screw member and each hook member. However, since the spine is scoliosis deformed including torsion, even when the rod member is bent, it is very difficult to engage the rod member with the top open groove portions of each screw member and hook member. Moreover, the longer the correction and fixation range by the spinal deformity correction and fixation system, the more difficult it becomes to engage the rod member with the top open groove portions of each screw member and hook member. As a result, the operation time becomes longer, and the burden on the surgeon and the patient increases.
[0009] Also, in the conventional correction and fixation method using a spinal deformity correction and fixation system, the outer peripheral surface of the rod member is firmly clamped by a dedicated surgical instrument equivalent to pliers, and the rod member is rotated approximately 90° to correct the scoliosis deformation including the torsion of the spine. However, when the rod member bent along the scoliosis deformation of the patient is rotated approximately 90° about its axis, the bending of the rod member will be replaced by the posterior curvature and anterior curvature of the patient. However, since this bending of the rod member does not match the physiological posterior curvature and anterior curvature of the patient, there is a risk of other inconveniences, and appropriate measures are required to correct the posterior curvature and / or anterior curvature intended by the surgeon.
[0010] Furthermore, in the conventional method of correcting and fixing the spinal deformity using the spinal deformity correction and fixation system, the outer peripheral surface of the rod member is firmly clamped with a dedicated surgical instrument equivalent to pliers and rotated 90 degrees, so there is a risk of damaging the parts of the outer peripheral surface of the rod member that are clamped with the surgical instrument equivalent to pliers. Furthermore, since the rod member is temporarily fixed to the top open groove parts of each screw member and each hook member by a set screw, there is a risk of damaging the parts of the outer peripheral surface of the rod member that come into contact with the set screw when the rod member is rotated. As a result, these damaged parts are one of the factors that induce breakage of the rod member after it is placed in the body.
[0011] Furthermore, in conventional methods of correcting and fixing the spinal deformity using a spinal deformity correction and fixation system, as described above, operations for correcting the scoliosis deformity of the spine are performed by rotating rod members or by directly applying compressive or tensile loads to multiple screw members arranged along the axial direction of the spine. However, since this correction operation applies a load directly to the implants of the spinal deformity correction and fixation system, it is difficult to apply a large corrective force to the spine.
[0012] The present invention has been made in consideration of the above points, and aims to provide an extracorporeal correction device which, when correcting and fixing a spinal deformity using a spinal deformity correction and fixation system, can improve the correction force by correcting the spinal deformity through operation from outside the body, while easily achieving the correction intended by the surgeon, and which can also eliminate the complexity of the correction and fixation surgery using the spinal deformity correction and fixation system, thereby further reducing the burden on the patient. [Means for solving the problem]
[0013] (Modes of the Invention) The aspects of the invention shown below are examples of the configuration of the present invention, and are described separately for the purpose of facilitating the understanding of various configurations of the present invention. Each item does not limit the technical scope of the present invention, and even if a part of the components of each item is replaced, deleted, or other components are added while taking into consideration the best mode for carrying out the invention, it is included in the technical scope of the present invention of this application.
[0014] (1) When correcting and fixing spinal deformity with a spinal deformity correction and fixation system including a vertebral fixing device fixed to each vertebra of the spine and a rod member connected to the vertebral fixing device, an external corrector that corrects the spinal deformity by an operation from outside the body and assists the correction and fixation by the spinal deformity correction and fixation system, wherein the vertebral fixing device is provided in a pair on the left and right with respect to one vertebra, and the external corrector is detachably attached to each of the pair of left and right vertebral fixing devices fixed to the one vertebra and extends toward the outside of the patient's body A pair of left and right a shaft member, and a horizontal arm member that is connected outside the patient's body to the pair of left and right shaft members and extends in the left-right direction The pair of left and right shaft members and the transverse arm member are respectively provided for a plurality of vertebrae along the cranial-caudal direction, and are connected outside the patient's body to adjacent shaft members along the cranial-caudal direction, and include a pair of longitudinal arm members extending substantially along the cranial-caudal direction. The longitudinal arm member is configured to be telescopically extendable along the longitudinal direction and fixable at an arbitrary length. An external corrector characterized by the above (corresponding to the invention of claim 1). In the external corrector according to (1), shaft members are respectively attached to the pair of left and right vertebral fixing devices fixed to one vertebra, and the pair of left and right shaft members are connected outside the body by a horizontal arm member. By these pair of shaft members and the horizontal arm member, one vertebra can be firmly and accurately held outside the body. And for a plurality of vertebrae, by providing a pair of shaft members and a horizontal arm member and individually operating the pair of shaft members and the horizontal arm member outside the body, various corrections such as correction applying a compressive load or a tensile load along the cranio-caudal direction or rotational correction can be performed along the intention of the operator for the plurality of vertebrae. Further, in the invention of claim 1, the pair of shaft members and the transverse arm member are respectively provided for the most cranial vertebra and the most caudal vertebra in, for example, the correction range for spinal deformity. Each shaft member, each transverse arm member, and each longitudinal arm member can hold the correction range in block units. Then, from the state where the correction range is held, for example, an operator (including an assistant) grips the ends of each shaft member (for example, four shaft members) outside the body, and while correcting the position of the entire spine in the left-right direction so as to adjust the balance of the patient's trunk in the left-right direction, as a spinal deformity, it is possible to firmly correct the scoliosis deformation including torsion into an intended state. Further, in the invention of claim 1, in the scoliosis deformation of the spine, for example, among the pair of left and right longitudinal arm members, for the longitudinal arm member on the convex side of the scoliosis deformation, while shortening its entire length, it is fixed at an arbitrary position, and on the other hand, for the longitudinal arm member on the concave side, by extending its entire length and fixing it at an arbitrary position, the scoliosis deformation can be further corrected.
[0017] (2) When correcting and fixing spinal deformity with a spinal deformity correction and fixation system including a vertebral fixator fixed to each vertebra of the spine and a rod member connected to the vertebral fixator, an external corrector that corrects the spinal deformity by an operation from outside the body and assists the correction and fixation by the spinal deformity correction and fixation system. The vertebral fixator is provided in a pair of left and right for one vertebra. The external corrector is detachably attached to the pair of left and right vertebral fixators fixed to the one vertebra respectively, and includes a pair of left and right shaft members extending toward the outside of the patient's body, and a transverse arm member connected to the pair of left and right shaft members outside the patient's body and extending in the left-right direction. The pair of left and right shaft members and the transverse arm member are respectively provided for a plurality of vertebrae along the cranial-caudal direction, and are connected outside the patient's body to adjacent shaft members along the cranial-caudal direction, and include a pair of longitudinal arm members extending substantially along the cranial-caudal direction. The vertical arm member is characterized by being composed of a rack and pinion unit. An external corrector (corresponding to the invention of claim 2 ). (2) item In the external orthosis described in In particular, By simply rotating the rotary knob provided in the rack and pinion unit, a compressive load or a tensile load can be applied to a pair of vertebrae to which a pair of vertebral fixators are fixed, improving the operability.
[0018] (3) When correcting and fixing spinal deformities with a spinal deformity correction and fixation system including vertebral fixators respectively fixed to each vertebra of the spine and rod members connected to the vertebral fixators, an external orthosis that corrects the spinal deformity by an operation from outside the body and assists the correction and fixation by the spinal deformity correction and fixation system, wherein the vertebral fixators are provided in a pair on the left and right with respect to one vertebra, the external orthosis is detachably attached to the pair of left and right vertebral fixators fixed to the one vertebra, respectively, and includes a pair of left and right shaft members extending toward the outside of the patient's body and a horizontal arm member connected to the pair of left and right shaft members outside the patient's body and extending in the left-right direction, and the pair of left and right shaft members and the horizontal arm member are respectively provided for a plurality of vertebrae along the cranio-caudal direction. A pair of longitudinal arm members that are connected outside the patient's body to shaft members adjacent along the head-tail direction and extend substantially along the head-tail direction. Adjacent along the cranio-caudal direction The An external orthosis (corresponding to the invention of claim 3), characterized by including a pair of bridge members installed on the horizontal arm member. In the external orthosis described in item (3), particularly, by including bridge members, it is possible to construct a base for correcting spinal deformities, particularly lordotic deformity and kyphotic deformity, outside the body.
[0019] Items (4)(3) An external orthosis described in 4 corresponding to the invention of (4) In the external orthosis described in item, an operator (including an assistant) can operate the height adjustment means to bring the vertebral fixator closer to or away from the bridge member together with the vertebra, and can correct the lordotic deformity and kyphotic deformity in the spinal deformity to a normal state.
[0020] Items (5)(1) to (4) An external orthosis according to any one of the preceding claims, wherein a grip is provided at an end of the shaft member that protrudes outside the body. Item (5) In the external orthosis according to the above, since the operator (including the assistant) can grip the grip and perform correction, the operability can be improved.
[0021] Items (6)(1) to (5) An external orthosis according to any one of the preceding claims, wherein a connector member is provided between the vertebral fixing device and the shaft member, and the connector member is configured to be attached to the vertebral fixing device in a state where a groove portion of the vertebral fixing device for receiving the rod member is open. Item (6) In the external orthosis according to the above, with the external orthosis, in a state where the intended correction by the operator has been achieved, the rod member can be engaged with the groove portion of each vertebral fixing device, and the operation of the correction and fixation surgery by the spinal deformity correction and fixation system can be significantly simplified. As a result, the operation time can be significantly shortened, and the burden on the operator and the patient can be further reduced.
Advantages of the Invention
[0022] When correcting and fixing spinal deformity with a spinal deformity correction and fixation system using the external orthosis according to the present invention, by correcting the spinal deformity through an operation from outside the body, while improving the correction force, the intended correction by the operator can be easily achieved. Moreover, with the external orthosis according to the present invention, the complexity of the correction and fixation surgery by the spinal deformity correction and fixation system can be eliminated, and as a result, the operation time can be significantly shortened, and ultimately the burden on the patient can be further reduced.
Brief Description of the Drawings
[0023]
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Mode for Carrying Out the Invention
[0024] Hereinafter, modes for carrying out the present invention will be described in detail with reference to FIGS. 1 to 24. The external orthoses 1A and 1B according to the first and second embodiments of the present invention assist in the correction and fixation while improving the correction force by correction by an external operation when correcting and fixing spinal deformities with the spinal deformity correction and fixation system 2, and can also eliminate the complexity of the correction and fixation surgery. Although the illustration of the entire spinal deformity correction and fixation system 2 is omitted, as shown in FIG. 2, it generally includes a plurality of screw members 3, 3 that are screwed into the vertebral body through a pair of left and right pedicles of each vertebra of the spine, and a pair of left and right rod members 5, 5 that are connected to the groove portions 10, 10 of the screw members 3, 3 and extend along the axial direction of the spine. In addition, in the spinal deformity correction and fixation system 2, if necessary, hook members (not shown) fixed to the vertebrae by hooking on the pedicles, laminae, transverse processes, etc. of the vertebrae, and cross-linking members (not shown) arranged so as to span the pair of left and right rod members 5, 5, and other components are also adopted. Note that the screw member 3 and the hook member etc. correspond to vertebral fixing tools.
[0025] The screw member 3 and the rod member 5 are formed of a material having excellent biocompatibility such as a titanium alloy. The rod member 5 is formed in a circular cross-sectional shape. The length of the rod member 5 is appropriately set corresponding to the degree of spinal deformity of the patient, that is, the correction range (axial correction range) for spinal deformity. As shown in FIGS. 2 and 3, the screw members 3, 3 are screwed into the vertebral body through a pair of left and right pedicles of each vertebra from the rear of the spine. The screw member 3 is generally also referred to as a pedicle screw or a pedicle screw. The screw member 3 includes a rod receiving portion 11 having a 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 through the pedicle of the vertebra.
[0026] As shown in Fig. 3, the rod receiving portion 11 is formed in a block shape having a U-shaped groove portion 10 with an open surface on the side opposite to the screw portion 12 side. The groove portion 10 is formed along the axial direction of the rod member 5. The rod member 5 is received in the groove portion 10. In the rod receiving portion 11, female screw portions 14, 14 are respectively formed on the inner wall surfaces of the opposing wall portions with the groove portion 10 as a boundary. A set screw 20 is screwed into these female screw portions 14, 14. The screw portion 12 is connected to the rod receiving portion 11 so as to be swingable (refer to the arrow in Fig. 3) along the extending direction of the groove portion 10 with respect to the rod receiving portion 11.
[0027] Next, first, the external orthosis 1A according to the first embodiment will be described in detail with reference to Figs. 1, 4 to 13. In the drawings, for the sake of convenience of explanation, the screw portion 12 side of the screw member 3 shown in Fig. 4 is taken as the lower side, and the rod receiving portion 11 side is taken as the upper side and will be described as appropriate. As shown in Figs. 1, 6, and 7, the external orthosis 1A according to the first embodiment of the present invention is detachably connected to a pair of left and right screw members 3, 3 screwed into the vertebral body via a pair of left and right pedicles of a vertebra, respectively, via connector members 100, 100, and includes shaft members 18, 18 extending toward the outside of the patient's body, and a horizontal arm member 19 for installing the pair of left and right shaft members 18, 18 outside the patient's body. As can be understood from Fig. 4, the connector member 17 is detachably attached to the rod receiving portion 11 (head portion) of the screw member 3. The connector member 17 is disposed around the rod receiving portion 11 of the screw member 3.
[0028] As shown in FIGS. 4 and 5, the connector member 17 includes a screw support portion 24 having a pair of support pieces 22, 22 arranged at intervals to support the rod receiving portion 11 of the screw member 3, a member restraint portion 26 having a U-shaped groove portion 25 with an open upper surface, and a rotating member 27 rotatably supported so as to span the tips of the pair of support pieces 22, 22 of the screw support portion 24. The screw support portion 24 and the member restraint portion 26 are integrally connected so that a part of each overlaps the other, and are formed so as to be arranged along a direction orthogonal to the extending direction of the groove portion 25 in a plan view. The member restraint portion 26 has a U-shaped groove portion 25 with an open upper surface. The groove portion 25 is formed along the cranio-caudal direction of the patient. Female screw portions 28, 28 are respectively formed on the opposing wall surfaces via the groove portion 25 of the member restraint portion 26. A set screw 29, a height adjustment rod member 96, or a long bolt member 78 is screwed into the female screw portions 28, 28.
[0029] A polygonal hole portion (not shown) is exposed from the bottom opening of the groove portion 25 of the member restraint portion 26. By fitting a dedicated surgical instrument into the polygonal hole portion and rotating the surgical instrument, the rotating member 27 rotates to open and close between the tips of the pair of support pieces 22, 22 of the screw support portion 24. Above the screw support portion 24, a support recess 30 for receiving one arc portion of the rod receiving portion 11 of the screw member 3 is formed. A pair of stopper claw portions 31 are provided in the support recess 30 so as to be able to protrude and retract. The stopper claw portions 31 are configured to advance and retreat within the support recess 30 by rotating a fixing screw member 32.
[0030] When attaching the connector member 17 to the rod receiving portion 11 of the screw member 3, a dedicated surgical instrument is fitted into the polygonal hole portion exposed from the bottom opening of the groove portion 25 of the member restraining portion 26, and the rotating member 27 is rotated by rotating it in one direction, so that the pair of support pieces 22, 22 of the screw support portion 24 are in an open state. Subsequently, while disposing one arc portion in the rod receiving portion 11 of the screw member 3 within the support recess 30 of the connector member 17, the dedicated surgical instrument is again fitted into the polygonal hole portion and rotated in the other direction to rotate the rotating member 27, and the rod receiving portion 11 of the screw member 3 is restrained by the rotating member 27. Subsequently, each fixing screw member 32 is rotated in one direction by a dedicated surgical instrument, and by screwing in each fixing screw member 32, the pair of stopper claw portions 31 press the recess 34 of the rod receiving portion 11 of the screw member 3 and are firmly fixed. As a result, the screw member 3 is firmly held by the connector member 17.
[0031] And even after attaching the connector member 17 to the rod receiving portion 11 of the screw member 3, the groove portion 10 of the rod receiving portion 11 of the screw member 3 remains in an open state. As a result, even after attaching the main body external orthosis 1A including the connector member 17 to the rod receiving portion 11 of the screw member 3, the rod member 5 can be accommodated in the groove portion 10 of the rod receiving portion 11 of each screw member 3 without any problem. On the other hand, when removing the connector member 17 from the rod receiving portion 11 of the screw member 3, it can be smoothly removed by performing an operation reverse to the above-described attachment operation.
[0032] Note that, as shown in FIGS. 1 and 6, the connector member 17 having the above-described configuration is attached to all the screw members 3 fixed to each vertebra of the spine. As can be understood from FIG. 6, a shaft member 18 is detachably attached to the connector member 17. Also, within the correction range of spinal deformity, shaft members 18, 18 are respectively attached to the connector members 100, 100 attached to the pair of left and right screw members 3, 3 at the most cranial side and the connector members 100, 100 attached to the pair of left and right screw members 3, 3 at the most caudal side.
[0033] As shown in FIG. 6, the shaft member 18 is generally configured in a shape where an elongated rod-like body is gently bent at appropriate locations. Specifically, the shaft member 18 includes a restraint shaft portion 35 fixed to the member restraint portion 26 of the connector member 17, a main shaft portion 36 that continuously extends obliquely upward and outward from the restraint shaft portion 35, and a tip shaft portion 37 that extends substantially horizontally from the upper end of the main shaft portion 36. The restraint shaft portion 35 extends along the cranio-caudal direction of the patient. The restraint shaft portion 35 is housed in the groove portion 25 of the member restraint portion 26 of the connector member 17 and is fixed by either the set screw 29 or a long bolt member 78 (see FIG. 11) described later.
[0034] The main shaft portion 36 is in the left-right direction and extends obliquely upward to the outside of the body. An annular receiving portion 40 for receiving a later-described horizontal arm member 19 is formed at a substantially central portion in the length direction of the main shaft portion 36. The annular receiving portion 40 projects radially outward from the outer peripheral surface of the main shaft portion 36. The tip shaft portion 37 is in the left-right direction from the upper end of the main shaft portion 36 and extends substantially horizontally. An annular support portion 41 for inserting and supporting the shaft portion 45 of the grip 44 is formed at the tip of the tip shaft portion 37. The shaft portion 45 of the grip 44 is inserted into the annular support portion 41 to support the grip 44. A pair of annular guide portions 48, 48 are formed at intervals along the axial direction on the tip shaft portion 37. The annular guide portions 48, 48 project radially outward from the outer peripheral surface of the tip shaft portion 37. One-end side support portion and the other-end side support portion of a later-described vertical arm member 57 are supported between the pair of annular guide portions 48, 48. And, as can be understood from FIG. 10, most of the main shaft portion 36 and the tip shaft portion 37 of the shaft member 18 are arranged outside the body.
[0035] As shown in Fig. 7, a pair of shaft members 18, 18 provided along the left - right direction of a vertebra has a lateral arm member 19 installed thereon. The lateral arm member 19 is formed in a plate shape as a whole and is erected. At both ends of the lateral arm member 19, a pair of split holding portions 52, 52 that are split into two along the thickness direction are formed. A slit 53 is formed between the pair of split holding portions 52, 52. The main shaft portion 36 of the shaft member 18 is inserted into the slit 53 between the pair of split holding portions 52, 52. The pair of split holding portions 52, 52 are supported on the annular receiving portion 40 of the main shaft portion 36. And, as can be understood from Fig. 10, most of the main shaft portion 36 of the shaft member 18 and the lateral arm member 19 are arranged outside the body.
[0036] Also, as shown in Figs. 8 - 10, a longitudinal arm member 57 is installed between the distal shaft portion 37 of the cranial - side shaft member 18 and the distal shaft portion 37 of the caudal - side shaft member 18. The longitudinal arm member 57 is configured to be stretchable along the longitudinal direction and fixable at an arbitrary length. Specifically, the longitudinal arm member 57 is formed in a rod shape as a whole. The longitudinal arm member 57 includes a cylindrical portion 58 and a shaft body portion 59 that is slidably inserted along the axial direction into the cylindrical portion 58. At one axial end of the cylindrical portion 58, a one - end - side engaging portion 61 that is engaged with the distal shaft portion 37 of the shaft member 18 is integrally connected. The one - end - side engaging portion 61 is plate - shaped and erected. A long hole 64 penetrating in the left - right direction is formed along the longitudinal direction in the one - end - side engaging portion 61. A slit 65 is formed in the lower wall portion of the one - end - side engaging portion 61, and the slit 65 communicates with the long hole 64.
[0037] The width length (the length along the vertical direction) of the long hole 64 is set to be larger than the outer diameter of the tip shaft portion 37 of the shaft member 18. The width length of the slit 65 is also set to be larger than the outer diameter of the tip shaft portion 37 of the shaft member 18. And the tip shaft portion 37 of the shaft member 18 is inserted and supported in the long hole 64 through the slit 65 of the one-end-side engaging portion 61. An annular flange portion 68 protruding radially outward is provided at the other end in the axial direction of the cylindrical portion 58. A set screw 69 is inserted along the radial direction through the peripheral wall portion of the cylindrical portion 58.
[0038] On the other hand, the shaft main body portion 59 includes a small-diameter shaft portion 73 and a large-diameter shaft portion 74 integrally connected to the axial end portion of the small-diameter shaft portion 73. The small-diameter shaft portion 73 of the shaft main body portion 59 is slidably inserted into the cylindrical portion 58. An annular flange portion 75 protrudes radially outward at the boundary portion between the small-diameter shaft portion 73 and the large-diameter shaft portion 74. At the axial end portion of the large-diameter shaft portion 74 on the side opposite to the annular flange portion 75, the other-end-side engaging portion 62 having the same structure as the one-end-side engaging portion 61 provided at the one axial end portion of the cylindrical portion 58 is integrally connected. Since the structure of the other-end-side engaging portion 62 is the same as the structure of the one-end-side engaging portion 61 provided on the cylindrical portion 58 described above, the description here is omitted. And the vertical arm member 57 includes the one-end-side engaging portion 61 and the other-end-side engaging portion 62 at both of its ends, and is configured such that the small-diameter shaft portion 73 of the shaft main body portion 59 is slidably inserted into the cylindrical portion 58. Also, by screwing the set screw 69 provided on the peripheral wall portion of the cylindrical portion 58 with a dedicated surgical instrument and pressing the outer peripheral surface of the small-diameter shaft portion 73 of the shaft main body portion 59 through which the tip of the set screw 69 passes through the inside of the cylindrical portion 58, the position along the axial direction of the small-diameter shaft portion 73 of the shaft main body portion 59 with respect to the cylindrical portion 58 is determined, and the overall length of the vertical arm member 57 is determined.
[0039] In addition, in spinal deformity, when correcting anterior curvature and posterior curvature in addition to lateral curvature, as shown in FIG. 11, the lower male screw portions 80 of the long bolt members 78 are respectively screwed into the female screw portions 28 of the member restraint portions 26 of the connector member 17 attached to the pair of left and right screw members 3 fixed to one vertebra on the cranial side, and the shaft member 18 is fixed to the connector member 17 by the long bolt member 78. On the other hand, the lower male screw portions 80 of the long bolt members 78 are also respectively screwed into the female screw portions 28 of the member restraint portions 26 of the connector member 17 attached to the pair of left and right screw members 3 fixed to one vertebra on the caudal side, and the shaft member 18 is fixed to the connector member 17 by the long bolt member 78. Upper male screw portions 79 and lower male screw portions 80 are respectively formed at the upper and lower ends of these long bolt members 78.
[0040] As shown in FIG. 12, bridge members 83 are installed between the adjacent cross-arm members 19 along the cranio-caudal direction. A pair of left and right bridge members 83 are provided corresponding to the pair of left and right screw members 3 provided for one vertebral body. Each bridge member 83 is formed in a plate shape as a whole and is installed between the cross-arm members 19 in an upright state. A long hole 84 penetrating in the vertical direction is formed along the longitudinal direction in the bridge member 83. A plurality of engaging groove portions 85 for engaging the cross-arm members 19 are formed at intervals on the head side and the tail side at the lower end of the bridge member 83. The upper surface of the bridge member 83 is formed into an arc-shaped concave surface 89 with the substantially central portion in the longitudinal direction being the deepest. The bridge member 83 is formed with rigidity that can be elastically deformed so as to be bendable along the left-right direction.
[0041] A pair of long bolt members 78, 78 arranged on the head side and the tail side are respectively inserted into the long holes 84, 84 of the pair of bridge members 83, 83 on the left and right. As shown in FIG. 13, fixing nut members 88 are respectively screwed onto the upper male thread portions 79 of the long bolt members 78 protruding from the upper ends of the pair of bridge members 83, 83 on the left and right. The lower end of the fixing nut member 88 is in contact with the upper surface of the bridge member 83. By screwing and fixing the fixing nut member 88 to the long bolt member 78, the pair of screw members 3, 3 (connector members 17) on the head side, the pair of screw members 3, 3 (connector members 17) on the tail side, the pair of shaft members 18, 18 on the head side, the pair of shaft members 18, 18 on the tail side, and the pair of bridge members 83, 83 on the left and right are integrally fixed.
[0042] As shown in FIG. 1, height adjustment means 95 for adjusting the height is provided between the bridge member 83 and the screw member 3 (connector member 17) located in the middle between the screw members 3, 3 on the head side and the tail side. The height adjustment means 95 includes a height adjustment rod member 96 screwed into the female thread portions 28, 28 of the member restraint portion 26 of the connector member 17, and a cylindrical member 97 integrally connected to the upper end of the height adjustment rod member 96. A male thread portion 100 screwed into the female thread portions 28, 28 of the member restraint portion 26 of the connector member 17 is formed at the lower end of the height adjustment rod member 96. The cylindrical member 97 is inserted through and integrally connected to the upper end of the height adjustment rod member 96. Then, the height adjustment rod member 96 is inserted into the long hole 84 from above the bridge member 83, and the male thread portion 100 is screwed into the female thread portions 28, 28 of the member restraint portion 26 of the connector member 17 attached to the screw member 3.
[0043] Then, a gap appears between the lower end of the cylindrical member 97 of the height adjustment means 95 and the upper end (arc-shaped concave surface 89) of the bridge member 83. Thereafter, using a dedicated surgical instrument, for example, a compression instrument with a divided tip that can approach and separate from each other, at its tip, support the lower end of the cylindrical member 97 and the upper end (arc-shaped concave surface 89) of the bridge member 83 respectively, and perform an operation to increase the distance between these cylindrical member 97 and bridge member 83. By narrowing the distance between the screw member 3 and the bridge member 83, one vertebra can be moved backward with respect to the bridge member 83. On the other hand, using the same dedicated surgical instrument (such as a compression instrument), support the upper end of the cylindrical member 97 and the lower end of the bridge member 83 at its tip, and perform an operation to narrow the distance between these cylindrical member 97 and bridge member 83. By expanding the distance between the screw member 3 and the bridge member 83, one vertebra can be moved forward with respect to the bridge member 83.
[0044] Next, when correcting and fixing spinal deformities with the spinal deformity correction and fixation system 2, a method of assisting the correction and fixation by the spinal deformity correction and fixation system 2 while correcting spinal deformities by an external operation using the external corrector 1A according to the first embodiment will be described. First, in spinal deformities such as scoliosis deformities, for each vertebra in the correction and fixation range of spinal deformities (for example, in the range of lumbar vertebrae L2 - L5), as shown in FIG. 2, using a dedicated surgical instrument, for example, a screw driver, screw the screw members 3, 3 into the vertebral bodies respectively from the rear of the spine through a pair of left and right pedicles of the vertebra. Subsequently, as shown in FIG. 4, attach the connector members 17 to all the screw members 3, 3 respectively. Since the method of attaching the connector member 17 to the rod receiving portion 11 of the screw member 3 has been described above, the description here is omitted.
[0045] Next, prepare four shaft members 18, 18. As shown in FIG. 6, for the pair of left and right screw members 3, 3 on the most cranial side, the restraint shaft portions 35 of the shaft members 18, 18 are accommodated in the groove portions 25 of the member restraint portions 26 of the connector members 100, 100 and fixed with set screws 29. Also, for the pair of left and right screw members 3, 3 on the most caudal side, the restraint shaft portions 35 of the shaft members 18, 18 are accommodated in the groove portions 25 of the member restraint portions 26 of the connector members 100, 100 and fixed with set screws 29. Then, referring to FIG. 10, most of the main shaft portions 36 that continuously extend obliquely upward from the restraint shaft portions 35 of each of the shaft members 18, 18 (four in number) and the tip shaft portions 37 (including the grip 44) that extend in a substantially horizontal direction from the main shaft portions 36 are positioned outside the body.
[0046] Next, prepare two transverse arm members 19, 19. As shown in FIG. 7, one transverse arm member 19 is installed on the pair of left and right shaft members 18, 18 on the cranial side, and the other transverse arm member 19 is installed on the pair of left and right shaft members 18, 18 on the caudal side. Specifically, the main shaft portions 36 of the pair of left and right shaft members 18, 18 are inserted into the slit 53 between the pair of split holding portions 52, 52 provided at both ends of the transverse arm member 19, and the pair of split holding portions 52, 52 are supported by the annular receiving portion 40 of the main shaft portion 36. With these pair of shaft members 18, 18 and the transverse arm member 19, the first vertebra on the cranial side and the caudal side can be firmly and accurately held outside the body. Note that since the main shaft portions 36 of the shaft members 18, 18 are inserted into the slit 53 between the pair of split holding portions 52, 52 of the transverse arm member 19 and connected to each other, the shaft member 18 can relatively move in the left-right direction with respect to the transverse arm member 19 by the length of the slit 53.
[0047] Next, the operator (including the assistant) grips the grips 44, 44 of the pair of left and right shaft members 18, 18 on the cranial side and the grips 44, 44 of the pair of left and right shaft members 18, 18 on the caudal side, and performs all correction operations such as sliding operations or rotational operations along the cranio-caudal direction or the left-right direction according to the intention of the operator on the vertebra on the cranial side and the caudal side. In this way, all correction operations can be performed according to the degree of scoliosis deformation including the patient's torsion.
[0048] Next, two longitudinal arm members 57, 57 are prepared. As shown in FIG. 8, a pair of left and right longitudinal arm members 57, 57 are installed on the shaft members 18, 18 adjacent to each other along the cranio-caudal direction, that is, the shaft members 18, 18 on the cranial side and the shaft members 18, 18 on the caudal side. Specifically, while inserting the portion between the annular guide portions 48, 48 of the distal shaft portion 37 of the cranial or caudal shaft member 18 into the slit 65 of the one-end-side engaging portion 61 of the longitudinal arm member 57, the distal shaft portion 37 is inserted into the long hole 64 of the one-end-side engaging portion 61 of the longitudinal arm member 57, and the one-end-side engaging portion 61 of the longitudinal arm member 57 is supported by the portion between the annular guide portions 48, 48 of the distal shaft portion 37 of the cranial shaft member 18.
[0049] On one hand, while inserting the portion between the annular guide portions 48, 48 with the distal shaft portion 37 of the caudal or cranial shaft member 18 into the slit 65 of the engagement portion 62 on the other end side of the longitudinal arm member 57, insert the distal shaft portion 37 into the long hole 64 of the engagement portion 62 on the other end side of the longitudinal arm member 57, and support the engagement portion 62 on the other end side of the longitudinal arm member 57 with the portion between the annular guide portions 48, 48 by the distal shaft portion 37 of the caudal shaft member 18. As a result, the longitudinal arm members 57, 57 will be arranged in a pair along the left - right direction. And, by each of the shaft members 18, 18 (all 4 pieces), each of the transverse arm members 19, 19 (all 2 pieces) and each of the longitudinal arm members 57, 57 (all 2 pieces), the correction range for spinal deformity can be held in block units. And from this state, for example, by an operator (including an assistant), grip the grips 44, 44 of each of the shaft members 18, 18 (4 shaft members 18, 18) outside the body, and while correcting the left - right position of the entire spine so as to adjust the left - right trunk balance of the patient, strongly correct the scoliosis deformation including torsion into the intended state.
[0050] Next, among the pair on the left and right, the opposing annular flange portions 68, 75 provided on one or both of the longitudinal arm members 57, 57 are brought close to or separated from each other using a dedicated surgical instrument, for example, a compression instrument with a divided tip that can be close to and separated from each other, etc., to expand and contract the longitudinal arm member 57 and set it to an arbitrary length. Then, by rotating the set screw 69 provided on the longitudinal arm member 57 with a dedicated surgical instrument, the tip of the set screw 69 presses the outer peripheral surface of the small - diameter shaft portion 73 of the shaft main body portion 59 that passes through the inside of the cylindrical portion 58, so that the position of the small - diameter shaft portion 73 of the shaft main body portion 59 along the axial direction with respect to the cylindrical portion 58 is restricted and that state is maintained. As a result, by expanding and contracting the pair of longitudinal arm members 57, 57 on the left and right, a compressive load or a tensile load can be applied to a pair of vertebrae (each pedicle portion) into which the pair of screw members 3, 3 in the cranial - caudal direction are screwed, and thus, it becomes possible to further correct the scoliosis deformation.
[0051] After that, in the case where there is no corrective operation for anterior curvature deformation and posterior curvature deformation due to spinal deformity of the patient, while maintaining the spinal deformity corrected by the external orthosis 1A, as the spinal deformity correction and fixation system 2, the rod members 5, 5 are engaged with the rod receiving portions 11, 11 (groove portions 10, 10) of the screw members 3, 3, and fixed by the set screws 20, 20, so that the spinal deformity can be corrected and fixed by the screw members 3, 3 and the pair of left and right rod members 5, 5.
[0052] By the way, in the case of correcting anterior curvature deformation and posterior curvature deformation in addition to lateral curvature deformation including torsion in spinal deformity, as shown in FIG. 11, instead of the set screw 29, the long bolt member 78 is used, and the lower male screw portion 80 of the long bolt member 78 is screwed into the female screw portions 28, 28 of the member restraint portion 26 of the connector member 17, so that the shaft member 18 is fixed to the connector member 17 (screw member 3) by the long bolt member 78. Subsequently, as described above, one lateral arm member 19 is installed on the pair of left and right shaft members 18, 18 on the cranial side, and the other lateral arm member 19 is installed on the pair of left and right shaft members 18, 18 on the caudal side. Subsequently, as described above, the shaft members 18, 18 on the cranial side and the shaft members 18, 18 on the caudal side are installed by the pair of left and right vertical arm members 57, 57 to obtain the state of FIG. 11.
[0053] Then, from the state shown in FIG. 11, as described above, for example, by an operator (including an assistant), the grips 44, 44 of the shaft members 18, 18 (the four shaft members 18, 18) are grasped outside the body, and while correcting the left-right position of the entire spine so as to adjust the balance of the patient's trunk in the left-right direction, firmly correcting the lateral curvature deformation including torsion in an intended manner, the lateral curvature deformation is further corrected by expanding and contracting one or both of the vertical arm members 57, 57 and fixing them at an arbitrary length.
[0054] Next, as shown in FIG. 12, the bridge member 83 is slightly bent so as to correspond to the arrangement state along the cranial-caudal direction of the screw members 3 screwed into each vertebra (for example, referring to FIG. 9, the pair of left and right screw members 3, 3 are arranged in a substantially inverted V shape in plan view). Subsequently, a pair of the bridge members 83, 83 are installed on the adjacent transverse arm members 19, 19 along the cranial-caudal direction. At this time, the transverse arm members 19, 19 are engaged with the corresponding engaging groove portions 85 among the plurality of engaging groove portions 85, 85 formed on the cranial side and the caudal side at the lower end of the bridge member 83 from above so as to be engaged with the bridge member 83. As a result, the bridge members 83, 83 are arranged in a pair along the left-right direction. Also at this time, the four long bolt members 78 are inserted into the long holes 84, 84 of the bridge members 83, 83 so as to arrange the bridge members 83, 83.
[0055] Next, as shown in FIG. 13, fixing nut members 88 are respectively screwed onto the upper male screw portions 79 of the long bolt members 78 protruding from the upper ends of the bridge members 83, 83. The lower ends of the fixing nut members 88 are in contact with the upper surfaces of the bridge members 83. By screwing and fixing the fixing nut members 88 onto the upper male screw portions 79 of the long bolt members 78, the pair of left and right screw members 3, 3 (connector members 100, 100) on the cranial side, the pair of left and right screw members 3, 3 (connector members 100, 100) on the caudal side, the pair of left and right shaft members 18, 18 on the cranial side, the pair of left and right shaft members 18, 18 on the caudal side, and the pair of left and right bridge members 83, 83 are unitized, and a base serving as a basis for anterior curvature correction and posterior curvature correction is constructed outside the body. Note that after the pair of left and right bridge members 83, 83 are installed on the adjacent transverse arm members 19, 19 in the cranial-caudal direction, the positions of the shaft members 18, 18 along the cranial-caudal direction are restricted. Therefore, the pair of left and right longitudinal arm members 57, 57 installed on the pair of left and right shaft members 18, 18 along the cranial-caudal direction may be removed. Note that the surgical field can be secured by removing the longitudinal arm member 57 from the pair of shaft members 18, 18.
[0056] Next, as shown in FIG. 1, a height adjustment rod member 96 as the height adjustment means 95 is inserted into the long holes 84, 84 of the bridge members 83, 83, and a male screw portion 100 provided at the lower portion thereof is screwed into female screw portions 28, 28 of a member restraint portion 26 of a connector member 17 attached to the screw member 3. This operation is performed on the member restraint portion 26 of the connector member 17 attached to the screw member 3 other than the screw member 3 (connector member 17) to which the long bolt member 78 is screwed. Subsequently, using a dedicated surgical instrument, for example, a compression instrument or the like with a divided tip that can approach and separate from each other, at the tip thereof, the lower end of the cylindrical member 97 and the upper end (arc-shaped concave surface 89) of the bridge member 83 are respectively supported, and an operation is performed to increase the distance between the cylindrical member 97 and the bridge member 83. By narrowing the distance between the screw member 3 and the bridge member 83, a vertebral body can be moved backward with respect to the bridge member 83.
[0057] On the other hand, using the same dedicated surgical instrument (compression instrument or the like), at the tip thereof, the upper end of the cylindrical member 97 and the lower end of the bridge member 83 are supported, and an operation is performed to narrow the distance between the cylindrical member 97 and the bridge member 83. By expanding the distance between the screw member 3 and the bridge member 83, a vertebral body can be moved forward with respect to the bridge member 83. As a result, the anterior curvature deformation and posterior curvature deformation in the spinal deformity of the patient can be corrected to the anterior curvature and posterior curvature intended by the surgeon.
[0058] Next, while maintaining the state after correcting spinal deformity with the extracorporeal orthosis 1A according to the first embodiment, referring to FIG. 2, as the spinal deformity correction and fixation system 2, the rod members 5, 5 are engaged with the rod receiving portions 11, 11 and the groove portions 10, 10 of all the screw members 3, 3, and fixed by the set screws 20, 20. In the above description, as the spinal deformity correction and fixation system 2, the spinal deformity is simply corrected and fixed only by a plurality of screw members 3, 3 and a pair of left and right rod members 5, 5. This is for the sake of easily explaining a method of assisting the correction and fixation by the extracorporeal orthosis 1A. Actually, if necessary, in addition to the screw members 3, hook members (not shown), cross-linking members (not shown), etc. may be used, and in addition to the pair of rod members 5, 5, further rod members 5 may be added and used.
[0059] As described above, in the extracorporeal orthosis 1A according to the first embodiment, shaft members 18, 18 that are detachably connected to a pair of left and right screw members 3, 3 fixed to one vertebra and extend toward the outside of the patient's body, and a horizontal arm member 19 that is installed outside the patient's body on the pair of left and right shaft members 18, 18 are provided. Thereby, by individually operating the pair of left and right shaft members 18, 18 and the horizontal arm member 19 outside the body, various corrections such as correction applying a compressive load or a tensile load along the cranio-caudal direction or rotational correction can be performed on a plurality of vertebrae according to the intention of the operator. Moreover, each of the shaft members 18, 18 and the horizontal arm member 19 is disposed outside the body, and by operating them outside the body, the spinal deformity is corrected, so that the correction force can be improved.
[0060] In addition, in the external orthosis 1A according to the first embodiment, a pair of left and right vertical arm members 57, 57 that are installed outside the patient's body are provided on the shaft members 18, 18 adjacent to each other along the cranio-caudal direction. Then, with these shaft members 18, 18, transverse arm members 19, 19, and vertical arm members 57, 57, the correction range for spinal deformity can be held in block units. From the state where the correction range is held, for example, an operator (including an assistant) grips the grips 44, 44 of the shaft members 18, 18 (for example, four shaft members 18, 18) outside the body, and while correcting the position of the entire spine in the left-right direction so as to adjust the balance of the patient's trunk in the left-right direction, as a spinal deformity, a lateral curvature deformation including torsion can be corrected with a large correction force.
[0061] After the external orthosis 1A corrects the spinal deformity, particularly the lateral curvature deformation, while maintaining the corrected state, as the spinal deformity correction fixation system 2, substantially straight rod members 5, 5 are engaged with the rod receiving portions 11, 11 (groove portions 10, 10) of the screw members 3, 3 and fixed by the set screws 20, 20, so that the spinal deformity can be corrected and fixed by the screw members 3, 3 and the pair of left and right rod members 5, 5.
[0062] As a result, when the spinal deformity correction and fixation system 2 corrects and fixes a spinal deformity, it is not necessary to bend the rod member 5 of the spinal deformity correction and fixation system 2 as in the prior art to correspond to the lateral curvature deformation, nor is it necessary to perform a complicated operation of forcibly engaging the rod member 5 with the rod receiving portion 11 of each screw member 3 fixed to each vertebra with a lateral curvature deformation including torsion. As a result, the complexity of the correction and fixation surgery by the spinal deformity correction and fixation system 2 can be eliminated. Further, operations such as firmly clamping and rotating the rod member 5 of the spinal deformity correction and fixation system 2 using a dedicated surgical instrument such as pliers are not necessary, and damage to the rod member 5, which is an implant, can be suppressed. In this way, by using the external corrector 1A, the spinal deformity correction and fixation system 2 can easily correct and fix the spinal deformity. Moreover, since the complexity of the correction and fixation surgery is eliminated and the surgery itself becomes easy, it is possible to contribute to shortening the surgery time, and thus reduce the burden on the surgeon and the patient.
[0063] Furthermore, in the external corrector 1A according to the first embodiment, the longitudinal arm member 57 is configured to be extendable and retractable along the longitudinal direction and fixable at an arbitrary length. Therefore, by fixing the longitudinal arm member 57 at an arbitrary length while expanding and contracting its entire length, the lateral curvature deformation can be further corrected. Furthermore, the external corrector 1A according to the first embodiment includes a pair of bridge members 83, 83 installed between the adjacent horizontal arm members 19, 19 along the cranial-caudal direction. Therefore, outside the body, a base serving as a basis for correcting the anterior curvature deformation and the posterior curvature deformation in the spinal deformity can be constructed.
[0064] Furthermore, the external corrector 1A according to the first embodiment includes a height adjustment means 95 capable of freely adjusting the height direction distance between the head of the screw member 3 and the bridge member 83. Therefore, an operator (including an assistant) can bring the screw member 3 closer to or separate it from the bridge member 83 together with the vertebra by operating the height adjustment means 95. As a result, the anterior curvature deformation and the posterior curvature deformation in the spinal deformity can be corrected to a normal state.
[0065] In the external orthosis 1A according to the first embodiment, the shaft member 18 is detachably attached to the rod receiving portion 11 of the screw member 3 via the connector member 17, but it may be configured to be directly attached to the rod receiving portion 11 of the screw member 3.
[0066] Next, the external orthosis 1B according to the second embodiment of the present invention will be described in detail with reference to FIGS. 14 to 24. When describing the external orthosis 1B according to the second embodiment, the differences from the external orthosis 1A according to the first embodiment will be mainly described. As shown in FIGS. 14 and 15, the external orthosis 1B according to the second embodiment includes shaft members 103, 103 that extend toward the outside of the patient's body and are detachably connected to a pair of left and right screw members 3, 3 via connector members 100, 100, and a horizontal arm member 104 that extends in the left - right direction and connects the pair of left and right shaft members 103, 103 to each other outside the patient's body.
[0067] As shown in FIGS. 16 and 17, the connector member 100 includes a pair of support pieces 110, 111 that are provided so as to be movable closer to and farther from each other to support the rod receiving portion 11 of the screw member 3, and a member restraint portion 113 that is integrally connected to one of the pair of support pieces 110 and has a U - shaped groove portion 114 with an open upper surface. By fitting a dedicated surgical instrument into the polygonal hole portion 116 and rotating it, the other support piece 111 can be moved closer to and farther from the one support piece 110. The groove portion 114 of the member restraint portion 113 is formed along the cranio - caudal direction of the patient. Female screw portions 117, 117 are respectively formed on the opposing wall surfaces via the groove portion 114. A set screw 29 is screwed into the female screw portions 117, 117.
[0068] When attaching the connector member 100 to the rod receiving portion 11 of the screw member 3, after interposing the rod receiving portion 11 of the screw member 3 between the pair of support pieces 110 and 111 of the connector member 100, a dedicated surgical instrument is fitted into the polygonal hole portion 116 and rotated in one direction to move the other support piece 111 closer to the one support piece 110, and the rod receiving portion 11 of the screw member 3 is held by sandwiching each flat surface portion between the pair of support pieces 110 and 111.
[0069] The connector member 100 employed in the external orthosis 1B according to the second embodiment is the same as the connector member 17 employed in the external orthosis 1A according to the first embodiment. Even after attaching the connector member 100 to the rod receiving portion 11 of the screw member 3, the groove portion 10 of the rod receiving portion 11 of the screw member 3 remains open upward. As a result, even after attaching the main body external orthosis 1B including the connector member 100 to the rod receiving portion 11 of the screw member 3, the rod member 5 can be accommodated in the groove portion 10 of the rod receiving portion 11 of each screw member 3 without any problem. Incidentally, the connector member 100 may be employed in the external orthosis 1A according to the first embodiment, and the connector member 17 (see FIGS. 4 and 5) may be employed in the external orthosis 1B according to the second embodiment.
[0070] As shown in FIGS. 18 and 22, the shaft member 103 has an L shape composed of a restraint shaft portion 120 fixed to the member restraint portion 113 (groove portion 114) of the connector member 100 and a main shaft portion 121 extending outward from the restraint shaft portion 120 upward. A pair of annular stopper portions 122, 122 are provided on the restraint shaft portion 120 so as to project axially at intervals. When the restraint shaft portion 120 is fitted into the member restraint portion 113 (groove portion 114) of the connector member 100, the pair of annular stopper portions 122, 122 are arranged so as to sandwich the member restraint portion 113 of the connector member 100 from the head and tail directions. A support member 125 is integrally connected to the upper end of the main shaft portion 121. The support member 125 extends along the head and tail direction. Specifically, the support member 125 extends in the same direction as the direction in which the groove portion 114, which is the member restraint portion 113 of the connector member 100, extends.
[0071] On one end portion of the support member 125 in the head and tail direction, a support groove portion 127 having a U shape in side view for supporting a grip member 130 (see FIG. 19) gripped by an operator or the like is formed. A fitting portion 132 (see FIG. 19) of the grip member 130 is detachably fitted into the support groove portion 127. A cylindrical portion 139 projects upward from the other end portion of the support member 125 in the head and tail direction. A male screw portion 140 extends upward from the radial center of the cylindrical portion 139.
[0072] The U-shaped groove portion 151 or the through hole 150 (see FIG. 20) of a later-described horizontal arm member 104 is inserted into the male screw portion 140. As shown in FIGS. 19 and 23, the grip member 130 includes a grip 131 gripped by an operator or the like and a fitting portion 132 arranged via a shaft portion from the longitudinal end surface of the grip 131. The fitting portion 132 is formed in a rectangular parallelepiped shape that abuts and fits into the support groove portion 127 of the support member 125. On the upper surface of the fitting portion 132, a pair of upper and lower disc portions 135, 135 and a support shaft portion 136 extending in the vertical direction between these disc portions 135, 135 are integrally provided.
[0073] Further, on both ends of the fitting portion 132 in the direction coinciding with the extending direction of the grip 131 thereof, when the fitting portion 132 is fitted into the support groove portion 127 of the support member 125, a pair of protruding portions 137, 137 that respectively abut against the wall surfaces around the support groove portion 127 are formed. The protruding portions 137 project from the fitting portion 132 in the head-tail direction respectively. And when the rectangular parallelepiped-shaped fitting portion 132 of the grip member 130 is detachably fitted into the support groove portion 127 of the support member 125, referring also to FIG. 15, the support member 125 and the grip 131 of the grip member 130 extend in directions substantially orthogonal to each other. In short, while the grip member 130 extends in the left-right direction, the support member 125 extends in the head-tail direction as described above. Further, when the fitting portion 132 is fitted into the support groove portion 127 of the support member 125 and the pair of protruding portions 137, 137 respectively abut against the wall surfaces around the support groove portion 127, the fitting portion 132 is fitted to the support member 125 so as not to be relatively movable along the left-right direction and the head-tail direction.
[0074] Referring to FIG. 15, a wing nut 141 for pressing and fixing the horizontal arm member 104 between the male screw portion 140 and the cylindrical portion 139 of the support member 125 is screwed. Referring also to FIG. 15, on the upper surfaces of the cylindrical portions 139, 139 of the support members 125, 125 corresponding to the pair of screw members 3, 3 in the head-tail direction on the right side respectively, boss members 144, 144 having uneven portions 143, 143 with a triangular cross section along the circumferential direction as shown in FIG. 18(a) are formed. On the other hand, referring to FIG. 15, on the upper surfaces of the cylindrical portions 139, 139 of the support members 125, 125 corresponding to the pair of screw members 3, 3 in the head-tail direction on the left side respectively, uneven portions 146, 146 with a triangular cross section along the same direction as the axial direction of the grip 131 as shown in FIG. 18(b) are continuously formed.
[0075] Referring to FIGS. 15 and 22, a laterally extending cross-arm member 104 is detachably connected between the support members 125, 125 corresponding to the pair of left and right screw members 3, 3 respectively. As shown in FIG. 20, the cross-arm member 104 is formed in a plate shape. A through-hole 150 is formed at one longitudinal end of the cross-arm member 104, and a U-shaped groove portion 151 that is U-shaped in plan view with an open other end face is formed along the longitudinal direction with a predetermined length at the other longitudinal end.
[0076] On the lower surface of the cross-arm member 104 and around the through-hole 150, a chrysanthemum seat 154 is formed in which uneven portions 153 having a triangular cross-section along the circumferential direction are formed. Also, on the lower surface of the cross-arm member 104 and around its U-shaped groove portion 151, uneven portions 156 having a triangular cross-section along its longitudinal direction are continuously formed. Referring to FIG. 15, the cross-arm member 104 connecting between the support members 125, 125 corresponding to the pair of left and right screw members 3, 3 on the head side is set to be shorter in length than the cross-arm member 104 connecting between the support members 125, 125 corresponding to the pair of left and right screw members 3, 3 on the tail side.
[0077] Then, referring to FIG. 15, the through-holes 150, 150 (see FIG. 20) of the cross-arm members 104, 104 are respectively inserted into the male screw portions 140, 140 of the support members 125, 125 corresponding to the pair of right and left screw members 3, 3 in the head-tail direction, and the wing nuts 141, 141 are respectively screwed thereon. On the other hand, the U-shaped groove portions 151, 151 (see FIG. 20) of the cross-arm members 104, 104 are inserted into the male screw portions 140, 140 of the support members 125, 125 corresponding to the pair of left and right screw members 3, 3 in the head-tail direction on the left side, and the wing nuts 141, 141 are respectively screwed thereon.
[0078] Accordingly, at the stage of temporarily fixing each wing nut 141, the lateral arm member 104 is configured to be rotatable with respect to the male screw portion 140 in the through hole 150. Also, at the stage of temporarily fixing each wing nut 141, the male screw portion 140 is movable longitudinally within the U-shaped groove portion 151 of the lateral arm member 104, and the distance between the male screw portions 140, 140 (support members 125, 125) corresponding to the left and right pair of screw members 3, 3 respectively, corresponding to the length of the U-shaped groove portion 151 of the lateral arm member 104, can be arbitrarily changed.
[0079] Thereafter, when each wing nut 141 is fully tightened, the lateral arm member 104 is firmly clamped between the support members 125, and the washer 154 around the through hole 150 and the washer 144 on the cylindrical portion 139 around each male screw portion 140 mesh with each other on the lower surface of the lateral arm member 104, so that the circumferential position of the lateral arm member 104 with respect to the male screw portion 140 is firmly constrained. Also, the uneven portion 156 around the U-shaped groove portion 151 and the uneven portion 146 on the cylindrical portion 139 around the male screw portion 140 mesh with each other on the lower surface of the lateral arm member 104, so that the position of the lateral arm member 104 along its longitudinal direction with respect to the male screw portion 140 is firmly constrained, and the distance between the male screw portions 140, 140 is appropriately determined.
[0080] Also, as shown in FIGS. 15, 23, and 24, a rack and pinion unit 160 for applying a compressive load or a tensile load to each vertebral body along the head-tail direction is detachably mounted on the support shaft portions 136, 136 provided on the fitting portions 132, 132 of the grip members 130, 130 corresponding to the pair of screw members 3, 3 in the head-tail direction respectively. Referring also to FIG. 21, the rack and pinion unit 160 includes a pair of hook portions 161, 161 engaged so as to be hooked on the support shaft portions 136, 136 corresponding to the pair of screw members 3, 3 in the head-tail direction respectively, a pair of L-shaped shaft portions 102, 102 integrally extending upward from the respective hook portions 161, 161, and a rack and pinion body 163 connected to the upper ends of the pair of L-shaped shaft portions 102, 102 respectively.
[0081] The rack and pinion body 163 includes a rack 168 extending along the head-tail direction from the upper end of one of a pair of L-shaped shaft portions 102, 102, a main body portion 169 integrally connected to the upper portion of the other L-shaped shaft portion 102 and incorporating a pinion meshing with the rack 168 extending from the upper end of one of the L-shaped shaft portions 102, and a rotary knob 170 protruding from the side surface of the main body portion 169, connected to the pinion, and rotatably supported by the main body portion 169.
[0082] In the rack and pinion unit 160, by rotating the rotary knob 170 of the rack and pinion body 163, the main body portion 169 including the hook portion 161 and the L-shaped shaft portion 102 moves along the rack 168 and can be fixed at an arbitrary position. Thereby, by hooking the pair of hook portions 161, 161 of the rack and pinion unit 160 to the support shaft portions 136, 136 corresponding to the pair of screw members 3, 3 in the head-tail direction respectively and rotating the rotary knob 170, the pair of screw members 3, 3 in the head-tail direction can be moved closer or farther apart, and thus, a compressive load or a tensile load can be applied to the pair of tapered bodies into which the pair of screw members 3, 3 in the head-tail direction are screwed.
[0083] Two rack and pinion units 160 are prepared. The pair of hook portions 161, 161 of one rack and pinion unit 160 shown in FIG. 21 have their open sides facing outward from each other. Also, the pair of hook portions 161, 161 of the other rack and pinion unit 160 have their open sides facing inward from each other. The rack and pinion unit 160 corresponds to the vertical arm member.
[0084] Next, when correcting and fixing spinal deformities with the spinal deformity correction and fixation system 2, a method of assisting the correction and fixation by the spinal deformity correction and fixation system 2 while correcting spinal deformities by an external operation using the external corrector 1B according to the second embodiment will be described with reference to FIGS. 22 to 24 and appropriately referring to other figures as well. First, in spinal deformities such as scoliosis, for each vertebra within the correction and fixation range of the spinal deformity (for example, in the range of lumbar vertebrae L2 - L5), using a dedicated surgical instrument, such as a screw driver, as shown in FIG. 2, screw members 3, 3 are respectively screwed into the vertebral body from the rear of the spine through a pair of left and right pedicles of the vertebra. Regarding FIGS. 14, 15, 22 - 24, except for the pair of left and right screw members 3, 3 arranged at the most cephalic and the most caudal positions, the illustration of the screw members 3, 3 in between is omitted. Subsequently, connector members 100, 100 are respectively attached to all the screw members 3, 3. Since the method of attaching the connector member 100 to the rod receiving portion 11 of the screw member 3 has been described above, the description here is omitted.
[0085] Next, four shaft members 103, 103 (see FIG. 18) including support members 125, 125 are prepared. Then, as shown in FIG. 22, for the pair of left and right screw members 3, 3 at the most cephalic position, the restraint shaft portions 120, 120 of the shaft members 103, 103 are accommodated in the groove portions 114, 114 of the member restraint portions 113, 113 of the connector members 100, 100 and fixed with set screws 29, 29. Also, for the pair of left and right screw members 3, 3 at the most caudal position, the restraint shaft portions 120, 120 of the shaft members 103, 103 are accommodated in the groove portions 114, 114 of the member restraint portions 113, 113 of the connector members 100, 100 and fixed with set screws 29, 29. In FIG. 15, the illustration of the set screw 29 is omitted.
[0086] At this time, a pair of annular stopper portions 122, 122 of the restraint shaft portion 120 are arranged so as to sandwich the member restraint portion 113 of the connector member 100 from the head-tail direction. Then, the main shaft portions 121, 121 that continuously extend from the restraint shaft portions 120, 120 of the respective shaft members 103, 103 (four in total) extend upward and are positioned outside the body. Further, each shaft member 103 is supported so as not to be relatively movable along the head-tail direction and the left-right direction with respect to the connector member 100. Also, referring to FIG. 15, the support members 125, 125 corresponding to the pair of left and right screw members 3, 3 located on the head side both extend toward the tail side. On the other hand, the support members 125, 125 corresponding to the pair of left and right screw members 3, 3 located on the tail side both extend toward the head side. Further, the support groove portions 127 of each support member 125 extend along the left-right direction.
[0087] Next, prepare two horizontal arm members 104, 104 (see FIG. 20). The horizontal arm members 104 extending in the left-right direction are detachably connected to the male screw portions 140, 140 of the support members 125, 125 corresponding to the pair of left and right screw members 3, 3 respectively. Specifically, referring to FIG. 15, the through holes 150, 150 (see FIG. 20) of the horizontal arm members 104, 104 are respectively inserted into the male screw portions 140, 140 of the support members 125, 125 corresponding to the pair of left and right screw members 3, 3 in the head-tail direction on the right side, and wing nuts 141, 141 are respectively screwed onto the respective male screw portions 140, 140. On the other hand, the U-shaped groove portions 151, 151 (see FIG. 20) of the horizontal arm members 104, 104 are inserted into the male screw portions 140, 140 of the support members 125, 125 corresponding to the pair of left and right screw members 3, 3 in the head-tail direction on the left side, and wing nuts 141, 141 are respectively screwed onto the respective male screw portions 140, 140.
[0088] When the wing nut 141 is temporarily fixed, the lateral arm member 104 is configured to be rotatable relative to the male screw portion 140 within the through hole 150. Also, when the wing nut 141 is temporarily fixed, the male screw portion 140 is movable longitudinally within the U-shaped groove portion 151 of the lateral arm member 104, and the distance between the male screw portions 140, 140 (support members 125, 125) corresponding to the pair of left and right screw members 3, 3 respectively, corresponding to the length of the U-shaped groove portion 151 of the lateral arm member 104, can be arbitrarily changed.
[0089] Next, the operator (including the assistant) refers to FIG. 15 to determine the circumferential position of the lateral arm member 104 with respect to the male screw portions 140, 140 corresponding to the pair of right-sided screw members 3, 3 in the cranio-caudal direction, and to determine the distance between the male screw portions 140, 140 corresponding to the pair of left and right screws 3, 3 on the cranial and caudal sides, respectively, the longitudinal positions of the lateral arm members 104, 104 with respect to the male screw portions 140, 140 corresponding to the pair of left-sided screw members 3, 3 in the cranio-caudal direction are determined, and the wing nuts 141, 141 are fully tightened.
[0090] Thereby, the lateral arm member 104 is firmly clamped between the support member 125, and the washer 153 around the through hole 150 on the lower surface of the lateral arm member 104 and the washer 144 on the cylindrical portion 139 around each male screw portion 140 engage with each other, so that the circumferential position of the lateral arm member 104 with respect to the male screw portion 140 is firmly constrained. Also, the uneven portion 156 around the U-shaped groove portion 151 provided on the lower surface of the lateral arm member 104 and the uneven portion 146 on the cylindrical portion 139 around the male screw portion 140 engage with each other, so that the position along the longitudinal direction of the lateral arm member 104 with respect to the male screw portion 140 is firmly constrained, and the distance between the male screw portions 140, 140 is appropriately determined.
[0091] Next, prepare four grip members 130 (see FIG. 19). Then, referring to FIG. 23, the rectangular parallelepiped-shaped fitting portions 132, 132 of the grip members 130, 130 are respectively fitted into the support groove portions 127, 127 corresponding to the respective screw members 3, 3. Then, the grips 131 of each grip member 130 extend outward from the patient in a direction orthogonal to the support member 125. In this state, referring also to FIG. 15, the distance between the tips of the grips 131, 131 of the grip members 130, 130 corresponding to the pair of right and left craniocaudal screw members 3, 3 is larger than the distance between the tips of the grips 131, 131 of the grip members 130, 130 corresponding to the pair of left and right craniocaudal screw members 3, 3 on the left side and is in an open state. Further, when the fitting portion 132 of the grip member 130 is fitted into the support groove portion 127 of the support member 125, the pair of protruding portions 137, 137 of the fitting portion 132 respectively abut against the wall surface around the support groove portion 127, so that the grip member 130 (fitting portion 132) is supported by the support member 125 so as not to be relatively movable along the left-right direction and the craniocaudal direction.
[0092] And as a basic correction, the operator (including the assistant) holds the grips 131 of each grip member 130 and corrects so that the vertebra supported by the pair of left and right caudal screw members 3, 3 and the vertebra supported by the pair of left and right cranial screw members 3, 3 are located on the normal approximate axis of the spinal column, that is, so as to adjust the balance of the patient's trunk in the left-right direction. In the present embodiment, after tightening each wing nut 141, it is basic to hold the grips 131, 131 of the grip members 130 and perform the correction operation as described above. However, without tightening each wing nut 141 and in a temporarily fixed state, the operator (including the assistant) holds each grip member 130 and arbitrarily operates it outside the body, so that a compressive load or a tensile load along the craniocaudal direction according to the intention of the operator can be applied to a plurality of vertebrae, and various corrections such as rotational correction can be performed. Moreover, since the respective shaft members 103, 103 and the horizontal arm member 104 are arranged outside the body and are operated outside the body to correct spinal deformity, the correction force can be improved.
[0093] Next, prepare two rack and pinion units 160, 160 (see FIG. 21). Then, referring to FIG. 24, attach the rack and pinion units 160 to the support shaft portions 136, 136 corresponding to the pair of screws 3, 3 in the head and tail directions, respectively. Specifically, attach the pair of hook portions 161, 161 of the rack and pinion unit 160 to the support shaft portions 136, 136 corresponding to the pair of screws 3, 3 in the head and tail directions, respectively, by hooking them.
[0094] Referring also to FIG. 15, the pair of hook portions 161, 161 of one of the rack and pinion units 160 shown in FIG. 21 are attached to the support shaft portions 136, 136 corresponding to the pair of left - hand head - tail direction screw members 3, 3 so as to be hooked from the inside along the head and tail direction. On the other hand, the pair of hook portions 161, 161 of the other rack and pinion unit 160 are attached to the support shaft portions 136, 136 corresponding to the pair of right - hand head - tail direction screw members 3, 3 so as to be hooked from the outside along the head and tail direction. Then, the correction range for spinal deformity can be held in block units by the respective shaft members (all 4), the respective cross - arm members 104 (all 2), and the racks 168 (all 2) of the respective rack and pinion units 160.
[0095] Further, in the present embodiment, referring to FIGS. 15 and 24, in the rack and pinion unit 160 attached to the support shaft portions 136, 136 corresponding to the pair of left - hand head - tail direction screw members 3, 3, its main body portion 169 is located on the tail side. Also, in the rack and pinion unit 160 attached to the support shaft portions 136, 136 corresponding to the pair of right - hand head - tail direction screw members 3, 3, its main body portion 169 is located on the head side.
[0096] Next, while an operator (including an assistant) etc. operates the grips 131, 131 of the respective grip members 130, 130 corresponding to the pair of right-sided cranial-caudal direction screw members 3, 3 so as to be close to each other, the rotation knob 170 of the main body portion 169 of the rack and pinion unit 160 corresponding to the pair of right-sided cranial-caudal direction screw members 3, 3 is rotated, the pair of right-sided cranial-caudal direction screw members 3, 3 are brought close to each other, and thus, a compressive load is applied to the pair of vertebrae (one pedicle site) into which the pair of right-sided cranial-caudal direction screw members 3, 3 are screwed.
[0097] Also, at substantially the same time as this, while operating the grips 131, 131 of the respective grip members 130, 130 corresponding to the pair of left-sided cranial-caudal direction screw members 3, 3 so as to be separated from each other, the rotation knob 170 of the main body portion 169 of the rack and pinion unit 160 corresponding to the pair of left-sided cranial-caudal direction screw members 3, 3 is rotated, the pair of left-sided cranial-caudal direction screw members 3, 3 are separated from each other, and thus, a tensile load is applied to the pair of vertebrae (the other pedicle site) into which the pair of left-sided cranial-caudal direction screw members 3, 3 are screwed. Thereby, the lateral curvature deformation including torsion can be corrected with a large correction force for each vertebra within the correction and fixation range of the spinal deformity.
[0098] Then, while maintaining the state after correcting the spinal deformity by the external corrector 1B according to the second embodiment, with reference to FIG. 2, as the spinal deformity correction and fixation system 2, the rod members 5, 5 are engaged with the groove portions 10, 10 of the rod receiving portions 11, 11 of all the screw members 3, 3 and fixed by the set screws 20, 20.
[0099] In addition, in the present embodiment, each wing nut 141 is fully tightened immediately before fitting the fitting portion 132 of the grip member 130 into the support groove portion 127 of the support member 125, and then corrected to adjust the patient's trunk balance in the left - right direction. However, not limited to this embodiment, immediately before fitting the fitting portion 132 of the grip member 130 into the support groove portion 127 of the support member 125, the wing nut 141 is temporarily fixed to make the movement of the wing nut 141 relative to the male screw portion 140 of the lateral arm member 104 free. Then, the rack - and - pinion unit 160 is respectively attached to a pair of support shaft portions 136, 136 in the cranio - caudal direction. By the rack - and - pinion unit 160, a compressive load or a tensile load is applied to a pair of vertebrae in the cranio - caudal direction to correct the scoliosis deformation, and then each wing nut 141 may be fully tightened. In short, the timing of fully tightening each wing nut 141 can be changed according to various factors such as the degree of scoliosis deformation and the size of the correction range.
[0100] As described above, in the external orthosis 1B according to the second embodiment, it includes left and right pair of screw members 3, 3 that are detachably attached to one vertebra respectively, shaft members 103, 103 that extend toward the outside of the patient's body, and a lateral arm member 104 that is connected outside the patient's body to the left and right pair of shaft members 103, 103 and extends in the left - right direction. Thus, similar to the external orthosis 1A according to the first embodiment, by gripping the grips 131, 131 of the respective grip members 130, 130 and individually operating them outside the body, for a plurality of vertebrae, corrections such as applying a compressive load or a tensile load along the cranio - caudal direction according to the intention of the operator, and rotational correction, and all kinds of corrections can be performed.
[0101] In addition, in the external orthosis 1B according to the second embodiment, rack and pinion units 160, 160, which are a pair of longitudinal arm members that are connected outside the patient's body to adjacent shaft members 103, 103 along the cranio-caudal direction and extend substantially along the cranio-caudal direction, are provided. Thereby, similar to the external orthosis 1A according to the first embodiment, each of these shaft members 103, 103, each of the transverse arm members 104, 104, and the rack and pinion units 160, 160 as the longitudinal arm members can hold the correction range for spinal deformity in block units.
[0102] Then, from the state where the correction range is held, for example, the operator (including an assistant) operates while gripping the grips 131, 131 of the grip members 130, 130 connected to the shaft members 103, 103 (for example, four shaft members 103, 103) outside the body, and by operating the pair of rack and pinion units 160, 160, while further correcting the left-right position of the entire spine so as to further adjust the left-right balance of the patient's trunk, scoliosis deformation including torsion can be corrected as a spinal deformity with a large correction force.
[0103] Furthermore, in the external orthosis 1B according to the second embodiment, a rack and pinion unit 160 is adopted as the longitudinal arm member. Thereby, by rotating the rotation knob 170 of the rack and pinion unit 160, it is possible to easily apply a compressive load or a tensile load to a pair of vertebral bodies (each pedicle site) into which the pair of screw members 3, 3 in the cranio-caudal direction are screwed, and the operability can be improved.
[0104] Note that also in the external orthosis 1B according to the second embodiment, the shaft member 103 is detachably attached to the rod receiving portion 11 of the screw member 3 via the connector member 100, but it may be configured to be directly attached to the rod receiving portion 11 of the screw member 3.
Explanation of Reference Numerals
[0105] 1A and 1B external orthosis, 2 spinal deformity correction and fixation system, 3 screw member (vertebral fixator), 5 rod member, 18 and 103 shaft members, 19 and 104 transverse arm members, 57 longitudinal arm member, 83 bridge member, 95 height adjustment means, 160 rack and pinion unit (longitudinal arm member)
Claims
1. When correcting and fixing spinal deformities with a spinal deformity correction and fixation system comprising vertebral fixators respectively fixed to each vertebra of the spine and rod members connected to the vertebral fixators, an external corrector for correcting the spinal deformity by an operation from outside the body and assisting the correction and fixation by the spinal deformity correction and fixation system, the vertebral fixators are provided in a pair on the left and right for one vertebra, the external corrector, is detachably attached to each of the pair of left and right vertebral fixators fixed to the one vertebra, and includes a pair of left and right shaft members extending toward the outside of the patient's body, and a horizontal arm member connected to the pair of left and right shaft members outside the patient's body and extending in the left-right direction, the pair of left and right shaft members and the horizontal arm member are respectively provided for a plurality of vertebrae along the cranial-caudal direction, and includes a pair of longitudinal arm members connected outside the patient's body to adjacent shaft members along the cranial-caudal direction and extending substantially along the cranial-caudal direction, wherein the longitudinal arm member is configured to be extendable and retractable along the longitudinal direction and fixable to an arbitrary length, and is characterized by the external corrector.
2. When correcting and fixing spinal deformities with a spinal deformity correction and fixation system comprising vertebral fixators respectively fixed to each vertebra of the spine and rod members connected to the vertebral fixators, an external corrector for correcting the spinal deformity by an operation from outside the body and assisting the correction and fixation by the spinal deformity correction and fixation system, the vertebral fixators are provided in a pair on the left and right for one vertebra, the external corrector, is detachably attached to each of the pair of left and right vertebral fixators fixed to the one vertebra, and includes a pair of left and right shaft members extending toward the outside of the patient's body, and a horizontal arm member connected to the pair of left and right shaft members outside the patient's body and extending in the left-right direction, the pair of left and right shaft members and the horizontal arm member are respectively provided for a plurality of vertebrae along the cranial-caudal direction, and includes a pair of longitudinal arm members connected outside the patient's body to adjacent shaft members along the cranial-caudal direction and extending substantially along the cranial-caudal direction, wherein the longitudinal arm member is characterized by being constituted by a rack and pinion unit and is an external corrector.
3. When correcting and fixing spinal deformities with a spinal deformity correction and fixation system including vertebral fixators respectively fixed to each vertebra of the spine and rod members connected to the vertebral fixators, an external corrector that corrects the spinal deformity by an operation from outside the body and assists the correction and fixation by the spinal deformity correction and fixation system, the vertebral fixators are provided in a pair on the left and right with respect to one vertebra, the external corrector, is detachably attached to a pair of left and right vertebral fixators fixed to the one vertebra, and includes a pair of left and right shaft members extending toward the outside of the patient's body, and a horizontal arm member connected outside the patient's body to the pair of left and right shaft members and extending in the left-right direction, the pair of left and right shaft members and the horizontal arm member are respectively provided for a plurality of vertebrae along the cranio-caudal direction, and includes a pair of vertical arm members connected outside the patient's body to the shaft members adjacent along the cranio-caudal direction and extending substantially along the cranio-caudal direction, and is characterized by including a pair of bridge members installed on the horizontal arm members adjacent along the cranio-caudal direction. An external corrector
4. The external corrector according to claim 3, further comprising height adjustment means capable of freely adjusting the height direction distance between the head of the vertebral fixator and the bridge member.
Citation Information
Patent Citations
Vertebral column implant
JP2012213625A
System and method for performing spinal surgery
JP2014208058A
Detorsion device for the treatment of spinal cord abnormalities
JP2014534009A
Systems and methods for correcting spinal deformities
US20120203279A1
System and methods for correcting spinal deformities
US20130096624A1