WO2015005110A1 - Temporary vertebral immobilization implement and temporary vertebral immobilization implement unit - Google Patents

Abstract

The purpose of the present invention is to provide a temporary vertebral immobilization implement (1), which limits bending of the spinal column and protects nerve tissue when setting a vertebral attachment implement such as a pedicle screw while allowing appropriate insertion of the vertebral attachment implement, and a temporary vertebral immobilization implement unit. To achieve said purpose, this temporary vertebral immobilization implement (1), which temporarily immobilizes vertebrae (50) by clamping long, flexible auxiliary vertebral immobilization members (40) when the auxiliary vertebral immobilization members (40) are disposed along the spiny processes (51) of multiple vertebrae (50), is provided with: a clamping section for clamping the auxiliary vertebral immobilization members (40); a fixing section for fixing the relative movement of the clamping section; and a releasing section for releasing the fixation of the relative movement by the fixing section.

Description

Spinal temporary fixation device and spinal temporary fixation device unit

The present invention relates to a temporary spine fixation device and a temporary spine fixation device unit, and more particularly, to a temporary spine fixation device and a temporary spine fixation device unit for temporarily fixing a spine during an operation.

Conventionally, spinal fixation devices that are attached to the spine by surgical operation to treat spinal deformities such as spinal diseases with instability and scoliosis are known (for example, Patent Document 1). Some spinal fixation devices use a rod-like member or the like that is substantially parallel to the axis of the spine after correction. Such a spinal fixation device is configured to attach the rod-like member or the like to the spinal column by inserting a spinal attachment such as a pedicle screw into a predetermined portion of the spine, for example.

JP 2000-350731 A

However, when a spinal attachment such as a pedicle screw is inserted into the spinal column, it may be displaced from a predetermined appropriate place. If the insertion position of such a spinal attachment deviates from the proper position, it can sometimes cause serious complications. It can also damage large blood vessels and nerve tissue. In recent years, navigation systems that can numerically calculate coordinates such as the spine position of a patient to be operated and confirm the position during the operation have become available. Although the use of such a navigation system has improved the accuracy of insertion of the spinal fixture into the spinal column, the risk of shifting the insertion position still remains. One reason for shifting the insertion position of the spinal attachment is that the spinal column may bend due to force applied to the spine when a puncture entrance such as a screw hole for inserting the spinal attachment is formed in the spine. Can be mentioned. When the spinal column is bent during the operation, the spine may be displaced from the originally planned position, and the insertion position of the spinal attachment may be shifted. Also, spinal flexion that occurs during a screw insertion operation can cause nerve damage during surgery if instability and compression factors on nerve tissue coexist.

In view of the above, when installing a spinal attachment such as a pedicle screw, the present invention can appropriately insert the spinal attachment while suppressing the bending of the spinal column and protecting the nerve tissue. An object is to provide a temporary fixation device and a spinal temporary fixation device unit.

In order to achieve the above object, a spinal fixation device according to the present invention is a spinal fixation auxiliary member that is formed in a long shape and has flexibility, and is arranged along the spinous processes of a plurality of spines. A spinal temporary fixation device for temporarily fixing a spine by clamping a spinal fixation auxiliary member, a clamping part for clamping the spine fixation auxiliary member, a fixing part for fixing relative movement of the clamping part, and a fixing part And a release unit that releases the fixed relative movement.

“Temporary fixing” refers to fixing performed temporarily or in the short term. For example, “temporary fixing” includes fixing in which a fixed state is set only during surgery and the fixed state is released before the end of surgery. *

According to the spinal cord temporary fixation device according to the present invention, since the relative movement of the holding portion can be fixed by the fixing portion, a plurality of spines can be temporarily fixed integrally through the spinal fixation auxiliary member, and the spinal column is bent. Can be suppressed. Therefore, when installing a spinal attachment such as a pedicle screw, the spinal attachment can be properly inserted while suppressing the bending of the spinal column and protecting the nerve tissue. Moreover, since the temporary spinal fixation device according to the present invention includes the release portion, the fixation of the relative movement of the holding portion can be released, so that the temporary spinal fixation device can be quickly and easily removed during the operation.

For example, the sandwiching part includes a pair of sandwiching pieces provided to be openable and closable, and the fixing part is configured to fix the relative movement of the pair of sandwiching pieces. As a result, the distance between the pair of clamping pieces does not change after the temporary spinal fixation device is attached, so that the clamping force of the temporary spinal fixation device weakens and comes off from the spinal fixation auxiliary member. It is possible to prevent the clamping force applied from becoming too strong.

The sandwiching portion may further include a rotation shaft, and the pair of sandwiching piece portions may be coupled to each other so as to be rotatable about the rotation shaft. Thereby, a pair of clamping piece part can be opened and closed easily.

For example, it further includes a pair of handle portions that are formed integrally with each of the pair of sandwiching piece portions and open and close the pair of sandwiching piece portions. Thereby, the distance between a pair of clamping piece parts can be adjusted easily.

As an example, the fixing portion includes an insertion hole formed in one of the pair of handle portions, and a long fixing portion main body that extends from the other of the pair of handle portions and is inserted into the insertion hole. The main body is fixed to one of the pair of handle portions while being inserted through the insertion hole. Thereby, the distance between a pair of handle parts can be kept constant, and therefore the distance between the pair of sandwiching pieces can be kept constant.

A plurality of claw portions may be formed on the fixing portion main body, and a locking portion that locks the claw portion may be formed on the inner surface of the insertion hole. Thereby, a fixing | fixed part main body can be more reliably fixed to one handle part.

As another example, the fixed portion includes an advancing / retreating shaft portion provided so as to be able to advance / retreat between a pair of handle portions, and an abutting member provided at a distal end portion of the advancing / retreating shaft portion and contacting the pair of handle portions . Thereby, the distance between a pair of clamping piece parts can be adjusted by adjusting the advance / retreat position of the advance / retreat shaft part.

The fixed portion further includes a support portion that supports the advance / retreat shaft portion, and the support portion includes a through-hole having an internal thread formed on the inner peripheral surface, and an advance / retreat shaft portion having an external thread formed on the outer peripheral surface. You may comprise so that it may penetrate through a through-hole. Thereby, the advance / retreat position of the advance / retreat shaft portion can be easily changed by rotating the advance / retreat shaft portion.

A plurality of long grooves may be formed on the clamping surface of the clamping part. Thereby, the auxiliary member for spinal fixation can be clamped more stably.

The tip portions of the pair of sandwiching pieces may be bent inward from each other. Thereby, the clamping state of the auxiliary member for spinal fixation can be further stabilized.

A temporary spinal fixation device unit according to the present invention includes the above-described temporary spinal fixation device and an auxiliary member for spinal fixation. Thus, when installing a spinal attachment such as a pedicle screw, a spinal fixation device unit that can properly insert the spine attachment while suppressing the bending of the spinal column and protecting the nerve tissue is provided. Realize.

For example, the spinal fixation auxiliary member is a pair of flexible elongated members, and the spinal fixation auxiliary member has a spinous process positioned between one elongated member and the other elongated member. In this way, the spinal process is performed along the spinous process, and the temporary spinal fixation device holds the pair of elongated members together with the spinous process in between. As a result, the spinal fixation auxiliary member can be arranged along the spinous process more easily, and the spine can be temporarily fixed more reliably.

According to the present invention, since the relative movement of the sandwiching portion can be fixed by the fixing portion, a plurality of vertebrae can be temporarily fixed integrally via the spinal fixation auxiliary member, and bending of the spinal column can be suppressed. . Therefore, when installing a spinal attachment such as a pedicle screw, the spinal attachment can be properly inserted while suppressing the bending of the spinal column and protecting the nerve tissue.

It is a perspective view of the spinal cord temporary fixation device concerning a 1st embodiment. It is a perspective view of the spinal cord temporary fixation device concerning a 1st embodiment. It is an enlarged view of the fixing | fixed part and handle part in the spinal cord temporary fixing instrument which concerns on 1st Embodiment. It is a top view of the auxiliary member for spinal fixation concerning a 1st embodiment. It is a use condition figure of the spinal cord temporary fixation device concerning a 1st embodiment. It is a use condition figure of the spinal cord temporary fixation device concerning a 1st embodiment. It is a schematic diagram which shows typically the insertion to the spine of a spine attachment tool. It is a perspective view of the spinal cord temporary fixation instrument concerning 2nd Embodiment. It is a perspective view of the spinal cord temporary fixation instrument concerning 2nd Embodiment. It is a use condition figure of the spinal cord temporary fixation device concerning a 2nd embodiment.

[First Embodiment]
Embodiments of the present invention will be described below with reference to the accompanying drawings. 1 and 2 are perspective views of the spinal temporary fixation device 1 according to the first embodiment. As shown in FIGS. 1 and 2, the temporary spinal fixation device 1 is provided with a holding part 2 that can be opened and closed, and a fixing part 3 that fixes the relative movement of the holding part 2. In the present embodiment, since the fixing portion 3 has a release function for releasing the fixation of the relative movement of the clamping portion 2, the fixing portion 3 also serves as the releasing portion.

The clamping part 2 includes a clamping part rotating shaft 5, a first clamping piece part 2a, and a second clamping piece part 2b. The 1st clamping piece part 2a and the 2nd clamping piece part 2b are connected mutually rotatably centering | focusing on the clamping part rotating shaft 5. As shown in FIG. The first clamping piece 2a and the second clamping piece 2b are closed by rotating in the direction A1 approaching each other about the clamping unit rotation shaft 5, and opened by rotating in the direction B1 away from each other. It becomes a state. Note that the closed state and the open state are relatively determined, and the closed state is not limited to a state in which the first sandwiching piece 2a and the second sandwiching piece 2b are in contact with each other. .

A spring 6 is attached to the sandwiching portion rotating shaft 5, and the spring 6 applies a force to the temporary spinal fixation device 1 so that the first sandwiching piece portion 2 a and the second sandwiching piece portion 2 b approach each other. Yes.

The spine temporary fixation device 1 is further provided with a handle portion 7 for opening and closing the clamping portion 2. The handle portion 7 includes a first handle portion 7a formed integrally with the first holding piece portion 2a and a second handle portion 7b formed integrally with the second holding piece portion 2b. Has been. The 1st clamping unit 8a comprised from the 1st clamping piece part 2a and the 1st handle part 7a, and the 2nd clamping unit 8b comprised from the 2nd clamping piece part 2b and the 2nd handle part 7b Are connected to each other on the clamping unit rotating shaft 5. The first clamping piece portion 2a and the second clamping piece portion 2b, and the first handle portion 7a and the second handle portion 7b extend radially outward from the clamping portion rotating shaft 5.

As shown in FIG. 1, the first handle portion 7 a and the second handle portion 7 b rotate and move in a direction A <b> 2 approaching each other about the sandwiching portion rotation shaft 5, so that the first sandwiching piece portion 2 a and the second handle portion 7 b The two clamping pieces 2b are rotated and moved in the direction A1 approaching each other. Further, as shown in FIG. 2, the first handle portion 7a and the second handle portion 7b rotate and move in the direction B2 away from each other about the sandwiching portion rotating shaft 5, whereby the first sandwiching piece portion 2a. And the second holding piece 2b are rotated in the direction B1 away from each other.

The first sandwiching piece 2a and the second sandwiching piece 2b include inner side surfaces 10a and 10b formed on surfaces facing each other, and front side surface 12a connected perpendicularly to the inner side surfaces 10a and 10b, 12b and back side surfaces 13a and 13b, and front side surfaces 12a and 12b and back side surfaces 13a and 13b and outer side surfaces 11a and 11b connected perpendicularly. The front side surfaces 12a and 12b are thinner at least partially from the clamping part rotating shaft 5 toward the tip parts 15a and 15b of the first and second clamping piece parts 2a and 2b. Since the back side surface 13a has the same configuration as the front side surface 12b and the back side surface 13b has the same configuration as the front side surface 12a, the description thereof is omitted.

The inner surface 10a, the outer surface 11a, and the rear side surface 13a of the first sandwiching piece 2a, and the inner surface 10b, the outer surface 11b, and the front side surface 12b of the second sandwiching piece 2b are first sandwiched. Connection notches 14a and 14b for connecting the unit 8a and the second holding unit 8b rotatably via the holding part rotating shaft 5 are formed.

The front end portions 15a and 15b of the first holding piece portion 2a and the second holding piece portion 2b are bent inward from each other. A plurality of long grooves 16a and 16b are formed in the inner side surfaces 10a and 10b of the bent end portions 15a and 15b. The long grooves 16a and 16b extend in the axial direction of the sandwiching portion rotating shaft 5, and a plurality of long grooves 16a and 16b are continuously provided from the distal ends of the first and second sandwiching piece portions 2a and 2b toward the proximal end. In addition, the axial direction of the clamping part rotating shaft 5 is the thickness direction of the first and second clamping piece parts 2a and 2b, and is the installation direction when a plurality of the spinal temporary fixation devices 1 are installed.

The first handle portion 7a and the second handle portion 7b include inner side surfaces 17a and 17b formed on surfaces facing each other, front side surfaces 19a and 19b vertically connected to the inner side surfaces 17a and 17b, and Back side surfaces 20a and 20b, and front side surfaces 19a and 19b and outer side surfaces 18a and 18b connected perpendicularly to the back side surfaces 20a and 20b are provided.

The front side surfaces 19a and 19b are thinner at least partially from the clamping portion rotating shaft 5 toward the tip portions 21a and 21b of the first and second handle portions 7a and 7b. Since the back side surface 20a has the same configuration as the front side surface 19b and the back side surface 20b has the same configuration as the front side surface 19a, description thereof is omitted.

At the front end portion 21b of the second handle portion 7b, a fixed portion rotating shaft 22 that allows the fixed portion 3 to rotate is extended from the front side to the back side of the second handle portion 7b. The fixed portion rotating shaft 22 constitutes a part of the fixed portion 3. The fixed portion rotating shaft 22 is provided in parallel with the sandwiching portion rotating shaft 5. In addition, an opening 23 for storing the proximal end of the fixed portion 3 attached to the fixed portion rotating shaft 22 is formed in the distal end portion 21b of the second handle portion 7b. The opening 23 is formed from the distal end surface 25b of the second handle portion 7b toward the sandwiching portion rotating shaft 5 and through the inner side surface 17b and the outer side surface 18b.

An insertion hole 26 through which the distal end of the fixed portion 3 is inserted is formed in the distal end portion 21a of the first handle portion 7a. The insertion hole 26 is formed in a rectangular shape penetrating from the inner side surface 17a to the outer side surface 18a of the first handle portion 7a. Unlike the second handle portion 7b, no opening is formed in the distal end surface 25a of the first handle portion 7a.

The fixing portion 3 includes an insertion hole 26, a fixing portion main body 27, and a leaf spring portion 28 in addition to the fixing portion rotating shaft 22 described above. An enlarged view of the fixing portion 3 and the handle portion 7 is shown in FIG. The fixing portion main body 27 is a long member extending from the second handle portion 7b, and is convex on the outer side O in the radial direction R of the clamping portion rotating shaft 5 and is curved in an arc shape. . That is, the fixed portion main body 27 is on the rotation trajectory of the insertion hole 26 when the first handle portion 7a is rotationally moved with respect to the second handle portion 7b around the sandwiching portion rotation shaft 5 in a front view. Has been arranged.

The base end portion 27b of the fixed portion main body 27 is attached to a fixed portion rotating shaft 22 provided in the second handle portion 7b, and is configured to rotate by the rotation of the fixed portion rotating shaft 22. The distal end portion 27a of the fixing portion main body 27 is inserted through the insertion hole 26 of the first handle portion 7a. With such a configuration, the first and second handle portions 7a and 7b rotate and move about the holding portion rotating shaft 5 with the distal end portion 27a of the fixing portion main body 27 inserted into the insertion hole 26. It has become.

A plurality of claw portions 33 are provided at the distal end portion 27 a of the fixing portion main body 27. The claw portion 33 protrudes from the inner side surface 27 c of the fixed portion main body 27 toward the inner I side in the radial direction R of the clamping portion rotating shaft 5. The claw portion 33 is continuously formed from the distal end portion 27 a of the fixed portion main body 27 toward the proximal end portion 27 b to the vicinity of the center C in the length direction of the fixed portion main body 27.

A locking portion 34 for locking the claw portion 33 is formed on the bottom side inner surface 26 a of the insertion hole 26. The locking portion 34 protrudes from the bottom side inner surface 26 a of the insertion hole 26 to the outer side O in the radial direction R, and the protruding portion enters a recess between adjacent claw portions 33 in the fixing portion main body 27. Thereby, the fixing portion main body 27 can be fixed to the first handle portion 7a. The bottom side inner surface 26a refers to a surface on the inner side I in the radial direction R of the sandwiching portion rotating shaft 5, and in the state where the distal end portion 27a of the fixing portion main body 27 is inserted into the insertion hole 26, The opposite surface.

The distance between the first handle portion 7a and the second handle portion 7b is determined by the position in the length direction of the fixing portion main body 27 at which the claw portion 33 is locked to the locking portion 34. Depending on the distance between the first handle part 7a and the second handle part 7b, the distance between the first holding piece part 2a and the second holding piece part 2b changes. Therefore, in order to maintain the distance between the first and second handle portions 7a, 7b when the desired distance between the first and second sandwiching piece portions 2a, 2b is reached, By selecting the position of the claw portion 33 to be engaged with the engaging portion 34, the first and second sandwiching piece portions 2a and 2b can be fixed in a desired positional relationship.

For example, as shown in FIG. 2, when the claw portion 33 is locked to the locking portion 34 on the distal end side of the distal end portion 27a of the fixed portion main body 27, the first and second handle portions 7a, Accordingly, the distance between the first and second sandwiching pieces 2a and 2b is fixed in a state of being further away from each other. On the other hand, as shown in FIG. 1, when the claw portion 33 is locked to the locking portion on the more proximal side of the distal end portion 27a, between the first and second handle portions 7a and 7b. The distance is shorter than that shown in FIG. 2, and accordingly, the first and second sandwiching piece portions 2a and 2b are fixed in a state of being closer to each other.

As described above, the relative movement of the first and second clamping piece portions 2a and 2b is fixed by locking the claw portion 33 of the fixing portion main body 27 to the locking portion 34 of the insertion hole 26 at a predetermined position. can do.

The leaf spring portion 28 of the fixed portion 3 is a long member having flexibility. The base end portion 30 of the leaf spring portion 28 is fixed to the fixing portion main body 27 at a position closer to the base end side of the fixing portion main body 27 than the center C in the length direction of the fixing portion main body 27. The leaf spring portion 28 is bent in the same direction as that of the fixed portion main body 27 from the base end portion 30 toward the tip end portion 31.

In a state where the fixing portion main body 27 and the leaf spring portion 28 are not inserted into the insertion hole 26, the distal end portion 31 of the leaf spring portion 28 is separated from the distal end portion 27 a of the fixing portion main body 27 by a predetermined distance in the radial direction R. If the distance in the radial direction R from the outer edge 31a of the leaf spring part 28 to the tip 33a of the claw part 33 at the tips of the fixed part body 27 and the leaf spring part 28 is h1 (FIG. 3), In a state where the spring portion 28 is not inserted into the insertion hole 26 of the first handle portion 7a, the distance h1 is larger than the height dimension h2 (FIG. 1) of the insertion hole 26 formed in the first handle portion 7a. large.

When the fixing portion main body 27 and the leaf spring portion 28 are inserted into the insertion hole 26, the leaf spring portion 28 is pushed and elastically deformed toward the fixing portion main body 27, and the tip of the claw portion 33 is extended from the outer edge 31 a of the leaf spring portion 28. The distance h1 up to 33a is made smaller than the height dimension h2 of the insertion hole 26 and inserted.

Since the leaf spring portion 28 inserted through the insertion hole 26 tends to move away from the fixing portion main body 27 due to the elastically deformed restoring force, a force toward the outer side O in the radial direction R is applied to the insertion hole 26. To the ceiling side inner surface 26b. The ceiling side inner side surface 26b refers to a surface facing the bottom side inner side surface 26a. Thereby, the fixing portion main body 27 is pressed toward the inner side I in the radial direction R. Therefore, the nail | claw part 33 and the penetration hole 26 will be in the latched state, and the state is hold | maintained. As a result, the rotational movement of the first and second handle parts 7a, 7b is fixed, and therefore the relative movement of the first and second clamping piece parts 2a, 2b is fixed.

By pushing up the fixing portion main body 27 toward the outer side O in the radial direction R against the restoring force of the leaf spring portion 28, the locking between the claw portion 33 and the locking portion 34 is released. Accordingly, the rotational movement of the first and second handle portions 7a and 7b is released from being fixed, and the relative movement of the first and second holding pieces 2a and 2b is thus released. In the present embodiment, the fixed portion rotating shaft 22, the fixed portion main body 27, the leaf spring portion 28, and the locking portion 34 fix and release the relative movement of the clamping portion 2. When the locking of the claw portion 33 and the locking portion 34 is released, the fixed portion main body 27 and the leaf spring portion 28 can be extracted from the insertion hole 26.

FIG. 4 shows a plan view of the spinal fixation auxiliary member 40. The spinal fixation auxiliary member 40 is a pair of elongated members 40a and 40b having flexibility. In the present embodiment, as the long members 40a and 40b, linear rods that extend linearly are employed. A plurality of fine irregularities 41 are formed on the surfaces of the long members 40a and 40b as slip stoppers.

1 to 3 and the spinal fixation auxiliary member 40 shown in FIG. 4 constitute a spinal temporary fixation device unit. The spinal cord temporary fixation device 1 and the spinal fixation auxiliary member 40 are made of, for example, a titanium alloy.

Fig. 5 and Fig. 6 show the use state of the spinal temporary fixation instrument unit during the operation. FIG. 5 shows a state immediately before the temporary spinal fixation device unit is attached to the patient. First, an incision is made in the patient's back to expose the patient's spine. In FIG. 5, the spine 50 and the spinous process 51 are schematically illustrated. The spinal fixation auxiliary member 40 is installed along the spinous process 51 of the spine 50.

One long member 40 a of the spinal fixation auxiliary member 40 is disposed on one side of the spinous process 51, and the other long member 40 b of the spinal fixation auxiliary member 40 is disposed on the other side of the spinous process 51. To do. That is, the spinal fixation auxiliary member 40 is disposed so that the spinous process 51 is sandwiched from both sides by the pair of elongated members 40a and 40b with the spinous process 51 as the center.

For the spinal cord temporary fixation device 1, the first gripping part 2a and the second gripping part 2b are opened, and the first gripping part 7a and the second gripping part 7b are gripped with fingers. Next, the first and second elongate members 40a and 40b are disposed between the first and second sandwiching piece portions 2a and 2b and the inwardly bent portions of the tip portions 15a and 15b. The second clamping pieces 2a and 2b are moved. In this state, when the first handle portion 7a and the second handle portion 7b are rotated in the direction A2 (FIG. 1) approaching each other by applying force with a finger, the first holding piece portion 2a and the second gripping portion 2a The sandwiching piece 2b rotates and moves in the direction A1 approaching each other, and the pair of long members 40a and 40b are sandwiched. At this time, the claw portion 33 moves in the insertion hole 26 while continuously engaging with the locking portion 34 by the force applied in the direction A2. And when the 1st clamping piece part 2a and the 2nd clamping piece part 2b approach each other further, the force which mutually approaches will be added to a pair of elongate member 40a, 40b. At this time, since the pair of long members 40 a and 40 b have flexibility, the pair of long members 40 a and 40 b is deformed according to the shape and size of the spine 50 and the spinous process 51.

Then, when the rotational movement of the first handle portion 7a and the second handle portion 7b is stopped, the rotational movement of the first sandwiching piece portion 2a and the second sandwiching piece portion 2b is also stopped. At this time, the claw portion 33 and the locking portion 34 are locked by being pressed by the leaf spring portion 28, and this state is maintained. Here, the distance between the 1st clamping piece part 2a and the 2nd clamping piece part 2b is adjusted according to the shape and dimension of the spine 50 and the spinous process 51 for every patient. In FIG. 6, as an example, the pair of long members is used by the spinal cord temporary fixing device 1 in a positional relationship in which the length direction of the pair of long members 40 a and 40 b and the axial direction of the clamping unit rotation shaft 5 are parallel. 40a and 40b are clamped. A plurality of temporary spinal fixation devices 1 are installed as necessary. In the present embodiment, as shown in FIG. 6, as an example, the spinal fixation auxiliary member 40 is held by the three temporary spinal fixation devices 1 via the holding portions 2.

As shown in FIG. 6, a plurality of spinous processes are obtained by holding the spinal fixation auxiliary member 40 with the spinal temporary fixation device 1 in a state where the spinal fixation auxiliary member 40 is disposed along the spinous processes 51 of the spine 50. 51 is fixed via the spinal fixation auxiliary member 40, and the plurality of spines 50 are temporarily fixed integrally.

As described above, in the state where the plurality of spines 50 are temporarily fixed integrally by the temporary spinal fixation device 1 according to the present embodiment, the spinal attachment tool 52 (such as a pedicle screw) of the spinal fixation device (not shown). Is inserted into the spine 50 (to be described later with reference to FIG. 7). A spinal fixation device (not shown) is a device that is attached to the spine by surgical operation to treat spinal deformities such as spinal diseases with instability and scoliosis, and is continuously applied for a certain period after the operation. The spine 50 is fixed in the patient's body. Since the spine 50 is fixed by the temporary spinal fixation device 1 only during the operation performed for insertion of the spine attachment 52, the insertion of the spine attachment 52 into the spine 50 is completed. The spine temporary fixation device 1 and the spinal fixation auxiliary member 40 are removed from the spine 50. At this time, by pushing up the fixing portion main body 27 toward the outer side O in the radial direction R, the locking of the claw portion 33 and the locking portion 34 is released, and the temporary spinal fixation device 1 is removed. Thereafter, the spine fixator (not shown) is attached to the spine 50 by attaching the spine fixator (not shown) to the spine 50 via the spine attachment tool 52.

Here, FIG. 7 schematically shows the insertion of the spine attachment tool 52 when the spine 50 is not temporarily fixed using the spinal cord temporary fixation device 1 according to the present embodiment. As shown in FIG. 7A, when a spinal attachment 52 having a screw portion 52a is to be inserted into the spine 50a, a hole for inserting the screw portion 52a needs to be formed in the spine 50a. Therefore, a strong force is locally applied to the spine 50a. As a result, as shown in FIG. 7B, the spine 50a is pushed downward to move, and the spinal column is bent. As shown in FIG. 7B, the spine 50 is displaced from the originally planned position due to the flexion of the spinal column during the operation, resulting in the insertion position of the spine attachment tool 52 being displaced. May end up.

However, as shown in FIG. 6, even if force is applied to the spine 50 by temporarily fixing a plurality of spines 50 using the temporary spinal fixation device 1 according to the present embodiment, the spine 50 is applied. The force from the fixture 52 can be distributed over the entire spine 50, and the spine can be prevented from bending. Accordingly, it is possible to appropriately insert the spinal attachment tool 52 such as a pedicle screw while protecting the nerve tissue.

As described above, according to the temporary spinal fixation device 1 according to the present embodiment, the relative movement of the sandwiching portion 2 can be fixed by the fixing portion 3, so that the plurality of spines 50 are integrated with each other via the auxiliary member 40 for spinal fixation. It is possible to temporarily fix the spinal column to the spine, and to suppress bending of the spinal column. Therefore, the spinal attachment tool 52 such as a pedicle screw can be properly inserted while protecting the nerve tissue. Moreover, since the temporary spinal fixation device 1 includes the release portion (in this embodiment, also used as the fixation portion 3), the fixation of the relative movement of the clamping portion 2 can be released. It can be removed quickly and easily.

On the other hand, if the pair of long members 40a and 40b of the auxiliary member for spinal fixation 40 is fastened and clamped by a wire or the like instead of being clamped by the spinal cord temporary fixation device 1, the clamping force is adjusted. And release cannot be performed easily.

The clamping part 2 includes first and second clamping piece parts 2a and 2b that are provided so as to be openable and closable, and the fixing part 3 fixes relative movement of the first and second clamping piece parts 2a and 2b. Is configured to do. Thereby, since the distance between the 1st and 2nd clamping piece parts 2a and 2b does not change after attachment of the spinal cord temporary fixation instrument 1, the clamping force of the spinal cord temporary fixation instrument 1 weakens, and it removes from the auxiliary member 40 for spinal fixation. It is possible to prevent the pinching force applied to the spinal fixation auxiliary member 40 from becoming too strong.

The sandwiching portion 2 further includes a sandwiching portion rotating shaft 5, and the first and second sandwiching piece portions 2 a and 2 b are coupled to each other so as to be rotatable around the sandwiching portion rotating shaft 5. Thereby, the 1st and 2nd clamping piece parts 2a and 2b can be opened and closed easily.

The temporary spinal fixation device 1 is formed integrally with each of the first and second sandwiching pieces 2a and 2b, and first and second handles for opening and closing the first and second sandwiching pieces 2a and 2b. Further provided are parts 7a and 7b. Thereby, the distance between the 1st and 2nd clamping piece parts 2a and 2b can be adjusted easily.

The fixing portion 3 includes an insertion hole 26 formed in the first handle portion 7a, and a long fixing portion main body 27 extending from the second handle portion 7b and inserted into the insertion hole 26, and is fixed. The part main body 27 is fixed to the first handle part 7 a in a state of being inserted through the insertion hole 26. Thereby, the distance between the 1st and 2nd handle parts 7a and 7b can be kept constant, therefore, the distance between the 1st and 2nd clamping piece parts 2a and 2b can be kept constant. it can.

A plurality of claw portions 33 are formed in the fixing portion main body 27, and a locking portion 34 that locks the claw portion 33 is formed on the bottom side inner surface 26 a of the insertion hole 26. Thereby, the fixing | fixed part main body 27 can be more reliably fixed to the 1st handle part 7a.

A plurality of long grooves 16a and 16b are formed on the inner side surfaces 10a and 10b (clamping surfaces) of the clamping unit 2. Thereby, the auxiliary member 40 for spinal fixation can be clamped more stably. Also,

The tip portions 15a and 15b of the first and second clamping piece portions 2a and 2b may be bent inward from each other. Thereby, the clamping state of the auxiliary member 40 for spinal fixation can be further stabilized. This is because not only can the spinal fixation auxiliary member 40 be easily held at the bent portion, but also the holding surface area in contact with the spinal fixation auxiliary member 40 can be made larger.

The spinal fixation auxiliary member 40 is a pair of flexible long members 40a and 40b, and the spine fixation auxiliary member 40 is between one long member 40a and the other long member 40b. The spinal process 51 is arranged along the spinous process 51 so that the spinous process 51 is positioned on the spine process 51. The temporary spinal fixation device 1 holds the pair of long members 40a and 40b with the spinous process 51 in between. It is. Accordingly, the spinal fixation auxiliary member 40 can be arranged along the spinous process 51 more easily, and the spine 50 can be temporarily fixed more reliably.

The spinal fixation auxiliary member 40 is flexible. Therefore, when the spinal fixation auxiliary member 40 is appropriately deformed according to the shape and size of the spine 50 and the spinous process 51 for each patient by the clamping force of the spinal temporary fixation device 1, The spine 50 can be appropriately temporarily fixed without the portion being shaved or deformed and without the fixing position of the spine 50 being changed.

On the other hand, if an inflexible member is used as the spinal fixation auxiliary member 40, the spinal fixation auxiliary member 40 is formed in a corrugated shape along the shape of the spinous process 51. However, since the shapes of the spine 50 and the spinous process 51 are different depending on the patient, the pre-formed corrugation may not correspond to the shape of the spine 50 and the spinous process 51 of the patient actually operated. In such a case, if the elongate member having no flexibility is forcibly fixed, the spinous process 51 or other portions of the spine 50 may be scraped or deformed. In addition, the distance between adjacent vertebrae 50 may expand and contract so as to match a pre-formed waveform, and the fixed position of vertebrae 50 may change.

In the present embodiment, the spinal fixation auxiliary member 40 and the temporary spinal fixation device 1 are made of a titanium alloy. Therefore, the spinal fixation auxiliary member 40 and the temporary spinal fixation device 1 can be easily applied to a living tissue, are stable against autoclaving or heat sterilization, and can maintain an appropriate strength. In addition, even when CT or X-ray imaging is performed during surgery, the occurrence of artifacts can be reduced, so that adverse effects on image evaluation in the insertion operation of the spinal attachment 52 can be suppressed.

When the spine attachment 52 is attached in the state where the spine 50 is temporarily fixed by the temporary spinal fixation device 1 according to the present embodiment, coordinates such as the spine position of the patient to be operated on are numerically calculated, and the position is confirmed during the operation. You may confirm the attachment position of the spinal attachment tool 52 using the navigation system which can be performed.

[Second Embodiment]
8 and 9 are perspective views of the spinal temporary fixation device 60 according to the second embodiment. In FIG. 9, the internal structure is clearly shown by virtually showing a part of the configuration shown in FIG. Similar to the spinal temporary fixation device 60 according to the first embodiment, the temporary spinal fixation device 60 is provided with a holding portion 62 that can be opened and closed, and a fixing portion 90 that fixes the relative movement of the holding portion 62. In the present embodiment, since the fixing unit 90 has a release function for releasing the fixation of the relative movement of the clamping unit 62, the fixing unit 90 also serves as the release unit. The clamping part 62 includes a clamping part rotating shaft 65, a first clamping piece part 62a, and a second clamping piece part 62b. The first clamping piece portion 62a and the second clamping piece portion 62b are connected to each other so as to be rotatable about the clamping portion rotation shaft 65, and are configured to be openable and closable as in the first embodiment. The leading ends of the first and second sandwiching piece portions 62a and 62b are bent inward, and a plurality of long grooves 76a and 76b are formed on the sandwiching surface.

A spring (not shown) is attached to the sandwiching portion rotating shaft 65, and the spring exerts a force on the temporary spinal fixation device 60 so that the first sandwiching piece portion 62a and the second sandwiching piece portion 62b are separated from each other. Have joined.

The spinal cord temporary fixing device 60 is further provided with a handle portion 67 for opening and closing the clamping portion 62. Similar to the first embodiment, the handle portion 67 is formed integrally with the first handle portion 67a formed integrally with the first holding piece portion 62a and the second holding piece portion 62b. It consists of a second handle portion 67b.

However, as shown in FIG. 9, from the first clamping unit 68a composed of the first clamping piece portion 62a and the first handle portion 67a, the second clamping piece portion 62b and the second handle portion 67b. The configured second clamping unit 68b does not intersect on the clamping part rotating shaft 65. The first clamping unit 68a is configured in a dogleg shape that bends on the clamping part rotating shaft 65. The second sandwiching unit 68b is formed in the shape of a letter that reverses the first sandwiching unit 68a, and the bent portions are connected by the sandwiching portion rotating shaft 65, respectively. Therefore, when the first handle portion 67a and the second handle portion 67b are brought close to each other, the first holding piece portion 62a and the second holding piece portion 62b are separated, and the first handle portion 67a and the second handle portion 67b are separated. When the is released, the first sandwiching piece 62a and the second sandwiching piece 62b come closer to each other.

As shown in FIG. 8, the fixed portion 90 includes a contact member 91, an advance / retreat shaft portion 92, a handle portion 93, and a support portion 80 that supports the advance / retreat shaft portion 92. In FIG. 9, the support portion 80 is shown transparently for the sake of explanation, and the configuration of the advance / retreat shaft portion 92 and the like is clearly shown. As shown in FIG. 9, the advancing / retreating shaft portion 92 is formed in a cylindrical shape, and is provided between the first handle portion 67a and the second handle portion 67b so as to be able to advance and retract with respect to the sandwiching portion rotating shaft 65. It has been. That is, the advancing / retreating shaft portion 92 can move so as to approach the sandwiching portion rotation shaft 65 and can move away from the sandwiching portion rotation shaft 65. A contact member 91 is provided at one end 92a of the advance / retreat shaft 92, and a handle 93 is fixed to the other end 92b. A male screw 95 is formed on the outer peripheral surface 92c of the advance / retreat shaft portion 92 over the entire circumference.

The abutting member 91 provided at the end portion 92a closer to the sandwiching portion rotating shaft 65 abuts on the inner side surfaces 69a and 69b of the first and second handle portions 67a and 67b. In the present embodiment, the contact member 91 has a substantially spherical shape. The handle portion 93 has a cylindrical shape having a diameter larger than the diameter of the advance / retreat shaft portion 92 in order to make it easier to transmit the rotational force.

Next, the support portion 80 will be described with reference to FIG. As shown in FIG. 8, the support portion 80 supports the advance / retreat shaft portion 92 by storing at least a part of the advance / retreat shaft portion 92 in the internal space S thereof.

The front side wall part 81a and the rear side wall part 81b of the support part 80 are fixed to the clamping part rotating shaft 65 from the outside of the first and second clamping units 68a and 68b. The front side wall 81a and the back side wall 81b face each other and extend in parallel to each other, and an outer wall 82 that is vertically connected to the front side wall 81a and the back side wall 81b between the front side wall 81a and the back side wall 81b. The outer wall 82 constitutes an upper surface 82a and a side surface 82b of the support portion 80.

The internal space S of the advance / retreat shaft portion 92 is defined by the front side wall portion 81 a, the back side wall portion 81 b, and the outer wall 82 of the support portion 80. The front side wall portion 81a and the rear side wall portion 81b are formed with position confirmation openings 84 extending in the length direction from the centers of the respective wall portions 81a and 81b, and the advance / retreat shaft 92 is advanced and retracted from the position confirmation openings 84. The position can be confirmed.

A through hole 83 is provided in the upper surface 82a of the support portion, and the advance / retreat shaft portion 92 is inserted therethrough. A holding unit storage opening 85 is formed in the side surface 82 b of the support portion 80, and ends of the first and second holding units 68 a and 68 b protrude outward from the holding unit storage opening 85.

The structure of the through hole 83 will be described with reference to the support 80 transparently shown in FIG. On the inner peripheral surface 83a of the through hole 83 provided in the upper surface 82a of the support portion 80, a female screw 96 is formed over the entire periphery. In the present embodiment, the through-hole inner wall portion 83 b that defines the through-hole 83 and constitutes the inner peripheral surface 83 a of the through-hole 83 extends from the outer wall 82 that constitutes the upper surface 82 a of the support portion 80 to the sandwiching portion rotating shaft 65. The position confirmation opening 84 and the holding unit storage opening 85 extend to the upper end positions. Therefore, the through hole 83 has a height dimension h3 from the upper surface 82a of the support portion to the upper end position of the position confirmation opening 84 and the holding unit storage opening 85. The opening shape of the through hole 83 is a circular shape having a diameter substantially the same as the diameter of the advance / retreat shaft portion 92.

The male screw 95 formed on the outer peripheral surface 92 c of the advance / retreat shaft portion 92 inserted through the through hole 83 is configured to engage with the female screw 96 formed on the inner peripheral surface 83 a of the through hole 83. When the advance / retreat shaft portion 92 is rotated by rotating the handle portion 93, the position of the advance / retreat shaft portion 92 is changed by the rotation of the male screw 95. The advancing / retreating shaft portion 92 moves so as to approach the clamping portion rotation shaft 65 or away from the clamping portion rotation shaft 65 according to the rotation direction.

By moving the advancing / retreating shaft portion 92 so as to approach the holding portion rotating shaft 65, the first and second handle portions 67a and 67b are gradually pushed and expanded by the contact member 91. The distance between the first and second sandwiching piece portions 62a and 62b becomes smaller. At this time, since the contact member 91 is spherical, the contact member 91 can be uniformly contacted with the first and second handle portions 67a and 67b, and the force for expanding the first and second handle portions 67a and 67b can be obtained. Both the handle portions 67a and 67b can be effectively transmitted in a balanced manner. Further, when the advance / retreat shaft portion 92 moves away from the sandwiching portion rotation shaft 65, the force between the first and second handle portions 67a, 67b is caused by the force of the spring (not shown) described above. The distance is getting smaller. Accordingly, the distance between the first and second sandwiching piece portions 62a and 62b increases.

FIG. 10 shows a use state of the spinal temporary fixation device 60 according to the second embodiment. As in the first embodiment, a pair of elongated members 40a and 40b, which are spinal fixation auxiliary members 40 shown in FIG. 4, are arranged along the spinous processes 51 on both sides of the spinous processes 51 of the spine. Similarly to the first embodiment, the spinal fixation auxiliary member 40 is clamped by the temporary spinal fixation device 60 via the clamping portion 62. At this time, the distance between the first and second clamping piece portions 62a and 62b is adjusted by rotating the handle portion 93 (FIGS. 8 and 9) to adjust the advance / retreat position of the advance / retreat shaft portion 92. . When the advance / retreat position of the advance / retreat shaft portion 92 is determined, the advance / retreat shaft portion 92 is fixed by the engagement of the male screw 95 of the advance / retreat shaft portion 92 and the female screw 96 of the through hole 83, so the first and second clamping pieces The relative movement of the parts 62a and 62b is fixed.

When the spine attachment tool 52 is inserted into the spine 50 with the spine 50 fixed, the temporary spinal fixation device 60 is removed. At this time, the handle portion 93 is rotated to move the advance / retreat shaft portion 92 away from the sandwiching portion rotation shaft 65. As a result, the fixed state of the first and second sandwiching piece portions 62a and 62b is released, the first sandwiching piece portion 62a and the second sandwiching piece portion 62b are separated from each other, and the temporary spinal fixation device 60 is removed. .

The temporary spinal fixation device 60 according to the second embodiment has the same effect as the temporary spinal fixation device 1 according to the first embodiment. In addition, the fixing portion 90 is provided at an advancing / retreating shaft portion 92 provided so as to be able to advance / retreat between the first and second handle portions 67a, 67b, and a tip portion (one end portion 92a) of the advancing / retreating shaft portion 92. And a contact member 91 that contacts the first and second handle portions 67a and 67b. Thereby, the distance between the 1st and 2nd clamping piece parts 62a and 62b can be adjusted by adjusting the advance / retreat position of the advance / retreat shaft part 92.

The fixing portion 90 further includes a support portion 80 that supports the advance / retreat shaft portion 92. The support portion 80 is provided with a through hole 83 in which a female screw 96 is formed on the inner peripheral surface 83a, and a male screw on the outer peripheral surface 92c. The advance / retreat shaft portion 92 formed with 95 is inserted into the through hole 83. Thereby, by rotating the advance / retreat shaft portion 92, the advance / retreat position of the advance / retreat shaft portion 92 can be easily changed.

[Other Embodiments]
Although the embodiments of the present invention have been described above, the present invention is not limited to the above-described embodiments, and various modifications and changes can be made based on the technical idea of the present invention. For example, in the first and second embodiments, the fixing portions 3 and 90 also serve as a release portion, but the present invention is not limited to this. You may comprise a fixing | fixed part and a cancellation | release part by a separate component.

In the spinal cord temporary fixation device 1 according to the first embodiment, the fixing portion main body 27 may have flexibility or may not have flexibility. In the first embodiment, the claw portion 33 is provided on the inner side surface 27 c of the fixing portion main body 27, and the locking portion 34 is provided on the bottom side inner surface 26 a of the insertion hole 26, but is not limited thereto. For example, the locking portion 34 may be formed on the ceiling-side inner surface 26 b or the penetration direction-side inner surface of the insertion hole 26, and the claw portion 33 may be provided at a position corresponding to the formed locking portion 34.

In the spinal cord temporary fixation devices 1 and 60 according to the first and second embodiments, the plurality of long grooves 16a, 16b, 76a, and 76b provided on the clamping surface extend in the axial direction of the clamping unit rotating shafts 5 and 65. Although formed, it is not limited to this. For example, the plurality of long grooves 16a, 16b, 76a, and 76b on the clamping surface may be formed so as to be inclined by about 20 degrees with respect to the axial direction of the clamping unit rotating shafts 5 and 65. The spinous process 51 is inclined toward the caudal side by about 10 to 30 degrees from the long axis of the spine 50. In some cases, the gap between the spinous processes 51 is narrow. Therefore, depending on the case, it may be necessary to hold the spinal cord temporary fixation devices 1 and 60 with an inclination of about 20 degrees with respect to the length direction of the pair of long members 40a and 40b. In such a case, as described above, the plurality of long grooves 16a, 16b, 76a, and 76b are formed so as to be inclined at about 20 degrees with respect to the axial direction of the sandwiching portion rotating shafts 5 and 65. Fixing devices are suitable. The plurality of long grooves 16 a, 16 b, 76 a, and 76 b are formed in parallel to the axial direction of the sandwiching part rotating shafts 5 and 65, and the axial direction of the sandwiching part rotating shafts 5 and 65. It is also possible to prepare another spinal fixation device that is inclined by about 20 degrees with respect to the two spinal fixation devices and select these two types of temporary spinal fixation devices during the operation according to the case. The inclination angle is not limited to 20 degrees and can be changed as appropriate. For example, it can be set from about 10 degrees to 30 degrees.

The spinal fixation auxiliary member 40 described above is a pair of long members 40a and 40b, but is not limited thereto. For example, it may be a single long member having an opening extending in the length direction. In this case, by inserting the spinous process 51 into the opening, the spinal fixation auxiliary member 40 can be disposed on both sides of the spinous process 51. The spinal fixation auxiliary member 40 is not limited to a linear rod as long as it has flexibility, and may be a long member formed in a corrugated shape.

In the fixing portion 90 according to the second embodiment, the contact member 91 provided at the end 92a of the advance / retreat shaft 92 is fixed to the end 92a of the advance / retreat shaft 92, for example. You may be comprised so that it may rotate with rotation. As another example, even when the contact member 91 is rotatably connected to the end 92a of the advance / retreat shaft 92 and the advance / retreat shaft 92 is rotated, the first and second handle portions The abutting member 91 that abuts on 67a and 67b may be configured to move forward and backward without rotating.

The spinal fixation device 1 and the spinal fixation auxiliary member 40 are made of a titanium alloy, but are not limited thereto. As materials for the spinal fixation devices 1 and 60 and the spinal fixation auxiliary member 40, materials that can be easily applied to living tissue, are stable against autoclaving or heat sterilization, and have an appropriate strength are selected. It is desirable to do. Furthermore, it is desirable to select a material that is unlikely to generate artifacts during CT and X-ray imaging.

Although the temporary spinal fixation devices 1 and 60 according to the first and second embodiments are used for accurately inserting the spine attachment tool 52 into a predetermined position of the spine 50, the application purpose is not limited thereto. For example, when the instability of the spine is high due to trauma, tumor, or the like, the spine can be temporarily fixed using the temporary spine fixation devices 1 and 60, and a desired operation can be performed.
To date, the present invention has been used during surgery for 8 cases of lumbar degenerative diseases (fixed cases of 2 or less intervertebral bones), and the braking effect has been confirmed by X-ray fluoroscopy. In these cases, there was no false needle insertion.

DESCRIPTION OF SYMBOLS 1,60 Temporary spinal fixation instrument 2,62 Clamping part 2a, 62a 1st clamping piece part 2b, 62b 2nd clamping piece part 3,90 Fixing part 5,65 Clamping part rotating shaft 7,67 Handle part 7a, 67a 1st handle part 7b, 67b 2nd handle part 15a, 15b Tip end part 16a, 16b, 76a, 76b Long groove 26 Insertion hole 26a Inner side surface on the bottom side of the insertion hole 27 Fixing part main body 33 Claw part 34 Engagement Stop 40 Auxiliary member for spinal fixation
40a, 40b A pair of elongated members 80 Support portion 83 Through hole 83a Inner peripheral surface of through hole 91 Contact member 92 Advance / retreat shaft portion 92a One end portion of the advance / retreat shaft portion (tip portion of advance / retreat shaft portion)
92c Advancing and retracting shaft outer peripheral surface 95 Male screw 96 Female screw

Claims (12)

Temporarily fixing the spine by clamping the spinal fixation auxiliary member in a state where the flexible spinal fixation auxiliary member formed in a long shape is disposed along the spinous processes of a plurality of spines. A spinal fixation device,
A clamping part for clamping the spinal fixation auxiliary member;
A fixing part for fixing the relative movement of the clamping part;
A spinal temporary fixation device comprising: a release portion that releases the fixation of the relative movement by the fixation portion. The sandwiching portion includes a pair of sandwiching pieces provided to be openable and closable,
The spinal temporary fixation device according to claim 1, wherein the fixing portion fixes relative movement of the pair of sandwiching piece portions. The clamping unit further includes a rotating shaft,
3. The temporary spinal fixation device according to claim 2, wherein the pair of sandwiching pieces are connected to each other so as to be rotatable about the rotation axis. 4. The temporary spinal fixation device according to claim 2, further comprising a pair of handle portions that are integrally formed with each of the pair of sandwiching piece portions and open and close the pair of sandwiching piece portions. . The fixing part is
An insertion hole formed in one of the pair of handle parts;
An elongated fixing portion main body extending from the other of the pair of handle portions and inserted through the insertion hole;
5. The temporary spinal fixation device according to claim 4, wherein the fixing portion main body is fixed to one of the pair of handle portions in a state of being inserted through the insertion hole. A plurality of claw portions are formed on the fixed portion main body,
The spinal temporary fixation device according to claim 5, wherein a locking portion that locks the claw portion is formed on an inner surface of the insertion hole. The fixing part is
An advancing and retracting shaft portion provided so as to be able to advance and retract between the pair of handle portions;
5. The temporary spinal fixation device according to claim 4, further comprising an abutting member provided at a distal end portion of the advance / retreat shaft portion and abutting against the pair of handle portions. The fixing part is
A support portion for supporting the advance / retreat shaft portion;
The support part is provided with a through-hole having an internal thread formed on the inner peripheral surface,
8. The spinal temporary fixation device according to claim 7, wherein an advancing / retreating shaft portion having a male screw formed on an outer peripheral surface is inserted into the through hole. The spinal temporary fixation device according to any one of claims 1 to 8, wherein a plurality of long grooves are formed in a clamping surface of the clamping part. The spinal temporary fixation device according to any one of claims 2 to 9, wherein the distal ends of the pair of sandwiching pieces are bent inward from each other. A spinal temporary fixation device according to any one of claims 1 to 10,
A spinal temporary fixation instrument unit comprising the spinal fixation auxiliary member. The spinal fixation auxiliary member is a pair of elongated members having flexibility,
The spinal fixation auxiliary member is disposed along the spinous process such that the spinous process is located between the one elongated member and the other elongated member,
The temporary spinal fixation device unit according to claim 11, wherein the temporary spinal fixation device holds the pair of long members with the spinous process therebetween.

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