KR20230122791A - Bone fixation device for spinal fusion and surgical tool set including the same - Google Patents

Abstract

The present invention relates to a bone fixation device for spinal fusion and a surgical tool set including the same, which is made of a cortical bone capable of fusion with a vertebral body, and has a tapered portion formed from the front end to the rear to facilitate insertion when inserted into the vertebral body, and an upper vertebral body. In a state inserted between the vertebral body and the lower vertebral body, a bone fixation device that fuses the front end to the upper vertebral body and the rear end to the lower vertebral body to fuse adjacent vertebral bodies, and a curved surface suitable for the back surface of the spine is formed at the rear end, the bone A first guide mechanism in which a guide hole for guiding the fixing mechanism and other instruments is formed in the longitudinal direction, and a second guide mechanism insertable into the guide hole of the first guide mechanism and in which a guide pin insertion hole is formed in the longitudinal direction; A guide pin that is primarily inserted into a surgical site through the guide pin insertion hole to form a treatment hole, and a space for securing a space in which the bone fixation mechanism is inserted into the vertebral body by expanding the treatment hole formed by inserting the guide pin An air reaming mechanism, an insertion mechanism for inserting the bone fixation mechanism into the guide hole of the first guide mechanism in order to insert the bone fixation mechanism into the procedure hole expanded by the air reaming mechanism, and a bone fixation mechanism inserted into the vertebral body By including an injection device for injecting an artificial bone component material in order to fix it so as not to be dislodged, it is possible to perform spinal fusion in which fusion between proximal vertebral bodies is well achieved.

Description

Bone fixation device for spinal fusion and surgical tool set including the same {Bone fixation device for spinal fusion and surgical tool set including the same}

The present invention relates to a bone fixation device for spinal fusion and a set of surgical instruments including the same, and more particularly, to treat nonunion of the spine by inserting it between an upper vertebral body and a lower vertebral body to achieve good fusion between adjacent vertebral bodies. It relates to a bone fixation device for spinal fusion and a set of surgical tools including the same.

In general, spinal stenosis is a disease that causes various neurological abnormalities such as intermittent lameness of nerve roots by compressing spinal nerves from the front, back, left, and right directions as the spinal canal, which is a passage through which spinal nerves pass, is narrowed due to degenerative factors. It happens a lot.

If there are only compression lesions of the spinal nerve due to spinal stenosis, only the bone and ligament tissue that is compressing the spinal nerve need to be removed. However, spinal fusion surgery is required when there is back pain due to spinal nerve compression lesions and degenerative changes (disc degeneration, facet joint degeneration) and spinal segmental instability.

8 is a photograph showing a conventional general spinal fusion. In general spinal fusion, after removing an intervertebral disc, a hollow artificial aid (cage) made of metal or plastic is filled with bone fragments and inserted into the area where the disc was removed. , After inserting and fixing pedicle screws into the vertebral body of the upper and lower parts of the damaged disc, it consists of a method of connecting and fixing a rod to the pedicle screws.

However, such a conventional spinal fusion surgery has a disadvantage in that extensive tissue damage occurs, such as removing a disc and removing bones and muscles, and 40 to 50% of the vertebral bodies are not fused even after the fusion surgery. The vertebrae naturally develop so that the bones do not fuse with each other after the differentiation of the vertebral body, and both the end plate and the intervertebral disc covering the vertebral body interfere with the fusion of adjacent vertebral bodies so that they do not fuse with each other. It is very difficult.

In addition, intervertebral body fixation using screws and rods is difficult to use because it does not improve bone union and can lead to other complications due to the subsequent prolapse of the screw due to osteoporosis.

In addition, screws made of metal or metal alloys may change due to corrosion, etc., and may have to be removed again by reoperation, such as rejection due to heterogeneous materials, so they are not suitable for spinal fusion, and a surgical tool capable of solving these problems is required. situation to be

Korean Patent Registration No. 10-2278767

The present invention has been devised to solve the above problems, and is made of cortical bone capable of fusion with the vertebral body to solve side effects caused by metal materials, and is inserted into the upper vertebral body and the lower vertebral body to fuse, thereby preventing fusion between adjacent vertebral bodies. Its purpose is to provide a bone fixation device for spinal fusion that can be performed well.

Another object of the present invention is to provide a bone fixation device for spinal fusion that can minimize tissue damage during surgery by integrating the disc through intervertebral intervertebral insertion without removing the disc.

In addition, by using the bone fixation device for spinal fusion proposed in the present invention, surgery can be performed conveniently within a very short time compared to conventional spinal fusion, thereby providing a set of surgical tools that can significantly reduce the burden of surgery on both doctors and patients. Its purpose is to provide

In order to achieve the above object, in the present invention, it is inserted between vertebral bodies for spinal fusion, and is made of a cortical bone capable of fusion with the vertebral body, and a tapered portion is formed from the front end to the rear to facilitate insertion when inserted into the vertebral body, In a state inserted between an upper vertebral body and a lower vertebral body, a bone fixation device for spinal fusion is provided, characterized in that the front end is fused to the upper vertebral body and the rear end is fused to the lower vertebral body to fuse adjacent vertebral bodies.

The bone fixation device of the present invention is characterized in that it is formed by excising the cortical bone of the fibula in a cylindrical shape having a predetermined length.

On the other hand, a guide pin may be inserted in the longitudinal direction to form a passable through hole.

In addition, a concave spiral groove is formed on the outer surface to improve fixation by increasing frictional force with the vertebral body, and the spiral groove may be formed to have at least one turn on the outer surface. Even in this case, a guide pin may be inserted in the longitudinal direction to form a passable through hole.

In the present invention, the diameter D1 of the tip is smaller than the diameter D2 of the rear end due to the tapered portion, and the ratio between the diameter D1 of the tip and the diameter D2 of the rear end (D1/D2) is,

0.7≤D1/D2≤0.9

It is characterized by being

In this case, the diameter D1 of the front end may be in the range of 3.5 mm to 4.5 mm, and the diameter D2 of the rear end may be in the range of 4.5 mm to 5.5 mm.

On the other hand, as a surgical tool set for achieving the above object, in the present invention, the above-described bone fixing mechanism and a curved surface suitable for the back surface of the spine are formed at the rear end, and for guiding the bone fixing mechanism and other instruments. A first guide mechanism having a guide hole formed in the longitudinal direction, a second guide mechanism insertable into the guide hole of the first guide mechanism and having a guide pin insertion hole formed in the longitudinal direction, and a surgical site through the guide pin insertion hole A guide pin that is primarily inserted into the hole to form a hole, a hole expansion mechanism for securing a space in which the bone fixation mechanism is inserted into the vertebral body by expanding the hole formed by the insertion of the guide pin, and the hole expansion mechanism An insertion mechanism for inserting the bone fixation mechanism into the guide hole of the first guide mechanism to insert the bone fixation mechanism into the expanded procedure hole, and an artificial bone component for fixing the bone fixation mechanism inserted into the vertebral body so as not to be separated. A surgical tool set for spinal fusion including an injection device for injecting a substance is provided.

The hole expansion mechanism is composed of two drills insertable into the guide hole, and a second hole expansion may be performed after the first hole expansion using two drills having different diameters.

Here, the drill may be formed with a guide pin insertion hole into which the guide pin is inserted in the longitudinal direction.

On the other hand, the insertion mechanism includes a head portion that can be inserted into the guide hole and then punched with a hammer to insert the bone fixation mechanism into the procedure hole, and a head that can be inserted into the guide hole. It is characterized by having a long body part.

In addition, the injection mechanism is inserted into the guide hole of the first guide mechanism, and is combined with a syringe containing the artificial bone component material to form an injection tube into which the artificial bone component material of the syringe is injected; It includes an injection stick insertable into the injection hole to push the artificial bone component injected into the back of the bone fixation device.

According to the present invention as described above, cortical bone capable of fusion with the vertebral body is inserted between the upper vertebral body and the lower vertebral body to fuse, thereby solving the side effects caused by the metal material, eliminating the need for a secondary removal operation, and fusion between adjacent vertebral bodies. It has the effect of making this work well.

In addition, there is an effect of minimizing tissue damage during surgery by integrating the disk through intervertebral intervertebral insertion without removing the disk.

In addition, by using the bone fixation device for spinal fusion proposed in the present invention, the operation can be conveniently performed within a very short time compared to the conventional spinal fusion, which has an effect of greatly reducing the burden of surgery on both the doctor and the patient.

1 is a perspective view showing embodiments of a bone fixation device for spinal fusion according to the present invention.
Figure 2 is a perspective view showing a surgical tool set including a bone fixation mechanism for spinal fusion of the present invention.
3 is a view showing the insertion of guide pins into the vertebral body using the surgical tool set of the present invention, (a) is a perspective view showing the insertion of the guide pins into the second guide mechanism, (b) is a guide to the vertebral body It is a perspective view showing the insertion of the pin.
Figure 4 is a perspective view showing the insertion of a bone fixation mechanism after expanding the procedure hole formed by the guide pin with a reaming mechanism in the present invention.
5 and 6 are side views illustrating the injection of an artificial bone component material using an injection device after inserting a bone fixation device.
7 is a front view and a side view showing a state in which the bone fixation mechanism of the present invention is inserted after the surgery is completed.
8 is a photograph showing a conventional general spinal fusion.

Advantages and features of the present invention, and methods of achieving them, will become clear with reference to the detailed description of the following embodiments taken in conjunction with the accompanying drawings. However, the present invention is not limited to the embodiments disclosed below and will be implemented in various different forms, but only these embodiments make the disclosure of the present invention complete, and common knowledge in the art to which the present invention belongs. It is provided to fully inform the holder of the scope of the invention, and the present invention is only defined by the scope of the claims. Like reference numbers designate like elements throughout the specification.

1 is a perspective view showing embodiments of a bone fixation device for spinal fusion according to the present invention, and FIG. 2 is a perspective view showing a surgical tool set including a bone fixation device for spinal fusion according to the present invention.

The bone fixation devices 10, 20, and 30 proposed in the present invention are inserted between vertebral bodies for spinal fusion, and are characterized in that they are made of cortical bones capable of fusion with the vertebral bodies.

That is, in the present invention, cortical bone is inserted between normal bones, and when the normal bone and the cortical bone are united from both sides, bone union is achieved and cortical bone fusion in nonunion treatment that can correct nonunion is applied to the vertebral body, thereby normal upper and lower vertebral bodies. By inserting a bone fixation device made of cortical bone into the vertebral body, it is possible to achieve bone union between adjacent vertebral bodies.

Here, the bone fixation mechanism may be made by excising the cortical bone of the fibula. That is, it can be used after excising the cortical bone of fibula bone, which has been disinfected so that it can be used in the human body and is commercially available, into a cylindrical shape having a predetermined thickness and length using a trephine for circular resection.

Considering the size of a typical vertebral body, the bone fixation device of the present invention for achieving fusion by being inserted between adjacent vertebral bodies is preferably made of a length of about 5 cm.

Here, in the present invention, it is preferable that a tapered portion T having a predetermined length is formed rearward from the front end 12, 22, 32 so that the bone fixation device can be easily inserted into the vertebral body.

The tapered part (T) is to make the front end (12) (22) (32) thinner than the rear end (14) (24) (34) so that the bone fixation mechanism can be easily inserted into the vertebral body, It may be formed at a certain ratio in the length of the bone fixation device, or it may be formed over the entire length of the bone fixation device. That is, the bone fixation device of the present invention may be formed in a tapered shape from the front end to the rear end.

In the present invention, the diameter D1 of the tip is smaller than the diameter D2 of the rear end due to the tapered portion, and the ratio between the diameter D1 of the tip and the diameter D2 of the rear end (D1/D2) is,

0.7≤D1/D2≤0.9

can be made with The ratio (D1/D2) between the diameter of the front end (D1) and the diameter of the rear end (D2) (D1/D2) facilitates the insertion of the bone fixation mechanism due to the taper portion, but does not make a large difference between the diameters of the front and rear ends, so the bone fixation mechanism It is a range that does not cause problems in achieving fusion when inserted into the hardness and vertebral body.

For example, when the bone fixation mechanism is made of a length of 5 cm, it is preferable that the diameter D1 of the front end is 4 mm and the diameter D2 of the rear end is 5 mm. The length, the diameter of the front end (D1), and the diameter of the rear end (D2) were applied as 5 cm, 4 mm, and 5 mm, respectively.

In this way, the bone fixation device having the tapered portion T formed at the front end is easier to insert when inserted into the vertebral body or into the guide hole of the first guide device to be described later, thereby improving the surgeon's convenience during surgery. there is.

The present invention proposes three embodiments as a bone fixation mechanism. The first embodiment is shown in FIG. 1 (a), and the second embodiment 20 of the present invention, as shown in FIG. 1 (b), has a through hole 26 penetrating in the longitudinal direction therein. The through hole 26 is a hole through which a guide pin, which will be described later, can be inserted and passed through, and may be formed to fit the size of the diameter of the guide pin.

In the present invention, it is proposed that the guide pin has a diameter of 1 mm, and accordingly, it is preferable that the through hole 26 also has a diameter of 1 mm.

In addition, as shown in (c) of FIG. 1, the third embodiment 30 of the present invention has a shape in which a concave spiral groove is formed on the outer surface to improve the fixing force by increasing the frictional force with the vertebral body. The spiral groove preferably has a cross-sectional shape rounded to a predetermined depth, and may be formed to have at least one turn on the outer surface of the bone fixation mechanism. In this case, a guide pin is inserted in the longitudinal direction to form a passable through hole 36 .

Since the bone fixation device of the present invention is made of cortical bone, when inserted between the upper and lower vertebral bodies, the distal end of the bone fixation device fuses with the upper vertebral body and the rear end fuses with the lower vertebral body, so that adjacent vertebral bodies can be fused.

Such a bone fixation device may be inserted into the vertebral body during spinal fusion using the surgical tool set shown in FIG. 2 .

The surgical tool set of the present invention largely includes a guide mechanism 100 for guiding the bone fixation mechanism 10, an air-reinforcing mechanism 200 for securing a space in which the bone fixation mechanism is inserted into the vertebral body, and inserting the bone fixation mechanism. It consists of an insertion mechanism 300 for the insertion and an injection mechanism 400 for injecting the artificial bone component material to prevent the inserted bone fixation mechanism from being separated.

First, the guide mechanism 100 can be inserted into the first guide mechanism 110 in which guide holes for guiding the bone fixation mechanism and other instruments are formed in the longitudinal direction and the guide holes of the first guide mechanism 110. and a second guide mechanism 120 in which a guide pin insertion hole is formed in the longitudinal direction, and a guide pin 130 that is primarily inserted into a surgical site through the guide pin insertion hole to form a treatment hole.

The first guide mechanism 110 has a curved surface that fits the back surface of the spine is formed at the rear end, so that the surgery can be performed while supporting the curved surface of the first guide mechanism 110 on the vertebral body during surgery.

In addition, since the bone fixation mechanism and other instruments are inserted through the guide hole, the guide hole is formed to have an inner diameter suitable for the thickness of the bone fixation mechanism, and the diameter of the second guide mechanism 120 and the inner diameter of the guide hole are It is desirable that they are made of the same size.

For example, when the bone fixation mechanism has a diameter of 5 mm, the first guide mechanism 110 may have an outer diameter of 7 mm and a guide hole of 5 mm, and the second guide mechanism 120 may have an outer diameter of 7 mm and a guide hole of 5 mm. It may be made of 5 mm so that it can be assembled by being inserted into the guide hole.

On the other hand, it is preferable that the guide pin 130 is made of 1 mm, and the guide pin insertion hole also has an inner diameter of 1 mm.

The air reaming mechanism 200 secures a space into the vertebral body into which the bone fixation mechanism is inserted by expanding a procedure hole formed by inserting the guide pin, and may be formed of a conventional drill.

In the present invention, by applying two drills having different diameters to the hole expansion mechanism 200, a second hole expansion can be performed after the first hole expansion.

Here, the drill may be formed with a guide pin insertion hole into which the guide pin is inserted in the longitudinal direction. In this case, the operation of forming a hole for operation with a guide pin and the operation for expanding the hole with the drill may be performed together.

On the other hand, in order to insert the bone fixation mechanism 10 into the procedure hole expanded by the reaming mechanism 200, the insertion mechanism 300 inserts the bone fixation mechanism into the guide hole of the first guide mechanism 110. included

The insertion mechanism 300 includes a head portion capable of being punched with a hammer to insert the bone fixation mechanism into the guide hole and then inserting the bone fixation mechanism into the procedure hole, and insertable into the guide hole. It has a body portion formed long so as to.

In addition, the injection device 400 for injecting the artificial bone component material in order to fix the bone fixation device inserted into the vertebral body so as not to be separated is combined with the syringe 430 containing the artificial bone component material, and the artificial bone component of the syringe It includes an injection tube 420 for injecting a material and an injection stick 410 for pushing the artificial bone component material injected into the injection tube 420 to the rear of the bone fixation device.

The injection tube 420 is inserted into the guide hole of the first guide mechanism 110, and when combined with the syringe 430, the injection hole passes through the injection tube so that the artificial bone component of the syringe can be injected into the rear of the bone fixation mechanism. is formed

In addition, the injection stick 410 can be inserted into the injection hole to push the artificial bone component material injected into the injection hole to the rear of the bone fixation device.

A surgical method using the surgical tool set for spinal fusion configured as described above is as follows.

3 is a view showing the insertion of guide pins into the vertebral body using the surgical tool set of the present invention, (a) is a perspective view showing the insertion of the guide pins into the second guide mechanism, (b) is a guide to the vertebral body Figure 4 is a perspective view showing the insertion of a pin, and Figure 4 is a perspective view showing the insertion of a bone fixation mechanism after expanding the procedure hole formed by the guide pin with an air reamer in the present invention, Figures 5 to 6 are bone fixation It is a side view showing the injection of an artificial bone component material using an injection device after inserting the device, and FIG. 7 is a front view and a side view showing a state in which the bone fixation device of the present invention is inserted after surgery is completed.

First, in a state in which the second guide mechanism 120 is inserted into the guide hole of the first guide mechanism 110 and assembled, the guide pin 130 is inserted into the surgical site through the guide pin insertion hole 122, Gradually form the operation hole.

At this time, a guide pin is inserted at an oblique angle from the lower vertebral body to the upper vertebral body through the pedicle of the lower vertebral body, and the angle α formed between the vertebral body and the guide pin 130 is in the range of 25 ° around the center line of the vertebral body The angle β with the horizontal line of the vertebral body is about 50°.

Then, as shown in the lower drawing of FIG. 4 , the second guide mechanism and the guide pin are removed from the first guide mechanism 110 and the air reaming mechanism 200 is inserted into the first guide mechanism 110 so that the guide pin The formed procedure hole is expanded to secure a space into which the bone fixation mechanism is inserted.

At this time, by applying two drills having different diameters as the hole expansion mechanism 200, a second hole expansion may be performed after the first hole expansion. For example, after primary expansion using a 4 mm diameter drill, secondary expansion is performed using a 5 mm diameter drill.

Thereafter, a bone fixation mechanism is inserted into the guide hole of the first guide mechanism 110, and after inserting the insertion mechanism 300, a hole is drilled with a hammer to insert the bone fixation mechanism into the operation hole of a desired part.

Then, in order to prevent the bone fixation device inserted into the vertebral body from being separated, the injection tube 420 is inserted into the first guide device 110 and the injection tube 430 containing the artificial bone component is used. Insert the artificial bone component material into the injection hole (420) (FIG. 5).

Thereafter, the injection stick 410 is pushed into the injection hole of the injection tube 420 to push the artificial bone component material injected into the injection hole to the rear of the bone fixation device (FIG. 6). Since there is an empty space at the rear of the bone fixation device, an artificial bone component material is inserted to fix the position so that the bone fixation device does not fall backward.

After 10 minutes, when the artificial bone component 50 hardens, the operation is completed.

Thereafter, in a state in which the bone fixation device is inserted between the upper vertebral body and the lower vertebral body, the front ends of the upper vertebral body and the bone fixation device are fused, and the lower vertebral body and the rear end of the bone fixation device are fused to fuse adjacent vertebral bodies.

As described above, the present invention solves the side effects caused by metal materials by inserting cortical bone capable of fusion with the vertebral body between the upper vertebral body and the lower vertebral body, eliminating the need for a secondary removal operation, and achieving good fusion between adjacent vertebral bodies. It has the effect of losing.

Although the above has been described based on the embodiments of the present invention, various changes or modifications may be made at the level of a technician having ordinary knowledge in the technical field to which the present invention belongs. Such changes and modifications can be said to belong to the present invention as long as they do not deviate from the scope of the technical idea provided by the present invention. Therefore, the scope of the present invention will be determined by the claims described below.

10, 20, 30: bone fixation device 50: artificial bone component material
100: guide mechanism 110: first guide mechanism
120: second guide mechanism 130: guide pin
200: reaming mechanism 300: insertion mechanism
400: injection mechanism

Claims (11)

It is inserted between vertebral bodies for spinal fusion, and is composed of cortical bones capable of fusion with the vertebral bodies,
When inserted into the vertebral body, a tapered portion is formed from the front end to the rear to facilitate insertion,
A bone fixation device for spinal fusion, characterized in that the front end is fused to the upper vertebral body and the rear end is fused to the lower vertebral body to fuse adjacent vertebral bodies in a state inserted between the upper and lower vertebral bodies. The method of claim 1,
A bone fixation device for spinal fusion, which is characterized in that it is formed by excising fibula cortical bone in a cylindrical shape having a predetermined length. The method of claim 1,
A bone fixation device for spinal fusion, characterized in that a guide pin is inserted in the longitudinal direction to form a passable through hole. According to claim 1 or claim 3,
A concave spiral groove is formed on the outer surface to improve the fixing force by increasing the frictional force with the vertebral body,
The spiral groove is a bone fixation device for spinal fusion, characterized in that formed to have at least one turn on the outer surface. The method of claim 1,
Due to the tapered portion, the diameter D1 of the front end is smaller than the diameter D2 of the rear end,
The ratio (D1/D2) between the diameter of the tip (D1) and the diameter of the rear end (D2) is,
0.7≤D1/D2≤0.9
Bone fixation device for spinal fusion, characterized in that. The method of claim 5,
The diameter (D1) of the tip is in the range of 3.5 mm to 4.5 mm,
The diameter of the rear end (D2) is a bone fixation device for spinal fusion, characterized in that in the range of 4.5 mm to 5.5 mm. A bone fixation device according to any one of claims 1 to 6;
a first guide mechanism in which a curved surface suitable for the back surface of the spine is formed at the rear end, and a guide hole for guiding the bone fixation mechanism and other instruments is formed in the longitudinal direction;
a second guide mechanism insertable into the guide hole of the first guide mechanism and having a guide pin insertion hole formed in the longitudinal direction;
A guide pin that is primarily inserted into the surgical site through the guide pin insertion hole to form a procedure hole;
an air-reinforcing mechanism for securing a space in the vertebral body into which the bone fixation mechanism is inserted by expanding the procedure hole formed by inserting the guide pin;
an insertion mechanism for inserting the bone fixation mechanism into the guide hole of the first guide mechanism in order to insert the bone fixation mechanism into the procedure hole expanded by the air reaming mechanism; and
an injection device for injecting an artificial bone component material to fix the bone fixation device inserted into the vertebral body so as not to be separated;
A set of surgical tools for spinal fusion, including a. The method of claim 7,
The air expansion mechanism is composed of two drills insertable into the guide hole,
A set of surgical tools for spinal fusion, characterized in that the secondary expansion after the primary expansion using two drills with different diameters. The method of claim 8,
The drill is a surgical tool set for spinal fusion, characterized in that the guide pin insertion hole is formed in the longitudinal direction into which the guide pin can be inserted. The method of claim 7,
The insertion mechanism is formed long enough to be inserted into the guide hole, including a head portion capable of being punched with a hammer to insert the bone fixation mechanism into the procedure hole by inserting the bone fixation mechanism into the guide hole and then perforating the bone fixation mechanism into the procedure hole. A set of surgical tools for spinal fusion, characterized in that it has a body to be. The method of claim 7,
The injection device is inserted into the guide hole of the first guide mechanism, and is combined with a syringe containing the artificial bone component material to form an injection hole into which the artificial bone component material of the syringe is injected;
A surgical instrument set for spinal fusion, characterized in that it includes an injection stick insertable into the injection hole to push the artificial bone component material injected into the injection hole to the rear of the bone fixation device.

Images