WO2022077446A1

WO2022077446A1 - Biologically self-locking artificial disc system kit, and method for implanting same

Info

Publication number: WO2022077446A1
Application number: PCT/CN2020/121541
Authority: WO
Inventors: 李志忠; 沃金; 孙国栋; 黄石书; 张文财; 沈奎
Original assignee: 暨南大学
Priority date: 2020-10-16
Filing date: 2020-10-16
Publication date: 2022-04-21

Abstract

A biologically self-locking artificial disc system (1) kit, comprising a biologically self-locking artificial disc system (1) and a screwing device (2). The biologically self-locking artificial disc system (1) comprises a fixing bracket (11), an artificial disc prosthesis (12), a prosthetic stem (13) and a locking screw (15). The fixing bracket (11) has a cylindrical structure. An external thread (111) is arranged on the outer surface of the fixing bracket (11), and an internal thread (112) matching the thread of the locking screw (15) is arranged on the inner surface of the fixing bracket (11). A deformable end (114) is arranged at one end of the fixing bracket (11), and a mounting slot (113) extending in an axial direction is arranged at another end of the fixing bracket (11). The artificial disc prosthesis (12) is connected onto the prosthetic stem (13). A fixing bracket locking portion (22) and a cone tip (21) are arranged at an end of a shank body of the screwing device (2). The surfaces of the fixing bracket locking portion (22) and the cone tip (21) are threaded. The thread of the fixing bracket locking portion (22) matches the internal thread (112) of the fixing bracket (11). Self-tapping capability is added such that hole punching and the screwing of the fixing bracket (11) of the artificial disc can be performed simultaneously during an artificial disc replacement surgery, thereby optimizing surgery steps and reducing surgery time.

Description

Kit of biological self-locking artificial intervertebral disc system and its implantation method

technical field

The present application relates to surgical prosthesis instruments, in particular to a kit and implantation method of an artificial intervertebral disc system.

Background technique

Artificial intervertebral discs are mainly used for the treatment of intervertebral disc degenerative diseases such as discogenic low back pain. Artificial intervertebral disc replacement surgery removes intervertebral discs and implants artificial intervertebral disc prostheses, which can reduce nerve root and dural sac compression and relieve pain. The original biomechanical state of the spine is preserved to prevent or delay the degeneration of adjacent segments.

Patent application ZL201510559841.0 discloses a biological self-locking artificial intervertebral disc system and its application, including an artificial intervertebral disc prosthesis, a prosthesis handle, an intervertebral disc base and a spiral mesh fixed bracket connected in sequence. After the intervertebral disc, use a special trephine to drill into the upper part of the vertebral body, take out the bone fragments in a circular shape, and then use a flat-head screwdriver to screw the helical mesh fixed bracket into the hole, and then implant the artificial intervertebral disc prosthesis. Among them, the operation process of using trephine to drill the vertebral body for bone extraction takes about 2 to 3 hours. The drilling process requires precise operation, the fault tolerance rate of drilling is low, and the operator's experience and skills are tested. The operation is difficult, and drilling The hole that comes out is prone to have a too large or too small diameter, which leads to the loosening of the fixing bracket or the inability to screw it into the hole, and more bone bleeding is likely to occur during the trephine drilling process. In view of the above, it is necessary to improve it to solve the above problems.

Application content

In view of the technical problems existing in the prior art, the present application provides a kit of biological self-locking artificial intervertebral disc system with self-tapping function and an implantation method thereof.

This application is realized through the following technical solutions:

A kit of a biological self-locking artificial intervertebral disc system, comprising a biological self-locking artificial intervertebral disc system and a screw-in device, the biological self-locking artificial intervertebral disc system comprising a fixing bracket, an artificial intervertebral disc prosthesis, a prosthesis handle and a locking screw, The fixing bracket is a tubular structure, the outer surface of the fixing bracket is provided with an outer thread for screwing into the vertebral body, the inner surface is provided with an inner thread matching the thread of the locking screw, and the radius of the circular section at one end of the fixing bracket is gradually reduced to form a deformed end, and the other end is An installation groove extending along the axial direction is provided for inserting the prosthesis handle and sliding along the installation groove. The artificial intervertebral disc prosthesis is connected to the prosthesis handle, and the locking screw is screwed into the fixing bracket and resists the prosthesis handle. To prevent the prosthesis handle from falling out of the installation groove, the end of the rod body of the screw-in device is provided with a fixed bracket locking part and a cone tip, the surface of the fixed bracket locking part and the cone tip is provided with threads, and the thread of the fixed bracket locking part and the fixed bracket The internal thread of the screwdriver is matched, and the tapered point is used for screwing the screw hole into the vertebral body.

Further, the deformed end is in the shape of a truncated cone, and its generatrix is a straight line, or the deformed end is in the shape of a curved-edge truncated body, and the generatrix is an arc.

Further, a plurality of cutting grooves are vertically opened on the deformation end along the axis, so that the deformation end has a certain degree of expansion and contraction in the radial direction.

Further, the biological self-locking artificial intervertebral disc system includes a distraction screw, the thread of the distraction screw is matched with the inner thread of the fixing bracket, and is used for screwing into the fixing bracket, and the deformed end is stretched to increase the fixing bracket. The interaction force between the vertebral body and the vertebral body enhances the pull-out resistance of the fixed bracket.

Further, the outer casing of the screw-in device is provided with a limit sleeve, the limit sleeve is provided with a through hole for inserting the screw-in device, and the radius of the circular section of the limit sleeve is larger than the radius of the circular section of the fixed bracket.

Further, the outer surface of the fixed support is physically modified to add micropores to form a surface microporous structure.

An implantation method of the kit of the above-mentioned biological self-locking artificial intervertebral disc system, the implantation method steps include:

Step S1: Use a tapping drilling tool to perform preliminary drilling on the vertebral body below the intervertebral body, and gradually drill holes from small to large to expand the hole diameter. After the preliminary drilling is completed, the hole diameter is smaller than the diameter of the fixed bracket.

Step S2: Rotate the fixing bracket on the fixing bracket locking part of the screw-in device, align the cone tip with the hole and groove that has been initially drilled in step S1, further carry out self-tapping drilling, screw the fixing bracket in and leave it in the hole. Inside the vertebral body, exit the screwdriver;

Step S3: Install the integrated artificial intervertebral disc prosthesis and the prosthesis handle along the installation groove, the prosthesis handle is inserted in the installation groove, and the artificial intervertebral disc prosthesis is located between the upper and lower vertebral bodies to replace the original intervertebral disc ;

Step S4: Screw the locking screw into the fixing bracket, and lock the position of the prosthesis stem by pressing against the prosthesis stem and tighten it.

Further, between step S2 and step S3, the following steps are further included: screw the spreading screw into the deformed end of the fixing bracket to expand the deformed end.

Further, step S2 includes the following steps: using an intraoperative C-arm machine to perform X-ray fluoroscopy, monitoring the screw-in depth of the screw-in device, and replacing the screw-in device with a current screw when the cone tip of the screw-in device is close to the spinal cord. There are universal flat head screwdrivers that screw the fixing bracket to a predetermined depth.

Further, before step S1, the following steps are further included: sleeve the limiting sleeve on the screw-in device.

Compared with the prior art, the present application has the following beneficial effects:

1. This application increases the self-tapping function of the biological self-locking artificial intervertebral disc system and the screw-in device by design, so that in the artificial intervertebral disc replacement, after preliminary drilling, the fixing bracket is matched with the screw-in device to perform self-tapping. Screw into the hole, one step in place, the fixing bracket is more fit and fixed in the vertebral body, increasing the anti-pullout force, avoiding the disadvantage that the diameter of the drilled hole does not match the fixing bracket. Because the operation process is gradually drilled, it is fault-tolerant. Compared with the trephine drilling of the prior art, the drilling operation reduces bone bleeding.

2. This application improves the fixation bracket of the artificial intervertebral disc. One end of the fixation bracket is vertically cut, and then the distraction screw is screwed into the fixation bracket to realize the expansion of the deformed end of the fixation bracket. On the premise, the anti-pullout force is increased, so that the fixing bracket is more stable and stable in the vertebral body, and it is not easy to withdraw, shift and fall off.

3. The application has a wide range of applications, and can be applied to cervical vertebra, lumbar vertebra, and thoracic vertebra. In actual operation, the size and shape of the biological self-locking artificial intervertebral disc system and the shape of the artificial intervertebral disc can be changed accordingly according to the needs of the operation.

4. The present application has a simple structure and is more convenient to manufacture.

Description of drawings

Fig. 1 is the schematic diagram of the state after the biological self-locking artificial intervertebral disc system is implanted into the vertebral body;

Fig. 2 is the exploded view of biological self-locking artificial intervertebral disc system;

Figure 3 is a perspective view of the screw-in device;

4 is a front view of the assembled biological self-locking artificial intervertebral disc system;

5 is a schematic diagram of the implantation and assembly process of the biological self-locking artificial intervertebral disc system;

Figure 6 is an exploded view of the artificial intervertebral disc.

The reference numerals are explained as follows:

1-Biological self-locking artificial intervertebral disc system; 11-fixing bracket; 111-external thread; 112-internal thread; 113-installation groove; 114-deformation end; 115-cut groove; 12-artificial intervertebral disc prosthesis; Body handle; 14-spreading screw; 15-locking screw; 2-screwing device; 21-cone tip; 22-fixing bracket locking part; 23-limiting sleeve; 3-vertebral body.

Detailed ways

In order to make the purpose, technical solutions and advantages of the present application more clearly understood, the present application will be described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application, but not to limit the present application.

Please refer to FIG. 2 and FIG. 3 comprehensively. A preferred embodiment of the present application is a kit of a biological self-locking artificial intervertebral disc system, including a biological self-locking artificial intervertebral disc system 1 and a screw-in device 2. The biological self-locking artificial The intervertebral disc system 1 is implanted in the human or animal vertebrae to replace the intervertebral disc, and the screwdriver 2 is used together with it to perform self-tapping drilling on the vertebral body 3 .

The biological self-locking artificial intervertebral disc system 1 includes a fixing bracket 11 , an artificial intervertebral disc prosthesis 12 , a prosthesis handle 13 , a locking screw 15 , and preferably a distraction screw 14 . As shown in FIG. 2 , the fixing bracket 11 has a substantially tubular structure, and the outer surface of the fixing bracket 11 is provided with an external thread 111, so that the fixing bracket 11 can be screwed into the vertebral body 3; the inner surface of the fixing bracket 11 is provided with an inner thread 112, which is connected with The threads of the opening screw 14 and the locking screw 15 are matched, that is, both the opening screw 14 and the locking screw 15 can be screwed into the interior of the fixing bracket 11; the radius of the circular section at one end of the fixing bracket 11 is gradually reduced to form the deformed end 114, which serves as a Preferably, the deformation end 114 is vertically provided with a number of notches 115 along the axis. When the spreader screw 14 is screwed into the deformation end 114 of the fixing bracket 11, because of the existence of the notches 115, the spreader screw 14 can make the deformation end 114 Expanding to the outer circumference, thereby increasing the interaction force between the fixing bracket 11 and the vertebral body 3, and enhancing the anti-pullout force of the fixing bracket 11; the other end of the fixing bracket 11 is provided with an axially extending installation groove 113 for sliding in The prosthesis handle 13 is connected with the artificial intervertebral disc prosthesis 12. Preferably, the artificial intervertebral disc prosthesis 12 and the prosthesis handle 13 are connected in a detachable manner, as shown in FIG. Maintenance and replacement, only need to remove the artificial intervertebral disc prosthesis and prosthesis stem. Preferably, the material of the fixation bracket 11, the prosthesis handle 13, the locking screw 15 and the distraction screw 14 is titanium alloy, the material of the artificial intervertebral disc prosthesis 12 is high molecular polyethylene, and the shape of the upper surface of the artificial intervertebral disc prosthesis 12 conforms to the material of the artificial intervertebral disc prosthesis 12. The shape of the lower surface of the vertebral body 3 above.

As shown in FIG. 3 , the screw-in device 2 is T-shaped, the rod end of the screw-in device 2 is provided with a fixed bracket locking part 22 and a cone tip 21 , and the surfaces of the fixed bracket locking part 22 and the cone tip 21 are provided with threads , the thread of the locking portion 22 of the fixing bracket is matched with the inner thread 112 of the fixing bracket 11 . Preferably, a limit sleeve 23 is provided on the outer shell of the screw-in device 2, and a through hole is formed in the limit sleeve 23, as shown by the dotted line in FIG. 3, for the rod body of the screw-in device 2 to be inserted. The circular section of the tail end is larger than the circular section of the fixed bracket 11 , and the limit sleeve 23 has the function of stop and limit to prevent the drilling of the vertebral body from being too deep. When in use, the limiting sleeve 23 is first sleeved outside the screw-in device 2, and then the fixing bracket 11 is screwed on, and then the vertebral body is implanted by self-tapping.

For the deformation end 114 of the fixing bracket 11 in the present application, two different solutions are provided, please refer to the partial enlarged view in FIG. It is in the shape of a curved side table, and the generatrix is an arc. Matchingly, the cone tip 21 of the screw-in device 2 is curved to fit the deformed end 114 .

Further, the outer surface or inner surface of the fixing bracket 1 is physically modified to form a surface microporous structure. Compared with the traditional fixing bracket, its surface has micro-scale micropores, which has two advantages. Osteoblast growth, which is conducive to bone growth; another is that the micropores reduce the surface elastic modulus, reducing the chance of implant loosening.

In the present application, the self-tapping function of the biological self-locking artificial intervertebral disc system and the screw-in device is increased by design, so that the fixing bracket is more fitted and fixed in the vertebral body, which increases the anti-pullout force and avoids the diameter of the drilled hole and the fixation. The disadvantage of the incompatibility of the stent is that the operation process is gradually drilled, the fault tolerance rate is large, the operation difficulty is greatly reduced, and the operation time is reduced. The fixing bracket of the intervertebral disc has been improved, and one end of the fixing bracket is vertically cut, and then the distraction screw is screwed into the fixing bracket to realize the expansion of the deformed end of the fixing bracket. The pull-out force makes the fixed bracket more stable and stable in the vertebral body, and it is not easy to withdraw, shift, or fall off; it has a wide range of applications and can be applied to cervical, lumbar, and thoracic vertebrae. In actual operation, biological self-locking artificial The size of the intervertebral disc system and the shape of the artificial intervertebral disc can be changed accordingly; the structure is simple, and the manufacture is relatively convenient.

Please refer to Figure 5 for artificial disc replacement surgery using this application:

Before surgery, it is necessary to accurately measure CT and X-ray data, understand the anterior and posterior diameter of the patient’s cervical spine, and select an intervertebral disc system of appropriate size. It must be flat and must not be deeper than the spinal canal, because there is a spinal cord in the spinal canal, and the spinal cord will be compressed if it is deeper than the spinal canal;

First, the vertebral body 3 below the intervertebral body is initially drilled, and tapping drilling tools of different sizes are used to drill the holes one by one from small to large, and the hole diameter is gradually enlarged in stages. Because the size of the fixing bracket 11 is large, it cannot be tapped at one time. , the direct tapping will cause the vertebral body 3 to expand and then rupture, so the tapping needs to gradually carry out preliminary drilling from small size to large size, and the hole diameter after the preliminary drilling is smaller than the diameter of the fixed bracket 11;

Next, screw the fixing bracket 11 on the fixing bracket locking part 22 of the screw-in device 2, the cone tip 21 is aligned with the hole and groove that has been initially drilled in the previous step, and further self-tapping drilling is performed, and the fixing bracket 11 is screwed. Enter and stay in the vertebral body 3, and exit the screw 2. It should be noted that during the operation, X-ray fluoroscopy needs to be performed by using the intraoperative C-arm machine multiple times to monitor the screwing depth of the screw 2. When the cone tip 21 of 2 is close to the spinal cord, replace the screwdriver 2 with an existing general-purpose flat-head screwdriver, and screw the fixing bracket 11 into a predetermined depth, because if the screwdriver 2 is screwed too deeply, it will cause the screwdriver 2. The tip 21 of the cone enters the spinal canal, thereby compressing the spinal cord;

Further screw the spreading screw 14 into the deformation end 114 of the fixing bracket 11 to expand the deformation end 114;

Slide the connected artificial intervertebral disc prosthesis 12 and the prosthesis handle 13 along the installation groove 113, the prosthesis handle 13 is in the installation groove 113, and the artificial intervertebral disc prosthesis 12 is located between the upper and lower vertebral bodies 3, replacing the original one. some intervertebral discs;

Screw the locking screw 15 into the fixing bracket 11, and lock the position of the prosthetic stem 13 by pressing against the prosthetic stem 13 and tighten it. In this way, the assembly and implantation are completed, the right side view is shown in Figure 1, and the front view is shown in Figure 4.

The above are only the preferred embodiments of the present application, and are not intended to limit the scope of the patent of the present application. Any equivalent structural transformation made by using the contents of the description and drawings of the present application, or directly or indirectly applied to other related technical fields, will The same includes.

Claims

A kit of a biological self-locking artificial intervertebral disc system, comprising a biological self-locking artificial intervertebral disc system (1) and a screw-in device (2), characterized in that the biological self-locking artificial intervertebral disc system (1) comprises a fixing bracket (11), an artificial intervertebral disc prosthesis (12), a prosthesis handle (13) and a locking screw (15), the fixing bracket (11) is a tubular structure, and the outer surface of the fixing bracket (11) is provided with an outer surface for screwing into the vertebral body Thread (111), the inner surface is provided with an internal thread (112) matching the thread of the locking screw (15), one end of the fixing bracket (11) has a circular cross-sectional radius gradually reduced to form a deformation end (114), and the other end is provided with a shaft along the axis The extending installation groove (113) is used for inserting the prosthesis stem (13) and sliding along the installation groove (113). The prosthesis stem (13) is connected with the artificial intervertebral disc prosthesis (12), the locking screw (15) is rotated Insert into the fixed bracket (11) and hold the prosthesis handle (13) to prevent the prosthesis handle (13) from falling out of the installation groove (113), the end of the rod body of the screw-in device (2) is provided with a fixed bracket lock The holding part (22) and the cone tip (21), the fixing bracket locking part (22) and the cone tip (21) are provided with threads on the surface, and the thread of the fixing bracket locking part (22) and the inner thread of the fixing bracket (11) (112) is matched, and the cone tip (21) is used for screwing the screw (2) into the vertebral body.
The kit of the biological self-locking artificial intervertebral disc system according to claim 1, wherein the deformation end (114) is in the shape of a truncated cone, and its generatrix is a straight line, or the deformation end (114) is in the shape of a curved edge Body shape, the busbar is an arc.
The kit of the biological self-locking artificial intervertebral disc system according to claim 2, characterized in that: the deformation end (114) is vertically provided with a plurality of notches (115) along the axis, so that the deformation end (114) radially Has a certain degree of shrinkage.
The kit of the biological self-locking artificial intervertebral disc system according to claim 3, characterized in that: the biological self-locking artificial intervertebral disc system (1) comprises a distraction screw (14), and the thread of the distraction screw (14) is the same as that of the screw (14). The internal threads (112) of the fixing bracket (11) are matched to be screwed into the fixing bracket (11), and the deformed end (114) is stretched to increase the gap between the fixing bracket (11) and the vertebral body (3). The interaction force increases the pull-out resistance of the fixed bracket (11).
The kit of biological self-locking artificial intervertebral disc system according to any one of claims 1 to 4, characterized in that: the outer sleeve of the screw-in device (2) is provided with a limit sleeve (23), and the limit sleeve (23) A through hole is provided in the middle for inserting the screw-in device (2), and the radius of the circular section of the limiting sleeve (23) is larger than the radius of the circular section of the fixing bracket (11).
The kit of the biological self-locking artificial intervertebral disc system according to any one of claims 1 to 4, wherein the outer surface of the fixing bracket (1) is physically modified to add micropores to form a surface micropore structure.
A method for implanting a kit of a biological self-locking artificial intervertebral disc system according to any one of claims 1 to 6, wherein the steps of the implantation method include:

Step S1: Use a tapping drilling tool to perform preliminary drilling on the vertebral body (3) below the intervertebral intervertebral body, and gradually drill holes from small to large to enlarge the hole diameter. After the preliminary drilling is completed, the hole diameter is smaller than the diameter of the fixing bracket (11).

Step S2: Screw the fixing bracket (11) on the fixing bracket locking part (22) of the screw-in device (2), and align the cone tip (21) with the hole and groove that has been initially drilled in Step S1, and further perform self-tapping Drill the hole with the wire, screw the fixing bracket (11) into and stay in the vertebral body (3), and withdraw from the screw-in device (2);

Step S3: The artificial intervertebral disc prosthesis (12) and the prosthesis handle (13) that are connected into one body are installed along the installation groove (113), the prosthesis handle (13) is inserted into the installation groove (113), and the artificial intervertebral disc is prosthesis. The body (12) is located between the upper and lower vertebral bodies (3) to replace the original intervertebral disc;

Step S4: screw the locking screw (15) into the fixing bracket (11), and lock the position of the prosthesis handle (13) by pressing against the prosthesis handle (13) and fasten it.
The implantation method according to claim 7, characterized in that: between step S2 and step S3, the following step is further included: screw the distraction screw (14) into the deformation end (114) of the fixing bracket (11), so that the The deformed end (114) expands and unfolds.
The implantation method according to claim 7 or 8, characterized in that: step S2 comprises the following steps: using an intraoperative C-arm machine to perform X-ray fluoroscopy during the operation, monitoring the screwing depth of the screw-in device (2), When the cone tip (21) of the screw-in device (2) is close to the spinal cord, the screw-in device (2) is replaced with an existing general-purpose flat-head screw-in device, and the fixing bracket (11) is screwed into a predetermined depth.
The implantation method according to claim 7 or 8, characterized in that: before step S1, it further comprises the following step: sleeve the limiting sleeve (23) on the screw-in device (2).