阅读说明：本技术 生物自锁型人工椎间盘系统的套件及其植入方法 (Kit of biological self-locking artificial intervertebral disc system and implantation method thereof ) 是由 李志忠 沃金 孙国栋 黄石书 张文财 沈奎 于 2020-10-16 设计创作，主要内容包括：本发明提供一种生物自锁型人工椎间盘系统的套件,包括生物自锁型人工椎间盘系统和旋入器,所述生物自锁型人工椎间盘系统包括固定支架、人工椎间盘假体、假体柄和锁定螺钉,固定支架为筒状结构,固定支架外表面设置有外螺纹,内表面设置有与锁定螺钉螺纹相匹配的内螺纹,固定支架的一端设置有形变端,另一端开设有一沿轴向延伸的安装槽,假体柄上连接有人工椎间盘假体,所述旋入器的杆体末端设置有固定支架锁持部和锥尖,固定支架锁持部和锥尖表面设置有螺纹,固定支架锁持部的螺纹与固定支架的内螺纹相匹配。本发明通过增加自攻丝功能,使人工椎间盘置换术中钻孔、旋入人工椎间盘的固定支架同时进行,从而优化手术步骤、减少手术时间。(The invention provides a kit of a biological self-locking type artificial intervertebral disc system, which comprises the biological self-locking type artificial intervertebral disc system and a screwing device, wherein the biological self-locking type artificial intervertebral disc system comprises a fixing support, an artificial intervertebral disc prosthesis, a prosthesis handle and a locking screw, the fixing support is of a cylindrical structure, the outer surface of the fixing support is provided with external threads, the inner surface of the fixing support is provided with internal threads matched with the threads of the locking screw, one end of the fixing support is provided with a deformation end, the other end of the fixing support is provided with an installation groove extending along the axial direction, the artificial intervertebral disc prosthesis is connected onto the prosthesis handle, the tail end of a rod body of the screwing device is provided with a fixing support locking part and a conical tip, the surfaces of the fixing support locking part and the conical tip are provided. The invention can simultaneously drill and screw in the fixing bracket of the artificial intervertebral disc in the artificial intervertebral disc replacement by adding the self-tapping function, thereby optimizing the operation steps and reducing the operation time.)

1. A kit of a bio-self-locking artificial intervertebral disc system, comprising a bio-self-locking artificial intervertebral disc system (1) and a screw driver (2), characterized in that: the biological self-locking type artificial intervertebral disc system (1) comprises a fixing support (11), an artificial intervertebral disc prosthesis (12), a prosthesis handle (13) and a locking screw (15), wherein the fixing support (11) is of a tubular structure, an external thread (111) for screwing into a vertebral body is arranged on the outer surface of the fixing support (11), an internal thread (112) matched with the locking screw (15) in a thread way is arranged on the inner surface of the fixing support, the radius of the circular section of one end of the fixing support (11) is gradually reduced to form a deformation end (114), an installation groove (113) extending along the axial direction is formed in the other end of the fixing support and used for being inserted into the prosthesis handle (13) and sliding along the installation groove (113), the artificial intervertebral disc prosthesis handle (13) is connected with the artificial intervertebral disc prosthesis (12), the locking screw (15) is screwed into the fixing support (11) and abuts against, the end of the rod body of the screwing device (2) is provided with a fixing support locking part (22) and a cone tip (21), the surfaces of the fixing support locking part (22) and the cone tip (21) are provided with threads, the threads of the fixing support locking part (22) are matched with the internal threads (112) of the fixing support (11), and the cone tip (21) is used for drilling and screwing the screwing device (2) into a vertebral body.

2. The kit for a bio-self-locking artificial disc system of claim 1, wherein: the deformation end (114) is in a circular truncated cone shape, and a bus of the deformation end is a straight line, or the deformation end (114) is in a curved edge circular truncated cone shape, and the bus is an arc line.

3. The kit for a bio-self-locking artificial disc system of claim 2, wherein: a plurality of cutting grooves (115) are vertically formed in the deformation end (114) along the axis, so that the deformation end (114) has certain radial stretchability.

4. The kit for a bio-self-locking artificial disc system according to claim 3, wherein: the biological self-locking artificial intervertebral disc system (1) comprises a distraction screw (14), wherein the thread of the distraction screw (14) is matched with the internal thread (112) of the fixed support (11) and is used for screwing into the fixed support (11) and distracting the deformation end (114) so as to increase the interaction force between the fixed support (11) and the vertebral body (3) and enhance the anti-extraction force of the fixed support (11).

5. The kit for a bio-self-locking artificial intervertebral disc system according to any one of claims 1 to 4, wherein: the limiting sleeve (23) is sleeved outside the screwing device (2), a through hole is formed in the limiting sleeve (23) and used for the screwing device (2) to be inserted into, and the radius of the circular section of the limiting sleeve (23) is larger than that of the circular section of the fixing support (11).

6. The kit for a bio-self-locking artificial intervertebral disc system according to any one of claims 1 to 4, wherein: the outer surface of the fixed support (1) is physically modified and micropores are added to form a surface micropore structure.

7. A method of implanting the kit of bio-self-locking artificial disc system of any one of claims 1 to 6, wherein the implanting method comprises the steps of:

step S1: and (3) preliminarily drilling the vertebral body (3) below the intervertebral by using a tapping drilling tool, gradually drilling and enlarging the aperture from small to large, wherein the aperture is smaller than the diameter of the fixed support (11) after the preliminary drilling is finished.

Step S2: screwing the fixing support (11) on a fixing support locking part (22) of the screwing device (2), aligning the conical tip (21) with the hole groove which is drilled preliminarily in the step S1, further performing self-tapping drilling, screwing the fixing support (11) into the vertebral body (3) and remaining in the vertebral body, and withdrawing the screwing device (2);

step S3: the artificial intervertebral disc prosthesis (12) and the prosthesis handle (13) which are connected into a whole are arranged along the installation groove (113), the prosthesis handle (13) is inserted in the installation groove (113), and the artificial intervertebral disc prosthesis (12) is positioned between the upper vertebral body and the lower vertebral body (3) to replace the original intervertebral disc;

step S4: the locking screw (15) is screwed into the fixed bracket (11), and the prosthesis handle (13) is locked and fastened by abutting against the prosthesis handle (13).

8. The method of implanting of claim 7, wherein: the following steps are also included between step S2 and step S3: the expansion screw (14) is screwed into the deformation end (114) of the fixed support (11) to expand the deformation end (114).

9. The method of implanting of claim 7 or 8, wherein: the step S2 includes the following steps: in the operation process, an intraoperative C-arm machine is used for X-ray fluoroscopy, the screwing depth of the screwing device (2) is monitored, when the conical tip (21) of the screwing device (2) approaches to a spinal cord, the screwing device (2) is replaced by an existing universal flat head screwing device, and the fixing support (11) is screwed into a preset depth.

10. The method of implanting of claim 7 or 8, wherein: step S1 is preceded by the steps of: the limiting sleeve (23) is sleeved on the screwing device (2).

Technical Field

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

Background

The artificial intervertebral disc is mainly used for treating intervertebral disc degenerative diseases such as intervertebral disc source lumbago, and the like, and the artificial intervertebral disc replacement operation can keep the original biomechanical state of the spine to a certain degree while relieving the compression of a nerve root dura mater sac and eliminating pain by excising the intervertebral disc and implanting an artificial intervertebral disc prosthesis so as to achieve the effect of preventing or delaying the degeneration of adjacent segments.

The invention patent ZL201510559841.0 discloses a biological self-locking type artificial intervertebral disc system and application thereof, which comprises an artificial intervertebral disc prosthesis, a prosthesis handle, an intervertebral disc base and a spiral reticular fixing support which are sequentially connected, wherein during operation, after an intervertebral disc is cut off, a special trephine is used for trephine drilling in the upper part of a vertebral body, bone blocks are annularly taken out, a flat head screwdriver is used for screwing the spiral reticular fixing support into a hole, and then the artificial intervertebral disc prosthesis is implanted. Wherein, the operation process that uses the trephine to get the bone to centrum drilling probably needs to last 2 ~ 3 hours, and the drilling process needs precision operation, and the fault-tolerant rate of drilling is lower, examines operator's experience skill, and the operation degree of difficulty is big, and the too big or undersize in aperture appears easily in the hole of drilling, leads to the fixed bolster installation not hard up or can't revolve the hole in, and the more condition of bone hemorrhage easily appears among the trephine drilling process. In view of the foregoing, there is a need for improvement to solve the above existing problems.

Disclosure of Invention

Aiming at the technical problems in the prior art, the invention provides a kit of a biological self-locking type artificial intervertebral disc system with a self-tapping function and an implantation method thereof.

The invention is realized by the following technical scheme:

a kit of a biological self-locking artificial intervertebral disc system comprises the biological self-locking artificial intervertebral disc system and a screwing device, wherein the biological self-locking artificial intervertebral disc system comprises a fixing support, an artificial intervertebral disc prosthesis, a prosthesis handle and a locking screw, the fixing support is of a tubular structure, the outer surface of the fixing support is provided with an external thread for screwing in a vertebral body, the inner surface of the fixing support is provided with an internal thread matched with the thread of the locking screw, the radius of the circular cross section of one end of the fixing support is gradually reduced to form a deformation end, the other end of the fixing support is provided with an installation groove extending along the axial direction and used for being inserted into the prosthesis handle and sliding along the installation groove, the prosthesis handle is connected with the artificial intervertebral disc prosthesis, the locking screw is screwed in the fixing support and abuts against the prosthesis handle to prevent the prosthesis handle from being separated from the installation groove, the tail end of a rod body, the thread of the locking part of the fixed support is matched with the internal thread of the fixed support, and the cone tip is used for screwing the drill hole of the screwdriver into the vertebral body.

Further, the deformation end is in a round table shape, and a bus of the deformation end is a straight line, or the deformation end is in a curved table shape, and the bus is an arc line.

Furthermore, a plurality of cutting grooves are vertically formed in the deformation end along the axis, so that the deformation end has certain expansibility in the radial direction.

Furthermore, the biological self-locking artificial intervertebral disc system comprises a propping screw, wherein the thread of the propping screw is matched with the internal thread of the fixed support and is used for screwing into the fixed support and propping the deformed end to increase the interaction force between the fixed support and the vertebral body and enhance the anti-extraction force of the fixed support.

Furthermore, a limiting sleeve is sleeved outside the screw in device, a through hole is formed in the limiting sleeve and used for the screw in device to be inserted, and the radius of the circular section of the limiting sleeve is larger than that of the circular section of the fixed support.

Further, the outer surface of the fixed support is physically modified and micropores are added to form a surface micropore structure.

A method for implanting the kit of the biological self-locking artificial intervertebral disc system comprises the following steps:

step S1: and (3) primarily drilling the vertebral body below the intervertebral by using a tapping drilling tool, gradually drilling from small to large to enlarge the aperture, wherein the aperture is smaller than the diameter of the fixed support after the primary drilling is finished.

Step S2: screwing the fixing support on the fixing support locking part of the screwdriver, aligning the conical tip with the hole groove which is drilled preliminarily in the step S1, further performing self-tapping drilling, screwing the fixing support into the vertebral body and keeping the fixing support in the vertebral body, and withdrawing the screwdriver;

step S3: installing the artificial intervertebral disc prosthesis and the prosthesis handle which are connected into a whole along the installation groove, inserting the prosthesis handle into the installation groove, and placing the artificial intervertebral disc prosthesis between an upper vertebral body and a lower vertebral body to replace the original intervertebral disc;

step S4: the locking screw is screwed into the fixed bracket, and the position of the prosthesis handle is locked and fastened by abutting against the prosthesis handle.

Further, the following steps are included between step S2 and step S3: and screwing the spreading screw into the deformation end of the fixed support to expand the deformation end.

Further, step S2 includes the following steps: in the operation process, an intraoperative C-arm machine is used for X-ray fluoroscopy, the screwing depth of the screw driver is monitored, when the conical tip of the screw driver approaches to the spinal cord, the screw driver is replaced by the existing universal flat head screw driver, and the fixing support is screwed into the preset depth.

Further, step S1 is preceded by the following steps: the limiting sleeve is sleeved on the driver.

Compared with the prior art, the invention has the following beneficial effects:

1. the invention increases the self-tapping function of the biological self-locking artificial intervertebral disc system and the screwdriver through design, so that in the artificial intervertebral disc replacement, after primary drilling, the fixing bracket is matched with the screwdriver to perform self-tapping and screwed into the hole, the hole is screwed in one step, the fixing bracket is fixed in the vertebral body more appropriately, the anti-extraction force is increased, the defect that the diameter of the drilled hole is not matched with that of the fixing bracket is avoided, the error tolerance rate is high because the hole is drilled step by step in the operation process, the operation difficulty is greatly reduced, the operation time is reduced, and compared with the prior art, the bone drilling operation is performed through trephine bone taking, and the bone bleeding is reduced.

2. The invention improves the fixing bracket of the artificial intervertebral disc, vertically cuts a groove at one end of the fixing bracket, and then screws the expansion screw into the fixing bracket to realize the expansion effect of the deformation end of the fixing bracket, and increases the anti-pull-out force on the premise of realizing the self-tapping function, so that the fixing bracket is more stable and stable in the vertebral body and is not easy to withdraw, shift and fall off.

3. The invention has wider application range, can be applied to cervical vertebra, lumbar vertebra and thoracic vertebra, and can correspondingly change the size and the shape of the biological self-locking artificial intervertebral disc system and the shape of the artificial intervertebral disc according to the operation requirement in actual operation.

4. The invention has simple structure and convenient manufacture.

Drawings

FIG. 1 is a schematic view of a bio-self-locking type artificial intervertebral disc system in a state after being implanted into a vertebral body;

FIG. 2 is an exploded view of a bio-self-locking artificial disc system;

FIG. 3 is a perspective view of the spinner;

FIG. 4 is a front view of the assembled bio-self-locking artificial disc system;

FIG. 5 is a schematic view of an implant assembly process of a bio-self-locking type artificial disc system;

fig. 6 is an exploded view of the artificial disc.

The reference numerals are explained below:

1-artificial intervertebral disc system of biological self-locking type; 11-a fixed support; 111-external threads; 112-internal thread; 113-a mounting groove; 114-deformed end; 115-cutting groove; 12-an artificial intervertebral disc prosthesis; 13-a prosthesis stem; 14-distraction screws; 15-locking screws; 2-a spinner; 21-cone tip; 22-fixed support locking part; 23-a limit sleeve; 3-vertebral body.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the invention and are not intended to limit the invention.

Referring to fig. 2 and 3 together, the kit of the bio-self-locking artificial intervertebral disc system according to the preferred embodiment of the present invention comprises two parts, a bio-self-locking artificial intervertebral disc system 1 and a screw driver 2, wherein the bio-self-locking artificial intervertebral disc system 1 is implanted into a human or animal vertebra for replacing intervertebral discs, and the screw driver 2 is used in cooperation with the human or animal vertebra for self-tapping drilling of a vertebral body 3.

The biological self-locking type artificial intervertebral disc system 1 comprises 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 support 11 is generally a tubular structure, and the outer surface of the fixing support 11 is provided with external threads 111 to facilitate the fixing support 11 to be screwed into the vertebral body 3; the inner surface of the fixing bracket 11 is provided with an internal thread 112, and the thread is matched with the threads of the distraction screw 14 and the locking screw 15, namely, the distraction screw 14 and the locking screw 15 can be screwed into the fixing bracket 11; the radius of the circular section at one end of the fixed bracket 11 is gradually reduced to form a deformation end 114, preferably, a plurality of cutting grooves 115 are vertically formed on the deformation end 114 along the axis, when the distraction screw 14 is screwed into the deformation end 114 of the fixed bracket 11, the distraction screw 14 can expand the deformation end 114 to the outer periphery because of the cutting grooves 115, so that the interaction force between the fixed bracket 11 and the vertebral body 3 is increased, and the pull-out resistance force of the fixed bracket 11 is enhanced; the other end of the fixing bracket 11 is provided with an axially extending mounting groove 113 for sliding into the prosthesis stem 13, the prosthesis stem 13 is connected with the artificial intervertebral disc prosthesis 12, and preferably, the artificial intervertebral disc prosthesis 12 and the prosthesis stem 13 are detachably connected, as shown in fig. 6, so that the maintenance and replacement of the artificial intervertebral disc prosthesis are facilitated, and only the artificial intervertebral disc prosthesis and the prosthesis stem need to be removed for replacement. Preferably, the fixing support 11, the prosthesis handle 13, the locking screw 15 and the spreading screw 14 are made of titanium alloy, the artificial intervertebral disc prosthesis 12 is made of high molecular polyethylene, and the shape of the upper surface of the artificial intervertebral disc prosthesis 12 is matched with the shape of the lower surface of the vertebral body 3 above the artificial intervertebral disc prosthesis.

As shown in fig. 3, the screw driver 2 is T-shaped, the end of the rod body of the screw driver 2 is provided with a fixing support locking portion 22 and a cone point 21, the surfaces of the fixing support locking portion 22 and the cone point 21 are provided with threads, and the threads of the fixing support locking portion 22 are matched with the internal threads 112 of the fixing support 11. Preferably, the screw driver 2 is sleeved with a limiting sleeve 23, a through hole is formed in the limiting sleeve 23, as shown by a dotted line in fig. 3, so that a rod body of the screw driver 2 can be inserted into the through hole, a circular cross section of the tail end of the limiting sleeve 23 is larger than a circular cross section of the fixing support 11, and the limiting sleeve 23 has a stop limiting function, so that a vertebral body can be prevented from being drilled too deeply. When the self-tapping implant is used, the limiting sleeve 23 is firstly sleeved outside the screwdriver 2, then the fixing support 11 is screwed on, and then the self-tapping implant is carried out on the vertebral body.

For the deformation end 114 of the fixing bracket 11 of the present invention, two different solutions are provided, please refer to the partial enlarged view in fig. 5, one is that the deformation end 114 is in a circular truncated cone shape, and the generatrix is a straight line; the other is that the deformation end 114 is in a curved table shape, the generatrix is an arc line, and the conical tip 21 of the screwdriver 2 is subjected to radian processing to be matched with the deformation end 114.

Furthermore, the outer surface or the inner surface of the fixing support 1 is physically modified to form a surface microporous structure, compared with the traditional fixing support, the surface of the fixing support is provided with micron-sized micropores, so that 2 advantages are achieved, one is that the micropores are beneficial to osteoblast growth, namely bone growth; the other is that the micropores reduce the surface elastic modulus and reduce the occurrence probability of implant loosening.

The self-tapping function of the biological self-locking type artificial intervertebral disc system and the spinner is increased through design, so that the fixing bracket is more appropriately fixed in the vertebral body, the anti-extraction force is increased, the defect that the diameter of a drilled hole is not matched with that of the fixing bracket is avoided, the operation process is gradual drilling, the fault tolerance rate is high, the operation difficulty is greatly reduced, the operation time is reduced, and compared with the prior art, the bone trepanning and bone taking are reduced in the drilling operation; the fixing support of the artificial intervertebral disc is improved, one end of the fixing support is vertically grooved, and then the expansion screw is screwed into the fixing support, so that the expansion effect of the deformation end of the fixing support is realized, and under the premise of realizing the self-tapping function, the anti-extraction force is increased, so that the fixing support is more stable and stable in the vertebral body and is not easy to withdraw, shift and fall off; the application range is wide, the artificial intervertebral disc can be applied to cervical vertebra, lumbar vertebra and thoracic vertebra, and the size and the shape of the biological self-locking artificial intervertebral disc system and the shape of the artificial intervertebral disc can be correspondingly changed according to the operation requirement in the actual operation; the structure is simple, and the manufacture is convenient.

Referring to fig. 5, the present invention is used for artificial disc replacement surgery:

before an operation, CT and X-ray data need to be accurately measured, the anterior-posterior diameter of the cervical vertebra of a patient is known, an intervertebral disc system with a proper size is selected, the front side of the artificial intervertebral disc prosthesis 12 is basically flush with the front edge of the vertebral body 3, the rear side of the artificial intervertebral disc prosthesis is flush with the front edge of the vertebral canal, and the artificial intervertebral disc prosthesis cannot be deeper than the vertebral canal, because the spinal cord is arranged in the vertebral canal, the spinal cord is pressed if the spinal cord;

firstly, preliminarily drilling a vertebral body 3 below an intervertebral, using tapping drilling tools with different sizes to successively drill from small to large, and gradually enlarging the aperture in different times, wherein the fixed support 11 is large in size and cannot be tapped at one time, and the vertebral body 3 is broken after being enlarged due to direct tapping, so that preliminary drilling needs to be gradually carried out from small to large in tapping, and the aperture is smaller than the diameter of the fixed support 11 after the preliminary drilling is finished;

next, screwing the fixing support 11 on a fixing support locking part 22 of the screwdriver 2, aligning a conical tip 21 with a hole groove which is drilled preliminarily in the previous step, further performing self-tapping drilling, screwing the fixing support 11 into the vertebral body 3, and withdrawing the screwdriver 2, wherein in the operation, X-ray fluoroscopy needs to be performed by using an intraoperative C-arm machine for multiple times, the screwing depth of the screwdriver 2 is monitored, when the conical tip 21 of the screwdriver 2 is close to the spinal cord, the screwdriver 2 is replaced by a conventional universal flat-head screwdriver, and the fixing support 11 is screwed into a preset depth, because if the screwdriver 2 is screwed too deep, the conical tip 21 of the screwdriver 2 enters the vertebral canal, so that the spinal cord is pressed;

further screwing the expansion screw 14 into the deformed end 114 of the fixed bracket 11 to expand and unfold the deformed end 114;

the artificial intervertebral disc prosthesis 12 and the prosthesis handle 13 which are connected into a whole slide in along the installation groove 113, the prosthesis handle 13 is arranged in the installation groove 113, the artificial intervertebral disc prosthesis 12 is positioned between the upper vertebral body 3 and the lower vertebral body 3, and the original intervertebral disc is replaced;

the locking screw 15 is screwed into the fixed stent 11, locking the prosthesis stem 13 in position and tightening by holding against the prosthesis stem 13. In this way, the assembled implant is completed, with a right side view as shown in fig. 1 and a front view as shown in fig. 4.

The above description is only for the preferred embodiment of the present invention and is not intended to limit the scope of the present invention, and all equivalent structural changes made by using the contents of the present specification and the drawings, or any other related technical fields, are equally encompassed.