A split type intervertebral fusion device for the cervical vertebra

Abstract

The present invention relates to the field of medical devices and discloses a split intervertebral fusion device for the cervical spine, which is suitable for treating and improving congenital diseases, deformities, degenerative diseases, cervical disc herniation, cervical fractures and other diseases of the cervical spine, effectively relieving nerve compression, improving clinical symptoms, and achieving better fusion effects.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a split intervertebral fusion device for the cervical spine, which is suitable for treating and improving congenital diseases, deformities, degenerative diseases, cervical disc herniation, cervical fractures and other diseases of the cervical spine, effectively relieving nerve compression, improving clinical symptoms, and achieving better fusion effects. Background Art

[0002] Degenerative lesions and trauma of the cervical intervertebral disc caused by various reasons often lead to disc herniation, destroying the integrity of the disc structure and causing the disc to lose its original function of movement and load bearing, causing people to suffer from symptoms such as pain and neurological dysfunction, which seriously affects people's daily activities. When conservative treatment of cervical intervertebral disc disease is ineffective, surgical treatment is generally required. Currently, commonly used surgical methods include discectomy and discectomy and fusion, but both the former and the latter destroy the normal movement and load bearing function of the diseased segment, and also change the biomechanical state of the adjacent segment intervertebral disc and other tissues, leading to aggravated degeneration of the adjacent segment. Therefore, their long-term efficacy is poor. For this reason, people have invented artificial intervertebral disc prostheses to reconstruct the function of the intervertebral disc and restore the normal physiological function of the cervical spine.

[0003] As a commonly used implantable artificial intervertebral disc prosthesis, intervertebral fusion devices have some special requirements in terms of material properties. For example, they must have good biocompatibility, non-toxicity, non-carcinogenicity, and corrosion resistance, and should not cause local tissue reactions after implantation. These are the basic requirements for artificial intervertebral disc prosthesis materials. In addition, from a biomechanical perspective, since the intervertebral disc is subject to multiple loads such as compression, bending, torsion, and shear under physiological conditions, and is the load-bearing axis of the functional unit of the spine, the material must also have performance conditions such as high strength, wear resistance, and fatigue resistance. The endplate of the artificial intervertebral disc prosthesis contacts the vertebral endplate bone, and the elastic modulus of their contact interface should be matched as much as possible, that is, the elastic modulus of the endplate should be close to that of the bone tissue. This can effectively avoid sinking and loosening of the implant. Currently, there are many artificial intervertebral disc prostheses, which can be divided into three types according to the different constituent materials: non-metallic, metal, and a combination of the two. In addition to the above-mentioned material requirements, there are also relatively strict requirements in terms of mobility, stability, safety, etc. The artificial intervertebral disc prosthesis needs to obtain immediate and long-term fixation when implanted. During use, the physiological activity performance of the replaced segment should be restored as much as possible, including the range of motion and rotation axis in multiple directions, so that the artificial intervertebral disc prosthesis can be synchronized with the spinal movement of multiple adjacent segments. Secondly, the artificial intervertebral disc prosthesis should also be easy and safe to install, with minimal surgical trauma, and easy to remove and renovate the prosthesis, so as to play its due role in clinical treatment.

[0004] However, due to the complexity of the physiological structure and biomechanical properties of the intervertebral disc and the lack of suitable animal models for animal research, the research and development of artificial intervertebral discs is relatively difficult. People are eager to obtain a new artificial intervertebral disc prosthesis with a reasonable structure and excellent material properties, so that it can better adapt to the intervertebral anatomy and biomechanical performance requirements of the cervical spine, completely replace the cervical intervertebral disc, and treat cervical intervertebral disc diseases. At present, there is still great potential in the shape design, fixation method, mechanical property improvement and bone fusion improvement of cervical intervertebral fusion devices. There are still many problems such as unstable fixation, inaccurate positioning, inconvenient operation, poor mechanical adaptability, easy recurrence after treatment, and unsatisfactory fusion effect. We try to make it closer and closer to people's expectations in order to achieve good clinical treatment effects. Summary of the Invention

[0005] The purpose of the present invention is to provide a split intervertebral fusion device for the cervical spine to solve the above-mentioned problems existing in the prior art, so that the artificial cervical intervertebral fusion device has a shape and structure that is compatible with the natural intervertebral disc, has suitable stability, accurate positioning and better biocompatibility, and enables the intervertebral fusion device to carry drugs and effectively release them, thereby improving the fusion effect and the one-time success rate of implantation, avoiding displacement and complications, making the operation more convenient, shortening the treatment time, reducing the possibility of revision, reducing the surgical risk, and ensuring the mobility, safety and reliability of the intervertebral fusion device implantation.

[0006] To achieve the above-mentioned purpose, the present invention provides a split intervertebral fusion device for cervical vertebrae, comprising a fusion device body and an auxiliary fixation structure, wherein the fusion device body comprises a main frame, a closed filling cavity, a mesh plate, an elastic corrugated plate, fixed balls, strip grooves, auxiliary fixation threaded holes, drug sustained-release holes and other basic structures, wherein the main frame is a hollow tetrahedron and has a front end plate, a rear end plate, a left side, a right side, a top surface and a bottom surface, wherein the left side, top surface, right side and bottom surface are connected to each other end to end as a whole to form a main frame body, the upper ends of the front end plate and the rear end plate are connected to the mesh plate, and the lower ends are connected to the bottom surface, The lower half of the main frame is provided with a closed filling cavity, which is surrounded by the front end plate, bottom surface, rear end plate, left side surface, right side surface and mesh plate, and is filled with a mixture of medicine and transplanted bone; the upper half of the main frame is provided with an elastic corrugated plate, the left and right sides of the elastic corrugated plate are fixedly connected to the left side surface and the right side surface and pass through the interior of the main frame in the front-to-back direction, the top surface and / or the bottom surface are densely covered with fixed balls with protruding outer surfaces, the fixed balls are hemispherical, and after implantation, the curved spherical surface of the fixed balls directly abuts against the human vertebrae; the outer surfaces of the left and right sides are fixedly connected to the left and right sides. The sides are respectively provided with at least two strip grooves, namely a first strip groove and a second strip groove, the first strip groove is located in the upper half of the main frame, and is a non-penetrating sinking groove, the second strip groove is located in the lower half of the main frame, and is a through groove that penetrates the left side or the right side, the lower halves of the left side and the right side are both covered with mesh holes for sustained drug release, the upper halves of the left side and the right side have no mesh holes, the bottom surface is provided with a plurality of circular or elliptical drug sustained release holes for drug release, the diameter of the drug sustained release holes is larger than the diameter of the mesh holes; the front end plate has a plurality of auxiliary fixing threaded holes, the auxiliary fixing The fixed threaded holes have at least four columns and are neatly arranged in two rows. The front end of the top surface is provided with a first development mark vertically aligned with the auxiliary fixing threaded holes in the same column; the auxiliary fixing structure is a two-line fixing plate, each of the strip fixing plates is provided with two screw holes corresponding to the auxiliary fixing threaded holes in the same column in the middle position, and each of the two ends of the strip fixing plate is also provided with screw holes for screws to pass through, the screw holes located at both ends of the strip fixing plate are perpendicular to the strip fixing plate or inclined away from the fusion device body, and a second development mark is provided near the upper end of the strip fixing plate, which can coincide with the first development mark after implantation.

[0007] The top surface and the bottom surface are respectively convex arc-shaped surfaces, and are made of an elastic material with certain supporting properties. The fixing beads are fixed to the top surface and / or the bottom surface by means of inlaying, integral molding, welding, etc., and can also be bonded and fixed by a biocompatible adhesive. The fixing beads are made of the same or different material as the top surface, and the fixing beads contain a small amount (less than 2%) of a drug that can inhibit cell proliferation. The outer surface of the fixing beads is roughened and coated with a drug layer that can promote prosthetic fusion. In this way, the bone tissue at the joint of the fusion device and the cervical vertebra at the initial implantation stage can be promoted to grow into the intervertebral fusion device, and fusion with the fusion device can effectively avoid excessive growth and tissue stacking, thereby avoiding re-protrusion of the intervertebral disc. Through the reasonable combination of drugs, the biocompatibility and implant stability of the intervertebral fusion device are further enhanced, and recurrence is not easy after treatment, and the fusion effect is better.

[0008] Furthermore, the elastic corrugated plates are arranged in 2-3 numbers, and the distance between the crest of the elastic corrugated plate close to the top surface and the top surface is 0.3-0.7 mm. The elastic corrugated plates work together to provide support and elastic buffering for the top surface and the left and right sides, thereby preventing the sinking and loosening of the fusion device body, while allowing the elastic deformation of the top surface to the maximum extent, so as to facilitate the implantation operation and further ensure the stability of the implantation.

[0009] Furthermore, the first strip groove is located between the mesh plate and the bottommost elastic corrugated plate, and the cross-section of the first strip groove is trapezoidal, that is, the first strip groove is in the shape of a trumpet with a larger outer opening, which is more conducive to tissue growth. The inner wall of the first strip groove is provided with a drug coating that can promote tissue growth, including but not limited to growth factors, cytokines, extracellular matrix molecules, cell attachment sequences, nanohydroxyapatite, a complex of nanohydroxyapatite and collagen, etc.; the second strip groove is located below the mesh plate, and its cross-section is rectangular, or trapezoidal with an outer opening smaller than an inner opening.

[0010] Furthermore, a connecting threaded hole is provided in the middle position of the front end for the prosthesis installer to be quickly connected to the fusion device. The aperture of the connecting threaded hole is larger than the aperture of the auxiliary fixing threaded holes on both sides. In addition, as a preference, arc-shaped development marks can also be provided on the left and right edges or the upper and lower edges of the connecting threaded hole to facilitate accurate positioning.

[0011] The drug-release holes on the bottom surface run through the entire bottom surface. If the bottom surface also has fixed balls, the drug-release holes are scattered between adjacent fixed balls, thereby facilitating the release of the drug filled in the closed filling cavity; there are gaps between the fixed balls on the top surface, and the gaps are densely covered with a mesh structure running through the top surface.

[0012] Preferably, the drug filled in the closed filling cavity is a bioactive agent, which can be a specific drug, growth factor, cytokine, extracellular matrix molecule, protein or a combination thereof, including but not limited to osteogenic or cartilage-forming proteins or peptides, bone promoters, bone digestive agents, anti-tumor agents, cell attractants, adhesion agents, anti-AIDS substances, antibiotics, anti-inflammatory drugs, anti-osteoporosis drugs, immunosuppressants, antiviral substances, enzyme inhibitors, hormones, neurotoxins, opioids, antihistamines, muscle relaxants and anti-Parkinson's disease substances, antispasmodics and muscle contractants, antiparasitic and / or antiprotozoal compounds, regulators of cell-extracellular matrix interactions (including cell growth inhibitors and anti-adhesion molecules), vasodilators, DNA, RNA or protein synthesis inhibitors, antihypertensive drugs, analgesics, local anesthetics, steroidal and non-steroidal anti-inflammatory agents, bone morphogenetic proteins, anti-angiogenic factors, angiogenic factors, antisecretory factors, anticoagulants and / or antithrombotic agents, imaging agents, etc. Bioactive agents also include RNA, such as siRNA and osteoclast stimulating factors; in some embodiments, bioactive agents can be factors that stop, remove, or reduce the activity of bone growth inhibitors; in some embodiments, bioactive agents can also be growth factors, cytokines, extracellular matrix molecules, or fragments or derivatives thereof, such as cell attachment sequences, such as RGD. The layout of the drugs filled in the closed filling cavity is as follows: drugs close to the main frame are mainly used to promote tissue growth or adhesion, while drugs adjacent to it are mainly used for anti-inflammatory and inhibition of excessive tissue growth. The drugs are attached to the transplanted bone or evenly distributed between the transplanted bones. The drugs filled in the closed filling cavity can promote the growth of surrounding tissues into the intervertebral fusion cage, and fusion with the fusion cage can effectively avoid excessive growth that causes tissue stacking and avoids compression of peripheral nerves.

[0013] Furthermore, the auxiliary fixing structure can be connected to the auxiliary fixing threaded hole on the front end plate through screws, and the auxiliary fixing structure can be positioned by coordinating the first developing mark and the second developing mark, and after the implantation of the target position is determined to be completed, it is fixed to the adjacent vertebrae through the screw holes at both ends of the strip fixing plate.

[0014] The length of the auxiliary fixing structure is substantially the same as the width of the fusion device body. During implantation, the auxiliary fixing structure can be pre-connected to the fusion device body via a screw. At this time, the auxiliary fixing structure can rotate relative to the fusion device body. After the fusion device body is implanted to the target position, the auxiliary fixing structure is rotated to the correct position, i.e., the position where the first development mark and the second development mark coincide, and the remaining screws are fixed.

[0015] Preferably, the front end plate is larger than the rear end plate, and the front end face of the fusion device body is larger than the rear end face, that is, the fusion device body tends to gradually become smaller from front to back.

[0016] Furthermore, the length of the auxiliary fixing structure is substantially the same as the width of the fusion device body. During implantation, the auxiliary fixing structure can be pre-connected to the fusion device body via a screw. At this time, the auxiliary fixing structure can rotate relative to the fusion device body. After the fusion device body is implanted to the target position, the auxiliary fixing structure can be rotated to the correct position and the fusion device body can be fixed to the human vertebrae via screws.

[0017] Furthermore, the outer surfaces of the left and right sides are also provided with a third strip groove, and the third strip grooves are all located in the lower half of the main frame, and are through grooves that pass through the left or right side. The third strip grooves are arranged parallel to the second strip grooves and at the same time parallel to the first strip grooves, or the third strip grooves are arranged crosswise with the second strip grooves.

[0018] Compared with the prior art, the present invention has the following beneficial technical effects:

[0019] The present invention solves the shortcomings of the cervical intervertebral fusion device in the prior art, such as unstable fixation, inaccurate positioning, inconvenient operation, poor mechanical adaptability, recurrence after treatment, and unsatisfactory fusion effect, and meets the patient's needs for treatment effect and doctor's convenience of surgical operation. Among them, the setting of the fixing beads on the top and / or bottom surface of the fusion device body allows the curved spherical surface of the fixing beads to achieve gentle fixation when it abuts against the human vertebra, which can prevent the loosening and falling of the fusion device and is not easy to cause damage to the human vertebra, making the application and operation safer and more reliable. The fixing beads contain drugs that can inhibit the proliferation of smooth muscle cells and are coated with a drug layer on the outer surface that can promote the fusion of prostheses, thereby promoting the growth of bone tissue at the joint between the fusion device and the cervical vertebra into the intervertebral fusion device at the initial implantation stage and fusion with the fusion device, and effectively avoiding excessive growth and tissue stacking, avoiding secondary herniation of the intervertebral disc, and further enhancing intervertebral fusion. The device has good biocompatibility and implant stability, is not prone to recurrence after treatment, and has a good fusion effect; the multiple strip grooves on the left and right sides, and the drug-release holes on the bottom are not only more conducive to the growth of surrounding tissues, but also can play a role in drug release. Combined with the unique distribution of the drugs filled in the filling cavity, it can promote the growth of surrounding tissues into the intervertebral fusion device and fusion with the fusion device, which can effectively avoid excessive growth and tissue stacking, and avoid compression of peripheral nerves; in addition, the arrangement of multiple elastic corrugated plates can support and elastically buffer the top surface and the left and right sides, avoiding sinking and loosening of the fusion device body, while allowing the top surface to deform elastically to the maximum extent, so as to facilitate implantation operation and further ensure the stability of implantation. The reasonable coordination of various structures forms an organic whole, and the synergistic effect solves the above-mentioned shortcomings in the existing technology and achieves good clinical treatment effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1It is a schematic diagram of the overall structure of the fusion device body of the present invention.

[0021] Figure 2 It is a cross-sectional view of the fusion device body of the present invention.

[0022] Figure 3 It is a structural schematic diagram of the auxiliary fixing structure of the present invention. DETAILED DESCRIPTION

[0023] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. All other related embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0024] Example 1

[0025] See attached Figure 1-3 As shown, the present invention proposes a split intervertebral fusion device for cervical vertebrae, comprising a fusion device body 1 and an auxiliary fixation structure 2, wherein the fusion device body 1 comprises a main frame, a closed filling cavity 3, a mesh plate 4, an elastic corrugated plate 5, a fixed ball 6, a strip groove, an auxiliary fixing threaded hole 7, a drug sustained-release hole 8 and other basic structures, wherein the main frame is a hollow tetrahedron, and has a front end plate 9, a rear end plate 10, a left side 11, a right side 12, a top surface 13 and a bottom surface 14, wherein the left side 11, the top surface 13, the right side 12 and the bottom surface 14 are connected to each other end to end as a whole to form a main frame body, the upper ends of the front end plate 9 and the rear end plate 10 are connected to the mesh plate 4, and the lower ends are connected to the bottom surface 14, the lower half of the main frame is provided with a closed filling cavity 3, the closed filling cavity The cavity 3 is surrounded by the front end plate 9, the bottom surface 14, the rear end plate 10, the left side 11, the right side 12 and the mesh plate 4, and is filled with a mixture of medicine and transplanted bone 15; the upper half of the main frame is provided with an elastic corrugated plate 5, the left and right sides of the elastic corrugated plate 5 are fixedly connected to the left side 11 and the right side 12 and pass through the interior of the main frame in the front-to-back direction, the top surface 13 or the bottom surface 14 is densely covered with fixed balls 6 with protruding outer surfaces, the fixed balls 6 are hemispherical, and after implantation, the curved spherical surface of the fixed balls 6 directly abuts against the human vertebrae. Compared with traditional fixed teeth, gentle fixation can be achieved when the fixed balls 6 abut against the human vertebrae, which can prevent the loosening and falling off of the fusion device body 1, and is not easy to cause damage to the human vertebrae, making the application safer and more reliable; Figure 1-2As shown, the outer surfaces of the left side 11 and the right side 12 are respectively provided with two strip grooves, namely a first strip groove 16 and a second strip groove 17. The first strip groove 16 is located in the upper half of the main frame, and the second strip groove 17 is located in the lower half of the main frame. The lower halves of the left side 11 and the right side 12 are both provided with mesh holes for sustained drug release. The upper halves of the left side 11 and the right side 12 have no mesh holes. The bottom surface 14 is provided with a plurality of circular or elliptical drug release holes 8 for drug release. The diameter of the drug release hole 8 is larger than the diameter of the mesh hole, which not only plays a role in sustained drug release, but also facilitates the growth of surrounding tissues. The front end plate 9 has a plurality of auxiliary fixing threaded holes 7. In this embodiment, the auxiliary fixing threaded holes 7 are provided in four columns and neatly arranged in two rows. The front end portion of the top surface 13 is provided with a first development mark 18 vertically aligned with the auxiliary fixing threaded holes 7 in the same column; the auxiliary fixing structure 2 is a two-line fixing plate 19, each of the strip-shaped fixing plates 19 is provided with two screw holes 20 corresponding to the auxiliary fixing threaded holes 7 in the same column in the middle position, and each of the two ends of the strip-shaped fixing plate 19 is also provided with screw holes 22 for screws 21 to pass through, and a second development mark 23 is provided near the upper end of the strip-shaped fixing plate 19, which can coincide with the first development mark 18 after implantation.

[0026] The first strip groove 16 is a non-through sinking groove, and the second strip groove 17 is a through groove that penetrates the left side or the right side. Furthermore, the first strip groove 16 is located between the mesh plate 4 and the lowermost elastic corrugated plate 5. The cross-section of the first strip groove 16 is trapezoidal, that is, the first strip groove 16 is a trumpet-shaped with a larger outer opening, which is more conducive to tissue growth. The inner wall of the first strip groove 16 is provided with a drug coating that can promote tissue growth, including but not limited to growth factors, cytokines, extracellular matrix molecules, cell attachment sequences, nanohydroxyapatite, a complex of nanohydroxyapatite and collagen, etc.; the second strip groove 17 is located below the mesh plate 4, and its cross-section is rectangular, or a trapezoidal shape with an outer opening smaller than the inner opening, so as to allow tissue growth while being more conducive to the release of the drug filled in the closed filling cavity.

[0027] The top surface 13 and the bottom surface 14 are respectively convex arc-shaped surfaces, and are made of an elastic material with certain supporting properties. The fixed ball 6 is fixed to the top surface 13 or the bottom surface 14 by means of inlaying, integral molding, welding, etc., and can also be bonded and fixed by a biocompatible adhesive. The fixed ball 6 is made of the same or different material as the top surface 13 or the bottom surface 14, and the fixed ball 6 contains a small amount (less than 2%) of drugs that can inhibit cell proliferation, including sirolimus, tacrolimus, irolimus, immunosuppressant ABT-578, C-proteinase inhibitor, 3-hydroxylase inhibitor, methylprednisolone, dexamethasone, mizoribine, rapamycin, paclitaxel and its derivatives, actinomycin, doxorubicin, dactinomycin, mitomycin, vincristine and its derivatives, statins, 2-chlorodeoxyadenosine, ribozymes, Bama Any one or more of the active drugs such as statin, probucol, estradiol, etc., the outer surface of the fixed ball 6 is roughened and coated with a drug layer that can promote prosthetic fusion, including bone morphogenetic protein, stem cells, CD31 antibody, CD133 antibody, CD34 antibody, CD45 antibody, Klotho protein, extracellular matrix (ECM), glial cell-derived neurotrophic factor and endothelial growth factor (VEGF), and any one or more of vascular growth factor, thereby promoting the growth of bone tissue at the joint of the fusion device and the cervical vertebra into the intervertebral fusion device at the initial implantation stage and fusion with the fusion device, and effectively avoiding excessive growth to cause tissue stacking, thereby avoiding causing re-protrusion of the intervertebral disc, and through the reasonable combination of drugs, further enhancing the biocompatibility and implant stability of the intervertebral fusion device, and not prone to recurrence after treatment, and having a better fusion effect.

[0028] Furthermore, the elastic corrugated plates 5 are provided in 2-3 numbers, and the distance between the crest of the elastic corrugated plate 5 close to the top surface 13 and the top surface is 0.3-0.7 mm. The elastic corrugated plates 5 work together to support and elastically buffer the top surface 13 and the left side 11 and the right side 12, thereby preventing the sinking and loosening of the fusion device body 1, while allowing the elastic deformation of the top surface 13 to the maximum extent, so as to facilitate the implantation operation and further ensure the stability of the implantation.

[0029] Furthermore, a connecting threaded hole 24 is provided in the middle of the front end plate 9 for the prosthesis installer to be quickly connected to the fusion device. The aperture of the connecting threaded hole 24 is larger than the apertures of the auxiliary fixing threaded holes 7 on both sides.

[0030] The drug-releasing holes 8 on the bottom surface 14 pass through the entire bottom surface 14. If the bottom surface 14 also has fixed beads 6, the drug-releasing holes are scattered between adjacent fixed beads 6, thereby facilitating the release of the drug filled in the closed filling cavity; there are gaps between the fixed beads 6 on the top surface 13, and the gaps are densely covered with a mesh structure that passes through the top surface 13.

[0031] Preferably, the drug filled in the closed filling cavity 3 is a bioactive agent, which can be a specific drug, growth factor, cytokine, extracellular matrix molecule, protein or a combination thereof, including but not limited to osteogenic or cartilage-forming proteins or peptides, bone promoters, bone digestive agents, anti-tumor agents, cell attractants, adhesion agents, anti-AIDS substances, antibiotics, anti-inflammatory drugs, anti-osteoporosis drugs, immunosuppressants, antiviral substances, enzyme inhibitors, hormones, neurotoxins, opioids, antihistamines, muscle relaxants and anti-Parkinson's disease substances, antispasmodics and muscle contractants, antiparasitic and / or antiprotozoal compounds, regulators of cell-extracellular matrix interactions (including cell growth inhibitors and anti-adhesion molecules), vasodilators, DNA, RNA or protein synthesis inhibitors, antihypertensive drugs, analgesics, local anesthetics, steroidal and non-steroidal anti-inflammatory agents, bone morphogenetic proteins, anti-angiogenic factors, angiogenic factors, antisecretory factors, anticoagulants and / or antithrombotic agents, imaging agents, etc. Bioactive agents also include RNA, such as siRNA and osteoclast-stimulating factors. In some embodiments, bioactive agents can be factors that inhibit, remove, or reduce the activity of bone growth inhibitors. In some embodiments, bioactive agents can also be growth factors, cytokines, extracellular matrix molecules, or fragments or derivatives thereof, such as cell attachment sequences, such as RGD. The layout of the drugs filled in the closed filling cavity 3 is as follows: drugs close to the main frame primarily promote tissue growth or adhesion, while drugs adjacent to it primarily provide anti-inflammatory effects and inhibit excessive tissue growth. These drugs adhere to the bone graft or are evenly distributed between the bone grafts. The drugs filled in the closed filling cavity 3 promote the ingrowth of surrounding tissues into the intervertebral fusion cage, while fusion with the cage effectively prevents excessive ingrowth that could cause tissue stacking and compression of peripheral nerves.

[0032] Furthermore, the auxiliary fixing structure 2 can be connected to the auxiliary fixing threaded hole 7 on the front end plate 9 by means of screws, and the auxiliary fixing structure 2 is positioned by means of the first developing mark 18 and the second developing mark 23, and is fixed to the adjacent vertebrae through the screw holes 22 at both ends of the strip fixing plate 19 after the implantation of the target position is determined. Preferably, the channels of the screw holes 22 at both ends of the strip fixing plate 19 are perpendicular to the strip fixing plate 19 or inclined in the direction away from the fusion device body 1.

[0033] The length of the auxiliary fixing structure 2 is substantially the same as the width of the fusion device body 1. During implantation, the auxiliary fixing structure 2 can be pre-connected to the fusion device body 1 via a screw. At this time, the auxiliary fixing structure 2 can rotate relative to the fusion device body 1. After the fusion device body 1 is implanted to the target position, the auxiliary fixing structure 2 is rotated to the correct position, i.e., the position where the first developing mark 18 and the second developing mark 23 coincide with each other, and the remaining screws are fixed to fix the fusion device body 1 to the human vertebrae.

[0034] Example 2

[0035] See attached Figure 1-2 The structure of this embodiment is basically the same as that of embodiment 1, except that, in this embodiment, the top surface 13 and the bottom surface 14 are densely covered with fixed balls 6 protruding from the outer surface. The fixed balls 6 are fixed to the top surface 13 and the bottom surface 14 by inlaying, integral molding, welding, etc., and can also be bonded and fixed by a biocompatible adhesive; the elastic corrugated plate 5 can also be set to one, and the distance between the crest of the elastic corrugated plate 5 and the top surface is 0.2-0.6mm. The elastic corrugated plate 5 supports and elastically buffers the top surface 13 and the left side 11 and the right side 12, thereby preventing the fusion device body 1 from sinking and loosening, while allowing the top surface 13 to deform elastically to the maximum extent, so as to facilitate the implantation operation and further ensure the stability of the implantation.

[0036] Preferably, in this embodiment, arc-shaped developing marks may also be provided on the left and right edges or the upper and lower edges of the connecting threaded hole 24 to facilitate accurate positioning.

[0037] Example 3

[0038] See attached Figure 1-3 The structure of this embodiment is basically the same as that of embodiment 1 or embodiment 2, except that, in this embodiment, the outer surfaces of the left side 11 and the right side 12 are respectively provided with three strip grooves, namely the first strip groove 16, the second strip groove and the third strip groove. As in embodiment 1, the first strip groove 16 is located in the upper half of the main frame and is a non-through sunken groove. In this embodiment, the second strip groove and the third strip groove are both located in the lower half of the main frame and are through grooves that penetrate the left side or right side. The second strip groove and the third strip groove are arranged in parallel and at the same time parallel to the first strip groove 16, or the second strip groove and the third strip groove are arranged crosswise.

[0039] Furthermore, the front end plate 9 is larger than the rear end plate 10, and the front end face of the fusion device body 1 is larger than the rear end face, that is, the fusion device body 1 has a tendency to gradually become smaller from front to back, ensuring that the fusion device body 1 is consistent with the intervertebral space of the human cervical spine, so that it has better compliance and stability.

[0040] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the present invention can be implemented in other specific forms or combinations thereof without departing from the spirit or essential characteristics of the present invention. Therefore, and without limitation, the scope of the present invention is defined by the appended claims rather than the foregoing description, and all variations that come within the meaning and range of equivalents of the claims are intended to be encompassed within the present invention.

[0041] Furthermore, as is known to those skilled in the art, this embodiment may also additionally provide other structures to facilitate necessary control and operation during implantation or removal, without departing from the purpose of the invention and without structural interference between the various structures, and can be implemented by those skilled in the art.

[0042] In addition, it should be understood that although this specification is described in terms of implementation methods, not every implementation method contains only one independent technical solution. This narrative method of the specification is only for the sake of clarity. Those skilled in the art should regard the specification as a whole. The technical solutions in each embodiment can also be appropriately combined to form other implementation methods that can be understood by those skilled in the art.

Claims

1. A split intervertebral fusion cage for cervical vertebrae, comprising a fusion cage body and an auxiliary fixation structure, characterized in that: The fusion device body includes a main frame, a closed filling cavity, a mesh plate, an elastic corrugated plate, fixed balls, strip grooves, auxiliary fixing threaded holes, and drug release holes, wherein the main frame is a hollow tetrahedron structure and has a front end plate, a rear end plate, a left side, a right side, a top surface and a bottom surface, the left side, the top surface, the right side and the bottom surface are interconnected end to end to form a main frame body, the upper ends of the front end plate and the rear end plate are connected to the mesh plate, and the lower ends are connected to the bottom surface, the lower half of the main frame is provided with a closed filling cavity, the closed filling cavity is surrounded by the front end plate, the bottom surface, the rear end plate, the left side, the right side and the mesh plate, and is filled with a mixture of drugs and transplanted bone, the layout of the drugs filled in the closed filling cavity is as follows: the drugs close to the main frame are mainly capable of promoting tissue growth or adhesion, and the drugs adjacent to it are mainly anti-inflammatory and inhibiting tissue excessive growth, the drugs are attached to the transplanted bone or evenly distributed between the transplanted bones; the upper half of the main frame is provided with an elastic corrugated plate, the left and right sides of the elastic corrugated plate The two sides are fixedly connected to the left and right sides and pass through the interior of the main frame in the front-to-back direction, and the top and / or bottom surfaces are densely covered with fixing balls protruding from the outer surface, and the fixing balls are hemispherical; the outer surfaces of the left and right sides are respectively provided with at least two strip grooves, namely the first strip groove and the second strip groove, and the front end plate has a plurality of auxiliary fixing threaded holes, and the auxiliary fixing threaded holes are arranged in four rows and neatly arranged in two rows, and the front end of the top surface is provided with a first developing mark vertically aligned with the auxiliary fixing threaded holes in the same row; the auxiliary fixing structure is a two-line fixing plate, each of the strip fixing plates is provided with two screw holes corresponding to the auxiliary fixing threaded holes in the same row in the middle position, and each of the two ends of the strip fixing plates is also provided with screw holes for screws to pass through, and a second developing mark is provided near the upper end of the strip fixing plate that can coincide with the first developing mark after implantation; the fixing balls contain drugs that can inhibit cell proliferation, and the outer surface of the fixing balls is roughened and coated with a drug layer that can promote prosthesis fusion.

2. The intervertebral fusion cage according to claim 1, wherein the first strip groove is located in the upper half of the main frame, the second strip groove is located in the lower half of the main frame, the lower halves of the left and right sides are both provided with mesh holes for sustained drug release, and the bottom surface is provided with a plurality of circular or elliptical drug release holes for drug release, and the diameter of the drug release holes is larger than the diameter of the mesh holes.

3. The intervertebral fusion device according to claim 2, wherein the first strip groove is a non-penetrating sunken groove, and the second strip groove is a through groove penetrating the left side or the right side thereof, the cross section of the first strip groove is trapezoidal and is located between the mesh plate and the lowest elastic corrugated plate, and the inner wall of the first strip groove is provided with a drug coating that can promote tissue growth; the second strip groove is located below the mesh plate, and its cross section is rectangular or trapezoidal with an outer opening smaller than an inner opening.

4. The intervertebral fusion cage according to claim 1, wherein the top and bottom surfaces are respectively convex arc-shaped surfaces and are made of an elastic material with supporting properties. The fixing beads are fixed to the top or bottom surface by inlaying, integral molding, welding, etc., or can be bonded and fixed by a biocompatible adhesive. The fixing beads are made of the same or different material as the top or bottom surface.

5. The intervertebral fusion cage according to claim 1, wherein the number of the elastic corrugated plates is 2-3, the distance between the crest of the elastic corrugated plate close to the top surface and the top surface is 0.3-0.7 mm, and the elastic corrugated plates cooperate to provide support and elastic buffering for the top surface and the left and right sides.

6. The intervertebral fusion cage according to any one of claims 1-5, wherein a connecting threaded hole is provided in the middle of the front end plate for a prosthesis installer to be quickly connected to the cage, and the diameter of the connecting threaded hole is larger than the diameters of the auxiliary fixing threaded holes on both sides thereof.

7. The intervertebral fusion cage according to any one of claims 1 to 5, wherein the drug-release holes on the bottom surface penetrate the entire bottom surface; when fixed balls are also provided on the bottom surface, the drug-release holes are dispersed between adjacent fixed balls; and there are gaps between the fixed balls on the top surface, and the gaps are densely covered with a mesh structure that penetrates the top surface.

8. The intervertebral fusion cage according to any one of claims 1 to 5, wherein the drug filled in the closed filling cavity is a bioactive agent.

9. The intervertebral fusion device according to any one of claims 1 to 5, wherein the auxiliary fixation structure can be connected to the auxiliary fixation threaded hole on the front end plate by a screw, the auxiliary fixation structure is positioned by the first and second developing marks, and after the implantation is completed in the target position, it is fixed to the adjacent vertebrae through the screw holes at both ends of the strip fixation plate.

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