A modular self-stabilizing atlantoaxial lateral mass fusion device

Abstract

The present application relates to a kind of self-stabilizing atlantoaxial lateral mass fusion device of assembly, belong to medical instrument technical field, solve the technical problem that the fusion device of existing clinical use still needs to cooperate atlantoaxial pedicle screw or occipital screw to be fixed with auxiliary after being placed and patient adaptation is not good and unstable fixation.The present application includes fusion device, fixer and connecting assembly, fixer is bent structure, including vertical portion and the bent portion that vertical portion is bent and extends, fixer is connected with the rear end of fusion device by its vertical portion;Connecting assembly includes fixing piece and connecting piece, fixing piece is used to fix fusion device and fixer to lateral mass joint, and connecting piece is used to connect fixer and fusion device.The present application is combined with fusion device and fixer by assembly design, reduces the dependence on complex nail and rod system in traditional atlantoaxial fusion surgery, and the bending design of fixer allows angle adjustment, so that it can better fit the anatomical structure of different patients.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of medical devices, and particularly relates to a combined self-stabilizing atlantoaxial lateral mass fusion device. BACKGROUND

[0002] As the uppermost two vertebrae at the junction of the spine and the skull, the atlantoaxial vertebrae are prone to diseases in the region, especially atlantoaxial dislocation caused by congenital developmental abnormalities or rheumatic immune diseases, which easily leads to compression of the upper cervical spinal cord and medulla oblongata, and further causes symptoms such as limb numbness and weakness, unsteady walking, and even life-threatening in severe cases. For patients with obvious symptoms, surgery is currently the most effective treatment, and specifically, atlantoaxial surgery is mainly divided into simple anterior approach, simple posterior approach, and anterior-posterior combined approach.

[0003] However, due to the proximity of important structures such as the medulla oblongata and the spinal cord, surgical treatment is difficult and high-risk. The anterior transoral surgical approach has a high risk of infection, and the patient's respiratory and swallowing functions are greatly affected during the postoperative recovery period, causing the patient a lot of pain.

[0004] Therefore, in recent years, more and more simple posterior release is used in clinical practice, followed by nail-rod or nail-plate system fixation, but posterior fixation fusion often needs to complete and maintain reduction, and the shear force borne by the internal fixation is large, the possibility of internal fixation fracture and loosening increases, and there are certain requirements for the patient's bone quality, otherwise the patient needs to wear external fixation for a long time after surgery to maintain reduction. In view of this problem, the implantation of a fusion cage (Cage) after posterior atlantoaxial lateral mass joint release has gradually been applied in clinical practice, and has been widely used due to its unique advantages. This technology can provide support to better maintain reduction and reduce the stress of occipital-cervical internal fixation, comply with Wolf's law and promote bone fusion.

[0005] However, the existing clinical fusion cage still needs to be fixed with atlantoaxial pedicle screws or occipital screws after placement to maintain its position between the lateral masses. This process inevitably requires the removal or destruction of the stabilizing muscle group between the atlantoaxial vertebrae, and may even injure the C2 nerve root, causing the patient to have long-term occipital-cervical pain after surgery. In addition, the placement of atlantoaxial pedicle screws and the connection of nail rods also has the risk of damaging the vertebral artery and venous plexus bleeding, further increasing the complexity and difficulty of the operation.

[0006] In addition, the existing fusion device also has obvious deficiencies in bone graft area monitoring, infection control and positioning, which limits the improvement of its clinical effect. Especially, the PEEK material fusion device is difficult to confirm the position through imaging after surgery, and the relative position of the fusion device cannot be accurately evaluated. With the development of implantable passive micro pressure sensor, bone graft area monitoring becomes possible, but how to realize this function in atlantoaxial surgery is still a problem. Moreover, the existing fusion device rarely considers the problem of reducing the risk of postoperative infection, and it is difficult to meet the needs of postoperative anti-inflammatory and antibiotic release, which may increase the risk of infection and delay the recovery of patients.

[0007] Therefore, how to optimize the atlantoaxial fusion technology has become a technical problem to be solved. SUMMARY

[0008] In order to solve the above technical problems, the present application provides the following technical solutions:

[0009] A self-stabilizing atlantoaxial lateral mass fusion device, comprising:

[0010] A fusion device, the shape of the fusion device is configured to match the anatomical shape of the atlantoaxial lateral mass joint, and the middle part of the fusion device is provided with a bone graft hole;

[0011] A fixator, the fixator is a bent structure, including a vertical part and a bent part extended from the vertical part, the fixator is connected with the rear end of the fusion device through the vertical part, and at least two fixing holes are formed in the fixator; and

[0012] A connecting assembly, the connecting assembly includes a fixing member, a connecting member and a locking member, the connecting member is used to connect the fixator and the fusion device first, the fixing member passes through the fixing hole, the fixing member is used to fix the fusion device and the fixator to the lateral mass joint, and the locking member is configured to replace the connecting member after the fixing member is fixed, and the locking member can partially cover the fixing hole.

[0013] Further, the fusion device includes a front end and a rear end, the front end is designed as a semicircular arc structure, and the rear end is in the shape of an isosceles trapezoid in the horizontal projection section.

[0014] Further, at least one of the upper and lower fitting surfaces of the fusion device is provided with an inverted tooth structure.

[0015] Further, at least one connecting hole is formed in the fixator, and the connecting member passes through the connecting hole.

[0016] Further, the number of fixing holes is two, and the number of connecting holes is one.

[0017] Further, the periphery of the fixator is designed as a circular arc chamfer.

[0018] Further, the bending angle of the bending part of the fixator relative to the vertical part ranges from 120° to 160°.

[0019] Further, the implantation direction of the fixing part forms an included angle of 25° to 35° with the vertical part or the bending part of the fixator.

[0020] Further, the rear end of the fusion cage is further provided with a mounting hole, and a medicine filling and detection assembly is assembled in the mounting hole.

[0021] Further, the medicine filling and detection assembly comprises:

[0022] a medicine filling and detection part, which is internally integrated with a medicine placement area;

[0023] The side surface of the fusion cage is provided with a medicine release channel in communication with the medicine placement area.

[0024] Further, the medicine filling and detection assembly further comprises a pressure monitoring assembly, and the pressure monitoring assembly comprises a pressure sensor and a partial pressure member covered thereon.

[0025] Further, the upper portion of the fusion cage is provided with a through hole in communication with the mounting hole, and a pressure bearing assembly is assembled in the through hole, and the pressure bearing assembly is configured to transmit the pressure from the vertebral body to the pressure monitoring assembly.

[0026] Further, the pressure bearing assembly comprises a ball and a force transmission member, and the ball partially protrudes out of the through hole to directly bear the bone pressure and transmits the pressure to the partial pressure member through the force transmission member.

[0027] Further, the ball is made of a material with imaging performance, preferably tantalum metal.

[0028] The present application can at least achieve one of the following beneficial effects:

[0029] (1) Through the modular design, the fusion cage and the fixator are organically combined, reducing the dependence on the complex nail rod system in the traditional atlantoaxial fusion surgery. And the bending design of the fixator allows angle adjustment, which can better fit the anatomical structure of different patients, avoid the instability caused by poor fitting in the traditional fixing method, reduce surgical trauma, better adapt to the atlantoaxial minimally invasive transmuscular approach, and the locking part can partially cover the fixing hole, thereby preventing the withdrawal of the fixing part used to fix the lateral mass joint, further enhancing the stability of the device.

[0030] (2) The shape of the fusion device is designed based on human anatomy, and the isosceles trapezoidal cross section at the rear end of the fusion device can effectively embed the lateral mass joint gap, and the semicircular structure at the front end is highly matched with the articular surface. This design provides immediate stability after implantation and effectively reduces the risk of postoperative displacement.

[0031] (3) Through the implantable pressure monitoring component in the drug filling and detection component, the mechanical environment changes of the bone graft area can be sensed and transmitted in real time. During the bone fusion process, the increase in the stiffness of the bone graft area will cause characteristic changes in the pressure transmitted to the fusion device. The doctor can receive these data through an external device, non-invasively and dynamically evaluate the bone fusion status, provide objective basis for clinical decision-making, and avoid relying solely on imaging lag judgment. At the same time, trend analysis of pressure data can assist in judging whether there is fusion delay or abnormal micro-motion, and timely warning of complication risks. The system can also establish an individualized rehabilitation model by combining the load changes in the patient's daily activities to guide the postoperative exercise intensity.

[0032] (4) The drug placement area of the drug filling and detection component can load antibiotics or bone induction factors and other drugs. The drugs are continuously and slowly released to the bone graft area through the drug release channel on the side, which can form an effective local drug concentration around the implant, significantly reducing the risk of deep postoperative infection. At the same time, local application of bone induction materials can directly act on the target area and cooperate with the bone graft hole to double promote bone fusion, especially for patients with poor bone healing ability.

[0033] (5) Tantalum metal balls are used as part of the pressure-bearing component. Tantalum metal has excellent X-ray imaging properties, making the fusion device clearly visible under intraoperative X-ray fluoroscopy, greatly assisting the doctor in accurately positioning the implant and ensuring that the device is in the best functional position.

[0034] (6) The drug release, pressure monitoring, and intraoperative imaging functions are set in a compact module, and the installation hole, through hole, and drug release channel in the fusion device structure are used to realize function linkage. Without significantly increasing the overall size of the device and the complexity of the operation, multiple additional values are achieved.

[0035] In the present application, the above-mentioned technical solutions can also be combined with each other to realize more preferred combination schemes. Other features and advantages of the present application will be described in the following content, and some advantages will become apparent from the description or by implementing the present application. The purpose and other advantages of the present application can be achieved and obtained by the content specifically pointed out in the text and the drawings. BRIEF DESCRIPTION OF DRAWINGS

[0036] The accompanying drawings are included to provide a further understanding of the embodiments, and are incorporated in and constitute a part of this specification, illustrate embodiments of the application, and together with the description serve to explain the principles of the application, and should not be considered limiting of the present application in any way. In the drawings:

[0037] Figure 1 This is a schematic diagram of the fusion device proposed in this invention fixed to the side mass joint;

[0038] Figure 2 This is a schematic diagram of the overall structure of the fusion device in Embodiment 1 of the present invention;

[0039] Figure 3 This is a schematic diagram of the fixture in Embodiment 1 of the present invention;

[0040] Figure 4 This is a schematic diagram of the assembly of the fixer and the locking component in Embodiment 1 of the present invention;

[0041] Figure 5 This is a top view of the fusion device in Embodiment 1 of the present invention;

[0042] Figure 6 This is a side view of the structure of the upper and lower bonding surfaces of the fusion device in Embodiment 1 of the present invention;

[0043] Figure 7 This is a picture of a fusion device sample produced according to Embodiment 1 of the present invention before assembly;

[0044] Figure 8 This is an image of the assembled fusion device sample produced according to Embodiment 1 of the present invention;

[0045] Figure 9 This is a top view of the fusion device in Embodiment 2 of the present invention;

[0046] Figure 10 This is a side view of the fusion device in Embodiment 2 of the present invention;

[0047] Figure 11 This is a rear view of the fusion device in Embodiment 2 of the present invention;

[0048] Figure 12 After the fusion device in Embodiment 2 of the present invention is installed, along... Figure 9 Structural cross-section of section AA in the middle;

[0049] Figure 13 During the installation of the fusion device in Embodiment 2 of the present invention, along Figure 9 Structural cross-section of section AA in the middle;

[0050] Figure 14 In Embodiment 2 of the present invention Figure 13 A magnified view of part A in the middle.

[0051] The attached figures are labeled as follows:

[0052] 1. Fusion device; 11. Upper caulking surface; 12. Lower caulking surface; 13. Positioning hole; 14. Bone graft hole; 15. Connecting hole; 16. Screw hole;

[0053] 2. Fixture; 21. Fixing hole; 22. Connecting hole; 23. Holding groove;

[0054] 3. Connecting components; 31. Fasteners; 32. Connectors; 33. Locking components;

[0055] 4. Lateral mass joint;

[0056] 5. Drug filling and testing components; 51. Drug filling and testing section; 52. Drug placement area; 53. Pressure sensor; 54. Pressure dividing component; 551. Ball bearing; 552. Force transmission component. Detailed Implementation

[0057] Example 1:

[0058] This invention provides a modular, self-stabilizing atlantoaxial lateral mass fusion device. Its design aims to optimize surgical procedures by combining anatomical adaptability with a self-stabilizing structure, reducing the use of traditional rod and screw fixation methods, thereby achieving minimally invasive surgery and lowering the incidence of postoperative complications. The specific embodiments of this invention are described in detail below with reference to the accompanying drawings.

[0059] like Figures 1 to 3 As shown, the fusion cage is fixed to the lateral mass joint 4 via atlantoaxial surgery posteriorly. Specifically, the fusion cage includes a fusion cage 1, a fixator 2, and a connecting assembly 3. The fixator 2 is a bent structure, including a vertical part and a bent part, and the connecting assembly 3 includes a fixator 31 and a connector 32.

[0060] Specifically, the fusion device 1 is made of PEEK (polyether ether ketone) material, and its shape is based on human anatomy, with its shape highly matching the anatomical shape of the atlantoaxial lateral mass joint.

[0061] like Figure 5 As shown, the fusion device 1 includes a front end and a rear end. The front end of the fusion device is designed as a semi-circular arc structure with a diameter of W1. The tail of the rear end is connected to the fixator 2, and its width is W2, where W2 is smaller than W1. The rear end of the fusion device 1 is designed as an isosceles trapezoid in the horizontal projection section. This design allows the fusion device 1 to better fit the lateral mass joint surface after implantation, avoiding the risk of displacement due to shape mismatch.

[0062] The fusion device 1 has a bone graft hole 14 in the middle, such as Figure 5 As shown, the bone graft hole 14 is used to fill the bone graft material to promote bone fusion. The design of the bone graft hole 14 conforms to Wolf's Law, accelerating bone tissue growth and healing by providing mechanical support and bio-induction.

[0063] like Figure 6As shown, the fusion cage 1 includes an upper fitting surface 11 and a lower fitting surface 12, wherein at least one of the upper fitting surface 11 and the lower fitting surface 12 is provided with a circular arc reverse tooth structure, preferably both are provided with a circular arc reverse tooth structure. These reverse tooth structures increase the contact area and friction to ensure the stability of the fusion cage after implantation.

[0064] The fixator 2 is made of titanium alloy material and is designed based on the anatomical morphology of the joint, as shown in Figure 3 The vertical part is used for fixed connection with the rear end of the fusion cage 1, and the bent part is bent away from the fusion cage at one end relative to the vertical part, and the bending angle ranges from 120° to 160°. This bending design enables the fixator 2 to adjust the angle according to the surgical requirements, so as to better attach to the lateral mass joint.

[0065] As shown in Figure 3 and Figure 4 The fixator 2 is provided with two fixing holes 21 and one connecting hole 22. The fixing hole 21 is used for the installation of the fixing piece 31, which is driven into the lateral mass joint through the fixing hole 21 of the fixator 2 and the screw hole 16 of the fusion cage 1, thereby playing a role in fixing the fusion cage. The setting of one connecting hole 22 and two fixing holes 21 can realize stable connection in the case of using the least combination of fixing pieces and connecting pieces. For other cases, other numbers of connecting holes 22 and fixing holes 21 can also be set.

[0066] The connecting hole 22 is used for the installation of the connecting piece 32, which is used to fixedly connect the fixator 2 with the fusion cage 1. The connecting piece 32 and the locking piece 33 are both made of titanium alloy material. The fixator 2 is also provided with holding grooves 23 on both sides, which are convenient for holding and operating the fixator 2 during the operation.

[0067] Through the modular design, the fusion cage and the fixator are organically combined, reducing the dependence on the complex nail rod system in the traditional atlantoaxial fusion surgery. Moreover, the bending design of the fixator makes it possible to design based on the anatomical morphology of the joint according to the imaging examination of the patient before the operation. Through the design and adjustment of the angle, the fixator can better fit the anatomical structure of different patients, avoiding the instability caused by poor fitting in the traditional fixing method, and reducing the surgical trauma, which is more suitable for the atlantoaxial minimally invasive transmuscular approach.

[0068] The morphology of the fusion cage is designed based on human anatomy. The isosceles trapezoidal cross section at the rear end of the fusion cage can effectively embed into the lateral mass joint gap, and the semicircular arc structure at the front end is highly matched with the joint surface. This design provides immediate stability after implantation and effectively reduces the risk of postoperative displacement.

[0069] Further, the fixator 2 is designed with a circular arc chamfer around, which effectively reduces the friction between the fixator and the surrounding soft tissue, avoiding damage to the soft tissue.

[0070] Further, the included angle between the fixing member 31 and the vertical part or the bent part of the connected fixator 2 is 25° to 35°, which ensures the best fixing effect of the fixing member 31, while avoiding the risk of loosening or breaking due to improper angle.

[0071] Further, as shown in Figure 2 and Figure 4 , the connecting assembly 3 includes a locking member 33, which replaces the connecting member 32 after the lateral mass joint screw is fixed. The locking member 33 has a larger screw tail than the connecting member 32, so the locking member 33 can partially cover the fixing hole 21, thereby preventing the withdrawal of the fixing member 31 used to fix the lateral mass joint 4, further enhancing the stability of the device.

[0072] As shown in Figure 7 and Figure 8 , the fusion cage 1 and the fixator 2 can be directly generated by 3D printing technology according to the imaging examination of the patient before the operation, such as the bending angle of the bent part relative to the vertical part, the included angle of the fixing member, etc. For the fixator 2, since the corresponding angle can be designed for the patient before the operation, the adjustment of the angle is realized, so that it is better attached to the rear of the lateral mass joint of the patient.

[0073] Embodiment two:

[0074] On the basis of embodiment one, in order to solve the obvious deficiencies in bone graft area monitoring, infection control and positioning, the fusion cage 1 is optimized in this embodiment.

[0075] Specifically, as shown in Figures 9 to 11 , the rear end of the fusion cage 1 is also provided with a mounting hole 4, which is used to assemble a medicine filling and detection assembly 5. The medicine filling and detection assembly 5 is located above the connecting hole 15 at the rear end of the fusion cage 1, and the medicine filling and detection assembly 5 can realize the functions of drug release and pressure monitoring.

[0076] The specific structure of the medicine filling and detection assembly 5 is shown in Figure 12 and Figure 13 , which includes a medicine filling and detection part 51, a medicine placement area 52, a pressure monitoring assembly and a pressure bearing assembly. The medicine filling and detection assembly 5 can move forward and backward along the mounting hole 4, thereby realizing the installation and removal of the medicine filling and detection assembly 5, and realizing the detachable installation of the preoperative medicine filling and pressure monitoring assembly. After the fixator 2 is installed, it can cover the mounting hole 4, so that the medicine filling and detection assembly 5 is fixed in the mounting hole.

[0077] Specifically, the medicine filling and detecting part 51 is the main structure of the medicine filling and detecting assembly 5, which integrates the medicine placement area 52 and the installation space of the pressure monitoring assembly. The front end of the medicine filling and detecting part 51 is designed in a wedge shape, and the rear end has a clamping part, which is convenient for surgical operation.

[0078] The medicine placement area 52 is used to accommodate degradable antibacterial drugs or bone inductive materials, which can be slowly released over time to inhibit infection and promote bone fusion. The medicine placement area 52 is arranged on the side of the medicine filling and detecting part 51. Preferably, the medicine placement area 52 includes a plurality of round holes, each of which is filled with a sustained-release drug carrier, which can achieve controlled release of the drug. Correspondingly, as shown in Figure 10 , the side of the cage 1 is provided with a drug release channel 6, which is in communication with the round holes of the medicine placement area 52, ensuring that the drug continuously diffuses from the inside to the outside to the bone graft area.

[0079] As shown in Figure 14 , the upper part of the medicine filling and detecting part 51 is provided with a mounting groove, and the pressure monitoring assembly is installed in the mounting groove. The pressure monitoring assembly is used to monitor the pressure change of the bone graft area and real-time feedback the stability state between the cage and the vertebral body. The pressure monitoring assembly includes a pressure sensor 53 and a pressure distribution member 54. The pressure distribution member 54 is arranged above the pressure sensor 53 and is used to uniformly transmit the pressure of the bone graft area to the pressure sensor 53, ensuring the accuracy of the monitoring data. The pressure sensor 53 can adopt a micro passive piezoelectric pressure sensor in the prior art, which can real-time feedback the pressure change without external power supply. The pressure sensor 53 converts the small deformation transmitted by the pressure distribution member 54 into an electrical signal by sensing the small deformation, realizing real-time monitoring of the pressure on the cage. The signal can be wirelessly transmitted to an external receiving device, which is convenient for long-term monitoring of bone fusion progress after surgery. Specifically, the pressure sensor 53 is a mature element in the prior art, such as a micro piezoelectric sensor based on MEMS technology, or a micro membrane pressure sensor. The pressure sensor 53 can transmit real-time pressure signals to an external receiving device through an integrated micro wireless transmission module. The above-mentioned pressure monitoring assembly is an implanted device, which is made of harmless materials to the human body, and will not be described in detail.

[0080] The pressure distribution member 54 is used to distribute and transmit the external applied pressure to the pressure sensor 53. Specifically, it can be made of biocompatible elastic material, which can effectively buffer and uniformly distribute the pressure from the vertebral bone, avoiding damage to the sensor. Specifically, it can be made of medical silicone or polyurethane, ensuring the stability and long-term reliability of the pressure monitoring.

[0081] The upper part of the cage 1 is provided with a through hole in communication with the installation hole 4, and a pressure bearing assembly is assembled in the through hole, which is used to bear the pressure of the vertebral bone above the cage 1 and conduct it to the internal pressure monitoring assembly.

[0082] Further, the pressure bearing assembly includes a ball 551 and a force transmission member 552. In particular, the ball 551 directly bears the bone pressure and further transmits the pressure to the pressure distribution member 54 through the force transmission member 552.

[0083] Further, the front end of the filling and detecting part 51 is wedge-shaped. When the filling and detecting part 51 moves forward along the mounting hole 4, the force transmission member 552 is pushed to move upward along the through hole, and the ball 551 is partially extended out of the through hole to ensure abutting with the bone and monitoring the pressure change between the fusion cage and the bone. The diameter of the upper opening of the through hole is smaller than that of the ball 551, so as to limit the ball from falling out and ensure the stability of the ball in the pressure bearing position. A limiting block is arranged at the lower opening position of the through hole to prevent the force transmission member 552 from falling out downward.

[0084] Further, the ball 551 is made of tantalum metal. At this time, the ball 551 not only has good biocompatibility, but also has imaging development performance. Therefore, the filling and detecting assembly 5 can be used to confirm the position of the fusion cage through imaging during the operation, which improves the accuracy of intraoperative positioning and facilitates the doctor to master the relative position of the fusion cage in real time.

[0085] Through the implantable pressure monitoring assembly in the filling and detecting assembly 5, the change of the mechanical environment of the bone graft area can be sensed and transmitted in real time. During the bone fusion process, the increase of the stiffness of the bone graft area will cause a characteristic change of the pressure transmitted to the fusion cage. The doctor can receive these data through an external device to non-invasively and dynamically evaluate the bone fusion state, provide an objective basis for clinical decision-making, and avoid relying on the lagging judgment of imaging. At the same time, the trend analysis of the pressure data can assist in judging whether there is fusion delay or micro-motion abnormality, and timely warning of the risk of complications. The system can also establish an individualized rehabilitation model in combination with the load change in the patient's daily activities to guide the postoperative exercise intensity.

[0086] Moreover, the drug placement area 52 of the filling and detecting assembly 5 can load antibiotics or bone induction factors and the like. The drug is continuously and slowly released to the bone graft area through the drug release channel 6 on the side, so as to form an effective local drug concentration around the implant and significantly reduce the risk of deep postoperative infection. At the same time, the local application of bone induction material can directly act on the target area and cooperate with the bone graft hole 14 to double promote bone fusion, which is especially suitable for patients with poor bone healing ability.

[0087] In addition, the tantalum metal ball 551 is used as part of the pressure bearing assembly. Tantalum metal has excellent X-ray development performance, so that the fusion cage is clearly visible under intraoperative X-ray perspective, which greatly assists the doctor to accurately position the implant and ensures that the device is in the best functional position.

[0088] The design highly integrates the three functions of drug slow release, pressure monitoring and intraoperative imaging in a compact module, and ingeniously utilizes the mounting hole 4, through hole and drug release channel 6 in the structure of the fusion device to realize function linkage, so that multiple additional values are realized without significantly increasing the overall size of the device and the complexity of the operation.

[0089] In summary, the present application solves the problems in the prior art by optimizing the design and structure of the fusion device, has the advantages of strong anatomical adaptability, high stability, promoting bone fusion, reducing the risk of postoperative inflammation, achieving accurate intraoperative positioning, etc., can effectively meet the clinical needs, and has important application prospect.

[0090] The above is only the preferred specific embodiment of the present application, but the protection scope of the present application is not limited to this, any person skilled in the art can easily think of changes or replacements within the technical range disclosed by the present application, which should be covered within the protection scope of the present application.

Claims

1. A modular self-stabilizing atlantoaxial lateral mass fusion device, characterized in that, include: The device includes a fusion unit with a bone graft hole in the middle; a fixator with a bent structure, including a vertical part and a bent part extending from the vertical part, the fixator being connected to the rear end of the fusion unit through its vertical part, and having at least two fixation holes; and a connecting assembly including a fixator, a connector, and a locking member, the connector being used to first connect the fixator and the fusion unit, the fixator passing through the fixation holes, the fixator being used to subsequently fix the fusion unit and the fixator to the lateral mass joint, and the locking member being configured to ultimately replace the connector after the fixator is fixed, the locking member being able to partially cover the fixation holes; The fusion unit has a mounting hole at its rear end for assembling a drug-filling and detection component that enables drug release and pressure monitoring. This component includes a drug-filling and detection section, a drug placement area, a pressure monitoring component, and a pressure-bearing component. The drug placement area contains biodegradable antimicrobial drugs or osteoinductive materials and is located on the side of the drug-filling and detection section. The side of the fusion unit has a drug release channel communicating with a circular hole in the drug placement area. The pressure monitoring component can sense and transmit changes in the mechanical environment of the bone graft area in real time. The pressure monitoring component includes a pressure sensor and a pressure-distributing component on it, which disperses and transmits externally applied pressure to the pressure sensor. The top of the fusion unit has a through hole communicating with the mounting hole, within which a pressure-bearing component is assembled. This component includes a ball bearing and a force-transmitting component. The ball bearing directly bears the bone pressure and transmits the pressure to the pressure-distributing component through the force-transmitting component. The ball bearing is made of tantalum.

2. The fusion apparatus according to claim 1, characterized in that, The fusion unit includes a front end and a back end. The front end is designed as a semi-circular arc structure, and the back end is an isosceles trapezoidal structure in the horizontal projection section.

3. The fusion device according to claim 1, characterized in that, The fusion device includes an upper bonding surface and a lower bonding surface, and at least one of the upper bonding surface and the lower bonding surface is provided with a reverse tooth structure.

4. The fusion apparatus according to claim 1, characterized in that, The fixture is also provided with at least one connection hole; the connector and the locking member pass through the connection hole.

5. The fusion apparatus according to claim 1, characterized in that, The fastener is designed with rounded corners around its perimeter.

6. The fusion apparatus according to claim 1, characterized in that, The bending angle of the bent portion of the fastener relative to the vertical portion ranges from 120° to 160°.

7. The fusion apparatus according to claim 1, characterized in that, The angle between the implantation direction of the fixation member and the vertical or bent part of the fixator is 25° to 35°.

Images