Dynamic pressure-regulating intelligent bionic intervertebral disc

Abstract

The application discloses a dynamic pressure-regulating intelligent bionic intervertebral disc, belongs to the technical field of medical bionic prostheses, and is formed by fixing an upper end plate, a lower end plate and a core assembly; the upper end plate and the lower end plate are provided with an anatomical curved surface and fixing teeth to realize initial stability; the core assembly comprises a sheath, a partitioned multi-layer air column and a composite nucleus; the air column is set with pressure according to a physiological load gradient; a built-in sensor, a micro-control unit in the nucleus and an air pump form a closed-loop control system, which can monitor a motion state in real time and dynamically regulate pressure, realizes self-adaptive buffering and support. The application has excellent buffering, fatigue resistance, compression resistance and shear resistance, can highly match spinal column motion, restores biomechanical functions and reduces the risk of adjacent segment degeneration. The application combines the internal air cavity structure with the intelligent control unit, simulates the mechanical buffering and self-adaptive behavior of the human lumbar intervertebral disc, can dynamically adjust the internal pressure and the rigidity distribution under different load conditions, and thus realizes more optimal load transmission, motion support and vibration attenuation.

Description

Technical Field

[0001] This invention belongs to the field of medical bionic prosthesis technology, specifically relating to a dynamic pressure-regulating intelligent bionic intervertebral disc. Background Technology

[0002] Currently, chronic low back pain has become a significant health problem affecting a wide range of people, with intervertebral disc degeneration being the most prominent causative factor. In the early stages of intervertebral disc degeneration, physical therapy or medication is often used to control symptoms. In later stages, surgical intervention is often required, such as spinal fusion and total disc replacement. However, spinal fusion comes at the cost of sacrificing the range of motion of the surgical segment and may trigger accelerated degeneration in adjacent segments. While total disc replacement can preserve some motor function and reduce the risk of lesions in adjacent segments, it still has a series of limitations in terms of biomechanical and biological functional matching.

[0003] Currently, widely used artificial intervertebral discs mainly fall into two categories: mechanical articulated and viscoelastic integrated designs. Mechanical articulated discs often use metal, polymer, or composite materials to achieve segmental movement through a rigid structure. However, due to the lack of an effective buffering mechanism, they are difficult to fully simulate the viscoelastic response characteristics of human lumbar intervertebral discs, which can easily lead to abnormal stress in facet joints and non-vertebral structures, thereby causing secondary degeneration of adjacent segments. The other type of viscoelastic integrated prosthesis (such as hydrogel-based prostheses) absorbs energy through the deformation of the material itself. Although this can improve stress distribution to some extent, it often suffers from insufficient mechanical strength, especially when subjected to long-term combined compression and shear loads. This can lead to problems such as material fatigue, cracking, or excessive deformation, resulting in prosthesis sinking, displacement, or even surgical failure.

[0004] In daily life, intervertebral discs mainly bear axial compression and anterior and posterior shear loads. Therefore, an ideal prosthesis must simultaneously meet the requirements of dynamic mechanical adaptability, fatigue resistance, range of motion matching, and sufficient structural stability. Existing designs have not adequately integrated these properties, resulting in higher postoperative complications, frequent revision surgeries, and seriously affecting patients' quality of life. Summary of the Invention

[0005] Against this backdrop, the present invention proposes a design concept for a dynamically pressure-adjustable intelligent bionic intervertebral disc. This design draws on the controllability and compliance of pneumatic systems, and combines an internal air cavity structure with an intelligent control unit to simulate the mechanical buffering and adaptive behavior of the human lumbar intervertebral disc. It can dynamically adjust the internal pressure and stiffness distribution under different load conditions, thereby achieving better load transfer, motion support and vibration attenuation.

[0006] Its "intelligence" lies in its ability to respond to changes in body posture and movement, adjust its mechanical properties in real time, and transmit its movement data to the doctor's or patient's mobile app. This not only makes up for the shortcomings of traditional rigid prostheses in shock absorption, but also overcomes the limitations of materials such as hydrogel in mechanical strength and durability. It provides a new solution for reconstructing the biomechanical function of the spine and also provides a solution for the subsequent monitoring of implanted prostheses.

[0007] The purpose of this invention is to provide a dynamically adjustable intelligent bionic intervertebral disc. This disc possesses excellent cushioning and shock absorption properties as well as dynamic fatigue resistance, can highly match the physiological range of motion of the spine, and has outstanding resistance to compression and shear. By combining pneumatic structure with intelligent control, this bionic intervertebral disc can respond in real time to complex load changes within the body, adaptively adjusting internal air pressure and stiffness, thereby restoring the normal biomechanical function of the spinal segment, extending the lifespan of the prosthesis, and reducing the risk of adjacent segment degeneration and postoperative revision.

[0008] A dynamic pressure-adjustable intelligent bionic intervertebral disc consists of an upper endplate assembly, a core assembly, and a lower endplate assembly, with the core assembly positioned between the upper and lower endplate assemblies.

[0009] The dynamically adjustable intelligent bionic intervertebral disc has a width (W1) of 47 mm, a depth (D1) of 33 mm, a mid-height (HM) of 9.4 mm, an anterior height (HA) of 8.4 mm, and a posterior height (HP) of 5.3 mm. These dimensions are designed specifically for a particular patient, and the corresponding dimensional parameters are obtained through CT or MR scans of the patient's intervertebral disc, allowing for a better match with the patient's dimensional data and thus achieving a better functional fit.

[0010] The upper endplate assembly consists of an upper endplate and upper fixation teeth. The upper curved surface of the upper endplate is generated by multiple curved surfaces of the adjacent vertebral surfaces, and the lower curved surface is generated by multiple curved surfaces of the adjacent core component surfaces. The circumferential surface of the upper endplate is consistent with the maximum outer perimeter of the adjacent vertebrae. The upper fixation teeth are arranged in two rows and symmetrically fixed to the left and right sides of the center line on the upper endplate. The curved surface design of the upper endplate can better fit the adjacent vertebrae and avoid stress concentration. The upper fixation teeth can precisely match the fixation tooth grooves on the vertebrae, which is beneficial for the initial fixation of the bionic intervertebral disc.

[0011] The lower endplate assembly consists of a lower endplate and lower fixation teeth. The lower curved surface of the lower endplate is generated by multiple curved surfaces of the adjacent vertebral surface, and the upper curved surface is generated by multiple curved surfaces of the adjacent core component surface. The circumferential surface of the lower endplate is consistent with the maximum outer perimeter of the adjacent vertebra. The lower fixation teeth are arranged in two rows and symmetrically fixed to the left and right sides of the center line on the upper part of the lower endplate. The curved surface design of the lower endplate can better fit the adjacent vertebrae and avoid stress concentration. The lower fixation teeth can precisely match the fixation tooth grooves on the vertebrae, which is beneficial for the initial fixation of the bionic intervertebral disc.

[0012] The core component consists of a sheath, an outer air column, an inner air column, and a composite nucleus pulposus. The sheath, outer air column, inner air column, and composite nucleus pulposus are arranged sequentially from the outside to the inside and are fixed to the upper and lower endplates, respectively. The sheath is 0.5 mm thick and is made of ultra-high molecular weight polyethylene, which has good biocompatibility and wear resistance.

[0013] The outer and inner air columns consist of an air column coating and a pressure sensor. The air column coating is made of ultra-high molecular weight polyethylene (UHMWPE), and the pressure sensor is embedded inside the air column coating. The outer and inner air columns are divided into four regions: a front region, a left region, a right region, and a rear region. The rear region of the outer and inner air columns has the highest internal pressure and the smallest spacing between the air columns (1.5 mm). There are 6 to 10 outer and inner air columns. The left and right regions have the next highest and equal internal pressures, and the spacing between the air columns is... The thickness is 2.0 mm, and the number of outer and inner air columns is 4 to 8; the air column in the front region has the lowest internal pressure and the maximum spacing between air columns is 2.5 mm, and the number of outer and inner air columns is 2 to 6; the critical positions of the four regions are allowed to partially overlap or cross; the upper curved surface of each air column is generated by multiple curved surfaces of the lower curved surface of the upper end plate, and the lower curved surface of each air column is generated by multiple curved surfaces of the upper curved surface of the lower end plate. The height of each air column is different, filling the space between the upper and lower end plates, and the upper and lower curved surfaces of the air column completely coincide with the curved surfaces of the upper and lower end plates that contact them.

[0014] Different pressure sensors correspond to different motion states. For example, when the forward flexion motion is 2°, the corresponding pressure sensor value is 2 kPa. Similarly, pressure and motion angle curves are obtained for forward flexion and extension, left and right lateral bending, left and right axial rotation, and compression states. Forward flexion is a positive pressure value, extension is a negative pressure value, left lateral bending is a positive pressure value, right lateral bending is a negative pressure value, left axial rotation is a positive pressure value, and right axial rotation is a negative pressure value. Each pressure sensor is connected and communicates with a micro air pump containing a control unit within the composite nucleus pulposus. The micro control unit can obtain real-time motion data. If an abnormality occurs, the relevant pressure can be adjusted through the micro air pump to achieve intelligent real-time monitoring and control. If obvious abnormal data occurs, an alarm can be issued to the client terminal (such as the doctor's terminal or client). The control unit uses a microcontroller unit such as the STM32L4 / L5 series or TI's MSP430 series. It integrates signal acquisition, intelligent algorithm processing, and drive output functions, and has wireless communication capabilities to achieve adaptive and intelligent adjustment of the pneumatic system.

[0015] The air pressure of the outer and inner air columns changes from the outside to the inside, with the outer layer pressure being greater than the inner layer pressure. The number of air column layers is greater than or equal to two. The gradient change in air pressure can reproduce the soft and hard distribution characteristics of the human lumbar intervertebral disc from the outside to the inside, thereby achieving personalized exercise matching.

[0016] The composite nucleus pulposus has a width W2 of 29 mm, a depth D2 of 14.5 mm, and a height H2 of 7.4 mm. The outer contour of the composite nucleus pulposus conforms to the shape of the nucleus pulposus of a specific object. The composite nucleus pulposus includes a nucleus pulposus buffer layer, a solid core, and a micro-pump. The buffer layer, solid core, and micro-pump are layered from the outside in, with the micro-pump located in the innermost layer. The solid core is wrapped around the micro-pump, and the nucleus pulposus buffer layer is wrapped around the solid core. The micro-pump contains a battery, an air column control valve plate, and a microcontroller unit. The solid core is made of a high-hardness material. The thickness of the nucleus pulposus buffer layer is 1 mm. The core is made of elastic material; the nucleus pulposus buffer layer can deform to a certain extent and act as a buffer under pressure, while the solid core and micro air pump have high rigidity and play a significant role in resisting compression. The integration of the three together gives the composite nucleus pulposus a certain buffering function and strong anti-compression performance; the upper curved surface of the composite nucleus pulposus is generated by multiple curved surfaces on the lower surface of the upper endplate, and the lower curved surface of the composite nucleus pulposus is generated by multiple curved surfaces on the upper surface of the lower endplate. The toroidal surface of the composite nucleus pulposus is consistent with the outer contour of the sheath. This curved surface design can better fit the adjacent upper and lower endplates, avoid stress concentration, and increase service life.

[0017] The upper and lower endplates have the same thickness, and the upper and lower fixing teeth have the same structure. Taking the upper endplate and upper fixing teeth as examples, the thickness HE of the upper endplate is 1mm. The curved surface of the upper endplate is in close contact with the contact surface of the adjacent vertebrae and is connected by the upper fixing teeth and fixing tooth grooves, thereby achieving stable initial fixation while avoiding stress concentration, increasing fatigue resistance, and extending service life. The length Lk of the upper fixing tooth is 15.0mm, the bottom width WK1 of the upper fixing tooth is 2mm, the top width WK2 of the upper fixing tooth is 1mm, the height HK of the upper fixing tooth is 2.0mm, the distance La from the end face tooth notch is 2.5mm, the length and width Lb of the tooth notch are 2mm, and the length Lc of the tooth notch gap is 3mm. Fixing tooth grooves are provided on the adjacent vertebrae, and the upper and lower fixing teeth are installed in the fixing tooth grooves.

[0018] The upper and lower endplate assemblies are made of high-strength polymer or titanium alloy and are manufactured using additive manufacturing.

[0019] The beneficial effects of this invention are as follows:

[0020] 1. The pneumatic intelligent response structure achieves dynamic mechanical adaptation; the core component adopts a multi-layered zoned air column design, with different air pressures and arrangement densities for the inner and outer layers of air columns based on the differences in the physiological load distribution of the spine, reproducing the gradient change in softness and hardness characteristics of the human lumbar intervertebral disc from the outside to the inside. Through the built-in pressure sensor, micro air pump, and micro control unit forming a closed-loop control system, it can monitor load changes in real time and dynamically adjust the air column pressure in each area, providing excellent cushioning and shock absorption and motion matching, while also possessing compression resistance, shear resistance, and high fatigue resistance, overcoming the limitations of the unadjustable properties of traditional hydrogels or solid materials.

[0021] Biomimetic structure and personalized size design enhance biomechanical matching; the overall size of the biomimetic intervertebral disc (including the endplate, composite nucleus pulposus, and air column height distribution) is designed based on the patient's CT / MR image data. The endplate surface closely fits the anatomical shape of the adjacent vertebrae, effectively avoiding stress concentration. The air columns in the annulus fibrosus region are arranged in anterior, left, right, and posterior zones, with the spacing and number mimicking the direction of the collagen fiber bundles in the human lumbar intervertebral disc, maintaining the overall structural stability and physiological load transmission characteristics.

[0022] The composite nucleus pulposus structure combines buffering and support functions; the composite nucleus pulposus adopts a three-layer composite configuration: an outer elastic buffer layer disperses instantaneous stress, and an internal solid core and micro air pump provide high-rigidity support; this design significantly enhances compressive strength while retaining a certain deformation buffering capacity, avoiding the problem of pure hydrogel materials being prone to failure under complex loads.

[0023] Integrated manufacturing and stable fixation extend implant lifespan: The upper and lower endplate components and fixation teeth are integrally molded using additive manufacturing, with high-strength polymers or titanium alloys selected to ensure both mechanical performance and biocompatibility. The contact surface between the endplate and the vertebra is designed with an anatomically matched curved structure, combined with a fixation tooth-tooth groove interface with optimized geometric parameters, achieving initial stable fixation, reducing the risk of micromovement and subsidence, and extending the service life. Attached Figure Description

[0024] Figure 1 This is a three-dimensional schematic diagram of the present invention;

[0025] Figure 2 This is a side view of the present invention;

[0026] Figure 3 This is a side view of the upper end plate assembly of the present invention;

[0027] Figure 4 This is a side view of the lower endplate assembly of the present invention;

[0028] Figure 5 This is a three-dimensional schematic diagram of the core components of the present invention;

[0029] Figure 6 This is a three-dimensional schematic diagram of the composite nucleus pulposus of the present invention;

[0030] Figure 7 This is a schematic diagram of the vertebral fixation groove structure of the present invention;

[0031] Figure 8 This is a three-dimensional schematic diagram of the end plate fixing teeth of the present invention;

[0032] Figure 9 This is a side view of the end plate fixing teeth of the present invention;

[0033] Figure 10 This is an example of a graph showing the relationship between the pressure of the pressure sensor and the angles of flexion, extension, lateral bending, and axial rotation in an embodiment of the present invention.

[0034] The components are: 1. Upper endplate assembly; 2. Core assembly; 3. Lower endplate assembly; 11. Upper endplate; 12. Upper fixing tooth; 13. Upper curved surface of the upper endplate; 14. Lower curved surface of the upper endplate; 15. Toroidal surface of the upper endplate; 31. Upper curved surface of the lower endplate; 32. Lower fixing tooth; 33. Lower curved surface of the lower endplate; 34. Upper curved surface of the lower endplate; 35. Toroidal surface of the lower endplate; 21. Sheath; 22. Outer air column; 23. Inner air column; 24. Composite nucleus pulposus; 25. Air column coating; 26. Pressure sensor; 241. Nucleus pulposus buffer layer; 242. Solid core; 243. Miniature air pump; 244. Upper curved surface of the composite nucleus pulposus; 245. Lower curved surface of the composite nucleus pulposus; 246. Toroidal surface of the composite nucleus pulposus; 121. Fixing tooth groove; a. Front region; b. Left region; c. Right region; d. Rear region. Detailed Implementation

[0035] like Figure 1 and Figure 2 As shown, a dynamic pressure-adjustable intelligent bionic intervertebral disc consists of an upper endplate assembly 1, a core assembly 2, and a lower endplate assembly 3, with the core assembly 2 positioned between the upper endplate assembly 1 and the lower endplate assembly 3.

[0036] like Figure 1 and Figure 2 As shown, the dynamically adjustable intelligent bionic intervertebral disc has a width W1 of 47 mm, a depth D1 of 33 mm, a mid-height HM of 9.4 mm, an anterior height HA of 8.4 mm, and a posterior height HP of 5.3 mm. These dimensions are designed specifically for a particular patient, and the corresponding dimensional parameters are obtained by scanning the intervertebral disc of that patient using CT or MR scans, allowing for a better match with the patient's dimensional data and thus achieving better functional adaptation.

[0037] like Figure 3 As shown, the upper endplate assembly 1 consists of an upper endplate 11 and upper fixing teeth 12. The upper curved surface 13 of the upper endplate 11 is generated by multiple curved surfaces of the adjacent vertebral surface, and the lower curved surface 14 is generated by multiple curved surfaces of the adjacent core component 2. The circumferential annular surface 15 of the upper endplate 11 is consistent with the maximum outer perimeter of the adjacent vertebra. The upper fixing teeth 12 are arranged in two rows and symmetrically fixed to the left and right sides of the center line on the upper endplate 11. The curved surface design of the upper endplate 11 can better fit the adjacent vertebra and avoid stress concentration. The upper fixing teeth 12 can precisely match the fixing tooth grooves on the vertebra, which is beneficial to the initial fixation of the bionic intervertebral disc.

[0038] like Figure 4 As shown, the lower endplate assembly 3 consists of a lower endplate 31 and lower fixing teeth 32. The lower curved surface 33 of the lower endplate 31 is generated by multiple curved surfaces of the adjacent vertebral surface, and the upper curved surface 34 is generated by multiple curved surfaces of the adjacent core assembly 2. The circumferential annular surface 35 of the lower endplate 31 is consistent with the maximum outer perimeter of the adjacent vertebra. The lower fixing teeth 32 are arranged in two rows and symmetrically fixed to the left and right sides of the center line on the upper part of the lower endplate 31. The curved surface design of the lower endplate 31 can better fit the adjacent vertebra and avoid stress concentration. The lower fixing teeth 32 can precisely match the fixing tooth grooves on the vertebra, which is beneficial to the initial fixation of the bionic intervertebral disc.

[0039] like Figure 5 As shown, the core component 2 consists of a sheath 21, an outer air column 22, an inner air column 23, and a composite nucleus pulposus 24. The sheath 21, outer air column 22, inner air column 23, and composite nucleus pulposus 24 are arranged sequentially from the outside to the inside and are respectively fixed to the upper endplate 11 and the lower endplate 31. The sheath 21 has a thickness of 0.5 mm and is made of ultra-high molecular weight polyethylene, which has good biocompatibility and wear resistance.

[0040] The outer air column 22 and inner air column 23 are composed of an air column coating 25 and a pressure sensor 26. The air column coating 25 is made of ultra-high molecular weight polyethylene. The pressure sensor 26 is built into the air column coating 25. The outer air column 22 and inner air column 23 are divided into four parts according to their position: front region a, left region b, right region c, and rear region d. The air column in the rear region d of the outer air column 22 and inner air column 23 has the highest internal pressure and the smallest spacing between the air columns (1.5 mm). The number of outer air columns 22 and inner air columns 23 is 6 to 10. The air column in the left region b and right region c has the next highest and equal internal pressure. The spacing between the columns is 2.0 mm, and the number of outer air columns 22 and inner air columns 23 is 4 to 8. The air column in the front region a has the lowest internal pressure and the spacing between the air columns is the largest, 2.5 mm. The number of outer air columns 22 and inner air columns 23 is 2 to 6. The critical positions of the four regions are allowed to partially overlap or cross. The upper curved surface of each air column is generated by multiple curved surfaces of the lower curved surface 14 of the upper end plate, and the lower curved surface of each air column is generated by multiple curved surfaces of the upper curved surface 34 of the lower end plate. The height of each air column is different. They fill the space between the upper end plate 11 and the lower end plate 31, and the upper and lower curved surfaces of the air column completely coincide with the curved surfaces of the upper end plate 11 and the lower end plate 31.

[0041] like Figure 10 As shown, the pressure of different pressure sensors corresponds to different motion states. For example, when the forward flexion motion is 2°, the corresponding pressure sensor value is 2 kPa. Similarly, pressure and motion angle curves are obtained for forward flexion and extension, left and right lateral bending, left and right axial rotation, and compression states. Forward flexion is a positive pressure value, extension is a negative pressure value, left lateral bending is a positive pressure value, right lateral bending is a negative pressure value, left axial rotation is a positive pressure value, and right axial rotation is a negative pressure value. Each pressure sensor 26 is connected and communicates with the micro air pump 243 containing the control unit in the composite nucleus pulposus 24. The micro control unit can obtain real-time motion data. If an abnormality occurs, the relevant pressure can be adjusted through the micro air pump 243 to achieve intelligent real-time monitoring and control. If obvious abnormal data occurs, an alarm can be issued to the client terminal (such as the doctor's terminal or client). The control unit adopts a microcontroller unit such as the STM32L4 / L5 series or TI's MSP430 series. It integrates signal acquisition, intelligent algorithm processing, and drive output functions, and has wireless communication capabilities to realize the adaptive and intelligent adjustment of the pneumatic system.

[0042] like Figure 5As shown, the air pressure of the outer air column 22 and the inner air column 23 changes from the outside to the inside, and the pressure of the outer layer is greater than that of the inner layer. The number of air column layers is greater than or equal to two. The gradient change of air pressure can reproduce the soft and hard distribution characteristics of the human lumbar intervertebral disc from the outside to the inside, thereby achieving personalized exercise matching.

[0043] like Figure 6 As shown, the composite nucleus pulposus 24 has a width W2 of 29 mm, a depth D2 of 14.5 mm, and a height H2 of 7.4 mm. The outer contour of the composite nucleus pulposus 24 conforms to the shape of the nucleus pulposus of a specific object. The composite nucleus pulposus 24 includes a nucleus pulposus buffer layer 241, a solid core 242, and a micro air pump 243. The nucleus pulposus buffer layer 241, the solid core 242, and the micro air pump 243 are layered from the outside to the inside, with the micro air pump 243 located in the innermost layer. The solid core 242 is wrapped around the micro air pump 243, and the nucleus pulposus buffer layer 241 is wrapped around the solid core 242. The micro air pump 243 contains a battery cell, an air column control valve plate, and a microcontroller unit. The solid core 242 is made of a material with high hardness. The nucleus pulposus buffer layer 241... The thickness is 1mm, and the material of the nucleus pulposus buffer layer 241 is elastic. The nucleus pulposus buffer layer 241 can undergo a certain deformation to play a buffering role when under pressure, while the solid core 242 and the micro air pump 243 have high rigidity and play a significant anti-compression role. The three are integrated together so that the composite nucleus pulposus 24 has a certain buffering function and strong anti-compression performance. The upper curved surface 244 of the composite nucleus pulposus is generated by multiple curved surfaces on the lower surface of the upper endplate, and the lower curved surface 245 of the composite nucleus pulposus is generated by multiple curved surfaces on the upper surface of the lower endplate. The toroidal surface 246 of the composite nucleus pulposus is consistent with the outer contour of the sheath 21. This curved surface design can better fit the adjacent upper endplate 11 and lower endplate 31, avoid stress concentration, and increase service life.

[0044] like Figure 7 , Figure 8 and Figure 9 As shown, the upper endplate 11 and lower endplate 31 have the same thickness, and the upper fixing tooth 12 and lower fixing tooth 32 have the same structure. Taking the upper endplate 11 and upper fixing tooth 12 as examples, the upper endplate 11 has a thickness HE of 1mm. The curved surface of the upper endplate 11 is in close contact with the contact surface of the adjacent vertebrae and is connected by the upper fixing tooth 12 and the fixing tooth groove 121, thereby achieving stable initial fixation while avoiding stress concentration, increasing fatigue resistance, and extending service life. The length Lk of the upper fixing tooth 12 is 15.0mm, the bottom width WK1 of the upper fixing tooth 12 is 2mm, the top width WK2 of the upper fixing tooth 12 is 1mm, the height HK of the upper fixing tooth 12 is 2.0mm, the distance La from the end face tooth is 2.5mm, the length and width Lb of the tooth is 2mm, and the length Lc of the tooth gap is 3mm. The adjacent vertebrae are provided with fixing tooth grooves 121, and the upper fixing tooth 12 and lower fixing tooth 32 are installed in the fixing tooth grooves 121.

[0045] like Figure 3 and Figure 4 As shown, the upper end plate assembly 1 and the lower end plate assembly 3 are made of high-strength polymer or titanium alloy, and are manufactured by additive manufacturing.

Claims

1. A dynamically pressure-regulating intelligent bionic intervertebral disc, characterized in that: It consists of an upper end plate assembly (1), a core assembly (2) and a lower end plate assembly (3); the core assembly (2) is located between the upper end plate assembly (1) and the lower end plate assembly (3); The upper endplate assembly (1) consists of an upper endplate (11) and upper fixing teeth (12). The upper curved surface (13) of the upper endplate (11) is generated by multiple curved surfaces of the adjacent vertebral surface, and the lower curved surface (14) is generated by multiple curved surfaces of the adjacent core assembly (2). The circumferential annular surface (15) of the upper endplate (11) is consistent with the maximum outer perimeter of the adjacent vertebra. The upper fixing teeth (12) are in two rows and are symmetrically fixed to the left and right sides of the center line on the upper endplate (11). The lower endplate assembly (3) consists of a lower endplate (31) and lower fixing teeth (32). The lower curved surface (33) of the lower endplate (31) is generated by multiple curved surfaces of the adjacent vertebral surface, and the upper curved surface (34) is generated by multiple curved surfaces of the adjacent core assembly (2). The circumferential annular surface (35) of the lower endplate (31) is consistent with the maximum outer periphery dimension of the adjacent vertebra. The lower fixing teeth (32) are in two rows and are symmetrically fixed to the left and right sides of the center line on the upper part of the lower endplate (31). The core component (2) consists of a sheath (21), an outer air column (22), an inner air column (23), and a composite nucleus pulposus (24). The sheath (21), the outer air column (22), the inner air column (23), and the nucleus pulposus (24) are arranged sequentially from the outside to the inside and are fixed to the upper endplate (11) and the lower endplate (31) respectively. The outer air column (22) and inner air column (23) are both composed of an air column coating (25) and a pressure sensor (26). The pressure sensor (26) is built into the air column coating (25). The outer air column (22) and inner air column (23) are divided into four parts according to their positions: a front region (a), a left region (b), a right region (c), and a rear region (d). The number of outer air columns (22) and inner air columns (23) is 6 to 10. The number is 4 to 8; the number of outer air columns (22) and inner air columns (23) is 2 to 6; the critical positions of the four regions are allowed to partially overlap or cross; the upper surface of each air column is generated by multiple surfaces of the lower surface of the upper end plate (14), and the lower surface of each air column is generated by multiple surfaces of the upper surface of the lower end plate (34). The height of each air column is different, filling between the upper end plate (11) and the lower end plate (31). The upper and lower surfaces of the air column completely coincide with the surfaces of the upper end plate (11) and the lower end plate (31) that are in contact with it. The composite nucleus pulposus (24) includes a nucleus pulposus buffer layer (241), a solid core (242), and a micro air pump (243). The nucleus pulposus buffer layer (241), the solid core (242), and the micro air pump (243) are wrapped in layers from the outside to the inside. The micro air pump (243) is located in the innermost layer. The solid core (242) is wrapped in the micro air pump (243), and the nucleus pulposus buffer layer (241) is wrapped in the solid core (242). The micro air pump (243) contains an electric cell, an air column control valve plate, and a micro control unit. The upper curved surface (244) of the composite nucleus pulposus is generated by multiple curved surfaces on the lower surface of the upper endplate. The lower curved surface (245) of the composite nucleus pulposus is generated by multiple curved surfaces on the upper surface of the lower endplate. The torus (246) of the composite nucleus pulposus is consistent with the outer contour of the sheath (21). The upper endplate (11) and lower endplate (31) have the same thickness, and the upper fixing tooth (12) and lower fixing tooth (32) have the same structure. Taking the upper endplate (11) and upper fixing tooth (12) as examples, the curved surface of the upper endplate (11) is closely fitted with the contact surface of the adjacent vertebrae and is connected through the upper fixing tooth (12) and the fixing tooth groove (121). A fixing tooth groove (121) is provided on the adjacent vertebrae, and the upper fixing tooth (12) and the lower fixing tooth (32) are installed in the fixing tooth groove (121); The outer contour of the composite nucleus pulposus (24) follows the shape of the nucleus pulposus of a specific object.

2. The dynamically pressure-regulating intelligent bionic intervertebral disc according to claim 1, characterized in that: The dynamically adjustable intelligent bionic intervertebral disc has a width W1 of 47 mm, a depth D1 of 33 mm, a middle height HM of 9.4 mm, an anterior height H(A) of 8.4 mm, and a posterior height HP of 5.3 mm.

3. The dynamically pressure-regulating intelligent bionic intervertebral disc according to claim 1, characterized in that: The sheath (21) and the air column coating (25) are both made of ultra-high molecular weight polyethylene; the upper end plate assembly (1) and the lower end plate assembly (3) are made of high-strength polymer or titanium alloy.

4. The dynamically pressure-regulating intelligent bionic intervertebral disc according to claim 1, characterized in that: The upper end plate assembly (1) and the lower end plate assembly (3) are manufactured by additive manufacturing.

5. The dynamically pressure-regulating intelligent bionic intervertebral disc according to claim 1, characterized in that: The upper endplate (11) has a thickness HE of 1 mm, the sheath (21) has a thickness of 0.5 mm, the upper fixing tooth (12) has a length Lk of 15.0 mm, the bottom width WK1 of the upper fixing tooth (12) is 2 mm, the top width WK2 of the upper fixing tooth (12) is 1 mm, the height HK of the upper fixing tooth (12) is 2.0 mm, the distance from the end face missing tooth La is 2.5 mm, the length and width of the missing tooth Lb are 2 mm, and the length of the gap between the missing teeth Lc is 3 mm; the composite nucleus pulposus (24) has a width W2 of 29 mm, a depth D2 of 14.5 mm, and a height H2 of 7.4 mm.

6. A dynamically pressure-regulating intelligent bionic intervertebral disc according to claim 2, characterized in that: The rear region (d) of the outer air column (22) and the inner air column (23) has the highest internal pressure and the smallest spacing between the air columns, which is 1.5 mm. The left region (b) and the right region (c) have the next highest internal pressure and the same pressure, with a spacing of 2.0 mm between the air columns. The front region (a) has the lowest internal pressure and the largest spacing between the air columns, which is 2.5 mm. The thickness of the nucleus pulposus buffer layer (241) is 1 mm, and the material of the nucleus pulposus buffer layer (241) is an elastic material.

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