CN112557222A - Fatigue test method and fatigue test device for polyether-ether-ketone artificial spinal fusion cage - Google Patents

Fatigue test method and fatigue test device for polyether-ether-ketone artificial spinal fusion cage Download PDF

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CN112557222A
CN112557222A CN202011560275.2A CN202011560275A CN112557222A CN 112557222 A CN112557222 A CN 112557222A CN 202011560275 A CN202011560275 A CN 202011560275A CN 112557222 A CN112557222 A CN 112557222A
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polyacetal block
gear
fusion cage
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梁明轩
赵天
赖匡杰
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China Jiliang University
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    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N3/00—Investigating strength properties of solid materials by application of mechanical stress
    • G01N3/32—Investigating strength properties of solid materials by application of mechanical stress by applying repeated or pulsating forces
    • G01N3/38—Investigating strength properties of solid materials by application of mechanical stress by applying repeated or pulsating forces generated by electromagnetic means
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01M—TESTING STATIC OR DYNAMIC BALANCE OF MACHINES OR STRUCTURES; TESTING OF STRUCTURES OR APPARATUS, NOT OTHERWISE PROVIDED FOR
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    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N3/00—Investigating strength properties of solid materials by application of mechanical stress
    • G01N3/02—Details
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N3/00—Investigating strength properties of solid materials by application of mechanical stress
    • G01N3/02—Details
    • G01N3/04—Chucks
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2203/00—Investigating strength properties of solid materials by application of mechanical stress
    • G01N2203/0058—Kind of property studied
    • G01N2203/0069—Fatigue, creep, strain-stress relations or elastic constants
    • G01N2203/0073—Fatigue

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Abstract

The fatigue test method of the polyether-ether-ketone artificial spinal fusion cage comprises the following steps: the body fluid simulation device comprises a body fluid simulation module (1), a flange A (2), a motor base (3), a torsion driving module (4), a compression driving module (5), a clamp module (6) and a flange B (7); the fatigue testing method of the polyether-ether-ketone artificial spinal fusion cage comprises the following steps: the polyether-ether-ketone artificial spinal fusion cage is arranged in a cavity formed by a lower polyacetal block (602) and an upper polyacetal block (604) in a clamp module (6), and a connecting rod (506) in a compression movement module (5) drives a gear shaft (501) to move along the axial direction of the gear shaft so as to realize the opening and closing movement of the clamp (6) and further perform a compression fatigue test on the fusion cage (605). The invention also relates to a fatigue testing device of the polyether-ether-ketone artificial spinal fusion cage, which is close to an application scene, generates flexible impact on torque and compression load, and has the advantages of high testing precision, wide application range and the like.

Description

Fatigue test method and fatigue test device for polyether-ether-ketone artificial spinal fusion cage
Technical Field
The invention belongs to the technical field of design optimization and performance test of artificial spinal fusion devices, and particularly relates to a fatigue test method and a fatigue test device for a polyether-ether-ketone artificial spinal fusion device in a body fluid environment.
Background
At present, artificial implants made of polyether-ether-ketone are widely applied, and particularly, the artificial spinal fusion cage (vertebral disc) is made of a material which has the advantages of high strength, good biocompatibility, durability and the like; many polyether-ether-ketone artificial implants need to be tested for biomechanical properties before replacing human bones, the traditional artificial fusion device testing method can only test single compression or torsion fatigue, and the load has rigid impact, so that the method is not suitable for fatigue testing of artificial implants made of novel polyether-ether-ketone materials; in addition, body fluid and temperature environment in a human body cannot be fully characterized in the traditional fatigue testing device, so that the application and popularization development of the polyether-ether-ketone artificial implant is slow. The fatigue test method of the multifunctional polyether-ether-ketone artificial spine fusion device is required to be designed, which can be used for conveniently simulating the body fluid environment and testing the compression fatigue and the torsion fatigue.
In the early days, the fusion of anterior cervical decompression bone grafting has been considered as a classic operation for treating cervical spondylosis, and autologous iliac bone grafting is also a 'gold standard' bone grafting method. However, anterior cervical decompression bone graft fusion has many insurmountable drawbacks: the bone grafting block is easy to shift, the bone grafting fusion rate needs to be improved, long-time external fixation is needed after the operation, complications are easy to occur, and the like. In recent years, the fusion cage between cervical vertebrae begins to be widely applied in cervical spondylosis surgery, and is judged from the effect: it can not only realize the instant stability after implantation, but also promote fusion, and well reconstruct and maintain the intervertebral space height and the physiological curvature of the cervical vertebra. As such, it is becoming increasingly popular with parties.
The national standard 'mechanical property test method of a spinal implant interbody fusion cage' relates to: a compression test device, a compression-shear test device, a pin-groove universal joint-shaped shear test device, a spherical universal joint-shaped (cross-shaped) torsion test device; experimental measurement requirements for the following technical parameters are also mentioned: maximum fatigue load or torque, mechanical failure, angular displacement offset, residual deformation, stiffness, proof mass, ultimate displacement, ultimate load or torque, yield limit, yield load or torque. The related technical literature represented by the Chinese people's republic of China medical industry standard YY/T0959-2014 discloses a mechanical property test method of the spinal implant intervertebral fusion cage, and specifically discloses a compression test device, a compression-shear test device, a pin-groove universal joint-shaped shear test device and a ball universal joint-shaped torsion test device. However, the aforementioned technical documents are currently only relatively rough suggestions.
Aiming at the design and application schemes of various typical polyether-ether-ketone artificial spinal fusion cages, people also urgently need to obtain related technologies such as performance experiment methods related to the matched spinal implant intervertebral fusion cage.
Disclosure of Invention
The invention aims to provide a fatigue test method capable of carrying out compression and torsion tests on a polyether-ether-ketone artificial spine fusion cage and a special fatigue test device for the polyether-ether-ketone artificial spine fusion cage; the fatigue testing method and the special fatigue testing device for the polyether-ether-ketone artificial spine fusion device can provide a self-formed system on the basis of GB/T16825.1, GB/T10623 and Chinese medicine industry standard YY/T0959-2014 and the like, and can carry out compression and torsion tests on the polyether-ether-ketone artificial spine fusion device. The medical community has been clearly informed by a series of in vitro and in vivo experiments: the polyether-ether-ketone polymer has good compatibility with human tissues, the elastic modulus of the polyether-ether-ketone polymer is very close to that of bones, and the polyether-ether-ketone polymer also has good plasticity and hardness and is an excellent material for the intervertebral fusion cage. The invention designs a special fatigue test method and a special fatigue test device for the polyether-ether-ketone artificial spine fusion cage aiming at the material characteristics and some special structural characteristics of the polyether-ether-ketone artificial spine fusion cage; the method meets the general standard, and is particularly suitable for the technical field of fatigue test of the polyether-ether-ketone artificial spine fusion cage.
The invention provides a fatigue test method for a polyether-ether-ketone artificial spine fusion cage, which is characterized by comprising the following steps of: the fatigue test method of the polyether-ether-ketone artificial spine fusion cage uses a special fatigue test device of the polyether-ether-ketone artificial spine fusion cage, and the fatigue test device of the polyether-ether-ketone artificial spine fusion cage comprises the following steps: the body fluid simulation module 1, a flange A2, a motor base 3, a torsion driving module 4, a compression driving module 5, a clamp module 6 and a flange B7; wherein: the clamp module 6 is connected with the body fluid simulation module 1 through a flange B7, the clamp module 6 is connected with the compression driving module 5 through a flange A2, the torsion driving module 4 is connected with the compression driving module 5 through a gear in a meshing manner, the torsion driving module 4 is connected with the body fluid simulation module 1 through a motor base 3, and the clamp module 6 is connected with the body fluid simulation module 1 through a flange A2;
the structure of the clamp module 6 is as follows: a lower clamp plate 601, a lower polyacetal block 602, an upper clamp plate 603, and an upper polyacetal block 604; wherein: the lower clamp plate 601 and the lower polyacetal block 602 are fixedly connected into a whole through bolts, the lower clamp plate 601 is connected with the internal thread rod 107 through a flange B7, the upper clamp plate 603 and the upper polyacetal block 604 are fixedly connected into a whole through bolts, and the upper clamp plate 603 is connected with the gear shaft 501 through a flange A2; the lower polyacetal block 602 and the upper polyacetal block 604 are matched to form a cavity structure capable of placing the PEEK artificial spinal fusion cage 605;
the top of the lower polyacetal block 602 and the bottom of the upper polyacetal block 604 are respectively provided with a cavity which is used for placing a test piece, namely a polyetheretherketone artificial spinal fusion cage, the main outline of the main part of the lower polyacetal block 602 is cuboid, the size of the cavity of the lower polyacetal block 602 and the size of the cavity of the upper polyacetal block 604 are determined by the size of the corresponding artificial fusion cage, the size of the cavities of the lower polyacetal block 602 and the size of the cavity of the upper polyacetal block 604 are the same, and the sum of the depths of the cavities of the lower polyacetal block and the upper polyacetal; the width and length of the cavity structure for placing the polyether-ether-ketone artificial spinal fusion cage 605 are the same as those of the fusion cage 605, the width and length of the cavity structure are in interference fit in the length and width directions, the fusion cage 605 is clamped in the cavity between the lower polyacetal block 602 and the upper polyacetal block 604, and the lower polyacetal block 602 and the lower clamping plate 601 realize the clamping of the artificial fusion cage in the cavity structure along with the relative movement of the thread pair between the inner threaded rod 107 and the outer threaded rod 108; (to ensure that the lower polyacetal block 602 and the upper polyacetal block 604 are tightly combined with the PEEK artificial spinal fusion cage 605 respectively so as to be capable of performing compression or/and torsion experiments during the compression experiment on the PEEK artificial spinal fusion cage;) the cage 605 and the lower polyacetal block 602 are fixed together at the bottom of the glass box 101 through the flange B7, the internal thread 107 and the external thread rod 108, the upper polyacetal block 604 moves up and down in a straight line under the action of the compression driving module 5, and the compression load at the bottom of the cavity of the upper polyacetal block 604 acts on the top of the cage 605, thereby realizing the compression fatigue experiment of the artificial fusion cage; the upper polyacetal block 604 torsionally reciprocates under the action of the torsional driving module 4, and the torsional shear load of the inner wall of the cavity of the upper polyacetal block 604 acts on the side surface of the fusion device 605, so as to realize the torsional fatigue test of the artificial fusion device 605;
the compression driving module 5 is constituted as follows: a gear shaft 501, a torque sensor 502, a gear 503, an eccentric wheel 504, a servo motor 505, a connecting rod 506, a connecting rod electric fork 507 and a load cell 508; the compression driving module 5 is mainly used for realizing the application of compression load of the clamp 6; the torque sensor 502 and the load cell 508 are both mounted on the gear shaft 501; the gear 503 and the gear shaft 501 are fixedly connected in the circumferential direction by adopting a flat key, one end of the connecting rod 506 is connected with the gear shaft 501 through a rotating pair, an eccentric connecting point on the eccentric wheel 504 is connected with the other end of the connecting rod 506 through a rotating pair, the motor 505 is connected with the eccentric wheel 504, the geometric center of the eccentric wheel 504 is collinear with the gear shaft 501, and the motor 505 drives the eccentric wheel 504 to rotate around the geometric center;
the connecting rod shifting fork 507 controls the connecting and the disconnecting of the connecting rod 506 and the gear shaft 501, and the connecting rod 506 drives the gear shaft 501 to reciprocate along the axial direction of the gear shaft, so that the upper polyacetal block 604 reciprocates up and down;
because the lower polyacetal block 602 is fixed by the locking switch 104, the volume of the cavity structure between the upper polyacetal block 604 and the lower polyacetal block 602 changes, and the application of the compressive fatigue load of the artificial fusion cage is realized;
the requirements of the fatigue testing method of the polyether-ether-ketone artificial spinal fusion cage are as follows:
constant-temperature physiological saline is placed in the body fluid simulation module 1 and used for simulating physiological fluid environments such as human body temperature, humidity and salinity; the polyether-ether-ketone artificial spine fusion cage for the experiment is arranged in constant-temperature physiological saline in the body fluid simulation module 1;
the requirements of the main components and the ion concentration content of the body fluid simulated physiological saline are as follows:
Na+：142.0mmol/L、Ka+：5.0mmol/L、Ca2+：20.5mmol/L、HCO3 -：4.2mmol/L、Cl-：147.8mmol/L、SO4 2-：0.5mmol/L；
the pH value of the physiological saline is 7.4, the control system 106 is in communication connection with the temperature controller 105, the temperature control of the simulated body fluid in the glass box 101 is realized through the temperature controller, the range of the simulated constant temperature body fluid environment temperature is 30-48 ℃, the general temperature fluctuation range is within +/-0.5 ℃ for general pet and human body temperatures; the control system 106 is in communication connection with the electromagnetic valve 109, and different body fluids are injected into and flow out of the glass box 101 through the opening and closing of the electromagnetic valve 109;
the polyether-ether-ketone artificial spinal fusion cage is arranged in a cavity formed by the lower polyacetal block 602 and the upper polyacetal block 604 in the clamp module 6, and the connecting rod 506 in the compression driving module 5 drives the gear shaft 501 to move along the axial direction of the gear shaft so as to realize the opening and closing movement of the clamp 6, thereby applying compression fatigue load to the fusion cage.
In the fatigue testing method for the polyether-ether-ketone artificial spinal fusion cage, the following contents are preferably claimed:
in the compression driving module 5, it is assumed that the output angular velocity of the servo motor 505 is ω 1.26rad/s, the radius of the eccentric 504 is R0.1 m, and the eccentricity is
Figure BDA0002860343900000041
The length L of the link 506 is 0.5m, and the displacement of the upper polyacetal block 604 along with the up-and-down reciprocating motion of the gear shaft 501 can be expressed as:
Figure BDA0002860343900000042
in the formula, x and t represent the displacement and time of the upper polyacetal block 604, and λ is the ratio of the eccentricity of the eccentric 504 to the length of the connecting rod 506, i.e.
Figure BDA0002860343900000043
The up-and-down reciprocating displacement curve of the upper polyacetal block 604 is shown in FIG. 6;
the first derivative of the displacement equation 1 for the movement of the upper base polyacetal block 604 with respect to time is obtained as the expression for the velocity equation for the upper base polyacetal block 604:
Figure BDA0002860343900000044
in the formula II, the reaction solution is,
Figure BDA0002860343900000045
the first derivative of the equation of the displacement of motion of the upper base polyacetal block 604, i.e., the moving velocity of the upper base polyacetal block 604, and the upper and lower reciprocating velocity curves thereof are shown in FIG. 7;
the equation 1 for the displacement of motion of the upper base mass 604 is taken as the second derivative with respect to time to obtain the equation for the acceleration of the upper base mass 604:
Figure BDA0002860343900000051
(iii) in the formula (III),
Figure BDA0002860343900000052
the second derivative of the equation of the displacement of motion of the upper base polyacetal block 604, i.e., the acceleration of the upper base polyacetal block 604, and the upper and lower reciprocation acceleration curves are shown in FIG. 8;
the requirements of the main components and the ion concentration content of the constant-temperature physiological saline placed in the body fluid simulation module 1 are as follows:
Na+：142.0mmol/L、Ka+：5.0mmol/L、Ca2+：20.5mmol/L、HCO3 -：4.2mmol/L、Cl-：147.8mmol/L、SO4 2-：0.5mmol/L；
the pH value of the normal saline is 7.4, the temperature range of the simulated constant temperature body fluid environment is 30-48 ℃, and the temperature fluctuation range is within +/-0.5 ℃ for the temperature of general pets and human bodies;
the body fluid simulation module 1 is also provided with a control system 106, a temperature controller 105 and an electromagnetic valve 109; the two are in communication connection, the temperature control of the simulated body fluid in the glass box 101 is realized through a temperature controller, the control system 106 is in communication connection with the electromagnetic valve 109, and different body fluids are injected into and flow out of the glass box 101 through the opening and closing of the electromagnetic valve 109.
The body fluid simulation module 1 is specifically composed of the following parts: a glass box 101, a base 102, a flange 103, a locking switch 104, a solenoid valve 109, an internal threaded rod 107, an external threaded rod 108, a temperature controller 105 and a control system 106; wherein: the glass box 101 is the installation foundation of the whole body fluid simulation module 1; the base 102 is connected with the glass box 101, the external thread rod 108 is connected with the base 102 through the flange 102, and the internal thread rod 107 is connected with the external thread rod 108 in a matching way; a locking switch 104 for effecting movement and fixation of the thread pair between the internally threaded rod 107 and the externally threaded rod 108 is disposed on the externally threaded rod 108 (and capable of effecting interference with the internally threaded rod 107 as necessary); the inner threaded rod 107 and the outer threaded rod 108 realize the movement and fixation of the thread pair through the opening and closing of the locking switch 104;
the size of the opening of the clamp module 6 is adjusted through the inner threaded rod 107 so as to adapt to fatigue test experiments of artificial fusion devices with different heights.
The torsional drive module 4 is specifically configured as follows: a servo motor 401, a gear electric fork 402, a gear shaft 403, a gear 404 and a coupling 405; wherein:
the servo motor 401 drives the gear 404 to rotate in a reciprocating manner through the gear shaft 403, the gear fork 402 controls the gear 404 to be meshed with the gear 503 in the compression driving module 5, and the gear shaft 501 is driven to rotate in a reciprocating manner, so that the clamp 6 is driven to realize the torsional fatigue test of the fusion cage; the gear 404 can slide on the gear shaft 403 under the control of the shift fork 402;
the servo motor 401 is connected with a gear shaft 403 through a coupler 405, the gear 404 is connected with the gear shaft 403 through a flat key, and the gear electric shifting fork 402 moves up and down to realize meshing and disengaging of the gear 404 and a gear 503 in the compression driving module 5;
the body fluid simulation module 1 is also provided with a control system 106, the servo motor 401 is in communication connection with the control system 106, the control system 106 gives the servo motor 401 forward and backward rotation, the alternating frequency of the forward and backward rotation is 5Hz, the range of the rotation angle is +/-10 degrees, and the change curve of the forward and backward rotation angle of the servo motor 401 is as shown in FIG. 9;
the control system 106 is in communication with the solenoid valve 109, the temperature control system 108, the stepper motor 401, the servo motor 505, the link electric fork 507, the gear electric fork 402, the torque sensor 502 and the pressure sensor 508.
The gear ratio of the straight gear 404 to the straight gear 503 is 1: 2; the torsional motion of the servo motor 401 is transmitted to the spur gear 503 through the spur gear 404, the torsional motion of the spur gear 503 is transmitted to the upper polyacetal block 604 through the gear shaft 501, the flange A2 and the upper clamping plate 603 in sequence, the torsional motion of the upper polyacetal block 604 is exerted on the artificial fusion device in the cavity through the cavity structure, and the torsional fatigue test of the artificial fusion device is realized.
The torque fatigue testing method of the polyether-ether-ketone artificial spinal fusion cage further meets one or the combination of the following requirements:
firstly, the control system 106 firstly controls the action adjustment of the connecting rod electric fork 507 to separate the connecting rod 506 from the gear shaft 501, then controls the action adjustment of the gear electric fork 402 to enable the gear 404 to be meshed with the gear 503, and simultaneously starts the servo motor 401 to output forward and reverse rotation movement; the torsion motion of the servo motor 401 is transmitted to the spur gear 503 through the spur gear 404, the torsion motion of the spur gear 503 is transmitted to the upper polyacetal block 604 through the gear shaft 501, the flange A2 and the upper clamping plate 603 in sequence, the torsion motion of the upper polyacetal block 604 is applied to the artificial fusion device in the cavity through the cavity structure, and the torsion fatigue test of the artificial fusion device is realized;
in the compression fatigue test method of the polyether-ether-ketone artificial spinal fusion cage, a control system 106 firstly stops a servo motor 401, a gear 404 is disengaged from a gear 503 by controlling the action adjustment of a gear electric fork 402, a connecting rod 506 is connected with a gear shaft 501 by controlling the action adjustment of a connecting rod electric fork 507, a stepping motor 505 is started to output a constant rotating speed, the rotating motion of the stepping motor 505 is transmitted to an upper polyacetal block 604 through an eccentric wheel 504, the connecting rod 506, the gear shaft 501, a flange A2 and an upper clamping plate 603 in sequence, and the upper polyacetal block 604 applies the vertical linear movement motion to the artificial fusion cage in a cavity through a cavity structure, so that the compression fatigue test of the artificial fusion cage is realized;
secondly, the top of the lower polyacetal block 602 and the bottom of the upper polyacetal block 604 are respectively provided with a rectangular cavity, the sizes of the cavities of the lower polyacetal block 602 and the upper polyacetal block 604 are determined by the sizes of the corresponding artificial fusion devices, the cavities of the lower polyacetal block 602 and the upper polyacetal block 604 have the same size, the sum of the depths of the two cavities does not exceed two thirds of the height of the polyetheretherketone artificial spinal fusion device 605, the width and the length of the cavity are the same as those of the fusion device 605, the two cavities are in interference fit in the length and the width directions, the fusion device 605 is clamped in the cavity between the lower polyacetal block 602 and the upper polyacetal block 604, and the lower polyacetal block 602 and the lower clamping plate 601 realize the clamping of the artificial fusion device in the cavity structure along with the relative movement of a thread pair between the inner threaded rod 107 and the; the fusion cage 605 and the lower polyacetal block 602 are fixed together at the bottom of the glass box 101 through a flange B7, an internal thread 107 and an external thread rod 108, the upper polyacetal block 604 moves linearly up and down under the action of the compression driving module 5, and the compression load of the bottom of the cavity of the upper polyacetal block 604 acts on the top of the fusion cage 605, so that the compression fatigue test of the artificial fusion cage is realized; the upper polyacetal block 604 is torsionally reciprocated by the torsional driving module 4, and the torsional shear load of the inner wall of the cavity of the upper polyacetal block 604 is applied to the side surface of the fusion cage 605, thereby realizing the torsional fatigue test of the artificial fusion cage 605.
The invention also claims a fatigue testing device of the polyether-ether-ketone artificial spine fusion cage, which comprises the following components: the body fluid simulation module 1, a flange A2, a motor base 3, a torsion driving module 4, a compression driving module 5, a clamp module 6 and a flange B7; wherein: the clamp module 6 is connected with the body fluid simulation module 1 through a flange B7, the clamp module 6 is connected with the compression driving module 5 through a flange A2, the torsion driving module 4 is connected with the compression driving module 5 through a gear in a meshing manner, the torsion driving module 4 is connected with the body fluid simulation module 1 through a motor base 3, and the clamp module 6 is connected with the body fluid simulation module 1 through a flange A2;
the structure of the clamp module 6 is as follows: a lower clamp plate 601, a lower polyacetal block 602, an upper clamp plate 603, and an upper polyacetal block 604; wherein: the lower clamp plate 601 and the lower polyacetal block 602 are fixedly connected into a whole through bolts, the lower clamp plate 601 is connected with the internal thread rod 107 through a flange B7, the upper clamp plate 603 and the upper polyacetal block 604 are fixedly connected into a whole through bolts, and the upper clamp plate 603 is connected with the gear shaft 501 through a flange A2; the lower polyacetal block 602 and the upper polyacetal block 604 are matched to form a cavity structure capable of placing the PEEK artificial spinal fusion cage 605;
the top of the lower polyacetal block 602 and the bottom of the upper polyacetal block 604 are respectively provided with a cavity which is used for placing a test piece, namely a polyetheretherketone artificial spinal fusion cage, the main outline of the main part of the lower polyacetal block 602 is cuboid, the size of the cavity of the lower polyacetal block 602 and the size of the cavity of the upper polyacetal block 604 are determined by the size of the corresponding artificial fusion cage, the size of the cavities of the lower polyacetal block 602 and the size of the cavity of the upper polyacetal block 604 are the same, and the sum of the depths of the cavities of the lower polyacetal block and the upper polyacetal; the width and length of the cavity structure for placing the polyether-ether-ketone artificial spinal fusion cage 605 are the same as those of the fusion cage 605, the width and length of the cavity structure are in interference fit in the length and width directions, the fusion cage 605 is clamped in the cavity between the lower polyacetal block 602 and the upper polyacetal block 604, and the lower polyacetal block 602 and the lower clamping plate 601 realize the clamping of the artificial fusion cage in the cavity structure along with the relative movement of the thread pair between the inner threaded rod 107 and the outer threaded rod 108; (to ensure that the lower polyacetal block 602 and the upper polyacetal block 604 are tightly combined with the PEEK artificial spinal fusion cage 605 respectively so as to be capable of performing compression or/and torsion experiments during the compression experiment on the PEEK artificial spinal fusion cage;) the cage 605 and the lower polyacetal block 602 are fixed together at the bottom of the glass box 101 through the flange B7, the internal thread 107 and the external thread rod 108, the upper polyacetal block 604 moves up and down in a straight line under the action of the compression driving module 5, and the compression load at the bottom of the cavity of the upper polyacetal block 604 acts on the top of the cage 605, thereby realizing the compression fatigue experiment of the artificial fusion cage; the upper polyacetal block 604 torsionally reciprocates under the action of the torsional driving module 4, and the torsional shear load of the inner wall of the cavity of the upper polyacetal block 604 acts on the side surface of the fusion device 605, so as to realize the torsional fatigue test of the artificial fusion device 605;
the compression movement module 5 is constituted as follows: a gear shaft 501, a torque sensor 502, a gear 503, an eccentric wheel 504, a servo motor 505, a connecting rod 506, a connecting rod electric fork 507 and a load cell 508; the compression movement module 5 is mainly used for realizing compression driving of the clamp 6; the torque sensor 502 and the load cell 508 are both mounted on the gear shaft 501; the gear 503 and the gear shaft 501 are fixedly connected in the circumferential direction by adopting a flat key, one end of the connecting rod 506 is connected with the gear shaft 501 through a rotating pair, an eccentric connecting point on the eccentric wheel 504 is connected with the other end of the connecting rod 506 through a rotating pair, the motor 505 is connected with the eccentric wheel 504, the geometric center of the eccentric wheel 504 is collinear with the gear shaft 501, and the motor 505 drives the eccentric wheel 504 to rotate around the center;
suppose the angular velocity of the output of the servo motor 505 is ω 1.26rad/s, the radius of the eccentric 504 is R0.1 m, and the eccentricity is
Figure BDA0002860343900000081
The length L of the link 506 is 0.5m, and the displacement of the upper polyacetal block 604 along with the up-and-down reciprocating motion of the gear shaft 501 can be expressed as:
Figure BDA0002860343900000082
in the formula, x and t represent the displacement and time of the upper polyacetal block 604, and λ is the ratio of the eccentricity of the eccentric 504 to the length of the connecting rod 506, i.e.
Figure BDA0002860343900000083
The up-and-down reciprocating displacement curve of the upper polyacetal block 604 is shown in FIG. 6;
the first derivative of the displacement equation 1 for the movement of the upper base polyacetal block 604 with respect to time is obtained as the expression for the velocity equation for the upper base polyacetal block 604:
Figure BDA0002860343900000084
in the formula II, the reaction solution is,
Figure BDA0002860343900000091
the first derivative of the equation of the displacement of motion of the upper base polyacetal block 604, i.e., the moving velocity of the upper base polyacetal block 604, and the upper and lower reciprocating velocity curves thereof are shown in FIG. 7;
the equation 1 for the displacement of motion of the upper base mass 604 is taken as the second derivative with respect to time to obtain the equation for the acceleration of the upper base mass 604:
Figure BDA0002860343900000092
(iii) in the formula (III),
Figure BDA0002860343900000093
the second derivative of the equation of the displacement of motion of the upper base polyacetal block 604, i.e., the acceleration of the upper base polyacetal block 604, and the upper and lower reciprocation acceleration curves are shown in FIG. 8;
the connecting rod shifting fork 507 controls the connecting and the disconnecting of the connecting rod 506 and the gear shaft 501, and the connecting rod 506 drives the gear shaft 501 to reciprocate along the axial direction of the gear shaft, so that the upper polyacetal block 604 reciprocates up and down;
because the lower polyacetal block 602 is fixed by the locking switch 104, the volume of the cavity structure between the upper polyacetal block 604 and the lower polyacetal block 602 is changed, so as to realize the compression fatigue test of the artificial fusion cage;
the requirements of the fatigue testing method of the polyether-ether-ketone artificial spinal fusion cage are as follows:
constant-temperature physiological saline is placed in the body fluid simulation module 1 and used for simulating physiological fluid environments such as human body temperature, humidity and salinity; the polyether-ether-ketone artificial spine fusion cage for the experiment is arranged in constant-temperature physiological saline in the body fluid simulation module 1;
the requirements of the main components and the ion concentration content of the body fluid simulated physiological saline are as follows:
Na+：142.0mmol/L、Ka+：5.0mmol/L、Ca2+：20.5mmol/L、HCO3 -：4.2mmol/L、Cl-：147.8mmol/L、SO4 2-：0.5mmol/L；
the pH value of the physiological saline is 7.4, the control system 106 is in communication connection with the temperature controller 105, the temperature control of the simulated body fluid in the glass box 101 is realized through the temperature controller, the range of the simulated constant temperature body fluid environment temperature is 30-48 ℃, the general temperature fluctuation range is within +/-0.5 ℃ for general pet and human body temperatures; the control system 106 is in communication connection with the electromagnetic valve 109, and different body fluids are injected into and flow out of the glass box 101 through the opening and closing of the electromagnetic valve 109;
the polyether-ether-ketone artificial spinal fusion cage is arranged in a cavity formed by the lower polyacetal block 602 and the upper polyacetal block 604 in the clamp module 6, and the connecting rod 506 in the compression movement module 5 drives the gear shaft 501 to move along the axial direction of the gear shaft so as to realize the opening and closing movement of the clamp 6, thereby carrying out a compression fatigue test on the fusion cage.
The body fluid simulation module 1 is specifically composed of the following parts: a glass box 101, a base 102, a flange 103, a locking switch 104, a solenoid valve 109, an internal threaded rod 107, an external threaded rod 108, a temperature controller 105 and a control system 106; wherein: the glass box 101 is the installation foundation of the whole body fluid simulation module 1; the base 102 is connected with the glass box 101, the external thread rod 108 is connected with the base 102 through the flange 102, and the internal thread rod 107 is connected with the external thread rod 108 in a matching way; a locking switch 104 for effecting movement and fixation of the thread pair between the internally threaded rod 107 and the externally threaded rod 108 is disposed on the externally threaded rod 108 (and capable of effecting interference with the internally threaded rod 107 as necessary); the inner threaded rod 107 and the outer threaded rod 108 realize the movement and fixation of the thread pair through the opening and closing of the locking switch 104;
the size of the opening of the clamp module 6 is adjusted through the inner threaded rod 107 so as to adapt to fatigue test experiments of artificial fusion devices with different heights;
artifical spinal fusion cage fatigue test device of polyether ether ketone, its characterized in that: the torsional drive module 4 is specifically configured as follows: a servo motor 401, a gear electric fork 402, a gear shaft 403, a gear 404 and a coupling 405; wherein:
the servo motor 401 drives the gear 404 to rotate in a reciprocating manner through the gear shaft 403, the gear fork 402 controls the gear 404 to be meshed with the gear 503 in the compression driving module 5, and the gear shaft 501 is driven to rotate in a reciprocating manner, so that the clamp 6 is driven to realize the torsional fatigue test of the fusion cage; the gear 404 can slide on the gear shaft 403 under the control of the shift fork 402;
the servo motor 401 is connected with a gear shaft 403 through a coupler 405, the gear 404 is connected with the gear shaft 403 through a flat key, and the gear electric shifting fork 402 moves up and down to realize meshing and disengaging of the gear 404 and a gear 503 in the compression driving module 5;
the body fluid simulation module 1 is also provided with a control system 106, the servo motor 401 is in communication connection with the control system 106, the control system 106 gives the servo motor 401 forward and backward rotation, the alternating frequency of the forward and backward rotation is 5Hz, the range of the rotation angle is +/-10 degrees, and the change curve of the forward and backward rotation angle of the servo motor 401 is as shown in FIG. 9;
the control system 106 is in communication with the solenoid valve 109, the temperature control system 108, the stepper motor 401, the servo motor 505, the link electric fork 507, the gear electric fork 402, the torque sensor 502 and the pressure sensor 508.
The gear ratio of the straight gear 404 to the straight gear 503 is 1: 2; the torsional motion of the servo motor 401 is transmitted to the spur gear 503 through the spur gear 404, the torsional motion of the spur gear 503 is transmitted to the upper polyacetal block 604 through the gear shaft 501, the flange A2 and the upper clamping plate 603 in sequence, the torsional motion of the upper polyacetal block 604 is exerted on the artificial fusion device in the cavity through the cavity structure, and the torsional fatigue test of the artificial fusion device is realized.
The torque fatigue testing device for the polyether-ether-ketone artificial spinal fusion cage further meets one or the combination of the following requirements:
firstly, the control system 106 firstly controls the action adjustment of the connecting rod electric fork 507 to separate the connecting rod 506 from the gear shaft 501, then controls the action adjustment of the gear electric fork 402 to enable the gear 404 to be meshed with the gear 503, and simultaneously starts the servo motor 401 to output forward and reverse rotation movement; the torsion motion of the servo motor 401 is transmitted to the spur gear 503 through the spur gear 404, the torsion motion of the spur gear 503 is transmitted to the upper polyacetal block 604 through the gear shaft 501, the flange A2 and the upper clamping plate 603 in sequence, the torsion motion of the upper polyacetal block 604 is applied to the artificial fusion device in the cavity through the cavity structure, and the torsion fatigue test of the artificial fusion device is realized;
in the compression fatigue test method of the polyether-ether-ketone artificial spinal fusion cage, a control system 106 firstly stops a servo motor 401, a gear 404 is disengaged from a gear 503 by controlling the action adjustment of a gear electric fork 402, a connecting rod 506 is connected with a gear shaft 501 by controlling the action adjustment of a connecting rod electric fork 507, a stepping motor 505 is started to output a constant rotating speed, the rotating motion of the stepping motor 505 is transmitted to an upper polyacetal block 604 through an eccentric wheel 504, the connecting rod 506, the gear shaft 501, a flange A2 and an upper clamping plate 603 in sequence, and the upper polyacetal block 604 applies the vertical linear movement motion to the artificial fusion cage in a cavity through a cavity structure, so that the compression fatigue test of the artificial fusion cage is realized;
secondly, the top of the lower polyacetal block 602 and the bottom of the upper polyacetal block 604 are respectively provided with a rectangular cavity, the sizes of the cavities of the lower polyacetal block 602 and the upper polyacetal block 604 are determined by the sizes of the corresponding artificial fusion devices, the cavities of the lower polyacetal block 602 and the upper polyacetal block 604 have the same size, the sum of the depths of the two cavities does not exceed two thirds of the height of the polyetheretherketone artificial spinal fusion device 605, the width and the length of the cavity are the same as those of the fusion device 605, the two cavities are in interference fit in the length and the width directions, the fusion device 605 is clamped in the cavity between the lower polyacetal block 602 and the upper polyacetal block 604, and the lower polyacetal block 602 and the lower clamping plate 601 realize the clamping of the artificial fusion device in the cavity structure along with the relative movement of a thread pair between the inner threaded rod 107 and the; the fusion cage 605 and the lower polyacetal block 602 are fixed together at the bottom of the glass box 101 through a flange B7, an internal thread 107 and an external thread rod 108, the upper polyacetal block 604 moves linearly up and down under the action of the compression driving module 5, and the compression load of the bottom of the cavity of the upper polyacetal block 604 acts on the top of the fusion cage 605, so that the compression fatigue test of the artificial fusion cage is realized; the upper polyacetal block 604 is torsionally reciprocated by the torsional driving module 4, and the torsional shear load of the inner wall of the cavity of the upper polyacetal block 604 is applied to the side surface of the fusion cage 605, thereby realizing the torsional fatigue test of the artificial fusion cage 605.
The invention can simultaneously meet the compression and torsion fatigue tests of the PEEK artificial spinal fusion cage product in the environment of body fluid of a human body, the generated torque and compression load have flexible impact, the influence of inertia load caused by rigid impact is greatly reduced, and the invention has the advantages of high test precision, wide application range and the like.
The invention realizes the comprehensive optimization of the experimental method on the basis of the prior art, has better foresight and operability and perfects the related technical field. The method has expectable huge economic value and social value.
Drawings
The invention is described in further detail below with reference to the following figures and embodiments:
FIG. 1 is a schematic diagram of the principle of the fatigue testing device for the artificial spinal fusion cage of polyetheretherketone;
FIG. 2 is a schematic diagram showing the principle of construction of the body fluid simulation module 1;
fig. 3 is a schematic diagram of the principle of the torsion drive module 4;
FIG. 4 is a schematic diagram of the principle of the compression driving module 5;
FIG. 5 is a schematic diagram of the principle of the construction of the clamp module 6;
FIG. 6 is a graph showing the up-and-down reciprocating displacement of the upper polyacetal block 604;
FIG. 7 is a graph showing the up-and-down reciprocating speed of the upper polyacetal block 604;
FIG. 8 is a graph showing the acceleration of the upper polyacetal block 604 reciprocating up and down;
fig. 9 is a displacement curve of the upper polyacetal block 604 reciprocating up and down.
Detailed Description
Example 1
A fatigue test method for a polyether-ether-ketone artificial spinal fusion cage uses a special fatigue test device for the polyether-ether-ketone artificial spinal fusion cage, and the fatigue test device for the polyether-ether-ketone artificial spinal fusion cage comprises the following steps: the body fluid simulation module 1, a flange A2, a motor base 3, a torsion driving module 4, a compression driving module 5, a clamp module 6 and a flange B7; wherein: the clamp module 6 is connected with the body fluid simulation module 1 through a flange B7, the clamp module 6 is connected with the compression driving module 5 through a flange A2, the torsion driving module 4 is connected with the compression driving module 5 through a gear in a meshing manner, the torsion driving module 4 is connected with the body fluid simulation module 1 through a motor base 3, and the clamp module 6 is connected with the body fluid simulation module 1 through a flange A2;
the structure of the clamp module 6 is as follows: a lower clamp plate 601, a lower polyacetal block 602, an upper clamp plate 603, and an upper polyacetal block 604; wherein: the lower clamp plate 601 and the lower polyacetal block 602 are fixedly connected into a whole through bolts, the lower clamp plate 601 is connected with the internal thread rod 107 through a flange B7, the upper clamp plate 603 and the upper polyacetal block 604 are fixedly connected into a whole through bolts, and the upper clamp plate 603 is connected with the gear shaft 501 through a flange A2; the lower polyacetal block 602 and the upper polyacetal block 604 are matched to form a cavity structure capable of placing the PEEK artificial spinal fusion cage 605;
the top of the lower polyacetal block 602 and the bottom of the upper polyacetal block 604 are respectively provided with a cavity which is used for placing a test piece, namely a polyetheretherketone artificial spinal fusion cage, the main outline of the main part of the lower polyacetal block 602 is cuboid, the size of the cavity of the lower polyacetal block 602 and the size of the cavity of the upper polyacetal block 604 are determined by the size of the corresponding artificial fusion cage, the size of the cavities of the lower polyacetal block 602 and the size of the cavity of the upper polyacetal block 604 are the same, and the sum of the depths of the cavities of the lower polyacetal block and the upper polyacetal; the width and length of the cavity structure for placing the polyether-ether-ketone artificial spinal fusion cage 605 are the same as those of the fusion cage 605, the width and length of the cavity structure are in interference fit in the length and width directions, the fusion cage 605 is clamped in the cavity between the lower polyacetal block 602 and the upper polyacetal block 604, and the lower polyacetal block 602 and the lower clamping plate 601 realize the clamping of the artificial fusion cage in the cavity structure along with the relative movement of the thread pair between the inner threaded rod 107 and the outer threaded rod 108; (to ensure that the lower polyacetal block 602 and the upper polyacetal block 604 are tightly combined with the PEEK artificial spinal fusion cage 605 respectively so as to be capable of performing compression or/and torsion experiments during the compression experiment on the PEEK artificial spinal fusion cage;) the cage 605 and the lower polyacetal block 602 are fixed together at the bottom of the glass box 101 through the flange B7, the internal thread 107 and the external thread rod 108, the upper polyacetal block 604 moves up and down in a straight line under the action of the compression driving module 5, and the compression load at the bottom of the cavity of the upper polyacetal block 604 acts on the top of the cage 605, thereby realizing the compression fatigue experiment of the artificial fusion cage; the upper polyacetal block 604 torsionally reciprocates under the action of the torsional driving module 4, and the torsional shear load of the inner wall of the cavity of the upper polyacetal block 604 acts on the side surface of the fusion device 605, so as to realize the torsional fatigue test of the artificial fusion device 605;
the compression movement module 5 is constituted as follows: a gear shaft 501, a torque sensor 502, a gear 503, an eccentric wheel 504, a servo motor 505, a connecting rod 506, a connecting rod electric fork 507 and a load cell 508; the compression movement module 5 is mainly used for realizing compression driving of the clamp 6; the torque sensor 502 and the load cell 508 are both mounted on the gear shaft 501; the gear 503 and the gear shaft 501 are fixedly connected in the circumferential direction by adopting a flat key, one end of the connecting rod 506 is connected with the gear shaft 501 through a rotating pair, an eccentric connecting point on the eccentric wheel 504 is connected with the other end of the connecting rod 506 through a rotating pair, the motor 505 is connected with the eccentric wheel 504, the geometric center of the eccentric wheel 504 is collinear with the gear shaft 501, and the motor 505 drives the eccentric wheel 504 to rotate around the center;
the connecting rod shifting fork 507 controls the connecting and the disconnecting of the connecting rod 506 and the gear shaft 501, and the connecting rod 506 drives the gear shaft 501 to reciprocate along the axial direction of the gear shaft, so that the upper polyacetal block 604 reciprocates up and down;
because the lower polyacetal block 602 is fixed by the locking switch 104, the volume of the cavity structure between the upper polyacetal block 604 and the lower polyacetal block 602 is changed, so as to realize the compression fatigue test of the artificial fusion cage;
the requirements of the fatigue testing method of the polyether-ether-ketone artificial spinal fusion cage are as follows:
constant-temperature physiological saline is placed in the body fluid simulation module 1 and used for simulating physiological fluid environments such as human body temperature, humidity and salinity; the polyether-ether-ketone artificial spine fusion cage for the experiment is arranged in constant-temperature physiological saline in the body fluid simulation module 1;
the requirements of the main components and the ion concentration content of the body fluid simulated physiological saline are as follows:
Na+：142.0mmol/L、Ka+：5.0mmol/L、Ca2+：20.5mmol/L、HCO3 -：4.2mmol/L、Cl-：147.8mmol/L、SO4 2-：0.5mmol/L；
the pH value of the physiological saline is 7.4, the control system 106 is in communication connection with the temperature controller 105, the temperature control of the simulated body fluid in the glass box 101 is realized through the temperature controller, the range of the simulated constant temperature body fluid environment temperature is 30-48 ℃, the general temperature fluctuation range is within +/-0.5 ℃ for general pet and human body temperatures; the control system 106 is in communication connection with the electromagnetic valve 109, and different body fluids are injected into and flow out of the glass box 101 through the opening and closing of the electromagnetic valve 109;
the polyether-ether-ketone artificial spinal fusion cage is arranged in a cavity formed by the lower polyacetal block 602 and the upper polyacetal block 604 in the clamp module 6, and the connecting rod 506 in the compression movement module 5 drives the gear shaft 501 to move along the axial direction of the gear shaft so as to realize the opening and closing movement of the clamp 6, thereby carrying out a compression fatigue test on the fusion cage.
In the compression motion module 5, it is assumed that the output angular velocity of the servo motor 505 is ω 1.26rad/s, the radius of the eccentric 504 is R0.1 m, and the eccentricity is
Figure BDA0002860343900000141
The length L of the link 506 is 0.5m, and the displacement of the upper polyacetal block 604 along with the up-and-down reciprocating motion of the gear shaft 501 can be expressed as:
Figure BDA0002860343900000142
in the formula, x and t represent the displacement and time of the upper polyacetal block 604, and λ is the ratio of the eccentricity of the eccentric 504 to the length of the connecting rod 506, i.e.
Figure BDA0002860343900000143
The up-and-down reciprocating displacement curve of the upper polyacetal block 604 is shown in FIG. 6;
the first derivative of the displacement equation 1 for the movement of the upper base polyacetal block 604 with respect to time is obtained as the expression for the velocity equation for the upper base polyacetal block 604:
Figure BDA0002860343900000144
in the formula II, the reaction solution is,
Figure BDA0002860343900000145
the first derivative of the equation of the displacement of motion of the upper base polyacetal block 604, i.e., the moving velocity of the upper base polyacetal block 604, and the upper and lower reciprocating velocity curves thereof are shown in FIG. 7;
the equation 1 for the displacement of motion of the upper base mass 604 is taken as the second derivative with respect to time to obtain the equation for the acceleration of the upper base mass 604:
Figure BDA0002860343900000146
(iii) in the formula (III),
Figure BDA0002860343900000147
the second derivative of the equation of the displacement of motion of the upper base polyacetal block 604, i.e., the acceleration of the upper base polyacetal block 604, and the upper and lower reciprocation acceleration curves are shown in FIG. 8;
the requirements of the main components and the ion concentration content of the constant-temperature physiological saline placed in the body fluid simulation module 1 are as follows:
Na+：142.0mmol/L、Ka+：5.0mmol/L、Ca2+：20.5mmol/L、HCO3 -：4.2mmol/L、Cl-：147.8mmol/L、SO4 2-：0.5mmol/L；
the pH value of the normal saline is 7.4, the temperature range of the simulated constant temperature body fluid environment is 30-48 ℃, and the temperature fluctuation range is within +/-0.5 ℃ for the temperature of general pets and human bodies;
the body fluid simulation module 1 is also provided with a control system 106, a temperature controller 105 and an electromagnetic valve 109; the two are in communication connection, the temperature control of the simulated body fluid in the glass box 101 is realized through a temperature controller, the control system 106 is in communication connection with the electromagnetic valve 109, and different body fluids are injected into and flow out of the glass box 101 through the opening and closing of the electromagnetic valve 109.
The body fluid simulation module 1 is specifically composed of the following parts: a glass box 101, a base 102, a flange 103, a locking switch 104, a solenoid valve 109, an internal threaded rod 107, an external threaded rod 108, a temperature controller 105 and a control system 106; wherein: the glass box 101 is the installation foundation of the whole body fluid simulation module 1; the base 102 is connected with the glass box 101, the external thread rod 108 is connected with the base 102 through the flange 102, and the internal thread rod 107 is connected with the external thread rod 108 in a matching way; a locking switch 104 for effecting movement and fixation of the thread pair between the internally threaded rod 107 and the externally threaded rod 108 is disposed on the externally threaded rod 108 (and capable of effecting interference with the internally threaded rod 107 as necessary); the inner threaded rod 107 and the outer threaded rod 108 realize the movement and fixation of the thread pair through the opening and closing of the locking switch 104;
the size of the opening of the clamp module 6 is adjusted through the inner threaded rod 107 so as to adapt to fatigue test experiments of artificial fusion devices with different heights.
The torsional drive module 4 is specifically configured as follows: a servo motor 401, a gear electric fork 402, a gear shaft 403, a gear 404 and a coupling 405; wherein:
the servo motor 401 drives the gear 404 to rotate in a reciprocating manner through the gear shaft 403, the gear fork 402 controls the gear 404 to be meshed with the gear 503 in the compression driving module 5, and the gear shaft 501 is driven to rotate in a reciprocating manner, so that the clamp 6 is driven to realize the torsional fatigue test of the fusion cage; the gear 404 can slide on the gear shaft 403 under the control of the shift fork 402;
the servo motor 401 is connected with a gear shaft 403 through a coupler 405, the gear 404 is connected with the gear shaft 403 through a flat key, and the gear electric shifting fork 402 moves up and down to realize meshing and disengaging of the gear 404 and a gear 503 in the compression driving module 5;
the body fluid simulation module 1 is also provided with a control system 106, the servo motor 401 is in communication connection with the control system 106, the control system 106 gives the servo motor 401 forward and backward rotation, the alternating frequency of the forward and backward rotation is 5Hz, the range of the rotation angle is +/-10 degrees, and the change curve of the forward and backward rotation angle of the servo motor 401 is as shown in FIG. 9;
the control system 106 is in communication with the solenoid valve 109, the temperature control system 108, the stepper motor 401, the servo motor 505, the link electric fork 507, the gear electric fork 402, the torque sensor 502 and the pressure sensor 508.
The gear ratio of the straight gear 404 to the straight gear 503 is 1: 2; the torsional motion of the servo motor 401 is transmitted to the spur gear 503 through the spur gear 404, the torsional motion of the spur gear 503 is transmitted to the upper polyacetal block 604 through the gear shaft 501, the flange A2 and the upper clamping plate 603 in sequence, the torsional motion of the upper polyacetal block 604 is exerted on the artificial fusion device in the cavity through the cavity structure, and the torsional fatigue test of the artificial fusion device is realized.
The torque fatigue testing method of the polyether-ether-ketone artificial spinal fusion cage further meets one or the combination of the following requirements:
firstly, the control system 106 firstly controls the action adjustment of the connecting rod electric fork 507 to separate the connecting rod 506 from the gear shaft 501, then controls the action adjustment of the gear electric fork 402 to enable the gear 404 to be meshed with the gear 503, and simultaneously starts the servo motor 401 to output forward and reverse rotation movement; the torsion motion of the servo motor 401 is transmitted to the spur gear 503 through the spur gear 404, the torsion motion of the spur gear 503 is transmitted to the upper polyacetal block 604 through the gear shaft 501, the flange A2 and the upper clamping plate 603 in sequence, the torsion motion of the upper polyacetal block 604 is applied to the artificial fusion device in the cavity through the cavity structure, and the torsion fatigue test of the artificial fusion device is realized;
in the compression fatigue test method of the polyether-ether-ketone artificial spinal fusion cage, a control system 106 firstly stops a servo motor 401, a gear 404 is disengaged from a gear 503 by controlling the action adjustment of a gear electric fork 402, a connecting rod 506 is connected with a gear shaft 501 by controlling the action adjustment of a connecting rod electric fork 507, a stepping motor 505 is started to output a constant rotating speed, the rotating motion of the stepping motor 505 is transmitted to an upper polyacetal block 604 through an eccentric wheel 504, the connecting rod 506, the gear shaft 501, a flange A2 and an upper clamping plate 603 in sequence, and the upper polyacetal block 604 applies the vertical linear movement motion to the artificial fusion cage in a cavity through a cavity structure, so that the compression fatigue test of the artificial fusion cage is realized;
secondly, the top of the lower polyacetal block 602 and the bottom of the upper polyacetal block 604 are respectively provided with a rectangular cavity, the sizes of the cavities of the lower polyacetal block 602 and the upper polyacetal block 604 are determined by the sizes of the corresponding artificial fusion devices, the cavities of the lower polyacetal block 602 and the upper polyacetal block 604 have the same size, the sum of the depths of the two cavities does not exceed two thirds of the height of the polyetheretherketone artificial spinal fusion device 605, the width and the length of the cavity are the same as those of the fusion device 605, the two cavities are in interference fit in the length and the width directions, the fusion device 605 is clamped in the cavity between the lower polyacetal block 602 and the upper polyacetal block 604, and the lower polyacetal block 602 and the lower clamping plate 601 realize the clamping of the artificial fusion device in the cavity structure along with the relative movement of a thread pair between the inner threaded rod 107 and the; the fusion cage 605 and the lower polyacetal block 602 are fixed together at the bottom of the glass box 101 through a flange B7, an internal thread 107 and an external thread rod 108, the upper polyacetal block 604 moves linearly up and down under the action of the compression driving module 5, and the compression load of the bottom of the cavity of the upper polyacetal block 604 acts on the top of the fusion cage 605, so that the compression fatigue test of the artificial fusion cage is realized; the upper polyacetal block 604 is torsionally reciprocated by the torsional driving module 4, and the torsional shear load of the inner wall of the cavity of the upper polyacetal block 604 is applied to the side surface of the fusion cage 605, thereby realizing the torsional fatigue test of the artificial fusion cage 605.
The embodiment can simultaneously meet the compression and torsion fatigue tests of the PEEK artificial spine fusion cage product in the environment of body fluid of a human body, the generated torque and compression load have flexible impact, the influence of inertial load caused by rigid impact is greatly reduced, and the method has the advantages of high test precision, wide application range and the like.
The embodiment realizes the comprehensive optimization of the experimental method on the basis of the prior art, has better foresight and operability, and perfects the related technical field. The method has expectable huge economic value and social value.
Example 2
The fatigue testing device for the polyether-ether-ketone artificial spine fusion cage comprises the following components: the body fluid simulation module 1, a flange A2, a motor base 3, a torsion driving module 4, a compression driving module 5, a clamp module 6 and a flange B7; wherein: the clamp module 6 is connected with the body fluid simulation module 1 through a flange B7, the clamp module 6 is connected with the compression driving module 5 through a flange A2, the torsion driving module 4 is connected with the compression driving module 5 through a gear in a meshing manner, the torsion driving module 4 is connected with the body fluid simulation module 1 through a motor base 3, and the clamp module 6 is connected with the body fluid simulation module 1 through a flange A2;
the structure of the clamp module 6 is as follows: a lower clamp plate 601, a lower polyacetal block 602, an upper clamp plate 603, and an upper polyacetal block 604; wherein: the lower clamp plate 601 and the lower polyacetal block 602 are fixedly connected into a whole through bolts, the lower clamp plate 601 is connected with the internal thread rod 107 through a flange B7, the upper clamp plate 603 and the upper polyacetal block 604 are fixedly connected into a whole through bolts, and the upper clamp plate 603 is connected with the gear shaft 501 through a flange A2; the lower polyacetal block 602 and the upper polyacetal block 604 are matched to form a cavity structure capable of placing the PEEK artificial spinal fusion cage 605;
the top of the lower polyacetal block 602 and the bottom of the upper polyacetal block 604 are respectively provided with a cavity which is used for placing a test piece, namely a polyetheretherketone artificial spinal fusion cage, the main outline of the main part of the lower polyacetal block 602 is cuboid, the size of the cavity of the lower polyacetal block 602 and the size of the cavity of the upper polyacetal block 604 are determined by the size of the corresponding artificial fusion cage, the size of the cavities of the lower polyacetal block 602 and the size of the cavity of the upper polyacetal block 604 are the same, and the sum of the depths of the cavities of the lower polyacetal block and the upper polyacetal; the width and length of the cavity structure for placing the polyether-ether-ketone artificial spinal fusion cage 605 are the same as those of the fusion cage 605, the width and length of the cavity structure are in interference fit in the length and width directions, the fusion cage 605 is clamped in the cavity between the lower polyacetal block 602 and the upper polyacetal block 604, and the lower polyacetal block 602 and the lower clamping plate 601 realize the clamping of the artificial fusion cage in the cavity structure along with the relative movement of the thread pair between the inner threaded rod 107 and the outer threaded rod 108; (to ensure that the lower polyacetal block 602 and the upper polyacetal block 604 are tightly combined with the PEEK artificial spinal fusion cage 605 respectively so as to be capable of performing compression or/and torsion experiments during the compression experiment on the PEEK artificial spinal fusion cage;) the cage 605 and the lower polyacetal block 602 are fixed together at the bottom of the glass box 101 through the flange B7, the internal thread 107 and the external thread rod 108, the upper polyacetal block 604 moves up and down in a straight line under the action of the compression driving module 5, and the compression load at the bottom of the cavity of the upper polyacetal block 604 acts on the top of the cage 605, thereby realizing the compression fatigue experiment of the artificial fusion cage; the upper polyacetal block 604 torsionally reciprocates under the action of the torsional driving module 4, and the torsional shear load of the inner wall of the cavity of the upper polyacetal block 604 acts on the side surface of the fusion device 605, so as to realize the torsional fatigue test of the artificial fusion device 605;
the compression movement module 5 is constituted as follows: a gear shaft 501, a torque sensor 502, a gear 503, an eccentric wheel 504, a servo motor 505, a connecting rod 506, a connecting rod electric fork 507 and a load cell 508; the compression movement module 5 is mainly used for realizing compression driving of the clamp 6; the torque sensor 502 and the load cell 508 are both mounted on the gear shaft 501; the gear 503 and the gear shaft 501 are fixedly connected in the circumferential direction by adopting a flat key, one end of the connecting rod 506 is connected with the gear shaft 501 through a rotating pair, an eccentric connecting point on the eccentric wheel 504 is connected with the other end of the connecting rod 506 through a rotating pair, the motor 505 is connected with the eccentric wheel 504, the geometric center of the eccentric wheel 504 is collinear with the gear shaft 501, and the motor 505 drives the eccentric wheel 504 to rotate around the center;
suppose the angular velocity of the output of the servo motor 505 is ω 1.26rad/s, the radius of the eccentric 504 is R0.1 m, and the eccentricity is
Figure BDA0002860343900000191
The length L of the link 506 is 0.5m, and the displacement of the upper polyacetal block 604 along with the up-and-down reciprocating motion of the gear shaft 501 can be expressed as:
Figure BDA0002860343900000192
in the formula, x and t represent the displacement and time of the upper polyacetal block 604, and λ is the ratio of the eccentricity of the eccentric 504 to the length of the connecting rod 506, i.e.
Figure BDA0002860343900000193
The up-and-down reciprocating displacement curve of the upper polyacetal block 604 is shown in FIG. 6;
the first derivative of the displacement equation 1 for the movement of the upper base polyacetal block 604 with respect to time is obtained as the expression for the velocity equation for the upper base polyacetal block 604:
Figure BDA0002860343900000194
in the formula II, the reaction solution is,
Figure BDA0002860343900000195
the first derivative of the equation of the displacement of motion of the upper base polyacetal block 604, i.e., the moving velocity of the upper base polyacetal block 604, and the upper and lower reciprocating velocity curves thereof are shown in FIG. 7;
the equation 1 for the displacement of motion of the upper base mass 604 is taken as the second derivative with respect to time to obtain the equation for the acceleration of the upper base mass 604:
Figure BDA0002860343900000201
(iii) in the formula (III),
Figure BDA0002860343900000202
the second derivative of the equation of the displacement of motion of the upper base polyacetal block 604, i.e., the acceleration of the upper base polyacetal block 604, and the upper and lower reciprocation acceleration curves are shown in FIG. 8;
the connecting rod shifting fork 507 controls the connecting and the disconnecting of the connecting rod 506 and the gear shaft 501, and the connecting rod 506 drives the gear shaft 501 to reciprocate along the axial direction of the gear shaft, so that the upper polyacetal block 604 reciprocates up and down;
because the lower polyacetal block 602 is fixed by the locking switch 104, the volume of the cavity structure between the upper polyacetal block 604 and the lower polyacetal block 602 is changed, so as to realize the compression fatigue test of the artificial fusion cage;
the requirements of the fatigue testing device for the polyether-ether-ketone artificial spine fusion cage are as follows:
constant-temperature physiological saline is placed in the body fluid simulation module 1 and used for simulating physiological fluid environments such as human body temperature, humidity and salinity; the polyether-ether-ketone artificial spine fusion cage for the experiment is arranged in constant-temperature physiological saline in the body fluid simulation module 1;
the requirements of the main components and the ion concentration content of the body fluid simulated physiological saline are as follows:
Na+：142.0mmol/L、Ka+：5.0mmol/L、Ca2+：20.5mmol/L、HCO3 -：4.2mmol/L、Cl-：147.8mmol/L、SO4 2-：0.5mmol/L；
the pH value of the physiological saline is 7.4, the control system 106 is in communication connection with the temperature controller 105, the temperature control of the simulated body fluid in the glass box 101 is realized through the temperature controller, the range of the simulated constant temperature body fluid environment temperature is 30-48 ℃, the general temperature fluctuation range is within +/-0.5 ℃ for general pet and human body temperatures; the control system 106 is in communication connection with the electromagnetic valve 109, and different body fluids are injected into and flow out of the glass box 101 through the opening and closing of the electromagnetic valve 109;
the polyether-ether-ketone artificial spinal fusion cage is arranged in a cavity formed by the lower polyacetal block 602 and the upper polyacetal block 604 in the clamp module 6, and the connecting rod 506 in the compression movement module 5 drives the gear shaft 501 to move along the axial direction of the gear shaft so as to realize the opening and closing movement of the clamp 6, thereby carrying out a compression fatigue test on the fusion cage.
The body fluid simulation module 1 is specifically composed of the following parts: a glass box 101, a base 102, a flange 103, a locking switch 104, a solenoid valve 109, an internal threaded rod 107, an external threaded rod 108, a temperature controller 105 and a control system 106; wherein: the glass box 101 is the installation foundation of the whole body fluid simulation module 1; the base 102 is connected with the glass box 101, the external thread rod 108 is connected with the base 102 through the flange 102, and the internal thread rod 107 is connected with the external thread rod 108 in a matching way; a locking switch 104 for effecting movement and fixation of the thread pair between the internally threaded rod 107 and the externally threaded rod 108 is disposed on the externally threaded rod 108 (and capable of effecting interference with the internally threaded rod 107 as necessary); the inner threaded rod 107 and the outer threaded rod 108 realize the movement and fixation of the thread pair through the opening and closing of the locking switch 104;
the size of the opening of the clamp module 6 is adjusted through the inner threaded rod 107 so as to adapt to fatigue test experiments of artificial fusion devices with different heights;
artifical spinal fusion cage fatigue test device of polyether ether ketone, its characterized in that: the torsional drive module 4 is specifically configured as follows: a servo motor 401, a gear electric fork 402, a gear shaft 403, a gear 404 and a coupling 405; wherein:
the servo motor 401 drives the gear 404 to rotate in a reciprocating manner through the gear shaft 403, the gear fork 402 controls the gear 404 to be meshed with the gear 503 in the compression driving module 5, and the gear shaft 501 is driven to rotate in a reciprocating manner, so that the clamp 6 is driven to realize the torsional fatigue test of the fusion cage; the gear 404 can slide on the gear shaft 403 under the control of the shift fork 402;
the servo motor 401 is connected with a gear shaft 403 through a coupler 405, the gear 404 is connected with the gear shaft 403 through a flat key, and the gear electric shifting fork 402 moves up and down to realize meshing and disengaging of the gear 404 and a gear 503 in the compression driving module 5;
the body fluid simulation module 1 is also provided with a control system 106, the servo motor 401 is in communication connection with the control system 106, the control system 106 gives the servo motor 401 forward and backward rotation, the alternating frequency of the forward and backward rotation is 5Hz, the range of the rotation angle is +/-10 degrees, and the change curve of the forward and backward rotation angle of the servo motor 401 is as shown in FIG. 9;
the control system 106 is in communication with the solenoid valve 109, the temperature control system 108, the stepper motor 401, the servo motor 505, the link electric fork 507, the gear electric fork 402, the torque sensor 502 and the pressure sensor 508.
The gear ratio of the straight gear 404 to the straight gear 503 is 1: 2; the torsional motion of the servo motor 401 is transmitted to the spur gear 503 through the spur gear 404, the torsional motion of the spur gear 503 is transmitted to the upper polyacetal block 604 through the gear shaft 501, the flange A2 and the upper clamping plate 603 in sequence, the torsional motion of the upper polyacetal block 604 is exerted on the artificial fusion device in the cavity through the cavity structure, and the torsional fatigue test of the artificial fusion device is realized.
The torque fatigue testing device for the polyether-ether-ketone artificial spinal fusion cage further meets one or the combination of the following requirements:
firstly, the control system 106 firstly controls the action adjustment of the connecting rod electric fork 507 to separate the connecting rod 506 from the gear shaft 501, then controls the action adjustment of the gear electric fork 402 to enable the gear 404 to be meshed with the gear 503, and simultaneously starts the servo motor 401 to output forward and reverse rotation movement; the torsion motion of the servo motor 401 is transmitted to the spur gear 503 through the spur gear 404, the torsion motion of the spur gear 503 is transmitted to the upper polyacetal block 604 through the gear shaft 501, the flange A2 and the upper clamping plate 603 in sequence, the torsion motion of the upper polyacetal block 604 is applied to the artificial fusion device in the cavity through the cavity structure, and the torsion fatigue test of the artificial fusion device is realized;
in the compression fatigue test method of the polyether-ether-ketone artificial spinal fusion cage, a control system 106 firstly stops a servo motor 401, a gear 404 is disengaged from a gear 503 by controlling the action adjustment of a gear electric fork 402, a connecting rod 506 is connected with a gear shaft 501 by controlling the action adjustment of a connecting rod electric fork 507, a stepping motor 505 is started to output a constant rotating speed, the rotating motion of the stepping motor 505 is transmitted to an upper polyacetal block 604 through an eccentric wheel 504, the connecting rod 506, the gear shaft 501, a flange A2 and an upper clamping plate 603 in sequence, and the upper polyacetal block 604 applies the vertical linear movement motion to the artificial fusion cage in a cavity through a cavity structure, so that the compression fatigue test of the artificial fusion cage is realized;
secondly, the top of the lower polyacetal block 602 and the bottom of the upper polyacetal block 604 are respectively provided with a rectangular cavity, the sizes of the cavities of the lower polyacetal block 602 and the upper polyacetal block 604 are determined by the sizes of the corresponding artificial fusion devices, the cavities of the lower polyacetal block 602 and the upper polyacetal block 604 have the same size, the sum of the depths of the two cavities does not exceed two thirds of the height of the polyetheretherketone artificial spinal fusion device 605, the width and the length of the cavity are the same as those of the fusion device 605, the two cavities are in interference fit in the length and the width directions, the fusion device 605 is clamped in the cavity between the lower polyacetal block 602 and the upper polyacetal block 604, and the lower polyacetal block 602 and the lower clamping plate 601 realize the clamping of the artificial fusion device in the cavity structure along with the relative movement of a thread pair between the inner threaded rod 107 and the; the fusion cage 605 and the lower polyacetal block 602 are fixed together at the bottom of the glass box 101 through a flange B7, an internal thread 107 and an external thread rod 108, the upper polyacetal block 604 moves linearly up and down under the action of the compression driving module 5, and the compression load of the bottom of the cavity of the upper polyacetal block 604 acts on the top of the fusion cage 605, so that the compression fatigue test of the artificial fusion cage is realized; the upper polyacetal block 604 is torsionally reciprocated by the torsional driving module 4, and the torsional shear load of the inner wall of the cavity of the upper polyacetal block 604 is applied to the side surface of the fusion cage 605, thereby realizing the torsional fatigue test of the artificial fusion cage 605.
The embodiment can simultaneously meet the compression and torsion fatigue tests of the PEEK artificial spine fusion cage product in the environment of body fluid of a human body, the generated torque and compression load have flexible impact, the influence of inertial load caused by rigid impact is greatly reduced, and the method has the advantages of high test precision, wide application range and the like.
The embodiment realizes the comprehensive optimization of the experimental method on the basis of the prior art, has better foresight and operability, and perfects the related technical field. The method has expectable huge economic value and social value.

Claims (10)

1. The fatigue test method of the polyether-ether-ketone artificial spinal fusion cage is characterized by comprising the following steps: the fatigue test method of the polyether-ether-ketone artificial spine fusion cage uses a special fatigue test device of the polyether-ether-ketone artificial spine fusion cage, and the fatigue test device of the polyether-ether-ketone artificial spine fusion cage comprises the following steps: the body fluid simulation device comprises a body fluid simulation module (1), a flange A (2), a motor base (3), a torsion driving module (4), a compression driving module (5), a clamp module (6) and a flange B (7); wherein: the body fluid simulation device comprises a clamp module (6), a compression driving module (5), a torsion driving module (4), a motor base (3), a body fluid simulation module (1), a motor base (3), a motor base (6), a motor base (7), a motor base (6), a clamp module (6), a motor base (2), a motor base (4), a motor base (6), a motor base (2), a motor base (6), a motor base (2), a motor base (;
the structure of the clamp module (6) is as follows: a lower clamping plate (601), a lower polyacetal block (602), an upper clamping plate (603), and an upper polyacetal block (604); wherein: the lower clamping plate (601) and the lower polyacetal block (602) are fixedly connected into a whole through bolts, the lower clamping plate (601) is connected with the internal thread rod (107) through a flange B (7), the upper clamping plate (603) and the upper polyacetal block (604) are fixedly connected into a whole through bolts, and the upper clamping plate (603) is connected with the gear shaft (501) through a flange A (2); the lower polyacetal block (602) and the upper polyacetal block (604) are matched to form a cavity structure capable of placing the polyetheretherketone artificial spinal fusion cage (605);
the top of the lower polyacetal block (602) and the bottom of the upper polyacetal block (604) are respectively provided with a cavity which is used for placing a test piece, namely a polyetheretherketone artificial spinal fusion cage, and the main outline of the main part of the lower polyacetal block (602) and the bottom of the upper polyacetal block (604) are cuboid in shape, and the sum of the depths of the cavities of the lower polyacetal block (602) and the upper polyacetal block (604) does not exceed two thirds of the height of the polyetheretherketone artificial spinal; the width and length of the cavity structure for placing the polyether-ether-ketone artificial spinal fusion cage (605) are the same as those of the fusion cage (605), the width and length of the cavity structure are in interference fit in the length and width directions, the fusion cage (605) is clamped in the cavity between the lower polyacetal block (602) and the upper polyacetal block (604), and the clamping of the artificial fusion cage in the cavity structure is realized by the relative movement of the lower polyacetal block (602) and the lower splint (601) along with the thread pair between the inner threaded rod (107) and the outer threaded rod (108); the fusion device (605) and the lower polyacetal block (602) are fixed together at the bottom of the glass box (101), the upper polyacetal block (604) moves up and down along a straight line under the action of the compression driving module (5), and the compression load of the bottom of the cavity of the upper polyacetal block (604) acts on the top of the fusion device (605), so that the compression fatigue load application of the artificial fusion device is realized; the upper polyacetal block (604) is torsionally reciprocated under the action of the torsional driving module (4), and the torsional shear load of the inner wall of the cavity of the upper polyacetal block (604) acts on the side surface of the fusion device (605), thereby realizing the application of the torsional fatigue load of the artificial fusion device (605);
the compression driving module (5) is composed as follows: the device comprises a gear shaft (501), a torque sensor (502), a gear (503), an eccentric wheel (504), a servo motor (505), a connecting rod (506), a connecting rod electric shifting fork (507) and a force measuring sensor (508); the compression driving module (5) is used for realizing compression application of the clamp (6); the torque sensor (502) and the force measuring sensor (508) are both arranged on the gear shaft (501); the gear (503) and the gear shaft (501) are fixedly connected in the circumferential direction, one end of the connecting rod (506) is connected with the gear shaft (501) through a rotating pair, an eccentric connecting point on the eccentric wheel (504) is connected with the other end of the connecting rod (506) through a rotating pair, the motor (505) is connected with the eccentric wheel (504), the geometric center of the eccentric wheel (504) is collinear with the gear shaft (501), and the motor (505) drives the eccentric wheel (504) to rotate around the geometric center;
the connecting rod electric shifting fork (507) controls the connecting and the disconnecting of the connecting rod (506) and the gear shaft (501), and the connecting rod (506) drives the gear shaft (501) to reciprocate along the axial direction of the gear shaft, so that the upper polyacetal block (604) reciprocates up and down;
because the lower polyacetal block (602) is fixed by the locking switch (104), the volume of the cavity structure between the upper polyacetal block (604) and the lower polyacetal block (602) is changed, and the compression fatigue test of the artificial fusion cage is realized;
the requirements of the fatigue testing method of the polyether-ether-ketone artificial spinal fusion cage are as follows:
constant-temperature physiological saline is placed in the body fluid simulation module (1) and used for simulating physiological fluid environments of human body temperature, humidity and salinity; the polyether-ether-ketone artificial spine fusion cage for the experiment is arranged in constant-temperature physiological saline in the body fluid simulation module (1);
the pH value of the normal saline is 7.4, the temperature range of the simulated constant temperature body fluid environment is 30-48 ℃, and the temperature fluctuation range is within +/-0.5 ℃;
the polyether-ether-ketone artificial spinal fusion cage is arranged in a cavity formed by a lower polyacetal block (602) and an upper polyacetal block (604) in a clamp module (6), and a connecting rod (506) in a compression movement module (5) drives a gear shaft (501) to move along the axial direction of the gear shaft so as to change the volume of the cavity of the clamp (6), so that a compression fatigue test is carried out on the fusion cage.
2. The fatigue testing method for the polyether-ether-ketone artificial spinal fusion cage according to claim 1, which is characterized in that:
in the compression motion module (5), the output angular speed of a servo motor (505) is omega, the radius of an eccentric wheel (504) is R, and the eccentricity is
Figure FDA0002860343890000031
The length of the connecting rod (506) is L, and the displacement of the upper polyacetal block (604) along with the up-and-down reciprocating motion of the gear shaft (501) can be expressed as follows:
Figure FDA0002860343890000032
in the formula, x and t represent the displacement and time of the upper polyacetal block (604), and λ is the ratio of the eccentricity of the eccentric cam (504) to the length of the connecting rod (506), that is
Figure FDA0002860343890000033
Taking the first derivative of the kinematic displacement equation (1) of the upper base pellet (604) with respect to time, the expression of the velocity equation of the upper base pellet (604) is obtained:
Figure FDA0002860343890000041
in the formula II, the reaction solution is,
Figure FDA0002860343890000043
represents the first derivative of the equation of the displacement of motion of the upper base polyacetal block (604), i.e., the velocity of motion of the upper base polyacetal block (604);
the equation (1) for the displacement of motion of the upper base polyacetal (604) is taken as the second derivative with respect to time to obtain the equation expression for the acceleration of the upper base polyacetal (604):
Figure FDA0002860343890000042
(iii) in the formula (III),
Figure FDA0002860343890000044
the second derivative of the equation of the displacement of motion of the upper base mass (604), i.e., the acceleration of motion of the upper base mass (604), is shown.
3. The fatigue testing method for the polyether-ether-ketone artificial spinal fusion cage according to claim 1, which is characterized in that: the requirements of the main components and the ion concentration content of the constant-temperature physiological saline placed in the body fluid simulation module (1) are as follows:
Na+：142.0mmol/L、Ka+：5.0mmol/L、Ca2+：20.5mmol/L、HCO3 -：4.2mmol/L、Cl-：147.8mmol/L、SO4 2-：0.5mmol/L；
the pH value of the normal saline is 7.4, the temperature range of the simulated constant temperature body fluid environment is 30-48 ℃ (aiming at the temperature of common pets and human bodies), and the temperature fluctuation range is within +/-0.5 ℃;
the body fluid simulation module (1) is also provided with a control system (106), a temperature controller (105) and an electromagnetic valve (109); the two are in communication connection, the temperature control of simulated body fluid in the glass box (101) is realized through a temperature controller, the control system (106) is in communication connection with the electromagnetic valve (109), and different body fluids are injected into and flow out of the glass box (101) through the opening and closing of the electromagnetic valve (109).
4. The fatigue testing method for the polyether-ether-ketone artificial spinal fusion cage according to claim 1, which is characterized in that:
the body fluid simulation module (1) is specifically composed of the following parts: the temperature control device comprises a glass box (101), a base (102), a flange (103), a locking switch (104), an internal thread rod (107), an external thread rod (108) and a temperature controller (105); wherein: the glass box (101) is an installation foundation of the whole body fluid simulation module (1); the base (102) is connected with the glass box (101), the external threaded rod (108) is connected with the base (102) through the flange (102), and the internal threaded rod (107) is connected with the external threaded rod (108) in a matching way; a locking switch (104) for effecting movement and fixation of the thread pair between the internally threaded rod (107) and the externally threaded rod (108) is arranged on the externally threaded rod (108); the inner threaded rod (107) and the outer threaded rod (108) realize the movement and fixation of a thread pair through the opening and closing of the locking switch (104);
the size of the opening of the clamp module (6) is adjusted through the inner threaded rod (107) so as to adapt to fatigue test experiments of artificial fusion devices with different heights.
5. The method for testing fatigue of the PEEK artificial spinal fusion cage according to any one of claims 1 to 4, wherein: the torsion driving module (4) is specifically composed as follows: the gear shifting mechanism comprises a servo motor (401), a gear electric shifting fork (402), a gear shaft (403), a gear (404) and a coupling (405); wherein:
the servo motor (401) drives the gear (404) to rotate in a reciprocating manner through the gear shaft (403), the gear (404) is controlled to be meshed with the gear (503) in the compression driving module (5) through the gear shifting fork (402), the gear shaft (501) is driven to rotate in a reciprocating manner, and therefore the clamp (6) is driven to realize torsion fatigue load application of the fusion cage; the gear (404) can slide on the gear shaft (403) under the control of the shifting fork (402);
the servo motor (401) is connected with a gear shaft (403) through a coupler (405), a gear (404) is connected with the gear shaft (403) through a flat key, and a gear electric shifting fork (402) moves up and down to realize meshing and disengaging of the gear (404) and a gear (503) in the compression driving module (5);
the body fluid simulation module (1) is also provided with a control system (106), the servo motor (401) is in communication connection with the control system (106), the control system (106) gives the servo motor (401) forward and reverse rotation, the alternating frequency of the forward and reverse rotation is 5Hz, and the range of the rotation angle is +/-10°；
The control system (106) is in communication connection with the electromagnetic valve (109), the temperature control system (108), the stepping motor (401), the servo motor (505), the connecting rod electric shifting fork (507), the gear electric shifting fork (402), the torque sensor (502) and the pressure sensor (508);
the gear ratio of the straight gear (404) to the straight gear (503) is 1: 2; the torsional motion of the servo motor (401) is transmitted to the straight gear (503) through the straight gear (404), the torsional motion of the straight gear (503) is transmitted to the upper polyacetal block (604) through the gear shaft (501), the flange A (2) and the upper clamping plate (603) in sequence, the upper polyacetal block (604) applies the torsional motion to the artificial fusion cage in the cavity through the cavity structure, and the torsional fatigue load application of the artificial fusion cage is realized.
6. The fatigue testing method for the polyether-ether-ketone artificial spinal fusion cage of claim 5, which is characterized by comprising the following steps of: the torque fatigue testing method of the polyether-ether-ketone artificial spine fusion cage further meets one or the combination of the following requirements:
firstly, a control system (106) firstly controls the action adjustment of a connecting rod electric fork (507) to separate a connecting rod (506) from a gear shaft (501), then controls the action adjustment of a gear electric fork (402) to engage a gear (404) with a gear (503), and simultaneously starts a servo motor (401) to output forward and reverse rotation movement; the torsional motion of the servo motor (401) is transmitted to the straight gear (503) through the straight gear (404), the torsional motion of the straight gear (503) is transmitted to the upper polyacetal block (604) through the gear shaft (501), the flange A (2) and the upper clamping plate (603) in sequence, the upper polyacetal block (604) applies the torsional motion to the artificial fusion cage in the cavity through the cavity structure, and the torsional fatigue load application of the artificial fusion cage is realized;
in the compression fatigue test method of the polyether-ether-ketone artificial spinal fusion cage, a control system (106) firstly stops a servo motor (401), a gear (404) is disengaged from a gear (503) by controlling the action adjustment of a gear electric fork (402), a connecting rod (506) is connected with a gear shaft (501) by controlling the action adjustment of a connecting rod electric fork (507), a stepping motor (505) is started to output a constant rotating speed, the rotating motion of the stepping motor (505) is transmitted to an upper polyacetal block (604) through an eccentric wheel (504), the connecting rod (506), the gear shaft (501), a flange A (2) and an upper clamping plate (603) in sequence, and the upper polyacetal block (604) applies the vertical linear movement action to the artificial fusion cage in a cavity through a cavity structure, so that the compression fatigue load application of the artificial fusion cage is realized;
secondly, the top of the lower polyacetal block (602) and the bottom of the upper polyacetal block (604) are respectively provided with a rectangular cavity, the sizes of the cavities of the lower polyacetal block (602) and the upper polyacetal block (604) are determined by the sizes of corresponding artificial fusion devices, the sizes of the cavities of the lower polyacetal block (602) and the upper polyacetal block (604) are the same, the sum of the depths of the cavities of the lower polyacetal block and the upper polyacetal block is not more than two thirds of the height of the polyetheretherketone artificial spinal fusion device (605), the width and the length of the cavity are the same as the width and the length of the fusion device (605), the width and the length of the cavity are in interference fit in the length and the width directions, the fusion device (605) is clamped in the cavity between the lower polyacetal block, the lower polyacetal block (602) and the lower clamping plate (601) realize the clamping of the artificial fusion device in the cavity structure along with the relative movement of the thread pair between the inner threaded rod (107) and the outer threaded rod (108); the fusion cage (605) and the lower polyacetal block (602) are fixed at the bottom of the glass box (101) together through a flange B (7), an internal thread (107) and an external thread rod (108), the upper polyacetal block (604) moves up and down linearly under the action of the compression driving module (5), and the compression load of the bottom of the cavity of the upper polyacetal block (604) acts on the top of the fusion cage (605), so that the application of the compression fatigue load of the artificial fusion cage is realized; the upper polyacetal block (604) is torsionally reciprocated by the torsional driving module (4), and the torsional shear load of the inner wall of the cavity of the upper polyacetal block (604) acts on the side surface of the fusion device (605), thereby realizing the application of the torsional fatigue load of the artificial fusion device (605).
7. Artifical spinal fusion cage fatigue test device of polyether ether ketone, its characterized in that:
the fatigue testing device for the polyether-ether-ketone artificial spinal fusion cage comprises the following components: the body fluid simulation device comprises a body fluid simulation module (1), a flange A (2), a motor base (3), a torsion driving module (4), a compression driving module (5), a clamp module (6) and a flange B (7); wherein: the body fluid simulation device comprises a clamp module (6), a compression driving module (5), a torsion driving module (4), a motor base (3), a body fluid simulation module (1), a motor base (3), a motor base (6), a motor base (7), a motor base (6), a clamp module (6), a motor base (2), a motor base (4), a motor base (6), a motor base (2), a motor base (6), a motor base (2), a motor base (;
the structure of the clamp module (6) is as follows: a lower clamping plate (601), a lower polyacetal block (602), an upper clamping plate (603), and an upper polyacetal block (604); wherein: the lower clamping plate (601) and the lower polyacetal block (602) are fixedly connected into a whole through bolts, the lower clamping plate (601) is connected with the internal thread rod (107) through a flange B (7), the upper clamping plate (603) and the upper polyacetal block (604) are fixedly connected into a whole through bolts, and the upper clamping plate (603) is connected with the gear shaft (501) through a flange A (2); the lower polyacetal block (602) and the upper polyacetal block (604) are matched to form a cavity structure capable of placing the polyetheretherketone artificial spinal fusion cage (605);
the top of the lower polyacetal block (602) and the bottom of the upper polyacetal block (604) are respectively provided with a cavity which is used for placing a test piece, namely a polyetheretherketone artificial spinal fusion cage, the main outline of the main part of the lower polyacetal block (602) and the upper polyacetal block (604) is in the shape of a cuboid, the sizes of the cavities of the lower polyacetal block (602) and the upper polyacetal block (604) are determined by the sizes of the corresponding artificial fusion cages, the sizes of the cavities of the lower polyacetal block (602) and the upper polyacetal block (604) are the same, and the sum of the depths of the cavities of the lower polyacetal block and the upper; the width and length of the cavity structure for placing the polyether-ether-ketone artificial spinal fusion cage (605) are the same as those of the fusion cage (605), the width and length of the cavity structure are in interference fit in the length and width directions, the fusion cage (605) is clamped in the cavity between the lower polyacetal block (602) and the upper polyacetal block (604), and the clamping of the artificial fusion cage in the cavity structure is realized by the relative movement of the lower polyacetal block (602) and the lower splint (601) along with the thread pair between the inner threaded rod (107) and the outer threaded rod (108); so as to ensure that the lower polyacetal block (602) and the upper polyacetal block (604) are tightly combined with the PEEK artificial spinal fusion cage (605) respectively in the process of carrying out a compression experiment on the PEEK artificial spinal fusion cage, so that the compression experiment or/and the torsion experiment can be carried out;
the fusion cage (605) and the lower polyacetal block (602) are fixed at the bottom of the glass box (101) together through a flange B (7), an internal thread (107) and an external thread rod (108), the upper polyacetal block (604) moves up and down along a straight line under the action of the compression driving module (5), and the compression load of the bottom of the cavity of the upper polyacetal block (604) acts on the top of the fusion cage (605), so that the compression fatigue test of the artificial fusion cage is realized; the upper polyacetal block (604) is torsionally reciprocated under the action of the torsional driving module (4), and the torsional shear load of the inner wall of the cavity of the upper polyacetal block (604) acts on the side surface of the fusion device (605), thereby realizing the torsional fatigue test of the artificial fusion device (605);
the compression movement module (5) is formed as follows: the device comprises a gear shaft (501), a torque sensor (502), a gear (503), an eccentric wheel (504), a servo motor (505), a connecting rod (506), a connecting rod electric shifting fork (507) and a force measuring sensor (508); the compression movement module (5) is used for realizing compression driving of the clamp (6); the torque sensor (502) and the force measuring sensor (508) are both arranged on the gear shaft (501); the gear (503) and the gear shaft (501) are fixedly connected in the circumferential direction, one end of the connecting rod (506) is connected with the gear shaft (501) through a rotating pair, an eccentric connecting point on the eccentric wheel (504) is connected with the other end of the connecting rod (506) through a rotating pair, the motor (505) is connected with the eccentric wheel (504), the geometric center of the eccentric wheel (504) is collinear with the gear shaft (501), and the motor (505) drives the eccentric wheel (504) to rotate around the center;
the output angular speed of the servo motor (505) is omega, the radius of the eccentric wheel (504) is R, and the eccentricity is
Figure FDA0002860343890000101
The length L of the connecting rod (506) is 0.5m, and the displacement of the upper polyacetal block (604) along with the up-and-down reciprocating motion of the gear shaft (501) can be expressed as:
Figure FDA0002860343890000102
in the formula, x and t represent the displacement and time of the upper polyacetal block (604), and λ is the ratio of the eccentricity of the eccentric cam (504) to the length of the connecting rod (506), that is
Figure FDA0002860343890000103
Taking the first derivative of the kinematic displacement equation (1) of the upper base pellet (604) with respect to time, the expression of the velocity equation of the upper base pellet (604) is obtained:
Figure FDA0002860343890000104
in the formula II, the reaction solution is,
Figure FDA0002860343890000106
represents the first derivative of the equation of the displacement of motion of the upper base polyacetal block (604), i.e., the velocity of motion of the upper base polyacetal block (604);
the equation (1) for the displacement of motion of the upper base polyacetal (604) is taken as the second derivative with respect to time to obtain the equation expression for the acceleration of the upper base polyacetal (604):
Figure FDA0002860343890000105
(iii) in the formula (III),
Figure FDA0002860343890000107
represents the second derivative of the equation of the displacement of motion of the upper base mass (604), i.e., the acceleration of motion of the upper base mass (604);
the connecting rod shifting fork (507) controls the connecting and the disconnecting of the connecting rod (506) and the gear shaft (501), and the connecting rod (506) drives the gear shaft (501) to reciprocate along the axial direction of the gear shaft, so that the upper polyacetal block (604) reciprocates up and down;
because the lower polyacetal block (602) is fixed by the locking switch (104), the volume of the cavity structure between the upper polyacetal block (604) and the lower polyacetal block (602) is changed, and the compression fatigue test of the artificial fusion cage is realized;
the requirements of the fatigue testing method of the polyether-ether-ketone artificial spinal fusion cage are as follows:
constant-temperature physiological saline is placed in the body fluid simulation module (1) and used for simulating physiological fluid environments such as human body temperature, humidity, salinity and the like; the polyether-ether-ketone artificial spine fusion cage for the experiment is arranged in constant-temperature physiological saline in the body fluid simulation module (1);
the requirements of the main components and the ion concentration content of the body fluid simulated physiological saline are as follows:
Na+：142.0mmol/L、Ka+：5.0mmol/L、Ca2+：20.5mmol/L、HCO3 -：4.2mmol/L、Cl-：147.8mmol/L、SO4 2-：0.5mmol/L；
the PH value of the physiological saline is 7.4, the control system (106) is in communication connection with the temperature controller (105), the temperature control of the simulated body fluid in the glass box (101) is realized through the temperature controller, the range of the simulated constant temperature body fluid environmental temperature is 30-48 ℃ (aiming at the temperature of common pets and human bodies), and the common temperature fluctuation range is within +/-0.5 ℃; the control system (106) is in communication connection with the electromagnetic valve (109), and different body fluids are injected into and flow out of the glass box (101) through the opening and closing of the electromagnetic valve (109);
the polyether-ether-ketone artificial spinal fusion cage is arranged in a cavity formed by a lower polyacetal block (602) and an upper polyacetal block (604) in a clamp module (6), and a connecting rod (506) in a compression movement module (5) drives a gear shaft (501) to move along the axial direction of the gear shaft so as to realize the opening and closing movement of the clamp (6), thereby carrying out a compression fatigue test on the fusion cage.
8. The fatigue testing device for the artificial spinal fusion cage of polyether-ether-ketone according to claim 7, characterized in that:
the body fluid simulation module (1) is specifically composed of the following parts: the temperature control device comprises a glass box (101), a base (102), a flange (103), a locking switch (104), an internal thread rod (107), an external thread rod (108) and a temperature controller (105); wherein: the glass box (101) is an installation foundation of the whole body fluid simulation module (1); the base (102) is connected with the glass box (101), the external threaded rod (108) is connected with the base (102) through the flange (102), and the internal threaded rod (107) is connected with the external threaded rod (108) in a matching way; a locking switch (104) for effecting movement and fixation of the thread pair between the internally threaded rod (107) and the externally threaded rod (108) is arranged on the externally threaded rod (108); the inner threaded rod (107) and the outer threaded rod (108) realize the movement and fixation of a thread pair through the opening and closing of the locking switch (104);
the size of the opening of the clamp module (6) is adjusted through the inner threaded rod (107) so as to adapt to fatigue test experiments of artificial fusion devices with different heights.
9. The fatigue testing device for the artificial spinal fusion cage of polyether ether ketone according to claim 8, characterized in that: the torsion driving module (4) is specifically composed as follows: the gear shifting mechanism comprises a servo motor (401), a gear electric shifting fork (402), a gear shaft (403), a gear (404) and a coupling (405); wherein:
the servo motor (401) drives the gear (404) to rotate in a reciprocating manner through the gear shaft (403), the gear (404) is controlled to be meshed with the gear (503) in the compression driving module (5) through the gear shifting fork (402), the gear shaft (501) is driven to rotate in a reciprocating manner, and therefore the clamp (6) is driven to achieve the torsional fatigue test of the fusion cage; the gear (404) can slide on the gear shaft (403) under the control of the shifting fork (402);
the servo motor (401) is connected with a gear shaft (403) through a coupler (405), a gear (404) is connected with the gear shaft (403) through a flat key, and a gear electric shifting fork (402) moves up and down to realize meshing and disengaging of the gear (404) and a gear (503) in the compression driving module (5);
the body fluid simulation module (1) is also provided with a control system (106), the servo motor (401) is in communication connection with the control system (106), the control system (106) gives positive and negative rotation to the servo motor (401), the alternating frequency of the positive and negative rotation is 5Hz, and the range of the rotation angle is +/-10 degrees;
the control system (106) is in communication connection with the electromagnetic valve (109), the temperature control system (108), the stepping motor (401), the servo motor (505), the connecting rod electric shifting fork (507), the gear electric shifting fork (402), the torque sensor (502) and the pressure sensor (508);
the gear ratio of the straight gear (404) to the straight gear (503) is 1: 2; the torsion motion of the servo motor (401) is transmitted to the straight gear (503) through the straight gear (404), the torsion motion of the straight gear (503) is transmitted to the upper polyacetal block (604) through the gear shaft (501), the flange A (2) and the upper clamping plate (603) in sequence, the torsion motion of the upper polyacetal block (604) is applied to the artificial fusion device in the cavity through the cavity structure, and the torsion fatigue test of the artificial fusion device is realized.
10. The fatigue testing device for the artificial spinal fusion cage of polyetheretherketone according to claim 9, characterized in that: the torque fatigue testing device for the polyether-ether-ketone artificial spinal fusion cage further meets one or the combination of the following requirements:
firstly, a control system (106) firstly controls the action adjustment of a connecting rod electric fork (507) to separate a connecting rod (506) from a gear shaft (501), then controls the action adjustment of a gear electric fork (402) to engage a gear (404) with a gear (503), and simultaneously starts a servo motor (401) to output forward and reverse rotation movement; the torsion motion of the servo motor (401) is transmitted to the straight gear (503) through the straight gear (404), the torsion motion of the straight gear (503) is transmitted to the upper polyacetal block (604) through the gear shaft (501), the flange A (2) and the upper clamping plate (603) in sequence, the torsion motion of the upper polyacetal block (604) is applied to the artificial fusion device in the cavity through the cavity structure, and the torsion fatigue test of the artificial fusion device is realized;
in the compression fatigue test method of the polyether-ether-ketone artificial spinal fusion cage, a control system (106) firstly stops a servo motor (401), a gear (404) is disengaged from a gear (503) by controlling the action adjustment of a gear electric fork (402), a connecting rod (506) is connected with a gear shaft (501) by controlling the action adjustment of a connecting rod electric fork (507), a stepping motor (505) is started to output a constant rotating speed, the rotating motion of the stepping motor (505) is transmitted to an upper polyacetal block (604) through an eccentric wheel (504), the connecting rod (506), the gear shaft (501), a flange A (2) and an upper clamping plate (603) in sequence, and the upper polyacetal block (604) applies the vertical linear movement action to the artificial fusion cage in a cavity through a cavity structure, so that the compression fatigue test of the artificial fusion cage is realized;
secondly, the top of the lower polyacetal block (602) and the bottom of the upper polyacetal block (604) are respectively provided with a rectangular cavity, the sizes of the cavities of the lower polyacetal block (602) and the upper polyacetal block (604) are determined by the sizes of corresponding artificial fusion devices, the sizes of the cavities of the lower polyacetal block (602) and the upper polyacetal block (604) are the same, the sum of the depths of the cavities of the lower polyacetal block and the upper polyacetal block is not more than two thirds of the height of the polyetheretherketone artificial spinal fusion device (605), the width and the length of the cavity are the same as the width and the length of the fusion device (605), the width and the length of the cavity are in interference fit in the length and the width directions, the fusion device (605) is clamped in the cavity between the lower polyacetal block, the lower polyacetal block (602) and the lower clamping plate (601) realize the clamping of the artificial fusion device in the cavity structure along with the relative movement of the thread pair between the inner threaded rod (107) and the outer threaded rod (108); the fusion device (605) and the lower polyacetal block (602) are fixed at the bottom of the glass box (101) together through a flange B (7), an internal thread (107) and an external thread rod (108), the upper polyacetal block (604) moves up and down in a linear way under the action of the compression driving module (5), and the compression load of the bottom of the cavity of the upper polyacetal block (604) acts on the top of the fusion device (605), so that the compression fatigue test of the artificial fusion device is realized; the upper polyacetal block (604) is torsionally reciprocated under the action of the torsional driving module (4), and the torsional shear load of the inner wall of the cavity of the upper polyacetal block (604) acts on the side surface of the fusion device (605), thereby realizing the torsional fatigue test of the artificial fusion device (605).
CN202011560275.2A 2020-12-25 2020-12-25 Fatigue test method and fatigue test device for polyether-ether-ketone artificial spinal fusion cage Pending CN112557222A (en)

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