CN215937821U - Static compression bending test device of zero notch fusion cage system - Google Patents
Static compression bending test device of zero notch fusion cage system Download PDFInfo
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- CN215937821U CN215937821U CN202121534804.1U CN202121534804U CN215937821U CN 215937821 U CN215937821 U CN 215937821U CN 202121534804 U CN202121534804 U CN 202121534804U CN 215937821 U CN215937821 U CN 215937821U
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
- A61F2/4657—Measuring instruments used for implanting artificial joints
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Abstract
The patent relates to a zero notch fuses static compression bending test device of system, and this test device includes: the fixture comprises two supports, the first support is provided with a first surface and a second surface, the second support is provided with a third surface and a fourth surface, and the first surface and the third surface are arranged oppositely; the test block comprises a first test block and a second test block and is used for simulating two vertebral bodies to be connected; the first test block and the second test block are respectively fixed on the first surface and the third surface; the zero notch fusion system to be tested is arranged between the first surface and the third surface and is fixedly connected with the first test block and the second test block. The zero-notch fusion cage system can be assembled according to the position relation between the zero-notch fusion cage system and the spine in the actual operation, the working environment of the zero-notch fusion cage system after the actual implantation can be simulated, the compression-resistant situation of the zero-notch fusion cage system after the operation can be simulated by applying load, and the compression-resistant bending capability of the zero-notch fusion cage system can be more accurately measured.
Description
Technical Field
This patent belongs to medical instrument technical field, particularly relates to a zero notch fusion cage system static compression bending test device.
Background
At present, the intervertebral fusion cage commonly used in clinic mainly plays a supporting role and does not have the function of inducing osteogenesis. Therefore, autologous bone or allogeneic bone needs to be implanted into the fusion device to achieve the purpose of promoting osseous fusion, however, the autologous bone needs to be taken out of the patient, which often causes surgical side damage to the patient and increases the pain of the patient, and the allogeneic bone is implanted to cause rejection reaction, poor bone fusion effect and other conditions.
Spinal plates are often used in spinal surgery to provide immediate spinal stabilization. The use of spinal plates can provide immediate stabilization of the spine, improving the post-surgical fusion rate of the spine. With the wide use of the spinal plate, related complications also appear, and early complications comprise internal fixation loosening, screw loosening and extraction to damage other tissues, other complications are caused, and strong foreign body sensation is generated; in addition, if a relatively long steel plate is adopted, the degeneration of the adjacent vertebral body can be increased, and the occurrence of the clinical vertebral disease can be finally caused.
Zero notch fusion cage is to prior art's current situation, provides simple structure, and biocompatibility is good, convenient operation's a zero notch artificial centrum, adopts zero notch design, lies in centrum clearance completely after the implantation, can effectively reduce or avoid complications such as adjacent segment degenerative change and postoperative foreign matter sense, is the improvement to traditional fusion art product, is again the necessary replenishment to novel artificial intervertebral disc replacement art product. However, after the patient performs the spinal decompression fusion operation, the zero-notch fusion cage can replace the intervertebral disc and bear the pressure between the upper vertebral body and the lower vertebral body, if the mechanical property of the zero-notch fusion cage system is insufficient, the stability is insufficient, the normal physiological curvature of the spinal column cannot be ensured, and the internal fixation is loosened in serious cases. Internal fixation loosening is the most major, serious complication.
However, the requirements for the intervertebral fusion device are YY/T1502-2016 spinal implant intervertebral fusion device, and the test methods required for the mechanical properties are YY/T0959 mechanical property test method for spinal implant intervertebral fusion device, YY/T0960 static axial compression and subsidence test method for spinal implant intervertebral fusion device, GB/T4340.1 part 1 of Vickers hardness test of metal material: test method and YY/T0586X-ray opacity test method for medical polymer products. For the zero notch fusion device system, the test is carried out according to the standard, the compared and reflected performance is mainly the characteristics of the zero notch fusion device such as axial compression, shearing, torsion, subsidence, hardness, size, visibility and the like, and the performance of the system after the zero notch fusion device is assembled cannot be reflected due to the fact that the related test loading method and the actual stress mode are different. It is not fully applicable to the zero notch fuser system. At present, no test method aiming at the mechanical property comparison of the zero notch fusion device system exists, and the performance of the zero notch fusion device systems of different models cannot be comprehensively evaluated.
Disclosure of Invention
In view of the foregoing analysis, the present disclosure provides a static compressive bending test apparatus for a zero notch fusion cage system, which is used to test corresponding physical properties of the zero notch fusion cage system under a condition of simulating an actual use state of the zero notch fusion cage to the maximum extent, so that a test result is more accurate.
The purpose of the invention is realized as follows:
in one aspect, a static compressive bending test device for a zero notch fusion cage system is provided, which includes: the fixture comprises two supports, wherein the first support is provided with a first surface and a second surface, the second support is provided with a third surface and a fourth surface, and the first surface and the third surface are arranged oppositely;
the test block comprises a first test block and a second test block and is used for simulating two vertebral bodies to be connected; the first test block and the second test block are respectively fixed on the first surface and the third surface; the zero notch fusion system to be tested is arranged between the first surface and the third surface and is fixedly connected with the first test block and the second test block.
In a preferred embodiment of the present invention, the first surface is provided with a first mounting groove, and the first test block is fixedly mounted in the first mounting groove;
the third surface is provided with a second mounting groove, and the second test block is fixedly mounted in the second mounting groove;
the first side wall surface of the first support and the first side wall surface of the second support are respectively provided with a first opening and a second opening, the first opening is communicated with the first mounting groove, and the second opening is communicated with the second mounting groove.
In a preferred embodiment of the present invention, the first test block is fixed on the first support through a first connecting block, the first connecting block is detachably connected to the first support, and the first connecting block at least partially covers the top surface of the first test block;
the second test block is fixed on the second support through a second connecting block, the second connecting block is detachably connected with the second support, and at least part of the second connecting block covers the top surface of the second test block.
In a preferred embodiment of the present invention, the first connecting block and the second connecting block are both U-shaped plates. In a preferred embodiment of the present invention, the first mounting groove and the second mounting groove are both U-shaped stepped grooves;
from the groove bottom to the groove opening, the U-shaped stepped groove is provided with a first space and a second space which are communicated, the first space is provided with a first cross section size, the second space is provided with a second cross section size, and the first cross section size is smaller than the second cross section size;
the longitudinal section of the first test block and the longitudinal section of the second test block are convex, the first test block and the second test block respectively comprise a first section and a second section, the size of the first section is larger than that of the second section, and the size of the cross section of the first section is equal to that of the second cross section.
In a preferred embodiment of the present invention, the first segment is installed in the second space seamlessly, and the height of the first segment is equal to the height of the second space; the U-shaped plate is arranged in the first space, and the U-shaped plate is sleeved on the second section.
In a preferred embodiment of the present invention, the upper surface of the U-shaped plate is flush with the lowest part of the second section; the projection of the U-shaped plate on the horizontal plane can simultaneously cover at least part of the top surface of the support and the end surface of the test block, wherein the first section of the test block is wider than the second section of the test block.
In a preferred embodiment of the present invention, the U-shaped stepped groove has a stepped surface, the stepped surface is provided with a screw hole, and the U-shaped plate is fixed to the stepped surface by a screw.
In a preferred embodiment of the present invention, the first side wall surface is a convex arc structure, and the shape of the convex arc structure is similar to the shape of the outer edge of the front side surface of the vertebral body;
after the first test block is installed on the first support, the inner side wall surface of the first test block is seamlessly spliced with the groove wall surface of the first installation groove, and the outer side wall surface of the first test block is conformal to the convex arc structure.
In a preferred embodiment of the present invention, the testing apparatus further includes a testing machine and a connecting device, the connecting device includes two connecting frames, a first end of the first connecting frame is connected to the first support, and a second end of the first connecting frame is connected to the first pressing end of the testing machine; the first end and the second support of second link are connected, and the second end and the second of second link are exerted pressure the end and are connected of testing machine.
In a preferred embodiment of the invention, the test block is made of polyurethane material, the polyurethane is 15-grade, and the limit of the compressive strength is 3.82-6.05 Mpa.
On the other hand, the static compression bending test method for the zero notch fusion system is provided, and the static compression bending test device for the zero notch fusion system comprises the following steps: assembling the test device, and fixedly installing the zero notch fusion device system between the first support and the second support; connecting the assembled test device to a testing machine; designing a test scheme, and setting a motion mode of the testing machine; starting the testing machine, pressurizing the first test block and the second test block by using static pressure generated by the testing machine, continuously measuring changed load and displacement at the same time, and outputting corresponding data of the displacement and the load; and obtaining the mechanical property parameters of the zero notch fusion device system based on the displacement and the load data. Compared with the prior art, the invention can realize at least one of the following beneficial effects:
a) the test device can assemble according to the position relation of zero notch fusion cage system and backbone in the actual operation, can simulate the operational environment of zero notch fusion cage after the actual implantation, simulate the condition of zero notch fusion cage pressurized unstability after the operation through applying load, the resistance to compression bending ability of survey zero notch fusion cage system that can be more accurate, the design to zero notch fusion cage system provides the basis, establish unified test scheme simultaneously, can be to different materials according to this test scheme, different models, the zero notch fusion cage system that different producers produced carries out the mechanical properties contrast.
b) The test block is used for simulating a vertebral body, the shape of the test block is set to be the shape simulating the front edge of a spinal bone, the first test block and the second test block are respectively fixed on the two supports, the zero notch fusion device system to be tested is fixed between the first test block and the second test block, the working environment of the zero notch fusion device after actual implantation can be simulated, and the accuracy and the reliability of a test result are guaranteed.
c) The static pressure is utilized to pressurize the zero notch fusion device system testing device, the changed load and displacement are continuously measured at the same time, and corresponding data of the displacement and the load are output.
Drawings
In order to more clearly illustrate the embodiments of the present specification or the technical solutions in the prior art, the drawings needed to be used in the description of the embodiments or the prior art are briefly introduced below, it is obvious that the drawings in the following description are only some embodiments described in the embodiments of the present specification, and it is also possible for a person skilled in the art to obtain other drawings according to the drawings.
FIG. 1 is an anterior side view of a spine after zero notch fusion;
FIG. 2 is a schematic structural diagram of a static compression bending test apparatus of a zero notch fusion system according to a preferred embodiment of the present invention;
FIG. 3 is an enlarged view of a portion of area A of FIG. 2;
FIG. 4 is a schematic diagram of a zero notch fuser system;
FIG. 5 is a schematic structural view of the zero notch fusion system static compression bending test device of the present invention assembled on a testing machine;
FIG. 6 is a graph of load displacement curves obtained from tests using the test apparatus of the present invention.
Reference numerals:
1-a support; 2, connecting blocks; 3-test block; 4-zero notch fuser system; 41-fixing plate;
42-a fusion device; 43-set screws; 5-a connecting frame; 6-hinge pin.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are some embodiments of the present application, but not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.
For the purpose of facilitating understanding of the embodiments of the present application, the following description will be made in terms of specific embodiments with reference to the accompanying drawings, which are not intended to limit the embodiments of the present application.
Example 1
The zero-notch fusion cage system is generally used for spinal decompression fusion and replacement of diseased discs. In the process of using the zero-notch fusion cage system, a transverse incision approach is selected at a preset position of a vertebra, an incision with the length of about 3-4 cm is made, skin, superficial fascia and muscle are sequentially incised, a pathological section intervertebral disc is exposed conventionally, intervertebral disc tissues and posterior longitudinal ligaments are incised, pathological tissues and a hyperplasia vertebral body are removed, cartilages of upper and lower end plates of a target gap are ground by using a high-speed abrasive drill, the head of an external force is pulled, the gap height is tested and measured in a trial mode, the zero-notch fusion cage with the proper size is implanted into an allogeneic bone and then is implanted into the intervertebral space, after the proper position is confirmed through X-ray fluoroscopy, the nail hole is locked by the zero-notch fusion cage, drilling is carried out by an electric drill to measure the depth, and fixing screws 43 are implanted into the upper and lower edges of the upper and lower vertebral bodies for anchoring and locking. The various views of the vertebra after the connection are shown in fig. 1 (a). FIGS. 1(b) - (d) are schematic illustrations of other zero notch fuser connections. In this case, since the spine is the main stressed bone of the human body, the zero-notch fusion cage usually bears corresponding stress in the human body, and the performance of the zero-notch fusion cage is directly related to the performance of the zero-notch fusion cage under different stresses.
Based on the above working mode of the zero-notch fusion cage, a specific embodiment of the invention discloses a static compression bending test method of a zero-notch fusion cage system, which is used for performing mechanical test on the zero-notch fusion cage system, and can test the mechanical property of the zero-notch fusion cage in a mode of simulating the working environment of a vertebral body through the zero-notch fusion cage, so as to obtain more accurate mechanical property parameters. As shown in fig. 2, the static compression bending test apparatus of the zero notch fusion system includes: the fixture comprises two supports 1, and the first support and the second support have the same structure; the first support has first face and second face, and the second support has third face and fourth face, and first face sets up with the third is relative, first face and third face are used for centre gripping test block 3. A test block 3, wherein the test block 3 is used for simulating a vertebral body; the quantity of test piece 3 is two, and first test piece and second test piece are fixed in respectively first face and third face for two centrums that the simulation is waited to connect, zero notch that first test piece and second test piece centre gripping awaited measuring fuse ware system 4, and laminate with the upper and lower surface of the zero notch fuse ware system 4 that awaits measuring respectively, the shape of grip surface of first test piece and second test piece, with the upper and lower surface looks adaptation of the zero notch fuse ware system 4 that awaits measuring.
During the test, firstly, the first test block and the second test block are respectively and fixedly installed on the first surface of the first support and the third surface of the second support, after the test block is fixedly installed, the zero notch fusion device system to be tested is respectively inserted into the first test block and the second test block through the first screw and the second screw, so that the zero notch fusion device system 4 is fixed between the first test block and the second test block, and the working environment of the zero notch fusion device system 4 after actual implantation can be simulated.
As shown in fig. 3 to 4, the zero-notch fusion system 4 to be tested includes a zero-notch fusion device and a fixing screw 43, the fixing plate 41 and the fusion device 42 constitute the zero-notch fusion device, and the fixing screw 43 is used to fix the zero-notch fusion device on the test block 3. Optionally, the fixing plate 41 and the fixing screw 43 are made of titanium alloy, and the fusion cage 42 is made of peek (polyether ether ketone). Every test, test 1 zero notch fusion ware system 4, install in the middle of the test piece 3 of both sides, it is specific, zero notch fusion ware inserts first test piece and second test piece respectively through first screw and second screw.
In a preferred embodiment of this embodiment, the first and second supports have the same or similar structure, and the support 1 further has a first sidewall surface and a second sidewall surface, the first sidewall surface is located in the anterior direction of the vertebral body, and the second sidewall surface is located in the posterior direction of the vertebral body. The first surface of the first support is provided with a first mounting groove, the third surface of the second support is provided with a second mounting groove, the first test block is fixedly mounted in the first mounting groove, the second test block is fixedly mounted in the second mounting groove, the bottom surface of the test block 3 is attached to the bottom surface of the mounting groove, the side surface of the test block 3 is attached to the wall surface of the mounting groove, and the shape of the test block 3 is basically consistent with that of the mounting groove of the support 1; the first side wall surfaces of the two supports 1 are provided with openings, the openings are communicated with the mounting grooves, namely, the first side wall surfaces of the first support and the second support are provided with first openings and second openings respectively, the first openings are communicated with the first mounting grooves, and the second openings are communicated with the second mounting grooves.
In a preferred embodiment of the present embodiment, the test block 3 is fixed in the mounting groove of the support 1 through the connecting block 2, the connecting block 2 is detachably and fixedly connected with the support 1, and the connecting block 2 at least partially covers the top surface of the test block 3. That is, the first test block is fixed on the first support through a first connecting block, the first connecting block is detachably connected with the first support, and the first connecting block at least partially covers the top surface of the first test block; the second test block is fixed on the second support through a second connecting block, the second connecting block is detachably connected with the second support, and at least part of the second connecting block covers the top surface of the second test block. Optionally, the connecting block 2 is a U-shaped plate, and after the test block 3 is fixed in the mounting groove by the connecting block 2, the projection area of the exposed part of the top surface of the test block 3 on the horizontal plane is larger than that of the zero-notch fusion device on the horizontal plane, so that the practical application environment is approached to the maximum extent.
In a preferred embodiment of this embodiment, the mounting groove is a U-shaped stepped groove, the groove bottom of the mounting groove is open to the top of the mounting groove, the mounting groove has a first space and a second space that are communicated, the first space has a first cross-sectional dimension, the second space has a second cross-sectional dimension, and the first cross-sectional dimension is smaller than the second cross-sectional dimension; the longitudinal section of test block 3 is the convex, test block 3 includes first section and second section, the size of first section is greater than the size of second section, the cross sectional dimension of first section equals the second cross sectional dimension of mounting groove, that is to say, first section seamless installation is in the second space, the height that highly equals the second space of first section, second section and U-shaped connecting block 2 are installed in first space, and the second section is located the U-shaped space of U-shaped connecting plate, and the appearance shape of second section is the same with the inner wall shape in the U-shaped space of U-shaped connecting block 2, U-shaped connecting block 2 can be located on the second section without pot cover. Optionally, after the installation, the upper surface of connecting block 2 and the lowest parallel and level of second section, connecting block 2 covers at least partial top surface of support 1 and the terminal surface that test block 3 first section exceeds the second section simultaneously in the projection of horizontal plane. For the zero notch fusion cage of different models, its size is different, can be through changing the design of 3 second sections of test blocks to realize the test to the zero notch fusion cage of different sizes, improved test device's commonality.
In a preferred embodiment of this embodiment, the U-shaped stepped groove has a stepped surface, the stepped surface is a U-shaped plane, after the connection, the bottom surface of the connection block 2 is flush with the U-shaped plane, and the end surface of the first section that is wider than the second section is flush with the U-shaped plane. Connecting block 2 fixes test block 3 in the mounting groove through the screw, and the ladder face in U-shaped ladder groove is equipped with the screw hole, and optionally, three screw hole is laid in the dispersion on the ladder face, and connecting block 2 is equipped with the screw hole of corresponding quantity.
In a preferred embodiment of this embodiment, the first side wall surface of the support 1 is a convex arc structure, the convex arc structure is an arc structure similar to the outer edge shape of the front side surface of the vertebral body, the test block 3 is installed on the first support and the second support, the inner side wall surface of the test block 3 is seamlessly spliced with the groove wall surface of the installation groove, and the outer side wall surface of the test block 3 is conformal to the convex arc structure, that is, after the test block 3 is installed on the first support and the second support, the outer side wall surface of the test block 3 has the same or similar shape as or substantially on the same convex arc surface as the outer edge shape of the front side surface of the vertebral body of the vertebral column. The support 1 is set to be in a basically forward convex shape and used for simulating the shape of a human vertebral body so as to maximally accord with the practical application environment of the zero notch fusion device system 4, and therefore more accurate and reliable mechanical performance parameters are obtained.
In this embodiment, zero notch fusion cage system static compression bending test device still includes testing machine and connecting device, testing machine passes through connecting device and is connected with the testing machine, the structure after testing machine and testing machine are connected is shown in fig. 5. The connecting device comprises two connecting frames 5, the first end of the first connecting frame is connected with the first support, and the second end of the first connecting frame is connected with the first pressure end of the testing machine; the first end of the second connecting frame is connected with the second support, and the second end of the second connecting frame is connected with the second pressure end of the testing machine; during testing, after the first pressure applying end and the second pressure applying end of the testing machine apply pressure to the first support and the second support, force is transmitted to the zero notch fusion device system 4.
In a preferred embodiment of this embodiment, the support 1 further has a third sidewall surface and a fourth sidewall surface, the third sidewall surface and the fourth sidewall surface are located on two sides of the front side of the vertebral body, the third sidewall surface and the fourth sidewall surface of the support 1 are both provided with a first connection hole, and the first connection hole plays roles of positioning the support and connecting with the connection device.
In this embodiment, the upper end of the connecting frame 5 is a block structure, and the upper end of the block structure is connected with the testing machine through a connecting pin, a plug or a thread; the lower end of the connecting frame 5 is in an inverted U shape and is provided with an installation space for installing the support 1, optionally, the lower end of the connecting frame 5 is provided with two vertical flat plates, the installation space of the support 1 is formed between the two vertical flat plates, the vertical flat plates are provided with second connecting holes, a cylindrical hinge pin 6 penetrates through the first connecting hole of the support 1 and the second connecting holes of the vertical flat plates, so that the support 1 is fixed on the connecting frame 5 of the connecting device, the first connecting holes can position the loading output end of the connecting frame 5 of the testing machine, on one hand, the stability of force application during testing can be ensured, on the other hand, the force application position can be determined to ensure the balance of the loaded force application, and the corresponding testing force is loaded through the testing machine, so that different performance tests of the zero-notch fusion device system 4 are completed.
Specifically, a first end of the first connecting frame is connected with the first support through a first hinge pin, and a second end of the first connecting frame is detachably connected with a first pressing end of the testing machine; the first end of the second connecting frame is detachably connected with the second support through a second hinge pin. This structural arrangement, the installation and the dismantlement of the support 1 of being convenient for, work as the testing machine exerts the force the back through link 5 just can transmit on the testing arrangement, the testing machine utilizes the static pressure to 3 pressurizations of test block, simultaneously continuous measurement change load and displacement to the corresponding data of output displacement and load.
In a preferred embodiment of the present embodiment, the support 1 and the connecting block 2 are made of aluminum alloy material, so as to ensure the connection strength.
In a preferred embodiment of this embodiment, the test block 3 is made of polyurethane, the polyurethane used to prepare the test block 3 is 15 grades, the compressive strength limit thereof is 3.82-6.05 Mpa, each test block 3 can be used only once, and the polyurethane block can eliminate the influence of bone characteristics and morphology measurement.
The zero notch fusion system testing method by using the static compression bending test of the zero notch fusion system of the embodiment comprises the following steps:
the method comprises the following steps: and assembling the test device, and fixedly mounting the zero notch fusion device system 4 on the test device.
Specifically, a support 1, a connecting block 2 and a test block 3 are prepared; the test device is characterized in that the support 1 is horizontally arranged, the two test blocks 3 are respectively and fixedly arranged in the mounting grooves of the two supports 1, the test blocks 3 are fixed on the support 1 through the connecting blocks 2, and the connecting blocks 2 are screwed down through screws to complete the assembly of the test device. Assembling based on the operation, placing the zero notch fusion device between the two test devices according to the implantation process and position of the zero notch fusion device in the operation, and ensuring that the front side surface of the zero notch fusion device is flush with the arc-shaped side surface of the test block 3; according to the implantation process of the zero-notch fusion device system in the operation, holes are pre-drilled in the upper test block 3 and the lower test block 3 respectively along the opening direction of the zero-notch fusion device by using a screw tap (the diameter is selected according to the size of a fixing screw), and the drilling angle is ensured by using a sleeve; and screwing a fixing screw 43 into the drilled hole, and fastening by using a torque not more than 2.5 N.m, preferably a fastening torque of 1.2-2 N.m, so as to complete the assembly of the test device and the zero notch fusion device system and obtain a test sample.
Step two: designing a test scheme and setting the motion mode of the testing machine.
Setting a software environment, opening a testing machine to edit a test scheme, setting the movement mode of the testing machine to be a displacement control mode, and setting the displacement control to be a loading speed not more than 25 mm/min, preferably 5-10 mm/min.
And step three, mounting the sample assembled in the step one on a testing machine for testing to obtain test data. And (4) connecting the assembled sample in the step one with two force application ends of the testing machine through a connecting device based on the operation. And starting the testing machine, pressurizing the sample by using the static pressure generated by the testing machine, continuously measuring the changed load and displacement at the same time, and outputting corresponding data of the displacement and the load.
And fourthly, obtaining mechanical property parameters of the zero notch fusion device system based on the displacement and the load data.
And obtaining mechanical property parameters of the zero notch fusion device system based on the load and displacement data obtained in the third step, wherein the mechanical property parameters comprise 2% of residual displacement, compressive bending yield load, compressive bending rigidity and compressive bending limit load. Wherein, 2% residual shift: residual deformation of 0.020 times the working length of the part as measured by the loader (see point B in fig. 6), the working length multiplied by 0.02 is 2% residual displacement.
Compressive bending stiffness: the yield load from the compressive bending is divided by the elastic displacement (see slope of BC in fig. 6). The greater the compressive bending stiffness, the better the mechanical properties for the zero notch fuser system 4 ability to resist deformation.
Compressive bending yield load: the compressive load applied in the longitudinal direction required to produce a residual deformation of 0.020 times the working length of the longitudinal part (see load at point D in fig. 6), the greater the compressive bending yield load, the better the mechanical properties of the zero-notch fusion cage.
Compressive bending limit load: the maximum compressive load applied to the assembly (see load at point E in fig. 6), the higher the compressive bending yield load, the better the mechanical properties of the zero-notch fusion cage. The zero notch fuser resists the maximum force that the compression can resist when bending deformation.
Specifically, load displacement data output by the testing machine is sorted by data processing software to obtain a zero notch fusion device compression bending displacement load curve a, linear fitting is carried out on an initial straight line part of the curve to obtain a fitting curve b, linear offset is carried out on the fitting curve, and offset distance is 2% of residual displacement to obtain an offset curve c. The ordinate of the intersection point of the displacement load curve a and the offset straight line c is compressive bending yield load, the slope of the fitting curve b is compressive bending rigidity, the maximum value of the ordinate on the displacement load curve a is compressive bending limit load, and the curves a-c are shown in fig. 6.
Compared with the prior art, the static compression bending test method for the zero notch fusion cage system provided by the embodiment can be assembled according to the position relation between the zero notch fusion cage system and the spine in the actual operation, the situation that the zero notch fusion cage system is pressed after the operation is simulated by applying a load, the compression bending resistance of the zero notch fusion cage system can be more accurately measured, the basis is provided for the design of the zero notch fusion cage system, the establishment of a unified test scheme is facilitated, and the mechanical property comparison can be carried out on the zero notch fusion cage systems produced by different materials, different models and different manufacturers according to the test scheme. Specifically, the test block is used for simulating a vertebral body, the first test block and the second test block are respectively fixed on the two supports during testing, the zero notch fusion device system to be tested is fixed between the first test block and the second test block, the working environment of the zero notch fusion device system after actual implantation can be simulated, and the accuracy and the reliability of a test result are guaranteed. For the zero notch fusion cage of different models, the sizes are different, and the design of the second section of the test block can be changed, so that the test on the zero notch fusion cage of different sizes is realized, and the universality of the test device is improved.
The above-mentioned embodiments, objects, technical solutions and advantages of the present application are described in further detail, it should be understood that the above-mentioned embodiments are merely exemplary embodiments of the present application, and are not intended to limit the scope of the present application, and any modifications, equivalent substitutions, improvements and the like made within the spirit and principle of the present application should be included in the scope of the present application.
Claims (7)
1. The utility model provides a zero notch fuser system static compression bending test device which characterized in that includes:
the fixture comprises two supports (1), wherein the first support is provided with a first surface and a second surface, the second support is provided with a third surface and a fourth surface, and the first surface and the third surface are arranged oppositely;
the test block (3) comprises a first test block and a second test block and is used for simulating two vertebral bodies to be connected; the first test block and the second test block are respectively fixed on the first surface and the third surface; the zero notch fusion device system (4) to be tested is arranged between the first surface and the third surface and fixedly connected with the first test block and the second test block, the first surface is provided with a first mounting groove, and the first test block is fixedly mounted in the first mounting groove;
and a second mounting groove is formed in the third surface, and the second test block is fixedly mounted in the second mounting groove.
2. The zero notch fuser system static compression bending test device according to claim 1, wherein the first test block is fixed on the first support through a first connecting block, the first connecting block is detachably connected with the first support, and the first connecting block at least partially covers the top surface of the first test block;
the second test block is fixed on the second support through a second connecting block, the second connecting block is detachably connected with the second support, and at least part of the second connecting block covers the top surface of the second test block.
3. The zero notch fuser system static compression bending test device of claim 2, wherein the first connecting block and the second connecting block are both U-shaped plates.
4. The zero notch fuser system static compression bending test device of claim 1, wherein the first mounting groove and the second mounting groove are both U-shaped stepped grooves;
from the groove bottom to the groove opening, the U-shaped stepped groove is provided with a first space and a second space which are communicated, the first space is provided with a first cross section size, the second space is provided with a second cross section size, and the first cross section size is smaller than the second cross section size;
the longitudinal section of the first test block and the longitudinal section of the second test block are convex, the first test block and the second test block respectively comprise a first section and a second section, the size of the first section is larger than that of the second section, and the size of the cross section of the first section is equal to that of the second cross section.
5. The zero notch fuser system static compression bending test device of claim 4, wherein the first section is installed seamlessly within the second space, the height of the first section being equal to the height of the second space;
the U-shaped plate is arranged in the first space, and the U-shaped plate is sleeved on the second section.
6. The zero notch fuser system static compression bending test apparatus of claim 5, wherein the upper surface of the U-shaped plate is flush with the lowest of the second section;
the projection of the U-shaped plate on the horizontal plane can simultaneously cover at least part of the top surface of the support (1) and the end surface of the first section wider than the second section.
7. The zero notch fuser system static compression bending test device as claimed in claim 6, wherein the first sidewall surface is a convex arc structure, the convex arc structure is similar to the shape of the outer edge of the front side of the vertebral body;
after the first test block is installed on the first support, the inner side wall surface of the first test block is seamlessly spliced with the groove wall surface of the first installation groove, and the outer side wall surface of the first test block is conformal to the convex arc structure.
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| CN113456320A (en) * | 2021-02-02 | 2021-10-01 | 浙江德康医疗器械有限公司 | Static compression bending test device and method for zero notch fusion device system |
| CN113456320B (en) * | 2021-02-02 | 2024-04-23 | 浙江德康医疗器械有限公司 | Static compression bending test device and method for zero notch fusion device system |
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