CN112842640A - Method and device for testing biological stability of implanted talus prosthesis - Google Patents
Method and device for testing biological stability of implanted talus prosthesis Download PDFInfo
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- CN112842640A CN112842640A CN202110199685.7A CN202110199685A CN112842640A CN 112842640 A CN112842640 A CN 112842640A CN 202110199685 A CN202110199685 A CN 202110199685A CN 112842640 A CN112842640 A CN 112842640A
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Images
Classifications
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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
-
- 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
- A61F2/42—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes
- A61F2/4225—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for feet, e.g. toes
Abstract
The invention discloses a testing method and a testing device for biological stability of an implanted talus prosthesis, wherein the talus prosthesis is implanted into an ankle mould body which is arranged in an experimental mechanism, the tested loading force comprises a rotating force and a pressure, the mechanical loading is carried out according to the real moving state of the ankle, and the testing device has two rotational degrees of freedom and a positioning and locking function, and can complete the quantitative tests of dorsal extension/toe flexion, adduction/abduction and inversion/eversion of an ankle testing unit; the test is divided into static limit moving range test and dynamic fatigue test, and a mechanical experiment machine simultaneously applies rotation and pressure loads. The testing method and the testing device can perform mechanical testing of human body movement simulation on the stability of the ankle and talar prosthesis, have the advantages of simple and feasible method and reliable result, and provide experimental basis and guidance for clinical application of the talar joint prosthesis.
Description
Technical Field
The invention relates to the technical field of medical and orthopedic joints, in particular to a method and a device for testing biological stability of a talus prosthesis implanted.
Background
The talus is a key bony structure connecting the lower limb and the foot, is irregular in shape, is covered by 5 articular surfaces, and is complex in anatomical structure; is a turning point of lower limbs and foot mechanics, and has concentrated stress and particularly important mechanical property; involving 5 mobile joints, more than 30 tendons (muscles) and ligaments, the exercise requirements are particularly high. The ankle surgery at home and abroad mainly adopts total talus excision and talus peripheral joint fusion which sacrifice talus function, the postoperative rehabilitation time is long, the joint movement is lost, the non-healing rate is high, the postoperative complications such as joint degeneration, joint stiffness, foot flexibility loss and the like are frequently accompanied, and the long-term curative effect is extremely poor. In recent years, with the progress of surgical techniques and manufacturing processes, surgical methods for joint replacement by preserving ankle joint function are becoming a focus of research, and eosin is brought for treating collapse necrosis of talus. Compared with ankle fusion, ankle replacement reduces postoperative lameness of patients, restores normal gait, relieves pain and improves life quality.
Talar joint prostheses mainly comprise three structural forms: 1. a total facet-preserved talus; 2. talus with talar facet fusion; 3. the talus bone fused at the calcaneal/talonavicular articular surface. Due to the loss of the joint ligaments, the stability and stress distribution of the talar prosthesis in the ankle needs to be tested to ensure the safety and effectiveness of the talar prosthesis. However, there are no experimental methods or devices for stability of talar joint prostheses in current research and current standards, which severely restrict preclinical validation of talar joint prostheses.
Disclosure of Invention
The invention aims to provide a method and a device for testing the biological stability of a talus prosthesis implanted, which provide experimental basis and guidance for clinical application of the talus joint prosthesis.
In order to achieve the above object, in a first aspect, the present invention provides a device for testing biological stability of an implanted talar prosthesis, the device for testing biological stability of an implanted talar prosthesis comprises a testing mechanism and a talar prosthesis stabilizing mechanism, the talar prosthesis stabilizing mechanism comprises a talar prosthesis, an ankle mold body, a fixing component and a rotary fixing component, the talar prosthesis is detachably connected with the ankle mold body and is located in the ankle mold body, the fixing component is fixedly connected with the ankle mold body and is located on one side of the ankle mold body, and the rotary fixing component is fixedly connected with the fixing component and is located on one side far away from the ankle mold body;
the experiment mechanism comprises a mechanics experiment machine, a pressure transmission assembly and a hydraulic assembly, the mechanics experiment machine is fixedly connected with the rotary fixing assembly and is positioned on one side of the rotary fixing assembly, the hydraulic assembly is fixedly connected with the fixing assembly and is positioned far away from one side of the fixing assembly, and the pressure transmission assembly is fixedly connected with the fixing assembly and the hydraulic assembly and is positioned on one side of the hydraulic assembly.
The fixing assembly comprises a plurality of supporting frames, a mounting seat and a mounting plate, the supporting frames are fixedly connected with the ankle mould body and are positioned on one side of the ankle mould body, the mounting seat is fixedly connected with the supporting frames and is positioned on one side of the supporting frames, and the mounting plate is fixedly connected with the ankle mould body and is positioned on one side far away from the supporting frames.
The hydraulic assembly comprises a concave pressure ball head and a hydraulic oil cylinder mounting table, the concave pressure ball head is fixedly connected with the mounting plate and is positioned on one side far away from the ankle mould body, and the hydraulic light mounting table is fixedly connected with the mechanics experiment machine and is positioned on one side of the mechanics experiment machine.
The pressure transmission assembly comprises a pressure system and an oil circuit system, the pressure system is fixedly connected with the fixing assembly and is positioned at one side far away from the mechanical experiment machine, and the oil circuit system is communicated with the pressure system and is positioned at one side of the pressure system.
The pressure system comprises a rotary power head and a cardan shaft, the cardan shaft is connected with the fixed assembly in a rotating mode and is located far away from one side of the mechanical experiment machine, and the rotary power head is fixedly connected with the cardan shaft and is located far away from one side of the fixed assembly.
The oil circuit system comprises an oil cylinder input cavity, an oil cylinder output cavity, an oil output pipeline and an oil return pipeline, wherein the oil cylinder input cavity is fixedly connected with the hydraulic oil cylinder mounting table and is positioned on one side of the hydraulic oil cylinder mounting table, the oil cylinder input cavity is fixedly connected with the hydraulic oil cylinder mounting table and is rotatably connected with the concave pressure ball head and is positioned on one side of the concave pressure ball head, and the oil output pipeline and the oil return pipeline are respectively communicated with the oil cylinder input cavity and are positioned between the oil cylinder input cavity and the oil cylinder input cavity.
In a second aspect, the present invention provides a method for testing the biological stability of an implanted talar prosthesis, which is applied to the device for testing the biological stability of an implanted talar prosthesis according to the first aspect, and comprises the following steps:
constructing a testing device based on an experimental mechanism and a talus prosthesis stabilizing mechanism, and starting a hydraulic assembly and a pressure transmission assembly to perform mechanical testing on the talus prosthesis stabilizing mechanism;
and respectively rotating the first steering wheel and the second steering wheel to perform toe-bending and back-stretching mechanical tests, and acquiring stability test results through the color change of the plurality of pressure-sensitive papers.
The invention relates to a testing method and a testing device for biological stability of an implanted talus prosthesis, wherein the testing device for biological stability of the implanted talus prosthesis comprises an experimental mechanism and a talus prosthesis stabilizing mechanism, the talus prosthesis stabilizing mechanism comprises a talus prosthesis, a ankle mould body, a fixing component and a rotary fixing component, the experimental mechanism comprises a mechanical experiment machine, a pressure transmission component and a hydraulic component, the testing device is constructed based on the experimental mechanism and the talus prosthesis stabilizing mechanism, and the hydraulic component and the pressure transmission component are started to perform mechanical test on the talus prosthesis stabilizing mechanism; the first steering wheel and the second steering wheel are respectively rotated to carry out toe bending and back stretching mechanical tests, and stability test results are obtained through color changes of the pressure-sensitive papers, so that experimental basis and guidance are provided for clinical application of the talar joint prosthesis.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings can be obtained according to the drawings without creative efforts.
Fig. 1 is a schematic structural diagram of a testing device for biological stability of an implanted talar prosthesis provided by the invention.
Fig. 2 is a schematic structural diagram of an experimental facility provided by the present invention.
Fig. 3 is a schematic structural view of a talar prosthesis stabilization mechanism provided by the present invention.
Fig. 4 is a schematic structural diagram of a fixing assembly provided by the present invention.
FIG. 5 is a schematic view of the ankle mold body provided by the present invention.
FIG. 6 is a schematic view of the mechanical loading pattern of the ankle during varus and valgus activity provided by the present invention.
FIG. 7 is a schematic view of the mechanical loading pattern of the ankle of the present invention during adduction and abduction activities.
Fig. 8 shows the freedom of movement to be met by the mechanical stability test provided by the present invention.
Figure 9 is a graph of the change in ankle rotation angle (left) and pressure load (right) for a toe flexion/extension movement provided by the present invention during a gait cycle.
FIG. 10 is a schematic diagram illustrating the steps of a method for testing the biological stability of an implanted talar prosthesis according to the present invention.
1-an experimental mechanism, 2-a talus prosthesis stabilizing mechanism, 21-a talus prosthesis, 22-an ankle mould body, 23-a fixing component, 24-a rotating fixing component, 11-a mechanical experiment machine, 12-a pressure transmission component, 13-a hydraulic component, 231-a supporting frame, 232-a mounting seat, 233-a mounting plate, 131-a concave pressure ball head and 132-a hydraulic oil cylinder mounting table, 121-a pressure system, 122-an oil circuit system, 1211-a rotary power head, 1212-a universal shaft, 1221-an oil cylinder input cavity, 1222-an oil cylinder output cavity, 1223-an output oil circuit pipeline, 1224-an oil return pipeline, 25-pressure-sensitive paper, 26-a first steering wheel, 27-a second steering wheel, 234-a rotary lug and 235-a rotary disc.
Detailed Description
Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to the same or similar elements or elements having the same or similar function throughout. The embodiments described below with reference to the drawings are illustrative and intended to be illustrative of the invention and are not to be construed as limiting the invention.
In the description of the present invention, it is to be understood that the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", and the like, indicate orientations or positional relationships based on the orientations or positional relationships illustrated in the drawings, and are used merely for convenience in describing the present invention and for simplicity in description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed in a particular orientation, and be operated, and thus, are not to be construed as limiting the present invention. Further, in the description of the present invention, "a plurality" means two or more unless specifically defined otherwise.
Referring to fig. 1 to 9, the present invention provides a device for testing the biological stability of an implanted talar prosthesis, the device for testing the biological stability of an implanted talar prosthesis comprises a testing mechanism 1 and a talar prosthesis stabilizing mechanism 2, the talar prosthesis stabilizing mechanism 2 comprises a talar prosthesis 21, an ankle mold body 22, a fixing component 23 and a rotating fixing component 24, the talar prosthesis 21 is detachably connected with the ankle mold body 22 and is located in the ankle mold body 22, the fixing component 23 is fixedly connected with the ankle mold body 22 and is located on one side of the ankle mold body 22, and the rotating fixing component 24 is fixedly connected with the fixing component 23 and is located on one side away from the ankle mold body 22;
experiment mechanism 1 includes mechanics experiment machine 11, pressure transmission subassembly 12 and hydraulic assembly 13, mechanics experiment machine 11 with rotatory fixed subassembly 24 fixed connection, and be located rotatory fixed subassembly 24 one side, hydraulic assembly 13 with fixed subassembly 23 fixed connection, and be located keep away from fixed subassembly 23 one side, pressure transmission subassembly 12 with fixed subassembly 23 with hydraulic assembly 13 fixed connection, and be located hydraulic assembly 13 one side.
In the present embodiment, the talar prosthesis 21 is implanted inside the ankle mold body 22, the ankle mold body 22 is installed in the experimental mechanism 1, the experimental mechanism 1 tests the loading force including the rotation force and the pressure, the mechanical loading is carried out according to the real activity state of the ankle, and the pressure transmission assembly 12 has two rotation degrees of freedom and the positioning and locking function, and can complete the quantitative test of the dorsiflexion/toe flexion, adduction/abduction and inversion/eversion of the ankle test unit; the test is divided into static limit moving range test and dynamic fatigue test, and the mechanical experiment machine 11 applies rotation and pressure load at the same time. The manufacturing process of the talar prosthesis 21 mainly comprises the following steps: CT scanning a talus model on a normal side, reconstructing a three-dimensional model of a talus in software and mirroring, designing the talus in a lightweight mode, carrying out 3D printing forming by adopting cobalt-chromium-molybdenum alloy powder, and carrying out surface polishing treatment; the stability of the ankle and talar prosthesis 21 can be subjected to a mechanical test simulating human body movement, and the method has the advantages of simplicity, feasibility and reliable result.
Further, the talar prosthesis stabilizing mechanism 2 further includes a plurality of pressure-sensitive papers 25, and the plurality of pressure-sensitive papers 25 are detachably connected to the talar prosthesis 21 and the ankle mold body 22 and are located in the talar prosthesis 21 and the ankle mold body 22.
In the present embodiment, the pressure-sensitive paper 25 is inserted into each joint surface of the talar prosthesis 21, and the pressure-sensitive paper 25 can change its color according to the magnitude of the contact force, so that the recording of the pressure distribution and the high-resolution image of the void point on the two contact surfaces can be rapidly realized.
Further, the talar prosthesis stabilization mechanism 2 further comprises a first steering wheel 26, wherein the first steering wheel 26 is rotatably connected with the fixing component 23 and is positioned on one side of the fixing component 23.
In this embodiment, the first steering wheel 26 is rotated to orient the ankle block 22 in the orientation of FIG. 6, and the pressure transmission assembly 12 transmits power to cause the ankle block 22 to rotate in the Z-direction. When inversion occurs, the medial border of the sole is lifted, the lateral border is lowered, and the lateral side of the sole is directed medially. When everting, the medial border of the sole descends and the lateral border rises, with the lateral side of the sole facing outwards. The varus/valgus mechanics test is a static force limit test. Applying a torsion force to a mechanical experiment machine 11, wherein the loading speed is 10-20 degrees per second, the adduction rotation angle is 20-30 degrees, and the abduction rotation angle is 20-30 degrees; during the test, the pressure-sensitive paper 25 is plugged on each joint surface, and after the test is finished, the pressure value of each area is obtained through the color change in the pressure-sensitive paper 25. And the talar prosthesis 21 is observed for loosening within the ankle.
Further, the talar prosthesis stabilization mechanism 2 further comprises a second steering wheel 27, wherein the second steering wheel 27 is rotatably connected with the fixing component 23 and is positioned on one side of the fixing component 23.
In this embodiment, the second steering wheel 27 is rotated to orient the ankle test module in the orientation shown in FIG. 7, and the pressure transmission assembly 12 transmits power to rotate the ankle block 22 in the Y-direction. Adduction/abduction mechanics tests are static force limit tests. Applying a torsion force to a mechanical experiment machine 11, wherein the loading speed is 10-20 degrees per second, the adduction rotation angle is 30-40 degrees, and the abduction rotation angle is 30-40 degrees; during the test, each joint surface is plugged with pressure-sensitive paper 25, and after the test is finished, the pressure value of each area is obtained through the color change in the pressure-sensitive paper 25. And the talar prosthesis 21 is observed for loosening within the ankle.
Further, the fixing assembly 23 includes a plurality of support frames 231, a mounting seat 232 and a mounting plate 233, the plurality of support frames 231 are all fixedly connected to the ankle mold body 22 and located at one side of the ankle mold body 22, the mounting seat 232 is fixedly connected to the plurality of support frames 231 and located at one side of the support frames 231, and the mounting plate 233 is fixedly connected to the ankle mold body 22 and located at one side far away from the plurality of support frames 231.
In this embodiment, the human ankle is divided into a fixed end and a movable end during the mechanical testing. In order to meet the test in three rotating directions and combine the loading characteristic of a mechanical fatigue tester, the invention adopts the backbone as a fixed end and the foot plate as a movable end. Wherein the backbone is fixed on the fixing frame mounting seat 232 through the external fixing support frame 231, and the steel nail passes through the tibia and the fibula to realize stable fixation; the foot plate is mounted on the ankle mounting plate 233 and the steel nails pass through the foot plate for stable mounting as shown in figure 4.
Further, the fixing assembly 23 further comprises a plurality of rotation lugs 234 and a plurality of rotation plates 235, the plurality of rotation lugs 234 are slidably connected to the mounting plate 233 and are located at one side of the mounting plate 233, and the plurality of rotation plates 235 are fixedly connected to the rotation lugs 234 and are located in the rotation lugs 234.
In the present embodiment, as shown in fig. 4, the ankle mounting plate 233 is mounted with 3 rotation ears 234 and 3 rotation disks 235 on the three X/Y/Z axes, wherein the rotation ears 234 can be position-adjusted on the ankle mounting plate 233, and finally locked by screws; the rotary disc 235 receives rotary power and transmits the force to the ankle mounting plate 233 through the rotary lug 234, thereby realizing rotary motion on the corresponding shaft. The position of the rotary lug 234 on the ankle mounting plate 233 is adjustable, so that the axes of the three rotary discs 235 are orthogonal in pairs and intersect at the origin, and the cartesian coordinate system is met.
Further, the hydraulic assembly 13 includes a concave pressure ball 131 and a hydraulic cylinder mounting table 132, the concave pressure ball 131 is fixedly connected to the mounting plate 233 and is located at a side far away from the ankle body 22, and the hydraulic light mounting table is fixedly connected to the mechanics experiment machine 11 and is located at a side of the mechanics experiment machine 11.
In the present embodiment, as shown in fig. 2, the ankle mold body 22 can receive continuous pressure by using the spherical surface of the concave pressure ball 131, and the torsion force is not affected, so that the rotation force and the pressure are independently controlled, and the composite linkage of the two forces is specified by the mechanical fatigue testing system.
Further, as shown in fig. 2, the pressure transmission assembly 12 includes a pressure system 121 and an oil system 122, the pressure system 121 is fixedly connected to the fixing assembly 23 and located on a side away from the mechanical experiment machine 11, and the oil system 122 is communicated with the pressure system 121 and located on a side of the pressure system 121.
In the present embodiment, the pressure system 121 is used to apply a rotational force and a pressure to the ankle mold body 22, and the pressure of the pressure system 121 is converted into an oil pressure to power the oil passage system 122.
Further, the pressure system 121 includes a rotary power head 1211 and a universal shaft 1212, the universal shaft 1212 is rotatably connected to the fixing assembly 23 and located at a side far from the mechanical experiment machine 11, and the rotary power head 1211 is fixedly connected to the universal shaft 1212 and located at a side far from the fixing assembly 23.
In the present embodiment, the rotary power head 1211 has both a pressing force in the Z-axis direction and a rotational force in the Z-axis direction, and can control these two forces individually or in combination. The rotational force is transmitted through the universal shaft 1212 and into the ankle mold body 22 for mechanical testing.
Further, the oil path system 122 includes an oil cylinder input cavity 1221, an oil cylinder output cavity 1222, an output oil path pipeline 1223 and an oil return pipeline 1224, the oil cylinder input cavity 1221 is fixedly connected to the hydraulic oil cylinder mounting table 132 and is located on one side of the hydraulic oil cylinder mounting table 132, the oil cylinder input cavity 1221 is fixedly connected to the hydraulic oil cylinder mounting table 132 and is rotationally connected to the concave pressure ball 131 and is located on one side of the concave pressure ball 131, the output oil path pipeline 1223 and the oil return pipeline 1224 are respectively communicated with the oil cylinder input cavity 1221 and are located between the oil cylinder input cavity 1221 and the oil cylinder input cavity 1221.
In this embodiment, the pressure in the pressure system 121 is converted into oil pressure by the cylinder input cavity 1221, the lubricating oil inside the pressure system is transmitted to the cylinder output cavity 1222 through the output oil pipeline 1223 to lubricate the concave pressure ball 131, the top rod of the cylinder output cavity 1222 is a ball head, and is just matched with the concave pressure ball 131, and the lubricating oil in the cylinder output cavity 1222 flows back to the cylinder input cavity 1221 through the oil return pipeline 1224 to be recovered, so that the oil circuit is smooth.
Referring to fig. 10, the present invention provides a testing method for biological stability of an implanted talar prosthesis, which is applied to the testing device for biological stability of an implanted talar prosthesis, and comprises the following steps:
s101, constructing a testing device based on the experimental mechanism 1 and the talar prosthesis stabilizing mechanism 2, and starting the hydraulic assembly 13 and the pressure transmission assembly 12 to perform mechanical testing on the talar prosthesis stabilizing mechanism 2.
Specifically, 1. surgically, the original damaged talus bone in the ankle is first removed and a 3D printed shaped metal talar prosthesis 21 is implanted. The manufacturing process of talar prosthesis 21 mainly includes: CT scans the talus model of the normal side, rebuilds the three-dimensional model of the talus and mirrors in software, and the talus is designed in a lightweight way, and is printed and formed in a 3D mode by adopting cobalt-chromium-molybdenum alloy powder and subjected to surface polishing treatment.
2. Pressure sensitive paper 25 is inserted into each articular surface of the talus. The pressure-sensitive paper 25 can change color according to the magnitude of the contact force, and can quickly realize the recording of pressure distribution on two contact surfaces and high-resolution images of the pore point.
3. The human ankle has rotational freedom in three directions as shown in fig. 8. They achieve respectively toe flexion and dorsiflexion in the X-axis direction, adduction and abduction in the Y-axis direction, and varus and valgus in the Z-axis direction. The test unit in the present invention also needs to satisfy the activity in these three directions, as shown by the coordinate axes in fig. 5.
4. The ankle of the human body is divided into a fixed end and a movable end in the process of mechanical testing. In order to meet the test in three rotating directions and combine the loading characteristic of a mechanical fatigue tester, the invention adopts the backbone as a fixed end and the foot plate as a movable end. Wherein the backbone is fixed on the fixing frame mounting seat 232 through the external fixing support frame 231, and the steel nail passes through the tibia and the fibula to realize stable fixation; the foot board is installed on ankle mounting panel 233, and the steel nail passes the foot board, realizes stable installation.
5. The ankle mounting plate 233 is provided with 3 rotary ears 234 and 3 rotary disks 235 on three X/Y/Z axes, wherein the rotary ears 234 can be adjusted in position on the ankle mounting plate 233 and finally locked by screws; the rotary disc 235 receives rotary power and transmits the force to the ankle mounting plate 233 through the rotary lug 234, thereby realizing rotary motion on the corresponding shaft. The position of the rotary lug 234 on the ankle mounting plate 233 is adjustable, so that the axes of the three rotary discs 235 are orthogonal in pairs and intersect at the origin, and the cartesian coordinate system is met.
6. The general structural form of the implanted talar prosthesis biostability testing device is shown in figure 1. The testing device consists of a mechanical experiment machine 11, a pressure transmission assembly 12, a hydraulic assembly 13 and a talar prosthesis stabilizing mechanism 2. The mechanical experiment machine 11 provides rotating force and pressure, and the rotating angle, the rotating speed and the pressure are specified by a servo control system; the pressure transmission assembly 12 is responsible for the positioning and fixing of the talar prosthesis stabilization mechanism 2, has two rotational degrees of freedom, and can lock position and angle; the hydraulic assembly 13 is responsible for converting the downward pressure of the mechanical fatigue tester into a lateral force.
7. The pressure loading strategy for achieving a human body weight imitation using hydraulic assembly 13 is shown in fig. 2. In order to better simulate the pressure effect of the human body weight on the ankle, the figure designs a pressure testing method based on hydraulic reversing.
8. The rotary power head 1211 on the mechanical fatigue tester has the pressure in the Z-axis direction and the rotary force in the Z-axis direction at the same time, and can control the two forces independently or compositely. The rotating force is transmitted to the testing device through the universal shaft 1212; the pressure of the rotary power head 1211 converts the force into oil pressure through the pressure cylinder input cavity 1221 and is transmitted to the pressure cylinder output cavity 1222 through the output oil line tubing 1223.
S102, rotating the first steering wheel 26 and the second steering wheel 27 respectively to perform toe-bending and back-stretching mechanical tests, and obtaining a stability test result through color change of the plurality of pressure-sensitive papers 25.
Specifically, the first steering wheel 26 and the second steering wheel 27 are rotated to orient the ankle testing module in the orientation shown in fig. 9, and the universal shaft 1212 transmits power to rotate the ankle block body 22 in the X-direction. Plantarflexion is the movement of the dorsum of the foot away from the lower leg, i.e. in the opposite direction of the rotational arrow in fig. 3; dorsal extension is the movement of the instep close to the calf, i.e. in the same direction as the rotational arrow in fig. 3.
The toe flexion/back extension mechanical test is divided into a static force limit test and a dynamic fatigue test.
During static force limit test, the tester applies torsional force at the loading speed of 10-20 degrees per second, the toe-bending rotation angle of 40-50 degrees and the back-stretching rotation angle of 20-30 degrees; at this point, pressure is synchronously applied, and force 2365.7N is continuously applied in force control mode. During the test, each joint surface is plugged with pressure-sensitive paper 25, and after the test is finished, the pressure value of each area is obtained through the color change in the pressure-sensitive paper 25. And the talar prosthesis 21 is observed for loosening within the ankle.
In the dynamic fatigue test, the fatigue machine simultaneously loads the rotating force and the pressure, and the loading conditions of the ankle rotating angle and the pressure load of the toe flexion/extension movement in one gait cycle are shown in fig. 9. The specific parameters for loading are shown in table 1, where one gait cycle is divided into 100 parts and one gait cycle is 1-3 seconds.
TABLE 1 ankle rotation angle and pressure load variation data for toe flexion/extension movement during one gait cycle
Wherein rotation of the first steering wheel 26 positions the ankle block 22 in the orientation shown in FIG. 6, and the pressure transmission assembly 12 transmits power to cause the ankle block 22 to rotate in the Z-direction. When inversion occurs, the medial border of the sole is lifted, the lateral border is lowered, and the lateral side of the sole is directed medially. When everting, the medial border of the sole descends and the lateral border rises, with the lateral side of the sole facing outwards. The varus/valgus mechanics test is a static force limit test. Applying a torsion force to a mechanical experiment machine 11, wherein the loading speed is 10-20 degrees per second, the adduction rotation angle is 20-30 degrees, and the abduction rotation angle is 20-30 degrees; during the test, the pressure-sensitive paper 25 is plugged on each joint surface, and after the test is finished, the pressure value of each area is obtained through the color change in the pressure-sensitive paper 25. And the talar prosthesis 21 is observed for loosening within the ankle.
When the second steering wheel 27 is rotated to orient the ankle testing module in the orientation shown in FIG. 7, the pressure transmitting assembly 12 transmits power to rotate the ankle mold body 22 in the Y-direction. Adduction/abduction mechanics tests are static force limit tests. Applying a torsion force to a mechanical experiment machine 11, wherein the loading speed is 10-20 degrees per second, the adduction rotation angle is 30-40 degrees, and the abduction rotation angle is 30-40 degrees; during the test, each joint surface is plugged with pressure-sensitive paper 25, and after the test is finished, the pressure value of each area is obtained through the color change in the pressure-sensitive paper 25. And the talar prosthesis 21 is observed for loosening within the ankle.
The invention relates to a testing method and a testing device for biological stability of an implanted talus prosthesis, wherein the testing device for biological stability of the implanted talus prosthesis comprises an experimental mechanism 1 and a talus prosthesis stabilizing mechanism 2, the talus prosthesis stabilizing mechanism 2 comprises a talus prosthesis 21, an ankle mould body 22, a fixing component 23 and a rotary fixing component 24, the experimental mechanism 1 comprises a mechanical experiment machine 11, a pressure transmission component 12 and a hydraulic component 13, the testing device is constructed based on the experimental mechanism 1 and the talus prosthesis stabilizing mechanism 2, and the hydraulic component 13 and the pressure transmission component 12 are started to perform mechanical test on the talus prosthesis stabilizing mechanism 2; the first steering wheel 26 and the second steering wheel 27 are respectively rotated to conduct toe-flexion and back-extension mechanical tests, stability test results are obtained through color changes of the pressure-sensitive papers 25, and experimental basis and guidance are provided for clinical application of the talar joint prosthesis.
While the invention has been described with reference to a preferred embodiment, it will be understood by those skilled in the art that various changes in form and detail may be made therein without departing from the spirit and scope of the invention as defined by the appended claims.
Claims (7)
1. A testing device for biological stability of implanted talar prosthesis is characterized in that,
the device for testing the biological stability of the implanted talar prosthesis comprises an experimental mechanism and a talar prosthesis stabilizing mechanism, wherein the talar prosthesis stabilizing mechanism comprises a talar prosthesis, an ankle die body, a fixing component and a rotating fixing component, the talar prosthesis is detachably connected with the ankle die body and is positioned in the ankle die body, the fixing component is fixedly connected with the ankle die body and is positioned on one side of the ankle die body, and the rotating fixing component is fixedly connected with the fixing component and is positioned on one side far away from the ankle die body;
the experiment mechanism comprises a mechanics experiment machine, a pressure transmission assembly and a hydraulic assembly, the mechanics experiment machine is fixedly connected with the rotary fixing assembly and is positioned on one side of the rotary fixing assembly, the hydraulic assembly is fixedly connected with the fixing assembly and is positioned far away from one side of the fixing assembly, and the pressure transmission assembly is fixedly connected with the fixing assembly and the hydraulic assembly and is positioned on one side of the hydraulic assembly.
2. The device for testing the biological stability of an implanted talar prosthesis according to claim 1,
the fixing assembly comprises a plurality of supporting frames, a mounting seat and a mounting plate, the supporting frames are fixedly connected with the ankle die body and are positioned on one side of the ankle die body, the mounting seat is fixedly connected with the supporting frames and is positioned on one side of the supporting frames, and the mounting plate is fixedly connected with the ankle die body and is positioned on one side of the supporting frames.
3. The device for testing the biological stability of an implanted talar prosthesis according to claim 1,
the hydraulic assembly comprises a concave pressure ball head and a hydraulic oil cylinder mounting table, the concave pressure ball head is fixedly connected with the mounting plate and is positioned on one side far away from the ankle mould body, and the hydraulic polished mounting table is fixedly connected with the mechanics experiment machine and is positioned on one side of the mechanics experiment machine.
4. The implanted talar prosthesis biostability test apparatus according to claim 3,
the pressure transmission assembly comprises a pressure system and an oil circuit system, the pressure system is fixedly connected with the fixing assembly and is positioned at one side far away from the mechanical experiment machine, and the oil circuit system is communicated with the pressure system and is positioned at one side of the pressure system.
5. The implanted talar prosthesis biostability test apparatus according to claim 4,
the pressure system comprises a rotary power head and a cardan shaft, the cardan shaft is connected with the fixed assembly in a rotating mode and is located far away from one side of the mechanical experiment machine, and the rotary power head is connected with the cardan shaft in a fixed mode and is located far away from one side of the fixed assembly.
6. The implanted talar prosthesis biostability test apparatus according to claim 4,
the oil circuit system comprises an oil cylinder input cavity, an oil cylinder output cavity, an oil output pipeline and an oil return pipeline, wherein the oil cylinder input cavity is fixedly connected with the hydraulic oil cylinder mounting table and is positioned on one side of the hydraulic oil cylinder mounting table, the oil cylinder input cavity is fixedly connected with the hydraulic oil cylinder mounting table and is rotatably connected with the concave pressure ball head and is positioned on one side of the concave pressure ball head, and the oil output pipeline and the oil return pipeline are respectively communicated with the oil cylinder input cavity and are positioned between the oil cylinder input cavity and the oil cylinder input cavity.
7. A method for testing the biological stability of an implanted talar prosthesis, which is applied to a device for testing the biological stability of an implanted talar prosthesis according to any one of claims 1 to 6, and which comprises the following steps:
constructing a testing device based on an experimental mechanism and a talus prosthesis stabilizing mechanism, and starting a hydraulic assembly and a pressure transmission assembly to perform mechanical testing on the talus prosthesis stabilizing mechanism;
and respectively rotating the first steering wheel and the second steering wheel to perform toe-bending and back-stretching mechanical tests, and acquiring stability test results through the color change of the plurality of pressure-sensitive papers.
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Cited By (1)
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| CN117379235A (en) * | 2023-12-13 | 2024-01-12 | 天津市医疗器械质量监督检验中心 | Hip joint prosthesis movement angle testing device |
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