A test device and a test method for a pre-angled connection part-containing implant system

Abstract

This invention discloses a test apparatus and method for an implant system with a pre-angled connection portion. The test apparatus includes a mounting base, a support base, an extension component, a locking assembly, and a loading rod. The bottom surface of the support base is arc-shaped, with an arc-shaped groove formed on the arc-shaped surface. One end of the extension component has a slider that is slidably installed in the arc-shaped groove, while the other end is fixed to the dental implant sample. The locking assembly includes an arc-shaped block with a limiting protrusion and a limiting block with a limiting groove. The limiting protrusion and the limiting groove automatically engage under gravity to lock the tilt angle of the extension component. Pushing up the connecting rod fixedly connected to the limiting block unlocks the component, allowing for precise angle adjustment using an angle scale. The loading rod is vertically positioned directly below the dental implant sample and is driven by a drive component to apply a load. An environmental simulation chamber can also be configured to immerse the sample in a constant-temperature physiological medium to simulate the oral cavity environment for fatigue testing. This invention provides convenient tilt angle adjustment and can simulate a real physiological stress environment, resulting in more accurate test data.

Description

Technical Field

[0001] This invention relates to the field of dental implant testing technology, specifically to a testing device and method for an implant system containing a pre-angled connection portion. Background Technology

[0002] Dental implants are medical implants that replace natural teeth. They are typically made of pure titanium or titanium alloys and are surgically implanted into the alveolar bone to support crowns, bridges, and other restorations, restoring oral chewing function. Due to their advantages such as reliable fixation, aesthetics, and comfort, they are widely used in the field of dental restoration. Because implants must withstand the dynamic loads of chewing for extended periods after implantation, their fatigue performance directly determines their lifespan and clinical safety. Therefore, their fatigue performance must be rigorously tested according to industry standard YY / T0521-2018 through professional testing.

[0003] According to industry standard YY / T0521-2018, for intraosseous dental implant systems with pre-angled connections, the implant body should be fixed by a support, ensuring that the angle between the implant's long axis and the loading direction of the testing equipment is 10° larger than the angle between the implant's long axis and the long axis of the pre-angled abutment portion. This represents a simulated 10° correction. In actual testing, implants of different models or from different manufacturers often require different fixing angles. Therefore, before fatigue performance testing, the fixing angle of the implant usually needs to be precisely adjusted and confirmed to meet the above standard requirements. Currently, the support for fixing the implant is fixed to the mounting base with bolts. When adjusting the fixing angle of the implant, tools must first be used to loosen or remove the bolts, adjust the implant to the target angle, and then use tools to tighten the bolts. This process often requires two people to operate, which is not only cumbersome and time-consuming but also inefficient, making it difficult to meet the needs of batch or frequent testing. Summary of the Invention

[0004] The purpose of this invention is to provide a test apparatus and method for an implant system containing a pre-angled connection portion, so as to solve the problems mentioned in the background art.

[0005] To achieve the above objectives, the present invention provides the following technical solution:

[0006] A test device for an implant system with a pre-formed angle connection includes a mounting base, a drive component, a loading rod, a support base, an extension component, and a locking assembly; the support base is fixedly installed on the bottom of the mounting base, and the bottom surface of the support base is an arc-shaped surface, with an arc-shaped groove formed on the arc-shaped surface;

[0007] The extension component includes an extension rod and a slider fixedly installed at one end of the extension rod, the slider being slidably installed in an arc-shaped groove; a dental implant sample is fixedly installed at the other end of the extension rod; the loading rod is vertically positioned directly below the dental implant sample, and the driving component is used to drive the loading rod to move vertically.

[0008] The locking assembly includes an arc-shaped block fixedly disposed inside an arc-shaped groove, a connecting rod slidably sleeved inside an extension component, a limiting block fixed to the top of the connecting rod, and a locking structure disposed between the limiting block and the arc-shaped block; an arc-shaped connecting groove for the connecting rod to pass through is provided along the length direction of the arc-shaped block, and the limiting block is located directly above the arc-shaped block; the locking structure is used to lock the limiting block to the arc-shaped block, and pushing the connecting rod upward can change the limiting block and the arc-shaped block from a locked state to a separated state.

[0009] Furthermore, the locking structure includes a plurality of limiting grooves disposed on the lower arc surface of the limiting block and a plurality of limiting protrusions disposed on the upper arc surface of the arc block that match the limiting grooves; the arc block is disposed along the length direction of the arc groove, and the arc block and the arc groove are concentric, the upper part of the arc block is an arc groove concentric with the arc groove, the limiting block is located inside the arc groove, and by pushing the connecting rod upward, the limiting protrusions and the limiting grooves can be changed from an engaged state to a disengaged state.

[0010] Furthermore, the extension rod has at least one strip-shaped hole extending along its axial direction on its side, and a connecting rod is vertically fixed on the connecting rod, with at least one end of the connecting rod extending out of the strip-shaped hole.

[0011] Furthermore, a sleeve is slidably fitted on the outer side of the extension rod, and the sleeve is fixedly connected to the connecting rod.

[0012] Furthermore, an angle scale line is provided on the bottom side of the support base along the circumferential extension direction of the arc surface; a liner is fixedly connected between the extension rod and the slider, the top surface of the liner is in contact with the arc surface, and an indicator line corresponding to the angle scale line is provided on the side of the liner.

[0013] Furthermore, a hemispherical support is fixedly connected to the end of the dental implant sample away from the extension rod, and the loading rod is vertically positioned directly below the hemispherical support; the axis of the loading rod and the center of the hemispherical support are on the same vertical line; the center of the arc surface coincides with the center of the hemispherical support.

[0014] Furthermore, a first stop and a second stop are respectively installed at the two ends of the arc-shaped slide groove;

[0015] The first stop component includes a first baffle and a fastening bolt, wherein the first baffle is fixedly installed at one end of the arc-shaped slide groove by the fastening bolt;

[0016] The second stop component includes a second baffle, a support block, a rotating seat, a connecting shaft, and a handle. The connecting shaft is rotatably connected to the support seat via the rotating seat, and the connecting shaft is fixedly connected to the second baffle. The handle is fixedly installed on the second baffle, and the support block is fixedly installed on the end face of the support seat to support the bottom surface of the second baffle so that the second baffle is in the stop position of the arc-shaped groove.

[0017] Furthermore, the testing apparatus also includes an open-top environmental simulation chamber, which is fixedly mounted on a fixed support. The environmental simulation chamber is used to hold a liquid medium at the target temperature. During the test, the dental implant sample is completely immersed in the liquid medium. A through hole is provided in the center of the bottom wall of the environmental simulation chamber for the loading rod to pass through. A sealing connector is fixed at the edge of the through hole. The sealing connector includes a sealing sleeve fixed at the edge of the through hole. The sealing sleeve is slidably fitted onto the outside of the loading rod.

[0018] Furthermore, the sealing connector also includes a flexible sheet, a first pressure ring, a second pressure ring, a stud, and a nut; two flexible sheets are provided, the flexible sheets are integrally formed with the sealing sleeve, the flexible sheets are annular, their inner edges are fixedly connected to the sealing sleeve, and their outer edges are in contact with the inner bottom surface and the outer bottom surface of the environmental simulation chamber, respectively;

[0019] The first pressure ring and the second pressure ring are respectively disposed on the inner bottom surface and the outer bottom surface of the environmental simulation box. The first pressure ring is fixedly connected to multiple studs. The multiple studs pass through the mounting through holes opened at corresponding positions on the two flexible sheets, the bottom wall of the environmental simulation box and the second pressure ring. A nut is screwed onto each stud.

[0020] Furthermore, a testing method for an implant system containing a pre-formed angle connection portion includes the following steps:

[0021] Step 1: Fix the dental implant sample to the end of the extension rod away from the slider;

[0022] Step 2: Push the connecting rod upward to separate the limiting block and the arc-shaped block, slide the slider along the arc-shaped groove, and adjust the extension rod to the target tilt angle; release the connecting rod, and rely on gravity to change the limiting block and the arc-shaped block from the separated state to the locked state;

[0023] Step 3: Start the drive unit to drive the loading rod to move vertically upward, so that the top of the loading rod directly or indirectly contacts the dental implant sample. Apply dynamic fatigue load to the dental implant sample according to the preset load and loading frequency, perform fatigue performance test, and record the test data.

[0024] Compared with the prior art, the beneficial effects of the present invention are:

[0025] This patent, by setting up a support base with an arc-shaped surface, and in conjunction with an arc-shaped groove and slider, as well as related scale lines and locking components, enables testers to adjust the dental implant sample to a predetermined tilt angle for testing according to actual needs, further simulating the real tilt environment of the dental implant sample after it is implanted in the human oral cavity, resulting in more accurate test results.

[0026] This invention, in conjunction with the inverted design of the support base and loading component, designs the locking assembly to achieve locking by gravity. Specifically, the weight of the connecting rod, limiting block, and connecting rod keeps the limiting protrusion and limiting groove in an engaged state without any force. At this time, since the dental implant sample is fixed on the extension rod, the load applied by the loading rod will be applied to the support base, not to the limiting block, thus preventing the limiting protrusion and limiting groove from disengaging. Once it is necessary to adjust the tilt angle of the dental implant sample, simply push the connecting rod upward to change the limiting protrusion and limiting groove from the engaged state to the disengaged state, and then the tilt angle of the dental implant sample can be adjusted, reducing the difficulty of angle adjustment and improving actual work efficiency.

[0027] This invention utilizes an environmental simulation chamber to place dental implant samples within a simulated human oral cavity environment during testing. This effectively overcomes the technical limitations of existing room-temperature air environment testing. On one hand, it accurately replicates the actual clinical stress environment of implants, eliminating deviations between the testing environment and clinical scenarios, and truthfully reflects the fatigue performance of implants under the combined effects of physiological media and dynamic loads, thus avoiding data distortion. On the other hand, it can accurately detect the fatigue limit, fatigue life, and fracture mode of implants in a biomimetic environment, thereby accurately determining the actual service life of implants and providing reliable assurance for clinical application safety. Furthermore, it provides precise data support for implant structural optimization design, helping to identify weak points in implant structure and further improving the clinical adaptability and service life of implants.

[0028] This technical solution places the arc-shaped surface at the bottom of the support base, then positions the loading rod below the dental implant sample, and fixes the environmental simulation chamber on the loading rod. This ensures that during the experiment, only the dental implant sample is completely immersed in the liquid environment inside the environmental simulation chamber, rather than the entire support base and related structures. This significantly reduces the difficulty of the experiment, minimizes corrosion of the support base and other structures, lowers experimental costs, and improves experimental accuracy. Furthermore, only a seal between the loading rod and the environmental simulation chamber is required, greatly simplifying the sealing and protection structure. In addition, this structural design allows operators to quickly switch between liquid and gaseous environmental testing environments, improving practical work efficiency. Attached Figure Description

[0029] Figure 1 This is a schematic diagram of the overall structure of the present invention;

[0030] Figure 2 This is a schematic diagram of the structure of the support base 4 and the environmental simulation box 8 of the present invention;

[0031] Figure 3 This is a schematic diagram of the structure of the support base 4, the extension component 5, and the first stop component 9 of the present invention;

[0032] Figure 4 This is a schematic diagram of the structure of the support base 4, the extension component 5, and the second stop component 10 of the present invention;

[0033] Figure 5 This is a schematic diagram of the structure of the second stop component 10 of the present invention;

[0034] Figure 6 This is a cross-sectional view of the support base 4 and a structural schematic diagram of the extension component 5 of the present invention;

[0035] Figure 7 For the present invention Figure 6 A front view structural diagram;

[0036] Figure 8 This is a schematic diagram of the structure of the extension component 5 of the present invention;

[0037] Figure 9 This is a schematic cross-sectional view of the sleeve 508 of the present invention;

[0038] Figure 10 This is a cross-sectional view of the sleeve 508 and a structural schematic diagram of the connecting rod 504 of the present invention;

[0039] Figure 11 This is a cross-sectional three-dimensional structural diagram of the environmental simulation chamber 8 of the present invention;

[0040] Figure 12 This is a cross-sectional view of the flexible sheet 12, the first pressure ring 14, and the second pressure ring 15 of the present invention.

[0041] In the diagram: 1. Mounting base; 2. Drive component; 3. Loading rod; 4. Support base; 401. Arc-shaped groove; 402. Arc-shaped block; 403. Arc-shaped groove; 404. Limiting protrusion; 405. Angle scale line; 5. Extension component; 501. Extension rod; 502. Liner block; 503. Slider; 504. Connecting rod; 505. Limiting block; 506. Limiting groove; 507. Indicator line; 508. Sleeve; 509. Strip hole; 510. Connecting rod; 6. Dental implant sample; 7. Hemispherical support; 8. Environmental simulation chamber; 9. First stop component; 901. First baffle; 902. Fastening bolt; 10. Second stop component; 1001. Second baffle; 1002. Support block; 1003. Rotating seat; 1004. Connecting shaft; 1005. Handle; 11. Fixing bracket; 12. Flexible sheet; 13. Sealing sleeve; 14. First pressure ring; 15. Second pressure ring; 16. Stud; 17. Nut. Detailed Implementation

[0042] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0043] Example 1

[0044] See Figures 1-2 The present invention provides a technical solution:

[0045] An experimental device for an implant system with a pre-angled connection includes a mounting base 1, a drive component 2, a loading rod 3, a support base 4, an extension component 5, and a locking assembly; the structure and working principle of these components are described in detail below.

[0046] Specifically, the specific structural shape of the mounting base 1 is not limited here; for example, it can be as follows: Figure 1 The structural shape shown can, of course, be similar to... Figure 1 The structural shapes shown may differ. For example, the mounting base 1 is fixedly set on the bottom surface of a fixed cantilever, fixed platform, etc. Its function is to install the support base 4 so that the support base 4 can remain in a fixed position during the test.

[0047] The support base 4 is fixedly installed at the bottom of the mounting base 1. In this embodiment, the support base 4 is installed at the bottom of the mounting base 1 by means of hexagon socket head cap screws, so as to realize the fixed connection between the two.

[0048] like Figures 1-4As shown, the bottom surface of the support base 4 is an arc-shaped surface. An arc-shaped groove 401 with a T-shaped cross-section is provided on the arc-shaped surface of the bottom of the support base 4. The two ends of the arc-shaped groove 401 extend out of the support base 4, and the openings at both ends are blocked by the first stop member 9 and the second stop member 10 respectively. The function of the first stop member 9 and the second stop member 10 is to limit the sliding range of the slider 503 inside the arc-shaped groove 401, prevent the slider 503 from coming out of the arc-shaped groove 401, and at the same time, the second stop member 10 can be easily opened when it is necessary to remove the slider 503 or other components from the arc-shaped groove 401 for maintenance or replacement.

[0049] like Figure 3 As shown, in this technical solution, the first stop component 9 includes a first baffle 901 and a fastening bolt 902. The first baffle 901 is fixedly installed at one end of the arc-shaped slide groove 401 by the fastening bolt 902. This prevents the slider 503 from sliding out from one end of the arc-shaped slide groove 401.

[0050] like Figure 4 , Figure 5 As shown, in this technical solution, the second stop component 10 includes a second baffle 1001, a support block 1002, a rotating seat 1003, a connecting shaft 1004, and a handle 1005.

[0051] The second baffle 1001 has a blocking state that covers the other end of the arc-shaped slide groove 401 and a yielding state that moves away from the other end of the arc-shaped slide groove 401. When the second baffle 1001 is in the blocking state, it can prevent the slider 503 from sliding out of the other end of the arc-shaped slide groove 401. When the second baffle 1001 is in the yielding state, the tester can slide the slider 503 out of the other end of the arc-shaped slide groove 401. In this way, the tester can quickly change the extension part 5 with different dental implant samples 6 installed, thereby further improving the overall work efficiency and ensuring the accuracy of the experiment.

[0052] The support block 1002 is fixed to the end face of the support base 4 to support the second baffle 1001, positioning it in the stop position of the arc-shaped slide groove 401. The connecting shaft 1004 is rotatably connected to the support base 4 via a rotating seat 1003, and is also fixedly connected to the second baffle 1001. The rotating seat 1003 can be a bearing seat, etc. A handle 1005 is fixedly connected to the second baffle 1001. Thus, the weight of the second baffle 1001, combined with the limiting effect of the support block 1002, keeps the second baffle 1001 in the stop position. Rotating the second baffle 1001 to the other side via the handle 1005 facilitates the disassembly and reinstallation of the extension component 5.

[0053] like Figures 1-3As shown, the bottom side of the support base 4 is provided with an angle scale line 405 extending along the circumference of the arc surface. In this embodiment, the angle range marked by the angle scale line 405 is 0-50°, where the 0° scale line is a vertical scale line. An indicator line 507 is provided on the side of the extension component 5 corresponding to the angle scale line 405. The indicator line 507 is parallel to the axis of the extension component 5. The function of the indicator line 507 is to accurately align a certain angle scale line 405, making the tilt angle of the extension component 5 visible. For example, when the indicator line 507 is aligned with the 32° angle scale line 405, it indicates that the tilt angle of the extension component 5 is 32°.

[0054] The extension component 5 includes an extension rod 501 and a slider 503. In this embodiment, a liner 502 is fixedly connected between the extension rod 501 and the slider 503. The top surface of the liner 502 is in contact with the arc-shaped surface, and the indicator line 507 is set on the side of the liner 502 corresponding to the angle scale line 405.

[0055] The slider 503 is fixed to one end of the extension rod 501, for example by welding; and the slider 503 is slidably disposed inside the arc-shaped groove 401, and the extension rod 501 is positioned at a predetermined tilt angle by a locking component.

[0056] A dental implant sample 6, coaxially aligned with the extension rod 501, is fixedly mounted at the end of the extension rod 501 away from the slider 503. The dental implant sample 6 is the implant to be tested. There are various methods for fixing the dental implant sample 6; for example, in this embodiment... Figure 3 , Figure 6 and Figure 7 The provided fixation method is threaded fixation, that is, the dental implant sample 6 is tightened and fixed to the end of the extension rod 501 away from the slider 503 by thread. Before the actual fatigue performance test, the dental implant sample 6 needs to be fixed in the rigid cylinder with the embedding material, and the bone plane end of the dental implant sample 6 should be exposed on the end face of the rigid cylinder. When fixing the dental implant sample 6, the extension rod 501 is inserted into the end of the rigid cylinder away from the bone plane end of the dental implant sample 6, and the threaded fixation is achieved by the internal thread on the inner surface of the rigid cylinder and the external thread on the outer surface of the extension rod 501. In addition, in some other embodiments, the dental implant sample 6 can also be fixed in other ways, such as by clamping with a suitable clamp. For example, a clamp is provided at the end of the extension rod 501 near the dental implant sample 6. The clamp clamps the outer surface of the rigid cylinder through the provided clamping cavity to achieve the connection and fixation between the dental implant sample 6 and the extension rod 501. Such clamps are common and commonly used tools in laboratories or fatigue performance testing fields, so they will not be described in detail.

[0057] The dental implant specimen 6 is coaxially arranged with the extension rod 501, ensuring that the tilt angle of the extension rod 501 is consistent with the tilt angle of the dental implant specimen 6. A hemispherical support member 7 is fixedly connected to the end of the dental implant specimen 6 furthest from the extension rod 501. The connection between the hemispherical support member 7 and the dental implant specimen 6 can be integrally formed or fixedly connected via an abutment. Specifically, one end of the abutment is fixedly connected to the dental implant specimen 6 with screws, and the other end of the abutment is inserted into a slot in the hemispherical support member 7 and fixedly connected to the inner wall of the slot with an adhesive, which can be a high-strength anaerobic retaining adhesive. The function of the hemispherical support member 7 is to contact the loading rod 3 and transfer the load on the loading rod 3 to the dental implant specimen 6. The hemispherical structural design ensures that even when the dental implant specimen 6 is tilted, the load on the loading rod 3 can still be accurately transferred to the dental implant specimen 6. The structure and placement of the abutment and hemispherical support 7 are detailed in the industry standard YY / T0521-2018, which is also a common and frequently used tool in the laboratory or dental implant fatigue performance testing field, so it will not be described in detail here.

[0058] The loading rod 3 is vertically positioned below the hemispherical support 7, with its axis aligned vertically with the center of the hemispherical support 7. The center of the arc-shaped surface of the loading rod coincides with the center of the hemispherical support 7. The loading rod 3 is driven to move up and down by the driving component 2. In this embodiment, the driving component 2 can be a hydraulic cylinder or an electric push rod, and the loading rod 3 can be the piston rod of a hydraulic cylinder or the push rod of an electric push rod.

[0059] The center of the arc surface coincides with the center of the hemispherical support 7. Under this condition, the staff can adjust the tilt angle of the dental implant sample 6 at any time according to actual needs. Since the axis of the loading rod 3 and the center of the hemispherical support 7 are on the same vertical line, after the tilt angle is adjusted, the loading rod 3 can still directly generate a thrust on the dental implant sample 6 by moving upward, without adjusting the relative position of the loading rod 3 and the dental implant sample 6.

[0060] like Figures 6-10 As shown, in this technical solution, the locking component includes an arc-shaped block 402 fixedly disposed inside the arc-shaped groove 401, a connecting rod 504 slidably sleeved inside the extension rod 501, and a limiting block 505 fixed to the top of the connecting rod 504.

[0061] The top of the connecting rod 504 extends out of the top surface of the slider 503; inside the support base 4, above the arc-shaped block 402, is an arc-shaped groove 403 concentric with the arc-shaped slide 401; the arc-shaped block 402, the arc-shaped groove 403, and the arc-shaped surface are concentrically arranged. The middle part of the arc-shaped block 402 has an arc-shaped connecting groove that connects the arc-shaped slide 401 and the arc-shaped groove 403 along the length direction of the arc-shaped block 402. The length of the arc-shaped block 402, the length of the arc-shaped connecting groove, and the length of the arc-shaped groove 403 are all consistent with the arc-shaped slide 401. The arc-shaped connecting groove is used for the connecting rod 504 to pass through, and the connecting rod 504 can slide along the length direction of the arc-shaped connecting groove.

[0062] The limiting block 505 is disposed inside the arc-shaped groove 403. The height of the arc-shaped groove 403 is greater than the thickness of the limiting block 505, and several limiting grooves 506 are formed on the lower arc surface of the limiting block 505. Several limiting protrusions 404 are integrally formed on the upper arc surface of the arc-shaped block 402. In this embodiment, the included angle between two adjacent limiting protrusions 404 is 1°, and the limiting protrusions 404 and the limiting grooves 506 are matched. In the above scheme, the included angle between two adjacent limiting protrusions 404 is 1°, which means that after connecting the two adjacent limiting protrusions 404 with the center of the arc-shaped groove 403, the included angle between the two connecting lines is 1°. The purpose of this limitation is to make the minimum adjustable angle of the limiting block 505 1° after the limiting protrusions 404 and the limiting grooves 506 are matched. For example, the original 31° tilt angle of the dental implant sample 6 can be adjusted to a 32° tilt angle, and the angle adjustment accuracy is stronger.

[0063] Specifically, the aforementioned limiting protrusion 404 and limiting groove 506 are matched with a toothed shape.

[0064] The extension rod 501 has a strip-shaped hole 509 extending axially on its side. The strip-shaped hole 509 communicates with the inner cavity of the extension rod 501, on which a connecting rod 504 is slidably fitted. A connecting rod 510 is vertically fixed on the connecting rod 504. Both ends of the connecting rod 510 extend out of the strip-shaped hole 509, allowing the tester to push the connecting rod 504 upward through the connecting rod 510, thereby moving the limiting block 505 upward. Pushing the connecting rod 510 upward can change the engagement state between the limiting protrusion 404 and the limiting groove 506 to the disengagement state. When the limiting protrusion 404 and the limiting groove 506 are in the engagement state, the tilt angle of the dental implant sample 6 is locked and cannot be adjusted. When the limiting protrusion 404 and the limiting groove 506 are in the disengagement state, the tilt angle of the dental implant sample 6 is adjustable, and the tilt angle of the dental implant sample 6 can be adjusted according to actual needs.

[0065] In the above scheme, in conjunction with the inverted design of the support base 4, the locking component is designed to achieve locking by gravity. Specifically, the weight of the connecting rod 504, the limiting block 505, and the connecting rod 510 allows the limiting protrusion 404 and the limiting groove 506 to remain engaged when not under stress. Since the dental implant sample 6 is fixed on the extension rod 501, the load applied by the loading rod 3 will not cause the limiting protrusion 404 and the limiting groove 506 to disengage. Once the tilt angle of the dental implant sample 6 needs to be adjusted, the connecting rod 510 can be manually pushed up to change the limiting protrusion 404 and the limiting groove 506 from the engaged state to the disengaged state, and then the tilt angle of the dental implant sample 6 can be adjusted, reducing the difficulty of angle adjustment and improving actual work efficiency.

[0066] To increase the overall counterweight of the locking assembly and facilitate the upward pushing of the connecting rod 510, a sleeve 508 is slidably fitted on the outside of the extension rod 501, and the sleeve 508 is fixedly connected to the end of the connecting rod 510. The function of the sleeve 508 is to further increase the gravity of the locking assembly, making the engagement between the limiting protrusion 404 and the limiting groove 506 more stable. At the same time, it facilitates the test personnel to push the limiting block 505 upward through the sleeve 508.

[0067] Example 2

[0068] The inventors discovered that current fatigue performance tests can only be conducted in a normal temperature air environment, which deviates significantly from the actual stress environment of implants in clinical practice. This makes it impossible to truly reflect the fatigue performance of implants under the combined effects of physiological media and dynamic loads, easily leading to distorted test data, making it difficult to accurately determine the actual service life of implants, and failing to provide reliable data support that is in line with clinical practice for implant structure optimization, thus exhibiting obvious technical defects.

[0069] Therefore, in view of the above problems, this embodiment provides a test device for an implant system with a pre-angled connection part that has the function of simulating the human oral environment, including a mounting base 1, a driving component 2, a loading rod 3, a support base 4, an extension component 5, a locking component and an environmental simulation box 8; the difference between this embodiment 2 and embodiment 1 is only that embodiment 2 adds a technical feature: the environmental simulation box 8. The structure and function of other components are the same as those in embodiment 1. Therefore, this embodiment focuses on describing the structure and function of the environmental simulation box 8, and other components will not be described again.

[0070] like Figure 1 , Figure 2 , Figure 11 , Figure 12As shown, the environmental simulation chamber 8 is a cylindrical structure with an open top. A through hole for the loading rod 3 to pass through is provided in the center of the bottom wall of the environmental simulation chamber 8. A sealing connector is fixed at the edge of the through hole, and the sealing connector is slidably sealed to the loading rod 3. As can be seen from the figure, the environmental simulation chamber 8 is fitted on the outside of the loading rod 3, and the loading rod 3 penetrates into the interior of the environmental simulation chamber 8 through the bottom wall of the environmental simulation chamber 8.

[0071] The inner cavity of the environmental simulation chamber 8 is used to hold liquid media such as physiological saline to simulate the oral cavity environment. Furthermore, the environmental simulation chamber 8 has a heating function, maintaining a constant internal temperature of approximately 37±2℃ to simulate the temperature inside the human oral cavity. Specifically, a heating plate or heating rod is installed on the inner sidewall or bottom wall of the environmental simulation chamber 8, and a temperature controller is fixed on the outer sidewall of the environmental simulation chamber 8 to control the constant temperature of the heating plate or heating rod, thus maintaining the constant temperature of the liquid media. During use, the dental implant sample 6 is completely immersed in the liquid environment inside the environmental simulation chamber 8, and the loading rod 3 abuts against the hemispherical support 7. Then, activating the drive component 2 allows the loading rod 3 to apply a load to the dental implant sample 6, thus initiating the test. In a preferred embodiment, a drain pipe with a valve can be installed on the sidewall of the environmental simulation chamber 8; when it is necessary to drain the liquid inside the environmental simulation chamber 8, the valve can be opened directly.

[0072] In one embodiment, the sealing connector includes a sealing sleeve 13 fixed to the edge of the through hole. The sealing sleeve 13 is fitted over the outside of the loading rod 3, which passes through the through hole in the middle of the sealing sleeve 13 and is slidably and sealingly connected to it. The sealing sleeve 13 is made of rubber and is fitted with the loading rod 3 by an interference fit, thereby preventing liquid inside the environmental simulation chamber 8 from leaking through the gap between the sealing sleeve 13 and the loading rod 3.

[0073] In another embodiment, the sealing connector includes a flexible sheet 12, a sealing sleeve 13, a first pressure ring 14, a second pressure ring 15, a stud 16, and a nut 17.

[0074] A sealing sleeve 13 is fixed to the edge of the through hole. The outer side of the loading rod 3 is sealed with the sealing sleeve 13, and a flexible sheet 12 is fixedly sealed around the outer periphery of the sealing sleeve 13. The sealing sleeve 13 can be made of the same material as the flexible sheet 12, and the sealing sleeve 13 and the flexible sheet 12 are integrally formed. The flexible sheet 12 can be made of rubber. The sealing sleeve 13 is sealed with the loading rod 3 by an interference fit, thereby preventing liquid inside the environmental simulation chamber 8 from leaking through the gap between the sealing sleeve 13 and the loading rod 3.

[0075] from Figure 11 and Figure 12 As can be clearly seen, in this embodiment, the flexible sheet 12 is annular with a V-shaped bend in the middle. This enables a flexible sealing connection between the loading rod 3 and the environmental simulation box 8. When the loading rod 3 rises or falls, the bend in the middle of the flexible sheet 12 is stretched to offset the distance the loading rod 3 rises. This prevents the force on the loading rod 3 from being transmitted to the environmental simulation box 8, keeping the environmental simulation box 8 stationary. This helps to maintain the stability of the liquid inside the environmental simulation box 8 and prevents the liquid inside the environmental simulation box 8 from oscillating or shaking.

[0076] The flexible sheet 12 is sealed and fixedly connected to the bottom wall of the environmental simulation chamber 8, such as... Figure 12 As shown, in this embodiment, two flexible sheets 12 are provided, and the outer edges of the two flexible sheets 12 contact the inner bottom surface and the outer bottom surface of the environmental simulation box 8, respectively. The first pressure ring 14 and the second pressure ring 15 are respectively provided on the inner bottom surface and the outer bottom surface of the environmental simulation box 8. The first pressure ring 14 is fixedly connected to a plurality of studs 16. The plurality of studs 16 pass through the mounting through holes opened at corresponding positions on the two flexible sheets 12, the bottom wall of the environmental simulation box, and the second pressure ring 15. A nut 17 is screwed onto each stud 16.

[0077] The first pressure ring 14 presses the outer edge of one of the flexible sheets 12 against the inner bottom surface of the environmental simulation chamber 8, and the second pressure ring 15 presses the outer edge of the other flexible sheet 12 against the outer bottom surface of the environmental simulation chamber 8. The stud 16, which is welded and fixed to the first pressure ring 14, passes through the two flexible sheets 12 and the bottom wall of the environmental simulation chamber 8, and is tightened by the nut 17, thereby achieving a sealed connection between the flexible sheet 12 and the environmental simulation chamber 8 to prevent liquid leakage.

[0078] The environmental simulation box 8 is fixedly installed on the fixed bracket 11, and the bottom end of the fixed bracket 11 is fixed to the ground and the workbench. The fixed bracket 11 is used to support and fix the position of the environmental simulation box 8 so that it is at a suitable height, and the overall position of the environmental simulation box 8 remains unchanged when the loading rod 3 moves vertically.

[0079] Example 3

[0080] This embodiment discloses a test method for an implant system containing a pre-angled connection portion, implemented based on the test apparatus in Embodiment 1 or Embodiment 2, including the following steps:

[0081] Step 1: Sample preparation and installation:

[0082] The dental implant sample 6 is fixed inside a rigid cylinder using an embedding material (such as acrylic resin), ensuring that the bone-plane end of the dental implant sample 6 protrudes from the end face of the rigid cylinder, thus guaranteeing that the dental implant sample 6 is coaxial with the rigid cylinder after embedding and curing. The end of the rigid cylinder furthest from the bone-plane end is fixedly connected to the end of the extension rod 501 furthest from the slider 503 using threads or clamps, ensuring that the dental implant sample 6 is coaxial with the extension rod 501. A hemispherical support member 7 is fixedly connected to the end of the dental implant sample 6 furthest from the extension rod 501.

[0083] Step 2: Adjust the tilt angle of the dental implant sample:

[0084] According to the requirements of industry standard YY / T 0521-2018, determine the target tilt angle (i.e., the angle between the long axis of the implant and the loading direction of the testing equipment is 10° larger than the angle between the long axis of the implant and the long axis of the pre-angled portion of the abutment). Push the connecting rod 510 or sleeve 508 upwards to separate the limiting groove 506 on the limiting block 505 from the limiting protrusion 404 on the arc-shaped block 402, thus releasing the locking state. Slide the slider 503 along the arc-shaped slide groove 401, while observing the indicator line 507 on the liner 502 and the angle scale line 405 on the bottom side of the support base 4, and adjust the extension rod 501 to the target tilt angle. Release the connecting rod 510 or sleeve 508, and rely on the gravity of the connecting rod 504, the limiting block 505, and the connecting rod 510 to re-engage and lock the limiting groove 506 and the limiting protrusion 404, completing the tilt angle positioning.

[0085] Step 3: Simulate the oral cavity environment (optional, based on the device in Example 2):

[0086] If a fatigue test simulating an oral cavity environment is required, inject physiological saline or other alternative physiological media into the environmental simulation chamber 8, and activate the heating device (such as a heating plate or heating rod) of the environmental simulation chamber 8 to keep the liquid medium temperature constant at 37℃±2℃ to simulate the temperature of the human oral cavity. Ensure that the dental implant sample 6 is completely immersed in the liquid medium, and that the hemispherical support 7 is above the liquid surface or that the contact area with the loading rod 3 is kept dry. Check that the sealing connections (sealing sleeve 13, flexible sheet 12, etc.) are properly sealed to prevent liquid leakage.

[0087] Step 4: Apply dynamic fatigue load:

[0088] Activate drive component 2 (such as a hydraulic cylinder or electric actuator) to drive loading rod 3 vertically upward, causing the top of loading rod 3 to abut against hemispherical bearing component 7. In accordance with industry standard YY / T 0521-2018, load the load according to preset load values ​​(e.g., setting the maximum and minimum loads based on the expected stress range of the implant), loading frequency (e.g., 0~15 Hz), and number of cycles (e.g., 2*10). 6 Times, 5*10 6Dynamic fatigue loads of sinusoidal or other waveforms are applied to the dental implant specimen 6 (until the specimen breaks). During the test, data such as the load-cycle curve, displacement change, and the number of cycles (fatigue life) at specimen fracture are recorded in real time using sensors and a data acquisition system. If the test is conducted in a simulated oral environment, the temperature and level of the liquid medium must be checked regularly, and the medium should be replenished or replaced as needed.

[0089] Step 5: Post-test processing:

[0090] When the preset number of cycles is reached or the dental implant specimen 6 fractures, the drive component 2 is stopped. If an environmental simulation chamber 8 is used, the liquid medium inside the chamber is emptied, and the dental implant specimen 6 is removed. The fracture mode of the specimen (such as implant body fracture, loosening or fracture of the connection part, etc.) is observed and recorded, and the fatigue damage morphology is analyzed using a stereomicroscope or scanning electron microscope. Based on the recorded test data, the fatigue limit and fatigue life of the implant are calculated, and its compliance with standard requirements is assessed.

[0091] Step Six: Replace the sample or adjust the angle:

[0092] If multiple tests are required or different models of dental implant specimens 6 need to be replaced, the second baffle 1001 of the second stop 10 can be moved away from the end of the arc-shaped slide groove 401 by rotating the handle 1005, and the extension component 5 together with the slider 503 can be slid out of the arc-shaped slide groove 401. After replacing the new extension component 5 or dental implant specimen 6, it can be reinstalled, and the tilt angle can be adjusted according to the above steps for testing.

[0093] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A test apparatus for an implant system containing a pre-angled connection portion, characterized in that, It includes a mounting base (1), a driving component (2), a loading rod (3), a support base (4), an extension component (5), and a locking assembly; the support base (4) is fixedly installed on the bottom of the mounting base (1), and the bottom surface of the support base (4) is an arc-shaped surface, and an arc-shaped groove (401) is provided on the arc-shaped surface; The extension component (5) includes an extension rod (501) and a slider (503) fixedly installed at one end of the extension rod (501). The slider (503) is slidably installed in the arc-shaped groove (401). A dental implant sample (6) is fixedly installed at the other end of the extension rod (501). The loading rod (3) is vertically positioned directly below the dental implant sample (6). The driving component (2) is used to drive the loading rod (3) to move vertically. The locking assembly includes an arc-shaped block (402) fixedly disposed inside the arc-shaped groove (401), a connecting rod (504) slidably sleeved inside the extension component (5), a limiting block (505) fixed to the top of the connecting rod (504), and a locking structure disposed between the limiting block (505) and the arc-shaped block (402); an arc-shaped connecting groove for the connecting rod (504) to pass through is provided along the length direction of the arc-shaped block (402), and the limiting block (505) is located directly above the arc-shaped block (402); the locking structure is used to lock and fix the limiting block (505) on the arc-shaped block (402), and pushing the connecting rod (504) upward can change the limiting block (505) and the arc-shaped block (402) from the locked state to the separated state.

2. The experimental apparatus for an implant system containing a pre-angled connection portion according to claim 1, characterized in that, The locking structure includes several limiting grooves (506) disposed on the lower arc surface of the limiting block (505) and several limiting protrusions (404) disposed on the upper arc surface of the arc block (402) that match the limiting grooves (506); the arc block (402) is disposed along the length direction of the arc groove (401), and the arc block (402) and the arc groove (401) are concentric. Above the arc block (402) is an arc groove (403) concentric with the arc groove (401). The limiting block (505) is located inside the arc groove (403). By pushing the connecting rod (504) upward, the limiting protrusions (404) and the limiting grooves (506) can be changed from an engaged state to a disengaged state.

3. The experimental apparatus for an implant system containing a pre-angled connection portion according to claim 1, characterized in that, The extension rod (501) has at least one strip-shaped hole (509) extending along its axial direction on its side. A connecting rod (510) is vertically fixed on the connecting rod (504), and at least one end of the connecting rod (510) extends out of the strip-shaped hole (509).

4. The experimental apparatus for an implant system containing a pre-angled connection portion according to claim 3, characterized in that, The extension rod (501) is slidably fitted with a sleeve (508), and the sleeve (508) is fixedly connected to the connecting rod (510).

5. The experimental apparatus for an implant system containing a pre-angled connection portion according to claim 1, characterized in that, An angle scale line (405) is provided on the bottom side of the support base (4) along the circumferential extension direction of the arc surface; a liner (502) is fixedly connected between the extension rod (501) and the slider (503), the top surface of the liner (502) is in contact with the arc surface, and an indicator line (507) corresponding to the angle scale line (405) is provided on the side of the liner (502).

6. The experimental apparatus for an implant system containing a pre-angled connection portion according to claim 1, characterized in that, The dental implant sample (6) is fixedly connected to a hemispherical support member (7) at one end away from the extension rod (501). The loading rod (3) is vertically positioned directly below the hemispherical support member (7). The axis of the loading rod (3) and the center of the hemispherical support member (7) are on the same vertical line. The center of the arc surface coincides with the center of the hemispherical support member (7).

7. The experimental apparatus for an implant system containing a pre-angled connection portion according to claim 1, characterized in that, The arc-shaped slide (401) has a first stop (9) and a second stop (10) installed at its two ends respectively. The first stop component (9) includes a first baffle (901) and a fastening bolt (902). The first baffle (901) is fixedly installed at one end of the arc-shaped slide groove (401) by the fastening bolt (902). The second stop component (10) includes a second baffle (1001), a support block (1002), a rotating seat (1003), a connecting shaft (1004), and a handle (1005). The connecting shaft (1004) is rotatably connected to the support seat (4) through the rotating seat (1003), and the connecting shaft (1004) is fixedly connected to the second baffle (1001). The handle (1005) is fixedly installed on the second baffle (1001), and the support block (1002) is fixedly installed on the end face of the support seat (4) to support the bottom surface of the second baffle (1001) so that the second baffle (1001) is in the stop state of the arc-shaped slide groove (401).

8. The experimental apparatus for an implant system with a pre-angled connection portion according to claim 1, characterized in that, The test apparatus also includes an open-top environmental simulation chamber (8), which is fixedly mounted on a fixed bracket (11). The environmental simulation chamber (8) is used to hold a liquid medium at the target temperature. During the test, the dental implant sample (6) is immersed in the liquid medium. A through hole is provided in the center of the bottom wall of the environmental simulation chamber (8) for the loading rod (3) to pass through. A sealing connector is fixed at the edge of the through hole. The sealing connector includes a sealing sleeve (13) fixed at the edge of the through hole. The sealing sleeve (13) is slidably sealed on the outside of the loading rod (3).

9. The experimental apparatus for an implant system with a pre-angled connection portion according to claim 8, characterized in that, The sealing connector also includes a flexible sheet (12), a first pressure ring (14), a second pressure ring (15), a stud (16), and a nut (17); there are two flexible sheets (12), the flexible sheet (12) and the sealing sleeve (13) are integrally formed, the flexible sheet (12) is circular, its inner edge is fixedly connected to the sealing sleeve (13), and its outer edge is in contact with the inner bottom surface and the outer bottom surface of the environmental simulation box (8) respectively; The first pressure ring (14) and the second pressure ring (15) are respectively disposed on the inner bottom surface and the outer bottom surface of the environmental simulation box (8). The first pressure ring (14) is fixedly connected to a plurality of studs (16). The plurality of studs (16) pass through the mounting through holes opened at corresponding positions on the two flexible sheets (12), the bottom wall of the environmental simulation box and the second pressure ring (15). A nut (17) is screwed onto each stud (16).

10. A testing method for an implant system containing a pre-formed angle connection portion, characterized in that, Based on the test apparatus according to any one of claims 1-9, the procedure includes the following steps: Step 1: Fix the dental implant sample (6) to the end of the extension rod (501) away from the slider (503); Step 2: Push the connecting rod (504) upward to separate the limiting block (505) and the arc block (402), slide the slider (503) along the arc groove (401) to adjust the extension rod (501) to the target tilt angle; release the connecting rod (504) and rely on gravity to change the limiting block (505) and the arc block (402) from the separated state to the locked state; Step 3: Start the drive component (2) to drive the loading rod (3) to move vertically upward, so that the top of the loading rod (3) directly or indirectly contacts the dental implant sample (6), apply dynamic fatigue load to the dental implant sample (6) according to the preset load and loading frequency, perform fatigue performance test, and record the test data.

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