Simulated organ strength testing device

Abstract

To provide a simulation organ strength test device which can achieve, a strength test of a simulation organ with greater accuracy.SOLUTION: A simulation organ strength test device is a device for performing a strength test by applying a load to a simulation organ, and comprises: a drive part 10; a load generation part 20; and a load transmission part 30. The load generation part 20 comprises: a first disk body 21 rotating by the drive part 10; a second disk body 22 facing the first disk body 21; a plurality of protrusions 24 which is arranged on the second disk body 22; and a pressing body 23 which is arranged on the first disk body 21 and inclines the second disk body 22 when passing the protrusion 24 by rotation of the first disk body 21. The load transmission part 30 comprises: a third disk body 31 for applying a load to the simulation organ; and a plurality of coil springs 32 for coupling the second and third disk bodies 22, 31. The load transmission part 30 transmits the load generated by the load generation part 20 to the simulation organ 100, from any oblique direction, to an axial direction of the simulation organ.SELECTED DRAWING: Figure 2

Description

Technical Field

[0001] The present invention relates to a simulated organ strength test device.

Background Art

[0002] Conventionally, as this type of technology, there is the technology described in Patent Document 1. In Patent Document 1, a stress luminescent substance layer is provided on the surface of a cadaver bone or a simulated bone, or on the surface of a member attached thereto, and the light of the stress luminescent substance that emits light due to the stress acting on the bone is measured by a camera, thereby measuring the stress distribution on the surface of the cadaver bone or the simulated bone, or on the surface of a member attached thereto.

Prior Art Documents

Patent Documents

[0003]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0004] Here, when commercially selling a newly developed medical device (for example, a product that is not a follow-up product such as an implant), since there is no equivalent product in the market, it is necessary to verify its safety. In this case, it is necessary to conduct a clinical trial (Phase III: Phase III clinical trial) in which it is directly implanted into a human. In this trial, since the test is conducted using a certain number of patients, it requires a high cost and about three years of time. Also, in the trial, evaluation is only performed during the follow-up period from the start. Therefore, if the results are statistically good, it can be commercially sold. However, since it is impossible to predict defects after commercialization, there is also a disadvantage to patients.

[0005] Furthermore, simulated clinical trials are known in which three-dimensional data of a patient's organs (e.g., bones, blood vessels, etc.) are obtained using CT (Computed Tomography) or MRI (Magnetic Resonance Imaging), and three-dimensional organs (simulated organs, simulated blood vessels, etc.) created based on this data are used to evaluate the performance and safety of medical devices (e.g., implants, etc.).

[0006] While simulated clinical trials are non-clinical trials, there are increasing examples of companies obtaining approval from the Minister of Health, Labour and Welfare based solely on simulated clinical trials, without requiring clinical trials, by conducting simulated clinical trials that ensure a certain level of accuracy for three-dimensional organs and implants. For those marketing implants, avoiding clinical trials can reduce costs and the time from development to market.

[0007] In order to conduct simulated clinical trials with a certain level of accuracy, a simulated organ strength testing device is required that can apply loads to simulated organs (three-dimensional organs or three-dimensional organs with implants attached) from directions in which forces are generated in accordance with the movements of an actual human being.

[0008] However, conventional testing equipment did not apply loads to simulated organs from a direction in which force is generated in response to human movement.

[0009] The present invention aims to solve these problems and provide a simulated organ strength testing device that can achieve more accurate strength testing of simulated organs. [Means for solving the problem]

[0010] The present invention provides a simulated organ strength testing device as described below.

[0011] (1) A simulated organ strength testing device (e.g., multi-axis spinal movement testing device 1) that performs strength testing by applying load to a simulated organ (e.g., simulated organ 100), A load generating unit (for example, load generating unit 20) that generates a load, A simulated organ strength testing device characterized by comprising a load transmission unit (for example, load transmission unit 30) that transmits the load generated by the load generation unit to the simulated organ from an arbitrary oblique direction with respect to the axial direction of the simulated organ (by converting the torque of the testing device into an axial load).

[0012] According to (1), it becomes possible to apply a load to the simulated organ from any oblique direction relative to the axial direction of the simulated organ, and to apply a load from a direction in which force is generated in response to human movement. This makes it possible to provide a simulated organ strength testing device that can achieve more accurate strength testing of simulated organs.

[0013] (2)(1) further includes a drive unit (for example, drive unit 10) that operates the load generating unit, The load generating unit is driven by the drive unit and has a plate-shaped first inclined member (for example, a second circular plate 22) that is tilted obliquely with respect to the axial direction of the simulated organ. The load transmission unit includes a plate-shaped second inclined member (for example, a third circular plate 31) that is inclined obliquely with respect to the axial direction of the simulated organ in conjunction with the first inclined member, and an elastic body (for example, a coil spring 32) that connects the first inclined member and the second inclined member. A simulated organ strength testing device characterized by applying a load to the simulated organ via the second inclined member.

[0014] According to (2), since the first inclined member and the second inclined member are connected by an elastic body, when a load is generated by tilting the first inclined member, the second inclined member tilts in conjunction with the first inclined member, making it possible to apply a load to the simulated organ from an oblique direction corresponding to the inclination of the first inclined member with respect to the axial direction of the simulated organ. This makes it possible to provide a simulated organ strength testing device that can achieve more accurate strength testing of simulated organs.

[0015] (3)(2) The drive unit has a pivot shaft (for example, pivot shaft 12) that serves as the pivot point of the first inclined member, and a motor (for example, motor 11) that drives the load generating unit, The load generating unit further comprises a plate-shaped rotating member (e.g., a first circular plate 21) that rotates by the motor, a plurality of protrusions (e.g., protrusions 24) arranged on the plate surface of the first inclined member, and a pressing body (e.g., a pressing body 23) arranged on the rotating member, which presses against the protrusions as it passes over them due to the rotation of the rotating member, thereby tilting the first inclined member obliquely with respect to the axial direction of the simulated organ. The simulated organ strength testing apparatus is characterized in that the rotation axis can be tilted in a direction inclined with respect to the axial direction of the simulated organ, and the angle of the plate surface of the second inclined member with respect to the axial direction of the simulated organ is variable according to the tilt of the rotation axis.

[0016] According to (3), by rotating a plate-shaped rotating member with a motor, the pressing body presses against the projection as it passes over it, tilting the first inclined member obliquely with respect to the axial direction of the simulated organ. The elastic body expands and contracts in conjunction with the first inclined member, causing the second inclined member to tilt, and the second inclined member can apply a load to the simulated organ from an oblique direction. Moreover, since the angle of the plate surface of the second inclined member is variable according to the tilt of the pivot axis, the angle of the plate surface of the second inclined member relative to the simulated organ can be set to any oblique direction when the pressing body is not in contact with the projection. This makes it possible to apply a load to the simulated organ from any oblique direction, and makes it possible to provide a simulated organ strength testing device that can achieve more accurate strength testing of simulated organs. [Effects of the Invention]

[0017] According to the present invention, it is possible to provide a simulated organ strength testing device that can perform strength tests of simulated organs with greater accuracy. [Brief explanation of the drawing]

[0018] [Figure 1] This figure illustrates a simulated organ that undergoes strength testing using a simulated organ strength testing device according to one embodiment of the present invention. [Figure 2]It is a perspective view showing the appearance of the multi-axis spinal movement test device 1 in one embodiment of the present invention. [Figure 3] It is a diagram schematically showing a state where the pressing body 23 of the multi-axis spinal movement test device 1 is in contact with the second disk body 22. [Figure 4] It is a diagram schematically showing a state where the pressing body 23 of the multi-axis spinal movement test device 1 is located at the top of the protrusion 24. [Figure 5] It is a perspective view showing the appearance of a modified example of the load generating unit 20 according to one embodiment of the present invention. [Figure 6] It is a perspective view showing the appearance of the multi-axis spinal movement test device 1 in another embodiment of the invention. [Figure 7] It is a perspective view showing the appearance of a modified example of the load generating unit 20 according to another embodiment shown in FIG. 6. [Figure 8] It is a perspective view showing the appearance of another modified example of the load generating unit 20 according to another embodiment shown in FIG. 6.

Embodiments for Carrying out the Invention

[0019] Hereinafter, one embodiment of the present invention will be described in detail with reference to the drawings.

[0020] [Outline of Simulated Clinical Trial] FIG. 1 is a diagram for explaining a simulated organ for which a strength test is performed by a simulated organ strength test device in one embodiment of the present invention. For example, when diseases such as spondylolisthesis or spinal stenosis occur, in order to maintain the spinal space normally, a treatment of implanting a metal implant 120 into the bone is performed. When this implant 120 is newly developed, in order to market this implant 120, a simulated clinical trial with a predetermined accuracy can be conducted to omit the clinical trial of the therapeutic trial.

[0021] In the simulated clinical trial, a strength test is performed on a simulated organ 100, which is created by implanting an implant 120 into a three-dimensional organ (e.g., simulated bone) 110 that mimics the Young's modulus of a living organism. Note that the simulated organ 100 is not limited to a three-dimensional organ 110 with an implant 120 implanted into it, but also includes the three-dimensional organ 110 alone.

[0022] The three-dimensional organ 110 is manufactured using a strength (e.g., bone density) that mimics the bio-Young's modulus calculated from three-dimensional data of the patient's organs (e.g., bone, blood vessels) obtained by CT or MRI. By conducting strength tests on such a three-dimensional organ 110 with an implant 120 embedded in it, it becomes possible to verify the impact that the implant 120 has on the patient's organs when the implant 120 is actually implanted in the patient's organs.

[0023] On the other hand, the three-dimensional organ 110 may be made of metal. By conducting strength tests on the three-dimensional organ 110 into which the implant 120 is embedded, it becomes possible to verify the strength of the implant 120 itself. By verifying the strength of the implant 120 itself, it becomes possible to develop products that reduce patient bone damage caused by overly strong products.

[0024] According to the above simulated clinical trial, it becomes possible to omit clinical trials for the 3D organ 110 and implant 120. Furthermore, by repeatedly performing strength tests, the condition of the simulated organ 100 can be visually observed over time, making it possible to observe and confirm signs of malfunctions occurring midway through the process. This allows for design changes to be made before malfunctions occur, thereby providing a safer product. In addition, by performing strength tests on multiple types of 3D organs 110 with varying strengths (e.g., bone density of simulated bone), it becomes possible to consider at what point the safety of the 3D organ 110 deteriorates.

[0025] To conduct such simulated clinical trials, a multi-axial spinal fixture is needed that can verify the axial compressive stress on the simulated organ 100 when it is subjected to biological movements such as flexion, extension, lateral flexion, and twisting, as well as the stress generated when it is twisted, and the angle at which the load is applied.

[0026] By using a multi-axis spinal fixture, it becomes possible to verify the strength of 100 simulated organs using actual physical testing, rather than conventional FEA (Finite Element Analysis), to conduct tests on patients' daily activities and risk analysis in the event of an accident. While FEA simulations can visualize data through display, they are ultimately theoretical numerical analysis. Physical testing, on the other hand, allows for detailed numerical and visual confirmation of behavior in response to actual loads and torques, and is highly valuable because it allows for the verification of unexpected events over time.

[0027] The multi-axis spinal movement testing device 1, which is an example of a simulated organ strength testing device according to the present invention, functions as such a multi-axis spinal jig. In the following description, the multi-axis spinal movement testing device 1, which is a jig for testing a simulated organ 100 that mimics the spine, will be described as an example, but the present invention is not limited to this and can also be applied to jigs for testing simulated organs 100 that mimic other organs.

[0028] [Configuration of Multi-Axis Spinal Motion Testing Device 1] Figure 2 is a perspective view showing the external appearance of the multi-axis spinal motion testing device 1 in one embodiment of the present invention. The multi-axis spinal motion testing device 1 comprises a drive unit 10, a load generating unit 20, a load transmission unit 30, a base unit 40, and a height adjustment unit 50.

[0029] The drive unit 10 includes a motor 11 that drives the load generating unit 20 and a pivot shaft 12 that serves as the pivot point for the load generating unit 20.

[0030] The load generating unit 20 includes a plate-shaped first disc body 21 that rotates by the motor 11, a second disc body 22 that faces the first disc body 21, a pressing body 23 fixed to the first disc body 21, and a projection 24 fixed to the second disc body 22 and pressed by the pressing body 23.

[0031] A pivot shaft 12 is inserted through the central axis of the first disc body 21, and the tip of the pivot shaft 12 protrudes from the center of the disc surface of the first disc body 21 (hereinafter referred to as the lower surface of the first disc body 21) that faces the second disc body 22. The second disc body 22 is a disc with a radius approximately the same as that of the first disc body 21.

[0032] The pressing body 23 is a comb-shaped member that widens from the top downwards. The upper surface of the pressing body 23 is formed to be flat, and the lower surface is formed to be spherical. The length of the upper part of the pressing body 23 is set to be slightly less than the straight line connecting two points on the outer edge of the first disc body 21 that are at a 90-degree angle to the center. The upper part of the pressing body 23 is fixed to the edge of the lower surface of the first disc body 21 along this straight line.

[0033] The projections 24 are hemispherical members, and four of them are arranged on the edge of the plate surface of the second disc body 22 (hereinafter referred to as the upper surface of the second disc body 22) that faces the first disc body 21. The four projections 24 are arranged at equal intervals from each other. That is, the angle formed by adjacent projections 24, 24 and the center of the upper surface of the second disc body 22 is 90 degrees.

[0034] A long hole 25 (see Figure 3(a)) is formed in the center of the second disc 22, penetrating the upper and lower plate surfaces. The long hole 25 extends in a direction inclined at 45 degrees with respect to the straight line connecting two protrusions 24, 24 that are point-symmetrical with respect to the center of the upper surface of the second disc 22.

[0035] The load transmission section 30 includes a third disc body 31, a coil spring 32, a universal joint 33, and a cylindrical bearing 34.

[0036] The third disc 31 is a disc with approximately the same radius as the first disc 21 and the second disc 22.

[0037] The coil spring 32 is an example of an elastic body and is a member that connects the second disc body 22 and the third disc body 31 such that the central axis of the second disc body 22 and the central axis of the third disc body 31 coincide. Four coil springs 32 are arranged on the outer circumference of the lower surface of the second disc body 22 and the upper surface of the third disc body 31, and are arranged at equal intervals from each other. Here, the coil springs 32 are positioned slightly closer to the center than the portion on the lower surface of the second disc body 22 that faces the projection 24. Note that an elastic body such as rubber may be used instead of coil springs.

[0038] The universal joint 33 has one end fixed to the center of the third disc body 31, and the other end is connected to a bearing 34.

[0039] When the second disc body 22 and the third disc body 31 are connected by four coil springs 32, the bearing 34 protrudes from the center of the second disc body 22 through the elongated hole 25 (see Figure 3). The tip of the pivot shaft 12 protruding from the first disc body 21 is inserted into this bearing 34, and the pressing body 23 contacts the upper surface of the second disc body 22. In other words, the pivot shaft 12 is pivotable around the universal joint 33.

[0040] The first disc 21 is rotatable independently of the second disc 22, and the lower surface of the pressing body 23 slides against the projection 24 as the first disc 21 rotates. The width of the lower surface of the pressing body 23 is set to a size that prevents the projection 24 from coming off the lower surface of the pressing body 23 when the first disc 21 is rotating.

[0041] Furthermore, the third disc 31 has a cylindrical through-hole 35 (see Figure 2) formed therein for connecting to the base 40. This hole 35 (see Figure 2) is formed in two locations that are point-symmetrical to each other, and is formed on the upper surface of the third disc 31, slightly outside the center of the straight line connecting adjacent coil springs 32, 32.

[0042] The base section 40 includes a cylindrical base 41, two cylindrical support columns 42, and two coil springs 43 that are loosely inserted into the two support columns 42, respectively.

[0043] The base 41 is a cylindrical body with a radius approximately the same as that of the third disc 31. The support columns 42, 42 are erected on the base 41, and coil springs 43, 43 are inserted into them. When the third disc 31 is positioned above the base 41 such that its central axis coincides with the central axis of the base 41, one end of the support columns 42, 42 is fixed to the part of the base 41 facing the holes 35, 35, and the other end is loosely fitted into the holes 35, 35.

[0044] The diameters of the coil springs 43, 43 are set to be larger than the diameters of the holes 35, 35, so that when the other ends of the support columns 42, 42 are inserted into the holes 35, 35 of the third disc body 31, the tips of the coil springs 43, 43 come into contact with the lower surface of the third disc body 31. As a result, the spring force of the coil springs 43, 43 supports the third disc body 31 so that it can swing above the base 41.

[0045] The height adjustment unit 50 has the function of adjusting the vertical position of the simulated organ 100 and is placed on the base stand 41 as needed.

[0046] Then, by arranging the load transmission unit 30, load generation unit 20, and drive unit 10 in that order above the base unit 40, the multi-axis spinal motion testing device 1 is assembled as shown in Figure 2. The simulated organ 100 is placed between the third disc 31 and the base stand 41. Alternatively, depending on the size of the simulated organ 100, a height adjustment unit 50 may be placed on the base stand 41, and the simulated organ 100 may be placed between the third disc 31 and the height adjustment unit 50.

[0047] [Basic operation of the multi-axis spinal motion testing device 1] Next, we will explain the basic operation of the multi-axis spinal motion testing device 1. Figure 3 schematically shows the state in which the pressing body 23 of the multi-axis spinal movement testing device 1 is in contact with the second disc body 22, with Figure 3(a) being a plan view of the second disc body 22 and Figure 3(b) being a side view of the multi-axis spinal movement testing device 1. Figure 4 schematically shows the state in which the pressing body 23 of the multi-axis spinal movement testing device 1 is located on the top of the projection 24, with Figure 4(a) being a plan view of the second disc body 22 and Figure 4(b) being a side view of the multi-axis spinal movement testing device 1.

[0048] In the multi-axis spinal motion testing device 1, for example, two consecutive simulated organs 100 of the spine are placed on a base platform 41.

[0049] As shown in Figure 3(a), the multi-axis spinal motion testing device 1 has a pressing body 23 in contact with the second disc body 22, and the first disc body 21, the second disc body 22, and the third disc body 31 are maintained in a horizontal state parallel to each other, as shown in Figure 3(b). In this state, the third disc body 31 applies a load vertically downward to the simulated organ 100. When the base stand 41 is placed on a horizontal plane, the axial direction of the simulated organ 100 placed on the base stand 41 is vertical.

[0050] In the basic state, when the motor 11 of the drive unit 10 is driven, the first disc body 21 rotates, and this rotation causes the pressing body 23 to move in a circular motion. As the pressing body 23 moves in a circular motion, the projection 24 comes into contact with the lower surface of the pressing body 23, and as the pressing body 23 continues to move in a circular motion, the pressing body 23 slides along the projection 24 and gradually rides up. After the lowest part of the pressing body 23 passes the projection 24, the pressing body 23 comes into contact with the second disc body 22 again.

[0051] As the pressing body 23 rides up onto the projection 24, a load is generated on the second disc body 22, and the projection 24 is gradually pushed down by the pressing body 23, causing the second disc body 22 to tilt relative to the first disc body 21. Then, as shown in Figure 4(a), when the lowest part of the pressing body 23 reaches the top of the projection 24, the second disc body 22 tilts to its maximum extent relative to the first disc body 21, as shown in Figure 4(b). Then, when the lowest part of the pressing body 23 passes over the projection 24 and the pressing body 23 contacts the second disc body 22 again, the second disc body 22 returns to a state parallel to the first disc body 21.

[0052] When the second disc 22 tilts, the load on the second disc 22 is transmitted to the third disc 31 via the four coil springs 32, and as shown in Figure 4(b), the third disc 31 tilts in conjunction with the second disc 22.

[0053] For the sake of convenience in the following explanation, the four protrusions 24 on the first disc body 21 will be referred to as protrusions 24a, 24b, 24c, and 24d in order of the direction of movement of the pressing body 23.

[0054] When the first disc 21 rotates, the contact area of ​​projection 24a on the second disc 22 is pressed down, causing the second disc 22 to tilt towards projection 24a before returning to its original position. Next, the contact area of ​​projection 24b on the second disc 22 is pressed down, causing the second disc 22 to tilt towards projection 24b before returning to its original position. Next, the contact area of ​​projection 24c on the second disc 22 is pressed down, causing the second disc 22 to tilt towards projection 24c before returning to its original position. Next, the contact area of ​​projection 24d on the second disc 22 is pressed down, causing the second disc 22 to tilt towards projection 24d before returning to its original position. In this way, as the contact areas of projections 24a, 24b, 24c, and 24d on the second disc 22 are pressed down in sequence, the edge of the second disc 22 swings up and down while sequentially changing the part that tilts.

[0055] The third disc 31 moves in conjunction with the second disc 22, with its edge oscillating vertically while sequentially changing the inclined portion. At this time, the movement of the second disc 22 is transmitted to the third disc 31 via four coil springs 32, so the third disc 31 moves slightly behind the second disc 22.

[0056] Thus, in the basic state, as the first disc 21 rotates, a load is applied from the third disc 31 to the simulated organ 100 placed between the third disc 31 and the base 41 from an oblique direction, circling around the simulated organ 100. As a result, as shown in Figure 4(b), each time a load is applied to the simulated organ 100, the upper of the two simulated organs 100 moves.

[0057] [Example of use of Multi-axis Spinal Motion Testing Device 1] The drive unit 10 is equipped with a drive control circuit (not shown) that drives and controls the motor 11, and it is possible to set the rotation mode of the first disc body 21 as appropriate. For example, in addition to rotating the first disc body 21 in one direction or in the opposite direction, it is also possible to reciprocate the first disc body 21 so that the pressing body 23 moves alternately on both sides of the projection 24a, or to reciprocate the first disc body 21 so that the pressing body 23 passes over two adjacent projections 24.

[0058] Furthermore, the pivot axis 12 can be tilted by the universal joint 33. For example, by tilting the pivot axis 12 in advance perpendicular to the longitudinal direction of the elongated hole 25, the axial directions of the first disc body 21, the second disc body 22, and the third disc body 31 can be tilted with respect to the axial direction of the simulated organ 100. Alternatively, by tilting the pivot axis 12 along the longitudinal direction of the elongated hole 25, the axial directions of the first disc body 21 and the second disc body 22 can be tilted with respect to the axial direction of the third disc body 31.

[0059] According to the multi-axis spinal movement testing device 1 of this embodiment, by appropriately setting the inclination angle of the pivot axis 12 and the rotation mode of the first disc body 21, it is possible to apply loads to the simulated organ 100 from various directions.

[0060] To give a specific example, in Figure 3(a), the pivot axis 12 is tilted along the longitudinal direction of the elongated hole 25 toward the space between projections 24b and 24c. At this time, the coil springs 32 corresponding to projections 24b and 24c are compressed. This makes it possible to increase the load that the simulated organ 100 receives from the coil springs 32 corresponding to projections 24b and 24c. In this state, by causing the first disc body 21 to reciprocate so that the pressing body 23 moves back and forth between projections 24b and 24c, it becomes possible to increase the load applied to the simulated organ 100.

[0061] In the strength test of the simulated organ 100, the simulated organ 100 is placed on the multi-axis spinal movement testing device 1, the drive unit 10 is driven, and a load is applied to the simulated organ 100 a predetermined number of times. After that, the degree of wear and damage to the simulated organ 100 is inspected. This makes it possible to determine the fatigue strength of the simulated organ 100. Furthermore, by changing the direction in which the load is applied to the simulated organ 100 and performing the same inspection, it becomes possible to determine the fatigue strength of the simulated organ 100 more accurately.

[0062] Furthermore, the load applied to the simulated organ 100 can be adjusted, for example, by changing the weight of the first disc 21 and the second disc 22.

[0063] As described above, this embodiment makes it possible to apply a load to the simulated organ 100 from any oblique direction with respect to the axial direction of the simulated organ, and to apply a load from a direction in which force is generated in response to human movement. This makes it possible to provide a multi-axis spinal movement testing device 1 that can realize more accurate strength testing of simulated organs.

[0064] Furthermore, according to this embodiment, since the second disc body 22 and the third disc body 31 are connected by a plurality of coil springs 32, a load is generated by tilting the second disc body 22, and the third disc body 31 tilts in conjunction with the second disc body 22, making it possible to apply a load to the simulated organ from a direction oblique to the axial direction of the simulated organ.

[0065] Furthermore, according to this embodiment, the drive unit 10 rotates the first disc body 21, causing the pressing body 23 to press against the projection 24 as it passes over it, tilting the second disc body 22 obliquely with respect to the axial direction of the simulated organ. The third disc body 31 tilts in conjunction with the second disc body 22, allowing the third disc body 31 to apply a load to the simulated organ 100 from an oblique direction. Moreover, since the angles of the plate surfaces of the first disc body 21, the second disc body 22, and the third disc body 31 are variable according to the tilt of the pivot axis 12, when the pressing body 23 is in contact with the plate surface of the second disc body 22 but not with the projection 24, the angle of the plate surface of the third disc body 31 relative to the simulated organ 100 can be set to any oblique direction. This makes it possible to apply a load to the simulated organ 100 from any oblique direction, and makes it possible to provide a simulated organ strength testing device that can achieve more accurate strength testing of the simulated organ.

[0066] Although one embodiment of the present invention has been described above, the embodiments of the present invention are not limited to those described above. For example, a bottomed hole may be formed in the second disc body 22 and the third disc body 31 at the mounting position of the coil spring 32, and the coil spring 32 may be inserted into this hole and supported so that it can be inserted and removed. This makes it possible to replace the coil spring 32 with one having a different spring constant, for example, when the simulated organ 100 is an enlarged or reduced version of the human skeleton.

[0067] Furthermore, the pressing body 23 may be configured to be interchangeable with respect to the first disc body 21. This allows for the provision of multiple pressing bodies 23 of different heights, and by changing the pressing bodies 23, the angle at which the third disc body 31 presses against the simulated organ 100 can be changed.

[0068] Furthermore, although the projection 24 is hemispherical according to the embodiment described above, it may be of any other shape as long as the pressing body 23 can smoothly overcome it.

[0069] Figure 5 is a perspective view showing a modified example of the load generating section 20. In this modified example of the load generating section 20, a coil spring 26 is attached in place of the pivot shaft 12 protruding from the center of the lower surface of the first disc body 21 shown in Figure 2, a crescent-shaped plate 27 is attached in place of the projection 24, and the tip of the coil spring 26 is inserted into the center of the upper surface of the second disc body 22, forming a hole (not shown) that rotatably supports the coil spring 26.

[0070] The crescent-shaped plate 27 comprises a convex curved upper surface, a flat lower surface, and an outer side surface consisting of a curved surface with the same curvature as the outer surface of the second disc body 22. The upper surface of the crescent-shaped plate 27 is formed in an arc shape that is larger in dimensions than the upper surface of the projection 24. This makes it possible to increase the load more gradually compared to the embodiment described above.

[0071] Furthermore, the lower surface of the semicircular plate 27 is fixed to the edge of the upper surface of the second disc body 22, and the outer surface and the outer surface of the second disc body 22 are included in the side surface of the same virtual cylinder. Four semicircular plates 27 are arranged at equal intervals on the upper surface of the second disc body 22.

[0072] When a modified version of the load generating unit 20 configured in this way is rotated by the drive unit 10, the first disc body 21 rotates independently of the second disc body 22, and the pressing body 23 rides up onto the semi-circular disc 27, pressing down on the second disc body 22, causing the second disc body 22 to tilt relative to the first disc body 21. As the second disc body 22 tilts, the third disc body 31 tilts in conjunction with it, and the third disc body 31 presses the simulated organ 100 from an oblique direction. Furthermore, as the first disc body 21 rotates, the pressing body 23 is positioned between adjacent semi-circular discs 27, 27, and as the first disc body 21 rotates again, the pressing body 23 rides up onto the next semi-circular disc 27. In this way, as the pressing body 23 sequentially rides onto the upper surfaces of the four semicircular plates 27, pressure can be applied from the third disc body 31 to the simulated organ 100 from an oblique direction so as to circle the simulated organ 100, similar to the embodiment described above. Furthermore, according to this embodiment, since the first disc body 21 and the second disc body 22 are connected by a coil spring 26, tilting the first disc body 21 causes the third disc body 31 to tilt in conjunction with the second disc body 22. This makes it possible to apply a load to the simulated organ 100 from an oblique direction with respect to the axial direction of the simulated organ 100, and makes it possible to provide a simulated organ strength testing device that can achieve more accurate strength testing of the simulated organ.

[0073] In the modified configuration described above, when the first disc body 21 rotates after the lowest part of the pressing body 23 has passed over the uppermost part of the meniscus 27, the pressing body 23 is positioned between the adjacent meniscus 27, 27, thus making it possible to stabilize the rotation of the second disc body 22.

[0074] [Other embodiments] Figure 6 is a perspective view showing the external appearance of a multi-axis spinal motion testing device 1 in another embodiment of the present invention. Note that, for the components shown in Figure 6, components that are the same as or have the same function as those related to the multi-axis spinal motion testing device 1 shown in Figure 2 are denoted by the same reference numerals, and detailed explanations are omitted.

[0075] The multi-axis spinal motion testing apparatus 1 shown in Figure 6 is the same as the multi-axis spinal motion testing apparatus 1 shown in Figure 2, but with the load transmission section 30 omitted, and instead of the pivot axis 12 protruding from the lower surface of the first disc body 21, the first disc body 21 and the second disc body 22 are connected by a coil spring 26, similar to the load generation section 20 shown in Figure 5. A hole (not shown) is formed in the center of the upper surface of the first disc body 21, and by inserting the tip of the coil spring 26 into this hole, the second disc body 22 is supported by the coil spring 26.

[0076] According to the multi-axis spinal motion testing device 1 shown in Figure 2, testing can be performed by setting a load by applying a load to the simulated organ 100 via the load transmission unit 30. On the other hand, according to the multi-axis spinal motion testing device 1 shown in Figure 6, the load transmission unit 30 is omitted, and testing can be performed by directly applying the load generated by the load generation unit 20 to the simulated organ 100.

[0077] The second disc body 22 is supported by the base portion 40. Specifically, just as the third disc body 31 in the multi-axis spinal motion testing device 1 shown in Figure 2 is pivotably supported by a support column 42 and a coil spring 43, the second disc body 22 is pivotably supported by a support column 42 and a coil spring 43.

[0078] According to the multi-axis spinal motion testing device 1 shown in Figure 6, the first disc body 21 rotates and the pressing body 23 rides up onto the projection 24, causing the second disc body 22 to oscillate. As a result, a load is transmitted to the simulated organ 100 placed on the base stand 41 via the second disc body 22.

[0079] [Modified versions of the load generating section 20 in other embodiments] Figure 7 is a perspective view showing the appearance of a modified example of the load generating unit 20 according to another embodiment shown in Figure 6. Note that, in the components shown in Figure 7, components that are the same as or have the same function as components related to the load generating unit 20 shown in Figure 6 are denoted by the same reference numerals, and detailed explanations are omitted.

[0080] The load generating unit 20 shown in Figure 7 is equipped with a wheel body 23a instead of the pressing body 23 shown in the load generating unit 20 shown in Figure 6.

[0081] The wheel body 23a is a disc-shaped member whose diameter is greater than the thickness of the first disc body 21 and less than the diameter of the first disc body 21. The first disc body 21 has an elongated hole 21a extending perpendicular to the radial direction on the outer circumference of its surface. The elongated hole 21a is a through hole that is slightly longer than the diameter of the wheel body 23a and slightly larger than the width of the wheel body 23a. Furthermore, when the first disc body 21 is rotated, the elongated hole 21a is positioned so that its center passes through the projection 24. A hole is formed in the center of the wheel body 23a into which a cylindrical support shaft 23b can be inserted.

[0082] A hole 21b into which a support shaft 23b is inserted is formed on the side of the first disc body 21. This hole 21b extends radially from the outer part of the elongated hole 21a on the side surface of the first disc body 21, passing through the central part of the wall surface of the elongated hole 21a to near the center of the first disc body 21.

[0083] Then, the wheel body 23a is placed inside the elongated hole 21a, and with the central axis of the hole in the wheel body 23a aligned with the central axis of the hole in the first disc body 21b, the support shaft 23b is inserted into the wheel body 23a and the hole in the first disc body 21b. In this way, the wheel body 23a is attached to the first disc body 21 in a state where it can rotate freely by the support shaft 23b. The length of the portion of the wheel body 23a that protrudes from the plate surface of the first disc body 21 is set to the width between the plate surfaces of the first disc body 21 and the second disc body 22, which are facing each other while connected by the coil spring 26. Therefore, when the wheel body 23a is in contact with the plate surface of the second disc body 22, the first disc body 21 and the second disc body 22 are maintained in a parallel state. Furthermore, the wheel body 23a can be replaced with another wheel body 23a (for example, a wheel body 23a with a different diameter) by removing the support shaft 23b. This makes it possible to adjust the magnitude of the load generated according to the content of the test.

[0084] According to the multi-axis spinal motion testing apparatus 1 using the load generating unit 20 shown in Figure 7, the wheel body 23a rotates together with the rotation of the first disc body 21 and rides onto the projection 24, causing the second disc body 22 to oscillate. As a result, the wheel body 23a rotates together with the rotation of the first disc body 21, making it possible to smoothly ride onto the projection 24 and to transmit the load to the simulated organ 100 more smoothly.

[0085] Figure 8 is a perspective view showing the appearance of another modified example of the load generating section 20 according to another embodiment shown in Figure 6.

[0086] The load generating section 20 shown in Figure 8 has four triangular prism-shaped protrusions 28 arranged on the second disc body 22 instead of the four spherical protrusions 24 shown in the load generating section 20 shown in Figure 7. The base of each protrusion 28 is an equilateral triangle, and one side of each protrusion 28 is fixed in contact with the surface of the second disc body 22. At this time, the central axis of each protrusion 28 extends in the radial direction of the second disc body 22.

[0087] Here, the four triangular prism-shaped protrusions 28 are referred to as protrusions 28a, 28b, 28c, and 28d, respectively, and the wheel body 23a is designed to be able to ride over the protrusions 28a, 28b, 28c, 28d, and then 28a in that order as the first disc body 21 rotates. By making the protrusions triangular prism-shaped in this way, it becomes possible to make the slope of the displacement curve of the load applied to the simulated organ 100 larger, thus enabling analysis that assumes an accident in which the load increases rapidly.

[0088] According to the load-generating section 20 shown in Figure 8, the opposing protrusions 28a and 28c, and protrusions 28b and 28d are of the same shape, while the adjacent protrusions 28a and 28b have different sizes of equilateral triangles forming their bases. According to the load-generating section 20 shown in Figure 8, the protrusions 28c and 28d protrude more from the surface of the second circular plate 22 than the protrusions 28a and 28c.

[0089] According to the multi-axis spinal motion testing apparatus 1 using the load generating unit 20 shown in Figure 8, the wheel body 23a rotates along with the rotation of the first disc body 21 and rides onto the projection 28, causing the second disc body 22 to oscillate.

[0090] In the load-generating section 20 shown in Figure 8, protrusions 28c and 28d protrude more than protrusions 28a and 28c. However, this is not limited to this configuration, and the sizes of the four protrusions 28 may all be different. Furthermore, the sizes of the protrusions 28 may be adjusted as appropriate by making the four protrusions 28 detachable. The same applies to the protrusions 24 in the load-generating section 20 shown in Figure 7; the sizes of the protrusions 24 may be adjusted as appropriate by making the four protrusions 24 detachable.

[0091] Furthermore, the load generating unit 20 shown in Figures 7 and 8 can also be applied to the multi-axis spinal motion testing device 1 shown in Figure 2. [Explanation of symbols]

[0092] 1. Simulated organ strength testing device 10 Drive unit 11 Motor 12 Rotation axes 20 Load generation section 21. First disc 21a long hole 21b Hole 22. Second disc 23 Pressing body 23a Wheel body 23b Support shaft 24, 24a~24d protrusion 25 long hole 26 Coil springs 27 Meniscus 28, 28a~28d protrusion 30 Load transmission section 31. Third disc 32 Coil springs 33 Universal Joint 34 Bearings 35 Hole 40 Base section 41 Base stand 42 Post 43 Coil spring 50 Height adjustment section 100 simulated organs 110 Three-dimensional organs 120 implants

Claims

1. A simulated organ strength testing device that performs strength tests by applying load to simulated organs, A load generating unit that generates a load, A drive unit that operates the load generating unit, The system includes a load transmission unit that transmits the load generated by the load generation unit to the simulated organ from an arbitrary oblique direction relative to the axial direction of the simulated organ, The load generating unit is driven by the drive unit and has a plate-shaped first inclined member that is tilted obliquely with respect to the axial direction of the simulated organ. The load transmission section includes a plate-shaped second inclined member that is inclined obliquely with respect to the axial direction of the simulated organ, and an elastic body that connects the first inclined member and the second inclined member. A simulated organ strength testing device characterized by applying a load to the simulated organ via the second inclined member.

2. The drive unit comprises a pivot shaft that serves as the pivot point of the first inclined member, and a motor that drives the load generating unit. The load generating unit further comprises a plate-shaped rotating member that rotates by the motor, a plurality of protrusions arranged on the plate surface of the first inclined member, and a pressing body arranged on the rotating member that presses against the protrusions as it passes over them due to the rotation of the rotating member, thereby tilting the first inclined member obliquely with respect to the axial direction of the simulated organ. The simulated organ strength testing apparatus according to claim 1, characterized in that the rotation axis can be tilted in a direction inclined with respect to the axial direction of the simulated organ, and the angle of the plate surface of the second inclined member with respect to the axial direction of the simulated organ is variable according to the tilt of the rotation axis.

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