CN111948098A - Testing arrangement of performance is pushed to simulation test bone cement - Google Patents
Testing arrangement of performance is pushed to simulation test bone cement Download PDFInfo
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Abstract
A testing device for testing the injection performance of bone cement through simulation test relates to the technical field of experimental equipment, and comprises a filling mechanism and a shell, wherein a cavity for placing a sample is arranged in the shell, a connecting channel is arranged between the shell and the cavity, a temperature regulator is arranged between the shell and the cavity, and the temperature regulator is used for changing the temperature of the inner side of the shell so as to keep the temperature in the shell at a set temperature; the filling mechanism extends into the inner cavity of the sample from the connecting channel so as to fill the inner cavity of the sample with bone cement. The testing device for testing the bone cement injection performance through simulation can change the temperature of the bone cement injection process to be closer to the temperature of the bone cement in the actual use process, so that the bone cement use performance result obtained through experiments is more accurate.
Description
Technical Field
The invention relates to the field of experimental equipment, in particular to a testing device for testing the injection performance of bone cement through simulation.
Background
PMMA (polymethyl methacrylate) bone cement is a room temperature curing polymer material, and is usually provided in the form of a set of liquid and powder, and the liquid and powder are mixed for use in surgery. The mixed liquid and powder can generate heat polymerization reaction.
The polymerization of PMMA bone cement can be divided into four basic steps: (1) and (3) mixing period: stirring the bone cement powder and the liquid to homogenize the bone cement powder and the liquid, wherein the bone cement is in a liquid state; (2) waiting period: the viscosity of the bone cement is continuously increased along with the reaction until the bone cement is in a toothpaste shape; (3) working period/application period: when the bone cement is in the shape of toothpaste, the bone cement can be used; (4) and (3) hardening period: the bone cement is hardened and difficult to shape, and heat is released. Due to the special physicochemical property of the PMMA bone cement polymerization process, the bone cement must be injected at a proper time in vertebroplasty, if the injection time is too early, the bone cement may leak, and if the injection time is too late, the bone cement may be difficult to shape and thus injection is difficult, so that it becomes one of the key factors for clinical accurate determination of the working time of the bone cement to ensure success of the operation.
The current performance (i.e., working time) of bone cements is measured primarily by monitoring the exothermic reaction that occurs during the powder-liquid mixing at ambient temperature (23 ℃), recording the time the mixture reaches the dough state and the maximum temperature reached, and estimating the working time of the bone cement from the dough time and the setting time. However, since the bone cement needs to be injected into the vertebral body of the human body, the temperature of the human body is different from the detection temperature, and therefore, the performance index result of the detection is not accurate, and the bone cement is not suitable for practical clinical use.
Disclosure of Invention
The invention aims to provide a testing device for simulation test of bone cement injection performance, which can detect the usability of bone cement at a set temperature, and the detected information is more suitable for clinical use conditions.
The invention is realized by the following steps:
a testing device for testing the injection performance of bone cement by simulation comprises: the temperature control device comprises a filling mechanism and a shell, wherein a cavity for placing a sample is arranged in the shell, a connecting channel is arranged between the shell and the cavity, and a temperature regulator is arranged between the shell and the cavity and used for changing the temperature of the inner side of the shell so as to keep the temperature in the shell at a set temperature; the filling mechanism extends into the inner cavity of the sample from the connecting channel so as to fill the inner cavity of the sample with bone cement.
In a possible embodiment, the temperature regulator comprises a heating body, a controller and a temperature detector, and the controller is respectively connected with the heating body and the temperature detector to control the heating body according to the temperature value detected by the temperature detector.
In a possible embodiment, the temperature regulator further comprises a display connected to the controller, the display being configured to display a set temperature and/or a temperature value detected by the temperature detector.
In a possible embodiment, a temperature control layer is arranged between the housing and the cavity.
In a possible embodiment, the temperature control layer comprises a thermally conductive liquid, and the temperature detector is disposed in the thermally conductive liquid.
In one possible embodiment, the housing is made of a thermal insulating material.
In a possible embodiment, the filling means comprises a bone cement filler for filling with bone cement, a driver extending through the connecting channel into the lumen of the test specimen, and a push rod extending into the bone cement filler, the driver being capable of pushing the push rod with a constant pushing force.
In a possible embodiment, the sample is connected with the cavity through a limiting structure.
In a possible embodiment, the heating body is a heating wire.
In a possible embodiment, the testing device for simulating the performance of a test bone cement bolus further comprises a timer, said timer being connected to said display for displaying the experimental time via said display.
The beneficial effects of the invention at least comprise:
the application provides a testing arrangement of performance is pushed to emulation simulation test bone cement is used for bone cement to push the performance test of in-process, in the test process, puts into the sample in the cavity, and the sample is used for simulating the bone of pushing the position in clinical use of bone cement, and the sample is the cancellous bone model for example. The temperature inside the housing is changed by the temperature regulator so that the temperature inside the housing is maintained at a set temperature, that is, the temperature regulator can maintain the temperature inside both the connecting passage and the cavity at a set temperature. The filling mechanism penetrates through the connecting channel to extend into the inner cavity of the sample in the cavity, and pushes the bone cement into the inner cavity of the sample in the cavity so as to test the usability performance of the bone cement. The set temperature can be adjusted according to actual use conditions, for example, bone cement needs to be injected into a human body in the experiment process, the body temperature of the human body is about 37 ℃, and therefore the set temperature can be set to be 37 ℃. By last, use the testing arrangement that the performance was injected to the simulation test bone cement that this application provided to carry out bone cement and inject the performance test of in-process for the ambient temperature that bone cement is located among the test procedure keeps unanimous with clinical application in-process, thereby can obtain the performance data of the bone cement that more is close to service environment, has better clinical reference value.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, it should be understood that the following drawings only illustrate some embodiments of the present invention and therefore should not be considered as limiting the scope, and for those skilled in the art, other related drawings can be obtained according to the drawings without inventive efforts.
Fig. 1 is a schematic structural diagram of a testing apparatus for testing a bone cement bolus injection performance through simulation according to an embodiment of the present invention;
fig. 2 is a schematic diagram of a relative position relationship between a housing and a sample in the testing device for simulation test of bone cement bolus injection performance according to the embodiment of the present invention.
In the figure:
1-a housing; 2-temperature control layer; 3-a heating body;
4-sample; 5-a cavity; 6-bone cement;
7-an electric wire; 8-a signal line; 9-a temperature detector;
10-a controller; 11-a display; 12-a push rod;
13-bone cement filler; 14-a connecting channel; 15-lumen.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all, embodiments of the present invention. The components of embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations.
Thus, the following detailed description of the embodiments of the present invention, presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, it need not be further defined and explained in subsequent figures.
In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings or the orientations or positional relationships that the products of the present invention are conventionally placed in use, and are only used for convenience in describing the present invention and simplifying the description, but do not indicate or imply that the equipment or elements that are referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," "third," and the like are used solely to distinguish one from another and are not to be construed as indicating or implying relative importance.
Furthermore, the terms "horizontal", "vertical", "overhang" and the like do not imply that the components are required to be absolutely horizontal or overhang, but may be slightly inclined. For example, "horizontal" merely means that the direction is more horizontal than "vertical" and does not mean that the structure must be perfectly horizontal, but may be slightly inclined.
In the description of the present invention, it should also be noted that, unless otherwise explicitly specified or limited, the terms "disposed," "mounted," "connected," and "connected" are to be construed broadly and may, for example, be fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.
Some embodiments of the invention are described in detail below with reference to the accompanying drawings. The embodiments described below and the features of the embodiments can be combined with each other without conflict.
First embodiment
Referring to fig. 1 and fig. 2, the present embodiment provides a testing apparatus for testing the performance of a bone cement bolus by simulation, which includes: the device comprises a filling mechanism and a shell 1, wherein a cavity 5 for placing a sample 4 is arranged in the shell 1, a connecting channel 14 is arranged between the shell 1 and the cavity 5, and a temperature regulator is arranged between the shell 1 and the cavity 5 and used for changing the temperature of the inner side of the shell 1 so as to keep the temperature in the shell 1 at a set temperature; the sample 4 has an inner cavity 15, and the inner cavity 15 of the sample 4 communicates with the connecting passage 14 of the housing 1. The filling means extends through the connecting channel 14 into the cavity 5 and further into the lumen 15 of the sample 4 to inject the bone cement 6 into the lumen 15 of the sample 4.
The above-mentioned sample 4 is used for simulating a site where the bone cement 6 is filled, for example, when the bone cement 6 is used for filling into cancellous bone, the sample 4 employs a cancellous bone model.
The set temperature can be set according to requirements, and preferably the adjustable range of the set temperature is 30-50 ℃, because the bone cement 6 is injected into a human body in clinic, the temperature of the human body is about 37 ℃, the set temperature can be set to 37 ℃, namely, the connecting channel 14 and the cavity 5 in the shell 1 are both 37 ℃, and the service performance of the bone cement 6 at the ambient temperature of 37 ℃ can be detected. Of course, since the human body temperature is not all 37 ℃, the temperature can be set to different temperatures such as 36.5 ℃, 36.7 ℃ and 37.1 ℃ so as to simulate the human body environment with different body temperatures and detect the service performance of the bone cement 6 at different temperatures.
The temperature regulator may include a heating body 3, or both the heating body 3 and a cooling body, the heating body 3 being used to raise the internal temperature of the casing 1, and the cooling body being used to lower the internal temperature of the casing 1. Since the performance test of bone cement is usually performed in a normal temperature environment, which is lower than the body temperature, the temperature regulator may be provided with only the heating body 3.
In a possible embodiment, the temperature regulator includes a heating body 3, a controller 10 and a temperature detector 9, the controller 10 is respectively connected with the heating body 3 and the temperature detector 9 to control the heating body 3 according to the temperature value detected by the temperature detector 9, and the temperature inside the housing 1 can be regulated by controlling the on-off state of the heating body 3. The temperature detector 9 is used for detecting the actual temperature inside the casing 1 and feeding back the actual temperature to the controller 10, and the controller 10 controls the opening and closing of the heating body 3 according to the actual temperature, so that the internal temperature of the casing 1 is kept at the set temperature. For example, when the actual temperature is lower than the set temperature, the controller 10 activates the heating body 3, and the heating body 3 heats the inside of the housing 1, thereby increasing the temperature inside the housing 1 so that the actual temperature approaches the set temperature. When the actual temperature is higher than the set temperature, the controller 10 turns off the heating body 3 to stop heating the housing 1, and the temperature of the housing 1 is gradually reduced in the normal temperature environment, so that the actual temperature approaches the set temperature.
Specifically, as shown in fig. 1 and 2, the heating body 3 may be resistance-energized to generate heat, or may be another heat generation method, such as electromagnetic heating.
In a possible embodiment, the heating body 3 is a heating wire, and the heating wire is connected with the controller 10 through a wire 7. A control switch is connected between the heating wire and the controller 10, and the controller 10 controls the control switch to control whether the heating wire is electrified or not, so as to control the heating temperature of the heating wire.
In a preferred embodiment, as shown in fig. 1, the thermostat further comprises a display 11, the display 11 is connected to the controller 10, and the display 11 is used for displaying the set temperature and/or the temperature value detected by the temperature detector 9.
For example, in one embodiment, the display 11 is used to display the set temperature, so that the experimenter can know the set temperature used in the current experiment.
In another embodiment, the display 11 is used for displaying the temperature value detected by the temperature detector 9, i.e. for displaying the actual temperature, so that the experimenter can know whether the actual temperature reaches the set temperature.
In a preferred embodiment, the display 11 is used for displaying both the set temperature and the actual temperature, so that on the one hand, the experimenter can know the current set temperature definitely, and on the other hand, the experimenter can know the actual temperature to judge whether the actual temperature reaches the set temperature.
Further, as shown in fig. 1, the temperature regulator includes a housing, a controller 10 is installed in the housing, the controller 10 is connected to the temperature detector 9 through a signal line 8, the controller 10 is connected to the heating body 3 through an electric wire 7, a display 11 is installed outside the housing, and a connection line between the display 11 and the controller 10 is located inside the housing.
Further, the controller 10 further comprises an input end connected with the controller 10 for inputting a control instruction to the controller 10 to change the set time. The input end may be a control switch, specifically, the control switch is disposed on the housing, the control switch is connected to the controller 10, the control switch may be of a pressing type, a rotating type, a toggling type or a touch type, and the user inputs the setting time to the controller 10 through the control switch to change the setting time.
In a possible implementation of this embodiment, the temperature detector 9 is a temperature sensor.
In the process of testing the pushing performance of the bone cement, the time from the state of the thin toothpaste to the state of difficult pushing (namely, the bone cement is difficult to push) of the bone cement 6 needs to be recorded, namely the working time of the bone cement. In the experiment process, an operator can time through a separate timer, and the operator can time through a stopwatch or a timing application in a mobile terminal such as a mobile phone and a computer.
Alternatively, in a possible embodiment, the testing device for simulating the performance of a test bone cement bolus further comprises a timer, and the timer is connected with the display 11. The timer is used for timing, and the display 11 synchronously displays the time recorded by the timer. The timer may be mounted inside the housing.
In one embodiment, the controller 10 includes a circuit board integrated with a plurality of control modules, and the timer may also be integrated on the circuit board.
In a possible embodiment, a temperature control layer 2 is arranged between the housing 1 and the cavity 5. In particular, the temperature control layer 2 may be a solid, liquid or vacuum sandwich. The temperature control layer 2 is used to reduce the heat dissipation speed of the housing 1, thereby reducing the energy consumption of the temperature regulator.
For example, in one possible embodiment, a sandwich is provided within the housing 1, outside the cavity 5, with a vacuum in the sandwich. Or a sand layer is arranged between the shell 1 and the cavity 5 for controlling the temperature.
Alternatively, as shown in fig. 1 and fig. 2, the temperature control layer 2 includes a heat conductive liquid, that is, the heat conductive liquid is filled between the housing 1 and the cavity 5, and the temperature detector 9 is disposed in the heat conductive liquid. The heat-conducting liquid can be supersaturated sodium acetate solution, paraffin, etc.
Further, in a preferred embodiment, the housing 1 is made of a heat insulating material. The heat insulating material may be asbestos, rock wool, high-density glass fiber cotton, hard foamed polyurethane, foamed styrene, etc. The casing 1 made of the heat insulating material can further reduce the heat dissipation speed of the casing 1, so as to be beneficial to keeping the temperature of the outer side and the inner side at the set temperature, namely keeping the temperature of the cavity 5 and the temperature of the connecting channel 14 at the set temperature.
The bone cement 6 is filled into the inner cavity 15 of the test specimen 4 via a filling mechanism, which in one possible embodiment comprises a bone cement filler 13 and a push rod 12, the bone cement filler 13 being a tubular structure for containing the bone cement 6, the push rod 12 extending into the bone cement filler 13 for pushing out the bone cement 6 located within the bone cement filler 13. A bone cement filler 13 extends through the connecting channel 14 into the inner cavity 15 of the sample 4 to fill the inner cavity 15 of the sample 4 with bone cement 6 directly.
Preferably, the filling mechanism further comprises a driver connected to the push rod 12, the driver being configured to push the push rod 12 to move at a constant speed. In particular, the drive may be hydraulically, pneumatically or electrically driven.
In a possible embodiment, the sample 4 is connected with the cavity 5 through a limiting structure. For example, the limiting structure may be a limiting groove, the limiting groove is disposed at the bottom of the cavity 5, the shape and size of the limiting groove match with the shape and size of the bottom of the sample 4, and the sample 4 is placed in the limiting groove to limit the sample 4 through the limiting groove.
Or the limiting structure comprises a clamping groove and a buckle, one of the clamping groove and the buckle is arranged in the cavity 5, the other of the clamping groove and the buckle is arranged in the sample 4, and after the sample 4 is placed into the cavity 5, the buckle extends into the clamping groove so that the sample 4 is connected with the cavity 5.
The testing device for testing the bone cement injection performance through simulation is suitable for testing the use performance of the bone cement for vertebroplasty.
When the testing device for testing the pushing performance of the bone cement by using the simulation is used for testing the usability of the bone cement, the following method can be adopted:
the set temperature for the test was set at 37 ℃ and sample 4 was a cancellous bone model. And starting a power supply of the testing device for testing the bone cement injection performance through simulation, and regulating and controlling the temperature inside the shell 1 by the temperature regulator. After the internal temperature of the housing 1 reaches the set temperature and the temperature is kept stable, the liquid and powder of the bone cement 6 are mixed under the same temperature condition as that of the operating room. When the liquid is initially added to the powder, a timer stopwatch is started, and stirring of the mixture at a rate of 60 to 100 times/minute is immediately started, and is stopped after the mixture is continuously stirred for a while, and is poured or sucked into an injector according to the fluidity of the bone cement 6, and then the bone cement filler 13 is immediately tilted upward, and the bone cement 6 is injected into the bone cement filler 13 through the injector until the bone cement 6 comes out of a discharge port of the bone cement filler 13. The testing procedure is performed strictly following the actual surgical procedure. After the injection is finished, a small amount of the bone cement 6 can be pushed out to judge whether the bone cement 6 is in a usable state. When the bone cement 6 reaches the usable state, the time at this time is recorded, the filler is inserted into the inner cavity 15 of the spongy bone inside through the hole in the testing device, a small amount of the bone cement 6 can be injected every 1min, the time at this time is recorded when the bone cement 6 is difficult to push, and the usability (i.e. the working time) of the bone cement 6 at the body temperature can be obtained by calculating the difference between two time points (the time when the bone cement 6 reaches the usable state and the time when the bone cement 6 is difficult to push).
Specific examples of comparison:
experimental example 1: the testing device for testing the pushing performance of the bone cement through simulation test provided by the embodiment is used for carrying out an experiment, specifically, the mixing of the bone cement is carried out under the condition that the ambient temperature (the temperature of an operating room) is 23 +/-1 ℃, the bone cement is poured into or sucked into an injector after being mixed, and the bone cement is injected into a bone cement filler, when the bone cement reaches a thin toothpaste state, the bone cement filler is immediately placed into a shell of the testing device for testing the pushing performance of the bone cement through simulation, the bone cement filler penetrates through a connecting channel and extends into an inner cavity of a sample, the set temperature is 37 ℃, the pushing of the bone cement is carried out every 1min, and the time from the thin toothpaste state to a difficult pushing state is recorded.
Comparative example 1: mixing the bone cement at the ambient temperature (operating room temperature) of 23 +/-1 ℃, pouring the mixture into or sucking the mixture into an injector, injecting the mixture into a bone cement filling device, immediately injecting the mixture into the body of a patient when the bone cement reaches a thin toothpaste state, injecting the mixture into the body of the patient once every 1min, and recording the time from the thin toothpaste state to a difficult-to-inject state.
Comparative example 2: the test method in the prior art is used for testing, specifically, the bone cement is mixed at the ambient temperature (operating room temperature) of 23 +/-1 ℃, the mixed bone cement is poured into or sucked into an injector and injected into a filler, when the mixed bone cement reaches a thin toothpaste state, the bone cement is injected at the ambient temperature immediately, the bone cement is injected once every 1min, and the time from the thin toothpaste state to the difficult-to-push state is recorded.
The experimental data are shown in table 1 below.
TABLE 1
As can be seen from table 1 above, the value obtained by performing the experiment with the testing apparatus for the simulation test of the bone cement bolus injection performance provided in this embodiment is similar to the value obtained in clinic, and the value obtained by directly performing the bolus injection test at the ambient temperature is greatly different from the value obtained in clinic.
The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (10)
1. The utility model provides a testing arrangement of performance is injected to emulation simulation test bone cement which characterized in that includes: the temperature control device comprises a filling mechanism and a shell, wherein a cavity for placing a sample is arranged in the shell, a connecting channel is arranged between the shell and the cavity, and a temperature regulator is arranged between the shell and the cavity and used for changing the temperature of the inner side of the shell so as to keep the temperature in the shell at a set temperature; the filling mechanism extends into the inner cavity of the sample from the connecting channel so as to fill the inner cavity of the sample with bone cement.
2. The device for testing the performance of a bone cement bolus according to claim 1, wherein the temperature regulator comprises a heating body, a controller and a temperature detector, and the controller is respectively connected with the heating body and the temperature detector to control the heating body according to the temperature value detected by the temperature detector.
3. The device for testing the performance of a bone cement bolus according to claim 2, wherein the temperature regulator further comprises a display, the display is connected to the controller, and the display is used for displaying the set temperature and/or displaying the temperature value detected by the temperature detector.
4. The device for testing the performance of a bone cement bolus according to claim 2, wherein a temperature control layer is disposed between the housing and the cavity.
5. The device for testing the performance of a bone cement bolus according to claim 4, wherein the temperature control layer comprises a heat conducting liquid, and the temperature detector is disposed in the heat conducting liquid.
6. The device for testing the performance of a bone cement bolus according to claim 1, wherein the housing is made of a thermal insulating material.
7. The device for testing the performance of a bone cement bolus according to claim 1, wherein the filling mechanism comprises a bone cement filler for filling bone cement, a driver extending through the connecting channel into the lumen of the test specimen, and a push rod extending into the bone cement filler, the driver being capable of pushing the push rod with a constant pushing force.
8. The device for testing the performance of injecting bone cement according to claim 1, wherein the sample is connected with the cavity through a limiting structure.
9. The device for testing the performance of a bone cement bolus according to claim 2, wherein the heating body is a heating wire.
10. The device for testing the performance of a bone cement bolus according to claim 3, further comprising a timer connected to the display for displaying the trial time via the display.
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| CN117705948A (en) * | 2023-12-20 | 2024-03-15 | 华南理工大学 | Ultrasonic testing device and method for rock damage under different conditions |
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