CN218546103U - Testing arrangement of size and pressure data corresponding relation - Google Patents
Testing arrangement of size and pressure data corresponding relation Download PDFInfo
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- CN218546103U CN218546103U CN202221957865.3U CN202221957865U CN218546103U CN 218546103 U CN218546103 U CN 218546103U CN 202221957865 U CN202221957865 U CN 202221957865U CN 218546103 U CN218546103 U CN 218546103U
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Abstract
The utility model relates to a testing arrangement of size and pressure data corresponding relation belongs to biomedical research technical field. This testing arrangement includes the basin, the apparatus that awaits measuring, loading system and data acquisition device, but the liftable platform makes to be awaited measuring the apparatus after the fixed apparatus that awaits measuring reduce to the basin in, simulate the state of the apparatus that awaits measuring in human environment, use the amesdial non-contact carry out the measurement of dimensional data, it can carry out real-time recording to the size and the pressure of the apparatus that awaits measuring still to be provided with data acquisition mechanism in the system, make data more accurate, reduce the deviation, make the detection of compliance scientific and testing arrangement aggregate erection convenient more, the operation is stable and be difficult to damage. The testing device can test the compliance of the instrument by simulating the actual use condition, and a method for testing the compliance data is established by combining the generating, collecting and processing systems of the compliance data, so that the instrument is scientifically defined and verified in the development and production stages, and the operation is simple.
Description
The present application claims priority of the chinese patent application entitled "a test device for measuring the correspondence between dimensions and pressure data" filed by the chinese patent office on 15/11/2021 under the application number 202122792304.4, and the utility model, which is incorporated herein by reference.
Technical Field
The utility model relates to a testing arrangement of size and pressure data corresponding relation belongs to biomedical research technical field.
Background
The compliance of products such as medical balloons, stents, surgical accessories and the like is an important performance parameter, which represents the corresponding relation between the size and the pressure, and the compliance of the products is required to be provided by medical device manufacturers in the technical requirements and specifications of the products. Therefore, during the development and manufacturing process, the device manufacturer should specify and verify the compliance of the device to avoid unintended expansion of the device during use, which would affect the normal use of the device. At the current instrument development stage, a complete set of compliance testing method does not exist, so that the compliance of the instrument cannot be scientifically verified.
The compliance data of the existing instruments are generally obtained through corresponding pressurizing programs, measuring tools such as a micrometer and the like, the simulation of a use environment and the definition of a data end point are lacked, the collection end point of the compliance data is determined according to visual inspection, deviation is easy to occur in artificial interpretation, scientific verification cannot be achieved, and the compliance data are mainly defined by experience.
SUMMERY OF THE UTILITY MODEL
An object of the utility model is to provide a testing arrangement of size and pressure data corresponding relation for measure the compliance of apparatus.
In order to achieve the above purpose, the utility model provides a following technical scheme: the utility model provides a testing arrangement of size and pressure data corresponding relation, is in including basin, loading system, the setting that are used for simulating internal microenvironment the accredited testing organization of basin top and with be connected the data acquisition mechanism of loading system and accredited testing organization, be provided with the connecting rod in the middle of the basin and connect accredited testing organization, accredited testing organization includes liftable platform and fixed setting up the amesdial of liftable platform top, last being provided with of liftable platform is used for testing the test table of the apparatus that awaits measuring and being used for fixing the briquetting of the apparatus that awaits measuring, loading system with the apparatus that awaits measuring is connected and right the apparatus that awaits measuring pressurizes.
Further, the to-be-tested instrument is a surgical accessory.
Further, the pressurizing mechanism uses any one of hydraulic pressure, air pressure or mechanical screw.
Further, the pressurizing mechanism is provided with a joint, and the joint is connected with the instrument to be tested.
Further, the pressurization mechanism may set pressurization parameters including a pressurization speed, a pressurization value, and a dwell time.
Further, a bottom plate is arranged above the water tank, and an internal environment simulation mechanism is arranged on the bottom plate.
Further, the in-vivo environment simulation device includes a temperature control component or a flow control component.
Further, the data acquisition mechanism is used for continuously or discontinuously sampling the instrument to be detected.
The beneficial effects of the utility model reside in that: the application provides a pair of testing arrangement of size and pressure data corresponding relation, wherein the basin is used for simulating in vivo microenvironment can carry out the simulation of environment to the apparatus that awaits measuring for it is more referential to record data. Liftable platform makes fixed await measuring after the apparatus will await measuring the apparatus reduce to the basin in, simulate the state of the apparatus that awaits measuring in human environment, use amesdial non-contact carry out dimensional data's measurement, it can carry out real-time recording to the size and the pressure of the apparatus that awaits measuring to still be provided with data acquisition mechanism in the system, can replace conventional visual inspection, make data more accurate, reduce the deviation, make the detection of compliance scientific and testing arrangement combination simple to operate more, the operation is stable and be difficult to damage. The testing device can be used for testing the compliance of the instrument by simulating the actual use condition, and the testing method is used for establishing a compliance data testing method by combining the generating, collecting and processing systems of compliance data, so that the instrument is scientifically defined and verified in the development and production stages, and the operation is simple.
The above description is only an outline of the technical solution of the present invention, and in order to make the technical means of the present invention more clearly understood and to be implemented in accordance with the content of the specification, the following detailed description will be given of preferred embodiments of the present invention in conjunction with the accompanying drawings.
Drawings
FIG. 1 is a schematic view of an overall testing apparatus for measuring a corresponding relationship between dimensions and pressure data according to an embodiment of the present disclosure;
fig. 2 is a flowchart of a method for testing the correspondence between the size and the pressure data.
Detailed Description
The technical solution of the present invention will be described clearly and completely with reference to the accompanying drawings, and obviously, the described embodiments are some, but not all embodiments of the present invention. Based on the embodiments in the present invention, all other embodiments obtained by a person skilled in the art without creative work belong to the protection scope of the present invention.
In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings, and are only for convenience of description and simplification of description, but do not indicate or imply that the mechanism or element 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," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
In the description of the present invention, it should be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected" and "connected" are to be construed broadly, and may be, for example, 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 meaning of the above terms in the present invention can be understood as a specific case by those skilled in the art.
In addition, the technical features mentioned in the different embodiments of the present application described below can be combined with each other as long as they do not conflict with each other. Referring to fig. 1, the present invention provides a device for testing the corresponding relationship between the size and the pressure data, comprising: the device comprises a water tank 1 for simulating a microenvironment in a body, a pressurizing mechanism (not shown) for pressurizing an instrument to be tested, a testing mechanism arranged above the water tank 1, a data acquisition mechanism for acquiring size and pressure data of the instrument to be tested, and a computer provided with software for processing and converting signals.
Wherein, basin 1 is used for simulating human microenvironment. A bottom plate 8 is arranged above the water tank 1, and an in-vivo environment simulation mechanism 9 is arranged on the bottom plate 8. The in-vivo environment simulation mechanism 9 comprises a temperature control component, a medium flow rate control component and a medium flow control component which are used for simulating the human body microenvironment. The in-vivo environment simulation mechanism 9 controls the temperature of the medium by a medium temperature control component, and the temperature control component can raise the temperature of the medium and keep the temperature constant. It should be noted that the in-vivo environment simulation mechanism 9 is generally used to simulate a human body microenvironment, and the set temperature is generally 37 ℃. The temperature control component can be a water bath, but is not limited to this, and can also be other temperature control devices. The medium can be used for simulating blood by using blood plasma or adding salt and other viscous substances into normal saline, so that the detection result of the device to be detected is more referential. In the preparation or use of the medium, the pH value of the medium can be adjusted by using an acid solution or an alkali solution, and the ion concentration of the medium is selected by adding a salt substance or a diluted solution. The medium flow rate control assembly and the medium flow control assembly can control the flow rate and the flow when the medium simulates the blood flow.
The middle of the water tank 1 is provided with a connecting rod 2 which is connected with a testing mechanism, the testing mechanism comprises a lifting platform 3 and a dial indicator 7 which is fixedly arranged above the lifting platform 3, the lifting platform is provided with a measuring table 4 for testing an instrument to be tested (not shown) and a pressing block 5 for fixing the instrument to be tested, and the pressurizing mechanism is connected with the instrument to be tested and pressurizes the instrument to be tested. It should be noted that, in this embodiment, the measuring table 4 is in a shape of a Chinese character 'ao', the protruding portions on both sides of the measuring table are provided with grooves oppositely, and the pressing block 5 is used for fixing the instrument to be measured. After the instrument to be measured is placed on the measuring table 4 and fixed, the lifting platform 3 is lowered and moved into the water tank 1, so that the instrument to be measured is completely positioned in a medium, and the measured data is more referential. After the test is finished, the lifting platform 3 is lifted out of the water tank 1, and the instrument to be tested is taken out. It should be noted that the dial indicator 7 performs non-contact measurement with the instrument to be measured, which is prior art and will not be described in detail herein.
The device to be measured is a surgical accessory, which may be a medical balloon or stent, or other surgical accessories requiring compliance determination, and is not limited herein.
And the pressurizing mechanism is connected with the instrument to be tested and is used for pressurizing the instrument to be tested. The pressurizing mechanism is connected with a multifunctional joint, and the multifunctional joint is connected with an apparatus to be tested. It should be noted that the multifunctional joint is a universal joint, and can connect different instruments to be tested. The pressurizing mechanism may use any one of hydraulic pressure, pneumatic pressure or mechanical screw, such as a pressurizing pump, but is not limited thereto, and the specific pressurizing mechanism is not limited.
The data acquisition mechanism is connected with the pressurizing mechanism and the testing mechanism and is used for acquiring the size and pressure data of the to-be-tested instrument at the same time, namely, in the process that the pressurizing mechanism pressurizes the to-be-tested instrument, the data acquisition mechanism acquires the size data of the to-be-tested instrument when the to-be-tested instrument bears a certain pressure and the size data of the to-be-tested instrument when the to-be-tested instrument bears the pressure. It should be noted that the size data is diameter data of the instrument to be measured. In this embodiment, the dimensional data is measured by a micrometer, and the pressure data is measured by a pressure sensor. In other embodiments, the size acquisition device may be a laser caliper that can monitor the diameter of the instrument under test in real time. The size acquisition device can also be other equipment, such as a high-speed camera for shooting the instrument to be measured and then carrying out processing calculation. The pressure sensor can be a film sensor and can detect the pressure of the instrument to be detected in real time. The specific device of the data acquisition mechanism is not limited, and the data acquisition mechanism can be selected according to the characteristics or requirements of the instrument to be measured.
The testing device also comprises a computer provided with software for processing and converting signals, and the computer is connected with the data acquisition mechanism and is used for receiving and processing the size and pressure data collected by the data acquisition mechanism. The computer processing of the collected dimensional and pressure data is prior art and will not be described in detail herein.
Referring to fig. 2, the method for testing the device using the relationship between the size and the pressure data in the present application includes the following steps:
s1, connecting the instrument to be tested with the pressurizing mechanism, and setting pressurizing parameters of the pressurizing mechanism;
s2, placing the instrument to be tested in the in-vivo environment simulation mechanism 9, changing the environment of a medium in the in-vivo environment simulation mechanism 9, and keeping for 5-30min to enable the medium to reach a steady state;
s3, starting the data acquisition mechanism;
s4, starting the pressurizing mechanism to pressurize the to-be-tested instrument, and acquiring a plurality of data of the to-be-tested instrument by the data acquiring mechanism, wherein the data comprise the size and the pressure of the to-be-tested instrument at the same time;
and S5, after the pressurization is finished, outputting the size and pressure data acquired by the data acquisition mechanism by a computer provided with signal processing and converting software.
In step S1, the pressurization parameters include a pressurization speed, a pressurization value, and a pressure holding time. The pressurizing parameters can also set other requirements, such as step pressurization or pressure fatigue of the instrument to be tested.
In step S2, the environment of the medium in the in-vivo environment simulation mechanism 9 is changed, that is, the medium is subjected to environment simulation by using the temperature control assembly, the medium flow rate control assembly and the medium flow rate control assembly, so that the medium conforms to the applicable environment of the apparatus to be measured, the apparatus to be measured can approach the actual use environment in the measurement environment, and the measurement data has a higher reference value for the actual operation.
And (4) the data acquisition mechanism in the step (S3) performs contact or non-contact sampling on the instrument to be detected. Contact or non-contact sampling is set based on a specific data acquisition mechanism, such as contact sampling when a film sensor measures pressure; and non-contact sampling is carried out when a micrometer is used for measuring the diameter of the instrument to be measured. And the data acquisition mechanism in the step S3 continuously or discontinuously samples the instrument to be detected. In the actual operation process, continuous sampling or intermittent sampling can be carried out according to the measurement requirements of the instrument to be measured. In the step S3, the data acquisition mechanism is started first, and the pressurizing pump is started after the step S4, so that the data acquisition mechanism can completely acquire the corresponding data of the pressure and the size of the to-be-measured instrument in the pressurizing process.
The computer output data with the software for processing and converting signals in the step S5 can process and convert the data collected by the data collecting mechanism.
The following describes in detail the method for testing the corresponding relationship between the size of the device to be tested and the pressure data in a specific embodiment:
step one, connecting a support to be measured with a pressure pump, setting a pressure parameter as step pressure, setting a pressure value as 12atm, and keeping the pressure time as 15s;
step two, placing the bracket to be tested in an in vivo environment simulation mechanism 9, keeping the medium stable for 10min, wherein the medium is plasma, the flow rate is 6mL/s, the temperature is 37 ℃, and the pH value is 7.0;
step three, starting a data acquisition mechanism, setting a sampling mode to be continuous sampling, and measuring the pressure of the support to be measured by a thin film sensor; adjusting the position of the micrometer to enable the micrometer to be aligned with the instrument to be measured; connecting the data acquisition mechanism with a computer provided with signal processing and converting software, and processing and converting the received data by the computer;
and step four, starting the pressure pump, pressurizing the support to be measured by the pressure pump, acquiring data of the support to be measured by the data acquisition mechanism, and outputting pressure corresponding to the pressurization time and diameter data to be measured by the computer after the set pressurization process is finished.
In conclusion, the application provides a testing arrangement of size and pressure data corresponding relation, wherein the basin is used for simulating in vivo microenvironment and can carries out the simulation of environment to the apparatus that awaits measuring for it has more referential to record the data. Liftable platform makes fixed await measuring after the apparatus will await measuring the apparatus reduce to the basin in, simulate the state of the apparatus that awaits measuring in human environment, use amesdial non-contact carry out dimensional data's measurement, it can carry out real-time recording to the size and the pressure of the apparatus that awaits measuring to still be provided with data acquisition mechanism in the system, can replace conventional visual inspection, make data more accurate, reduce the deviation, make the detection of compliance scientific and testing arrangement combination simple to operate more, the operation is stable and be difficult to damage. The compliance of the instrument can be tested by simulating the actual use condition by using the testing device, and the testing method is a method for establishing compliance data testing by combining the generating, collecting and processing systems of compliance data, so that the instrument is scientifically defined and verified in the development and production stages, and the operation is simple. The technical features and the detection items of the above-described embodiments may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the above-described embodiments are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.
The above-mentioned embodiments only represent several embodiments of the present invention, and the description thereof is specific and detailed, but not to be construed as limiting the scope of the invention. It should be noted that, for those skilled in the art, without departing from the spirit of the present invention, several variations and modifications can be made, which are within the scope of the present invention. Therefore, the protection scope of the present invention should be subject to the appended claims.
Claims (8)
1. The utility model provides a testing arrangement of size and pressure data corresponding relation, its characterized in that is in including basin, loading system, the setting that is used for simulating internal microenvironment the accredited testing organization of basin top and with be connected the data acquisition mechanism of loading system and accredited testing organization, be provided with the connecting rod in the middle of the basin and connect accredited testing organization, accredited testing organization includes liftable platform and fixed the setting and is in the amesdial of liftable platform top, last being provided with of liftable platform is used for testing the measuring station of the apparatus that awaits measuring and being used for fixing the briquetting of the apparatus that awaits measuring, loading system with the apparatus that awaits measuring is connected and right the apparatus pressurization of awaiting measuring.
2. The device for testing the correspondence between the size and the pressure data according to claim 1, wherein the instrument to be tested is a surgical accessory.
3. The apparatus for testing the correspondence between the size and the pressure data according to claim 1, wherein the pressurizing mechanism is used for pressurizing by any one of hydraulic pressure, pneumatic pressure and mechanical screw.
4. The device for testing the correspondence between the size and the pressure data according to claim 1, wherein the pressurizing mechanism has a connector, and the connector is connected with the instrument to be tested.
5. The apparatus for testing the correlation between the size and the pressure data according to claim 1, wherein the pressing mechanism is capable of setting pressing parameters, the pressing parameters including pressing speed, pressing value and holding time.
6. The apparatus for testing the correspondence between the size and the pressure data according to claim 1, wherein a bottom plate is disposed above the water tank, and an in-vivo environment simulation mechanism is disposed on the bottom plate.
7. The apparatus for testing the correspondence between the size and the pressure data according to claim 6, wherein the in-vivo environment simulation apparatus includes a temperature control component or a flow control component.
8. The device for testing the correspondence between the size and the pressure data according to claim 1, wherein the data acquisition mechanism continuously or intermittently samples the device under test.
Applications Claiming Priority (2)
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CN202122792304 | 2021-11-15 | ||
CN2021227923044 | 2021-11-15 |
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CN218546103U true CN218546103U (en) | 2023-02-28 |
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