Testing device and testing method

Abstract

The present invention provides a testing device and method for testing the target performance of a medical catheter. The testing device includes a liquid tank assembly, comprising a tank body for containing liquid, the liquid being used to immerse the distal end of the medical catheter when the distal end extends into the tank body; a power device disposed outside the tank body; the power device being connected to the proximal end of the medical catheter and driving the medical catheter to rotate; and a detection device for detecting first rotation information of the proximal end of the medical catheter and second rotation information of the distal end of the medical catheter as the medical catheter rotates. The second rotation information and the first rotation information are used to characterize the target performance of the medical catheter. Using the testing device to test the target performance of a medical catheter has the advantages of high repeatability and accurate measurement.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a testing device and a testing method. Background Art

[0002] Arrhythmia refers to abnormalities in the frequency, rhythm, origin, conduction velocity and excitation order of cardiac impulses. It is one of the common heart diseases with high morbidity and mortality rates. Therefore, the treatment of arrhythmia has always received widespread attention from the medical community around the world.

[0003] Treatments for arrhythmias primarily include medication and interventional therapy. Interventional therapies include pacemaker implantation, cardioversion, and radiofrequency catheter ablation. Radiofrequency ablation is a fast, safe, and effective treatment. Radiofrequency ablation involves inserting an electrode into a specific location in the heart via a vein or artery. Radiofrequency current is then introduced into the cardiac tissue, causing a localized increase in temperature and leading to localized coagulative necrosis, thereby blocking the abnormal conduction bundle and its point of origin.

[0004] Medical catheters used for radiofrequency ablation and other types of interventional medical catheters need to have good torque control (i.e., the rotation performance of the medical catheter in the vascular pathway when the medical catheter is in a controlled and non-controlled bending state) to facilitate the medical catheter to find the target position in the body. In the past, the evaluation of the torque control of medical catheters mainly came from the actual experience of clinicians, and there were many individual differences and uncertainties. Alternatively, in another testing method, the proximal end of the medical catheter can be driven to rotate by a motor, and the image acquisition element can simultaneously capture the rotation video of the distal end of the medical catheter. The video is then slowed down and the rotation angle of the distal end of the medical catheter is read. The torque control of the medical catheter is then evaluated based on the rotation angle of the distal end of the medical catheter and the rotation angle of the proximal end of the medical catheter. This method is slow and discontinuous, and the manual reading of the rotation angle of the distal end of the medical catheter has a large error, cumbersome operation, and low repetition rate. Summary of the Invention

[0005] The object of the present invention is to provide a testing device and a testing method for evaluating the target performance of a medical catheter and improving the accuracy of medical experiments.

[0006] To achieve the above objectives, the present invention provides a testing device for testing target performance of a medical catheter, comprising:

[0007] A liquid tank assembly, comprising a tank body, wherein the tank body is used to contain liquid, wherein the liquid is used to immerse the distal end of the medical tube when the distal end of the medical tube extends into the interior of the tank body;

[0008] a power device, disposed outside the box; the power device is used to connect to the proximal end of the medical catheter and drive the medical catheter to rotate; and

[0009] A detection device is used to detect first rotation information of the proximal end of the medical catheter and second rotation information of the distal end of the medical catheter when the medical catheter rotates; the second rotation information and the first rotation information are used to characterize the target performance of the medical catheter.

[0010] Optionally, an interface is provided on the side wall of the box; the testing device further comprises an auxiliary structural member; the distal end of the auxiliary structural member is used to pass through the interface and extend into the interior of the box, and the outer wall of the auxiliary structural member is sealedly connected to the interface; the auxiliary structural member has an axially through-going first inner cavity, and when the auxiliary structural member is in a working state, the shape of the first inner cavity matches the shape of a predetermined cavity; a liquid stop valve is further provided at the proximal end of the first inner cavity, for preventing the liquid from flowing out of the proximal end of the first inner cavity;

[0011] The distal end of the medical tube is used to pass through the first inner cavity and extend into the interior of the box.

[0012] Optionally, the auxiliary structural component includes a sheath and / or a blood vessel model.

[0013] Optionally, the testing device further includes a fixing assembly, which includes at least one first fixing member, which is arranged inside the box and is used to connect with the part of the auxiliary structural member located inside the box to keep the part of the auxiliary structural member located inside the box fixed.

[0014] Optionally, the box assembly further comprises a bottom plate, which is arranged at the bottom of the box, and the bottom plate is further provided with a plurality of connecting parts;

[0015] The first fixing member includes a first fixing seat and a first clamping member; the first fixing seat is used to connect with part of the connecting portion; the first clamping member is connected to the first fixing seat and is used to clamp the part of the auxiliary structural member located inside the box.

[0016] Optionally, the first clamping member has a clamping space for clamping the auxiliary structural member, and the first clamping member is configured so that the size of the clamping space can be adjusted according to the size of the portion of the auxiliary structural member located inside the box; and / or,

[0017] The first clamping member is detachably connected to the first fixing seat.

[0018] Optionally, the proximal end of the auxiliary structural member is located outside the box; the fixing assembly further includes a second fixing member, which is arranged outside the box and is used to connect with the proximal end of the auxiliary structural member and keep the proximal end of the auxiliary structural member fixed; and / or,

[0019] The second fixing member is movably arranged outside the box body to allow the position of the second fixing member to be adjusted.

[0020] Optionally, the detection device includes a first detection device and a second detection device; the first detection device is arranged outside the box, for detecting the first rotation information of the proximal end of the medical catheter; the second detection device is arranged inside the box, for detecting the second rotation information of the distal end of the medical catheter.

[0021] Optionally, the box assembly further includes a bottom plate, which is arranged at the bottom of the box, and a plurality of connecting parts are provided on the bottom plate;

[0022] The second detection device is used to connect with part of the connecting portion.

[0023] Optionally, the testing device further includes a mounting mechanism for connecting to the second detection device; the mounting mechanism is at least partially located inside the box and includes a motion module, which is used to drive the second detection device to perform at least one degree of freedom of movement to adjust the position of the second detection device.

[0024] Optionally, the motion module is configured to drive the second detection device to translate along a first direction, a second direction, and a third direction; the first direction, the second direction, and the third direction are perpendicular to each other.

[0025] Optionally, the mounting mechanism further includes a base; the motion module includes a first sliding rod, a movable seat, a second sliding rod, a sleeve and a third sliding rod; the first sliding rod extends along the first direction, and the opposite ends of the first sliding rod are connected to the box body through one of the bases; the movable seat is arranged on the first sliding rod and can move along the first sliding rod under the action of an external force; the second sliding rod is arranged on the movable seat and can move along the second direction under the action of an external force; the sleeve is arranged on the second sliding rod, and the axial direction of the sleeve extends along the third direction; the third sliding rod is passed through the sleeve and can move along the third direction under the action of an external force;

[0026] The second detection device is connected to the third sliding bar.

[0027] Optionally, the target performance is torque controllability, the first detection device includes a first angle sensor component, and the first rotation information includes a rotation angle value; the second detection device includes a torque sensor, and the second rotation information includes a torque value.

[0028] Optionally, the target performance is torque controllability, the first detection device includes a first angle sensor component, and the second detection device includes a second angle sensor component; the first rotation information and the second rotation information both include rotation angle values.

[0029] Optionally, the second angle sensor assembly includes a sensor body and a connecting member; the sensor body includes a base, a turntable, a signal transmitter, and a signal receiver; the base is provided with a mounting slot having two opposing mounting surfaces; the turntable is rotatably disposed on the base and at least partially located within the mounting slot; the turntable is provided with slits uniformly arranged along the circumference of the turntable; the signal transmitter and the signal receiver are respectively disposed on the two mounting surfaces, and the signal generated by the signal transmitter is received by the signal receiver after passing through the slits; the connecting member is coaxially arranged with the turntable and is configured to remain relatively stationary with respect to the turntable;

[0030] The distal end of the medical catheter is used to be connected to the connecting piece and to drive the connecting piece to rotate synchronously with the distal end of the medical catheter.

[0031] Optionally, a fixing hole is provided on the base and a central through hole is provided on the turntable; the connecting member includes a sleeve, which is installed at the fixing hole through a bearing, and the sleeve passes through the central through hole of the turntable and is configured to remain relatively stationary with the turntable; the sleeve has a second inner cavity, and the second inner cavity is used to load the distal end of the medical catheter.

[0032] Optionally, a screw hole is provided on the side wall of the sleeve, and the connector further includes a top screw, which is passed through the screw hole and is used to keep the distal end of the medical catheter in a straight state in the second inner cavity.

[0033] Optionally, the testing device further includes a control module, which is communicatively connected to the power device and the detection device; and is used to control the power device to operate according to set parameters and drive the medical catheter to rotate, and to process the second rotation information and the first rotation information to characterize the target performance.

[0034] Optionally, the testing device further includes a display module, which is communicatively connected to the control module and is configured to display the relationship between the first rotation information and the second rotation information to represent the target performance.

[0035] Optionally, the liquid tank assembly further includes a temperature maintaining mechanism, which is communicatively connected to the control module and is configured to maintain the liquid within a predetermined temperature range.

[0036] Optionally, the temperature maintaining mechanism includes a temperature sensor, a heating device and a circulation device; the temperature sensor is arranged inside the box to monitor the temperature of the liquid; the heating device is used to heat the liquid; and the circulation device is used to drive the liquid to circulate.

[0037] Optionally, the testing device further includes a workbench and a guide rail arranged on the workbench; the box is arranged on the workbench, and the guide rail is located outside the box; and the power device is movably arranged on the guide rail.

[0038] To achieve the above objectives, the present invention further provides a testing method for testing target performance of a medical catheter, which is based on the aforementioned testing device and comprises:

[0039] Protruding the distal end of the medical catheter into the interior of the liquid tank and immersing the distal end in the liquid;

[0040] The power device drives the medical catheter to rotate;

[0041] The detection device obtains first rotation information of the proximal end of the medical catheter and second rotation information of the distal end of the medical catheter; and

[0042] The first rotation information and the second rotation information are analyzed to obtain the target performance of the medical catheter.

[0043] Optionally, the testing device further includes a control module, which is in communication with the power device and the detection device, and the first rotation information and the second rotation information both include rotation angle values;

[0044] When the power device drives the medical tube to rotate, the control module controls the power device to stop rotating when the rotation angle of the proximal end of the medical tube reaches a predetermined value; or,

[0045] The control module controls the power device to stop rotating when the rotation angle of the distal end of the medical catheter reaches a predetermined value.

[0046] To achieve the above objectives, the present invention further provides a testing method for testing target performance of a medical catheter, based on the aforementioned testing device, characterized in that it comprises:

[0047] Installing the auxiliary structural member on the box body of the liquid tank assembly, and filling the first inner cavity of the auxiliary structural member with the liquid;

[0048] Passing the distal end of the medical catheter through the first inner cavity of the auxiliary structural member and extending into the interior of the box;

[0049] The power device drives the medical catheter to rotate;

[0050] The detection device acquires first rotation information of the proximal end of the medical catheter and second rotation information of the distal end of the medical catheter; and

[0051] The first rotation information and the second rotation information are analyzed to obtain the target performance of the medical catheter.

[0052] Compared with the prior art, the testing device and testing method of the present invention have the following advantages:

[0053] First, the aforementioned testing device is used to test the target performance of a medical catheter. The testing device includes a liquid tank assembly, a power unit, and a detection device. The liquid tank assembly includes a tank body, the tank body being configured to contain liquid, the liquid being configured to submerge the distal end of the medical catheter when the distal end of the medical catheter extends into the tank body. The power unit is disposed outside the tank body and is configured to connect to the proximal end of the medical catheter to drive the medical catheter to rotate. The detection device is configured to detect first rotational information of the proximal end of the medical catheter and second rotational information of the distal end of the medical catheter during rotation. The second rotational information and the first rotational information are used to characterize the target performance. In actual operation, the liquid is within a predetermined temperature range, typically a temperature range equivalent to that of normal blood in the human body, such as approximately 37°C. This means that the liquid simulates a blood environment. Thus, when the distal end of the medical catheter is immersed in the liquid, the target performance of the medical catheter in blood can be quantitatively tested. By controlling the test conditions, the test results of the target performance of the medical catheter can be highly reproducible.

[0054] Second, an interface is provided on the side wall of the box, and the test device further includes an auxiliary structural member; the distal end of the auxiliary structural member is used to pass through the interface and extend into the interior of the box, and the outer wall of the auxiliary structural member is sealed with the interface; the auxiliary structural member has a first inner cavity that runs axially through, and when the auxiliary structural member is in a working state, the shape of the first inner cavity matches the shape of a predetermined cavity; a liquid stop valve is also provided at the proximal end of the first inner cavity, and the liquid stop valve is used to prevent the liquid from flowing out of the proximal end of the first inner cavity; the distal end of the medical catheter is used to pass through the first inner cavity and extend into the interior of the box. The working state described here refers to the test state, and the purpose of providing the auxiliary structural member is to simulate the shape of the medical catheter in the human vascular pathway, so as to further test the target performance of the medical catheter when the distal end of the medical catheter is in different shapes, such as a straight state or a curved state. BRIEF DESCRIPTION OF THE DRAWINGS

[0055] The accompanying drawings are provided for a better understanding of the present invention and are not intended to limit the present invention.

[0056] Figure 1 is a schematic diagram of the overall structure of a testing device provided according to one embodiment of the present invention;

[0057] Figure 2 is a schematic structural diagram of a fixture of a testing device provided according to one embodiment of the present invention;

[0058] Figure 3 1 is a schematic structural diagram of a first fixing member of a testing device provided according to an embodiment of the present invention. The first fixing member shown in the figure is used to fix the distal end of the sheath tube;

[0059] Figure 4 1 is a schematic structural diagram of a first fixing member of a testing device provided according to an embodiment of the present invention. The first fixing member in the figure is used to fix the distal end of a blood vessel model;

[0060] Figure 5 is a schematic structural diagram of a second fixing member of a testing device provided according to one embodiment of the present invention;

[0061] Figure 6 1 is a schematic structural diagram of an auxiliary structural member of a testing device provided according to one embodiment of the present invention, wherein the auxiliary structural member is a sheath tube;

[0062] Figure 7 is a structural schematic diagram of an installation mechanism of a testing device provided according to one embodiment of the present invention;

[0063] Figure 8 is a schematic diagram of the overall structure of a second angle sensor assembly of a testing device provided according to one embodiment of the present invention;

[0064] Figure 9 1 is a partial structural diagram of a second angle sensor assembly of a test device provided according to an embodiment of the present invention, showing a first sub-base;

[0065] Figure 10 1 is a partial structural diagram of a second angle sensor assembly of a testing device provided according to an embodiment of the present invention, showing a turntable;

[0066] Figure 11 is a relationship diagram of first rotation information and second rotation information obtained when a medical catheter A is subjected to a torsion controllability test using a testing device provided by one embodiment of the present invention;

[0067] Figure 12 is a relationship diagram between first rotation information and second rotation information obtained when a medical catheter B is subjected to a torsion controllability test using a testing device provided by one embodiment of the present invention;

[0068] [Description of reference numerals is as follows]:

[0069] 1100-box, 1200-temperature maintaining mechanism, 1210-temperature sensor, 1220-heating device, 1230-circulation device;

[0070] 2000-power unit, 2100-fixture;

[0071] 3000 - Second angle sensor assembly, 3111 - Mounting slot, 3112 - Mounting surface, 3113 - First sub-base, 3114 - Second sub-base, 3115 - Notch, 3120 - Rotating disk, 3121 - Slit, 3122 - Center through hole, 3210 - Sleeve, 3211 - Second inner cavity, 3220 - Top screw, 3300 - Bearing;

[0072] 4000-Torque sensor;

[0073] 5000-workbench, 5100-guide rail;

[0074] 6000-control display device;

[0075] 7000- auxiliary structural parts, 7100- main body, 7200- shell;

[0076] 8000 - fixing assembly, 8100 - first fixing member, 8110 - first fixing seat, 8120 - first clamping member, 8121 - first clamping plate, 8122 - second clamping plate, 8123 - clamping space, 8124 - positioning plate, 8200 - second fixing member, 8210 - second fixing seat, 8220 - second clamping member, 8221 - third clamping plate, 8222 - fourth clamping plate, 8223 - connecting plate;

[0077] 9000-installation mechanism, 9100-base, 9210-first slide bar, 9220-movable seat, 9230-second slide bar, 9240-sleeve, 9250-third slide bar. DETAILED DESCRIPTION

[0078] The following describes the embodiments of the present invention through specific specific examples. Those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the illustrations provided in this embodiment only illustrate the basic concept of the present invention in a schematic manner, and the drawings only show components related to the present invention rather than being drawn according to the number, shape and size of components during actual implementation. During actual implementation, the type, quantity and proportion of each component can be changed at will, and the component layout type may also be more complicated.

[0079] In addition, each embodiment described below has one or more technical features. However, this does not mean that users of the present invention must implement all technical features in any embodiment at the same time, or that they can only implement some or all technical features in different embodiments separately. In other words, as long as implementation is possible, those skilled in the art can, based on the disclosure of the present invention and depending on design specifications or implementation requirements, selectively implement some or all technical features in any embodiment, or selectively implement a combination of some or all technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.

[0080] As used herein, "proximal" and "distal" refer to the relative orientation, position, and direction of components or actions relative to each other from the perspective of a physician using the product. While the terms "proximal" and "distal" are not intended to be limiting, "proximal" generally refers to the end of the product that is closest to the physician during normal operation, while "distal" generally refers to the end that first enters the patient's body. As used in this specification, the singular forms "a," "an," and "the" include plural referents, and the plural form "plurality" includes more than two referents, unless the context clearly indicates otherwise. As used in this specification, the term "or" is generally used in a sense including "and / or," unless the context clearly indicates otherwise, and the terms "mounted," "connected," and "connected" are to be broadly construed, meaning, for example, fixedly connected, removably connected, or integrally connected. They can be mechanically connected or electrically connected. They can be directly connected or indirectly connected through an intermediary, and can include internal communication between two components or an interaction between two components. Those skilled in the art will understand the specific meanings of these terms in the present invention based on the specific circumstances.

[0081] To make the objects, advantages, and features of the present invention more apparent, the present invention is further described below in detail with reference to the accompanying drawings. It should be noted that the drawings are greatly simplified and not to exact scale, and are intended solely to facilitate and clearly illustrate the embodiments of the present invention. The same or similar reference numerals in the drawings represent the same or similar components.

[0082] Figure 1 The overall structure diagram of the testing device provided by one embodiment of the present invention is shown in FIG. Figure 1 The testing device is used to test the target performance of a medical catheter and includes a liquid tank assembly, a power unit 2000, and a detection device. The liquid tank assembly includes a tank 1100 for containing liquid, which is used to submerge the distal end of the medical catheter when the distal end is inserted into the tank 1100. The power unit 2000 is disposed outside the tank 1100 and is connected to the proximal end of the medical catheter to drive the catheter to rotate. The detection device is used to detect first rotation information of the proximal end and second rotation information of the distal end of the medical catheter during rotation. The second and first rotation information are used to characterize the target performance. Here, the "distal end of the medical catheter" refers to the end of the medical catheter that first enters the patient's body during actual use, and the "proximal end of the medical catheter" refers to the end of the medical catheter that is closest to the physician during actual use. The target performance may be, for example, torque controllability.

[0083] During actual operation, the liquid is maintained within a predetermined temperature range. In this embodiment, the "predetermined temperature range" refers to a temperature range comparable to that of blood in a patient's body, for example, approximately 37°C. In other words, the liquid simulates the blood environment in a patient's body. This allows the testing device to simulate a condition where the distal end of the medical catheter is completely immersed in blood, resembling the actual operating environment of the medical catheter, and to test the catheter's torque controllability in this condition, resulting in more accurate test results. The power device drives the medical catheter to rotate, while the detection device simultaneously detects rotational information at both the proximal and distal ends of the catheter. While ensuring consistent test conditions, the test results exhibit good repeatability. In other embodiments, the "predetermined temperature range" can also be a temperature range required under other test conditions and can be adjusted accordingly based on actual test conditions. This is not a limitation of this application.

[0084] Optionally, refer to Figure 2 The output end of the power device 2000 is provided with a clamp 2100 for clamping the proximal end of the medical catheter, enabling the output end of the power device 2000 to drive the proximal end of the medical catheter to rotate synchronously. Furthermore, the detection device may include a first detection device and a second detection device. The first detection device is disposed outside the housing 1100, specifically, on the output end of the power device, and detects first rotation information of the proximal end of the medical catheter by detecting rotation information from the output end of the power device. The second detection device is disposed inside the housing 1100 and detects second rotation information of the distal end of the medical catheter immersed in the liquid.

[0085] Furthermore, the testing device also includes a control module to enhance its automation. The control module is in communication with the detection device and the power unit 2000, and is configured to control the power unit to operate according to set parameters and drive the medical catheter to rotate. It is also configured to process the second rotation information and the first rotation information to characterize the torsion controllability of the medical catheter.

[0086] Specifically, the first detection device may be a first angle sensor assembly, and the second detection device may be a second angle sensor assembly 3000. Those skilled in the art will appreciate how to dispose the first angle sensor at the output of the power device, and this will not be described in detail herein. The structure of the second angle sensor assembly 3000 will be described later.

[0087] During testing, the operator can set the target rotation angle of the power device 2000 (i.e., the target rotation angle of the proximal end of the medical catheter) in the control module. The first angle sensor assembly detects the rotation angle value of the output end of the power device 2000 (i.e., the rotation angle value of the proximal end of the medical catheter) in real time as the first rotation information. The second angle sensor assembly also detects the rotation angle value of the distal end of the medical catheter in real time as the second rotation information. When the rotation angle value of the output end of the power device reaches the set target value, the power device 2000 stops operating. During this process, the control module can evaluate the torque controllability of the medical catheter based on the deviation between the rotation angle values ​​of the distal end and the proximal end of the medical catheter. Generally, the smaller the deviation between the rotation angle values ​​of the proximal end and the distal end of the medical catheter, the better the torque controllability of the medical catheter.

[0088] Alternatively, an operator may set a target rotation angle value for the distal end of the medical catheter in the control module, and the control module then controls the power unit 2000 to operate until the final rotation angle value of the distal end of the medical catheter reaches the set target rotation angle value. The control module may also evaluate the torsion controllability of the medical catheter based on the deviation between the rotation angle value of the distal end of the medical catheter and the rotation angle value of the proximal end of the medical catheter.

[0089] It should be noted that the second detection device may also be a torque sensor 4000, which is used to monitor the torque value at the distal end of the medical catheter during rotation. When the rotation angle and rotation speed of the proximal end of the medical catheter are the same, the greater the torque value at the distal end of the medical catheter, the better the torque controllability of the medical catheter.

[0090] The testing device may further include a display module, the display module being communicatively connected to the control module and configured to display the first rotation information and the second rotation information, and the relationship between the second rotation information and the first rotation information, to indicate the torque controllability of the medical catheter.

[0091] In addition, the display module can also be used to display temperature information of the liquid, which may include the predetermined temperature range and the actual temperature of the liquid. Specifically, the housing assembly may further include a temperature maintenance mechanism 1200, which is communicatively connected to the control module and is used to maintain the liquid within the predetermined temperature range. The temperature maintenance mechanism 1200 may include a temperature sensor 1210, a heating device 1220, and a circulation device 1230. The temperature sensor 1210 may be located within the housing 1100 to monitor the temperature of the liquid in real time and transmit the real-time temperature to the control module for display on the display module. The heating device 1220 may be an electric heating rod located within the housing 1100, which is used to heat the liquid when the temperature falls below the predetermined temperature range. The circulation device 1230 is used to circulate the liquid to achieve heat exchange within the liquid and maintain a uniform temperature. The circulation device 1230 may be a circulation pump located outside the housing 1100 or a stirring device located within the housing 1100.

[0092] Optionally, the testing device further includes a workbench 5000, on which the liquid tank assembly, power unit 2000, control module, and display module can be mounted. As a further improvement, the workbench 5000 is further provided with a guide rail 5100, located outside the housing 1100. The power unit 2000 is movably mounted on the guide rail 5100, allowing the relative position of the power unit 2000 and the housing 1100 to be adjusted based on the actual length of the medical catheter. Furthermore, those skilled in the art will appreciate that the control module and display module can be integrated into a control and display device 6000.

[0093] Furthermore, an interface (not marked in the figure) is provided on the side wall of the box body 1100. The testing device also includes an auxiliary structural member 7000. The distal end of the auxiliary structural member 7000 is used to pass through the interface and extend to the interior of the box body 1100, and the outer wall of the auxiliary structural member 7000 is sealed with the interface to ensure that the liquid does not flow out of the interface. The auxiliary structural member 7000 has an axially through-going first inner cavity, and when the auxiliary structural member 7000 is in a working state, the shape of the first inner cavity matches the shape of a predetermined cavity. A liquid stop valve is also provided at the proximal end of the first inner cavity, and the liquid stop valve is used to prevent the liquid from flowing out from the proximal end of the first inner cavity. The distal end of the medical catheter is used to pass through the first inner cavity and extend to the interior of the box body 1100. The operating state described herein refers to the state during a torque control test of the medical catheter, and the predetermined lumen refers to a vascular channel within a patient's body. The matching of the morphology of the first lumen with the morphology of the predetermined lumen means that the morphology of the first lumen is as close as possible to that of the predetermined lumen. In actual operation, the auxiliary structural member 7000 can be customized according to the morphology of the predetermined lumen, or the auxiliary structural member 7000 can be a flexible and bendable structure, and during operation, the operator adjusts the auxiliary structural member 7000 according to the morphology of the predetermined lumen to ensure that the morphology of the first lumen is as close as possible to that of the predetermined lumen. The advantage of providing the auxiliary structural member 7000 is that, when the medical catheter passes through the first lumen, it can simulate the morphology of the medical catheter in a vascular channel within the body, further aligning with the actual state of use of the medical catheter, thereby improving the accuracy of the torque control test.

[0094] The auxiliary structural component 7000 may include at least one of a blood vessel model and a sheath. It is understood that when the auxiliary structural component 7000 only includes a sheath, the tube body of the sheath can be bent on a horizontal plane, a vertical plane, or an inclined plane to match the inner cavity of the sheath with the shape of the blood vessel passage. When the auxiliary structural component 7000 includes both a blood vessel model and a sheath, the distal end of the blood vessel model can pass through the interface and be sealed with the interface, and the distal end of the sheath can pass through the blood vessel model to enter the interior of the box 1100. At this time, the sheath has the first inner cavity, and under the constraint of the blood vessel model, the shape of the first inner cavity matches the shape of the blood vessel passage.

[0095] Please refer back to Figure 1The testing device further includes a fixing assembly 8000. The fixing assembly 8000 includes at least one first fixing member 8100, which is disposed inside the box 1100 and is connected to the portion of the auxiliary structure 7000 located inside the box 1100 to keep the portion of the auxiliary structure 7000 located inside the box 1100 fixed.

[0096] In a non-limiting embodiment, the liquid tank assembly further includes a bottom plate (not shown), which is disposed at the bottom of the tank body 1100 and has a plurality of connection portions, such as screw holes. The first fixing member 8100 can be connected to some of the screw holes via screws, and the specific connection position can be adjusted according to actual needs.

[0097] Please refer to Figure 3 and Figure 4 The first fixing member 8100 may include a first fixing seat 8110 and a first clamping member 8120. The first fixing seat 8110 is used to be connected to the bottom plate by screws. The first clamping member 8120 is preferably connected to the first fixing seat 8110 in a pluggable or other detachable manner. Of course, the first clamping member 8120 can also be integrally formed with the first fixing seat 8110. The first clamping member 8120 includes a first clamping plate 8121 and a second clamping plate 8122. The first clamping plate 8121 has a clamping area, and the second clamping plate 8122 also has a clamping area. When the first clamping plate 8121 and the second clamping plate 8122 are matched, the clamping areas of the two are spliced ​​to form a clamping space 8123 for clamping the portion of the auxiliary structure 7000 located in the box body 1100.

[0098] In some embodiments, the size of the clamping space 8123 is fixed, for example, see Figure 3 , the clamping area of ​​the first clamping plate 8121 is V-shaped. The second clamping plate 8122 includes a positioning portion 8122a and a limiting portion 8122b, the positioning portion 8122a is connected to the first clamping plate 8121, and the limiting portion 8122b is fixedly connected to the positioning portion 8122a and extends into the clamping area of ​​the first clamping plate 8121 to enclose together with the first clamping plate 8121 to form the clamping space 8123. Alternatively, in other embodiments, the size of the clamping space 8123 can be adjusted according to the size of the distal end of the auxiliary structural member 7000. Please focus on Figure 4, the clamping area of ​​the first clamping plate 8121 is V-shaped, and the closed end of the V-shape is preferably formed as a rounded corner. The first clamping member 8120 also includes a positioning plate 8124, which is fixedly connected to the first clamping plate 8121 and is located at the open end of the V-shaped clamping area. The second clamping plate 8122 is arranged at one end of the positioning plate 8124 toward the first clamping plate 8121, and can be moved in a direction close to or away from the closed end of the V-shaped clamping area, so that the operator can adjust the size of the clamping space 8123 by adjusting the distance from the second clamping plate 8122 to the closed end of the V-shaped clamping area. In this embodiment, the second clamping plate 8122 is connected to the positioning plate 8124 by a bolt, and the operator can adjust the size of the clamping space 8123 by rotating the bolt. In this application, there is no restriction on the shape of the first clamping plate 8121 and the second clamping plate 8122, which can be as follows Figure 3 or Figure 4 The structure shown can also be adjusted accordingly based on the auxiliary structural member 7000.

[0099] Please refer back to Figure 1 Combined with Figure 5 The fixing assembly also includes a second fixing member 8200, which is used to connect to the proximal end of the auxiliary structural member 7000 when the proximal end of the auxiliary structural member 7000 is located outside the box 1100, so as to keep the proximal end of the auxiliary structural member 7000 fixed. The second fixing member 8200 includes a second fixing seat 8210 and a second clamping member 8220, and the second fixing seat 8210 can be movably arranged on the guide rail 5100 of the workbench 5000 to facilitate adjustment of its position. The second clamping member 8220 includes a third clamping plate 8221, a fourth clamping plate 8222 and a connecting plate 8223, wherein the third clamping plate 8221 can be connected to the second fixing seat 8210 in a plug-in or other detachable manner through the connecting plate 8223. Of course, the third clamping plate 8221 and the connecting plate 8223 can also be integrally formed with the second fixing seat 8210, and this application does not impose any restrictions on this. The third clamping plate 8221 and the fourth clamping plate 8222 are used to clamp the proximal end of the auxiliary structure 7000. It should be noted that the auxiliary structure 7000 includes a body 7100 and a shell 7200 (such as Figure 6 As shown), the main body 7100 is, for example, the tube body of the sheath tube, and the shell 7200 is, for example, the joint part of the sheath tube; the third clamping plate 8221 and the fourth clamping member 8222 are used to clamp the shell 7200 to avoid deformation of the first inner cavity due to extrusion.

[0100] Those skilled in the art will appreciate that the second detection device typically needs to be connected to the distal end of the medical catheter to detect the second rotational information of the distal end of the medical catheter. Because the distal end of the medical catheter passes through the first lumen of the auxiliary structural member 7000, the position of the distal end of the medical catheter is related to the shape of the first lumen. Therefore, the position of the second detection device within the housing 1100 should be adjustable.

[0101] In some optional implementations, the second detection device can be connected to the screw holes on the base plate by screws, and the specific connection position is selected according to needs. Alternatively, in other implementations, the test device further includes a mounting mechanism 9000 (such as Figure 7 The mounting mechanism 9000 is at least partially located within the housing 1100 and is configured to connect to the second detection device. The mounting mechanism 9000 may be connected to a side wall of the housing 1100, or to the bottom plate, or to an external device. The mounting mechanism 9000 includes a motion module configured to cause the second detection device to move in at least one degree of freedom to adjust its position.

[0102] In an exemplary embodiment, the motion module is configured to drive the second detection device to perform motion with multiple degrees of freedom, for example, to drive the second detection device to perform motion with three degrees of freedom. Specifically, the motion of the second detection device includes translational motion along a first direction, translational motion along a second direction, and translational motion along a third direction, wherein the first direction, the second direction, and the third direction are perpendicular to each other.

[0103] Specifically, the mounting mechanism 9000 further includes a base 9100. The motion module includes a first sliding rod 9210, a movable seat 9220, a second sliding rod 9230, a sleeve 9240, and a third sliding rod 9250. The first sliding rod 9210 extends along the first direction, and the opposite ends of the first sliding rod 9210 are connected to the housing 1100 via a base 9100. The movable seat 9220 is disposed on the first sliding rod 9210 and is capable of moving along the first sliding rod (i.e., moving along the first direction) under the action of an external force. The second sliding rod 9230 is disposed on the movable seat 9220 and is capable of moving along the second direction under the action of an external force. The sleeve 9240 is disposed on the second sliding rod 9230, and the axial direction of the sleeve 9240 extends along the third direction. The third sliding rod 9250 is disposed within the sleeve 9240 and is capable of moving along the third direction under the action of an external force. In this embodiment, the second detection device may be connected to the third sliding bar 9250. In other words, when the movable seat 9220 moves along the first sliding bar 9210, the second detection device moves accordingly along the first direction; when the second sliding bar 9230 moves along the second direction, the second detection device moves accordingly along the second direction; and when the third sliding bar 9250 moves along the third direction, the second detection device moves accordingly along the third direction.

[0104] As mentioned above, in some embodiments, the second detection device may include a second angle sensor component, the structure of which is as follows: Figures 8 to 10 shown.

[0105] Please refer to Figures 8 to 10The second angle sensor assembly 3000 includes a sensor body and a connector. The sensor body includes a base, a rotating disk 3120, a signal transmitter, and a signal receiver. The base is provided with a mounting slot 3111 having two opposing mounting surfaces 3112. The rotating disk 3120 can be a circular structure, rotatably mounted on the base and at least partially positioned within the mounting slot 3111. The rotating disk 3120 is provided with slits 3121 evenly spaced along its circumference. The signal transmitter and the signal receiver are respectively mounted on the two mounting surfaces 3112. The signal transmitted by the signal transmitter is received by the signal receiver after passing through the slits. The connector is coaxially arranged with the rotating disk 3120 and is configured to remain stationary relative to the rotating disk 3120. The distal end of the medical catheter is connected to the connector, causing the connector to rotate synchronously with the distal end of the medical catheter, thereby driving the rotating disk 3120 to rotate synchronously. In this way, the turntable 3120 "cuts" the signal emitted by the signal transmitter during the rotation process, so that the signal is intermittently received by the signal receiver to detect the rotation angle of the distal end of the medical catheter.

[0106] In more detail, the base includes a first sub-base 3113 and a second sub-base 3114. The first sub-base 3113 has the mounting groove 3111. The second sub-base 3114 is connected to the first sub-base 3113 and is also used to connect to the base plate or the mounting mechanism 9000. The second sub-base 3114 has a notch 3115 connected to the mounting groove 3111, and fixing holes (not marked in the figure) are provided on the two opposite side walls of the notch 3115. The turntable 3120 is provided with a central through hole 3122. The connecting member includes a sleeve 3210 and a third fixing member (not shown in the figure). The sleeve 3210 passes through the central through hole 3122 of the turntable 3120 and can be welded to the turntable 3120. The sleeve 3210 also passes through the fixing hole and is connected to the hole wall of the fixing hole through a bearing 3300. The cannula 3210 further includes an axially extending second lumen 3211 for receiving the distal end of the medical catheter. The third fixing member is used to maintain relative stationary contact between the distal end of the medical catheter and the cannula 3210, allowing the cannula 3210 to rotate synchronously with the distal end of the medical catheter. The third fixing member may be a locking nut disposed at opposite ends of the cannula 3210.

[0107] Furthermore, a screw hole is provided on the side wall of the cannula 3210. The connector also includes a top screw 3220, which is inserted through the screw hole. For some relatively flexible medical catheters, when in a controlled bending state, the top screw 3220 can apply pressure to the distal end of the medical catheter to maintain the portion of the medical catheter inserted into the second inner cavity 3211 of the cannula 3210 in a straight position.

[0108] It can be understood that the connector is connected to the testing portion at the distal end of the medical catheter, and the distal end of the medical catheter needs to be completely immersed in the liquid, so the connector should also be immersed in the liquid.

[0109] Next, this article will introduce a specific method for testing the torsion controllability of a medical catheter using the testing device.

[0110] First, the auxiliary structural member 7000 is mounted on the housing 1100 and a liquid is added to the housing 1100, maintaining the liquid within a predetermined temperature range, such as approximately 37°C. It should be noted that the liquid should completely fill the first lumen of the auxiliary structural member 7000 to ensure that the medical catheter is completely immersed in the liquid while in the first lumen. Furthermore, the shape of the first lumen must meet testing requirements, such as selecting a suitable blood vessel model or bending the sheath tube and maintaining it in the bent state using the first fixture.

[0111] Next, the distal end of the medical catheter is passed through the first inner cavity of the auxiliary structural component 7000 and extended into the interior of the box body 1100 .

[0112] Next, the position of the second detection device is adjusted and connected to the distal end of the medical catheter.

[0113] Next, parameters are set on the control and display device 6000 , such as the target rotation angle of the proximal end of the medical catheter or the target rotation angle of the distal end of the medical catheter.

[0114] Finally, the power unit 2000 is activated, operating according to the set parameters and driving the medical catheter to rotate. Simultaneously, the detection device acquires the first and second rotation information and transmits them to the control and display device. The control and display device processes the first and second rotation information to characterize the torsion controllability of the medical catheter.

[0115] In this embodiment, the control display device displays the first rotation information curve and the second rotation information curve on the same image to represent the torque control performance of the medical catheter. Figure 11and Figure 12 , Figure 11 FIG. 2 shows the rotation angle curves of the proximal and distal ends of the medical catheter A when it rotates. Figure 12 The figure shows the rotation angle curves of the proximal and distal ends of medical catheter B during rotation. The horizontal axis in the figure represents the number of rotation angles collected, in units of ", and the vertical axis represents the rotation angle value, in units of "°". The solid line represents the rotation angle curve of the proximal end of the medical catheter, and the dotted line represents the rotation angle curve of the distal end of the medical catheter. Those skilled in the art will understand that the quality of the torque controllability can be judged based on the deviation between the rotation angle curves of the proximal end of the medical catheter and the rotation angle curves of the distal end of the medical catheter. The smaller the deviation between the two, the better the torque controllability of the medical catheter. Figure 12 The corresponding medical catheter B has better twist control than Figure 11 The corresponding twist controllability of medical catheter A.

[0116] It is understandable that if the auxiliary structure 7000 is not used during the test, the distal end of the medical tube can be directly passed through the interface and extended into the interior of the box 1100, and then the power device 2000 can drive the medical tube to rotate.

[0117] While the present invention is disclosed above, it is not limited thereto. Those skilled in the art may make various modifications and variations to the present invention without departing from the spirit and scope of the present invention. Thus, the present invention is intended to encompass such modifications and variations as long as they fall within the scope of the claims and their equivalents.

Claims

1. A test device for testing target performance of a medical catheter, characterized in that: include: A liquid box assembly includes a box body, the box body is used to contain liquid, the liquid is used to immerse the distal end of the medical tube when the distal end of the medical tube extends into the interior of the box body; an interface is provided on the side wall of the box body; a power device, disposed outside the box; the power device is used to connect to the proximal end of the medical catheter and drive the medical catheter to rotate; an auxiliary structural member, wherein the distal end of the auxiliary structural member is configured to pass through the interface and extend into the interior of the housing, and the outer wall of the auxiliary structural member is sealedly connected to the interface; the auxiliary structural member has an axially extending first inner cavity, and when the auxiliary structural member is in a working state, the shape of the first inner cavity matches the shape of a predetermined cavity; a liquid stop valve is further provided at the proximal end of the first inner cavity, for preventing the liquid from flowing out of the proximal end of the first inner cavity; the distal end of the medical catheter is configured to pass through the first inner cavity and extend into the interior of the housing; as well as, a detection device for detecting first rotation information of a proximal end of the medical catheter and second rotation information of a distal end of the medical catheter when the medical catheter rotates; The second rotation information and the first rotation information are used to characterize the target performance of the medical catheter.

2. The testing device according to claim 1, wherein: The auxiliary structural component includes a sheath and / or a blood vessel model.

3. The testing device according to claim 1, wherein: The testing device also includes a fixing assembly, which includes at least one first fixing member. The first fixing member is arranged inside the box and is used to connect with the part of the auxiliary structural member located inside the box to keep the part of the auxiliary structural member located inside the box fixed.

4. The testing device according to claim 3, characterized in that: The box assembly further includes a bottom plate, which is arranged on the bottom of the box, and a plurality of connecting parts are further provided on the bottom plate; The first fixing member includes a first fixing seat and a first clamping member; the first fixing seat is used to connect with part of the connecting portion; the first clamping member is connected to the first fixing seat and is used to clamp the part of the auxiliary structural member located inside the box.

5. The testing device according to claim 4, characterized in that: The first clamping member has a clamping space for clamping the auxiliary structure, and the first clamping member is configured so that the size of the clamping space can be adjusted according to the size of the portion of the auxiliary structure located inside the box; and / or, The first clamping member is detachably connected to the first fixing seat.

6. The testing device according to claim 3, characterized in that: The proximal end of the auxiliary structural member is located outside the box; the fixing assembly further includes a second fixing member, which is arranged outside the box and is used to connect with the proximal end of the auxiliary structural member and keep the proximal end of the auxiliary structural member fixed; and / or, The second fixing member is movably arranged outside the box body to allow the position of the second fixing member to be adjusted.

7. The testing device according to claim 1, characterized in that: The detection device includes a first detection device and a second detection device; the first detection device is arranged outside the box and is used to detect the first rotation information of the proximal end of the medical catheter; the second detection device is arranged inside the box and is used to detect the second rotation information of the distal end of the medical catheter.

8. The testing device according to claim 7, characterized in that: The box assembly further includes a bottom plate, which is arranged at the bottom of the box, and a plurality of connecting parts are provided on the bottom plate; The second detection device is used to connect with part of the connecting portion.

9. The testing device according to claim 7, characterized in that: The testing device also includes a mounting mechanism for connecting to the second detection device; the mounting mechanism is at least partially located inside the box and includes a motion module, which is used to drive the second detection device to perform at least one degree of freedom of movement to adjust the position of the second detection device.

10. The testing device according to claim 9, characterized in that: The motion module is configured to drive the second detection device to translate along a first direction, a second direction, and a third direction; the first direction, the second direction, and the third direction are perpendicular to each other.

11. The testing device according to claim 10, characterized in that: The mounting mechanism further includes a base; the motion module includes a first sliding rod, a movable seat, a second sliding rod, a sleeve and a third sliding rod; the first sliding rod extends along the first direction, and the opposite ends of the first sliding rod are connected to the box body through one of the bases; the movable seat is arranged on the first sliding rod and can move along the first sliding rod under the action of an external force; the second sliding rod is arranged on the movable seat and can move along the second direction under the action of an external force; the sleeve is arranged on the second sliding rod, and the axial direction of the sleeve extends along the third direction; the third sliding rod is passed through the sleeve and can move along the third direction under the action of an external force; The second detection device is connected to the third sliding bar.

12. The testing device according to claim 7, characterized in that: The target performance is torque controllability, the first detection device includes a first angle sensor component, and the first rotation information includes a rotation angle value; the second detection device includes a torque sensor, and the second rotation information includes a torque value.

13. The testing device according to claim 7, characterized in that: The target performance is torque controllability, the first detection device includes a first angle sensor component, and the second detection device includes a second angle sensor component; the first rotation information and the second rotation information both include rotation angle values.

14. The testing device according to claim 13, characterized in that: The second angle sensor assembly includes a sensor body and a connecting member; the sensor body includes a base, a turntable, a signal transmitter, and a signal receiver; the base is provided with a mounting slot having two opposing mounting surfaces; the turntable is rotatably disposed on the base and at least partially located within the mounting slot; the turntable is provided with slits uniformly arranged along the circumference of the turntable; the signal transmitter and the signal receiver are respectively disposed on the two mounting surfaces, and the signal generated by the signal transmitter is received by the signal receiver after passing through the slits; the connecting member is coaxially arranged with the turntable and is configured to remain stationary relative to the turntable; The distal end of the medical catheter is used to be connected to the connecting piece and to drive the connecting piece to rotate synchronously with the distal end of the medical catheter.

15. The testing device according to claim 14, characterized in that: The base is provided with a fixing hole, and the turntable is provided with a central through hole; the connecting member includes a sleeve, which is installed at the fixing hole through a bearing, and passes through the central through hole of the turntable and is configured to remain relatively stationary with the turntable; the sleeve has a second inner cavity, and the second inner cavity is used to load the distal end of the medical catheter.

16. The testing device according to claim 15, characterized in that A screw hole is provided on the side wall of the sleeve, and the connector further includes a top screw which is passed through the screw hole and is used to keep the distal end of the medical catheter in a straight line in the second inner cavity.

17. The testing device according to claim 1, wherein: The testing device also includes a control module, which is in communication with the power device and the detection device; and is used to control the power device to operate according to set parameters and drive the medical catheter to rotate, and to process the second rotation information and the first rotation information to characterize the target performance.

18. The testing device according to claim 17, characterized in that The testing device further includes a display module, which is in communication with the control module and is configured to display a relationship between the first rotation information and the second rotation information to represent the target performance.

19. The testing device according to claim 17, characterized in that The liquid tank assembly further includes a temperature maintaining mechanism, which is communicatively connected to the control module and is configured to maintain the liquid within a predetermined temperature range.

20. The testing device according to claim 19, characterized in that The temperature maintaining mechanism includes a temperature sensor, a heating device and a circulation device; the temperature sensor is arranged inside the box to monitor the temperature of the liquid; the heating device is used to heat the liquid; and the circulation device is used to drive the liquid to circulate.

21. The testing device according to claim 1, wherein: The testing device further comprises a workbench and a guide rail arranged on the workbench; the box is arranged on the workbench, and the guide rail is located outside the box; the power device is movably arranged on the guide rail.

22. A testing method for testing target performance of a medical catheter, based on the testing device according to claim 1, characterized in that: include: Installing the auxiliary structural member on the box body of the liquid tank assembly, and filling the first inner cavity of the auxiliary structural member with the liquid; Passing the distal end of the medical catheter through the first inner cavity of the auxiliary structural member and extending into the interior of the box; The power device drives the medical catheter to rotate; The detection device obtains first rotation information of the proximal end of the medical catheter and second rotation information of the distal end of the medical catheter; as well as, The first rotation information and the second rotation information are analyzed to obtain the target performance of the medical catheter.

23. The testing method according to claim 22, characterized in that: The testing device further includes a control module, which is in communication with the power device and the detection device, and the first rotation information and the second rotation information both include rotation angle values; When the power device drives the medical tube to rotate, the control module controls the power device to stop rotating when the rotation angle of the proximal end of the medical tube reaches a predetermined value; or, The control module controls the power device to stop rotating when the rotation angle of the distal end of the medical catheter reaches a predetermined value.

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