An extracorporeal testing device for a miniature intervention pump

Abstract

The application discloses an in-vitro testing device for a micro interventional pump, which comprises an inlet section, a clamping section and an outlet section which are independently designed and hollow inside, the inner diameters of the inlet section and the outlet section are consistent with the inner diameter of a real blood vessel at an implantation position to simulate a mechanical environment in a human body, the clamping section is detachably connected between the inlet section and the outlet section to facilitate installation and replacement, different lengths or cross-sectional shapes of the outlet section are replaced according to the blood vessel morphology at the implantation position to adapt to different testing simulation requirements, the clamping section is curved and the curvature is adapted to the curvature of the micro interventional pump, flexible clamping blocks are arranged inside the clamping section for clamping the micro interventional pump, and sensor interfaces for connecting testing sensors such as pressure sensors and temperature sensors are arranged outside the inlet section and the outlet section. The device can be used for in-vitro testing of various micro interventional pumps, the hemodynamic characteristics of the testing environment are consistent with physiological conditions, the blood compatibility is good, and the device can meet the requirements of in-vitro hemolysis experiments and particle image velocimetry experiments.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medical devices, and particularly relates to an extracorporeal testing device for a micro interventional pump. BACKGROUND

[0002] The micro interventional pump is currently the smallest artificial heart in the world, and is used for acute phase of cardiogenic shock and high-risk percutaneous coronary intervention (PCI), and can also be used for cardiomyopathy, myocarditis or as a transitional treatment for heart surgery or transplantation. As a temporary heart assist device, the micro interventional pump can reduce the left ventricular load, maintain circulatory perfusion, reduce endothelin release and calcium overload, improve hemodynamic disorders, and prevent patients from dying due to organ perfusion insufficiency, systemic inflammatory response and multiple organ dysfunction. Since obtaining CE certification in 2005, the types of micro interventional pumps have gradually increased, and the use has become more and more common, and currently more than 300 countries have used it. In the United States alone, the number of users exceeds 50,000 cases. However, due to the small size, in order to achieve a blood flow of 3-5L per minute, the rotational speed of the micro interventional pump needs to reach tens of thousands of revolutions per minute, which may cause blood damage, and the structure of the micro interventional pump and the blood outflow state of the outlet also affect the utility of the micro interventional pump and the effect of blood on the blood vessel wall.

[0003] Due to the various types and shapes of micro interventional pumps, there is currently a lack of a unified testing device that meets blood compatibility. SUMMARY

[0004] To solve at least one problem mentioned in the background, the purpose of the present application is to provide an extracorporeal testing device for a micro interventional pump, which provides a testing device with strong blood compatibility, wide pump applicability, convenient loading and unloading, and mechanical environment simulation for extracorporeal testing of the micro interventional pump.

[0005] The present application is achieved by the following technical solutions:

[0006] An extracorporeal testing device for a micro interventional pump, comprising an inlet section, a clamping section and an outlet section which are hollow inside; one end of the clamping section is detachably connected to the inlet section, and the other end is detachably connected to the outlet section; the clamping section is curved, and the curvature of the clamping section is adapted to the curvature of the micro interventional pump to be tested; one end of the inlet section and the outlet section which is not connected to the clamping section is used to connect an external testing circulation pipeline; the clamping section is provided with a clamping block inside for clamping the micro interventional pump to be tested, and the inner diameter of the clamping block is adapted to the outer diameter of the micro interventional pump to be tested;

[0007] The clamping section comprises a vertical section and a curved section, which are connected to form a curved clamping section, and the clamping block is arranged in the vertical section, and the pump clamping positioning hole is arranged at the joint of the vertical section and the curved section;

[0008] The extrusion block is hollow and cylindrical, and the outer diameter of the extrusion block is smaller than the inner diameter of the vertical section, when the inlet section is connected with the clamping section, the clamping block is sleeved outside the extrusion block, and the outer diameter of the extrusion block is smaller than the inner diameter of the clamping block, so that the extrusion block extrudes the clamping block for extrusion adjustment.

[0009] The inner diameters of the inlet section and the outlet section are matched with the shape of the aorta of the human body corresponding to the use of the micro-intervention pump to be tested, and the bending angle of the curved section is consistent with the angle of the micro-intervention pump implanted in the human body.

[0010] In one embodiment, when the micro-intervention pump to be tested is clamped in the clamping section by the clamping block, the inlet end of the micro-intervention pump to be tested is located at the joint of the clamping section and the inlet section, the outlet end of the micro-intervention pump to be tested is located at the joint of the clamping section and the outlet section, and the sensor interface is arranged outside the inlet section and the outlet section for connecting the test sensor.

[0011] In one embodiment, the clamping section is internally provided with a pump clamping positioning hole for positioning the clamping block when clamping the micro-intervention pump, the pump clamping positioning hole is close to the end of the clamping section connected with the outlet section, the clamping block is close to the end of the clamping section connected with the inlet section, and the clamping block and the pump clamping positioning hole are axially aligned.

[0012] In one embodiment, the inlet section, the outlet section and the clamping section are independently arranged, and the corresponding inlet section, clamping section and outlet section are processed by matching the shapes of various micro-intervention pumps.

[0013] In one embodiment, the outer side of the end of the inlet section close to the extrusion block is provided with external threads, the inner side of the end of the clamping section connected with the inlet section is provided with internal threads, the inner side of the end of the outlet section connected with the clamping section is provided with internal threads, and the outer side of the end of the clamping section connected with the outlet section is provided with external threads.

[0014] In one embodiment, the end of the inlet section and the outlet section not connected with the clamping section is provided with a pagoda interface for connecting an external test circulating pipeline.

[0015] In one embodiment, the inlet section, the outlet section and the clamping section are made of a transparent material with blood compatibility, and the clamping block is made of a soft material with blood compatibility.

[0016] The micro-interventional pump in-vitro testing device according to the present application has the following beneficial effects: the micro-interventional pump in-vitro testing device comprises an inlet section, a clamping section and an outlet section, the inlet section, the clamping section and the outlet section are hollow inside, one end of the clamping section is detachably connected to the inlet section, and the other end of the clamping section is detachably connected to the outlet section, the clamping section is curved, the curvature of the clamping section is adapted to the curvature of the micro-interventional pump to be tested, one end of the inlet section and the outlet section, which is not connected to the clamping section, is used to connect an external testing circulation pipeline, the clamping section is internally provided with a clamping block for clamping the micro-interventional pump to be tested, the inner diameter of the clamping block is adapted to the outer diameter of the micro-interventional pump to be tested, and the outside of the inlet section and the outlet section is provided with a sensor interface for connecting a testing sensor. The three-section design and the detachable connection between the clamping section and the inlet section and the outlet section make the testing device suitable for in-vitro testing of any micro-interventional pump, and the testing device is convenient to assemble and disassemble, has strong blood compatibility, and meets the physiological mechanics environment simulation conditions. BRIEF DESCRIPTION OF DRAWINGS

[0017] In order to more clearly illustrate the specific embodiments of the present application or the technical solutions in the prior art, the following will briefly introduce the drawings needed to be used in the description of the specific embodiments or the prior art. Obviously, the drawings described below are some embodiments of the present application, and those skilled in the art can also obtain other drawings according to these drawings without creative labor.

[0018] Figure 1 is a schematic diagram of the overall structure of the micro-interventional pump in-vitro testing device according to the embodiment of the present application;

[0019] Figure 2 is a schematic diagram of the cross-sectional structure of the inlet section of the micro-interventional pump in-vitro testing device according to the embodiment of the present application;

[0020] Figure 3 is a schematic diagram of the cross-sectional structure of the clamping section of the micro-interventional pump in-vitro testing device according to the embodiment of the present application;

[0021] Figure 4 is a schematic diagram of the cross-sectional structure of the outlet section of the micro-interventional pump in-vitro testing device according to the embodiment of the present application;

[0022] Figure 5 is a schematic diagram of the cross-sectional structure of the micro-interventional pump in-vitro testing device according to the embodiment of the present application;

[0023] Wherein, 1, import section; 2, clamping section; 3, export section; 4, pagoda interface; 5, round tube; 6, external thread; 7, extrusion block; 8, internal thread; 9, clamping area; 10, pump clamping positioning hole; 11, sensor interface; 13, clamping block. DETAILED DESCRIPTION

[0024] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all. The components of the embodiments of the present application described and shown in the accompanying drawings can be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of the present application provided in the accompanying drawings is not intended to limit the scope of the claimed present application, but only represents selected embodiments of the present application. Based on the embodiments of the present application, all other embodiments obtained by those skilled in the art without creative work fall within the scope of the present application.

[0025] In the description of the embodiments of the present application, it should be understood that the terms "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise" and the like indicate the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the embodiments of the present application and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the embodiments of the present application.

[0026] Hereinafter, with reference to Figures 1 to 5 The in-vitro testing device for the micro interventional pump according to the embodiments of the present application will be specifically described.

[0027] As Figures 1-5 shown, the in-vitro testing device for the micro interventional pump according to the embodiments of the present application comprises an internal hollow import section 1, a clamping section 2 and an export section 3; one end of the clamping section 2 is detachably connected to the import section 1, and the other end is detachably connected to the export section 3; the clamping section 2 is curved, and the curvature of the clamping section 2 is adapted to the curvature of the micro interventional pump to be tested; the ends of the import section 1 and the export section 3 not connected to the clamping section 2 are used to connect external testing circulating pipelines; the clamping section 2 is internally provided with a clamping block 13 for clamping the micro interventional pump to be tested, the inner diameter of the clamping block is adapted to the outer diameter of the micro interventional pump to be tested, and the import section 1 and the export section 3 are externally provided with a sensor interface 11 for connecting a testing sensor.

[0028] In one embodiment, the inlet section 1, the outlet section 3 and the clamping section 2 are independently arranged.

[0029] Here, through the three-section independent structure design of the inlet section 1, the clamping section 2 and the outlet section 3, appropriate inlet section 1 and outlet section 3 can be selected according to the length of the actual micro interventional pump; the clamping section 2 with matching bending degree and diameter can be selected according to the bending degree and diameter of the actual micro interventional pump, so that the applicability of the test device is wide, and the test device has the characteristics of convenient installation and diversified combination. By matching the shape of various micro interventional pumps to process the corresponding inlet section 1, clamping section 2 and outlet section 3, the test device can be applied to the in vitro test of any specification of micro interventional pump.

[0030] It should be noted that the inlet section 1, the clamping section 2 and the outlet section 3 are hollow inside and the inner diameter shape and size can be changed, which can be adapted to the shape of the blood vessel under various pathological conditions, that is, the inside of the inlet section 1, the clamping section 2 and the outlet section 3 is a hollow cylindrical inside to adapt to the outer wall of the micro interventional pump, and at the same time make the micro interventional pump force evenly during testing, or the inside of the inlet section 1 and the outlet section 3 can also be a cavity adapted to the shape of the blood vessel under various pathological conditions, and the inside of the clamping section 2 can also be a cavity adapted to the shape of the micro interventional pump. The detachable connection between the clamping section 2 and the inlet section 1 and the outlet section 3 can be threaded connection, buckle connection or other any detachable connection mode. The clamping block 13 is detachably installed in the inside of the clamping section 2, so as to clamp and fix the micro interventional pump to be tested in the clamping section 2, and the area where the clamping block 13 is installed in the clamping section 2 forms the clamping area 9 of the clamping section 2 for clamping and positioning the micro interventional pump. The shape of the clamping block 13 can be adapted to the shape of the micro interventional pump, such as the shape of the clamping block 13 can be a hollow rubber ring, or a structure convenient for fixing in the inner cavity of the clamping section 2 and realizing clamping and fixing of the micro interventional pump. The sensor interface 11 arranged outside the inlet section 1 and the outlet section 3 is used for installing or connecting the sensor for collecting test data. Through the installed or connected sensor, the flow data, pressure data and other signals of the micro interventional pump to be tested can be collected and monitored.

[0031] For example, when the micro-interventional pump under test is clamped in the clamping section 2 by the clamping block 13, the inlet end of the micro-interventional pump under test is located at the connection between the clamping section 2 and the inlet section 1, and the outlet end of the micro-interventional pump under test is located at the connection between the clamping section 2 and the outlet section 3. Simultaneously, the inner diameters of the inlet section 1 and the outlet section 3 are adapted to the shape of the human aorta corresponding to the micro-interventional pump under test, for example, designed to simulate the shape of the human aorta. Furthermore, the curvature of the clamping section 2 matches the curvature of the micro-interventional pump, and its fixed position is the same as the actual valve position. This achieves a simulation of the mechanical environment and fixation method under real-world usage scenarios.

[0032] In one embodiment, the clamping section 2 is provided with a pump clamping positioning hole 10 for positioning the clamping block 13 when clamping the micro interventional pump. The pump clamping positioning hole 10 is close to one end of the clamping section 2 that connects to the outlet section 3, and the clamping block 13 is close to one end of the clamping section 2 that connects to the inlet section 1. The clamping block 13 and the pump clamping positioning hole 10 are axially aligned.

[0033] Here, the clamping block 13 can be a cylindrical body composed of a cylinder and a truncated cone connected together. The inner diameter of the pump clamping positioning hole 10 is the same as the inner diameter of the small circle of the truncated cone, and the small diameter end of the truncated cone is aligned with the pump clamping positioning hole 10. This achieves stable clamping and accurate positioning of the micro-invasive pump.

[0034] Furthermore, the clamping section 2 includes a vertical section and a curved section, which are connected to form the curved clamping section 2. The clamping block 13 is disposed within the vertical section, and the pump clamping positioning hole 10 is disposed at the connection between the vertical section and the curved section. The inlet section 1, outlet section 3, and vertical section are all cylindrical, and their inner diameters can be changed. The bending angle of the curved section can be changed to adapt to the shape of the micro-interventional pump, so that the micro-interventional pump is subjected to uniform force during testing. Here, the vertical section and the curved section can be integrally formed. The outer diameter of the cylinder of the clamping block 13 can be smaller than the inner diameter of the vertical section to facilitate the installation of the clamping block 13. Therefore, the angle of the clamping section can be changed to suit different test simulation requirements (such as simulating the bending angle of the aortic arch), and the inner diameters of the inlet section 1, outlet section 3, and vertical section can be changed to suit different test simulation requirements (such as simulating aortas of different sizes), that is, to adapt to the shape of the human aorta corresponding to the micro-interventional pump under test, for example, designed to simulate the shape of the human aorta. Here, the pipe lengths of both the inlet and outlet sections can be changed (e.g., to simulate different inflow and outflow channel lengths), making it suitable for various types of intervention pump designs.

[0035] Here, the inner diameters of the inlet and outlet sections are adapted to the shape of the human aorta corresponding to the micro-interventional pump under test, for example, designed to simulate the shape of the human aorta. The bending angle of the curved section is consistent with the angle at which the micro-interventional pump under test is implanted in the human body to simulate the biomechanical environment inside the body.

[0036] In one embodiment, the inlet section 1 is provided with a squeezing block 7 at the end connected to the clamping section 2. The squeezing block 7 extends in a direction away from the inlet section 1. The squeezing block 7 is a hollow cylinder and its outer diameter is smaller than the inner diameter of the vertical section. When the inlet section 1 is connected to the clamping section 2, the clamping block 13 is sleeved on the squeezing block 7. The outer diameter of the squeezing block 7 is smaller than the inner diameter of the clamping block 13, so that the squeezing block 7 squeezes the clamping block 13 to squeeze and adjust, thereby clamping and fixing the micro-interventional pump.

[0037] Preferably, the outer side of the inlet section 1 near the extrusion block 7 is provided with an external thread 6, the inner side of the clamping section 2 connected to the inlet section 1 is provided with an internal thread 8, the inner side of the outlet section 3 connected to the clamping section 2 is provided with an internal thread 8, and the outer side of the clamping section 2 connected to the outlet section 3 is provided with an external thread 6. This achieves a low-cost and high-efficiency detachable connection between the clamping section 2 and the inlet section 1 and outlet section 3. Here, to ensure the sealing of the connection, when the clamping section 2 is connected between the inlet section 1 and the outlet section 3, a washer with a diameter adapted to the pipe diameter and the external thread 6 can be added.

[0038] In one embodiment, a pagoda interface 4 is provided at the end of the inlet section 1 and outlet section 3 that is not connected to the clamping section 2. The pagoda interface 4 is used to connect to an external test circulation pipeline, thereby enabling quick disassembly and connection with the external test circulation pipeline while ensuring the overall sealing.

[0039] In one embodiment, the inlet section 1, outlet section 3, and clamping section 2 are made of a blood-compatible transparent material, such as polycarbonate. Here, the inlet section, outlet section, and clamping section are made of a highly transparent material with good blood compatibility, facilitating observation of changes in the internal environment of the testing device and meeting the requirements of in vitro hemolysis experiments and particle image velocimetry experiments. The clamping block 13 is made of a blood-compatible, soft material, such as silicone. Therefore, the clamping block of the clamping section is made of a soft, highly stable material with good blood compatibility. The clamping block has a hole in the middle, but its shape matches the shape of the clamping area. The softness of the clamping block can adapt to interventional pumps of different diameters, simultaneously fulfilling the functions of clamping, occlusion (simulating valve closure), and leak prevention (sealing function). This also ensures that the testing device has high blood compatibility.

[0040] Here, the outer part between the pagoda interface 4 of the inlet section 1 and the threaded part of the outlet section 3 can be set as a round pipe 5.

[0041] Specifically, before testing, it is necessary to select a clamping section 2 that matches the diameter and curvature of the micro-interventional pump under test, and an inlet section 1 and an outlet section 3 that match the length of the micro-interventional pump under test. Then, a clamping block 13 with a central hole is placed in the clamping area 9 of the clamping section 2. The micro-interventional pump under test is then passed through the hole in the clamping block 13 and the pump clamping positioning hole 10. The inlet section 1 of the micro-interventional pump should be at the internal thread 8 of the clamping section 2, while the outlet section 3 should be at the external thread 6 of the clamping section 2. After placing the micro-interventional pump, the inlet section 1 is connected to the internal thread 8 of the clamping section 2 via the external thread 6. Then, the clamping block 13 in the clamping area 9 is compressed by the squeezing block 7 of the inlet section 1, reducing the central hole of the clamping block 13 until there is no gap between the silicone block and the micro-interventional pump, thereby achieving fixation of the interventional pump and uniform force distribution in the clamping position. Finally, the external thread 6 of the clamping section 2 and the internal thread 8 of the outlet section 3 are connected, and the entire in vitro testing device for the micro-interventional pump is assembled. To prevent liquid leakage, a washer with a diameter similar to the pipe diameter can be added between the external thread 6 of clamping section 2 and the internal thread 8 of outlet section 3. During testing, the entire in vitro testing device needs to be connected to the extracorporeal circulation pipeline through the pagoda-shaped interface to realize the in vitro testing of the micro-interventional pump. The signals collected by the in vitro testing device are transmitted to the data acquisition unit through the sensor interface 11 of inlet section 1 and outlet section 3.

[0042] Therefore, the in vitro testing device for the micro-interventional pump of the present invention, through its three-section design and detachable connection between the clamping section 2 and the inlet section 1 and outlet section 3, makes the testing device applicable to the in vitro testing of various micro-interventional pumps, thus having a wide range of applications. The inner diameters of the inlet section 1 and outlet section 3 are the same as the diameter of the aorta, and the curvature of the clamping section 2 matches the curvature of the pump tube. Its fixed position is the same as the actual valve position, simulating the mechanical environment and fixation method under real-world usage scenarios. The sections are connected by threads, and the testing device is connected to the outside via a pagoda-shaped opening, making it easy to install and remove. The inlet and outlet sections 3 and the clamping section 2 are all made of polycarbonate material, ensuring good blood compatibility. Both the inlet section 1 and outlet section 3 are designed with sensor interfaces 11 for easy data acquisition.

[0043] In the description of this invention, the terms "first," "second," "another," and "yet another" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the stated features. In the description of embodiments of this invention, "a plurality of" means two or more, unless otherwise explicitly specified.

[0044] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "connected" and "linked" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances. Furthermore, in the description of this invention, unless otherwise stated, "a plurality of" means two or more.

[0045] Although embodiments of the invention have been shown and described, those skilled in the art will understand that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the claims and their equivalents.

Claims

1. An in vitro testing device for a miniature interventional pump, characterized in that, It includes an internally hollow inlet section, a clamping section, and an outlet section; one end of the clamping section is detachably connected to the inlet section, and the other end is detachably connected to the outlet section; the clamping section is curved, and the curvature of the clamping section is adapted to the curvature of the micro-interventional pump to be tested; the ends of the inlet and outlet sections not connected to the clamping section are used to connect to an external test circulation pipeline; the clamping section is provided with a clamping block for clamping the micro-interventional pump to be tested, and the inner diameter of the clamping block is adapted to the outer diameter of the micro-interventional pump to be tested; The clamping section includes a vertical section and a curved section, which are connected to form a curved clamping section. The clamping block is disposed within the vertical section. The clamping section has a pump clamping positioning hole inside, which is used to position the clamping block when clamping the micro-interventional pump. The pump clamping positioning hole is located near the end of the clamping section that connects to the outlet section, and the clamping block is located near the end of the clamping section that connects to the inlet section. The clamping block and the pump clamping positioning hole are axially aligned. The pump clamping positioning hole is located at the connection between the vertical section and the curved section. The inlet section is provided with a squeezing block at one end connected to the clamping section. The squeezing block extends in a direction away from the inlet section. The squeezing block is a hollow cylinder and its outer diameter is smaller than the inner diameter of the vertical section. When the inlet section is connected to the clamping section, the clamping block is sleeved on the squeezing block. The outer diameter of the squeezing block is smaller than the inner diameter of the clamping block, so that the squeezing block squeezes the clamping block for squeezing adjustment. The inner diameters of the inlet and outlet sections are adapted to the shape of the aorta of the human body corresponding to the micro-interventional pump under test, and the bending angle of the curved section is consistent with the angle at which the micro-interventional pump under test is implanted in the human body.

2. The in vitro testing device for the micro-interventional pump according to claim 1, characterized in that, When the micro-interventional pump to be tested is clamped in the clamping section by the clamping block, the inlet end of the micro-interventional pump to be tested is located at the connection between the clamping section and the inlet section, and the outlet end of the micro-interventional pump to be tested is located at the connection between the clamping section and the outlet section. Sensor interfaces are provided on the outside of the inlet section and the outlet section for connecting test sensors.

3. The in vitro testing device for the micro-interventional pump according to claim 1, characterized in that, The inlet section, outlet section, and clamping section are independently configured, and the corresponding inlet section, clamping section, and outlet section are machined to match the shape of various micro interventional pumps.

4. The in vitro testing device for the micro-interventional pump according to claim 1, characterized in that, The inlet section has an external thread on the outer side of the end near the extrusion block, the clamping section has an internal thread on the inner side of the end connected to the inlet section, the outlet section has an internal thread on the inner side of the end connected to the clamping section, and the clamping section has an external thread on the outer side of the end connected to the outlet section.

5. The in vitro testing device for the micro-interventional pump according to claim 1, characterized in that, The inlet and outlet sections are provided with a pagoda interface at the ends not connected to the clamping section. The pagoda interface is used to connect to an external test circulation pipeline.

6. The in vitro testing device for the micro-interventional pump according to any one of claims 1-5, characterized in that, The inlet section, outlet section, and clamping section are made of a transparent material that is compatible with blood, and the clamping block is made of a soft material that is compatible with blood.

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