Catheter pump position judgment device and method, catheter pump, ventricular assist system, storage medium and equipment

Abstract

The invention relates to a catheter pump position judgment device and method, a catheter pump, a ventricular assist system, a storage medium and equipment.The catheter pump position judgment device comprises a sampling module, a processing module and a judgment module, and the sampling module is configured to collect operation data of a driving motor of the catheter pump in the conveying process; the operation data at least comprises rotating speed data; the processing module is configured to determine a range value of the rotating speed data; the judgment module is configured to determine the position state of the catheter pump according to the comparison result of the range value and a preset threshold value. The method does not need to depend on an additional pressure sensor or multiple times of radiography, and can judge whether the catheter pump is located in the aorta, the transvalvular position or the left ventricle by collecting the rotating speed data of the driving motor and analyzing the range value of the rotating speed data.

Description

Technical Field

[0001] The present invention relates to the technical field of ventricular assist devices, and in particular to a catheter pump position determination device, method, catheter pump, ventricular assist system, storage medium and device. Background Art

[0002] Percutaneous vascular assist devices (pVADs) are widely used in high-risk percutaneous coronary intervention (PCI) and other cardiac interventional procedures to provide temporary mechanical circulatory support. During traditional pVAD implantation, doctors first place a guidewire into the ventricle for guidance, then deliver a catheter pump along the guidewire to the target location.

[0003] In clinical practice, doctors usually use digital subtraction angiography (DSA) technology to monitor the position of the catheter pump in real time to ensure that it reaches the transvalvular position accurately. However, this traditional positioning method has several technical drawbacks:

[0004] First, if the DSA imaging effect is blurry, doctors often need to increase the number of developments and extend the operation time to make an accurate judgment. This not only increases the difficulty of the operation, but also causes patients and medical staff to be exposed to excessive X-rays, bringing the risk of physiological damage; secondly, frequent DSA angiography will prolong the entire operation time and increase the risk of infection and other complications for patients.

[0005] In addition, in traditional pVAD technology that requires guidewire insertion and guidance, the guidewire needs to enter the outflow chamber and exit through the internal channel of the pump body. This design makes it impossible to start the motor of the catheter pump during the delivery process, otherwise the rotating impeller will collide with the guidewire, causing serious safety hazards; and the motor cannot be started before the catheter pump reaches the target position, so the motor operation data cannot be used for position judgment, resulting in doctors having to rely entirely on imaging methods to position the catheter pump. Summary of the Invention

[0006] In view of this, embodiments of the present invention provide a catheter pump position determination device, method, catheter pump, ventricular assist system, storage medium and equipment to solve the problems existing in the prior art.

[0007] The present invention adopts the following technical solutions:

[0008] In a first aspect, an embodiment of the present invention provides a catheter pump position determination device, comprising:

[0009] a sampling module configured to collect operating data of a driving motor of the catheter pump during the conveying process, the operating data including at least speed data;

[0010] a processing module configured to determine a range value of the speed data;

[0011] The judgment module is configured to determine the position state of the catheter pump based on a comparison result between the extreme difference value and a preset threshold value.

[0012] In a second aspect, an embodiment of the present invention provides a method for determining the position of a catheter pump, comprising:

[0013] Collecting operating data of the driving motor of the catheter pump during the conveying process, the operating data at least including speed data;

[0014] Determine the range of speed data;

[0015] The position state of the catheter pump is determined based on the comparison result of the extreme difference value and the preset threshold value.

[0016] In a third aspect, an embodiment of the present invention provides a catheter pump for use in conjunction with the above-mentioned catheter pump position judgment device, which includes, from the distal end to the proximal end, a pigtail tube, a distal flow chamber, a cannula, a proximal flow chamber and a drive motor. An impeller is provided in the proximal flow chamber, and the impeller is driven and rotated by the drive motor; a fluid channel is configured between the distal flow chamber and the proximal flow chamber; the cannula is provided with a penetration channel, and the penetration channel is for the proximal end of the guide wire to pass through, so that at least part of the section of the guide wire does not overlap with the fluid channel and does not pass through the proximal flow chamber, so as to avoid the guide wire interfering with the running impeller.

[0017] In a fourth aspect, an embodiment of the present invention provides a ventricular assist system, comprising a catheter pump and a catheter pump position determination device as described above; the catheter pump comprises an impeller disposed in a proximal flow chamber, and the catheter pump is configured such that no guidewire passes through the proximal flow chamber during delivery to avoid interference of the guidewire with the running impeller.

[0018] In a fifth aspect, an embodiment of the present invention provides a computer-readable storage medium, wherein the storage medium stores at least one instruction, and the at least one instruction is loaded and executed by a processor to implement the catheter pump position determination method as described above.

[0019] In a sixth aspect, an embodiment of the present invention provides an electronic device, comprising a processor and a memory, wherein the memory stores at least one instruction, and the instruction is loaded and executed by the processor to implement the catheter pump position determination method as described above.

[0020] One embodiment of the above invention has the following advantages or beneficial effects:

[0021] The embodiment of the present invention provides a catheter pump position determination device and determination method, which does not rely on additional pressure sensors or multiple angiography. By collecting the speed data of the drive motor and analyzing its range value, it can accurately determine whether the catheter pump has reached the transvalvular position. The present invention further achieves accurate judgment of whether the catheter pump is located in the aorta or ventricle by comparing the range value relative to the preset threshold value within the continuous sampling window and the historical record of the transvalvular position. This non-invasive position determination method based on speed data not only improves the accuracy and reliability of positioning, but also simplifies the operation process, reduces the difficulty of operation for doctors and the risk to patients.

[0022] In addition, an embodiment of the present invention also provides a catheter pump and involves a new guidewire insertion path solution. By setting a insertion port on the proximal wall of the cannula, the guidewire can pass through the side wall of the cannula after passing through the pigtail tube, completely avoiding the key working area of the impeller rotation in the proximal flow chamber, so that the catheter pump can safely start the motor during the guidewire-guided delivery process, providing a basic condition for real-time position judgment of the catheter pump in the human body. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the following briefly introduces the drawings required for describing the embodiments, which constitute a part of the present invention. The exemplary embodiments of the present invention and their descriptions are provided to explain the present invention and do not constitute an undue limitation of the present invention. In the drawings:

[0024] Figure 1 A schematic diagram of the three-dimensional structure of a catheter pump provided in one embodiment of the present invention;

[0025] Figure 2 A front view of a catheter pump provided in accordance with an embodiment of the present invention;

[0026] Figure 3 for Figure 2 A partial enlarged view of point A in the middle;

[0027] Figure 4 A schematic diagram of the structure of a shielding structure provided by one embodiment of the present invention on the outside of the cannula wall;

[0028] Figure 5 A schematic diagram of the structure of a shielding structure provided by one embodiment of the present invention on the inner side of the intubation tube wall;

[0029] Figure 6 A schematic diagram of a waveform of the speed data of a drive motor provided by one embodiment of the present invention;

[0030] Figure 7 A schematic diagram of a waveform of rotational speed data of a catheter pump in the aorta provided by one embodiment of the present invention;

[0031] Figure 8 A schematic diagram of a rotational speed data waveform of a catheter pump in a transvalvular position provided by one embodiment of the present invention;

[0032] Figure 9 A schematic diagram of a speed waveform of a catheter pump provided by one embodiment of the present invention when entering the left ventricle;

[0033] Figure 10 A structural block diagram of a catheter pump position determination device provided by one embodiment of the present invention;

[0034] Figure 11 A flow chart of a method for determining the position of a catheter pump provided in one embodiment of the present invention;

[0035] Figure 12 A detailed flow chart of a method for determining the position of a catheter pump provided in one embodiment of the present invention.

[0036] Description of reference numerals:

[0037] Pigtail tube 11, distal flow chamber 12, cannula 13, penetration port 131, shielding structure 132, proximal flow chamber 14, driving motor 15, guide wire 16. DETAILED DESCRIPTION

[0038] To make the objectives, technical solutions, and advantages of the present invention more clear, the technical solutions of the present invention will be clearly and completely described below in conjunction with specific embodiments of the present invention and corresponding drawings. In the description of the present invention, it should be noted that the term "or" is generally used in the sense of including "and / or" unless the content clearly indicates otherwise.

[0039] In the description of this invention, it should be noted that, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "connected" should be understood broadly. Furthermore, in the description of this application, the terms "first," "second," and so on are used solely for descriptive purposes and should not be construed as indicating or implying relative importance. In specific embodiments, "distal end" refers to the end of the catheter pump, farther from the operator, along the delivery direction of the catheter pump; "proximal end" refers to the end of the catheter pump, closer to the operator, along the delivery direction of the catheter pump.

[0040] Obviously, the embodiments described are only some of the embodiments of the present invention, not all of them. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0041] A percutaneous ventricular assist device (pVAD) (hereinafter referred to as a VAD) is a crucial instrument in the transitional phase of treatment and transplantation for patients with severe heart failure. In a preferred embodiment, the VAD comprises an external control device and a transvalvular catheter pump. This catheter pump is percutaneously and invasively placed at the transvalvular site to increase blood flow, reduce myocardial oxygen consumption, and, in the short term, enhance the heart's pumping function in patients with acute heart failure. For example, in left ventricular assist, the transvalvular site is the aortic valve. The inflow chamber and pigtail of the catheter pump are placed in the left ventricle, while the outflow chamber is located in the aorta, allowing blood to be pumped from the left ventricle into the aorta, alleviating the burden on the heart and maintaining adequate blood circulation.

[0042] During the delivery process, traditional catheter pump position determination relies on DSA imaging technology, which not only increases the radiation exposure of patients and medical staff, but also prolongs the operation time and increases risks when the imaging is unclear. In addition, the structure of the catheter pump using the traditional guidewire threading method requires the proximal end of the guidewire to pass through the blood outflow chamber area, which will interfere with the rotation path of the impeller in the catheter pump and make it impossible to start the drive motor and collect operating data during the delivery process. Therefore, it also limits medical personnel from determining the transvalvular position based on the operating status of the catheter pump.

[0043] To solve the above problems, the present invention provides a catheter pump in one embodiment. Figure 1 Preferably, the catheter pump comprises, from distal to proximal ends, a pigtail tube 11, a distal flow chamber 12, a cannula 13, a proximal flow chamber 14, and a drive motor 15. The proximal flow chamber 14 houses an impeller driven by the drive motor 15. The impeller has a helical structure and is configured to rotate at high speed under the drive motor 15, generating blood flow. During operation, the impeller pumps blood in the left ventricle from the distal flow chamber 12 through the cannula 13 into the proximal flow chamber 14, and ultimately into the aorta, thereby assisting the circulation.

[0044] Preferably, the above-mentioned distal flow chamber 12 and proximal flow chamber 14 both refer to chamber structures in the catheter pump for guiding blood flow. In this embodiment, the catheter pump is preferably used for left heart assist, so the distal flow chamber 12 is used as a blood inflow chamber for receiving blood from the left ventricle; the proximal flow chamber 14 is used as a blood outflow chamber for transporting blood to the aorta; the cannula 13 is located between the distal flow chamber 12 and the proximal flow chamber 14, and the cannula 13, the distal flow chamber 12 and the proximal flow chamber 14 together constitute a fluid channel for blood flow. Preferably, when the catheter pump is in the transvalvular position, it means that the cannula 13 is located at the position of the aortic valve, and the distal flow chamber 12 is located in the left ventricle, and the proximal flow chamber 14 is located in the aorta.

[0045] Preferably, a penetration channel is provided on the cannula 13 for the proximal end of the guide wire 16 to pass through, so that at least part of the guide wire 16 does not overlap with the fluid channel and does not pass through the proximal flow chamber 14, so as to avoid the guide wire interfering with the running impeller.

[0046] Optionally, the penetration channel can adopt a variety of structural forms to achieve the functional goal of partially or completely separating the penetration path of the guide wire 16 from the fluid channel and not passing through the proximal flow chamber 14, so that the catheter pump can safely start the motor during the guide wire 16 guided delivery process, providing a structural basis for the catheter pump to realize position judgment based on the operating data of the drive motor 15.

[0047] In a preferred embodiment, the passageway is provided as a guide base fixed to the outer surface of cannula 13. This guide base is provided with a through hole parallel to the main axis of cannula 13, allowing guidewire 16 to pass through and extend along the outer surface of cannula 13. This allows guidewire 16 to be completely located outside the fluid passageway, avoiding any interference with the working components within the fluid passageway (particularly the impeller within proximal flow chamber 14). In this embodiment, the size and location of the guide base are not specifically limited; those skilled in the art may adapt its specifications and location based on clinical needs.

[0048] In another preferred embodiment, the penetration channel is integrated into the tube wall structure of the cannula 13 to form an independent guide wire 16 channel, which is arranged parallel to the central axis of the cannula 13 and has openings at the proximal and distal ends of the cannula 13, forming a complete guide wire 16 penetration passage.

[0049] refer to Figure 2 、 Figure 3 In another preferred embodiment, the penetration channel is configured as a penetration opening 131 extending through the wall of the cannula 13. This penetration opening 131 is preferably located at the proximal end of the cannula 13 and is capable of communicating with the lumen of the pigtail tube 11, forming a through-path from the sidewall of the cannula 13 to the pigtail tube 11. Through penetration opening 131, the guidewire 16 can first be inserted through the pigtail tube 11 and then extend out of the catheter pump through penetration opening 131. This allows the guidewire 16 to completely avoid the proximal flow chamber 14, thereby eliminating the risk of interference between the guidewire 16 and the impeller within the proximal flow chamber 14.

[0050] Preferably, in order to prevent blood from leaking from the penetration opening 131 after the guide wire 16 is withdrawn, a one-way closable shielding structure 132 is provided on the inner side of the penetration opening 131. The shielding structure 132 is configured to open when the guide wire 16 is inserted and to close the penetration opening 131 after the guide wire 16 is withdrawn.

[0051] Specifically, Figure 4This is a view of the shielding structure 132 displayed from the outside of the tube wall of the cannula 13. In this view, a through-hole 131 is provided on the tube wall of the cannula 13, and a shielding structure 132 is provided in the through-hole 131. When no guide wire 16 is passed through, the shielding structure 132 can completely cover the through-hole 131. Figure 5 The shielding structure 132 is shown from the inner side of the tube wall of the cannula 13. One side of the shielding structure 132 ( Figure 5 The red line portion in the middle is fixedly connected to the tube wall of the cannula 13 to form a one-way openable structure.

[0052] When the guidewire 16 is inserted from the pigtail tube 11, the guidewire 16 pushes the shielding structure 132 to rotate toward the interior of the cannula 13, allowing the shielding structure 132 to open and expose the insertion opening 131, thereby forming a through passage for the guidewire 16. When the guidewire 16 is withdrawn, the shielding structure 132 automatically rotates back to its original position due to its own elasticity, so that the shielding structure 132 re-covers the insertion opening 131, thereby effectively sealing the insertion opening 131. Due to the presence of the shielding structure 132, when the catheter pump is in operation, the blood pressure will further press the shielding structure 132 against the insertion opening 131, thereby improving the reliability of the seal.

[0053] Optionally, the shielding structure 132 can be made of a polymer material with good biocompatibility and elastic recovery properties. This embodiment does not specifically limit the specific material, thickness, shape and other parameters of the shielding structure 132. Those skilled in the art can make reasonable selections and adjustments based on actual application requirements and manufacturing processes, as long as the function of opening when the guide wire 16 is inserted and automatically closing the insertion port 131 after the guide wire 16 is withdrawn can be achieved.

[0054] Furthermore, the embodiment of the present invention provides a catheter pump position determination device, referring to Figure 10 The device preferably includes a sampling module 22, a processing module 23, and a judgment module 24. The sampling module 22 is configured to collect operating data of the catheter pump's drive motor 15 during delivery; the processing module 23 is configured to determine the range of rotational speed data within the operating data; and the judgment module 24 is configured to determine the position of the catheter pump based on a comparison of the range of rotational speed data with a preset threshold. It should be noted that the catheter pump position determination device of the present invention has broader applicability and can be used with both catheter pumps requiring guidewire guidance as described in the above embodiments and catheter pumps not requiring guidewire guidance. Its core determination principle is based on analysis of the drive motor's operating data and is independent of the specific delivery method of the catheter pump.

[0055] In a preferred embodiment, the device further comprises a control module 21 configured to control the drive motor 15 to operate at a preset speed, which is lower than the normal operating speed of the catheter pump to avoid interfering with the patient's blood flow.

[0056] Since the catheter pump usually has a high speed under normal working conditions to meet the needs of clinical auxiliary blood supply, but in the position determination stage, the main function of the catheter pump is to provide position information rather than hemodynamic support, so using a lower speed can minimize interference to the patient while ensuring data collection.

[0057] It should be noted that an excessively low speed may cause the drive motor 15 to start unstably or become insensitive to load changes, affecting the accuracy of position determination. Therefore, although the preset speed is lower than the normal operating speed, it must still be maintained within a reasonable range to ensure stable motor operation and a clear response to external load changes (this response is the fluctuation of the operating data collected by the sampling module 22). The specific preset speed value can be adjusted and optimized based on the model and size of the catheter pump and the clinical application scenario, and is not specifically limited in this embodiment.

[0058] In a preferred embodiment, the operating data collected by sampling module 22 may be selected from the speed data or current data of drive motor 15. Those skilled in the art will appreciate that, in the operating characteristics of the drive motor 15 of a catheter pump, both speed data and current data can reflect changes in load and hemodynamics. Compared to current data, speed data responds more directly and stably to load changes and is less susceptible to external interference. Therefore, in this embodiment, sampling module 22 preferably collects and processes speed data.

[0059] Specifically, when the catheter pump travels in the blood vessel, because the distal flow chamber 12 and the proximal flow chamber 14 are in the same environment and have similar pressures, the rotation speed thereof does not change much with changes in flow rate. Figure 6 B in the Figure 7 When the catheter pump is in the transvalvular position, due to the presence of the valve, the distal flow chamber 12 is located in the left ventricle, and the proximal flow chamber 14 is located in the aorta. The pressures at both ends are different. With each heartbeat, the speed will show the same changes as the heart rate cycle, such as Figure 6 Center C and Figure 8 If the catheter pump is inserted too deeply, causing the distal flow chamber 12 and the proximal flow chamber 14 to be in the left ventricle, the speed waveform will show little change, such as Figure 6 D in the middle and Figure 9 .

[0060] In a preferred embodiment, the sampling module 22 is further configured to collect rotational speed data within at least one sampling window at a preset sampling interval.

[0061] Preferably, the preset sampling interval t is set to 10-100ms. If the sampling interval is too short, higher-precision data can be obtained, but it will occupy more system memory and increase calculation time. If the sampling interval is too long, although the system burden can be reduced, it may cause subsequent calculations to be inaccurate. To achieve a balance between system resources and data accuracy, the preset sampling interval t is preferably set to 20ms.

[0062] Preferably, the sampling window is configured such that when the catheter pump moves at a preset delivery speed, its moving distance is less than the distance between the distal flow chamber 12 and the proximal flow chamber 14 , or its moving distance is less than the length of the cannula 13 .

[0063] Specifically, the preset delivery speed is the standard propulsion speed commonly used by clinicians in catheter pump interventional operations. At this preset speed, it is necessary to ensure that during the data acquisition process of a single sampling window, the displacement distance of the catheter pump will not exceed the distance between the distal flow chamber 12 and the proximal flow chamber 14, or will not exceed the length of the cannula 13.

[0064] Because processing module 23 calculates the range of the speed data within each sampling window as a basis for determining the catheter pump's position, it is essential to ensure that the data within each sampling window is collected while the catheter pump is in the same position. If the sampling window is too large, causing the catheter pump to move excessively during a single data acquisition process, the catheter pump may transition from one position to another, such as from a fully aortic position to a transvalvular position. This can result in data from mixed positions within the same calculation cycle, making the range of the calculated data inaccurately reflect the actual position of the catheter pump.

[0065] By limiting the duration of the sampling window, it can be ensured that the data set processed by the processing module 23 during each calculation corresponds to a single position state of the catheter pump, thereby ensuring that the extreme difference calculation result can truly reflect the speed fluctuation characteristics under this position state, providing a reliable decision-making basis for the judgment module 24.

[0066] In a preferred embodiment, the sampling window is set to 5 seconds, that is, (5000 / t) rotation speed data can be recorded within the sampling window.

[0067] In actual applications, the speed data is often affected by various factors such as the motor's own vibration, power supply fluctuations, electromagnetic interference, and blood flow pulsation, generating high-frequency noise and random fluctuations. Therefore, in a preferred embodiment, the sampling module 22 is also configured to perform necessary filtering processing on the collected speed data to eliminate noise interference.

[0068] In a preferred embodiment, the processing module 23 is further configured to: determine a range value of the speed data in at least one sampling window; wherein the range value is the difference between the maximum value and the minimum value of the speed data in the sampling window.

[0069] Specifically, when the catheter pump is in the transvalvular position, because the proximal flow chamber 14 and the distal flow chamber 12 are located in the aorta and left ventricle, respectively, with completely different pressure environments, the speed data exhibits obvious periodic fluctuations, with clear peaks (maximum speed data) and troughs (minimum speed data) generated within each cardiac cycle. The processing module 23 first determines the values of several peaks and troughs, then calculates the average of the peaks and troughs, and finally calculates the difference between these two averages as the final range value. This averaging method based on multi-cycle data can effectively filter out the influence of random noise and occasional outliers, making the calculated range value more stable and reliable, accurately reflecting the true state of the catheter pump position.

[0070] In contrast, when the catheter pump is completely within the left ventricle or the aorta, because the proximal flow chamber 14 and the distal flow chamber 12 are in similar pressure environments, the fluctuation amplitude of the speed data is smaller, and the calculated range value is significantly lower than that of the transvalvular position state. Therefore, this significant range difference provides a clear quantitative basis for the judgment module 24 to accurately distinguish between different catheter pump position states, providing real-time and reliable position feedback for clinical operations.

[0071] In a preferred embodiment, determination module 24 is further configured to determine that the catheter pump is currently in a transvalvular position if the range difference within the current sampling window exceeds a preset threshold. In this case, sampling module 22 may only collect speed data within a single sampling window, and processing module 23 may only calculate the range difference within the current sampling window.

[0072] In a preferred embodiment, the preset threshold value can be selected as 500 (unit: rpm). This value can be adjusted according to actual needs and is not specifically limited in this embodiment. Specifically, the preset threshold value is set based on extensive clinical data and experimental verification, and can effectively distinguish the rotational speed fluctuation characteristics of transvalvular positions from non-transvalvular positions (i.e., within the aorta or left ventricle). When the calculated range value is greater than the preset threshold value, the judgment module 24 can directly determine that the catheter pump is currently in the transvalvular position without further data collection and analysis, thereby simplifying the data processing process, reducing the computational burden, and improving the device's response speed.

[0073] In a preferred embodiment, the judgment module 24 is further configured to: determine whether the catheter pump is currently located in the aorta or the ventricle based on the comparison result of the extreme difference values in at least two consecutive sampling windows relative to a preset threshold and the historical record of the transvalvular position.

[0074] Specifically, when the extreme difference value does not exceed the preset threshold, it indicates that the catheter pump is not in a transvalvular position. However, a single extreme difference value cannot directly determine whether it is located in the aorta or the left ventricle, because the speed fluctuation characteristics are similar in these two cases. Therefore, it is necessary to combine the timing information of the catheter pump position change and the historical position records to make further position judgments. At this time, speed data within at least two sampling windows is required.

[0075] In a preferred embodiment, determination module 24 is further configured to determine that the catheter pump is located within the aorta when there is no historical record of the catheter pump transvalvular position and the range difference values within multiple consecutive sampling windows are no greater than a preset threshold. This is because in a typical interventional procedure, the catheter pump is typically first inserted through a peripheral blood vessel and then reaches the heart through the aorta. If no transvalvular feature is detected, it indicates that the catheter pump has not yet reached the aortic valve and is still located within the aorta.

[0076] In a preferred embodiment, the determination module 24 is further configured to determine that the catheter pump is located in the left ventricle when a historical record of the catheter pump's transvalvular position exists and the range error value within the current sampling window is no greater than a preset threshold. This is because the catheter pump generates a characteristic record of its transvalvular position as it moves from the aorta through the aortic valve into the left ventricle. Once the catheter pump has fully entered the left ventricle, the range error value decreases again, but at this point the catheter pump is already located within the left ventricle.

[0077] In a preferred embodiment, determination module 24 is further configured to determine that the catheter pump is located within the aorta if the catheter pump has a history of two valve-crossing positions and the range difference within the current sampling window is no greater than a preset threshold. This corresponds to the catheter pump first entering the left ventricle from the aorta and then withdrawing from the left ventricle to the aorta, during which two valve-crossing characteristics are generated. After the second valve-crossing is completed, the catheter pump returns to the aorta, and the range difference decreases again.

[0078] In a more specific embodiment, the judgment module 24 is further configured to use two flags, Alert and Loc, to indicate the position status of the catheter pump and provide position prompt information to the user accordingly. Preferably, if the range value within the current sampling window is less than a preset threshold, Alert = 1; if the range value within the current sampling window is greater than the preset threshold, Alert = 0; if there is no historical record of translobar position in the historical records, Loc = 0; if there is a historical record of translobar position in the historical records, Loc = 1, and this is always maintained.

[0079] Specifically, when the range value within the sampling window is less than a preset threshold, the judgment module 24 sets Alert=1, indicating that the catheter pump is operating in the blood vessel; as the catheter pump gradually extends into the heart and crosses the heart valve, that is, when the distal flow chamber 12 enters the heart and the proximal flow chamber 14 is still in the aorta, the speed waveform changes, and its range value exceeds the preset threshold. The judgment module 24 believes that it has reached the correct position, sets Alert=0, and sets the flag bit Loc=1 at the same time; if the catheter pump continues to go deeper, it will completely enter the left ventricle. At this time, the judgment module 24 sets Alert=1 again, and the Loc flag bit remains unchanged at 1.

[0080] In the aforementioned flag-based implementation, when Alert = 1 and Loc = 0, the catheter pump is located in the aorta or an earlier vessel; when Alert = 0 and Loc = 1, it indicates the correct position, with the catheter pump in a transvalvular position; and when Alert = 1 and Loc = 1, it indicates the catheter pump is in the ventricle. By setting flags, clinicians can be provided with clear and intuitive position feedback, effectively guiding the precise positioning of the catheter pump and improving the safety and effectiveness of clinical applications.

[0081] In a preferred embodiment, the device further includes an alarm module 25 , which is configured to generate an alarm prompt based on the position determination result of the determination module 24 .

[0082] Preferably, when the judgment module 24 determines that the catheter pump is located in the aorta and has not yet reached the expected position, the alarm module 25 will trigger a prompt message "The catheter pump has not reached the correct position"; when it is determined that the catheter pump is in a transvalvular position, it will generate a prompt "The catheter pump is detected to be in a transvalvular position, please use DSA to confirm", guiding the doctor to confirm the position through imaging methods such as digital subtraction angiography (DSA); when it is determined that the catheter pump has completely entered the left ventricle, it will issue a warning "The catheter pump is detected to be in the heart, please withdraw it slightly", reminding the doctor to adjust the position of the catheter pump to avoid possible damage to the heart cavity.

[0083] Preferably, the alarm module 25 can generate various forms of alarm prompts, including but not limited to text prompts on the display screen, color-coded indications (such as red for warning, green for correct position), sound alarms, and optional vibration reminders.

[0084] Specifically, the control module 21, sampling module 22, processing module 23, judgment module 24 and alarm module 25 in the embodiment of the present invention are all integrated into the extracorporeal control device of the ventricular assist device. The extracorporeal control device serves as the core control unit of the entire ventricular assist system. It is not only responsible for the routine operation control of the catheter pump, but also obtains the speed data of the drive motor 15 on the catheter pump in real time through a dedicated data interface. Each functional module then performs its own function to determine the current position status of the catheter pump, and finally generates corresponding position prompts and alarm information on the human-computer interaction interface of the extracorporeal control device.

[0085] Based on the catheter pump position determination device provided in the above embodiment, taking the catheter pump that requires guidewire guidance in the above embodiment as an example, the specific operation method is as follows:

[0086] First, under the guidance of imaging methods such as digital subtraction angiography (DSA), the doctor places the guide wire 16 into the patient's ventricle, then passes the guide wire 16 through the pigtail tube 11 of the catheter pump and out from the insertion port 131, and uses auxiliary structures such as the sheath to establish an interventional pathway for the catheter pump.

[0087] Next, the control module 21 can set the catheter pump motor speed to a preset speed lower than the working speed. At the same time, the operator gradually advances the catheter pump along the pre-established pathway toward the heart. During this process, the sampling module 22 continuously collects speed data, the processing module 23 performs real-time data processing, and the judgment module 24 performs catheter pump position judgment. The operator needs to closely observe the position status information displayed on the human-computer interaction interface of the extracorporeal control device.

[0088] When the catheter pump reaches the correct transvalvular position, the judgment module 24 determines the current position status based on the calculation result of the speed extreme difference value, and the alarm module 25 immediately updates the prompt information on the human-computer interaction interface. The original "catheter pump is in the wrong position" alarm prompt disappears, and instead displays the confirmation information "the catheter pump is detected to be in the transvalvular position". At this time, the operator only needs to confirm through DSA imaging once to verify that the catheter pump has been accurately positioned in the ideal transvalvular position, which significantly reduces the need for repeated DSA positioning and reduces the radiation exposure risk of patients and medical staff.

[0089] Finally, after the precise positioning of the catheter pump is completed, the guide wire 16 is withdrawn, the catheter pump is left in the correct position, the surgical operation is completed, and the subsequent treatment stage begins.

[0090] The catheter pump position determination device described above replaces some imaging positioning processes, simplifying clinical procedures and shortening surgical time. It also improves the accuracy and real-time nature of position determination, providing strong support for the safe and efficient use of catheter pumps. Furthermore, this method fully utilizes the speed characteristics of the catheter pump itself, eliminating the need for additional sensors or equipment. This method offers significant advantages, including simple structure, low cost, and ease of implementation.

[0091] An embodiment of the present invention further provides a ventricular assist system, comprising a catheter pump and an external control device. A catheter pump position determination device is integrated into the external control device, and its corresponding functional modules are implemented via a software program. The ventricular assist system can utilize either the catheter pump with the innovative perforation channel described in the above embodiment, or a catheter pump with other structural forms, such as a catheter pump without a guidewire 16, or a catheter pump structure with a guidewire 16 but in which the guidewire 16 does not pass through the impeller in the proximal flow chamber 14. Regardless of the catheter pump structure employed, the external control device can determine the position of different catheter pump types based on motor operating data, resulting in improved system compatibility and technical adaptability.

[0092] refer to Figure 11 、 Figure 12 One embodiment of the present invention further provides a method for determining the position of a catheter pump, the method comprising at least the following steps:

[0093] Step S31 : collecting operating data of the driving motor of the catheter pump during the delivery process, where the operating data at least includes speed data.

[0094] In a preferred embodiment, before collecting the operating data of the drive motor 15 , the drive motor 15 is first controlled to run at a preset speed, which is configured to be lower than the normal operating speed of the catheter pump to avoid interfering with the patient's blood flow.

[0095] In a preferred embodiment, the collected operating data of the drive motor 15 may be speed data or current data of the drive motor 15 . In this embodiment, the speed data is preferably collected and processed.

[0096] In a preferred embodiment, step S31 further specifically includes: collecting rotational speed data within at least one sampling window at a preset sampling interval.

[0097] Preferably, the preset sampling interval t is set to 10-100 ms. To achieve a balance between system resources and data accuracy, the preset sampling interval t is preferably set to 20 ms.

[0098] Preferably, the sampling window is configured such that when the catheter pump moves at a preset delivery speed, its moving distance is less than the distance between the distal flow chamber 12 and the proximal flow chamber 14 , or its moving distance is less than the length of the cannula 13 .

[0099] By limiting the duration of the sampling window, it can be ensured that the data set processed in each calculation in the subsequent steps corresponds to a single position state of the catheter pump, thereby ensuring that the range value calculation results can truly reflect the speed fluctuation characteristics under this position state, providing a reliable decision-making basis for subsequent position judgment.

[0100] In a preferred embodiment, the sampling window is set to 5s, that is, (5000 / t) rotation speed data can be recorded within the sampling window.

[0101] In a preferred embodiment, after the rotation speed data is collected, it is necessary to perform filtering processing on the rotation speed data to eliminate noise interference in the original data.

[0102] Step S32: determining the range value of the speed data.

[0103] In a preferred embodiment, step S32 further specifically includes: determining a range value of the rotational speed data in at least one sampling window; wherein the range value is the difference between the maximum value and the minimum value of the rotational speed data in the sampling window.

[0104] Specifically, when the catheter pump is in the transvalvular position, since the proximal flow chamber 14 and the distal flow chamber 12 are respectively located in the aorta and the left ventricle with completely different pressure environments, the speed data shows obvious periodic fluctuations, and clear peaks (maximum values of the speed data) and troughs (minimum values of the speed data) are generated in each cardiac cycle. After obtaining the speed data within a sampling window, the values of several peaks and several troughs are first determined, and then the average values of the peaks and the average values of the troughs are calculated respectively. Finally, the difference between the two average values is calculated as the final extreme value.

[0105] In contrast, when the catheter pump is completely within the left ventricle or the aorta, because the proximal flow chamber 14 and the distal flow chamber 12 are in similar pressure environments, the fluctuation amplitude of the speed data is smaller, and the calculated range value is significantly lower than the transvalvular position state. Therefore, this significant range difference provides a clear quantitative basis for subsequent position determination, thereby distinguishing different catheter pump position states and providing real-time, reliable position feedback for clinical operations.

[0106] Step S33: determining the position state of the catheter pump according to the comparison result between the range value and the preset threshold value.

[0107] In a preferred embodiment, step S33 further specifically includes: if the range value within the current sampling window is greater than a preset threshold, determining that the catheter pump is currently in a transvalvular position. In this case, in step S31, only the speed data within a single sampling window may be collected, and in step S32, only the range value of the speed data within the current sampling window may be calculated.

[0108] In a preferred embodiment, the preset threshold value can be selected as 500 (unit: rpm). This value can be adjusted according to actual needs and is not specifically limited in this embodiment. Specifically, the preset threshold value can effectively distinguish the rotational speed fluctuation characteristics of the transvalvular position from the non-transvalvular position (i.e., within the aorta or left ventricle). When the calculated range value is greater than the preset threshold value, the catheter pump can be directly determined to be in the transvalvular position without further data collection and analysis, thereby simplifying the data processing process, reducing the computational burden, and improving the speed of position determination.

[0109] In a preferred embodiment, step S33 further specifically includes: judging whether the catheter pump is currently located in the aorta or the ventricle based on a comparison result of the extreme difference values in at least two consecutive sampling windows relative to a preset threshold and a historical record of the transvalvular position.

[0110] Specifically, when the extreme difference value does not exceed the preset threshold, it indicates that the catheter pump is not in a transvalvular position. However, a single extreme difference value cannot directly determine whether it is located in the aorta or the left ventricle, because the speed fluctuation characteristics are similar in these two cases. Therefore, it is necessary to combine the timing information of the catheter pump position change and the historical position records to make further position judgments. At this time, speed data within at least two sampling windows is required.

[0111] In a preferred embodiment, step S33 further specifically includes: if the catheter pump has no history of transvalvular position, and the range difference values within multiple consecutive sampling windows are no greater than a preset threshold, determining that the catheter pump is located within the aorta. This is because in a typical interventional procedure, the catheter pump is usually first inserted from a peripheral blood vessel and then reaches the heart through the aorta. If no transvalvular feature is detected, it indicates that the catheter pump has not yet reached the aortic valve and is still located within the aorta.

[0112] In a preferred embodiment, step S33 further specifically includes determining that the catheter pump is located in the left ventricle when a historical record of a transvalvular position exists for the catheter pump and the range error value within the current sampling window is not greater than a preset threshold. This is because as the catheter pump enters the left ventricle from the aorta through the aortic valve, a characteristic record of the transvalvular position is generated. Once the catheter pump has fully entered the left ventricle, the range error value decreases again, but at this point the catheter pump is already located within the left ventricle.

[0113] In a preferred embodiment, step S33 further includes determining that the catheter pump is located within the aorta if the catheter pump has a history of two valve-crossing positions and the range difference within the current sampling window is no greater than a preset threshold. This corresponds to the catheter pump first entering the left ventricle from the aorta and then withdrawing from the left ventricle to the aorta, during which two valve-crossing characteristics are generated. After the second valve-crossing is completed, the catheter pump returns to the aorta, and the range difference decreases again.

[0114] In a preferred embodiment, in step S33, two flags, Alert and Loc, can also be used to indicate the position status of the catheter pump and provide position prompt information to the user accordingly. Preferably, if the range value within the current sampling window is less than a preset threshold, Alert = 1; if the range value within the current sampling window is greater than the preset threshold, Alert = 0; if there is no historical record of translobar position in the historical records, Loc = 0; if there is a historical record of translobar position in the historical records, Loc = 1, and this is always maintained.

[0115] Preferably, in step S33, when the range value within the sampling window is less than a preset threshold, Alert=1, indicating that the catheter pump is operating in the blood vessel; as the catheter pump gradually extends into the heart, when it crosses the heart valve, that is, when the distal flow chamber 12 enters the heart and the proximal flow chamber 14 is still in the aorta, the speed waveform changes, and its range value exceeds the preset threshold, it is considered that it has reached the correct position, and Alert=0 is set, and the flag bit Loc=1 is set at the same time; if the catheter pump continues to go deeper, it will completely enter the left ventricle, and Alert=1 is set again, and the Loc flag bit remains unchanged at 1.

[0116] In the aforementioned flag-based implementation, when Alert = 1 and Loc = 0, the catheter pump is located in the aorta or an earlier vessel; when Alert = 0 and Loc = 1, it indicates the correct position, with the catheter pump in a transvalvular position; and when Alert = 1 and Loc = 1, it indicates the catheter pump is in the ventricle. By setting flags, clinicians can be provided with clear and intuitive position feedback, effectively guiding the precise positioning of the catheter pump and improving the safety and effectiveness of clinical applications.

[0117] In a preferred embodiment, the method further includes step S34 of generating an alarm prompt based on the position determination result.

[0118] Preferably, when it is determined that the catheter pump is located in the aorta and has not yet reached the expected position, a prompt message of "the catheter pump has not reached the correct position" is triggered; when it is determined that the catheter pump is in a transvalvular position, a prompt of "the catheter pump is detected to be in a transvalvular position, please use DSA to confirm" is generated to guide the doctor to confirm the position through imaging methods such as digital subtraction angiography (DSA); when it is determined that the catheter pump has completely entered the left ventricle, a warning of "the catheter pump is detected to be in the heart, please withdraw it slightly" is generated to remind the doctor to adjust the position of the catheter pump to avoid possible damage to the heart cavity.

[0119] Specifically, the present method embodiment and the aforementioned device embodiment originate from the same inventive concept, and many technical features are no longer described one by one, and can be naturally inherited in the present embodiment.

[0120] One embodiment of the present application provides a computer-readable storage medium, wherein the storage medium stores at least one instruction, and the at least one instruction is loaded and executed by a processor to implement the catheter pump position determination method described above.

[0121] An embodiment of the present application provides an electronic device, comprising a processor and a memory, wherein the memory stores at least one instruction, and the instruction is loaded and executed by the processor to implement the catheter pump position determination method described above.

[0122] Those skilled in the art will understand that all or part of the steps to implement the above embodiments may be accomplished by hardware, or by a program to instruct the relevant hardware, and the program may be stored in a computer-readable storage medium, which may be a read-only memory, a disk, or an optical disk, etc.

[0123] The embodiments of the present invention are described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific implementation methods. The above-mentioned specific implementation methods are merely illustrative and not restrictive. Under the guidance of the present invention, ordinary technicians in this field can also make many forms without departing from the scope of protection of the present invention and the claims, all of which are protected by the present invention.

Claims

1. A catheter pump position determination device, characterized in that: include: a sampling module configured to collect operating data of a driving motor of the catheter pump during the delivery process, wherein the operating data at least includes speed data; a processing module configured to determine a range value of the speed data; The judgment module is configured to determine the position state of the catheter pump according to a comparison result between the range value and a preset threshold value.

2. The catheter pump position determination device according to claim 1, characterized in that: Also includes: The control module is configured to control the drive motor to operate at a preset speed, where the preset speed is lower than a normal operating speed of the catheter pump.

3. The catheter pump position determination device according to claim 1, characterized in that: The sampling module is further configured to: collect the rotational speed data within at least one sampling window at a preset sampling interval; The processing module is further configured to: determine a range value of the rotational speed data within at least one of the sampling windows; the range value is the difference between the maximum value and the minimum value of the rotational speed data within the sampling window.

4. The catheter pump position determination device according to claim 3, characterized in that: The sampling window is configured such that, when the catheter pump moves at a preset delivery speed, the moving distance thereof is smaller than the distance between the distal flow chamber and the proximal flow chamber.

5. The catheter pump position determination device according to claim 3, characterized in that: The judgment module is further configured to: if the range value within the current sampling window is greater than the preset threshold, determine that the catheter pump is currently located at a transvalvular position.

6. The catheter pump position determination device according to claim 5, characterized in that: The judgment module is further configured to: determine whether the catheter pump is currently located in the aorta or in the ventricle based on a comparison result of the extreme difference values in at least two consecutive sampling windows relative to the preset threshold and a historical record of the transvalvular position.

7. The catheter pump position determination device according to claim 6, characterized in that: The judgment module is further configured to: When there is no historical record of the transvalvular position of the catheter pump, and the extreme difference values in a plurality of consecutive sampling windows are not greater than the preset threshold, it is determined that the catheter pump is located in the aorta; When there is a historical record of a transvalvular position of the catheter pump, and the range value in the current sampling window is not greater than the preset threshold, it is determined that the catheter pump is located in the left ventricle; When there are two historical records of transvalvular positions of the catheter pump and the range value in the current sampling window is not greater than the preset threshold, it is determined that the catheter pump is located in the aorta.

8. The catheter pump position determination device according to claim 1, characterized in that: Also includes: The alarm module is configured to generate an alarm prompt according to the position judgment result of the judgment module.

9. A method for determining the position of a catheter pump, characterized in that: include: Collecting operating data of a driving motor of the catheter pump during the delivery process, wherein the operating data at least includes speed data; Determining a range value of the speed data; The position state of the catheter pump is determined based on a comparison result of the range difference value and a preset threshold value.

10. A catheter pump for use with the catheter pump position determination device according to any one of claims 1 to 8, characterized in that: The device comprises, from the distal end to the proximal end, a pigtail tube, a distal flow chamber, a cannula, a proximal flow chamber and a drive motor. The proximal flow chamber is provided with an impeller, which is driven and rotated by the drive motor. A fluid channel is configured between the distal flow chamber and the proximal flow chamber. The cannula is provided with a penetration channel for the proximal end of the guide wire to pass through, so that at least a portion of the guide wire does not overlap with the fluid channel and does not pass through the proximal flow chamber, so as to avoid the guide wire interfering with the running impeller.

11. The catheter pump according to claim 10, wherein The penetration channel includes a penetration opening that penetrates the proximal wall of the cannula, and the penetration opening is connected to the pigtail tube, and is used to guide the guide wire to penetrate through the pigtail tube and extend out of the catheter pump through the penetration opening.

12. The catheter pump according to claim 11, wherein A one-way closable shielding structure is provided on the inner side of the penetration opening. The shielding structure is configured to open when the guide wire is inserted and to close the penetration opening after the guide wire is withdrawn.

13. A ventricular assist system, characterized in that: comprising a catheter pump and a catheter pump position determination device according to any one of claims 1 to 8; The catheter pump includes an impeller disposed in a proximal flow chamber, and the catheter pump is configured such that no guidewire passes through the proximal flow chamber during delivery, so as to avoid interference of the guidewire with the running impeller.

14. A computer-readable storage medium, characterized in that The storage medium stores at least one instruction, and the at least one instruction is loaded and executed by the processor to implement the catheter pump position determination method according to claim 9.

15. An electronic device, characterized in that: The electronic device includes a processor and a memory, wherein the memory stores at least one instruction, and the instruction is loaded and executed by the processor to implement the catheter pump position determination method according to claim 9.

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