Balloon catheter control device, balloon catheter system, electronic device, and storage medium

Abstract

The present invention provides a balloon catheter control device, a balloon catheter system, an electronic device, and a storage medium. The balloon catheter control device is configured for controlling a balloon catheter, and the balloon catheter is configured for intervening in a target lumen to intermittently occlude the coronary sinus. The balloon catheter control device comprises: a central processing unit, configured for acquiring a pressure change rate in the target lumen according to the pressure in the target lumen fed back by a corresponding pressure sensor before the balloon catheter is started for treatment, monitoring the expansion state of a balloon according to the pressure change rate in the target lumen, determining a current diameter of the balloon as a target diameter when the pressure change rate in the target lumen meets a requirement, and controlling a fluid injection apparatus to adjust the diameter of the balloon according to the pressure in the balloon fed back by the corresponding pressure sensor during the process in which the balloon catheter is started for treatment; and an information display unit, configured for displaying related information. According to the present invention, the blood vessel diameter can be quickly determined according to the pressure change rate before the treatment, and the balloon can be quickly adjusted during the treatment process, so as to solve the problems of slow response, complex operation, and low efficiency of coronary sinus balloon counterpulsation.

Description

Balloon catheter control device, balloon catheter system, electronic device and storage medium Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to a balloon catheter control device, a balloon catheter system, an electronic device and a storage medium capable of automatically calibrating and adjusting the pressure inside a balloon. Background Art

[0002] Current treatments for coronary heart disease include balloon counterpulsation of the coronary sinus (also known as the coronary sinus), which intervenes in the coronary sinus through repeated inflation and deflation of the balloon to improve coronary microvascular function. The currently used coronary sinus balloon counterpulsation system injects a fixed volume of fluid into the balloon via a syringe to change the pressure inside the balloon, thereby changing the balloon diameter. During the treatment process, controlling the balloon diameter is very critical. A balloon diameter that is too large can cause serious harm to the patient, and a balloon diameter that is too small may not achieve the therapeutic effect. Moreover, the balloon diameter required for different blood vessels is not the same, and the balloon diameter must match the diameter of the current blood vessel being intervened. In the existing technology, the pressure and balloon diameter in the balloon are mainly controlled manually by querying the balloon compliance table. It is impossible to quickly control the balloon during the treatment process, nor can it achieve the rapid response required by the system for different blood vessel diameters, which ultimately affects the progress and efficiency of the entire operation. Before starting treatment, it is also necessary to know the blood vessel diameter so that the required balloon diameter can be set according to the blood vessel diameter. The current practice is to insert an ultrasound catheter into the blood vessel to obtain an ultrasound image. The doctor then measures the blood vessel diameter based on the ultrasound image and determines the required diameter of the balloon based on the blood vessel diameter before starting the surgery. The entire process is cumbersome, complex to operate, and inefficient.

[0003] Therefore, designing a balloon catheter control device, balloon catheter system, electronic equipment and storage medium that can not only quickly measure different blood vessel diameters but also automatically calibrate and adjust the pressure inside the balloon has certain clinical significance for coronary sinus balloon counterpulsation. Summary of the Invention

[0004] The purpose of the present invention is to provide a balloon catheter control device, a balloon catheter system, an electronic device and a storage medium, which can realize rapid control of the balloon during treatment and quickly measure the blood vessel diameter before starting treatment, so as to solve the problems of slow response, complex operation and low efficiency of the existing coronary sinus balloon counterpulsation system.

[0005] To solve the above technical problems, the present invention provides a balloon catheter control device for controlling a balloon catheter used to intervene in a target lumen to intermittently occlude the coronary sinus. The balloon catheter control device comprises:

[0006] a central processing unit, configured to obtain a pressure change rate within the target lumen based on the pressure within the target lumen fed back by the corresponding pressure sensor before initiating treatment with the balloon catheter, monitor the expansion state of the balloon in the balloon catheter based on the pressure change rate within the target lumen, and determine the current diameter of the balloon as a target diameter when the pressure change rate within the target lumen meets a requirement, and further configured to control a fluid injection device to adjust the diameter of the balloon based on the pressure within the balloon fed back by the corresponding pressure sensor during initiation of treatment with the balloon catheter;

[0007] The information display unit is used to display relevant information.

[0008] Optionally, in the balloon catheter control device, the central processing unit is used to control the fluid injection device to gradually inject fluid into the balloon multiple times before the balloon catheter starts treatment, so that the balloon gradually expands, and the central processing unit is used to obtain the pressure change rate in the target lumen each time the fluid is injected. When the pressure change rate in the target lumen is less than or equal to a threshold value, the requirement is met.

[0009] Optionally, in the balloon catheter control device, the central processing unit is configured to obtain a pressure change rate within the target lumen during each fluid injection based on a pressure change within the target lumen during a single fluid injection and a single fluid injection amount, and the central processing unit is further configured to determine whether the pressure change rate within the target lumen meets a requirement based on a threshold value;

[0010] If the pressure change rate in the target lumen is greater than a threshold, continue injecting fluid into the balloon;

[0011] If the pressure change rate in the target lumen is less than or equal to a threshold, the central processing unit obtains the current diameter of the balloon according to the current pressure in the balloon, and uses the current diameter as the target diameter.

[0012] Optionally, in the balloon catheter control device, the central processing unit is used to obtain the current diameter of the balloon based on the current pressure in the balloon during the balloon catheter treatment start-up process, and compare the current diameter of the balloon with the target diameter. If the current diameter of the balloon is not within the threshold range of the target diameter, the fluid injection device is controlled to inject or withdraw at least part of the fluid.

[0013] Optionally, in the balloon catheter control device, the threshold range of the target diameter is ±10% of the target diameter.

[0014] Optionally, in the balloon catheter control device, the central processing unit includes a storage module, the storage module stores a balloon compliance table, the balloon compliance table includes pressure data in the balloon and balloon diameter data corresponding to the pressure data;

[0015] The central processing unit is used to obtain a functional relationship between the pressure inside the balloon and the diameter of the balloon according to the balloon compliance table, and convert the pressure inside the balloon into the diameter of the balloon based on the functional relationship.

[0016] Optionally, in the balloon catheter control device, the central processing unit is used to obtain the target fluid volume required for the balloon based on the target diameter in advance during the balloon catheter treatment start-up process, and then control the fluid injection device to inject fluid into the balloon according to the target fluid volume. The central processing unit is also used to determine the current diameter of the balloon based on the current pressure in the balloon and the functional relationship, and then determine whether the current diameter of the balloon is within the preset target diameter threshold range. If not, the central processing unit obtains a new fluid volume based on the current pressure in the balloon, and then controls the fluid injection device to inject or withdraw at least part of the fluid according to the new fluid volume.

[0017] Optionally, in the balloon catheter control device, the central processing unit also includes a pressure signal processing module, a calculation processing module and a flow control module; the pressure signal processing module is used to process the pressure signal fed back by the pressure sensor; the calculation processing module is used to process relevant data; and the flow control module is used to control the fluid injection device.

[0018] The present invention also provides a balloon catheter system, comprising a balloon catheter device, a fluid injection device, and any one of the balloon catheter control devices; the balloon catheter device and the fluid injection device are both communicatively connected to the balloon catheter control device; the balloon catheter device is fluidically connected to the fluid injection device;

[0019] The balloon catheter device includes a balloon catheter and a plurality of pressure sensors; the balloon catheter includes a balloon and a catheter body, the balloon is sheathed and fixed to the distal end of the catheter body, the catheter body is provided with a blood access cavity and a balloon filling cavity, the balloon filling cavity is communicated with the inner cavity of the balloon; at least one pressure sensor is fluidically connected to the proximal end of the balloon filling cavity for collecting the pressure in the balloon; at least another pressure sensor is fluidically connected to the proximal end of the blood access cavity for collecting the pressure in the target lumen;

[0020] Before starting treatment, the fluid injection device injects fluid into the balloon through the balloon filling chamber to expand the balloon; during the start-up treatment process, the fluid injection device injects and withdraws at least part of the fluid into the balloon through the balloon filling chamber in a reciprocating cycle to switch the balloon back and forth between an expanded state and a contracted state.

[0021] Optionally, in the balloon catheter system, the number of the pressure sensors is two, and the two pressure sensors are respectively a first pressure sensor and a second pressure sensor. The first pressure sensor is fluidically connected to the proximal end of the balloon filling cavity, and the second pressure sensor is fluidically connected to the proximal end of the blood access cavity.

[0022] Optionally, in the balloon catheter system, the balloon catheter device also includes a three-way valve, the first port of the three-way valve is fluidically connected to the proximal end of the balloon filling chamber, the second port of the three-way valve is fluidically connected to at least one corresponding pressure sensor, and the third port of the three-way valve is fluidically connected to the fluid injection device.

[0023] The present invention further provides an electronic device comprising: a processor and a memory, wherein the processor is configured to execute a balloon catheter control program stored in the memory to implement a balloon catheter control method, wherein the balloon catheter control method is applied to a balloon catheter configured to be inserted into a target lumen to intermittently occlude the coronary sinus, and wherein the balloon catheter control method comprises:

[0024] Before the balloon catheter treatment is started, a pressure change rate in the target lumen is obtained based on the pressure in the target lumen fed back by the corresponding pressure sensor, and the expansion state of the balloon in the balloon catheter is monitored based on the pressure change rate in the target lumen, and the current diameter of the balloon is determined as the target diameter when the pressure change rate in the target lumen meets the requirement;

[0025] During the treatment process started by the balloon catheter, the fluid injection device is controlled according to the pressure in the balloon fed back by the corresponding pressure sensor to adjust the diameter of the balloon.

[0026] The present invention also provides a storage medium storing one or more programs, wherein the one or more programs can be executed by one or more processors to implement a balloon catheter control method. The balloon catheter control method is applied to a balloon catheter used to intervene in a target lumen to intermittently occlude the coronary sinus. The balloon catheter control method includes:

[0027] Before the balloon catheter treatment is started, a pressure change rate in the target lumen is obtained based on the pressure in the target lumen fed back by the corresponding pressure sensor, and the expansion state of the balloon in the balloon catheter is monitored based on the pressure change rate in the target lumen, and the current diameter of the balloon is determined as the target diameter when the pressure change rate in the target lumen meets the requirement;

[0028] During the treatment process started by the balloon catheter, the fluid injection device is controlled according to the pressure in the balloon fed back by the corresponding pressure sensor to adjust the diameter of the balloon.

[0029] Compared with the prior art, the balloon catheter control device, balloon catheter system, electronic device, and storage medium provided by the present invention have the following advantages:

[0030] Before the balloon catheter treatment is started, the fluid injection device injects fluid into the balloon catheter to expand the balloon. At the same time, the central processing unit obtains the pressure change rate in the target lumen based on the pressure in the target lumen fed back by the corresponding pressure sensor, and monitors the expansion state of the balloon based on the pressure change rate in the target lumen. When the pressure change rate in the target lumen meets the requirements, the current diameter of the balloon is determined as the target diameter, which is the diameter of the currently intervened blood vessel. With this configuration, the present invention does not need to measure the blood vessel diameter through ultrasonic imaging technology, but instead uses the balloon catheter system itself to quickly measure the diameter of the intervened blood vessel based on the intravascular pressure change rate, so that the system can quickly respond to different blood vessel diameters, thereby simplifying preoperative operations, greatly saving preoperative time, and improving surgical efficiency.

[0031] During treatment, the balloon catheter system described above uses a fluid injection device to repeatedly inject and withdraw fluid into the balloon catheter, switching the balloon between expanded and contracted states, thereby achieving both auxiliary and therapeutic purposes. During treatment, the central processing unit controls the fluid injection device based on the pressure inside the balloon fed back by the corresponding sensor to adjust the balloon's diameter, ensuring that the balloon's state always meets the desired requirements. This allows for rapid control of the balloon during treatment and enables automatic calibration and adjustment of the pressure inside the balloon, effectively improving surgical efficiency and safety.

[0032] Since the electronic device and storage medium provided in this application belong to the same inventive concept as the balloon catheter control device and balloon catheter system provided in this application, the electronic device and storage medium provided in this application have all the advantages of the balloon catheter control device and balloon catheter system provided in this application. Therefore, the beneficial effects of the electronic device and storage medium provided in this application will not be described one by one here. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] Those skilled in the art will appreciate that the accompanying drawings are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention.

[0034] FIG1 is a block diagram of a balloon catheter system according to an embodiment of the present invention;

[0035] FIG2 is a schematic structural diagram of a balloon catheter system provided in an embodiment of the present invention, wherein a fluid injection device is not shown;

[0036] FIG3 is a schematic structural diagram of a balloon catheter device and a fluid injection device connected thereto provided by an embodiment of the present invention, wherein the fluid injection device is a syringe pump;

[0037] FIG4 is a flowchart of a balloon catheter system for automatically measuring blood vessel diameter according to an embodiment of the present invention;

[0038] FIG5 is a flowchart of a balloon catheter system for automatically adjusting fluid volume according to an embodiment of the present invention;

[0039] FIG6 is a flowchart of the automatic calibration and adjustment of the pressure inside the balloon by the balloon catheter control device according to an embodiment of the present invention;

[0040] FIG7 is a block diagram of a central processing unit according to an embodiment of the present invention;

[0041] FIG8 is a flowchart of a balloon catheter control device processing a pressure signal according to an embodiment of the present invention;

[0042] FIG9 is a front view of the balloon catheter control device provided in an embodiment of the present invention as an all-in-one device;

[0043] FIG10 is a side view of the balloon catheter control device provided in an embodiment of the present invention as an all-in-one device.

[0044] Among them, [the accompanying drawings are explained as follows]: 100-balloon catheter control device; 110-central processing unit; 111-pressure signal processing module; 112-flow control module; 113-computing processing module; 114-storage module; 120-information display unit; 200-balloon catheter device; 210-balloon catheter; 211-balloon; 212-blood access cavity; 213-balloon filling cavity; 214-first connection position; 215-second connection position; 220-first pressure sensor; 230-second pressure sensor; 300-fluid injection device; 301-injection pump. DETAILED DESCRIPTION

[0045] The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments. The advantages and features of the present invention will become more apparent from the following description. It should be noted that the drawings are greatly simplified and not to exact scale, and are only used to facilitate and clearly illustrate the embodiments of the present invention.

[0046] The terms "fluid connection" and "fluid communication" used in this article have equivalent meanings. In addition, the pressure in the blood vessel is very close to the pressure in the blood-filled cavity and is within an acceptable error range. The pressure in the balloon is also very close to the pressure in the balloon-filled cavity and is within an acceptable error range.

[0047] The core of this invention is a balloon catheter control device for controlling a balloon catheter primarily used for coronary sinus balloon counterpulsation. This device automatically calibrates and adjusts the pressure within the balloon, enabling rapid balloon control during treatment and rapid system response to varying vessel diameters. This eliminates the need for ultrasonic diameter measurement, effectively improving surgical progress and efficiency.

[0048] The balloon catheter of the present invention is used to intermittently occlude the coronary sinus by inserting it into the target lumen (i.e., blood vessel), thereby improving coronary microvascular function. Intermittent occlusion of the coronary sinus helps enhance coronary microcirculatory activity, reduce the incidence of coronary microvascular obstruction, and reduce infarct size. During treatment, the balloon catheter of the present invention intermittently inflates and deflates the balloon with a medium such as gas or liquid to achieve intermittent occlusion of the coronary sinus.

[0049] In order to enable those skilled in the art to better understand the technical solutions provided by the present invention, the present invention will be further described in detail below in conjunction with the accompanying drawings and specific embodiments. In the following description, a large number of specific details are provided to provide a more thorough understanding of the present invention. However, it is easy to understand for those skilled in the art that the present invention can be implemented without one or more of these details. In other examples, in order to avoid confusion with the present invention, some technical features well known in the art are not described.

[0050] FIG1 is a block diagram of the balloon catheter system provided by the present invention. As shown in FIG1 , the balloon catheter system includes a balloon catheter control device 100, a balloon catheter apparatus 200, and a fluid injection device 300, which are communicatively connected to the balloon catheter control device 100. The balloon catheter apparatus 200 is fluidically connected to the fluid injection device 300. The fluid injection device 300 is used to inject and withdraw fluid into the balloon catheter apparatus 200 to control the cyclical filling and deflation of the balloon 211 (see FIG2 ) in the balloon catheter apparatus 200. The fluid described herein can be a gas or a liquid, and the fluid can be visualized or non-visible.

[0051] The balloon catheter control device 100 is a computing and processing device. Based on the description of this application specification, those skilled in the art should understand how to implement the functions described therein and achieve the corresponding technical effects. Specifically, the balloon catheter control device 100 includes a central processing unit 110 and an information display unit 120. The central processing unit 110 and the information display unit 120 can be integrated or designed separately. Integration refers to combining the central processing unit 110 and the information display unit 120 to form a single entity. A separate design refers to providing the central processing unit 110 and the information display unit 120 separately and independently, without being assembled together. The information display unit 120 is primarily used to display relevant information, which can be a variety of information, including, for example, intra-balloon pressure, intravascular pressure, rate of change of intravascular pressure, balloon diameter (such as the current balloon diameter, target diameter, etc.), or other information. Those skilled in the art should understand how to select the information to be displayed. The central processing unit 110 is responsible for the specific calculations and processing tasks, which can be implemented by some common data processing devices, equipment, or components. Specifically, those skilled in the art should understand how to select them, and this will not be explained in detail here.

[0052] Balloon catheter control device 100 is used to control balloon catheter 210. It reads the pressure signal collected by balloon catheter device 200 and automatically calibrates and adjusts the pressure within the balloon based on the pressure signal. When balloon catheter control device 100 communicates with balloon catheter device 200, the communication method is either wired or wireless, preferably wired.

[0053] Referring to Figures 2 and 3, a balloon catheter device 200 includes a balloon catheter 210 and multiple pressure sensors (labeled 220, 230). The multiple pressure sensors can be two or more. Preferably, two pressure sensors are used, namely a first pressure sensor 220 and a second pressure sensor 230. For simplicity, the following description uses two pressure sensors for schematic illustration.

[0054] Balloon catheter 210 is the interventional treatment component, which achieves both support and therapeutic purposes by inserting it into a designated vascular location within the human body and performing cyclical inflation and deflation. As will be appreciated, balloon catheter 210 comprises a balloon 211 and a catheter body, with balloon 211 positioned over and secured to the distal end of the catheter body. During treatment, balloon 211 cyclically inflates and deflates, switching between expanded and deflated states to intermittently occlude the coronary sinus.

[0055] At the same time, multiple pressure sensors are fluidically connected to the proximal end of the balloon catheter 210; at least one pressure sensor is used to collect the pressure within the balloon 211 (hereinafter referred to as the intra-balloon pressure); and at least another pressure sensor is used to collect the pressure within the blood vessel (i.e., the pressure within the target lumen). In a specific embodiment, a first pressure sensor 220 and a second pressure sensor 230 are fluidically connected to the proximal end of the balloon catheter 210, with the first pressure sensor 220 used to collect the intra-balloon pressure and the second pressure sensor 230 used to collect the intra-vascular pressure.

[0056] In more detail, the catheter body is provided with a blood access cavity 212 and a balloon filling cavity 213. The blood access cavity 212 is provided along the axial direction of the balloon catheter 210, extending from the distal end to the proximal end of the balloon catheter 210. The blood access cavity 212 is generally a central cavity, coaxial with the balloon catheter 210. The balloon filling cavity 213 extends from the position of the balloon 211 to the proximal end of the balloon catheter 210. The distal end of the balloon filling cavity 213 is connected to the inner cavity of the balloon 211 for injecting or withdrawing fluid. The balloon filling cavity 213 can be an annular cavity or a non-annular cavity. A non-annular cavity refers to a localized arrangement along the circumference of the outer periphery of the blood access cavity 212. In this embodiment, the balloon filling cavity 213 is provided around the entire periphery of the blood access cavity 212, forming an annular cavity, which can more quickly fill or empty the balloon 211. Furthermore, at least one pressure sensor is fluidically connected to the proximal end of the balloon filling chamber 213, and at least another pressure sensor is fluidically connected to the proximal end of the blood access chamber 212. Specifically, in this embodiment, a first pressure sensor 220 is fluidically connected to the proximal end of the balloon filling chamber 213 and forms a first connection point 214, and a second pressure sensor 230 is fluidically connected to the proximal end of the blood access chamber 212 and forms a second connection point 215.

[0057] It should be understood that the present invention disposes the first pressure sensor 220 outside the balloon filling chamber 213 and connects it to the proximal end of the balloon filling chamber 213 via a fluid conduit to maintain fluid communication. In an optional embodiment, the balloon catheter system of the present invention further includes a three-way valve, which connects the balloon filling chamber 213, the fluid injection device 300, and the first pressure sensor 220, respectively. That is, the first port of the three-way valve is fluidically connected to the proximal end of the balloon filling chamber 213, the second port of the three-way valve is fluidically connected to the first pressure sensor 220, and the third port of the three-way valve is fluidically connected to the fluid injection device 300. This approach is simple, can achieve pressure monitoring, and can also inject and withdraw fluid, and is also convenient for installing the first pressure sensor 220.

[0058] It should also be understood that the present invention does not place the second pressure sensor 230 directly within the blood vessel for measurement, but rather performs measurements externally. This approach offers improved safety and ease of operation. Therefore, the second pressure sensor 230 is positioned directly outside the blood access lumen 212 and is connected to the proximal end of the blood access lumen 212 via a fluid conduit, maintaining fluid communication therewith.

[0059] In some embodiments, the multiple pressure sensors are not integrated with the balloon catheter 210 and are detachable, which facilitates interventional treatment using the balloon catheter 210 alone without using the pressure sensors. Of course, in other embodiments, the multiple pressure sensors may be integrated with the balloon catheter 210 and are not detachable.

[0060] In practice, the balloon catheter device 200 is communicatively connected to the balloon catheter control device 100 via a plurality of pressure sensors. Preferably, each pressure sensor is communicatively connected to the balloon catheter control device 100 via an electronic data transmission line. In addition, the pressure signal collected by each pressure sensor is transmitted to the balloon catheter control device 100 in the form of an analog signal (such as a voltage analog signal or a current analog signal). The balloon catheter control device 100 then further processes the pressure signal to obtain corresponding pressure data for subsequent calculation and processing.

[0061] Furthermore, in order to quickly measure the diameter of the blood vessel and determine the balloon diameter required for the current vascular intervention, the balloon catheter system of the present invention is configured as follows: before the balloon catheter 210 starts treatment, the fluid injection device 300 injects fluid into the balloon 211 through the balloon filling chamber 213 to expand the balloon 211. At the same time, the central processing unit 110 obtains the intravascular pressure change rate based on the intravascular pressure feedback from the corresponding pressure sensor, and monitors the expansion state of the balloon 211 based on the intravascular pressure change rate. When the intravascular pressure change rate meets the requirements, the current diameter of the balloon 211 is determined as the target diameter, which is also the blood vessel diameter. The present invention directly measures the balloon diameter by the pressure change rate, and can measure the blood vessel size of different patients. Therefore, it is suitable for measuring various blood vessel diameters, and the range of blood vessels measured is large, which can better meet actual clinical needs. It is understood that based on the pressure change rate, the blood vessel diameter can be measured for different patients and at different locations. During the measurement process, the state of the blood vessel occlusion by balloon 211 can be quickly determined based on the pressure change rate. Once balloon 211 is fully inflated and the blood vessel is occluded, the blood vessel diameter can be determined. In this way, a rapid response to varying blood vessel diameters during treatment is achieved, enabling rapid and accurate blood vessel diameter measurement and avoiding the need for ultrasound catheter-mediated vascular measurement, greatly improving efficiency and simplifying procedures. Furthermore, based on the pressure change rate, the balloon diameter can be more precisely adjusted to avoid damage caused by overexpansion of balloon 211.

[0062] Preferably, before starting treatment, the fluid injection device 300 gradually injects fluid into the balloon 211 multiple times to gradually expand the balloon 211. At the same time, the central processing unit 110 obtains the pressure change rate in the blood vessel each time the fluid is injected, and when the pressure change rate in the blood vessel is less than or equal to the threshold, the requirement is met.

[0063] With such a configuration, the present invention does not need to measure the blood vessel diameter through ultrasonic imaging technology. Instead, the balloon catheter system itself can quickly measure the diameter of the interventional blood vessel based on the rate of change of intravascular pressure, so that the system can quickly respond to different blood vessel diameters, thereby simplifying preoperative operations, greatly saving preoperative time, and improving surgical efficiency.

[0064] Further, please refer to FIG. 4 for an exemplary embodiment of the balloon catheter system of the present invention for automatically measuring the diameter of a blood vessel.

[0065] As shown in FIG4 , before treatment, a balloon catheter 210 is inserted into the treatment vessel and the fluid in the balloon catheter 210 is emptied. After the fluid in the balloon catheter 210 is emptied, the fluid injection device 300 continuously injects small amounts of fluid into the balloon catheter 210 in a stepwise manner (e.g., a stepwise increasing flow rate or a stepwise progressive flow rate), and the intravascular pressure is read by the second sensor 230. During this process, the central processing unit 110 determines the intravascular pressure change rate for each fluid injection based on the intravascular pressure change and the amount of fluid injected per injection. The central processing unit 110 then determines whether the intravascular pressure change rate meets the requirements based on a threshold. If the intravascular pressure change rate is greater than the threshold, the fluid injection device 300 continues to inject a certain amount of fluid into the balloon 211. If the intravascular pressure change rate is less than or equal to the threshold, the central processing unit 110 records the current intraballoon pressure and then determines the current diameter of the balloon 211 based on the current intraballoon pressure, and uses the current diameter of the balloon 211 as the target diameter of the balloon 211.

[0066] Optionally, the central processing unit 110 stores a balloon compliance table. The functional relationship between the intra-balloon pressure and the balloon diameter can be obtained from the balloon compliance table, and the pressure within the balloon 211 can be converted to the diameter of the balloon 211 based on this functional relationship. Those skilled in the art will appreciate that the balloon compliance table contains a number of balloon pressure data and a number of balloon diameter data, with each balloon pressure data corresponding to each balloon diameter data. When the central processing unit 110 accesses the balloon compliance table, it can fit the functional relationship between the intra-balloon pressure y and the balloon diameter x using a univariate linear fit, i.e., y = b0 + b1 * x; where b0 and b1 are constants in the fitting function, and the accuracy of the regression model is determined using the least squares method. The balloon compliance table provided herein can be pre-calibrated and stored in the central processing unit 110 automatically by the system, or manually entered and stored in the central processing unit 110, without limitation in the present invention.

[0067] Therefore, before treatment, the central processing unit 110 can calculate the rate of change in intravascular pressure after each fluid injection: intravascular pressure change rate = intravascular pressure change amount / single fluid injection volume. When the intravascular pressure change rate exceeds a preset threshold, the fluid injection device 300 continues to inject fluid into the balloon catheter 210 until the intravascular pressure change rate falls below the preset threshold. This indicates that the balloon 211 has fully inflated and occluded the blood vessel. The current balloon pressure is recorded and then converted by the central processing unit 110 based on the balloon compliance table to obtain the current balloon diameter. The current balloon diameter matches the diameter of the currently involved blood vessel. After determining the target diameter of the balloon 211, the balloon catheter 210 is emptied.

[0068] Furthermore, during treatment, the diameter of balloon 211 after inflation and expansion should be within a target diameter threshold range. In this embodiment, central processing unit 110 determines whether the balloon diameter meets the requirements based on the target diameter threshold range. Preferably, the target diameter threshold range is ±10% of the target diameter, which minimizes blood vessel damage while ensuring the balloon's occlusion effectiveness.

[0069] To quickly control the balloon 211 during treatment, the balloon catheter system of the present invention is further configured as follows: during treatment, the fluid injection device 300 reciprocatingly injects and withdraws at least a portion of the fluid into the balloon catheter 210, causing the balloon 211 to switch back and forth between an expanded state and a contracted state, and the central processing unit 110 controls the output of the fluid injection device 300 based on the pressure within the balloon collected by the corresponding sensor (such as the first pressure sensor 220) to adjust the diameter of the balloon 211. The output of the fluid injection device 300 can be understood as injecting or withdrawing at least a portion of the fluid into the balloon catheter 210 to achieve the effect of reducing or increasing the diameter of the balloon 211. In this way, automatic calibration and adjustment of the pressure within the balloon is achieved, achieving rapid control of the balloon 211 during treatment, effectively improving surgical efficiency and enhancing surgical safety.

[0070] FIG5 illustrates an exemplary embodiment of a balloon catheter system according to the present invention that automatically adjusts flow rate to regulate intra-balloon pressure. As shown in FIG5 , upon initiation of treatment, the central processing unit 110 pre-determines the target fluid volume required for the balloon based on the target diameter and then controls the fluid injection device 300 to inject fluid into the balloon 211 according to the target fluid volume. After fluid injection, the balloon 211 is inflated and expanded. Simultaneously, the central processing unit 110 determines the current balloon diameter based on the intra-balloon pressure detected by the first pressure sensor 220 and the balloon compliance table, and then determines whether the current balloon diameter is within a threshold range of the target diameter. If not, the central processing unit 110 recalculates a new fluid volume based on the intra-balloon pressure and controls the fluid injection device 300 to inject or withdraw at least part of the fluid according to the new fluid volume. If so, the central processing unit 110 continues to monitor the current balloon diameter based on the intra-balloon pressure. If the current balloon diameter is not within the target diameter threshold range, the fluid volume is reduced or increased. It should be understood that when the current diameter of the balloon is within the threshold range of the target diameter, the fluid injection device 300 no longer injects or withdraws fluid, but maintains the current pressure in the balloon to ensure the stability of the balloon.

[0071] Please refer to Figure 6. For the balloon catheter control device 100, the specific working method of its automatic calibration and adjustment of the pressure inside the balloon is as follows: during the interventional treatment process, the central processing unit 110 reads the pressure inside the balloon collected by the first pressure sensor 220 in real time, and then calculates the balloon diameter under the corresponding balloon pressure based on the balloon compliance table, and then determines whether the current balloon diameter is within the threshold range of the target diameter; if not, the fluid injection device 300 is controlled to inject or withdraw at least part of the fluid to reduce or increase the amount of injected fluid, thereby realizing automatic adjustment of the pressure inside the balloon and effectively controlling the balloon diameter required for treatment; if not, the pressure inside the balloon continues to be read and the above process is repeated.

[0072] Those skilled in the art will appreciate that all or part of the processes in the above-described embodiments can be implemented by instructing the relevant hardware through a computer program. The program can be stored in a computer-readable storage medium, and when executed, the program can include the processes of the above-described embodiments. The storage medium can be a magnetic disk, an optical disk, a read-only memory (ROM), a random access memory (RAM), a flash memory, a hard disk drive (HDD), or a solid-state drive (SSD). The storage medium can also include a combination of the above-mentioned types of memory.

[0073] In one embodiment, the present invention further provides an electronic device comprising: a processor and a memory, wherein the processor is configured to execute a balloon catheter control program stored in the memory to implement a balloon catheter control method, wherein the balloon catheter control method is applied to a balloon catheter 210, and the balloon catheter 210 is configured to intervene in a blood vessel to intermittently occlude the coronary sinus, wherein the balloon catheter control method comprises: before initiating treatment with the balloon catheter 210, obtaining a pressure change rate within the blood vessel based on the pressure within the blood vessel fed back by a corresponding pressure sensor (such as 230), monitoring the expansion state of the balloon 211 based on the pressure change rate within the blood vessel, and then determining the current diameter of the balloon 211 as a target diameter when the pressure change rate within the blood vessel meets the requirement; and, during the initiation of treatment with the balloon catheter 210, controlling the fluid injection device 300 based on the pressure within the balloon fed back by the corresponding pressure sensor (such as 220) to adjust the diameter of the balloon 211 so that the diameter of the balloon 211 always meets the requirement.

[0074] The processor and the memory can be connected in any suitable manner, including bus or other manners. The processor can be a central processing unit (CPU), or can be other general-purpose processors, digital signal processors (DSP), application-specific integrated circuits (ASICs), field programmable gate arrays (FPGAs) or other programmable logic devices, discrete gate or transistor logic devices, discrete hardware components and other chips, or a combination of the above-mentioned chips. As a non-transient computer-readable storage medium, the memory can be used to store non-transient software programs, non-transient computer executable programs and modules, such as the program instructions / modules corresponding to the method provided in the embodiment of the present invention. The processor executes various functional applications and data processing of the processor by running the non-transient software programs, instructions and modules stored in the memory, that is, implementing the method in the above method embodiment. One or more modules are stored in the memory, and when executed by the processor, the method in the above embodiment is executed.

[0075] The specific details of the electronic device can be understood by referring to the corresponding descriptions and effects in the following embodiments, which will not be repeated here.

[0076] It should be noted that each step or function of the central processing unit 110 during its implementation can be accomplished by hardware-integrated logic circuits or software-based instructions within the central processing unit 110. The following division of the various modules or units of the central processing unit 110 is merely a division of logical functions; in actual implementation, they can be fully or partially integrated into a single physical entity or physically separated. Furthermore, these modules or units can be implemented entirely in the form of software invoked through processing elements or entirely in hardware. Furthermore, these modules or units can be fully or partially integrated together or implemented independently.

[0077] Referring to FIG7 , in an exemplary embodiment, the central processing unit 110 includes a pressure signal processing module 111, a flow control module 112, a calculation processing module 113, and a storage module 114. The pressure signal processing module 111 is configured to process the pressure signals fed back by all pressure sensors. The processed pressure data is stored in the storage module 114 or directly transmitted to the calculation processing module 113.

[0078] FIG8 shows an exemplary embodiment of processing a pressure signal. As shown in FIG8 , first, the central processing unit 110 reads the pressure signal (i.e., an analog signal), and then the pressure signal processing module 111 processes the pressure signal, which can be processed by software and / or hardware filtering. Specifically, the pressure signal is first subjected to hardware filtering processing by a hardware filter, and then converted into a digital signal through analog-to-digital conversion. Further, the digital signal is subjected to software filtering processing by a digital filter and an average weighted filter to filter out noise in the digital signal, improve the signal-to-noise ratio of the electronic signal, and thereby improve the accuracy of the pressure data read. In practice, the hardware filtering can adopt a bandpass filter, and the software filtering includes but is not limited to a Kalman filter, a Butterworth filter, an average weighted filter, etc. Those skilled in the art should know that in addition to the signal filtering methods listed in the embodiments of the present invention, other known filtering methods can also be used, and the present invention is not limited to this. The pressure data (i.e., digital signal) obtained after processing is further transmitted to the calculation and processing module 113.

[0079] The flow control module 112 is used to control the fluid injection device 300, thereby controlling the injection and withdrawal of fluid. For example, the flow control module 112 transmits the fluid volume transmitted by the calculation processing module 113 as a control condition to the fluid injection device 300. The fluid injection device 300 generates control information based on the control condition obtained through communication and adjusts its output state according to the preset control information.

[0080] Please refer to Figure 3. In one embodiment, the fluid injection device 300 uses a syringe pump 301. This syringe pump 301 has its own stepper motor, and the stepper motor outputs fluid according to the pulse signal. For example, in this embodiment, the syringe pump 301 controls the volume of fluid injected into the balloon catheter 210 by the number of steps of the stepper motor. Of course, in other cases, the stepper motor can be replaced with other types of motors, as long as it can inject or withdraw fluid. The syringe pump 301 can store fluid in advance, or be connected to an external gas or liquid supply device to inject gas or liquid into the balloon catheter 210. It should also be noted that the fluid injection device 300 is not limited to the driving method of the motor, and can also be a pneumatic device or a hydraulic device, as long as it can achieve the filling and pressure relief of the medium in the balloon 211.

[0081] The calculation and processing module 113 is mainly responsible for calculation and processing work, which may include any calculation and processing work described in the above embodiments, for example, including obtaining the changes in intravascular pressure each time the fluid is injected and determining the current balloon diameter before treatment, and obtaining the balloon diameter according to the pressure inside the balloon during treatment, and judging whether the balloon diameter meets the requirements, etc.

[0082] The storage module 114 is used to store various information. The stored information may include, for example: a balloon compliance table, a balloon diameter required for vascular treatment (ie, a target diameter), and / or an executable program.

[0083] The central processing unit 110 may also include an input module and an output module. A user may input various information to the balloon catheter control device 110 via the input module. The input module may be a keyboard, mouse, touch screen, or other input device, without limitation. The central processing unit 110 may also transmit information to external devices via the output module, including control information to the fluid injection device 300 and data to be displayed to the information display unit 120.

[0084] Of course, in other implementations, part or all of the functions of the above modules may be implemented in the form of software (program).

[0085] Referring to Figures 9 and 10, in an exemplary embodiment, the central processing unit 110 and the information display unit 120 are integrated into a single device, forming an all-in-one device with high performance and convenience. The central processing unit 110 serves as the host portion of the all-in-one device, while the information display unit 120 serves as the display portion of the all-in-one device. The all-in-one device may include a touch screen and a display screen. The user can read the current pressure value of the balloon catheter 210 (such as intravascular pressure and intra-balloon pressure) through the display screen. At the same time, the user can also input the compliance relationship between the intra-balloon pressure and the balloon diameter through the touch screen, thereby achieving data exchange between the user and the device.

[0086] Finally, it should be noted that the balloon catheter device 200, balloon catheter control device 100 and fluid injection device 300 described above can be connected to each other in different ways to achieve the functions of the balloon catheter system of the present invention, and are not limited to the scope disclosed in the above embodiments.

[0087] In summary, the present invention provides the following beneficial effects: The balloon catheter control device 100 can rapidly adjust the expanded diameter of the balloon catheter 210 to a desired threshold range, thereby preventing vascular damage caused by overexpansion and preventing incomplete balloon expansion, which can lead to ineffective treatment. Furthermore, the present invention can automatically calibrate the required balloon diameter for treatment through communication between the balloon catheter control device 100, the balloon catheter device 200, and the fluid injection device 300, thereby improving surgical efficiency and ensuring surgical safety. Furthermore, the compliant characteristics of the balloon can more accurately measure the vessel diameter and the desired expanded diameter of the balloon within the vessel.

[0088] In general, during the process of starting circulatory treatment, the present invention can automatically adjust the inflation and deflation of the balloon 211, and monitor the pressure inside the balloon in real time online through a sensor. The pressure inside the balloon is converted into the balloon diameter through the balloon compliance relationship. The system then automatically determines whether the current balloon diameter reaches the target diameter required for treatment. If the target diameter is not reached, the system automatically adjusts the amount of fluid output to the balloon catheter until the balloon reaches the target diameter required for treatment to meet the treatment needs of the coronary sinus.

[0089] The above description is merely a description of preferred embodiments of the present invention and does not limit the scope of the present invention. Any changes or modifications made by persons skilled in the art based on the above disclosure are within the scope of protection of the present invention. Obviously, various modifications and variations may be made by persons skilled in the art without departing from the spirit and scope of the present invention. Thus, if such modifications and variations fall within the scope of the present invention and its equivalents, the present invention is intended to include such modifications and variations.

Claims

1. A balloon catheter control device for controlling a balloon catheter used for intermittently occluding the coronary sinus by inserting the balloon catheter into a target lumen. The balloon catheter control device comprises: a central processing unit, configured to obtain a pressure change rate within the target lumen based on the pressure within the target lumen fed back by the corresponding pressure sensor before initiating treatment with the balloon catheter, monitor the expansion state of the balloon in the balloon catheter based on the pressure change rate within the target lumen, and determine the current diameter of the balloon as a target diameter when the pressure change rate within the target lumen meets a requirement, and further configured to control a fluid injection device to adjust the diameter of the balloon based on the pressure within the balloon fed back by the corresponding pressure sensor during initiation of treatment with the balloon catheter; The information display unit is used to display relevant information.

2. The balloon catheter control device according to claim 1, characterized in that: The central processing unit is used to control the fluid injection device to gradually inject fluid into the balloon multiple times before the balloon catheter starts treatment, so that the balloon gradually expands, and the central processing unit is used to obtain the pressure change rate in the target lumen during each fluid injection. When the pressure change rate in the target lumen is less than or equal to a threshold, the requirement is met.

3. The balloon catheter control device according to claim 2, characterized in that: The central processing unit is configured to obtain a pressure change rate within the target lumen during each fluid injection based on a pressure change within the target lumen during a single fluid injection and a single fluid injection amount, and the central processing unit is further configured to determine whether the pressure change rate within the target lumen meets a requirement based on a threshold value; If the pressure change rate in the target lumen is greater than a threshold, continue injecting fluid into the balloon; If the pressure change rate in the target lumen is less than or equal to a threshold, the central processing unit obtains the current diameter of the balloon according to the current pressure in the balloon, and uses the current diameter as the target diameter.

4. The balloon catheter control device according to claim 1, characterized in that: The central processing unit is used to obtain the current diameter of the balloon based on the current pressure inside the balloon during the initiation of treatment by the balloon catheter, and compare the current diameter of the balloon with the target diameter. If the current diameter of the balloon is not within the threshold range of the target diameter, the fluid injection device is controlled to inject or withdraw at least part of the fluid.

5. The balloon catheter control device according to claim 4, characterized in that: The threshold interval of the target diameter is ±10% of the target diameter.

6. The balloon catheter control device according to claim 4, characterized in that: The central processing unit includes a storage module, wherein the storage module stores a balloon compliance table, wherein the balloon compliance table includes pressure data in the balloon and balloon diameter data corresponding to the pressure data; The central processing unit is used to obtain a functional relationship between the pressure inside the balloon and the diameter of the balloon according to the balloon compliance table, and convert the pressure inside the balloon into the diameter of the balloon based on the functional relationship.

7. The balloon catheter control device according to claim 6, characterized in that: The central processing unit is used to obtain the target fluid volume required for the balloon based on the target diameter in advance during the start-up treatment of the balloon catheter, and then control the fluid injection device to inject fluid into the balloon according to the target fluid volume. The central processing unit is also used to determine the current diameter of the balloon based on the current pressure in the balloon and the functional relationship, and then determine whether the current diameter of the balloon is within the threshold range of the preset target diameter. If not, the central processing unit obtains a new fluid volume based on the current pressure in the balloon, and then controls the fluid injection device to inject or withdraw at least part of the fluid according to the new fluid volume.

8. The balloon catheter control device according to claim 6, characterized in that: The central processing unit also includes a pressure signal processing module, a calculation processing module and a flow control module; the pressure signal processing module is used to process the pressure signal fed back by the pressure sensor; the calculation processing module is used to process relevant data; and the flow control module is used to control the fluid injection device.

9. A balloon catheter system, characterized in that: comprising a balloon catheter device, a fluid injection device, and a balloon catheter control device according to any one of claims 1 to 8; the balloon catheter device and the fluid injection device are both communicatively connected to the balloon catheter control device; the balloon catheter device is fluidically connected to the fluid injection device; The balloon catheter device includes a balloon catheter and a plurality of pressure sensors; the balloon catheter includes a balloon and a catheter body, the balloon is sheathed and fixed to the distal end of the catheter body, the catheter body is provided with a blood access cavity and a balloon filling cavity, the balloon filling cavity is communicated with the inner cavity of the balloon; at least one pressure sensor is fluidically connected to the proximal end of the balloon filling cavity for collecting the pressure in the balloon; At least one other pressure sensor is fluidly connected to the proximal end of the blood access lumen for collecting the pressure within the target lumen; Before starting treatment, the fluid injection device injects fluid into the balloon through the balloon filling cavity to expand the balloon; During the start-up treatment process, the fluid injection device repeatedly injects and withdraws at least part of the fluid into the balloon through the balloon filling chamber, so that the balloon switches back and forth between the expanded state and the contracted state.

10. The balloon catheter system according to claim 9, characterized in that There are two pressure sensors, which are a first pressure sensor and a second pressure sensor. The first pressure sensor is fluidically connected to the proximal end of the balloon filling cavity, and the second pressure sensor is fluidically connected to the proximal end of the blood access cavity.

11. The balloon catheter system according to claim 9, characterized in that The balloon catheter device also includes a three-way valve, a first port of the three-way valve is fluidically connected to the proximal end of the balloon filling chamber, a second port of the three-way valve is fluidically connected to at least one corresponding pressure sensor, and a third port of the three-way valve is fluidically connected to the fluid injection device.

12. An electronic device, characterized in that: include: A processor and a memory, wherein the processor is configured to execute a balloon catheter control program stored in the memory to implement a balloon catheter control method, wherein the balloon catheter control method is applied to a balloon catheter configured to be inserted into a target lumen to intermittently occlude the coronary sinus, and wherein the balloon catheter control method comprises: Before the balloon catheter treatment is started, a pressure change rate in the target lumen is obtained based on the pressure in the target lumen fed back by the corresponding pressure sensor, and the expansion state of the balloon in the balloon catheter is monitored based on the pressure change rate in the target lumen, and the current diameter of the balloon is determined as the target diameter when the pressure change rate in the target lumen meets the requirement; During the treatment process started by the balloon catheter, the fluid injection device is controlled according to the pressure in the balloon fed back by the corresponding pressure sensor to adjust the diameter of the balloon.

13. A storage medium, characterized in that: The storage medium stores one or more programs, which can be executed by one or more processors to implement a balloon catheter control method. The balloon catheter control method is applied to a balloon catheter used to intervene in a target lumen to intermittently occlude the coronary sinus. The balloon catheter control method includes: Before the balloon catheter treatment is started, a pressure change rate in the target lumen is obtained based on the pressure in the target lumen fed back by the corresponding pressure sensor, and the expansion state of the balloon in the balloon catheter is monitored based on the pressure change rate in the target lumen, and the current diameter of the balloon is determined as the target diameter when the pressure change rate in the target lumen meets the requirement; During the treatment process started by the balloon catheter, the fluid injection device is controlled according to the pressure in the balloon fed back by the corresponding pressure sensor to adjust the diameter of the balloon.

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