Flexible balloon for wall-adhesion monitoring, and wall-adhesion monitoring system

Abstract

A flexible balloon for wall-adhesion monitoring, and a wall-adhesion monitoring system. The flexible balloon comprises a balloon body (1) and a flexible electrode (2) mounted on the outside of the balloon body (1). The flexible electrode (2) comprises: two electrode pieces (21), which are attached to the outside of the flexible balloon at an interval and used to monitor impedance and capacitive reactance; a flexible pull wire (22), which is connected between the two electrode pieces (21) and used to tightly hold the balloon body (1) when the balloon body (1) is in an expanded state; two metal guide wires (23), which are respectively correspondingly connected to the two electrode pieces (21), so as to form a monitoring loop; and two insulating films (24), which are respectively arranged on two sides of the two metal guide wires (23) so as to be attached to the outside of the balloon body (1), thereby limiting the relative positions of the flexible electrode (2) and the balloon body (1). In the flexible balloon, as the interior of the balloon body (1) is continuously filled with normal saline, the two electrode pieces (21) are continuously adhered to the inner wall of a blood vessel, such that the impedance and capacitive reactance in the monitoring loop continuously change; thus, it can be determined whether the flexible balloon is tightly adhered to the inner wall of the blood vessel, thereby ensuring the ablation effect.

Description

A flexible balloon for wall adhesion monitoring and a wall adhesion monitoring system Technical Field

[0001] The present invention relates to a flexible balloon for wall adhesion monitoring and also relates to a wall adhesion monitoring system comprising the flexible balloon, belonging to the technical field of medical devices. Background Art

[0002] Ultrasonic ablation technology refers to the use of the characteristics of ultrasound waves that can pass through human tissues and focus on specific target areas, concentrating the energy to a sufficient intensity to make the focal area reach instantaneous high temperature, destroying the target tissue, which manifests as coagulative necrosis in tissue pathology, thereby achieving the purpose of destroying the lesion area while leaving the tissue outside the lesion area undamaged.

[0003] However, existing ultrasound ablation technology cannot detect balloon adhesion. Poor balloon adhesion can easily lead to loss of ultrasonic energy during the ablation process, resulting in suboptimal ablation results. Good adhesion not only ensures ablation results, but also provides real-time feedback on the ablation progress based on adhesion data, ensuring ablation results and shortening procedure time. Summary of the Invention

[0004] The primary technical problem to be solved by the present invention is to provide a flexible balloon for wall adhesion monitoring.

[0005] Another technical problem to be solved by the present invention is to provide a wall adhesion monitoring system including the flexible balloon.

[0006] In order to achieve the above technical objectives, the present invention adopts the following technical solutions:

[0007] According to a first aspect of an embodiment of the present invention, there is provided a flexible balloon for wall adhesion monitoring, comprising a balloon body and a flexible electrode mounted on the outside of the balloon body;

[0008] Wherein, the flexible electrode comprises:

[0009] Two electrode sheets are spaced apart and attached to the outside of the flexible balloon for monitoring impedance and capacitive reactance;

[0010] a flexible drawing wire connected between the two electrode sheets, and used for holding the balloon body tightly when the balloon body is in an expanded state;

[0011] Two metal guide wires are respectively connected to the two electrode sheets to form a monitoring circuit;

[0012] Two insulating films are respectively provided on both sides of the two metal guide wires, so as to be attached to the outside of the balloon body, thereby limiting the relative position of the flexible electrode and the balloon body;

[0013] As the balloon body is continuously filled with physiological saline, the two electrode sheets continuously stick to the inner wall of the blood vessel, so that the impedance and capacitance in the monitoring circuit continuously change.

[0014] Preferably, there are multiple flexible electrodes, and the multiple flexible electrodes are evenly distributed on the outside of the balloon body.

[0015] Preferably, the flexible balloon further comprises:

[0016] A pressure sensor is arranged on the inner side of the balloon body to monitor the internal water pressure of the balloon body.

[0017] Preferably, the flexible balloon further comprises:

[0018] The balloon body is made of silicone and the electrode sheet is a flexible circuit board.

[0019] According to a second aspect of an embodiment of the present invention, there is provided a wall adhesion monitoring system, comprising:

[0020] The catheter is a multi-lumen tube, comprising at least a guidewire lumen, a guide wire lumen, a liquid inlet lumen, and a liquid outlet lumen;

[0021] The flexible balloon, wherein the balloon body of the flexible balloon is sleeved on the distal end of the catheter and is connected to the liquid inlet cavity and the liquid outlet cavity;

[0022] The controller is provided at the proximal end of the catheter and is electrically connected to the flexible electrode of the flexible balloon via a wire passing through the wire cavity, so as to control the flexible balloon to perform wall adhesion monitoring.

[0023] Preferably, the controller includes:

[0024] a filtering circuit electrically connected to the flexible electrode to receive and filter the monitoring data of the flexible electrode;

[0025] an adhesion monitoring chip electrically connected to the filter circuit to receive the filtered monitoring data and perform digital conversion to form adhesion monitoring time series data;

[0026] an MCU main control circuit electrically connected to the adhesion monitoring chip to receive the adhesion monitoring time series data and construct an adhesion change curve;

[0027] A display unit is electrically connected to the MCU main control circuit and is used to display the wall adhesion change curve.

[0028] Preferably, the wall-adherence monitoring system further comprises:

[0029] A temperature sensor is provided on the catheter and located inside the balloon body, so as to monitor the internal temperature of the balloon body.

[0030] Preferably, the wall-adherence monitoring system further comprises:

[0031] An ultrasonic transducer is arranged at the distal end of the catheter and located inside the flexible balloon for use in ultrasonic ablation.

[0032] Preferably, the wall adhesion change curve changes according to the change of the ultrasonic ablation degree, so that the corresponding ultrasonic ablation power can be matched according to the wall adhesion change curve until the ablation endpoint is reached.

[0033] Preferably, the wall-adherence monitoring system further comprises:

[0034] An alarm device is electrically connected to the MCU main control circuit to receive an alarm signal sent by the MCU main control circuit and emit an alarm sound;

[0035] The MCU main control circuit can determine whether the ablation endpoint is reached according to the wall adhesion change curve, and send an alarm signal to the alarm when the ablation endpoint is reached.

[0036] Compared with the prior art, the present invention has the following technical effects:

[0037] 1. Adhesion monitoring, using flexible electrodes on the balloon's surface, determines whether the balloon is in close contact with the vessel wall, ensuring effective ablation. This solves the existing technical problem of poor adhesion, which leads to loss of ultrasonic energy and poor ablation results during ablation. This improves ablation effectiveness, shortens procedure time, and reduces adverse reactions in patients.

[0038] 2. The sheet-shaped flexible electrode has a simple structure, does not take up too much installation space, and is easy to use.

[0039] 3. The adhesion monitoring system can display the adhesion change curve in real time, allowing doctors to judge the adhesion of the flexible balloon in a more intuitive way. The doctor can also adjust the intensity of ultrasonic ablation in real time according to the adhesion change curve to ensure the best ablation effect until the ablation endpoint is reached. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] FIG1 is a schematic structural diagram of a flexible balloon for wall adhesion monitoring provided by a first embodiment of the present invention;

[0041] FIG2 is a schematic structural diagram of a flexible electrode in the first embodiment of the present invention;

[0042] FIG3 is a schematic structural diagram of a wall adhesion monitoring system provided by a second embodiment of the present invention;

[0043] FIG4 is a cross-sectional view of a catheter in a second embodiment of the present invention;

[0044] FIG5 is a schematic diagram of data interaction between the controller and the flexible balloon in the second embodiment of the present invention. DETAILED DESCRIPTION

[0045] The technical content of the present invention is described in detail below with reference to the accompanying drawings and specific embodiments.

[0046] In an embodiment of the present invention, a flexible balloon equipped with an ultrasonic transducer is delivered to a designated location through a catheter, excess air inside the flexible balloon is evacuated using a booster pump, and physiological saline is injected into the flexible balloon to fill it tightly against the blood vessel wall. At the same time, wall adhesion is monitored through flexible electrodes on the surface of the balloon body to determine whether the flexible ablation balloon is tightly adhered to the inner wall of the blood vessel, thereby ensuring the ablation effect.

[0047] First embodiment

[0048] As shown in Figure 1, a first embodiment of the present invention provides a flexible balloon for wall adhesion monitoring, comprising a balloon body 1 and a flexible electrode 2. Balloon body 1 is designed to be sheathed over a catheter, inserted into a patient's blood vessel, and, when inflated, occlude the vessel. This allows the ultrasound transducer on the catheter to perform ultrasonic ablation on the lesion within the vessel. Flexible electrode 2 is mounted on the outside of balloon body 1 to monitor impedance and capacitive reactance, thereby determining the wall adhesion of balloon body 1.

[0049] Specifically, as shown in Figure 2, in this embodiment, the flexible electrode 2 includes two electrode sheets 21, a flexible wire drawing 22, two metal guide wires 23, and two insulating films 24. The two electrode sheets 21 are sheet-like structures, preferably flexible printed circuit boards (FPCs), and are spaced apart and attached to the outside of the flexible balloon 1 for monitoring impedance and capacitive reactance. The flexible wire drawing 22 is connected between the two electrode sheets 21 to hold the balloon body 1 in place when the balloon body 1 is expanded. The two metal guide wires 23 are connected to the two electrode sheets 21, respectively. As shown in Figure 2, the right end of the metal guide wire 23 on the left is connected to the left electrode sheet 21, and the left end of the metal guide wire 23 on the right is connected to the right electrode sheet 21. Both metal guide wires 23 can be connected to a controller via wires, thereby forming a monitoring circuit. Two insulating films 24 are provided on either side of the two metal guide wires 23 for attachment to the outside of the balloon body 1, thereby limiting the relative position of the flexible electrode 2 and the balloon body 1.

[0050] It can be understood that in this monitoring circuit, as physiological saline is continuously filled into the balloon body 1, the balloon body 1 will gradually fill up, causing the two electrode sheets 21 to continuously adhere to the inner wall of the blood vessel. During this process, the impedance and capacitance in the monitoring circuit continue to change. The values ​​of the impedance and capacitance can be monitored by the two electrode sheets 21 to determine whether the balloon body 1 is completely adhered to the wall.

[0051] In the above embodiment, preferably, there are multiple flexible electrodes 2, and the multiple flexible electrodes 2 are evenly distributed on the outside of the balloon body 1. Therefore, the balloon body 1 can be fully monitored for wall adhesion by the multiple flexible electrodes 2 to ensure the wall adhesion effect of the balloon body 1.

[0052] In the above embodiment, the flexible balloon preferably further includes a pressure sensor (not shown). The pressure sensor is disposed inside the balloon body 1 to monitor the internal water pressure of the balloon body 1. Thus, by controlling the internal water pressure of the balloon body 1, the filling level of the balloon body 1 can be adjusted, thereby cooperating with the flexible electrode 2 to monitor the wall adhesion of the balloon body 1.

[0053] In the above embodiment, preferably, the balloon body 1 is made of silicone and the electrode sheet 21 is a flexible circuit board, but the specific materials of the balloon body 1 and the electrode sheet 21 are not limited and can be adaptively selected according to actual needs.

[0054] Second embodiment

[0055] As shown in FIG3 , based on the first embodiment, the second embodiment of the present invention provides a wall adhesion monitoring system, including a catheter 10 , the flexible balloon 20 and a controller 30 .

[0056] Specifically, as shown in FIG4 , the catheter 10 is a multi-lumen tube, comprising at least a guidewire lumen 101, a guidewire lumen 102, a liquid inlet lumen 103, and a liquid outlet lumen 104. A guidewire 110 is inserted into the guidewire lumen 101, and the guidewire 110 can be used to control the bending direction of the catheter 10 in the blood vessel. A guidewire 120 is inserted into the guidewire lumen 102, and the controller 30 can be connected to the flexible electrode 2 on the flexible balloon 20 through the guidewire 120. The liquid inlet lumen 103 and the liquid outlet lumen 104 cooperate to form a water circulation channel, and the balloon body 1 of the flexible balloon is sleeved on the distal end of the catheter and is connected to the liquid inlet lumen 103 and the liquid outlet lumen 104, so that the liquid inlet lumen 103 can be used to fill the balloon body 1 with saline, and the liquid outlet lumen 104 can be used to extract the saline from the balloon body 1.

[0057] The controller 30 is provided at the proximal end of the catheter 10 for controlling the flexible balloon 20 to perform wall adhesion monitoring. Specifically, as shown in FIG5 , the controller 30 includes a filter circuit 301, a wall adhesion monitoring chip 302, an MCU main control circuit 303, and a display unit 304. Among them, the filter circuit 301 is electrically connected to the flexible electrode 2 to receive the monitoring data of the flexible electrode 2 and filter it. The wall adhesion monitoring chip 302 is electrically connected to the filter circuit 301 to receive the filtered monitoring data and perform digital conversion to form wall adhesion monitoring time series data. The MCU main control circuit 303 is electrically connected to the wall adhesion monitoring chip 302 to receive the wall adhesion monitoring time series data and construct a wall adhesion change curve. The display unit 304 is electrically connected to the MCU main control circuit 303 to display the wall adhesion change curve.

[0058] The specific working process is as follows:

[0059] First, the catheter 10 and the flexible balloon 20 are extended together into a designated area in the patient's blood vessel via the guidewire 110;

[0060] Secondly, physiological saline is continuously filled into the balloon body 1 through the liquid inlet cavity 103 by an external water supply device until the flexible electrode 2 contacts the inner wall of the blood vessel and begins wall monitoring;

[0061] Then, as the balloon body 1 continues to fill, the impedance value and the capacitance value monitored by the flexible electrode 2 continue to change, and the flexible electrode 2 transmits the monitored data to the filter circuit 301 in real time;

[0062] Then, the filter circuit 301 filters the signal and transmits the filtered monitoring data to the wall-attached monitoring chip 302;

[0063] Then, the adhesion monitoring chip 302 receives the filtered monitoring data and performs digital conversion to form adhesion monitoring time series data, and transmits it to the MCU main control circuit 303;

[0064] Finally, the MCU main control circuit 303 receives the adhesion monitoring time series data, constructs an adhesion variation curve, and controls the display unit 304 to display the adhesion variation curve.

[0065] Therefore, whether the balloon body 1 is completely adhered to the wall can be judged by observing the degree of change in the wall adhesion change curve, and the wall adhesion of the balloon body 1 can be ensured by controlling the internal pressure of the balloon body 1.

[0066] In the above embodiment, preferably, the wall-adherence monitoring system further includes an ultrasonic transducer 40 and a temperature sensor 50. The ultrasonic transducer 40 is arranged at the distal end of the catheter 10 and is located inside the flexible balloon 20 for ultrasonic ablation. In this embodiment, the ultrasonic transducer can be switched between ablation mode and measurement mode. In ablation mode, the ultrasonic transducer converts electrical signals into mechanical vibrations to continuously generate ultrasonic waves, and heats up the tissue within the energy focus range of the sound wave transmission to achieve the purpose of ablation. In measurement mode, the ultrasonic transducer converts pulsed electrical signals into mechanical signals to generate a single ultrasonic wave, and calculates tissue morphological changes, temperature changes, and changes in the inner diameter of the blood vessels by analyzing the echo signals. Therefore, by continuously switching the working mode, it is possible to ensure efficiency, avoid excessive ablation, and improve the effect of ultrasonic ablation.

[0067] In the above embodiment, the wall adhesion monitoring system preferably further includes a temperature sensor 50. The temperature sensor 50 is provided on the catheter 10 and located inside the balloon body 1 to monitor the internal temperature of the balloon body 1. Thus, temperature monitoring can further prevent excessive ablation by the ultrasonic transducer 40.

[0068] It is understood that in the above embodiment, as the ultrasonic transducer 40 continues to ablate, the pressure exerted by the balloon body 1 on the inner wall of the blood vessel also changes. Accordingly, the impedance and capacitive reactance values ​​monitored by the flexible electrode 2 also change, thereby enabling the wall adhesion variation curve to change with the degree of ultrasonic ablation. Thus, the corresponding ultrasonic ablation power can be matched to the wall adhesion variation curve to ensure the optimal ablation effect until the ablation endpoint is reached.

[0069] In the above embodiment, the adhesion monitoring system preferably further includes an alarm (not shown). The alarm is electrically connected to the MCU main control circuit 303. The MCU main control circuit 303 can determine whether the ablation endpoint has been reached based on the adhesion change curve and send an alarm signal to the alarm when the ablation endpoint is reached. In response, the alarm can receive the alarm signal sent by the MCU main control circuit 303 and sound an alarm to alert the doctor to the end of the ablation process and avoid causing additional harm to the patient.

[0070] In summary, the flexible balloon and system for wall adhesion monitoring provided by the embodiments of the present invention have the following beneficial effects:

[0071] 1. Adhesion monitoring is performed using flexible electrodes 2 on the surface of the balloon body 1 to determine whether the flexible balloon is closely adhering to the vessel wall, ensuring effective ablation. This solves the existing technical problem of poor adhesion, which leads to loss of ultrasonic energy during ablation and poor ablation results. This improves ablation effectiveness, shortens procedure time, and reduces adverse reactions in patients during surgery.

[0072] 2. The sheet-shaped flexible electrode 2 has a simple structure, does not take up too much installation space, and is easy to use.

[0073] 3. The adhesion monitoring system can display the adhesion change curve in real time, allowing doctors to judge the adhesion of the flexible balloon in a more intuitive way. The doctor can also adjust the intensity of ultrasonic ablation in real time according to the adhesion change curve to ensure the best ablation effect until the ablation endpoint is reached.

[0074] It should be noted that the above embodiments are merely examples, and the technical solutions of the various embodiments may be combined and are all within the scope of protection of the present invention.

[0075] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of the technical features being referred to. Thus, a feature identified as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of the present invention, "plurality" means two or more, unless otherwise specifically defined.

[0076] The flexible balloon and system for monitoring adhesion provided by the present invention are described in detail above. Any obvious modification to the present invention without departing from its essence would constitute an infringement of the present invention's patent rights and would incur corresponding legal liability.

Claims

1. A flexible balloon for adherent monitoring, characterized in that It includes a balloon body and a flexible electrode installed outside the balloon body; Wherein, the flexible electrode comprises: Two electrode sheets are spaced and attached to the outside of the flexible balloon to monitor impedance and capacitive reactance; A flexible drawing wire connected between the two electrode sheets to hold the balloon body tightly when the balloon body is in an expanded state; Two metal guide wires are respectively connected to the two electrode sheets to form a monitoring circuit; Two insulating films are respectively arranged on both sides of the two metal guide wires, so as to be attached to the outside of the balloon body, thereby limiting the relative position of the flexible electrode and the balloon body; As the balloon body is continuously filled with physiological saline, the two electrode sheets are continuously pressed against the inner wall of the blood vessel, so that the impedance and capacitance in the monitoring circuit are continuously changed.

2. The flexible balloon according to claim 1, characterized in that: There are multiple flexible electrodes, and the multiple flexible electrodes are evenly distributed on the outside of the balloon body.

3. The flexible balloon according to claim 1, wherein Also includes: The pressure sensor is arranged on the inner side of the balloon body to monitor the internal water pressure of the balloon body.

4. The flexible balloon according to claim 1, wherein Also includes: The balloon body is made of silicone and the electrode sheet is a flexible circuit board.

5. An adherent monitoring system, characterized in that include: The catheter is a multi-lumen tube, comprising at least a guidewire lumen, a guide wire lumen, a liquid inlet lumen and a liquid outlet lumen; The flexible balloon according to any one of claims 1 to 4, wherein the balloon body of the flexible balloon is sleeved on the distal end of the catheter and is connected to the liquid inlet cavity and the liquid outlet cavity; The controller is arranged at the proximal end of the catheter and is electrically connected to the flexible electrode of the flexible balloon through a wire passing through the wire cavity, so as to control the flexible balloon to perform wall adhesion monitoring.

6. The adherent monitoring system according to claim 5, characterized in that The controller comprises: A filtering circuit, electrically connected to the flexible electrode, to receive monitoring data of the flexible electrode and perform filtering; The wall adhesion monitoring chip is electrically connected to the filtering circuit to receive the filtered monitoring data and perform digital conversion to form wall adhesion monitoring time series data; The MCU main control circuit is electrically connected to the adhesion monitoring chip to receive the adhesion monitoring time series data and construct an adhesion change curve; A display unit is electrically connected to the MCU main control circuit to display the wall adhesion change curve.

7. The adherent monitoring system according to claim 5, wherein Also includes: A temperature sensor is arranged on the catheter and located inside the balloon body to monitor the internal temperature of the balloon body.

8. The adherent monitoring system according to claim 5, characterized in that Also includes: The ultrasonic transducer is arranged at the distal end of the catheter and located inside the flexible balloon for ultrasonic ablation.

9. The wall-adherence monitoring system according to claim 8, characterized in that: The wall adhesion variation curve changes according to the change of the ultrasonic ablation degree, so that the corresponding ultrasonic ablation power can be matched according to the wall adhesion variation curve until the ablation end point is reached.

10. The adherent monitoring system according to claim 9, wherein Also includes: An alarm device, the alarm device is electrically connected to the MCU main control circuit to receive an alarm signal sent by the MCU main control circuit and emit an alarm sound; The MCU main control circuit can determine whether the ablation endpoint is reached according to the wall adhesion change curve, and send an alarm signal to the alarm device when the ablation endpoint is reached.

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