Balloon catheter device capable of monitoring blood pressure and controlled drug release and control method thereof

Abstract

The application discloses a balloon catheter device capable of monitoring blood pressure and controllable drug release and a control method thereof, and relates to the technical field of medical instruments.The device comprises a balloon catheter, an external receiving control module, a monitoring module and a drug release module.The monitoring module is integrated in the catheter inside the balloon catheter and is used for collecting the pressure of the position where the monitoring module is located to obtain the blood pressure.The drug release module is integrated on the catheter outer wall surface of the balloon catheter and is used for releasing drugs under the action of voltage.The external receiving control module is used for receiving the blood pressure obtained by the monitoring module, applying voltage to the drug release module through the obtained blood pressure, adjusting the application amplitude and application time of the voltage, obtaining the capacitance of the drug release module, determining the drug release amount of the drug release module based on the capacitance, and inhibiting thrombosis through drug release to ensure more accurate blood pressure monitoring and form a closed-loop feedback regulation system.The application can realize in-situ monitoring of blood pressure and precise controllable drug release.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a balloon catheter device capable of monitoring blood pressure and controllable drug release and a control method thereof. BACKGROUND

[0002] Cardiovascular disease (CVD for short) is one of the main causes of death worldwide, accounting for more than 30% of global deaths. Vascular stenosis or obstruction is the main cause of CVD. Balloon catheters, a kind of interventional medical devices, are widely used in angioplasty for blood revascularization to treat cardiovascular diseases. Through minimally invasive interventional surgery, balloon catheters can expand the stenotic blood vessels of patients and improve blood flow, and can also be used to deliver and release vascular stents, so they have been widely used in clinical practice. Balloon catheters can only mechanically expand and prop open the stenosis site, but cannot solve the problems of endothelial damage, inflammatory response at the lesion site, and the inability to monitor blood pressure in situ, which can easily lead to thrombosis and failure to timely detect the physiological state of the patient's blood pressure.

[0003] Recently, the emergence of drug-eluting balloon catheters not only achieves mechanical expansion, but also has the additional function of drug delivery to the vascular wall to prevent restenosis. However, drug-eluting balloon catheters directly coat drugs on the outer wall of the catheter. During drug administration, drug loss, uneven contact area between the balloon and the vascular wall, and uneven coating force can affect the drug administration effect. In addition, this drug release behavior is spontaneous and continuous, and the amount, rate, and time of drug release are difficult to control, which cannot meet the temporary needs during surgery. Furthermore, the current drug-eluting balloon catheters lack real-time feedback on the hemodynamic recovery after drug release, so the effectiveness of drug therapy cannot be determined, and the control of drug administration during surgery often relies on prior experience. For vascular stenosis and obstruction, blood pressure is an important hemodynamic parameter, so in-situ real-time monitoring of blood pressure is expected to provide a reliable physiological indicator for drug-eluting balloon catheter surgery. However, drug-eluting balloon catheters cannot monitor the patient's blood pressure in situ. Therefore, controllable drug release behavior and in-situ monitoring of blood pressure are the directions that need to be optimized in current drug-eluting balloon catheters. SUMMARY

[0004] The purpose of the present application is to provide a balloon catheter device capable of monitoring blood pressure and controllable drug release and a control method thereof, which can achieve in-situ monitoring of blood pressure and precise controllable drug release.

[0005] To achieve the above-mentioned purpose, the present application provides the following solutions:

[0006] In a first aspect, the application provides a balloon catheter device capable of monitoring blood pressure and controllable drug release, comprising a balloon catheter, an external receiving control module, a monitoring module and a drug release module, wherein the external receiving control module is connected with the monitoring module and the drug release module respectively.

[0007] The monitoring module is integrated inside the catheter of the balloon catheter, and is used to collect the pressure at the position of the monitoring module to obtain blood pressure.

[0008] The drug release module is integrated on the outer wall of the catheter of the balloon catheter, and is used to release drugs under the action of voltage.

[0009] The external receiving control module is used to receive the blood pressure obtained by the monitoring module, apply voltage to the drug release module, adjust the application amplitude and application time of the voltage, obtain the capacitance of the drug release module, and determine the drug release amount of the drug release module based on the capacitance.

[0010] Optionally, the wall of the catheter has a slot, the monitoring module is integrated at the slot, the lead wire used when the drug release module is connected with the external receiving control module enters the inside of the catheter through the slot, and the slot is packaged by glue, and the glue is also used to fix the monitoring module; wherein the glue is biocompatible glue.

[0011] The drug release module surrounds the outer wall of the catheter and is integrated on the outer wall of the catheter.

[0012] Optionally, the monitoring module comprises a pressure sensor and a flexible printed circuit board, the pressure sensor is integrated on the flexible printed circuit board, and the pressure sensor is connected with the flexible printed circuit board, and the flexible printed circuit board is connected with the external receiving control module.

[0013] Optionally, the pressure sensor comprises a conductive layer, a piezoresistive layer, an insulating layer and a substrate layer which are sequentially stacked from top to bottom.

[0014] The conductive layer comprises four metal electrodes, and the four metal electrodes are connected with the flexible printed circuit board; the material of the metal electrode is gold.

[0015] The piezoresistive layer comprises four piezoresistors, the four piezoresistors are distributed on the four edges of the piezoresistive layer, and the four piezoresistors are connected with the four metal electrodes to form a Wheatstone bridge structure.

[0016] The material of the insulating layer is silicon dioxide.

[0017] The material of the substrate layer is silicon.

[0018] The insulating layer and the base layer jointly form a groove, constituting a pressure cavity.

[0019] Optionally, the drug release module comprises, from top to bottom, a drug-loaded film, a flexible interdigitated electrode and a polyimide base, the drug-loaded film being capable of releasing drugs under the action of voltage, and the flexible interdigitated electrode being connected to the external receiving control module through a wire; wherein the material of the flexible interdigitated electrode is gold.

[0020] Optionally, the drug release module further comprises a polyvinyl alcohol film, the polyvinyl alcohol film being located between the flexible interdigitated electrode and the drug-loaded film.

[0021] Optionally, the drug release amount of the drug release module is determined based on the capacitance, specifically comprising: taking the capacitance as input, and determining the drug release amount of the drug release module based on a pre-determined relationship curve between capacitance and drug release amount.

[0022] Optionally, the monitoring module is arranged adjacent to the drug release module; and the external receiving control module is configured to regulate the application amplitude and application time of the voltage based on the blood pressure, so as to adjust the drug release rate of the drug release module.

[0023] Optionally, the voltage is -2V.

[0024] In a second aspect, the application provides a control method of a balloon catheter device capable of monitoring blood pressure and controllable drug release, for controlling the balloon catheter device capable of monitoring blood pressure and controllable drug release, the control method of the balloon catheter device capable of monitoring blood pressure and controllable drug release comprising: receiving the blood pressure obtained by the monitoring module when the balloon catheter device is in a working position, and applying a voltage to the drug release module, while obtaining the capacitance of the drug release module, and determining the drug release amount of the drug release module based on the capacitance.

[0025] According to the specific embodiments provided by the application, the application has the following technical effects:

[0026] The application provides a balloon catheter device capable of monitoring blood pressure and controlled drug release and a control method thereof, which comprises a balloon catheter, an external receiving control module, a monitoring module and a drug release module, the monitoring module is integrated in the catheter inside the balloon catheter and is used for collecting the pressure at the position of the monitoring module to obtain the blood pressure, the drug release module is integrated on the catheter outer wall surface of the balloon catheter and is used for releasing drugs under the action of voltage, the external receiving control module is used for receiving the blood pressure obtained by the monitoring module, applying voltage to the drug release module, adjusting the application amplitude and application time of the voltage, obtaining the capacitance of the drug release module while the drug is released, determining the drug release amount of the drug release module based on the capacitance, and inhibiting thrombosis through drug release to ensure more accurate blood pressure monitoring and form a closed-loop feedback regulation system. The application realizes in-situ monitoring of blood pressure by arranging the monitoring module, and realizes precise and controllable drug release by arranging the drug release module and applying voltage to the drug release module to release drugs, so that the drug release amount, drug release rate and drug release time can be changed by adjusting the application amplitude and application time of the voltage. BRIEF DESCRIPTION OF DRAWINGS

[0027] In order to more clearly illustrate the technical solutions in the embodiments of the application or the prior art, the following will briefly introduce the drawings needed in the embodiments. Obviously, the drawings in the following description only constitute some embodiments of the application, and for those skilled in the art, other drawings can also be obtained without creative labor.

[0028] Figure 1 A schematic diagram of the overall framework of a balloon catheter device capable of monitoring blood pressure and controlled drug release provided in Embodiment 1 of the application.

[0029] Figure 2 A schematic diagram of the overall connection of a balloon catheter device capable of monitoring blood pressure and controlled drug release provided in Embodiment 1 of the application.

[0030] Figure 3 A structural schematic diagram of a pressure sensor provided in Embodiment 1 of the application; wherein, Figure 3 (a) in FIG. 1 is a front view of the pressure sensor, Figure 3 (b) in FIG. 1 is a front view of the pressure sensor when it is subjected to pressure, Figure 3 (c) in FIG. 1 is a top view of the pressure sensor.

[0031] Figure 4 A structural schematic diagram of a drug release module provided in Embodiment 1 of the application; wherein, Figure 4 (a) in FIG. 2 is a flexible interdigital electrode, Figure 4 (b) in FIG. 2 is a polyvinyl alcohol film, Figure 4 (c) in FIG. 2 is a heparin-loaded polypyrrole.

[0032] Figure 5 A structural schematic diagram of a computer device provided for Embodiment 3 of the present application.

[0033] Reference signs:

[0034] 1-external receiving control module; 2-monitoring module; 3-drug release module; 4-balloon; 5-catheter; 21-conductive layer; 22-pressure sensitive resistor; 23-pressure sensitive resistor layer; 24-pressure cavity; 25-insulating layer; 26-substrate layer; 31-drug-loaded film; 32-flexible interdigital electrode; 33-polyimide substrate; 34-polyvinyl alcohol film. DETAILED DESCRIPTION

[0035] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative labor fall within the scope of protection of the present application.

[0036] Embodiment 1

[0037] In recent years, with the continuous development of drug release systems capable of responding to various internal and external stimuli, the control of drug delivery systems based on external stimulus signals has been widely studied. For intravascular catheter systems, the complexity and high control cost of temperature, magnetic, light, pH and other response means, the electric stimulation system has the advantages of easy control, repeatable and reliable signal input, good compatibility with interventional medical devices, and can realize the control of drug delivery and information feedback at the same time, but at present, the electric stimulation control drug delivery system integrated into the balloon catheter has not been comprehensively experimentally verified and regular summarized.

[0038] Based on this, the present embodiment provides a balloon catheter device capable of monitoring blood pressure and controllable drug release, which realizes precise and controllable drug release through electric stimulation, as shown in Figure 1 and Figure 2 The balloon catheter device capable of monitoring blood pressure and controllable drug release includes a balloon catheter, an external receiving control module 1, a monitoring module 2 and a drug release module 3, and the external receiving control module 1 is connected with the monitoring module 2 and the drug release module 3 respectively.

[0039] The monitoring module 2 is integrated inside the catheter 5 of the balloon catheter, and the monitoring module 2 is used for collecting the pressure at the position where the monitoring module 2 is located to obtain the blood pressure.

[0040] The drug release module 3 is integrated on the outer wall surface of the catheter 5 of the balloon catheter, and the drug release module 3 is used for releasing drugs under the action of voltage.

[0041] The external receiving control module 1 is used for receiving the blood pressure acquired by the monitoring module 2, applying a voltage to the drug release module 3, adjusting the application amplitude and application time of the voltage, acquiring the capacitance of the drug release module 3 while the drug is released, determining the drug release amount of the drug release module 3 based on the capacitance, and inhibiting thrombosis through the drug release to ensure more accurate blood pressure monitoring, thereby forming a closed-loop feedback regulation system.

[0042] The balloon catheter device of the embodiment has a balloon structure at the proximal end for mechanically expanding the blood vessel during the operation.

[0043] As shown in Figure 1 When the balloon catheter device of the embodiment enters the blood vessel, the drug release module 3 enters first, the monitoring module 2 enters second, and the balloon 4 of the balloon catheter enters last, that is, the balloon catheter device is arranged from front to back as the drug release module 3, the monitoring module 2 and the balloon 4. In the following, the monitoring module 2 and the drug release module 3 will be described in detail.

[0044] (1) Monitoring module 2

[0045] The monitoring module 2 mainly includes a pressure sensor and a flexible printed circuit board integrated in the catheter 5. When the monitoring module 2 is integrated in the catheter 5, a slot is first formed on the wall of the catheter 5, and then the monitoring module 2 is placed in the catheter 5 through the slot. At this time, the monitoring module 2 is exposed at the slot of the catheter 5, and finally it is protected by biocompatible glue. That is, the slot is filled with biocompatible glue so that the slot of the catheter 5 is filled, and the monitoring module 2 can be fixed by the biocompatible glue. Specifically, the pressure sensor of the monitoring module 2 is integrated into the flexible printed circuit board, the back of the flexible printed circuit board is pasted on the inner wall of the catheter 5 by biocompatible glue, so that the monitoring module 2 is fixed at the slot position and monitors the pressure in situ. The slot position is also encapsulated by biocompatible glue. The biocompatible glue can be RTV (room temperature vulcanized silicone rubber).

[0046] In order to be able to lead out the signal of the monitoring module 2, the monitoring module 2 is electrically connected to the external receiving control module 1. Specifically, the flexible printed circuit board can be led out to the outlet of the catheter 5 of the balloon catheter, and then connected to the external receiving control module 1 through external wires, or the flexible printed circuit board is not led out to the outlet of the catheter 5 of the balloon catheter, but directly connected to the external receiving control module 1 through part of the wires located inside the catheter 5 and part of the wires located outside the catheter 5. After the catheter 5 is placed in the blood vessel of the human body, the pressure value can be monitored in situ and in real time by the monitoring module 2 to obtain the blood pressure, and the blood pressure signal is transmitted to the external receiving control module 1 through the wires for real-time display.

[0047] At this time, in the embodiment, the wall surface of the catheter 5 has a slot, the monitoring module 2 is integrated at the slot, and the slot is packaged by glue, and the glue is also used to fix the monitoring module 2, wherein the glue is biocompatible glue. The monitoring module 2 comprises a pressure sensor and a flexible printed circuit board, the pressure sensor is integrated on the flexible printed circuit board, and the pressure sensor is connected with the flexible printed circuit board, the flexible printed circuit board is connected with the external receiving control module 1, and the flexible printed circuit board can be connected with the external receiving control module 1 through a wire.

[0048] The pressure sensor used in the embodiment can be any existing pressure sensor. As an example, the structure of the pressure sensor provided by the embodiment is shown in FIG. 2, which is composed of three materials of silicon, silicon dioxide and gold, and comprises a conductive layer 21, a piezoresistive layer 23, an insulating layer 25 and a substrate layer 26 which are sequentially stacked from top to bottom. The insulating layer 25 and the substrate layer 26 are etched to form a groove together, thereby forming a pressure cavity 24. The pressure cavity 24 penetrates the insulating layer 25 but does not penetrate the substrate layer 26, so as to form the pressure cavity 24 between the piezoresistive layer 23 and the substrate layer 26. Figure 3 The conductive layer 21 comprises four metal electrodes, all of which are connected with the flexible printed circuit board. The four metal electrodes can be located at four corners of the piezoresistive layer 23, and each metal electrode is provided with a solder pad. The metal electrodes are connected with the flexible printed circuit board through bonding wires, and the material of the metal electrodes is gold. The piezoresistive layer 23 comprises four piezoresistors 22 which are distributed at four edges of the piezoresistive layer 23. The four piezoresistors 22 are connected with the four metal electrodes, so as to be connected with the flexible printed circuit board through the four metal electrodes, thereby forming a Wheatstone bridge structure. The piezoresistive layer 23 is a silicon film, i.e., the material of the piezoresistive layer 23 is silicon, and the four piezoresistors 22 prepared on the piezoresistive layer 23 are shown in FIG. 2 by a middle red dashed line. Figure 3 The material of the insulating layer 25 is silicon dioxide, which plays a role of electrical isolation and protection. The material of the substrate layer 26 is silicon, which serves as a supporting material of the entire pressure sensor, and provides mechanical strength and structural support. When pressure is applied to the piezoresistive layer 23, the Wheatstone bridge formed by the four piezoresistors 22 will generate a voltage signal which is linearly proportional to the applied pressure. Subsequently, the voltage signal is transmitted to the external receiving control module 1 through the flexible printed circuit board and the wire, so as to collect blood pressure in situ. The pressure sensor of the embodiment is a silicon-silicon bonding structure, which has good linearity, repeatability and stability, high sensitivity, and is convenient for users to debug the output by using an operational amplifier or an integrated circuit. It is suitable for oil-filled isolation and various simple packaging pressure sensors.

[0049] (II) Drug release module 3

[0050] The drug release module 3 of the embodiment surrounds the outer wall of the catheter 5 and is integrated on the outer wall of the catheter 5. The drug release module 3 is connected to the external receiving control module 1 through a wire. Since the drug release module 3 is integrated on the outer wall of the catheter 5, the wire needs to be introduced into the inside of the catheter 5. At this time, the wire used for connecting the drug release module 3 and the external receiving control module 1 is arranged to enter the inside of the catheter 5 through a slot.

[0051] As shown in Figure 4 The drug release module 3 of the embodiment includes, from top to bottom, a drug-loaded film 31, a flexible interdigital electrode 32, and a polyimide substrate 33. The drug-loaded film 31 can release drugs under the action of voltage. For example, the drug-loaded film 31 can be a film in which drugs are combined with the film by electrostatic force and hydrogen bonds. When a voltage is applied, the hydrogen bonds can be broken, and at this time, the drugs are separated from the film to achieve drug release. For another example, the drug-loaded film 31 can be a film in which drugs are located in the pores of the film. When a voltage is applied, the pores become larger, and at this time, the drugs are separated from the film to achieve drug release. Therefore, the drug-loaded film 31 of the embodiment can be any drug-loaded film that can separate drugs from the film under electrical stimulation. The flexible interdigital electrode 32 is connected to the external receiving control module 1 through a wire. The material of the flexible interdigital electrode 32 is gold.

[0052] It should be noted that the drug-loaded film 31 is attached to the flexible interdigital electrode 32, and the flexible interdigital electrode 32 is attached to the polyimide substrate 33. In order to further make the drug-loaded film 31 and the flexible interdigital electrode 32 attach better, the drug release module 3 of the embodiment further includes a polyvinyl alcohol film 34. The polyvinyl alcohol film 34 is located between the flexible interdigital electrode 32 and the drug-loaded film 31, and serves as glue to make the drug-loaded film 31 and the flexible interdigital electrode 32 attach better and more closely.

[0053] The drug-loaded film 31 of the embodiment is adhered to the flexible interdigital electrode 32 by spin coating. The drug release module 3 is connected to the external receiving control module 1 through the wire placed in the balloon catheter. The drug-loaded film 31 is stimulated to release drugs by the adjustable voltage applied by the external receiving control module 1. Since the dielectric constant of the drug-loaded film 31 changes after the drug is released, the electrical parameters of the flexible interdigital electrode 32 will change at this time. Therefore, the electrical parameter feedback information of the drug-loaded film 31 can be further monitored by the external receiving control module 1. The electrical parameter feedback information can be monitored by a digital bridge or an impedance analyzer in the external receiving control module 1. The electrical parameter feedback information includes capacitance and impedance. The doctor obtains the dose of the released drug by the standard curve of the electrical parameter and the drug release amount, that is, obtains the drug release amount. At this time, in the embodiment, the drug release amount of the drug release module 3 is determined based on the capacitance. Specifically, the capacitance is taken as the input, and the drug release amount of the drug release module 3 is determined based on the pre-determined relationship curve between the capacitance and the drug release amount.

[0054] The drug release module 3 of the embodiment mainly comprises a drug-loaded film 31, which can adopt any existing film as long as it can release drugs under the action of voltage, including but not limited to a heparin-loaded polypyrrole film. At this time, the structural schematic diagram of the drug release module 3 is as shown in the figure, from bottom to top, they are polyimide, gold (i.e. flexible interdigital electrode 32), polyvinyl alcohol and heparin-loaded polypyrrole (PPy-Hep). Figure 4

[0055] The embodiment can also form linkage through the monitoring module 2 and the drug release module 3 integrated on the balloon catheter, and the release process is regulated through feedback blood pressure information during the interventional operation, that is, the monitoring module 2 and the drug release module 3 are jointly regulated, the voltage can be regulated through the pressure value monitored by the monitoring module 2, the release rate of the drug release module 3 is increased or decreased, and the drug released by the drug release module 3 can ensure that the pressure value monitored by the monitoring module 2 is more accurate, and the influence of the thrombus on the pressure sensor is eliminated.

[0056] At this time, in the embodiment, the monitoring module 2 and the drug release module 3 are arranged adjacently, and the external receiving control module 1 is further used for regulating the application amplitude and application time of the voltage based on the blood pressure, so as to adjust the release rate of the drug release module 3.

[0057] Preferably, the voltage applied in the embodiment is-2V, at this time, the release rate is more stable, the release effect is better, and the precise and controllable drug release is realized.

[0058] The pressure value measured by the monitoring module of the embodiment is fed back to the external receiving control module, the external receiving control module regulates the application amplitude and application time of the voltage based on the blood pressure, so as to adjust the release rate of the drug release module, the capacitance of the drug release module is obtained at the same time of the drug release, the release amount of the drug release module is determined based on the capacitance, the thrombus formation can be inhibited through the drug release, the blood pressure monitoring is ensured to be more accurate, and a closed-loop feedback regulation system is formed.

[0059] The working process of the balloon catheter device of the embodiment is as follows:

[0060] Step 1: The balloon catheter comprising the monitoring module 2 and the drug release module 3 is placed into the human body through the hemostatic sheath.

[0061] Step 2: The monitoring module 2 starts to monitor the pressure value in situ, the pressure value monitored by the monitoring module 2 is received by the external receiving control module 1 connected to the tail of the balloon catheter, the blood pressure is obtained, and the pressure collection is completed.

[0062] Step 3: The external power supply in the external receiving control module 1 is turned on, the direct current voltage is adjusted to-2V, and is applied to the drug release module 3.

[0063] ​Step 4: The drug release module 3 starts to release the mode drug from the drug release module 3.

[0064] Step 5: The external receiving control module 1 starts to monitor the electrical parameters (capacitance and impedance) of the drug release module 3, and the standard curve of capacitance and drug release amount can help the doctor accurately obtain the drug release amount.

[0065] Step 6: The monitoring module 2 and the drug release module 3 are linked and mutually regulated.

[0066] Step 7: After the drug release module 3 releases the drug, it can ensure the accuracy of the monitoring value of the monitoring module 2.

[0067] Step 8: The external receiving control module 1 can obtain the pressure value obtained by the monitoring module 2, and the doctor can increase or decrease the voltage according to the feedback pressure value to control the drug release rate of the drug release module 3 and perform personalized treatment.

[0068] Compared with the existing products, the embodiment has the functions of multifunctional joint regulation, in-situ precise pressure measurement, in-situ precise on-demand drug release, and mutual regulation. The doctor can obtain accurate drug release amount according to the feedback electrical parameter information, increase or decrease the drug release rate of the drug release module 3 by regulating the voltage according to the pressure value monitored by the monitoring module 2, and ensure that the drug released by the drug release module 3 is more accurate. The pressure value monitored by the monitoring module 2 can eliminate the influence of thrombus on the pressure sensor. In addition, the embodiment has the advantage of biocompatibility, i.e. all components are made of biocompatible materials, which reduces the biological rejection reaction caused by interventional surgery and improves the stability of monitoring.

[0069] The technical problems solved by the present embodiment are: (1) Real-time in-situ monitoring: Traditional monitoring methods cannot monitor blood pressure in real time in-situ, so they cannot provide real-time data of in-situ blood pressure during surgery, which leads to the inability to timely adjust potential problems during surgery, and the pressure values obtained by the method of leading blood outward for pressure monitoring are biased, and the influence of thrombus on the monitoring module 2 cannot be eliminated during surgery. (2) Difficulty in obtaining drug release amount: Existing technologies cannot obtain the released drug dose in real time, and cannot achieve controllable drug release. Therefore, the research and development goals of the present embodiment are: (1) Real-time monitoring: Develop a balloon catheter device that can accurately monitor blood pressure in real time in-situ. (2) Controllable treatment: Establish a drug release module that can be integrated into the balloon catheter, control the drug release rate by externally applied voltage, and obtain the drug release amount to achieve controllable drug release. (3) Joint regulation: The pressure value monitored by the monitoring module 2 can be used to regulate the voltage, increasing or decreasing the drug release rate of the drug release module 3; the drug released by the drug release module 3 can ensure that the pressure value monitored by the monitoring module 2 is more accurate, and eliminate the influence of thrombus on the pressure sensor. In order to achieve this research and development goal, the technical development needs are: (1) Sensor technology: Small, low-power and biocompatible sensors are needed to monitor key biomechanical and biochemical parameters. (2) Wireless communication technology: A communication and power supply method without external power supply, such as NFC, is needed to make long-term, wireless monitoring possible. (3) Data processing algorithm: An algorithm that can process and analyze a large amount of sensor data to provide meaningful insights and help doctors make better clinical decisions. Based on this, the research and development concept of the present embodiment is: Balloon catheters are commonly used in cardiovascular diseases for angioplasty to restore blood vessel patency and local drug delivery to reduce restenosis. However, problems such as drug loss during drug delivery, uncontrollable coating dosage, doctors' inability to obtain drug dosage, and lack of real-time hemodynamic feedback still exist. The present embodiment constructs a balloon catheter integrating the monitoring module 2 and the drug release module 3, realizes the functions of accurate drug release and in-situ accurate pressure measurement, and successfully performs joint regulation to accurately obtain blood pressure values and drug release amounts. In order to achieve the above research and development concept, the research and development challenges are: (1) Monitoring module 2: The accuracy of in-situ blood pressure measurement, the pressure sensor integrated into the balloon catheter. (2) Drug release module 3: The adhesion of the drug release module, the accurate acquisition of the drug release amount value during the operation process, and the integration of the drug release module into the balloon catheter. (3) Work system integration: Integrate the monitoring module 2 and the drug release module 3 into the balloon catheter, while ensuring the stability and biocompatibility of the balloon catheter device. (4) Clinical verification: Verify the overall performance of the balloon catheter through clinical trials. By overcoming these research and development challenges, the present embodiment successfully develops a balloon catheter device. The balloon catheter device that can monitor blood pressure and accurately control drug release is expected to become an important progress in the treatment of cardiovascular diseases, providing a promising direction for the accurate and effective treatment and monitoring of cardiovascular diseases.

[0070] Embodiment 2

[0071] The embodiment provides a control method of a balloon catheter device capable of monitoring blood pressure and controlled drug release, which is used for controlling the balloon catheter device capable of monitoring blood pressure and controlled drug release described in Embodiment 1, and the control method of the balloon catheter device capable of monitoring blood pressure and controlled drug release comprises the following steps: receiving blood pressure obtained by a monitoring module when the balloon catheter device is in a working position, applying a voltage to a drug release module, simultaneously obtaining a capacitance of the drug release module, and determining a drug release amount of the drug release module based on the capacitance.

[0072] Embodiment 3

[0073] In an exemplary embodiment, a computer device, which can be a server or a terminal, is provided, and an internal structure diagram of the computer device can be as shown in Figure 5 The computer device includes a processor, a memory, an input / output interface (I / O) and a communication interface. The processor, the memory and the input / output interface are connected through a system bus, and the communication interface is connected to the system bus through the input / output interface. The processor of the computer device is used to provide computing and control capabilities. The memory of the computer device includes a non-volatile storage medium and an internal memory. The non-volatile storage medium stores an operating system, a computer program and a database. The internal memory provides an environment for the operating system and the computer program in the non-volatile storage medium to run. The database of the computer device is used to store data. The input / output interface of the computer device is used to exchange information between the processor and external devices. The communication interface of the computer device is used to communicate with external terminals through network connection. The computer program is executed by the processor to implement a control method of a balloon catheter device capable of monitoring blood pressure and controlled drug release.

[0074] Those skilled in the art can understand that Figure 5 The structure shown in the figure is only a block diagram of part of the structure related to the scheme of the present application, and does not constitute a limitation on the computer device to which the scheme of the present application is applied. The specific computer device can include more or fewer components than those shown in the figure, or combine certain components, or have a different arrangement of components.

[0075] In an exemplary embodiment, a computer device is provided, which includes a memory and a processor, the memory stores a computer program, and the processor implements the control method of the balloon catheter device capable of monitoring blood pressure and controlled drug release in Embodiment 2 when executing the computer program.

[0076] Embodiment 4

[0077] In one example embodiment, a computer readable storage medium storing a computer program is provided, the computer program, when executed by a processor, implements the control method of the blood pressure monitorable and drug controllable releasing balloon catheter device in embodiment 2.

[0078] Embodiment 5

[0079] In one example embodiment, a computer program product is provided, comprising a computer program, the computer program, when executed by a processor, implements the control method of the blood pressure monitorable and drug controllable releasing balloon catheter device in embodiment 2.

[0080] It should be noted that the user information (including but not limited to user equipment information, user personal information, etc.) and data (including but not limited to data for analysis, stored data, displayed data, etc.) involved in the present application are all information and data authorized by the user or authorized by all parties, and the collection, use and processing of related data need to comply with relevant regulations.

[0081] The technical features of the above embodiments can be combined arbitrarily. In order to make the description simple, all possible combinations of the technical features in the above embodiments are not described, however, as long as the combinations of the technical features do not exist contradictory, they should be considered as the scope of the present application.

[0082] The principles and implementation modes of the present application are described by using specific examples in the present application, and the above embodiment descriptions are only used to help understand the method and its core idea of the present application; at the same time, for those skilled in the art, according to the idea of the present application, the specific implementation mode and application range will be changed. In conclusion, the content of the present application should not be understood as a limitation.

Claims

1. A balloon catheter device for monitoring blood pressure and controlled drug release, characterized by, The balloon catheter device capable of monitoring blood pressure and controlling drug release comprises a balloon catheter, an external receiving control module, a monitoring module and a drug release module, the external receiving control module is connected with the monitoring module and the drug release module respectively; The monitoring module is integrated inside the catheter of the balloon catheter, and the monitoring module is used for collecting the pressure at the position of the monitoring module to obtain blood pressure; The drug release module is integrated on the outer wall of the catheter of the balloon catheter, and the drug release module is used for releasing drugs under the action of voltage; The wall of the catheter has a slot, the monitoring module is integrated at the slot, the lead wire used when the drug release module is connected with the external receiving control module enters the inside of the catheter through the slot, and the slot is packaged by glue, and the glue is also used for fixing the monitoring module; The drug release module comprises a drug-loaded film, a flexible finger electrode and a polyimide substrate which are sequentially stacked from top to bottom, the drug-loaded film is a drug-loaded film which can make drugs separate from the film under electrical stimulation, and the flexible finger electrode is connected with the external receiving control module through a lead wire; The external receiving control module is used for receiving the blood pressure obtained by the monitoring module, applying voltage to the drug release module, adjusting the application amplitude and application time of the voltage, obtaining the capacitance of the drug release module while releasing drugs, determining the drug release amount of the drug release module based on the capacitance, and specifically taking the capacitance as input to determine the drug release amount of the drug release module based on a previously determined relationship curve between the capacitance and the drug release amount; The monitoring module and the drug release module are arranged adjacent to each other; and the external receiving control module is used for adjusting the application amplitude and application time of the voltage based on the blood pressure to adjust the drug release rate of the drug release module.

2. The blood pressure monitorable and drug controllable releasing balloon catheter apparatus as claimed in claim 1, wherein, The glue is biocompatible glue; The drug release module surrounds the outer wall of the catheter and is integrated on the outer wall of the catheter.

3. The blood pressure monitorable and drug controllable releasing balloon catheter apparatus as claimed in claim 1, wherein, The monitoring module comprises a pressure sensor and a flexible printed circuit board, the pressure sensor is integrated on the flexible printed circuit board, and the pressure sensor is connected with the flexible printed circuit board, and the flexible printed circuit board is connected with the external receiving control module.

4. The blood pressure monitorable and drug controllable releasing balloon catheter apparatus as claimed in claim 3, wherein, The pressure sensor comprises a conductive layer, a pressure-sensitive resistance layer, an insulating layer and a substrate layer which are sequentially stacked from top to bottom; The conductive layer comprises four metal electrodes, and the four metal electrodes are connected with the flexible printed circuit board; the metal electrode is made of gold; The pressure-sensitive resistance layer comprises four pressure-sensitive resistors, the four pressure-sensitive resistors are distributed on the four edges of the pressure-sensitive resistance layer, and the four pressure-sensitive resistors are connected with the four metal electrodes to form a Wheatstone bridge structure; The material of the insulating layer is silicon dioxide; The material of the substrate layer is silicon; The insulating layer and the substrate layer jointly form a groove to constitute a pressure cavity.

5. The blood pressure monitorable and drug controllable releasing balloon catheter apparatus as claimed in claim 1, wherein, The material of the flexible finger electrode is gold.

6. The blood pressure monitorable and drug controllable releasing balloon catheter apparatus as claimed in claim 5, wherein, The drug release module further comprises a polyvinyl alcohol film between the flexible finger electrode and the drug-loaded film.

7. The blood pressure monitorable and drug controllable releasing balloon catheter apparatus as claimed in claim 1, wherein, The voltage is -2V.

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