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

Abstract

The invention discloses a balloon catheter device capable of monitoring blood pressure and releasing medicine and a control method of the balloon catheter device, 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 medicine releasing module, the monitoring module is integrated in a catheter body of the balloon catheter and used for collecting pressure of the position where the monitoring module is located, and the medicine releasing module is connected with the external receiving control module; the drug release module is integrated on the catheter outer wall face of the balloon catheter and used for releasing drugs under the action of voltage, and the external receiving control module is used for receiving the blood pressure obtained by the monitoring module, applying the 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 and controlling the drug release module to release the drugs. The medicine release amount of the medicine release module is determined based on the capacitance, thrombus formation can be inhibited through medicine release, it is guaranteed that blood pressure monitoring is more accurate, and a closed-loop feedback adjusting system is formed. According to the application, in-situ blood pressure monitoring and precise controlled drug release can be realized.

Description

Technical Field

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

[0002] Cardiovascular disease (CVD) is one of the leading causes of death worldwide, accounting for more than 30% of deaths worldwide. Vascular stenosis or blockage is the main cause of CVD. Balloon catheters (an interventional medical device used to dilate blood vessels at blocked sites) are widely used in angioplasty for the revascularization of cardiovascular diseases. Through minimally invasive interventional surgery, balloon catheters can dilate patients' narrowed diseased blood vessels and improve blood flow. They can also be used to deliver and release vascular stents, so they have been widely used clinically. Balloon catheters only mechanically expand and open the narrowed site, and cannot solve the problems of endothelial damage, inflammatory response, and inability to monitor blood pressure in situ at the site of the lesion. They are prone to cause thrombosis in the later stage and fail to detect the patient's blood pressure physiological state in time.

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

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

[0005] To achieve the above objectives, this application provides the following solutions:

[0006] In a first aspect, the present application provides a balloon catheter device capable of monitoring blood pressure and controlled drug release, the balloon catheter device capable of monitoring blood pressure and controlled drug release comprising: a balloon catheter, an external receiving control module, a monitoring module and a drug release module, the external receiving control module being connected to the monitoring module and the drug release module respectively;

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

[0008] The drug release module is integrated on the outer wall of the balloon catheter, and the drug release module 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 applied 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 surface of the catheter is provided with a groove, the monitoring module is integrated in the groove, the wire used to connect the drug release module with the external receiving control module enters the interior of the catheter through the groove, and the groove is encapsulated 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 includes 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 to the flexible printed circuit board, and the flexible printed circuit board is connected to the external receiving control module.

[0013] Optionally, the pressure sensor includes a conductive layer, a piezoresistive layer, an insulating layer and a substrate layer stacked in sequence from top to bottom;

[0014] The conductive layer includes four metal electrodes, and the four metal electrodes are all connected to the flexible printed circuit board; the material of the metal electrodes is gold;

[0015] The varistor layer includes four varistors, the four varistors are distributed on four sides of the varistor layer, and the four varistors are connected to 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 base layer is silicon;

[0018] The insulating layer and the base layer together form a groove to form a pressure chamber.

[0019] Optionally, the drug release module includes a drug-encapsulated film, a flexible interdigitated electrode and a polyimide substrate stacked in sequence from top to bottom, the drug-encapsulated film can release drugs under the action of voltage, and the flexible interdigitated electrode is 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, wherein the polyvinyl alcohol film is located between the flexible interdigitated electrodes and the drug-encapsulated film.

[0021] Optionally, determining the drug release amount of the drug release module based on the capacitance specifically includes: 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 disposed adjacent to the drug release module; the external receiving control module is used to regulate the applied amplitude and application time of the voltage based on the blood pressure to adjust the drug release rate of the drug release module.

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

[0024] In the second aspect, the present application provides a method for controlling a balloon catheter device that can monitor blood pressure and release drugs in a controlled manner, which is used to control the above-mentioned balloon catheter device that can monitor blood pressure and release drugs in a controlled manner. The method for controlling the balloon catheter device that can monitor blood pressure and release drugs in a controlled manner comprises: when the balloon catheter device is in the working position, receiving the blood pressure obtained by the monitoring module, applying voltage to the drug release module, and simultaneously 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 in this application, this application has the following technical effects:

[0026] The present application provides a balloon catheter device capable of monitoring blood pressure and controlling drug release and a control method thereof, comprising: a balloon catheter, an external receiving control module, a monitoring module and a drug release module, wherein the monitoring module is integrated inside the catheter of the balloon catheter and is used to collect the pressure at the location 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 is used to release drugs under the action of voltage, 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 voltage application amplitude and application time, obtain the capacitance of the drug release module while releasing the drug, determine the drug release amount of the drug release module based on the capacitance, and inhibit thrombosis by drug release, ensure more accurate blood pressure monitoring, and form a closed-loop feedback regulation system. The present application realizes in-situ monitoring of blood pressure by setting a monitoring module, and releases drugs by setting a drug release module and applying voltage to the drug release module, and can change the drug release amount, drug release rate and drug release time by adjusting the voltage application amplitude and application time, thereby realizing accurate and controllable drug release. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0028] Figure 1 This is a schematic diagram of the overall framework of a balloon catheter device capable of monitoring blood pressure and controlling drug release provided in Example 1 of the present application.

[0029] Figure 2 This is a schematic diagram of the overall connection of a balloon catheter device capable of monitoring blood pressure and controlling the release of drugs provided in Example 1 of the present application.

[0030] Figure 3 This is a schematic diagram of the structure of the pressure sensor provided in Example 1 of the present application; wherein, Figure 3 (a) is the front view of the pressure sensor. Figure 3 (b) is the front view of the pressure sensor when it is under pressure. Figure 3 (c) in the figure is a top view of the pressure sensor.

[0031] Figure 4 This is a schematic diagram of the structure of the drug release module provided in Example 1 of the present application; wherein, Figure 4 (a) is the preparation of flexible interdigitated electrodes. Figure 4 (b) is for preparing polyvinyl alcohol film, Figure 4 (c) is the preparation of polypyrrole loaded with heparin.

[0032] Figure 5 A schematic diagram of the structure of a computer device provided in Example 3 of the present application.

[0033] Reference numerals:

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

[0035] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of this application.

[0036] Example 1

[0037] In recent years, with the continuous development of drug release systems that can respond to various internal and external stimuli, controlled drug delivery systems based on external stimulation signals have been widely studied. For intravascular catheter systems, the complexity and control cost of temperature, magnetism, light, pH and other response methods are too high. The electrical stimulation system has the advantages of easy control, repeatable and reliable signal input, good compatibility with implantable medical devices, and the ability to simultaneously control drug delivery and information feedback. However, at present, the integration of electrical stimulation controlled drug delivery systems into balloon catheters has not been fully experimentally verified and summarized.

[0038] Based on this, this embodiment provides a balloon catheter device that can monitor blood pressure and control the release of drugs, and achieves precise controllable drug release through electrical stimulation, such as Figure 1 and Figure 2 As shown, the balloon catheter device capable of monitoring blood pressure and controlling drug release comprises: a balloon catheter, an external receiving control module 1, a monitoring module 2 and a drug release module 3, wherein the external receiving control module 1 is connected to 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. The monitoring module 2 is used to collect the pressure at the location of the monitoring module 2 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 to release drugs under the action of voltage.

[0041] The external receiving control module 1 is used to receive the blood pressure obtained by the monitoring module 2, apply voltage to the drug release module 3, adjust the voltage application amplitude and application time, obtain the capacitance of the drug release module 3 while releasing the drug, and determine the drug release amount of the drug release module 3 based on the capacitance. Drug release can inhibit thrombosis, ensure more accurate blood pressure monitoring, and form a closed-loop feedback regulation system.

[0042] The balloon catheter device of this embodiment has a balloon structure at the proximal end, which is used for mechanically dilating blood vessels during surgery.

[0043] like Figure 1 As shown, when the balloon catheter device used in this 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 composed of the drug release module 3, the monitoring module 2 and the balloon 4 from front to back. Below, this embodiment introduces the monitoring module 2 and the drug release module 3 in detail:

[0044] (I) Monitoring module 2

[0045] The monitoring module 2 mainly includes a pressure sensor and a flexible printed circuit board integrated inside the catheter 5. The pressure sensor is integrated on the flexible printed circuit board. When the monitoring module 2 is integrated inside the catheter 5, a slot is first opened on the wall of the catheter 5, and then the monitoring module 2 is placed inside the catheter 5 through the slot. At this time, the monitoring module 2 is exposed at the slot of the catheter 5, and finally encapsulated and 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 at the same time. Specifically, the pressure sensor of the monitoring module 2 is integrated into the flexible printed circuit board, and the back of the flexible printed circuit board is attached to the inner wall of the catheter 5 by biocompatible glue, so that the monitoring module 2 is fixed at the slot position, and the pressure is monitored in situ. The slot position is also encapsulated by biocompatible glue. Among them, 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 set to be electrically connected to the external receiving control module 1. Specifically, the flexible printed circuit board can be led out to the catheter 5 outlet of the balloon catheter, and then connected to the external receiving control module 1 through an external wire. Alternatively, the flexible printed circuit board is not led out to the catheter 5 outlet of the balloon catheter, but is directly connected to the external receiving control module 1 through part of the wire located inside the catheter 5 and part of the wire located outside the catheter 5. After the catheter 5 is inserted into the human blood vessel, the monitoring module 2 can be used to continuously monitor the pressure value in real time in situ to obtain the blood pressure, and the blood pressure signal can be transmitted to the external receiving control module 1 through the wire for real-time display.

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

[0048] The pressure sensor used in this embodiment can be any existing pressure sensor. As an example, the structure of the pressure sensor provided in this embodiment is as follows: Figure 3 As shown, it is composed of three materials, silicon, silicon dioxide and gold, including a conductive layer 21, a varistor layer 23, an insulating layer 25 and a base layer 26 stacked in sequence from top to bottom. The insulating layer 25 and the base layer 26 are etched to form a groove together to form a pressure cavity 24. The pressure cavity 24 penetrates the insulating layer 25 but does not penetrate the base layer 26, so as to form a pressure cavity 24 between the varistor layer 23 and the base layer 26. The conductive layer 21 includes four metal electrodes, and the four metal electrodes are all connected to the flexible printed circuit board. The four metal electrodes can be located at the four corners of the varistor layer 23. Each metal electrode is provided with a pad, and the metal electrode is connected to the flexible printed circuit board through a bonding wire. The material of the metal electrode is gold. The varistor layer 23 includes four varistors 22, which are distributed on four sides of the varistor layer 23. The four varistors 22 are connected to four metal electrodes to form a Wheatstone bridge structure. The varistor layer 23 is a silicon film, that is, the material of the varistor layer 23 is silicon. The four varistors 22 prepared on the varistor layer 23 are as follows: Figure 3 As shown by the red dotted line in the middle. The material of the insulating layer 25 is silicon dioxide, which plays a role of electrical isolation and protection. The material of the base layer 26 is silicon, which serves as the supporting material of the entire pressure sensor and provides mechanical strength and structural support. When pressure acts on the varistor layer 23, the Wheatstone bridge formed by the four varistors 22 will generate a voltage signal that is linearly proportional to the applied pressure. The voltage signal is subsequently transmitted to the external receiving control module 1 through a flexible printed circuit board and a wire, so that blood pressure can be collected in situ. The pressure sensor of this embodiment is a silicon-silicon bonding structure with good linearity, repeatability and stability, high sensitivity, and is convenient for users to use operational amplifiers or integrated circuits to debug the output. It is suitable for oil-filled isolation and various simple packaged pressure sensors.

[0049] (II) Drug Release Module 3

[0050] The drug release module 3 of this 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 interior of the catheter 5. At this time, the wire used to connect the drug release module 3 with the external receiving control module 1 enters the interior of the catheter 5 through the groove.

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

[0052] It should be noted that the drug-encapsulated film 31 is bonded to the flexible finger-inserted electrode 32, and the flexible finger-inserted electrode 32 is bonded to the polyimide substrate 33. In order to further make the drug-encapsulated film 31 and the flexible finger-inserted electrode 32 fit better, the drug release module 3 of this embodiment also includes: a polyvinyl alcohol film 34. The polyvinyl alcohol film 34 is located between the flexible finger-inserted electrode 32 and the drug-encapsulated film 31, which is equivalent to glue, so that the drug-encapsulated film 31 and the flexible finger-inserted electrode 32 fit better and more tightly.

[0053] The drug-encapsulated film 31 of this embodiment is adhered to the flexible interdigitated electrode 32 by spin coating, and the drug release module 3 is connected to the external receiving control module 1 through a wire placed inside the balloon catheter. The drug-encapsulated 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-encapsulated film 31 will change after the drug is released, the electrical parameters of the flexible interdigitated electrode 32 will change at this time. Therefore, the electrical parameter feedback information of the drug-encapsulated film 31 can be further monitored by the external receiving control module 1. Specifically, it can be monitored by a digital bridge or impedance analyzer in the external receiving control module 1. The electrical parameter feedback information includes capacitance and impedance. The doctor obtains the dosage of the released drug through the standard curve of electrical parameters and drug release amount, that is, obtains the drug release amount. At this time, in this embodiment, the drug release amount of the drug release module 3 is determined based on capacitance, which specifically includes: taking capacitance as input, and determining the drug release amount of the drug release module 3 based on the relationship curve between capacitance and drug release amount determined in advance.

[0054] The drug release module 3 of this embodiment mainly includes a drug-carrying film 31. The drug-carrying film 31 can be any existing film as long as it can release drugs under the action of voltage, including but not limited to a polypyrrole film loaded with heparin. At this time, the structural schematic diagram of the drug release module 3 is as follows: Figure 4 As shown, from bottom to top are polyimide, gold (ie, the flexible interdigitated electrode 32 ), polyvinyl alcohol, and polypyrrole encapsulating heparin (PPy-Hep).

[0055] This embodiment can also form a linkage through the monitoring module 2 and the drug release module 3 integrated on the balloon catheter. During the interventional surgery, the drug release process can be regulated by feeding back blood pressure information, that is, the monitoring module 2 and the drug release module 3 are jointly regulated. The voltage can be regulated by the pressure value monitored by the monitoring module 2 to increase or decrease the drug release rate of the drug release module 3. The drugs released by the drug release module 3 can ensure that the pressure value monitored by the monitoring module 2 is more accurate, eliminating the influence of blood clots on the pressure sensor.

[0056] At this time, in this embodiment, the monitoring module 2 is arranged adjacent to the drug release module 3 , and the external receiving control module 1 is also used to adjust the applied amplitude and application time of the voltage based on the blood pressure to adjust the drug release rate of the drug release module 3 .

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

[0058] The monitoring module of this embodiment measures the pressure value and feeds it back to the external receiving control module. The external receiving control module adjusts the drug release rate of the drug release module based on the applied amplitude and application time of the blood pressure regulation voltage. While releasing the drug, the capacitance of the drug release module is obtained, and the drug release amount of the drug release module is determined based on the capacitance. The drug release can inhibit thrombosis, ensure more accurate blood pressure monitoring, and form a closed-loop feedback regulation system.

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

[0060] Step 1: inserting a balloon catheter including a monitoring module 2 and a drug release module 3 into a human body through a hemostatic sheath.

[0061] Step 2: The monitoring module 2 starts to start and monitors 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 to obtain the blood pressure and complete the pressure collection.

[0062] Step 3: Turn on the external power supply in the external receiving control module 1 , adjust the DC voltage to -2V, and apply it to the drug release module 3 .

[0063] Step 4: The drug release module 3 starts to start, and the model drug is released from the drug release module 3.

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

[0065] Step 6: The monitoring module 2 and the drug release module 3 are linked to each other for mutual regulation.

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

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

[0068] Compared with existing products, this embodiment has a multifunctional combined regulation function, can realize the in-situ precise pressure measurement function, can realize the in-situ precise on-demand drug release function, clinicians can obtain the precise drug release amount based on the feedback electrical parameter information, and can also realize mutual regulation, that is, the voltage can be regulated by the pressure value monitored by the monitoring module 2, and the drug release rate of the drug release module 3 can be increased or decreased. 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 addition, this embodiment has the advantage of biocompatibility, that is, all components are made of biocompatible materials, which reduces the biological rejection reaction that may be caused by interventional surgery and improves the stability of monitoring.

[0069] The technical problems that this embodiment aims to solve are: (1) Lack of real-time in-situ monitoring: the traditional monitoring method cannot monitor blood pressure in real time in situ, so it cannot provide real-time data of in-situ blood pressure during surgery, resulting in the inability to adjust potential problems in the surgery in a timely manner, and the pressure value obtained by drawing blood out for pressure monitoring has deviations, and the influence of thrombus on monitoring module 2 cannot be eliminated during surgery. (2) Difficulty in obtaining the amount of drug released: the existing technology cannot obtain the dose of released drugs in real time, and cannot achieve controlled drug release. Therefore, the research and development goals of this 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, and the drug release rate can be adjusted by externally applied voltage, and the drug release amount can be obtained to achieve controlled drug release. (3) Combined regulation: the voltage can be regulated by the pressure value monitored by the monitoring module 2, and the drug release rate of the drug release module 3 can be increased or decreased; 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 thrombus on the pressure sensor is eliminated. In order to achieve this research and development goal, the demand for technological development is as follows: (1) Sensor technology: Miniaturized, low-power and biocompatible sensors are needed to monitor key biomechanical and biochemical parameters. (2) Wireless communication technology: A communication and power supply method that does not require an 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 large amounts of sensor data is needed to provide meaningful insights and help doctors make better clinical decisions. Based on this, the research and development concept of this embodiment is as follows: Balloon catheters are often used in angioplasty in cardiovascular diseases to restore vascular patency and local drug delivery to reduce restenosis. However, problems such as drug loss during drug delivery, uncontrollable coating dosage, doctors cannot know the dosage, and lack of real-time hemodynamic feedback still exist. This embodiment constructs a balloon catheter with integrated monitoring module 2 and drug release module 3, realizes the functions of precise drug release and in-situ precise pressure measurement, and successfully performs joint regulation to accurately obtain blood pressure values ​​and drug release amounts. In order to realize the above research and development concept, the research and development challenges faced are as follows: (1) Monitoring module 2: Accuracy of in-situ blood pressure measurement, pressure sensor integrated into the balloon catheter. (2) Drug release module 3: Adhesion of the drug release module, accurate acquisition of drug release amount during surgery, and integration of the drug release module into the balloon catheter. (3) Working 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 R&D challenges, this embodiment successfully developed a balloon catheter device, which can monitor blood pressure and accurately control drug release and is expected to become an important advancement in the field of cardiovascular disease treatment, and provide a promising direction for the accurate and effective treatment and monitoring of cardiovascular diseases.

[0070] Example 2

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

[0072] Example 3

[0073] In an exemplary embodiment, a computer device is provided. The computer device may be a server or a terminal. The internal structure diagram thereof may be as follows: Figure 5 As shown. The computer device includes a processor, a memory, an input / output interface (Input / Output, referred to as 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 operation of the operating system and the computer program in the non-volatile storage medium. 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 an external device. The communication interface of the computer device is used to communicate with an external terminal through a network connection. When the computer program is executed by the processor, a control method for a balloon catheter device that can monitor blood pressure and controllably release drugs is implemented.

[0074] Those skilled in the art will understand that Figure 5 The structure shown in the figure is only a block diagram of a part of the structure related to the solution of the present application, and does not constitute a limitation on the computer device to which the solution of the present application is applied. The specific computer device may 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, including a memory and a processor, wherein a computer program is stored in the memory, and when the processor executes the computer program, the control method of the balloon catheter device capable of monitoring blood pressure and controlling drug release in Example 2 is implemented.

[0076] Example 4

[0077] In an exemplary embodiment, a computer-readable storage medium is provided, storing a computer program, which, when executed by a processor, implements the control method of the balloon catheter device capable of monitoring blood pressure and controlling drug release in Example 2.

[0078] Example 5

[0079] In an exemplary embodiment, a computer program product is provided, including a computer program, which, when executed by a processor, implements the method for controlling the balloon catheter device capable of monitoring blood pressure and controlling drug release in Example 2.

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

[0081] The technical features of the above embodiments may be combined arbitrarily. To make the description concise, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0082] This article uses specific examples to illustrate the principles and implementation methods of this application. The description of the above embodiments is only used to help understand the method and core ideas of this application. At the same time, for those skilled in the art, according to the ideas of this application, there will be changes in the specific implementation methods and application scope. In summary, the content of this specification should not be understood as limiting this application.

Claims

1. A balloon catheter device capable of monitoring blood pressure and controlling drug release, characterized in that: 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, wherein the external receiving control module is connected to 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 to collect the pressure at the location of the monitoring module to obtain the blood pressure; The drug release module is integrated on the outer wall of the balloon catheter, and the drug release module is used to release drugs under the action of voltage; 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 applied 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.

2. The balloon catheter device capable of monitoring blood pressure and controlling drug release according to claim 1, characterized in that: The wall surface of the catheter is provided with a groove, the monitoring module is integrated in the groove, the wire used for connecting the drug release module with the external receiving control module enters the interior of the catheter through the groove, and the groove is encapsulated by glue, and the glue is also used to fix the monitoring module; 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 balloon catheter device capable of monitoring blood pressure and controlling drug release according to claim 1, characterized in that: The monitoring module includes a pressure sensor and a flexible printed circuit board. The pressure sensor is integrated on the flexible printed circuit board and connected to the flexible printed circuit board. The flexible printed circuit board is connected to the external receiving control module.

4. The balloon catheter device capable of monitoring blood pressure and controlling drug release according to claim 3, characterized in that: The pressure sensor comprises a conductive layer, a piezoresistive layer, an insulating layer and a substrate layer which are stacked in sequence from top to bottom; The conductive layer includes four metal electrodes, and the four metal electrodes are all connected to the flexible printed circuit board; the material of the metal electrodes is gold; The varistor layer includes four varistors, the four varistors are distributed on four sides of the varistor layer, and the four varistors are connected to the four metal electrodes to form a Wheatstone bridge structure; The material of the insulating layer is silicon dioxide; The material of the base layer is silicon; The insulating layer and the base layer together form a groove to form a pressure chamber.

5. The balloon catheter device capable of monitoring blood pressure and controlling drug release according to claim 1, characterized in that: The drug release module includes a drug-containing film, a flexible interdigitated electrode and a polyimide substrate stacked in sequence from top to bottom. The drug-containing film can release drugs under the action of voltage. The flexible interdigitated electrode is connected to the external receiving control module through a wire; wherein the material of the flexible interdigitated electrode is gold.

6. The balloon catheter device capable of monitoring blood pressure and controlling drug release according to claim 5, characterized in that: The drug release module further comprises: a polyvinyl alcohol film, wherein the polyvinyl alcohol film is located between the flexible interdigitated electrodes and the drug-encapsulated film.

7. The balloon catheter device capable of monitoring blood pressure and controlling drug release according to claim 1, characterized in that: Determining the drug release amount of the drug release module based on the capacitance specifically includes: 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.

8. The balloon catheter device capable of monitoring blood pressure and controlling drug release according to claim 1, characterized in that: The monitoring module is disposed adjacent to the drug release module; the external receiving control module is used to regulate the applied amplitude and application time of the voltage based on the blood pressure to adjust the drug release rate of the drug release module.

9. The balloon catheter device capable of monitoring blood pressure and controlling drug release according to claim 1, characterized in that: The voltage is -2V.

10. A method for controlling a balloon catheter device capable of monitoring blood pressure and controlling drug release, for controlling the balloon catheter device capable of monitoring blood pressure and controlling drug release according to any one of claims 1 to 9, characterized in that: The control method of the balloon catheter device capable of monitoring blood pressure and controlling drug release includes: when the balloon catheter device is in the working position, receiving the blood pressure obtained by the monitoring module, applying voltage to the drug release module, and obtaining the capacitance of the drug release module, and determining the drug release amount of the drug release module based on the capacitance.

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