CN111840757B

CN111840757B - Pressure measurable sacculus pipe and intelligent self-evolution auxiliary equipment thereof

Info

Publication number: CN111840757B
Application number: CN202010624453.7A
Authority: CN
Inventors: 任鹏宇; 周乐; 屈建强; 韩鹏; 高忠权; 徐创新; 李云; 刘曙光; 苗宇; 闫先侠; 吕博强
Original assignee: Second Affiliated Hospital School of Medicine of Xian Jiaotong University
Current assignee: Second Affiliated Hospital School of Medicine of Xian Jiaotong University
Priority date: 2020-07-02
Filing date: 2020-07-02
Publication date: 2022-06-17
Anticipated expiration: 2040-07-02
Also published as: CN111840757A

Abstract

The invention discloses a pressure measurable sacculus catheter and intelligent self-evolution auxiliary equipment thereof. The intelligent self-evolution auxiliary equipment of the balloon catheter consists of a plurality of modules, has the functions of receiving and processing signals of a pressure sensor, recommending an optimal operation scheme, realizing near-mid-range operation and equipment control, intra-operative operation decision and the like, and simultaneously has the intelligent self-evolution characteristic; the auxiliary equipment processes the data and then recommends an optimal operation scheme and assists the operator in completing the operation; in addition, the auxiliary equipment realizes self evolution of the balloon catheter interventional therapy strategy through continuously added patient diagnosis and treatment follow-up data and updated prior knowledge.

Description

Pressure measurable sacculus pipe and intelligent self-evolution auxiliary equipment thereof

The technical field is as follows:

the invention relates to a pressure-measurable balloon catheter for treatment technologies such as nerve intervention and blood vessel intervention and intelligent self-evolution auxiliary equipment thereof, belonging to the field of balloon catheters for interventional therapy in the medical field.

Background art:

interventional therapeutics is an emerging discipline integrating image diagnosis and clinical treatment. Under the guidance and monitoring of digital subtraction angiography machine, CT, ultrasonic and magnetic resonance imaging equipment, puncture needle, catheter and other interventional devices are used to introduce specific instrument into the pathological change part of human body via natural pore canal or small wound for minimally invasive treatment. It is the clinical three-column discipline which is parallel to the traditional internal medicine and surgery. Among a plurality of interventional devices, the balloon catheter and the balloon catheter technology leading the balloon catheter occupy an important position in interventional therapeutics and are applied to the treatment of various vascular diseases and non-vascular diseases, such as arterial embolism, arterial stenosis, trigeminal neuralgia and the like. In the practical application of the balloon catheter, after the balloon part of the balloon catheter is delivered to a treatment site, the contrast agent is advanced, and the expansion of the balloon is the most basic and the most central operation. Through the expansion of the saccule, pressure jump is generated at the pathological change part, thereby realizing the purpose of disease treatment, such as the compression and the enlargement of the arterial stenosis part, the compression and the damage of the trigeminal semilunar ganglion, and the like. Therefore, when the balloon catheter is used for treating diseases, the most central treatment factor is pressure, but the pressure in the balloon is often ignored.

In the treatment of internal carotid stenosis, a guide wire is first delivered to the area to be treated, then a balloon catheter is guided to the stenosis site to be treated through the guide wire, and a surgeon propels a certain amount of contrast agent into the balloon according to own experience and digital blood vessel subtraction to expand the balloon to treat the stenosis region of the blood vessel. Throughout the procedure, the operator is concerned with the angiographic results and the volume of contrast injected into the balloon (typically the manufacturer will give a recommended bolus dose of contrast), and is largely unaware of the pressure within the balloon and the pressure between the balloon wall and the vessel wall. However, these pressures are critical to the treatment of internal carotid artery stenosis.

In the trigeminal neuralgia microballoon sac compression treatment, the trigeminal nerve is compressed by expanding the trigeminal nerve Mylar sac through the saccule conduit, the pain sense nerve fiber of the trigeminal nerve is damaged by mechanical pressure, the pain sense conduction is blocked, and the aim of relieving pain is fulfilled. In the actual surgical treatment process, doctors judge whether the pain fibers are damaged or not according to two points and the tactile fibers and the motor fibers are well preserved: balloon inflation shape and compression duration. The balloon was first assisted in dilatation inside the Mylar sac with a 1ml syringe propelling the contrast media and the effect of trigeminal semilunar compression was evaluated based on the shape of the balloon dilatation. The shape of the Mylar sac of different patients is different, and the size of the sac volume is different, so that the judgment of the disease treatment effect according to the expanded shape of the saccule obviously has defects. Secondly, after the balloon is pressed and expanded to a shape satisfied by a doctor, the pressing time is calculated. However, the compression time depends on the experience of the surgeon, and the compression time of each patient is different according to the subjective judgment of the surgeon. As with balloon catheters used in vascular interventions to treat disease, the most important treatment factor, pressure, has never been considered quantitatively. Therefore, the curative effect and complications of the current trigeminal neuralgia microballoon compression treatment basically depend on the experience of doctors and the subjective judgment in the operation. Just so, the treatment effect between different doctors is great, and the treatment effect is also great between the different patients of same doctor treatment, is unfavorable for the homogenization of this technique to be promoted very much, does not also accord with the accurate treatment direction that current country advocated yet.

In consideration of the important role of the pressure in the balloon in treating diseases by the balloon catheter, a pressure-measurable balloon catheter and an intelligent self-evolution auxiliary device thereof are developed, and the pressure-measurable balloon catheter and the intelligent self-evolution auxiliary device are used for monitoring the pressure in the balloon and the pressure between the balloon wall and tissues in the operation, and realizing the recommendation of an optimal operation scheme, the control of operation and the like.

The invention content is as follows:

the invention aims to solve the problems and provide a pressure-measurable balloon catheter and an intelligent self-evolution auxiliary device thereof, which can accurately and dynamically monitor and record the volume of a contrast agent in the balloon catheter, the pressure in the balloon and the pressure between the balloon wall and tissues in the disease treatment process, effectively control the speed of the contrast agent entering or exiting the balloon, timely release the pressure exceeding a safe threshold value, establish interventional therapy judgment standards of brand-new balloon catheter dilatation, compression and the like by taking the time integral of the pressure as a quantification standard, intelligently recommend an optimal surgical scheme, realize near-middle-distance intelligent surgical operation, promote the precision and individualized treatment process of vascular and non-vascular diseases, improve the medical safety to the maximum extent, and lay a foundation for standard establishment and consensus of the future balloon catheter interventional therapy industry.

In order to solve the above problems, the present invention provides a balloon catheter capable of measuring pressure, including: the catheter comprises a catheter balloon part, a catheter body part, a catheter tail part, a pressure sensor output connecting wire, a pressure sensor output interface, a pressure sensor lead, a contrast agent lumen inlet, a guide wire lumen inlet and catheter scales.

The catheter balloon part is the most important part of the invention, consists of a plurality of structures, integrates a balloon, a pressure sensor, a catheter balloon part side hole, a balloon attachment point, a metal marker, a pressure sensor lead and the like, allows contrast agents and the like to enter and exit the balloon, and realizes balloon expansion and contraction, pressure information sensing, pressure information output, tracking and positioning of the catheter balloon part in an operation and the like. The sacculus is made of elastic materials, is a compliance sacculus or semi-compliance, and is spherical or oval when being filled with liquid and gas; the optional balloon material may be a single component or a mixed component such as natural latex, polyurethane, thermoplastic elastomer polymer material, silica gel, and the like. The pressure sensor is a core component of the invention and is used for measuring the pressure of the balloon part of the catheter; optionally, the pressure sensor can be selected from various types such as a nano generator, a piezoelectric sensor, a flexible sensor, an elastic sensor, a film sensor and the like; alternatively, the pressure sensor may be located at the head end of the balloon catheter body (i.e., inside the balloon) to measure the pressure (pressure) inside the balloon, or may be located on the surface of the balloon to directly measure the pressure (pressure) between the balloon and the external tissue. The side hole of the balloon part of the catheter is positioned at the head end of the balloon catheter body, and the outside of the side hole is provided with a balloon for allowing liquid and gas substances such as contrast agent to enter and flow out. The balloon attachment point is located at the head end of the balloon catheter body and is in sealed connection with the balloon catheter body to form a closed space between the balloon and the head end of the catheter body, the catheter body is communicated with external traffic only through the side hole, the balloon is enabled to be expanded without any displacement when expanded, and the selectable balloon attachment point can be achieved through thermal molding, bundling, welding and the like. The metal marker is positioned near the sacculus at the head end of the sacculus catheter body, X-rays cannot penetrate through the metal marker, the metal marker is used for positioning in sacculus operation, precious metals such as medical stainless steel, medical cobalt-based alloy, medical titanium and titanium alloy, medical magnesium alloy, gold, silver, platinum and the like are mainly selected, and shape memory alloys such as tantalum, niobium, zirconium and nickel titanium with good chemical stability and good physical corrosion resistance are selected, and the selectable metal marker can be made into an easily-recognized shape for analysis in operation, such as a ring shape, a dot shape and the like. The catheter balloon portion pressure sensor wire is a part of the pressure sensor wire, is located at the head end of the catheter body portion, is embedded in balloon catheter materials, is spirally wound and penetrates through the whole balloon catheter, has the function of transmitting information data sensed by the pressure sensor, also has the function of enhancing the supporting strength and the tensile strength of the balloon catheter, avoids the risk of being remained on a human body due to catheter breakage, and reduces iatrogenic injury and infection risks.

The catheter body part is a main body part of the pressure sensor, is connected with the catheter balloon part and the catheter tail part and is in a hollow tubular shape, and a pressure sensor lead is embedded in the wall of the pressure sensor body part; the catheter body part is made of medical high polymer materials, and can be selected from polyurethane, silicon rubber, polyester fiber, polyvinylpyrrolidone, polyether-ether-ketone, polymethyl methacrylate, polyvinyl alcohol, polylactic acid, polyethylene and the like; in addition, the catheter body can be made into different models according to different application scenes, and the catheter body comprises a catheter length, a catheter shape, a catheter thickness and the like.

The tail part of the conduit is positioned at the tail end of the conduit body part and is mainly used for connecting and fixing the conduit body part.

The pressure sensor lead penetrates through the whole conductor body part, one end of the pressure sensor lead is connected with the pressure sensor, and the other end of the pressure sensor lead is connected with the output interface of the pressure sensor; the pressure sensor lead is a metal lead, is embedded in the materials of the catheter and the output connecting wire of the pressure sensor, is spirally coiled and penetrates through the whole balloon catheter; the primary function of the pressure sensor is to transmit the pressure intensity/pressure information monitored by the pressure sensor; the balloon catheter has the advantages that the supporting strength and the tensile strength of the balloon catheter are enhanced, the breakage of the catheter in the operation and the residue of broken stumps on a human body are avoided, and the iatrogenic injury and infection risks are reduced; and finally, the pressure sensor lead has certain elasticity by spirally winding the lead, so that the lead is prevented from being damaged when the balloon catheter is bent and folded.

The pressure sensor output connecting wire is a connecting part of the invention, one end of the pressure sensor output connecting wire is connected with the catheter body part, and the other end of the pressure sensor output connecting wire is connected with the pressure sensor output interface; the pressure sensor lead enters from the joint of the connecting line and the pipe body part, spirally winds and walks and is embedded in the pressure sensor lead material; the pressure sensor output connecting wire is mainly used for protecting the pressure sensor wire so as to ensure the output of pressure sensing information; the material of the output connecting wire of the pressure sensor is medical high polymer material, and polyurethane, silicon rubber, polyester fiber, polyvinylpyrrolidone, polyether ether ketone, polymethyl methacrylate, polyvinyl alcohol, polylactic acid, polyethylene and the like can be selected.

The output interface of the pressure sensor is an important part of the invention, one end of the output interface is connected with a pressure sensor lead to receive information data of the pressure sensor, and the other end of the output interface is connected with an information acquisition system in intelligent evolution type auxiliary equipment of the balloon catheter, and the output interface is mainly used for converting and transmitting pressure sensing information; optionally, the connection between the output interface of the pressure sensor and the information acquisition system may be a wired connection, or a wireless connection for information transmission; if the wireless information transmission mode is adopted for information interaction, the remote operation is realized, and the radiation irradiation of the operating doctor is avoided.

The contrast agent lumen inlet is positioned at the tail part of the catheter, is an opening of a hollow pipeline in the balloon catheter, is connected with the contrast agent perfusion interface, allows contrast agents or other substances to enter or exit, and is communicated with the closed space of the balloon through a side hole at the head end of the balloon part of the catheter.

The guide wire lumen inlet is formed in a part of the balloon catheter matched with the guide wire for use and is positioned at the tail part or the body part of the catheter, and the communicated guide wire lumen penetrates through the whole length of the catheter or partially penetrates through the whole length of the catheter so as to provide a space channel for guiding the balloon catheter to the guide wire of the appointed operation part.

The catheter scale is positioned on the outer wall of the catheter body part of the balloon catheter and used for estimating the propelling distance of the balloon part of the catheter in the middle of an operation.

An intelligent self-evolving auxiliary device of a pressurizable balloon catheter, comprising: the system comprises a balloon catheter auxiliary equipment management system, a power supply module, a central processing unit, an information processing module, a power control module, a contrast agent propelling system, a contrast agent perfusion interface, an information acquisition system, an operation interface and a display system.

The operation interface is a human-computer interaction end, and an operation doctor can control the operation interface according to the preoperative treatment scheme recommendation provided by the display system and the actual condition in the operation to send an instruction to the balloon catheter auxiliary equipment management system so as to control the operation of the whole intelligent self-evolution type auxiliary equipment and the like. Optionally, the operation interface may be integrally connected with other components of the intelligent self-evolution auxiliary device, and may also perform information interaction by using a wireless information transmission manner; if the wireless information transmission mode is adopted for information interaction, the remote operation is realized, and the radiation irradiation of the operating doctor is avoided.

The balloon catheter auxiliary equipment management system is connected with the operation interface, the power supply management module and the central processing unit; the operation interface is connected with the operation interface and is used for receiving instructions to control the operation of the whole auxiliary equipment; the purpose of connecting with power management module is to control the power management module to provide energy for each component of the equipment; the purpose of interacting with the central processing unit is to upgrade the evolution of system software, modify system parameters, access and analyze operation information, and the like; the balloon catheter auxiliary management system can also acquire medical record information of a patient, test examination, imaging information, postoperative symptom relieving information, discharge follow-up visit and the like, and store and construct a patient database; in addition, the balloon catheter auxiliary equipment management system is connected with the Internet, the latest high-quality documents related to the balloon catheter interventional therapy are inquired in real time, the deduction knowledge map is summarized, and a knowledge map database is stored and constructed.

The power management system provides energy for all components of the balloon catheter auxiliary device, and mainly completes battery management, wired/wireless charging, and provides a data interface (wired or wireless) for program upgrading and parameter modification.

The central processing unit is an information processing core of the balloon catheter auxiliary equipment and is used for data calculation, hardware system management, work coordination and the like.

The information processing module is one of the cores of the balloon catheter auxiliary equipment, and is used for performing real-time data processing according to input data such as pressure information, time information, volume information of a contrast agent perfused in the balloon and the like under the support of a central processing unit, completing modulation, demodulation, calculation, storage and the like of the data, and completing the drawing calculation of a pressure variation curve in the balloon before a dynamic operation, a pressure variation curve in the balloon during the dynamic operation, a pressure variation curve between the wall of the dynamic balloon and tissues, a dynamic volume variation curve, and pressure time integral, volume time integral and other information corresponding to each curve; the calculation results are displayed in real time by being connected with a display, so that the operation doctor can conveniently observe and make intraoperative judgment; judging the current treatment state according to the loaded balloon catheter interventional treatment strategy, giving a recommended treatment scheme, and displaying the recommended treatment scheme through a display system for reference of an operating doctor; receiving a decision from an operator, calculating the perfusion volume and pressure of the contrast agent in the balloon, and sending an instruction to control the power control module; the information processing module stores each time of decision (selected contrast agent perfusion pressure, perfusion volume, corresponding duration and the like) of an operating doctor, constructs a doctor decision database, matches the decision database with data in a patient information database, combines the latest knowledge map database data, deduces a more accurate balloon catheter interventional treatment strategy by methods such as deep learning and convolutional neural network, replaces a loaded strategy, realizes intelligent self-evolution of auxiliary equipment, and recommends a more accurate treatment scheme for the operating doctor; the information processing module also sets a pressure safety threshold according to the balloon material of the balloon catheter, and controls the power control system to stop the perfusion of the contrast agent when the pressure in the balloon input by the information acquisition system in real time exceeds the safety threshold, so that the risk of the balloon bursting due to the sudden increase of the pressure is reduced; the information processing module establishes a balloon catheter damage database and an early warning strategy according to pressure release characteristics of a balloon catheter contrast agent during perfusion extracted from experimental data, accurately diagnoses catheter damage, balloon rupture, damaged parts and the like in an operation to reduce iatrogenic damage caused by continuous operation due to balloon catheter damage, matches the actual conditions of the balloon catheter with pressure release data during perfusion after the operation to establish a pressure release database during perfusion, extracts the characteristics by utilizing a convolutional neural network and the like again in combination with the previous data, and self-evolves the balloon catheter damage early warning strategy.

And one end of the power control system is connected with the information processing module and receives a control instruction, and the other end of the power control system is connected with the contrast agent propelling system and controls the contrast agent propelling system to operate.

The contrast agent propelling system is one of core systems of the invention and comprises a contrast agent propelling device, a contrast agent storage bin and a contrast agent perfusion volume monitoring device; one end of the power control module is connected with the power control module and operates under the control of the power control module; one end of the contrast medium injection port is connected with the contrast medium injection port at the tail part of the balloon catheter to complete the pushing or withdrawing of the contrast medium in the balloon catheter; one end of the system is connected with the information processing module and inputs the propelling and withdrawing volume information of the contrast medium in the balloon catheter; the contrast agent propulsion system has the function of maintaining constant pressure in the balloon catheter, prevents the contrast agent in the balloon from reversely flowing backwards after the balloon contrast agent is filled, and effectively maintains the pressure of an operation area, so that a three-way pipe and an assistant are not needed in the operation, and the labor is saved; the propulsion system also has the functions of quantitative contrast agent delivery and quick exit, and can realize free switching among various functions. Optionally, the contrast agent propulsion system may be integrally connected with other components of the intelligent self-evolution auxiliary device, and may also perform information interaction in a wireless information transmission manner; if the wireless information transmission mode is adopted for information interaction, the remote operation is realized, and the radiation irradiation of the operating doctor is avoided.

The information acquisition system is one of the core components of the balloon catheter, one end of the information acquisition system is connected with the output interface of the pressure sensor, the pressure information and the time duration information sensed by the pressure sensor in the balloon catheter are received in real time and are subjected to data conversion, the other end of the information acquisition system is connected with the information processing module, and the information subjected to the data conversion is input into the information processing module for data processing.

The display system is another human-computer interaction interface of the system, is connected with the information processing module, receives information data output by the information processing module, recommends a treatment scheme and the like, and displays the information data, the recommended treatment scheme and the like in a visualization mode and the like for reference of an operating doctor. Optionally, the display system may be integrated with other components of the intelligent self-evolution auxiliary device, and may also perform information interaction in a wireless information transmission manner; if the wireless information transmission mode is adopted for information interaction, the remote operation is realized, and the radiation irradiation of the operating doctor is avoided.

In addition, the present invention may have some other non-intelligent auxiliary kits or devices, which are introduced in the specific embodiments, according to different application scenarios, in addition to the above intelligent self-evolving auxiliary devices.

The invention has the beneficial effects that:

(1) the real-time dynamic monitoring and data acquisition of the pressure intensity/pressure in the saccule of the saccule catheter and the pressure intensity/pressure between the saccule wall and the tissue are realized.

(2) Direct or indirect pressure/pressure measurement with delivery of the pressure sensor to the operating area inside the body is achieved, eliminating errors in outside body measurements due to catheter factors (catheter blockage, bending, expansion, contraction, etc.).

(3) The pressure sensor lead is made of medical metal and the like, and is characterized in that the pressure sensor lead is embedded and spirally coiled in the wall of the catheter and penetrates through the whole balloon catheter, so that the supporting strength and the tensile strength of the balloon catheter are enhanced, the breakage of the catheter in the operation and the residue of broken residual ends on a human body are avoided, and the risk of iatrogenic injury and infection is reduced.

(4) The balloon catheter realizes the tight seamless connection of the balloon material and the catheter body material, and ensures the tightness and the stability during expansion of the balloon.

(5) The accurate judgment of the position of the sacculus in the operation is realized.

(4) The accurate perfusion of the volume of the contrast agent in the saccule in the operation and the real-time dynamic perfusion volume data acquisition are realized.

(5) The accurate control of the perfusion speed and the withdrawal speed of the contrast agent in the saccule in the operation is realized.

(6) Solves the problem of reverse backflow of the contrast agent in the saccule when the perfusion of the contrast agent is stopped in the operation,

(7) the free switching between intraoperative contrast agent dosage delivery and rapid withdrawal is realized;

(8) the risk of the balloon bursting due to sudden increase of pressure in the operation is reduced;

(9) accurate diagnosis and early warning of catheter injury, balloon rupture and damaged parts in the operation are realized;

(10) the storage of patient information, image data, laboratory examination and postoperative follow-up information and the construction of a patient information database are realized.

(11) The real-time retrieval of the latest high-quality literature relevant to the balloon catheter interventional therapy, the real-time summary of the latest prior knowledge, and the construction and self-evolution of the balloon catheter interventional therapy knowledge map and the map library are realized.

(12) The establishment of the intraoperative decision information database of the operating physician is realized.

(13) The method realizes the matching analysis of patient information data and decision data in doctor operation, combines balloon catheter interventional therapy knowledge map library data, and constructs and self-evolves balloon catheter interventional therapy strategies through methods such as deep learning.

(14) The establishment of a pressure release database during the perfusion of the contrast agent and the construction and self-evolution of the balloon catheter damage early warning strategy are realized.

(15) Human-computer interaction is realized, and the intelligent device assists preoperative optimal selection scheme recommendation and intraoperative surgical decision of balloon catheter interventional therapy.

(16) The remote human-computer interaction, the wireless information transmission and the near-center control are realized, and the radiation irradiation of the operating doctor in the operation process is avoided.

Description of the drawings:

for ease of illustration, the invention is described in detail by the following detailed description and the accompanying drawings.

FIG. 1 is a schematic diagram of the overall structure and non-intelligent kit of a balloon catheter (embodiment one) for measuring the internal pressure of the balloon for trigeminal semilunar compression;

FIG. 2 is a view showing the configuration of a balloon portion of a balloon catheter (example one) for measuring the internal pressure of the balloon for trigeminal semilunar compression;

FIG. 3 is a schematic view showing the overall structure and the kit of a balloon catheter (embodiment II) for measuring the internal pressure of a balloon used in the angioplasty and dilatation;

FIG. 4 is a view showing a configuration of a balloon portion of a balloon catheter (example II) for measuring an internal pressure of a balloon used in a angioplasty and dilatation catheter for stenosis;

FIG. 5 is a schematic diagram of the overall structure and kit of a balloon catheter (example three) for trigeminal semilunar compression to measure pressure between the balloon wall and the tissue;

FIG. 6 is a diagram of a balloon portion configuration of a balloon catheter (example three) for trigeminal semilunar compression for measuring pressure between the balloon wall and tissue;

fig. 7 is a schematic structural diagram of an intelligent self-evolving auxiliary device of a balloon catheter capable of measuring the internal pressure of a balloon (suitable for the first, second and third embodiments).

In fig. 1, 1a-1 puncture inner core tip, 1a-2 puncture inner core body part, 1a-3 puncture inner core tail, 2a-1 catheter sheath head, 2a-2 catheter sheath body part, 2a-3 catheter sheath tail, 2a-4 catheter sheath scales, 3a-1 catheter balloon part, 3a-2 catheter body part, 3a-3 catheter tail, 3a-4 pressure sensor output connecting wire, 3a-5 pressure sensor output interface, 3a-6 pressure sensor lead, 3a-7 catheter scales and 3a-8 contrast agent lumen inlet.

In FIG. 2, the pressure sensor 3a-1-1, the side hole of the balloon portion of the catheter 3a-1-2, the balloon 3a-1-3, the balloon attachment point 3a-1-4, the metal marker 3a-1-5, the pressure sensor lead 3a-1-6, and the lumen of the contrast agent 3 a-1-7.

In fig. 3, 1b of an arterial sheath, 2b-1 of a catheter saccule part, 2b-2 of a catheter body part, 2b-3 of a catheter tail part, 2b-4 of a pressure sensor output connecting line, 2b-5 of a pressure sensor output interface, 2b-6 of a pressure sensor lead, 2b-7 of a catheter scale, 2b-8 of a contrast agent lumen inlet, 2b-9 of a guide wire lumen inlet, 3b of a contrast tube, 4b of a catheter guide tube, 5b of a guide wire, 6b of a stent and 7b of a stent conveyor.

In FIG. 4, a 2b-1-1 pressure sensor, a 2ab-1-2 catheter balloon side hole, a 2b-1-3 balloon, a 2b-1-4 balloon attachment point, a 2b-1-5 metal marker, a 2b-1-6 pressure sensor wire, a 2b-1-7 contrast agent lumen, and a 2b-1-8 guidewire lumen.

In fig. 5, the puncture inner core tip is 1c-1, the puncture inner core body is 1c-2, the puncture inner core tail is 1c-3, the catheter sheath head is 2c-1, the catheter sheath body is 2c-2, the catheter sheath tail is 2c-3, the catheter sheath scale is 2c-4, the catheter balloon is 3c-1, the catheter body is 3c-2, the catheter tail is 3c-3, the output connecting wire of the flexible pressure sensor is 3c-4, the output interface of the flexible pressure sensor is 3c-5, the lead of the flexible pressure sensor is 3c-6, the catheter scale is 3c-7 and the lumen inlet of the contrast agent is 3 c-8.

In FIG. 6, a 3c-1-1 flexible pressure sensor, a 3c-1-2 catheter balloon side hole, a 3c-1-3 balloon, a 3c-1-4 balloon attachment point, a 3c-1-5 metal marker, a 3c-1-6 pressure sensor lead, and a 3c-1-7 contrast agent lumen.

In fig. 7, 1a balloon catheter auxiliary device management system, 2a power supply module, 3a central processing unit, 4 an information processing module, 5 a power control module, 6 a contrast medium propulsion system, 7 a contrast medium perfusion interface, 8 an information acquisition system, 9 a surgical operation interface, and 10 a display system.

The specific implementation mode is as follows:

as shown in fig. 1 to 7, the following technical solutions are adopted in the present embodiment: a balloon catheter that can measure pressure, comprising: the catheter comprises a catheter balloon part, a catheter body part, a catheter tail part, a pressure sensor output connecting wire, a pressure sensor output interface, a pressure sensor lead, a contrast agent lumen inlet, a guide wire lumen inlet and catheter scales.

The catheter balloon part is the most important part of the invention, consists of a plurality of structures, integrates a balloon, a pressure sensor, a side hole of the catheter balloon part, a balloon attachment point, a metal marker, a pressure sensor lead and the like, allows contrast agents and the like to enter and exit the balloon, realizes balloon expansion and contraction, pressure information sensing, pressure information output, tracking and positioning of the catheter balloon part in operation and the like, is made of elastic materials, is a compliant balloon or semi-compliant balloon, and is spherical or oval when being filled with liquid and gas; the optional balloon material may be a single component or a mixed component such as natural latex, polyurethane, thermoplastic elastomer polymer material, silica gel, and the like. The pressure sensor is a core component of the invention and is used for measuring the pressure of the balloon part of the catheter; optionally, the pressure sensor can be selected from various types such as a nano generator, a piezoelectric sensor, a flexible sensor, an elastic sensor, a film sensor and the like; alternatively, the pressure sensor may be located at the head end of the balloon catheter body (i.e., inside the balloon) to measure the pressure (pressure) inside the balloon, or may be located on the surface of the balloon to directly measure the pressure (pressure) between the balloon and the external tissue. The side hole of the balloon part of the catheter is positioned at the head end of the balloon catheter body, and the outside of the side hole is provided with a balloon for allowing liquid and gas substances such as contrast agent to enter and flow out. The balloon attachment point is located at the head end of the balloon catheter body and is in sealed connection with the balloon catheter body to form a closed space between the balloon and the head end of the catheter body, the catheter body is communicated with external traffic only through the side hole, the balloon is enabled to be expanded without any displacement when expanded, and the selectable balloon attachment point can be achieved through thermal molding, bundling, welding and the like. The metal marker is positioned near a sacculus at the head end of the sacculus catheter body, X-rays cannot penetrate through the sacculus, the metal marker is used for positioning in sacculus operation, medical stainless steel, medical cobalt-based alloy, medical titanium and titanium alloy, medical magnesium alloy, gold, silver, platinum and other precious metals and tantalum, niobium, zirconium and nickel-titanium shape memory alloy with good chemical stability and physical corrosion resistance are mainly selected, and the selectable metal marker can be made into an easily-recognized shape for analysis in operation, such as a ring shape, a point shape and the like. The catheter balloon portion pressure sensor wire is a part of the pressure sensor wire, is located at the head end of the catheter body portion, is embedded in balloon catheter materials, is spirally wound and penetrates through the whole balloon catheter, has the function of transmitting information data sensed by the pressure sensor, also has the function of enhancing the supporting strength and the tensile strength of the balloon catheter, avoids the risk of being remained on a human body due to catheter breakage, and reduces iatrogenic injury and infection risks.

The pressure sensor lead penetrates through the whole conductor body part, one end of the pressure sensor lead is connected with the pressure sensor, and the other end of the pressure sensor lead is connected with the output interface of the pressure sensor; the pressure sensor lead is a metal lead, is embedded in the materials of the catheter and the output connecting wire of the pressure sensor, is spirally coiled and penetrates through the whole balloon catheter; the primary function of the pressure sensor is to transmit the pressure intensity/pressure information monitored by the pressure sensor; the balloon catheter has the advantages that the supporting strength and the tensile strength of the balloon catheter are enhanced, the breakage of the catheter in the operation and the residue of broken stumps on a human body are avoided, and the iatrogenic injury and infection risks are reduced; and finally, the pressure sensor wire has certain elasticity by spirally winding the wire, so that the wire is prevented from being damaged when the balloon catheter is bent and folded.

The pressure sensor output connecting wire is a connecting part of the invention, one end of the connecting wire is connected with the conductor body part, and the other end of the connecting wire is connected with the pressure sensor output interface; the pressure sensor lead enters from the joint of the connecting wire and the conductor body part, spirally winds and travels, and is embedded in the pressure sensor lead material; the pressure sensor output connecting wire is mainly used for protecting the pressure sensor wire so as to ensure the output of pressure sensing information; the material of the output connecting wire of the pressure sensor is medical high polymer material, and polyurethane, silicon rubber, polyester fiber, polyvinylpyrrolidone, polyether ether ketone, polymethyl methacrylate, polyvinyl alcohol, polylactic acid, polyethylene and the like can be selected.

The operation interface is a human-computer interaction end, and an operation doctor can control the operation interface according to the preoperative treatment scheme recommendation provided by the display system and the actual condition in the operation to send an instruction to the balloon catheter auxiliary equipment management system, so that the operation of the whole intelligent self-evolution auxiliary equipment is controlled, and the like. Optionally, the operation interface may be integrally connected with other components of the intelligent self-evolution auxiliary device, and may also perform information interaction by using a wireless information transmission manner; if the wireless information transmission mode is adopted for information interaction, the remote operation is realized, and the radiation irradiation of a surgeon is avoided.

The balloon catheter auxiliary equipment management system is connected with the operation interface, the power supply management module and the central processing unit; the operation interface is connected with the operation interface and is used for receiving instructions to control the operation of the whole auxiliary equipment; the purpose of connecting with power management module is to control the power management module to provide energy for each component of the equipment; the purpose of interacting with the central processing unit is to upgrade the evolution of system software, modify system parameters, access and analyze operation information, and the like; the balloon catheter auxiliary management system can also acquire medical record information of a patient, test examination, imaging information, postoperative symptom relieving information, discharge follow-up visit and the like, and store and construct a patient database; in addition, the balloon catheter auxiliary equipment management system is connected with the Internet, latest high-quality documents related to balloon catheter interventional therapy are inquired in real time, a knowledge map is summarized and deduced, and a knowledge map database is stored and constructed.

The information processing module is one of the cores of the balloon catheter auxiliary equipment, and is used for performing real-time data processing according to input data such as pressure information, time information, volume information of a contrast agent perfused in the balloon and the like under the support of a central processing unit, completing modulation, demodulation, calculation, storage and the like of the data, and completing the drawing calculation of a pressure variation curve in the balloon before a dynamic operation, a pressure variation curve in the balloon during the dynamic operation, a pressure variation curve between the wall of the dynamic balloon and tissues, a dynamic volume variation curve, and pressure time integral, volume time integral and other information corresponding to each curve; the calculation results are displayed in real time by being connected with a display, so that the operation doctor can conveniently observe and make intraoperative judgment; judging the current treatment state according to the loaded balloon catheter interventional treatment strategy, giving a recommended treatment scheme, and displaying the recommended treatment scheme through a display system for reference of an operating doctor; receiving a decision from an operator, calculating the perfusion volume and pressure of the contrast agent in the balloon, and sending an instruction to control the power control module; the information processing module stores each decision (selected contrast agent perfusion pressure, perfusion volume, corresponding duration and the like) of the operating doctor, constructs a doctor decision database, matches the doctor decision database with data in the patient information database, combines the latest knowledge map database data, and deduces a more accurate balloon catheter interventional treatment strategy through methods such as deep learning and convolutional neural network to replace the loaded strategy, so that intelligent self-evolution of auxiliary equipment is realized, and a more accurate treatment scheme is recommended for the operating doctor; the information processing module also sets a pressure safety threshold according to the balloon material of the balloon catheter, and when the pressure in the balloon input by the information acquisition system in real time exceeds the safety threshold, the power control system is controlled to stop the perfusion of the contrast agent, so that the risk of bursting of the balloon due to the sudden increase of the pressure is reduced; the information processing module establishes a balloon catheter damage database and an early warning strategy according to pressure release characteristics of a balloon catheter contrast agent during perfusion extracted from experimental data, accurately diagnoses catheter damage, balloon rupture, damaged parts and the like in an operation to reduce iatrogenic damage caused by continuous operation due to balloon catheter damage, matches the actual conditions of the balloon catheter with pressure release data during perfusion after the operation to establish a pressure release database during perfusion, extracts the characteristics by utilizing a convolutional neural network and the like again in combination with the previous data, and self-evolves the balloon catheter damage early warning strategy.

One end of the power control system is connected with the information processing module and receives a control instruction, and the other end of the power control system is connected with the contrast agent propulsion system and controls the contrast agent propulsion system to operate.

The display system is another human-computer interaction interface of the system, is connected with the information processing module, receives information data output by the information processing module, recommends treatment schemes and the like, and presents the information data, the recommended treatment schemes and the like in a visual mode and the like for reference of an operating doctor. Optionally, the display system may be integrally connected with other components of the intelligent self-evolution auxiliary device, and may also perform information interaction in a wireless information transmission manner; if the wireless information transmission mode is adopted for information interaction, the remote operation is realized, and the radiation irradiation of a surgeon is avoided.

The first embodiment is as follows: a balloon catheter capable of measuring the internal pressure of a balloon for trigeminal semilunar compression and an intelligent self-evolution auxiliary device thereof are illustrated by figures 1, 2 and 7.

Before trigeminal balloon compression begins, balloon catheter intelligent self-evolution auxiliary equipment is started, and balloon catheter auxiliary equipment management system 1 is driven through operation interface 9 to read operation patient information including medical record data, examination and examination, image data and the like, and information processing module 4 is input with the help of central processing unit 3 to be processed. Then adding a contrast agent into the contrast agent propelling system 6, connecting the contrast agent perfusion interface 7 with the contrast agent lumen inlets 3a-8, and connecting the information acquisition system 8 with the pressure sensor output interfaces 3 a-5; a balloon catheter exhaust command is input through an operation interface, a power control module 5 is started by a data processing module 4 under the assistance of a central processing unit 3 through a balloon catheter auxiliary equipment management system 1, a contrast agent propulsion system 6 is controlled, and the balloon catheter is perfused and discharged with a contrast agent through a contrast agent perfusion interface 7 so as to achieve the purpose of exhaust; after the air exhaust is finished, a balloon catheter external pressure test command is input through the operation interface 9, a balloon catheter auxiliary equipment management system 1 is used, under the assistance of a central processing unit 3, a data processing module 4 is used for starting a power control module 5 and controlling a contrast agent propulsion system 6, contrast agent is slowly perfused into the balloon catheter through a contrast agent perfusion interface 7, at the moment, a pressure sensor 3a-1-1 at the balloon part of the balloon catheter collects dynamic change information of the pressure value in the balloon in real time and transmits the information out through a pressure sensor lead 3a-1-6, at the tail part of a pressure sensor output connecting line 3a-4, the information is transmitted to an information acquisition system 8 through a pressure sensor output interface 3a-5, the information acquisition system 8 transmits the data into the information processing module 4 after completing data conversion, a balloon catheter in-vitro perfusion balloon internal pressure-contrast agent perfusion volume model is constructed under the assistance of the central processing unit 3, and visual display is realized through the display system 10. At this time, the information processing module 4 solves the recommended treatment scheme, the contrast agent propulsion volume, the pressure in the balloon, the compression duration and the like of the current operation through the loaded balloon catheter interventional treatment strategy according to the patient information read by the balloon catheter auxiliary device management system 1 and the solved in-vitro perfusion balloon pressure-contrast agent perfusion volume model of the balloon catheter to be used in the current operation.

When the operation is started, the sharp end 1a-1 of the puncture inner core is inserted into the tail part 2a-3 of the conduit sheath, so that the sharp end 1a-1 of the puncture inner core extends out of the head part 2a-1 of the conduit sheath through the tail part 2a-3 of the conduit sheath to form a puncture needle, and a soft tissue channel from the horn of the mouth to the foramen ovale of the skull base is constructed. After the channel is constructed, the puncture inner core is pulled out, and the catheter sheath is kept. Then the catheter balloon part 3a-1 is inserted from the catheter sheath tail part 2a-3, and the catheter balloon part 3a-1 is delivered into the Mycobacteria under the guidance of the catheter scale 3a-7, the catheter sheath scale 2a-4 and the intraoperative fluoroscopy technology. At the moment, the operation physician can decide operation details and progress according to past experience or a recommended scheme provided by the intelligent self-evolution auxiliary equipment; inputting trigeminal nerve saccule compression treatment scheme through an operation interface, starting a power control module 5 by a data processing module 4 under the assistance of a saccule conduit auxiliary equipment management system 1 and a central processing unit 3 by a data processing module 4, controlling a contrast medium propulsion system 6, slowly filling a contrast medium into a saccule conduit through a contrast medium filling interface 7, acquiring dynamic change information of pressure value in the saccule in real time by a pressure sensor 3a-1-1 at the saccule part of the saccule conduit at the moment, transmitting the dynamic change information out through a pressure sensor lead 3a-1-6, transmitting the information to an information acquisition system 8 through a pressure sensor output interface 3a-5 at the tail part of a pressure sensor output connecting line 3a-4, transmitting the data to the information processing module 4 after the data conversion of the information acquisition system 8 is completed, and constructing a saccule inner pressure-contrast medium filling volume model under the assistance of the central processing unit 3, and further calculating the pressure difference between the internal perfusion and the external perfusion sacculus under the same contrast agent perfusion volume, constructing a construct internal and external contrast agent perfusion sacculus internal pressure difference-perfusion volume model, and realizing visual display of all dynamic data and models through the display system 10. When the treatment is completed, the information processing module 4 drives the power control module 5 to control the contrast agent propulsion system 6 under the help of the central processing unit 3, so that the contrast agent perfused in the balloon catheter is withdrawn from the contrast agent perfusion interface 7 at a proper speed. When the saccule 3a-1-3 of the saccule part 3a-1 of the catheter is completely retracted, the saccule catheter and the catheter sheath are pulled out slowly in sequence to complete the operation.

After operation, the follow-up visit information (including short-term follow-up visit and long-term follow-up visit) of the patient is read through the balloon catheter auxiliary equipment management system 1, data pairing is carried out on preoperative patient information, balloon internal pressure-perfusion volume data perfused by a balloon catheter external contrast agent, balloon internal pressure-perfusion volume data perfused by a balloon catheter internal contrast agent, patient operation treatment schemes (treatment parameters and the like), and the like, and then a new balloon catheter interventional treatment strategy is constructed through deep learning by combining with knowledge map data constructed by the balloon catheter auxiliary equipment management system 1, so that intelligent self-evolution of the balloon catheter interventional treatment strategy is realized.

Example two: a balloon catheter for measuring the internal pressure of a balloon for carotid artery stenosis angioplasty and an intelligent self-evolving auxiliary device thereof are illustrated by figures 3, 4 and 7.

Before carotid artery stenosis angioplasty begins, balloon catheter intelligent self-evolution auxiliary equipment is started, the balloon catheter auxiliary equipment management system 1 is driven through the operation interface 9 to read operation patient information including medical record information, examination and examination, image information and the like, and the information is input into the information processing module 4 with the help of the central processing unit 3 to be processed. Contrast is added to the contrast propulsion system 6, connecting the contrast perfusion interface 7 with the contrast tube 3 b.

At the beginning of the operation, a puncture is made in the femoral or other artery and the arterial sheath 1b is inserted into the artery to create the operative passage. The guide wire 5b is inserted into the contrast tube 3b, and then the contrast tube 3b enters from the tail part of the arterial sheath 1b and enters into the artery. An operation doctor inputs an angiography command through an operation interface 9, signals enter a data processing module 4 through a balloon catheter auxiliary device management system 1, under the assistance of a central processing unit 3, a power control module 5 is started, a contrast medium propulsion system 6 is controlled, a contrast medium is injected into a contrast tube 3b through a contrast medium perfusion interface 7, and meanwhile, the operation doctor starts a DSA machine to complete one angiography. The operator repeats the above steps based on the angiographic results, and the guidewire 5b is gradually delivered over the lesion site. The contrast tube 3b is then withdrawn and the guide wire 5b is left in place. And selecting a proper catheter guide tube 4b according to the contrast result, connecting the catheter guide tube with a contrast agent perfusion interface 7, and inserting the tail part of the guide wire into the lumen of the guide tube 4 b. Guided by the guide wire 5b, the tail of the artery sheath 1b extends into the blood vessel. The operator inputs an angiography instruction again through the operation interface 9, the signal enters the data processing module 4 through the balloon catheter auxiliary device management system 1, the power control module 5 is started under the assistance of the central processing unit 3, the contrast agent propulsion system 6 is controlled, the contrast agent is injected into the catheter guide tube 4b through the contrast agent perfusion interface 7, and meanwhile, the operator starts the DSA machine to complete one-time angiography. The surgeon repeats the above steps and slowly advances the delivery catheter based on the angiographic results until it stops 2-3cm from the lower margin of the lesion. An appropriate balloon catheter 2b is selected according to the intraoperative imaging result. The contrast agent perfusion interface 7 and the contrast agent lumen inlet 2b-8 are connected firstly, and then the information acquisition system 8 and the pressure sensor output interface 2b-5 are connected. The balloon catheter exhaust command is input through the operation interface 9, signals enter the data processing module 4 through the balloon catheter auxiliary equipment management system 1, the power control module 5 is started under the assistance of the central processing unit 3, the contrast agent propulsion system 6 is controlled, and the balloon catheter 2b is perfused and discharged with contrast agents through the contrast agent perfusion interface 7 so as to achieve the purpose of exhaust. After the air exhaust is finished, inputting a balloon catheter external pressure test command through an operation interface 9, starting a power control module 5 by a data processing module 4 through a balloon catheter auxiliary equipment management system 1 under the assistance of a central processing unit 3, controlling a contrast medium propelling system 6, slowly injecting a contrast medium into the balloon catheter through a contrast medium injecting interface 7, acquiring dynamic change information of the pressure value in the balloon in real time by a pressure sensor 2b-1-1 at the balloon part of the balloon catheter at the moment, transmitting the information out through a pressure sensor lead 2b-1-6, transmitting the information to an information acquisition system 8 through a pressure sensor output interface 2b-5 at the tail part of a pressure sensor output connecting line 3a-4, transmitting the data to the information processing module 4 after the data conversion is finished by the information acquisition system 8, a balloon catheter in-vitro perfusion balloon internal pressure-contrast agent perfusion volume model is constructed under the assistance of the central processing unit 3, and visual display is realized through the display system 10. At this time, the information processing module 4 solves the recommended treatment plan, the contrast agent propulsion volume, the pressure in the balloon, the compression duration and the like of the current operation through the loaded balloon catheter interventional treatment strategy according to the patient information read by the balloon catheter auxiliary device management system 1 and the solved in-vitro perfusion balloon pressure-contrast agent perfusion volume model of the balloon catheter to be used in the current operation.

The tail part of the guide wire 5b is inserted from the guide wire lumen inlet 2b-1-8 at the head part of the balloon catheter 2b, extends into the vessel from the tail part of the catheter guide tube 4b under the guide of the guide wire 5b, and enters the vessel through the arterial sheath 1 b. The operator inputs an angiography instruction again through the operation interface 9, the signal enters the data processing module 4 through the balloon catheter auxiliary device management system 1, the power control module 5 is started under the assistance of the central processing unit 3, the contrast agent propulsion system 6 is controlled, the contrast agent is injected into the catheter guide tube 4b through the contrast agent perfusion interface 7, and meanwhile, the operator starts the DSA machine to complete one-time angiography. The surgeon repeats the above steps and advances the balloon catheter 2b slowly within the catheter guide tube 4b, depending on the angiographic results, until the balloon catheter balloon portion 2b-1 enters the lesion area. The surgeon can then decide on the details and progress of the procedure based on his own experience or the recommendations provided by the intelligent self-evolving aids. Inputting a balloon dilatation scheme for carotid stenosis angioplasty through an operation interface, managing a system 1 through a balloon catheter auxiliary device, starting a power control module 5 by a data processing module 4 with the assistance of a central processing unit 3, controlling a contrast agent propulsion system 6, slowly injecting a contrast agent into a balloon catheter through a contrast agent injection interface 7, acquiring dynamic change information of a pressure value in the balloon by a pressure sensor 2b-1-1 at the balloon part of the balloon catheter in real time, transmitting the dynamic change information out through a pressure sensor lead 2b-1-6, transmitting the information to an information acquisition system 8 through a pressure sensor output interface 2b-5 at the tail part of a pressure sensor output connecting line 2b-4, transmitting the data to the information processing module 4 after the data conversion by the information acquisition system 8, and constructing a balloon intra-perfusion balloon pressure-contrast agent injection body in the balloon catheter body with the assistance of the central processing unit 3 And integrating the model, further calculating the pressure difference between the internal perfusion and the external perfusion sacculus under the same contrast agent perfusion volume, constructing the internal and external contrast agent perfusion sacculus internal pressure difference-perfusion volume model, and realizing visual display of all dynamic data and models through the display system 10. When the balloon dilatation is completed, the information processing module 4 drives the power control module 5 to control the contrast agent propulsion system 6 under the help of the central processing unit 3, so that the contrast agent perfused in the balloon catheter is withdrawn from the contrast agent perfusion interface 7 at a proper speed. When the saccule 2b-1-3 of the saccule part 2b-1 of the catheter is completely retracted, the saccule catheter 2b is slowly pulled out. Finally, the stent 6b is connected to the stent delivery device 7b, the tail of the guide wire exposed outside the body is inserted into the delivery device, and the guide wire 5b is guided by the tail of the catheter guide tube 4b to enter the blood vessel through the arterial sheath 1 b. An operation doctor inputs an angiography instruction through an operation interface 9, signals enter a data processing module 4 through a balloon catheter auxiliary device management system 1, under the assistance of a central processing unit 3, a power control module 5 is started, a contrast agent propulsion system 6 is controlled, contrast agents are injected into a catheter guide tube 4b through a contrast agent perfusion interface 7, and meanwhile, the operation doctor starts a DSA machine to complete one-time angiography. The surgeon repeats the above steps according to the result of angiography, and slowly delivers the stent 6b to the lesion region through the stent delivery device 7 b. The stent 6b is released at the lesion site by the stent delivery device 7b over the entire course of the lesion. The stent delivery device 7b is withdrawn. After the occurrence of the abnormal condition is confirmed by the revascularization, the guide wire 5b, the catheter guide tube 4b and the arterial sheath 1b are sequentially withdrawn, the puncture site is sutured or pressure-bandaged, and the operation is ended.

Example three: a balloon catheter capable of measuring the pressure between the balloon wall and the tissues for trigeminal semilunar compression and an intelligent self-evolution auxiliary device thereof are illustrated by figures 5, 6 and 7.

Before trigeminal balloon compression begins, balloon catheter intelligent self-evolution auxiliary equipment is started, balloon catheter auxiliary equipment management system 1 is driven through operation interface 9 to read operation patient information including medical record data, examination and examination, image data and the like, information processing module 4 is input under the help of central processing unit 3, recommended treatment scheme of the operation is solved through loaded balloon catheter interventional treatment strategy, and contrast agent impels volume, pressure in the balloon, compression duration and the like. Then adding a contrast agent into the contrast agent propelling system 6, connecting the contrast agent perfusion interface 7 with the contrast agent lumen inlet 3c-8, and connecting the information acquisition system 8 with the pressure sensor output interface 3 c-5; the balloon catheter exhaust command is input through the operation interface, the power control module 5 is started by the data processing module 4 under the assistance of the central processing unit 3 through the balloon catheter auxiliary equipment management system 1, the contrast agent propulsion system 6 is controlled, and the balloon catheter is perfused and discharged with contrast agent through the contrast agent perfusion interface 7 so as to achieve the purpose of exhaust. When the operation is started, the sharp end 1c-1 of the puncture inner core is inserted into the tail part 2c-3 of the conduit sheath, so that the sharp end 1c-1 of the puncture inner core extends out of the head part 2c-1 of the conduit sheath through the tail part 2c-3 of the conduit sheath to form a puncture needle, and a soft tissue channel from the horn of the mouth to the foramen ovale of the skull base is constructed. After the channel is constructed, the puncture inner core is pulled out, and the catheter sheath is kept. The catheter balloon portion 3c-1 is then inserted through the catheter sheath tail portion 2c-3, and the catheter balloon portion 3c-1 is delivered into the Mylar sac under the guidance of the catheter scale 3c-7, the catheter sheath scale 2c-4 and intraoperative fluoroscopy techniques. The surgeon can then decide on the details and progress of the procedure based on his own experience or the recommendations provided by the intelligent self-evolving aids. Inputting a trigeminal nerve balloon compression treatment scheme through an operation interface, starting a power control module 5 by a data processing module 4 under the assistance of a central processing unit 3 through a balloon catheter auxiliary equipment management system 1, controlling a contrast agent propulsion system 6, slowly injecting a contrast agent into a balloon catheter through a contrast agent injection interface 7, acquiring dynamic change information of a pressure value between the balloon wall and a tissue in real time by a pressure sensor 3c-1-1 of the balloon wall of the balloon catheter at the moment, transmitting the dynamic change information out through a pressure sensor lead 3c-1-6, transmitting the information to an information acquisition system 8 through a pressure sensor output interface 3c-5 at the tail part of a pressure sensor output connecting line 3c-4, transmitting the data to the information processing module 4 after the data conversion of the information acquisition system 8 is completed, and constructing a pressure value between the balloon wall and the tissue-contrast agent injection volume under the assistance of the central processing unit 3 And the model, all dynamic data and the model are displayed visually through the display system 10. When the treatment is completed, the information processing module 4 drives the power control module 5 to control the contrast agent propulsion system 6 under the help of the central processing unit 3, so that the contrast agent perfused in the balloon catheter is withdrawn from the contrast agent perfusion interface 7 at a proper speed. When the saccule 3c-1-3 of the saccule part 3c-1 of the catheter is completely retracted, the saccule catheter and the catheter sheath are pulled out slowly in sequence to complete the operation.

While there have been shown and described what are at present considered to be the fundamental principles of the invention and its essential features and advantages, it will be understood by those skilled in the art that the invention is not limited by the embodiments described above, which are merely illustrative of the principles of the invention, but that various changes and modifications may be made therein without departing from the spirit and scope of the invention as defined by the appended claims and their equivalents.

Claims

1. The utility model provides an intelligence of measurable pressure sacculus pipe is from evolving formula auxiliary assembly which characterized in that: the pressure measurable sacculus catheter comprises a catheter sacculus part, a catheter body part, a catheter tail part, a pressure sensor output connecting wire, a pressure sensor output interface, a pressure sensor lead, catheter scales, a contrast agent lumen inlet and a guide wire lumen inlet; the catheter balloon part comprises a pressure sensor, a catheter balloon part side hole, a balloon attachment point, a metal marker, a pressure sensor lead, a contrast agent lumen and/or a guide wire lumen; in addition, the puncture inner core, the catheter sheath scale, the arterial sheath, the contrast tube, the catheter guiding tube, the guide wire, the bracket and the bracket conveyor are also included; the catheter balloon part is integrated with a balloon, a pressure sensor, a catheter balloon part side hole, a balloon attachment point, a metal marker and a pressure sensor lead, so that a contrast agent is allowed to enter and exit the balloon, balloon expansion and contraction, pressure information sensing, pressure information output and intraoperative catheter balloon part tracking and positioning are realized; the saccule is made of elastic material and can be inflated into a spherical shape or an oval shape; the pressure sensor is used for measuring the pressure in the guide saccule and the operation area; the side hole of the balloon part of the catheter allows the contrast medium liquid and gas substances to enter and flow out; the balloon attachment point is the sealing connection between the balloon and the balloon catheter body;

the metal marker is used for positioning in the sacculus operation; the balloon part pressure sensor lead of the catheter is embedded in a balloon catheter material and spirally wound to penetrate through the whole balloon catheter; the catheter body part is connected with the catheter balloon part and the catheter tail part and is in a hollow tubular shape, and a pressure sensor lead is embedded in the wall of the catheter body part; the tail part of the conduit is positioned at the tail end of the conduit body part and is used for connecting and fixing the conduit body part; the output connecting line of the pressure sensor is a connecting part; the pressure sensor output interface is used for converting and transmitting pressure data; the contrast agent lumen inlet is an opening of a hollow pipeline in the balloon catheter and is connected with a contrast agent perfusion interface; the entrance of the guide wire lumen appears in a part of the balloon catheter matched with the guide wire for use, and provides a space channel for the guide wire for guiding the balloon catheter to reach the appointed operation position; the catheter scale is used for estimating the propelling distance of the balloon part of the catheter in the middle of the operation;

the intelligent self-evolution auxiliary equipment comprises a surgical operation interface, a balloon catheter auxiliary equipment management system, a power supply module, a central processing unit, an information processing module, a power control module, a contrast agent propulsion system, a contrast agent perfusion interface, an information acquisition system and a display system; the operation interface is a human-computer interaction end, and an operation doctor controls the operation interface to send an instruction to the balloon catheter auxiliary equipment management system according to the preoperative treatment scheme recommendation provided by the display system and the actual intraoperative condition, so as to control the operation of the whole intelligent self-evolution auxiliary equipment; the balloon catheter auxiliary equipment management system is connected with the operation interface, the power supply management module and the central processing unit, and is used for controlling the operation of the whole auxiliary equipment, controlling the energy supply of equipment components, evolving and upgrading system software, modifying system parameters, accessing and analyzing diagnosis and treatment information of patients and constructing a knowledge map database; the power management system provides energy for all components of the auxiliary equipment, completes battery management, wired/wireless charging and provides a data interface for program upgrading and parameter modification, and the data interface is wired or wireless; the central processing unit is used for data calculation, hardware system management and work coordination; the information processing module is used for carrying out real-time data processing according to input pressure information, time information and volume information data of a contrast agent perfused in the saccule under the support of a central processing unit, completing modulation, demodulation, calculation and storage of data, and completing the drawing calculation of a pressure change curve in the saccule before a dynamic operation, a pressure change curve in the saccule during the dynamic operation, a pressure change curve between the wall of the dynamic saccule and a tissue, a dynamic volume change curve, and pressure time integral and volume time integral information corresponding to each curve; the pressure change curve in the balloon before the dynamic operation, the pressure change curve in the balloon during the dynamic operation, the pressure change curve between the wall of the dynamic balloon and the tissue, the dynamic volume change curve and the pressure time integral and volume time integral information corresponding to the curves are displayed in real time by being connected with a display, so that an operating doctor can conveniently observe and make judgment in the operation; judging the current treatment state according to the loaded balloon catheter interventional treatment strategy, giving a recommended treatment scheme, and displaying the recommended treatment scheme through a display system for reference of an operating doctor; receiving a decision from an operator, calculating the perfusion volume and pressure of the contrast agent in the balloon, and sending an instruction to control the power control module; the information processing module stores each decision of the operating doctor, the selected perfusion pressure and perfusion volume of the contrast agent and the corresponding duration, constructs a doctor decision database, matches the doctor decision database with data in the patient information database, combines the latest data of the knowledge map database, deduces a more accurate balloon catheter interventional treatment strategy by a deep learning and convolution neural network method, replaces the loaded strategy, realizes the intelligent self-evolution of auxiliary equipment, and recommends a more accurate treatment scheme for the operating doctor; the information processing module also sets a pressure safety threshold according to the balloon material of the balloon catheter, and controls the power control system to stop the perfusion of the contrast agent when the pressure in the balloon input by the information acquisition system in real time exceeds the safety threshold, so that the risk of the balloon bursting due to the sudden increase of the pressure is reduced; the information processing module establishes a balloon catheter damage database and an early warning strategy according to pressure release characteristics extracted from experimental data during balloon catheter contrast agent perfusion, accurately diagnoses catheter damage, balloon rupture and damaged parts in an operation to reduce iatrogenic damage caused by continuous operation due to balloon catheter damage, matches the actual conditions of the balloon catheter with pressure release data during perfusion after the operation to establish a pressure release database during perfusion, extracts the characteristics by combining the previous data and utilizing a convolutional neural network method again, and self-evolves the balloon catheter damage early warning strategy; the power control system controls the operation of the contrast agent propulsion system; the contrast agent propulsion system comprises a contrast agent propulsion device, a contrast agent storage bin and a contrast agent perfusion volume monitoring device; one end of the power control module is connected with the power control module and operates under the control of the power control module; one end of the contrast medium injection port is connected with the contrast medium injection port at the tail part of the balloon catheter to complete the pushing or withdrawing of the contrast medium in the balloon catheter; one end of the system is connected with the information processing module and inputs the propelling and withdrawing volume information of the contrast medium in the balloon catheter; the contrast agent propulsion system has a constant pressure maintaining function in the balloon catheter, and when the balloon contrast agent is completely filled, the contrast agent in the balloon is prevented from reversely flowing backwards, so that the pressure of an operation area is effectively maintained; one end of the information acquisition system is connected with the output interface of the pressure sensor, receives pressure information and time duration information sensed by the pressure sensor in the balloon catheter in real time, converts the pressure information and the time duration information, and the other end of the information acquisition system is connected with the information processing module, and inputs the information after data conversion into the information processing module for data processing; the display system is a human-computer interaction interface, is connected with the information processing module, receives information data output by the information processing module, recommends a treatment scheme, and presents the treatment scheme in a visual mode.

2. The intelligent self-evolving auxiliary device for a pressurizable balloon catheter of claim 1, wherein: the pressure sensor is integrated in the balloon catheter, so that the real-time dynamic monitoring and data acquisition of the pressure/pressure between the balloon wall and the tissue are realized.

3. The intelligent self-evolving auxiliary device of a pressurizable balloon catheter of claim 1, wherein: the pressure sensor conducting wire is embedded and spirally coiled in the wall of the catheter and penetrates through the whole balloon catheter, so that the supporting strength and the tensile strength of the balloon catheter are enhanced, the breakage of the catheter in the operation and the residue of broken stumps on a human body are avoided, and the risk of iatrogenic injury and infection is reduced.

4. The intelligent self-evolving auxiliary device of a pressurizable balloon catheter of claim 1, wherein: due to the use of the contrast agent propelling system, the contrast agent in the balloon is freely, conveniently, accurately and controllably perfused, and the perfusion volume of the contrast agent in the balloon is acquired in real time and dynamically.

5. The intelligent self-evolving auxiliary device of a pressurizable balloon catheter of claim 1, wherein: due to the existence of the information processing module, modulation, demodulation, calculation and storage of data can be completed, an optimal treatment scheme is intelligently recommended, a doctor decision database and a balloon catheter damage database are constructed, a more accurate balloon catheter interventional treatment strategy and a balloon catheter damage early warning strategy are deduced, a loaded strategy is updated, and intelligent self-evolution of auxiliary equipment is realized.

6. The intelligent self-evolving auxiliary device of a pressurizable balloon catheter of claim 1, wherein: because the balloon catheter auxiliary equipment management system is established, the construction of a patient information database, the establishment of a knowledge map database, the evolution and the upgrade of system software, the modification of system parameters and the access and analysis of operation information are realized, and the patient information database comprises patient image data, laboratory examination, hospitalization and discharge follow-up information.

7. The intelligent self-evolving auxiliary device of a pressurizable balloon catheter of claim 1, wherein: the remote human-computer interaction, the wireless information transmission and the near-center control are realized, and the radiation irradiation of the operating doctor in the operation process is avoided.