CN111840757B - A pressure-measurable balloon catheter and its intelligent self-evolving auxiliary equipment - Google Patents
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- A61M2025/1079—Balloon catheters with special features or adapted for special applications having radio-opaque markers in the region of the balloon
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Abstract
Translated fromChinese
Description
Translated fromChinese技术领域：Technical field:
本发明涉及一种用于神经介入、血管介入等治疗技术的可测压球囊导管及其智能自演进式辅助设备，属于医疗领域中的介入治疗用球囊导管领域。The invention relates to a pressure-measurable balloon catheter and an intelligent self-evolving auxiliary device used for nerve intervention, vascular intervention and other treatment technologies, and belongs to the field of balloon catheters for interventional therapy in the medical field.
背景技术：Background technique:
介入治疗学，是一门融合了影像诊断和临床治疗于一体的新兴学科。它是在数字减影血管造影机、CT、超声和磁共振等影像设备的引导和监视下，利用穿刺针、导管及其他介入器材，通过人体自然孔道或微小的创口将特定的器械导入人体病变部位进行微创治疗的一系列技术的总称。目前已经成为与传统的内科、外科并列的临床三大支柱性学科。在众多的介入器材中，球囊导管及其引领的球囊导管技术在介入治疗学中占据重要的地位，应用于各种血管疾病及非血管疾病的治疗，如动脉栓塞、动脉狭窄、三叉神经痛等。在球囊导管的实际应用中，当球囊导管的球囊部被递送至治疗部位后，造影剂的推进、球囊的扩张式最基本，也是最核心的操作。通过球囊的扩张，在病变部位产生压力阶差，从而实现疾病治疗的目的，如动脉狭窄部受压扩大、三叉神经半月节受压毁损等。因此球囊导管在疾病治疗时，最核心的治疗因素是压力，然而球囊内压力却往往被忽视。Interventional therapy is an emerging discipline that integrates imaging diagnosis and clinical treatment. Under the guidance and monitoring of imaging equipment such as digital subtraction angiography, CT, ultrasound and magnetic resonance, it uses puncture needles, catheters and other interventional equipment to introduce specific instruments into human lesions through natural human orifices or tiny wounds The general term for a series of techniques for minimally invasive treatment of the site. At present, it has become the three pillars of clinical disciplines, which are side by side with traditional internal medicine and surgery. Among the many interventional devices, balloon catheter and its leading balloon catheter technology occupy an important position in interventional therapy, and are used in the treatment of various vascular and non-vascular diseases, such as arterial embolism, arterial stenosis, trigeminal nerve Pain etc. In the practical application of the balloon catheter, after the balloon portion of the balloon catheter is delivered to the treatment site, the advancement of the contrast agent and the expansion of the balloon are the most basic and core operations. Through the expansion of the balloon, a pressure gradient is generated at the lesion site, so as to achieve the purpose of disease treatment, such as the compression and expansion of the arterial stenosis, and the compression and damage of the trigeminal nerve semilunar ganglion. Therefore, in the treatment of diseases with balloon catheters, the core treatment factor is pressure, but the pressure in the balloon is often ignored.
在颈内动脉狭窄的治疗中，首先将导丝递送至需治疗区域，然后通过导丝将球囊导管引导至需治疗的狭窄部位，手术医生根据自身经验以及数字血管减影，给球囊内推进一定量的造影剂，使球囊扩张以治疗血管狭窄区。在整个过程中，手术医师关注的是血管造影结果以及球囊内造影剂注射体积（一般厂家会给出一个推荐造影剂推注剂量），基本不关注球囊内压力以及球囊壁与血管壁之间的压力。然而这些压力才是颈内动脉狭窄治疗的关键。In the treatment of internal carotid artery stenosis, the guide wire is first delivered to the area to be treated, and then the balloon catheter is guided to the stenosis area to be treated through the guide wire. A certain amount of contrast medium is advanced, causing the balloon to expand to treat the narrowed area of the blood vessel. During the whole process, the surgeon pays attention to the angiography results and the injection volume of the contrast agent in the balloon (generally, the manufacturer will give a recommended contrast agent bolus dose), and basically does not pay attention to the pressure in the balloon and the balloon wall and the blood vessel wall. pressure between. However, these pressures are the key to the treatment of internal carotid artery stenosis.
在三叉神经痛微球囊压迫治疗中，通过在球囊导管扩张三叉神经麦氏囊，压迫三叉神经，利用机械压力破坏三叉神经痛觉神经纤维，阻滞痛觉传导，达到止痛目的。在实际手术治疗过程中，医生根据两点来评判痛觉纤维是否已经受到了损伤而触觉纤维和运动纤维得到了良好的保存：球囊扩张形状和压迫持续时间。首先借用1ml注射器推进造影剂来协助球囊在麦氏囊内扩张，并根据球囊扩张的形状来评估三叉神经半月节压迫的效果。而不同患者的麦氏囊形状各不相同，囊体积大小也不相同，因此根据球囊扩张的形状来评判疾病治疗效果显然存在不足。其次在球囊压扩张至医生满意的形状后，进行压迫时间计算。然而压迫时间的长短也完全依靠医生经验，每一位患者的压迫时间会根据手术医生的主观判断而有所不同。同血管介入中球囊导管治疗疾病相同，最重要的治疗因素压力从未被量化考虑。因此，目前三叉神经痛微球囊压迫治疗的疗效和并发症基本取决于医生的经验及术中主观判断。正因为如此，不同医生之间的治疗效果相差较大，同一医生治疗的不同患者之间治疗效果也相差较大，非常不利于该技术的同质化推广，也不符合当前国家提倡的精准化治疗方向。In the treatment of trigeminal neuralgia with microballoon compression, the balloon catheter is used to expand the McBurney bursa of the trigeminal nerve, compress the trigeminal nerve, and use mechanical pressure to destroy the pain nerve fibers of the trigeminal nerve, block pain conduction, and achieve the purpose of pain relief. In the actual surgical treatment process, doctors judge whether the pain fibers have been damaged and the tactile fibers and motor fibers have been well preserved according to two points: the shape of balloon expansion and the duration of compression. First, a 1ml syringe was used to propel contrast agent to assist balloon expansion in McFarland's capsule, and the effect of trigeminal meniscus compression was evaluated according to the shape of balloon expansion. The shape and size of McBurner's bursa vary from patient to patient. Therefore, it is obviously insufficient to judge the treatment effect of the disease according to the shape of balloon expansion. Second, after the balloon pressure is inflated to a shape that the doctor is satisfied with, the compression time is calculated. However, the length of the compression time also depends entirely on the doctor's experience, and the compression time of each patient will vary according to the surgeon's subjective judgment. As in vascular intervention with balloon catheters, the most important therapeutic factor, pressure, has never been quantified. Therefore, the curative effect and complications of microballoon compression therapy for trigeminal neuralgia basically depend on the doctor's experience and subjective judgment during the operation. Because of this, the therapeutic effects of different doctors are quite different, and the therapeutic effects of different patients treated by the same doctor are also quite different. treatment direction.
考虑到球囊内压力在球囊导管治疗疾病中的重要作用，我们开发了一种可测压的球囊导管及其智能自演进式辅助设备，用于术中监测球囊内压力以及囊壁与组织之间压力，并实现优选手术方案推荐和手术操作控制等。Considering the important role of intra-balloon pressure in the treatment of diseases with balloon catheter, we developed a pressure-measurable balloon catheter and its intelligent self-evolving auxiliary device for intraoperative monitoring of intra-balloon pressure and balloon wall Pressure between tissue and tissue, and achieve optimal surgical plan recommendation and surgical operation control.
发明内容：Invention content:
本发明的目的就在于为了解决上述问题而提供一种可测压的球囊导管及其智能自演进式辅助设备，能够准确的动态监测、记录疾病治疗过程中球囊导管内造影剂体积，球囊内压力以及球囊壁与组织之间压力，有效控制造影剂进入或退出球囊的速度，及时释放超出安全阈值的压力，建立以压强的时间积分为量化标准的全新球囊导管扩张术、压迫术等介入治疗评判标准，智能推荐优选手术方案，实现近中距离智能手术操作，推动血管及非血管性疾病的精准化及个体化治疗的进程，最大程度上提高医疗安全性，并对未来涉及球囊导管介入治疗行业标准制定和共识达成奠定基础。The purpose of the present invention is to provide a pressure-measurable balloon catheter and its intelligent self-evolving auxiliary equipment in order to solve the above problems, which can accurately and dynamically monitor and record the volume of the contrast agent in the balloon catheter during the disease treatment process. The pressure in the balloon and the pressure between the balloon wall and the tissue can effectively control the speed of the contrast agent entering or exiting the balloon, release the pressure exceeding the safety threshold in time, and establish a new balloon catheter dilatation technique with the time integral of the pressure as the quantitative standard, The evaluation criteria for interventional therapy such as compression surgery, intelligently recommend the optimal surgical plan, realize the intelligent surgical operation at short and medium distances, promote the process of precise and individualized treatment of vascular and non-vascular diseases, maximize medical safety, and have a positive impact on the future. It lays the foundation for the establishment of industry standards and consensus on balloon catheter interventional therapy.
为了解决上述问题，本发明提供了一种技术方案一种可测压的球囊导管，包括：导管球囊部、导管体部、导管尾部、压力传感器输出连接线、压力传感器输出接口、压力传感器导线、造影剂管腔入口、导丝管腔入口和导管刻度。In order to solve the above problems, the present invention provides a technical solution of a balloon catheter capable of measuring pressure, comprising: a catheter balloon part, a catheter body part, a catheter tail part, a pressure sensor output connection line, a pressure sensor output interface, a pressure sensor Guidewire, contrast lumen access, guidewire lumen access, and catheter graduations.
所述的导管球囊部为本发明最重要的部分，由多种结构组成，集成有球囊、压力传感器、导管球囊部侧孔、球囊附着点、金属标记物以及压力传感器导线等，允许造影剂等进出球囊、实现球囊扩张与收缩、压力信息感知、压力信息输出、术中导管球囊部追踪定位等。所述的球囊由弹性材料制成，为顺应性球囊或半顺应性，在充斥液体、气体时充盈为球形或卵圆形；可选的球囊材质可以是天然乳胶、聚氨酯、热塑性弹性体高分子材料、硅胶等单一成分或者混合成分。所述压力传感器为本发明核心部件，用于测量导管球囊部的压力；可选的，压力传感器可选纳米发电机、压电传感器、柔性传感器、弹性传感器、薄膜传感器等多种类型；可选的，压力传感器可以位于球囊导管体部头端（即位于球囊内部）以测量球囊内部压力（压强），也可以位于球囊表面以直接测量球囊与外界组织之间的压力（压强）。所述导管球囊部侧孔位于球囊导管体部头端，其外为球囊，允许造影剂等液体、气体物质进入以及流出。所述球囊附着点位于球囊导管体部头端，为球囊与球囊导管体部的密封连接，形成球囊与导管体部头端的密闭空间，仅通过侧孔连通导管体部与外界交通，且在保证球囊在扩张时仅膨胀而不会出现任何移位，可选的球囊附着点可通过热塑型、捆扎、焊接等实现。所述金属标记物位于球囊导管体部头端球囊附近，X光不能穿透，用于球囊部术中定位，主要选择医用不锈钢、医用钴基合金、医用钛和钛合金、医用镁合金、金、银、铂等贵金属，以及化学稳定性好和抗生理腐蚀性好的钽、铌、锆、镍钛形状记忆合金，可选的金属标记物可做成易识别形状用于术中分析，如环状，点状等。所述导管球囊部压力传感器导线为压力传感器导线的一部分位于导管体部头端，包埋于球囊导管材料内，螺旋盘绕，贯穿整个球囊导管，具有传输压力传感器感知的信息数据的作用，还具有增强球囊导管支撑强度和拉伸强度的作用，避免导管断裂而残留于人体的风险，降低医源性损伤和感染风险。The catheter balloon part is the most important part of the present invention, which is composed of various structures, and integrates a balloon, a pressure sensor, a side hole of the catheter balloon part, a balloon attachment point, a metal marker and a pressure sensor wire, etc., It allows contrast agents to enter and exit the balloon, realize balloon expansion and contraction, pressure information perception, pressure information output, intraoperative catheter balloon tracking and positioning, etc. The balloon is made of elastic material, which is a compliant balloon or semi-compliant, and fills into a spherical or oval shape when filled with liquid and gas; the optional balloon material can be natural latex, polyurethane, thermoplastic elastic bulk polymer materials, silica gel and other single components or mixed components. The pressure sensor is the core component of the present invention, and is used to measure the pressure of the balloon portion of the catheter; optionally, the pressure sensor can be of various types, such as nanogenerators, piezoelectric sensors, flexible sensors, elastic sensors, and thin-film sensors; Optionally, the pressure sensor can be located at the tip of the balloon catheter body (that is, inside the balloon) to measure the pressure inside the balloon (pressure), or it can be located on the surface of the balloon to directly measure the pressure between the balloon and the external tissue ( pressure). The side hole of the balloon portion of the catheter is located at the head end of the balloon catheter body, and the outside is a balloon, allowing liquid and gas substances such as contrast agents to enter and flow out. The balloon attachment point is located at the head end of the balloon catheter body, which is the sealed connection between the balloon and the balloon catheter body, forming a closed space between the balloon and the head end of the catheter body, and connecting the catheter body and the outside world only through the side holes. Transportation, and while ensuring that the balloon is only inflated without any displacement when inflated, optional balloon attachment points can be achieved by thermoplastic molding, strapping, welding, etc. The metal marker is located near the balloon at the head end of the balloon catheter body and cannot be penetrated by X-rays. It is used for intraoperative positioning of the balloon, and medical stainless steel, medical cobalt-based alloys, medical titanium and titanium alloys, and medical magnesium are mainly selected. Alloys, gold, silver, platinum and other precious metals, as well as tantalum, niobium, zirconium, nickel-titanium shape memory alloys with good chemical stability and good resistance to physiological corrosion, optional metal markers can be made into easily identifiable shapes for intraoperative use Analysis, such as ring, point, etc. The catheter balloon pressure sensor wire is a part of the pressure sensor wire located at the head end of the catheter body, embedded in the balloon catheter material, spirally coiled, running through the entire balloon catheter, and has the function of transmitting the information data sensed by the pressure sensor. It also has the effect of enhancing the support strength and tensile strength of the balloon catheter, avoiding the risk of catheter rupture and remaining in the human body, and reducing the risk of iatrogenic injury and infection.
所述导管体部为本发明的主体部分，连接导管球囊部以及导管尾部，为中空管状，且压力传感器导线包埋于其壁中；导管体部材料为医用高分子材料，可选用聚氨酯、硅橡胶、聚酯纤维、聚乙烯基吡咯烷酮、聚醚醚酮、聚甲基丙烯酸甲酯、聚乙烯醇、聚乳酸、聚乙烯等；此外导管体部可根据不同的应用场景制作不同型号，包括导管长度、导管形状和导管粗细等变化。The catheter body is the main part of the present invention, connecting the catheter balloon part and the catheter tail, and is a hollow tubular shape, and the pressure sensor wire is embedded in its wall; the catheter body material is a medical polymer material, and polyurethane, Silicone rubber, polyester fiber, polyvinylpyrrolidone, polyether ether ketone, polymethyl methacrylate, polyvinyl alcohol, polylactic acid, polyethylene, etc.; in addition, the catheter body can be made of different models according to different application scenarios, including Variations in catheter length, catheter shape, and catheter thickness.
所述的导管尾部位于导管体部尾端，主要用于连接、固定导管体部。The catheter tail is located at the tail end of the catheter body, and is mainly used for connecting and fixing the catheter body.
所述的压力传感器导线贯穿整个导管体部，一端与压力传感器相连接，一端与压力传感器输出接口相连；压力传感器导线为金属导线，包埋于导管以及压力传感器输出连接线的材料之中，螺旋盘绕，贯穿整个球囊导管；其首要作用是传输压力传感器监测到的压强/压力信息；其次要作用是增强球囊导管的支撑强度和拉伸强度，避免术中导管断裂以及断裂残端在人体的残留，从而降低了医源性损伤和感染风险；最后导线螺旋盘绕行进使压力传感器导线具有一定弹性，在球囊导管弯曲、打折时避免导线损坏。The pressure sensor wire runs through the entire catheter body, one end is connected with the pressure sensor, and the other end is connected with the pressure sensor output interface; the pressure sensor wire is a metal wire, embedded in the catheter and the material of the pressure sensor output connection wire, and the spiral Coiled through the entire balloon catheter; its primary function is to transmit the pressure/pressure information monitored by the pressure sensor; its secondary function is to enhance the support strength and tensile strength of the balloon catheter to avoid intraoperative catheter rupture and rupture of the broken stump in the human body Therefore, the risk of iatrogenic injury and infection is reduced. Finally, the spiral coiling of the wire makes the pressure sensor wire have a certain elasticity, so as to avoid damage to the wire when the balloon catheter is bent or folded.
所述的压力传感器输出连接线，为本发明连接部分，一端连接导管体部，另一端与压力传感器输出接口相连接；压力传感器导线由连接线与导管体部的连接处进入，螺旋盘绕行走，包埋于压力传感器导线材料之中；压力传感器输出连接线的主要作用是保护压力传感器导线以保证压力感知信息的输出；压力传感器输出连接线的材料同样使用医用高分子材料，可选用聚氨酯、硅橡胶、聚酯纤维、聚乙烯基吡咯烷酮、聚醚醚酮、聚甲基丙烯酸甲酯、聚乙烯醇、聚乳酸、聚乙烯等。The pressure sensor output connection wire is the connection part of the present invention, one end is connected to the catheter body, and the other end is connected to the pressure sensor output interface; the pressure sensor wire enters from the connection between the connection wire and the catheter body, spirally coils, Embedded in the wire material of the pressure sensor; the main function of the pressure sensor output connection wire is to protect the pressure sensor wire to ensure the output of pressure sensing information; the material of the pressure sensor output connection wire is also made of medical polymer materials, and polyurethane, silicon can be selected Rubber, polyester fiber, polyvinyl pyrrolidone, polyether ether ketone, polymethyl methacrylate, polyvinyl alcohol, polylactic acid, polyethylene, etc.
所述压力传感器输出接口为本发明重要部分，其一端压力传感器导线相连，接受压力传感器信息数据，另一端与球囊导管的智能演进式辅助设备中信息采集系统相连，主要作用是进行压力感知信息的转换及传送；可选的，压力传感器输出接口与信息采集系统之间的连接可选择有线连接，也可选择无线连接进行信息传输；若采用无线信息传输方式进行信息交互的好处在于实现远程操作，避免手术医生射线照射。The pressure sensor output interface is an important part of the present invention. One end of the pressure sensor wire is connected to receive information data from the pressure sensor, and the other end is connected to the information acquisition system in the intelligent evolutionary auxiliary equipment of the balloon catheter. The main function is to sense pressure information. Optionally, the connection between the output interface of the pressure sensor and the information acquisition system can be wired or wireless; , to avoid radiation exposure of the surgeon.
所述的造影剂管腔入口位于导管尾部，为球囊导管内中空的管道的开口，与造影剂灌注接口相连接，允许造影剂或其他物质进入或者退出，通过导管球囊部头端的侧孔与球囊密闭空间相交通。The contrast agent lumen inlet is located at the tail of the catheter, which is the opening of the hollow pipe in the balloon catheter, and is connected with the contrast agent perfusion interface, allowing the contrast agent or other substances to enter or exit, through the side hole at the head end of the balloon part of the catheter. It communicates with the enclosed space of the balloon.
所述导丝管腔入口在部分配合导丝使用的球囊导管出现，位于导管尾部或者导管体部，连通的导丝管腔贯穿或部分贯穿导管全长，为引导球囊导管到达指定手术部位的导丝提供空间通道。The guide wire lumen entrance appears in part of the balloon catheter used with the guide wire, located at the tail of the catheter or the catheter body, and the connected guide wire lumen runs through or partially runs through the entire length of the catheter to guide the balloon catheter to the designated surgical site. The guide wire provides spatial access.
所述的导管刻度，位于球囊导管的导管体部外壁，用于手术中间估算导管球囊部推进距离。The catheter scale is located on the outer wall of the catheter body of the balloon catheter, and is used to estimate the advancing distance of the catheter balloon during the operation.
一种可测压球囊导管的智能自演进式辅助设备，包括：球囊导管辅助设备管理系统、电源模块、中央处理器、信息处理模块、动力控制模块、造影剂推进系统，造影剂灌注接口、信息采集系统、手术操作界面、显示系统。An intelligent self-evolving auxiliary device capable of measuring a balloon catheter, comprising: a balloon catheter auxiliary device management system, a power supply module, a central processing unit, an information processing module, a power control module, a contrast agent propulsion system, and a contrast agent perfusion interface , Information acquisition system, surgical operation interface, display system.
所述手术操作界面为人机交互端，手术医师可以根据显示系统提供的术前治疗方案推荐以及术中实际情况操控手术操作界面发送指令至球囊导管辅助设备管理系统，控制整个智能自演进式辅助设备的运行等。可选的，手术操作界面可以与智能自演进式辅助设备其他部件集成连接于一体，也可采用无线信息传输方式进行信息交互；若采用无线信息传输方式进行信息交互的好处在于实现远程操作，避免手术医生射线照射。The surgical operation interface is a human-computer interaction terminal, and the surgeon can control the operation interface to send instructions to the balloon catheter auxiliary equipment management system according to the preoperative treatment plan recommendation provided by the display system and the actual situation during the operation, so as to control the entire intelligent self-evolving auxiliary equipment. equipment operation, etc. Optionally, the surgical operation interface can be integrated and connected with other components of the intelligent self-evolving auxiliary equipment, and wireless information transmission can also be used for information interaction; Surgeon radiation exposure.
所述球囊导管辅助设备管理系统与手术操作界面、电源管理模块以及中央处理器相连接；与手术操作界面相连接目的在于接受指令以控制整个辅助设备的运行；与电源管理模块相连接的目的在于控制电源管理模块为设备各元器件提供能量；与中央处理器相交互的目的在于系统软件演进升级、系统参数修改、手术信息存取分析等；球囊导管辅助管理系统还可获取患者的病历信息，化验检查、影像学信息、术后症状缓解信息、出院随访等，储存并构建患者数据库；此外球囊导管辅助设备管理系统还将与互联网相连接，实时查询有关球囊导管介入治疗的最新高质量文献，总结推演知识图谱，存储并构建知识图谱数据库。The balloon catheter auxiliary equipment management system is connected with a surgical operation interface, a power management module and a central processing unit; the purpose of connecting with the surgical operation interface is to receive instructions to control the operation of the entire auxiliary equipment; the purpose of connecting with the power management module It 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 system software, modify system parameters, access and analyze surgical information, etc.; the balloon catheter auxiliary management system can also obtain the patient's medical records Information, laboratory examinations, imaging information, postoperative symptom relief information, discharge follow-up, etc., to store and build a patient database; in addition, the balloon catheter auxiliary equipment management system will also be connected to the Internet to query the latest information about balloon catheter interventional therapy in real time. High-quality literature, summarize and deduce knowledge graph, store and build knowledge graph database.
所述电源管理系统为球囊导管辅助设备的所有元器件提供能量，主要完成电池管理、有线/无线充电、以及提供程序升级及修改参数的数据接口（有线或无线）。The power management system provides energy for all components of the balloon catheter auxiliary equipment, and mainly completes battery management, wired/wireless charging, and provides a data interface (wired or wireless) for program upgrade and parameter modification.
所述中央处理器为球囊导管辅助设备的信息处理核心，用于数据计算、各硬件系统管理、工作协调等。The central processing unit is the information processing core of the balloon catheter auxiliary equipment, and is used for data calculation, management of various hardware systems, work coordination, and the like.
所述信息处理模块为球囊导管辅助设备的核心之一，在中央处理器支持下，根据输入的压力信息、时间信息以及球囊内灌注造影剂体积信息等数据进行实时数据处理，完成数据的调制解调、计算、存储等，并完成动态术前球囊内压强变化曲线、动态术中球囊内压强变化曲线、动态球囊壁与组织间压强变化曲线、动态体积变化曲线以及各个曲线对应的压强时间积分、体积时间积分等信息的绘制计算；通过与显示器相连接，将以上计算结果实时显示，便于手术医师观察并做出术中判断；根据已加载的球囊导管介入治疗策略，评判目前治疗状态，并给出推荐治疗方案，并通过显系统呈现，供手术医师参考；接受来自手术医生的决策，计算球囊内造影剂灌注体积及压强，发送指令操控动力控制模块；信息处理模块储存手术医生的每一次决策（选择的造影剂灌注压强、灌注体积以及对应的持续时间等），并构建医生决策数据库，并与患者信息数据库内数据配对，结合最新的知识图谱数据库数据，通过深度学习、卷积神经网络等方法推演更加精准的球囊导管介入治疗策略，替换已加载策略，实现辅助设备的智能自演进，为手术医师推荐更加精准的治疗方案；信息处理模块还根据球囊导管的球囊材质设定压力安全阈值，当信息采集系统实时输入的球囊内压力超过安全阈值，则控制动力控制系统停止造影剂灌注，因此降低了球囊因压力的突然增高而发生爆裂的风险；信息处理模块根据实验数据提取的球囊导管造影剂灌注时压力释放特征建立球囊导管破损数据库及预警策略，准确诊断术中导管损伤、球囊破裂、损伤部位等，以降低因球囊导管破损而继续实施操作所带来的医源性损伤，且术后将球囊导管实际情况与灌注时压力释放数据配对，构建灌注时释压数据库，并结合既往数据再次利用卷积神经网络等方法提取特征，自演进球囊导管破损预警策略。The information processing module is one of the cores of the balloon catheter auxiliary equipment. With the support of the central processing unit, real-time data processing is performed according to the input pressure information, time information and the volume information of the contrast agent perfused in the balloon to complete the data processing. Modulation, demodulation, calculation, storage, etc., and complete the dynamic preoperative balloon pressure change curve, dynamic intraoperative balloon pressure change curve, dynamic balloon wall and tissue pressure change curve, dynamic volume change curve and the corresponding curve of each curve Drawing and calculation of the pressure time integral, volume time integral and other information; by connecting with the monitor, the above calculation results are displayed in real time, which is convenient for the surgeon to observe and make intraoperative judgment; according to the loaded balloon catheter interventional treatment strategy, judgment The current treatment status and the recommended treatment plan are given and presented through the display system for the surgeon's reference; accept the decision from the surgeon, calculate the volume and pressure of the contrast agent in the balloon, and send commands to control the power control module; the information processing module Store every decision made by the surgeon (selected contrast agent perfusion pressure, perfusion volume and corresponding duration, etc.), and build a doctor's decision database, which is paired with the data in the patient information database, combined with the latest knowledge map database data, through the depth Learning, convolutional neural network and other methods deduce more accurate balloon catheter interventional treatment strategies, replace the loaded strategies, realize the intelligent self-evolution of auxiliary equipment, and recommend more accurate treatment plans for surgeons; the information processing module also based on the balloon catheter The balloon material sets the pressure safety threshold, when the real-time input of the balloon pressure from the information acquisition system exceeds the safety threshold, the power control system is controlled to stop the contrast medium perfusion, thus reducing the risk of balloon burst due to a sudden increase in pressure. ;The information processing module establishes the balloon catheter damage database and early warning strategy according to the pressure release characteristics of the balloon catheter contrast agent perfusion extracted from the experimental data, and accurately diagnoses intraoperative catheter damage, balloon rupture, injury site, etc., so as to reduce the risk of balloon catheter damage. The iatrogenic injury caused by the continuous operation after being damaged, and the actual situation of the balloon catheter after the operation is matched with the pressure release data during perfusion, the pressure release database during perfusion is constructed, and the convolutional neural network and other methods are used again in combination with the previous data. Extract features and self-evolve an early warning strategy for balloon catheter damage.
所述动力控制系统，一端与信息处理模块相连，接受控制指令，另一端与造影剂推进系统相连接，控制造影剂推进系统运行。One end of the power control system is connected with the information processing module to receive control instructions, and the other end is connected with the contrast agent propulsion system to control the operation of the contrast agent propulsion system.
所述造影剂推进系统为本发明核心系统之一，包含造影剂推进装置、造影剂存贮仓、造影剂灌注体积监测装置；一端与动力控制模块相连接，在其控制下运行；一端与球囊导管尾部的造影剂灌注接口相连接，完成球囊导管内造影剂的推进或者退出；还有一端与信息处理模块相连接，输入球囊导管内造影剂的推进和退出体积信息；造影剂推进系统具有球囊导管内恒压维持功能，当球囊造影剂灌注完毕后，防止球囊内造影剂逆向倒流，有效维持术区压力，故术中不必使用三通管及助手协助，节省人力；推进系统还具有造影剂量化输送与快速退出功能，并可实现各种功能之间的自由切换。可选的，造影剂推进系统可以与智能自演进式辅助设备其他部件集成连接于一体，也可采用无线信息传输方式进行信息交互；若采用无线信息传输方式进行信息交互的好处在于实现远程操作，避免手术医生射线照射。The contrast agent propulsion system is one of the core systems of the present invention, including a contrast agent propulsion device, a contrast agent storage bin, and a contrast agent perfusion volume monitoring device; one end is connected to the power control module and runs under its control; one end is connected to the ball The contrast agent perfusion interface at the tail of the balloon catheter is connected to complete the advancement or withdrawal of the contrast agent in the balloon catheter; the other end is connected to the information processing module, and the information of the advancement and withdrawal volume of the contrast agent in the balloon catheter is input; the contrast agent advancement The system has the function of maintaining constant pressure in the balloon catheter. When the contrast agent in the balloon is perfused, it can prevent the contrast agent from flowing backwards in the balloon and effectively maintain the pressure in the operation area. Therefore, there is no need to use a three-way tube and assistants during the operation, saving manpower; The propulsion system also has the functions of contrast dosed delivery and quick withdrawal, and can realize free switching between various functions. Optionally, the contrast agent propulsion system can be integrated and connected with other components of the intelligent self-evolving auxiliary equipment, and can also use wireless information transmission for information exchange. Avoid radiation exposure of the surgeon.
信息采集系统为本发明的核心部件之一，一端与压力传感器输出接口相连接，实时接收球囊导管内的压力传感器感知的压强信息以及时间持续信息，并进行数据转换，另一端与信息处理模块相连接，将数据转换后的信息输入信息处理模块内进行数据处理。The information acquisition system is one of the core components of the present invention, one end is connected to the output interface of the pressure sensor, receives the pressure information and time duration information sensed by the pressure sensor in the balloon catheter in real time, and performs data conversion, and the other end is connected to the information processing module. are connected, and the converted information is input into the information processing module for data processing.
显示系统为本系统另一人机交互界面，与信息处理模块相连接，接收信息处理模块输出信息数据、推荐治疗方案等，以可视化等方式呈现，供手术医师参考。可选的，显示系统可以与智能自演进式辅助设备其他部件集成连接于一体，也可采用无线信息传输方式进行信息交互；若采用无线信息传输方式进行信息交互的好处在于实现远程操作，避免手术医生射线照射。The display system is another human-computer interaction interface of the system, which is connected with the information processing module, receives the information data output from the information processing module, recommends treatment plans, etc., and presents it in a visual way for the reference of the surgeon. Optionally, the display system can be integrated and connected with other components of the intelligent self-evolving auxiliary equipment, and can also use wireless information transmission for information exchange; the advantage of using wireless information transmission for information exchange is to achieve remote operation and avoid surgery. Doctor radiation exposure.
此外，本发明专利除了以上智能自演进式辅助设备外，根据不同的应用场景，还可能具有其他一些非智能辅助套件或设备，在具体实施例中进行介绍。In addition, in addition to the above intelligent self-evolving auxiliary equipment, the patent of the present invention may also have some other non-intelligent auxiliary kits or equipment according to different application scenarios, which will be introduced in specific embodiments.
本发明的有益效果：Beneficial effects of the present invention:
（1）实现了球囊导管球囊内压强/压力、球囊壁与组织之间压强/压力的实时动态监测及数据采集。(1) Real-time dynamic monitoring and data acquisition of the pressure/pressure in the balloon catheter and the pressure/pressure between the balloon wall and the tissue are realized.
（2）实现了将压力传感器递送至体内手术区域而进行的直接或间接压强/压力测量，消除体外测量因导管因素所致的误差（导管阻塞、折弯、膨胀、收缩等）。(2) Realize direct or indirect pressure/pressure measurement by delivering the pressure sensor to the surgical area in vivo, eliminating errors in in vitro measurement due to catheter factors (catheter obstruction, bending, expansion, contraction, etc.).
（3）由于压力传感器导线选用医用金属等材料，特征在于包埋且螺旋盘绕行进于导管壁内，贯穿整个球囊导管，因此增强了球囊导管的支撑强度和拉伸强度，避免术中导管断裂以及断裂残端在人体的残留，从而降低了医源性损伤和感染风险。(3) Since the pressure sensor wire is made of medical metal and other materials, it is characterized by being embedded and spirally coiled in the catheter wall and running through the entire balloon catheter, thus enhancing the support strength and tensile strength of the balloon catheter and avoiding intraoperative catheterization. The fracture and the residue of the fractured stump in the human body, thereby reducing the risk of iatrogenic injury and infection.
（4）实现了球囊材质与导管体材质的紧密无缝连接，保证球囊的密闭性和膨胀时的稳定性。(4) The tight and seamless connection between the balloon material and the catheter body material is realized to ensure the airtightness and stability of the balloon during inflation.
（5）实现了术中球囊位置的准确判定。(5) Accurate determination of the intraoperative balloon position is achieved.
（4）实现了术中球囊内造影剂体积的精准灌注、及实时动态灌注体积数据采集。(4) Accurate intraoperative perfusion of the contrast agent volume in the balloon and real-time dynamic perfusion volume data acquisition are realized.
（5）实现了术中球囊内造影剂灌注速度、退出速度的精确控制。(5) Accurate control of intraoperative contrast agent perfusion rate and withdrawal rate in the balloon is realized.
（6）解决了术中停止造影剂灌注时球囊内造影剂的逆向倒流的问题，(6) Solved the problem of the reverse flow of the contrast agent in the balloon when the contrast agent perfusion was stopped during the operation,
（7）实现了术中造影剂量化输送与快速退出之间的自由切换；(7) Free switching between intraoperative contrast dosed delivery and rapid withdrawal is achieved;
（8）降低了术中球囊因压力的突然增高而发生爆裂的风险；(8) Reduce the risk of balloon burst due to sudden increase in pressure during surgery;
（9）实现了术中导管损伤、球囊破裂以及损坏部位的准确诊断及预警；(9) Accurate diagnosis and early warning of intraoperative catheter injury, balloon rupture and damaged parts are realized;
（10）实现了患者信息、影像数据、化验检查、术后随访信息的存储及患者信息数据库的构建。(10) The storage of patient information, imaging data, laboratory examinations, postoperative follow-up information and the construction of patient information database are realized.
（11）实现了球囊导管介入治疗相关的最新高质量文献的实时检索、最新先验知识的实时总结、球囊导管介入治疗知识图谱及图谱库的构建及自演进。(11) Real-time retrieval of the latest high-quality literature related to balloon catheter intervention, real-time summary of the latest prior knowledge, construction and self-evolution of balloon catheter intervention knowledge map and atlas library.
（12）实现了手术医师术中决策信息数据库的建立。(12) The establishment of the surgeon's intraoperative decision-making information database is realized.
（13）实现了患者信息数据与医生术中决策数据的配对分析、结合球囊导管介入治疗知识图谱库数据，通过深度学习等方法构建以及自演进球囊导管介入治疗策略。(13) The paired analysis of patient information data and the doctor’s intraoperative decision-making data, combined with balloon catheter interventional therapy knowledge atlas data, and self-evolved balloon catheter interventional therapy strategies were constructed and self-evolved through deep learning and other methods.
（14）实现了造影剂灌注时释压数据库的建立，以及球囊导管破损预警策略的构建及自演进。(14) The establishment of pressure relief database during contrast medium perfusion, as well as the construction and self-evolution of balloon catheter damage warning strategy.
（15）实现了人机交互，智能设备辅助球囊导管介入治疗的术前优选方案推荐及术中手术决策。(15) Human-computer interaction is realized, and intelligent equipment assists the preoperative optimal plan recommendation and intraoperative surgical decision-making of balloon catheter interventional therapy.
（16）实现了远距离人机交互，无线信息传输、近中程控制，避免手术医生手术过程中射线照射。(16) It realizes long-distance human-computer interaction, wireless information transmission, and short and medium-range control, avoiding radiation exposure of the surgeon during the operation.
附图说明：Description of drawings:
为了易于说明，本发明由下述的具体实施及附图作以详细描述。For ease of description, the present invention is described in detail by the following specific implementations and accompanying drawings.
图1是用于三叉神经半月节压迫术的可测球囊内压的球囊导管（实施例一）的整体结构及非智能套件示意图；Figure 1 is a schematic diagram of the overall structure and a non-intelligent kit of a balloon catheter (Example 1) for measuring the internal pressure of the balloon used for trigeminal nerve meniscus compression;
图2是用于三叉神经半月节压迫术的可测球囊内压的球囊导管（实施例一）的球囊部构造图；FIG. 2 is a structural diagram of the balloon portion of a balloon catheter (Example 1) that can measure the internal pressure of the balloon used in trigeminal nerve meniscus compression surgery;
图3是用于血管狭窄扩张成型术的可测球囊内压的球囊导管（实施例二）的整体结构及套件示意图；FIG. 3 is a schematic diagram of the overall structure and kit of a balloon catheter (Example 2) that can measure the internal pressure of the balloon for vascular stenosis dilatation;
图4是用于血管狭窄扩张成型术的可测球囊内压的球囊导管（实施例二）的球囊部构造图；4 is a structural diagram of a balloon portion of a balloon catheter (Example 2) that can measure the internal pressure of the balloon used for vascular stenosis dilatation;
图5是用于三叉神经半月节压迫术的可测球囊壁与组织之间压力的球囊导管（实施例三）的整体结构及套件示意图；5 is a schematic diagram of the overall structure and kit of a balloon catheter (Example 3) for measuring the pressure between the balloon wall and tissue for trigeminal nerve meniscus compression;
图6是用于三叉神经半月节压迫术的可测球囊壁与组织之间压力的球囊导管（实施例三）的球囊部构造图；FIG. 6 is a structural diagram of the balloon portion of the balloon catheter (Example 3) that can measure the pressure between the balloon wall and the tissue for compression of the trigeminal nerve meniscus;
图7是可测球囊内压的球囊导管的智能自演进式辅助设备结构示意图（适用于实施例一、二、三）。FIG. 7 is a schematic structural diagram of an intelligent self-evolving auxiliary device for a balloon catheter capable of measuring the internal pressure of the balloon (applicable to
图1中，1a-1穿刺内芯尖端，1a-2穿刺内芯体部，1a-3穿刺内芯尾部，2a-1导管鞘头部，2a-2导管鞘体部，2a-3导管鞘尾部，2a-4导管鞘刻度，3a-1导管球囊部，3a-2导管体部，3a-3导管尾部，3a-4压力传感器输出连接线，3a-5压力传感器输出接口，3a-6压力传感器导线，3a-7导管刻度，3a-8造影剂管腔入口。In Figure 1, 1a-1 pierces the tip of the inner core, 1a-2 pierces the inner core body, 1a-3 pierces the inner core tail, 2a-1 the head of the catheter sheath, 2a-2 the body of the catheter sheath, 2a-3 the catheter sheath Tail, 2a-4 Catheter sheath scale, 3a-1 Catheter balloon, 3a-2 Catheter body, 3a-3 Catheter tail, 3a-4 Pressure sensor output cable, 3a-5 Pressure sensor output port, 3a-6 Pressure Transducer Lead, 3a-7 Catheter Scale, 3a-8 Contrast Lumen Inlet.
图2中，3a-1-1压力传感器，3a-1-2导管球囊部侧孔，3a-1-3球囊，3a-1-4球囊附着点，3a-1-5金属标记物，3a-1-6压力传感器导线，3a-1-7造影剂管腔。In Fig. 2, 3a-1-1 pressure sensor, 3a-1-2 side hole of catheter balloon, 3a-1-3 balloon, 3a-1-4 balloon attachment point, 3a-1-5 metal marker , 3a-1-6 Pressure Transducer Lead, 3a-1-7 Contrast Lumen.
图3中，1b动脉鞘，2b-1导管球囊部，2b-2导管体部，2b-3导管尾部，2b-4压力传感器输出连接线，2b-5压力传感器输出接口，2b-6压力传感器导线，2b-7导管刻度，2b-8造影剂管腔入口，2b-9导丝管腔入口，3b造影管，4b导管引导管，5b导丝，6b支架，7b支架输送器。In Figure 3, 1b arterial sheath, 2b-1 catheter balloon, 2b-2 catheter body, 2b-3 catheter tail, 2b-4 pressure sensor output connection line, 2b-5 pressure sensor output port, 2b-6 pressure Sensor lead, 2b-7 catheter scale, 2b-8 contrast medium lumen entrance, 2b-9 guide wire lumen entrance, 3b contrast tube, 4b catheter guide tube, 5b guide wire, 6b stent, 7b stent delivery.
图4中，2b-1-1压力传感器，2ab-1-2导管球囊部侧孔，2b-1-3球囊，2b-1-4球囊附着点，2b-1-5金属标记物，2b-1-6压力传感器导线，2b-1-7造影剂管腔，2b-1-8导丝管腔。In Fig. 4, 2b-1-1 pressure sensor, 2ab-1-2 side hole of catheter balloon, 2b-1-3 balloon, 2b-1-4 balloon attachment point, 2b-1-5 metal marker , 2b-1-6 pressure sensor wire, 2b-1-7 contrast medium lumen, 2b-1-8 guide wire lumen.
图5中，1c-1穿刺内芯尖端，1c-2穿刺内芯体部，1c-3穿刺内芯尾部，2c-1导管鞘头部，2c-2导管鞘体部，2c-3导管鞘尾部，2c-4导管鞘刻度，3c-1导管球囊部，3c-2导管体部，3c-3导管尾部，3c-4柔性压力传感器输出连接线，3c-5柔性压力传感器输出接口，3c-6柔性压力传感器导线，3c-7导管刻度，3c-8造影剂管腔入口。In Figure 5, 1c-1 pierces the tip of the inner core, 1c-2 pierces the inner core body, 1c-3 pierces the inner core tail, 2c-1 the head of the catheter sheath, 2c-2 the body of the catheter sheath, 2c-3 the catheter sheath Tail, 2c-4 catheter sheath scale, 3c-1 catheter balloon, 3c-2 catheter body, 3c-3 catheter tail, 3c-4 flexible pressure sensor output cable, 3c-5 flexible pressure sensor output interface, 3c -6 flexible pressure sensor leads, 3c-7 catheter scale, 3c-8 contrast lumen inlet.
图6中，3c-1-1柔性压力传感器，3c-1-2导管球囊部侧孔，3c-1-3球囊，3c-1-4球囊附着点，3c-1-5金属标记物，3c-1-6压力传感器导线，3c-1-7造影剂管腔。In Fig. 6, 3c-1-1 flexible pressure sensor, 3c-1-2 side hole of catheter balloon, 3c-1-3 balloon, 3c-1-4 balloon attachment point, 3c-1-5 metal mark Object, 3c-1-6 Pressure Transducer Lead, 3c-1-7 Contrast Lumen.
图7中，1球囊导管辅助设备管理系统，2电源模块，3中央处理器，4信息处理模块，5动力控制模块，6造影剂推进系统，7造影剂灌注接口，8信息采集系统，9手术操作界面，10显示系统。In Fig. 7, 1 balloon catheter auxiliary equipment management system, 2 power supply module, 3 central processing unit, 4 information processing module, 5 power control module, 6 contrast agent propulsion system, 7 contrast agent perfusion interface, 8 information acquisition system, 9 Surgical operation interface, 10 display system.
具体实施方式：Detailed ways:
如图1-7所示，本具体实施方式采用以下技术方案：一种可测压的球囊导管，包括：导管球囊部、导管体部、导管尾部、压力传感器输出连接线、压力传感器输出接口、压力传感器导线、造影剂管腔入口、导丝管腔入口和导管刻度。As shown in Figures 1-7, this specific embodiment adopts the following technical solutions: a pressure-measurable balloon catheter, comprising: a catheter balloon, a catheter body, a catheter tail, a pressure sensor output connection line, and a pressure sensor output Interface, pressure sensor lead, contrast lumen access, guidewire lumen access, and catheter scale.
所述的导管球囊部为本发明最重要的部分，由多种结构组成，集成有球囊、压力传感器、导管球囊部侧孔、球囊附着点、金属标记物以及压力传感器导线等，允许造影剂等进出球囊、实现球囊扩张与收缩、压力信息感知、压力信息输出、术中导管球囊部追踪定位等，所述的球囊由弹性材料制成，为顺应性球囊或半顺应性，在充斥液体、气体时充盈为球形或卵圆形；可选的球囊材质可以是天然乳胶、聚氨酯、热塑性弹性体高分子材料、硅胶等单一成分或者混合成分。所述压力传感器为本发明核心部件，用于测量导管球囊部的压力；可选的，压力传感器可选纳米发电机、压电传感器、柔性传感器、弹性传感器、薄膜传感器等多种类型；可选的，压力传感器可以位于球囊导管体部头端（即位于球囊内部）以测量球囊内部压力（压强），也可以位于球囊表面以直接测量球囊与外界组织之间的压力（压强）。所述导管球囊部侧孔位于球囊导管体部头端，其外为球囊，允许造影剂等液体、气体物质进入以及流出。所述球囊附着点位于球囊导管体部头端，为球囊与球囊导管体部的密封连接，形成球囊与导管体部头端的密闭空间，仅通过侧孔连通导管体部与外界交通，且在保证球囊在扩张时仅膨胀而不会出现任何移位，可选的球囊附着点可通过热塑型、捆扎、焊接等实现。所述金属标记物位于球囊导管体部头端球囊附近，X光不能穿透，用于球囊部术中定位，主要选择医用不锈钢、医用钴基合金、医用钛和钛合金、医用镁合金、金、银、铂等贵金属，以及化学稳定性好和抗生理腐蚀性好的钽、铌、锆、镍钛形状记忆合金，可选的金属标记物可做成易识别形状用于术中分析，如环状，点状等。所述导管球囊部压力传感器导线为压力传感器导线的一部分位于导管体部头端，包埋于球囊导管材料内，螺旋盘绕，贯穿整个球囊导管，具有传输压力传感器感知的信息数据的作用，还具有增强球囊导管支撑强度和拉伸强度的作用，避免导管断裂而残留于人体的风险，降低医源性损伤和感染风险。The catheter balloon part is the most important part of the present invention, which is composed of various structures, and integrates a balloon, a pressure sensor, a side hole of the catheter balloon part, a balloon attachment point, a metal marker and a pressure sensor wire, etc., Allowing contrast agents to enter and exit the balloon, realizing balloon expansion and contraction, pressure information perception, pressure information output, intraoperative tracking and positioning of the balloon part of the catheter, etc. The balloon is made of elastic material and is a compliant balloon or Semi-compliant, it fills into a spherical or oval shape when filled with liquid and gas; the optional balloon material can be a single component or a mixed component such as natural latex, polyurethane, thermoplastic elastomer polymer material, and silica gel. The pressure sensor is the core component of the present invention, and is used to measure the pressure of the balloon portion of the catheter; optionally, the pressure sensor can be of various types, such as nanogenerators, piezoelectric sensors, flexible sensors, elastic sensors, and thin-film sensors; Optionally, the pressure sensor can be located at the tip of the balloon catheter body (that is, inside the balloon) to measure the pressure inside the balloon (pressure), or it can be located on the surface of the balloon to directly measure the pressure between the balloon and the external tissue ( pressure). The side hole of the balloon portion of the catheter is located at the head end of the balloon catheter body, and the outside is a balloon, allowing liquid and gas substances such as contrast agents to enter and flow out. The balloon attachment point is located at the head end of the balloon catheter body, which is the sealed connection between the balloon and the balloon catheter body, forming a closed space between the balloon and the head end of the catheter body, and connecting the catheter body and the outside world only through the side holes. Transportation, and while ensuring that the balloon is only inflated without any displacement when inflated, optional balloon attachment points can be achieved by thermoplastic molding, strapping, welding, etc. The metal marker is located near the balloon at the head end of the balloon catheter body and cannot be penetrated by X-rays. It is used for intraoperative positioning of the balloon, and medical stainless steel, medical cobalt-based alloys, medical titanium and titanium alloys, and medical magnesium are mainly selected. Alloys, gold, silver, platinum and other precious metals, as well as tantalum, niobium, zirconium, nickel-titanium shape memory alloys with good chemical stability and good resistance to physiological corrosion, optional metal markers can be made into easily identifiable shapes for intraoperative use Analysis, such as ring, point, etc. The catheter balloon pressure sensor wire is a part of the pressure sensor wire located at the head end of the catheter body, embedded in the balloon catheter material, spirally coiled, running through the entire balloon catheter, and has the function of transmitting the information data sensed by the pressure sensor. It also has the effect of enhancing the support strength and tensile strength of the balloon catheter, avoiding the risk of catheter rupture and remaining in the human body, and reducing the risk of iatrogenic injury and infection.
所述导管体部为本发明的主体部分，连接导管球囊部以及导管尾部，为中空管状，且压力传感器导线包埋于其壁中；导管体部材料为医用高分子材料，可选用聚氨酯、硅橡胶、聚酯纤维、聚乙烯基吡咯烷酮、聚醚醚酮、聚甲基丙烯酸甲酯、聚乙烯醇、聚乳酸、聚乙烯等；此外导管体部可根据不同的应用场景制作不同型号，包括导管长度、导管形状、导管粗细等变化。The catheter body is the main part of the present invention, connecting the catheter balloon part and the catheter tail, and is a hollow tubular shape, and the pressure sensor wire is embedded in its wall; the catheter body material is a medical polymer material, and polyurethane, Silicone rubber, polyester fiber, polyvinylpyrrolidone, polyether ether ketone, polymethyl methacrylate, polyvinyl alcohol, polylactic acid, polyethylene, etc.; in addition, the catheter body can be made of different models according to different application scenarios, including Changes in catheter length, catheter shape, catheter thickness, etc.
所述的导管尾部位于导管体部尾端，主要用于连接、固定导管体部。The catheter tail is located at the tail end of the catheter body, and is mainly used for connecting and fixing the catheter body.
所述的压力传感器导线贯穿整个导管体部，一端与压力传感器相连接，一端与压力传感器输出接口相连；压力传感器导线为金属导线，包埋于导管以及压力传感器输出连接线的材料之中，螺旋盘绕，贯穿整个球囊导管；其首要作用是传输压力传感器监测到的压强/压力信息；其次要作用是增强球囊导管的支撑强度和拉伸强度，避免术中导管断裂以及断裂残端在人体的残留，从而降低了医源性损伤和感染风险；最后导线螺旋盘绕行进使压力传感器导线具有一定弹性，在球囊导管弯曲、打折时避免导线损坏。The pressure sensor wire runs through the entire catheter body, one end is connected with the pressure sensor, and the other end is connected with the pressure sensor output interface; the pressure sensor wire is a metal wire, embedded in the catheter and the material of the pressure sensor output connection wire, and the spiral Coiled through the entire balloon catheter; its primary function is to transmit the pressure/pressure information monitored by the pressure sensor; its secondary function is to enhance the support strength and tensile strength of the balloon catheter to avoid intraoperative catheter rupture and rupture of the broken stump in the human body Therefore, the risk of iatrogenic injury and infection is reduced. Finally, the spiral coiling of the wire makes the pressure sensor wire have a certain elasticity, so as to avoid damage to the wire when the balloon catheter is bent or folded.
所述的压力传感器输出连接线，为本发明连接部分，一端连接导管体部，另一端与压力传感器输出接口相连接；压力传感器导线由连接线与导管体部的连接处进入，螺旋盘绕行走，包埋于压力传感器导线材料之中；压力传感器输出连接线的主要作用是保护压力传感器导线以保证压力感知信息的输出；压力传感器输出连接线的材料同样使用医用高分子材料，可选用聚氨酯、硅橡胶、聚酯纤维、聚乙烯基吡咯烷酮、聚醚醚酮、聚甲基丙烯酸甲酯、聚乙烯醇、聚乳酸、聚乙烯等。The pressure sensor output connection wire is the connection part of the present invention, one end is connected to the catheter body, and the other end is connected to the pressure sensor output interface; the pressure sensor wire enters from the connection between the connection wire and the catheter body, spirally coils, Embedded in the wire material of the pressure sensor; the main function of the pressure sensor output connection wire is to protect the pressure sensor wire to ensure the output of pressure sensing information; the material of the pressure sensor output connection wire is also made of medical polymer materials, and polyurethane, silicon can be selected Rubber, polyester fiber, polyvinyl pyrrolidone, polyether ether ketone, polymethyl methacrylate, polyvinyl alcohol, polylactic acid, polyethylene, etc.
所述压力传感器输出接口为本发明重要部分，其一端压力传感器导线相连，接受压力传感器信息数据，另一端与球囊导管的智能演进式辅助设备中信息采集系统相连，主要作用是进行压力感知信息的转换及传送；可选的，压力传感器输出接口与信息采集系统之间的连接可选择有线连接，也可选择无线连接进行信息传输；若采用无线信息传输方式进行信息交互的好处在于实现远程操作，避免手术医生射线照射。The pressure sensor output interface is an important part of the present invention. One end of the pressure sensor wire is connected to receive information data from the pressure sensor, and the other end is connected to the information acquisition system in the intelligent evolutionary auxiliary equipment of the balloon catheter. The main function is to sense pressure information. Optionally, the connection between the output interface of the pressure sensor and the information acquisition system can be wired or wireless; , to avoid radiation exposure of the surgeon.
所述的造影剂管腔入口位于导管尾部，为球囊导管内中空的管道的开口，与造影剂灌注接口相连接，允许造影剂或其他物质进入或者退出，通过导管球囊部头端的侧孔与球囊密闭空间相交通。The contrast agent lumen inlet is located at the tail of the catheter, which is the opening of the hollow pipe in the balloon catheter, and is connected with the contrast agent perfusion interface, allowing the contrast agent or other substances to enter or exit, through the side hole at the head end of the balloon part of the catheter. It communicates with the enclosed space of the balloon.
所述导丝管腔入口在部分配合导丝使用的球囊导管出现，位于导管尾部或者导管体部，连通的导丝管腔贯穿或部分贯穿导管全长，为引导球囊导管到达指定手术部位的导丝提供空间通道。The guide wire lumen entrance appears in part of the balloon catheter used with the guide wire, located at the tail of the catheter or the catheter body, and the connected guide wire lumen runs through or partially runs through the entire length of the catheter to guide the balloon catheter to the designated surgical site. The guide wire provides spatial access.
所述的导管刻度，位于球囊导管的导管体部外壁，用于手术中间估算导管球囊部推进距离。The catheter scale is located on the outer wall of the catheter body of the balloon catheter, and is used to estimate the advancing distance of the catheter balloon during the operation.
一种可测压球囊导管的智能自演进式辅助设备，包括：球囊导管辅助设备管理系统、电源模块、中央处理器、信息处理模块、动力控制模块、造影剂推进系统，造影剂灌注接口、信息采集系统、手术操作界面、显示系统。An intelligent self-evolving auxiliary device capable of measuring a balloon catheter, comprising: a balloon catheter auxiliary device management system, a power supply module, a central processing unit, an information processing module, a power control module, a contrast agent propulsion system, and a contrast agent perfusion interface , Information acquisition system, surgical operation interface, display system.
所述手术操作界面为人机交互端，手术医师可以根据显示系统提供的术前治疗方案推荐以及术中实际情况操控手术操作界面发送指令至球囊导管辅助设备管理系统，控制整个智能自演进式辅助设备的运行等。可选的，手术操作界面可以与智能自演进式辅助设备其他部件集成连接于一体，也可采用无线信息传输方式进行信息交互；若采用无线信息传输方式进行信息交互的好处在于实现远程操作，避免手术医生射线照射。The surgical operation interface is a human-computer interaction terminal, and the surgeon can control the operation interface to send instructions to the balloon catheter auxiliary equipment management system according to the preoperative treatment plan recommendation provided by the display system and the actual situation during the operation, so as to control the entire intelligent self-evolving auxiliary equipment. equipment operation, etc. Optionally, the surgical operation interface can be integrated and connected with other components of the intelligent self-evolving auxiliary equipment, and wireless information transmission can also be used for information interaction; Surgeon radiation exposure.
所述球囊导管辅助设备管理系统与手术操作界面、电源管理模块以及中央处理器相连接；与手术操作界面相连接目的在于接受指令以控制整个辅助设备的运行；与电源管理模块相连接的目的在于控制电源管理模块为设备各元器件提供能量；与中央处理器相交互的目的在于系统软件演进升级、系统参数修改、手术信息存取分析等；球囊导管辅助管理系统还可获取患者的病历信息，化验检查、影像学信息、术后症状缓解信息、出院随访等，储存并构建患者数据库；此外球囊导管辅助设备管理系统还将与互联网相连接，实时查询有关球囊导管介入治疗的最新高质量文献，总结推演知识图谱，存储并构建知识图谱数据库。The balloon catheter auxiliary equipment management system is connected with a surgical operation interface, a power management module and a central processing unit; the purpose of connecting with the surgical operation interface is to receive instructions to control the operation of the entire auxiliary equipment; the purpose of connecting with the power management module It 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 system software, modify system parameters, access and analyze surgical information, etc.; the balloon catheter auxiliary management system can also obtain the patient's medical records Information, laboratory examinations, imaging information, postoperative symptom relief information, discharge follow-up, etc., to store and build a patient database; in addition, the balloon catheter auxiliary equipment management system will also be connected to the Internet to query the latest information about balloon catheter interventional therapy in real time. High-quality literature, summarize and deduce knowledge graph, store and build knowledge graph database.
所述电源管理系统为球囊导管辅助设备的所有元器件提供能量，主要完成电池管理、有线/无线充电、以及提供程序升级及修改参数的数据接口（有线或无线）。The power management system provides energy for all components of the balloon catheter auxiliary equipment, and mainly completes battery management, wired/wireless charging, and provides a data interface (wired or wireless) for program upgrade and parameter modification.
所述中央处理器为球囊导管辅助设备的信息处理核心，用于数据计算、各硬件系统管理、工作协调等。The central processing unit is the information processing core of the balloon catheter auxiliary equipment, and is used for data calculation, management of various hardware systems, work coordination, and the like.
所述信息处理模块为球囊导管辅助设备的核心之一，在中央处理器支持下，根据输入的压力信息、时间信息以及球囊内灌注造影剂体积信息等数据进行实时数据处理，完成数据的调制解调、计算、存储等，并完成动态术前球囊内压强变化曲线、动态术中球囊内压强变化曲线、动态球囊壁与组织间压强变化曲线、动态体积变化曲线以及各个曲线对应的压强时间积分、体积时间积分等信息的绘制计算；通过与显示器相连接，将以上计算结果实时显示，便于手术医师观察并做出术中判断；根据已加载的球囊导管介入治疗策略，评判目前治疗状态，并给出推荐治疗方案，并通过显系统呈现，供手术医师参考；接受来自手术医生的决策，计算球囊内造影剂灌注体积及压强，发送指令操控动力控制模块；信息处理模块储存手术医生的每一次决策（选择的造影剂灌注压强、灌注体积以及对应的持续时间等），并构建医生决策数据库，并与患者信息数据库内数据配对，结合最新的知识图谱数据库数据，通过深度学习、卷积神经网络等方法推演更加精准的球囊导管介入治疗策略，替换已加载策略，实现辅助设备的智能自演进，为手术医师推荐更加精准的治疗方案；信息处理模块还根据球囊导管的球囊材质设定压力安全阈值，当信息采集系统实时输入的球囊内压力超过安全阈值，则控制动力控制系统停止造影剂灌注，因此降低了球囊因压力的突然增高而发生爆裂的风险；信息处理模块根据实验数据提取的球囊导管造影剂灌注时压力释放特征建立球囊导管破损数据库及预警策略，准确诊断术中导管损伤、球囊破裂、损伤部位等，以降低因球囊导管破损而继续实施操作所带来的医源性损伤，且术后将球囊导管实际情况与灌注时压力释放数据配对，构建灌注时释压数据库，并结合既往数据再次利用卷积神经网络等方法提取特征，自演进球囊导管破损预警策略。The information processing module is one of the cores of the balloon catheter auxiliary equipment. With the support of the central processing unit, real-time data processing is performed according to the input pressure information, time information and the volume information of the contrast agent perfused in the balloon to complete the data processing. Modulation, demodulation, calculation, storage, etc., and complete the dynamic preoperative balloon pressure change curve, dynamic intraoperative balloon pressure change curve, dynamic balloon wall and tissue pressure change curve, dynamic volume change curve and the corresponding curve of each curve Drawing and calculation of the pressure time integral, volume time integral and other information; by connecting with the monitor, the above calculation results are displayed in real time, which is convenient for the surgeon to observe and make intraoperative judgment; according to the loaded balloon catheter interventional treatment strategy, judgment The current treatment status and the recommended treatment plan are given and presented through the display system for the surgeon's reference; accept the decision from the surgeon, calculate the volume and pressure of the contrast agent in the balloon, and send commands to control the power control module; the information processing module Store every decision made by the surgeon (selected contrast agent perfusion pressure, perfusion volume and corresponding duration, etc.), and build a doctor's decision database, which is paired with the data in the patient information database, combined with the latest knowledge map database data, through the depth Learning, convolutional neural network and other methods deduce more accurate balloon catheter interventional treatment strategies, replace the loaded strategies, realize the intelligent self-evolution of auxiliary equipment, and recommend more accurate treatment plans for surgeons; the information processing module also based on the balloon catheter The balloon material sets the pressure safety threshold, when the real-time input of the balloon pressure from the information acquisition system exceeds the safety threshold, the power control system is controlled to stop the contrast medium perfusion, thus reducing the risk of balloon burst due to a sudden increase in pressure. ;The information processing module establishes the balloon catheter damage database and early warning strategy according to the pressure release characteristics of the balloon catheter contrast agent perfusion extracted from the experimental data, and accurately diagnoses intraoperative catheter damage, balloon rupture, injury site, etc., so as to reduce the risk of balloon catheter damage. The iatrogenic injury caused by the continuous operation after being damaged, and the actual situation of the balloon catheter after the operation is matched with the pressure release data during perfusion, the pressure release database during perfusion is constructed, and the convolutional neural network and other methods are used again in combination with the previous data. Extract features and self-evolve an early warning strategy for balloon catheter damage.
所述动力控制系统，一端与信息处理模块相连，接受控制指令，另一端与造影剂推进系统相连接，控制造影剂推进系统运行。One end of the power control system is connected with the information processing module to receive control instructions, and the other end is connected with the contrast agent propulsion system to control the operation of the contrast agent propulsion system.
所述造影剂推进系统为本发明核心系统之一，包含造影剂推进装置、造影剂存贮仓、造影剂灌注体积监测装置；一端与动力控制模块相连接，在其控制下运行；一端与球囊导管尾部的造影剂灌注接口相连接，完成球囊导管内造影剂的推进或者退出；还有一端与信息处理模块相连接，输入球囊导管内造影剂的推进和退出体积信息；造影剂推进系统具有球囊导管内恒压维持功能，当球囊造影剂灌注完毕后，防止球囊内造影剂逆向倒流，有效维持术区压力，故术中不必使用三通管及助手协助，节省人力；推进系统还具有造影剂量化输送与快速退出功能，并可实现各种功能之间的自由切换。可选的，造影剂推进系统可以与智能自演进式辅助设备其他部件集成连接于一体，也可采用无线信息传输方式进行信息交互；若采用无线信息传输方式进行信息交互的好处在于实现远程操作，避免手术医生射线照射。The contrast agent propulsion system is one of the core systems of the present invention, including a contrast agent propulsion device, a contrast agent storage bin, and a contrast agent perfusion volume monitoring device; one end is connected to the power control module and runs under its control; one end is connected to the ball The contrast agent perfusion interface at the tail of the balloon catheter is connected to complete the advancement or withdrawal of the contrast agent in the balloon catheter; the other end is connected to the information processing module, and the information of the advancement and withdrawal volume of the contrast agent in the balloon catheter is input; the contrast agent advancement The system has the function of maintaining constant pressure in the balloon catheter. When the contrast agent in the balloon is perfused, it can prevent the contrast agent from flowing backwards in the balloon and effectively maintain the pressure in the operation area. Therefore, there is no need to use a three-way tube and assistants during the operation, saving manpower; The propulsion system also has the functions of contrast dosed delivery and quick withdrawal, and can realize free switching between various functions. Optionally, the contrast agent propulsion system can be integrated and connected with other components of the intelligent self-evolving auxiliary equipment, and can also use wireless information transmission for information exchange. Avoid radiation exposure of the surgeon.
信息采集系统为本发明的核心部件之一，一端与压力传感器输出接口相连接，实时接收球囊导管内的压力传感器感知的压强信息以及时间持续信息，并进行数据转换，另一端与信息处理模块相连接，将数据转换后的信息输入信息处理模块内进行数据处理。The information acquisition system is one of the core components of the present invention, one end is connected to the output interface of the pressure sensor, receives the pressure information and time duration information sensed by the pressure sensor in the balloon catheter in real time, and performs data conversion, and the other end is connected to the information processing module. are connected, and the converted information is input into the information processing module for data processing.
显示系统为本系统另一人机交互界面，与信息处理模块相连接，接收信息处理模块输出信息数据、推荐治疗方案等，以可视化等方式呈现，供手术医师参考。可选的，显示系统可以与智能自演进式辅助设备其他部件集成连接于一体，也可采用无线信息传输方式进行信息交互；若采用无线信息传输方式进行信息交互的好处在于实现远程操作，避免手术医生射线照射。The display system is another human-computer interaction interface of the system, which is connected with the information processing module, receives the information data output from the information processing module, recommends treatment plans, etc., and presents it in a visual way for the reference of the surgeon. Optionally, the display system can be integrated and connected with other components of the intelligent self-evolving auxiliary equipment, and can also use wireless information transmission for information exchange; the advantage of using wireless information transmission for information exchange is to achieve remote operation and avoid surgery. Doctor radiation exposure.
此外，本发明专利除了以上智能自演进式辅助设备外，根据不同的应用场景，还可能具有其他一些非智能辅助套件或设备，在具体实施例中进行介绍。In addition, in addition to the above intelligent self-evolving auxiliary equipment, the patent of the present invention may also have some other non-intelligent auxiliary kits or equipment according to different application scenarios, which will be introduced in specific embodiments.
实施例一：用于三叉神经半月节压迫术的可测球囊内压的球囊导管及其智能自演进式辅助设备，由图1、图2和图7阐明。Embodiment 1: The balloon catheter and its intelligent self-evolving auxiliary device for measuring the inner pressure of the balloon used in the compression of the trigeminal nerve meniscus, as illustrated in FIG. 1 , FIG. 2 and FIG. 7 .
三叉神经球囊压迫术开始前，开启球囊导管智能自演进式辅助设备，通过手术操作界面9驱动球囊导管辅助设备管理系统1读取手术患者信息，包括病历资料、检查化验、影像资料等，在中央处理器3的帮助下输入信息处理模块4，待处理。然后将造影剂加入造影剂推进系统6内，连接造影剂灌注接口7和造影剂管腔入口3a-8，连接信息采集系统8和压力传感器输出接口3a-5；通过手术操作界面输入球囊导管排气命令，经球囊导管辅助设备管理系统1，在中央处理器3的协助下，由数据处理模块4启动动力控制模块5，控制造影剂推进系统6，通过造影剂灌注接口7对球囊导管进行造影剂灌注和排出以达到排气的目的；排气完毕后，再通过手术操作界面9输入球囊导管体外压强测试命令，经球囊导管辅助设备管理系统1，在中央处理器3的辅助下，由数据处理模块4启动动力控制模块5，控制造影剂推进系统6，通过造影剂灌注接口7对球囊导管内缓慢灌注造影剂，此时球囊导管球囊部的压力传感器3a-1-1实时采集球囊内压强值的动态变化信息，并经过压力传感器导线3a-1-6传出，在压力传感器输出连接线3a-4的尾部，通过压力传感器输出接口3a-5将信息送达信息采集系统8处，信息采集系统8完成数据转换后将数据传入信息处理模块4处，在中央处理器3的辅助下构建球囊导管体外灌注球囊内压强-造影剂灌注体积模型，并通过显示系统10实现可视化展示。此时，信息处理模块4根据球囊导管辅助设备管理系统1读取的患者信息以及已经求解的本次手术拟使用的球囊导管的体外灌注球囊内压强-造影剂灌注体积模型，通过加载的球囊导管介入治疗策略求解本次手术的推荐治疗方案，造影剂推进体积、囊内压强、压迫持续时间等。Before the trigeminal nerve balloon compression operation, turn on the intelligent self-evolving auxiliary equipment of the balloon catheter, and drive the balloon catheter auxiliary
手术开始时，将穿刺内芯尖端1a-1插入导管鞘尾部2a-3，使穿刺内芯尖端1a-1通过导管鞘尾部2a-3，由导管鞘头部2a-1探出形成穿刺针，构建嘴角至颅底卵圆孔的软组织通道。当通道构建好后，拔出穿刺内芯，留置导管鞘。然后将导管球囊部3a-1由导管鞘尾部2a-3插入，在导管刻度3a-7、导管鞘刻度2a-4以及术中透视技术的指引下，将导管球囊部3a-1递送至麦氏囊内。此时手术医师可以根据既往经验或者智能自演进式辅助设备提供的推荐方案决定手术细节和进程；通过手术操作界面输入三叉神经球囊压迫治疗方案，经球囊导管辅助设备管理系统1，在中央处理器3的协助下，由数据处理模块4启动动力控制模块5，控制造影剂推进系统6，通过造影剂灌注接口7对球囊导管内缓慢灌注造影剂，此时球囊导管球囊部的压力传感器3a-1-1实时采集球囊内压强值的动态变化信息，并经过压力传感器导线3a-1-6传出，在压力传感器输出连接线3a-4的尾部，通过压力传感器输出接口3a-5将信息送达信息采集系统8处，信息采集系统8完成数据转换后将数据传入信息处理模块4处，在中央处理器3的辅助下构建球囊导管体内灌注球囊内压强-造影剂灌注体积模型，并进一步计算相同造影剂灌注体积下体内灌注与体外灌注球囊内的压强差，构建体内外造影剂灌注球囊内压强差-灌注体积模型，所有动态数据、模型均通过显示系统10实现可视化展示。当治疗完成时，信息处理模块4在中央处理器3的帮助下，驱动动力控制模块5控制造影剂推进系统6，使灌注于球囊导管内的造影剂以合适的速度由造影剂灌注接口7退出。当导管球囊部3a-1的球囊3a-1-3完全回缩后，依次缓慢拔出球囊导管、导管鞘，完成手术。At the beginning of the operation, insert the puncture
术后，通过球囊导管辅助设备管理系统1读取该患者随访信息（包括短期随访以及长期随访），与术前患者信息、球囊导管体外造影剂灌注的球囊内压强-灌注体积数据、球囊导管体内造影剂灌注的球囊内压强-灌注体积数据、患者手术治疗方案（治疗参数等）等数据进行数据配对，再结合球囊导管辅助设备管理系统1构建的知识图谱数据，通过深度学习构建新的球囊导管介入治疗策略，实现球囊导管介入治疗策略的智能自演进。After operation, the follow-up information of the patient (including short-term follow-up and long-term follow-up) was read through the balloon catheter auxiliary
实施例二：用于颈动脉狭窄血管内成形术的可测球囊内压的球囊导管及其智能自演进式辅助设备，由图3、图4和图7阐明。Embodiment 2: A balloon catheter capable of measuring the internal pressure of the balloon and its intelligent self-evolving auxiliary device for endovascular angioplasty of carotid artery stenosis, as illustrated in FIG. 3 , FIG. 4 and FIG. 7 .
颈动脉狭窄血管内成形术开始前，开启球囊导管智能自演进式辅助设备，通过手术操作界面9驱动球囊导管辅助设备管理系统1读取手术患者信息，包括病历资料、检查化验、影像资料等，在中央处理器3的帮助下输入信息处理模块4，待处理。将造影剂加入造影剂推进系统6内，连接造影剂灌注接口7与造影管3b。Before endovascular angioplasty for carotid stenosis, turn on the intelligent self-evolving auxiliary equipment of the balloon catheter, and drive the
手术开始时，于股动脉或其他动脉处穿刺，将动脉鞘1b插入动脉内建立手术通道。将导丝5b穿入造影管3b内，再将造影管3b由动脉鞘1b尾部进入，进入动脉内。手术医师通过手术操作界面9输入血管造影指令，信号通过球囊导管辅助设备管理系统1进入数据处理模块4，在中央处理器3的协助下，启动动力控制模块5，控制造影剂推进系统6，通过造影剂灌注接口7对造影管3b内注入造影剂，同时手术医师启动DSA机，完成一次血管造影。手术医师根据血管造影结果，重复以上步骤，将导丝5b逐步递送并越过病变位置。接下来将造影管3b退出，导丝5b留置原位不动。根据造影结果选择合适的导管引导管4b，先与造影剂灌注接口7相连，再将导丝尾部插入引导管4b的管腔内。在导丝5b的引导下由动脉鞘1b尾部伸入，进入血管内。手术医师再次通过手术操作界面9输入血管造影指令，信号通过球囊导管辅助设备管理系统1进入数据处理模块4，在中央处理器3的协助下，启动动力控制模块5，控制造影剂推进系统6，通过造影剂灌注接口7对导管引导管4b内注入造影剂，同时手术医师启动DSA机，完成一次血管造影。手术医师根据血管造影结果，重复以上步骤并缓慢递送导管引导管前进，直至距离病变下缘2-3cm处停止。根据术中造影结果选择合适的球囊导管2b。先连接造影剂灌注接口7和造影剂管腔入口2b-8，再连接信息采集系统8和压力传感器输出接口2b-5。通过手术操作界面9输入球囊导管排气命令，信号通过球囊导管辅助设备管理系统1进入数据处理模块4，在中央处理器3的协助下，启动动力控制模块5，控制造影剂推进系统6，通过造影剂灌注接口7对球囊导管2b进行造影剂灌注和排出以达到排气的目的。排气完毕后，再通过手术操作界面9输入球囊导管体外压强测试命令，经球囊导管辅助设备管理系统1，在中央处理器3的辅助下，由数据处理模块4启动动力控制模块5，控制造影剂推进系统6，通过造影剂灌注接口7对球囊导管内缓慢灌注造影剂，此时球囊导管球囊部的压力传感器2b-1-1实时采集球囊内压强值的动态变化信息，并经过压力传感器导线2b-1-6传出，在压力传感器输出连接线3a-4的尾部，通过压力传感器输出接口2b-5将信息送达信息采集系统8处，信息采集系统8完成数据转换后将数据传入信息处理模块4处，在中央处理器3的辅助下构建球囊导管体外灌注球囊内压强-造影剂灌注体积模型，并通过显示系统10实现可视化展示。此时，信息处理模块4根据球囊导管辅助设备管理系统1读取的患者信息以及已经求解的本次手术拟使用的球囊导管的体外灌注球囊内压强-造影剂灌注体积模型，通过加载的球囊导管介入治疗策略求解本次手术的推荐治疗方案，造影剂推进体积、囊内压强、压迫持续时间等。At the beginning of the operation, the femoral artery or other artery is punctured, and the
将导丝5b的尾部从球囊导管2b头部的导丝管腔入口2b-1-8插入，在导丝5b的引导下由导管引导管4b的尾部伸入，通过动脉鞘1b进入血管内。手术医师再次通过手术操作界面9输入血管造影指令，信号通过球囊导管辅助设备管理系统1进入数据处理模块4，在中央处理器3的协助下，启动动力控制模块5，控制造影剂推进系统6，通过造影剂灌注接口7对导管引导管4b内注入造影剂，同时手术医师启动DSA机，完成一次血管造影。手术医师根据血管造影结果，重复以上步骤并缓慢递送球囊导管2b在导管引导管4b内前进，直至球囊导管球囊部2b-1进入病变区域。此时手术医师可以根据自身经验或者智能自演进式辅助设备提供的推荐方案决定手术细节和进程。通过手术操作界面输入颈动脉狭窄血管内成形术球囊扩张方案，经球囊导管辅助设备管理系统1，在中央处理器3的协助下，由数据处理模块4启动动力控制模块5，控制造影剂推进系统6，通过造影剂灌注接口7对球囊导管内缓慢灌注造影剂，此时球囊导管球囊部的压力传感器2b-1-1实时采集球囊内压强值的动态变化信息，并经过压力传感器导线2b-1-6传出，在压力传感器输出连接线2b-4的尾部，通过压力传感器输出接口2b-5将信息送达信息采集系统8处，信息采集系统8完成数据转换后将数据传入信息处理模块4处，在中央处理器3的辅助下构建球囊导管体内灌注球囊内压强-造影剂灌注体积模型，并进一步计算相同造影剂灌注体积下体内灌注与体外灌注球囊内的压强差，构建体内外造影剂灌注球囊内压强差-灌注体积模型，所有动态数据、模型均通过显示系统10实现可视化展示。当球囊扩张完成时，信息处理模块4在中央处理器3的帮助下，驱动动力控制模块5控制造影剂推进系统6，使灌注于球囊导管内的造影剂以合适的速度由造影剂灌注接口7退出。当导管球囊部2b-1的球囊2b-1-3完全回缩后，缓慢拔出球囊导管2b。最后，将支架6b与支架递送器7b相连，将导丝露在体外的尾部插入递送器内，在导丝5b的引导下由导管引导管4b的尾部伸入，通过动脉鞘1b进入血管内。手术医师通过手术操作界面9输入血管造影指令，信号通过球囊导管辅助设备管理系统1进入数据处理模块4，在中央处理器3的协助下，启动动力控制模块5，控制造影剂推进系统6，通过造影剂灌注接口7对导管引导管4b内注入造影剂，同时手术医师启动DSA机，完成一次血管造影。手术医师根据血管造影结果，重复以上步骤，通过支架递送器7b将支架6b缓慢递送至病变区域。通过支架递送器7b在病变区释放支架6b覆盖病变全程。撤出支架递送器7b。再次行血管造影已确认无异常状况后，依次撤出导丝5b、导管引导管4b及动脉鞘1b，缝合或加压包扎穿刺点，结束手术。Insert the tail of the
术后，通过球囊导管辅助设备管理系统1读取该患者随访信息（包括短期随访以及长期随访），与术前患者信息、球囊导管体外造影剂灌注的球囊内压强-灌注体积数据、球囊导管体内造影剂灌注的球囊内压强-灌注体积数据、患者手术治疗方案（治疗参数等）等数据进行数据配对，再结合球囊导管辅助设备管理系统1构建的知识图谱数据，通过深度学习构建新的球囊导管介入治疗策略，实现球囊导管介入治疗策略的智能自演进。After operation, the follow-up information of the patient (including short-term follow-up and long-term follow-up) was read through the balloon catheter auxiliary
实施例三：用于三叉神经半月节压迫术的可测球囊壁与组织间压力的球囊导管及其智能自演进式辅助设备，由图5、图6和图7阐明。Embodiment 3: The balloon catheter and its intelligent self-evolving auxiliary device for measuring the pressure between the balloon wall and the tissue for the compression of the trigeminal nerve meniscus, as illustrated in FIG. 5 , FIG. 6 and FIG. 7 .
三叉神经球囊压迫术开始前，开启球囊导管智能自演进式辅助设备，通过手术操作界面9驱动球囊导管辅助设备管理系统1读取手术患者信息，包括病历资料、检查化验、影像资料等，在中央处理器3的帮助下输入信息处理模块4，通过加载的球囊导管介入治疗策略求解本次手术的推荐治疗方案，造影剂推进体积、囊内压强、压迫持续时间等。然后将造影剂加入造影剂推进系统6内，连接造影剂灌注接口7和造影剂管腔入口3c-8，连接信息采集系统8和压力传感器输出接口3c-5；通过手术操作界面输入球囊导管排气命令，经球囊导管辅助设备管理系统1，在中央处理器3的协助下，由数据处理模块4启动动力控制模块5，控制造影剂推进系统6，通过造影剂灌注接口7对球囊导管进行造影剂灌注和排出以达到排气的目的。手术开始时，将穿刺内芯尖端1c-1插入导管鞘尾部2c-3，使穿刺内芯尖端1c-1通过导管鞘尾部2c-3，由导管鞘头部2c-1探出形成穿刺针，构建嘴角至颅底卵圆孔的软组织通道。当通道构建好后，拔出穿刺内芯，留置导管鞘。然后将导管球囊部3c-1由导管鞘尾部2c-3插入，在导管刻度3c-7、导管鞘刻度2c-4以及术中透视技术的指引下，将导管球囊部3c-1递送至麦氏囊内。此时手术医师可以根据自身经验或者智能自演进式辅助设备提供的推荐方案决定手术细节和进程。通过手术操作界面输入三叉神经球囊压迫治疗方案，经球囊导管辅助设备管理系统1，在中央处理器3的协助下，由数据处理模块4启动动力控制模块5，控制造影剂推进系统6，通过造影剂灌注接口7对球囊导管内缓慢灌注造影剂，此时球囊导管球囊壁的压力传感器3c-1-1实时采集球囊壁与组织间压强值的动态变化信息，并经过压力传感器导线3c-1-6传出，在压力传感器输出连接线3c-4的尾部，通过压力传感器输出接口3c-5将信息送达信息采集系统8处，信息采集系统8完成数据转换后将数据传入信息处理模块4处，在中央处理器3的辅助下构建球囊导管球囊壁与组织间压强-造影剂灌注体积模型，所有动态数据、模型均通过显示系统10实现可视化展示。当治疗完成时，信息处理模块4在中央处理器3的帮助下，驱动动力控制模块5控制造影剂推进系统6，使灌注于球囊导管内的造影剂以合适的速度由造影剂灌注接口7撤出。当导管球囊部3c-1的球囊3c-1-3完全回缩后，依次缓慢拔出球囊导管、导管鞘，完成手术。Before the trigeminal nerve balloon compression operation, turn on the intelligent self-evolving auxiliary equipment of the balloon catheter, and drive the balloon catheter auxiliary
术后，通过球囊导管辅助设备管理系统1读取该患者随访信息（包括短期随访以及长期随访），与术前患者信息、球囊导管体外造影剂灌注的球囊内压强-灌注体积数据、球囊导管体内造影剂灌注的球囊内压强-灌注体积数据、患者手术治疗方案（治疗参数等）等数据进行数据配对，再结合球囊导管辅助设备管理系统1构建的知识图谱数据，通过深度学习构建新的球囊导管介入治疗策略，实现球囊导管介入治疗策略的智能自演进。After operation, the follow-up information of the patient (including short-term follow-up and long-term follow-up) was read through the balloon catheter auxiliary
以上显示和描述了本发明的基本原理和主要特征和本发明的优点，本行业的技术人员应该了解，本发明不受上述实施例的限制，上述实施例和说明书中描述的只是说明本发明的原理，在不脱离本发明精神和范围的前提下，本发明还会有各种变化和改进，这些变化和改进都落入要求保护的本发明范围内，本发明要求保护范围由所附的权利要求书及其等效物界定。The basic principles, main features and advantages of the present invention are shown and described above. Those skilled in the art should understand that the present invention is not limited by the above-mentioned embodiments, and the descriptions in the above-mentioned embodiments and the description are only for illustrating the present invention. principle, without departing from the spirit and scope of the present invention, the present invention will also have various changes and improvements, these changes and improvements all fall within the scope of the claimed invention, and the claimed scope of the present invention is determined by the appended rights Requirements and their equivalents are defined.
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