CN112169171B - Orthotopic implantation of bionic anal sphincter system based on functional reconstruction of defecation - Google Patents

Orthotopic implantation of bionic anal sphincter system based on functional reconstruction of defecation Download PDF

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CN112169171B
CN112169171B CN202011163874.0A CN202011163874A CN112169171B CN 112169171 B CN112169171 B CN 112169171B CN 202011163874 A CN202011163874 A CN 202011163874A CN 112169171 B CN112169171 B CN 112169171B
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anal sphincter
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rectum
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颜国正
柴川页
韩玎
华芳芳
姚盛健
丁紫凡
肖敦玺
杨辰
王立超
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Shanghai Jiao Tong University
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Abstract

一种基于便意功能重建的原位植入仿生肛门括约肌系统,包括:人工肛门括约肌模块、传感检测与转换模块、盆神经刺激模块、体外控制模块和体外供能模块,其中:人工肛门括约肌模块将在体内获取的压力信号传输至传感检测与转换模块以产生电刺激强度信号并通过盆神经刺激模块产生对应强度的刺激电信号以刺激盆神经,体外供能模块与人工肛门括约肌模块相连并为其提供能量,体外控制模块与人工肛门括约肌模块相连以供佩戴者自行控制排便。本发明具有人机接口及控制功能,通过传感检测与转换模块对直肠或肛管中粪便的量进行检测,并基于检测信息构建对应强度的电信号对盆神经进行刺激,以激活佩戴者整个排便反射神经通路,从而真正形成便意感知功能重建。

Figure 202011163874

A bionic anal sphincter system implanted in situ based on functional reconstruction of defecation, including: artificial anal sphincter module, sensor detection and conversion module, pelvic nerve stimulation module, external control module and external energy supply module, wherein: artificial anal sphincter module The pressure signal obtained in the body is transmitted to the sensing detection and conversion module to generate an electrical stimulation intensity signal, and the pelvic nerve stimulation module generates a corresponding intensity stimulation electrical signal to stimulate the pelvic nerve. The external energy supply module is connected to the artificial anal sphincter module and To provide energy for it, the external control module is connected with the artificial anal sphincter module for the wearer to control defecation by himself. The invention has man-machine interface and control functions, detects the amount of feces in the rectum or anal canal through the sensor detection and conversion module, and constructs an electrical signal of corresponding intensity based on the detection information to stimulate the pelvic nerve to activate the wearer's whole body. Defecation reflex neural pathways, so as to truly form the functional reconstruction of the perception of defecation.

Figure 202011163874

Description

基于便意功能重建的原位植入仿生肛门括约肌系统Orthotopic implantation of bionic anal sphincter system based on functional reconstruction of defecation

技术领域technical field

本发明涉及的是一种医疗器械领域的技术,具体是一种基于便意功能重建的原位植入仿生肛门括约肌系统。The invention relates to a technology in the field of medical devices, in particular to an in situ implanted bionic anal sphincter system based on reconstruction of defecation function.

背景技术Background technique

大便失禁常由括约肌或神经损伤造成,是临床上常见的老年病之一,指人体失去对粪便排出的控制能力,易造成各种并发症,而且给患者的正常生活和身心带来巨大的不良影响。人工肛门括约肌通过植入人体直肠末端代替肛门括约肌实现控便排便功能。正常人体排便机制中,肠道内容物逐渐积累扩张肠壁刺激壁内传感器产生冲动,从而通过排便反射产生便意。便意的形成需要神经系统参与,神经系统中的盆神经是排便反射通路中周围感受器与排便中枢、神经电信号传出与传入的中继,并明确提示人体是否需要排便以及排便是否完成。现有人工肛门括约肌系统是一个受外部控制的机械装置,虽然能通过传感检测模块感知直肠或肛管中粪便的量,但没有与生物体形成交互的接口,没有真正形成便意及重建便意功能,难以使患者本身产生便意。Fecal incontinence is often caused by sphincter or nerve damage. It is one of the common geriatric diseases in clinical practice. It refers to the loss of the ability of the human body to control the excretion of feces. Influence. The artificial anal sphincter is implanted into the end of the human rectum to replace the anal sphincter to achieve the function of defecation control. In the normal human defecation mechanism, intestinal contents gradually accumulate and expand the intestinal wall to stimulate the intramural sensor to generate an impulse, thereby generating the desire to defecate through the defecation reflex. The formation of the desire to defecate requires the participation of the nervous system. The pelvic nerve in the nervous system is the relay between the peripheral receptors and the defecation center in the defecation reflex pathway, the outgoing and incoming nerve electrical signals, and clearly indicates whether the human body needs to defecate and whether the defecation is complete. The existing artificial anal sphincter system is an externally controlled mechanical device. Although it can sense the amount of feces in the rectum or anal canal through the sensing module, it does not have an interface for interaction with living organisms, and does not really form and reconstruct the function of defecation , it is difficult to make the patient himself feel comfortable.

发明内容Contents of the invention

本发明针对现有括约肌系统缺乏人体交互的生理学接口,没有神经系统的参与所以人体无法真正产生便意的缺陷,提出一种基于便意功能重建的原位植入仿生肛门括约肌系统,具有人性化人机接口及控制功能,通过传感检测与转换模块对直肠或肛管中粪便的量进行检测,并基于检测信息构建对应强度的电信号,通过神经刺激电极对盆神经进行刺激以激活佩戴者整个排便反射神经通路,从而实现便意功能重建。The present invention aims at the defect that the existing sphincter system lacks a physiological interface for human body interaction, and the human body cannot truly produce the desire to defecate without the participation of the nervous system, and proposes an in situ implanted bionic anal sphincter system based on the reconstruction of the defecation function, which has a humanized man-machine Interface and control function, through the sensor detection and conversion module to detect the amount of feces in the rectum or anal canal, and based on the detection information to construct an electrical signal of corresponding intensity, stimulate the pelvic nerve through nerve stimulation electrodes to activate the wearer's entire defecation Reflex neural pathways, so as to realize the functional reconstruction of defecation.

本发明是通过以下技术方案实现的:The present invention is achieved through the following technical solutions:

本发明涉及一种基于便意功能重建的原位植入仿生肛门括约肌系统,包括:人工肛门括约肌模块、传感检测与转换模块、盆神经刺激模块、体外控制模块和体外供能模块,其中:人工肛门括约肌模块将在体内获取的压力信号传输至传感检测与转换模块以产生电刺激强度信号并通过盆神经刺激模块产生对应强度的刺激电信号以刺激盆神经,体外供能模块与人工肛门括约肌模块相连并为其提供能量,体外控制模块与人工肛门括约肌模块相连以供佩戴者自行控制排便。The invention relates to a bionic anal sphincter system implanted in situ based on functional reconstruction of defecation, including: artificial anal sphincter module, sensor detection and conversion module, pelvic nerve stimulation module, external control module and external energy supply module, wherein: artificial The anal sphincter module transmits the pressure signal obtained in the body to the sensing detection and conversion module to generate electrical stimulation intensity signals, and then generates stimulation electrical signals of corresponding intensity through the pelvic nerve stimulation module to stimulate the pelvic nerves. The external energy supply module and the artificial anal sphincter The module is connected to provide energy for it, and the external control module is connected to the artificial anal sphincter module for the wearer to control defecation by himself.

所述的人工肛门括约肌模块设置于直肠或肛管,包括:依次相连的执行机构、驱动与控制机构和电源管理机构,以及体内能量接收机构和体内无线通信机构,其中:执行机构夹持直肠或肛管形成肛肠角,体内能量接收机构与体外供能模块相连,体内无线通信机构与体外控制模块相连以接收排便信号。The artificial anal sphincter module is set on the rectum or anal canal, and includes: an actuator, a drive and control mechanism, a power management mechanism connected in sequence, and an energy receiving mechanism in the body and a wireless communication mechanism in the body, wherein: the actuator clamps the rectum or The anal canal forms an anorectal angle, the internal energy receiving mechanism is connected with the external energy supply module, and the internal wireless communication mechanism is connected with the external control module to receive defecation signals.

所述的执行机构为封闭三环结构,包括:从上而下的三个操作臂和两个转动轴,其中:第一操作臂和第三操作臂同向设置且一端固定在第一转动轴上,第二操作臂与其余操作臂异向设置且一端固定在第二转动轴上。The actuator is a closed three-ring structure, including: three operating arms and two rotating shafts from top to bottom, wherein: the first operating arm and the third operating arm are arranged in the same direction and one end is fixed on the first rotating shaft Above, the second operating arm is set opposite to the other operating arms and one end is fixed on the second rotating shaft.

所述的传感检测与转换模块包括:多个压力传感器、压力信息处理器和刺激电信号强度编码器,其中:压力传感器设置于执行机构的轴向和径向上,压力信息处理器与压力传感器相连以将其输出的压力信号转换为数字压力信号并获取表征直肠或肛管内粪便量的特征参数,刺激电信号强度编码器与压力信息处理器相连并获取其输出的特征参数以构建对应的电刺激强度信号。The sensing detection and conversion module includes: a plurality of pressure sensors, a pressure information processor and a stimulus electrical signal strength encoder, wherein: the pressure sensor is arranged on the axial and radial directions of the actuator, and the pressure information processor and the pressure sensor connected to convert the output pressure signal into a digital pressure signal and obtain the characteristic parameters representing the amount of feces in the rectum or anal canal; Electrical stimulation intensity signal.

技术效果technical effect

与现有技术相比,本发明独有的人机接口及控制功能,基于直肠或肛管中粪便量的检测信息构建对应强度的电信号对盆神经进行刺激,能够在大便失禁患者的直肠或肛管处原位植入仿生肛门括约肌系统以代替功能缺失的括约肌进行控便与排便,并能够激活神经源性患者的神经通路,以激活佩戴者整个排便反射神经通路,从而真正形成便意感知功能重建。Compared with the prior art, the unique man-machine interface and control function of the present invention, based on the detection information of the amount of feces in the rectum or anal canal, constructs electrical signals of corresponding strength to stimulate the pelvic nerves, and can stimulate the pelvic nerves in the rectum or anal canal of patients with fecal incontinence. The bionic anal sphincter system is implanted in situ in the anal canal to replace the dysfunctional sphincter for defecation control and defecation, and can activate the neural pathways of neurogenic patients to activate the wearer's entire defecation reflex neural pathway, so as to truly form the sensory function of defecation reconstruction.

附图说明Description of drawings

图1为本实施例的原理示意图;Fig. 1 is the schematic diagram of the principle of the present embodiment;

图2为本实施例的应用示意图;Fig. 2 is the application schematic diagram of this embodiment;

图3为执行机构的结构示意图;Fig. 3 is the structural representation of executive mechanism;

图中:人工肛门括约肌模块1、传感检测与转换模块2、盆神经刺激模块3、体外控制模块4、体外供能模块5、执行机构6、驱动与控制机构7、电源管理机构8、体内能量接收机构9、体内无线通信机构10、第一操作臂至第三操作臂11~13、压力传感器14、压力信息处理器15、刺激电信号强度编码器16、安装位17、无线能量发射控制器18、发射线圈19、接收线圈20、盆神经21。In the figure: artificial anal sphincter module 1, sensing detection and conversion module 2, pelvic nerve stimulation module 3, external control module 4, external energy supply module 5, actuator 6, driving and control mechanism 7, power management mechanism 8, and internal Energy receiving mechanism 9, internal wireless communication mechanism 10, first operating arm to third operating arm 11-13, pressure sensor 14, pressure information processor 15, stimulation electrical signal strength encoder 16, installation position 17, wireless energy transmission control Device 18, transmitting coil 19, receiving coil 20, pelvic nerve 21.

具体实施方式Detailed ways

如图1所示,本实施例包括:人工肛门括约肌模块1、传感检测与转换模块2、盆神经刺激模块3、体外控制模块4和体外供能模块5,其中:人工肛门括约肌模块1将在体内获取的压力信号传输至传感检测与转换模块2以产生电刺激强度信号并通过盆神经刺激模块3产生对应强度的刺激电信号以激活排便反射神经通路,体外供能模块5与人工肛门括约肌模块1相连并为其提供能量,体外控制模块4与人工肛门括约肌模块5相连以供佩戴者通过控制人工肛门括约肌模块1进行排便。As shown in Figure 1, this embodiment includes: artificial anal sphincter module 1, sensing detection and conversion module 2, pelvic nerve stimulation module 3, external control module 4 and external energy supply module 5, wherein: artificial anal sphincter module 1 will The pressure signal obtained in the body is transmitted to the sensing detection and conversion module 2 to generate an electrical stimulation intensity signal, and the pelvic nerve stimulation module 3 generates a corresponding intensity stimulation electrical signal to activate the defecation reflex nerve pathway. The external energy supply module 5 and the artificial anus The sphincter module 1 is connected to provide energy for it, and the external control module 4 is connected to the artificial anal sphincter module 5 for the wearer to defecate by controlling the artificial anal sphincter module 1 .

所述的人工肛门括约肌模块1设置于直肠或肛管,包括:执行机构6、驱动与控制机构7、电源管理机构8、体内能量接收机构9和体内无线通信机构10,其中:执行机构6、驱动与控制机构7和电源管理机构8依次相连,体内能量接收机构9与体外供能模块5相连以接收能量,体内无线通信机构10与体外控制模块4相连以接收排便信号。The artificial anal sphincter module 1 is set in the rectum or anal canal, and includes: an actuator 6, a drive and control mechanism 7, a power management mechanism 8, an energy receiving mechanism 9 in the body and a wireless communication mechanism 10 in the body, wherein: the actuator 6, The drive and control mechanism 7 is connected to the power management mechanism 8 in sequence, the internal energy receiving mechanism 9 is connected to the external energy supply module 5 to receive energy, and the internal wireless communication mechanism 10 is connected to the external control module 4 to receive defecation signals.

如图3所示,所述的执行机构6为封闭三环结构,包括:从上而下的三个操作臂11~13和两个转动轴,其中:第一操作臂11和第三操作臂13同向设置且一端固定在第一转动轴上,第二操作臂12与其余操作臂异向设置且一端固定在第二转动轴上。As shown in Figure 3, the actuator 6 is a closed three-ring structure, including: three operating arms 11-13 and two rotating shafts from top to bottom, wherein: the first operating arm 11 and the third operating arm 13 are arranged in the same direction and one end is fixed on the first rotating shaft, and the second operating arm 12 is arranged in a different direction from the remaining operating arms and one end is fixed on the second rotating shaft.

所述的执行机构6采用硅凝胶或医用硅胶模以实现柔顺夹持且具有良好的生物相容性以保障血供安全性。The actuator 6 adopts silicone gel or medical silicone mold to achieve flexible clamping and has good biocompatibility to ensure the safety of blood supply.

所述的人工肛门括约肌模块1的植入体内的部分采用医用钛合金和医用PEEK高分子材料,具体的加工工艺是采用3D电子束熔融打印技术和多孔式结构,其表面修饰和活化处理采用等离子喷涂技术。The implanted part of the artificial anal sphincter module 1 is made of medical titanium alloy and medical PEEK polymer material, and the specific processing technology is 3D electron beam fusion printing technology and porous structure, and its surface modification and activation treatment adopts plasma spraying technology.

所述的传感检测与转换模块2包括:多个压力传感器14、压力信息处理器15和刺激电信号强度编码器16,其中:压力传感器14设置于执行机构6的轴向和径向上,压力信息处理器15与压力传感器14相连以将其输出的压力信号转换为数字压力信号并获取表征直肠或肛管内粪便量的特征参数,刺激电信号强度编码器16与压力信息处理器15相连,压力信息处理器获取表征直肠或肛管内粪便量的特征参数后,刺激电信号强度编码器将粪便量的特征参数构建对应的电刺激强度信号,并通过盆神经刺激模块盆神经进行电刺激,以激活佩戴者的整个排便反射神经通路,从而实现便意功能重建。The sensing detection and conversion module 2 includes: a plurality of pressure sensors 14, a pressure information processor 15 and a stimulus electrical signal strength encoder 16, wherein: the pressure sensors 14 are arranged on the axial and radial directions of the actuator 6, and the pressure The information processor 15 is connected with the pressure sensor 14 to convert the output pressure signal into a digital pressure signal and obtain the characteristic parameters representing the amount of feces in the rectum or anal canal, and the electrical signal strength encoder 16 is connected with the pressure information processor 15, After the pressure information processor acquires the characteristic parameters representing the amount of feces in the rectum or anal canal, the electrical stimulation signal intensity encoder constructs the corresponding electrical stimulation intensity signal from the characteristic parameters of the feces amount, and performs electrical stimulation on the pelvic nerve through the pelvic nerve stimulation module. In order to activate the wearer's entire defecation reflex nerve pathway, so as to realize the reconstruction of defecation function.

所述的压力传感器14包括:硅凝胶传导介质和带有硅胶膜的压力传感器裸片,其中:硅凝胶传导介质用于传导肠道压力,硅胶模附于压力传感器裸片外并与直肠或肛管直接接触。The pressure sensor 14 includes: a silicone gel conduction medium and a pressure sensor die with a silicone membrane, wherein: the silicone gel conduction medium is used to conduct intestinal pressure, and the silicone mold is attached to the outside of the pressure sensor die and connected to the rectum Or direct contact with the anal canal.

如图2所示,所述的人工肛门括约肌模块1包绕于安装位17,即位于直肠或肛管处,执行机构6保持夹闭状态实现控便。系统通过体外供能模块5的无线能量传输为人工肛门括约肌模块1提供能源,体外供能模块5的无线能量发射控制器18与无线能量发射线圈19连接,体内能量接收机构9的接收线圈20与发射线圈19耦合。人工肛门括约肌模块1的执行机构6沿轴向和径向布置压力传感器14,用于检测粪便的量并获得腔内压力,检测信息通过特征提取形成对应强度的电信号,并通过盆神经刺激模块3对盆神经21进行电刺激,以激活佩戴者的整个排便反射神经通路,从而实现便意功能重建。随后佩戴者根据便意的紧迫性通过体外控制模块4自行决定何时排便,具体是利用体外控制模块4向体内无线通信机构10发送无线通讯信号,进一步控制人工肛门括约肌实现排便,排便完成后,人工肛门括约肌恢复夹闭状态。As shown in FIG. 2 , the artificial anal sphincter module 1 is wrapped around the installation position 17 , that is, located at the rectum or anal canal, and the actuator 6 is kept in a clamped state to realize defecation control. The system provides energy for the artificial anal sphincter module 1 through the wireless energy transmission of the external energy supply module 5, the wireless energy transmission controller 18 of the external energy supply module 5 is connected with the wireless energy transmission coil 19, and the receiving coil 20 of the internal energy receiving mechanism 9 is connected with the wireless energy transmission coil 19. The transmitting coil 19 is coupled. The actuator 6 of the artificial anal sphincter module 1 arranges pressure sensors 14 along the axial and radial directions to detect the amount of feces and obtain the intracavity pressure. The detection information forms an electrical signal of corresponding intensity through feature extraction, and passes through the pelvic nerve stimulation module. 3. Conduct electrical stimulation to the pelvic nerve 21 to activate the wearer's entire defecation reflex nerve pathway, thereby realizing functional reconstruction of defecation. Then the wearer decides when to defecate according to the urgency of the defecation intention through the external control module 4. Specifically, the external control module 4 is used to send a wireless communication signal to the internal wireless communication mechanism 10 to further control the artificial anal sphincter to achieve defecation. The anal sphincter returns to its clamped state.

与现有技术相比,本装置能够根据直肠或肛管内粪便量的压力检测信息形成不同强度的神经刺激电信号,并由神经刺激电极发出以激励盆神经,激活整个排便反射的神经通路,让患者产生不同紧迫程度的感知便意。Compared with the existing technology, this device can form nerve stimulation electrical signals of different strengths according to the pressure detection information of the amount of feces in the rectum or anal canal, and send out nerve stimulation electrodes to stimulate the pelvic nerves and activate the nerve pathway of the entire defecation reflex. Allow patients to feel the need to defecate with different degrees of urgency.

上述具体实施可由本领域技术人员在不背离本发明原理和宗旨的前提下以不同的方式对其进行局部调整,本发明的保护范围以权利要求书为准且不由上述具体实施所限,在其范围内的各个实现方案均受本发明之约束。The above specific implementation can be partially adjusted in different ways by those skilled in the art without departing from the principle and purpose of the present invention. The scope of protection of the present invention is subject to the claims and is not limited by the above specific implementation. Each implementation within the scope is bound by the invention.

Claims (1)

1.一种基于便意功能重建的原位植入仿生肛门括约肌系统,其特征在于,包括:人工肛门括约肌模块、传感检测与转换模块、盆神经刺激模块、体外控制模块和体外供能模块,其中:人工肛门括约肌模块将在体内获取的压力信号传输至传感检测与转换模块以产生电刺激强度信号并通过盆神经刺激模块产生对应强度的刺激电信号以刺激盆神经,体外供能模块与人工肛门括约肌模块相连并为其提供能量,体外控制模块与人工肛门括约肌模块相连以供佩戴者自行控制排便;1. A bionic anal sphincter system implanted in situ based on functional reconstruction of the bowel movement, comprising: an artificial anal sphincter module, a sensing detection and conversion module, a pelvic nerve stimulation module, an external control module and an external energy supply module, Among them: the artificial anal sphincter module transmits the pressure signal obtained in the body to the sensing detection and conversion module to generate electrical stimulation intensity signals, and generates stimulation electrical signals of corresponding intensity through the pelvic nerve stimulation module to stimulate the pelvic nerves, and the external energy supply module and The artificial anal sphincter module is connected to provide energy for it, and the external control module is connected to the artificial anal sphincter module for the wearer to control defecation by himself; 所述的传感检测与转换模块包括:多个压力传感器、压力信息处理器和刺激电信号强度编码器,其中:压力传感器设置于人工肛门括约肌模块的执行机构的轴向和径向上,压力信息处理器与压力传感器相连以将其输出的压力信号转换为数字压力信号并获取表征直肠或肛管内粪便量的特征参数,刺激电信号强度编码器与压力信息处理器相连,压力信息处理器获取表征直肠或肛管内粪便量的特征参数后,刺激电信号强度编码器将粪便量的特征参数构建对应的电刺激强度信号,并通过盆神经刺激模块盆神经进行电刺激,以激活佩戴者的整个排便反射神经通路,从而实现便意功能重建;The sensing detection and conversion module includes: a plurality of pressure sensors, a pressure information processor and a stimulating electric signal strength encoder, wherein: the pressure sensor is arranged on the axial and radial directions of the actuator of the artificial anal sphincter module, and the pressure information The processor is connected with the pressure sensor to convert the output pressure signal into a digital pressure signal and obtain the characteristic parameters representing the amount of feces in the rectum or anal canal. After characterizing the characteristic parameters of the amount of feces in the rectum or anal canal, the electrical stimulation signal intensity encoder constructs the corresponding electrical stimulation intensity signal from the characteristic parameters of the feces amount, and performs electrical stimulation through the pelvic nerve of the pelvic nerve stimulation module to activate the wearer's The whole defecation reflex neural pathway, so as to realize the functional reconstruction of defecation; 所述的人工肛门括约肌模块设置于直肠或肛管,包括:依次相连的执行机构、驱动与控制机构和电源管理机构,以及体内能量接收机构和体内无线通信机构,其中:执行机构夹持直肠或肛管形成肛肠角,体内能量接收机构与体外供能模块相连,体内无线通信机构与体外控制模块相连以接收排便信号;The artificial anal sphincter module is set on the rectum or anal canal, and includes: an actuator, a drive and control mechanism, a power management mechanism connected in sequence, and an energy receiving mechanism in the body and a wireless communication mechanism in the body, wherein: the actuator clamps the rectum or The anal canal forms an anorectal angle, the internal energy receiving mechanism is connected to the external energy supply module, and the internal wireless communication mechanism is connected to the external control module to receive defecation signals; 所述的执行机构为封闭三环结构,包括:从上而下的三个操作臂和两个转动轴,其中:第一操作臂和第三操作臂同向设置且一端固定在第一转动轴上,第二操作臂与其余操作臂异向设置且一端固定在第二转动轴上;The actuator is a closed three-ring structure, including: three operating arms and two rotating shafts from top to bottom, wherein: the first operating arm and the third operating arm are arranged in the same direction and one end is fixed on the first rotating shaft , the second operating arm is set opposite to the rest of the operating arms and one end is fixed on the second rotating shaft; 所述的压力传感器包括:硅凝胶传导介质和带有硅胶膜的压力传感器裸片,其中:硅凝胶传导介质用于传导肠道压力,硅胶模附于压力传感器裸片外并与直肠或肛管直接接触;The pressure sensor includes: a silicone gel conduction medium and a pressure sensor bare chip with a silicone membrane, wherein: the silicone gel conduction medium is used to conduct intestinal pressure, and the silicone mold is attached to the outside of the pressure sensor bare chip and connected to the rectum or direct contact with the anal canal; 所述的人工肛门括约肌模块的植入体内的部分采用医用钛合金和医用PEEK高分子材料,具体的加工工艺是采用D电子束熔融打印技术和多孔式结构,其表面修饰和活化处理采用等离子喷涂技术;The implanted part of the artificial anal sphincter module is made of medical titanium alloy and medical PEEK macromolecule material, and the specific processing technology is to use 3D electron beam fusion printing technology and porous structure, and its surface modification and activation treatment adopts plasma spraying technology; 所述的执行机构采用硅凝胶或医用硅胶模以实现柔顺夹持且具有良好的生物相容性以保障血供安全性。The actuator adopts silicone gel or medical silicone mold to achieve soft clamping and has good biocompatibility to ensure the safety of blood supply.
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