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CN115382080A - Catheter with pressure measuring function, intracavity treatment catheter and intelligent intracavity treatment device - Google Patents

Catheter with pressure measuring function, intracavity treatment catheter and intelligent intracavity treatment device Download PDF

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CN115382080A
CN115382080A CN202210978839.7A CN202210978839A CN115382080A CN 115382080 A CN115382080 A CN 115382080A CN 202210978839 A CN202210978839 A CN 202210978839A CN 115382080 A CN115382080 A CN 115382080A
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catheter
pressure
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perfusion
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CN115382080B (en
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汤敬东
余波
张军伟
张亚东
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Shanghai Yingte Weiluo Medical Technology Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B18/1492Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0068Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
    • A61M25/007Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345Vascular system
    • A61B2018/00404Blood vessels other than those in or around the heart
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00589Coagulation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M2025/0001Catheters; Hollow probes for pressure measurement
    • A61M2025/0002Catheters; Hollow probes for pressure measurement with a pressure sensor at the distal end
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00Special media to be introduced, removed or treated
    • A61M2202/04Liquids
    • A61M2202/0468Liquids non-physiological
    • A61M2202/048Anaesthetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3331Pressure; Flow

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Abstract

具有测压功能的导管、腔内治疗导管和智能腔内治疗装置,导管管身装配设置有至少一压力传感器,其压力传感单元至少包括敏感元件和至少两根传感器尾线,敏感元件设置在导管管身外表面并形成一柱状空间,传感器尾线设置在导管管身外表面或凸伸入所述导管腔内,传感器尾线分别与敏感元件进行安装设置,且安装位置应位于所述敏感元件的柱状空间内,压力传感器感测组织对导管管身表面施加的径向力和/或摩擦力,和/或对导管尖端施加的轴向力,并通过信号处理单元将所述压力信息传输至所述导管的外部。本发明的具有测压功能导管的尺寸可控,可以根据导管的尺寸适配符合尺寸要求的压力传感器,可以满足具有测压功能的导管结构紧凑、空间小的要求。

Figure 202210978839

Catheter with pressure measurement function, intracavitary therapy catheter and intelligent intracavitary therapy device, the catheter body is equipped with at least one pressure sensor, and its pressure sensing unit includes at least a sensitive element and at least two sensor tail wires. The sensitive element is set on The outer surface of the catheter body forms a columnar space. The sensor tail wire is arranged on the outer surface of the catheter body or protrudes into the catheter lumen. The sensor tail wires are respectively installed with the sensitive elements, and the installation position should be located at the In the columnar space of the sensitive element, the pressure sensor senses the radial force and/or frictional force exerted by the tissue on the surface of the catheter body, and/or the axial force exerted on the catheter tip, and sends the pressure information through the signal processing unit transmitted to the outside of the catheter. The size of the conduit with pressure measurement function of the present invention is controllable, and a pressure sensor that meets the size requirements can be adapted according to the size of the conduit, and the requirements of compact structure and small space for the conduit with pressure measurement function can be met.

Figure 202210978839

Description

具有测压功能的导管、腔内治疗导管和智能腔内治疗装置Catheters with Manometry, Endoluminal Therapy Catheters and Smart Endoluminal Therapy Devices

技术领域technical field

本发明涉及医疗器械领域,尤其涉及一种具有测压功能的导管、腔内治疗导管和智能腔内治疗装置。The invention relates to the field of medical instruments, in particular to a catheter with pressure measurement function, an intracavity treatment catheter and an intelligent intracavity treatment device.

背景技术Background technique

微创介入手术正成为医疗器械治疗领域的广泛应用手段,因此相应介入导管的应用越来越频繁。当导管在人体腔道内行进或诊疗时,会与人体腔道内表面组织相接触,该接触力往往会影响治疗过程或治疗效果,对于某些过程,接触力过大会损伤正常组织,在另外一些过程中,接触力过小可能会达不到治疗效果。因此,导管管身压力检测正成为微创介入手术中的重要应用。Minimally invasive interventional surgery is becoming a widely used method in the field of medical device treatment, so the application of corresponding interventional catheters is becoming more and more frequent. When the catheter travels or diagnoses in the human cavity, it will contact the inner surface tissue of the human cavity. The contact force will often affect the treatment process or treatment effect. For some processes, excessive contact force will damage normal tissues. In other processes If the contact force is too small, the therapeutic effect may not be achieved. Therefore, catheter tube pressure detection is becoming an important application in minimally invasive interventional surgery.

浙江清华柔性电子技术研究院在202011049050.0中公开了一种柔性压力传感器,其包括导管、敏感元件以及可延展导线,敏感元件和可延展导线均设置于导管的表面,并分别呈蛇形蜿蜒状设置,且所述可延展导线电连接于敏感元件。导管的表面的不同位置制备多个敏感元件以及可延展导线,以实现压力传感的阵列式集成,从而实现多点测量,多个敏感元件可以组成阵列模组。当导管深入血管内部时,导管会自适应血管内部的形状而发生弯折、拉伸或压缩变形,此时,蜿蜒状的可延展导线也会随着导管的变形而变形,导管以及可延展导线不会对敏感元件形成拉扯力,该阵列式的敏感元件可以牢牢黏贴在导管的表面而不脱离,从而使得阵列式柔性压力传感器具有较高的延展性。但是,这个柔性压力传感器提及的导管类以于类似于敏感元件的承载载体,而上一段落提及的非介入导管,虽然这种结构很小,但是该专利提及的导管结构容易弯折、拉伸或压缩变形不适用于我司的介入导管这个应用场景。Zhejiang Tsinghua Institute of Flexible Electronic Technology discloses a flexible pressure sensor in 202011049050.0, which includes a catheter, a sensitive element, and an extensible wire. Both the sensitive element and the extensible wire are arranged on the surface of the catheter, and are snake-shaped set, and the extensible wire is electrically connected to the sensitive element. Multiple sensitive elements and extensible wires are prepared at different positions on the surface of the catheter to realize array integration of pressure sensing, thereby realizing multi-point measurement, and multiple sensitive elements can form an array module. When the catheter goes deep into the inside of the blood vessel, the catheter will adapt to the shape of the inside of the blood vessel and undergo bending, stretching or compression deformation. The wire will not form a pulling force on the sensitive element, and the arrayed sensitive element can be firmly adhered to the surface of the catheter without detachment, so that the arrayed flexible pressure sensor has high ductility. However, the catheter mentioned in this flexible pressure sensor is similar to the carrier of the sensitive element, while the non-interventional catheter mentioned in the previous paragraph has a small structure, but the catheter structure mentioned in the patent is easy to bend, Tensile or compressive deformation is not suitable for the application scenario of our interventional catheters.

申请号为201611080407.5的发明专利公开了一种可以测压的射频消融导管,该发明用于辅助定位,同样未公布具体装配方式及压力传感器的形式。The invention patent with the application number 201611080407.5 discloses a radiofrequency ablation catheter capable of measuring pressure. This invention is used to assist in positioning. The specific assembly method and the form of the pressure sensor are also not disclosed.

综上所述,在介入导管中急需要一种新的具有测压功能的医用介入导管,并且压力传感器与医用导管装配后还能满足结构紧凑、空间小的功效。To sum up, there is an urgent need for a new medical interventional catheter with pressure measurement function in the interventional catheter, and the pressure sensor and the medical catheter can meet the functions of compact structure and small space after being assembled.

发明内容Contents of the invention

本发明的第一目的在于提供一种具有测压功能的导管,以解决现有技术中压力传感器与医用导管装配后无法满足结构紧凑、空间小的要求的技术问题。The first object of the present invention is to provide a catheter with pressure measurement function to solve the technical problem in the prior art that the assembled pressure sensor and medical catheter cannot meet the requirements of compact structure and small space.

本发明的第二目的在于提供一种具有测压功能的腔内治疗导管,以解决现有技术中压力传感器与医用导管装配后无法满足结构紧凑、空间小的要求的技术问题。The second object of the present invention is to provide an intracavity treatment catheter with pressure measurement function to solve the technical problem in the prior art that the assembled pressure sensor and medical catheter cannot meet the requirements of compact structure and small space.

本发明的第三目的在于提供一种具有测压功能的智能腔内治疗装置,以解决现有技术中压力传感器与医用导管装配后无法满足结构紧凑、空间小的要求的技术问题。The third purpose of the present invention is to provide an intelligent intracavity treatment device with pressure measurement function, so as to solve the technical problem in the prior art that the assembled pressure sensor and medical catheter cannot meet the requirements of compact structure and small space.

为了解决上述技术问题,本发明主要采用以下的技术手段:In order to solve the above technical problems, the present invention mainly adopts the following technical means:

本发明提供的一种具有测压功能的导管,The invention provides a catheter with pressure measurement function,

所述导管管身装配设置有至少一压力传感器,所述压力传感器包括压力传感单元和信号处理单元,所述压力传感单元至少包括敏感元件和至少两根传感器尾线,The catheter body is equipped with at least one pressure sensor, the pressure sensor includes a pressure sensing unit and a signal processing unit, the pressure sensing unit includes at least a sensitive element and at least two sensor tail wires,

所述敏感元件设置在所述导管管身外表面并形成一柱状空间,The sensitive element is arranged on the outer surface of the catheter body and forms a columnar space,

所述传感器尾线呈细条状,其设置在所述导管管身外表面或凸伸入所述导管腔内,沿所述导管管体方向延伸,所述些根传感器尾线分别与所述敏感元件进行安装设置,且安装位置位于所述柱状空间内,The sensor tail wires are thin strips, which are arranged on the outer surface of the catheter body or protrude into the catheter lumen, and extend along the direction of the catheter body. The sensor tail wires are respectively connected to the catheter body. The sensitive element is installed and set, and the installation position is located in the columnar space,

所述压力传感器感测组织对所述导管管身表面施加的径向力和/或摩擦力,和/或对导管尖端施加的轴向力,并通过所述信号处理单元将压力信息传输至所述导管的外部。The pressure sensor senses the radial force and/or frictional force exerted by the tissue on the surface of the catheter body, and/or the axial force exerted on the catheter tip, and transmits the pressure information to the catheter through the signal processing unit. the outside of the catheter.

较佳地,所述敏感元件缠绕或热缩到所述导管管身外表面,在控制所述压力传感器尺寸的同时以使所述导管管身外表面光滑。Preferably, the sensitive element is wound or heat-shrunk on the outer surface of the catheter tube body, so as to make the outer surface of the catheter tube body smooth while controlling the size of the pressure sensor.

较佳地,所述压力传感器采用薄膜电阻应变压力传感器,所述敏感元件包括设置有弹性膜片本体、所述传感器尾线,还包括与所述传感器尾线安装设置的连接单元,使用状态下,所述弹性膜片本体适配所述导管管身尺寸卷设于所述导管管身外表面,所述连接单元向所述导管管内方向延伸设置,以使安装在其上的所述传感器尾线的位置不凸出于卷设后的弹性膜片本体形成的所述柱状空间。Preferably, the pressure sensor adopts a thin-film resistance strain pressure sensor, and the sensitive element includes an elastic diaphragm body, the sensor tail wire, and a connection unit installed with the sensor tail wire. , the elastic membrane body adapts to the size of the catheter body and is rolled on the outer surface of the catheter body, and the connecting unit is extended toward the inner direction of the catheter, so that the sensor tail mounted on it The position of the line does not protrude from the columnar space formed by the rolled elastic diaphragm body.

较佳地,所述弹性膜片本体缠绕或热缩到所述导管管身外表面,或所述导管管身外表面沿着管体周向开设按装槽以不凸出外表面的方式安装所述弹性膜片本体,卷设于所述导管管身外表面的所述弹性膜片本体的尺寸宽度在 1mm-80mm的范围内。Preferably, the elastic diaphragm body is wound or heat-shrunk to the outer surface of the catheter tube body, or the outer surface of the catheter tube body is provided with a mounting groove along the circumference of the tube body so as to install the tube without protruding from the outer surface. As for the elastic membrane body, the width of the elastic membrane body wound on the outer surface of the catheter tube body is within the range of 1mm-80mm.

较佳地,所述导管的管身适配位置上开设与所述传感器尾线个数相适配的孔,所述连接单元和传感器尾线通过所述孔凸伸进所述导管的腔内,并将所述传感器尾线设置在所述导管的腔内且沿所述导管管体方向延伸。Preferably, a hole matching the number of the sensor tail wires is provided at the fitting position of the catheter body, and the connecting unit and the sensor tail wires protrude into the lumen of the catheter through the holes , and the sensor tail wire is arranged in the lumen of the catheter and extends along the direction of the catheter body.

较佳地,所述导管的管体外表面沿周向开设若干安装槽安装所述些传感器尾线。Preferably, the outer surface of the tube of the catheter is provided with several installation grooves along the circumference to install the sensor tail wires.

较佳地,所述连接单元与所述传感器尾线为一体制成,所述连接单元为一倒角结构,且所述连接单元通过焊接的方式焊设在所述弹性膜片本体与所述导管管身接触的内表面上。Preferably, the connection unit is integrally made with the sensor tail wire, the connection unit is a chamfered structure, and the connection unit is welded between the elastic diaphragm body and the On the inner surface that the catheter barrel contacts.

较佳地,所述薄膜电阻应变压力传感器的厚度在0.05mm-1mm的范围内;长度在1mm-80mm的范围内,量程在1-100N的范围内,精度在±0.1N的范围内。Preferably, the thickness of the thin film resistance strain pressure sensor is in the range of 0.05mm-1mm; the length is in the range of 1mm-80mm, the measuring range is in the range of 1-100N, and the accuracy is in the range of ±0.1N.

一种腔内治疗导管,所述腔内治疗导管包括进入作用对象管腔病灶部位的导管可插入段,所述导管可插入段包括工作段和介入段,所述腔内治疗导管采用如上述所述的具有测压功能的导管,至少一所述压力传感器设置在所述工作段上,使用时,所述压力传感器检测作用对象管腔的压力值。An intracavity treatment catheter, the intracavity treatment catheter includes a catheter insertable section that enters the target lumen lesion, the catheter insertable section includes a working section and an intervention section, and the intracavity treatment catheter adopts the above-mentioned In the above-mentioned catheter with pressure measurement function, at least one pressure sensor is arranged on the working section, and when in use, the pressure sensor detects the pressure value of the lumen of the acting object.

较佳地,所述压力传感器位于所述导管表面,用于感受来自所述导管表面的径向挤压力或摩擦力,来指示所述导管所处的径向空间。Preferably, the pressure sensor is located on the surface of the catheter, and is used to sense the radial extrusion force or friction force from the surface of the catheter to indicate the radial space where the catheter is located.

较佳地,所述压力传感器为多个,至少两个所述压力传感器位于所述导管尖端或分别位于所述导管两尖端,以获得来自所述导管尖端的轴向力,后提示所述导管的前进方向及轴向空间。Preferably, there are multiple pressure sensors, and at least two of the pressure sensors are located at the tip of the catheter or at both tips of the catheter respectively, so as to obtain the axial force from the tip of the catheter, and then prompt the catheter to The forward direction and axial space.

较佳地,所述压力传感器的工作温度为-10℃-300℃,瞬时高温为3-5s 内达到≥200℃。Preferably, the working temperature of the pressure sensor is -10°C-300°C, and the instantaneous high temperature reaches ≥200°C within 3-5s.

较佳地,所述压力传感器满足工作温度范围内反复升温或降温100次而维持其基本性能不丧失的性能要求。Preferably, the pressure sensor meets the performance requirement of maintaining its basic performance without losing its basic performance after repeated heating or cooling within the working temperature range for 100 times.

一种智能腔内治疗的装置,所述装置至少包括灌注子装置和腔内治疗子装置,A device for intelligent intracavity treatment, the device at least includes a perfusion sub-device and an endocavity treatment sub-device,

所述灌注子装置包括:灌注附件,所述灌注附件包括依次连通的储药器、液路和穿刺器;灌注主件,所述灌注主件包括通讯连接的灌注控制系统和灌注驱动器,所述灌注驱动器用于控制液路中的制剂的流量大小,所述灌注控制系统与所述穿刺器压力检测器通讯连接;The perfusion sub-device includes: a perfusion accessory, which includes a drug reservoir, a liquid circuit, and a puncture device connected in sequence; a perfusion main part, which includes a communication-connected perfusion control system and a perfusion driver. The perfusion driver is used to control the flow rate of the preparation in the liquid circuit, and the perfusion control system is connected in communication with the piercer pressure detector;

所述腔内治疗子装置包括:如上述所述的腔内治疗导管,所述压力传感器与所述灌注控制系统通讯连接;腔内治疗设备,所述腔内治疗设备与所述腔内治疗导管连接且与所述压力传感器通讯连接,所述腔内治疗设备用于产生脉冲能量,通过所述压力传感器获得对所述导管管身表面当前施加的径向力和/或摩擦力,和/或对所述导管尖端施加的轴向力,以适配调整后续施加到所述导管上的压力信息。The intracavity treatment sub-device includes: the intracavity treatment catheter as described above, the pressure sensor is connected to the perfusion control system in communication; the intracavity treatment device is connected to the intracavity treatment catheter Connected and communicated with the pressure sensor, the intracavitary treatment device is used to generate pulse energy, and obtain the radial force and/or friction force currently applied to the surface of the catheter body through the pressure sensor, and/or The axial force applied to the tip of the catheter is adapted to adjust the pressure information subsequently applied to the catheter.

与现有技术相比,本发明具有以下优点:Compared with the prior art, the present invention has the following advantages:

首先:敏感元件设置在导管管身外表面并形成一柱状空间,传感器尾线的安装位置在该柱状空间内,且传感器尾线径向距离不会超过敏感元件形成的柱状空间的宽度,敏感元件与导管管体的宽度尺寸大小一致或略大一点时,本发明的具有测压功能导管的尺寸可控,可以根据导管的尺寸适配符合尺寸要求的压力传感器,可以满足具有测压功能的导管结构紧凑、空间小的要求。Firstly: the sensitive element is set on the outer surface of the catheter body and forms a columnar space, the installation position of the sensor tail wire is in the columnar space, and the radial distance of the sensor tail line will not exceed the width of the columnar space formed by the sensitive element, the sensitive element When it is the same as or slightly larger than the width of the catheter body, the size of the catheter with the pressure measurement function of the present invention is controllable, and the pressure sensor that meets the size requirements can be adapted according to the size of the catheter, which can meet the requirements of the catheter with the pressure measurement function. Compact structure and small space requirements.

接着,敏感元件缠绕或热缩到管体表面,在控制尺寸的同时以使管体表面光滑的功效。Then, the sensitive element is wound or heat-shrunk to the surface of the tube body, which can make the surface of the tube body smooth while controlling the size.

然后,当压力传感器采用薄膜电阻应变压力传感器时,敏感元件包括设置有弹性膜片本体、传感器尾线还包括与所述传感器尾线安装设置的连接单元,使用状态下,弹性膜片本体适配所述导管管身尺寸卷设于所述管身外表面,弹性膜片本体适配导管管身尺寸的这种设置,可以根据管体的要求设计具有极强的实用性,而且弹性膜片本体直接包覆或通过生物介质包覆在导管管身上,后通过开设的孔让传感器尾线位于腔内或通过管体表面开设的槽让传感器尾线位于导管表面,工艺简单且装配方便,非常实用。Then, when the pressure sensor adopts a thin-film resistance strain pressure sensor, the sensitive element includes an elastic diaphragm body, and the sensor tail wire also includes a connection unit installed with the sensor tail wire. The size of the catheter tube body is rolled on the outer surface of the tube body, and the elastic diaphragm body adapts to the setting of the catheter body size, which can be designed according to the requirements of the tube body with strong practicability, and the elastic diaphragm body Cover the catheter tube directly or through the biological medium, and then let the sensor tail wire be located in the cavity through the opened hole or let the sensor tail wire be located on the catheter surface through the groove opened on the surface of the tube body. The process is simple and easy to assemble, which is very practical .

随后,该导管管身装配有压力传感器,可以感测组织对导管表面施加的径向力或摩擦力,或对导管尖端施加的轴向力。导管内部有信号处理单元 (如信号处理单元包括信号传输线),可以将感测到的压力信号传输到配套的主机并显示,术者根据预设值调整接触力大小。这种导管不仅可以检测检测作用对象当前管腔的压力值,而且根据预设值调整接触力大小,整个治疗可以形成一个实时治疗环,根据具体情况可以实时调整接触力大小。特别是,当微创介入手术中,介入导管行进及治疗过程中,组织对导管施加的力主要通过医生的感觉来评判,该过程具有极大的不确定性,会随术者的不同而差异很大,同时需要大量的练习及经验积累,学习曲线较长。通过该功能的应用,可以将相关手术过程规范化,从而降低医生的使用难度,缩短学习时间。换句话来说,将神经元算法等在这个应用场景应用后,后续可以根据检测检测作用对象当前管腔的压力值,直接根据深度学习给出施加到作用对象的某个位置某个装置具体调整大小,让治疗设备更具有智能性。The catheter barrel is then fitted with pressure sensors that can sense radial force or friction exerted by tissue on the catheter surface, or axial force on the catheter tip. There is a signal processing unit inside the catheter (for example, the signal processing unit includes a signal transmission line), which can transmit the sensed pressure signal to the supporting host and display it, and the operator adjusts the contact force according to the preset value. This kind of catheter can not only detect the pressure value of the current lumen of the target, but also adjust the contact force according to the preset value. The whole treatment can form a real-time treatment circle, and the contact force can be adjusted in real time according to the specific situation. In particular, in minimally invasive interventional surgery, during the advancement of the interventional catheter and the treatment process, the force exerted by the tissue on the catheter is mainly judged by the doctor's feeling. This process has great uncertainty and will vary with different surgeons. It is very large, and requires a lot of practice and experience accumulation, and the learning curve is long. Through the application of this function, the relevant surgical process can be standardized, thereby reducing the difficulty of use by doctors and shortening the learning time. In other words, after the neuron algorithm is applied in this application scenario, the subsequent pressure value of the current lumen of the target can be detected, and the specific position of a certain device applied to the target can be given directly based on deep learning. Adjust the size to make the treatment equipment more intelligent.

附图说明Description of drawings

图1为现有的压力传感器的一种实例结构图;Fig. 1 is a kind of example structural diagram of existing pressure sensor;

图2为具有测压功能的导管的一种实施例结构图;Fig. 2 is a structural diagram of an embodiment of a catheter with a pressure measuring function;

图3A-图3B为本发明压力传感器的展开图及使用实例图;Fig. 3A-Fig. 3B are the expansion diagram and usage example diagram of the pressure sensor of the present invention;

图4A-图4D为导管剖面图及局部放大图;Fig. 4A-Fig. 4D are the sectional view and partial enlarged view of the catheter;

图5为智能腔内治疗装置的一实例图;Fig. 5 is an example diagram of the intelligent intracavity treatment device;

图6为具有测压功能的导管的原理应用图。Fig. 6 is a principle application diagram of a catheter with pressure measurement function.

具体实施方式Detailed ways

以下通过特定的具体实例说明本发明的实施方式,本领域技术人员可由本说明书所揭露的内容轻易地了解本发明的其他优点与功效。本发明还可以通过另外不同的具体实施方式加以实施或应用,本说明书中的各项细节也可以基于不同观点与应用,在没有背离本发明的精神下进行各种修饰或改变。Embodiments of the present invention are described below through specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific implementation modes, and various modifications or changes can be made to the details in this specification based on different viewpoints and applications without departing from the spirit of the present invention.

第一实施例first embodiment

当本申请人需要开发具有测压功能的导管时,一种常见的思路是将压力传感器集成到导管中使得导管具有测压的功能。比如,压力传感器包括压力传感单元和信号处理单元,压力传感单元至少包括敏感元件和转换元件。信号处理单元包括信号调制模块和信息通信模块。常见的一种转换元件多采用惠斯顿电桥,敏感元件在压力作用下发生形变,引起惠斯顿电桥的电阻值发生变化,惠斯顿电桥变得不平衡从而发生电信号输出。而薄膜电阻应变压力传感器由于优异的性能收到越来越多的关注,它通常以弹性膜片作为敏感元件,直接在弹性膜片上溅射一层金属薄膜,然后通过光刻等技术制作成电阻,该电阻被用作转换元件。如图1所示,一种薄膜电阻应变压力传感器包括弹性膜片1112、平面直条型尾线1113及至少两根插针1114。平面直条型尾线1113及插针1114一般被用作转换元件。当将该薄膜电阻应变压力传感器应用于导管时发现,平面直条型尾线1113一般直接通过焊接方式设置在弹性膜片1112的端部,焊接点在焊接时有几个毫米的偏差,由此导致整个传感器的宽度的尺寸也存在大的偏差,无法准确确定传感器的宽度等尺寸。还有目前压力传感器与医用导管装配时,存在产品尺寸偏大和表面台阶明显的情况。而大量的医用导管结构紧凑、空间狭小,上述压力传感器结构及装配工艺无法满足医用介入导管压力检测的功能,本申请的发明人在项目研发时经过多次试验后发现了这个技术问题。When the applicant needs to develop a catheter with a pressure measurement function, a common idea is to integrate a pressure sensor into the catheter so that the catheter has a pressure measurement function. For example, a pressure sensor includes a pressure sensing unit and a signal processing unit, and the pressure sensing unit includes at least a sensitive element and a conversion element. The signal processing unit includes a signal modulation module and an information communication module. A common conversion element is a Wheatstone bridge. The sensitive element is deformed under pressure, causing the resistance value of the Wheatstone bridge to change, and the Wheatstone bridge becomes unbalanced to generate an electrical signal output. The thin-film resistance strain pressure sensor has received more and more attention due to its excellent performance. It usually uses an elastic diaphragm as a sensitive element, directly sputters a layer of metal film on the elastic diaphragm, and then makes it into a resistor, which is used as the switching element. As shown in FIG. 1 , a thin film resistive strain pressure sensor includes an elastic diaphragm 1112 , a plane straight tail wire 1113 and at least two pins 1114 . The flat straight tails 1113 and pins 1114 are generally used as conversion elements. When the thin film resistance strain pressure sensor is applied to the catheter, it is found that the plane straight tail wire 1113 is usually directly arranged on the end of the elastic diaphragm 1112 by welding, and the welding point has a deviation of several millimeters during welding, thus As a result, there is a large deviation in the size of the width of the entire sensor, and it is impossible to accurately determine the size of the sensor, such as the width. In addition, when the pressure sensor is assembled with the medical catheter, the product size is too large and the surface steps are obvious. However, a large number of medical catheters have compact structures and small spaces. The above-mentioned pressure sensor structure and assembly process cannot meet the pressure detection function of medical interventional catheters. The inventor of this application discovered this technical problem after many tests during project development.

为此,本申请人在此基础上做了压力传感器的改进,并据此开发了一种新型具有测压功能的导管。这里的导管主要是指医用导管,也称为医疗导管,主要用于医疗的管状橡胶制器,分为外用和体内用两种类型,本发明的导管主要是指体内用的医用导管,也有人称为介入式医用导管。For this reason, the applicant has improved the pressure sensor on this basis, and developed a new type of catheter with pressure measurement function accordingly. The catheter here mainly refers to a medical catheter, also known as a medical catheter, which is mainly used for medical tubular rubber devices, and is divided into two types: external use and internal use. The catheter of the present invention mainly refers to a medical catheter for internal use, also known as It is an interventional medical catheter.

请参阅图2,其为本发明一种具有测压功能的导管的一实例示例图。导管116管身装配设置有至少一压力传感器53。它包括压力传感单元和信号处理单元(图中未绘示)。Please refer to FIG. 2 , which is an illustration diagram of an example of a catheter with pressure measuring function according to the present invention. The tube body of the conduit 116 is equipped with at least one pressure sensor 53 . It includes a pressure sensing unit and a signal processing unit (not shown in the figure).

还请参阅图3A-图3B所示,其为本发明压力传感器53的一种实例图。Please also refer to FIGS. 3A-3B , which are diagrams of an example of the pressure sensor 53 of the present invention.

压力传感器53采用薄膜电阻应变压力传感器53,压力传感单元至少包括敏感元件和至少两根传感器尾线113,敏感元件包括设置有弹性膜片本体 112、弹性膜片本体112呈薄膜状,使用状态时,可以将弹性膜片本体112 卷设成预定尺寸的形状,在本实例中,弹性膜片本体112卷设成与导管116 的外表面宽度相适配的圆柱空间。传感器尾线113还包括与传感器尾线113 安装设置的连接单元115。连接单元115可以为一倒角结构,且连接单元115通过焊接的方式焊设在弹性膜片本体112且与导管116管身接触的内表面上。这种设计弹性膜片本体112卷设成的圆柱空间的尺寸即为传感器的宽度尺寸值,连接单元115与弹性膜片本体112通过焊接连接时,焊接的精度及焊接点的偏差,都不会影响传感器的宽度范围。并且弹性膜片本体112的厚度为传感器的整体厚度,这种设计满足具有测压功能的导管结构紧凑、空间小的要求。还需要说明的是,压力传感器53可以用薄膜电阻应变压力传感器53,也可以采用其它压力传感器,本发明并不局限于压力传感器。The pressure sensor 53 adopts a thin film resistance strain pressure sensor 53. The pressure sensing unit includes at least a sensitive element and at least two sensor tail wires 113. The sensitive element includes an elastic diaphragm body 112, and the elastic diaphragm body 112 is film-shaped. In this case, the elastic membrane body 112 can be rolled into a shape with a predetermined size. In this example, the elastic membrane body 112 is rolled into a cylindrical space matching the width of the outer surface of the conduit 116 . The sensor tail wire 113 also includes a connection unit 115 installed with the sensor tail wire 113 . The connecting unit 115 may be a chamfered structure, and the connecting unit 115 is welded on the inner surface of the elastic diaphragm body 112 and in contact with the tube body of the conduit 116 . The size of the cylindrical space formed by the elastic diaphragm body 112 of this design is the width dimension value of the sensor. When the connecting unit 115 and the elastic diaphragm body 112 are connected by welding, the welding accuracy and the deviation of the welding points will not be affected. Affects the width range of the sensor. Moreover, the thickness of the elastic diaphragm body 112 is the overall thickness of the sensor, and this design meets the requirements of a compact structure and a small space for a catheter with a pressure measurement function. It should also be noted that the pressure sensor 53 may be a thin film resistance strain pressure sensor 53 or other pressure sensors, and the present invention is not limited to the pressure sensor.

请参阅图4A-图4D,导管116的管身适配位置上开设与传感器尾线113 个数相适配的孔,连接单元115和传感器尾线113通过孔凸伸进导管腔内,并将传感器尾线113设置在导管腔内且沿导管116管体方向延伸。连接单元 115为倒角结构时,倒角结构的高度与角度直接可以控制传感器尾线113在导管腔内的位置,本实例中传感器尾线113为两根,设置倒角结构的高度与角度直接调整两根传感器尾线113之间的距离,在导管腔内与导管116的内腔表面之间的距离(如紧贴于导管116的内腔表面或直接位于导管116的腔体中部等)。Please refer to Fig. 4A-Fig. 4D, the tube body adaptation position of catheter 116 offers the hole that matches with sensor tail wire 113 numbers, and connecting unit 115 and sensor tail wire 113 protrude into catheter lumen through hole, and The sensor tail wire 113 is arranged in the lumen of the catheter and extends along the tube body of the catheter 116 . When the connection unit 115 is a chamfered structure, the height and angle of the chamfered structure can directly control the position of the sensor tail wire 113 in the catheter lumen. In this example, there are two sensor tail wires 113, and the height and angle of the chamfered structure are set Directly adjust the distance between the two sensor tail wires 113, the distance between the catheter lumen and the lumen surface of the catheter 116 (such as being close to the lumen surface of the catheter 116 or directly in the middle of the catheter 116 cavity, etc. ).

使用状态下,弹性膜片本体112适配导管116管身尺寸卷设于管身外表面,连接单元115向导管116管内方向延伸设置,以使安装在其上的传感器尾线113的位置不凸出于卷设后的弹性膜片本体112的柱状空间。In the state of use, the elastic diaphragm body 112 is adapted to the size of the tube body of the tube 116 and rolled on the outer surface of the tube body, and the connecting unit 115 is extended to the inside of the tube 116, so that the position of the sensor tail wire 113 installed on it is not convex. Out of the columnar space of the rolled elastic film body 112 .

在本实例中,连接单元115可以为一倒角结构,也可以是其它连接件结构,不局限于此。一般来说,连接单元115可以与传感器尾线113为一体制成。In this example, the connecting unit 115 may be a chamfered structure, or other connecting member structures, but is not limited thereto. In general, the connection unit 115 can be integrally made with the sensor tail wire 113 .

弹性膜片本体112可以缠绕或热缩到管体表面,或管体表面沿着管体周向开设按装槽以尽可能不凸出表面的安装弹性膜片本体112,卷设于管身外表面的弹性膜片本体112的尺寸宽度可以在1mm-80mm的范围内。The elastic diaphragm body 112 can be wound or heat-shrunk onto the surface of the pipe body, or the surface of the pipe body is provided with a mounting groove along the circumference of the pipe body to install the elastic diaphragm body 112 so as not to protrude from the surface as much as possible, and roll it outside the pipe body The size and width of the elastic diaphragm body 112 on the surface may be in the range of 1mm-80mm.

薄膜电阻应变压力传感器53的厚度在0.05mm-1mm的范围内;长度在 1mm-80mm的范围内,量程在1-100N的范围内,精度在±0.1N的范围内。The thickness of the thin-film resistance strain pressure sensor 53 is in the range of 0.05mm-1mm; the length is in the range of 1mm-80mm, the measuring range is in the range of 1-100N, and the accuracy is in the range of ±0.1N.

在本实例中,传感器尾线113可以设置导管116的腔体内,也可以设置在导管116的腔体外表面,如管体表面沿着管体外表面周向开设若干安装槽安装些传感器尾线113。传感器尾线113还可以设置导管116的尖端部或直接伸出导管116外,这些都应落入本发明的保护范围。In this example, the sensor tail wires 113 can be arranged in the cavity of the catheter 116, or can be arranged on the outer surface of the catheter 116 cavity, for example, the surface of the pipe body is provided with several installation grooves along the circumference of the outer surface of the tube to install the sensor tail wires 113. The sensor tail wire 113 can also be provided at the tip of the catheter 116 or directly extend out of the catheter 116, all of which should fall within the protection scope of the present invention.

实施例二Embodiment two

压力传感器53可以采用压阻式,也可以选用光纤压力传感器53或其它传感器。本发明的具有测压功能的导管不局限于传感器具体某一类型,只要符合我司的核心思路都应落入本发明的保护范围。The pressure sensor 53 can be piezoresistive, or an optical fiber pressure sensor 53 or other sensors can be selected. The catheter with pressure measuring function of the present invention is not limited to a specific type of sensor, as long as it conforms to the core idea of our company, it should fall into the protection scope of the present invention.

一种具有测压功能的导管,导管116管身装配设置有至少一压力传感器 53,压力传感器53包括压力传感单元和信号处理单元,压力传感单元至少包括敏感元件和至少两根传感器尾线113,A catheter with a pressure measurement function. The catheter 116 is equipped with at least one pressure sensor 53. The pressure sensor 53 includes a pressure sensing unit and a signal processing unit. The pressure sensing unit includes at least a sensitive element and at least two sensor tail wires 113,

敏感元件设置在导管116管身外表面并形成一柱状空间,The sensitive element is arranged on the outer surface of the tube body of the catheter 116 and forms a columnar space,

传感器尾线113呈细条状,其设置在导管116管身外表面或凸伸入导管腔内,沿导管116管体方向延伸,些传感器尾线113分别与敏感元件进行安装设置,且安装位置应位于敏感元件的柱状空间内,The sensor tail wires 113 are thin strips, which are arranged on the outer surface of the catheter 116 body or protrude into the catheter lumen, and extend along the direction of the catheter 116 body. The sensor tail wires 113 are respectively installed with sensitive elements, and the installation positions should be located within the columnar space of the sensitive element,

压力传感器53感测组织对导管116管身表面施加的径向力和/或摩擦力,和/或对导管116尖端施加的轴向力,并通过信号处理单元将压力信息传输至导管116的外部。The pressure sensor 53 senses the radial force and/or friction force exerted by the tissue on the surface of the catheter 116, and/or the axial force applied to the tip of the catheter 116, and transmits the pressure information to the outside of the catheter 116 through the signal processing unit .

敏感元件缠绕或热缩到管体表面,在控制压力传感器53尺寸的同时以使管体表面光滑。The sensitive element is wound or heat-shrunk onto the surface of the pipe body, so as to control the size of the pressure sensor 53 and at the same time make the surface of the pipe body smooth.

压力传感器53的敏感元件可以呈方块式,这种情况下导管116管身外表面开设与方块形状厚度相适应的槽,将敏感元件设置在槽内也可以实现镶嵌式安装。The sensitive element of the pressure sensor 53 can be in the form of a block. In this case, the outer surface of the conduit 116 has a groove suitable for the thickness of the block shape. Setting the sensitive element in the groove can also realize embedded installation.

本实例中,压力传感器53的个数可以是多个,每个传感器的传感器尾线113可以为两根。传感器尾线113呈细条状,其设置在导管116管身外表面或凸伸入导管腔内,沿导管116管体方向延伸,通过设置的该些压力传感器53可以分别感测组织对导管116管身表面施加的径向力和/或摩擦力,和 /或对导管116尖端施加的轴向力,并通过信号处理单元将压力信息传输至导管116的外部。比如,设置在导管116上的两端点部的压力传感器53分别传回来的压力值,一般前进方向端部的压力值与另一端部的压力值的对比,可以判断出当前导管116在运动过程是否存在被阻的现象。In this example, the number of pressure sensors 53 may be multiple, and each sensor may have two sensor tail wires 113 . The sensor tail wire 113 is in the shape of a thin strip, which is arranged on the outer surface of the catheter 116 or protrudes into the catheter lumen, and extends along the direction of the catheter 116 body. The pressure sensors 53 provided can sense the pressure of the tissue on the catheter 116 respectively. The radial force and/or frictional force exerted on the surface of the tube body, and/or the axial force applied to the tip of the catheter 116 , and the pressure information is transmitted to the outside of the catheter 116 through the signal processing unit. For example, the pressure values sent back by the pressure sensors 53 at the two ends of the conduit 116, the comparison of the pressure value at the end of the general forward direction and the pressure value at the other end can determine whether the current conduit 116 is moving. There is a phenomenon of being blocked.

当导管为介入式导管时,特别是插入血管中的导管来说,具有良好的生物相容性非常重要,因此,可以在压力传感器的外部再包覆一层生物相容性的材料层,这个材料层可以采用现有的包覆在导管的生物相容性材料层。比如,在压力传感器的敏感元件外直接包覆一层生物相容性材料层。When the catheter is an interventional catheter, especially for catheters inserted into blood vessels, it is very important to have good biocompatibility. Therefore, a layer of biocompatible material can be coated on the outside of the pressure sensor. The material layer can be an existing biocompatible material layer coated on the catheter. For example, a layer of biocompatible material is directly coated on the outside of the sensitive element of the pressure sensor.

简单说明具有测压功能的导管的制备过程,首先S1,在导管预设位置开设孔,接着S2,让压力传感器的敏感元件的内表面上涂上胶后,将传感器尾线通过孔伸入导管腔内,并沿导管管体方向延伸;随后S3,敏感元件包覆到导管的外表面。再后S4,如果有其它压力传感器还需要安装,通过步骤S1-S3,将其压力传感器都安装到导管上,最后S5,在导管和/或敏感元件上包覆一层生物相容性材料层,并将信号处理单元的输出端连接到外部接口,将所述压力信息传输至所述导管的外部。Briefly explain the preparation process of the catheter with pressure measurement function, first S1, open a hole at the preset position of the catheter, and then S2, let the inner surface of the sensitive element of the pressure sensor be coated with glue, and then extend the sensor tail wire into the guide through the hole. In the lumen, and extending along the direction of the catheter body; then S3, the sensitive element is coated on the outer surface of the catheter. After S4, if there are other pressure sensors that need to be installed, through steps S1-S3, all the pressure sensors are installed on the catheter, and finally S5, a layer of biocompatible material is coated on the catheter and/or the sensitive element , and the output end of the signal processing unit is connected to the external interface, and the pressure information is transmitted to the outside of the catheter.

实施例三Embodiment Three

很多情况下,在进行腔内治疗的时候需要给人体周围组织灌注药液,保护周围组织或者使腔体组贴紧治疗器械。其中,一个典型的应用是在使用射频主机和导管(以下简称静脉曲张射频治疗系统)进行下肢静脉曲张热凝治疗的过程中,需要向下肢静脉周边组织注射麻醉肿胀液。一方面,在麻醉肿胀液的压迫下,使得病变血管壁贴紧射频导管,并排出血管内血液,确保热量的高效传递,从而保证治疗的有效性。同时,麻醉肿胀液可以隔离治疗部位和周边正常组织,起到保护正常组织的作用。再者,麻醉肿胀液还可以起到麻醉效果,改善病人感受。In many cases, it is necessary to perfuse the surrounding tissues of the human body with liquid medicine during intracavitary treatment to protect the surrounding tissues or make the cavity group close to the treatment device. Among them, a typical application is that in the process of thermal coagulation treatment of varicose veins of lower extremities using a radio frequency host and a catheter (hereinafter referred to as radio frequency treatment system for varicose veins), it is necessary to inject anesthesia and swelling fluid to peripheral tissues of lower extremity veins. On the one hand, under the pressure of the anesthesia and swelling fluid, the diseased blood vessel wall is pressed against the radiofrequency catheter, and the blood in the blood vessel is discharged to ensure the efficient transfer of heat, thereby ensuring the effectiveness of the treatment. At the same time, the anesthesia and swelling fluid can isolate the treatment site from the surrounding normal tissues and protect the normal tissues. Furthermore, the anesthesia swelling solution can also play an anesthesia effect and improve the patient's experience.

目前,静脉曲张射频治疗系统没有检测血管对射频导管的压力,药物灌注控制系统也没有对体内穿刺器14的压力进行检测。即使某些腔内治疗产品或者药液灌注产品自身具有压力检测或者其它的检测功能,由于两者是相互独立工作的,两者也无法形成联动。如此,药物灌注的速率和剂量多数情况下就纯靠术者自身的经验来把握。那么,就有可能出现速率过快,剂量过多或者过少的问题,尤其对于刚刚接触相关术式者易出现此类问题。为此,可以将上述的具有测压功能的导管引入到智能腔内治疗装置。At present, the radiofrequency treatment system for varicose veins does not detect the pressure of blood vessels on the radiofrequency catheter, and the drug perfusion control system does not detect the pressure of the puncture device 14 in the body. Even if some intracavity treatment products or medicinal liquid perfusion products have pressure detection or other detection functions, since the two work independently of each other, the two cannot form a linkage. In this way, the rate and dose of drug infusion are mostly determined by the operator's own experience. Then, there may be problems of too fast rate, too much or too little dose, especially for those who are new to related operations. For this purpose, the above-mentioned catheter with pressure measurement function can be introduced into the intelligent intracavity treatment device.

本发明一实施例的一种智能腔内治疗的装置,装置至少包括灌注子装置和腔内治疗子装置,灌注子装置包括:An intelligent intracavity treatment device according to an embodiment of the present invention, the device at least includes a perfusion sub-device and an endocavity treatment sub-device, and the perfusion sub-device includes:

灌注附件10,包括依次连通的储药器11、液路12和穿刺器14;The perfusion accessory 10 includes a drug reservoir 11, a liquid circuit 12 and a piercer 14 that are connected in sequence;

灌注主件20,灌注主件20包括通讯连接的灌注控制系统21和灌注驱动器22,灌注驱动器能够控制液路12中的制剂的流量大小,灌注控制系统 21与穿刺器压力检测器141通讯连接;The perfusion main part 20, the perfusion main part 20 includes a perfusion control system 21 and a perfusion driver 22 connected by communication, the perfusion driver can control the flow rate of the preparation in the liquid circuit 12, and the perfusion control system 21 is connected in communication with the puncture device pressure detector 141;

腔内治疗子装置包括:Endoluminal therapy sub-units include:

腔内治疗导管32,腔内治疗导管32包括依次连接的体外段321、体内段322、腔内治疗段323,腔内治疗段323能够在治疗对象的腔体40内移动,腔内治疗段323上设有一个或多个如上述实施例提到的压力传感器53,如上述实施例提到的压力传感器53与灌注控制系统21通讯连接;The intracavitary treatment catheter 32, the intracavitary treatment catheter 32 includes an extracorporeal section 321, an internal body section 322, and an intracavitary treatment section 323 which are sequentially connected. One or more pressure sensors 53 as mentioned in the above embodiment are provided on it, and the pressure sensor 53 mentioned in the above embodiment is connected with the perfusion control system 21 in communication;

腔内治疗设备31,腔内治疗设备与腔内治疗导管32连接且与如上述实施例提到的压力传感器53通讯连接,腔内治疗设备用于产生脉冲能量。The intracavity treatment device 31 is connected with the intracavity treatment catheter 32 and communicated with the pressure sensor 53 as mentioned in the above embodiment, and the intracavity treatment device is used to generate pulse energy.

治疗导管体内段322置入腔体结构的腔体并到达预期位置,灌注附件 10穿刺器14进入腔体周围组织后,启动药液灌注。在灌注过程中,穿刺器压力检测器141或如上述实施例提到的压力传感器53将所测压力数据发送至灌注控制系统或者腔内治疗设备进行处理,而后对灌注速率进行动态调控,当穿刺器压力检测器141或如上述实施例提到的压力传感器53达到预设阈值时,系统停止灌注并向外发出诸如声音、灯光、颜色变化、闪烁、字体或符号的尺寸变化等警示信号。The inner section 322 of the treatment catheter is inserted into the cavity of the cavity structure and arrives at the expected position. After the perfusion accessory 10 puncturer 14 enters the tissue around the cavity, the perfusion of the medicinal solution is started. During the perfusion process, the puncturer pressure detector 141 or the pressure sensor 53 mentioned in the above-mentioned embodiments sends the measured pressure data to the perfusion control system or the intracavitary treatment equipment for processing, and then dynamically regulates the perfusion rate. When the puncture When the pressure detector 141 or the pressure sensor 53 mentioned in the above-mentioned embodiments reaches the preset threshold, the system stops perfusion and sends out warning signals such as sound, light, color change, flashing, font or symbol size change.

一方面,腔内治疗导管32监测腔体组织壁对治疗导管的压力,并反馈给体外治疗设备,作为灌注效果的参考。同时,药液灌注产品监测体内穿刺器14的压力并反馈给灌注控制系统,形成闭环控制。另外一方面,也可以将腔内治疗子装置和药液灌注子装置连接起来,形成一个大的系统,使用腔内治疗子装置和药液灌注子装置的压力数据,通过算法预算来自动控制灌注的速度和剂量,从而达到使用最少的灌注药液,同事确保治疗效果的目的。并且,通过腔内压力传感器53获得对导管116管身表面当前施加的径向力和/或摩擦力,和/或对导管116尖端施加的轴向力,以适配调整后续施加到导管116上压力信息。On the one hand, the intracavitary treatment catheter 32 monitors the pressure of the cavity tissue wall on the treatment catheter, and feeds back to the external treatment device as a reference for the perfusion effect. At the same time, the liquid medicine perfusion product monitors the pressure of the puncture device 14 in the body and feeds it back to the perfusion control system to form a closed-loop control. On the other hand, the intracavity treatment sub-device and the liquid medicine perfusion sub-device can also be connected to form a large system, using the pressure data of the intracavity treatment sub-device and the liquid medicine perfusion sub-device to automatically control the perfusion through the algorithm budget The speed and dosage can achieve the purpose of using the least perfusion liquid and ensuring the therapeutic effect. Moreover, the radial force and/or frictional force currently applied to the surface of the catheter 116 tube body, and/or the axial force applied to the tip of the catheter 116 is obtained through the intracavity pressure sensor 53, so as to adapt and adjust the subsequent application to the catheter 116 pressure information.

实施例四Embodiment four

本发明还提供一种腔内治疗导管32,腔内治疗导管32包括进入作用对象管腔病灶部位的导管可插入段60,腔内治疗导管32采用如上述实施例提及具有测压功能的导管,至少一压力传感器53设置在工作段61上,使用时,压力传感器53检测作用对象管腔的压力值。请参阅图6,其为腔内治疗导管32的一种应用原理图。导管可插入段60进入人体管腔病灶部位30,诊疗过程中,压力传感器53检测来自组织的压力F,压力信号经内部信号传输导线及体外段321传输至主机70。The present invention also provides an intracavitary treatment catheter 32. The intracavitary treatment catheter 32 includes a catheter insertable section 60 that enters the target lumen lesion. , at least one pressure sensor 53 is arranged on the working section 61, and when in use, the pressure sensor 53 detects the pressure value of the lumen of the target lumen. Please refer to FIG. 6 , which is a schematic diagram of an application of the intracavitary treatment catheter 32 . The catheter insertable section 60 enters the lesion site 30 in the human lumen. During diagnosis and treatment, the pressure sensor 53 detects the pressure F from the tissue, and the pressure signal is transmitted to the host computer 70 through the internal signal transmission wire and the extracorporeal section 321 .

还请参阅图2,腔内治疗导管32具体可包括导管可插入段60和体外段 321,导管可插入段60的远端是工作段61,工作段61可包括功能段611和压力传感器53,近端是介入段62;F为施加到导管116的工作段61的压力。Also referring to FIG. 2 , the intracavitary treatment catheter 32 may specifically include a catheter insertable section 60 and an extracorporeal section 321 , the distal end of the catheter insertable section 60 is a working section 61 , and the working section 61 may include a functional section 611 and a pressure sensor 53 , The proximal end is the intervening section 62 ; F is the pressure applied to the working section 61 of the catheter 116 .

在一种实施例中,压力传感器53位于导管116表面,可以感受来自导管116表面的径向挤压力或摩擦力,来指示导管116所处的径向空间。在另一种实施例中,压力传感器53可同时位于导管116尖端,可以感受来自导管116尖端的轴向力,来提示导管116的前进方向及轴向空间。In one embodiment, the pressure sensor 53 is located on the surface of the conduit 116 and can sense the radial extrusion force or friction force from the surface of the conduit 116 to indicate the radial space where the conduit 116 is located. In another embodiment, the pressure sensor 53 can be located at the tip of the catheter 116 at the same time, and can sense the axial force from the tip of the catheter 116 to prompt the advancing direction and axial space of the catheter 116 .

压力传感器53的工作温度为-10℃-300,瞬时高温为3-5s内达到≥ 200℃。压力传感器53满足工作温度范围内反复升温或降温100次而维持其基本性能不丧失的性能要求。The working temperature of the pressure sensor 53 is -10°C-300°C, and the instantaneous high temperature reaches ≥ 200°C within 3-5s. The pressure sensor 53 satisfies the performance requirement of repeatedly heating up or cooling down 100 times within the working temperature range without losing its basic performance.

传感器具体性能参数如下表:The specific performance parameters of the sensor are as follows:

Figure RE-GDA0003913390780000121
Figure RE-GDA0003913390780000121

整个治疗可以形成一个实时治疗环,根据具体情况可以实时调整接触力大小。特别是,当微创介入手术中,介入导管行进及治疗过程中,组织对导管施加的力主要通过医生的感觉来评判,该过程具有极大的不确定性,会随术者的不同而差异很大,同时需要大量的练习及经验积累,学习曲线较长。通过该功能的应用,可以将相关手术过程规范化,从而降低医生的使用难度,缩短学习时间。换句话来说,将神经元算法等在这个应用场景应用后,后续可以根据检测检测作用对象当前管腔的压力值,直接根据深度学习给出施加到作用对象的某个位置某个装置具体调整大小,让治疗设备更具有智能性。The whole treatment can form a real-time treatment ring, and the contact force can be adjusted in real time according to the specific situation. In particular, in minimally invasive interventional surgery, during the advancement of the interventional catheter and the treatment process, the force exerted by the tissue on the catheter is mainly judged by the doctor's feeling. This process has great uncertainty and will vary with different surgeons. It is very large, and requires a lot of practice and experience accumulation, and the learning curve is long. Through the application of this function, the relevant surgical process can be standardized, thereby reducing the difficulty of use by doctors and shortening the learning time. In other words, after the neuron algorithm is applied in this application scenario, the subsequent pressure value of the current lumen of the target can be detected, and the specific position of a certain device applied to the target can be given directly based on deep learning. Adjust the size to make the treatment equipment more intelligent.

上面结合附图对本发明的实施方式作了详细说明,但是本发明并不限于上述实施方式。即使对本发明作出各种变化,倘若这些变化属于本发明权利要求及其等同技术的范围之内,则仍落入在本发明的保护范围之中。The embodiments of the present invention have been described in detail above with reference to the accompanying drawings, but the present invention is not limited to the above embodiments. Even if various changes are made to the present invention, if these changes fall within the scope of the claims of the present invention and equivalent technologies, they still fall within the protection scope of the present invention.

Claims (14)

1. A catheter with pressure measuring function is characterized in that,
the catheter body is provided with at least one pressure sensor in an assembling way, the pressure sensor comprises a pressure sensing unit and a signal processing unit, the pressure sensing unit at least comprises a sensing element and at least two sensor tail wires,
the sensitive element is arranged on the outer surface of the catheter body and forms a cylindrical space,
the sensor tail lines are in a thin strip shape, are arranged on the outer surface of the catheter body or protrude into the catheter cavity and extend along the direction of the catheter body, the sensor tail lines are respectively arranged with the sensitive elements, and the installation positions are positioned in the columnar space,
the pressure sensor senses the radial force and/or friction force exerted by the tissue on the surface of the catheter shaft and/or the axial force exerted on the catheter tip, and transmits pressure information to the outside of the catheter through the signal processing unit.
2. The pressure sensing catheter according to claim 1, wherein the sensing element is wrapped or heat shrunk onto the outer surface of the catheter shaft to smooth the outer surface of the catheter shaft while controlling the size of the pressure sensor.
3. The catheter with pressure measuring function according to claim 1, wherein the pressure sensor is a thin film resistance strain pressure sensor, the sensing element includes an elastic diaphragm body, the sensor tail wire, and a connecting unit mounted on the sensor tail wire, in a use state, the elastic diaphragm body is adapted to the catheter body and is wound on the outer surface of the catheter body, and the connecting unit extends towards the inside of the catheter tube so that the position of the sensor tail wire mounted on the connecting unit does not protrude out of the cylindrical space formed by the wound elastic diaphragm body.
4. The pressure measuring catheter as claimed in claim 3, wherein the elastic diaphragm body is wound or shrunk on the outer surface of the catheter shaft, or a pressing groove is formed on the outer surface of the catheter shaft along the circumferential direction of the catheter body so that the elastic diaphragm body is installed without protruding out of the outer surface, and the size width of the elastic diaphragm body wound on the outer surface of the catheter shaft is in the range of 1mm to 80 mm.
5. The catheter with pressure measuring function according to claim 3, wherein holes matched with the number of the sensor tails are formed in the catheter body at the matched positions, the connecting unit and the sensor tails protrude into the cavity of the catheter through the holes, and the sensor tails are arranged in the cavity of the catheter and extend along the direction of the catheter body.
6. The pressure measuring catheter according to claim 1 or 3, wherein a plurality of mounting grooves are formed in the outer surface of the catheter body along the circumferential direction for mounting the sensor tails.
7. The catheter with pressure measuring function according to claim 3, wherein the connecting unit is integrally formed with the sensor tail wire, the connecting unit is of a chamfered structure, and the connecting unit is welded to an inner surface of the elastic diaphragm body, which is in contact with the catheter shaft, in a welding manner.
8. A catheter with pressure measurement function according to claim 3, wherein the thickness of the thin film resistance strain pressure sensor is in the range of 0.05mm to 1 mm; the length is in the range of 1mm-80mm, the range is in the range of 1-100N, and the precision is in the range of +/-0.1N.
9. An intraluminal therapeutic catheter comprising a catheter insertable section into a lesion site of a lumen of a subject, said catheter insertable section comprising a working section and an intervention section, said intraluminal therapeutic catheter employing the catheter having a pressure measurement function according to any one of claims 1 to 8, at least one of said pressure sensors being provided on said working section, said pressure sensor detecting a pressure value of the lumen of the subject in use.
10. The intracavity treatment catheter of claim 9 wherein said pressure sensor is located on said catheter surface for sensing a radially compressive or frictional force from said catheter surface to indicate radial spacing of said catheter.
11. The intracavity treatment catheter of claim 9 wherein said pressure sensor is a plurality of at least two of said pressure sensors located at said catheter tip or at both said catheter tips respectively to obtain axial force from said catheter tip to indicate said catheter advancement direction and axial spacing.
12. The intracavity therapeutic catheter of claim 9 wherein said pressure transducer has an operating temperature of-10 ℃ to 300 ℃ and an instantaneous elevated temperature of 200 ℃ or greater within 3 to 5 seconds.
13. The intracavity therapy catheter of claim 9 wherein said pressure sensor meets performance requirements of repeatedly increasing and decreasing temperature within an operating temperature range of 100 times without loss of substantial performance thereof.
14. An intelligent intracavity therapeutic device is characterized in that,
the device at least comprises a perfusion sub-device and an intracavity treatment sub-device,
the perfusion sub-device comprises: the perfusion accessory comprises a medicine storage device, a liquid path and a puncture device which are sequentially communicated; the perfusion main part comprises a perfusion control system and a perfusion driver which are in communication connection, the perfusion driver is used for controlling the flow of the preparation in the liquid path, and the perfusion control system is in communication connection with the puncture outfit pressure detector;
the intraluminal therapeutic sub-device comprises: the endoluminal treatment catheter according to any of claims 9-13, wherein the pressure sensor is communicatively coupled to the perfusion control system; the intracavity treatment device is connected with the intracavity treatment catheter and is in communication connection with the pressure sensor, the intracavity treatment device is used for generating pulse energy, and the radial force and/or the friction force currently applied to the surface of the catheter body and/or the axial force applied to the catheter tip are obtained through the pressure sensor so as to adapt and adjust the pressure information subsequently applied to the catheter.
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