CN112006670A - Control system for composite venous catheter and real-time monitoring of central venous pressure - Google Patents
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Abstract
Description
技术领域technical field
本申请涉及医疗器械技术领域,具体涉及一种复合静脉导管及实时监测中心静脉压的控制系统。The application relates to the technical field of medical devices, in particular to a composite venous catheter and a control system for real-time monitoring of central venous pressure.
背景技术Background technique
腹腔镜肝切除以其手术创伤轻,术后康复快等优势备受瞩目,目前随着腹腔镜技术的发展及外科器械的改进,腹腔镜肝切除术已被广泛开展,手术适应症也不断拓宽。难以控制的术中出血是腹腔镜肝切除术中转开腹最常见的因素,因此,有效预防术中出血和及时有效的控制出血是腹腔镜肝切除术能否顺利实施的关键,其中做好预防术中出血更加重要。Laparoscopic hepatectomy has attracted much attention due to its advantages of less surgical trauma and faster postoperative recovery. At present, with the development of laparoscopic technology and the improvement of surgical instruments, laparoscopic hepatectomy has been widely carried out, and the surgical indications have been continuously expanded. . Intraoperative bleeding that is difficult to control is the most common factor for converting laparoscopic hepatectomy to laparotomy. Therefore, effective prevention of intraoperative bleeding and timely and effective control of bleeding are the keys to the smooth implementation of laparoscopic hepatectomy. Intraoperative bleeding is more important.
低中心静脉压技术是预防术中出血的关键技术,但如何实时准确的监测中心静脉压是一个难点。目前使用的检测中心静脉压的方法是使用换能器进行转换,因为普通换能器体积太大只能通过长线连接到远端测试设备,即远离静脉压测量位置,不能直接原位测试。而且远端测试会受到麻醉医生的经验、手术病人的体位及腹腔镜气腹的压力等因素干扰,准确性有待加强。为了更加安全的进行腹腔镜肝切除术,在腹腔镜肝切除的临床工作中急需实时、准确的监测中心静脉压力的设备。Low central venous pressure technology is the key technology to prevent intraoperative bleeding, but it is difficult to monitor central venous pressure accurately in real time. The current method for detecting central venous pressure is to use transducers for conversion, because the volume of ordinary transducers is too large and can only be connected to a remote test device through a long line, that is, far from the venous pressure measurement position, and cannot be directly tested in situ. Moreover, the remote test will be interfered by factors such as the experience of the anesthesiologist, the position of the surgical patient, and the pressure of the laparoscopic pneumoperitoneum, and the accuracy needs to be strengthened. In order to perform laparoscopic hepatectomy more safely, a real-time and accurate device for monitoring central venous pressure is urgently needed in the clinical work of laparoscopic hepatectomy.
发明内容SUMMARY OF THE INVENTION
目前尚无可以在腹腔镜肝切除的临床工作中急需实时、准确的监测中心静脉压力的设备,因为存在以下技术难题:行业内符合体积要求的基于光纤传到的微型压力传感器芯片由于其加工工艺的原因,存在传感器容易损坏、测量范围不适用的问题,而不能直接应用于中心静脉压测量。其测量范围通常在6-42 cm H2O,即不能覆盖0-5 cm H2O范围,(而0—5 cm H2O压力范围非常重要,尤其是接近0 cmH2O时,是危险监测区域。)也即不能覆盖低中心静脉压所需的测量范围0-15 cmH2O。At present, there is no equipment that can urgently monitor central venous pressure in real time and accurately in the clinical work of laparoscopic hepatectomy, because of the following technical difficulties: the miniature pressure sensor chip based on optical fiber transmission that meets the volume requirements in the industry due to its processing technology The reason is that the sensor is easily damaged and the measurement range is not applicable, so it cannot be directly applied to the measurement of central venous pressure. Its measurement range is usually 6-42 cm H 2 O, that is, it cannot cover the 0-5 cm H 2 O range, (while the 0-5 cm H 2 O pressure range is very important, especially when it is close to 0 cm H 2 O, it is dangerous. monitoring area.) that is, does not cover the measurement range 0-15 cmH 2 O required for low central venous pressure.
本申请提供一种适用于原位测量中心静脉压的复合导管及其加工工艺。可人工任意调节传感器偏移,解决生产过程中的量程不匹配问题。同时本申请还具有良好的生物相容性,生物相容性改进与传感器装配同步完成,提高性能节省生产成本。综上,该导管利用附着于光纤尖端的微型压力传感器芯片来检测中心静脉压,可进行原位压力检测;可调偏移量结构设计可调节有市场上的传感器的偏移量,到达中心静脉压测量所需的范围。本申请实施例的方案安全可靠寿命长,生物相容性好、可以批量加工、实时测量直接准确。因为介入人体部分是无源期间,所以不涉及电磁兼容安全相关的研发设计,具有审批相对有源压力传感器简单、上市快的优点。The present application provides a composite catheter suitable for in-situ measurement of central venous pressure and a manufacturing process thereof. The sensor offset can be adjusted arbitrarily manually to solve the problem of range mismatch in the production process. At the same time, the present application also has good biocompatibility, and the improvement of biocompatibility is completed simultaneously with the assembly of the sensor, thereby improving performance and saving production costs. In summary, the catheter uses a micro pressure sensor chip attached to the tip of the optical fiber to detect central venous pressure, and can perform in-situ pressure detection; the adjustable offset structure design can adjust the offset of the sensors on the market to reach the central vein range required for pressure measurement. The solutions of the embodiments of the present application are safe, reliable, have a long service life, have good biocompatibility, can be processed in batches, and are directly and accurately measured in real time. Because the intervention of the human body is a passive period, it does not involve R&D and design related to electromagnetic compatibility safety, which has the advantages of simpler approval than active pressure sensors and faster time to market.
第一方面,本申请实施例提供了一种复合静脉导管,包括:外周管腔;位于所述外周管腔内部空间的中心管腔,所述中心管腔用于容纳压力传感器及用于传导所述压力传感器信号的线路,所述压力传感器位于所述复合静脉导管的植入端;所述中心管腔和所述外周管腔之间具有至少一个膈膜;所述至少一个膈膜一侧连接到所述中心管腔的外侧壁上,另一侧连接所述外周管腔的内侧壁,以便在所述中心管腔和的外侧壁和所述外周管腔的内侧壁之间形成至少两个通道,所述至少两个通道中各通道之间相互独立;其中,在所述复合静脉导管的使用状态下,所述植入端用于植入到受试对象静脉血管中,所述压力传感器用于检测静脉压;所述至少两个通道用于输送药液。In a first aspect, the embodiments of the present application provide a composite venous catheter, comprising: a peripheral lumen; a central lumen located in the inner space of the peripheral lumen, the central lumen being used for accommodating a pressure sensor and conducting The circuit of the pressure sensor signal, the pressure sensor is located at the implantation end of the composite venous catheter; there is at least one diaphragm between the central lumen and the peripheral lumen; the at least one diaphragm is connected on one side to the outer sidewall of the central lumen, and the other side is connected to the inner sidewall of the peripheral lumen to form at least two between the outer sidewall of the central lumen and the inner sidewall of the peripheral lumen channel, each of the at least two channels is independent of each other; wherein, in the use state of the composite venous catheter, the implantation end is used for implanting into the venous blood vessel of the subject, and the pressure sensor Used to detect venous pressure; the at least two channels are used to deliver medical fluid.
在一些实施例中,所述压力传感器为光纤压力传感器,所述用于传导所述压力传感器信号的线路为所述光纤压力传感器的信号传导光纤;在所述复合静脉导管的非使用状态下,第一膈膜和第一切线之间的夹角不为90度,所述第一膈膜为所述至少一个膈膜中的任一膈膜,所述第一切线为所述第一膈膜和所述所述中心管腔的外侧壁连接处的切线。In some embodiments, the pressure sensor is an optical fiber pressure sensor, and the line for conducting the signal of the pressure sensor is a signal conducting optical fiber of the optical fiber pressure sensor; when the composite venous catheter is not in use, The included angle between the first diaphragm and the first tangent is not 90 degrees, the first diaphragm is any one of the at least one diaphragm, and the first tangent is the first diaphragm A tangent to the junction of the diaphragm and the lateral wall of the central lumen.
在一些实施例中,在所述复合静脉导管的非使用状态下,所述第一膈膜和第一切线之间的夹角为30度-60度,或者,所述第一膈膜和第一切线之间的夹角为120度-150度。In some embodiments, in the non-use state of the composite venous catheter, the angle between the first diaphragm and the first tangent is 30 degrees to 60 degrees, or, the first diaphragm and the The included angle between the first tangents is 120°-150°.
在一些实施例中,所述压力传感器为或包括硅传感器芯片。In some embodiments, the pressure sensor is or includes a silicon sensor chip.
在一些实施例中,所述压力传感器具有传感器原始传感面,所述传感器原始传感面在水凝胶的作用下呈凸起状态。In some embodiments, the pressure sensor has an original sensing surface of the sensor, and the original sensing surface of the sensor is in a convex state under the action of the hydrogel.
在一些实施例中,在所述传感器原始传感面外侧还设置由传感器封装传感面,所述传感器封装传感面通过医用Parylene系列材料镀膜而成,所述传感器封装传感面的厚度为1-10µm。In some embodiments, a sensor package sensing surface is also provided outside the original sensing surface of the sensor, the sensor package sensing surface is coated with medical Parylene series materials, and the thickness of the sensor package sensing surface is 1-10µm.
在一些实施例中,所述至少一个膈膜为在所述中心管腔和所述外周管腔之间均匀分布的3个膈膜,所述至少两个通道为在所述中心管腔和所述外周管腔之间均匀分布的4个通道。In some embodiments, the at least one diaphragm is three diaphragms evenly distributed between the central lumen and the peripheral lumen, and the at least two channels are between the central lumen and the peripheral lumen. 4 channels evenly distributed between the peripheral lumens.
在一些实施例中,第一通道在所述植入端具有多个出口,所述第一通道为所述至少两个通道中的任一通道。In some embodiments, the first channel has a plurality of outlets at the implant end, and the first channel is any one of the at least two channels.
第二方面,本申请实施例提供了一种实时监测中心静脉压的控制系统,包括第一方面所述的复合静脉导管、输液泵和干涉式压力探测器;其中,复合静脉导管的插入端插入到所述输液泵端口,所述复合静脉导管中的用于传导所述压力传感器信号的线路连接到所述干涉式压力探测器。In a second aspect, an embodiment of the present application provides a control system for real-time monitoring of central venous pressure, including the composite venous catheter, the infusion pump and the interferometric pressure detector described in the first aspect; wherein the insertion end of the composite venous catheter is inserted into the To the infusion pump port, the line in the composite venous catheter for conducting the pressure sensor signal is connected to the interferometric pressure probe.
在一些实施例中,所述输液泵为私服电机控制蠕动泵。In some embodiments, the infusion pump is a motor-controlled peristaltic pump.
本申请实施例提供的方案具有如下方案。The solutions provided in the examples of the present application have the following solutions.
1.体积小巧,只需要一次微创插入血管即可同时检测压力及给多种药液,相比传统方法可减少创伤次数。可以独立控制多路药液独立输入,克服了传统静脉导管注射药物时,需要注入前次药物注射时在管腔内残存余量的问题,提高给药量控制准确度。系统可实现闭环测量,自动控制中心静脉压在一个安全的区间,使得手术医师可以专注微创手术本身。1. Small in size, it only needs one minimally invasive insertion into the blood vessel to simultaneously detect the pressure and give a variety of liquid medicines, which can reduce the number of trauma compared with the traditional method. The independent input of multiple drug solutions can be independently controlled, which overcomes the problem of the residual amount remaining in the lumen of the previous drug injection when the traditional intravenous catheter is used to inject drugs, and improves the accuracy of drug dose control. The system can realize closed-loop measurement and automatically control the central venous pressure in a safe range, so that the surgeon can focus on the minimally invasive surgery itself.
2.在腹腔镜肝切除术前准备时,麻醉医生常规会置入中心静脉导管,应用这种复合型静脉导管,可以起到一举两得的作用,既可以快速输液,也可以实时监测中心静脉压。减少了创伤、增加了测压传感器的稳定性。2. When preparing for laparoscopic hepatectomy, anesthesiologists routinely insert a central venous catheter. The application of this composite venous catheter can serve two birds with one stone, including rapid infusion and real-time monitoring of central venous pressure. Reduced trauma and increased load cell stability.
3.本申请实施例提供的复合静脉导管利用附着于光纤尖端的硅传感器芯片来检测中心静脉压,具有直接准确实时的作用,避免了麻醉医生的经验、手术病人的体位及腹腔镜气腹的压力等因素。特别的,设计了一个侧面测压的微型导压通道,使传感器敏感面保存在复合管内即可检测中心静脉压力,防止传感器敏感面损坏。3. The composite venous catheter provided in the embodiment of the present application uses a silicon sensor chip attached to the tip of the optical fiber to detect central venous pressure, which has a direct, accurate and real-time effect, avoiding the experience of anesthesiologists, the position of the surgical patient, and laparoscopic pneumoperitoneum. stress and other factors. In particular, a micro pressure guiding channel for lateral pressure measurement is designed, so that the sensitive surface of the sensor can be stored in the composite tube to detect the central venous pressure and prevent the sensitive surface of the sensor from being damaged.
4.本申请实施例提供的方案具有对光纤压力传感器弯曲保护效果,使得光纤压力传感器弯曲稳定性提高。4. The solutions provided by the embodiments of the present application have the effect of protecting the optical fiber pressure sensor from bending, so that the bending stability of the optical fiber pressure sensor is improved.
5.本申请实施例提出一种传感器的传感面的封装设计及加工工艺。该工艺结合复核管特定的微调结构,其实施效果具有在保护传感器不被物理、化学损坏的同时,可以通过增加或减少偏移量,以调节传感器量程,使之适合术中中心静脉压测量。5. The embodiment of the present application proposes a package design and processing technology of a sensing surface of a sensor. Combined with the specific fine-tuning structure of the review tube, this process has the effect of protecting the sensor from physical and chemical damage, while increasing or decreasing the offset to adjust the sensor range to make it suitable for intraoperative central venous pressure measurement.
附图说明Description of drawings
图1为本申请实施例提供的复合静脉导管的透视图;1 is a perspective view of a composite venous catheter provided by an embodiment of the application;
图2为本申请实施例提供的复合静脉导管的截面图;2 is a cross-sectional view of a composite venous catheter provided in an embodiment of the application;
图3为本申请实施例提供的复合静脉导管在弯曲状态下的截面图;3 is a cross-sectional view of the composite venous catheter provided in an embodiment of the application in a bent state;
图4为本申请实施例提供的复合静脉导管中传感器模块的结构示意图;4 is a schematic structural diagram of a sensor module in a composite venous catheter provided by an embodiment of the present application;
图5为本申请实施例提供的复合静脉导管中压力传感器的结构示意图。FIG. 5 is a schematic structural diagram of a pressure sensor in a composite venous catheter provided by an embodiment of the present application.
具体实施方式Detailed ways
下列实施例仅用于说明本申请,而不应视为限制本申请的范围。实施例中未注明具体条件者,按照常规条件或制造商建议的条件进行。所用试剂或仪器未注明生产厂商者,均为可以通过市售购买获得的常规产品。The following examples are intended to illustrate the present application only and should not be construed as limiting the scope of the present application. If the specific conditions are not indicated in the examples, it is carried out according to the conventional conditions or the conditions suggested by the manufacturer. The reagents or instruments used without the manufacturer's indication are conventional products that can be purchased from the market.
在进一步描述本申请具体实施方式之前,应理解,本申请的保护范围不局限于下述特定的具体实施方案;还应当理解,本申请实施例中使用的术语是为了描述特定的具体实施方案,而不是为了限制本申请的保护范围;在本申请说明书和权利要求书中,除非文中另外明确指出,单数形式“一个”、“一”和“这个”包括复数形式。Before further describing the specific embodiments of the present application, it should be understood that the protection scope of the present application is not limited to the following specific specific embodiments; it should also be understood that the terms used in the examples of the present application are for describing specific specific embodiments, Rather than limiting the scope of protection of this application; in the specification and claims of this application, the singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise.
当实施例给出数值范围时,应理解,除非本申请另有说明,每个数值范围的两个端点以及两个端点之间任何一个数值均可选用。除非另外定义,本申请中使用的所有技术和科学术语与本技术领域技术人员通常理解的意义相同。除实施例中使用的具体方法、设备、材料外,根据本技术领域的技术人员对现有技术的掌握及本申请的记载,还可以使用与本申请实施例中所述的方法、设备、材料相似或等同的现有技术的任何方法、设备和材料来实现本申请。When numerical ranges are given in the examples, it is to be understood that, unless otherwise indicated herein, both endpoints of each numerical range and any number between the two endpoints may be selected. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as commonly understood by one of ordinary skill in the art. In addition to the specific methods, equipment, and materials used in the examples, those skilled in the art can also use the methods, equipment, and materials described in the examples of the present application, according to the mastery of the prior art by those skilled in the art and the records of the present application. Any methods, devices and materials of the similar or equivalent prior art to carry out the present application.
本申请实施例提供了一种复合静脉导管及实时监测中心静脉压的控制系统,在腹腔镜肝脏切除手术过程中在静脉注射药物的同时,实时、准确的监测中心静脉压力,让腹腔镜肝切除手术更加安全。体积小巧,只需要一次微创即可同时检测压力及给多种药液,从而减少创伤次数。可以独立控制多路药液独立输入,克服了传统静脉导管注射药物时,需要注入前次药物注射时在管腔内残存余量的问题,提高给药量控制准确度。系统可实现闭环测量,自动控制中心静脉压在一个安全的区间,使得手术医师可以专注微创手术本身。The embodiment of the present application provides a composite venous catheter and a control system for real-time monitoring of central venous pressure. During laparoscopic liver resection, while intravenously injecting drugs, the central venous pressure can be monitored in real time and accurately, allowing laparoscopic liver resection Surgery is safer. Small in size, it only needs one minimally invasive procedure to detect pressure and administer multiple liquid medicines at the same time, thereby reducing the number of traumas. The independent input of multiple drug solutions can be independently controlled, which overcomes the problem of the residual amount remaining in the lumen of the previous drug injection when the traditional intravenous catheter is used to inject drugs, and improves the accuracy of drug dose control. The system can realize closed-loop measurement and automatically control the central venous pressure in a safe range, so that the surgeon can focus on the minimally invasive surgery itself.
在一些实施例中,复合静脉导管具有前端测压功能,具备多路输液管、压力测量、给药、闭环控制中心静脉压压力功能。整体设计具有鲁棒性好、测量准确、小体积的特点,其实施效果可减少创伤,简化手术步骤,从而降低手术风险; 复合静脉导管结构包括中心管腔和外周管腔,且外周管腔壁相对轴向是倾斜的。中心管腔用于存放光纤压力传感器及其信号传导光纤。外周管腔用于导通药液,并起到隔离缓冲保护光纤压力传感器的作用。还有如下优点:由于外周管腔壁相对轴向是倾斜的,允许光纤压力传感器更大活动范围以缓解弯曲压力。同时外周管腔存在多个输液通道,允许多种药液独立输入、独立控制;外周管腔每一个腔道都有多个出口,可以防止血栓堵塞, 降低医疗风险;支持连续式或脉动式给药方式,其中脉动式可以清理血栓堵塞出液口,降低医疗风险;该复合静脉导管生物相容性好、且可以矫正偏移量的传感器尖端保护结构及其加工工艺,其实施效果可以解决目前市场上已有的硅压力传感器无法应用于中心静脉压力测量的问题。In some embodiments, the composite venous catheter has a front-end pressure measurement function, and has the functions of multiple infusion tubes, pressure measurement, drug administration, and closed-loop control of central venous pressure. The overall design has the characteristics of good robustness, accurate measurement and small volume, and its implementation effect can reduce trauma, simplify surgical steps, and thus reduce surgical risks; the composite venous catheter structure includes a central lumen and a peripheral lumen, and the peripheral lumen wall It is inclined relative to the axial direction. The central lumen is used to store the fiber optic pressure sensor and its signal conducting fibers. The peripheral lumen is used to conduct the liquid medicine and play the role of isolation buffer to protect the optical fiber pressure sensor. There are also the following advantages: since the peripheral lumen wall is inclined relative to the axial direction, it allows a larger range of motion of the fiber optic pressure sensor to relieve bending pressure. At the same time, there are multiple infusion channels in the peripheral lumen, allowing independent input and independent control of various liquid medicines; each lumen in the peripheral lumen has multiple outlets, which can prevent thrombus blockage and reduce medical risks; support continuous or pulsatile dosing The pulsatile type can clear the thrombus blocking the liquid outlet and reduce the medical risk; the composite venous catheter has good biocompatibility and can correct the offset of the sensor tip protection structure and its processing technology, and its implementation effect can solve the current problem. The existing silicon pressure sensors on the market cannot be applied to the problem of central venous pressure measurement.
接下来,结合图1-图5对本申请实施例的方案进行具体说明。Next, the solutions of the embodiments of the present application will be described in detail with reference to FIGS. 1 to 5 .
如图1所示,本申请实施例提供了一中复合静脉导管1,包括:外周管腔;位于所述外周管腔内部空间的中心管腔,所述中心管腔用于容纳压力传感器及用于传导所述压力传感器信号的线路,所述压力传感器位于所述复合静脉导管的植入端;所述中心管腔和所述外周管腔之间具有至少一个膈膜;所述至少一个膈膜一侧连接到所述中心管腔的外侧壁上,另一侧连接所述外周管腔的内侧壁,以便在所述中心管腔和的外侧壁和所述外周管腔的内侧壁之间形成至少两个通道,所述至少两个通道中各通道之间相互独立;其中,在所述复合静脉导管的使用状态下,所述植入端用于植入到受试对象静脉血管中,所述压力传感器用于检测静脉压;所述至少两个通道用于输送药液。As shown in FIG. 1 , the embodiment of the present application provides a composite venous catheter 1, including: a peripheral lumen; a central lumen located in the inner space of the peripheral lumen, the central lumen is used for accommodating a pressure sensor and a a line for conducting the signal of the pressure sensor, the pressure sensor is located at the implantation end of the composite venous catheter; there is at least one diaphragm between the central lumen and the peripheral lumen; the at least one diaphragm One side is connected to the outer sidewall of the central lumen and the other side is connected to the inner sidewall of the peripheral lumen so as to form between the central lumen and the outer sidewall and the inner sidewall of the peripheral lumen At least two channels, each channel in the at least two channels is independent of each other; wherein, in the use state of the composite venous catheter, the implantation end is used to implant into the vein blood vessel of the subject, so The pressure sensor is used to detect the venous pressure; the at least two channels are used to deliver the medicinal liquid.
中心管腔可以为图1所示的传感通道11,传感通道11在植入端的出口为传感通道出口111。至少两个通道中的通道可以为图1所示的输液通道12,输液通道12在植入端的出口为输液通道出口121。压力传感器及用于传导所述压力传感器信号的线路属于图1中的传感器模块2。The central lumen can be the sensing channel 11 shown in FIG. 1 , and the outlet of the sensing channel 11 at the implantation end is the sensing channel outlet 111 . The channel in the at least two channels may be the infusion channel 12 shown in FIG. 1 , and the outlet of the infusion channel 12 at the implantation end is the infusion channel outlet 121 . The pressure sensor and the lines for conducting the signal of the pressure sensor belong to the sensor module 2 in FIG. 1 .
复合静脉导管1中的外周管腔、中心管腔以及膈膜可以采用专用医用材料,如氟塑料、PU等,适合多孔挤压成型工艺的材料。The peripheral lumen, the central lumen and the diaphragm in the composite venous catheter 1 can be made of special medical materials, such as fluoroplastics, PU, etc., which are suitable for the porous extrusion molding process.
在一些实施例中,所述压力传感器为光纤压力传感器,所述用于传导所述压力传感器信号的线路为所述光纤压力传感器的信号传导光纤;在所述复合静脉导管的非使用状态下,第一膈膜和第一切线之间的夹角不为90度,所述第一膈膜为所述至少一个膈膜中的任一膈膜,所述第一切线为所述第一膈膜和所述所述中心管腔的外侧壁连接处的切线。信号传导光纤可以如图4所示的传感器传导光纤23。In some embodiments, the pressure sensor is an optical fiber pressure sensor, and the line for conducting the signal of the pressure sensor is a signal conducting optical fiber of the optical fiber pressure sensor; when the composite venous catheter is not in use, The included angle between the first diaphragm and the first tangent is not 90 degrees, the first diaphragm is any one of the at least one diaphragm, and the first tangent is the first diaphragm A tangent to the junction of the diaphragm and the lateral wall of the central lumen. The signal conducting fibers may be sensor conducting fibers 23 as shown in FIG. 4 .
可以如图2和图3所示,中心管腔和的外侧壁和外周管腔的内侧壁之间的膈膜相对中心管腔的轴向是倾斜的,从而当复合静脉导管弯曲时,光纤在复合静脉导管内部多个方向自由运动,以减少弯曲半径。As shown in Figures 2 and 3, the diaphragm between the central lumen and the outer sidewall of the peripheral lumen and the inner sidewall of the peripheral lumen is inclined relative to the axial direction of the central lumen, so that when the composite venous catheter is bent, the fiber is in The interior of the composite venous catheter is free to move in multiple directions to reduce the bend radius.
在一些实施例中,在所述复合静脉导管的非使用状态下,所述第一膈膜和第一切线之间的夹角为30度-60度,或者,所述第一膈膜和第一切线之间的夹角为120度-150度。In some embodiments, in the non-use state of the composite venous catheter, the angle between the first diaphragm and the first tangent is 30 degrees to 60 degrees, or, the first diaphragm and the The included angle between the first tangents is 120°-150°.
通过控制膈膜相对中心管腔倾斜角度,更便于当复合静脉导管弯曲时,光纤在复合静脉导管内部多个方向自由运动,以减少弯曲半径。By controlling the inclination angle of the diaphragm relative to the central lumen, when the composite venous catheter is bent, the optical fiber moves freely in multiple directions inside the composite venous catheter, so as to reduce the bending radius.
在一些实施例中,所述压力传感器为或包括硅传感器芯片。In some embodiments, the pressure sensor is or includes a silicon sensor chip.
在一些实施例中,参阅图4和图5,所述压力传感器具有传感器原始传感面21,所述传感器原始传感面21在水凝胶的作用下呈凸起状态。传感器原始传感面21第一层保护材料,其在传感器封装水凝胶24的作用下呈现如图4所示的凸起状态。传感器封装水凝胶24可以为低硬度的PDMS材料。In some embodiments, referring to FIGS. 4 and 5 , the pressure sensor has a sensor original sensing surface 21 , and the sensor original sensing surface 21 is in a convex state under the action of the hydrogel. The original sensing surface 21 of the sensor is the first layer of protective material, which exhibits a raised state as shown in FIG. 4 under the action of the sensor encapsulation hydrogel 24 . The sensor encapsulating hydrogel 24 may be a low stiffness PDMS material.
在一些实施例中,在所述传感器原始传感面外侧还设置由传感器封装传感面22,所述传感器封装传感面22通过医用Parylene系列材料镀膜而成,所述传感器封装传感面22的厚度为1-10µm。传感器封装传感面22采用医用Parylene系列材料,如Parylene-C、Parylene-N、Parylene-D等。传感器封装传感面22可以通过Parylene CVD镀膜工艺制备而成。In some embodiments, a sensor package sensing surface 22 is further provided outside the original sensing surface of the sensor. The sensor package sensing surface 22 is coated with medical Parylene series materials. The sensor package sensing surface 22 The thickness is 1-10µm. The sensing surface 22 of the sensor package adopts medical Parylene series materials, such as Parylene-C, Parylene-N, Parylene-D and so on. The sensing surface 22 of the sensor package can be prepared by a Parylene CVD coating process.
在一些实施例中,所述至少一个膈膜为在所述中心管腔和所述外周管腔之间均匀分布的3个膈膜,所述至少两个通道为在所述中心管腔和所述外周管腔之间均匀分布的4个通道。存在多个输液通道,可允许多种药液独立输入、独立控制。In some embodiments, the at least one diaphragm is three diaphragms evenly distributed between the central lumen and the peripheral lumen, and the at least two channels are between the central lumen and the peripheral lumen. 4 channels evenly distributed between the peripheral lumens. There are multiple infusion channels, which allow independent input and independent control of multiple liquid medicines.
在一些实施例中,第一通道在所述植入端具有多个出口,所述第一通道为所述至少两个通道中的任一通道。每个输液通道都有多个出口,可以防止血栓堵塞, 降低医疗风险。In some embodiments, the first channel has a plurality of outlets at the implant end, and the first channel is any one of the at least two channels. Each infusion channel has multiple outlets, which can prevent thrombus blockage and reduce medical risks.
本申请实施例还挺了一种实时监测中心静脉压的控制系统,包括复合静脉导管1、输液泵(未示出)和干涉式压力探测器(未示出);其中,复合静脉导管1的插入端插入到所述输液泵端口,所述复合静脉导管1中的用于传导所述压力传感器信号的线路连接到所述干涉式压力探测器。The embodiment of the present application also proposes a control system for monitoring central venous pressure in real time, including a composite venous catheter 1, an infusion pump (not shown) and an interferometric pressure detector (not shown); wherein, the composite venous catheter 1 The insertion end is inserted into the infusion pump port, and the line in the composite venous catheter 1 for conducting the pressure sensor signal is connected to the interferometric pressure detector.
在一些实施例中,所述输液泵为私服电机控制蠕动泵。In some embodiments, the infusion pump is a motor-controlled peristaltic pump.
接下来,介绍复合静脉导管及控制系统使用方式。Next, the composite venous catheter and the use of the control system are introduced.
首先将复合静脉导管的插入端连接到输液泵端口,光纤连接到干涉式压力探测器上。校准零点,给输液泵输入药液。设置期望的中心静脉压范围,将复合管植入适当部位后,即可开启自动压力控制功能。First, connect the insertion end of the composite venous catheter to the port of the infusion pump, and connect the optical fiber to the interferometric pressure probe. Calibrate the zero point and input the liquid medicine to the infusion pump. Set the desired central venous pressure range, and after the composite tube is implanted in the appropriate location, the automatic pressure control function can be turned on.
光纤保护原理:由于复合管直径纤细,内部空间需要尽可能留给输送药液,这是因为药液表面张力原因,需要强大的压力才能输送药液,且药量难以控制,这就对后端给药装置设计早成困难。因此不能采用传统增加外壳的方式保护光纤,即光纤不再是弯曲时中性区域。本发明结构允许光纤在复合管内部多个方向自由运动,以减少弯曲半径。 如图2和图3所示,当复合管弯曲时,此时光纤会偏向一侧以减少弯曲应力。Optical fiber protection principle: Because the diameter of the composite tube is slender, the internal space needs to be reserved as much as possible for the delivery of the liquid medicine. This is because of the surface tension of the liquid medicine, which requires a strong pressure to deliver the liquid medicine, and the amount of the medicine is difficult to control. Drug delivery device design has long been difficult. Therefore, the optical fiber cannot be protected by the traditional method of adding a casing, that is, the optical fiber is no longer a neutral area when bending. The structure of the present invention allows the optical fiber to move freely in multiple directions inside the composite tube to reduce the bend radius. As shown in Figures 2 and 3, when the composite tube is bent, the fiber is deflected to one side to reduce bending stress.
复合静脉导管1的制造装配工艺如下。The manufacturing and assembling process of the composite venous catheter 1 is as follows.
传感器模块2装配工艺:Assembly process of sensor module 2:
首先,将牵引套管(未示出)套在传感器模块2上。First, a traction sleeve (not shown) is placed over the sensor module 2 .
然后,将牵引套管穿过复合静脉导管1的传感通道11,由于牵引套管较硬较细,可以较容易地进入传感通道11,从传感通道出口111)穿出。Then, the traction cannula is passed through the sensing channel 11 of the composite venous catheter 1. Since the traction cannula is relatively rigid and thin, it can easily enter the sensing channel 11 and pass through the sensing channel outlet 111).
其次,通过牵引套管牵引传感器模块2穿过传感通道11,并使得传感器封装传感面22到达传感通道出口111内部接近端口位置。Next, the sensor module 2 is pulled through the sensing channel 11 through the pulling sleeve, and the sensing surface 22 of the sensor package is made to reach the position close to the port inside the outlet 111 of the sensing channel.
最后,继续牵拉牵引套管3,使之抽离传感通道11。Finally, continue to pull the pulling sleeve 3 to make it withdraw from the sensing channel 11 .
由此,可以得到图1所示的复合静脉导管1。Thereby, the composite venous catheter 1 shown in FIG. 1 can be obtained.
接下来,介绍传感器模块2封装工艺。Next, the packaging process of the sensor module 2 is introduced.
将传感器模块2缓慢抽离复合静脉导管1即可实现分离。The separation can be achieved by slowly pulling the sensor module 2 away from the composite venous catheter 1 .
接下来,介绍传感器原始传感面21的封装加工工艺(需具体化)。Next, the packaging and processing technology of the original sensing surface 21 of the sensor (need to be specified) is introduced.
首先,传感器原始传感面21可以用点胶机,增加适量PDMS水凝胶。常温真空保存,且保持传感器原始传感面21垂直向下形成凸起,直到水凝胶凝固。如果水凝胶没有形成凸起,可以再次重复本步骤。其次,带有传感器封装传感面22的传感器模块2,进行ParyleneCVD镀膜工艺。镀膜厚度为1-10µm,以不影响传感器灵敏度为宜。First, the original sensing surface 21 of the sensor can use a glue dispenser to add an appropriate amount of PDMS hydrogel. Store in a vacuum at room temperature, and keep the original sensing surface 21 of the sensor to form a protrusion vertically downward until the hydrogel solidifies. If the hydrogel does not form bulges, this step can be repeated again. Next, the sensor module 2 with the sensor package sensing surface 22 is subjected to the ParyleneCVD coating process. The thickness of the coating is 1-10µm, which should not affect the sensitivity of the sensor.
传感器原始传感面21和传感器传导光纤23可以为市售的,可一体购买。传感器原始传感面21和传感器传导光纤23的最大外径不超过0.25mm。The original sensing surface 21 of the sensor and the conductive optical fiber 23 of the sensor can be commercially available and can be purchased in one piece. The maximum outer diameter of the original sensing surface 21 of the sensor and the conducting fiber 23 of the sensor does not exceed 0.25mm.
传感器模块2封装结构如图4,包括:传感器原始传感面21,传感器封装传感面22,传感器传导光纤23,传感器封装水凝胶24。其中传感器原始传感面21与传感器封装水凝胶2.4连接,传感器封装水凝胶24与传感器封装传感面22连接,传感器封装传感面22与传感器传导光纤23连接。传感器传导光纤2.3与后端测试系统连接。The package structure of the sensor module 2 is shown in FIG. 4 , including: the original sensor surface 21 of the sensor, the sensor package sensor surface 22 , the sensor conductive fiber 23 , and the sensor package hydrogel 24 . The original sensing surface 21 of the sensor is connected to the sensor package hydrogel 2.4 , the sensor package hydrogel 24 is connected to the sensor package sensing surface 22 , and the sensor package sensing surface 22 is connected to the sensor conductive fiber 23 . The sensor conducting fiber 2.3 is connected to the back-end test system.
接下来,介绍 传感器偏移量调节步骤。Next, the sensor offset adjustment procedure is described.
通过扩腔锥扩大中心腔端口直径,并形成一个锥形尖端口。将光纤压力传感器光纤通过牵引导丝从锥形尖端口插入复合管,通过拉动牵引导丝将光纤引入并穿过复合管中心腔。去掉牵引导丝,并将光纤接入干涉式压力探测器。在标准大气压下,通过牵拉光纤,使压力传感器进入锥形口,继续牵拉光纤,并观察压力读数,当读数为合适的偏置如10 cmH2O时,停止牵拉,用医用环氧胶固定光纤、传感器及复合管腔体,观察压力偏置。The diameter of the central lumen port is enlarged by the lumen expansion cone, and a tapered tip port is formed. The fiber optic pressure sensor fiber was inserted into the composite tube from the tapered tip port by pulling the guide wire, and the optical fiber was introduced and passed through the central lumen of the composite tube by pulling the pulling wire. The pulling wire was removed and the fiber was inserted into the interferometric pressure detector. Under standard atmospheric pressure, by pulling the fiber, the pressure sensor enters the tapered port, continue to pull the fiber, and observe the pressure reading, when the reading is a suitable offset such as 10 cmH 2 O, stop pulling, use medical epoxy Fix the optical fiber, sensor and composite lumen with glue, and observe the pressure offset.
接下来,介绍 给药方式。Next, the mode of administration is described.
采用私服电机控制蠕动泵,蠕动泵挤压储液室的方式进行控制。其中,连续式给药状态下,采用恒力矩模式驱动蠕动泵;脉动式给药状态下,采用恒速模式驱动蠕动泵。The peristaltic pump is controlled by a private service motor, and the peristaltic pump is controlled by squeezing the liquid storage chamber. Among them, in the state of continuous administration, the peristaltic pump is driven by a constant torque mode; in the state of pulsatile administration, the peristaltic pump is driven by a constant speed mode.
在本申请实施例中,用一种实时监测中心静脉压的复合静脉导管在腹腔镜肝脏切除手术过程中实时、准确的监测中心静脉压力。该复合静脉导管具有性能稳定、体积小、可同行给药和测压、创伤小的特点。所描述的工艺,复用输液通道作为测压传感器及其传导光纤的保护通道;另一方面本发明提出的传感器的封装方式,不仅保护了传感器、达到了短时间接触血液的生物相容性要求;再次,所提出的封装方式结合复合管的特殊结构,可以调节压力传感器的偏移量,使之不受加工工艺影响。In the embodiment of the present application, a composite venous catheter for real-time monitoring of central venous pressure is used to monitor central venous pressure in real time and accurately during laparoscopic liver resection. The composite venous catheter has the characteristics of stable performance, small volume, parallel administration and pressure measurement, and small trauma. In the described process, the multiplexed infusion channel is used as the protection channel of the pressure sensor and its conducting optical fiber; on the other hand, the packaging method of the sensor proposed by the present invention not only protects the sensor, but also meets the biocompatibility requirement of short-term contact with blood ; Again, the proposed packaging method combined with the special structure of the composite tube can adjust the offset of the pressure sensor so that it is not affected by the processing technology.
本申请的实施效果可以让腹腔镜肝切除手术更加安全,减少术中出血,改善患者愈后。The implementation effect of the present application can make laparoscopic liver resection safer, reduce intraoperative bleeding, and improve patient outcomes.
以上所述的具体实施方式,对本申请的目的、技术方案和有益效果进行了进一步详细说明,所应理解的是,以上所述仅为本申请的具体实施方式而已,并不用于限定本申请的保护范围,凡在本申请的精神和原则之内,所做的任何修改、等同替换、改进等,均应包含在本申请的保护范围之内。The specific embodiments described above further describe the purpose, technical solutions and beneficial effects of the present application in detail. It should be understood that the above descriptions are only specific embodiments of the present application, and are not intended to limit the Within the scope of protection, any modification, equivalent replacement, improvement, etc. made within the spirit and principle of this application shall be included in the protection scope of this application.
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Application publication date: 20201201 |