WO2022183591A1 - 导流调节装置 - Google Patents

导流调节装置 Download PDF

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Publication number
WO2022183591A1
WO2022183591A1 PCT/CN2021/092297 CN2021092297W WO2022183591A1 WO 2022183591 A1 WO2022183591 A1 WO 2022183591A1 CN 2021092297 W CN2021092297 W CN 2021092297W WO 2022183591 A1 WO2022183591 A1 WO 2022183591A1
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WIPO (PCT)
Prior art keywords
balloon
side hole
channel
valve plate
gas source
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PCT/CN2021/092297
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English (en)
French (fr)
Inventor
李晓坤
徐玲
Original Assignee
江苏赛腾医疗科技有限公司
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Publication of WO2022183591A1 publication Critical patent/WO2022183591A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1601—Control or regulation
    • A61M1/1603—Regulation parameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1698—Blood oxygenators with or without heat-exchangers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3653—Interfaces between patient blood circulation and extra-corporal blood circuit
    • A61M1/3659—Cannulae pertaining to extracorporeal circulation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3666—Cardiac or cardiopulmonary bypass, e.g. heart-lung machines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3331—Pressure; Flow
    • A61M2205/3334—Measuring or controlling the flow rate

Definitions

  • the present disclosure relates to the technical field of fluid control, and in particular, to a diversion regulating device.
  • Extracorporeal cardiopulmonary support (extracorporeal membrane oxygenation, ECMO) is a percutaneous implantable mechanical circulatory assistance technology.
  • the extracorporeal cardiopulmonary support device usually consists of three parts: the main engine, the pump head and the membrane oxygenator.
  • the host controls and monitors the operation of the extracorporeal cardiopulmonary support device, the pump head is used to circulate the blood inside and outside the body, and the membrane oxygenator is used to provide oxygen and exchange carbon dioxide in the blood discharged from the body.
  • the extracorporeal cardiopulmonary support device mainly drains the venous blood in the patient to the outside, and the blood is returned to the patient after oxygenating and removing carbon dioxide in the blood through the membrane oxygenator.
  • extracorporeal cardiopulmonary support devices mainly have two forms: venovenous ECMO (VV-ECMO) and venous-arterial ECMO (VA-ECMO).
  • VV-ECMO venovenous ECMO
  • VA-ECMO venous-arterial ECMO
  • the former only has respiratory assistance.
  • the latter has both circulatory and respiratory assistance.
  • VA-ECMO femoral arteriovenous cannulation
  • IABP Intelligent Balloon Pump Therapy
  • the oxygenated blood flow with high oxygen content returned by the femoral artery is far away from the coronary inlet, which does not help to improve the blood oxygenation near the coronary inlet, so it cannot improve the insufficient oxygen supply to the heart. Also, because of the presence of the IABP balloon, it is not possible to deliver high-oxygen blood to the heart by cannulating the subclavian artery or other arterial circuit closer to the coronary entrance.
  • the IABP balloon greatly disturbs the aortic blood flow, which is likely to cause poor perfusion of organs (liver, kidney), etc., resulting in complications and unfavorable patient prognosis.
  • the purpose of the present disclosure is to provide a diversion adjustment device, which can adjust the flow direction and flow rate of the fluid in the catheter by changing the state of the balloon.
  • the blood flow direction and/or flow rate in the catheter can be changed according to clinical needs, the blood volume perfused to the coronary artery and the content of blood oxygen in the blood can be increased, and the problem of insufficient oxygen supply to the heart itself can be improved or solved. question.
  • the present disclosure provides a flow regulation device, comprising a catheter for guiding blood in extracorporeal cardiopulmonary support, and an adjustment assembly for regulating the flow direction and/or flow of blood in the catheter ;in,
  • the conduit includes a pipe wall, a channel defined by the pipe wall, and a side hole opened on the pipe wall, one end of the channel is an inlet, the other end is an outlet, the side hole communicates with the channel and is located at the between said inlet and said outlet;
  • the adjustment assembly includes a gas source, a balloon and a trachea, the balloon is disposed in the channel and between the outlet and the side hole, the gas source is connected to the balloon through the trachea , used to inflate or deflate the balloon; the balloon is inflated after inflation to at least partially block the passage, increasing the amount of fluid expelled through the side hole, the balloon being deflated Post-contraction to reduce blockage of the channel and increase the amount of fluid expelled through the outlet.
  • side holes are provided on the tube wall of the catheter, an inflatable balloon is inserted into the catheter, and the balloon is inflated or deflated by an external air source to flexibly adjust the flow direction and flow of the fluid in the catheter.
  • the balloon when the external air source inflates the balloon, the balloon gradually expands to block the channel at least partially. At this time, the fluid cannot be smoothly discharged from the channel outlet, and the fluid accumulated between the channel inlet and the balloon exerts an impact on the tube wall.
  • the pressure increases, forcing the fluid out of the side hole; when the balloon deflates and deflates, the resistance of the balloon to the fluid decreases, and the fluid is more easily expelled from the channel outlet, thereby reducing the amount of fluid expelled from the side hole.
  • the direction of blood flow can be changed according to clinical needs, so as to implement perfusion of organs in different directions.
  • the side hole of the catheter can be placed near the entrance of the coronary artery of the heart.
  • the hole shoots in the direction of the coronary inlet, increasing the blood pressure, blood flow and blood oxygen content at the coronary inlet; the balloon is deflated at the time outside the cardiac ejection cycle, so that most of the blood flow flows out in the direction of the channel outlet, increasing the pressure on the outside of the heart.
  • Perfusion of organs other than the heart thereby improving or solving the problem of insufficient oxygen supply to the heart itself.
  • FIG. 1 is a schematic structural diagram of a diversion adjustment device in a balloon deflated state provided by an embodiment of the present disclosure
  • FIG. 2 is a schematic structural diagram of a diversion adjustment device in a balloon inflation state provided by an embodiment of the present disclosure
  • FIG. 3 is a schematic diagram of a blood flow direction in a deflated state of a balloon provided by an embodiment of the present disclosure
  • FIG. 4 is a schematic diagram of a blood flow direction in a balloon inflation state provided by an embodiment of the present disclosure
  • FIG. 5 is a schematic structural diagram of a diversion adjustment device in a balloon deflated state provided by an embodiment of the present disclosure
  • FIG. 6 is a schematic structural diagram of a diversion adjustment device in a balloon inflation state provided by an embodiment of the present disclosure
  • FIG. 7 is a schematic diagram of a blood flow direction in a state where the balloon is deflated according to an embodiment of the present disclosure
  • FIG. 8 is a schematic diagram of the blood flow direction of the balloon in an inflated state provided by an embodiment of the present disclosure.
  • the main problem of patients with acute heart failure is the lack of blood supply and oxygen supply to various organs including the heart.
  • the current clinical method of VA-ECMO combined with IABP can solve the problem of blood supply to the heart, it cannot improve the problem of oxygen supply to the heart.
  • the key to improving the oxygen supply of the heart is to introduce the blood with high oxygen content into the coronary arteries.
  • the oxygen content of the blood that has undergone extracorporeal oxygenation is higher than that of the arterial blood.
  • the flow rate of blood flow is determined by the power source such as the external blood pump and the pressure flow resistance, and the blood flow direction is determined by the position of the cannula and the opening of the cannula, which cannot change the blood flow during the blood delivery. direction of flow. That is, existing cannulas cannot meet the need for infusion of high oxygen content blood close to the coronary arteries.
  • the embodiments of the present disclosure provide a flow regulation device, which can change the flow direction of oxygenated blood in the human body, so as to increase the blood oxygen supply to the coronary arteries during cardiac ejection, and to increase the blood oxygen supply to the coronary arteries outside the cardiac ejection.
  • Fig. 1 shows a diversion adjustment device provided by an embodiment of the present disclosure
  • the device includes a conduit 1 and an adjustment assembly 2
  • the conduit 1 is a hose, and is used for guiding fluid
  • the adjustment assembly 2 is used for The flow direction and/or flow rate of the fluid in the conduit 1 is adjusted.
  • the catheter is used to guide the oxygenated blood
  • the regulating component is used to regulate the oxygenated blood in the The flow direction and/or flow in the human body.
  • the conduit 1 may include a pipe wall 11 , a channel 12 defined by the pipe wall 11 , and a side hole 13 opened on the pipe wall 11 , one end of the channel 12 is an inlet 15 , the other end is an outlet 14 , and the side hole 13 It communicates with the channel 12 and is located between the inlet 15 and the outlet 14 .
  • the side holes 13 can be strip-shaped holes arranged along the length of the conduit 1 to minimize the influence of the side holes 13 on the cross-section of the channel 12 and ensure that the fluid flows from the inlet 15 to the outlet 14 during the process , the leakage to the side hole 13 is as little as possible.
  • the adjustment assembly 2 may include a gas source, a balloon 21 and a trachea 22, the balloon 21 is arranged in the channel 12 and is located between the outlet 14 and the side hole 13; 21 is inflated or deflated; balloon 21 is inflated after inflation to at least partially block passage 12, increasing the amount of fluid expelled through side hole 13, and balloon 21 is deflated after deflation to reduce obstruction of passage 12 , increasing the amount of fluid discharged through outlet 14 .
  • the air source includes a first air source 23 and a second air source 25 , the first air source 23 is used to inflate the balloon 21 , and the second air source 25 is used to exhaust the balloon 21 Specifically, the first gas source 23 may be a high-pressure gas source, the second gas source 25 may be a negative pressure gas source or the atmosphere, and both the first gas source 23 and the second gas source 25 are provided outside the channel 12 .
  • One end of the trachea 22 is connected to the balloon 21, and the other end is a branch pipeline.
  • the branch pipeline includes a first branch pipe and a second branch pipe. The first branch pipe is connected to the first gas source 23, and the second branch pipe is connected to the second gas source. Source 25 is connected.
  • the first branch pipe is provided with a first valve 24, the second branch pipe is provided with a second valve 26, the first valve 24 is used to connect/close the gas delivery between the first gas source 23 and the balloon 21, and the second valve 26 It is used to connect/close the gas delivery between the second gas source 25 and the balloon 21 .
  • the balloon When inflating, the balloon can be inflated through an external high-pressure air source by opening the valve connecting the balloon to the high-pressure air source. When deflated, the valve connecting the balloon to the atmosphere can be opened. Due to the contraction force of the balloon itself, the gas in it will be quickly discharged into the atmosphere, or the exhaust port of the second branch pipe can be connected to the negative pressure source to accelerate the exhaust. .
  • the flow direction of the fluid is associated with the state of the balloon, and the flow direction of the fluid in the catheter can be adjusted by changing the state of the balloon. details as follows:
  • the valve 24 makes the balloon 21 in a contracted state, as shown in FIG. 1 , at this time, the balloon 21 hardly blocks the channel 12, and the resistance in the channel 12 is much smaller than the resistance of the tube wall 11, so the fluid entering the channel 12 Most of the fluid will flow out through the outlet 14 , and a small amount of fluid or even no fluid will flow out from the side hole 13 .
  • the second valve 26 block the communication between the second air source 25 and the balloon 21, open the first valve 24, conduct the first air source 23 and the balloon 21, and drive the first air source 23 to inflate the balloon 21 , the balloon 21 inflates after inflation, blocking the channel 12 between the inlet 15 and the outlet 14 , forcing the fluid that could originally flow out from the outlet 14 to be discharged from the side hole 13 instead.
  • the degree of obstruction of the channel 12 by the balloon 21 can be adjusted by controlling the amount of inflation.
  • the balloon 21 does not completely block the channel 12, the fluid can flow out from the side hole 13 and the outlet 14 at the same time.
  • the channel 12 is used, the fluid can only flow out from the side hole 13 .
  • the adjusting device provided by the embodiments of the present disclosure can be used for extracorporeal cardiopulmonary support to dynamically adjust the direction and amount of blood perfusion, thereby improving or solving the problem of insufficient oxygen supply to the heart itself.
  • Figures 3 and 4 are application scenarios of the adjusting device provided by the present disclosure. Please refer to Figure 3.
  • One end of the catheter 1 is connected to ECMO outside the body, and the other end of the catheter 1 is inserted from the subclavian artery 3, and enters other In the aorta, the side hole 13 of the catheter 1 is placed near the entrance of the coronary artery 4 of the heart, and the blood after extracorporeal oxygenation is introduced into the channel 12 through the entrance 15, and the ejection cycle of the heart is obtained by monitoring the monitoring equipment.
  • the balloon 21 is inflated, so that the oxygenated blood is ejected from the side hole 13 to the inlet direction of the coronary artery 4 (as shown in FIG. 4 ), and the blood pressure, blood flow and blood oxygen content at the inlet of the coronary artery 4 are increased;
  • the balloon 21 is deflated at times other than the cardiac ejection cycle, so that most of the blood flow flows out in the direction of the channel outlet 14 (as shown in FIG. 3 ), increasing the perfusion to other organs except the heart.
  • FIGS. 3 and 4 are intubated through the subclavian artery 3 , but the device provided by the embodiment of the present disclosure can be used for intubation at other locations and when the blood flow direction needs to be changed.
  • Fig. 5 shows another flow diversion adjustment device provided by an embodiment of the present disclosure.
  • the device includes a conduit 1 and an adjustment assembly 2.
  • the conduit 1 is a hose and is used to divert fluid
  • the adjustment assembly 2 is used for It is used to adjust the flow direction and/or flow rate of the fluid in the conduit 1 .
  • the device of the present disclosure when applied to extracorporeal cardiopulmonary support assistance, it may belong to a part of the extracorporeal cardiopulmonary support assistance device.
  • the direction and/or flow of blood in the body may be applied to extracorporeal cardiopulmonary support assistance.
  • the conduit 1 may include a pipe wall 11, a channel 12 defined by the pipe wall 11, a side hole 13 opened on the pipe wall 11, and a valve plate 27 disposed near the side hole 13.
  • One end of the channel 12 is an inlet 15, and the other end is a valve plate 27.
  • the side hole 13 communicates with the channel 12 and is located between the inlet 15 and the outlet 14.
  • One side of the valve plate 27 is connected to the edge of the side hole 13, and the other side of the valve plate 27 is the active side.
  • the adjustment assembly 2 includes an air source, a balloon 21 and a trachea 22.
  • the balloon 21 is arranged in the channel 12 and is located between the outlet 14 and the side hole 13; Inflate or vent.
  • the air source includes a first air source 23 for inflating the balloon 21 and a second air source 25 for exhausting the balloon 21.
  • the first air source 23 may be a high-pressure air source
  • the second gas source 25 may be a negative pressure gas source or the atmosphere.
  • One end of the trachea 22 is connected to the balloon 21, and the other end is a branch pipeline.
  • the branch pipeline includes a first branch pipe and a second branch pipe. The first branch pipe is connected to the first gas source 23, and the second branch pipe is connected to the second gas source.
  • the sources 25 are connected, and both the first gas source 23 and the second gas source 25 are arranged outside the channel 12 .
  • a first valve 24 is arranged on the first branch pipe, a second valve 26 is arranged on the second branch pipe, the first valve 24 is used to connect/close the gas delivery between the first gas source 23 and the balloon 21, and the second valve 26 It is used to connect/close the gas delivery between the second gas source 25 and the balloon 21 .
  • the trachea can be arranged along the inner or outer wall of the catheter.
  • a tracheal channel can also be opened on the tube wall of the catheter, and the catheter can be inserted into the channel of the catheter from the tracheal channel, so that the inner wall of the catheter can be made smoother and minimized. Obstruction of the fluid in the channel by the small trachea.
  • the valve plate 27 is connected to the edge of the side hole 13 through an elastic member.
  • the balloon 21 When the balloon 21 is inflated, the inflated balloon 21 blocks the channel 12, preventing the fluid from being discharged from the outlet 14, and the pressure exerted by the fluid accumulated in the channel 12 on the tube wall 11 increases.
  • the pressure is greater than the supporting force of the elastic member At this time, the movable side of the valve plate is deflected away from the side hole 13 , and the fluid in the channel 12 is discharged from the side hole 13 .
  • the balloon 21 When the balloon 21 is deflated and contracted, the obstruction in the channel 12 is gradually eliminated, and the fluid can be discharged from the outlet 14 smoothly, so that the pressure of the fluid on the pipe wall 11 is reduced, and the pressure exerted on the valve plate is also reduced.
  • the elastic member drives the movable side of the valve plate to block the side hole 13 and restore its initial position to achieve the effect of automatic reset.
  • the movable side of the valve plate is connected to a traction cable, and the traction cable extends toward the inlet 15 of the channel 12 .
  • the active side of the valve plate is deflected away from the side hole 13, thereby opening the side hole 13 and allowing fluid to flow out of the side hole 13.
  • the active side of the valve plate It is close to the side hole 13 so as to block the side hole 13 and prevent the fluid from flowing out of the side hole 13 .
  • the valve plate when the balloon 21 is inflated and inflated, the valve plate can be controlled by the traction cable to open, so that the fluid in the channel 12 can be discharged through the side hole 13, and when the balloon 21 is deflated and contracted, the valve plate can be controlled by the traction cable to close, so that the The fluid in the channel 12 is discharged from the outlet 14 .
  • valve plate shape and size are matched with the side hole 13.
  • the outer wall of the valve plate is flush with the outer wall of the catheter 1, so as to avoid hooking the vascular tissue when the catheter is pulled out.
  • FIG. 7 and 8 are schematic diagrams of states when the adjusting device according to the embodiment of the present disclosure is used for extracorporeal cardiopulmonary support.
  • the inlet 15 of the catheter 1 is connected to ECMO
  • the side hole 13 of the catheter 1 is placed near the inlet of the coronary artery 4 of the heart
  • the blood after extracorporeal oxygenation is injected into the catheter channel 12 through the inlet 15, and contracts outside the cardiac ejection cycle.
  • the balloon 21 is closed, and the valve plate is closed, and most of the blood flow will flow out along the direction of the channel outlet 14 to perfuse other organs except the heart. Referring to FIG.
  • the blood flow can be output by pulsating synchronously with the heart, so that the perfusion volume to the coronary artery and the content of blood oxygen in the perfused blood can be increased.
  • a valve plate is arranged on the edge of the side hole, and the opening and closing of the valve plate is controlled according to the state of the balloon. When the valve plate is in the closed state, it can guide the blood to flow out to the outlet. The blood that emerges from the side hole directly flushes the aortic wall causing dissection.

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Abstract

一种导流调节装置，包括导管（1）和调节组件（2），导管（1）包括管壁（11）、由管壁（11）限定的通道（12）和开设在管壁（11）上的侧孔（13），通道（12）的一端为入口（15）、另一端为出口（14），侧孔（13）与通道（12）连通且位于入口（15）与出口（14）之间；调节组件（2）包括气源、球囊（21）和气管（22），球囊（21）设置在通道（12）内且位于出口（14）与侧孔（13）之间，气源通过气管（22）与球囊（21）相连，用于对球囊（21）进行充气或排气；球囊（21）在充气后膨胀，以至少部分阻塞通道（12），增加经侧孔（13）排出的流体的量，球囊（21）在排气后收缩，以减小对通道（12）的阻塞，增加经出口（14）排出的流体的量。导流调节装置能够通过改变球囊（21）的状态而调整导管（1）中流体的流向及流量。

Description

导流调节装置 技术领域
本公开涉及流体控制技术领域，特别涉及一种导流调节装置。
背景技术
体外心肺支持辅助(extracorporeal membrane oxygenation,ECMO)，为一种可经皮置入的机械循环辅助技术。体外心肺支持辅助装置通常由主机、泵头和膜式氧合器三个部分构成。主机对体外心肺支持辅助装置的运行进行控制和监测，泵头用于使体内外的血液进行循环，膜式氧合器用于提供氧气并交换体内排出的血液内的二氧化碳。体外心肺支持辅助装置主要引流患者体内的静脉血液至体外，经过膜式氧合器氧合并排除血液中的二氧化碳后的血液回输患者体内。根据血液回输的途径不同，体外心肺支持辅助装置主要有静脉到静脉(venovenous ECMO,VV-ECMO)和静脉到动脉(venous-arterial ECMO,VA-ECMO)两种形式，前者仅具有呼吸辅助作用，而后者同时具有循环和呼吸辅助作用。
对于急性心衰患者，其主要问题是包括心脏在内的各主要脏器供血供氧不足，且由于心脏自身供氧不足，则心脏输出进一步减少从而进一步加剧症状，最终导致患者因心力衰竭而死亡。目前临床上通常采用VA-ECMO(股动静脉插管)和IABP(Intra-Aortic Balloon Pump Therapy，主动脉球囊反搏)的方法进行生命支持及改善心衰的情况。但这一方法存在几个主要缺陷：
(1)经股动脉回输的氧合后的高含氧量血流离冠脉入口很远，无助于改善冠脉入口附近的血液氧合，因此无法改善心脏供氧不足的情况。并且，由于IABP球囊的存在，也无法通过在锁骨下动脉或其他动脉回路这些离冠脉入口更近的地方插管，来向心脏输入高氧含量的血液。
(2)由于缺陷(1)的存在，在患者自身肺部功能有缺陷造成氧合不足时，IABP球囊挤压入冠脉的血液也为氧含量较低的血液，虽然增加了心脏血供，但无助于根本性减轻心脏供氧不足的问题，无法或不足以纠正心衰的发展。
(3)IABP球囊对主动脉血流扰动较大，容易造成器官(肝脏、肾脏)等的灌注不良的情况，造成并发症且不利于患者预后。
可见，相关技术中缺乏有效解决或改善心脏自身供氧不足问题的方案。
发明内容
针对现有技术的缺陷，本公开的目的在于提供一种导流调节装置，能够通过改变球囊的状态而调整导管中流体的流向及流量。将本公开用于体外心肺支持辅助时，能够根据临床需求改变导管中血液流向和/或流量，增加对冠脉灌注的血液量及血液中血氧的含量，改善或解决心脏自身供氧不足的问题。
本公开提供了一种导流调节装置，包括导管和调节组件，所述导管用于在体外心肺支持辅助中导流血液，所述调节组件用于调节所述导管中血液的流向和/或流量；其中，
所述导管包括管壁、由管壁限定的通道和开设在所述管壁上的侧孔，所述通道的一端为入口、另一端为出口，所述侧孔与所述通道连通且位于所述入口与所述出口之间；
所述调节组件包括气源、球囊和气管，所述球囊设置在所述通道内且位于所述出口与所述侧孔之间，所述气源通过所述气管与所述球囊相连，用于对所述球囊进行充气或排气；所述球囊在充气后膨胀，以至少部分阻塞所述通道，增加经所述侧孔排出的流体的量，所述球囊在排气后收缩，以减小对所述通道的阻塞，增加经所述出口排出的流体的量。
本公开在导管的管壁上开设侧孔，在导管内置入可膨胀球囊，利用外部气源对球囊进行充气或排气，来灵活调节导管内流体的流向和流量。具体的，当外部气源为球囊充气时，球囊逐渐膨胀以至少部分阻塞通道，此时流体不能顺畅的自通道出口排出，集聚在通道入口与球囊之间的流体对 管壁施加的压力增大，迫使流体向侧孔排出；当球囊排气收缩时，球囊对流体的阻力减小，流体更容易从通道出口排出，从而减少从侧孔排出的流体的量。
将本公开的导流调节装置用于血液灌注时，可以根据临床需求改变血流方向，以实施对不同方向脏器的灌注。具体的，应用本公开的调节装置进行体外心肺支持辅助时，可以将导管的侧孔放置于心脏冠脉入口附近，在心脏射血时，通过对球囊进行充气使得氧合后的血液从侧孔射向冠状动脉入口方向，增加冠状动脉入口处血压、血流量以及血液含氧量；在心脏射血周期以外的时间收缩球囊，使得大部分血流顺着通道出口方向流出，增加对除了心脏以外其他脏器的灌注，从而改善或解决心脏自身供氧不足的问题。
附图说明
为了更清楚地说明本公开的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单的介绍。显而易见地，下面描述中的附图仅仅是本公开的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其它附图。
图1是本公开实施例提供的球囊收缩状态下的导流调节装置的结构示意图；
图2是本公开实施例提供的球囊膨胀状态下的导流调节装置的结构示意图；
图3是本公开实施例提供的球囊收缩状态下的血液流向的示意图；
图4是本公开实施例提供的球囊膨胀状态下的血液流向的示意图；
图5是本公开实施例提供的球囊收缩状态下的导流调节装置的结构示意图；
图6是本公开实施例提供的球囊膨胀状态下的导流调节装置的结构示意图；
图7是本公开实施例提供的球囊收缩状态下的血液流向的示意图；
图8是本公开实施例提供的球囊膨胀状态下的血液流向的示意图。
图中：1-导管，2-调节组件；11-管壁，12-通道，13-侧孔，14-出口，15-入口；21-球囊，22-气管，23-第一气源，24-第一阀，25-第二气源，26-第二阀，27-阀门板；3-锁骨下动脉，4-冠状动脉。
具体实施方式
为了使本技术领域的人员更好地理解本公开方案，下面将结合本公开实施例中的附图，对本公开实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本公开一部分的实施例，而不是全部的实施例。基于本公开中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都应当属于本公开保护的范围。
需要说明的是，本公开的说明书和权利要求书及附图中的术语“第一”、“第二”等是用于区别类似的对象，而不必用于描述特定的顺序或先后次序。应该理解这样使用的数据在适当情况下可以互换，以便这里描述的本公开的实施例能够以除了在这里图示或描述的那些以外的顺序实施。此外，术语“包括”和“具有”以及他们的任何变形，意图在于覆盖不排他的包含。
急性心衰患者的主要问题在于包括心脏在内的各脏器供血供氧不足，目前临床采用的VA-ECMO配合IABP的方法虽然能够解决心脏供血问题，但无法改善心脏供氧问题。
改善心脏供氧问题的关键在于将含氧量高的血液导入冠状动脉，经过体外氧合的血液的含氧量高于动脉血液的含氧量，如果将体外氧合的血液导向冠状动脉，必然能够改善心脏供氧。然而，目前血液插管在回输血流时，由体外血泵等动力源及压力流阻决定血流的流速，由置管位置及插管开口等决定血流方向，无法改变血液输送过程中血流的方向。即，现有的插管不能满足在靠近冠状动脉的地方输入高含氧量血液的需求。为此，本公开实施例提供一种导流调节装置，能够改变氧合后血液在人体内的流向，实现在心脏射血时，增加对冠状动脉的血氧供给，在心脏射血以外，增加对其他脏器的血氧供给的效果，模拟心脏搏动产生的血压血流搏动，改善或者消除心脏缺氧的问题。
图1示出了本公开实施例提供的一种导流调节装置，请参见图1，该装置包括导管1和调节组件2，导管1为软管，用于导流流体，调节组件2用于调节导管1内流体的流向和/或流量。具体的，本公开的装置应用于体外心肺支持辅助时，可以属于体外心肺支持辅助装置的一部分，此时，导管用于导流氧合后的血液，调节组件用于调节氧合后的血液在人体内的流向和/或流量。
请参见图1，导管1可以包括管壁11、由管壁11限定的通道12和开设在管壁11上的侧孔13，通道12的一端为入口15、另一端为出口14，侧孔13与通道12连通且位于入口15与出口14之间。在一个可行的实现方式中，侧孔13可以是沿导管1的长度方向设置的条形孔，以尽量减小侧孔13对通道12截面的影响，确保流体在从入口15流向出口14过程中，尽量少的向侧孔13泄漏。
调节组件2可以包括气源、球囊21和气管22，球囊21设置在通道12内且位于出口14与侧孔13之间；气源通过气管22与球囊21相连，用于对球囊21进行充气或排气；球囊21在充气后膨胀，以至少部分阻塞通道12，增加经侧孔13排出的流体的量，球囊21在排气后收缩，以减小对通道12的阻塞，增加经出口14排出的流体的量。
在一个可行的实现方式中，气源包括第一气源23和第二气源25，第一气源23用于对球囊21进行充气，第二气源25用于对球囊21进行排气，具体的，第一气源23可以是高压气源，第二气源25可以是负压气源或者大气，第一气源23和第二气源25均设置在通道12以外。气管22的一端与球囊21相连，另一端为分支管路，分支管路的包括第一支管和第二支管，第一支管与第一气源23相连，第二支管与所述第二气源25相连。第一支管上设有第一阀24，第二支管上设有第二阀26，第一阀24用于连通/关闭第一气源23与球囊21之间的气体输送，第二阀26用于连通/关闭第二气源25与球囊21之间的气体输送。充气时，可以通过打开球囊连通到高压气源的阀门，通过外部高压气源为球囊充气。放气时，可以打开球囊连通大气的阀门，由于球囊自身收缩力，会将其中的气体迅速排放到大气中，也可以把第二支管的排气口与负压源相连以加速排气。
本公开实施例中，流体的流向与球囊的状态关联，通过改变球囊的状态可以调节流体在导管内的流向。具体如下：
关闭第一阀24，阻断第一气源23与球囊21的连通，打开第二阀26，使第二气源25与球囊21连通，或者，在球囊21排气之后关闭第一阀24，使球囊21处于收缩状态，如图1所示，此时，球囊21几乎不对通道12造成阻塞，通道12内的阻力远小于管壁11的阻力，因此，进入通道12的流体绝大部分会顺着出口14流出，少部分流体甚至没有流体会从侧孔13流出。关闭第二阀26，阻断第二气源25与球囊21的连通，打开第一阀24，导通第一气源23与球囊21，并驱动第一气源23为球囊21充气，球囊21充气后膨胀，将入口15与出口14之间的通道12阻塞，迫使原本可以从出口14流出的流体改从侧孔13排出。实际应用中，球囊21对通道12的阻塞程度可以通过控制充气量来调节，在球囊21未完全阻塞通道12时，流体可以同时从侧孔13和出口14流出，在球囊21完全阻塞通道12时，流体可以仅从侧孔13流出。
本公开实施例提供的调节装置可用于体外心肺支持辅助，以动态调整血流灌注方向及灌注量，从而改善或解决心脏自身供氧不足的问题。图3和图4是本公开提供的调节装置的应用场景图，请参见图3，导管1的一端在体外连接ECMO，导管1的另一端自锁骨下动脉3插入，经过心脏主动脉后进入其他主动脉，导管1的侧孔13被放置于心脏冠状动脉4的入口附近，将体外氧合后的血液通过入口15导入通道12，利用监测设备监测获得心脏的射血周期，在心脏射血时，对球囊21进行充气，使氧合后的血液从侧孔13射向冠状动脉4的入口方向(如图4所示)，增加冠状动脉4入口处血压、血流量以及血液含氧量；在心脏射血周期以外的时间收缩球囊21，使大部分血流顺着通道出口14方向流出(如图3所示)，增加对除心脏以外的其他脏器的灌注。
图3和图4均通过锁骨下动脉3进行插管，但在其他部位插管及需要改变血流方向时，均可以采用本公开实施例提供的装置。
图5示出了本公开实施例提供的另一种导流调节装置，请参见图5，该装置包括导管1和调节组件2，导管1为软管，用于导流流体，调节组件2 用于调节导管1内流体的流向和/或流量。具体的，本公开的装置应用于体外心肺支持辅助时，可以属于体外心肺支持辅助装置的一部分，此时，导管1用于导流氧合后的血液，调节组件2用于调节氧合后的血液在人体内的流向和/或流量。
导管1可以包括管壁11、由管壁11限定的通道12、开设在管壁11上的侧孔13和设置在侧孔13附近的阀门板27，通道12的一端为入口15、另一端为出口14，侧孔13与通道12连通且位于入口15与出口14之间，阀门板27的一侧与侧孔13的边沿相连，阀门板27的另一侧为活动侧。
调节组件2包括气源、球囊21和气管22，球囊21设置在通道12内且位于出口14与侧孔13之间；气源通过气管22与球囊21相连，用于对球囊21进行充气或排气。其中，气源包括用于对球囊21进行充气的第一气源23和用于对球囊21进行排气的第二气源25，具体的，第一气源23可以是高压气源，第二气源25可以是负压气源或者大气。气管22的一端与球囊21相连，另一端为分支管路，分支管路的包括第一支管和第二支管，第一支管与第一气源23相连，第二支管与所述第二气源25相连，第一气源23和第二气源25均设置在通道12以外。在第一支管上设置第一阀24，在第二支管上设置第二阀26，第一阀24用于连通/关闭第一气源23与球囊21之间的气体输送，第二阀26用于连通/关闭第二气源25与球囊21之间的气体输送。需要说明的是，气管可以沿着导管内壁或者外壁设置，当然，也可以在导管的管壁上开设气管通道，将导管自气管通道插入导管的通道内，从而可以使导管内壁较光滑，尽量减小气管对通道内流体的阻碍。
在一个可行的实现方式中，阀门板27通过弹性件与所述侧孔13的边沿相连。在球囊21充气膨胀时，膨胀后的球囊21堵塞通道12，阻碍流体从出口14排出，集聚在通道12内的流体向管壁11施加的压力增大，当压力大于弹性件的支撑力时，阀门板的活动侧向远离侧孔13的方向偏转，通道12内流体从侧孔13排出。在球囊21排气收缩时，通道12内的阻碍逐渐消除，流体能够顺畅的从出口14排出，从而流体对管壁11的压力减小，施加在阀门板上的压力也减小，当施加在阀门板上的压力小于弹性件的支撑力时，弹性件带动阀门板的活动侧封堵侧孔13，恢复其初始位置，达到 自动复位的效果。
在一个可行的实现方式中，阀门板的活动侧连接牵引索，牵引索向通道12的入口15延伸。当牵引索处于松弛状态时，阀门板的活动侧向远离侧孔13的方向偏转，从而打开侧孔13，允许流体从侧孔13流出，当牵引索处于收紧状态时，阀门板的活动侧贴近侧孔13，从而封堵侧孔13，阻止流体从侧孔13流出。具体的，可以在球囊21充气膨胀时，通过牵引索控制阀门板打开，使通道12内流体可以经侧孔13排出，在球囊21排气收缩时候，通过牵引索控制阀门板关闭，使通道12内流体从出口14排出。
进一步的，阀门板的形状和尺寸均与侧孔13相匹配，当阀门板封堵侧孔13时，阀门板的外壁与导管1的外壁齐平，从而避免在拔出导管时勾连血管组织。
图7和图8是将本公开实施例的调节装置用于体外心肺支持辅助时的状态示意图。请参见图7，导管1入口15连接ECMO，导管1的侧孔13放置于心脏冠状动脉4入口附近，体外氧合后的血液通过入口15注入导管通道12，在心脏射血周期以外的时间收缩球囊21，并关闭阀门板，大部分血流会顺着通道出口14方向流出，对除心脏以外的其他脏器进行灌注。请参见图8，在心脏射血时，对球囊21进行充气，并打开阀门板，氧合后的血液会从侧孔13射向冠状动脉4的入口方向，增加冠状动脉入口处血压、血流量以及血液含氧量。
本公开实施例在导管侧孔被放置于心脏冠状动脉入口附近时，通过与心脏同步的搏动输出血流，可以增加对冠状动脉的灌注量及灌注血液中血氧的含量。通过与心脏同步射血，能够模拟心脏搏动产生的血压血流搏动，提升下游器官(肝脏、肾脏等)的血流灌注效果。并且，在侧孔边沿设置阀门板，配合球囊状态对阀门板进行开合控制，阀门板在关闭状态下，能够引导血液向出口流出，在开启状态下，能够引导血液缓慢流向主动脉，防止从侧孔迸出的血液直接冲刷主动脉壁造成夹层。
以上实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这 些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上实施例仅表达了本公开的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本公开构思的前提下，还可以做出若干变形和改进，这些都属于本公开的保护范围。因此，本公开专利的保护范围应以所附权利要求为准。

Claims (10)

  1. 一种导流调节装置，其特征在于：包括导管和调节组件，所述导管用于导流流体，所述调节组件用于调节所述导管中流体的流向和/或流量；其中，
    所述导管包括管壁、由管壁限定的通道和开设在所述管壁上的侧孔，所述通道的一端为入口、另一端为出口，所述侧孔与所述通道连通且位于所述入口与所述出口之间；
    所述调节组件包括气源、球囊和气管，所述球囊设置在所述通道内且位于所述出口与所述侧孔之间，所述气源通过所述气管与所述球囊相连，用于对所述球囊进行充气或排气；所述球囊在充气后膨胀，以至少部分阻塞所述通道，增加经所述侧孔排出的流体的量，所述球囊在排气后收缩，以减小对所述通道的阻塞，增加经所述出口排出的流体的量。
  2. 根据权利要求1所述的装置，其特征在于，所述气源设置在所述通道以外。
  3. 根据权利要求2所述的装置，其特征在于，所述气源包括第一气源和第二气源，所述第一气源用于对所述球囊进行充气，所述第二气源用于对所述球囊进行排气。
  4. 根据权利要求3所述的装置，其特征在于，所述第一气源为高压气源；所述第二气源为负压气源或者大气。
  5. 根据权利要求3所述的装置，其特征在于，所述气管的一端与所述球囊相连、另一端为分支管路，所述分支管路包括第一支管和第二支管，所述第一支管与所述第一气源相连，所述第二支管与所述第二气源相连。
  6. 根据权利要求5所述的装置，其特征在于，所述第一支管上设有第一阀，所述第二支管上设有第二阀。
  7. 根据权利要求1所述的装置，其特征在于，所述导管还包括阀门板，所述阀门板的一侧与所述侧孔的周边相连，所述阀门板的另一侧为活动侧，当所述球囊处于收缩状态时，所述阀门板的活动侧贴近所述侧孔，当所述球囊处于膨胀状态时，所述阀门板的活动侧向远离所述侧孔的一侧偏转。
  8. 根据权利要求7所述的装置，其特征在于，所述阀门板的形状和尺寸均与所述侧孔相匹配。
  9. 根据权利要求7所述的装置，其特征在于，所述阀门板通过弹性件与所述侧孔的边沿相连；
    在所述球囊膨胀的情况下，所述阀门板的活动侧能够向远离所述侧孔的方向偏转；在所述球囊收缩的情况下，所述弹性件能够带动所述阀门板的活动侧靠近所述侧孔。
  10. 根据权利要求7所述的装置，其特征在于，所述阀门板的活动侧连接牵引索，所述牵引索向所述通道的入口延伸，
    当所述牵引索处于松弛状态时，所述阀门板的活动侧向远离所述侧孔的方向偏转，当所述牵引索处于收紧状态时，所述阀门板的活动侧贴近所述侧孔。
PCT/CN2021/092297 2021-03-02 2021-05-08 导流调节装置 WO2022183591A1 (zh)

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