ECMO trial stop device

Abstract

The present disclosure relates to the technical field of medical devices, and particularly relates to an ECMO trial stop device. The present disclosure provides an ECMO trial stop device, which comprises a valve body, a shunt baffle and a knob arranged outside the valve body for controlling rotation of the shunt baffle, the valve body is provided with a first joint, a second joint, a third joint and a fourth joint which are in communication with the inside of the valve body; the shunt baffle is arranged inside the valve body, and the shunt baffle can make the valve body form a first flow guiding state and a second flow guiding state; in the first flow guiding state, the first joint and the second joint are in communication, and the third joint and the fourth joint are in communication; in the second flow guiding state, the first joint and the third joint are in communication, and the second joint and the fourth joint are in communication. Through implementation of the technical scheme of the present disclosure, it can be ensured that during the ECMO trial stop, occurrence of trial stop "false negative" and "false positive" is avoided; and rapid conversion between trial stop and continued assistance can be performed, so that accidents during the trial stop are prevented.

Description

TECHNICAL FIELD

[0001] The present disclosure relates to the technical field of medical devices, in particular to an ECMO trial stop device. BACKGROUND

[0002] ECMO is a temporary auxiliary device for patients with circulatory and / or respiratory failure. When the patient's heart and lung function recovers, the auxiliary ECMO can be removed. When the VA-ECMO (VA bypass for combined heart and lung replacement mode) is removed, a trial stop test is needed to evaluate whether the ECMO can be removed to ensure patient safety or auxiliary again.

[0003] The current three VA-ECMO trial stop test schemes have certain defects. Scheme one is a reduced flow (0.5-1L / min) test. In order to enable blood to continue to circulate, the patient still has a certain flow assistance. Its disadvantage is that the patient may not be able to tolerate after weaning (false positive). Scheme two is a pump empty reverse flow (negative 0.5L / min) test. It increases the burden on the heart (0.5L / min). Like scheme one, it cannot completely achieve 0 flow. Its disadvantage is that it may fail the test for some patients who can be weaned (false negative). The above-mentioned scheme one and scheme two cannot guarantee the accuracy of the weaning index. Scheme three is a short circuit bridge test. Blood stratification and thrombus are easily formed at the ECMO cannula, causing cannula blockage, which requires forced removal of ECMO or replacement of the cannula. SUMMARY

[0004] In order to solve the above technical problems or at least partially solve the above technical problems, the present disclosure provides an ECMO trial stop device, comprising a valve body, a shunt baffle and a knob arranged outside the valve body for controlling rotation of the shunt baffle, wherein the valve body is provided with a first joint, a second joint, a third joint and a fourth joint which are in communication with the inside of the valve body;

[0005] The shunt baffle is arranged inside the valve body, and the shunt baffle can make the valve body form a first flow guiding state and a second flow guiding state;

[0006] In the first flow guiding state, the first joint and the second joint are in communication, and the third joint and the fourth joint are in communication;

[0007] In the second flow guiding state, the first joint and the fourth joint are in communication, and the second joint and the third joint are in communication.

[0008] Optionally, a limiting block is arranged on the inner wall of the valve body, and the limiting block is used to limit the shunt baffle at the position of the first flow guiding state or the second flow guiding state.

[0009] Optionally, a sealing strip is arranged on the limiting block, and the sealing strip is in abutment with the shunt baffle in the position of the first flow guiding state and the second flow guiding state.

[0010] Optionally, the first joint, the second joint, the third joint and the fourth joint are evenly arranged in the circumferential direction of the valve body.

[0011] Optionally, the first joint and the third joint are arranged as a first joint assembly, the second joint and the fourth joint are arranged as a second joint assembly, the first joint assembly and the second joint assembly are oppositely arranged on two sides of the valve body, and the first joint and the second joint are adjacently arranged, and the third joint and the fourth joint are adjacently arranged.

[0012] Optionally, a heparin coating is arranged on the inner wall of the valve body.

[0013] The present disclosure also provides a use method of the ECMO trial stop device.

[0014] Step one: adjust the ventilator level and the dosage of vasoactive drugs;

[0015] Step two: reduce the ECMO speed, clamp the pipe clamp at the standby decoupling position of the post-membrane ECMO loop and the pre-pump ECMO loop, then reduce the ECMO speed to 0 rpm, and cut the pipe clamp at the standby decoupling position;

[0016] Step three: connect the joints of the ECMO trial stop device with the broken ends of the post-membrane ECMO loop and the pre-pump ECMO loop, perform equipment exhaust before connecting the last broken end, ensure that there is no air in the loop and the ECMO trial stop device during connection, adjust the ECMO trial stop device to the second flow guiding state;

[0017] Step four: adjust the trial stop device to the first flow guiding state, adjust the ECMO speed, enter the trial stop state, and observe the patient's physical indicators during the trial stop period; if the patient's physical indicators are unstable during the trial stop period, adjust the trial stop device to the second flow guiding state, and continue the trial stop after stabilization.

[0018] Step five: if the patient's physical indicators meet the weaning criteria during the trial stop period, the ECMO can be removed; if the patient's physical indicators do not meet the weaning criteria during the trial stop period, adjust back to the second flow guiding state to continue ECMO assistance, and then trial stop again after the indicators recover.

[0019] Optionally, in step two, the ECMO speed is reduced to 1500 rpm.

[0020] Optionally, in the fourth step, the ECMO rotating speed is adjusted to 3 L / min, and the ECMO flow is 3 L / min, and the patient enters a trial stop state, the trial stop time is 1 hour, and the patient's physical indicators are observed, including heart rate, blood pressure, central venous pressure, echocardiogram, arterial and venous blood gas examination after 1 hour of trial stop.

[0021] Optionally, in the fifth step, the weaning criteria are as follows: stable blood pressure and heart rate after 1 hour of trial stop, CVP increase < 2 mmHg, normal left and right heart function assessed by echocardiogram, arterial blood gas lactic acid < 1.5 mmol / l, oxygen partial pressure > 80 mmHg, no respiratory and metabolic acid-base imbalance, and venous blood gas oxygen saturation > 65 mmHg, which meet the weaning criteria, and the ECMO can be removed.

[0022] Compared with the prior art, the beneficial effects of the present disclosure are as follows: the present disclosure is provided with four joints connected with the ECMO loop after the membrane and the ECMO loop before the pump, i.e., the arterial cannula membrane lung end, the venous cannula centrifugal pump end, the arterial cannula patient end, and the venous cannula patient end are connected, the valve body is formed into a first flow state (trial stop machine state) and a second flow state (auxiliary ECMO state) by a shunt baffle, in the first flow state, the arterial cannula patient end and the venous cannula patient end are communicated, and the arterial cannula membrane lung end and the venous cannula centrifugal pump end are communicated, so that no assistance is provided to the patient during the stop test, and the increase in the heart burden of the membrane lung oxygenator and other extracorporeal loops during the trial stop machine is reduced, and the occurrence of trial stop "false negative" is avoided; during the trial stop, no circulation assistance is provided, and no trial stop "false positive" occurs; in the second flow state, the valve body is switched between the first flow state and the second flow state by a knob driving the shunt baffle, the trial stop can be repeatedly attempted, and the membrane lung and the centrifugal pump have a larger flow during the ECMO trial stop, so that blood stratification and thrombosis are not easily caused. BRIEF DESCRIPTION OF DRAWINGS

[0023] The accompanying drawings, which are incorporated into and form a part of the specification, illustrate embodiments consistent with the present disclosure and, together with the description, serve to explain the principles of the disclosure.

[0024] In order to more clearly illustrate the technical solutions in the embodiments of the present disclosure or the prior art, the accompanying drawings needed to be used in the embodiments or prior art description will be briefly introduced as follows. Obviously, those skilled in the art can obtain other drawings according to these drawings without any creative effort.

[0025] Figure 1 It is a structural schematic view of the valve body inside the present disclosure;

[0026] Figure 2 It is a structural schematic view of the ECMO loop after the membrane and the ECMO loop before the pump which are not disconnected.

[0027] Figure 3 A structure schematic diagram of a second flow guiding state of the present disclosure;

[0028] Figure 4 A structure schematic diagram of a first flow guiding state of the present disclosure;

[0029] Figure 5 A structure schematic diagram of a three-dimensional of the present disclosure.

[0030] Wherein, 1-valve body; 2-shunt baffle; 3-knob; 4-limiting block; A-first joint; B-second joint; C-third joint; D-fourth joint. DETAILED DESCRIPTION

[0031] In order to enable the above-mentioned purposes, features and advantages of the present disclosure to be more clearly understood, the schemes of the present disclosure will be further described below. It should be noted that the embodiments of the present disclosure and the features in the embodiments can be combined with each other without conflict.

[0032] In the following description, many specific details are set forth in order to provide a thorough understanding of the present disclosure, but the present disclosure can also be implemented in other ways different from those described herein; obviously, the embodiments in the description are only some of the embodiments of the present disclosure, not all the embodiments.

[0033] ECMO is a temporary auxiliary device for patients with circulatory and / or respiratory failure. When the patient's heart and lung function recovers, the auxiliary ECMO can be removed. The current three VA-ECMO trial stop test schemes all have certain defects. Scheme one may appear after weaning the patient cannot tolerate and needs to be assisted again (false positive), scheme two may fail the test of some patients who can be weaned (false negative), and the above-mentioned scheme one and scheme two cannot guarantee the accuracy of the weaning index. Scheme three is a short-circuit bridge test, which is easy to form blood stratification and thrombus at the ECMO cannula, causing the cannula to be blocked, and ECMO needs to be forced to be removed or the cannula needs to be replaced.

[0034] Based on this, the ECMO trial stop device provided by the embodiments of the present disclosure can ensure that the membrane lung and centrifugal pump have a larger flow during the ECMO trial stop, and blood thrombus is not easy to form, at the same time, during the trial stop, the increase of the extracorporeal circuit such as the membrane lung oxygenator on the heart burden is reduced, and the occurrence of trial stop "false negative" is avoided; the scheme does not assist circulation during the trial stop, and does not appear trial stop "false positive"; at the same time, it also ensures that there is blood flow in the arterial and venous cannula and the distal perfusion tube, and blood stratification and thrombus are not easy to cause. It can also quickly switch between trial stop and continue assistance, and prevent accidents during trial stop.

[0035] The ECMO trial stop device will be described in detail through specific embodiments below:

[0036] Referring to Figures 1 to 5 The ECMO trial stop device provided by the present disclosure comprises a valve body 1, a shunt baffle 2, and a knob 3 arranged outside the valve body 1 for controlling the rotation of the shunt baffle 2. The specific shape of the knob 3 can be set as needed, and a long strip-shaped knob or a circular knob can be selected. Preferably, an indication mark is made on the knob 3 to distinguish the flow state.

[0037] The shunt baffle 2 of the present disclosure is arranged inside the valve body 1, and the shunt baffle 2 can make the valve body 1 form a first flow state and a second flow state. For example, the first flow state is a trial stop state, that is, the arterial cannula patient end and the venous cannula patient end are communicated, the arterial cannula membrane lung end and the venous cannula centrifugal pump end are communicated, and the shunt baffle 2 divides the valve body 1 into two independent passages. At this time, the patient end independently circulates, and the equipment end also independently circulates. At this time, the equipment is not stopped, which prevents the switching of the second flow state when the patient is not able to be offline. Further, the valve body 1 is provided with a first joint A, a second joint B, a third joint C, and a fourth joint D which are communicated with the inside of the valve body 1. The above four joints are respectively connected to the broken ends of the post-membrane ECMO loop and the pre-pump ECMO loop. Preferably, the above four joints are respectively capped to form a sterile environment, and the joints are sequentially opened when connected to the pipeline, and strict sterile operation is performed. The material of the present disclosure is selected from materials that can be subjected to high-pressure sterilization or ethylene oxide sterilization, which is convenient for secondary use.

[0038] In the first flow state, the first joint A and the second joint B are communicated, and the third joint C and the fourth joint D are communicated; in the second flow state, the first joint A and the fourth joint D are communicated, and the second joint B and the third joint C are communicated. Preferably, the first joint A, the second joint B, the third joint C, and the fourth joint D are evenly arranged on the circumference of the valve body 1 to facilitate better operation. Further, the first joint A and the third joint C are arranged as a first joint assembly, and the second joint B and the fourth joint D are arranged as a second joint assembly. The first joint assembly and the second joint assembly are oppositely arranged on the two sides of the valve body 1, and the first joint A and the second joint B are adjacently arranged, and the third joint C and the fourth joint D are adjacently arranged. This arrangement is more conducive to sterile operation and facilitates handheld operation of the device.

[0039] As Figure 2 The state shown in the figure is the state of the conventional post-membrane ECMO loop and pre-pump ECMO loop without being disconnected. The pipeline used in the above loop is generally arranged as a 3 / 8 inch pipeline. Figure 3 and 4As shown, the post-membrane ECMO loop and the pre-pump ECMO loop are connected to the various joints of the present disclosure after being disconnected, and the connection mode can adopt interference fit connection, threaded connection and the like. The present disclosure specifically selects interference fit connection, that is, the diameter of the joint is slightly larger than the inner diameter of the pipeline.

[0040] For example, the first joint A is connected to the venous cannula centrifugal pump end, the second joint B is connected to the arterial cannula membrane lung end, the third joint C is connected to the arterial cannula patient end, and the fourth joint D is connected to the venous cannula patient end. The second flow guide state is an auxiliary ECMO state, which is used for regulation and control in an emergency state where the patient is not suitable for shutdown to prevent accidents. In the second flow guide state, the first joint A and the fourth joint D are connected by rotating the shunt baffle 2, and the second joint B and the third joint C are connected, which is equivalent to the state of the post-membrane ECMO loop and the pre-pump ECMO loop not being disconnected.

[0041] In some embodiments, a limiting block 4 is arranged on the inner wall of the valve body 1, and the limiting block 4 is used to limit the position of the shunt baffle 2 in the first flow guide state or the second flow guide state. The position is the standard position of the first flow guide state and the second flow guide state, that is, the position of the shunt baffle 2 that can separate the valve body 1 into two independent passages. Taking the valve body 1 as a cube and a cylinder as an example, the position of the shunt baffle 2 in the first flow guide state and the second flow guide state is on the mutually perpendicular central axes of the valve body 1. Preferably, the number of limiting blocks 4 is four, and the specific arrangement is as shown in Figure 3 and Figure 4 As shown, the shunt baffle 2 can be switched between the flow guide states by rotating 45 degrees back and forth, which is simple, safe and reliable. Further, a sealing strip is arranged on the limiting block 4, and the sealing strip abuts against the shunt baffle 2 in the position of the first flow guide state and the second flow guide state, so as to achieve better sealing effect between the two flow guide cavities.

[0042] In some embodiments, a heparin coating is arranged on the inner wall of the valve body 1 to prevent blood coagulation and thrombus formation.

[0043] The present disclosure also provides a use method of the above-mentioned ECMO trial shutdown device, which comprises the following steps:

[0044] Step one: adjust the ventilator level and the dosage of vasoactive drugs;

[0045] Step two: reduce the ECMO speed to 1500 rpm, such as Figure 2The clamp is closed at the position of the clamp and the ECMO speed is reduced to 0 rpm. The ECMO speed is reduced to 1500 rpm to prevent blood reflux. If the speed is lower than 1500 rpm, blood reflux is likely to occur. If the speed is higher than 1500 rpm, the pressure is too high to cause the pipeline to be stretched out when the clamp is closed.

[0046] Step three: The connectors of the ECMO test stop device are connected to the broken ends of the post-membrane ECMO loop and the pre-pump ECMO loop respectively. The remaining part is injected with sterile saline, and the gas is discharged. When the last broken end is connected, water is sprayed into the connection port at the same time to ensure that there is no air in the loop and the test stop device during connection. When the ECMO test stop device is connected after the air is exhausted, the test stop device is rotated to the second flow guide state, the four pipeline clamps are loosened, the ECMO speed is 1500 rpm, and the state is a low-energy auxiliary state, which is set to allow the patient assembly to adapt to the stop state. Then continue to reduce the speed to adjust the ECMO speed to 1.5 L / min (the flow rate is reduced, and the speed is also reduced accordingly). After 0.5 mg / Kg of heparin is administered intravenously, the test stop is started (heparin can not be used if there is a bleeding tendency);

[0047] Step four: Adjust the test stop device to the first flow guide state, and adjust the ECMO speed to 3 L / min. Enter the test stop state, and the test stop time is 1 hour. Observe the patient's heart rate, blood pressure, central venous pressure, and echocardiogram. After 1 hour of test stop, arterial and venous blood gas tests are performed. If the patient's physical indicators are unstable during the test stop, the test stop device can be adjusted to the second flow guide state, and the test stop can be continued after the patient's physical indicators are stable.

[0048] Step five: After 1 hour of test stop, the patient's physical indicators meet the weaning criteria, i.e., stable blood pressure and heart rate, CVP increase <2 mmHg, echocardiogram assessment of left and right heart function is normal, arterial blood gas lactic acid <1.5 mmol / l, oxygen partial pressure >80 mmHg, no respiratory and metabolic acid-base imbalance, and venous blood gas oxygen saturation >65 mmHg. The ECMO can be removed. If the patient's physical indicators do not meet the weaning criteria during the test stop, adjust back to the second flow guide state and continue ECMO assistance. When the indicators recover, the test stop is performed again.

[0049] It has to be understood that any reference to both a technical term "first flow guiding state" and a technical term "second flow guiding state" is only intended to distinguish an entity or an operation from the other, and does not necessarily require or imply any such actual relationship or order between the entities or operations. Also, the use of the term "comprising" or "including" or any other variant thereof is intended to cover the non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but can also include other elements not expressly listed or inherent to such process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising a" does not exclude the existence of additional identical elements in the process, method, article, or apparatus including the element.

[0050] The foregoing is merely illustrative of the various ways and techniques by which the present disclosure can be implemented. Numerous modifications and adaptations will be readily apparent to those of ordinary skill in the art, and can be made without departing from the spirit or scope of the present disclosure. Accordingly, the disclosure is not to be limited by the foregoing description, but is only limited by the scope of the appended claims.

Claims

1. An ECMO trial stop device, characterized in that, The valve body (1), the shunt baffle (2) and the knob (3) arranged outside the valve body (1) for controlling the rotation of the shunt baffle (2), wherein, The valve body (1) is provided with a first joint (A), a second joint (B), a third joint (C) and a fourth joint (D) which are in communication with the inside of the valve body (1); The shunt baffle (2) is arranged inside the valve body (1), and the shunt baffle (2) can make the valve body (1) form a first flow state and a second flow state; In the first flow state, the first joint (A) and the second joint (B) are in communication, and the third joint (C) and the fourth joint (D) are in communication; In the second flow state, the first joint (A) and the fourth joint (D) are in communication, and the second joint (B) and the third joint (C) are in communication; The first joint (A) and the third joint (C) are arranged as a first joint assembly, the second joint (B) and the fourth joint (D) are arranged as a second joint assembly, the first joint assembly and the second joint assembly are arranged adjacent to each other on both sides of the valve body (1), and the first joint (A) and the second joint (B) are arranged adjacent to each other, and the third joint (C) and the fourth joint (D) are arranged adjacent to each other; The first joint (A) is connected to the centrifugal pump end of the venous cannula, the second joint (B) is connected to the membrane lung end of the arterial cannula, the third joint (C) is connected to the patient end of the arterial cannula, and the fourth joint (D) is connected to the patient end of the venous cannula.

2. The ECMO trial stop device of claim 1, wherein, A limiting block (4) is arranged on the inner wall of the valve body (1), and the limiting block (4) is used to limit the shunt baffle (2) to the position of the first flow state or the second flow state.

3. The ECMO trial stop device of claim 2, wherein, A sealing strip is arranged on the limiting block (4), and the sealing strip abuts against the shunt baffle (2) when the valve body (1) is in the first flow state or the second flow state.

4. The ECMO trial stop device according to any one of claims 1 to 3, characterized in that The first joint (A), the second joint (B), the third joint (C) and the fourth joint (D) are evenly arranged on the circumference of the valve body (1).

5. The ECMO trial stop device of claim 1, wherein, The inner wall of the valve body (1) is provided with a heparin coating.

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