Fluid suction device for controlling suction pressure, medical device and method for vascular suction

Abstract

The application provides a fluid suction device, a medical device and a blood vessel suction method for controlling suction pressure. A suction pump is connected to the suction pipeline for providing pulse pressure to suction fluid. A fluid flow rate, pressure or flow sensor is arranged in the suction pump, the suction pipeline or any position where fluid flows between the suction pump and the suction pipeline. The fluid flow rate, pressure or flow sensor is electrically connected to the controller of the suction pump. Resistance in the suction pipeline is obtained according to the detection result of the fluid flow rate, pressure or flow sensor. When the detection result shows that the resistance increases by more than a preset value, the suction efficiency of the suction pump is increased. The application can continuously and real-timely measure pipeline resistance and its change during the suction process, control optimal suction pressure, improve suction efficiency, reduce blood loss and improve suction safety.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, in particular, to a fluid aspiration device for controlling aspiration pressure, a medical device and a vascular aspiration method. BACKGROUND

[0002] Thrombus is a common clinical disease. The main hazards of thrombus are 1) thrombus blocks the blood vessel lumen, causing the blood to be blocked from flowing back to the distal end; 2) thrombus falls off and causes serious harm such as pulmonary embolism, cerebral embolism and myocardial embolism. Thrombus aspiration is a method of sending a catheter to the thrombus under negative pressure and directly sucking the thrombus into the catheter to remove the thrombus. The advantages of thrombus aspiration by catheter intervention method are (1) minimally invasive. High-risk embolism patients are critically ill and often difficult to tolerate traditional open surgery. Relatively speaking, interventional treatment completes catheter aspiration operation under local anesthesia, with small trauma and rapid recovery; (2) rapid and effective.

[0003] At present, the development of thrombus aspiration technology focuses on the following aspects:

[0004] 1. Aspiration catheter and overall system composition - the aspiration catheter overall system is composed of a guide or balloon guide catheter, a delivery catheter and an aspiration catheter, an aspiration pump, a thrombus plaque collector and a thrombus plaque fragmenter (US 2019 / 0216476A1 - Penumbar Inc.)

[0005] 2. Aspiration catheter with pre-treatment function for thrombus plaque - a metal wire stirring device (CN 201410670082) or a blade (US 2019 / 0142452A1 - Penumbar Inc.) is arranged at the front end of the aspiration catheter to fragment the thrombus plaque for aspiration.

[0006] 3. Aspiration catheter with aspiration and flushing two channels, control box linked with two channels of catheter, complete aspiration and flushing under synchronous control (US 10944944B2 - Boston Scientific Scimed Inc.); further prevent aspiration channel from being blocked, and the process of removing the catheter to remove the thrombus plaque and inserting the catheter again.

[0007] The resistance in the catheter of the aspiration system is a variable, which changes with the relative position, shape, etc. of the thrombus. At present, there is no effective method for continuously and real-timely measuring the resistance in the catheter and its change when the thrombus is continuously aspirated. Without the technology for real-timely monitoring the resistance and the change of the resistance, the aspiration pressure can only be controlled by the experienced operator, which is difficult to improve the aspiration efficiency, reduce the blood loss and has the safety hidden danger. When the aspiration force is 60ml / min, the blood loss caused by the aspiration can reach 30ml / min. In the process of the pulmonary embolism aspiration operation, if the blood loss exceeds 300-350ml, the aspiration operation must be stopped. There is also a clinical report that the increase of the blood loss causes the decrease of the hemoglobin concentration, which makes the incidence of the adverse events of the aspiration operation increase, the decrease of the hemoglobin concentration below the normal indicates the poor prognosis and is the risk factor of the recent mortality of the acute pulmonary embolism patients. SUMMARY

[0008] In view of the defects in the prior art, the purpose of the present application is to provide a fluid aspiration device for controlling the aspiration pressure, a medical device and a vascular aspiration method.

[0009] According to the present application, a fluid aspiration device for controlling the aspiration pressure is provided, which comprises an aspiration pump, an aspiration pipeline and a fluid flow rate, pressure or flow sensor.

[0010] The aspiration pump is connected to the aspiration pipeline and is used for providing a pulse pressure to aspirate the fluid.

[0011] The fluid flow rate, pressure or flow sensor is arranged at any position where the fluid flows through in the aspiration pump, the aspiration pipeline or between the aspiration pump and the aspiration pipeline. The fluid flow rate, pressure or flow sensor is electrically connected to the controller of the aspiration pump. The number of the fluid flow rate, pressure or flow sensors is one or more.

[0012] The resistance in the aspiration pipeline is obtained according to the result detected by the fluid flow rate, pressure or flow sensor.

[0013] When the increase of the resistance exceeds the preset value, the aspiration efficiency of the aspiration pump is increased.

[0014] Preferably, the aspiration pump has an adjustable constant baseline pressure P0 and can superimpose a pulse pressure with a pressure change amount dP on the basis of the constant baseline pressure P0. The frequency, amplitude and waveform of the pulse pressure are adjustable.

[0015] In the state of the constant baseline pressure P0, the flow rate of the fluid is Q0, and the resistance R0(t) at the time t is P0(t) / Q0(t).

[0016] In the case of superimposing a pressure change amount dP on a constant baseline pressure P0, the flow rate change amount is dQ, and the resistance R(t) at time t is dP(t) / dQ(t).

[0017] Preferably, the fluid flow rate sensor comprises a heater, a first temperature sensor and a second temperature sensor.

[0018] The first temperature sensor and the second temperature sensor have a preset distance D, and the heater is arranged at the first temperature sensor or on the side of the first temperature sensor away from the second temperature sensor.

[0019] The heater heats the temperature of the fluid to be measured to make the fluid to be measured generate a temperature pulse for the first temperature sensor and the second temperature sensor to detect, and obtain the time interval T of the temperature pulse detected by the first temperature sensor and the second temperature sensor.

[0020] The flow rate V of the fluid is D / T, and the flow Q of the fluid is VA, A being the cross-sectional area of the position where the fluid flow rate sensor is located.

[0021] Preferably, the first temperature sensor and the second temperature sensor are both semiconductor sensors.

[0022] Preferably, the fluid flow rate sensor is packaged in a sheet structure.

[0023] According to the present application, a medical device is provided, comprising the fluid suction device for controlling suction pressure.

[0024] Preferably, the medical device comprises a vascular interventional instrument, and the fluid flow rate sensor, the pressure sensor or the flow sensor is arranged in the suction pipeline or arranged at or built in the liquid storage tank interface of the vascular interventional instrument.

[0025] Preferably, the vascular interventional instrument comprises a guide wire, a balloon catheter, a contrast catheter or a guide catheter.

[0026] According to the present application, a vascular suction method for controlling suction pressure is provided, which uses the fluid suction device for controlling suction amount to perform vascular suction, increases the suction efficiency of the suction pump when the resistance increase exceeds the preset value, and stops suction or gives a warning when the flow rate of suction is greater than the preset value.

[0027] Preferably, the suction pump has an adjustable constant baseline pressure P0 and can superimpose a pulse pressure with a pressure change amount dP on the basis of the constant baseline pressure P0, and the frequency, amplitude and waveform of the pulse pressure are adjustable.

[0028] In the state of constant baseline pressure P0, the flow rate of the fluid is Q0, and the resistance R0(t) at time t is P0(t) / Q0(t);

[0029] In the case of constant baseline pressure P0 superimposed with pressure change dP, the change in flow rate is dQ, and the resistance R(t) at time t is dP(t) / dQ(t).

[0030] Compared with the prior art, the present application has the following beneficial effects:

[0031] The present application can continuously and real-timely measure the pipeline resistance and its change during the suction process, control the optimal suction pressure, improve the suction efficiency and reduce the amount of blood loss, and improve the suction safety. In addition, the present application is also beneficial for (1) optimizing the suction efficiency according to the actual situation during the suction in the human body, and not relying on experienced operators; (2) simple and reliable suction equipment and instruments; (3) when using the built-in sensor of the suction pump, no power supply is needed in the suction catheter, avoiding the coagulation concerns caused by the heat generated by the power supply and other factors affecting safety. BRIEF DESCRIPTION OF DRAWINGS

[0032] Other features, objects and advantages of the present application will become more apparent from the following detailed description of non-limiting embodiments with reference to the attached drawings:

[0033] Figure 1 The working principle diagram of the fluid flow rate sensor of the present application;

[0034] Figure 2 The structural schematic diagram of the blood suction equipment;

[0035] Figure 3 The schematic diagram of measuring the change in pipeline flow rate and suction pressure according to the embodiment of the present application;

[0036] Figure 4 The working principle diagram of the present application. DETAILED DESCRIPTION

[0037] The present application will be described in detail below with reference to specific embodiments. The following embodiments will help those skilled in the art to further understand the present application, but do not limit the present application in any form. It should be noted that those skilled in the art can make several changes and improvements without departing from the concept of the present application. These all belong to the protection scope of the present application.

[0038] The application provides a fluid suction device for controlling suction pressure, comprising a suction pump, a suction pipeline and a fluid flow rate, pressure or flow sensor.

[0039] Wherein, the fluid flow rate sensor detects the flow rate V of the fluid in the path; wherein, the flow rate Q of the fluid = VA, A is the cross-sectional area of the position where the fluid flow rate sensor is located; at time t, the resistance R(t) in the suction pipeline = P / Q, P is the suction pressure of the suction pump; in the state of detecting that the resistance increases by more than a preset value, the suction efficiency of the suction pump is increased.

[0040] As shown in Figure 1 The fluid flow rate sensor comprises a heater 2, a first temperature sensor 1 and a second temperature sensor 3, and the heater 2, the first temperature sensor 1 and the second temperature sensor 3 are arranged on the same substrate 4 for convenient installation. The first temperature sensor 1 and the second temperature sensor 3 have a preset distance D, and the heater 2 is arranged at the first temperature sensor 1 or on the side of the first temperature sensor 1 away from the second temperature sensor 3.

[0041] The working principle of the fluid flow rate sensor is as follows:

[0042] The heater 2 heats the temperature of the fluid to be measured, so that the fluid to be measured generates a temperature pulse, which is detected by the first temperature sensor 1 and the second temperature sensor 3. Since the heater 2 is arranged at the first temperature sensor 1 or on the side of the first temperature sensor 1 away from the second temperature sensor 3, the first temperature sensor 1 will detect the temperature pulse earlier than the second temperature sensor 3, that is, the time interval T of the temperature pulse detected by the first temperature sensor 1 and the second temperature sensor 3.

[0043] Thus, we get:

[0044] The flow rate V of the fluid to be measured = D / T, and the flow rate Q of the fluid to be measured = VA, A is the cross-sectional area of the position where the fluid flow rate sensor is located.

[0045] The suction pump has an adjustable constant baseline pressure P0 and can superimpose a pulse pressure with a pressure change of dP onto the constant baseline pressure P0. The frequency, amplitude, and waveform of the pulse pressure are adjustable. Both the constant baseline pressure P0 and the pressure change dP are negative pressures. Under the constant baseline pressure P0, the fluid flow rate is Q0, and the resistance at time t is R0(t) = P0(t) / Q0(t). Under the constant baseline pressure P0 superimposed with the pressure change dP, the flow rate change is dQ, and the resistance at time t is R(t) = dP(t) / dQ(t). Under the constant baseline pressure, the thrombus is static, and the pulse pressure is used to aspirate the thrombus.

[0046] Both the first and second temperature sensors of this invention are semiconductor sensors, such as MEMS sensors. Meanwhile, the fluid flow rate sensor is packaged in a sheet-like structure for easy mounting on the surface of a detection device or embedding inside a pipeline.

[0047] This invention provides a blood aspiration device that acquires the blood flow rate and volume using a fluid flow rate sensor. Blood aspiration devices, such as vascular interventional devices, are mentioned here. Vascular interventional devices include guidewires, balloon catheters, angiography catheters, or guiding catheters, thereby detecting the blood aspiration flow rate and volume during thrombectomy procedures. Figure 2 , 3 As shown in the dashed box, the fluid velocity sensor can be installed inside the suction pump 8, inside the suction line 5 of the blood suction device, at the rear end of the suction line 5, or at the inlet and outlet of the storage tank 7 used for liquid storage after suction, as well as in the suction pump. Figure 4 The five positions S1 to S5 shown can all be equipped with sensors, or only one; this invention does not impose any restrictions. For example, a single sensor at position S5 is sufficient to achieve the function, and since the space at position S5 is relatively large, a more conventional sensor can be used. When used outside the aspiration tubing 5, no power supply is required in the aspiration tubing to avoid concerns about blood clotting caused by heat from the power source and other factors affecting safety. During vascular aspiration, the aspiration pressure must always be kept lower than the intravascular pressure, and the aspiration pressure must be negative.

[0048] Figure 2 As shown, a display 6 can also be set up. The fluid velocity sensor sends the acquired flow velocity and flow rate information to the display via wired or wireless means for real-time reporting of the patient's status during interventional aspiration.

[0049] This blood aspiration device can be used to aspirate thrombi, and can measure the blood flow rate, volume, and resistance in blood vessels or cavities to enable real-time control of blood loss during thrombus aspiration, reduce the decrease in hemoglobin concentration caused by increased blood loss, and reduce the incidence of adverse clinical events during aspiration surgery.

[0050] Embodiment 2

[0051] The present application provides a blood vessel suction method for controlling suction pressure, which adopts the fluid suction device for controlling suction amount to perform blood vessel suction, and in the state that the detected resistance increase exceeds the preset value, increases the suction efficiency of the suction pump, and in the case that the suction flow is greater than the preset value, stops the suction or gives a warning.

[0052] The suction pump has an adjustable constant baseline pressure P0, and can superimpose a pulse pressure with a pressure change amount dP on the basis of the constant baseline pressure P0, and the pulse pressure frequency and amplitude are adjustable;

[0053] In the state of the constant baseline pressure P0, the flow of the fluid is Q0, and the resistance R0(t) at time t is P0(t) / Q0(t);

[0054] In the case of superimposing the constant baseline pressure P0 with the pressure change amount dP, the flow change amount is dQ, and the resistance R(t) at time t is dP(t) / dQ(t).

[0055] As Figure 3 The figure shows the change of the suction pressure and the detected flow collected in a test using the present application.

[0056] In the description of the present application, it should be understood that the terms "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as a limitation on the present application.

[0057] The specific embodiments of the present application have been described above. It should be understood that the present application is not limited to the above specific embodiments, and those skilled in the art can make various changes or modifications within the scope of the claims, which does not affect the essential content of the present application. In the case of no conflict, the embodiments of the present application and the features in the embodiments can be combined with each other arbitrarily.

Claims

1. A fluid suction device for controlling suction pressure, characterized by, The application relates to a fluid suction device for controlling suction pressure. The fluid suction device comprises a suction pump, a suction pipeline and a fluid flow rate, pressure or flow sensor. The suction pump is connected to the suction pipeline to provide pulse pressure for sucking thrombus. The fluid flow rate, pressure or flow sensor is arranged at any position of the suction pump, the suction pipeline or blood flow between the suction pump and the suction pipeline, and is electrically connected to the controller of the suction pump. The number of the fluid flow rate, pressure or flow sensor is one or more. The resistance in the suction pipeline is obtained according to the detection result of the fluid flow rate, pressure or flow sensor. When the increase of the resistance exceeds a preset value, the suction efficiency of the suction pump is increased. The suction pump has an adjustable constant baseline pressure P0, and can superimpose pulse pressure with a pressure change amount dP on the basis of the constant baseline pressure P0. The frequency, amplitude and waveform of the pulse pressure are adjustable. When the constant baseline pressure P0 is in a state, the flow rate of blood is Q0, and the resistance R0(t)=P0(t) / Q0(t) at the moment t. When the constant baseline pressure P0 is superimposed with the pressure change amount dP, the flow rate changes by dQ, and the resistance R(t)=dP(t) / dQ(t) at the moment t. The fluid flow rate sensor comprises a heater, a first temperature sensor and a second temperature sensor. The first temperature sensor and the second temperature sensor have a preset distance D, and the heater is arranged at the first temperature sensor or at the side of the first temperature sensor away from the second temperature sensor. The heater heats the temperature of the blood to be measured, so that the blood to be measured generates a temperature pulse, which is detected by the first temperature sensor and the second temperature sensor, and the time interval T of the temperature pulse detected by the first temperature sensor and the second temperature sensor is obtained. The flow rate V of blood is D / T, and the flow rate Q of blood is VA, wherein A is the cross-sectional area of the position where the fluid flow rate sensor is arranged. During the blood vessel suction process, the suction pressure is always lower than the pressure in the blood vessel, and the suction pressure is negative pressure.

2. The fluid suction device of claim 1, wherein, According to the blood flow rate, flow rate and resistance, the amount of blood loss during the thrombus suction process is controlled in real time.

3. The fluid suction apparatus that controls suction pressure according to claim 1, characterized by, Under the constant baseline pressure, the thrombus is in a static state, and the pulse pressure is used to suck the thrombus.

4. A medical device, characterized by The first temperature sensor and the second temperature sensor are both semiconductor sensors.

5. The medical device of claim 4, wherein, The fluid flow rate sensor is packaged in a sheet structure.

6. The medical device of claim 5, wherein, The application further discloses a fluid suction device for controlling suction pressure. The medical device comprises a blood vessel intervention instrument, and the fluid flow rate, pressure or flow sensor is arranged in the suction pipeline or at a liquid storage tank interface of the blood vessel intervention instrument or in the suction pump. The blood vessel intervention instrument comprises a guide wire, a balloon catheter, a contrast catheter or a guide catheter. The application further discloses a medical device. The medical device comprises a blood vessel intervention instrument, and the fluid flow rate, pressure or flow sensor is arranged in the suction pipeline or at a liquid storage tank interface of the blood vessel intervention instrument or in the suction pump. The blood vessel intervention instrument comprises a guide wire, a balloon catheter, a contrast catheter or a guide catheter.

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