Extracorporeal circulation catheter with sensor

Abstract

In order to solve the technical problem of poor stability of a catheter in vivo in the prior art, the utility model provides the extracorporeal circulation catheter with the sensor, the extracorporeal circulation catheter comprises an intracorporeal end head, the intracorporeal end head is provided with a drainage port along the catheter wall, and the sensor is arranged at the front end and / or the rear end of the drainage port. The sensor is additionally arranged near the drainage opening of the catheter to monitor the liquid pressure of the catheter in the environments where the catheter is located at different positions, and the aorta pressure waveform of a patient is combined, so that the position of the head of the inner end of the catheter can be judged, an operator can be conveniently guided to insert the catheter in place without monitoring, and the operation efficiency is improved. And in addition, the position of the extracorporeal circulation guide pipe and the flow and pressure conditions in the guide pipe can be monitored during the operation period of the extracorporeal centrifugal pump, so that the stability and safety of the guide pipe in the body are improved.

Description

TECHNICAL FIELD

[0001] The utility model relates to artificial auxiliary heart spare part technical field especially, relate to a kind of extracorporeal circulation catheter with sensor. BACKGROUND

[0002] At present, cardiogenic shock (CS) and high-risk PCI are two common and severe cardiovascular diseases. Cardiogenic shock (CS) is a syndrome caused by acute myocardial infarction or other causes, which leads to severe insufficient heart pumping function and further leads to insufficient perfusion of systemic tissues. High-risk PCI refers to the risk of myocardial infarction, cardiogenic shock or death faced by patients during or after percutaneous coronary intervention (PCI), which is usually related to factors such as severe coronary artery disease, left main or multi-vessel involvement, and left ventricular dysfunction. These two diseases have a significant impact on the quality of life and prognosis of patients.

[0003] For these two diseases, mechanical circulatory support devices (MCS) have become an important treatment method. MCS aims to help patients improve heart pumping volume, maintain blood supply to vital organs, and reduce heart load, thereby improving the vital signs of patients. MCS can be divided into temporary auxiliary devices and long-term auxiliary devices, and temporary auxiliary devices are more commonly used in the treatment of cardiogenic shock and high-risk PCI.

[0004] Temporary auxiliary device technology includes aortic counterpulsation balloon (IABP), percutaneous auxiliary device based on catheter axial flow pump (Impella), extracorporeal membrane oxygenation (ECMO), and auxiliary circulation based on extracorporeal centrifugal pump. However, these technologies have their own advantages and disadvantages. For example, IABP and Impella have limited auxiliary flow, and may not be effective for critically ill patients; ECMO can provide higher auxiliary flow, but its operation is complex and has a higher risk of complications.

[0005] Auxiliary circulation devices based on in-vitro centrifugal pumps have attracted much attention due to their ability to provide high flow rates. It directly extracts blood from the left heart through a percutaneous extracorporeal circulation catheter and pumps it into the femoral artery after passing through an extracorporeal blood pump. Compared with ECMO, its structure is simpler. However, in the current structure, the extracorporeal circulation catheter is the only channel for blood to be drawn out of the body and returned to the body. Therefore, the patency, compatibility and matching of the catheter with the blood vessel are key factors to ensure the success of the treatment. The existing extracorporeal circulation catheter mainly consists of three parts: an intracorporeal end head, a main body and a connecting part. The intracorporeal end head is the frontmost part of the catheter, and in order to ensure the patency of blood flow, it is usually designed as a straight tube with a length of 50-60 cm. One or more round holes are specially provided on the wall of the end head, and the main function of these round holes is to allow the catheter to extract blood from the heart. The main body is a key part connecting the intracorporeal end head and the connecting part. It adopts a soft tubular structure with certain toughness and elasticity, which enables it to adapt to various shapes and curvatures of the intracorporeal end head and the blood vessel. The connecting part is the interface between the catheter and the extracorporeal blood pump.

[0006] The common extracorporeal circulation pipeline needs to be connected with the heart and arterial system through surgical operation, and the common connection positions include the left ventricle and the aorta. In order to reduce the influence of surgical operation on the patient, the catheter can be placed in the body by interventional method to establish a circulation path. A common circulation path is to place the drainage tube into the large vein of the human body, reach the right atrium, and then place the drainage port of the drainage tube in the left atrium through the foramen ovale puncture hole, so as to facilitate the pipeline to extract the arterial blood of the left atrium. However, due to the relatively complex path from the femoral vein to the left atrium, it needs to pass through multiple blood vessel branches and heart structures, in order to reduce the blindness and uncertainty of the operation, the catheter needs to be guided by X-ray after entering the blood vessel from the femoral vein, and then enter the left atrium to extract blood. However, this method not only increases the difficulty and time of the operation, but also increases the radiation risk of the patient and the operator. In addition, during the entire auxiliary period, the catheter head end also needs to be kept in a suitable position in the left atrium to ensure sufficient drainage volume, but there is currently a lack of monitoring devices in the body, and once the catheter position is improper, it can cause serious harm to the patient, such as thrombosis, heart perforation, etc.

[0007] Therefore, how to improve the stability and safety of the catheter in the body has become a technical problem to be solved by those skilled in the art. Practical new type content

[0008] The utility model aims at solving the technical problems existing in the prior art, and provides an extracorporeal circulation catheter with a sensor, which can improve the stability and safety of the catheter in the body.

[0009] The utility model discloses a technical scheme is realized through following measures, a kind of extracorporeal circulation catheter with sensor, including in-vivo end head, in-vivo end head is provided with drainage port along pipe wall, the front end and / or rear end of the drainage port is provided with sensor.

[0010] Further, the in-vivo end head is provided with a curved section.

[0011] Further, the drainage port is provided with more than 6.

[0012] Further, the drainage port is provided with a rectangular, circular or square shape.

[0013] Further, the sensor includes a pressure sensor and / or a deformation sensor.

[0014] Further, the sensor is provided with multiple, and multiple sensors form a sensor array along the axis direction of the in-vivo end head.

[0015] Further, the sensor array includes a first sensing region, a second sensing region and a third sensing region arranged in sequence from the distal end to the proximal end of the extracorporeal circulation catheter.

[0016] Further, the first sensing region and the second sensing region are located on both sides of the drainage port.

[0017] The extracorporeal circulation catheter with sensor includes an in-vivo end head, and the in-vivo end head is provided with a drainage port along the pipe wall. By adding a sensor near the drainage port of the catheter, the liquid pressure of the environment at different positions of the catheter is monitored, and the position of the in-vivo end head of the catheter is determined in combination with the aortic pressure waveform of the patient. The catheter can be inserted into position without monitoring, which is convenient for guiding the operator to operate. Moreover, the position of the extracorporeal circulation catheter, the flow and pressure in the catheter can be monitored during the operation of the extracorporeal centrifugal pump, thereby improving the stability and safety of the catheter in the body. BRIEF DESCRIPTION OF DRAWINGS

[0018] Figure 1 is the first embodiment schematic diagram of the utility model;

[0019] Figure 2 is the second embodiment schematic diagram of the utility model;

[0020] Reference signs:

[0021] 100 catheter, 110 in-vivo end head, 120 curved section, 130 drainage port, 200 sensor, 210 first sensing region, 220 second sensing region, 230 third sensing region. DETAILED DESCRIPTION

[0022] In the description of the present application, it should be understood that the terms "longitudinal", "transverse", "upper", "lower", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer" and the like indicate 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.

[0023] In the description of the present application, unless otherwise specified and limited, it should be noted that the terms "mounting", "connecting", "connection" should be understood broadly, for example, it can be mechanical connection or electrical connection, or the communication between two elements, or direct connection, or indirect connection through intermediate medium. For those skilled in the art, the specific meaning of the above terms can be understood according to the specific circumstances. The terms "extracorporeal circulation conduit" and "conduit" refer to the same component.

[0024] In the description of the present application, the description of the terms "one embodiment", "some embodiments", "example", "specific example" or "some examples" means that the specific features, structures, materials or characteristics described in connection with the embodiment or example are included in at least one embodiment or example of the present application. In the present application, the illustrative description of the above terms does not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any one or more embodiments or examples in a suitable manner.

[0025] The embodiments of the present application are described in detail below, and examples of the embodiments are shown in the drawings, wherein the same or similar reference numerals represent the same or similar elements or elements having the same or similar functions throughout. The embodiments described below by referring to the drawings are exemplary and are only used to explain the present application, and cannot be understood as a limitation on the present application.

[0026] The extracorporeal circulation catheter 100 of the embodiment has a sensor, which includes an in-vivo end head 110 directly contacting the in-vivo environment of the patient, and a drainage port 130 provided along the wall of the catheter 100, so that the blood can smoothly enter the inside of the catheter 100, and the front end and / or the rear end of the drainage port 130 is provided with a sensor 200. By adding the sensor 200 near the drainage port 130 of the catheter 100, the liquid pressure of the environment where the catheter 100 is located at different positions is monitored, combined with the aortic pressure waveform of the patient, so that the position of the in-vivo end head 110 of the catheter 100 can be determined, which can not only facilitate the operator to insert the catheter 100 into the position without monitoring, but also can continuously monitor the position of the extracorporeal circulation catheter 100 and the flow and pressure in the catheter 100 during the operation of the extracorporeal centrifugal pump, thereby improving the stability and safety of the catheter 100 in the body, and ensuring the continuity and safety of the treatment.

[0027] Further, in other embodiments of the present application, in order to reach the left atrium through femoral vein puncture, the length of the extracorporeal circulation catheter 100 used in the present application should be more than 70 cm, and in order to match the anatomical position of the human body blood vessels and heart, a curved section 120 is usually arranged on the side of the in-vivo end head 110 close to the main body part, so that the catheter 100 can be more naturally fitted to the blood vessel, reducing the stimulation and damage to the blood vessel wall. Then the distal end of the catheter 100 passes through the atrial septal perforation, and about 3-4 cm is reserved in the left atrium, to ensure that the blood can smoothly enter the catheter 100.

[0028] In the present case, the side of the in-vivo end head 110 close to the main body part is the proximal end of the catheter 100, and the side away from the main body part is the distal end of the catheter 100.

[0029] Further, in other embodiments of the present application, the drainage port 130 is arranged on the side wall of the in-vivo end head 110 reserved in the left atrium, which facilitates the blood to enter the catheter 100 from these drainage ports 130, and ensures that the flow rate or suction pressure is not too large under large flow, thereby ensuring the smooth progress of the treatment. The number and size of the drainage ports 130 are various, and the specific design is determined according to the flow demand, and usually the number is more than 6, which is better, especially the symmetric arrangement on the side wall of the in-vivo end head 110 is the best. The shape of the drainage port 130 can be circular, oval or square, to adapt to different treatment needs.

[0030] To further improve the accuracy of the position monitoring of the catheter 100 in the human body and the accuracy of the evaluation of the drainage condition, the embodiment is provided with the sensors 200 at both ends of the drainage port 130 area. Specifically, the first sensing area 210 is located at the distal end of the catheter 100, and the second sensing area 220 is located at the proximal end of the catheter 100, and the third sensing area 230 is further provided at a certain distance from the proximal end of the drainage port 130 area. These sensors 200 form a sensor 200 array, which can provide more detailed pressure distribution for the operator and help determine whether the catheter 100 reaches the predetermined position. Moreover, through the data of the sensors 200 at different positions, the drainage condition of the catheter 100 can be more accurately evaluated, thereby further improving the stability and safety of the catheter 100 in the body.

[0031] Further, in other embodiments of the present application, the sensors 200 include pressure sensors 200 and / or deformation sensors 200. In specific implementation, the data collected by the installed sensors 200 can be pressure or deformation, which is ultimately converted into the blood pressure at the position of the catheter 100. The pressure sensor 200 can be selected as an absolute pressure sensor 200 or a relative pressure sensor 200. The relative pressure sensor 200 measures the pressure difference between two sensing areas in the sensor 200 array, which is particularly suitable for complex human environments because it can provide more detailed pressure change information. In specific implementation, the third sensing area 230 can be arranged at the bending part of the catheter 100 to monitor the pressure difference between the inside and outside of the catheter 100, so as to more accurately determine the position of the in-vivo end head 110, thereby improving the stability and safety of the catheter 100 in the body.

[0032] In other embodiments of the present application, the sensor 200 can be a single pressure sensor 200 or a single other sensor 200, and the single pressure sensor 200 can also be a type of sensor 200 with a larger size in the axial or length direction. When the atrial septum contacts the pressure sensor 200, different pressure values will be generated, thereby also determining the position of the in-vivo end head 110 and the drainage port area of the in-vivo end head 110.

[0033] In order to better manage the data collected by the sensor 200, the auxiliary circulation device based on the extracorporeal centrifugal pump in the application further comprises a controller, a display device, an alarm device and a data terminal. The data terminal can select a cloud platform to realize remote storage and access of data. The lead of the sensor 200 can be buried in the wall of the catheter 100 in a spiral form, which not only ensures the flexibility of the catheter 100, but also ensures the reliability of data transmission. The other end of the lead is connected with the controller, the sensor 200 collects the pressure data of the blood at the end head 110 of the body, and transmits the pressure data to the controller. The controller is connected with the display device, and the collected pressure data can be displayed through the display device. The controller is also connected with the data terminal and the alarm device, and the collected pressure data is stored through the data terminal. The threshold corresponding to the pressure data is also preset in the controller. If the collected pressure data is greater than the corresponding threshold, the controller will issue an instruction to the alarm device to alarm.

[0034] During the insertion process of the catheter 100 of the application, the pressure signal changes of the first sensing area 210, the second sensing area 220 and the third sensing area 230 can be monitored to accurately determine whether the catheter 100 reaches the predetermined position. When the catheter 100 does not enter the left atrium, the pressure signals returned by the sensors 200 of the first sensing area 210, the second sensing area 220 and the third sensing area 230 are consistent, which are usually venous pressure or right atrial pressure, and have low fluctuation and low amplitude (less than 5mmHg). When the catheter 100 begins to enter the left atrium, the sensor 200 of the first sensing area 210 will measure the pressure of the left atrium, and the pressure amplitude will increase obviously by about 10mmHg, while the sensors 200 of the second sensing area 220 and the third sensing area 230 which do not enter the left atrium still display the right atrial pressure. During the continuous forward movement, until the pressure waveforms of the first sensing area 210 and the second sensing area 220 are consistent, which are left atrial pressure waveforms, and the pressure waveform of the third sensing area 230 is right atrial or venous pressure, it can be determined that the catheter 100 reaches the appropriate position. The structure selected in the application is completely based on the change of pressure data, which can be completed without X-ray guidance, greatly reducing the radiation risk, and also providing convenience for bedside intubation.

[0035] In other embodiments of the present application, when the installed sensor 200 is selected as a relative pressure sensor 200, the venous pressure can be used as a reference for calculation, or the pressure data of the third sensing area 230 can be used as a reference. This selection enables us to more comprehensively understand the pressure changes inside and outside the catheter 100, so as to timely discover and handle possible problems. For example, when the pressure inside the catheter 100 is abnormal, each sensor 200 will appear the same amplitude of pressure rise or fall. With the increase of the placement time of the catheter 100, thrombus may be attached inside the catheter 100, or part of the aperture may be blocked, which will be reflected on the pressure waveform measured by the sensor 200, and then the position of the catheter 100 is adjusted to improve the stability and safety of the catheter 100 in the body.

[0036] In other embodiments, the data collected by the sensor 200 can be combined with the data of the operating speed, auxiliary flow and overall power consumption of the extracorporeal centrifugal pump to adjust the parameters of the extracorporeal centrifugal pump or the subsequent treatment strategy of the patient, so as to realize more refined treatment management. This intelligent treatment scheme not only can improve the treatment effect, but also can reduce the medical cost and improve the comfort of the patient.

[0037] Although the embodiments of the present application have been shown and described, it should be understood by those skilled in the art that various changes, modifications, replacements and deformations can be made to these embodiments without departing from the principles and purposes of the present application, and the scope of the present application is defined by the claims and their equivalents.

Claims

1. An extracorporeal circulation catheter with a sensor, characterized in that: The device comprises an in-vivo end portion (110), wherein the in-vivo end portion (110) is provided with a drainage port (130) along the tube wall, and a sensor (200) is provided at the front end and / or the rear end of the drainage port (130).

2. The extracorporeal circulation catheter with a sensor according to claim 1, characterized in that: The in-body end portion (110) is provided with a curved section (120).

3. An extracorporeal circulation catheter with a sensor according to claim 1 or 2, characterized in that: The drainage ports (130) are provided in a number of six or more.

4. The extracorporeal circulation catheter with a sensor according to claim 3, characterized in that: The drainage port (130) is provided in a rectangular, circular or square shape.

5. An extracorporeal circulation catheter with a sensor according to claim 1, 2 or 4, characterized in that: The sensor (200) includes a pressure sensor (200) and / or a deformation sensor (200).

6. The extracorporeal circulation catheter with a sensor according to claim 5, characterized in that: A plurality of sensors (200) are provided, and the plurality of sensors (200) form a sensor (200) array along the axial direction of the intracorporeal end portion (110).

7. The extracorporeal circulation catheter with a sensor according to claim 6, characterized in that: The sensor (200) array comprises a first sensing region (210), a second sensing region (220) and a third sensing region (230) which are sequentially arranged from the distal end to the proximal end of the extracorporeal circulation catheter (100).

8. The extracorporeal circulation catheter with a sensor according to claim 7, characterized in that: The first sensing area (210) and the second sensing area (220) are located on both sides of the drainage port (130).

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