Extracorporeal circulation catheter with sensor

Abstract

In order to solve the technical problem that in-vivo stability of a catheter in the prior art is poor, the extracorporeal circulation catheter with the sensor is provided and comprises an in-vivo end head, a drainage opening is formed in the in-vivo end head along the catheter wall, and the sensor is arranged at the front end and / or the rear end of the drainage opening. 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 invention relates to the technical field of artificial auxiliary heart parts, and in particular to an extracorporeal circulation catheter with a sensor. Background Art

[0002] Currently, cardiogenic shock (CS) and high-risk PCI are two common and serious cardiovascular diseases. Cardiogenic shock (CS) is a syndrome of severe insufficiency of cardiac pumping function due to acute myocardial infarction or other reasons, which in turn 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 lesions, involvement of the left main trunk or multiple vessels, and left ventricular dysfunction. These two conditions have a significant impact on the patient's quality of life and recovery.

[0003] Mechanical circulatory support devices (MCS) have become an important treatment for these two diseases. MCS is designed to help patients increase the amount of blood pumped by the heart, maintain blood supply to important organs, reduce cardiac load, and thus improve the patient's vital signs. MCS can be divided into temporary and long-term assistance devices, and temporary assistance devices are more commonly used in the treatment of cardiogenic shock and high-risk PCI.

[0004] Temporary assist device technologies include intraaortic balloon pump (IABP), percutaneous assist device (Impella) based on catheter axial flow pump, extracorporeal membrane oxygenation (ECMO), and auxiliary circulation based on extracorporeal centrifugal pump. However, each of these technologies has its own advantages and disadvantages. For example, the assist flow of IABP and Impella is limited, and the effect may not be good for critically ill patients; although ECMO can provide a higher assist flow, its operation is complicated and the risk of complications is high.

[0005] The auxiliary circulation device based on the extracorporeal centrifugal pump has attracted much attention because of its ability to provide high flow. It directly draws blood from the left heart through a percutaneous extracorporeal circulation catheter and pumps it into the femoral artery after passing through the 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 degree of the catheter with the blood vessels are key factors to ensure the success of treatment. The existing extracorporeal circulation catheter mainly consists of three parts: the end head in the body, the main body and the connection part. The end head in the body is the front end of the catheter. In order to ensure the smooth flow of blood, it is usually designed as a straight tube with a length of 50-60cm. One or more circular holes are specially opened on the wall of the end head. The main function of these circular holes is to allow the catheter to draw blood from the heart. The main body is the key part connecting the end head in the body and the connection part. It adopts a soft tubular structure with a certain toughness and elasticity, which enables it to adapt to various shapes and curvatures of the end head in the body and blood vessels. The connection part is the interface between the catheter and the extracorporeal blood pump.

[0006] Common extracorporeal circulation circuits need to be connected to the heart and arterial system through surgery. Common connection locations include the left ventricle and the aorta. In order to reduce the impact of surgical operations on patients, the catheter can be inserted into the body through interventional methods to establish a circulation path. A common circulation path is to enter the drainage tube from the human body's large veins. After reaching the right atrium, the drainage port of the drainage tube is placed in the left atrium through the atrial septal puncture hole, so that the pipeline can extract arterial blood from the left atrium. However, since the path from the femoral vein to the left atrium is relatively complex and needs to cross multiple vascular branches and heart structures, in order to reduce the blindness and uncertainty of the surgical operation, after the catheter enters the blood vessel from the femoral vein, it needs to enter the left atrium through the atrial septum under X-ray guidance for blood extraction. However, this method not only increases the difficulty and duration of the operation, but also increases the radiation risk of patients and operators. In addition, during the entire auxiliary period, the catheter tip also needs to be kept in a suitable position in the left atrium to ensure sufficient drainage, but the existing body lacks monitoring devices. Once the catheter is improperly positioned, it may cause significant 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 that needs to be solved urgently by those skilled in the art. Summary of the invention

[0008] The present invention aims to solve 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 technical solution of the present invention is achieved through the following measures: an extracorporeal circulation catheter with a sensor includes an in-vivo end portion, a drainage port is arranged along the tube wall of the in-vivo end portion, and a sensor is arranged at the front end and / or rear end of the drainage port.

[0010] Furthermore, the inner end portion of the body is provided with a curved section.

[0011] Furthermore, the number of the drainage ports is more than 6.

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

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

[0014] Furthermore, a plurality of sensors are provided, and the plurality of sensors form a sensor array along the axial direction of the intracorporeal end portion.

[0015] Furthermore, the sensor array includes a first sensing area, a second sensing area and a third sensing area which are sequentially arranged from the distal end to the proximal end of the extracorporeal circulation catheter.

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

[0017] The present application discloses an extracorporeal circulation catheter with a sensor, comprising an in-vivo end portion, a drainage port being arranged along the tube wall of the in-vivo end portion, and a sensor being arranged at the front end and / or rear end of the drainage port. By adding a sensor near the drainage port of the catheter, the liquid pressure of the environment in which the catheter is located at different positions is monitored, and the position of the in-vivo end portion of the catheter can be judged in combination with the patient's aortic pressure waveform, which can conveniently guide the operator to insert the catheter into place without monitoring, and can also monitor the position of the extracorporeal circulation catheter and the flow and pressure conditions in the catheter during the operation of the extracorporeal centrifugal pump, thereby improving the stability and safety of the catheter in the body. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 is a schematic diagram of a first embodiment of the present invention;

[0019] Figure 2 is a schematic diagram of a second embodiment of the present invention;

[0020] Reference numerals:

[0021] 100 catheter, 110 intracorporeal end portion, 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 invention, it should be understood that the terms "longitudinal", "lateral", "up", "down", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inside" and "outside" etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as a limitation on the present invention.

[0023] In the description of the present invention, unless otherwise specified and limited, it should be noted that the terms "installed", "connected" and "connected" should be understood in a broad sense, for example, it can be a mechanical connection or an electrical connection, or it can be the internal communication of two components, it can be a direct connection, or it can be indirectly connected through an intermediate medium. For ordinary technicians in this field, the specific meanings of the above terms can be understood according to specific circumstances. The terms "extracorporeal circulation catheter" and "catheter" both refer to the same component.

[0024] In the description of this specification, the description with reference to the terms "one embodiment", "some embodiments", "examples", "specific examples" or "some examples" means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described may be combined in any one or more embodiments or examples in a suitable manner.

[0025] Embodiments of the present invention are described in detail below, examples of which are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and cannot be understood as limiting the present invention.

[0026] The present embodiment provides an extracorporeal circulation catheter 100 with a sensor, comprising an internal end portion 110 directly in contact with the patient's internal environment, the internal end portion 110 being provided with a drainage port 130 along the tube wall so that blood can smoothly enter the interior of the catheter 100, and a sensor 200 being provided at the front end and / or rear end of the drainage port 130. By adding a 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, and the position of the internal end portion 110 of the catheter 100 can be determined in combination with the patient's aortic pressure waveform, which can conveniently guide the operator to insert the catheter 100 into place without monitoring, and can also continuously monitor the position of the extracorporeal circulation catheter 100 and the flow and pressure conditions 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 treatment.

[0027] Furthermore, 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 blood vessels and the heart, a curved section 120 is usually provided on the side of the end head 110 in the body close to the main body, so that the catheter 100 can more naturally fit the direction of the blood vessels, reducing the stimulation and damage to the blood vessel wall. Then the distal end of the catheter 100 passes through the atrial septum puncture, leaving about 3-4 cm in the left atrium to ensure that blood can smoothly enter the catheter 100.

[0028] In this case, the side of the intracorporeal end head 110 close to the main body is the proximal end of the catheter 100 , and the side away from the main body is the distal end of the catheter 100 .

[0029] Furthermore, in other embodiments of the present application, the drainage ports 130 are arranged on the side wall of the internal end portion 110 reserved in the left atrium, so as to facilitate blood to enter the catheter 100 from these drainage ports 130, and ensure that the flow rate or suction pressure will not be too large under large flow, thereby ensuring the smooth progress of treatment. The number and size of the drainage ports 130 vary, and the specific design is determined according to the flow demand. Generally, the number of more than 6 is better, especially the symmetrical arrangement on the side wall of the internal end portion 110 is the best. The shape of the drainage ports 130 can be circular, oval or square to meet different treatment needs.

[0030] In order to further improve the accuracy of monitoring the position of the catheter 100 in the human body and the accuracy of assessing the drainage status, the present embodiment is provided with sensors 200 at both ends of the drainage port 130 region. Specifically, a first sensing region 210 located at the distal end of the catheter 100 and a second sensing region 220 located at the proximal end of the catheter 100, and a third sensing region 230 is also provided after a certain distance from the proximal end of the drainage port 130 region. These sensors 200 are combined to form a sensor 200 array, which can provide the operator with a more detailed pressure distribution and help determine whether the catheter 100 has reached the predetermined position. Moreover, through the data of the sensors 200 at different positions, the drainage status of the catheter 100 can be more accurately assessed, thereby further improving the stability and safety of the catheter 100 in the body.

[0031] Further, in other embodiments of the present application, the sensor 200 includes a pressure sensor 200 and / or a deformation sensor 200. In a specific implementation, the data collected by the installed sensor 200 can be pressure or deformation, which is finally converted into the blood pressure at the location 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. This structure is particularly suitable for complex human environments because it can provide more detailed pressure change information. In a specific implementation, the third sensing area 230 can be selected to be set at the bend 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 end head 110 in the body, thereby improving the stability and safety of the catheter 100 in the body.

[0032] In other embodiments of the present application, the sensor 200 may be a single pressure sensor 200 or a single other sensor 200. The single pressure sensor 200 may 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 determining the position of the intracorporeal end head 110 of the catheter 100 and the guide port area of ​​the intracorporeal 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 this application also includes 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 wire 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 wire is connected to the controller, and the sensor 200 collects the pressure data of the blood at the end head 110 in the body and transmits it to the controller. The controller is connected to a display device, which can display the collected pressure data through the display device; and the controller is also connected to a data terminal and an alarm device, and the collected pressure data is stored through the data terminal. A 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 a command to the alarm device to alarm.

[0034] During the insertion of the catheter 100 of the present application, by monitoring the changes in the pressure signals of the first sensing area 210, the second sensing area 220 and the third sensing area 230, it is possible to accurately determine whether the catheter 100 has reached the predetermined position. When the catheter 100 has not entered 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 relatively consistent, usually venous pressure or right atrial pressure, with low volatility and low amplitude (less than 5 mmHg). 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 significantly by about 10 mmHg, while the sensors 200 of the second sensing area 220 and the third sensing area 230 that have not entered the left atrium still display the right atrial pressure. During the process of continuing to move forward, until the pressure waveforms of the first sensing area 210 and the second sensing area 220 are consistent, both 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 has reached a suitable position. The structure selected in the present application is completely based on the change of pressure data, and can be completed without X-ray guidance, which greatly reduces the radiation risk and also provides 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 calculation can be performed based on the venous pressure, 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 promptly discover and deal with possible problems. For example, when the pressure inside the catheter 100 is abnormal, each sensor 200 will experience a pressure increase or decrease of the same magnitude. As the catheter 100 is placed for an increased time, thrombi may be attached to the inside of the catheter 100, or some openings may be blocked, which will be reflected in 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 extracorporeal centrifugal pump's operating speed, auxiliary flow, and overall power consumption to adjust the extracorporeal centrifugal pump parameters or the patient's subsequent treatment strategy to achieve more refined treatment management. This intelligent treatment plan can not only improve the treatment effect, but also reduce medical costs and improve the patient's comfort.

[0037] Although embodiments of the present invention have been shown and described, those skilled in the art will appreciate that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention 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. An 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 more than six.

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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