Catheter with pressure measurement function, intracavitary treatment catheter and intelligent intracavitary treatment device

Abstract

A catheter with a pressure measuring function, an intracavitary treatment catheter and an intelligent intracavitary treatment device. At least one pressure sensor is assembled on the catheter body. The pressure sensing unit of the pressure sensor at least includes a sensitive element and at least two sensor tail wires. The sensitive element is arranged on the outer surface of the catheter body to form a columnar space. The sensor tail wires are arranged on the outer surface of the catheter body or extend into the catheter cavity. The sensor tail wires are respectively installed with the sensitive element, and the installation position should be within the columnar space of the sensitive element. The pressure sensor senses the radial force and / or frictional force exerted by the tissue on the surface of the catheter body, and / or the axial force exerted on the catheter tip, and transmits the pressure information to the outside of the catheter through a signal processing unit. The size of the catheter with a pressure measuring function of the present invention is controllable, and a pressure sensor meeting the size requirements can be adapted according to the size of the catheter, which can meet the requirements of the catheter with a pressure measuring function for a compact structure and a small space.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and particularly to a catheter with pressure measurement function, an intraluminal therapy catheter, and an intelligent intraluminal therapy device. Background Art

[0002] Minimally invasive interventional surgery is becoming a widely used means in the field of medical device treatment, so the corresponding interventional catheters are used more and more frequently. When the catheter travels or performs diagnosis and treatment in the human body cavity, it will come into contact with the inner surface tissue of the human body cavity. This contact force often affects the treatment process or treatment effect. For some processes, too large a contact force will damage normal tissues, and in some other processes, too small a contact force may not achieve the treatment effect. Therefore, catheter body pressure detection is becoming an important application in minimally invasive interventional surgery.

[0003] Zhejiang Tsinghua Institute of Flexible Electronics Technology disclosed a flexible pressure sensor in 202011049050.0, which includes a catheter, a sensitive element, and a stretchable wire. The sensitive element and the stretchable wire are both arranged on the surface of the catheter and are respectively arranged in a serpentine shape, and the stretchable wire is electrically connected to the sensitive element. Multiple sensitive elements and stretchable wires are prepared at different positions on the surface of the catheter to achieve array integration of pressure sensing, so as to achieve multi-point measurement. Multiple sensitive elements can form an array module. When the catheter penetrates deep into the blood vessel, the catheter will adapt to the shape inside the blood vessel and bend, stretch or compress. At this time, the serpentine stretchable wire will also deform with the deformation of the catheter. The catheter and the stretchable wire will not form a pulling force on the sensitive element. The array-type sensitive elements can firmly adhere to the surface of the catheter without detachment, so that the array-type flexible pressure sensor has high ductility. However, the catheter mentioned in this flexible pressure sensor is similar to a carrier for sensitive elements. Although the structure of the non-interventional catheter mentioned in the previous paragraph is very small, the catheter structure mentioned in this patent is prone to bending, stretching or compression deformation and is not suitable for the application scenario of our company's interventional catheter.

[0004] The invention patent with the application number 201611080407.5 discloses a radiofrequency ablation catheter that can measure pressure. This invention is used for auxiliary positioning and does not disclose the specific assembly method and the form of the pressure sensor either.

[0005] In summary, there is an urgent need for a new medical interventional catheter with pressure measurement function in interventional catheters, and after the pressure sensor is assembled with the medical catheter, it can still meet the effects of compact structure and small space. Summary of the Invention

[0006] The first object of the present invention is to provide a catheter with a pressure measuring function, so as to solve the technical problem that the pressure sensor cannot meet the requirements of compact structure and small space after being assembled with a medical catheter in the prior art.

[0007] The second object of the present invention is to provide an intracavitary treatment catheter with a pressure measuring function, so as to solve the technical problem that the pressure sensor cannot meet the requirements of compact structure and small space after being assembled with a medical catheter in the prior art.

[0008] The third object of the present invention is to provide an intelligent intracavitary treatment device with a pressure measuring function, so as to solve the technical problem that the pressure sensor cannot meet the requirements of compact structure and small space after being assembled with a medical catheter in the prior art.

[0009] In order to solve the above technical problems, the present invention mainly adopts the following technical means:

[0010] A catheter with a pressure measuring function provided by the present invention,

[0011] At least one pressure sensor is assembled and arranged on the catheter body. The pressure sensor includes a pressure sensing unit and a signal processing unit. The pressure sensing unit at least includes a sensitive element and at least two sensor tail wires.

[0012] The sensitive element is arranged on the outer surface of the catheter body and forms a columnar space.

[0013] The sensor tail wires are in a strip shape. They are arranged on the outer surface of the catheter body or protrude into the catheter cavity and extend along the direction of the catheter body. These sensor tail wires are respectively installed with the sensitive element, and the installation positions are located in the columnar space.

[0014] The pressure sensor senses the radial force and / or frictional force exerted by the tissue on the surface of the catheter body, and / or the axial force exerted on the catheter tip, and transmits the pressure information to the outside of the catheter through the signal processing unit.

[0015] Preferably, the sensitive element is wound or heat-shrunk onto the outer surface of the catheter body to control the size of the pressure sensor while making the outer surface of the catheter body smooth.

[0016] Preferably, the pressure sensor adopts a thin film resistive strain pressure sensor. The sensitive element includes an elastic diaphragm body and the sensor tail wires, and also includes a connection unit installed with the sensor tail wires. In the use state, the elastic diaphragm body adapts to the size of the catheter body and is wound around the outer surface of the catheter body. The connection unit extends towards the inside of the catheter, so that the position of the sensor tail wires installed on it does not protrude from the columnar space formed by the wound elastic diaphragm body.

[0017] Preferably, the elastic diaphragm body is wound or heat-shrunk onto the outer surface of the catheter body, or the outer surface of the catheter body is provided with mounting grooves along the circumferential direction of the tube body to mount the elastic diaphragm body in a manner that does not protrude from the outer surface. The size width of the elastic diaphragm body wound on the outer surface of the catheter body is in the range of 1 mm to 80 mm.

[0018] Preferably, holes adapted to the number of sensor tail wires are provided at the adapted positions on the outer surface of the catheter body. The connection unit and the sensor tail wires protrude into the cavity of the catheter through the holes, and the sensor tail wires are arranged in the cavity of the catheter and extend along the direction of the catheter body.

[0019] Preferably, a plurality of mounting grooves are provided along the circumferential direction on the outer surface of the catheter body to mount the sensor tail wires.

[0020] Preferably, the connection unit and the sensor tail wires are integrally formed. The connection unit is a chamfered structure, and the connection unit is welded to the inner surface where the elastic diaphragm body contacts the catheter body by welding.

[0021] Preferably, the thickness of the thin-film resistive strain pressure sensor is in the range of 0.05 mm to 1 mm; the length is in the range of 1 mm to 80 mm, the measuring range is in the range of 1 - 100 N, and the accuracy is in the range of ±0.1 N.

[0022] An intracavitary treatment catheter, the intracavitary treatment catheter includes an insertable segment of the catheter that enters the lesion site of the lumen of the target object. The insertable segment of the catheter includes a working segment and an intervention segment. The intracavitary treatment catheter adopts the catheter with a pressure measuring function as described above. At least one pressure sensor is arranged on the working segment. When in use, the pressure sensor detects the pressure value of the lumen of the target object.

[0023] Preferably, the pressure sensor is located on the surface of the catheter and is used to sense the radial extrusion force or frictional force from the surface of the catheter to indicate the radial space where the catheter is located.

[0024] Preferably, there are multiple pressure sensors. At least two pressure sensors are located at the tip of the catheter or at the two tips of the catheter respectively to obtain the axial force from the tip of the catheter, and then to indicate the advancing direction and axial space of the catheter.

[0025] Preferably, the operating temperature of the pressure sensor is -10°C - 300°C, and the instantaneous high temperature reaches ≥200°C within 3 - 5 s.

[0026] Preferably, the pressure sensor meets the performance requirement of maintaining its basic performance without loss after being repeatedly heated or cooled 100 times within the working temperature range.

[0027] An intelligent intracavitary treatment device, which at least includes a perfusion sub-device and an intracavitary treatment sub-device.

[0028] The perfusion sub-device includes: a perfusion accessory, which includes a medicine reservoir, a liquid path and a puncture device connected in sequence; a perfusion main unit, which includes a perfusion control system and a perfusion driver connected by communication. The perfusion driver is used to control the flow rate of the preparation in the liquid path, and the perfusion control system is communicatively connected to the puncture device pressure detector.

[0029] The intracavitary treatment sub-device includes: the intracavitary treatment catheter as described above, and the pressure sensor is communicatively connected to the perfusion control system; an intracavitary treatment device, which is connected to the intracavitary treatment catheter and communicatively connected to the pressure sensor. The intracavitary treatment device is used to generate pulsed energy, and obtain the radial force and / or frictional force currently applied to the surface of the catheter body and / or the axial force applied to the catheter tip through the pressure sensor, so as to adaptively adjust the subsequent pressure information applied to the catheter.

[0030] Compared with the prior art, the present invention has the following advantages:

[0031] First: The sensitive element is arranged on the outer surface of the catheter body and forms a columnar space. The installation position of the sensor tail wire is within this columnar space, and the radial distance of the sensor tail wire does not exceed the width of the columnar space formed by the sensitive element. When the width dimension of the sensitive element is the same as or slightly larger than that of the catheter body, the size of the catheter with pressure measurement function of the present invention is controllable, and a pressure sensor meeting the size requirements can be adapted according to the size of the catheter, which can meet the requirements of the catheter with pressure measurement function for a compact structure and small space.

[0032] Next, the sensitive element is wound or heat-shrunk onto the surface of the tube body, which has the effect of making the surface of the tube body smooth while controlling the size.

[0033] Then, when the pressure sensor adopts a thin film resistive strain pressure sensor, the sensitive element includes an elastic diaphragm body, a sensor tail wire, and a connection unit installed with the sensor tail wire. In the use state, the elastic diaphragm body is wound around the outer surface of the tube body to adapt to the size of the catheter body. This setting of the elastic diaphragm body adapting to the size of the catheter body can be designed with strong practicability according to the requirements of the tube body. Moreover, the elastic diaphragm body is directly coated or coated on the catheter body through a biological medium, and then the sensor tail wire is located in the cavity through the opened hole or on the surface of the catheter through the groove opened on the surface of the tube body. The process is simple and the assembly is convenient, which is very practical.

[0034] Subsequently, the catheter body is equipped with a pressure sensor that can sense the radial force or frictional force exerted by the tissue on the catheter surface, or the axial force exerted on the catheter tip. There is a signal processing unit inside the catheter (such as the signal processing unit includes signal transmission lines), which can transmit the sensed pressure signal to the supporting main unit and display it. The operator adjusts the contact force according to the preset value. This kind of catheter can not only detect the pressure value of the current lumen of the object being detected, but also adjust the contact force according to the preset value. The whole treatment can form a real-time treatment loop, and the contact force can be adjusted in real time according to the specific situation. In particular, during minimally invasive interventional surgery, when the interventional catheter is advancing and treating, the force exerted by the tissue on the catheter is mainly judged by the doctor's feeling. This process has great uncertainty and varies greatly with different operators. At the same time, it requires a lot of practice and experience accumulation, and the learning curve is long. Through the application of this function, the relevant surgical process can be standardized, thereby reducing the difficulty of use for doctors and shortening the learning time. In other words, after applying neuron algorithms and the like in this application scenario, subsequently, according to the detected pressure value of the current lumen of the object being detected, the specific adjustment size applied to a certain position and a certain device of the object can be directly given according to deep learning, making the treatment device more intelligent. Description of the Drawings

[0035] Figure 1 It is an example structure diagram of an existing pressure sensor;

[0036] Figure 2 It is a structure diagram of an embodiment of a catheter with a pressure measurement function;

[0037] Figure 3A - Figure 3B It is an unfolded view and a usage example diagram of the pressure sensor of the present invention;

[0038] Figure 4A - Figure 4D It is a cross-sectional view of the catheter and a partially enlarged view;

[0039] Figure 5 It is an example diagram of an intelligent intracavitary treatment device;

[0040] Figure 6 It is a principle application diagram of a catheter with a pressure measurement function. Detailed Embodiments

[0041] The following specific examples illustrate the embodiments of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention.

[0042] First embodiment

[0043] When the applicant needs to develop a catheter with a pressure measurement function, a common idea is to integrate the pressure sensor into the catheter so that the catheter has the function of measuring pressure. For example, the pressure sensor includes a pressure sensing unit and a signal processing unit. The pressure sensing unit includes at least a sensitive element and a conversion element. The signal processing unit includes a signal modulation module and an information communication module. A common conversion element often uses a Wheatstone bridge. The sensitive element deforms under the action of pressure, causing the resistance value of the Wheatstone bridge to change. The Wheatstone bridge becomes unbalanced and an electrical signal is output. The thin film resistive strain pressure sensor has received more and more attention due to its excellent performance. It usually uses an elastic diaphragm as the sensitive element, sputters a layer of metal film directly on the elastic diaphragm, and then uses photolithography and other technologies to make it into a resistor. The resistor is used as a conversion element. As Figure 1 As shown, a thin film resistive strain pressure sensor includes an elastic diaphragm 1112, a flat straight tail wire 1113 and at least two pins 1114. The flat straight tail wire 1113 and the pins 1114 are generally used as conversion elements. When the thin film resistive strain pressure sensor is applied to a catheter, it is found that the flat straight tail wire 1113 is generally directly set at the end of the elastic diaphragm 1112 by welding, and the welding point has a deviation of several millimeters during welding, which causes a large deviation in the width of the entire sensor, and the width and other dimensions of the sensor cannot be accurately determined. In addition, when the current pressure sensor is assembled with a medical catheter, there is a situation where the product size is too large and the surface steps are obvious. However, a large number of medical catheters have compact structures and small spaces. The above-mentioned pressure sensor structure and assembly process cannot meet the function of medical interventional catheter pressure detection. The inventor of this application discovered this technical problem after many experiments during project development.

[0044] To this end, the applicant has made improvements to the pressure sensor on this basis, and has developed a new type of catheter with pressure measurement function. The catheter here mainly refers to medical catheters, also known as medical catheters, which are tubular rubber devices mainly used for medical treatment and are divided into two types: external use and internal use. The catheter of the present invention mainly refers to medical catheters for internal use, also known as invasive medical catheters.

[0045] See also Figure 2 , which is an example diagram of a catheter with a pressure measurement function of the present invention. The catheter 116 is equipped with at least one pressure sensor 53. It includes a pressure sensing unit and a signal processing unit (not shown in the figure).

[0046] See also Figure 3A - Figure 3B As shown, it is an example diagram of the pressure sensor 53 of the present invention.

[0047] The pressure sensor 53 uses a thin-film resistive strain pressure sensor 53. The pressure sensing unit at least includes a sensitive element and at least two sensor tail wires 113. The sensitive element includes an elastic diaphragm body 112, and the elastic diaphragm body 112 is in a thin-film shape. In the use state, the elastic diaphragm body 112 can be rolled into a shape with a predetermined size. In this example, the elastic diaphragm body 112 is rolled into a cylindrical space adapted to the outer surface width of the catheter 116. The sensor tail wire 113 also includes a connection unit 115 installed on the sensor tail wire 113. The connection unit 115 can be a chamfer structure, and the connection unit 115 is welded to the inner surface of the elastic diaphragm body 112 in contact with the body of the catheter 116 by welding. The size of the cylindrical space formed by rolling the elastic diaphragm body 112 in this design is the width dimension value of the sensor. When the connection unit 115 is welded to the elastic diaphragm body 112, the welding accuracy and the deviation of the welding points will not affect the width range of the sensor. And the thickness of the elastic diaphragm body 112 is the overall thickness of the sensor. This design meets the requirements of the catheter structure with a pressure measurement function being compact and having a small space. It should also be noted that the pressure sensor 53 can be a thin-film resistive strain pressure sensor 53, or other pressure sensors can be used. The present invention is not limited to pressure sensors.

[0048] Please refer to Figure 4A - Figure 4D , holes adapted to the number of sensor tail wires 113 are opened at the position on the body of the catheter 116 adapted to the body. The connection unit 115 and the sensor tail wire 113 protrude into the catheter cavity through the holes, and the sensor tail wire 113 is arranged in the catheter cavity and extends along the direction of the catheter body 116. When the connection unit 115 is a chamfer structure, the height and angle of the chamfer structure can directly control the position of the sensor tail wire 113 in the catheter cavity. In this example, there are two sensor tail wires 113. By setting the height and angle of the chamfer structure, the distance between the two sensor tail wires 113 can be directly adjusted, and the distance between the two sensor tail wires 113 and the inner cavity surface of the catheter 116 in the catheter cavity (such as being close to the inner cavity surface of the catheter 116 or directly located in the middle of the cavity of the catheter 116, etc.).

[0049] In the use state, the elastic diaphragm body 112 is rolled on the outer surface of the catheter body 116 to adapt to the size of the catheter body 116, and the connection unit 115 extends towards the inside of the catheter 116, so that the position of the sensor tail wire 113 installed on it does not protrude from the cylindrical space of the rolled elastic diaphragm body 112.

[0050] In this example, the connection unit 115 can be a chamfer structure, or other connection piece structures, not limited to this. Generally speaking, the connection unit 115 can be integrally formed with the sensor tail wire 113.

[0051] The elastic diaphragm body 112 can be wound or heat-shrunk onto the surface of the tube body, or the surface of the tube body can be provided with mounting grooves along the circumferential direction of the tube body to install the elastic diaphragm body 112 as inconspicuously as possible on the surface. The size width of the elastic diaphragm body 112 wound on the outer surface of the tube body can be in the range of 1 mm to 80 mm.

[0052] The thickness of the thin film resistive strain pressure sensor 53 is in the range of 0.05 mm to 1 mm; the length is in the range of 1 mm to 80 mm, the measuring range is in the range of 1 - 100 N, and the accuracy is in the range of ±0.1 N.

[0053] In this embodiment, the sensor tail wire 113 can be arranged inside the cavity of the catheter 116, or can be arranged on the outer surface of the cavity of the catheter 116. For example, the surface of the tube body is provided with several mounting grooves along the circumferential direction of the outer surface of the tube body to install the sensor tail wire 113. The sensor tail wire 113 can also be arranged at the tip of the catheter 116 or directly extend outside the catheter 116, and all of these should fall within the protection scope of the present invention.

[0054] Embodiment 2

[0055] The pressure sensor 53 can be piezoresistive, or an optical fiber pressure sensor 53 or other sensors can be selected. The catheter with a pressure measuring function of the present invention is not limited to a specific type of sensor, as long as it conforms to the core idea of our company, it should fall within the protection scope of the present invention.

[0056] A catheter with a pressure measuring function, at least one pressure sensor 53 is assembled and arranged on the tube body of the catheter 116. The pressure sensor 53 includes a pressure sensing unit and a signal processing unit. The pressure sensing unit at least includes a sensitive element and at least two sensor tail wires 113.

[0057] The sensitive element is arranged on the outer surface of the tube body of the catheter 116 and forms a columnar space.

[0058] The sensor tail wires 113 are in the shape of thin strips, which are arranged on the outer surface of the tube body of the catheter 116 or protrude into the catheter cavity and extend along the direction of the tube body of the catheter 116. These sensor tail wires 113 are respectively installed with the sensitive element, and the installation position should be within the columnar space of the sensitive element.

[0059] The pressure sensor 53 senses the radial force and / or frictional force exerted by the tissue on the surface of the tube body of the catheter 116, and / or the axial force exerted on the tip of the catheter 116, and transmits the pressure information to the outside of the catheter 116 through the signal processing unit.

[0060] The sensitive element is wound or heat-shrunk onto the surface of the tube body to make the surface of the tube body smooth while controlling the size of the pressure sensor 53.

[0061] The sensitive element of the pressure sensor 53 can be in a square shape. In this case, a groove adapted to the thickness of the square shape is formed on the outer surface of the tube body of the catheter 116, and the sensitive element can be arranged in the groove to achieve an inlaid installation.

[0062] In this embodiment, the number of the pressure sensors 53 can be multiple, and the sensor tail wires 113 of each sensor can be two. The sensor tail wires 113 are in a thin strip shape, which are arranged on the outer surface of the tube body of the catheter 116 or extend into the catheter cavity, and extend along the direction of the catheter body 116. The radial force and / or frictional force exerted by the tissue on the surface of the catheter body 116, and / or the axial force exerted on the tip of the catheter 116 can be sensed by the pressure sensors 53 respectively, and the pressure information is transmitted to the outside of the catheter 116 through the signal processing unit. For example, by comparing the pressure values respectively transmitted back by the pressure sensors 53 arranged at the two end portions of the catheter 116, that is, comparing the pressure value at the generally advancing end portion with the pressure value at the other end portion, it can be determined whether there is a blocked phenomenon during the movement of the current catheter 116.

[0063] When the catheter is an interventional catheter, especially a catheter inserted into a blood vessel, it is very important to have good biocompatibility. Therefore, a layer of biocompatible material layer can be further coated outside the pressure sensor, and this material layer can adopt the existing biocompatible material layer coated on the catheter. For example, a layer of biocompatible material layer is directly coated outside the sensitive element of the pressure sensor.

[0064] Briefly describe the preparation process of the catheter with a pressure measurement function. First, in step S1, a hole is formed at a preset position of the catheter. Then, in step S2, after applying glue on the inner surface of the sensitive element of the pressure sensor, the sensor tail wire is extended into the catheter cavity through the hole and extends along the direction of the catheter body. Subsequently, in step S3, the sensitive element is coated on the outer surface of the catheter. Then, in step S4, if other pressure sensors need to be installed, the other pressure sensors are installed on the catheter through steps S1 - S3. Finally, in step S5, a layer of biocompatible material layer is coated on the catheter and / or the sensitive element, and the output end of the signal processing unit is connected to an external interface to transmit the pressure information to the outside of the catheter.

[0065] Embodiment 3

[0066] In many cases, when performing endovascular therapy, it is necessary to perfuse liquid medicine into the surrounding tissues of the human body to protect the surrounding tissues or make the cavity tissues close to the treatment device. Among them, a typical application is that during the thermocoagulation treatment of varicose veins in the lower extremities using a radiofrequency host and a catheter (hereinafter referred to as the varicose vein radiofrequency treatment system), it is necessary to inject an anesthetic swelling solution into the tissues around the lower extremity veins. On the one hand, under the pressure of the anesthetic swelling solution, the diseased blood vessel wall is pressed against the radiofrequency catheter, and the blood in the blood vessel is discharged, ensuring the efficient transfer of heat, thereby ensuring the effectiveness of the treatment. At the same time, the anesthetic swelling solution can isolate the treatment site from the surrounding normal tissues and play a role in protecting the normal tissues. Moreover, the anesthetic swelling solution can also have an anesthetic effect and improve the patient's feeling.

[0067] Currently, the varicose vein radiofrequency treatment system does not detect the pressure of the blood vessel on the radiofrequency catheter, and the drug perfusion control system does not detect the pressure of the puncture device 14 in the body. Even if some endovascular treatment products or liquid medicine perfusion products themselves have pressure detection or other detection functions, since the two work independently of each other, they cannot form a linkage. In this way, the rate and dose of drug perfusion mostly depend on the operator's own experience. Then, problems such as too fast a rate, too much or too little dose may occur, especially for those who have just come into contact with the relevant surgical procedures. For this reason, the above-mentioned catheter with pressure measurement function can be introduced into the intelligent endovascular treatment device.

[0068] An intelligent endovascular treatment device according to an embodiment of the present invention, the device at least includes a perfusion sub-device and an endovascular treatment sub-device, and the perfusion sub-device includes:

[0069] A perfusion accessory 10, including a medicine reservoir 11, a liquid path 12 and a puncture device 14 that are connected in sequence;

[0070] A perfusion main unit 20, the perfusion main unit 20 includes a perfusion control system 21 and a perfusion driver 22 that are communicatively connected. The perfusion driver can control the flow rate of the preparation in the liquid path 12, and the perfusion control system 21 is communicatively connected to the puncture device pressure detector 141;

[0071] The endovascular treatment sub-device includes:

[0072] An endovascular treatment catheter 32, the endovascular treatment catheter 32 includes an external section 321, an internal section 322, and an endovascular treatment section 323 that are connected in sequence. The endovascular treatment section 323 can move in the cavity 40 of the treatment object. One or more pressure sensors 53 as mentioned in the above embodiment are provided on the endovascular treatment section 323, and the pressure sensors 53 as mentioned in the above embodiment are communicatively connected to the perfusion control system 21;

[0073] An intravascular treatment device 31 is connected to an intravascular treatment catheter 32 and communicatively connected to a pressure sensor 53 as mentioned in the above embodiments. The intravascular treatment device is used to generate pulsed energy.

[0074] The in-vivo section 322 of the treatment catheter is inserted into the cavity of the cavity structure and reaches the expected position. After the perfusion accessory 10 puncture device 14 enters the tissue around the cavity, the liquid medicine perfusion is started. During the perfusion process, the puncture device pressure detector 141 or the pressure sensor 53 as mentioned in the above embodiments sends the measured pressure data to the perfusion control system or the intravascular treatment device for processing, and then dynamically regulates the perfusion rate. When the puncture device pressure detector 141 or the pressure sensor 53 as mentioned in the above embodiments reaches the preset threshold, the system stops the perfusion and sends out warning signals such as sound, light, color change, flashing, size change of font or symbol.

[0075] On the one hand, the intravascular treatment catheter 32 monitors the pressure of the cavity tissue wall on the treatment catheter and feeds it back to the extracorporeal treatment device as a reference for the perfusion effect. At the same time, the liquid medicine perfusion product monitors the pressure of the in-vivo puncture device 14 and feeds it back to the perfusion control system to form a closed-loop control. On the other hand, the intravascular treatment sub-device and the liquid medicine perfusion sub-device can also be connected to form a large system. Using the pressure data of the intravascular treatment sub-device and the liquid medicine perfusion sub-device, the perfusion speed and dose are automatically controlled through algorithmic budgeting, so as to achieve the purpose of using the least amount of perfusion liquid medicine and ensuring the treatment effect at the same time. And, the radial force and / or frictional force currently applied to the surface of the catheter body 116 and / or the axial force applied to the tip of the catheter 116 are obtained through the intravascular pressure sensor 53 to adapt and adjust the subsequent pressure information applied to the catheter 116.

[0076] Embodiment 4

[0077] The present invention also provides an intravascular treatment catheter 32. The intravascular treatment catheter 32 includes a catheter insertable section 60 that enters the lumen lesion site of the target object. The intravascular treatment catheter 32 adopts the catheter with a pressure measurement function as mentioned in the above embodiments. At least one pressure sensor 53 is arranged on the working section 61. When in use, the pressure sensor 53 detects the pressure value of the lumen of the target object. Please refer to Figure 6 , which is a schematic application diagram of the intravascular treatment catheter 32. The catheter insertable section 60 enters the human lumen lesion site 30. During the diagnosis and treatment process, the pressure sensor 53 detects the pressure F from the tissue, and the pressure signal is transmitted to the host 70 through the internal signal transmission wire and the extracorporeal section 321.

[0078] Please also refer to Figure 2, the intracavitary treatment catheter 32 may specifically include an insertable section 60 of the catheter and an external section 321. The distal end of the insertable section 60 of the catheter is a working section 61, and the working section 61 may include a functional section 611 and a pressure sensor 53. The proximal end is an intervention section 62; F is the pressure applied to the working section 61 of the catheter 116.

[0079] In one embodiment, the pressure sensor 53 is located on the surface of the catheter 116 and can sense the radial extrusion force or friction force from the surface of the catheter 116 to indicate the radial space where the catheter 116 is located. In another embodiment, the pressure sensor 53 can be simultaneously located at the tip of the catheter 116 and can sense the axial force from the tip of the catheter 116 to prompt the advancing direction and axial space of the catheter 116.

[0080] The operating temperature of the pressure sensor 53 is -10°C - 300°C, and the instantaneous high temperature reaches ≥ 200°C within 3 - 5 s. The pressure sensor 53 meets the performance requirement of maintaining its basic performance without loss after repeatedly heating or cooling within the operating temperature range for 100 times.

[0081] The specific performance parameters of the sensor are as follows in the table:

[0082]

[0083] The whole treatment can form a real-time treatment loop, and the contact force can be adjusted in real time according to the specific situation. In particular, during minimally invasive interventional surgery, during the advancement and treatment of the interventional catheter, the force exerted by the tissue on the catheter is mainly judged by the doctor's feeling. This process has great uncertainty and varies greatly with different operators. At the same time, it requires a lot of practice and experience accumulation, and the learning curve is long. Through the application of this function, the relevant surgical process can be standardized, thereby reducing the difficulty of use for doctors and shortening the learning time. In other words, after applying neural network algorithms and the like in this application scenario, subsequently, according to the detected pressure value of the current lumen of the object of action, the specific adjustment size applied to a certain position of a certain device of the object of action can be directly given according to deep learning, making the treatment device more intelligent.

[0084] The embodiments of the present invention have been described in detail above in conjunction with the accompanying drawings, but the present invention is not limited to the above embodiments. Even if various changes are made to the present invention, provided that these changes fall within the scope of the claims of the present invention and their equivalent technologies, they still fall within the protection scope of the present invention.

Claims

1. A catheter with a pressure measurement function, characterized in that at least one pressure sensor is assembled on the catheter body, and the pressure sensor includes a pressure sensing unit and a signal processing unit. The pressure sensing unit at least includes a sensitive element and at least two sensor tail wires. The sensitive element is arranged on the outer surface of the catheter body and forms a columnar space. The sensor tail wires are in the shape of thin strips, which are arranged on the outer surface of the catheter body or protrude into the catheter cavity and extend along the direction of the catheter body. The sensor tail wires are respectively installed with the sensitive element, and the installation positions are located within the columnar space. The pressure sensor senses the radial force and / or frictional force exerted by the tissue on the surface of the catheter body, and / or the axial force exerted on the catheter tip, and transmits the pressure information to the outside of the catheter through the signal processing unit. The sensitive element includes an elastic diaphragm body and the sensor tail wires, and also includes a connection unit installed with the sensor tail wires. In the use state, the elastic diaphragm body is adapted to the size of the catheter body and is wound around the outer surface of the catheter body. The connection unit extends towards the inside of the catheter tube so that the positions of the sensor tail wires installed on it do not protrude from the columnar space formed by the wound elastic diaphragm body.

2. The catheter with pressure measurement function according to claim 1, characterized in that, The sensitive element is wound or heat-shrunk onto the outer surface of the catheter body to control the size of the pressure sensor while making the outer surface of the catheter body smooth.

3. The catheter with pressure measurement function according to claim 1, characterized in that, The pressure sensor adopts a thin film resistive strain pressure sensor.

4. The catheter with pressure measuring function according to claim 1, characterized in that, The elastic diaphragm body is wound or heat-shrunk onto the outer surface of the catheter body, or the outer surface of the catheter body is provided with mounting grooves along the circumferential direction of the tube body to install the elastic diaphragm body in a non-protruding manner. The size width of the elastic diaphragm body wound around the outer surface of the catheter body is in the range of 1 mm - 80 mm.

5. The catheter with pressure measurement function according to claim 1, wherein, Holes adapted to the number of sensor tail wires are opened at the adapted positions on the catheter body. The connection unit and the sensor tail wires protrude into the catheter cavity through the holes, and the sensor tail wires are arranged in the catheter cavity and extend along the direction of the catheter body.

6. The catheter with pressure measurement function according to claim 1, characterized in that, A plurality of mounting grooves are opened along the circumferential direction on the outer surface of the catheter tube to install the sensor tail wires.

7. The catheter with a pressure measuring function as described in claim 1, characterized in that, The connection unit and the sensor tail wires are integrally formed. The connection unit is a chamfer structure, and the connection unit is welded to the inner surface where the elastic diaphragm body contacts the catheter body by welding.

8. The catheter with pressure measuring function according to claim 3, characterized in that, The thickness of the thin film resistive strain pressure sensor is in the range of 0.05 mm - 1 mm; the length is in the range of 1 mm - 80 mm, the measuring range is in the range of 1 - 100 N, and the accuracy is in the range of ±0.1 N.

9. An endovascular treatment catheter, characterized in that, The intracavitary treatment catheter includes an insertable section of the catheter that enters the lesion site of the lumen of the target object. The insertable section of the catheter includes a working section and an intervention section. The intracavitary treatment catheter adopts the catheter with a pressure measurement function as described in any one of claims 1 to 8. At least one of the pressure sensors is arranged on the working section. When in use, the pressure sensor detects the pressure value of the lumen of the target object.

10. The endovascular treatment catheter according to claim 9, wherein, The pressure sensor is located on the surface of the catheter and is used to sense the radial extrusion force or frictional force from the surface of the catheter to indicate the radial space where the catheter is located.

11. The endovascular treatment catheter according to claim 9, characterized in that, There are multiple pressure sensors, and at least two of the pressure sensors are located at the tip of the catheter or respectively at the two tips of the catheter to obtain the axial force from the tip of the catheter, and then prompt the advancing direction and axial space of the catheter.

12. The endovascular treatment catheter according to claim 9, wherein The operating temperature of the pressure sensor is -10°C - 300°C, and the instantaneous high temperature reaches ≥200°C within 3 - 5 s.

13. The intracavitary treatment catheter according to claim 9, wherein The pressure sensor meets the performance requirement of maintaining its basic performance without loss after 100 times of repeated heating or cooling within the operating temperature range.

14. An intelligent intracavitary treatment device, characterized in that the device at least includes an infusion sub-device and an intracavitary treatment sub-device, the infusion sub-device includes: an infusion accessory, the infusion accessory includes a medicine reservoir, a liquid path, and a puncture device that are connected in sequence; an infusion main unit, the infusion main unit includes an infusion control system and an infusion driver that are communicatively connected, the infusion driver is used to control the flow rate of the preparation in the liquid path, and the infusion control system is communicatively connected to the puncture device pressure detector; the intracavitary treatment sub-device includes: an intracavitary treatment catheter as described in any one of claims 9 - 13, the pressure sensor is communicatively connected to the infusion control system; an intracavitary treatment device, the intracavitary treatment device is connected to the intracavitary treatment catheter and communicatively connected to the pressure sensor, and the intracavitary treatment device is used to generate pulsed energy, and obtain the radial force and / or frictional force currently applied to the surface of the catheter body and / or the axial force applied to the tip of the catheter through the pressure sensor, so as to adaptively adjust the subsequent pressure information applied to the catheter.

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