Conveying system and method for artificial valve

Abstract

The invention belongs to the technical field of medical instruments, and relates to a delivery system and method for an artificial valve, the system comprises a guide wire used for building a delivery passage for the artificial valve to be delivered, and the end part of the guide wire is provided with a guide wire head; the ultrasonic probe is arranged on the guide wire head and is used for transmitting an ultrasonic signal to the aorta and receiving an ultrasonic echo signal; the processing module is used for receiving and responding to the ultrasonic echo signal, determining an aortic valve opening area according to the ultrasonic echo signal, and outputting a first control instruction according to the aortic valve opening area and the pre-acquired current position of the guide wire head; the mechanical device receives and responds to the first control instruction while bearing the guide wire, and drives the guide wire head to move to the aortic valve opening area. According to the invention, the valve passing operation difficulty is reduced, the operation time is shortened, other operation risks possibly caused by too long operation time are avoided, and the safety is higher.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a delivery system and method for artificial valves. Background Art

[0002] With the aging of the population, the incidence of valvular heart disease is increasing rapidly, among which aortic stenosis has gradually become the most common valvular heart disease in the elderly. In recent years, transcatheter aortic valve implantation has become an effective alternative treatment for traditional high-risk surgical open-chest aortic valve replacement surgery with a minimally invasive technique that does not require thoracotomy and extracorporeal circulation. It inserts an interventional catheter through the femoral artery, delivers the artificial heart valve to the aortic valve area and opens it, thereby completing the implantation of the artificial valve and restoring the valve function.

[0003] Existing interventional surgeries are extremely complicated to operate and require the solidarity and cooperation of multiple departments such as cardiology, cardiac surgery, and medical imaging. In the process of operating the guidewire to pass through the aortic valve, the doctor needs to subjectively judge the position of the valve opening through intraoperative CT and other images, and then manually operate the guidewire to pass the guidewire through the aortic valve to achieve cross-valve operation of the guidewire head. However, since the guidewire head is relatively thin and soft, it is easy to deflect under the impact of blood flow, making it difficult to accurately control the position of the guidewire head. Therefore, the cross-valve operation is difficult and the operation time will be greatly extended due to the difficulty in accurate positioning, which is easy to cause other uncontrollable surgical risks and may even endanger the patient's life in severe cases. Summary of the invention

[0004] In view of this, the present invention provides a delivery system and method for an artificial valve, which utilizes the ultrasonic principle to achieve rapid positioning of the aortic valve opening area, obtains control instructions for a mechanical device based on the positioning of the aortic valve opening area and the current position of the guidewire head, and utilizes the mechanical device to achieve automatic control of the guidewire, so that the guidewire head can quickly and accurately overlap with the aortic valve opening area, thereby autonomously completing the guidewire valve passage, and preparing for aortic valve implantation, effectively reducing the difficulty of the valve passage operation, greatly shortening the operation time, and at the same time, effectively avoiding other surgical risks that may be caused by excessively long operation time, and having a high degree of safety.

[0005] To achieve the above object, the technical solution of the present invention is:

[0006] A delivery system for an artificial valve, comprising:

[0007] A guide wire, used to build a delivery path for the artificial valve to be delivered, the end of the guide wire having a guide wire head;

[0008] An ultrasonic probe, arranged on the guide wire head, and used for transmitting ultrasonic signals to the aorta and receiving ultrasonic echo signals;

[0009] A processing module, configured to receive and respond to the ultrasonic echo signal, determine the aortic valve opening area according to the ultrasonic echo signal, and output a first control instruction according to the aortic valve opening area and the current position of the guidewire head acquired in advance;

[0010] The mechanical device carries the guide wire, receives and responds to the first control instruction, and drives the guide wire head to move to the aortic valve opening area.

[0011] Preferably, the processing module comprises:

[0012] An ultrasonic transceiver unit, used for receiving the ultrasonic echo signal and preprocessing the ultrasonic echo signal to obtain a preprocessed echo signal;

[0013] A first central processing unit is used to determine the aortic valve opening area according to the preprocessed echo signal and the radial section flow velocity field in the aorta where the guidewire head is currently located, and output a first control instruction according to the aortic valve opening area and the current position of the guidewire head obtained in advance;

[0014] The aortic valve opening area is an area in the radial section flow velocity field in the aorta where the guidewire head is currently located, where the blood flow velocity of the radial section in the aorta meets preset conditions.

[0015] Preferably, the guide wire head is a hemispherical structure, and the diameter of the guide wire head matches the diameter of the guide wire.

[0016] Preferably, the guidewire head is also provided with a pressure sensor electrically connected to the processing module, for obtaining pressure information of the guidewire head, and the processing module is used to receive and respond to the pressure information of the guidewire head. When the pressure information of the guidewire head is greater than the pressure threshold, the processing module outputs a second control instruction, and the mechanical device is used to receive and respond to the second control instruction to control the guidewire to stop moving or move toward the distal end of the aortic valve opening area until the value of the pressure signal fed back by the pressure sensor is less than the pressure threshold.

[0017] Preferably, the processing module also includes a pressure signal receiving unit and a second central processing unit. The pressure signal receiving unit is connected to the pressure sensor signal and is used to receive and send pressure information received by the guide wire head. The second central processing unit is used to receive and respond to the pressure information received by the guide wire head and output the second control instruction to the mechanical device.

[0018] Preferably, it also includes a display, which is electrically connected to the processing module and is used to display the aortic valve opening area and the current position of the pre-acquired guide wire head. The display is also used to display a warning message, which is a warning message generated when the pressure information received by the guide wire head is greater than a pressure threshold.

[0019] Preferably, it also includes an artificial valve to be delivered and an artificial valve delivery device, wherein the artificial valve delivery device is electrically connected to the processing module, and the artificial valve delivery device is used to deliver the artificial valve to be delivered to the aortic valve opening area via the guide wire.

[0020] A method for delivering an artificial valve, based on the above-mentioned delivery system, comprises the following steps:

[0021] Moving the wire guide head and acquiring the current position of the wire guide head in real time;

[0022] When the current position of the guidewire head reaches the preset position of the aorta, the ultrasonic probe is used to transmit an ultrasonic signal to the aorta and receive an ultrasonic echo signal;

[0023] The processing module receives and responds to the ultrasonic echo signal, determines the aortic valve opening area according to the ultrasonic echo signal, and outputs a first control instruction according to the aortic valve opening area and the current position of the guidewire head acquired in advance;

[0024] The mechanical device receives and responds to the first control instruction, drives the guide wire head to move to the aortic valve opening area, and then delivers the artificial valve to be delivered to the aortic valve opening area through the guide wire;

[0025] During the process of the mechanical device driving the guidewire head to move, the pressure sensor on the guidewire head obtains the pressure information of the guidewire head in real time. When the pressure information of the guidewire head is greater than the pressure threshold, the processing module outputs a second control instruction, and the mechanical device is used to receive and respond to the second control instruction to control the guidewire to stop moving or move toward the distal end of the aortic valve opening area until the value of the pressure signal fed back by the pressure sensor is less than the pressure threshold.

[0026] Preferably, the current position of the guide wire head is obtained based on the preprocessed echo signal or an external medical imaging device.

[0027] Preferably, the first control instruction includes the moving direction, distance and speed of the guide wire.

[0028] Compared with the prior art, the present invention provides a delivery system and method for an artificial valve, which, by setting an ultrasonic probe on the guide wire head, uses the ultrasonic principle to quickly locate the aortic valve opening area, obtains control instructions for the mechanical device based on the positioning of the aortic valve opening area and the current position of the guide wire head, and uses the mechanical device to automatically control the guide wire, so that the guide wire head can quickly and accurately overlap with the aortic valve opening area, and then autonomously complete the guide wire passing the valve, prepare for the aortic valve implantation, effectively reduce the difficulty of the valve passing operation, greatly shorten the operation time compared to manual operation, and at the same time, effectively avoid other surgical risks that may be caused by excessively long operation time, have high safety, strong practicality, and are worthy of promotion. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 This is a structural block diagram of Example 1 of the present invention.

[0030] Figure 2 This is a flow chart of Example 1 of the present invention.

[0031] Figure 3 This is a structural block diagram of Example 2 of the present invention.

[0032] Reference numerals:

[0033] 10. Guide wire; 11. Guide wire head; 12. Ultrasonic probe; 13. Pressure sensor; 20. Processing module; 21. Ultrasonic transceiver unit; 22. Pressure signal receiving unit; 30. Mechanical device; 40. Artificial valve to be delivered; 50. Artificial valve delivery device; 60. Display. DETAILED DESCRIPTION

[0034] In order to enable those skilled in the art to better understand the technical solution of the present invention and to implement it, the following will be combined with the attached Figure 1 To the attached Figure 3 , the technical solution in the present invention is described clearly and in detail.

[0035] In the description of the present invention, it is to be understood that the terms “center”, “longitudinal”, “lateral”, “length”, “width”, “thickness”, “up”, “down”, “front”, “back”, “left”, “right”, “vertical”, “horizontal”, “top”, “bottom”, “inside”, “outside”, “clockwise”, “counterclockwise”, “axial”, “radial”, “circumferential”, etc., indicating orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply 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 limiting the present invention.

[0036] In addition, it should be further explained that, in the description of the embodiments of the present invention, unless otherwise specified, “ / ” means or, for example, A / B can mean A or B: “and / or” in the text is merely a description of the association relationship of associated objects, indicating that three relationships may exist, for example, A and / or B can mean: A exists alone, A and B exist at the same time, and B exists alone. In addition, in the description of the embodiments of the present invention, “multiple” refers to two or more than two.

[0037] The following terms "first", "second", "third" and "fourth" are used for descriptive purposes only and should not be understood as suggesting or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, features defined as "first", "second", "third" and "fourth" may explicitly or implicitly include one or more of the features. In the description of the present invention, unless otherwise specified, "plurality" means two or more.

[0038] Example 1

[0039] like Figure 1 As shown, the present invention provides a delivery system for an artificial valve, comprising a guidewire 10, a processing module 20, a mechanical device 30, an artificial valve 40 to be delivered and an artificial valve delivery device 50, wherein the guidewire 10 is used to build a delivery channel for the artificial valve 40 to be delivered, a guidewire head 11 is provided at the end of the guidewire 10, and an ultrasonic probe 12 is provided on the guidewire head 11, the ultrasonic probe 12 is used to transmit an ultrasonic signal to the aorta and receive an ultrasonic echo signal, a wireless communication connection is adopted between the ultrasonic probe 12 and the processing module 20, and the ultrasonic echo signal is sent to the processing module 20, the processing module 20 is used to receive and respond to the ultrasonic echo signal, determine the aortic valve opening area, and output a first control instruction according to the aortic valve opening area and the current position of the guidewire head 11 obtained in advance, and the mechanical device 30 is used to receive and respond to the first control instruction, drive the guidewire 10 to move, so that the guidewire head 11 moves to the aortic valve opening area. The artificial valve delivery device 50 is used to deliver the artificial valve 40 to be delivered to the aortic valve opening area via the guide wire 10 .

[0040] In this embodiment 1, the diameter of the guide wire 10 is selected according to the patient's age, gender, and degree of blood vessel blockage.

[0041] Preferably, the diameter of the guide wire 10 is selected to be 4 mm.

[0042] The guide wire head 11 is located at the front end of the guide wire 10. Figure 1 As shown in the dotted frame, the guide wire head 11 adopts a hemispherical structure, and the diameter of the guide wire head 11 matches the diameter of the guide wire 10 to reduce the damage to the blood vessel wall when the guide wire 10 moves in the patient's body.

[0043] The ultrasonic probe 12 is preferably a wireless ultrasonic probe to prevent the cable of the wired ultrasonic probe from being entangled with the guide wire 10 , thereby affecting the movement of the guide wire 10 . The size of the ultrasonic probe 12 is selected and determined according to the diameter of the guide wire head 11 .

[0044] Among them, as one of the preferred solutions of this embodiment, the ultrasonic probe 12 adopts a cylindrical wireless ultrasonic probe with a diameter of 4 mm and a length of 6 mm.

[0045] In this embodiment 1, the processing module 20 includes an ultrasonic transceiver unit 21 and a first central processing unit. The ultrasonic transceiver unit 21 is used to receive an ultrasonic echo signal, preprocess the ultrasonic echo signal, obtain a preprocessed echo signal, and send the preprocessed echo signal to the first central processing unit.

[0046] The preprocessing process is to perform denoising and filtering operations on the echo signal to improve the accuracy of subsequent processing.

[0047] The first central processing unit is used to establish a radial section flow velocity field in the aorta where the guidewire head 11 is currently located according to the preprocessed echo signal, determine the aortic valve opening area according to a preset gradient algorithm and the radial section flow velocity field in the aorta where the guidewire head 11 is currently located, and output a first control instruction according to the aortic valve opening area and the current position of the guidewire head 11 obtained in advance.

[0048] In this embodiment 1, the aortic valve opening area is the area in the radial section flow velocity field in the aorta where the guidewire head 11 is currently located, where the blood flow velocity in the radial section of the aorta meets the preset conditions. The current position of the guidewire head 11 is obtained in advance, calculated based on the preprocessed echo signal, or obtained based on an external medical imaging device, wherein the external medical imaging device is a CT device.

[0049] Among them, the process of outputting the first control instruction according to the aortic valve opening area and the current position of the guidewire head 11 obtained in advance is specifically: obtaining the first control instruction according to the distance between the aortic valve opening area and the current position of the guidewire head 11 obtained in advance, wherein the first control instruction includes the movement parameters of the guidewire 10, and the movement parameters include the moving direction, distance and speed of the guidewire 10.

[0050] In this embodiment 1, the mechanical device 30 includes a mechanical device 30 body and a driving motor. The output end of the mechanical device 30 body is connected to the guide wire 10, and the output end of the driving motor is connected to the input end of the mechanical device 30 body. The driving motor can drive the mechanical device 30 body according to the first control instruction and then drive the guide wire 10, so that the guide wire head 11 moves to the aortic valve opening area.

[0051] It should be understood that both the artificial valve delivery device 50 and the mechanical device 30 can be realized through the cooperation of motors and other structures. In this embodiment 1, the model of the motor and the specific driving method are not limited, as long as the artificial valve delivery device 50 and the mechanical device 30 can achieve their corresponding delivery functions.

[0052] In this embodiment, the artificial valve delivery device 50 and the mechanical device 30 can preferably be implemented by linear motors.

[0053] Working principle:

[0054] The delivery system for artificial valves of the present embodiment 1 is provided with an ultrasonic probe 12 on the guidewire head 11, and the ultrasonic probe 12 is used to transmit ultrasonic signals to the aorta and receive ultrasonic echo signals. An ultrasonic transceiver unit 21 is provided in the processing module 20 to receive the ultrasonic echo signals sent by the ultrasonic probe 12 via wireless communication, and to perform preprocessing operations such as denoising and filtering on the ultrasonic echo signals to obtain preprocessed echo signals to improve the accuracy of subsequent processing. The first central processing unit is used to determine the aortic valve opening area according to the preprocessed echo signals, and output a first control instruction according to the current position of the guidewire head 11 and the aortic valve opening area. The mechanical device 30 receives and responds to the first control instruction, drives the guidewire 10 to move, so that the guidewire head 11 moves to the aortic valve opening area, and then delivers the artificial valve 40 to be delivered to the aortic valve opening area via the guidewire 10.

[0055] Specifically, in actual operation, the current position of the guidewire head 11 can be observed and determined in real time through an external medical imaging device. When the current position of the guidewire head 11 reaches the position near the aortic valve, the ultrasonic probe 12 is controlled to emit ultrasonic waves and receive ultrasonic echo signals of blood flow through the aortic valve, and then the ultrasonic echo signals are sent to the processing module 20. The processing module 20 determines the velocity field of the radial section of the aorta based on the ultrasonic echo signals, and determines the aortic valve opening area therefrom. Afterwards, the processing module 20 also outputs a first control instruction based on the current position of the guidewire head 11 and the aortic valve opening area. The mechanical device 30 drives the guidewire 10 to move according to the first control instruction, so that the guidewire head 11 moves to the aortic valve opening area. When the current position of the guidewire head 11 coincides with the aortic valve opening area, the positioning of the aortic valve opening area and the valve-passing operation of the guidewire 10 are automatically completed without manual processing.

[0056] In actual operation, when the current position of the guide wire head 11 coincides with the aortic valve opening area, the aortic valve opening area can be accurately positioned, and the guide wire head 11 can be moved so that it completely passes through the aortic valve opening area and reaches the left ventricle when the valve is opened, thereby realizing the function of establishing a delivery channel for the artificial valve through the guide wire 10. When replacing the artificial valve, the artificial valve 40 to be delivered is delivered to the current position of the guide wire head 11, thereby achieving accurate position correspondence and achieving a better replacement effect.

[0057] In this embodiment 1, when determining the aortic valve opening area, the processing module 20 first establishes a radial section flow velocity field in the aorta where the guidewire head 11 is currently located through the received ultrasonic echo signal, so as to represent the blood flow velocity at each section position in the aorta. Subsequently, through the gradient algorithm, in the radial section flow velocity field in the aorta where the guidewire head 11 is currently located, the area where the blood flow velocity of the radial section in the aorta meets the preset conditions is determined as the aortic valve opening area. Specifically, the aortic valve is a valve that opens and closes when the left ventricle of the heart pumps blood to the aorta. Therefore, compared with the blood flow velocity in other areas of the aorta, the blood flow velocity at the aortic valve opening position is faster. Therefore, the preset condition in this embodiment 1 can be set as the area where the blood flow velocity of the radial section in the aorta is the largest in the radial section flow velocity field in the aorta where the guidewire head 11 is currently located, or the area where the blood flow velocity of the radial section in the aorta exceeds the pressure threshold. Only the area where the flow velocity meets the preset conditions can be identified as the aortic valve opening area.

[0058] It should be noted that in this embodiment 1, the gradient algorithm is preferably used to determine the aortic valve opening area. In actual operation, other algorithms can also be used for determination, as long as the processing module 20 can accurately determine the area where the blood flow velocity of the radial section of the aorta meets the preset conditions from the radial section flow velocity field in the aorta where the guidewire head 11 is currently located.

[0059] In this embodiment 1, the first control instruction includes an instruction to start the driving mechanical device 30 and the movement parameters of the guidewire 10, wherein the movement parameters include the movement direction, distance and speed of the guidewire 10. Specifically, when the first central processing unit generates the first control instruction, it can be determined based on the distance between the current position of the guidewire head 11 and the position of the aortic valve opening area. The current position of the guidewire head 11 can be determined by an external imaging device, or the guidewire head 11 can be positioned based on the ultrasonic probe 12, which is not limited in this embodiment.

[0060] Specifically, the position of the aortic valve opening area can be set as the first three-dimensional spatial position, and the current position of the guidewire head 11 can be set as the second three-dimensional spatial position. The two are subtracted to obtain a three-dimensional displacement matrix. After the displacement speed is selected in combination with the flow velocity information obtained by ultrasound, a first control instruction is generated to control the motor.

[0061] As attached Figure 2 As shown, this embodiment 1 also provides a method for delivering an artificial valve, comprising the following steps:

[0062] The guide wire head 11 is moved, and the current position of the guide wire head 11 is determined based on an external medical imaging device.

[0063] When the current position of the guidewire head 11 is at the preset position, the ultrasonic probe 12 is used to transmit ultrasonic signals to the aorta and receive ultrasonic echo signals.

[0064] The location of the aortic valve opening area is determined based on the ultrasound echo signal.

[0065] The processing module 20 receives and responds to the ultrasonic echo signal, determines the aortic valve opening area according to the ultrasonic echo signal, and outputs a first control instruction according to the aortic valve opening area and the current position of the guidewire head 11 acquired in advance.

[0066] The mechanical device 30 receives and responds to the first control instruction, drives the guidewire head 11 to move to the aortic valve opening area, and then delivers the artificial valve 40 to be delivered to the aortic valve opening area through the guidewire 10.

[0067] Specifically, according to the first control instruction, the guidewire 10 is driven to move by the mechanical device 30 so that the guidewire head 11 moves to the aortic valve opening area. After that, the artificial valve 40 to be delivered is delivered through the guidewire 10 and through the aortic valve opening area through the artificial valve delivery device 50.

[0068] Example 2

[0069] As attached Figure 3 As shown, the delivery system for artificial valves of this embodiment 2 is basically the same in structure and principle as the delivery system and method for artificial valves of embodiment 1, except that:

[0070] The guidewire head 11 is also provided with a pressure sensor 13 for obtaining pressure information of the guidewire head 11. The processing module 20 is used to receive and respond to the pressure information of the guidewire head 11. When the pressure information of the guidewire head 11 is greater than the pressure threshold, the processing module 20 outputs a second control instruction. The mechanical device 30 is used to receive and respond to the second control instruction to control the guidewire 10 to stop moving or move toward the distal end of the aortic valve opening area until the pressure signal value fed back by the pressure sensor 13 of the guidewire head 11 is reached.

[0071] In this embodiment 2, a preferred method is to attach the pressure sensor 13 to the surface of the guide wire head 11 , and the pressure sensor 13 is an active pressure sensor 13 or a passive pressure sensor 13 .

[0072] When a passive pressure sensor 13 is used, the problem of the active pressure sensor 13 being too large to pass through the artery can be avoided, and the cable of the active pressure sensor 13 and the guide wire 10 being entangled with each other, thereby affecting the movement of the guide wire 10, can be avoided.

[0073] Preferably, the pressure sensor 13 is a thin film pressure sensor 13 or a piezoelectric pressure sensor 13 , and the size of the pressure sensor 13 is adapted to the size of the guide wire 10 .

[0074] For example, when the diameter of the guidewire 10 is 4 mm, a circular thin film pressure sensor 13 with a diameter of 4 mm can also be selected and attached to the surface of the hemispherical guidewire head 11, so that when the guidewire head 11 moves in the blood vessel, the pressure exerted on the guidewire head 11 can be obtained at the same time to prevent the myocardium or blood vessels from being damaged and causing accidents during the guidewire 10 passing through the valve.

[0075] The processing module 20 also includes a pressure signal receiving unit 22 and a second central processing unit. The pressure signal receiving unit 22 is connected to the pressure sensor 13 by wireless communication, and is used to receive and send pressure information received by the guide wire head 11. The second central processing unit is used to receive and respond to the pressure information received by the guide wire head 11, and output a second control instruction.

[0076] In addition, the delivery system also includes a display 60 for information display. The display 60 is connected to the processing module 20 and is used to display the aortic valve opening area and the current position of the guide wire head 11 acquired in advance. The display 60 can also be used to display warning information, which is a warning information generated when the pressure information received by the guide wire head 11 is greater than the pressure threshold.

[0077] In this embodiment 2, the display 60 can intuitively display the image formed based on the ultrasonic signal fed back by the ultrasonic probe 12, which is convenient for the operator to view. At the same time, the display 60 can also display the current position information of the guide wire head 11, which can be the position located by the ultrasonic signal fed back by the ultrasonic probe 12, or it can be the position of the guide wire head 11 obtained by an external imaging device. This embodiment 2 is not limited as long as it can satisfy the operator's intuitive viewing.

[0078] In addition, the display 60 can also be used to display an alarm message when the value of the pressure signal exceeds a preset pressure threshold, so as to remind the operator that the current guide wire 10 may apply too much pressure to the patient and the valve operation is abnormal.

[0079] In actual use, the display 60 can also display the value of the pressure signal in real time for the operator to view. When the operator observes that the real-time pressure value is close to the preset pressure threshold, the operator can manually control the mechanical device 30 to stop running, further reducing the occurrence of possible abnormal situations.

[0080] Working principle:

[0081] The delivery system for artificial valves shown in the present embodiment 2 adopts a pressure sensor 13 provided on the end surface of the guide wire head 11 to obtain the pressure information of the front end of the guide wire head 11 in real time.

[0082] Specifically, a pressure receiving unit 22 and a second central processing unit are provided in the processing module 20. The pressure receiving unit 22 is connected to the pressure sensor 13 by wireless communication, and the pressure receiving unit 22 is connected to the second central processing unit. The pressure signal receiving unit 22 is used to receive the pressure information, and the pressure information received by the guide wire head 11 is sent to the second central processing unit. The second central processing unit compares the pressure information received by the guide wire head 11 with the preset pressure threshold. If the value of the pressure information received by the guide wire head 11 exceeds the pressure threshold, it is determined that the pressure caused by the guide wire 10 on the blood vessel or myocardium during the movement is too large. At this time, a second control instruction is generated and sent to the mechanical device 30. After receiving the second control instruction, the mechanical device 30 stops driving the guide wire 10 to move to reduce the pressure applied by the guide wire 10 to the human body, or the mechanical device 30 can also stop the guide wire 10 from moving forward and control the guide wire 10 to move backward by a preset distance after receiving the second control instruction, that is, move in the direction outside the patient's body until the value of the pressure signal fed back by the pressure sensor 13 is less than the pressure threshold. The specific value of the pressure threshold can be flexibly set according to the patient's gender, age, and disease condition, and this embodiment does not limit its specific value.

[0083] It should be noted that the delivery method for the artificial valve in this embodiment 2 is basically the same as the delivery method in embodiment 1, and will not be repeated here.

[0084] The delivery system and method of the present invention, before operating the delivery system, first turn on the power of the delivery system, and turn on the CT device to cooperate in positioning the guidewire 10. Subsequently, the guidewire 10 with an ultrasonic probe is passed through the femoral artery on the inner thigh of the patient, and successively passes through the abdominal aorta, thoracic aorta, descending aorta, aortic arch and superior aorta, and reaches the aortic root. During the above process, the current position of the guidewire head 11 can be continuously tracked in real time through the CT device, and real-time feedback is given on the display 60; when the operator determines that the guidewire head 11 is in a preset position, that is, when the guidewire head 11 is near the aortic root, the ultrasonic probe is controlled to turn on and receive the ultrasonic signal fed back by the ultrasonic probe; after receiving the ultrasonic signal, the processing module 20 can establish the radial section flow velocity field of the guidewire head 11 in the current aorta, and present it on the display 60, and then the processing module 20 determines the aortic valve opening area in the radial section flow velocity field in the aorta according to the gradient algorithm, and determines the aortic valve opening area in the aortic valve opening area. After that, the processing module 20 generates a first control instruction, and the mechanical device 30 controls the movement of the guidewire 10 according to the first control instruction, so that the guidewire head 11 moves to the aortic valve opening area under the drive of the mechanical device 30 to realize automatic valve-passing operation. After completing the guidewire 10 valve-passing work, the artificial valve delivery device 50 is operated to control the artificial valve 40 to be delivered to the aortic valve opening area at the aortic root along the constructed guidewire 10 passage, and then the valve is opened to complete the replacement of the aortic valve. When a pressure sensor 13 is provided on the guidewire head 11, the pressure signal fed back by the pressure sensor 13 is received in real time during the operation and presented on the display 60. If the pressure of the guidewire head 11 on the myocardium exceeds the set safety range, a warning message of "abnormal valve-passing" appears on the display 60, and the guidewire 10 valve-passing is stopped at the same time.

[0085] The delivery system and method for an artificial valve of the present invention are used to solve the problems in the prior art that the operation of passing the guidewire 10 through the valve is difficult, time-consuming, and prone to other surgical risks. An ultrasonic probe is set on the guidewire head 11, and the ultrasonic principle is used to quickly locate the aortic valve opening area, and the guidewire 10 is automatically controlled in combination with the mechanical device 30, so that the guidewire head 11 can quickly and accurately overlap with the aortic valve opening area, thereby automatically completing the preparatory work of aortic valve implantation such as passing the guidewire 10 through the valve, which reduces the difficulty of the valve passing operation and shortens the operation time compared to manual operation, thereby avoiding other surgical risks that may be caused by the operation time process.

[0086] The present invention provides a delivery system and method for an artificial valve. An ultrasonic probe is arranged on a guide wire head 11, and the ultrasonic principle is used to quickly locate the aortic valve opening area. According to the positioning of the aortic valve opening area and the current position of the guide wire head 11, a control instruction of a mechanical device 30 is obtained, and the mechanical device 30 is used to automatically control the guide wire 10, so that the guide wire head 11 can quickly and accurately overlap with the aortic valve opening area, and then the guide wire 10 can be passed through the valve autonomously, so as to prepare for the aortic valve implantation, effectively reduce the difficulty of the valve passing operation, greatly shorten the operation time compared with manual operation, and at the same time, effectively avoid other surgical risks that may be caused by excessively long operation time, and have high safety. In addition, the guidewire head 11 is set as a hemispherical structure, which reduces the damage of the guidewire 10 to the blood vessel wall during the movement. At the same time, the ultrasonic probe adopts a wireless ultrasonic probe to avoid the entanglement between the ultrasonic probe cable and the guidewire 10, reduce the impact on the movement of the guidewire 10, and ensure the safety and accuracy of the movement of the guidewire 10. By setting a pressure sensor 13 in the device, real-time monitoring of the pressure information received by the guidewire head 11 is achieved, and the pressure information received by the guidewire head 11 is used as a control instruction for controlling the mechanical device 30 to ensure that when the pressure received by the guidewire head 11 exceeds the preset value, the guidewire 10 can be stopped in time to continue to move forward, thereby improving the safety of the system. By setting a display 60, the aortic valve opening area, the current position of the guidewire head 11 and the pressure warning information are displayed in real time, providing the operator with basic information for operation decision-making, which is highly practical and worthy of promotion.

[0087] It is to be understood that the present invention is described by some embodiments, and it is known to those skilled in the art that various changes or equivalent substitutions may be made to these features and embodiments without departing from the spirit and scope of the present invention. In addition, under the teachings of the present invention, these features and embodiments may be modified to adapt to specific circumstances and materials without departing from the spirit and scope of the present invention. Therefore, the present invention is not limited by the specific embodiments disclosed herein, and all embodiments falling within the scope of the claims of this application are within the scope of protection of the present invention.

Claims

1. A delivery system for an artificial valve, characterized in that: include: A guide wire (10) is used to build a delivery path for the artificial valve (40) to be delivered, and the end of the guide wire (10) is provided with a guide wire head (11); An ultrasonic probe (12) is arranged on the guide wire head (11), and the ultrasonic probe (12) is used to transmit ultrasonic signals to the aorta and receive ultrasonic echo signals; A processing module (20) is used to receive and respond to the ultrasonic echo signal, determine the aortic valve opening area according to the ultrasonic echo signal, and output a first control instruction according to the aortic valve opening area and the current position of the guidewire head (11) obtained in advance; The mechanical device (30) carries the guide wire (10), receives and responds to the first control instruction, and drives the guide wire head (11) to move to the aortic valve opening area.

2. A delivery system for an artificial valve according to claim 1, characterized in that: The processing module (20) comprises: An ultrasonic transceiver unit (21) is used to receive the ultrasonic echo signal and preprocess the ultrasonic echo signal to obtain a preprocessed echo signal; A first central processing unit is used to determine the aortic valve opening area according to the pre-processed echo signal and the radial section flow velocity field in the aorta where the guidewire head (11) is currently located, and output a first control instruction according to the aortic valve opening area and the current position of the guidewire head (11) obtained in advance; The aortic valve opening area is an area in the radial section flow velocity field in the aorta where the guidewire head (11) is currently located, where the blood flow velocity of the radial section in the aorta meets a preset condition.

3. A delivery system for an artificial valve according to claim 1, characterized in that: The guide wire head (11) is a hemispherical structure, and the diameter of the guide wire head (11) matches the diameter of the guide wire (10).

4. A delivery system for an artificial valve according to claim 3, characterized in that: The guidewire head (11) is also provided with a pressure sensor (13) electrically connected to the processing module (20) for obtaining pressure information of the guidewire head (11). The processing module (20) is used to receive and respond to the pressure information of the guidewire head (11). When the pressure information of the guidewire head (11) is greater than a pressure threshold, the processing module (20) outputs a second control instruction. The mechanical device (30) is used to receive and respond to the second control instruction to control the guidewire (10) to stop moving or move toward the distal end of the aortic valve opening area until the value of the pressure signal fed back by the pressure sensor (13) is less than the pressure threshold.

5. A delivery system for an artificial valve according to claim 4, characterized in that: The processing module (20) also includes a pressure signal receiving unit (22) and a second central processing unit. The pressure signal receiving unit (22) is connected to the pressure sensor (13) by signal, and is used to receive and send pressure information received by the guide wire head (11). The second central processing unit is used to receive and respond to the pressure information received by the guide wire head (11), and output the second control instruction to the mechanical device (30).

6. A delivery system for an artificial valve according to claim 5, characterized in that: It also includes a display (60), which is electrically connected to the processing module (20) and is used to display the aortic valve opening area and the current position of the pre-acquired guide wire head (11). The display (60) is also used to display warning information, which is a warning information generated when the pressure information received by the guide wire head (11) is greater than a pressure threshold.

7. A delivery system for an artificial valve according to claim 6, characterized in that: It also includes an artificial valve (40) to be delivered and an artificial valve delivery device (50), wherein the artificial valve delivery device (50) is electrically connected to the processing module (20), and the artificial valve delivery device (50) is used to deliver the artificial valve (40) to be delivered to the aortic valve opening area via the guide wire (10).

8. A method for delivering an artificial valve, characterized in that: A delivery system for an artificial valve according to claim 7, comprising the following steps: Moving the wire guide head (11) and acquiring the current position of the wire guide head (11) in real time; When the current position of the guide wire head (11) reaches a preset position of the aorta, the ultrasonic probe (12) is used to transmit an ultrasonic signal to the aorta and receive an ultrasonic echo signal; The processing module (20) receives and responds to the ultrasonic echo signal, determines the aortic valve opening area according to the ultrasonic echo signal, and outputs a first control instruction according to the aortic valve opening area and the current position of the guidewire head (11) acquired in advance; The mechanical device (30) receives and responds to the first control instruction, drives the guide wire head (11) to move to the aortic valve opening area, and then delivers the artificial valve (40) to be delivered to the aortic valve opening area via the guide wire (10); During the process of the mechanical device (30) driving the guidewire head (11) to move, the pressure sensor (13) on the guidewire head (11) obtains the pressure information of the guidewire head (11) in real time. When the pressure information of the guidewire head (11) is greater than the pressure threshold, the processing module (20) outputs a second control instruction, and the mechanical device (30) is used to receive and respond to the second control instruction to control the guidewire (10) to stop moving or move toward the distal end of the aortic valve opening area until the value of the pressure signal fed back by the pressure sensor (13) is less than the pressure threshold.

9. A method for delivering an artificial valve according to claim 8, characterized in that: The guide wire head (11) is moved, and the current position of the guide wire head (11) is acquired in real time based on the preprocessed echo signal or an external medical imaging device.

10. A method for delivering an artificial valve according to claim 8, characterized in that: The first control instruction includes the moving direction, distance and speed of the guide wire (10).

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