A delivery system for a prosthetic valve

Abstract

The application belongs to the technical field of medical devices, and relates to a delivery system for a prosthetic valve, which comprises a guide wire, an ultrasonic probe and a processing module. The guide wire is used to build a delivery channel for a prosthetic valve to be delivered, and the end of the guide wire is provided with a guide wire head. The ultrasonic probe is arranged on the guide wire head, and is used to emit ultrasonic signals to the aorta and receive ultrasonic echo signals. The processing module is used to receive and respond to the ultrasonic echo signals, determine an aortic valve opening area according to the ultrasonic echo signals, output a first control instruction according to the aortic valve opening area and a current position of the guide wire head obtained in advance, and drive the guide wire head to move to the aortic valve opening area. The application reduces the difficulty of over-valve operation, shortens the operation time, avoids other surgical risks caused by long operation time, and has high safety.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medical devices, and particularly relates to a delivery system for a prosthetic valve. BACKGROUND

[0002] With the aggravation of population aging, the incidence of heart valve disease is showing a rapid growth trend, among which aortic valve 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 minimally invasive technology without the need for thoracotomy and extracorporeal circulation. It sends an interventional catheter through the femoral artery, delivers a prosthetic heart valve to the aortic valve area, and opens it to complete the implantation of the prosthetic valve and restore the valve function.

[0003] The existing interventional operation is abnormally complex, and requires the joint efforts of departments such as cardiology, cardiac surgery, and medical imaging. During the operation of threading the guide wire through the aortic valve, the doctor needs to subjectively judge the valve opening position through intraoperative CT imaging, and then manually operate the guide wire to make the guide wire pass through the aortic valve, so as to realize the trans-valve operation of the guide wire head. However, due to the thin and soft guide wire head, it is difficult to accurately control the position of the guide wire head under the impact of blood flow, so the trans-valve operation is difficult, the operation time is greatly prolonged due to the difficulty in accurate positioning, and other uncontrollable surgical risks are easily caused, and in severe cases, the patient's life safety may be endangered. SUMMARY

[0004] Therefore, the present application provides a delivery system for a prosthetic valve, which utilizes the principle of ultrasound to quickly locate the aortic valve opening area, obtains a control instruction for a mechanical device according to the location of the aortic valve opening area and the current position of the guide wire head, and utilizes the mechanical device to automatically control the guide wire, so that the guide wire head can quickly and accurately coincide with the aortic valve opening area, thereby autonomously completing the guide wire trans-valve operation and preparing for the aortic valve implantation, effectively reducing the difficulty of trans-valve operation, greatly shortening the operation time, and effectively avoiding other surgical risks caused by prolonged operation time, thereby improving the safety.

[0005] To achieve the above-mentioned purpose, the technical scheme of the present application is as follows:

[0006] A delivery system for a prosthetic valve, comprising:

[0007] a guide wire for establishing a delivery path for a prosthetic 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, the ultrasonic probe being configured to emit ultrasonic signals to the aorta and receive ultrasonic echo signals;

[0009] a processing module configured to receive and respond to the ultrasonic echo signals, and determine an aortic valve opening region according to the ultrasonic echo signals, and output a first control instruction according to the aortic valve opening region and a previously acquired current position of the guide wire head;

[0010] a mechanical device configured to receive and respond to the first control instruction while carrying the guide wire, and drive the guide wire head to move to the aortic valve opening region.

[0011] Preferably, the processing module comprises:

[0012] an ultrasonic transceiver configured to receive the ultrasonic echo signals, and pre-process the ultrasonic echo signals to obtain pre-processed echo signals;

[0013] a first central processing unit configured to determine the aortic valve opening region according to the pre-processed echo signals and a radial cross-section flow velocity field of the aorta in which the guide wire head is currently located, and output the first control instruction according to the aortic valve opening region and the previously acquired current position of the guide wire head;

[0014] wherein the aortic valve opening region is a region in the radial cross-section flow velocity field of the aorta in which the guide wire head is currently located, in which the blood flow velocity of the radial cross-section of the aorta satisfies a preset condition.

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

[0016] Preferably, the guide wire head is further provided with a pressure sensor electrically connected to the processing module, configured to acquire pressure information of the guide wire head, and the processing module is configured to receive and respond to the pressure information of the guide wire head, and output a second control instruction when the pressure information of the guide wire head is greater than a pressure threshold, and the mechanical device is configured to receive and respond to the second control instruction, and control the guide wire to stop moving or move to a distal end direction of the aortic valve opening region until the value of the pressure signal fed back by the pressure sensor is less than the pressure threshold.

[0017] Preferably, the processing module further comprises a pressure signal receiving unit and a second central processing unit, the pressure signal receiving unit is signal connected to the pressure sensor, configured to receive and send the pressure information of the guide wire head, and the second central processing unit is configured to receive and respond to the pressure information of the guide wire head, and output the second control instruction to the mechanical device.

[0018] Preferably, the display 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, and is also used to display warning information generated when the pressure information on the guide wire head is greater than a pressure threshold.

[0019] Preferably, the artificial valve conveying device is electrically connected to the processing module, and is used to convey the artificial valve to be conveyed to the aortic valve opening area through the guide wire.

[0020] Compared with the prior art, the present application provides a conveying system for an artificial valve, which realizes rapid positioning of the aortic valve opening area by using the ultrasonic principle through the ultrasonic probe arranged on the guide wire head, obtains the control instruction of the mechanical device according to the positioning of the aortic valve opening area and the current position of the guide wire head, and realizes automatic control of the guide wire by using the mechanical device, so that the guide wire head can be quickly and accurately overlapped with the aortic valve opening area, and the guide wire is automatically passed through the valve, thereby effectively reducing the difficulty of the valve passing operation, greatly shortening the operation time compared with manual operation, effectively avoiding other surgical risks caused by long operation time, and having high safety and strong practicability, and is worth promoting. BRIEF DESCRIPTION OF DRAWINGS

[0021] Figure 1 is a structural block diagram in embodiment 1 of the present application.

[0022] Figure 2 is a flowchart in embodiment 1 of the present application.

[0023] Figure 3 is a structural block diagram in embodiment 2 of the present application.

[0024] REFERENCE NUMERALS:

[0025] 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 conveyed; 50, artificial valve conveying device; 60, display. DETAILED DESCRIPTION

[0026] In order to enable those skilled in the art to better understand the technical solutions of the present application and implement the same, the following will combine the accompanying drawings to clearly and exhaustively describe the technical solutions in the present application. Figure 1 to the accompanying drawings, Figure 3 , the technical solutions in the present application are clearly and exhaustively described.

[0027] In the description of the present application, it should be understood that the terms "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application.

[0028] In addition, it should be further pointed out that in the description of the embodiments of the present application, unless otherwise specified, " / " means or, for example, A / B can mean A or B: "and / or" in the text only describes the relationship between the associated objects, which means that there can be three relationships, for example, A and / or B, which can mean that A exists alone, A and B exist together, and B exists alone, and in addition, in the description of the embodiments of the present application, "multiple" means two or more than two.

[0029] The following terms "first", "second", "third", "fourth" are only for description purposes, and cannot be understood as implying or implying relative importance or implicitly indicating the number of indicated technical features. Therefore, the features defined with "first", "second", "third", "fourth" can explicitly or implicitly include one or more of the features, and in the description of the present application, unless otherwise specified, the meaning of "multiple" is two or more than two.

[0030] Embodiment 1

[0031] As Figure 1 shown, the present application provides a delivery system for a prosthetic valve, which comprises a guide wire 10, a processing module 20, a mechanical device 30, a prosthetic valve to be delivered 40 and a prosthetic valve delivery device 50. The guide wire 10 is used to build a delivery channel for the prosthetic valve to be delivered 40. The end of the guide wire 10 is provided with a guide wire head 11, and the guide wire head 11 is provided with an ultrasonic probe 12. The ultrasonic probe 12 is used to emit ultrasonic signals to the aorta and receive ultrasonic echo signals. The ultrasonic probe 12 is connected to the processing module 20 by wireless communication, and is used to send the ultrasonic echo signals to the processing module 20. The processing module 20 is used to receive and respond to the ultrasonic echo signals, 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 guide wire head 11 obtained in advance. The mechanical device 30 is used to receive and respond to the first control instruction, drive the guide wire 10 to move, so that the guide wire head 11 moves to the aortic valve opening area. The prosthetic valve delivery device 50 is used to deliver the prosthetic valve to be delivered 40 to the aortic valve opening area through the guide wire 10.

[0032] In this embodiment 1, the diameter of the guide wire 10 is selected according to the patient's age, gender and the degree of vascular occlusion and other conditions.

[0033] Preferably, the diameter of the guide wire 10 is selected as a 4mm guide wire 10.

[0034] The guide wire head 11 is located at the front end of the guide wire 10, that is, the component in the dashed box in Figure 1 The guide wire head 11 adopts a hemispherical structure, and the diameter size of the guide wire head 11 matches the diameter size of the guide wire 10, so as to reduce the damage to the blood vessel wall when the guide wire 10 moves in the patient's body.

[0035] The ultrasonic probe 12 preferably adopts a wireless ultrasonic probe to avoid 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 size of the guide wire head 11.

[0036] As one of the preferred schemes of this embodiment, the ultrasonic probe 12 adopts a cylindrical wireless ultrasonic probe with a diameter of 4mm and a length of 6mm.

[0037] 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, pre-process the ultrasonic echo signal to obtain a pre-processed echo signal, and send the pre-processed echo signal to the first central processing unit.

[0038] The pre-processing process is a denoising and filtering operation on the echo signal to improve the accuracy of subsequent processing.

[0039] The first central processing unit is configured to establish a radial cross-sectional flow field of the aorta in which the guide wire head 11 is currently located according to the pre-processed echo signal, determine the aortic valve opening region according to a preset gradient algorithm and in combination with the radial cross-sectional flow field of the aorta in which the guide wire head 11 is currently located, and output a first control instruction according to the aortic valve opening region and a pre-acquired current position of the guide wire head 11.

[0040] In this embodiment 1, the aortic valve opening region is a region in the radial cross-sectional flow field of the aorta in which the guide wire head 11 is currently located, in which the blood flow velocity of the radial cross-section of the aorta satisfies a preset condition. The pre-acquired current position of the guide wire head 11 is calculated according to the pre-processed echo signal or obtained according to an external medical imaging device, wherein the external medical imaging device is a CT device.

[0041] The process of outputting the first control instruction according to the aortic valve opening area and the current position of the guide wire head 11 is specifically: obtaining the first control instruction according to the distance between the aortic valve opening area and the current position of the guide wire head 11, wherein the first control instruction includes the movement parameters of the guide wire 10, and the movement parameters include the movement direction, distance and speed of the guide wire 10.

[0042] 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 with the guide wire 10, and the output end of the driving motor is connected with the input end of the mechanical device 30 body. The driving motor can drive the guide wire 10 by driving the mechanical device 30 body according to the first control instruction, so as to move the guide wire head 11 to the aortic valve opening area.

[0043] It should be understood that the artificial valve delivery device 50 and the mechanical device 30 can be realized by cooperation of motors and other structures. In this embodiment 1, the type and specific driving mode of the motor are not limited, as long as the artificial valve delivery device 50 and the mechanical device 30 can realize their corresponding delivery functions.

[0044] In this embodiment, the artificial valve delivery device 50 and the mechanical device 30 can be preferably realized by a linear motor.

[0045] Working principle:

[0046] The artificial valve delivery system of this embodiment 1 sets the ultrasonic probe 12 on the guide wire head 11, emits ultrasonic signals to the aorta by the ultrasonic probe 12, receives ultrasonic echo signals, sets the ultrasonic transceiver unit 21 in the processing module 20 to receive the ultrasonic echo signals sent by the ultrasonic probe 12 through wireless communication, and performs denoising and filtering preprocessing operations on the ultrasonic echo signals to obtain preprocessed echo signals, so as 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 the first control instruction according to the current position of the guide wire head 11 and the aortic valve opening area. The mechanical device 30 receives and responds to the first control instruction to drive the guide wire 10 to move, so that the guide wire head 11 moves to the aortic valve opening area, and then the artificial valve 40 to be delivered is delivered to the aortic valve opening area through the guide wire 10.

[0047] Specifically, in actual operation, the current position of the guide wire head 11 can be observed and determined in real time through an external medical imaging device. When the current position of the guide wire 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. Then, the ultrasonic echo signals are sent to the processing module 20. The processing module 20 determines the radial cross-section velocity field of the aorta according to the ultrasonic echo signals, and determines the aortic valve opening area therefrom. Then, the processing module 20 outputs a first control instruction according to the current position of the guide wire head 11 and the aortic valve opening area. The mechanical device 30 drives the guide wire 10 to move according to the first control instruction, so that the guide wire head 11 moves to the aortic valve opening area. When the current position of the guide wire head 11 coincides with the aortic valve opening area, the positioning of the aortic valve opening area and the over-valve operation of the guide wire 10 are automatically completed, without the need for manual processing.

[0048] 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 to completely pass through the aortic valve opening area to reach the left ventricle when the valve is open, 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, so that accurate position correspondence can be achieved, and a better replacement effect can be achieved.

[0049] In this embodiment 1, when determining the aortic valve opening area, the processing module 20 first establishes a radial cross-section flow velocity field in the aorta where the guide wire head 11 is currently located, which represents the blood flow velocity at each cross-section position in the aorta. Then, through a gradient algorithm, the region in the radial cross-section of the aorta where the blood flow velocity satisfies a preset condition 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 into the aorta. Therefore, compared with the blood flow velocity in other regions of the aorta, the blood flow velocity at the aortic valve opening position is faster. Therefore, in this embodiment 1, the preset condition can be set as the region in the radial cross-section of the aorta where the blood flow velocity is the maximum, or the region in the radial cross-section of the aorta where the blood flow velocity exceeds a pressure threshold. Only the region where the flow velocity satisfies the preset condition can be determined as the aortic valve opening area.

[0050] It should be noted that in this embodiment 1, a 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 region of the radial cross-section of the aorta in which the blood flow velocity of the radial cross-section of the aorta meets the preset condition from the radial cross-section flow velocity field of the aorta in which the guide wire head 11 is currently located.

[0051] In this embodiment 1, the first control instruction includes a command for driving the mechanical device 30 to start and movement parameters of the guide wire 10, wherein the movement parameters include the moving direction, distance and speed of the guide wire 10. Specifically, the first central processing unit can determine the distance between the current position of the guide wire head 11 and the position of the aortic valve opening area when generating the first control instruction. The current position of the guide wire head 11 can be determined by an external imaging device or based on the positioning of the ultrasonic probe 12. This embodiment is not limited.

[0052] Specifically, the position of the aortic valve opening area can be set as a first three-dimensional space position, and the current position of the guide wire head 11 can be set as a second three-dimensional space position. The three-dimensional displacement matrix is obtained by subtracting the second three-dimensional space position from the first three-dimensional space position. After selecting the displacement speed in combination with the flow velocity information obtained by ultrasound, the first control instruction is generated to control the motor.

[0053] As shown in FIG. 1, Figure 2 The embodiment 1 also provides a delivery method for a prosthetic valve, which includes the following steps:

[0054] 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.

[0055] When the current position of the guide wire head 11 is at a preset position, an ultrasonic probe 12 is used to emit an ultrasonic signal to the aorta and receive an ultrasonic echo signal.

[0056] The position of the aortic valve opening area is determined according to the ultrasonic echo signal.

[0057] 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 previously obtained current position of the guide wire head 11.

[0058] 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 to-be-delivered prosthetic valve 40 to the aortic valve opening area through the guide wire 10.

[0059] Specifically, according to the first control command, 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. Then, the artificial valve 40 to be delivered is delivered through the guidewire 10 and passes through the aortic valve opening area by the artificial valve delivery device 50.

[0060] Example 2

[0061] As attached Figure 3 As shown, the delivery system for artificial valves in Embodiment 2 is basically the same in structure and principle as the delivery system and method for artificial valves in Embodiment 1, except that:

[0062] A pressure sensor 13 is also provided on the guidewire tip 11 to acquire pressure information received by the guidewire tip 11. The processing module 20 is used to receive and respond to the pressure information received by the guidewire tip 11. When the pressure information received by the guidewire tip 11 is greater than the pressure threshold, the processing module 20 outputs a second control command. The mechanical device 30 is used to receive and respond to the second control command to control the guidewire 10 to stop moving or move towards the distal end of the aortic valve opening region until the pressure signal fed back by the pressure sensor 13 of the guidewire tip 11 is reached.

[0063] In this embodiment 2, the preferred method is to attach the pressure sensor 13 to the surface of the guide wire head 11. The pressure sensor 13 is an active pressure sensor 13 or a passive pressure sensor 13.

[0064] 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. At the same time, the cable of the active pressure sensor 13 and the guide wire 10 are not tangled together, which would affect the movement of the guide wire 10.

[0065] 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.

[0066] 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 be used to attach to the surface of the hemispherical guidewire tip 11. This allows the pressure on the guidewire tip 11 to be acquired simultaneously as it moves through the blood vessel, preventing damage to the myocardium or blood vessels during the guidewire 10's passage through the valve and thus preventing accidents.

[0067] 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 wirelessly connected to the pressure sensor 13 and is used to receive and send the 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 command.

[0068] In addition, the delivery system further comprises a display 60 for information display, the display 60 is connected with the processing module 20, and is used for displaying the current position of the aortic valve opening area and the pre-acquired guide wire head 11. The display 60 can also be used to display warning information, which is generated when the pressure information received by the guide wire head 11 is greater than the pressure threshold value.

[0069] In the embodiment 2, the display 60 can directly display the image formed based on the ultrasonic signal fed back by the ultrasonic probe 12, so as to facilitate the operator to view. In addition, 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 the position of the guide wire head 11 acquired by the external image device. The embodiment 2 is not limited as long as the operator can directly view.

[0070] In addition, the display 60 can also be used to display the warning information when the value of the pressure signal exceeds the preset pressure threshold value, so as to prompt the operator that the current guide wire 10 may exert too large pressure on the patient, and the over-valve operation is abnormal.

[0071] 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 value, the operator can manually control the mechanical device 30 to stop running, so as to further reduce the occurrence of abnormal conditions.

[0072] Working principle:

[0073] The delivery system for artificial valve shown in the embodiment 2 adopts the pressure sensor 13 arranged on the end surface of the guide wire head 11, which is used for acquiring the pressure information of the front end of the guide wire head 11 in real time.

[0074] Specifically, the pressure receiving unit 22 and the second central processing unit are arranged in the processing module 20, the pressure receiving unit 22 is connected with the pressure sensor 13 through wireless communication, and the pressure receiving unit 22 is connected with the second central processing unit. The pressure receiving unit 22 receives the pressure information, and sends the pressure information received by the guide wire head 11 to the second central processing unit. The second central processing unit compares the pressure information received by the guide wire head 11 with a preset pressure threshold value, if the value of the pressure information received by the guide wire head 11 exceeds the pressure threshold value, it is determined that the guide wire 10 causes too large pressure on the blood vessel or the myocardium during the movement, at this time, the 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 continuing to move forward after receiving the second control instruction, and control the guide wire 10 to move backward by a preset distance, that is, to move in the direction of the patient's body outward, until the value of the pressure signal fed back by the pressure sensor 13 is less than the pressure threshold value. The specific value of the pressure threshold value can be flexibly set according to the gender, age and disease of the patient, and the embodiment is not limited to the specific size.

[0075] It should be noted that the delivery method for the artificial valve in the embodiment 2 is basically the same as the delivery method in the embodiment 1, which will not be repeated here.

[0076] The delivery system and method of the present application first turn on the power supply of the delivery system before operating the delivery system, and turn on the CT device to cooperate with the positioning of the guide wire 10. Then, the guide wire 10 with the ultrasonic probe is inserted through the femoral artery in the inner thigh of the patient, and sequentially passes through the abdominal aorta, thoracic aorta, descending aorta, aortic arch and upper aorta to reach the aortic root. In the above process, the current position of the guide wire head 11 can be continuously tracked in real time by the CT device, and the real-time feedback is displayed on the display 60. When the operator determines that the guide wire head 11 is at the preset position, that is, the guide wire head 11 is near the aortic root, the ultrasonic probe is turned on and receives the ultrasonic signal feedback by the ultrasonic probe. After receiving the ultrasonic signal, the processing module 20 can establish the radial section flow field of the guide wire head 11 in the current aorta and display it on the display 60. Then, the processing module 20 determines the aortic valve opening area in the radial section flow field of the aorta according to the gradient algorithm. After determining the aortic valve opening area, the processing module 20 generates a first control instruction, and the mechanical device 30 controls the movement of the guide wire 10 according to the first control instruction, so that the guide wire head 11 is driven by the mechanical device 30 to move to the aortic valve opening area, realizing the automatic crossing operation. After completing the crossing operation of the guide wire 10, the operator controls the artificial valve delivery device 50 to make the artificial valve 40 to be delivered pass through the guide wire 10 channel to the aortic valve opening area of the aortic root, and then open the valve to complete the replacement of the aortic valve. When the pressure sensor 13 is arranged on the guide wire head 11, the pressure signal feedback by the pressure sensor 13 is received in real time during the operation and displayed on the display 60. If the pressure of the guide wire head 11 on the myocardium exceeds the set safety range, the warning information of "abnormal crossing" appears on the display 60, and the crossing of the guide wire 10 is stopped at the same time.

[0077] The delivery system and method for artificial valve of the present application solve the problems of difficult crossing operation of the guide wire 10, long operation time and other surgical risks in the prior art. The ultrasonic probe arranged on the guide wire head 11 realizes rapid positioning of the aortic valve opening area by using the ultrasonic principle, and the mechanical device 30 realizes automatic control of the guide wire 10, so that the guide wire head 11 can quickly and accurately coincide with the aortic valve opening area, thereby automatically completing the crossing operation of the guide wire 10, which is a preparation work for aortic valve implantation. The present application reduces the difficulty of crossing operation, shortens the operation time compared with manual operation, and avoids other surgical risks that may be caused by the operation time.

[0078] The application provides a delivery system for a prosthetic valve, which realizes rapid positioning of an aortic valve opening area by arranging an ultrasonic probe on a guide wire head 11, uses ultrasonic principle, obtains a control instruction of a mechanical device 30 according to the positioning of the aortic valve opening area and the current position of the guide wire head 11, and realizes automatic control of the guide wire 10 by the mechanical device 30, so that the guide wire head 11 can be quickly and accurately overlapped with the aortic valve opening area, and the guide wire 10 is automatically passed through the valve, thereby effectively reducing the difficulty of passing through the valve operation, greatly shortening the operation time compared with manual operation, effectively avoiding other surgical risks caused by long operation time, and being high in safety. In addition, the guide wire head 11 is arranged as a hemispherical structure, reducing damage of the guide wire 10 to the blood vessel wall during movement, meanwhile, the ultrasonic probe is a wireless ultrasonic probe, avoiding mutual winding of the ultrasonic probe cable and the guide wire 10, reducing the influence on the movement of the guide wire 10, and ensuring the safety and accuracy of the movement of the guide wire 10. The pressure sensor 13 is arranged in the device, realizes real-time monitoring of the pressure information received by the guide wire head 11, and uses the pressure information received by the guide wire head 11 as the control instruction of the mechanical device 30, so that the guide wire 10 can be stopped from continuing to move in time when the pressure received by the guide wire head 11 exceeds a preset value, and the safety of the system is improved. The display 60 is arranged, realizes real-time display of the aortic valve opening area, the current position of the guide wire head 11 and pressure warning information, provides basic information for operation decision of the operator, is high in practicability, and is worth promoting.

[0079] It can be understood that the present application is described by some embodiments, and those skilled in the art know that various changes or equivalent replacements can be made to the features and embodiments without departing from the spirit and scope of the present application. In addition, the features and embodiments can be modified to adapt to specific conditions and materials under the guidance of the present application without departing from the spirit and scope of the present application. Therefore, the present application is not limited by the specific embodiments disclosed herein, and all embodiments falling within the scope of the claims of the present application are within the scope of the present application.

Claims

1. A delivery system for a prosthetic valve, characterized by, The application relates to a device for guiding a delivery wire (10) to a target position in aortic valve opening area, comprising: the delivery wire (10) for building a delivery path for a to-be-delivered artificial valve (40), an end of the delivery wire (10) being provided with a delivery wire head (11); an ultrasonic probe (12) arranged on the delivery wire head (11), the ultrasonic probe (12) being used for emitting ultrasonic signals to an aorta and receiving ultrasonic echo signals; a processing module (20) used for receiving and responding to the ultrasonic echo signals and determining the aortic valve opening area according to the ultrasonic echo signals, and outputting a first control instruction according to the aortic valve opening area and a current position of the delivery wire head (11) which is acquired in advance; and a mechanical device (30) for carrying the delivery wire (10) and receiving and responding to the first control instruction, and driving the delivery wire head (11) to move to the aortic valve opening area. The processing module (20) comprises: an ultrasonic transceiver unit (21) used for receiving the ultrasonic echo signals and pre-processing the ultrasonic echo signals to obtain pre-processed echo signals; and a first central processing unit used for determining the aortic valve opening area according to the pre-processed echo signals and a radial cross-section flow field of the aorta in which the delivery wire head (11) is currently located, and outputting the first control instruction according to the aortic valve opening area and the current position of the delivery wire head (11) which is acquired in advance. The aortic valve opening area is a region in the radial cross-section flow field of the aorta in which the delivery wire head (11) is currently located, and the blood flow speed of the radial cross-section of the aorta in the region satisfies a preset condition. The delivery wire head (11) is further provided with a pressure sensor (13) which is electrically connected with the processing module (20), the pressure sensor (13) is located on the end surface of the delivery wire head (11) and is used for acquiring pressure information of the delivery wire head (11), the processing module (20) is used for receiving and responding to the pressure information of the delivery wire head (11), when the pressure information of the delivery wire head (11) is greater than a pressure threshold value, the processing module (20) outputs a second control instruction, and the mechanical device (30) is used for receiving and responding to the second control instruction, and controlling the delivery wire (10) to stop moving or moving to the distal end direction 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 value. The processing module (20) further comprises a pressure signal receiving unit (22) and a second central processing unit, the pressure signal receiving unit (22) is signal-connected with the pressure sensor (13) and is used for receiving and sending the pressure information of the delivery wire head (11), and the second central processing unit is used for receiving and responding to the pressure information of the delivery wire head (11) and outputting the second control instruction to the mechanical device (30). The delivery wire head (11) is a hemispherical structure, and the diameter size of the delivery wire head (11) matches the diameter size of the delivery wire (10). ​ ​ ​ ​ ​ 2. A delivery system for a prosthetic valve according to claim 1, characterized in that, ​ 3. The delivery system for a prosthetic valve of claim 1, wherein, The display (60) is electrically connected with 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 generated when the pressure information borne by the guide wire head (11) is greater than a pressure threshold.

4. The delivery system for a prosthetic valve of claim 3, wherein, The artificial valve (40) to be delivered and an artificial valve delivery device (50) are also included. The artificial valve delivery device (50) is electrically connected with the processing module (20), and is used to deliver the artificial valve (40) to be delivered to the aortic valve opening area through the guide wire (10).

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