CN115444621A - Prosthetic heart valve and transvalve differential pressure detection system - Google Patents

Abstract

The application relates to a prosthetic heart valve and a trans-valve differential pressure detection system, wherein the prosthetic heart valve comprises a valve, a support and a differential pressure detection device, the valve is fixed on the support, and the differential pressure detection device is integrated on the support; the differential pressure detection device comprises a pressure sensor, an electric energy receiving circuit, a signal sending circuit and a first flexible circuit board; the electric energy receiving circuit is respectively connected with the signal transmitting circuit and the pressure sensor, the pressure sensor is connected with the signal transmitting circuit, part of components in the electric energy receiving circuit and the signal transmitting circuit are arranged on a first flexible circuit board, and the first flexible circuit board is fixed on the support; the pressure sensor is fixed on the bracket and is used for detecting the pressure and/or the pressure difference at two sides of the valve; the electric energy receiving circuit is used for receiving and converting the wireless energy into electric energy; and the signal transmitting circuit is used for processing and transmitting the detection signal of the pressure sensor. The artificial heart valve of the present application can continuously and accurately detect the cross-valve pressure difference.

Description

Prosthetic heart valve and trans-valve differential pressure detection system

Technical Field

The application relates to the technical field of medical devices, in particular to an artificial heart valve and a trans-valve pressure difference detection system.

Background

When the function of the heart valve of the human body is damaged, such as valve stenosis and valve hardening, the function of the heart can be adversely affected. The trans-valve pressure difference of the artificial heart valve refers to the pressure difference generated by the blocking effect of the valve orifice on the blood flow when the blood flows through the artificial valve, and is one of the most important hemodynamic parameters for evaluating the function of the artificial heart valve. The method can accurately measure the valve trans-valve pressure difference in time, and has important significance for finding and preventing the artificial heart valve from having poor working state or potential complications.

The measurement of the cross-valve pressure difference is divided into direct measurement and indirect measurement. The direct measurement is that the pressure signals of the atrium and the ventricle are directly collected through a catheter intervention mode, and then the difference is made on the collected pressure signals to obtain the cross-valve pressure difference. The pressure catheter with a pressure sensor is usually introduced into a human body from a vein, and then is gradually guided into the heart to realize pressure signal acquisition. Since the pressure conduit measurement method can directly measure the pressure signal at the target point, the measurement accuracy is often high. The indirect measurement mode is that the mode of ultrasonic electrocardiogram is adopted, the maximum flow velocity of the blood flow frequency spectrum at the early diastole stage of the cusp valve is measured by continuous Doppler, and then the simplified Bernoulli equation in hydrodynamics is adopted to calculate the pressure step difference at the two ends of the valve, so as to realize the indirect measurement of the trans-valvular pressure difference. Compared with a direct measurement mode of a pressure catheter, an indirect measurement mode of the ultrasonic electrocardiogram is simpler and more convenient to operate, minimally invasive surgery for a patient is not needed, and the mode of measuring the cross-valve pressure difference by the ultrasonic electrocardiogram is widely applied to monitoring and health examination of the patient in a hospital.

However, due to the limitations of the simplified bernoulli equation, there is a difference in the results of the ultrasound electrocardiography measurement and the catheter measurement. After the patient has undergone a prosthetic heart valve replacement procedure, physicians prefer to use a catheter measurement to obtain the trans-valve pressure difference for more accurate measurement. No matter ultrasonic electrocardiogram or catheter measurement, a patient is required to continuously go to a hospital for periodic examination, and the transvalve pressure difference measurement is realized by means of professional equipment, so that the economic burden of the patient is undoubtedly improved. Meanwhile, the two measurement modes are difficult to realize continuous monitoring of the cross-valve pressure difference, and timely and accurate early warning cannot be carried out on the condition that some cross-valve pressure differences are increased, so that the patient misses the optimal treatment time.

Disclosure of Invention

In view of the above, the present application provides an artificial heart valve and a trans-valve differential pressure detection system that can continuously and accurately detect a trans-valve differential pressure.

In order to solve the above technical problems, the present application provides an artificial heart valve, which includes a valve, a stent, and a differential pressure detection device, wherein the valve is fixed on the stent, and the differential pressure detection device is integrated with the stent;

the pressure difference detection device comprises a pressure sensor, an electric energy receiving circuit, a signal sending circuit and a first flexible circuit board;

the electric energy receiving circuit is respectively connected with the signal sending circuit and the pressure sensor, the pressure sensor is connected with the signal sending circuit, partial components in the electric energy receiving circuit and the signal sending circuit are arranged on the first flexible circuit board, and the first flexible circuit board is fixed on the bracket;

the pressure sensor is fixed on the bracket and used for detecting the pressure and/or the pressure difference on two sides of the valve;

the electric energy receiving circuit is used for receiving and converting the wireless energy into electric energy;

and the signal transmitting circuit is used for processing and transmitting the detection signal of the pressure sensor.

Optionally, the first flexible circuit board includes a first insulating layer, a biocompatible layer, a component layer, a circuit layer, and a second insulating layer in sequence, and components of the electric energy receiving circuit and the signal sending circuit are disposed on the component layer.

Optionally, the pressure sensor includes a second flexible circuit board fixed to the support, the second flexible circuit board includes a first extension arm, a second extension arm and a third extension arm, the first extension arm and the second extension arm are respectively attached to two sides of the valve, and the third extension arm is fixed to the support.

Optionally, the pressure sensor further comprises: the first pressure sensing module is arranged at the end part of the first extension arm; and the second pressure sensing module is arranged at the end part of the second extension arm.

Optionally, the pressure sensor further includes a wheatstone bridge disposed on the surface of the second flexible circuit board, a first variable resistor in the wheatstone bridge is disposed on the first extension arm, a second variable resistor in the wheatstone bridge is disposed on the second extension arm, and a fixed resistor of the wheatstone bridge is disposed on the third extension arm.

Optionally, the electric energy receiving circuit comprises a first coupling coil and a power circuit, the first coupling coil is used for receiving external electric energy; the signal transmitting circuit comprises a microcontroller, a load modulation circuit and a second coupling coil, and the second coupling coil is used for transmitting a detection signal of the pressure sensor; the input end of the power circuit is connected with the first coupling coil, the output end of the power circuit is respectively connected with the microcontroller and the pressure sensor, the microcontroller is respectively connected with the load modulation circuit and the pressure sensor, the input end of the load modulation circuit is connected with the microcontroller, and the output end of the load modulation circuit is connected with the second coupling coil.

Optionally, the signal sending circuit further includes a signal processing circuit, an input end of the signal processing circuit is connected to the pressure sensor, an output end of the signal processing circuit is connected to the microcontroller, and the signal processing circuit is configured to condition and amplify a detection signal of the pressure sensor.

Optionally, the first coupling coil and the second coupling coil are wound on the outer side of the support, and two ends of the first coupling coil and two ends of the second coupling coil are connected to pins on the first flexible circuit board respectively.

The application still provides a cross valve pressure differential detecting system, including external device and as any one above the artificial heart valve, external device with pressure differential detection device wireless connection, external device be used for to pressure differential detection device transmission wireless energy, and receive the detected signal that pressure differential detection device sent is in order to acquire cross valve pressure differential.

Optionally, the external device comprises a receiver, a transmitter, and a controller;

the controller is electrically connected with the receiver and the transmitter respectively;

the transmitter is configured to transmit wireless energy to the power circuit;

the receiver is used for receiving the detection signal sent by the signal sending circuit.

The artificial heart valve comprises a valve, a support and a differential pressure detection device, wherein the valve is fixed on the support, and the differential pressure detection device is integrated on the support; the pressure difference detection device comprises a pressure sensor, an electric energy receiving circuit, a signal sending circuit and a first flexible circuit board; the electric energy receiving circuit is respectively connected with the signal sending circuit and the pressure sensor, the pressure sensor is connected with the signal sending circuit, components in the electric energy receiving circuit and the signal sending circuit are arranged on a first flexible circuit board, and the first flexible circuit board is fixed on the support; the pressure sensor is fixed on the bracket and used for detecting the pressure and/or the pressure difference at two sides of the valve; the electric energy receiving circuit is used for receiving and converting the wireless energy into electric energy; and the signal transmitting circuit is used for processing and transmitting the detection signal of the pressure sensor. The artificial heart valve of the present application can continuously and accurately detect the cross-valve pressure difference.

Drawings

FIG. 1 is a schematic structural view of a prosthetic heart valve according to a first embodiment;

fig. 2 is a schematic configuration diagram showing a differential pressure detecting apparatus according to a first embodiment;

fig. 3 is a schematic structural view of a first flexible circuit board shown according to the first embodiment;

fig. 4 is a schematic structural view of the pressure sensor according to the first embodiment;

fig. 5 is a schematic plan view of a prosthetic heart valve according to the first embodiment;

FIG. 6 is an equivalent circuit diagram of a Wheatstone bridge shown according to the first embodiment;

FIG. 7 is a schematic diagram showing the circuit connection according to the first embodiment;

fig. 8 is a schematic diagram showing the operating principle of the circuit according to the first embodiment;

FIG. 9 is a schematic view of a further prosthetic heart valve shown in accordance with the first embodiment;

fig. 10 is a schematic structural diagram of a cross-valve differential pressure detection system according to a second embodiment.

Detailed Description

The following description of the embodiments of the present application is provided for illustrative purposes, and other advantages and capabilities of the present application will become apparent to those skilled in the art from the present disclosure.

In the following description, reference is made to the accompanying drawings that describe several embodiments of the application. It is to be understood that other embodiments may be utilized and that mechanical, structural, electrical, and operational changes may be made without departing from the spirit and scope of the present application. The following detailed description is not to be taken in a limiting sense, and the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

Although the terms first, second, etc. may be used herein to describe various elements in some instances, these elements should not be limited by these terms. These terms are only used to distinguish one element from another.

Also, as used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context indicates otherwise. It will be further understood that the terms "comprises," "comprising," "includes" and/or "including," when used in this specification, specify the presence of stated features, steps, operations, elements, components, items, species, and/or groups, but do not preclude the presence, or addition of one or more other features, steps, operations, elements, components, items, species, and/or groups thereof. The terms "or" and/or "as used herein are to be construed as inclusive or meaning any one or any combination. Thus, "a, B or C" or "a, B and/or C" means "any of the following: a; b; c; a and B; a and C; b and C; A. b and C ". An exception to this definition will occur only when a combination of elements, functions, steps or operations are inherently mutually exclusive in some way.

First embodiment

Fig. 1 is a schematic structural view of a prosthetic heart valve according to a first embodiment. As shown in fig. 1, the artificial heart valve of the present application includes a valve 2, a stent 3, and a differential pressure detection device 4, wherein the valve 2 is fixed on the stent 3, and the differential pressure detection device 4 is integrated with the stent 3. As shown in fig. 2, the differential pressure detection device 4 includes a pressure sensor 1, an electric energy receiving circuit 401, a power conversion module 403, a first controller 404, a signal transmission circuit 402, and a first flexible circuit board 202; the electric energy receiving circuit 401 is respectively connected with the signal sending circuit 402 and the pressure sensor 1, the pressure sensor 1 is connected with the signal sending circuit 402, part of components in the electric energy receiving circuit 401 and the signal sending circuit 402 are arranged on the first flexible circuit board 202, and the first flexible circuit board 202 is fixed on the support 3; the pressure sensor 1 is fixed on the support 3 and is used for detecting the pressure and/or the pressure difference at two sides of the valve 2; an electric energy receiving circuit 401 for receiving and converting wireless energy into electric energy; and a signal transmission circuit 402 for processing and transmitting the detection signal of the pressure sensor 1.

In the structure, through integrating the pressure difference detection device 4 on the artificial heart valve, the pressure sensor 1 in the pressure difference detection device 4 can acquire the pressure and/or the pressure difference on two sides of the valve 2 in real time, the electric energy receiving circuit 401 receives external wireless energy transmission and converts the external wireless energy transmission into electric energy, the long-term stable power supply of the pressure difference detection device 4 is realized, the signal sending circuit 402 can transmit the detection signal acquired by the pressure sensor 1, and the artificial heart valve has the long-term real-time monitoring function of the cross-valve pressure difference.

As shown in fig. 3, the first flexible circuit board 202 includes, in order: the first insulating layer 2021 can be made of silica gel, polyimide, or the like, preferably silica gel; the biocompatible layer 2022, the component layer 2023, the circuit layer 2024, the second insulating layer 2025, and the components of the electric energy receiving circuit 401 and the signal transmitting circuit 402 are disposed on the component layer 2023. A flexible circuit is arranged on the circuit layer 2024, and components of the flexible circuit are fixed on the circuit layer 2024 through welding; the first insulating layer 2021 and the second insulating layer 2025 realize insulating water-proof property of the entire first flexible circuit board 202.

As shown in fig. 4, the pressure sensor 1 includes a second flexible circuit board 10 fixed on the support 3, the second flexible circuit board 10 includes a first extension arm 11, a second extension arm 12 and a third extension arm 13, the first extension arm 11 and the second extension arm 12 are respectively attached to two sides of the valve 2, and the third extension arm 13 is fixed on the support 3.

In an embodiment, the pressure sensor 1 further comprises: the first pressure sensing module is arranged at the end part of the first extension arm 11; and a second pressure sensing module disposed at an end of the second extension arm 12. Specifically, two MEMS (Micro-Electro-Mechanical Systems) pressure sensors may be respectively disposed on the first extension arm 11 and the second extension arm 12 of the second flexible circuit board 10, and the two MEMS pressure sensors are respectively attached to two sides of the artificial heart valve for measuring pressures at two sides of the artificial heart valve. The MEMS pressure sensor is small in size, on the order of millimeters, and therefore is less affected by the deformation of the valve 2 when it is attached to the surface of the valve 2. The second flexible circuit board 10 has good conformal ability with the surface of the valve 2, and can bear certain deformation generated by opening and closing of the valve 2.

In an embodiment, differential pressure detection across the valve 2 can also be achieved by designing a single pressure sensor. As shown in fig. 4 and 5, the pressure sensor 1 includes a wheatstone bridge disposed on the surface of the second flexible circuit board 10, as shown in fig. 5 (a), a first variable resistor 102 in the wheatstone bridge is disposed on the first extension arm 11, as shown in fig. 5 (b), a second variable resistor 103 in the wheatstone bridge is disposed on the second extension arm 12, and a fixed resistor 101 in the wheatstone bridge is disposed on the third extension arm 13.

The extending direction of the first extending arm 11 and the extending direction of the second extending arm 12 of the second flexible circuit board 10 are opposite. Preferably, the first extension arm 11 and the second extension arm 12 can form a flexible strip for easy manufacturing. On the second flexible sensor 10, 4 resistors are arranged, which are respectively a first fixed resistor 101, a first variable resistor 102, a second variable resistor 103 and a second fixed resistor 104, to form a wheatstone bridge structure. Wherein the first variable resistor 102 and the second variable resistor 103 are respectively arranged at the upper and lower sides of the valve 2 for sensing the pressure at both sides of the valve 2. The first fixed resistor 101 and the second fixed resistor 104 are arranged on the stent 3, independently of the pressure on both sides of the valve 2. In order to improve the sensitivity, the first variable resistor 102 and the second variable resistor 103 should be increased in length as much as possible, so that an M-shape as shown in fig. 4 may be adopted, and other shapes such as a serpentine shape, a grid shape, etc. may be adopted, so that the magnitudes of the resistance values of the first variable resistor 102 and the second variable resistor 103 vary according to the magnitude of the pressure change applied to the second flexible circuit board 10.

It should be noted that, after the valve 2 is closed, the pressure difference is provided on the valve 2, the pressure sensor 1 linearly converts the pressure difference into electrical signals such as voltage and current by changing the resistance value of the piezoresistor and then changing the balance form of the wheatstone bridge, and then the signals are collected and amplified by the circuit and then output to an external processor, and whether the artificial heart valve works normally is judged according to the pressure value corresponding to the magnitude of the output signal; the normal opening and closing of the valve 2 can be monitored in real time through the pressure sensor 1, whether the blood circulation is recovered smoothly or not is detected, and timely intervention can be performed when the blood circulation is abnormal.

Specifically, the first variable resistor 102 is disposed at an end of the first extension arm 11, and the second variable resistor 103 is disposed at an end of the second extension arm 12. The second flexible circuit board 10 further includes a third extension arm 13, the first fixed resistor 101 of the wheatstone bridge is disposed at an end of the third extension arm 13, and the third extension arm 13 and the flexible strip form a predetermined angle, such as a vertical angle shown in fig. 4. A second fixed resistor 104 of the wheatstone bridge is arranged at the junction of the third extension arm 13 and the flexible strip. Of course, in other embodiments, if the third extension arm 13 is not disposed on the second flexible circuit board 10, the first fixed resistor 101 and the second fixed resistor 104 may be disposed on the middle region of the flexible strip.

Referring to fig. 6, an equivalent circuit diagram of a wheatstone bridge according to a first embodiment of the present application is shown, wherein the wheatstone bridge includes resistors R1 and R4 with fixed resistances and resistors R2 and R3 with variable resistances. R1, R2, R3 and R4 are connected to form four arms of a Wheatstone bridge. Wherein R1 and R2 are connected in series, R3 and R4 are connected in series, the circuit where R1 and R2 are located is connected with the circuit where R3 and R4 are located in parallel, fixed voltage Ve is applied to the two ends A and B of the circuit, and the voltage Vs at the two ends C and D is detected. When voltages are added to the ends a and B for excitation, if the four resistors R1, R2, R3, and R4 have equal values, the voltage across Vs is half Ve, and the difference Δ Vs =0. The variable resistors R2 and R3 may be piezoresistors, and when pressure acts on the device, the variable resistors R2 and R3 on the bridge arm may change to generate Δ Vs having a linear relationship with the pressure. The Δ Vs is conditioned and collected, and the magnitude of the pressure can be measured. Therefore, the resistance change at two sides of the valve is measured in real time through the Wheatstone bridge structure, and the sensitivity of the pressure sensor can be obviously improved. Since there are a common-mode voltage signal and a difference Δ Vs signal generated when the voltage is applied to the two ends of Vs, in order to obtain a high-precision resistance value change signal, it is necessary to reduce the influence of noise and suppress the common-mode signal by a conditioning circuit, and extract the Δ Vs signal. The conditioning circuit comprises an operational amplifier and a precision resistor, and is used for collecting and converting the voltage difference value of the Wheatstone bridge into a pressure value.

As shown in fig. 7, the electric energy receiving circuit 401 includes a first coupling coil 201 and a power circuit 221, the first coupling coil 201 is wound around the outside of the bracket 3, and both ends of the first coupling coil 201 are connected to pins on the first flexible circuit board 202. The signal transmitting circuit 402 includes the microcontroller 222, the load modulation circuit 223 and the second coupling coil 220. The first coupling coil 201 of the electric energy receiving circuit 401 and the second coupling coil 220 of the signal transmitting circuit 402 may be designed as a single body. The first coupling coil 201 is used for receiving external electric energy, the second coupling coil 220 is used for sending a detection signal of the pressure sensor 1, the input end of the power circuit 221 is connected with the first coupling coil 201, the output end of the power circuit 221 is respectively connected with the microcontroller 222 and the pressure sensor 1, the microcontroller 222 is respectively connected with the load modulation circuit 223 and the pressure sensor 1, the input end of the load modulation circuit 223 is connected with the microcontroller 222, and the output end of the load modulation circuit 223 is connected with the second coupling coil 220.

Specifically, the external electric energy may be coupled to the first coupling coil 201 in the differential pressure detection device 4 in the form of high-frequency electromagnetic energy, and the power circuit is configured to rectify and stabilize the received high-frequency electric energy and convert the rectified and stabilized electric energy into a working voltage suitable for the microcontroller and the pressure sensor. The Microcontroller may be a Micro Controller Unit (MCU) with low power consumption, so as to reduce the power consumption of the circuit of the differential pressure detection device 4, thereby obtaining a longer electric energy and data transmission distance.

The detection signal of the differential pressure detection device 4 is transmitted to an external device through the second coupling coil 220 by means of load impedance modulation. Referring to fig. 8, the working principle of load impedance modulation is that a coil L1 (external coil) and a capacitor C connected in parallel therewith form a parallel resonant circuit, a load modulation circuit 223 is provided with a switch S, the on-off state of the switch S is controlled according to the high and low levels of an effective data stream, the effective data stream is generated according to the detection data of the pressure sensor 1, and in the process of the alternating on-off state of the switch S, an additional impedance R is alternately switched on and off, which causes the voltage variation at the two ends of the coil L2 (equivalent to the second coupling coil 220), and due to the inductive coupling effect between the coil L2 and the coil L1 (external coil), the voltage variation at the two ends of the coil L2 causes the amplitude variation of the voltage at the two ends of the coil L1. In this way, the microcontroller 222 controls the switch S to be turned on or off according to the detection data of the pressure sensor 1, that is, the corresponding signal of the detection data can be transmitted to the external device through the second coupling coil 220, and the change of the voltage amplitude of the coil L2 can use the principle of envelope detection to demodulate the low-frequency signal, and further perform data shaping to read the detection data, thereby realizing the transmission of the detection signal.

In this way, the working power supply of the pressure difference detection device 4 is provided based on the electric energy receiving circuit 401, the pressure detection data is synchronously transmitted to an external device through the signal transmitting circuit 402, the structure is simple, a power supply module and a signal transmission line are not required to be arranged, the requirement for long-term operation can be met, and when the pressure detection device is applied to monitoring the valve pressure, the wound and the cost caused by device replacement can be reduced.

The signal transmitting circuit 402 further includes a signal processing circuit, an input end of the signal processing circuit is connected to the pressure sensor 1, an output end of the signal processing circuit is connected to the microcontroller 222, and the signal processing circuit is configured to condition and amplify a detection signal of the pressure sensor 1. The first coupling coil 201 of the differential pressure detection device 4 receives the energy wirelessly transmitted by the external device, and the wireless energy is converted by the power circuit 221, so that the requirement of the functional module circuit on the working voltage of each circuit can be met. After the pressure sensor 1 is connected to the working voltage, the pressure sensor 1 starts to measure the pressure, and outputs the analog value of the pressure to the signal processing circuit, the signal processing circuit performs analog-to-digital conversion on the analog value and performs corresponding signal processing operation, and finally sends the pressure digital signal to an external device through the second coupling coil 220, so that one-time transpetal differential pressure measurement is completed. The pressure sensor 1, the signal processing circuit, and the second coupling coil 220 are monitored and managed by the circuit controller.

Fig. 9 is a schematic structural view of a further artificial heart valve according to the first embodiment, and as shown in fig. 9, the artificial heart valve includes a valve 2, a stent 3 and a pressure sensor 1, and the end of the first extension arm 11 and the end of the second extension arm 12 of the second flexible circuit board 10 of the pressure sensor 1 are respectively fixed on two side surfaces of the valve 2 to measure a pressure difference value on two sides of the valve 2.

In the above structure, the first extension arm 11 and the second extension arm 12 of the second flexible circuit board 10 both have flexibility, and can be sufficiently attached to the surfaces of the two sides of the valve 2, so that the pressure sensor 1 and the valve 2 are well integrated and conformal. A wheatstone bridge is formed on the second flexible circuit board 10, so that the pressure sensor 1 has high measurement precision, and accurate measurement of the cross-petal pressure difference can be realized.

The main working principle of the artificial heart valve is: the pressure sensor 1 is arranged on an artificial heart valve, the artificial heart valve is firstly placed on a catheter in a compressed mode, then passes through a blood vessel and reaches a diseased aortic valve, and finally the artificial heart valve is released from the catheter to push aside a diseased part of an aortic valve leaflet. The normal opening and closing functions of the aortic valve are recovered, and the blood circulation is recovered to be smooth. The pressure sensor 1 can be used for detecting whether the artificial heart valve has a treatment effect or not, and can monitor whether the pressure difference between the upper side and the lower side of the valve 2 reaches the level of a normal person or not in real time.

The third extension arm 13 of the second flexible circuit board 10 is fixed on the bracket 3, so that the pressure sensor 1 and the bracket 3 are integrated conformally, and the overall stability of the device is improved. The support 3 is latticed, and the third extension arm spans at least one grid of support 3, ensures that pressure sensor 1 and support 3 are firmly laminated.

The artificial heart valve comprises a valve, a support and a pressure difference detection device, wherein the valve is fixed on the support, and the pressure difference detection device is integrated on the support; the differential pressure detection device comprises a pressure sensor, an electric energy receiving circuit, a signal sending circuit and a first flexible circuit board; the electric energy receiving circuit is respectively connected with the signal transmitting circuit and the pressure sensor, the pressure sensor is connected with the signal transmitting circuit, components in the electric energy receiving circuit and the signal transmitting circuit are arranged on a first flexible circuit board, and the first flexible circuit board is fixed on the support; the pressure sensor is fixed on the bracket and is used for detecting the pressure and/or the pressure difference at two sides of the valve; the electric energy receiving circuit is used for receiving and converting the wireless energy into electric energy; and the signal transmitting circuit is used for processing and transmitting the detection signal of the pressure sensor. The artificial heart valve of the present application can continuously and accurately detect the cross-valve pressure difference.

Second embodiment

The application also provides a transvalvular pressure difference detection system, which comprises an external device and the artificial heart valve as described in the first embodiment, wherein the external device is wirelessly connected with the pressure difference detection device, and the external device is used for transmitting wireless energy to the pressure difference detection device and receiving a detection signal sent by the pressure difference detection device to obtain the transvalvular pressure difference.

The pressure difference detection device is integrated on the artificial heart valve and is used for directly measuring the trans-valve pressure difference. A pressure difference detection device has no power module, belongs to a passive implantation instrument, and is powered by an external device in a wireless energy transmission mode. The external device can also receive a detection signal sent by the pressure difference detection device to display the acquired cross-petal pressure difference signal, so that the real-time continuous monitoring of the cross-petal pressure difference is realized.

As shown in fig. 10, the external device 5 includes a receiver 501, a transmitter 506, and a second controller 503; the second controller 503 is electrically connected with the receiver 501 and the transmitter 506 respectively, and the transmitter 506 is used for transmitting wireless energy to the electric energy receiving circuit 401; the receiver 501 is configured to receive the detection signal sent by the signal sending circuit 402. The external device 5 further comprises a storage device 504 and a display device 505 for storing and displaying the acquired transpetal differential pressure signal, and the transmitter 506, the receiver 501 and the display device 505 are monitored and managed by the second controller 503.

The power supply of the differential pressure detection device 4 is provided by the external device 5 by means of wireless energy transmission. The external device 5 includes a power source 502 capable of sending electromagnetic waves of a certain frequency to generate a magnetic field, and the electric energy receiving circuit 401 in the differential pressure detection device 4 can obtain energy from the magnetic field of the certain frequency to generate induced electromotive force and induced current at the frequency, and generate a direct current power source after rectification and filtering for providing to each module of the differential pressure detection device 4.

In the aspect of wireless communication, multiple communication schemes including WIFI, bluetooth, zigbee, near field communication and the like can be adopted. Or adopting the following mode: the transmitter 506 of the external device 5 generates a magnetic field of a target frequency band, and performs ASK (Amplitude Shift Keying) or OOK (On-Off Keying) modulation On the magnetic field. The electric power receiving circuit 401 of the differential pressure detection device 4 induces the magnetic field to generate an induced electromotive force, and detects the induced signal to obtain information transmitted from the transmitter 506 of the external device 5. When the signal transmitting circuit 402 of the differential pressure detecting device 4 needs to feed back to the receiver 501 of the external device 5, the differential pressure detecting device 4 changes the amount of the magnetic field drawn by the resonant network by adjusting the parameters of the resonant network of the signal transmitting circuit 402, generates an envelope subcarrier on the receiver 501 of the external device 5, and then the external device 5 detects the subcarrier to obtain the communication data transmitted by the differential pressure detecting device 4.

The cross-valve pressure difference detection system comprises an external device and the artificial heart valve, wherein the external device is wirelessly connected with a pressure difference detection device in the artificial heart valve, and the external device is used for transmitting wireless energy to the pressure difference detection device and receiving a detection signal sent by the pressure difference detection device to obtain the cross-valve pressure difference. By the above mode, the cross-flap pressure difference detection system can continuously and accurately acquire the cross-flap pressure difference detection signal.

The above embodiments are merely illustrative of the principles and utilities of the present application and are not intended to limit the present application. Any person skilled in the art can modify or change the above-described embodiments without departing from the spirit and scope of the present application. Accordingly, it is intended that all equivalent modifications or changes which may be made by those skilled in the art without departing from the spirit and technical spirit of the present disclosure be covered by the claims of the present application.

Claims (10)

1. An artificial heart valve, comprising a valve, a stent and a differential pressure detection device, wherein the valve is fixed on the stent, and the differential pressure detection device is integrated with the stent;

the pressure difference detection device comprises a pressure sensor, an electric energy receiving circuit, a signal sending circuit and a first flexible circuit board;

the electric energy receiving circuit is respectively connected with the signal transmitting circuit and the pressure sensor, the pressure sensor is connected with the signal transmitting circuit, part of components in the electric energy receiving circuit and the signal transmitting circuit are arranged on the first flexible circuit board, and the first flexible circuit board is fixed on the bracket;

the pressure sensor is fixed on the bracket and is used for detecting the pressure and/or the pressure difference on two sides of the valve;

the electric energy receiving circuit is used for receiving and converting the wireless energy into electric energy;

and the signal transmitting circuit is used for processing and transmitting the detection signal of the pressure sensor.

2. The prosthetic heart valve of claim 1, wherein the first flexible circuit board comprises, in order, a first insulating layer, a biocompatible layer, a component layer, a circuit layer, and a second insulating layer, components of the electrical energy receiving circuit and the signal transmitting circuit being disposed on the component layer.

3. The prosthetic heart valve of claim 2, wherein the pressure sensor comprises a second flexible circuit board secured to the stent, the second flexible circuit board including first, second, and third extension arms, the first and second extension arms respectively engaging sides of the valve, the third extension arm secured to the stent.

4. The prosthetic heart valve of claim 3, wherein the pressure sensor further comprises: the first pressure sensing module is arranged at the end part of the first extension arm; and the second pressure sensing module is arranged at the end part of the second extension arm.

5. The prosthetic heart valve of claim 3, wherein the pressure sensor further comprises a Wheatstone bridge disposed on the second flexible circuit board surface, a first variable resistor in the Wheatstone bridge being disposed at the first extending arm, a second variable resistor in the Wheatstone bridge being disposed at the second extending arm, a fixed resistor of the Wheatstone bridge being disposed at the third extending arm.

6. The prosthetic heart valve of any of claims 1-5, wherein the electrical energy receiving circuit comprises a first coupled coil for receiving external electrical energy and a power circuit; the signal transmitting circuit comprises a microcontroller, a load modulation circuit and a second coupling coil, and the second coupling coil is used for transmitting a detection signal of the pressure sensor; the input end of the power circuit is connected with the first coupling coil, the output end of the power circuit is respectively connected with the microcontroller and the pressure sensor, the microcontroller is respectively connected with the load modulation circuit and the pressure sensor, the input end of the load modulation circuit is connected with the microcontroller, and the output end of the load modulation circuit is connected with the second coupling coil.

7. The prosthetic heart valve of claim 6, wherein the signal transmission circuit further comprises a signal processing circuit, an input of the signal processing circuit is connected with the pressure sensor, an output of the signal processing circuit is connected with the microcontroller, and the signal processing circuit is used for conditioning and amplifying a detection signal of the pressure sensor.

8. The prosthetic heart valve of claim 6, wherein the first coupling coil and the second coupling coil are wound outside the stent, and two ends of the first coupling coil and two ends of the second coupling coil are respectively connected with pins on the first flexible circuit board.

9. A trans-valve pressure differential sensing system comprising an external device and the prosthetic heart valve of any one of claims 1-8, the external device being wirelessly connected to the pressure differential sensing device, the external device being configured to transmit wireless energy to the pressure differential sensing device and receive a sensing signal from the pressure differential sensing device to obtain a trans-valve pressure differential.

10. The system according to claim 9, wherein the external device comprises a receiver, a transmitter and a controller;

the controller is electrically connected with the receiver and the transmitter respectively;

the transmitter is used for transmitting wireless energy to the electric energy receiving circuit;

the receiver is used for receiving the detection signal sent by the signal sending circuit.

Images