CN117503433B - Artificial aortic valve and heart monitoring system - Google Patents

Artificial aortic valve and heart monitoring system Download PDF

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Publication number
CN117503433B
CN117503433B CN202410003929.3A CN202410003929A CN117503433B CN 117503433 B CN117503433 B CN 117503433B CN 202410003929 A CN202410003929 A CN 202410003929A CN 117503433 B CN117503433 B CN 117503433B
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aortic valve
potential information
valve
artificial
prosthetic
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CN117503433A (en
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曾莉钧
蒲小波
冯沅
陈茂
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West China Hospital of Sichuan University
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West China Hospital of Sichuan University
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/25—Bioelectric electrodes therefor
    • A61B5/279—Bioelectric electrodes therefor specially adapted for particular uses
    • A61B5/28—Bioelectric electrodes therefor specially adapted for particular uses for electrocardiography [ECG]
    • A61B5/283—Invasive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/24—Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
    • A61B5/316—Modalities, i.e. specific diagnostic methods
    • A61B5/318—Heart-related electrical modalities, e.g. electrocardiography [ECG]
    • A61B5/367—Electrophysiological study [EPS], e.g. electrical activation mapping or electro-anatomical mapping
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/686—Permanently implanted devices, e.g. pacemakers, other stimulators, biochips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/243—Deployment by mechanical expansion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2466—Delivery devices therefor

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Transplantation (AREA)
  • Vascular Medicine (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Mechanical Engineering (AREA)
  • Physiology (AREA)
  • Prostheses (AREA)

Abstract

The invention discloses a prosthetic aortic valve and a heart monitoring system, belongs to the aortic valve in the technical field of medical equipment, and aims to solve the technical problems that potential monitoring cannot be carried out on a heart chamber and conduction functions of heart atria and ventricles cannot be effectively evaluated in the prior art. The artificial valve comprises an artificial valve frame and a plurality of valve leaves attached to the artificial valve frame, wherein the artificial valve frame comprises an upstream inflow end, a downstream outflow end and a contraction part positioned in the middle; a carrier is fixed at the intersection point of the diamond-shaped support at the upstream inflow end, and a mapping electrode which can be attached to the surface of heart tissue is arranged on one surface of the carrier outwards; a wireless transmitting coil is fixed at one end of the contraction part or the downstream outflow end, which is close to the contraction part, and the mapping electrode is communicated with the wireless transmitting coil through a wire; the mapping electrode transmits the potential information mapped to the junction of the atrioventricular junction to the wireless sending coil through a lead, and the wireless sending coil transmits the potential information of the junction of the atrioventricular junction out of the body.

Description

Artificial aortic valve and heart monitoring system
Technical Field
The invention belongs to the technical field of medical instruments, and relates to an aortic valve, in particular to a prosthetic aortic valve and a heart monitoring system.
Background
The aortic valve, also called the semilunar valve, is located between the left ventricle and the aorta, inhibiting blood flow back into the main artery into the left ventricle, morphologically resembling the pulmonary valve. Aortic valve stenosis is a common cardiovascular disease that is mainly caused by sequelae of rheumatic fever, congenital aortic valve structural abnormalities, or senile aortic valve calcification.
In the treatment of aortic valve stenosis, transcatheter valve replacement (Transcatheter aortic valve replacement, TAVR) is a minimally invasive surgical procedure for treating severe aortic valve stenosis or regurgitation by compressing and transcatheter the prosthetic aortic valve, delivering from the femoral artery-descending aorta to the aortic root and releasing to the aortic annulus. Since the aortic root is adjacent to the atrioventricular space of the heart, the heart conduction system is shaped downwards, and the atrioventricular conduction disorder or left bundle branch block is easily caused by mechanical compression or damage to the atrioventricular conduction bundle of the heart during or after operation, the pacemaker needs to be implanted in time, and the risk of cardiac insufficiency is increased.
The patent application 2021800478933 discloses an artificial aortic valve pacing system comprising an artificial aortic valve and a non-implanted unit. The artificial aortic valve comprises a plurality of artificial valve leaflets; a frame; a cathode and an anode mechanically coupled to the frame; and a prosthetic valve coil in non-radio communication with the cathode and the anode. The artificial aortic valve does not comprise any active electronic components. The non-implanted unit comprises an energy transmission coil; sensing skin ECG electrodes; and a non-implantable control circuit driving the cathode and anode to apply a pacing signal to the heart, detecting at least one cardiac parameter using the sensed skin ECG electrode, and wirelessly transmitting energy from the energy transmission coil to the prosthetic valve coil by inductive coupling at least partially in response to the detected cardiac parameter, thereby setting a parameter of the pacing signal.
As in the above patent application, in the prior art, a prosthetic aortic valve is compressed and then delivered through a catheter to the aortic annulus, and an integrated electrode on the prosthetic aortic valve is used to monitor cardiac signals and transmit the monitored signals out of the body. The control circuit is implanted in the patent application of the invention, and the control circuit wirelessly transmits energy from the energy transmission coil to the artificial valve coil through driving the cathode and the anode and through inductive coupling so as to apply pacing signals to the heart of a patient to realize the pacing of the heart. However, setting the cathode, anode and coil on the artificial aortic valve to realize cardiac pacing is a remedial measure for conducting block, and monitoring the electric potential of heart chamber and evaluating the conducting function of heart chamber in operation, thereby adjusting the valve position, preventing the damage of conducting beam in operation and reducing the risk of conducting block after operation; meanwhile, the device has the function of monitoring atrioventricular conduction after operation, can be used for postoperative management and evaluating pacemaker implantation indications.
Disclosure of Invention
The invention aims at: the artificial aortic valve and the heart detection system are provided for solving the technical problems that potential monitoring cannot be carried out on a heart chamber and conduction functions of a heart chamber cannot be effectively evaluated in the prior art.
The invention adopts the following technical scheme for realizing the purposes:
a prosthetic aortic valve comprising a prosthetic valve frame, and a plurality of leaflets attached to the prosthetic valve frame, the prosthetic valve frame comprising an upstream inflow end, a downstream outflow end, and a constriction positioned in the middle; a carrier is fixed at the intersection point of the diamond-shaped support at the upstream inflow end, and a mapping electrode which can be attached to the surface of heart tissue is arranged on one surface of the carrier outwards; a wireless transmitting coil is fixed at one end of the contraction part or the downstream outflow end, which is close to the contraction part, and the mapping electrode is communicated with the wireless transmitting coil through a wire;
the mapping electrode transmits the potential information mapped to the junction of the atrioventricular junction to the wireless sending coil through a lead, and the wireless sending coil transmits the potential information of the junction of the atrioventricular junction out of the body.
Further, the artificial valve frame is made of nickel-titanium alloy; the inner side of the upstream inflow end is fixed with a skirt edge which is made of polyethylene.
Further, the material of the valve leaflet is pericardial tissue, synthetic material or polymeric material; the valve leaves are sewn on the skirt edge through suture lines.
Further, the carrier is made of polyether-ether-ketone, and is fixed at the crossing point of the diamond-shaped bracket in a tether tying or gluing mode.
Further, the material of the mapping electrode is platinum or platinum iridium alloy, the mapping electrode is strip-shaped, and the width of the mapping electrode is 1mm-2mm.
Further, the width of the carrier is 3-5mm, and the mapping electrodes are embedded on the carrier in a single or paired mode.
Further, the wireless transmitting coil is a gold wire bonding wire, and an insulating layer is arranged on the outer layer of the gold wire bonding wire; the wireless transmitting coil is fixed on the inner layer or the outer layer of the artificial valve frame in an electric isolation mode.
The heart monitoring system comprises a prosthetic aortic valve, a display device and a delivery device or/and an extracorporeal device, wherein a wireless receiving coil is arranged at the front end of the delivery device, a wireless receiving coil is also arranged at the front end of the extracorporeal device, and the wireless receiving coil of the delivery device and the wireless receiving coil of the extracorporeal device are connected with the display device through leads;
the artificial aortic valve adopts the artificial aortic valve;
when the artificial aortic valve is delivered, the delivery equipment releases the artificial aortic valve to a designated position, the upstream inflow end of the expanded artificial aortic valve is abutted against the surface of the atrioventricular space of the heart, the mapping electrode transmits potential information mapped to the intersection of the atrioventricular space to the wireless transmitting coil through a lead, and the wireless transmitting coil transmits the potential information of the intersection of the atrioventricular space to the wireless receiving coil of the delivery equipment and then to the display equipment through the lead; after the artificial aortic valve is placed and the placement position is confirmed to be correct, the delivery device is taken out, and the wireless transmitting coil transmits the potential information of the atrioventricular junction to the wireless receiving coil of the external device and then to the display device through a lead.
Further, in the process of delivering the artificial aortic valve, when the mapping electrode maps the his bundle potential information or the left bundle branch potential information, the implantation position or implantation depth of the artificial aortic valve is adjusted through the delivery device.
Further, the mapping potential information of the mapping electrode comprises atrial potential information, his bundle potential information, ventricular potential information and left bundle branch potential information, and the mapped atrial potential information, his bundle potential information, ventricular potential information and left bundle branch potential information are displayed on the display device.
The beneficial effects of the invention are as follows:
1. in the invention, a carrier is fixedly arranged at the intersection point of the diamond-shaped support at the upstream inflow end of the artificial valve frame, and a mapping electrode is arranged through the carrier, the mapping electrode can be attached to the surface of heart tissue after the artificial aortic valve is released and expanded, the potential information at the junction of the atrioventricular node is mapped, and the mapped potential information is transmitted to the outside through a wireless transmitting coil, so that the potential monitoring of the heart chamber is realized, and the conduction function of the heart atrioventricular node can be effectively evaluated according to the potential monitoring condition.
2. In the invention, the carrier is fixed at the crossing point of the diamond-shaped bracket and is not influenced by different states of the artificial valve, namely, the artificial valve is in a compressed state during delivery and is in an expanded state after release, so that the artificial valve is suitable for artificial valves of different types and sizes.
3. According to the invention, the array structure of the electrode and the single-bipolar signal multiplexing method greatly improve the utilization rate of electrode points, and can capture individual data of the electrical activity of heart tissue adjacent to the electrode.
4. In the invention, the wireless receiving coil can be arranged in a delivery system, and can receive cardiac electric signals in artificial valve implantation, if the electric potential of a conducting beam is detected, the implantation position or depth of the valve should be adjusted in time, and the conducting beam is avoided.
5. According to the invention, the electrode is implanted into heart tissue along with the artificial valve, so that the heart electrical activity can be detected after operation, the pacemaker implantation indication can be evaluated according to the atrioventricular conduction function, and the invasive electrophysiological examination is not required to be repeatedly performed.
6. In the invention, the atrioventricular function detection can be used for not only the management in and after the implantation of the artificial valve, but also the detection of the heart conduction system function of a patient in the long-term follow-up process, especially when the conditions of syncope, dizziness, amaurosis and the like caused by unknown reasons occur.
7. According to the invention, the heart monitoring system can detect the potential in the TAVR operation by arranging the artificial valve part and the non-implanted part, so that the implantation position or implantation depth of the artificial valve can be adjusted in real time according to the detection result to avoid damaging the heart, the TAVR operation can be managed, and the potential in the heart of a patient after the user operation can be monitored for a long time by the external equipment to determine the treatment effect and the subsequent treatment scheme. At the same time, the structure of the present application may also be used as a conduction system to send pacing signals to the electrodes through an extracorporeal device.
Drawings
FIG. 1 is a schematic diagram of the structure of the present invention;
FIG. 2 is a schematic diagram of the connection of a mapping electrode to a wireless transmitting coil in the present invention;
FIG. 3 is a schematic diagram of the connection of a wireless transmitting coil and a wireless receiving coil in the present invention;
FIG. 4 is a schematic diagram of the present invention showing electrical potentials when delivering a prosthetic aortic valve;
FIG. 5 is a schematic diagram of the present invention receiving and displaying electrical potentials at a TAVR post-operative extracorporeal device;
FIG. 6 is a schematic view of the present invention after installation of a prosthetic valve frame;
FIG. 7 is a schematic diagram showing the left bundle branch proximal segment unblocked in accordance with the present invention;
wherein, the A diagram represents a Hill-bundle potential diagram when the left bundle branch near section is not blocked, and the B diagram represents an LB (left bundle branch) potential diagram when the left bundle branch near section is not blocked;
FIG. 8 is a schematic diagram showing left bundle branch proximal segment block according to the present invention;
wherein, the A diagram represents a Hill-bundle potential diagram when the left bundle branch is blocked, and the B diagram represents an LB (left bundle branch) potential diagram when the left bundle branch is blocked;
wherein, the reference numerals are as follows:
1-artificial valve frame, 2-downstream outflow end, 3-constriction part, 4-upstream inflow end, 5-valve leaf, 6-wireless transmitting coil, 7-carrier, 8-mapping electrode, 9-wire, 10-wireless receiving coil, 11-display device, 12-delivery device, 13-external device.
Detailed Description
For the purpose of making the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention, and it is apparent that the described embodiments are some embodiments of the present invention, but not all embodiments of the present invention.
Thus, all other embodiments, which can be made by one of ordinary skill in the art without undue burden from the invention, are intended to be within the scope of the invention.
Example 1
The embodiment provides a prosthetic aortic valve, which is used for collecting potential information of the surface of heart tissue, and particularly can be used for mapping and collecting potential information of an atrioventricular junction. The prosthetic aortic valve in this embodiment is typically self-expanding, balloon-expandable or mechanically expandable, and prosthetic valves known in the art may be used, such as Venus (open medical, china), coreValve (Medun force, U.S. A.), sapaen (Edwardsies, U.S. A.), lotus (Boston science, U.S. A.).
The drawings of the application take CoreValve Evolut-R as an example, and technical innovation is carried out on the basis, as shown in figures 1-3, the artificial aortic valve comprises:
artificial valve frame 1 the artificial valve frame 1 is formed by a diamond shaped stent comprising an upstream inflow end 4, a downstream outflow end 2 and a constriction 3 located therebetween. The artificial valve frame 1 is made of nickel-titanium alloy; the inner side of the upstream inflow end 4 is fixed with a skirt which is made of polyethylene and has the function of preventing the perivalvular leakage. When the artificial aortic valve is delivered and installed, the artificial valve frame 1 is in a compressed state and is delivered to the aortic valve annulus through the femoral artery-abdominal aorta-aortic root for release, the artificial valve frame 1 in a fully-unfolded state is in a shape of a combination of a plurality of diamonds, and the artificial valve frame 1 in the state can be regarded as a combination of diamond-shaped brackets.
A plurality of leaflets 5 are provided, each of which is attached to the artificial valve frame 1. The material of the valve leaflet 5 is usually pericardial tissue, such as porcine pericardial tissue, and may be synthetic or polymeric. The valve blade 5 is sewn on the skirt through a suture, and the suture can be made of polytetrafluoroethylene.
The carrier 7 is made of polyether-ether-ketone, the carrier 7 is fixed at the intersection of the diamond-shaped brackets at the upstream inflow end 4, the part can be close to the atrioventricular space surface of the heart after implantation, and the Hirschner-left bundle branch of the heart conduction system is shaped downwards. The carrier 7 is fastened to the diamond shaped support at the crossing points in a tethered strapping or gluing, in which arrangement the fastening location of the carrier 7 is not affected by the compressed or expanded state of the artificial valve frame 1. The tether comprises a monofilament or multifilament nylon thread or a suture-like material. The number of carriers 7 on the artificial valve frame 1 is not limited, and the carriers 7 may be fixed at each adjacent crossing point, or the carriers 7 may be fixed at one or more crossing points at each interval. The width of the carrier 7 is 3-5mm.
The plurality of mapping electrodes 8 are provided, and the material is platinum or platinum iridium alloy, and the shape is not limited, and preferably an elongated shape is used. The mapping electrodes 8 have a width of 1-2mm and the mapping electrodes 8 are fitted on the carrier 7 in a single or paired manner against the outwardly facing side of the heart tissue surface. If the mapping electrodes 8 are embedded into a single carrier 7 in a paired manner, the distance between two adjacent mapping electrodes 8 is set to be 1-2mm and is matched with the width of the carrier 7 to be 3-5mm; if the mapping electrodes 8 are embedded in a single carrier 7 in a single manner, the number of mapping electrodes 8 is the same as the number of carriers 7.
The wireless transmitting coil 6 is made of gold wire bonding wires, and an insulating layer is arranged on the outer layer of the gold wire bonding wires; the insulating layer is polyimide film or polytetrafluoroethylene film. The wireless transmission coil 6 is fixed to the inner layer or the outer layer of the artificial valve frame 1 in an electrically isolated form, i.e. the wireless transmission coil 6 is fixed to the constriction 3 of the artificial valve frame 1, or the wireless transmission coil 6 is fixed to the downstream outflow end 2 of the artificial valve frame 1 near the end of the constriction 3.
The wire 9 is made of metal conductive material, and is mostly made of stainless steel, and is covered with an insulating coating (such as polyimide film or polytetrafluoroethylene film) to form a diamond-shaped bracket and is fixed on the bracket in a bundling or gluing manner. The wire 9 may be used to communicate the mapping electrode 8 and the wireless transmitting coil 6 in a non-radio manner.
It should be noted that the entire prosthetic aortic valve does not include active electronics.
As shown in fig. 2, the mapping electrode 8 transmits the potential information mapped to the junction of the atrioventricular junction to the wireless transmitting coil 6 through the lead 9, and the wireless transmitting coil 6 transmits the potential information of the junction of the atrioventricular junction out of the body. As shown in fig. 3, the wireless transmitting coil 6 is connected to the wireless receiving coil 10 in a signal manner, and the signal from the wireless transmitting coil 6 can be received by the wireless receiving coil 10.
Example 2
The present embodiment provides a cardiac monitoring system that includes a prosthetic valve portion and a non-implanted portion.
The prosthetic valve part is mainly a prosthetic aortic valve, and the prosthetic aortic valve adopts the prosthetic aortic valve in example 1.
The non-implanted portion comprises a display device 11, a delivery device 12 and/or an extracorporeal device 13, the delivery device 12, the extracorporeal device 13 being optional or present simultaneously.
As shown in fig. 4, the delivery device 12 is provided with a wireless receiving coil 10, and the wireless receiving coil 10 of the delivery device 12 may be connected to the display device 11 through a wire. When the artificial aortic valve is delivered and installed through the delivery device 12, the wireless receiving coil 10 of the delivery device 12 can receive signals marked and carried by the wireless sending coil 6 in the artificial aortic valve in real time in an inductive coupling mode and transmit the signals to the display device 11 for in-vitro display, so that the installation position of the artificial aortic valve can be adjusted in real time. The delivery device 12 delivers the prosthetic aortic valve to the aortic root via the femoral artery-abdominal aorta-descending aorta, the upstream inflow end 4 of the deployed prosthetic valve frame 1 is abutted against the atrioventricular surface of the heart, and the mapping electrode 8 adjacent to the heart tissue can map the atrioventricular junction potential (the mapping potential information of the mapping electrode 8 comprises atrial potential information, his bundle potential information, ventricular potential information and left bundle branch potential information), and the mapping potential information is transmitted to the wireless transmitting coil 6 through the lead 9, and is directly connected to the display device 11 through the wireless receiving coil 10 of the delivery device 12 and the lead, so that the atrial potential (a), the his bundle potential (H) and the ventricular potential (V) are displayed. The left bundle branch (LB) potential can be mapped, in part, to the mapping electrode 8 near the ventricular septum. In TAVR procedures, the prosthetic valve implantation site or depth should be adjusted to avoid damaging the cardiac conduction system, if H-potential or LB-potential is detected. After the prosthetic valve is placed, the delivery device is withdrawn from the body as shown in fig. 6.
As shown in fig. 5, the external device 13 is provided with a wireless receiving coil 10, and the wireless receiving coil 10 of the external device 13 can be connected with the display device 11 through a wire. After the artificial aortic valve is installed and the delivery device 12 is taken out, the wireless receiving coil 10 of the external device 13 can receive signals marked and carried by the wireless transmitting coil 6 in the artificial aortic valve in real time in an inductive coupling mode and transmit the signals to the display device 11 for external display, so that real-time display is carried out for management after TAVR operation. Since the approach to the heart tract is avoided even though care is taken during the operation, the self-expansion process is still performed after implantation of the prosthetic valve, and thus, the prosthetic valve may be pressed against the heart tract by a part of the patient after the operation to cause functional impairment. If the electrocardiogram of the patient's body surface shows a high or three-degree conduction block, a pacemaker implantation indication is provided. If the electrocardiogram of the body surface of a patient only shows the prolongation of PR interval with or without left bundle branch block, the indication of a pacemaker is not clear. Intra-cardiac potential detection by the prosthetic valve system, if it is found that the HV interval is prolonged, the hospitalization time should be prolonged, and the atrioventricular conduction function should be continuously monitored to evaluate whether a pacemaker needs to be implanted.
In patients with atypical left bundle branch block or incomplete left bundle branch block patterns on the body surface, if the LB potential is mapped, as shown in FIG. 7, indicating that the left bundle branch proximal segment of the patient is not blocked, if the effect of correcting cardiac insufficiency by left bundle branch pacing is poor, other treatment modes such as cardiac resynchronization therapy (CRRT) should be considered; wherein, the A diagram represents the Hill-bundle potential diagram when the left bundle branch near segment is not blocked, and the B diagram represents the LB (left bundle branch) potential diagram when the left bundle branch near segment is not blocked. In a TAVR postoperative patient with a body surface electrocardiogram exhibiting left bundle branch block, as shown in FIG. 8, the LB potential is vanished, indicating that the patient is truly left bundle branch near block, left bundle branch pacing may be considered to correct cardiac insufficiency beyond the left bundle branch block; namely, the heart monitoring system can also guide the action of selecting a pacing mode according to the mapping LB potential; wherein, the A diagram represents the Hill-bundle potential diagram when the left bundle branch is blocked, and the B diagram represents the LB (left bundle branch) potential diagram when the left bundle branch is blocked.
In the extracorporeal device 13 of the heart monitoring system, a control circuit may be further provided, by which a pulse signal may be sent to the wireless transmission coil 6 in the body, in which case the wireless transmission coil 6 in the body acts as an energy transmission coil, sending a pacing signal to the electrodes. If desired for pacing, the in vivo prosthetic valve may also include additional passive electronic components, such as diodes, capacitors, control circuitry, etc., which may be used to control the direction of current flow, capacitors may be used to increase the efficiency of the circuitry, and control circuitry may be used to drive the electrodes as the cathode and anode for pacing.
The specific working process of the heart monitoring system is as follows:
when the artificial aortic valve is delivered, the delivery device 12 releases the artificial aortic valve to a designated position, the upstream inflow end 4 of the deployed artificial aortic valve is abutted against the surface of the atrioventricular space of the heart, the mapping electrode 8 transmits the potential information mapped to the atrioventricular junction to the wireless transmitting coil 6 through the lead 9, and the wireless transmitting coil 6 transmits the potential information of the atrioventricular junction to the wireless receiving coil 10 of the delivery device 12 and then to the display device 11 through the lead;
after the artificial aortic valve is placed and the placement position is confirmed to be correct, the delivery device 12 is taken out, and the wireless transmitting coil 6 transmits the potential information of the atrioventricular junction to the wireless receiving coil 10 of the external device 13 and then transmits the potential information to the display device 11 through a lead.
The heart monitoring system can detect the potential in the TAVR operation by arranging the artificial valve part and the non-implanted part, so that the implantation position or implantation depth of the artificial valve can be adjusted in real time according to the detection result, the heart is prevented from being damaged, the management after the TAVR operation can be performed, and the intra-cardiac potential of a patient after the operation of a user can be monitored for a long time through external equipment so as to determine the treatment effect and the follow-up treatment scheme. At the same time, the structure of the present application may also be used as a conduction system to send pacing signals to the electrodes through an extracorporeal device.

Claims (10)

1. A prosthetic aortic valve comprising a prosthetic valve frame (1), and a plurality of leaflets (5) attached to the prosthetic valve frame (1), the prosthetic valve frame (1) comprising an upstream inflow end (4), a downstream outflow end (2) and a constriction (3) in the middle; the method is characterized in that: the artificial valve frame (1) is formed by combining diamond-shaped brackets, a carrier (7) is fixed at the intersection point of the diamond-shaped brackets of the upstream inflow end (4), the carrier (7) is made of polyether-ether-ketone, the carrier (7) is fixed at the intersection point of the diamond-shaped brackets of the upstream inflow end (4), the part can be close to the atrioventricular space surface of a heart after implantation, and a mapping electrode (8) which can be attached to the surface of heart tissue is arranged on the outward side of the carrier (7); a wireless transmitting coil (6) is fixed at one end of the contraction part (3) or the downstream outflow end (2) close to the contraction part (3), and the mapping electrode (8) is communicated with the wireless transmitting coil (6) through a lead (9);
the mapping electrode (8) transmits the potential information mapped to the junction of the atrioventricular junction to the wireless sending coil (6) through the lead (9), and the wireless sending coil (6) transmits the potential information of the junction of the atrioventricular junction out of the body.
2. The prosthetic aortic valve as claimed in claim 1, wherein: the artificial valve frame (1) is made of nickel-titanium alloy; a skirt edge is fixed at the inner side of the upstream inflow end (4), and the skirt edge is made of polyethylene.
3. The prosthetic aortic valve as claimed in claim 2 wherein: the material of the valve leaf (5) is pericardial tissue, synthetic material or polymeric material; the valve leaf (5) is sewn on the skirt through a suture.
4. The prosthetic aortic valve as claimed in claim 1, wherein: the carrier (7) is made of polyether-ether-ketone, and the carrier (7) is fixed at the crossing point of the diamond-shaped bracket in a tying or gluing mode by a tether.
5. The prosthetic aortic valve as claimed in claim 1, wherein: the material of the mapping electrode (8) is platinum or platinum iridium alloy, the mapping electrode (8) is strip-shaped, and the width of the mapping electrode (8) is 1-2mm.
6. The prosthetic aortic valve as claimed in claim 1, wherein: the width of the carrier (7) is 3-5mm, and the mapping electrodes (8) are embedded on the carrier (7) singly or in pairs.
7. The prosthetic aortic valve as claimed in claim 1, wherein: the wireless transmitting coil (6) is a gold wire bonding wire, and an insulating layer is arranged on the outer layer of the gold wire bonding wire; the wireless transmitting coil (6) is fixed on the inner layer or the outer layer of the artificial valve frame (1) in an electric isolation mode.
8. A cardiac monitoring system, characterized by: the device comprises a prosthetic aortic valve, a display device (11) and a delivery device (12) or/and an extracorporeal device (13), wherein a wireless receiving coil (10) is arranged at the front end of the delivery device (12), a wireless receiving coil (10) is also arranged at the front end of the extracorporeal device (13), and the wireless receiving coil (10) of the delivery device (12) and the wireless receiving coil (10) of the extracorporeal device (13) are connected with the display device (11) through leads;
a prosthetic aortic valve employing the prosthetic aortic valve of any one of claims 1-7;
when the artificial aortic valve is delivered, the delivery device (12) releases the artificial aortic valve to a designated position, the upstream inflow end (4) of the deployed artificial aortic valve is attached to the atrial-ventricular septum surface of the heart, the mapping electrode (8) transmits potential information mapped to the atrial-ventricular junction to the wireless transmitting coil (6) through the lead (9), and the wireless transmitting coil (6) transmits the potential information of the atrial-ventricular junction to the wireless receiving coil (10) of the delivery device (12) and then to the display device (11) through the lead; after the artificial aortic valve is placed and the placement position is confirmed to be correct, the delivery device (12) is taken out; the wireless transmitting coil (6) transmits the potential information of the junction of the atrioventricular node to the wireless receiving coil (10) of the external device (13) and then transmits the potential information to the display device (11) through a lead.
9. A cardiac monitoring system as set forth in claim 8 wherein: when the mapping electrode (8) maps the his bundle potential information or the left bundle branch potential information in the process of delivering the artificial aortic valve, the implantation position or implantation depth of the artificial aortic valve is adjusted through the delivery device (12).
10. A cardiac monitoring system as set forth in claim 8 wherein: the mapping potential information of the mapping electrode (8) comprises atrial potential information, hill-bundle potential information, ventricular potential information and left-bundle branch potential information, and the mapped atrial potential information, hill-bundle potential information, ventricular potential information and left-bundle branch potential information are displayed on the display device (11).
CN202410003929.3A 2024-01-03 2024-01-03 Artificial aortic valve and heart monitoring system Active CN117503433B (en)

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