Pace-making lead for monitoring pressure in cardiac cavity

Abstract

The invention discloses a pace-making lead for monitoring pressure in a cardiac cavity, and belongs to the field of medical instruments. The pace-making wire comprises a wingspan structure position sensor for monitoring the fixing effect of the pace-making wire, an annular structure blood pressure sensor for monitoring the pressure in a cardiac cavity, and a signal processing and communication module connected through a wire. The position sensor and the blood pressure sensor are made of functional materials with a force-electricity conversion effect, the stress condition of the wing-shaped structure is reflected through an output electrical signal, the fixed condition is judged and monitored, meanwhile, the blood pressure sensor is subjected to the effect of the pressure in the cardiac cavity, the pressure signal is converted into the electrical signal, and the electrical signal is sent to the monitoring center. And the blood pressure condition in the heart cavity is monitored in real time through the signal. According to the invention, the fixing condition of the cardiac pacemaker can be periodically monitored, the safety of the equipment is improved, and the health and safety of a patient are better guaranteed; meanwhile, the blood pressure condition of the patient is monitored in real time, and abnormal blood pressure can be found in time.

Description

Technical Field

[0001] The present invention belongs to the field of medical devices, and in particular relates to a pacing lead for monitoring intracardiac pressure, which has the functions of detecting whether an electrode position is dislodged and measuring the intracardiac pressure in real time. Background Art

[0002] Cardiac pacemakers are an effective treatment for arrhythmias. They are mainly composed of a pulse generator, a pacing wire and a pacing electrode. The principle is based on the detection of the patient's cardiac electrical signals. When an abnormal heart rhythm occurs, the pulse transmitter is triggered to generate electrical stimulation, which is transmitted to the electrode through the wire, stimulating the myocardium to correct the abnormal heart rhythm and achieve the therapeutic function.

[0003] Cardiac pacing leads include active and passive types. Active pacing leads rely on the spiral structure at the top to fix the electrode by screwing the spiral structure into the endocardium. Active pacing leads are prone to penetrate the endocardium during the screwing and fixation process, causing serious damage to the heart. Passive pacing leads use the wingspan structure at the front end of the pacing lead to fix the pacing lead on the trabeculae of the endocardium, which can effectively avoid myocardial damage caused by the screwing and fixation of active pacing leads. However, since the passive electrode is operated in the three-dimensional structure of the heart cavity during the fixation process, it is difficult to judge the effect of the wingspan structure and the trabeculae fixation, and there is a risk of falling off after surgery, which affects the pacing effect. In addition, cardiac pacemakers based on active and passive pacing leads feedback heart rhythm changes through electrocardiogram detection, and cannot quantify the pressure changes in the heart cavity. There are inherent shortcomings in the treatment of special arrhythmia diseases, such as orthostatic hypotension.

[0004] Functional materials with force-electric conversion effect can convert mechanical motion into electrical signals, including piezoelectric materials and triboelectric materials. Sensors constructed with these functional materials can feedback the real-time state of mechanical motion and directly convert mechanical motion into electrical signals. The sensor itself does not require additional power supply, and the entire sensor module can achieve zero power consumption, which can effectively reduce the power consumption of the overall system. Summary of the invention

[0005] In order to realize the measurement of cardiac chamber pressure based on the existing cardiac pacemaker and avoid sudden cardiac conditions of the patient, the present invention provides a pacing lead for monitoring the intra-cardiac pressure, which realizes the monitoring of the fixation effect of the cardiac pacemaker pacing electrode after implantation and the measurement of the intra-cardiac blood pressure.

[0006] The pacing lead includes a wing span structure position sensor for monitoring the fixation effect of the pacing lead, a ring structure blood pressure sensor for monitoring the pressure in the heart chamber, and a signal processing and communication module connected by a lead. The entire sensor system is integrated with the pacing electrode structure and pulse transmitter unit of the cardiac pacemaker.

[0007] The signal processing and communication module is responsible for analyzing, identifying and processing the ECG signals and sensor pressure signals monitored in the heart, and triggering the pulse transmitter to work.

[0008] The wing span structure position sensor is a position sensor added on the basis of the wing span structure of the passive pacing lead, and the position sensor is enclosed in the wing span structure of the passive pacing lead; the wing span structure includes a plurality of wing span units, each wing span unit is evenly fixed at the lower part of the top of the pacing lead in the circumferential direction, and preferably consists of four wing span unit structures;

[0009] The blood pressure sensor includes a plurality of sheet structures which are uniformly wrapped around the pacing wire in the circumferential direction and are preferably fixed below the wingspan structure of the position sensor.

[0010] The position sensor and pressure sensor are encapsulated in the flexible rubber material of the pacing lead.

[0011] A cardiac pacemaker using the pacing lead of the present invention is implanted in a heart model, and the position sensor is fixedly "stuck" between the trabeculae during the implantation of the pacing lead. The electrical signal generated by the position sensor is fed back by pulling the pacing lead to fix the trabeculae. If each wing span structure maintains a similar electrical signal output during the pulling process and reaches an appropriate range, it indicates that the fixed position effect is good. If signals of different sizes appear in each wing span unit, it means that the fixation is uneven and needs fine-tuning. Based on the periodic movement of the heart, the wing span structure of the position sensor will periodically feed back the electrical signal that interacts with the trabecular mechanics, and the entire system judges and monitors the fixation situation through the characteristics of each wing span signal.

[0012] The ring-shaped blood pressure sensor is wrapped around the pacing wire and is located in the heart cavity. Its electrical signal is mainly affected by the pressure changes in the cavity. Therefore, the pressure changes in the heart cavity are monitored in real time through the electrical signal characteristics of the blood pressure sensor.

[0013] When an abnormal signal appears in the position sensor, the pacemaker issues an early warning through the signal processing and communication module, allowing the patient to seek medical treatment in time; when the blood pressure sensor detects an abnormal signal of intracavitary pressure, it triggers the pacemaker pulse transmitter to emit electrical pulses to stimulate the endocardium to enhance cardiac function, preferably for diseases with symptoms of orthostatic hypotension.

[0014] Both the position sensor and the blood pressure sensor are flexible and use functional materials with force-electric conversion effect, specifically piezoelectric film materials or triboelectric materials; preferably, the position sensor uses piezoelectric materials and the pressure sensor uses triboelectric materials.

[0015] The piezoelectric film material preferably uses polyvinylidene fluoride, polyvinylidene fluoride composite material or lead zirconate titanate composite film material; the triboelectric material uses flexible polymer materials and metal materials, preferably polydimethylsiloxane, polytetrafluoroethylene, polyester resin, platinum, gold, etc.

[0016] The advantages of the present invention are:

[0017] (1) A functional material with a force-electricity conversion effect is applied to the wing-shaped structure unique to the passive electrode. Through the characteristics of the functional material with a force-electricity conversion effect, the force condition of the wing-shaped structure is reflected by the output electrical signal. After processing the output electrical signal, the force condition of each wing-shaped structure is obtained. By observing the magnitude, range, and equality of the force and electricity reflected at each wing-shaped structure, the fixation condition of the electrode can be judged during the implantation of a cardiac pacemaker.

[0018] (2) The stress conditions of the wing-shaped structures are output to external devices through the force-electricity conversion module and the signal transmission module. Patients and relevant medical staff can judge whether the electrode has been displaced or broken after implantation based on the stress conditions of each wing-shaped structure, so as to prevent the patient from not seeking medical treatment in time or seeking medical treatment only after severe discomfort occurs, which may cause more serious consequences. This improves the safety of the device and better protects the health and safety of the patient.

[0019] (3) Functional materials with force-to-electric conversion effect are applied to pacing wires, specifically at the lower part of the wing-shaped structure. This part is located in the heart cavity after implantation and is mainly affected by the pressure in the heart cavity. The functional materials used can convert this pressure signal into an electrical signal and output it outside the body through a signal transmission module. The signal can then be used to monitor the blood pressure in the heart cavity in real time, so that the patient and related medical staff can monitor the patient's blood pressure in real time and promptly discover and seek medical treatment when abnormal blood pressure occurs.

[0020] (4) The functional material with force-to-electricity conversion effect used in the present invention is a flexible material with small mass and volume, and can be encapsulated in the original structure of the passive pacing electrode. It will not affect the implantation of the device and the normal use of the pacing electrode, and will not cause more steps than the traditional pacemaker implantation. It can fully utilize the space of the electrode itself and give it more functions. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 It is a schematic diagram of signal transmission of a cardiac pacemaker composed of a pacing wire of the present invention;

[0022] Figure 2 is a schematic diagram of the pacemaker electrode structure of the present invention;

[0023] Figure 3It is a schematic diagram of the structure of the force-electricity conversion device of the pacemaker electrode of the present invention.

[0024] In the figure:

[0025] 11-stimulation electrode module, 12-pulse generator module, 13-position monitoring module, 14-blood pressure detection module, 15-processor module, 16-communication module, 31-functional material, 32-metal electrode layer. DETAILED DESCRIPTION

[0026] The present invention will be further described in detail below with reference to the accompanying drawings and embodiments.

[0027] The present invention designs a pacing lead for monitoring the intracardiac pressure, which is composed of a cardiac pacemaker with a passive electrode having a force-to-electric conversion effect functional material. The force-to-electric conversion characteristics of the force-to-electric conversion functional material are utilized, combined with the structure of a traditional passive cardiac pacemaker electrode, and a position monitoring module and a blood pressure detection module are respectively integrated into the wing-shaped structure used for fixing the electrode and the pacing lead, thereby realizing the monitoring of the fixation effect of the cardiac pacemaker electrode after implantation and the measurement of the intracardiac blood pressure, providing patients implanted with relevant cardiac pacemaker devices and relevant medical personnel with the ability to monitor the electrode position and detect the patient's blood pressure, thereby providing convenience for treatment.

[0028] The present invention is a cardiac pacemaker composed of a pacing wire for monitoring intracardiac pressure, such as Figure 1 As shown, it includes: a stimulation electrode module 11, a pulse generator module 12, a position monitoring module 13, a blood pressure detection module 14, a processor module 15 and a communication module 16.

[0029] Among them, the stimulation electrode module 11 is located in the heart cavity, close to the myocardial cells, transmitting the pulse electrical signals generated by the pulse generator 12, acting on the myocardial cells, affecting the contraction of the myocardium, completing the purpose of cardiac pacing and heart rate regulation, and at the same time collecting cardiac electrical signals and sending them to the processor module 15, and making corresponding adjustments to parameters such as pacing threshold, pulse width, and pulse frequency.

[0030] The position monitoring module 13 is located in the wing-shaped structure for fixing the passive electrode, such as Figure 2 As shown, since the wing-like structure will hang in the myocardium during use, the module can convert the mechanical signals around it into electrical signals and transmit them back to the processor module 15, and determine the position information and fixation status of the electrode by analyzing and processing the signals.

[0031] The blood pressure detection module 14 is located at the front end of the electrode and behind the wing-shaped electrode. Figure 2During use, this position is located in the heart cavity and is in the blood environment. When the blood pressure changes, the force it receives will change. The force signal is converted into an electrical signal through the force-electric conversion device and transmitted back to the processor module 15. After processing and analysis, the blood pressure data is obtained.

[0032] The force-electricity conversion device structures used in the position monitoring module 13 and the blood pressure detection module 14 are as follows Figure 3 As shown, it mainly includes two parts, the middle part is a functional material 31 with a force-electricity conversion effect, and the two side parts are metal electrode layers 32. Due to its own characteristics, piezoelectric materials will generate polarized charges on the surface when subjected to external forces, and a potential difference will be generated between the upper and lower surfaces, converting mechanical energy into electrical energy. After connecting the wires through the electrodes and connecting to the load, an electrical signal will be formed.

[0033] The processor module 15 is the core of the whole system. It is connected to the stimulation electrode module 11, the pulse generator module 12, the position monitoring module 13, the blood pressure detection module 14 and the communication module 16. All data storage and output, and the scheduling between the modules are completed by the processor module 15. Specifically, it includes processing and analyzing the ECG data returned by the stimulation electrode 11, adjusting the pulse intensity, frequency and other parameters of the pulse generator 12; processing the data returned by the position detection module 13 to obtain the electrode fixation information; processing and analyzing the data returned by the blood pressure monitoring module 14 to obtain the blood pressure information in the heart; processing the information returned by the communication module 16 to regulate the overall work of the pacemaker.

[0034] The communication module 16 realizes wireless connection with external devices through Bluetooth or other means. The data collected by the pacemaker is transmitted to the external device through this module to facilitate further detailed analysis of the signal. At the same time, the external device instructions are transmitted to the processor module 15 through this module to realize the regulation of parameters, working status, etc.

Claims

1. A pacing lead for monitoring intracardiac pressure, characterized in that: It includes a wingspan structure position sensor for monitoring the fixing effect of the pacing lead, a ring-shaped structure blood pressure sensor for monitoring the pressure in the heart cavity, and a signal processing and communication module connected by a wire; the wingspan structure position sensor is a position sensor added to the wingspan structure of the passive pacing lead; the ring-shaped structure blood pressure sensor is a plurality of sheet structures, which are circumferentially wrapped around the pacing lead and are located below the wingspan structure; the position sensor and the blood pressure sensor both use functional elements with force-to-electricity conversion effect.

2. A pacing lead for monitoring intracardiac pressure according to claim 1, characterized in that: The position sensor is enclosed within the passive pacing lead wingspan structure.

3. A pacing lead for monitoring intracardiac pressure according to claim 1, characterized in that: The functional element with force-electricity conversion effect has a flexible feature and a hierarchical structure, wherein the middle layer is a functional material with force-electricity conversion effect and the two side portions are metal electrode layers.

4. A pacing lead for monitoring intracardiac pressure according to claim 3, characterized in that: The functional material with force-electricity conversion effect is a piezoelectric film material or a triboelectric material.

5. A pacing lead for monitoring intracardiac pressure according to claim 4, characterized in that: The piezoelectric film material uses polyvinylidene fluoride, polyvinylidene fluoride composite material or lead zirconate titanate composite film material; the friction electric material uses flexible polymer material and metal material, using polydimethylsiloxane, polytetrafluoroethylene, polyester resin, platinum or gold.

6. A pacing lead for monitoring intracardiac pressure according to claim 1, integrated with a pacing electrode structure and a pulse transmitter unit into a cardiac pacemaker, and explained using a heart model, characterized in that: The pacemaker is implanted into the heart model, and the wingspan structure including the position sensor is fixed and "stuck" between the trabeculae during the implantation of the pacing lead. The electrical signal generated by the position sensor of the pacing lead is fed back to the effect of the fixation of the trabeculae by pulling up the pacing lead. If each wing span structure maintains a similar electrical signal output during the pulling process and reaches a suitable range, it indicates that the fixation effect is good; if different signals appear in each wing span unit, it means that the fixation is uneven and needs fine-tuning; based on the periodic movement of the heart, the wing span structure of the position sensor will periodically feedback the electrical signal that interacts with the trabeculae mechanics, and the entire system judges and monitors the fixation status through the characteristics of each wing span signal; The ring-shaped blood pressure sensor is placed in the heart cavity as a whole. Its electrical signal is affected by the pressure change in the cavity. The pressure change in the heart cavity is monitored in real time through the electrical signal characteristics of the blood pressure sensor. When an abnormal signal appears in the position sensor, the pacemaker issues an early warning through the signal processing and communication module; When the blood pressure sensor detects abnormal intracardiac pressure signals, it triggers the pacemaker pulse transmitter to emit electrical pulses to stimulate the endocardium and enhance cardiac function.

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