Multifunctional electrophysiological electrode catheter

Abstract

The invention discloses a multifunctional electrophysiological electrode catheter, and relates to the field of medical auxiliary equipment. Comprising a catheter, an outer layer, a high-position right ventricular electrode, a His beam electrode, a right ventricular electrode, an element groove, a main circuit, a pace-making control module, a miniature signal amplifier, a miniature signal filter, an analog-to-digital converter, a digital signal processor, a main control signal processing unit, a data transmission interface and a navigation positioning system module. According to the invention, the high-position right atrial electrode, the His beam electrode and the right ventricle electrode are integrated through a single catheter, and synchronous mapping of the high-position right atrial electrode, the His beam electrode and the right ventricle electrode is realized respectively. The device has the functions of electrophysiological signal mapping and cardiac pacing, and is provided with an independent signal processing module, so that high precision and stability of signal acquisition and processing are ensured. The design of the catheter supports single-puncture-point operation. The navigation positioning module is combined with an electric field and magnetic field sensor to position the catheter in the heart cavity.

Description

Technical Field

[0001] The invention relates to the field of medical auxiliary equipment, in particular to a multifunctional electrophysiological electrode catheter. Background Art

[0002] Currently, electrophysiological mapping and radiofrequency ablation have become important clinical means in the diagnosis and treatment of arrhythmias. The traditional method requires the introduction of multiple catheters and electrodes through multiple venous puncture points to locate electrophysiological signal recording and pacing intervention in multiple cardiac chambers such as the high right atrium, His bundle and right ventricle. This multi-puncture, multi-catheter parallel operation method increases the complexity and operation time of the operation. There are multiple catheters working simultaneously in the blood vessels and cardiac chambers, and there are cases of mutual entanglement and signal interference between the catheters, which increases the difficulty and risk of the operation. In addition, the mutual interference between multiple puncture points and multiple catheters leads to a decrease in the accuracy of electrophysiological signal recording and increases the probability of cardiac complications such as cardiac perforation, thrombosis, infection and vascular damage.

[0003] Based on the above limitations, the solutions of traditional equipment in reducing puncture points and integrating multi-point electrode recording and pacing functions are still imperfect and need to be improved. A multifunctional electrophysiological mapping electrode device that can achieve multi-point potential mapping and corresponding position pacing functions through a single puncture point and a single catheter will help reduce the probability of vascular complications, reduce mutual interference between catheters, simplify the surgical process, and reduce the difficulty and risk of operation. Summary of the invention

[0004] The main purpose of the present invention is to provide a multifunctional electrophysiological electrode catheter, which can effectively solve the problems in the background technology.

[0005] To achieve the above object, the technical solution adopted by the present invention is: a multifunctional electrophysiological electrode catheter, wherein the outer layer, the high right atrial electrode, the His bundle electrode, and the right ventricular electrode are all arranged at different positions inside the catheter and arranged longitudinally;

[0006] The element slot is connected to the conduit; the main circuit and related functional modules are accommodated therein;

[0007] The main circuit is electrically connected to a micro signal amplifier, the micro signal amplifier is electrically connected to a micro signal filter, the micro signal filter is electrically connected to an analog-to-digital converter, the analog-to-digital converter is electrically connected to a digital signal processor, the digital signal processor is electrically connected to a pacing control module, the digital signal processor is electrically connected to a main control signal processing unit, the digital signal processor is electrically connected to a navigation and positioning system module, and the main control signal processing unit is electrically connected to a data transmission interface.

[0008] Furthermore, a right atrial electric field sensor and a right atrial magnetic field sensor are provided near the high-position right atrial electrode, and the high-position right atrial electrode is electrically connected to the right atrial circuit;

[0009] A His bundle electric field sensor and a right atrium magnetic field sensor are provided near the His bundle electrode, and the His bundle electrode is electrically connected to the right atrium circuit;

[0010] A right ventricular electric field sensor and a right ventricular magnetic field sensor are provided in the vicinity of the right ventricular electrode, and the right ventricular electrode is electrically connected to the right atrium circuit;

[0011] Furthermore, the high-position right atrial electrode, His bundle electrode, and right ventricular electrode are distributed inside the catheter along the longitudinal axis, and each electrode and the corresponding sensing and pacing circuits extend through independent insulating channels.

[0012] Furthermore, the high-position right atrial electrode, His bundle electrode, right ventricular electrode and the corresponding pacing control module and digital signal processor wires are radially fixed in the component slot, and the matching tolerance between the wires and the component slot does not exceed 0.01 mm.

[0013] Furthermore, the junction areas where the high-position right atrial electrode, His bundle electrode, right ventricular electrode and corresponding circuits are electrically connected are fixed by positioning grooves, and the depth of each positioning groove is 30%-50% of the thickness of the electrode.

[0014] Furthermore, the analog-to-digital converter and the digital signal processor are electrically connected via a group of wires, the cross-section of the wires is flat, and a wire sleeve is provided around the outer periphery of the wires.

[0015] Furthermore, the plug-in portion between the data transmission interface and the main control signal processing unit is designed as a polygonal cross-section structure, an octagonal cross-section is selected, and the eight side surface wires are plugged in for multi-point positioning.

[0016] Compared with the prior art, the present invention has the following beneficial effects:

[0017] By integrating the high right atrial electrode, His bundle electrode, right ventricular electrode and corresponding signal processing and pacing control modules into a single catheter, physicians can complete multi-site electrophysiological mapping and pacing interventions through a single puncture point. This effectively reduces the number of punctures, reduces the risk of infection and bleeding at the blood vessels and catheter entrances, and significantly reduces the probability of vascular complications. At the same time, the single catheter layout simplifies the interventional pathway, thereby shortening the operation time and reducing signal interference between catheters, improving the overall controllability and safety of the operation.

[0018] On the basis of the above integration, the device also uses sophisticated internal line arrangement and rigorous insulation design to enable efficient and orderly signal recording and electrical stimulation transmission of multi-point electrodes in a single catheter. The close and orderly connection between the components allows the interventional device to maintain a stable position in the heart cavity, avoiding mechanical interference and signal mixing between multiple catheters. This not only improves the accuracy of electrophysiological signal recording, but also reduces the probability of cardiac complications such as cardiac perforation, thrombosis and infection, significantly improving the success rate and safety of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 It is a schematic diagram of the structure of the catheter of the present invention;

[0020] Figure 2 It is a cross-sectional view of part A of the present invention;

[0021] Figure 3 It is a cross-sectional view of part B of the present invention;

[0022] Figure 4 It is a cross-sectional view of part C of the present invention;

[0023] Figure 5 It is a diagram of the internal components of the overall structure of the present invention;

[0024] Figure 6 This is a diagram of the internal components of the component slot structure of the present invention;

[0025] Figure 7 This is a diagram of the catheter and intraoperative path of the present invention.

[0026] In the figure:

[0027] 1. Catheter; 2. Outer layer; 3. High right atrial electrode; 301. Right atrial electric field sensor; 302. Right atrial magnetic field sensor; 303. Right atrial circuit; 4. His bundle electrode; 401. His bundle electric field sensor; 402. His bundle magnetic field sensor; 403. His bundle circuit; 5. Right ventricular electrode; 501. Right ventricular electric field sensor; 502. Right ventricular magnetic field sensor; 503. Right ventricular circuit; 6. Component slot; 7. Main circuit; 8. Pacemaker control module; 9. Miniature signal amplifier; 10. Miniature signal filter; 11. Analog-to-digital converter; 12. Digital signal processor; 13. Main control signal processing unit; 14. Data transmission interface; 15. Navigation and positioning system module;

[0028] a, inferior vena cava; b, right atrium; c, right ventricle. DETAILED DESCRIPTION

[0029] The subject matter described herein will now be discussed with reference to example embodiments. It should be understood that the discussion of these embodiments is only to enable those skilled in the art to better understand and implement the subject matter described herein, and is not a limitation of the scope of protection, applicability or examples set forth in the claims. The functions and arrangements of the elements discussed can be changed without departing from the scope of protection of the contents of this specification. Various examples can omit, replace or add various processes or components as needed. For example, the described method can be performed in an order different from the described order, and various steps can be added, omitted or combined. In addition, the features described relative to some examples can also be combined in other examples.

[0030] As used herein, the term "including" and its variations represent open terms, meaning "including but not limited to". The term "based on" means "based at least in part on". The terms "one embodiment" and "an embodiment" mean "at least one embodiment". The term "another embodiment" means "at least one other embodiment". The terms "first", "second", etc. may refer to different or the same objects. Other definitions may be included below, whether explicit or implicit. Unless the context clearly indicates otherwise, the definition of a term is consistent throughout the specification.

[0031] Example

[0032] See also Figure 1-7 , the present invention provides a technical solution:

[0033] A multifunctional electrophysiological electrode catheter, wherein the outer layer 2, the high right atrial electrode 3, the His bundle electrode 4, and the right ventricular electrode 5 are all arranged at different positions inside the catheter 1 and arranged longitudinally;

[0034] The element slot 6 is connected to the conduit 1; the main circuit 7 and related functional modules are accommodated therein;

[0035] The main line 7 is electrically connected to the micro signal amplifier 9, the micro signal amplifier 9 is electrically connected to the micro signal filter 10, the micro signal filter 10 is electrically connected to the analog-to-digital converter 11, the analog-to-digital converter 11 is electrically connected to the digital signal processor 12, the digital signal processor 12 is electrically connected to the pacing control module 8, the digital signal processor 12 is electrically connected to the main control signal processing unit 13, the digital signal processor 12 is electrically connected to the navigation and positioning system module 15, and the main control signal processing unit 13 is electrically connected to the data transmission interface 14.

[0036] Catheter 1 is the main body of the device, which is a slender flexible tubular structure. High-positioned right atrial electrodes, His bundle electrodes, and right ventricular electrodes are distributed in sequence along the longitudinal interior of the catheter. These electrodes adopt a circular local convex structure to ensure good contact with specific positions of the heart cavity and signal acquisition stability. The outer layer is a layer of protective material attached to the inner wall of the catheter, which is used to isolate the action, circuit and external blood flow field, and keep the internal components of the catheter clean and insulated. Through the above structure, each electrode can achieve electrical signal mapping and pacing intervention at a specific position without adding additional puncture paths, thereby reducing vascular complications caused by multiple punctures and interference and risks caused by multiple catheter operations.

[0037] In the proximal area inside the catheter or at one end of the catheter connected to the external control device, a component slot is set. The component slot is an internal storage space for integrating the main circuit and related functional modules. The main circuit is a signal and energy transmission channel that runs through the entire catheter. It is electrically connected to the high-position right atrial electrode, the His bundle electrode, and the right ventricular electrode. The stable transmission of multi-point signal input and output is achieved through electrical coupling and isolation of high-insulation materials. In the component slot, the micro-signal amplifier is electrically connected to the main circuit to preliminarily amplify the weak electrophysiological signals from each electrode; the micro-signal filter is connected to the micro-signal amplifier to filter out high-frequency noise and interference; the analog-to-digital converter is electrically connected to the micro-signal filter to convert the amplified and purified analog signal into a digital signal; after the digital signal processor is electrically connected to the analog-to-digital converter, the digital signal is calculated and analyzed. In addition, the digital signal processor is electrically connected to the power supply, pacing control module, main control signal processing unit and navigation and positioning system module respectively. Through this series and layered electrical connection relationship, the digital signal processor obtains stable energy supply from the power supply on the one hand, and obtains pacing output instructions from the pacing control module on the other hand, integrates the processed signals and data through the main control signal processing unit, and transmits them to the external operating device through the data transmission interface; the navigation and positioning system module provides data support for the precise positioning and path planning of the catheter in the heart cavity. The closed-loop system of signal acquisition, processing, execution and transmission formed enables this device to simultaneously realize multi-point potential mapping and pacing intervention at the corresponding position in a single catheter.

[0038] Furthermore, a right atrial electric field sensor 301 and a right atrial magnetic field sensor 302 are provided near the high right atrial electrode 3, and the high right atrial electrode 3 is electrically connected to a right atrial line 303;

[0039] A His bundle electric field sensor 401 and a right atrium magnetic field sensor 402 are provided near the His bundle electrode 4, and the His bundle electrode 4 is electrically connected to a right atrium line 403;

[0040] A right ventricular electric field sensor 501 and a right ventricular magnetic field sensor 502 are provided near the right ventricular electrode 5 , and the right ventricular electrode 5 is electrically connected to a right atrium line 503 .

[0041] In this embodiment, in order to enhance the accuracy and flexibility of multi-point potential mapping and pacing intervention, the electrodes corresponding to each cardiac chamber position are equipped with independent sensing components: right atrial electric field sensors and right atrial magnetic field sensors are arranged near the high right atrial electrode. These two types of sensors detect local potential changes and local magnetic field characteristics respectively, thereby providing more comprehensive electrophysiological data support for the high right atrial region.

[0042] Similarly, the His bundle electric field sensor and His bundle magnetic field sensor are also configured near the His bundle electrode. Such multiple sensors can accurately locate and measure the electrophysiological state of each target area, and transmit the relevant information to the main control signal processing unit and pacing control module along independent lines. By integrating the electric field and magnetic field sensors and dedicated lines of each part into one catheter, this device realizes high-precision synchronous mapping of electrophysiological signals of multiple cardiac chambers and targeted therapeutic intervention.

[0043] Furthermore, the high-position right atrial electrode 3, the His bundle electrode 4, and the right ventricular electrode 5 are distributed inside the catheter 1 along the longitudinal axis direction, and each electrode and the corresponding sensing and pacing circuits extend through independent insulating channels.

[0044] In this embodiment, the high right atrial electrode, the His bundle electrode and the right ventricular electrode are orderly distributed inside the catheter along the longitudinal axis, and each electrode is equipped with an independent insulating channel to extend the corresponding sensing and pacing circuits. In this way, the signal acquisition and electrical stimulation transmission channels of each electrode are separated from each other, avoiding interference and noise coupling caused by direct contact or too close arrangement between the lines, thereby ensuring high-fidelity transmission of electrophysiological signals of each electrode for a specific cardiac chamber position. At the same time, the design of this independent insulating channel is also conducive to modular and standardized production. When maintaining or replacing the internal circuit, there is no need to affect the normal operation of other electrodes, and it provides the possibility of flexible adjustment of the number, position or material of electrodes for different patient conditions in the future. By arranging multiple electrodes and their independent circuits in layers and sections on the longitudinal axis, the device achieves precise positioning, no mutual interference, and easy-to-expand internal structure in structure, which better supports the stable realization of multi-point potential mapping and corresponding position pacing functions.

[0045] Furthermore, the high-position right atrial electrode 3, His bundle electrode 4, right ventricular electrode 5 and the corresponding pacing control module 8, digital signal processor 12 are radially fixed in the component slot 6, and the matching tolerance between the wire and the component slot 6 does not exceed 0.01 mm.

[0046] In this embodiment, the connecting wires of the high right atrial electrode, His bundle electrode, right ventricular electrode, pacing control module, and digital signal processor are radially positioned by precise fixing in the component slot. These wires are adapted in the component slot with a strict accuracy of no more than 0.01 mm tolerance, effectively reducing the shaking or misalignment of the wires during operation, thereby ensuring stable and clear signal transmission.

[0047] Furthermore, the junction areas where the high right atrial electrode 3, the His bundle electrode 4, the right ventricular electrode 5 are electrically connected to the corresponding circuits are fixed by positioning grooves, and the depth of each positioning groove is 30%-50% of the thickness of the electrode.

[0048] In this embodiment, in order to make the connection between the high right atrial electrode, the His bundle electrode and the right ventricular electrode and the corresponding circuit more reliable and stable, a positioning groove fixing method is adopted. The depth of each positioning groove is strictly controlled within the range of 30%-50% of the electrode thickness. Through such precise depth ratio control, it can be ensured that the bottom of the electrode is fully embedded and supported in the positioning groove to reduce the displacement and loosening of the electrode when it is used due to blood flow, catheter bending or external force; such depth does not excessively invade the electrode structure itself, and will not weaken the electrode strength or affect the transmission efficiency of the electrical signal.

[0049] Furthermore, the analog-to-digital converter 11 and the digital signal processor 12 are electrically connected via a set of wires, the cross section of the wires is flat, and a wire sleeve is provided around the outer periphery of the wires.

[0050] In this embodiment, in order to achieve high-quality electrical signal connection between the analog-to-digital converter and the digital signal processor, a group of flat cross-section wires are used for electrical connection, and a wire sleeve is configured on the periphery of the wire. Compared with traditional round cross-section wires, flat cross-section wires can arrange more transmission paths in the same cross-section, thereby increasing signal bandwidth or improving data throughput efficiency. At the same time, the flat cable structure is conducive to maintaining a neat and orderly wiring method in a limited space, reducing interference and mechanical stress caused by cable bending and twisting. The external wire sleeve plays a protective and fixing role, providing electrical insulation and a certain degree of mechanical buffering for the wire, and preventing the inner wall of the conduit or other components from wearing the wire.

[0051] Furthermore, the plug-in portion between the data transmission interface 14 and the main control signal processing unit 13 is designed as a polygonal cross-section structure, an octagonal cross-section is selected, and the eight side surface wires are plugged in for multi-point positioning.

[0052] In this embodiment, the plug-in part of the data transmission interface and the main control signal processing unit adopts an octagonal cross-section design. This polygonal cross-section structure can provide more contact edges under the same space conditions, thereby achieving multi-point positioning and more stable connection. When plugging, the eight edges work together to effectively reduce the plug-in error and increase the contact area and contact strength between the wire and the terminal. At the same time, the multi-point positioning method reduces the risk of shaking or loosening of the interface during use.

[0053] Those skilled in the art should understand that the various embodiments disclosed above can be changed and modified in various ways without departing from the essence of the invention. Therefore, the protection scope of the present invention should be defined by the appended claims.

[0054] It should be noted that not all steps and units in the above processes are necessary, and some steps or units can be ignored according to actual needs. The execution order of each step is not fixed and can be determined as needed. The device structure described in the above embodiments can be a physical structure or a logical structure, that is, some units may be implemented by the same physical entity, or some units may be implemented by multiple physical entities, or some components in multiple independent devices may be implemented together.

[0055] The specific embodiments set forth above describe exemplary embodiments, but do not represent all embodiments that may be implemented or fall within the scope of protection of the claims. The term "exemplary" used throughout this specification means "used as an example, instance, or illustration" and does not mean "preferred" or "having advantages" over other embodiments. For the purpose of providing an understanding of the described techniques, the specific embodiments include specific details. However, these techniques may be implemented without these specific details. In some instances, in order to avoid obscuring the concepts of the described embodiments, well-known structures and devices are shown in block diagram form.

[0056] The above description of the present disclosure is provided to enable any person of ordinary skill in the art to implement or use the present disclosure. Various modifications to the present disclosure will be apparent to those of ordinary skill in the art, and the general principles defined herein may be applied to other variations without departing from the scope of protection of the present disclosure. Therefore, the present disclosure is not limited to the examples and designs described herein, but is consistent with the widest range of principles and novel features disclosed herein.

Claims

1. A multifunctional electrophysiological electrode catheter, comprising a main body (1), an outer layer (2), a high-position right atrial electrode (3), a His bundle electrode (4), a right ventricular electrode (5), an element slot (6), and a main circuit (7), wherein: The outer layer (2), the high right atrial electrode (3), the His bundle electrode (4), and the right ventricular electrode (5) are all located at different positions inside the catheter (1) and arranged longitudinally; The element slot (6) is connected to the conduit (1); the main circuit (7) and related functional modules are accommodated therein; The main circuit (7) is electrically connected to a micro signal amplifier (9), the micro signal amplifier (9) is electrically connected to a micro signal filter (10), the micro signal filter (10) is electrically connected to an analog-to-digital converter (11), the analog-to-digital converter (11) is electrically connected to a digital signal processor (12), the digital signal processor (12) is electrically connected to a pacing control module (8), the digital signal processor (12) is electrically connected to a main control signal processing unit (13), the digital signal processor (12) is electrically connected to a navigation and positioning system module (15), and the main control signal processing unit (13) is electrically connected to a data transmission interface (14).

2. The multifunctional electrophysiological electrode catheter according to claim 1, characterized in that: A right atrial electric field sensor (301) and a right atrial magnetic field sensor (302) are provided adjacent to the high-position right atrial electrode (3), and the high-position right atrial electrode (3) is electrically connected to a right atrial circuit (303); A His bundle electric field sensor (401) and a right atrium magnetic field sensor (402) are provided near the His bundle electrode (4), and the His bundle electrode (4) is electrically connected to the right atrium circuit (403); A right ventricular electric field sensor (501) and a right ventricular magnetic field sensor (502) are provided near the right ventricular electrode (5), and the right ventricular electrode (5) is electrically connected to the right atrium line (503).

3. The multifunctional electrophysiological electrode catheter according to claim 1, characterized in that: The high-position right atrial electrode (3), the His bundle electrode (4), and the right ventricular electrode (5) are distributed inside the catheter (1) along the longitudinal axis direction, and each electrode and the corresponding sensing and pacing circuits are extended through independent insulating channels.

4. The multifunctional electrophysiological electrode catheter according to claim 1, characterized in that: The high-position right atrial electrode (3), the His bundle electrode (4), the right ventricular electrode (5) and the corresponding pacing control module (8), the wire of the digital signal processor (12) are radially fixed in the component slot (6), and the matching tolerance between the wire and the component slot (6) does not exceed 0.01 mm.

5. The multifunctional electrophysiological electrode catheter according to claim 1, characterized in that: The junction areas where the high right atrial electrode (3), the His bundle electrode (4), the right ventricle electrode (5) are electrically connected to the corresponding circuits are fixed by positioning grooves, and the depth of each positioning groove is 30%-50% of the thickness of the electrode.

6. The multifunctional electrophysiological electrode catheter according to claim 1, characterized in that: The analog-to-digital converter (11) and the digital signal processor (12) are electrically connected via a group of wires, the wire cross-section is flat, and a wire sleeve is provided around the wire.

7. The multifunctional electrophysiological electrode catheter according to claim 1, characterized in that: The plug-in portion of the data transmission interface (14) and the main control signal processing unit (13) is designed as a polygonal cross-section structure, an octagonal cross-section is selected, and eight side surface wires are plugged in for multi-point positioning.

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