Electrophysiological catheter system and method for detecting attaching degree of electrophysiological catheter

Abstract

The invention relates to the technical field of electrophysiological catheter systems, and provides an electrophysiological catheter system and an electrophysiological catheter attaching detection method. An electrophysiology catheter system comprises an electrophysiology catheter, the electrophysiology catheter is provided with a perfusion channel and an electrode assembly, the perfusion channel is communicated with an inner cavity of the electrophysiology catheter, perfusion holes are distributed in the surface of the electrode assembly, and the perfusion holes are communicated with the inner cavity of the electrophysiology catheter; the perfusion device is connected with the perfusion channel, fluid is conveyed to the perfusion channel through the perfusion device, the fluid is discharged out of the electrode assembly through the perfusion hole, the perfusion device is provided with a perfusion detection unit, and perfusion parameters of the fluid are detected through the perfusion detection unit; the perfusion parameters are obtained through the processor, and the perfusion parameters are converted into attaching pressure signals. The contact state between the electrophysiology catheter electrode assembly and the target tissue can be conveniently detected.

Description

Technical Field

[0001] This invention relates to the field of electrophysiological catheter system technology, specifically to an electrophysiological catheter system and an electrophysiological catheter contact detection method. Background Technology

[0002] Atrial fibrillation (AF) is the most common arrhythmia in clinical practice, and its incidence gradually increases with age. Currently, catheter ablation has become an important treatment for AF. Pulsed electric field ablation is a novel tissue ablation technique based on physical energy factors that has emerged in recent years. It mainly utilizes the principle of irreversible electroporation, applying a high-voltage pulsed electric field to cells to cause irreversible perforation of the cell membrane, leading to gradual cell necrosis and ultimately achieving tissue ablation.

[0003] When an ablation catheter releases ablation energy, the contact state between the catheter and the target tissue affects the uniformity and effectiveness of the ablation. For example, insufficient contact between the catheter and the target tissue may lead to incomplete ablation, increasing the risk of atrial fibrillation recurrence; while excessive contact may cause damage or perforation of the target tissue. When using a pulsed electric field ablation catheter, because the blood in the atrioventricular cavity of the heart has a lower resistance than myocardial tissue, poor electrode contact can lead to a significant increase in the current density in the blood near the catheter, potentially causing blood electrolysis and the formation of microbubbles, which may increase the risk of stroke in patients.

[0004] In related technologies, ablation catheter apposition detection often uses impedance sensing on the electrodes of the ablation catheter to reflect the degree of apposition. First, the resistance between the electrodes is measured, then compared with a certain threshold to determine if the apposition is good, and the electrode apposition is adjusted to an ideal state. However, measuring the impedance between electrodes requires using analog switches to repeatedly switch the connection states of multiple electrodes to measure the resistance between pairs of electrodes. However, switching introduces voltage signal changes, introducing noise into ECG signal acquisition. Therefore, ECG signal acquisition cannot be performed simultaneously with impedance measurement, making real-time monitoring impossible. Furthermore, the resistance value between electrodes is affected not only by the degree of apposition but also by factors such as the size of the electrode contact area. Therefore, the actual measured resistance value varies greatly, making it difficult to determine a suitable threshold, and limiting the accuracy of impedance detection in reflecting the degree of apposition. Summary of the Invention

[0005] One objective of this invention is to provide an electrophysiological catheter system that facilitates the detection of the contact status between the balloon catheter electrode assembly and the target tissue.

[0006] An electrophysiological catheter system, comprising:

[0007] An electrophysiological catheter is provided with a perfusion channel and an electrode assembly. The electrode assembly is used to adhere to the target tissue and perform electrophysiological work. The perfusion channel is connected to the inner lumen of the electrophysiological catheter. The surface of the electrode assembly is distributed with perfusion holes, which are connected to the inner lumen of the electrophysiological catheter.

[0008] An infusion device is connected to the infusion channel. The infusion device is equipped with an infusion detection unit. Fluid is delivered to the infusion channel through the infusion device and discharged from the electrode assembly through the infusion hole. The infusion parameters of the fluid are detected by the infusion detection unit.

[0009] The system includes a processor electrically connected to the electrophysiological catheter, which acquires the perfusion parameters and converts them into contact pressure signals.

[0010] In some embodiments, the infusion device is equipped with an infusion pump for connection to the infusion channel to deliver fluid into the infusion channel.

[0011] In some embodiments, the infusion parameters include infusion flow rate, infusion fluid pressure, or infusion velocity.

[0012] In some embodiments, the electrophysiological catheter is a balloon catheter, the electrode assembly is a balloon electrode assembly, and the balloon catheter includes the balloon electrode assembly and an insertion tube; the balloon electrode assembly includes a balloon body and an electrode, the balloon body being used to inflate when fluid is introduced and to contract when fluid is expelled; the electrode is disposed on the surface of the balloon body; the surface of the balloon electrode assembly has perfusion holes distributed therein, the perfusion holes communicating with the inner lumen of the balloon body to allow fluid to exit the balloon electrode assembly; the distal end of the insertion tube is connected to the proximal end of the balloon electrode assembly, the insertion tube having a perfusion channel communicating with the inner lumen of the balloon body.

[0013] In some embodiments, the infusion device includes an infusion pump and an infusion detection unit; the infusion pump is connected to the infusion channel to deliver fluid to the infusion channel; and the infusion detection unit is used to detect infusion parameters of the infusion device related to the fluid delivery status.

[0014] In some embodiments, the infusion parameters include infusion flow rate, infusion fluid pressure, or infusion velocity.

[0015] In some embodiments, the injection holes are distributed on the electrode.

[0016] In some embodiments, the injection holes are distributed along the edge of the electrode.

[0017] In some embodiments, the balloon electrode assembly includes flexible circuit boards arranged circumferentially around the balloon, and the electrodes on each flexible circuit board include a distal electrode and a proximal electrode, the distal electrode and the proximal electrode being located on the distal side and the proximal side of the balloon, respectively.

[0018] In some embodiments, the distal electrode and the proximal electrode on the same flexible circuit board are both a single unit.

[0019] In some embodiments, a signal acquisition unit is further included, which is connected to the electrode to acquire electrophysiological signals of the target tissue when the electrode is in contact with the target tissue, wherein the electrophysiological signals are preferably unipolar electrical signals;

[0020] In some embodiments, the processor is further configured to determine, based on the acquired electrophysiological signals, which electrodes on the electrode assembly are already attached electrodes that have come into contact with the target tissue.

[0021] In some embodiments, the processor is further configured to determine the contact position of the electrode assembly based on the amplitude and waveform of the electrophysiological signal, specifically the contact position of the electrodes on the electrode assembly.

[0022] In some embodiments, the contact pressure signal includes a contact pressure value, and the processor is further configured to preset a contact pressure threshold as a set threshold, and when the contact pressure value meets the set threshold, issue a prompt that the contacted electrode can perform the electrophysiological work.

[0023] In some embodiments, a signal processing unit and an information output unit are also included. The signal processing unit is used to process monopolar electrical signals and determine, based on the electrophysiological signals, which electrodes on the electrode assembly have already adhered to the target tissue. The information output unit is used to transmit the information of the adhered electrodes to the user.

[0024] In some embodiments, the electrophysiological work includes ablation and / or mapping.

[0025] In some embodiments, the electrophysiological catheter is an ablation catheter and / or a mapping catheter, and the corresponding electrophysiological catheter system is an ablation system and / or a mapping system.

[0026] Another object of the present invention is to provide a method for detecting the degree of contact between electrophysiological catheters based on the above-mentioned electrophysiological catheter system, comprising:

[0027] S1. Fluid is delivered to the electrode assembly of the electrophysiology catheter;

[0028] S2. Place the electrode assembly of the electrophysiological catheter against the target tissue and detect the perfusion parameters of the fluid;

[0029] S3. Obtain the infusion parameters and convert the infusion parameters into a contact pressure signal;

[0030] S4. Determine the contact state between the electrode assembly and the target tissue based on the change in the contact pressure signal.

[0031] In some embodiments, the contact pressure signal is a contact pressure value, and the electrophysiological catheter detection method further includes setting a threshold value for the preset contact pressure; and determining whether the contact pressure value meets the set threshold value.

[0032] In some embodiments, the electrophysiological catheter contact detection method further includes: issuing an indication that the electrophysiological catheter can perform electrophysiological work when the contact pressure value meets a set threshold.

[0033] In some embodiments, the electrophysiological catheter contact detection method further includes: when the electrode assembly of the electrophysiological catheter is in contact with the target tissue, acquiring the electrophysiological signal of the target tissue, wherein the electrophysiological signal is preferably a unipolar electrical signal.

[0034] In some embodiments, the electrophysiological catheter contact detection method further includes: determining, based on the electrophysiological signal, which electrodes on the electrode assembly have already contacted the target tissue.

[0035] In some embodiments, the electrophysiological catheter contact detection method further includes: determining the contact position of the electrode assembly based on the amplitude and waveform of the electrophysiological signal.

[0036] In some embodiments, the electrophysiological catheter contact detection method further includes: processing electrophysiological signals through the signal processing unit, determining which electrodes on the electrode assembly have already contacted the target tissue based on the electrophysiological signals, and transmitting the contact electrode information to the user through the information output unit.

[0037] The beneficial effects of this invention are:

[0038] According to the embodiment of the present invention, the electrophysiological catheter system delivers fluid to the electrode assembly through the perfusion device. When electrophysiological work is carried out using the electrophysiological catheter system, the electrode assembly is in contact with the target tissue, and the perfusion parameters of the perfusion device related to the fluid delivery state will change. The perfusion detection unit can detect the perfusion parameters, and then the processor converts the perfusion parameters into a contact pressure signal, which facilitates the detection of the contact state between the electrophysiological catheter electrode assembly and the target tissue. Attached Figure Description

[0039] Figure 1This is a schematic diagram of one embodiment of the electrophysiological catheter system in this invention;

[0040] Figure 2 yes Figure 1 Schematic diagram of the structure of the balloon electrode assembly;

[0041] Figure 3 yes Figure 2 The left view;

[0042] Figure 4 yes Figure 2 A schematic diagram of a flexible circuit board and its electrodes;

[0043] Figure 5 This is a schematic diagram of the discharge path when fluid is discharged from the balloon electrode assembly;

[0044] Figure 6 This is a schematic diagram showing the side of the balloon electrode assembly in contact with the target tissue.

[0045] Figure 7 This is a schematic diagram of the unipolar electrical signals corresponding to each electrode of the balloon electrode assembly in a contact state;

[0046] Figure 8 This is a flowchart of a method for detecting the degree of contact of an electrophysiological catheter in one embodiment.

[0047] List of feature names corresponding to the labels in the figure:

[0048] 1000, balloon catheter;

[0049] 100. Operating handle; 110. Cable assembly;

[0050] 200. Insertion tube; 210. Infusion channel;

[0051] 300. Balloon electrode assembly; 310. Balloon body; 320. Electrode; 321. Distal electrode; 322. Proximal electrode;

[0052] 330. Flexible circuit board; 331. First flexible circuit board; 332. Second flexible circuit board; 333. Third flexible circuit board; 334. Fourth flexible circuit board; 335. Fifth flexible circuit board; 336. Sixth flexible circuit board;

[0053] 340. Drive lever;

[0054] 350. Injection hole;

[0055] 360° Remote connection socket;

[0056] 2000, System Host;

[0057] 400. Signal acquisition unit;

[0058] 500. Signal processing unit;

[0059] 600, Processor;

[0060] 700. Information Output Unit;

[0061] 800. Target Organization;

[0062] 3000, Injection device;

[0063] 901. Infusion pump; 902. Infusion detection unit; 903. Infusion connection pipe; 904. Saline bag. Detailed Implementation

[0064] The present invention will now be described in further detail with reference to the accompanying drawings and specific embodiments. Similar elements in different embodiments are referred to by associated similar element reference numerals. In the following embodiments, many details are described to facilitate a better understanding of the invention. However, those skilled in the art will readily recognize that some features may be omitted in different situations, or may be replaced by other elements, materials, or methods. In some cases, certain operations related to the present invention are not shown or described in the specification. This is to avoid obscuring the core parts of the invention with excessive description. For those skilled in the art, detailed description of these related operations is not necessary; they can fully understand the related operations based on the description in the specification and general technical knowledge in the art.

[0065] The embodiments described in the detailed implementation can be combined in any suitable manner without contradiction. For example, different implementation methods can be formed by combining different embodiments. In order to avoid unnecessary repetition, the various possible combinations of the embodiments will not be described separately.

[0066] Furthermore, the features, operations, or characteristics described in the specification can be combined in any suitable manner to form various embodiments. At the same time, the steps or actions in the method description can be rearranged or adjusted in a manner obvious to those skilled in the art. Therefore, the various orders in the specification and drawings are only for the clear description of a particular embodiment and do not imply a necessary order, unless otherwise stated that a particular order must be followed.

[0067] The serial numbers assigned to components in this document, such as "first" and "second," are used only to distinguish the described objects and have no sequential or technical meaning. The terms "connection" and "linkage" used in this invention, unless otherwise specified, include both direct and indirect connections (linkages).

[0068] Those skilled in the art should understand that the terms "proximal" and "distal" used in this article are conventional medical terms. For the instrument to be operated on, the proximal end is the end closer to the user, and the distal end is the end furthest from the user, usually the end that first enters the patient's body. For more information on proximal and distal ends, please refer to [reference needed]. Figure 1 The orientation shown in the diagram. Accordingly, the proximal-distal direction is the distribution direction of the proximal and distal ends of the corresponding component, while the circumferential direction is the direction in which the corresponding component surrounds the axis corresponding to the proximal-distal direction.

[0069] like Figure 1-6 As shown, in an embodiment of the present invention, an electrophysiological catheter system with a balloon catheter is provided. Relying on the perfusion orifice and perfusion detection unit distributed on the balloon electrode assembly, when a part of the perfusion orifice is blocked by the target tissue, the perfusion detection unit can detect the perfusion parameters related to the fluid delivery state of the perfusion device and convert the perfusion parameters into a contact pressure signal, thereby facilitating the detection of the contact state between the balloon catheter electrode assembly and the target tissue.

[0070] In some embodiments, based on the above-described detection of contact pressure, the signal acquisition unit acquires electrophysiological signals of the target tissue when the electrode is in contact with the target tissue. Preferably, it acquires the monopolar electrical signals of the target tissue. This can determine which electrodes have already been in contact with the target tissue. The processor is also used to issue a prompt that the electrodes in contact can be ablated when the contact pressure signal meets a set threshold. This helps the operator determine whether the balloon electrode assembly is in the expected contact state with the target tissue, thus ensuring the ablation effect of the electrophysiological catheter system.

[0071] Embodiments of the electrophysiological catheter system in this invention:

[0072] Please refer to Figure 1 In one embodiment, the electrophysiological catheter system includes a balloon catheter 1000, a system host 2000, and an infusion device 3000.

[0073] The balloon catheter 1000 includes an operating handle 100, an insertion tube 200, and a balloon electrode assembly 300, which are connected sequentially from the proximal end to the distal end of the balloon catheter 1000. A cable assembly 110 extends from the operating handle 100 of the balloon catheter 1000, connecting to a system host 2000. The system host 2000 includes a signal acquisition unit 400, a processor 600, and an information output unit 700.

[0074] Those skilled in the art will understand that the operating handle 100 is designed for user gripping and operation, and its specific functions can be designed as needed. The insertion tube 200 is connected to the distal end of the operating handle 100, enabling movement of the balloon electrode assembly 300, and providing a substrate for the installation of corresponding circuits, liquid circuits, and / or gas circuits, allowing these circuits, liquid circuits, and / or gas circuits to connect to the balloon electrode assembly 300 via the operating handle 100. Figure 2 The balloon electrode assembly 300 includes a balloon body 310 and electrodes 320. The balloon body 310 is used to inflate when fluid is introduced and to contract when fluid is discharged. The electrodes 320 are disposed on the surface of the balloon body 310 and can follow the inflation and contraction of the balloon body 310. When the balloon body 310 is inflated, by adjusting the position of the balloon electrode assembly 300, the electrodes 320 can be brought into contact with the target tissue 800, such as the myocardium causing atrial fibrillation, thereby realizing the conduction of electrical energy.

[0075] Furthermore, those skilled in the art should know that the balloon electrode assembly 300 of the present invention can be made of polymer materials such as nylon, PEBAX, PET, and polyurethane, and is flexible, capable of being filled with fluids such as liquids or gases, and contracting when the fluids are discharged; when the balloon 310 is filled, it can generate tension and form a corresponding shape, such as a sphere, an ellipsoid, or other desired shape; when the balloon 310 contracts, the balloon electrode assembly 300 transforms into a cylindrical structure, facilitating entry and exit from the sheath.

[0076] Electrode 320 is used to adhere to target tissue 800 and deliver ablation energy to target tissue 800. Electrode 320 can be located on flexible circuit board 330, which is attached to the outer surface of capsule 310. The number of flexible circuit boards 330 can be set as needed. For example... Figure 2 and Figure 4As shown, the capsule 310 has six flexible circuit boards 330, namely a first flexible circuit board 331, a second flexible circuit board 332, a third flexible circuit board 333, a fourth flexible circuit board 334, a fifth flexible circuit board 335, and a sixth flexible circuit board 336. Each flexible circuit board 330 is distributed circumferentially around the capsule 310. Each flexible circuit board 330 has a distal electrode 321 and a proximal electrode 322, located on the distal and proximal sides of the capsule 310, respectively. Specifically, the first flexible circuit board 331 has a first distal electrode and a first proximal electrode; the second flexible circuit board 332 has a second distal electrode and a second proximal electrode; the third flexible circuit board 333 has a third distal electrode and a third proximal electrode; the fourth flexible circuit board 334 has a fourth distal electrode and a fourth proximal electrode; the fifth flexible circuit board 335 has a fifth distal electrode and a fifth proximal electrode; and the sixth flexible circuit board 336 has a sixth distal electrode and a sixth proximal electrode.

[0077] The flexible circuit board 330 can be fixed to the capsule 310 by any feasible method, such as bonding or thermoforming, and can deform with the capsule 310 to take on the desired shape to contact the target tissue 800. When the capsule 310 is fully inflated, it has a large outer surface area, which allows it to support a large area of ​​electrode 320 and position the electrode 320 circumferentially around the capsule 310. Please refer to [reference needed]. Figures 2 to 4 The distal electrode 321 has its proximal end located at the axial midpoint of the capsule 310 and its distal end located at the distal end of the capsule 310. The proximal electrode 322 has its distal end located at the axial midpoint of the capsule 310 and its proximal end located at the proximal end of the capsule 310. Electrodes 320 with the above structure can achieve a larger target tissue contact area.

[0078] Please refer to Figure 5 In some embodiments, the balloon electrode assembly 300 may include a distal connector 360 to which the distal end of the balloon body 310 is fixed; the balloon electrode assembly 300 also includes a drive rod 340 connected to the distal connector 360 and located on the proximal side of the distal connector 360, the drive rod 340 being used to drive the distal connector 360 to move in a proximal direction to adjust the shape of the balloon body 310. For example, pushing the drive rod 340 distally can increase the axial (i.e., proximal-distal) dimension of the balloon body 310, while moving the drive rod 340 proximally can decrease the axial dimension of the balloon body 310. In one specific embodiment, the drive rod 340 may pass through the insertion tube 200, with its distal end located in the balloon body 310 and its proximal end connected to a drive component on the operating handle 100.

[0079] Those skilled in the art will understand that, in some embodiments, such as Figure 5As shown, an infusion channel 210 is formed between the inner wall of the insertion tube 200 and the outer peripheral surface of the drive rod 340. The infusion channel 210 communicates with the inner cavity of the capsule 310 to deliver fluid (such as...) to the capsule 310. Figure 5 (As shown in the dotted filling). The drive rod 340 can be a solid rod or a hollow rod. When a hollow rod is used, fluid can also be transported through the drive rod 340. In addition, the drive rod 340 is not a necessary structure and can be omitted. The shape of the capsule 310 can be changed simply by filling or discharging fluid.

[0080] The infusion device 3000 includes an infusion pump 901 and an infusion detection unit 902. The infusion pump 901 is connected to the infusion channel 210 to deliver fluid to the infusion channel 210. The infusion detection unit 902 is used to detect the infusion parameters of the infusion device 3000 related to the fluid delivery status.

[0081] Those skilled in the art should understand that, in some specific embodiments, the perfusion pump 901 can be a peristaltic pump, a syringe pump, or a plunger pump, etc., and the specific type is not limited. The detection object of the perfusion detection unit 902 can be determined according to the perfusion parameters being tested. For example, the perfusion parameters may include perfusion flow rate, perfusion fluid pressure, or perfusion velocity. The corresponding perfusion detection unit 902 can be a flow detection unit, a pressure detection unit, or a velocity detection unit. In some specific embodiments, the flow detection unit, pressure detection unit, and velocity detection unit can be a flow sensor, a pressure sensor, and a velocity sensor, respectively. The specific structure of these sensors can refer to existing structures in related technologies. Considering that they are not directly related to the innovative content and technical problem to be solved in this application, they will not be described in detail here.

[0082] It should be noted that the infusion device 3000 can operate in a constant flow mode, where the infusion pump 901 maintains a constant, preset flow rate. Regardless of changes in the resistance of the infusion path, the system will overcome the resistance within the operating capacity of the infusion pump 901 to ensure a constant flow rate. In constant flow mode, the infusion detection unit 902 can detect the infusion fluid pressure. In some embodiments, the infusion device 3000 can also operate in a constant pressure mode, where the infusion pump 901 maintains a constant, preset pumping pressure, and the infusion flow rate fluctuates with changes in the resistance of the downstream infusion path. In constant pressure mode, the infusion detection unit 902 can detect either the infusion flow rate or the infusion velocity. During ablation and when the infusion detection unit 902 acquires infusion parameters, the infusion device 3000 can operate in the same mode or in different modes.

[0083] The infusion pump 901 and the balloon catheter 1000 can be connected via an infusion connecting tube 903. The location of the infusion detection unit 902 is not limited; for example, it can be installed on the pump body of the infusion pump 901 or on the infusion connecting tube 903. The infused fluid is an infusion solution, such as physiological saline, which can be contained in a physiological saline bag 904 to ensure a continuous supply of physiological saline.

[0084] The surface of the balloon electrode assembly 300 is provided with perfusion holes 350, which communicate with the inner cavity of the balloon body 310 to allow fluid to drain from the balloon electrode assembly 300. The perfusion holes 350 can be used to deliver physiological saline to the area surrounding the balloon electrode assembly 300, providing a cooling effect during ablation. In some embodiments, the perfusion holes 350 are distributed on the electrode 320. When the electrode 320 is in contact with the target tissue 800, the perfusion holes 350 are blocked by the target tissue 800, indicating that the electrode 320 is in contact with the target tissue 800. When the electrode 320 is not in contact with the target tissue 800, the perfusion parameters are not affected by the blockage of the perfusion holes 350 by the target tissue 800. In some specific embodiments, the perfusion holes 350 can be evenly distributed on the surface of the balloon body 310, allowing the target tissue 800 to block the perfusion holes 350 regardless of whether the electrode 320 is in contact with the target tissue 800. In other specific embodiments, the infusion holes 350 may be simultaneously distributed in the capsule 310 and the electrode 320. Please refer to... Figures 2 to 4 In some embodiments, the injection holes 350 are distributed along the edge of the electrode 320, which helps to reduce the impact on the area and electric field of the electrode 320. Those skilled in the art will understand that the distribution spacing and arrangement structure of the injection holes 350 can be designed as needed to meet the requirements for obtaining injection parameters. For example, the injection holes 350 are distributed in a row along the edge of the electrode 320, and the distribution spacing can be 0.5 to 3 mm.

[0085] Figure 5 The arrows in the diagram indicate the process of fluid being discharged through the infusion channel 210, the capsule 310, and the infusion hole 350 within the insertion tube 200. Figure 6 The arrow in the image indicates the process of fluid being discharged through injection hole 350.

[0086] It should be noted that the aforementioned balloon catheter 1000 can be a pulsed electric field ablation (PFA) catheter or a radiofrequency ablation (RF) catheter. The main structures of the aforementioned operating handle 100, insertion tube 200, balloon body 310, electrode 320, distal connector 360, and drive rod 340 can refer to existing structures in related technologies. Considering that they are not directly related to the innovative content and technical problem to be solved in this invention, they will not be described in detail here. Of course, in some embodiments, the balloon catheter 1000 with the perfusion port 350 in this application can also be a mapping catheter, and the corresponding electrophysiological catheter system can be a mapping system. For the ablation catheter, the better the contact between the electrode 320 and the target tissue 800, the deeper the ablation foci, the greater the possibility of achieving pulmonary vein isolation, and it also helps to avoid the formation of air bubbles, thereby avoiding air embolism. While pulsed electric field ablation (PFA) technology has lower requirements for catheter-to-myocardial tissue contact (compared to traditional radiofrequency ablation), the lack of real-time contact indication can still lead to physicians being unable to accurately determine the contact status between electrode 320 and target tissue 800. Contact status includes whether there is contact and the contact pressure. Furthermore, because the atrial wall of a diseased heart often has fibrotic changes and a smooth surface structure, there is a risk of catheter displacement during the procedure, preventing the formation of continuous transmural damage in the pre-designed ablation area and directly affecting the ablation success rate. For mapping catheters, adequate contact between electrode 320 and target tissue 800 can improve the quality of local potential acquisition and spatial positioning accuracy, thereby improving the accuracy of three-dimensional model construction of the cardiac chamber. It should be noted that the balloon catheter 1000 with perfusion port 350 in this application can also be other types of electrophysiological catheters, which will not be elaborated here.

[0087] In some embodiments, the processor 600 is used to acquire perfusion parameters and convert the perfusion parameters into contact pressure signals. Those skilled in the art will understand that the method of converting perfusion parameters into contact pressure signals is not limited. For example, based on the number of perfusion orifices 350, the impact of blocked perfusion orifices 350 on fluid flow rate can be calculated proportionally. Alternatively, based on the distribution location of the perfusion orifices 350, before using the balloon catheter 1000, the contact pressure corresponding to the blocking of different locations and numbers of perfusion orifices 350 can be experimentally calibrated to establish a mapping relationship or generate a fitting formula. The fitting formula is stored in the processing device, and when using the balloon catheter 1000, the corresponding contact pressure signal is obtained based on the detected perfusion parameters through the mapping relationship or fitting formula.

[0088] In some embodiments, the electrophysiological catheter system further includes a signal acquisition unit 400.

[0089] The signal acquisition unit 400 is connected to the electrode 320 to acquire the monopolar electrical signal of the target tissue 800 when the electrode 320 is in contact with the target tissue 800. The processor 600 is connected to the perfusion detection unit 902 and the signal acquisition unit 400, and is used to determine which electrodes 320 have already been in contact with the target tissue 800 based on the acquired monopolar electrical signals. By identifying the electrodes 320 that have been in contact through the signal acquisition unit 400, and by processing the perfusion parameters detected by the perfusion detection unit 902 to obtain the contact pressure signal, more contact information of the balloon catheter 1000 is obtained, thereby facilitating the detection of the contact state between the balloon catheter 1000 electrode 320 assembly and the target tissue 800.

[0090] In some embodiments, the contact pressure signal includes a contact pressure value. The processor 600 is further configured to preset a contact pressure threshold to a set threshold, and when the contact pressure value meets the set threshold, issue a prompt that the contacted electrode 320 is ready to operate. The preset contact pressure threshold is used to define the conditions under which the catheter electrode assembly and the target tissue achieve a stable contact state. When this condition is met, the catheter can start electrophysiological work. This setting can prevent the electrode 320 from starting when the contact state is poor, thereby reducing the adverse risks caused by insufficient contact. For example, for ablation catheters, more sufficient contact can prevent the electrode 320 from releasing energy when the contact state is poor, resulting in insufficient ablation and / or electrolysis of blood and generation of microbubbles; for mapping catheters, more sufficient contact can avoid problems such as local electrophysiological signal distortion, enhanced far-field interference, and modeling or timing misjudgment caused by electrode 320 floating.

[0091] Those skilled in the art will understand that the contact pressure threshold (i.e., the set threshold) can be set according to different tissue environments, electrode assembly compliance, and operating strategies. In some specific embodiments, the set threshold for the ablation catheter may include: a contact pressure value P of 60 < P ≤ 130 mmHg, which is beneficial for adapting to pressure fluctuations caused by heartbeat; the set threshold may also include: a contact pressure value P > 100 mmHg lasting for more than 3 seconds, reflecting a relatively stable contact between the electrode 320 and the target tissue 800. Obviously, the above set thresholds are beneficial for more accurately reflecting that an effective and stable contact has been formed between the balloon electrode assembly 300 and the target tissue 800. Under appropriate conditions, performing ablation at this time will help ensure the ablation effect. In some specific embodiments, the set threshold for the mapping catheter may include a contact pressure value P of 40 < P ≤ 60 mmHg. Starting mapping at this time will help ensure the accuracy of model construction.

[0092] Simultaneously, for the signal acquisition unit 400, when the electrode 320 is in contact with the target tissue 800, it can acquire the monopolar electrical signal of the target tissue 800. Those skilled in the art will understand that the monopolar electrical signal can form a circuit between the probe electrode 320 (which can be used as a probe electrode 320) and a reference electrode 320 (usually located far from the heart, such as on the body surface or in a large chamber within the heart). It primarily reflects the depolarization and repolarization process of the myocardium in a very small area directly below the probe electrode 320, facilitating the user to locate the earliest activation point and precisely position the ablation target by moving the catheter. Since the amplitude and waveform of the monopolar electrical signal when the electrode 320 is in contact with the target tissue 800 differ significantly from when it is not in contact with the target tissue 800 (which is nearly flat), it is beneficial for accurately reflecting whether the electrode 320 is in contact with the target tissue 800. The electrophysiological catheter system may include an information output unit 700, which transmits information to the user about which electrodes 320 have been attached to the target tissue 800. For example, the information output unit 700 may be a display that marks the electrodes 320 that have been attached to the target tissue 800 with different colors on the balloon electrode assembly 300 model. The processor 600 may also be used to determine the attachment position of the electrodes 320 by the amplitude and waveform of the monopolar electrical signal, thereby enabling precise ablation of the ablation target.

[0093] like Figure 7 As shown, when the first distal electrode 321 and the first proximal electrode 322 are in contact with the target tissue 800, while the other electrodes 320 are not in contact with the target tissue 800, the unipolar electrical signals collected by the first distal electrode 321 and the first proximal electrode 322 will show significant differences.

[0094] In some specific embodiments, it can also be determined manually which electrodes 320 have affixed to the target tissue 800. Specifically, the electrophysiological catheter system may include a signal processing unit 500 and an information output unit 700. The signal processing unit 500 can process monopolar electrical signals and determine which electrodes 320 have affixed to the target tissue 800 based on the monopolar electrical signals. The information output unit 700 is used to transmit this information about which electrodes 320 have affixed to the target tissue 800 to the user. The signal processing unit 500 may be a processor 600, and the information output unit 700 may be a display.

[0095] It should be noted that those skilled in the art will understand that, in the ablation mode, the discharge of electrode 320 can take different forms. For example, it can be a discharge between two electrodes 320 arranged in pairs along the proximal-distal direction, a discharge between two adjacent electrodes 320 along the circumferential direction, or an oblique discharge between one of the distal electrodes 321 and a proximal electrode 322 located in a circumferentially adjacent position.

[0096] In other embodiments, the signal acquisition unit 400 and / or the signal processing unit 500 may be integrated into the system host 2000 or may be independent units separate from the system host 2000. The system host 2000 itself may be primarily used to control the ablation energy supply of the electrode 320; it may also be used to acquire and process the electrophysiological signals of the mapping catheter to achieve control of cardiac chamber model reconstruction and electrical activity analysis.

[0097] It should be noted that those skilled in the art should understand that in the electrophysiological catheter system of the present invention, the shape of the electrophysiological catheter depends on the shape of the substrate to which the flexible circuit board in the electrode assembly is attached, such as... Figures 1-6 As shown in some embodiments of the present invention, the substrate to which the flexible circuit board is attached is a spherical balloon, thus the electrophysiological catheter as a whole is a balloon catheter, and the corresponding electrode assembly is a spherical electrode assembly. In other embodiments, the electrophysiological catheter of this application may also adopt other inflatable and deformable structural forms, such as petal-shaped or umbrella-shaped structures, mesh-supported structures, tapered bulging structures, hydraulically bendable flexible segments, ring-shaped or sleeve-shaped filling structures, and segmented multi-cavity structures, etc. The above structures can all be unfolded, expanded, or have their shape changed by corresponding driving structures to adapt to the inner wall morphology of different target tissues, achieve stable contact, improve the contact quality between the electrode and the tissue, and promote the effectiveness of energy release or signal acquisition; it can also achieve perfusion through the perfusion holes provided in the electrode assembly. Through controllable filling and deformation, the electrophysiological catheter can achieve better operational stability and treatment accuracy under ablation and / or mapping, thereby improving the overall treatment effect. In use, fluid is delivered to the electrode assemblies with different structural forms through the infusion device. When the electrode assembly comes into contact with the target tissue, the infusion parameters of the infusion device related to the fluid delivery state will change. The infusion detection unit can detect the infusion parameters and then the processor converts the infusion parameters into a contact pressure signal, which facilitates the detection of the contact state between the catheter electrode assembly and the target tissue.

[0098] like Figure 8 As shown, based on the above-mentioned electrophysiological catheter, embodiments of the present invention also provide a method for detecting the degree of contact between the electrophysiological catheter and the catheter, comprising the following steps:

[0099] S1. Fluid is delivered to the electrode assembly 300 of the electrophysiological catheter;

[0100] S2. Place the electrode assembly 300 of the electrophysiological catheter against the target tissue 800 and detect the perfusion parameters of the fluid.

[0101] S3. Obtain the infusion parameters and convert them into a contact pressure signal;

[0102] S4. Determine the contact state between the electrode assembly 300 and the target tissue 800 based on the change in the contact pressure signal.

[0103] In some specific embodiments, the electrophysiological catheter is specifically an ablation catheter. When the contact pressure value P is 60 < P ≤ 85 mmHg, the contact state between the balloon catheter 1000 electrode 320 assembly and the target tissue 800 can be determined to be slight contact; when the contact pressure value P is 85 < P ≤ 120 mmHg, the contact state between the balloon catheter 1000 electrode 320 assembly and the target tissue 800 can be determined to be stable contact; when the contact pressure value P is P > 130 mmHg, the contact state between the balloon catheter 1000 electrode 320 assembly and the target tissue 800 can be determined to be excessive contact.

[0104] The above examples illustrate the present invention only to aid in understanding it and are not intended to limit the scope of the invention. Those skilled in the art can make various simple deductions, modifications, or substitutions based on the principles of this invention.

Claims

1. An electrophysiological catheter system, characterized in that, include: An electrophysiological catheter is provided with a perfusion channel and an electrode assembly. The electrode assembly is used to adhere to the target tissue and perform electrophysiological work. The perfusion channel is connected to the inner lumen of the electrophysiological catheter. The surface of the electrode assembly is distributed with perfusion holes, which are connected to the inner lumen of the electrophysiological catheter. An infusion device is connected to the infusion channel. The infusion device is equipped with an infusion detection unit. Fluid is delivered to the infusion channel through the infusion device and discharged from the electrode assembly through the infusion hole. The infusion parameters of the fluid are detected by the infusion detection unit. The system includes a processor electrically connected to the electrophysiological catheter, which acquires the perfusion parameters and converts them into contact pressure signals.

2. The electrophysiological catheter system as described in claim 1, characterized in that, The infusion device is equipped with an infusion pump, which is connected to the infusion channel to deliver fluid to the infusion channel.

3. The electrophysiological catheter system as described in claim 1, characterized in that, The infusion parameters include infusion flow rate, infusion fluid pressure, or infusion velocity.

4. The electrophysiological catheter system as described in claim 1, characterized in that, The electrophysiological catheter is a balloon catheter, and the electrode assembly is a balloon electrode assembly. The balloon catheter includes the balloon electrode assembly and an insertion tube. The balloon electrode assembly includes a balloon body and electrodes. The balloon body is used to inflate when fluid is introduced and to contract when fluid is expelled. The electrodes are disposed on the surface of the balloon body. The surface of the balloon electrode assembly has perfusion holes that communicate with the inner lumen of the balloon body to allow fluid to be expelled from the balloon electrode assembly. The distal end of the insertion tube is connected to the proximal end of the balloon electrode assembly, and the insertion tube has a perfusion channel that communicates with the inner lumen of the balloon body.

5. The electrophysiological catheter system as described in claim 4, characterized in that, The injection holes are distributed on the electrode.

6. The electrophysiological catheter system as described in claim 5, characterized in that, The injection holes are distributed along the edge of the electrode.

7. The electrophysiological catheter system as described in claim 4, characterized in that, The balloon electrode assembly includes flexible circuit boards arranged at intervals along the circumference of the balloon body. The electrodes on each flexible circuit board include a distal electrode and a proximal electrode, which are located on the distal side and the proximal side of the balloon body, respectively.

8. The electrophysiological catheter system as described in claim 7, characterized in that, The distal electrode and the proximal electrode on the same flexible circuit board are both one.

9. The electrophysiological catheter system according to any one of claims 1 to 8, characterized in that, It also includes a signal acquisition unit, which is electrically connected to the electrophysiological catheter and is used to acquire the electrophysiological signals of the target tissue when the electrode assembly is in contact with the target tissue.

10. The electrophysiological catheter system as described in claim 9, characterized in that, The processor is also used to determine, based on the electrophysiological signals, which electrodes on the electrode assembly are already attached to the target tissue.

11. The electrophysiological catheter system as described in claim 9, characterized in that, The processor is also used to determine the contact position of the electrode assembly based on the amplitude and waveform of the electrophysiological signal.

12. The electrophysiological catheter system according to any one of claims 1 to 8, characterized in that, The contact pressure signal includes a contact pressure value. The processor is also used to preset a contact pressure threshold as a set threshold. When the contact pressure value meets the set threshold, a prompt is issued that the contact electrode can perform the electrophysiological work.

13. The electrophysiological catheter system according to any one of claims 1 to 8, characterized in that, It also includes a signal processing unit and an information output unit. The signal processing unit is used to process monopolar electrical signals and determine which electrodes on the electrode assembly have been attached to the target tissue based on the electrophysiological electrical signals. The information output unit is used to transmit the information of the attached electrodes to the user.

14. The electrophysiological catheter system according to any one of claims 1 to 8, characterized in that, The electrophysiological work includes ablation and / or mapping.

15. The electrophysiological catheter system according to any one of claims 1 to 8, characterized in that, The electrophysiological catheter is an ablation catheter and / or a mapping catheter, and the corresponding electrophysiological catheter system is an ablation system and / or a mapping system.

16. A method for detecting the degree of contact between electrophysiological catheters, characterized in that, include: S1. Fluid is delivered to the electrode assembly of the electrophysiology catheter; S2. Place the electrode assembly of the electrophysiological catheter against the target tissue and detect the perfusion parameters of the fluid; S3. Obtain the infusion parameters and convert the infusion parameters into a contact pressure signal; S4. Determine the contact state between the electrode assembly and the target tissue based on the change in the contact pressure signal.

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