Ablation catheter and electrode dislocation identification method thereof

Abstract

The invention discloses an ablation catheter and an electrode dislocation identification method thereof, and relates to the technical field of pulse field ablation. The expandable assembly is arranged at the far end of the catheter shaft, and the expandable assembly can be driven by the catheter shaft to a designated position in a contraction state and then switched to an expansion state; each electrode assembly comprises an electrode body and a base layer which are fixedly connected, the electrode body is exposed out of the base layer, and a contrast agent is uniformly dispersed in the material of the base layer. According to the electrode assembly, the base layer is arranged on the inner side wall of the electrode body, and the contrast agent is uniformly dispersed in the material of the base layer, so that during X-ray fluoroscopy, an operator can be assisted to clearly observe the form of the electrode body and accurately judge whether the electrode assembly and the expandable assembly are continuously attached or not, the expandable assembly is prevented from being dragged into a sheathing canal rationally, and the working efficiency is improved. Even if the electrode assembly is separated from the expandable assembly, the electrode assembly cannot be further physically damaged, and the condition that electrode fragments are left in the heart cavity is effectively prevented.

Description

Technical Field

[0001] The present invention relates to the technical field of pulsed field ablation, and in particular to an ablation catheter and an electrode dislocation identification method thereof. Background Art

[0002] Pulsed field ablation is a new non-thermal ablation method that selectively targets the myocardium and can significantly reduce the risk of collateral damage associated with thermal ablation. The ablation electrode is the core component of pulsed field ablation.

[0003] Currently, in electrode manufacturing solutions, electrodes need to be attached to the surface of an expandable component. However, since the electrodes will experience expansion, contraction, and extrusion of the expandable component during placement, as well as being affected by factors such as high temperatures during treatment, failure to promptly identify whether the electrodes are debonding, shifting, or even falling off the expandable component during use will pose serious hidden dangers.

[0004] In existing technologies, electrodes are made of a certain hardness. To ensure smooth passage of the ablation catheter within the sheath, the electrodes need to be designed to be very thin. Even when using materials with good imaging properties, it is still difficult to clearly see the electrodes attached to the surface of the expandable assembly under X-ray fluoroscopy, making it difficult to determine whether the electrodes have detached from the expandable assembly. If the expandable assembly is rashly inserted into the sheath and then dragged, it is likely to cause further physical damage to the electrodes, or even produce electrode fragments that could be left in the cardiac cavity, posing a life-threatening risk to the patient. Therefore, we propose an ablation catheter and its associated electrode dislocation detection method to address these challenges and provide safer clinical support. Summary of the Invention

[0005] The purpose of the present invention is to provide an ablation catheter and a method for identifying electrode dislocation thereof, which solves the technical problem that it is difficult to clearly see the status of the electrodes attached to the surface of the expandable component of the existing ablation catheter under X-ray fluoroscopy. If the expandable component is rashly placed into the sheath and dragged, it is likely to cause further physical damage to the electrode and even produce electrode fragments that are left in the heart cavity, posing a life risk to the patient.

[0006] To achieve the above objectives, the present invention provides an ablation catheter, comprising:

[0007] a catheter shaft, wherein the proximal end of the catheter shaft is used for placement outside the body, and the distal end of the catheter shaft is used for intervention into tissue;

[0008] An expandable component is provided at the distal end of the catheter shaft, the expandable component including an expanded state and a contracted state, and the expandable component can be driven by the catheter shaft to a specified position in the contracted state and then switched to the expanded state;

[0009] There are several electrode assemblies, and the electrode assemblies are arranged in an array on the circumferential side of the expandable component. The electrode assembly includes an electrode body and a base layer that are fixedly connected. The electrode body is exposed on the base layer, and the base layer is adhered to the outer wall of the expandable component, and the contrast agent is evenly dispersed in the material of the base layer.

[0010] In some embodiments, the expandable component is made of a material containing a contrast agent, and the mass percentage of the contrast agent in the material of the expandable component is lower than the mass percentage of the contrast agent in the material of the base layer, so that the expandable component and the electrode component have different development intensities when irradiated by X-rays.

[0011] In some embodiments, the base layer is made of a mixture of a contrast agent and an organic polymer compound with insulating properties, the organic polymer compound is at least one of PI or PET, and the mass percentage of the organic polymer compound in the material of the base layer is 62% to 91%, and the mass percentage of the contrast agent in the material of the base layer is 9% to 38%; the expandable component is made of a mixture of a contrast agent and one or more materials of Nylon, Pebax, TPU, and PET, and the mass percentage of the contrast agent in the material of the expandable component is 1%-8%.

[0012] In some embodiments, the proximal end of the expandable component and the distal end of the expandable component are respectively connected to a developing ring, and the material of the developing ring is uniformly dispersed with contrast agent.

[0013] In some embodiments, the proximal end of the electrode assembly is connected to a first petiole, which extends into the interior of the catheter shaft, the distal end of the electrode assembly is connected to a second petiole, the distal end of the expandable assembly is provided with a terminal tube, the second petiole extends into the interior of the terminal tube, and at least one of the first petiole or the second petiole includes a cable electrically connected to the electrode body.

[0014] In some embodiments, the outer surface of the electrode body is composited with a conductive film, the electrode body is made of one of silver and copper, the conductive film is made of one of gold or platinum, and the thickness of the electrode body is not less than 15 μm.

[0015] In some embodiments, the catheter shaft includes a fluid delivery lumen and an inner tube extending axially, the distal end of the outer tube is connected to the proximal end of the expandable assembly, and the distal end of the inner tube is connected to the distal end of the expandable assembly.

[0016] In some embodiments, the expandable component is a balloon, and the catheter shaft further includes a fluid delivery lumen extending axially, the fluid delivery lumen is arranged in the gap between the outer tube and the inner tube, and the distal end of the fluid delivery lumen is connected to the interior of the balloon.

[0017] In some embodiments, the ablation catheter further comprises: a control component, wherein the control component comprises:

[0018] A handle connected to the proximal end of the catheter shaft; a bending adjustment assembly provided on the handle and connected to the distal end of the catheter shaft, the bending adjustment assembly being used to control the bending direction of the distal end of the catheter shaft; a straightening assembly provided on the handle and connected to the proximal end of the inner tube, the straightening assembly being used to push forward or pull back the inner tube to adjust the distance between the proximal and distal ends of the expandable assembly; a mapping catheter interface connected to the inner tube, the mapping catheter interface being used to insert a mapping catheter.

[0019] Accordingly, the technical solution of the present invention further provides a method for identifying electrode dislocation of an ablation catheter, which is applied to any of the electrode assemblies described above, comprising an image recognition device, a processor, and any of the ablation catheters described above, wherein the ablation catheter has a second development feature, and the method comprises:

[0020] The expandable component is in an expanded state; the image recognition device collects an X-ray image of the ablation catheter; the processor obtains the position of the second development feature and the electrode assembly in the X-ray image; the processor uses the degree of overlap and / or relative distance between the electrode assembly and the second development feature as a calculated value, and if the calculated value is greater than a preset threshold, abnormal information is displayed.

[0021] In some embodiments, the second visualization feature is a visualization ring provided at the proximal end and the distal end of the expandable component of the ablation catheter, and / or the second visualization feature is a visualization material within the expandable component.

[0022] Compared with the above background technology, the ablation catheter provided by the present invention has the following beneficial effects: because the electrode body is firmly bonded to the base layer, it is necessary to avoid the separation of the electrode assembly as a whole from the expandable assembly during operation. By adhering the electrode body to the base layer and evenly dispersing the contrast agent in the material of the base layer, the problem of insufficient imaging of the electrode body itself is compensated. During X-ray fluoroscopy, it can assist the operator to clearly and continuously observe the shape and distribution of the electrode assembly, and judge whether there is a separation phenomenon based on the posture relationship between different electrode assemblies, so as to avoid rashly dragging the expandable assembly into the sheath. Even if the electrode assembly is separated from the expandable assembly, it will not be further physically damaged, thereby preventing the electrode fragments from being left in the heart cavity. Even if the electrode assembly is separated from the expandable assembly, the operator will be promptly reminded of the relevant danger based on the position of the electrode assembly relative to the expandable assembly, so that measures can be taken to find or capture and recover the electrode fragments, and prevent the electrode fragments from further flowing from the heart cavity to other parts of the body, which can effectively avoid the risk of stroke or blood vessel blockage and rupture. The electrode dislocation identification method of the ablation catheter used in the present invention also has the above beneficial effects. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are merely embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the provided drawings without paying any creative work.

[0024] Figure 1 A schematic plan view of an ablation catheter provided by an embodiment of the present invention;

[0025] Figure 2 A schematic diagram of the assembly between the expandable component and the electrode component provided in one embodiment of the present invention;

[0026] Figure 3 A schematic diagram of the assembly between an expandable assembly and an electrode assembly provided in another embodiment of the present invention;

[0027] Figure 4 A schematic diagram of the assembly of an expandable assembly and an electrode assembly under X-ray irradiation provided by one embodiment of the present invention;

[0028] Figure 5 A partial cross-sectional schematic diagram of an expandable assembly in an expanded state provided by one embodiment of the present invention;

[0029] Figure 6 A partial cross-sectional schematic diagram of an expandable assembly in an expanded state provided by another embodiment of the present invention.

[0030] Specifically, 1-catheter shaft; 101-fluid delivery cavity; 102-inner tube; 103-outer tube; 2-expandable component; 3-electrode assembly; 301-electrode body; 302-base layer; 303-first petiole; 304-second petiole; 4-end tube; 5-control component; 501-handle; 502-bending adjustment component; 503-straightening component; 504-mapping catheter interface; 505-filling interface; 6-conductive film. DETAILED DESCRIPTION

[0031] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0032] In order to enable those skilled in the art to better understand the scheme of the present invention, the present invention is further described in detail below in conjunction with the accompanying drawings and specific embodiments. For the distal end and proximal end in the specific embodiments, the distal end refers to the part of the corresponding component away from the operator, usually the end where the component enters the patient's body or the surgical area, and the proximal end refers to the part of the corresponding component close to the operator, usually the end held or operated by the operator. For a single component, the end closer to the operator is the proximal end, and the end farther away from the operator is the distal end. In addition, it should be noted that the connection mentioned in this application includes both direct connections between systems, components, and parts, and connections between systems, components, and parts through a medium, that is, indirect connections. Those skilled in the art should not understand this as a limitation but should adapt it according to specific needs, which does not exceed the scope of protection of this application.

[0033] like Figure 1 、 Figure 2 、 Figure 4 and Figure 5 As shown, in order to achieve the above-mentioned purpose, the present invention provides an ablation catheter, comprising: a catheter shaft 1, the proximal end of the catheter shaft 1 is used to be placed outside the body, and the distal end of the catheter shaft 1 is used to intervene in tissue; an expandable component 2 is provided at the distal end of the catheter shaft 1, wherein the expandable component 2 includes an expanded state and a contracted state. It should be noted that the expandable component 2 can be driven to a specified position by the catheter shaft 1 in the contracted state and then switched to the expanded state.

[0034] A plurality of electrode assemblies 3 are arranged in an array on the circumferential side of the expandable component 2. Preferably, 6-12 electrode assemblies 3 are arranged in an array on the circumferential side of the expandable component 2. The electrode assembly 3 includes an electrode body 301 and a base layer 302 that are fixedly connected. The electrode body 301 is exposed on the base layer 302. The base layer 302 is attached to the outer wall of the expandable component 2, and the material of the base layer 302 is uniformly dispersed with contrast agent. Optionally, the base layer 302 extends outward by a certain area relative to the electrode body 301. Specifically, the base layer 302 can be set to an elliptical structure with smooth edges to enhance the development effect of the electrode assembly 3. When the expandable assembly 2 is in its expanded state, under normal operating conditions, the electrodes can be observed under X-rays to be evenly distributed, with an overall spherical, circular, or quasi-circular shape. Specifically, by providing a base layer 302 on the inner sidewall of the electrode body 301 and adding a contrast agent to the material of the base layer 302, preferably, the contrast agent comprises one or more of BaSO4, (BiO)2CO3, Bi2O3, BiOCl, and tungsten. During X-ray fluoroscopy, the surgeon can clearly observe the shape of the electrode body 301 and accurately determine whether the electrode assembly 3 and the expandable assembly 2 remain in contact based on the uniform distribution of the electrode assembly 3. This prevents the expandable assembly 2 from being dragged into the sheath. Even if the electrode assembly 3 detaches from the expandable assembly 2, it will not suffer further physical damage, thereby preventing electrode fragments from being left in the cardiac cavity.

[0035] It should be noted that when the electrode assembly 3 is in a detached state, one or more of the 6-12 electrode assemblies 3 are unevenly distributed on the surface of the expandable assembly 2, such as one or more of the 8-10 electrode assemblies 3 are angularly misaligned; or one or more of the 6-12 electrode assemblies 3 are overall irregularly shaped (such as S-shaped, J-shaped, etc.) rather than arc-shaped; in the case where the electrode assembly 3 is seriously detached from the expandable assembly 2, the electrode assembly 3 and the expandable assembly 2 are completely separated.

[0036] This allows for accurate determination of whether the electrode assembly 3 and expandable assembly 2 remain in close contact, preventing the expandable assembly 2 from being dragged rashly into the sheath and preventing electrode fragments from being left in the cardiac cavity. Furthermore, when the electrode assembly 3 is detached from the expandable assembly 2, the position of the electrode assembly 3 relative to the expandable assembly 2 is used to promptly alert the operator to the dangers involved, allowing them to quickly locate or capture and recover the electrode fragments, preventing them from further dispersing from the cardiac cavity to other parts of the body, effectively avoiding the risk of stroke or blood vessel blockage or rupture.

[0037] In some embodiments of the present invention, expandable assembly 2 is constructed from a material containing a contrast agent. The mass percentage of contrast agent in expandable assembly 2 is lower than that in base layer 302. This allows expandable assembly 2 and electrode assembly 3 to exhibit different imaging intensities when exposed to X-rays, thereby distinguishing the imaging properties of expandable assembly 2 from those of the electrode. This imaging gradient ensures that, during X-ray fluoroscopy, expandable assembly 2 and electrode assembly are clearly spatially distinct, enabling precise assessment of the morphology of electrode body 301 and the relative position of the electrode and expandable assembly 2.

[0038] In some embodiments, an image recognition device is also provided, and developing rings (not shown in the figure) are respectively connected to the proximal end and the distal end of the expandable component 2. The material of the developing rings is evenly dispersed with contrast agent, so that the developing rings are more transparent to X-rays. By collecting X-ray images through the image recognition device, the developing position of the expandable component 2 can be accurately obtained.

[0039] In some embodiments of the present invention, the base layer 302 is made of a mixture of a contrast agent and an organic polymer compound having insulating properties. The organic polymer compound is at least one of PI or PET, wherein both PI and PET are non-metallic materials with high insulation resistance to ensure that they do not affect the normal monitoring operation of the electrode assembly 3. In addition, it should be noted that the mass percentage of the organic polymer compound in the material of the base layer 302 is 62% to 91%, and the mass percentage of the contrast agent in the material of the base layer 302 is 9% to 38%. This allows for precise control of the imaging intensity of the entire base layer 302, and the contrast agent is evenly dispersed in the organic polymer compound, so that the imaging intensity at each position of the base layer 302 remains consistent, thereby enabling a clearer and more complete observation of the position status of the electrode assembly 3.

[0040] In some embodiments of the present invention, the expandable component 2 is made of a mixture of a contrast agent and one or more materials selected from Nylon, Pebax, TPU, and PET. The mass percentage of the contrast agent in the material of the expandable component 2 is 1%-8%. At this time, the mass percentage of the contrast agent in the material of the expandable component 2 is different from the mass percentage of the contrast agent in the material of the base layer 302, thereby ensuring that the expandable component 2 and the electrode component 3 have different development intensities when irradiated by X-rays, thereby enabling the development properties of the expandable component 2 to be different from the development properties of the electrode, further ensuring that the expandable component 2 and the electrode are clearly layered in space, such as Figure 4 As shown, it is possible to more accurately determine whether the electrode assembly 3 is detached from the expandable assembly 2 .

[0041] On the other hand, the mass percentage of the contrast agent in the material of the expandable component 2 is controlled between 1% and 8%, ensuring that not too much contrast agent is mixed into the material of the expandable component 2, so as to reduce the hardness of the expandable component and the distal end of the ablation catheter, thereby improving the passability of the entire ablation catheter in the sheath, and further reducing the probability of the electrode assembly 3 being peeled off from the surface of the expandable component 2 by the inner wall of the sheath.

[0042] like Figure 2 、 Figure 3 and Figure 4 As shown, in some embodiments of the present invention, the proximal end of the electrode assembly 3 is connected to a first petiole 303, which extends from the surface of the expandable assembly to the interior of the catheter shaft 1. The distal end of the electrode assembly 3 is connected to a second petiole 304, and the distal end of the expandable assembly 2 is provided with a terminal tube 4, which extends from the surface of the expandable assembly to the interior of the terminal tube 4. At least one of the first petiole 303 or the second petiole 304 includes a cable (not shown) electrically connected to the electrode body 301. Preferably, the first petiole 303 is electrically connected to the electrode body 301 via the cable to provide the required power to the electrode body 301. On the other hand, by connecting the first petiole 303 to the proximal end of the electrode assembly 3 and the second petiole 304 to the distal end of the electrode assembly 3, the connection force between the electrode assembly 3 and the expandable assembly 2 can be enhanced. Even after the electrode assembly 3 is partially separated from the expandable assembly 2, the first petiole 303 can still be connected to the catheter shaft 1, and the second petiole 304 can still be connected to the terminal tube 4. The electrode assembly 3 will not fall directly into the heart and cause adverse events such as thrombosis and blood vessel blockage, thereby further avoiding the risk of stroke or blood vessel blockage or rupture. Specifically, Figure 3 The proximal end of the middle electrode assembly 3 is connected to a first petiole 303, and the distal end of the electrode assembly 3 is connected to a second petiole 304. The base structure is not shown. It is understood that in other embodiments, only the proximal end of the electrode assembly 3 may be connected to the first petiole 303, while the distal end of the electrode assembly 3 may not be provided with the second petiole 304. This improves the connection security of the electrode assembly while also taking into account the flexibility of the distal end of the catheter and reducing the resistance caused by the second petiole during entry and exit of the sheath.

[0043] In some embodiments, the imaging ring at the distal end of the expandable assembly 2 can be used directly as the terminal tube 4. Specifically, the imaging ring and the terminal tube 4 are the same component, and the second petiole 304 extends into the interior of the imaging ring, thereby reducing the volume of the ablation catheter and optimizing the overall ablation catheter structure. Alternatively, the imaging ring at the distal end of the expandable assembly 2 can be positioned on the inner sidewall of the terminal tube 4, primarily to ensure precise imaging of the distal end of the expandable assembly 2.

[0044] In some embodiments of the present invention, the outer surface of the electrode body 301 is composited with a conductive film 6, such as Figure 6 As shown, the electrode body 301 is made of one of silver and copper, and the conductive film 6 is made of one of gold or platinum. This reduces the manufacturing cost of the entire electrode assembly 3. Furthermore, gold or platinum has better developability and corrosion resistance than copper. The conductive film 6 serves as the primary conductive medium to enhance the conductivity of the electrode assembly 3, thereby improving the performance of the electrode assembly without affecting its electrical properties. It should be noted that the thickness of the electrode body 301 is no less than 15 μm, and the base layer 302 and the expandable assembly 2 are bonded together with glue, thereby ensuring that the electrode assembly 3 has both good conductivity and developability.

[0045] In some embodiments of the present invention, the catheter shaft 1 includes an outer tube 103 and an inner tube 102 extending along the axial direction, the distal end of the outer tube 103 is connected to the proximal end of the expandable component 2, and the distal end of the inner tube 102 is connected to the distal end of the expandable component 2, so as to structurally facilitate the regulation of the relative telescopic relationship between the inner tube 102 and the outer tube 103, adjust the expandable component to an expanded state or a contracted state, and facilitate the control of the expandable component in and out of the sheath.

[0046] In some embodiments of the present invention, the expandable component 2 is a balloon, and the catheter shaft 1 further includes an axially extending fluid delivery lumen 101 disposed in the gap between the outer tube 103 and the inner tube 102. The distal end of the fluid delivery lumen 101 communicates with the interior of the expandable component 2. Filling medium can be introduced into or withdrawn from the expandable component 2 through the fluid delivery lumen 101, thereby flexibly controlling the expansion and contraction of the expandable component 2. Furthermore, a filling port 505 is provided on the handle 501, communicating with the fluid delivery lumen 101. Filling port 505 allows for the introduction and withdrawal of filling medium from the fluid delivery lumen 101.

[0047] It should be noted that the inner tube 102 is located in the fluid delivery cavity 101, and the distal end of the inner tube 102 is connected to the distal end of the expandable component 2. In the initial state, the terminal tube 4 and the distal end of the inner tube 102 are far away from each other. At this time, the expandable component 2 is in a stretched state, and the expandable component 2 fits the outer wall of the inner tube 102, so that the expandable component 2 is convenient to withdraw into the matching sheath or extend from the sheath. When the expandable component 2 needs to be expanded, the inner tube 102 is pulled back to make the terminal tube 4 and the distal end of the inner tube 102 close to each other, so that the proximal end and the distal end of the expandable component 2 are close to each other. At this time, the filling medium is input into the expandable component 2 through the fluid delivery cavity 101, which can control the expandable component 2 to expand to a spherical shape. At this time, since 8-10 electrode assemblies 3 are evenly distributed on the surface of the expandable component 2, the multiple electrode assemblies 3 are enclosed as a whole to present a spherical shape.

[0048] Some embodiments of the present invention further include: a control component 5, which includes: a handle 501 arranged at the proximal end of the catheter shaft 1, a bending adjustment component 502 arranged on the handle 501, and the bending adjustment component 502 is connected to the distal end of the catheter shaft 1. The bending direction of the distal end of the catheter shaft 1 can be controlled by the bending adjustment component 502 to accurately adjust the orientation position of the expandable component 2 to reach the target tissue position.

[0049] In some embodiments, a straightening component 503 is provided on the handle 501, and the straightening component 503 is connected to the proximal end of the inner tube 102. The inner tube 102 can be pushed forward or pulled back by the straightening component 503 to adjust the distance between the proximal end and the distal end of the expandable component 2. That is, by pushing the inner tube 102 forward or pulling back by the straightening component 503, the proximal end and the distal end of the expandable component 2 can be moved away from or closer to each other.

[0050] In some embodiments, a mapping catheter interface 504 is provided on the handle 501 , the mapping catheter interface 504 is connected to the inner tube 102 , and the mapping catheter is passed through the mapping catheter interface 504 .

[0051] In another aspect, the present invention further includes a method for identifying electrode dislocation of an ablation catheter, comprising an image recognition device (not shown), a processor (not shown), and the aforementioned ablation catheter, wherein the ablation catheter has a second imaging feature. The method comprises:

[0052] When the expandable component 2 is in the expanded state;

[0053] The image recognition device collects X-ray images of the ablation catheter;

[0054] The processor obtains the position of the second imaging feature and the electrode assembly in the X-ray image;

[0055] The processor uses the overlap degree and / or relative distance between the electrode assembly and the second development feature as a calculated value, and displays abnormal information if the calculated value is greater than a preset threshold.

[0056] The above method uses an ablation catheter to automatically identify or compare electrodes, alerting the operator to potential electrode assembly detachment, enhancing intraoperative awareness of electrode attachment and assisting the operator in deciding whether to abort or continue the ongoing procedure. It is understood that this method is intended to assist the operator in making decisions. Upon receiving abnormal information and combining it with X-ray images, the operator can independently assess, based on experience or the actual situation, whether the abnormality is indeed detachment. Alternatively, the operator can adjust the X-ray direction and re-evaluate and make a comprehensive decision based on this method.

[0057] In some embodiments, the second visualization feature is a visualization ring provided at the proximal and distal ends of the expandable assembly of the ablation catheter, and / or the second visualization feature is a visualization material within the expandable assembly. These features are used to further enhance the operator's understanding of the adhesion between the expandable assembly and the electrode assembly, providing a benchmark for calculation based on the contour or distribution, or providing a basis for judgment by the operator.

[0058] In some embodiments, the processor uses the overlap degree and / or relative distance between the electrode assembly 4 and the second development feature as a calculated value, wherein obtaining the calculated value of the relative distance may specifically include:

[0059] According to the preset size information of the expandable component 2 in the expanded state, an X-ray image is collected by an image recognition device to obtain the development position of the electrode assembly 3 and the development ring, and the center position of the expandable component 2 is determined. According to the pre-set setting that several electrode assemblies 3 are distributed at the same latitude of the expandable component 2 and the spacing between two adjacent electrode assemblies 3 is equal under ideal working conditions, the deflection azimuth of the expandable component 2 is calculated in combination with the center position of the expandable component 2 and the development positions of several electrode assemblies 3; several electrode bodies 301 are numbered, and the development position information of several electrode assemblies 3 is accurately matched with the position information of each position at the corresponding latitude on the surface of the expandable component 2, and a specific electrode assembly 3 with an error greater than a preset threshold is identified, and its abnormal information is extracted, and at the same time, the position of the electrode assembly 3 and the number of the electrode assembly 3 corresponding to the abnormal information are clearly displayed.

[0060] In some embodiments, the processor uses the degree of overlap and / or relative distance between the electrode assembly 3 and the second development feature as a calculated value, wherein obtaining the calculated value of the degree of overlap may specifically include: enhancing the contrast of the image (optional step), extracting the areas of the electrode assembly 3 and the expandable assembly 2 respectively, extracting the portion of the electrode assembly 3 covered by the expandable assembly 2 (overlapping area) or the uncovered portion (non-overlapping area), calculating the ratio of the extracted portion to the total display area of ​​the electrode assembly 3, and comparing the ratio with a preset threshold value, identifying a specific electrode assembly 3 whose error is greater than the preset threshold value, extracting its abnormal information, and clearly displaying the position of the electrode assembly 3 and the number of the electrode assembly 3 corresponding to the abnormal information.

[0061] Furthermore, both the overlap degree and the relative distance can be used as calculated values. The aforementioned preset thresholds can be set by the operator based on experience or needs, or can be preset. For example, the preset thresholds for the overlap degree can be 60% or 70%, and the preset thresholds for judging the relative distance error can be balloon diameter * 0.4 or balloon diameter * 0.3. This solution does not impose specific limitations and can be set accordingly as needed.

[0062] In summary, by providing a base layer 302 on the inner side wall of the electrode body 301 and uniformly dispersing the contrast agent in the material of the base layer 302, the surgeon can clearly observe the shape of the electrode body 301 during X-ray fluoroscopy, accurately determine whether the electrode assembly 3 and the expandable assembly 2 maintain a continuous fit, and avoid rashly dragging the expandable assembly 2 into the sheath. Even if the electrode assembly 3 is separated from the expandable assembly 2, it will not suffer further physical damage, effectively preventing the possibility of electrode fragments being left in the cardiac cavity. Moreover, after the electrode assembly 3 is separated from the expandable assembly 2, it can be discovered in a timely manner and measures can be taken to find or capture and recover the electrode fragments, effectively avoiding the risk of stroke or blood vessel blockage or rupture.

[0063] It should be noted that, in this specification, relational terms such as first and second are merely used to distinguish one entity from other entities, but do not necessarily require or imply any actual relationship or order between these entities.

[0064] The principles and implementation methods of the present invention are described herein using specific examples. The description of the above examples is only intended to help understand the method and core concept of the present invention. It should be noted that those skilled in the art may make various improvements and modifications to the present invention without departing from the principles of the present invention, and such improvements and modifications also fall within the scope of protection of the present invention.

Claims

1. An ablation catheter, characterized in that: include: a catheter shaft, wherein the proximal end of the catheter shaft is used for placement outside the body, and the distal end of the catheter shaft is used for intervention into tissue; An expandable component is provided at the distal end of the catheter shaft, the expandable component including an expanded state and a contracted state, and the expandable component can be driven by the catheter shaft to a specified position in the contracted state and then switched to the expanded state; There are several electrode assemblies, and the electrode assemblies are arranged in an array on the circumferential side of the expandable component. The electrode assembly includes an electrode body and a base layer that are fixedly connected. The electrode body is exposed on the base layer, and the base layer is adhered to the outer wall of the expandable component, and the contrast agent is evenly dispersed in the material of the base layer.

2. The ablation catheter according to claim 1, characterized in that: The expandable component is made of a material containing a contrast agent, and the mass percentage of the contrast agent in the material of the expandable component is lower than the mass percentage of the contrast agent in the material of the base layer, so that the expandable component and the electrode component have different development intensities when irradiated by X-rays.

3. The ablation catheter according to claim 2, characterized in that: The base layer is made of a mixture of a contrast agent and an organic polymer compound having insulating properties, wherein the organic polymer compound is at least one of PI or PET, and the mass percentage of the organic polymer compound in the material of the base layer is 62% to 91%, and the mass percentage of the contrast agent in the material of the base layer is 9% to 38%; The expandable component is made of a mixture of a contrast agent and one or more materials selected from Nylon, Pebax, TPU, and PET, and the mass percentage of the contrast agent in the material of the expandable component is 1%-8%.

4. The ablation catheter according to claim 1, characterized in that: The proximal end of the expandable component and the distal end of the expandable component are respectively connected with a developing ring, and the material of the developing ring is uniformly dispersed with contrast agent.

5. The ablation catheter according to claim 1, characterized in that: The proximal end of the electrode assembly is connected to a first petiole, which extends into the interior of the catheter shaft. The distal end of the electrode assembly is connected to a second petiole. The distal end of the expandable assembly is provided with a terminal tube, and the second petiole extends into the interior of the terminal tube. At least one of the first petiole or the second petiole includes a cable electrically connected to the electrode body.

6. The ablation catheter according to claim 1, characterized in that: The outer surface of the electrode body is composited with a conductive film, the electrode body is made of one of silver and copper, the conductive film is made of one of gold or platinum, and the thickness of the electrode body is not less than 15 μm.

7. The ablation catheter according to claim 1, characterized in that: The catheter shaft includes an outer tube and an inner tube extending in the axial direction, the distal end of the outer tube is connected to the proximal end of the expandable assembly, and the distal end of the inner tube is connected to the distal end of the expandable assembly.

8. The ablation catheter according to claim 7, characterized in that: The expandable component is a balloon, and the catheter shaft further includes a fluid delivery cavity extending axially. The fluid delivery cavity is arranged in the gap between the outer tube and the inner tube, and the distal end of the fluid delivery cavity is connected to the interior of the balloon.

9. The ablation catheter according to claim 7, characterized in that: Also includes: A control component, comprising: a handle connected to the proximal end of the catheter shaft; a bending adjustment assembly, provided on the handle and connected to the distal end of the catheter shaft, the bending adjustment assembly being used to control the bending direction of the distal end of the catheter shaft; a straightening assembly, disposed on the handle and connected to the proximal end of the inner tube, the straightening assembly being used to push forward or pull back the inner tube to adjust the distance between the proximal end and the distal end of the expandable assembly; The mapping catheter interface is connected to the inner tube, and the mapping catheter interface is used to pass the mapping catheter.

10. A method for identifying electrode dislocation of an ablation catheter, characterized in that: The method comprises an image recognition device, a processor, and the ablation catheter according to any one of claims 1 to 9, wherein the ablation catheter has a second visualization feature, and the method comprises: The expandable component is in an expanded state; The image recognition device collects X-ray images of the ablation catheter; The processor obtains the position of the second development feature and the electrode assembly in the X-ray image; The processor uses the overlap degree and / or relative distance between the electrode assembly and the second developing feature as a calculated value, and displays abnormal information if the calculated value is greater than a preset threshold.

11. The electrode out-of-position identification method according to claim 10, characterized in that: The second visualization feature is a visualization ring provided at the proximal end and the distal end of the expandable component of the ablation catheter, and / or the second visualization feature is a visualization material in the expandable component.

Images