A pfa combination electrode one-stop ablation catheter and system
By designing a combined ring electrode, the electrode shape can be switched, which solves the problems of short electrode spacing and high discharge voltage in existing PFA catheters, improves the uniformity and efficiency of ablation, reduces damage, and achieves better treatment results.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- SHAOXING MAYO XINCI MEDICAL TECH CO LTD
- Filing Date
- 2026-02-10
- Publication Date
- 2026-05-15
AI Technical Summary
Existing PFA catheters have short electrode spacing and high discharge voltage, which easily generate bursts and microbubbles. The electrode pairs have small damage areas, uneven ablation lines, and small contact areas between the electrodes and tissues, resulting in increased ineffective ablation energy.
A combined ring electrode is designed, comprising a fixed electrode, an active displacement electrode, and a passive displacement electrode. The electrode morphology can be switched by controlling a handle, enabling bipolar and unipolar discharge, thereby increasing the contact area between the electrode and the tissue and improving the uniformity of ablation.
It improves tissue adhesion quality, enhances the homogeneity and therapeutic effect of ablation, reduces ineffective ablation, prevents burst and microbubble damage, and improves ablation efficiency.
Smart Images
Figure CN121667834B_ABST
Abstract
Description
Technical Field
[0001] This application relates to the field of medical device technology, and in particular to a PFA combined electrode one-stop ablation catheter and system. Background Technology
[0002] In recent years, with the widespread application of pulsed electric field ablation (PFA) technology, it is gradually replacing traditional radiofrequency ablation in the field of interventional treatment of tachyarrhythmias. Compared with catheter radiofrequency ablation, PFA technology has significant advantages such as strong tissue selectivity, low complication rate, high treatment efficiency, and short learning curve. Currently, there are two main types of PFA catheters: ring multipolar electrodes and balloon array electrodes. However, regardless of the type of catheter used, the PFA discharge method uses two adjacent electrodes for bipolar discharge. The disadvantage of this PFA discharge ablation method is:
[0003] (1) Due to the short electrode spacing and high discharge voltage, detonation and microbubbles are easily generated.
[0004] (2) Due to the short size of the electrodes, the damage area caused by the discharge of each electrode is relatively small.
[0005] (3) The ablation lines formed by multiple electrode pairs are prone to uneven damage distribution.
[0006] (4) The small contact area between the electrode and the target tissue leads to an increase in ineffective ablation energy. Summary of the Invention
[0007] This application provides a PFA combined electrode one-stop ablation catheter and system, which is designed with a combined ring electrode to realize the one-stop function of three-dimensional mapping of a single electrode and PFA ablation of multiple electrodes. The combined electrode of this application can perform both bipolar discharge and unipolar discharge, thereby improving the homogeneity and therapeutic effect of ablation on the target tissue while improving the quality of tissue adhesion.
[0008] This application provides a one-stop ablation catheter with PFA combined electrode, comprising:
[0009] 4. Catheter body;
[0010] An electrode ring 1 is disposed at the head end of the catheter body. The electrode ring 1 has a plurality of annular electrodes, each annular electrode comprising:
[0011] The electrode is fixedly installed at a predetermined position on the electrode ring.
[0012] An active displacement electrode is connected to a control handle. An electrode ring 1 is provided with an electrode movement groove 16. The active displacement electrode can move back and forth along the electrode ring 1 based on the operation of the control handle and the electrode movement groove 16.
[0013] A passive shifting electrode is connected to the active shifting electrode and moves between the fixed electrode and the active shifting electrode as the active shifting electrode moves.
[0014] The control handle 7 is connected to the proximal end of the catheter body 4. By controlling the electrode configuration of the electrode ring 1, the electrode ring 1 can be switched between a single-electrode sequential state and a combined electrode state, wherein:
[0015] In the single-electrode sequential state, the spacing between adjacent electrodes remains uniform in order to achieve bipolar PFA ablation;
[0016] In the combined electrode configuration, two or more adjacent electrodes are combined into one to form an extended electrode, thereby achieving unipolar PFA ablation.
[0017] This application provides a PFA combined electrode one-stop ablation system, including the PFA combined electrode one-stop ablation catheter as described above.
[0018] This application presents a combined ring electrode that enables a one-stop function of three-dimensional mapping with a single electrode and PFA ablation with multiple electrodes. The combined electrode of this application can perform both bipolar discharge and unipolar discharge, thereby improving the homogeneity and therapeutic effect of ablation on the target tissue while improving the quality of tissue adhesion.
[0019] The above description is only an overview of the technical solution of this application. In order to better understand the technical means of this application and to implement it in accordance with the contents of the specification, and to make the above and other objects, features and advantages of this application more obvious and understandable, the following are specific embodiments of this application. Attached Figure Description
[0020] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the scope of this application. Furthermore, the same reference numerals denote the same parts throughout the drawings. In the drawings:
[0021] Figure 1 This is a schematic diagram of the overall structure of the PFA combined electrode one-stop ablation catheter of this application;
[0022] Figure 2 This is a partial structural diagram of the PFA combined electrode one-stop ablation catheter of this application;
[0023] Figure 3 This is a schematic cross-sectional view of the PFA combined electrode one-stop ablation catheter of this application, wherein... Figure 3 Part A represents the cross-sectional structure of the catheter annulus, Part B represents the cross-sectional structure of the catheter body, Part C represents the overall structure of the ablation catheter, and Part D represents the cross-sectional structure of the handle end. Detailed Implementation
[0024] Exemplary embodiments of the present disclosure will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.
[0025] Currently, the most commonly used PFA catheter in clinical practice is the ring electrode catheter, which can simultaneously perform three-dimensional mapping and synchronous PFA bipolar discharge ablation. Taking the surgical procedure of PFA catheter ablation for atrial fibrillation as an example, the main operational process of three-dimensional mapping and PFA ablation treatment using a conventional PFA catheter is as follows:
[0026] 1. The interatrial septum is punctured via the femoral vein, and a left atrial sheath is inserted and heparinized.
[0027] 2. Insert the PFA ring ablation catheter through the sheath, and move the electrode ring at the tip of the catheter within the left atrium to construct a three-dimensional anatomical image of the left atrium and mark the ablation line of the pulmonary vein vestibule.
[0028] 3. Keep all or part of the electrodes of the electrode ring in contact with the pulmonary vein vestibular ablation line, and perform synchronous bipolar discharge with two adjacent electrodes.
[0029] 4. Check for any missed ablation points and perform additional ablation until the target pulmonary vein vestibule is completely isolated.
[0030] 5. Repeat the above operation to complete the bidirectional electrical isolation of all pulmonary vein vestibules.
[0031] 6. Retrieve the electrode ring at the tip of the PFA annular electrode catheter into the sheath.
[0032] 7. Remove the sheath and PFA ablation catheter together from the body, properly treat the puncture site, and the surgical procedure is complete.
[0033] This application designs a combined ring electrode that, when inserted into the target cardiac cavity, operates in the following two electrode configurations:
[0034] (1) Individual electrodes are arranged sequentially at equal intervals on the electrode ring for rapid three-dimensional modeling, high-density excitation mapping, and synchronous PFA ablation of adjacent electrode pairs.
[0035] (2) Two or more adjacent electrodes are brought close together to form a combined extended electrode to achieve multi-electrode combined PFA ablation.
[0036] Specifically, embodiments of this application provide a one-stop ablation catheter with PFA combined electrodes, such as... Figure 1 , Figure 2 As shown, it includes:
[0037] 4. Catheter body;
[0038] An electrode ring 1 is disposed at the distal end of the catheter body. The electrode ring 1 has multiple annular electrodes, each including:
[0039] The electrode is fixedly installed at a predetermined position on the electrode ring.
[0040] An active displacement electrode is connected to a control handle. The active displacement electrode can move back and forth along the electrode ring 1 based on the operation of the control handle. In some examples, the electrode ring 1 is provided with an electrode movement groove 16. The active displacement electrode moves back and forth along the electrode ring 1 based on the electrode movement groove 16, and the active displacement electrode is limited by the electrode movement groove 16.
[0041] A passive displacement electrode is connected to the active displacement electrode and moves between the fixed electrode and the active displacement electrode as the active displacement electrode moves. In some embodiments, the electrode ring 1 is a polyurethane and micro-steel wire braided composite structure with a diameter of not less than 10 mm, and the annular electrode is made of platinum-iridium alloy with a length of not less than 3 mm. In the single-electrode sequential state, the electrode spacing is not less than 2 mm.
[0042] In specific examples, such as Figure 1 As shown, the electrode ring diameter is not less than 10mm, and the ring circumference is not greater than 9F. A single electrode is attached to the electrode ring in a ring shape. Depending on the requirements, there are three types: fixed electrodes that cannot move, passively displacing electrodes that can move back and forth within the electrode spacing range, such as... Figure 2 As shown, the active displacement electrode can be actively moved back and forth by the control guidewire located in the inner core of the catheter, while simultaneously driving the passive displacement electrode to move back and forth.
[0043] In this embodiment of the application, the combined electrode 13 is located on the electrode ring 1, such as... Figure 2As shown, by manipulating the movement of the combined steel wire, two or more adjacent electrodes can form one or more combined electrodes 13. There are three types of individual electrodes that complete the electrode combination: a) Fixed electrodes that cannot move, which determine the spacing between the combined electrodes. b) Passively displaced electrodes that are driven by actively displaced electrodes, and their movement range is determined by the limiting point and the traction guide wire. c) Actively displaced electrodes that are connected to the distal end of the control steel wire and can slide back and forth in the electrode groove, and their back and forth movement range is determined by the number of combined electrodes.
[0044] The control handle 7 is connected to the proximal end of the catheter body 4. By controlling the electrode configuration of the electrode ring 1, the electrode ring 1 can be switched between a single-electrode sequential state and a combined electrode state, wherein:
[0045] In the single-electrode sequential state, the spacing between adjacent electrodes remains uniform in order to achieve bipolar PFA ablation;
[0046] In the combined electrode configuration, two or more adjacent electrodes are combined into one to form an extended electrode, thereby achieving unipolar PFA ablation.
[0047] In this example, the proximal end refers to the end closer to the surgeon, and the distal end refers to the end furthest from the surgeon; this applies to both proximal and distal ends of all components. In a specific example, the sequential single-electrode assembly is in either an initial or non-combined state, with all electrodes located on an electrode ring and all being ring-shaped electrodes. Each single electrode is at least 3 mm long, has an outer diameter no greater than 9F, an electrode spacing of at least 2 mm, is made of platinum-iridium alloy, and the conductive guidewire runs within the guidewire cannula inside the catheter.
[0048] In some embodiments, such as Figure 1 As shown, the tip of the catheter body is also equipped with a visualization electrode 3, which displays the catheter's position and orientation in a three-dimensional mapping system. Specifically, the visualization electrodes 3 are located near the electrode ring, with no fewer than two electrodes. They are annular electrodes, with a length of no less than 1 mm and an outer diameter of no more than 9F, made of platinum-iridium alloy. The conductive guidewire runs within a guidewire microtube inside the catheter. Their function is to display the position and orientation of the catheter tip in real time on the three-dimensional model.
[0049] In specific examples, such as Figure 1 As shown, the catheter body 4 of this application has a length of not less than 500 mm and an outer diameter of not more than 9F. The tube wall is made of polyurethane and micro-steel wire braided material. The catheter body running structure includes: electrode and positioning sensor guidewire and its running microtube, electrode assembly control steel wire and its running microtube, and catheter tip bending control steel wire and its running microtube, with a quantity of more than one set.
[0050] It also includes an electrode ring guide tube 5, which is fitted onto the guide tube body 4 and can slide freely back and forth. It is made of polyurethane and has a length of not less than 10mm. It is used for recycling and loading electrode rings.
[0051] In a specific example, the control handle 7 is equipped with a catheter tip bending control knob 6, located at the far end of the control handle and connected to the catheter tip bending wire. The bending control wire travels inside the catheter body 4, so that the catheter tip can be bent in both directions by manual operation or by the surgical robot, with a maximum bending arc of not less than 180 degrees.
[0052] like Figure 3 As shown, the control handle 7 has an extension cable 10 and a cable plug 9 at its tail. In some examples, the extension cable 10 is at least 1 meter long and has an outer diameter of no more than 5 mm. Its distal end is connected to the cable plug, and its proximal end is connected to the main unit in a plug-in manner.
[0053] This application presents a combined ring electrode design that achieves a one-stop function of three-dimensional mapping with a single electrode and PFA ablation with multiple electrodes. The combined electrode can perform both bipolar and unipolar discharge, increasing the contact area between the electrode and the target tissue through the combination of multiple electrodes. This application increases the electrode length through electrode combination, improving tissue adhesion quality and enhancing the homogeneity and therapeutic effect of ablation on the target tissue. Using the combined electrode for unipolar discharge reduces ineffective ablation and improves ablation efficiency.
[0054] In some embodiments, the control handle 7 is connected to the active displacement electrode via an electrode assembly controlling the steel wire 20;
[0055] The passive displacement electrode is connected to the active displacement electrode via a guide wire 15, so as to control the electrode shape of the electrode ring 1 based on the control handle 7.
[0056] In some embodiments, each fixed electrode has an electrode movement groove 16 provided near its proximal end to limit the maximum movement range of the active displacement electrode. For example... Figure 3 As shown, the control handle 7 is connected to the corresponding connection point via the electrode assembly control wire 14, the connection point between the active displacement electrode and the electrode assembly control wire, and the traction wire 15 connected to the passive displacement electrode.
[0057] In some embodiments, the length of the electrode moving chute 16 is adapted to the length of the guide wire 15, such that when the active displacement electrode moves to the end of the electrode moving chute 16, the passive displacement electrode is located between the fixed electrode and the active displacement electrode, thereby achieving uniform electrode arrangement.
[0058] In some embodiments, the catheter body 4 is further provided with an inner cavity flushing tube 8, which runs in the form of a microtube, with its distal end opening into the electrode moving slide 16 and its proximal end communicating with the side tube at the tail of the control handle 7, for continuously flushing the electrode moving slide 16.
[0059] like Figure 3 The diagram also shows a catheter tip bending control knob 6, a single electrode and combined electrode switching connection sliding button 11, an electrode combination control knob 12, a driven displacement electrical limit point 17, an electrode lead wire 18, an electrode guide wire 19, an electrode combination control wire 20, a catheter lumen 21, and a tip bending control wire 22, wherein the electrode guide wire 19, the electrode combination control wire 20, and the tip bending control wire 22 are provided with corresponding traveling microtubes.
[0060] This application also provides an application example of the PFA combined electrode one-stop ablation catheter:
[0061] Figure 1 A: Schematic diagram of the catheter structure with 9 sequential electrodes on the electrode ring in a non-combined state (E1-E9 from far to near, their function is rapid mapping and conventional PFA ablation).
[0062] Figure 1 B: Schematic diagram of the conduit structure with three sequential electrodes on the electrode ring (from far to near, they are E123, E456, and E789, which function as PFA combined electrode ablation).
[0063] Figure 2 Left side of the middle group of pictures: Schematic diagram of the principle of retracting the control wire to make the sequential electrodes on the electrode ring in a state of equal distance separation (retracting the wire controls the E1 active displacement electrode to move towards the handle end. After the moving distance exceeds the length of the traction guide wire 15 connected to the passive displacement electrode, the passive displacement electrode is driven to move towards the handle end synchronously through the connected traction guide wire 15 until the E1 active displacement electrode moves to the head end of the active displacement electrode slide, reaching the maximum limit, and completing the equal distance arrangement of the sequential electrodes).
[0064] Figure 2 The right-hand panel shows the forward-advancing control wire, which combines the nine sequential electrodes on the electrode ring into three groups, from far to near: combined electrodes E123, E456, and E789. During the electrode combination process, electrodes E3, E6, and E9 are fixed electrodes, and their positions remain unchanged. E1, E4, and E7 are active displacement electrodes, which are actively displaced by the control wire. E2, E5, and E8 are passive displacement electrodes, which are passively displaced by the limiting point and the traction guide wire 15 connected to the active displacement electrode. Taking combined electrode E123 as an example, the forward-advancing control wire moves electrode E1 towards the catheter tip. After moving to position E2, the traction wire continues to be advanced, and the active displacement electrode E1 drives the passive displacement electrode E2 to move towards the catheter tip until the fixed electrode E3 is in position. The three electrodes E1, E2, and E3 are then combined into combined electrode E123, completing the switch from sequential electrodes to combined electrodes.
[0065] The PFA combined electrode one-stop ablation catheter of this application has a single electrode ring attached to the electrode ring. The electrodes are divided into three types: a) fixed electrode, b) passive displacement electrode, and c) active displacement electrode. The fixed electrode is fixed at a specific position on the electrode ring. The passive displacement electrode can be pushed and pulled back and forth within the electrode spacing range. The active displacement electrode can be actively moved back and forth by the control guidewire located in the inner core of the catheter, and can also drive the passive displacement electrode to move back and forth. By changing the electrode shape in real time during operation, two PFA ablation modes can be freely switched: the single electrode shape with equal electrode spacing can perform bipolar PFA ablation (bipolar ablation mode), and the combined electrode shape can perform PFA unipolar ablation.
[0066] Each fixed electrode has a predetermined electrode movement groove on the handle side to limit the movement range of the active displacement electrode. A traction guide wire is provided between the active displacement electrode and the passive displacement electrode. During the movement of the active displacement electrode in the opposite direction to the fixed electrode, the passive displacement electrode is moved back to the sequential single electrode state by the traction steel wire. The length of the traction steel wire is set according to the length of the electrode movement groove. When the active displacement electrode moves to the end of the electrode movement groove, the passive displacement electrode moved by the traction steel wire is in the middle of the fixed electrode and the active displacement electrode, so that the individual electrodes can be evenly arranged in the combined electrode unfolded state.
[0067] This design allows for free switching between two PFA ablation modes by changing the electrode configuration in real time during operation. Specifically, a single electrode configuration with equal electrode spacing can perform bipolar PFA ablation (bipolar ablation mode), while a combined electrode configuration can perform unipolar PFA ablation.
[0068] By combining multiple adjacent single electrodes in real time, the contact area between the actual ablation electrode and the target tissue is increased, thereby improving the ablation quality and efficiency.
[0069] This application increases the effective length of the electrodes through electrode combinations, combined with a monopolar ablation mode. This improves tissue adhesion quality, enhances the homogeneity and therapeutic effect of target tissue ablation, and effectively prevents blast injury and microbubble embolism. The combined electrodes extend the length and curvature of the actual ablation electrode, while the monopolar PFA ablation mode reduces ineffective ablation sites and areas, achieving precise treatment.
[0070] This application also proposes a one-stop ablation system for PFA combined electrodes, including the aforementioned one-stop ablation catheter for PFA combined electrodes.
[0071] It should be noted that, in the embodiments of this application, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes that element.
[0072] The sequence numbers of the embodiments in this application are for descriptive purposes only and do not represent the superiority or inferiority of the embodiments.
[0073] The embodiments of this application have been described above with reference to the accompanying drawings. However, this application is not limited to the specific embodiments described above. The specific embodiments described above are merely illustrative and not restrictive. Those skilled in the art can make many other forms under the guidance of this application without departing from the spirit and scope of the claims. All of these forms are within the protection scope of this application.
Claims
1. A one-stop ablation catheter with PFA combined electrodes, characterized in that, include: Catheter body (4); An electrode ring (1) is disposed at the head end of the catheter body. The electrode ring (1) is provided with a plurality of annular electrodes, the annular electrodes comprising: The electrode is fixedly installed at a predetermined position on the electrode ring. An active displacement electrode is connected to a control handle, and the active displacement electrode can move back and forth along the electrode ring (1) based on the operation of the control handle; A passive displacement electrode is connected to the active displacement electrode via a guide wire (15). The passive displacement electrode moves between the fixed electrode and the active displacement electrode as the active displacement electrode moves, so as to control the electrode shape of the electrode ring (1) based on the control handle (7). Each fixed electrode is provided with an electrode moving groove (16) at its proximal end to limit the maximum movement range of the active displacement electrode. The length of the electrode moving groove (16) is adapted to the length of the traction guide wire (15) so that when the active displacement electrode moves to the end of the electrode moving groove (16), the passive displacement electrode is located between the fixed electrode and the active displacement electrode, thereby achieving uniform electrode arrangement. The control handle (7) is connected to the proximal end of the catheter body (4). By controlling the electrode configuration of the electrode ring (1), the electrode ring (1) can be switched between a single-electrode sequential state and a combined electrode state, wherein: In the single-electrode sequential state, the spacing between adjacent electrodes remains uniform in order to achieve bipolar PFA ablation; In the combined electrode configuration, two or more adjacent electrodes are combined into one to form an extended electrode, thereby achieving unipolar PFA ablation.
2. The PFA combined electrode one-stop ablation catheter as described in claim 1, characterized in that, The control handle (7) is connected to the active displacement electrode via an electrode assembly control wire (20).
3. The PFA combined electrode one-stop ablation catheter as described in claim 1, characterized in that, The catheter body (4) is also provided with an inner cavity flushing tube (8). The inner cavity flushing tube (8) runs in the form of a microtube, with its distal end opening into the electrode moving groove (16) and its proximal end communicating with the side tube at the tail of the control handle (7), for continuously flushing the electrode moving groove (16).
4. The PFA combined electrode one-stop ablation catheter as described in claim 1, characterized in that, The control handle (7) is also provided with a catheter bending control knob. The head end of the catheter is connected to the catheter bending control knob through a bending control wire. The bending control wire travels inside the catheter body (4).
5. The PFA combined electrode one-stop ablation catheter as described in claim 1, characterized in that, The control handle (7) is provided with an extension cable (10) and a cable plug (9) at its tail.
6. The PFA combined electrode one-stop ablation catheter as described in claim 1, characterized in that, The head end of the catheter body is also provided with a visualization electrode (3), which displays the position and orientation of the catheter in a three-dimensional mapping system based on the visualization electrode (3).
7. The PFA combined electrode one-stop ablation catheter as described in claim 1, characterized in that, The electrode ring (1) is a composite structure of polyurethane and micro-steel wire braid, with a diameter of not less than 10 mm. The ring electrode is made of platinum-iridium alloy, with a length of not less than 3 mm and an electrode spacing of not less than 2 mm in the single-electrode sequential state.
8. A one-stop ablation system for PFA combined electrodes, characterized in that, Including the PFA combined electrode one-stop ablation catheter as described in any one of claims 1-7.