Needle myocardial ablation catheter and pulsed ablation system

Abstract

The utility model provides a kind of needle myocardial ablation catheter and pulse ablation system, the needle myocardial ablation catheter includes tube body component, the head end of the tube body component is provided head end component, the tube body component is connected with handle component, connector is also provided on the handle component, the head end component includes ablation needle, multiple electrodes and magnetic sensor, the ablation needle is movably arranged in the tube body component, when needing ablation, the ablation needle can be stretched out from the head end of the tube body component and extend towards the direction away from the tube body component, needle detection structure is arranged in the handle component to obtain the needle length of the ablation needle.The utility model embodiment can realize the reliable positioning of ablation needle position, combined with the setting of magnetic sensor, three-dimensional real-time visualization of needle length can be realized.

Description

Technical Field

[0001] This utility model relates to the technical field of ablation devices, and more specifically, to a needle-type myocardial ablation catheter and a pulse ablation system. Background Technology

[0002] Hypertrophic cardiomyopathy (HCM) is a hereditary cardiomyopathy characterized by asymmetric ventricular hypertrophy. It is classified into obstructive and non-obstructive HCM based on the presence or absence of left ventricular outflow tract obstruction. Treatment for HCM primarily aims to relieve symptoms, reduce complications, and prevent sudden cardiac death. For obstructive HCM, the main goal is to relieve obstruction-related symptoms. Previously used medications include beta-blockers and cerebrovascular enzyme inhibitors (CCBs). While these medications can partially alleviate obstruction, they do not directly target the underlying sarcomere protein mutations and therefore cannot adequately improve patient symptoms. Furthermore, they can cause a decrease in heart rate and blood pressure. Therefore, drug therapy has limited efficacy in patients with severe obstructive HCM. For patients who still experience severe symptoms and a large outflow tract pressure gradient after adequate drug therapy, surgical procedures (septal myocardectomy) or interventional treatments (such as anhydrous ethanol ablation or radiofrequency ablation) should be considered.

[0003] Surgical treatment involves directly removing a portion of the myocardium to improve localized hypertrophy. This procedure is complex, requiring open-chest surgery, general anesthesia, cardiopulmonary bypass, long hospital stays, slow recovery, and high levels of expertise, making it generally unacceptable to patients. Anhydrous ethanol ablation of the ventricular septum involves injecting anhydrous ethanol via a catheter into the septal branches supplying the myocardial tissue, creating an artificial septal myocardial infarction to relieve left ventricular outflow tract obstruction. However, anhydrous ethanol ablation has produced unpredictable complications, including: 1. Large-area myocardial infarction leading to heart failure and ventricular aneurysm formation; 2. Large-area necrosis of the ventricular septum potentially leading to cardiac perforation; 3. Involvement of the cardiac conduction bundle, causing cardiac arrest or atrioventricular block, requiring pacemaker implantation; 4. The establishment of collateral circulation leading to re-thickening of necrotic myocardial cells, resulting in disease recurrence.

[0004] Radiofrequency ablation pathways mostly use radiofrequency ablation needles or interventional catheters, but due to the characteristics of radiofrequency energy, there are the following drawbacks: poor penetration into fibrotic myocardium; the need for perfusion, small perfusion volume can easily generate microbubbles, while large perfusion volume will affect the ablation effect; perfusion increases the burden of heart failure in patients; and it may damage the left bundle branch. Utility Model Content

[0005] In order to solve the problems existing in the surgical (ventricular septal myocardectomy) or interventional treatment for hypertrophic cardiomyopathy in the prior art, this utility model provides a needle-type myocardial ablation catheter and a pulse ablation system.

[0006] In view of this, one aspect of the present invention provides a needle-type myocardial ablation catheter, including a tube body assembly, a head end assembly at the head end of the tube body assembly, the tube body assembly being connected to a handle assembly, and a connector head on the handle assembly. The head end assembly includes an ablation needle, multiple electrodes, and a magnetic sensor. The ablation needle is movably disposed within the tube body assembly. When ablation is required, the ablation needle can extend from the head end of the tube body assembly and extend in a direction away from the tube body assembly. A needle exit detection structure is provided within the handle assembly to obtain the needle exit length of the ablation needle.

[0007] In some embodiments, the plurality of electrodes include end electrodes and at least one ring electrode, the end electrodes and the ring electrodes being paired with the ablation needle to serve as two electrode pairs.

[0008] In some embodiments, the terminal electrode is paired with the ablation needle to form a first discharge mode, and the ring electrode is paired with the ablation needle to form a second discharge mode.

[0009] In some embodiments, the end electrode is disposed on the axially outer side of the head end of the tube assembly, and includes a first part and a second part. The end electrode is connected to the tube assembly through the second part. The second part has a threaded knurled structure to facilitate thermal fusion with the tube assembly to form an integral part. The end electrode also includes a through hole that axially penetrates the first part and the second part and communicates with the internal cavity of the tube assembly to allow the ablation needle to pass through.

[0010] In some embodiments, the ring electrode is disposed at a predetermined distance from the end electrode on the tube body assembly, and when there are multiple ring electrodes, the spacing between two adjacent ring electrodes is equal.

[0011] In some embodiments, the magnetic sensor is disposed inside the tube assembly, and the magnetic sensor is elongated and arranged along the length direction of the tube assembly. The magnetic sensor is used to cooperate with each of the electrodes to achieve rapid positioning.

[0012] In some embodiments, an insulating layer is provided on the surface of the ablation needle, the insulating layer covering the middle section of the ablation needle; an insulating sleeve is also provided in the through hole, the tail end of the insulating sleeve being fixed to the inner wall of the tube body assembly.

[0013] In some embodiments, the tail end of the ablation needle is connected to the ablation needle connector, and the ablation needle connector is connected to the handle assembly.

[0014] In some embodiments, the ablation needle connection portion has a cavity, the ablation needle electrode wire is disposed in the cavity, one end of the ablation needle electrode wire is welded to the tail end of the ablation needle, and the other end extends and is welded to the connector.

[0015] In some embodiments, the tube body assembly includes an adjustable bend and a tube body. The head end of the adjustable bend is connected to the head end assembly, and the tail end of the adjustable bend is heat-fused to the tube body. An adjusting pull ring is provided inside the connection between the adjustable bend and the head end assembly, and two adjusting pull lines are symmetrically arranged on both sides of the adjusting pull ring.

[0016] In some embodiments, the adjustable bend section is a multi-cavity structure, comprising at least four cavities: a first cavity, a second cavity, a third cavity, and a fourth cavity. The first cavity and the second cavity facilitate the passage of the two adjustment wires. The third cavity and the fourth cavity are respectively channels for the movement of the ablation needle connection and channels for accommodating the electrode wires.

[0017] In some embodiments, the handle assembly includes a handle housing, a bending adjustment button is provided at the head end of the handle housing, a sliding button and a needle extension scale are provided on the handle housing, the needle extension scale serves as an indicator to indicate the extension length of the ablation needle, and the needle extension detection structure is disposed inside the handle housing.

[0018] In some embodiments, the bending adjustment button is a push-pull button, and the bending adjustment cable extends from the internal cavity of the tube body assembly to the handle assembly and is bidirectionally connected to the bending adjustment button. The adjustable bending section can be deflected in a single direction by moving the push-pull button.

[0019] In some embodiments, the bending button is a rotary button, which controls the bidirectional deflection of the adjustable bending segment by rotating the button.

[0020] In some embodiments, the needle detection structure includes a connecting slider and a sliding rheostat. The sliding button, the connecting slider, and the sliding rheostat are connected in sequence. A rheostat wire is provided at the tail of the sliding rheostat, and the rheostat wire is connected to the connector. By pushing and pulling the sliding button, the needle of the ablation needle can be moved out and retracted, and the sliding rheostat can be moved so that the slider inside it can be displaced accordingly, thereby changing the resistance value of the moving section of the sliding rheostat. The correspondence between the needle length of the ablation needle and the resistance value of the sliding rheostat is calibrated.

[0021] In some embodiments, the handle assembly is connected to an infusion tube for supplying saline solution to the tip assembly. One end of the infusion tube is connected to the cavity end corresponding to the ablation needle connection portion within the adjustable bend, extends to a hemostatic valve connector within the handle assembly, and exits from the tail end of the handle assembly. The connector exchanges data with an external device via a cable.

[0022] Another aspect of this utility model embodiment provides a pulse ablation system, including the needle myocardial ablation catheter, pulse ablation device, and three-dimensional mapping system described in any of the above embodiments, wherein the pulse ablation device is used to provide energy to the needle myocardial ablation catheter.

[0023] This embodiment of the invention can reliably locate the position of the ablation needle, and combined with the setting of the magnetic sensor, it can realize three-dimensional real-time visualization of the needle length.

[0024] To make the above-mentioned objects, features and advantages of the present utility model embodiments more apparent and understandable, preferred embodiments are described below in detail with reference to the accompanying drawings. Attached Figure Description

[0025] In drawings that are not necessarily drawn to scale, the same reference numerals may describe similar parts in different views. The same reference numerals with or without letter suffixes may indicate different instances of similar parts. The drawings generally illustrate various embodiments by way of example rather than limitation and, together with the description and claims, serve to illustrate the disclosed embodiments. Where appropriate, the same reference numerals are used in all drawings to refer to the same or similar parts. Such embodiments are illustrative and not intended to be exhaustive or exclusive embodiments of the apparatus or method. The accompanying drawings, which are provided to further understand the present invention and form part of this application, illustrate exemplary embodiments of the present invention and, together with their description, serve to explain the present invention and do not constitute an undue limitation of the present invention. In the drawings:

[0026] Figure 1 This is a connection diagram of the pulse ablation system provided in this embodiment of the present invention;

[0027] Figure 2 This is a schematic diagram of the needle-type myocardial ablation catheter provided in this embodiment of the utility model;

[0028] Figure 3 This is a schematic diagram of the tip assembly of the needle-type myocardial ablation catheter provided in this embodiment of the present invention;

[0029] Figure 4 This is a cross-sectional view of the tip assembly of the needle-type myocardial ablation catheter provided in this embodiment of the present invention;

[0030] Figure 5 This is a schematic diagram of the structure of the ablation needle and the ablation needle connection part in the needle-type myocardial ablation catheter provided in this embodiment of the utility model;

[0031] Figure 6 This is a schematic diagram of the tube body assembly of the needle-type myocardial ablation catheter provided in this embodiment of the present invention;

[0032] Figure 7 This is a cross-sectional view of the adjustable bend of the tube body assembly in the needle-type myocardial ablation catheter provided in this embodiment of the present invention.

[0033] Figure 8 This is a schematic diagram of the unidirectional bending of the needle-type myocardial ablation catheter provided in this embodiment of the utility model;

[0034] Figure 9 This is a schematic diagram of the handle assembly in the needle-type myocardial ablation catheter provided in this embodiment of the present invention;

[0035] Figure 10 This is a schematic diagram of one of the needle insertion detection structures of the handle assembly in the needle-type myocardial ablation catheter provided in this embodiment of the present invention;

[0036] Figure 11 This is the second schematic diagram of the needle insertion detection structure of the handle assembly in the needle-type myocardial ablation catheter provided in this embodiment of the present invention.

[0037] The above figures include the following reference numerals:

[0038] 1-Head assembly; 11-Ablation needle; 12-End electrode; 121-First part; 122-Second part; 123-Through hole; 13-First ring electrode; 14-Second ring electrode; 15-Third ring electrode; 16-Magnetic sensor; 17-Insulating layer; 18-Insulating sleeve; 19-Ablation needle connection part; 2-Tube body assembly; 21-Adjustable bending section; 211-Adjusting ring; 212-Adjusting wire; 213-First cavity; 214-Second cavity; 215-Third cavity; 216-Fourth cavity; 22-Tube body section; 3-Handle assembly; 31-Adjusting button; 32-Sliding button; 33-Needle exit scale; 34-Handle shell; 35-Connecting slider; 36-Sliding rheostat; 4-Perfusion tube; 5-Connector; 10-Needle-type myocardial ablation catheter; 20-Pulse ablation device; 30-Three-dimensional mapping system. Detailed Implementation

[0039] The specific embodiments of the present invention will now be described in detail with reference to the accompanying drawings, but these are not intended to limit the scope of the present invention.

[0040] It should be understood that various modifications can be made to the embodiments disclosed herein. Therefore, the above description should not be considered as limiting, but merely as an example of embodiments. Other modifications within the scope and spirit of this invention will be apparent to those skilled in the art.

[0041] The accompanying drawings, which are included in and form part of this specification, illustrate embodiments of the present invention and, together with the general description of the present invention given above and the detailed description of the embodiments given below, serve to explain the principles of the present invention.

[0042] These and other features of the present invention will become apparent from the following description of preferred forms of embodiments given as non-limiting examples, with reference to the accompanying drawings.

[0043] It should also be understood that although the present invention has been described with reference to some specific examples, those skilled in the art can certainly implement many other equivalent forms of the present invention, which have the features described in the claims and are therefore all within the scope of protection defined herein.

[0044] The above and other aspects, features and advantages of the present invention will become more apparent when taken in conjunction with the accompanying drawings and in view of the following detailed description.

[0045] Specific embodiments of the present invention will now be described with reference to the accompanying drawings; however, it should be understood that the disclosed embodiments are merely examples of the present invention, which may be implemented in various ways. Well-known and / or repeated functions and structures are not described in detail to avoid unnecessary or redundant details that could obscure the present invention. Therefore, the specific structural and functional details disclosed herein are not intended to be limiting, but merely to serve as the basis and representative basis for the claims to teach those skilled in the art to use the present invention in a variety of substantially any suitable detailed structures.

[0046] It should be noted that the terms "first," "second," etc., in the specification, claims, and accompanying drawings of this utility model are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments of the utility model described herein can be implemented in orders other than those illustrated or described herein. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion; for example, a process, method, system, product, or apparatus that comprises a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products, or apparatus.

[0047] This specification may use the phrases “in one embodiment,” “in another embodiment,” “in yet another embodiment,” or “in other embodiments,” all of which may refer to one or more of the same or different embodiments according to the present invention.

[0048] An embodiment of this utility model provides a needle-type myocardial ablation catheter for achieving ventricular pulse ablation during the treatment of hypertrophic cardiomyopathy. The needle-type myocardial ablation catheter is suitable for pulse ablation systems, such as... Figure 1 -to Figure 11As shown, the pulse ablation system includes a needle-type myocardial ablation catheter 10, a pulse ablation device 20, and a three-dimensional mapping system 30. The needle-type myocardial ablation catheter 10 is connected to the three-dimensional mapping system 30 via the pulse ablation device 20 through a cable, for example. The pulse ablation device 20 is used to provide energy to the needle-type myocardial ablation catheter 10.

[0049] like Figure 2 As shown, the needle-type myocardial ablation catheter 10 can be used to treat patients with hypertrophic obstructive cardiomyopathy. It performs pulsed ablation on the hypertrophic portion of the myocardium via vascular intervention, causing irreversible electroporation of the target myocardial tissue and achieving a reduction in the volume of the hypertrophic myocardium. The pulsed electric field ablation (PFA) used here releases ablation energy by designing an appropriate pulsed electric field and employing multiple short-duration, high-voltage electrical pulses. This makes the ablation process non-thermal (without Joule heating), effectively inducing electroporation in myocardial cells, allowing extracellular cations to enter the cells, leading to cell fragmentation and death. Therefore, pulsed electric field ablation is also known as irreversible electroporation.

[0050] Specifically, the needle-type myocardial ablation catheter 10 includes a tube body assembly 2, a head end assembly 1 at the head end of the tube body assembly 2, a tail end assembly 3 connected to a handle assembly 3, a handle assembly 3 connected to an infusion tube 4, and a connector 5 on the handle assembly 3.

[0051] Specifically, the head end assembly 1 is located on the distal side of the tube body assembly 2, and it is integrally formed with the head end of the tube body assembly 2, for example, by heat fusion connection. The tail end of the tube body assembly 2 extends into the interior of the handle assembly 3, and the infusion tube 4 and the connector 5 can be disposed at the tail end of the handle assembly 3.

[0052] Combination Figure 1 and Figure 2 In the pulse ablation system, the pulse ablation device 20 provides pulse energy to the needle myocardial ablation catheter 10, and the head end assembly 1 located at the head end of the tube body assembly 2 performs pulse ablation on the target myocardial tissue to achieve the therapeutic purpose.

[0053] In addition, the accompanying three-dimensional mapping system 30 can monitor the status and position of the needle myocardial ablation catheter 10 in the human body in real time, so as to guide the operator to quickly locate the ablation site and complete the operation by accurately locating the ablation position.

[0054] Furthermore, the tip assembly 1 includes an ablation needle 11 for pulsed ablation, multiple electrodes, and a magnetic sensor 16. The ablation needle 11 is movably disposed within the tube body assembly 2, and when ablation is required, it can extend from the tip of the tube body assembly 2 and extend away from the tube body assembly 2. The ablation needle 11 can extend to different lengths relative to the tube body assembly 2 depending on the ablation site, facilitating the operator's operation. This embodiment employs a single-needle ablation method. Compared to the existing spiral and double-needle structures, the single-needle setup causes less mechanical damage to the target tissue, reducing surgical risks.

[0055] Specifically, the ablation needle 11 is made of nickel-titanium material, with a diameter of φ0.3-0.5mm and an overall length of 20-30mm. In this embodiment, the ablation needle 11 can be manufactured by grinding the tip of a nickel-titanium wire. The nickel-titanium material used in this ablation needle 11 provides higher resistance to bending and greater toughness, thus ensuring surgical safety.

[0056] Furthermore, to enhance its intraoperative imaging performance, the surface of the ablation needle 11 is gold-plated, and a gold-plated imaging layer is coated on the surface of the ablation needle 11, the thickness of which is 0.1-50 μm. Here, by setting a gold-plated imaging layer on the ablation needle 11, the method of wrapping an ultra-thin platinum-iridium tube on the outside of the ablation needle can be replaced, which simplifies the structure while ensuring its imaging performance.

[0057] In addition, an insulating layer 17 is provided on the surface of the ablation needle 11. The insulating layer 17 is made of pyrene, for example, by deposition on the surface of the ablation needle 11 by vacuum vapor deposition. Of course, the material of the insulating layer 17 is not limited to pyrene coating. It can also be replaced with PTFE coating, or by PTFE, PI, polyurethane, polyether block polyamide, etc., to achieve the purpose of insulation.

[0058] The insulating layer 17 here specifically covers the middle portion of the ablation needle 11, for example, the portion between a first position 2-10 mm from the tip of the ablation needle 11 and a second position 2-5 mm from the tail of the ablation needle 11. In this embodiment, the thickness and length of the insulating layer 17 can be set according to actual needs; preferably, the thickness of the insulating layer 17 is 20-50 μm.

[0059] Furthermore, the electrode includes an end electrode 12 and at least one ring electrode. The end electrode 12 is disposed axially outside the head end of the tube body assembly 2. The end electrode 12 is made of platinum-iridium material and can be used as a discharge electrode or a mapping electrode during ablation surgery. There may be one or more ring electrodes.

[0060] The exposed length of the end electrode 12 is preferably 1.5mm-2mm. Furthermore, the tail end of the end electrode 12 is connected to an end electrode wire, which extends through the internal cavity of the tube body assembly 2 to the tail end of the handle assembly 3 and connects to the connector 5.

[0061] In this embodiment, the terminal electrode 12 and the ring electrode can be paired with the ablation needle 11 respectively. When used as two electrode pairs, they can be used for discharge ablation and mapping, among other things. The arrangement of the terminal electrode 12 with multiple ring electrodes also provides various discharge methods, offering more options for the operator. This embodiment's multi-electrode structure can meet the needs of discharge ablation and mapping, while also satisfying other requirements.

[0062] Specifically, this embodiment can have two discharge modes: a first discharge mode and a second discharge mode. In the first discharge mode, the ablation needle 11 and the terminal electrode 12 discharge simultaneously. The ablation foci generated in this mode can start from the endocardial surface at the puncture site and extend into the deep myocardial tissue. However, because the distance between the ablation needle 11 and the terminal electrode 12 is relatively short, using high energy output can easily generate an electric arc, causing thermal damage to the myocardial tissue. In the second discharge mode, the ablation needle 11 and the ring electrode discharge simultaneously. In this mode, the ablation foci cluster starts about 1 mm from the endocardial surface at the puncture site, forms an ellipsoid with the ablation needle 11 as the axis, and penetrates into the deep myocardial tissue. In this mode, because the distance between the ablation needle 11 and the ring electrode is relatively long, compared with the first discharge mode, using high energy output is less likely to generate an electric arc, resulting in less damage to the endocardial surface on the puncture side. For example, when the ablation needle is inserted into the interventricular septum through the right ventricle for ablation, discharge mode 2 can more effectively protect structures such as the His bundle on the endocardial surface, resulting in higher safety. In practice, the first or second discharge mode can be selected according to the ablation needs during the operation. For example, the first discharge mode can be selected when it is necessary to damage the surface of the needle, and the second discharge mode can be selected when it is necessary to protect the endocardial surface of the needle.

[0063] Further, the end electrode 12 includes a first part 121 and a second part 122. The end electrode 12 is connected to the tube body assembly 2 through the second part 122. The radial dimension of the first part 121 is larger than the radial dimension of the second part 122. Preferably, the radial dimension of the first part 121 is the same as the radial dimension of the tube body assembly 2. Both the first part 121 and the second part 122 are preferably cylindrical to maintain surface conformity with the tube body assembly 2. The structure of the end electrode 12 can be formed, for example, by machining.

[0064] Furthermore, the second part 122 of the end electrode 12 here has a knurled thread structure, which facilitates its integral formation with the tube body assembly 2 through heat fusion, thereby enhancing the robustness of the head end assembly 1. The knurled thread tail end of the end electrode 12 is more secure and less likely to fall off. In addition, the knurled thread structure of the second part 122 of the end electrode 12 can be replaced by welding a high-strength draw wire (e.g., made of SUS304 / SUS316 material) to the tail end and heat-melting or bonding it to the inside of the tube body assembly 2, thereby fixing the end electrode 12 to prevent it from falling off.

[0065] The ablation needle 11 is disposed within the internal cavity of the tube body assembly 2 and can move through the end electrode 12 to extend out. To control the movement of the ablation needle 11, its tail end is connected to an ablation needle connecting part 19, which is connected to the handle assembly 3. The movement of the ablation needle 11 is controlled by operating the ablation needle connecting part 19. Specifically, the tail end of the ablation needle connecting part 19 extends through the internal cavity of the tube body assembly 2 into the interior of the handle assembly 3 and is connected to an operating mechanism on the handle 3. The extension and retraction of the ablation needle 11 relative to the end face of the end electrode 12 is controlled by operating the handle assembly 3. Preferably, the ablation needle 11 and the ablation needle connecting part 19 are freely movable within the internal cavity of the tube body assembly 2.

[0066] Furthermore, the ablation needle connecting part 19 has a cavity, and the ablation needle electrode wire is disposed in the cavity. One end of the ablation needle electrode wire is welded to the tail end of the ablation needle 11, and the other end extends and is welded to the connector 5. Compared with a one-piece needle, which has high internal resistance and poor pulse ablation effect, this embodiment uses the structure formed by the ablation needle 11 and the ablation needle connecting part 19, and directly connects the wire to the tail end of the ablation needle, which can effectively reduce the needle internal resistance, thereby achieving the desired ablation effect.

[0067] The ablation needle connection 19 is preferably a threaded stainless steel tube, and the tail end of the ablation needle 11 can be welded to the threaded stainless steel tube.

[0068] Preferably, the threaded stainless steel tube can be replaced with a tightly wound spring formed from multiple strands of stainless steel wire. The tightly wound spring offers good weldability, bendability, and pushability, while still meeting various performance requirements. Specifically, the advantage of the tightly wound spring over the threaded stainless steel tube is that the tightly wound spring is softer, allowing it to accommodate tube bending requirements while maintaining pushing performance. Furthermore, the cut end face of the threaded stainless steel tube is prone to deformation, a defect not present in the tightly wound spring. The tightly wound spring pushes the needle out of the tube without gaps between the spring strands, resulting in superior pushing performance.

[0069] To facilitate the installation of the end electrode 12 and the movement of the ablation needle 11, the end electrode 1 further includes a through hole 123. The through hole 123 axially penetrates the first part 121 and the second part 122 and communicates with the internal cavity of the tube body assembly 2. The through hole 123 allows the ablation needle 11 to pass freely and extend from the end face of the end electrode 12. Here, the diameter of the channel formed by the through hole 123 is larger than the diameter of the ablation needle 11, so that saline solution can pass through the gap between the channel and the ablation needle 11.

[0070] In addition, an insulating sleeve 18 is provided inside the through hole 123. The insulating sleeve 18 is made of PI material, but it can also be made of PEEK, TPU, or other materials. The insulating sleeve 18 is fitted to the inner wall of the through hole 123, and the ablation needle 11 can pass through the insulating sleeve 18. Furthermore, the tail end of the insulating sleeve 18 is fixed to the inner wall of the tube body assembly 2 by adhesive to enhance the insulation performance inside the terminal electrode 12.

[0071] During the pulse ablation operation, the non-insulated part of the ablation needle 11 near the distal end of the needle tip (the part not covered by the insulating sleeve 18) can be used as a discharge electrode to cooperate with the end electrode 12, the ring electrode, etc. to achieve discharge. The non-insulated part of the ablation needle 11 near the needle tail (the part not covered by the insulating sleeve 18) is convenient for welding with the electrode wire and the ablation needle connection part 19.

[0072] The ablation needle 11 here has an ablation needle lead connected to its tail. The ablation needle lead extends from the cavity inside the ablation needle connection part 19 to the inside of the handle assembly 3 and connects to the connector 5 at the tail end of the handle assembly 3. The ablation needle lead is directly soldered to the needle tail, which reduces the internal resistance from the ablation needle to the connector end, meeting the low internal resistance requirement of pulse ablation.

[0073] In this embodiment, the insulating sleeve 18 and the insulating layer 17 provide dual protection for the insulation and withstand voltage of the ablation needle 11, and can increase the ablation voltage parameters during ablation to produce a larger damage range and depth.

[0074] Furthermore, at least one ring electrode is provided on the tube body assembly 2. The ring electrode can cooperate with the end electrode 12 and the ablation needle 11 to achieve discharge ablation and mapping. Here, the ring electrode is set on the tube body assembly 2 at a predetermined distance from the end electrode 12. The ring electrode can be a platinum-iridium electrode ring, which is sleeved on the outside of the tube body assembly 2, for example, by applying glue or heat fusion to fix it to the tube body assembly 2. Furthermore, the axial length of the end electrode 12 and the ring electrode can be 1-3 mm, preferably 2 mm.

[0075] Furthermore, each of the ring electrodes is connected to a ring electrode wire, which extends through the internal cavity of the tube body assembly 2 to the tail end of the handle assembly 3 and is connected to the connector 5.

[0076] In this embodiment, the number of ring electrodes can be 1-5. For example, in this embodiment, a first ring electrode 13, a second ring electrode 14, and a third ring electrode 15 can be sequentially arranged on the tube body assembly 2 from far to near. Furthermore, when there are multiple ring electrodes, the spacing between two adjacent ring electrodes is equal, and this electrode spacing can be 1-5 mm, preferably 2 mm. In this way, the size of each electrode and its position on the tube body assembly 2 can be predetermined, facilitating rapid positioning using the electrode positions.

[0077] Furthermore, the magnetic sensor 16 is disposed inside the tube assembly 2, for example, fixed to the inner wall of the tube assembly 2 by adhesive. The magnetic sensor 16 is, for example, elongated and arranged along the length of the tube assembly 2. The tail end of the magnetic sensor 16 is connected to a magnetic sensor wire, which extends through the internal cavity of the tube assembly to the tail end of the handle assembly 3 and connects to the connector 5.

[0078] The magnetic sensor 16 enables the tip of the tube assembly 2 to be positioned during surgery via magnetic positioning. It also allows the position of the tip of the needle-type myocardial ablation catheter 10 to be displayed in real time in the accompanying three-dimensional mapping system 30, providing reliable guidance for the surgeon. Specifically, the positional relationship between the magnetic sensor 16 and each electrode is predetermined, allowing for rapid positioning in conjunction with the electrodes. This is achieved by pre-mapping and recording the relative positions of the magnetic sensor 16 and each electrode, thereby displaying the real-time position of the tip of the needle-type myocardial ablation catheter 10 during surgery via the three-dimensional mapping system 30.

[0079] Furthermore, the tube body assembly 2 includes an adjustable bend 21 and a tube body section 22 connected in sequence. The head end of the adjustable bend 21 is connected to the head end assembly 1, and the tail end of the adjustable bend 21 is heat-fused to the tube body section 22. The outer diameter of the tube body assembly 2 is 8Fr (1Fr = 1 / 3 mm). Depending on the bend type of the conduit, the length of the adjustable bend 21 in this embodiment is 20-70 mm.

[0080] An adjusting pull ring 211 is provided inside the connection between the adjustable bending section 21 and the head end assembly 1. Two adjusting pull wires 212 are welded to both sides of the adjusting pull ring 211, and the two adjusting pull wires 212 are symmetrically distributed at 180° to each other. The adjusting pull ring 211 is made of SUS304 stainless steel, and its radial dimension is smaller than the outer diameter of the tube body assembly 2. In addition, the material of the adjusting pull ring 211 can also be replaced with platinum-iridium alloy, SUS316, etc. The adjusting pull wires 212 are preferably stainless steel ropes, but can also be replaced with stainless steel round wires, stainless steel flat wires, etc. By pulling the adjusting pull wires 212, the adjustable bending section 21 can be bent through the adjusting pull ring 211.

[0081] The adjustable section 21 described here has a multi-cavity structure to accommodate different functional channels, such as the channel for the adjusting pull wire 212, the channel for the ablation needle 11, and the channel for the electrode wire. Specifically, it includes at least four cavities: a first cavity 213, a second cavity 214, a third cavity 215, and a fourth cavity 216. The first cavity 213 and the second cavity 214 are adjusting pull wire cavities, allowing two adjusting pull wires 212 to pass through and extend into the interior of the handle assembly 3. The third cavity 215 and the fourth cavity 216 are channels for the movement of the ablation needle connection portion 19 of the ablation needle 11 and for accommodating the electrode wire, respectively. Of course, the functions of the different cavities can be interchanged, and no specific limitation is made here.

[0082] Furthermore, in this embodiment, the handle assembly 3 is provided with a bending adjustment mechanism and a needle exit detection mechanism. The bending adjustment mechanism is used to achieve a maximum 180° deflection adjustment of the head end assembly 1, and the needle exit detection mechanism is used to control the entry and exit of the ablation needle 11 and can determine the needle exit length of the ablation needle 11 through both direct observation and simulation.

[0083] Specifically, the handle assembly 3 includes a handle housing 34, with a bending adjustment button 31 at the head end of the handle housing 34, a sliding button 32 on the handle housing 34, and a needle extension scale 33 on the surface of the handle housing 34 near the sliding button 32. The needle extension scale 33 is formed by screen printing or laser engraving to indicate the extension length of the ablation needle 11, thereby providing a visual reference for the operator.

[0084] The bending adjustment button 31 is a push-pull button. The adjustable bending section 21 can be adjusted by moving the push-pull button. Specifically, the bending adjustment cable 212 in the adjustable bending section 21 extends from the internal cavity of the tube body assembly 2 to the handle assembly 3 and is bidirectionally connected to the bending adjustment button 31. By pushing or pulling the bending adjustment button 31, the adjustable bending section 21 can be deflected in one direction, and the maximum deflection angle is 180°.

[0085] In some embodiments, the push-pull button can be replaced with a rotary button, and the adjustment of the adjustable bending section 21 can be controlled by rotating the button. The bending shape of the adjustable bending section 21 can also be replaced by a single-direction deflection, with the deflection angles being symmetrical in both directions, each reaching 180°.

[0086] Furthermore, the needle detection structure includes a connecting slider 35 and a sliding rheostat 36, wherein the sliding button 32, the connecting slider 35, and the sliding rheostat 36 are connected in sequence. A rheostat wire 361 is provided at the tail of the sliding rheostat 36, and the rheostat wire 361 is connected to the connector 5 by, for example, welding.

[0087] The sliding rheostat 36 described here works by changing the resistance value by altering the length of the resistance wire. It typically consists of a resistance wire, a slider, terminals, a metal rod, and a ceramic cylinder. The resistance wire is wound around an insulating ceramic cylinder and coated with insulating varnish. By moving the slider, the length of the resistance wire connected to the circuit can be changed, thereby altering the resistance value and controlling the current in the circuit.

[0088] In this embodiment, the tail end of the ablation needle connection 19 extends into the interior of the handle housing 34 and is fixedly connected to the connecting slider 35. Thus, by pushing and pulling the sliding button 32, the connecting slider 35 and the ablation needle connection 19 can be moved in sequence, thereby causing the ablation needle 11 at the head end of the tube body assembly 2 to extend and retract relative to the end face of the end electrode 12, thereby realizing the control of the position of the ablation needle 11 during the operation.

[0089] Furthermore, while pushing or pulling the sliding button 32, the sliding rheostat 36 is also driven to cause a corresponding displacement of its internal slider, thereby changing the resistance value of the moving section of the sliding rheostat 36. Here, the correspondence between the needle extension length of the ablation needle 11 and the resistance value of the sliding rheostat 36 can be calibrated, and the relationship between the resistance value and the needle extension length can be quantified and recorded on the controller of the relevant device (e.g., the three-dimensional mapping system 30). In this way, during use, data is exchanged with the device via cable to obtain the electrical signal converted from the resistance change caused by pushing or pulling the sliding button 32. This allows the matching three-dimensional mapping system 30 to provide needle extension indication and needle extension length monitoring functions, thus facilitating the operator's operation.

[0090] The needle insertion structure in the handle assembly 3 of this embodiment is simple and meets the operator's operational needs. The needle insertion scale and needle insertion detection structure set therein provide the operator with reliable positioning between the ablation needle 11 and each of the electrodes from the catheter end and the device end, respectively. Combined with the setting of the magnetic sensor 16, real-time three-dimensional visualization of the needle insertion length can be realized.

[0091] Furthermore, the infusion tube 4 is used to supply saline to the tip assembly 1. One end of the tube is connected to the cavity end corresponding to the ablation needle connection part 19 in the adjustable bend section 21, and extends to the hemostatic valve connector in the handle assembly 3, and then leads out from the tail end of the handle assembly 3, for the purpose of preoperative or intraoperative saline infusion of the ablation needle channel.

[0092] The connector 5 serves as a data / energy exchange interface. The electrical devices within the needle-type myocardial ablation catheter 10, such as the ablation needle 11, the end electrode 12, the ring electrode, the magnetic sensor 16, and the sliding rheostat 36, all have their corresponding wires passing through the handle assembly 3 and connecting to the connector 5. Data exchange is then conducted with devices such as the three-dimensional mapping system 30 via cables. The connector 5 can be located externally to the handle assembly 3 and connected to relevant cables for easy connection and replacement.

[0093] In this embodiment, it is considered that vascular interventional catheters cause less surgical damage to patients compared to other treatment catheters; the choice of pulse ablation energy, due to its tissue selectivity and non-thermal ablation characteristics, makes this method safer and more effective than radiofrequency ablation; in addition, needle ablation addresses the pain point of insufficient ablation depth when other large-tip catheters are used for HCM ablation.

[0094] This embodiment describes a needle-type pulse ablation catheter for vascular intervention. Its tip is equipped with an ablation needle, an end electrode, and several ring electrodes, with a magnetic sensor located inside the tip. The ablation needle can freely extend and retract relative to the catheter's channel. The ablation needle is made of nickel-titanium material with an insulating layer on its surface. The non-insulated portion serves as a discharge electrode, working in conjunction with the end electrode or ring electrodes to form an electrode pair for discharge, thereby ablating the target myocardial tissue. The handle end is equipped with a needle extension structure and a needle extension detection structure to control the extension of the ablation needle. A sliding rheostat is used to achieve real-time three-dimensional visualization of the needle extension length.

[0095] Furthermore, the knurled structure at the end of the terminal electrode improves the stability of the terminal electrode placement, and the internal opening provides a suitable channel for the ablation needle to meet the needle withdrawal requirements. In addition, an insulating layer is set on the ablation needle, and an insulating sleeve is set at the opening of the terminal electrode. The insulating sleeve and insulating layer provide double protection for the insulation and withstand voltage effect of the ablation needle, which can increase the ablation voltage parameters during ablation to produce a larger damage range and depth. The tip adopts an adjustable bending structure, which can be controlled by the handle assembly to adjust the bending of the catheter tip to meet the operator's needs for ablation of target tissues at different locations. The needle withdrawal structure of the handle assembly meets the operator's operation needs. Through the needle withdrawal scale and needle withdrawal detection structure, the operator can be provided with reliable positioning between the ablation needle and each electrode from the catheter end and the three-dimensional device end at the same time. Combined with the setting of the magnetic sensor, the three-dimensional visualization of the needle withdrawal length can be realized.

[0096] The second embodiment of this utility model provides a pulse ablation system, which includes a needle-type myocardial ablation catheter 10, a pulse ablation device 20, and a three-dimensional mapping system 30. The needle-type myocardial ablation catheter 10 is connected to the three-dimensional mapping system 30 via the pulse ablation device 20 through a cable, for example. The pulse ablation device 20 is used to provide energy to the needle-type myocardial ablation catheter 10.

[0097] This embodiment of the invention can reliably locate the position of the ablation needle, and combined with the setting of the magnetic sensor, it can realize three-dimensional real-time visualization of the needle length.

[0098] In the above embodiments of this utility model, the descriptions of each embodiment have different focuses. For parts not described in detail in a certain embodiment, please refer to the relevant descriptions of other embodiments.

[0099] For ease of description, spatial relative terms such as "above," "on top of," "on the upper surface of," "above," etc., are used herein to describe the spatial positional relationship of a device or feature as shown in the figures to other devices or features. It should be understood that spatial relative terms are intended to encompass different orientations in use or operation beyond the orientation of the device as described in the figures. For example, if the device in the figures were inverted, a device described as "above" or "on top of" other devices or structures would subsequently be positioned as "below" or "under" other devices or structures. Thus, the exemplary term "above" can include both "above" and "below." The device may also be positioned in other different ways, rotated 90 degrees, or in other orientations, and the spatial relative descriptions used herein will be interpreted accordingly.

[0100] In addition to the above, it should be noted that the terms "one embodiment," "another embodiment," and "embodiment" used in this specification refer to specific features, structures, or characteristics described in connection with that embodiment, which are included in at least one embodiment of the general description in this application. The appearance of the same term in multiple places in the specification does not necessarily refer to the same embodiment.

[0101] Furthermore, when a specific feature, structure, or characteristic is described in conjunction with any embodiment, it is claimed that implementing such a feature, structure, or characteristic in conjunction with other embodiments also falls within the scope of this utility model.

[0102] In the above embodiments, the descriptions of each embodiment have different focuses. For parts not described in detail in a certain embodiment, please refer to the relevant descriptions in other embodiments.

[0103] The above description is merely a preferred embodiment of this utility model and is not intended to limit the utility model. Various modifications and variations can be made to this utility model by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this utility model should be included within the protection scope of this utility model.

Claims

1. A needle-type myocardial ablation catheter, characterized in that, The device includes a tube body assembly, a head end assembly at the head end of the tube body assembly, and a handle assembly connected to the tube body assembly. The handle assembly is also provided with a connector. The head end assembly includes an ablation needle, multiple electrodes, and a magnetic sensor. The ablation needle is movably disposed within the tube body assembly. When ablation is required, the ablation needle can extend from the head end of the tube body assembly and extend in a direction away from the tube body assembly. The handle assembly is provided with a needle exit detection structure to obtain the needle exit length of the ablation needle.

2. The needle-type myocardial ablation catheter according to claim 1, characterized in that, The plurality of electrodes include end electrodes and at least one ring electrode, the end electrodes and the ring electrodes being paired with the ablation needle to form two electrode pairs.

3. The needle-type myocardial ablation catheter according to claim 2, characterized in that, The terminal electrode is paired with the ablation needle to form a first discharge mode, and the ring electrode is paired with the ablation needle to form a second discharge mode.

4. The needle-type myocardial ablation catheter according to claim 2, characterized in that, The end electrode is disposed on the axial outer side of the head end of the tube assembly, and includes a first part and a second part. The end electrode is connected to the tube assembly through the second part. The second part has a threaded knurled structure to facilitate thermal fusion with the tube assembly to form an integral part. The end electrode also includes a through hole that axially penetrates the first part and the second part and communicates with the internal cavity of the tube assembly to facilitate the passage of the ablation needle.

5. The needle-type myocardial ablation catheter according to claim 4, characterized in that, The ring electrode is disposed at a predetermined distance from the end electrode on the tube body assembly. When there are multiple ring electrodes, the spacing between two adjacent ring electrodes is equal.

6. The needle-type myocardial ablation catheter according to claim 4, characterized in that, The magnetic sensor is disposed inside the tube assembly. The magnetic sensor is elongated and arranged along the length of the tube assembly. The magnetic sensor is used in conjunction with each of the electrodes to achieve rapid positioning.

7. The needle-type myocardial ablation catheter according to claim 4, characterized in that, An insulating layer is provided on the surface of the ablation needle, and the insulating layer covers the middle section of the ablation needle; an insulating sleeve is also provided in the through hole, and the tail end of the insulating sleeve is fixed to the inner wall of the tube body assembly.

8. The needle-type myocardial ablation catheter according to claim 7, characterized in that, The tail end of the ablation needle is connected to the ablation needle connecting part, and the ablation needle connecting part is connected to the handle assembly.

9. The needle-type myocardial ablation catheter according to claim 8, characterized in that, The ablation needle connection part has a cavity, and the ablation needle electrode wire is located in the cavity. One end of the ablation needle electrode wire is welded to the tail end of the ablation needle, and the other end extends and is welded to the connector.

10. The needle-type myocardial ablation catheter according to claim 1, characterized in that, The tube body assembly includes an adjustable bend and a tube body. The head end of the adjustable bend is connected to the head end assembly, and the tail end of the adjustable bend is heat-fused to the tube body. An adjusting pull ring is provided inside the connection between the adjustable bend and the head end assembly, and two adjusting pull lines are symmetrically arranged on both sides of the adjusting pull ring.

11. The needle-type myocardial ablation catheter according to claim 10, characterized in that, The adjustable bend section has a multi-cavity structure, including at least four cavities: a first cavity, a second cavity, a third cavity, and a fourth cavity. The first cavity and the second cavity facilitate the passage of the two bending pull wires. The third cavity and the fourth cavity are channels for the movement of the ablation needle connection and channels for accommodating the electrode wires, respectively.

12. The needle-type myocardial ablation catheter according to claim 10, characterized in that, The handle assembly includes a handle housing, with a bending adjustment button at the head end of the handle housing, a sliding button and a needle extension scale on the handle housing, the needle extension scale serving as an indicator to indicate the extension length of the ablation needle, and the needle extension detection structure disposed inside the handle housing.

13. The needle-type myocardial ablation catheter according to claim 12, characterized in that, The bending adjustment button is a push-pull button. The bending adjustment cable extends from the internal cavity of the tube body assembly to the handle assembly and is bidirectionally connected to the bending adjustment button. The adjustable bending section can be deflected in one direction by moving the push-pull button.

14. The needle-type myocardial ablation catheter according to claim 12, characterized in that, The bending adjustment button is a rotary button, which controls the bidirectional deflection of the adjustable bending section by rotating the button.

15. The needle-type myocardial ablation catheter according to claim 12, characterized in that, The needle detection structure includes a connecting slider and a sliding rheostat. The sliding button, the connecting slider, and the sliding rheostat are connected in sequence. A rheostat wire is provided at the tail of the sliding rheostat, and the rheostat wire is connected to the connector. By pushing and pulling the sliding button, the needle of the ablation needle can be moved out and retracted, and the sliding rheostat can be moved so that the slider inside it can be displaced accordingly, thereby changing the resistance value of the moving section of the sliding rheostat. The corresponding relationship between the needle length of the ablation needle and the resistance value of the sliding rheostat is calibrated.

16. The needle-type myocardial ablation catheter according to claim 10, characterized in that, The handle assembly is connected to the infusion tube, which supplies saline solution to the head assembly. One end of the infusion tube is connected to the cavity end corresponding to the ablation needle connection in the adjustable bend, extends to the hemostatic valve connector in the handle assembly, and exits from the tail end of the handle assembly. The connector exchanges data with an external device via a cable.

17. A pulse ablation system, characterized in that... The invention includes the needle-type myocardial ablation catheter, the pulse ablation device, and the three-dimensional mapping system as described in any one of claims 1-15, wherein the pulse ablation device is used to provide energy to the needle-type myocardial ablation catheter.

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