CN115645036A - Pulse ablation device - Google Patents

Abstract

The application discloses a pulse ablation device, which comprises an outer tube, an ablation catheter of an inner tube, an electrode assembly and an operating handle, wherein the ablation catheter is arranged in the outer tube in a penetrating mode and can move axially relative to the outer tube; the angle control assembly and the axial movement assembly are arranged in the single handle through the middle core rod through the unique arrangement mode and the unique mechanism design of the mechanical assembly, so that the traditional operating handle design for ablation pulse is optimized, smaller operation difficulty is provided for the application of an operator, particularly a doctor, in the operation, and the operation and the precision control are facilitated.

Description

Pulse ablation device

Technical Field

The application relates to the technical field of medical instruments, in particular to a pulse ablation device for a pulse ablation system.

Background

In the field of electrophysiology, it is common practice to deliver energy and perform tissue ablation using ablation catheters. After the head end (far end) of the ablation catheter is inserted into the heart and reaches a corresponding treatment target point, an energy platform connected with the tail end (near end) of the ablation catheter sends energy media (such as energy of radio frequency, ultrasound, pulse and the like) to an energy delivery electrode on the head end of the ablation catheter, and the electrode is attached to the tissue and transfers the energy to the tissue to ablate the tissue.

The common ablation methods in the current stage include radio frequency, ultrasound or cryotherapy, which have some advantages and limitations, for example, ablation energy may not selectively destroy tissues in the ablation region, and depending on the adhesion force of the catheter, may cause damage to the adjacent esophagus, coronary artery, phrenic nerve, etc. Therefore, the purpose of exploring a safe and efficient Ablation method to achieve persistent pulmonary vein isolation without injuring adjacent tissues is a recent research hotspot in the industry, and besides applying precise and safe radio frequency Ablation with pressure induction and according to an Ablation Index (AI) or an injury index (LSI), a new high-power short-time (HPSD) Ablation method in recent two years also shows one side of high efficiency and safety, namely a pulsed electric Field (PFA) Ablation technology, and particularly, as the initial application of new pulsed electric Field non-thermal energy shows a better clinical effect, various researches around PFA products are increasing.

In the atrial fibrillation ablation operation, the bending angle or the expansion degree of an ablation electrode positioned in human tissues such as the heart needs to be adjusted through a handle, in the prior art, a mechanism for driving the bending of the ablation electrode and a mechanism for driving the ablation electrode to expand or contract are generally configured on different operation handles, and in the process of performing the operation by a doctor, the control on the expected action of an ablation catheter usually needs to be completed through the cooperative operation of multiple persons, which is a great challenge on the operation efficiency and the accuracy.

Disclosure of Invention

In view of the above disadvantages of the related art, the present application aims to provide a pulse ablation device to solve the problems of inconvenience and complexity caused by different handles required for different operations in the prior art.

To achieve the above and other related objects, the disclosed impulse ablation device includes: the ablation catheter comprises an outer tube extending from a proximal end to a distal end and an inner tube which is arranged in the outer tube in a penetrating way and can move axially relative to the outer tube; an electrode assembly comprising a plurality of electrode elements disposed between an outer tube and an inner tube of the ablation catheter, each electrode element comprising a proximal structure secured to a distal end of the outer tube and a distal structure secured to a distal end of the inner tube; the operation handle is used for being connected with the ablation catheter and comprises a handle body, an angle control assembly and an axial movement assembly, wherein the angle control assembly is arranged on the handle body and used for controlling the distal end of the ablation catheter to perform angle steering, and the axial movement assembly is used for driving the inner tube to move relative to the outer tube so as to enable the electrode elements to be converted between a contraction state and an expansion state.

In an embodiment of the present application, the operating handle includes a handle body formed with an external grip portion, a first accommodating space and a second accommodating space, wherein the first accommodating space and the second accommodating space are respectively formed inside the handle body and located at distal end portions and proximal end portions.

In an embodiment of the present application, the angle control assembly includes an angle driving mechanism disposed in the first accommodating space and an angle knob disposed at a distal end of the handle body and fixedly connected to the angle driving mechanism.

In an embodiment of the present application, the axial movement assembly includes an axial driving mechanism disposed in the second accommodating space and fixedly connected to the proximal end of the inner tube, and a toggle button partially disposed in the second accommodating space and used for operating the axial movement of the axial driving mechanism.

In an embodiment of the application, a thread guide hole for penetrating the thread guide is formed in a portion, corresponding to the second accommodating space, of the side wall of the handle body, so that the thread guide enters the handle body from the thread guide hole.

In an embodiment of the present application, the guidewire port is located in the handle body adjacent to the proximal end thereof.

In an embodiment of the application, the handle body comprises a first shell and a second shell connected with the first shell in a clamping manner, wherein a first accommodating space formed in the first shell and the second shell is a closed space; the second accommodating space formed in the first housing and the second housing is an open space to expose a part of the toggle button arranged therein.

In an embodiment of the present application, a proximal cover is sleeved on the proximal end of the handle body to fix the proximal ends of the first and second housings.

In an embodiment of the present application, the toggle button disposed in the open space of the second accommodating space is located at a position 1/3 of the side of the handle body near the proximal end thereof.

In an embodiment of the present application, the electrode handle further includes a third receiving space formed in the handle body and located at a proximal end thereof for receiving an electrode connector, wherein the electrode connector is electrically connected to the electrode assembly through an electrode lead.

In an embodiment of the present application, the ablation catheter further includes a central core rod having a hollow structure, and the central core rod is used for connecting the outer tube and the inner tube of the ablation catheter, and the central core rod is further used for disposing the angle driving mechanism in the first accommodating space and disposing the axial movement mechanism in the second accommodating space.

In one embodiment of the present application, the proximal end of the outer tube is fixed in the mandrel; the near end of the inner tube is fixedly connected to the axial movement mechanism.

In an embodiment of the application, a compartment for clamping the central rod is arranged between the first accommodating space and the second accommodating space in the handle body, and a clamping structure is arranged in the compartment to clamp the central rod in the handle body.

In one embodiment of the present application, the compartment is located in the handle body adjacent 1/3 of a distal side thereof.

In an embodiment of the present application, the central core rod includes a hollow rod body and a clamping portion disposed in a middle of the rod body to be clamped in the compartment so as to clamp the rod body in the handle body.

In an embodiment of the present application, the rod body includes a first limiting portion disposed at a distal end of the rod body, a second limiting portion disposed between the first limiting portion and the engaging portion, and a third limiting portion disposed between the engaging portion and a proximal end of the rod body.

In an embodiment of the present application, the first position-limiting portion and/or the second position-limiting portion is a slot provided on the rod body for matching with a snap ring or a card; the third limiting part is a lug which is integrally formed on the rod body.

In an embodiment of the present application, a first wire slot for passing a traction wire is disposed on the rod body between the distal end of the rod body and the second limiting portion.

In an embodiment of the present application, a proximal portion of the shaft has a second wire groove, the second wire groove extends from a proximal end of the shaft toward a distal end and terminates between the third limiting portion and the engaging portion, so that an opening for passing an electrode wire is formed in a portion between the third limiting portion and the engaging portion.

In an embodiment of the present application, the angle drive mechanism includes: the first traction piece is slidably sleeved between the second limiting part and the clamping part of the middle core rod; the traction part is integrally formed with the first spiral part; the first sleeve is sleeved between the first limiting part and the clamping part of the middle core rod, the far end of the first sleeve is fixedly connected with the angle knob, and an internal thread corresponding to the external thread of the first spiral part is formed on the inner wall of the first sleeve body and is used for driving the first traction piece screwed in the first sleeve body to move between the second limiting part and the clamping part when the angle knob drives the first sleeve body to rotate.

In an embodiment of the present application, a distal end of the mandrel protrudes beyond a distal end of the first sleeve and is located within the angle knob.

In an embodiment of the application, a linear guide rail is disposed on the rod body between the second limiting portion and the clamping portion, and a guide groove corresponding to the linear guide rail is formed in an inner wall of the first traction piece.

In an embodiment of the present application, the first spiral portion is provided with a first wire hole for passing a traction wire from the distal end of the outer tube and/or the inner tube.

In an embodiment of the present application, the pulling portion is provided with a second wire hole for fixing a pulling wire from the distal end of the outer tube and/or the inner tube.

In an embodiment of the present application, a distal end of the first sleeve is exposed out of the first accommodating space of the handle body to engage with the angle knob.

In an embodiment of the present application, a sleeve locking groove is formed at a distal end of the first accommodating space, and a locking strip corresponding to the sleeve locking groove is disposed on an outer peripheral wall of the first sleeve to limit a portion of the first sleeve in the first accommodating space.

In an embodiment of the present application, the axial drive mechanism comprises: the second traction piece is arranged between the third limiting part of the middle core rod and the near end of the rod body in a sliding mode; the fixing device comprises a second spiral part provided with external threads and a fixing pipe integrally formed with the second spiral part; and the second sleeve is sleeved between the third limiting part of the middle core rod and the near end of the rod body, and an internal thread corresponding to the external thread of the second spiral part is formed on the inner wall of the cylinder body of the second sleeve and is used for driving the second traction piece screwed therein to displace between the third limiting part and the near end of the rod body when the angle knob drives the first sleeve to rotate.

In an embodiment of the present application, the dial knob is integrally formed at the proximal end of the second sleeve to drive the second sleeve to rotate when being dialed.

In an embodiment of the application, a section of the central rod from the third position-limiting portion toward the proximal end is two symmetrical pillar structures, and a second wire groove is formed between the two symmetrical pillar structures.

In an embodiment of the present application, the second traction member has two crescent holes respectively for penetrating two symmetrical pillar structures on the rod body.

In an embodiment of the application, the proximal end of the inner tube is fixed to the fixed tube of the second pulling member.

In an embodiment of the present application, a through hole for passing an electrode lead is formed on the second spiral portion of the second pulling member.

To sum up, the pulse ablation device of this application is for the mechanism that drives ablation electrode turn round and the mechanism that drives ablation electrode expand or contract among the prior art is disposed on different operating handles, this application has both realized the turn round function of ablation pipe on single handle body, has also realized the control of the inflation and the shrink of electrode ball, and this application disposes angle control subassembly and axial motion subassembly in single handle through a well core bar through configuration mode and the mechanism design of exclusive mechanical component, not only optimized traditional operating handle design of ablating the pulse, also provided littleer operation degree of difficulty for operating personnel especially doctor's application in the operation, and then do benefit to going on of operation and the control of precision.

Drawings

The specific features of the invention to which this application relates are set forth in the appended claims. The features and advantages of the invention to which this application relates will be better understood by reference to the exemplary embodiments described in detail below and the accompanying drawings. The drawings are briefly described as follows:

fig. 1 shows a schematic view of a pulse ablation system in an embodiment of the present application.

Fig. 2 is an enlarged schematic view of a portion a of fig. 1.

Fig. 3 is a schematic view illustrating a contracted state of an electrode assembly according to an embodiment of the present application.

Fig. 4 is a schematic view illustrating an expanded state of the electrode assembly according to an embodiment of the present application.

Fig. 5 is a schematic structural diagram of a retaining ring according to an embodiment of the present disclosure.

FIG. 6 is a schematic cross-sectional view of the distal fixation ring disposed at the distal end of the inner tube according to one embodiment of the present application.

Fig. 7 is a schematic view of an operating handle according to an embodiment of the present application.

Fig. 8 is an exploded view of the first and second housings of the operating handle according to an embodiment of the present invention.

Fig. 9 is a schematic view showing an internal configuration of an operating handle according to an embodiment of the present application.

FIG. 10 is an exploded view of the operating handle of the present application in one embodiment.

Fig. 11 is an exploded view of an embodiment of an angle control assembly according to the present application.

FIG. 12 is an exploded view of an embodiment of the axial drive mechanism of the present application.

FIG. 13 is a schematic view of the operating handle of the present application assembled with an angle control assembly and an axial drive mechanism in one embodiment.

Detailed Description

The following embodiments are provided to illustrate the present disclosure, and other advantages and effects will be apparent to those skilled in the art from the disclosure.

In the following description, reference is made to the accompanying drawings that describe several embodiments of the application. It is to be understood that other embodiments may be utilized and that mechanical, structural, electrical, and operational changes may be made without departing from the spirit and scope of the present disclosure. The following detailed description is not to be taken in a limiting sense, and the scope of embodiments of the present application is defined only by the claims of the issued patent. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. Spatially relative terms, such as "upper," "lower," "left," "right," "lower," "below," "lower," "above," "upper," and the like, may be used herein to facilitate describing one element or feature's relationship to another element or feature as illustrated in the figures.

Although the terms first, second, etc. may be used herein to describe various elements or parameters in some instances, these elements or parameters should not be limited by these terms. These terms are only used to distinguish one element or parameter from another element or parameter. For example, a first housing may be referred to as a second housing, and similarly, a second housing may be referred to as a first housing, without departing from the scope of the various described embodiments. The first housing and the second housing are both housings of a handle as described herein.

Also, as used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context indicates otherwise. It will be further understood that the terms "comprises," "comprising," "includes" and/or "including," when used in this specification, specify the presence of stated features, steps, operations, elements, components, items, species, and/or groups, but do not preclude the presence, or addition of one or more other features, steps, operations, elements, components, items, species, and/or groups thereof. The terms "or" and/or "as used herein are to be construed as inclusive or meaning any one or any combination. Thus, "a, B or C" or "a, B and/or C" means "any of the following: a; b; c; a and B; a and C; b and C; A. b and C ". An exception to this definition will occur only when a combination of elements, functions, steps or operations are inherently mutually exclusive in some way.

Cardiac pulsed electric field ablation is a novel ablation mode using a pulsed electric field as energy. The pulse electric field ablation is to adopt a plurality of short-time and high-voltage electric pulses to release ablation energy by designing a proper pulse electric field, so that the ablation process is non-thermal energy ablation (no focal ear generates heat), myocardial cells are effectively induced to generate electroporation, and extracellular ions enter the cells to cause the myocardial cells to be fragmented and dead. The damage to the tissue with higher pulse electric field threshold value is also reversible, so that the myocardial conduction system can be directionally damaged, and complications caused by damage to other surrounding tissues are avoided; compared with the traditional radio frequency and freezing energy, the pulsed electric field ablation is non-thermal energy ablation, so that the pulsed electric field can selectively damage cardiac muscle, and blood vessels, nerves and tissues around the heart, such as lungs, esophagus, phrenic nerves and the like, are reserved.

In this application, when describing any one of the components or portions of the handle, ablation catheter, or electrode assembly in the impulse ablation device or ablation device, the terms "proximal" and "distal" are relative orientations, positions, and directions of elements or actions with respect to one another from the perspective of a physician using the product, although "proximal" and "distal" are not intended to be limiting, and "proximal" generally refers to the end of the product that is closer to the physician during normal operation, while "distal" generally refers to the end that is first introduced into the patient. It can also be said that "proximal" refers to the side proximal to the user/operator direction, and correspondingly "distal" is the side distal to the user/operator direction; the "distal end" is the side proximate to the target tissue, such as when the ablation catheter delivers the electrode assembly to the site of the target tissue within the human body; in this application, the terms "proximal" and "distal" refer to a direction and do not denote a component or an element of a device/component. For example, the "proximal end" of the ablation catheter refers to the end of the ablation catheter in the user/operator direction in the use state, and the "distal end" of the ablation catheter refers to the end of the ablation catheter away from the user/operator direction in the use state, it being understood that the expressions "proximal side" or "distal side" may also be used in the present application to indicate a relative position, direction.

In the present application, the term "couple" or "connect" refers to a mechanical connection between two members or portions, which may be a separable or assemblable connection or an inseparable, integrally-formed connection; in the present application, the term "integrally formed" refers to a structure integrally formed as one piece by a processing process such as stamping, cutting, casting, injection molding, etc., the structure being one member and being inseparable. In this application, the terms "coupled" or "connected" may also be directly connected or indirectly connected through intervening media, and may refer to the communication between two elements or the interaction between two elements.

In this application, the term "electrically connected" refers to an electrical connection for enabling transmission of electrical signals of two parts; for example, in some embodiments of the present application, the electrode elements and electrode connectors in the electrode assembly are pathways for electrical signals to be carried through the electrode leads.

In the present application, the term "axial movement" refers to a movement along the direction of the axis, such as an axial movement of the inner tube, and refers to a movement of the inner tube as a whole along the direction of the axis, which may be a movement from the distal direction toward the proximal direction, or a movement from the proximal direction toward the distal direction.

The pulse ablation system disclosed herein includes a control apparatus or delivery console and a pulse ablation device, wherein the control apparatus or delivery console provides pulse ablation energy output and control, measurement and/or monitoring of a physiological condition of a patient, and delivery of one or more predetermined or automated procedures of delivering ablation or treatment energy in response to the monitored/measured condition. For example, the processing circuitry may be configured to execute a therapy program prior to or at the time of delivery of ablation or therapeutic energy. The control unit may include a dedicated user input device (e.g., buttons, switches, a touch screen provided GUI interface, etc.) that allows the operator to quickly and easily perform relevant procedures, such as system parameters, the medical device used, the target tissue type, non-target tissue types, the energy modality of the intended treatment, the user's assessment/judgment, etc., prior to initiating delivery of the treatment or ablation energy.

The pulsed ablation device may be directly coupled to a control apparatus or delivery console (such as a pulsed electric field generator including an energy control, delivery, and monitoring system). The control device or delivery console may also include a controller in communication with the generator for operating and controlling various functions of the generator. Further, the impulse ablation device may include one or more diagnostic or treatment regions for energy, treatment, and/or detection or diagnostic interaction between the impulse ablation device and a treatment site. The pulsed ablation device can deliver pulsed electric field electroporation energy to a target tissue region near one or more treatment regions.

Referring to fig. 1, a schematic diagram of a pulse ablation system according to an embodiment of the present application is shown, wherein the pulse ablation system includes a delivery console 1 and a pulse ablation device 2; wherein, the pulse ablation device 2 comprises an operating handle 20, an ablation catheter 30 and electrode components 40 and 50.

In the present application, the ablation catheter 30 may be a catheter that can be delivered to a target tissue region via a sheath or an intravascular introducer, such as the use state of the ablation catheter 30, the guiding sheath is advanced into the right ventricle via the superior vena cava and the right atrium, the distal end of the ablation catheter 30 is extended from the distal end of the guiding sheath and inserted into a predetermined position of the ventricular wall, the electrode assembly 40,50 is extended, and then the electrode assembly 40,50 is expanded by operation, and pulse energy is released under the control of the control device/apparatus to perform ablation. The elongate body of the ablation catheter 30 may define a proximal portion, a distal portion, and a longitudinal axis, and may further include one or more lumens disposed within the elongate body thereof to provide mechanical, electrical, and/or fluid communication between the elongate body proximal portion and the elongate distal portion.

Referring to fig. 2, which is an enlarged view taken at a in fig. 1, as shown in the figure, the ablation catheter 30 includes an outer tube 31 and an inner tube 32 extending from a proximal end to a distal end, wherein the proximal end of the outer tube 31 is fixed to an operating handle, the distal ends of the outer tube 31 and the inner tube 32 are fixed with electrode assemblies 40,50, specifically, the distal end of the outer tube 31 is provided with a plurality of electrode elements, and the proximal end structure of each electrode element is fixed to the distal end portion of the outer tube 31. The inner tube 32 is disposed through the outer tube 31 and is capable of axial movement (as indicated by the arrow in fig. 2) relative to the outer tube 31, i.e., the inner tube 32 is operable to move telescopically within the outer tube 31.

An electrode assembly 40,50 is fixed to the distal end of the inner tube 32, and specifically, a plurality of electrode elements are provided at the distal end of the inner tube 32 and the distal end of the outer tube 31, the proximal structure of each electrode element is fixed to the distal end portion of the outer tube 31, and the distal structure of each electrode element is fixed to the distal end portion of the inner tube 32, such that the plurality of electrode elements in the electrode assembly 40,50 are fixed between the distal end of the outer tube 31 and the distal end of the inner tube 32, and such that the plurality of electrode elements in the electrode assembly 40,50 are switched between a contracted state and an expanded state when the inner tube 32 and the outer tube 31 are relatively moved.

Referring to fig. 3, which is a schematic view illustrating a contracted state of the electrode assembly in an embodiment of the present application, as shown in the present application, the contracted state of the electrode assembly 40,50 refers to a state in which a proximal portion/proximal end structure of each of a plurality of electrode elements in the electrode assembly 40,50 is gradually separated from a distal portion/distal end structure thereof until the proximal portion/proximal end structure and the distal portion/distal end structure of each electrode element reach a maximum distance, at which time the electrode assembly 40,50 is in a long bar shape as a whole, in a state shown in fig. 3.

Referring to fig. 4, which is a schematic view of an expanded state of the electrode assembly in one embodiment of the present application, as shown, the expanded state of the electrode assembly 40,50 in the present application refers to a state in which the proximal portion/end structure of each of the plurality of electrode elements in the electrode assembly 40,50 is gradually closer to the distal portion/end structure thereof, and the entire electrode assembly 40,50 is spherically expanded, as shown in fig. 4. I.e., the intermediate portion/connection between the proximal portion/proximal structure and the distal portion/distal structure of each of the plurality of electrode elements, tends to move away from the axis of the electrode assembly 40,50 until a predetermined minimum distance is reached between the proximal portion/proximal structure and the distal portion/distal structure of each electrode element.

In some embodiments, the outer tube 31 or the inner tube 32 of the ablation catheter 30 is made of a material including polyether block amide, nylon, polyurethane, or silicone, for example. In some embodiments, the ablation catheter 30 is configured to accommodate bending capabilities, and the ablation catheter 30 can be deployed to any tissue site in the heart to accommodate various focal sites. The ablation catheter 30 is a braided catheter body made of polyurethane and PEBAX materials and stainless steel wires, and has good torque response and support. In still other embodiments, the material of the ablation catheter 30 is a polymer material, and more preferably a thermoplastic material, and the thermoplastic material includes one or more combinations of polymer materials such as PET (polyethylene terephthalate), PEBAX (polyether amide), PTFE (polytetrafluoroethylene), PI (polyimide), and PA (nylon), so as to obtain the ablation catheter 30 with certain hardness and softness, which not only avoids damage to the electrode lead or the pull wire disposed therein, but also better isolates the electrode lead or the pull wire. More preferably, the ablation catheter 30 is made of PET material, so as to obtain a sleeve with a certain hardness, and prevent the ablation catheter 30 from deforming during the movement of the pull wire, so that the ablation catheter 30 has a better use effect.

In some embodiments, the inner tube 32 of the ablation catheter 30 may have a lumen therein that can receive the guidewire 28 so that the tip portion of the catheter can be delivered over the wire to the treatment site. The lumen of inner tube 32 may be configured to receive various sizes of guidewire 28. In some embodiments, guidewire 28 may be introduced into inner tube 32 through a guidewire inlet of the handle.

In some embodiments, the ablation catheter 30 is provided with a channel (not shown) for passing the pull wire and the electrode lead, in one embodiment, for example, one or more collars or sleeves (not shown) are provided between the outer tube 31 and the inner tube 32, the collars or sleeves are provided with channels for passing the pull wire and the electrode lead, in another embodiment, the channels for passing the pull wire and the electrode lead can also be provided on the tube body of the outer tube 31, for example, a lead or a guide wire channel is provided in the tube wall of the outer tube 31, so that the pull wire extends from the distal end of the ablation catheter 30 to the pull mechanism of the handle; and electrode leads extending from the electrode assemblies 40,50 mounted on the distal end of the ablation catheter 30 to electrode connectors on the handle and electrically connected thereto.

In this application, the impulse ablation device further includes an electrode assembly comprised of one or more electrode elements (which may also be referred to as treatment elements in some examples) at, coupled to, or on the distal end portion of the elongate body of the ablation catheter for energy, therapeutic, and/or research or testing interaction between the ablation apparatus and the treatment site or region. As a non-limiting example, the electrode assembly may be transitionable between a contracted state and an expanded state in which each electrode element has an arcuate or substantially circular configuration. For example, the electrode elements may form, in the expanded state, spheres or other expanded body structures, such as spheres, cones, rugby spheres, hourglass shapes, pear shapes, onion shapes, etc., the cross-sections of which may lie in a plane substantially orthogonal to the longitudinal axis of the elongate body.

In one embodiment, the degree of expansion of the electrode assembly in the expanded state determines the degree of contact of each of the electrode elements with tissue. The spherical orientation of the inflated spheres may facilitate application of energy emitted by the plurality of electrode elements to target tissue at the site to be treated in proximity or contact. In one example, the target tissue is, for example, a target tissue in a human heart, such as a pulmonary vein ostium.

In the present application, the plurality of electrode elements in the electrode assembly may also perform diagnostic functions, such as collecting intracardiac electrocardiogram/electrogram (EGM or EKG)/or Monophasic Action Potential (MAP) and performing selective pacing of intracardiac sites for diagnostic purposes. The measured signal may be fed back to a control device, and the plurality of electrode elements in the electrode assembly may also monitor the proximity of target tissues and the quality of contact with those tissues using impedance-based measurements. The energy generator of the control device may include a high speed relay to disconnect/reconnect a particular electrode from the generator during the energy delivery procedure. Following delivery of the pulsed energy, the relay may reconnect one or more electrode elements for diagnostic purposes.

In the present application, and as shown in fig. 1, the electrode assembly 40,50 includes a plurality of electrode elements disposed between the outer tube 31 and the inner tube 32 of the ablation catheter 30, each electrode element including a proximal structure secured to the distal end of the outer tube 31 and a distal structure secured to the distal end of the inner tube 32; that is, the distal end of the inner tube 32 and the distal end of the outer tube 31 are commonly provided with a plurality of electrode elements, the proximal structure of each electrode element being fixed to the distal portion of the outer tube 31, and the distal structure of each electrode element being fixed to the distal portion of the inner tube 32, such that the plurality of electrode elements in the electrode assembly 40,50 are fixed between the distal end of the outer tube 31 and the distal end of the inner tube 32, such that relative movement of the inner tube 32 and the outer tube 31 causes the plurality of electrode elements in the electrode assembly to switch between a contracted state and an expanded state.

In embodiments where the electrode assembly 40,50 includes a plurality of electrode elements, in some embodiments, a control apparatus or delivery console may be configured to electrically connect a set of electrode elements of the ablation device to a set of electrode channels. The control device or delivery console may be configured to selectively deliver energy to the set of electrodes using the set of electrode channels. One or more ablation devices, each having a set of electrodes, may be connected to the delivery console. The set of electrodes may comprise any number of electrodes, for example 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20 or more electrodes. In one embodiment, the description is made, for example, with the number of electrode elements of the electrode assembly being 6.

In some embodiments, the electrode elements in the electrode assemblies 40,50 are, for example, nitinol, which may also be coated with one or more of gold, tantalum, iridium oxide, or other materials.

In the present application, the plurality of electrode elements in the electrode assembly 40,50 are fixed to the outer tube 31 or the inner tube 32 by fixing rings.

Referring to fig. 5, which is a schematic structural diagram of the fixing ring in one embodiment of the present invention, it should be noted that the fixing ring fixed on the outer tube 31 or the inner tube 32 has a similar structure, and in different directions, the fixing ring fixed on the outer tube 31 is a proximal fixing ring 33 in the following embodiment, and the fixing ring fixed on the distal end of the inner tube is a distal fixing ring 34 in the following embodiment.

In an embodiment, a proximal fixing ring 33 is disposed in a lumen of a distal end (as shown at D1 in fig. 4) of the outer tube 31, the proximal fixing ring 33 is used for fixing a proximal structure of the electrode assembly, a plurality of proximal limiting portions are uniformly disposed on a ring body of the proximal fixing ring 33, each of the plurality of proximal limiting portions correspondingly fixes an electrode element, and in this embodiment, each of the proximal limiting portions has a proximal engaging slot 331 for engaging the proximal structure. A covering layer (not shown) for fixing the electrode assembly is wrapped on the ring body of the proximal fixing ring 33, and the covering layer wraps a proximal portion/proximal end structure of each of the plurality of electrode elements in the electrode assembly in the proximal locking groove 331 of the proximal fixing ring 33 to reinforce the fixation of the electrode assembly on the proximal fixing ring 33. The coating layer is made of insulating materials, such as insulating tapes and the like.

Referring to fig. 6, a cross-sectional view of a distal end fixing ring disposed at a distal end of an inner tube in an embodiment of the present disclosure is shown, as shown in the figure, in the embodiment, a distal end fixing ring 34 is disposed in a lumen of a distal end (as shown at D2 in fig. 4) of the inner tube 32, the distal end fixing ring 34 is used for fixing a distal end structure of the electrode set, a plurality of distal end limiting portions are uniformly disposed on a ring body of the distal end fixing ring 34, each of the plurality of distal end limiting portions corresponds to one electrode element, and in the embodiment, each distal end limiting portion has a distal end engaging slot 341 for engaging with the proximal end structure. A plurality of distal end slots 341 for engaging the distal end structure of the electrode assembly are formed on the peripheral side wall of the distal end fixing ring 34, and the distal end portion/distal end structure of each of the plurality of electrode elements in the electrode assembly is engaged with the corresponding distal end slot 341.

Referring now to fig. 7 in conjunction with fig. 1, fig. 7 is a schematic illustration of an operating handle in one embodiment of the present application, and as shown, the impulse ablation device includes an operating handle 20 coupled to a proximal portion of an ablation catheter 30, which is an elongate body. The operating handle 20 includes a connector (electrode connector in the present application) that can establish communication with the control device 1. The operating handle 20 may also include one or more actuation or control members 24 and 25 to control the distal end of the ablation catheter 30 to perform deflection, steering, or axial movement, among other actions. The operating handle 20 for the ablation catheter 30 of the present application is used for connecting the inner tube 32 and the outer tube 31 of the ablation catheter 30, and in an embodiment, an electrode connector (not shown in fig. 7) is further disposed on the operating handle 20 for electrically connecting each electrode element of the electrode assemblies 40,50 at the distal end of the ablation catheter 30. In the present embodiment, the operating handle 20 includes a handle body 21, an angle control assembly 24, and an axial moving assembly 25.

In one embodiment, the operating handle 20 includes a handle body 21 formed with an external grip portion in an ergonomic one-handed gripping configuration of the operator, and the handle body 21 is defined in terms of the direction from the distal end D2 toward the proximal end D1 as a distal end portion, i.e., a portion approximately between 1/2 of the entire handle body 21 and the distal end, and a proximal end portion, i.e., a portion approximately between 1/2 of the entire handle body 21 and the proximal end.

Referring to fig. 8 and 9, fig. 8 is an exploded view illustrating a first housing and a second housing of an operating handle according to an embodiment of the present disclosure, and fig. 9 is an exploded view illustrating an internal structure of an operating handle according to an embodiment of the present disclosure, as shown in the drawing, in the embodiment, a first accommodating space 213 and a second accommodating space 214 are provided in the handle body 21, wherein the first accommodating space 213 is located at a distal end portion of the handle body 21; the second accommodating space 214 is located at the proximal end portion of the handle body 21. In the present embodiment, the first and second receiving spaces 213 and 214 formed in the handle body 21 are implemented by assembling the first and second housings 211 and 212.

The angle control assembly 24 is arranged on the handle body 21 and used for controlling the distal end of the ablation catheter 30 to carry out angle steering; in an embodiment, the angle control assembly 24 includes an angle drive mechanism 240 and an angle knob 243. The angle driving mechanism 240 is disposed in the first accommodating space 213, the angle knob 243 is disposed at the distal end of the handle body 21 and is fixedly connected to the angle driving mechanism 240, and when the angle knob 243 is operated and rotated, corresponding components in the angle driving mechanism 240 can be driven to rotate.

In the present application, the angle control assembly 24 is used to drive the distal end of the ablation catheter 30 to steer/bend so that the electrode assembly at the distal end of the ablation catheter 30 more precisely acts on the target tissue to achieve the desired therapeutic effect.

The axial movement assembly 25 is adapted to drive the inner tube 32 relative to the outer tube 31 to transition the plurality of electrode elements between a contracted state and an expanded state. In an embodiment, the angle control assembly 24 includes an axial drive mechanism 250 and a toggle button 253. Wherein the axial driving mechanism 250 is disposed in the second accommodating space 214 and fixedly connected to the proximal end of the inner tube 32; the toggle button 253 is partially located in the second accommodating space 214 and is used for operating the axial driving mechanism 250 to axially move, and when the toggle button 253 is operated, corresponding parts of the axial driving mechanism 250 located in the second accommodating space 214 can be driven to axially move so as to pull or push the inner tube 32 to axially move relative to the outer tube 31, so that the electrode elements arranged at the distal end of the ablation catheter 30 can be contracted and expanded.

In an embodiment, a portion of the sidewall of the handle body 21 corresponding to the second accommodating space 214 is provided with a guide wire hole 210 for passing a guide wire, so that the guide wire 28 enters the inner tube 32 connected to the handle body 21 from the guide wire hole 210. In this embodiment, the guidewire port 210 is located in the handle body 21 adjacent to the proximal end thereof. Specifically, the guide wire hole 210 is formed by a channel obliquely inserted into the sidewall of the handle body 21, and the channel of the guide wire hole 210 forms an angle of about 10 ° to 60 ° with the axial line of the handle body 21, so that in operation, the guide wire 28 is inserted from the proximal end of the handle body 21 through the guide wire hole 210 into a delivery tube inside the handle body 21, and then passes through the lumen of the delivery tube until reaching the desired tissue site. In an embodiment, the included angle between the channel of the guide wire hole 210 and the axial line of the handle body 21 may be 10 °, 15 °, 20 °, 25 °, 30 °, 35 °, 40 °, 45 °,50 °, 55 °, or 60 °.

In an embodiment, the handle body 21 includes a first housing 211 and a second housing 212, the first housing 211 and the second housing 212 are connected and fixed by a snap-fit structure, in this embodiment, a plurality of hooks (not shown) are disposed on the first housing 211, a plurality of holes or slots 2120 corresponding to each hook are disposed on the second housing 212, and when the first housing 211 and the second housing 212 are assembled, the hooks on the first housing 211 are snapped into the holes or slots 2120 on the second housing 212 to assemble the two together.

In an embodiment, the first receiving space 213 and the second receiving space 214 formed in the handle body 21 are realized by assembling the first housing 211 and the second housing 212, wherein the first receiving space 213 formed in the first housing 211 and the second housing 212 is a closed space, that is, when the first housing 211 and the second housing 212 are assembled together, the components arranged in the first receiving space 213 are not visible; the second receiving space 214 formed in the first housing 211 and the second housing 212 is an open space (in a portion indicated by 215 in fig. 9) to expose a portion of the toggle button 253 disposed therein, that is, when the first housing 211 and the second housing 212 are assembled together, a portion of the toggle button 253 disposed in the second receiving space 214 exposes the handle body 21, and specifically, in the present embodiment, for convenience of operation, a half of the toggle button 253 leaks out of the second receiving space 214 or the handle body 21 so as to be operated by toggling for use.

In an embodiment, in order to strengthen the combination of the first housing 211 and the second housing 212, the proximal end of the handle body 21 is sleeved with a proximal cover 22 to fix the proximal ends of the first housing 211 and the second housing 212, in an embodiment, the proximal cover 22 is screwed on the proximal ends of the first housing 211 and the second housing 212 by respectively arranging internal threads on the proximal cover 22 and external threads on the proximal end of the handle body 21; or fixed at the proximal ends of the first housing 211 and the second housing 212 by means of clamping or screw locking. In this embodiment, the proximal cap 22 has a through hole 220 to allow a cable plug from an ablation control device to be inserted over the electrode connector 23 mounted in the handle body 21.

In an embodiment, a third accommodating space 215 is further formed in the handle body 21, the third accommodating space 215 is located at a proximal end of the handle body 21 (the first housing 211 and the second housing 212) and is used for accommodating the electrode connector 23, in this embodiment, the electrode connector 23 is fixed in the third accommodating space 215, a distal end of the third accommodating space is an output end, a proximal end of the third accommodating space is an input end, the output end of the electrode connector 23 is electrically connected to the electrode assembly through an electrode lead, and the input end of the electrode connector 23 is a plug structure or an interface so that a cable plug from an ablation control device is inserted into the electrode connector 23 installed in the handle body 21.

In some embodiments, the set of electrodes can include any number of electrodes, such as 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 14, 16, 18, 20, or more electrodes; accordingly, the electrode connector 23 for connecting a group of electrodes by electrode wires has terminals corresponding to the distance between each electrode, for example, in an embodiment of the present application, the number of electrode elements in the electrode assembly is 10, and the number of terminals on the electrode connector 23 is 10; for another example, if the number of electrode elements of the electrode assembly is 6, the number of terminals on the electrode connector 23 is 10, and in a specific embodiment, the terminals in the electrode connector 23 are pins corresponding to the insertion holes.

In the embodiment shown in fig. 9, a central core rod 26 is further disposed in the handle body 21, the central core rod 26 is used for connecting the outer tube 31 and the inner tube 32 of the ablation catheter 30, and the central core rod 26 is further used for disposing the angle driving mechanism 240 in the first accommodation space 213 and disposing the axial movement mechanism 25 in the second accommodation space 214. The outer tube 31 and the inner tube 32 of the ablation catheter 30 are secured to the mandrel 26.

In an embodiment, the proximal end of the outer tube 31 is fixed to the distal end portion of the central core rod 26, that is, the proximal end of the outer tube 31 is fixedly connected to the distal end of the central core rod 26, and in a specific implementation, the outer tube 31 may be fixed to the distal end of the central core rod 26 by screw locking, or by snap-fitting, or by heat fusion, etc.

In another embodiment, the proximal end of the outer tube 31 is fixed to the middle portion of the central core rod 26, in this embodiment, the outer tube 31 is inserted into the central core rod 26 to reach the middle portion of the central core rod 26, and then is fixedly connected to the central core rod 26, a first wire slot 265 is formed on the rod body 260 of the central core rod 26, so that the bending pulling wire 27 from the distal end of the ablation catheter 30 passes through the first wire slot 265 to be connected to a pulling block, which is referred to as a first pulling member 241 in this embodiment; the first wire slot 265 is opened on the shaft 260 of the center core rod 26 and extends from the distal end to the proximal end for a distance, and the proximal end of the outer tube 31 is fixed on the middle portion of the center core rod 26 at a distance from the proximal end of the first wire slot 265 so as to leave a gap for the pull wire to pass through. In a specific implementation, the outer tube 31 can be fixed to the middle portion (near the proximal end of the wire slot) of the central core rod 26 by screw locking or snap fitting or heat fusing.

In one embodiment, the proximal end of the inner tube 32 is fixedly connected to the axial moving mechanism 25, and the axial moving mechanism 25 includes a pulling block for pulling the inner tube 32 to move in the axial direction, which is referred to as a second pulling member in this embodiment, which will be described in detail later; the traction block is provided with a fixing hole for fixing the near end of the inner tube 32, so that the inner tube 32 is fixed on the traction block in a screw locking or clamping or hot melting mode and the like.

In the embodiment shown in fig. 9, a compartment 216 for engaging the central rod 26 is disposed between the first receiving space 213 and the second receiving space 214 in the handle body 21, and an engaging structure (not shown) is disposed in the compartment 216 to clamp the central rod 26 in the handle body 21. In this embodiment, the fastening structure is a fastening block, and is used to cooperate with a fastening groove formed on the middle core rod 26 to limit the middle core rod 26 from rotating or moving axially in the handle body 21; the compartment 216 between the first receiving space 213 and the second receiving space 214 is located in the handle body 21 near about 1/3 of the distal side thereof, i.e., the compartment 216 is located closer to the distal side of the handle body 21 as a whole of the handle body 21.

Accordingly, in the present embodiment, the central stem 26 includes a hollow rod 260 and a clamping portion 261 disposed in the middle of the rod 260 for clamping in the compartment 216 to clamp the rod 260 in the handle body 21. The engaging portion 261 is a circular sheet integrally formed on the rod body 260 of the central core rod 26, the circular sheet is provided with a slot or a notch corresponding to the engaging block in the compartment 216, when the engaging portion 261 of the central core rod 26 is combined with the engaging block of the compartment 216, the side walls on both sides of the compartment 216 limit the displacement of the central core rod 26 in the distal and proximal directions, and the engaging block of the compartment 216 limits the rotation of the central core rod 26 in the handle body 21.

Referring to fig. 10, which is an exploded schematic view of the operating handle of the present application in one embodiment, as shown in the drawing, in the present embodiment, the hollow rod 260 of the central rod 26 includes a plurality of limiting portions, specifically, a first limiting portion 262, a second limiting portion 263, and a third limiting portion 264; the first position-limiting portion 262 is disposed at a distal portion of the rod 260, the second position-limiting portion 263 is disposed between the first position-limiting portion 262 and the engaging portion 261, and the third position-limiting portion 264 is disposed between the engaging portion 261 and a proximal end of the rod 260. In this embodiment, the first position-limiting portion 262 and/or the second position-limiting portion 263 are/is a slot formed on the rod 260 for engaging with a snap ring or a card; the third position-limiting portion 264 is a projection integrally formed on the rod 260.

Referring to fig. 11, which is an exploded schematic view of an embodiment of the angle control assembly of the present application, as shown in the drawing, in the embodiment, a clamping groove is formed on the rod 260 of the central core rod 26 around the cylindrical rod 260 to form the first limiting portion 262 or the second limiting portion 263, and the clamping groove may be matched with a clamping ring 29 or a clamping sheet to limit a component disposed on the rod 260.

In the example of fig. 10, the third position-limiting portion 264 is a protrusion (bump) or a bump (protruding block) integrally formed on the rod 260 to limit the moving range of the corresponding component of the axial driving mechanism 250. Of course, as for the arrangement of the first position-limiting portion 262 and the second position-limiting portion 263, the third position-limiting portion 264 may also adopt the implementation manner of the first position-limiting portion 262 and the second position-limiting portion 263.

In the example of fig. 11, a wire groove is formed on a distal portion of the rod body 260 of the central core rod 26, in this embodiment, a first wire groove 265 for passing a pull wire 27 is formed on the rod body 260 from the distal end of the rod body 260 to the second stopper portion 263, so that the bending pull wire 27 from the distal end of the outer tube 31 passes through the first wire groove 265 to be connected to a pull block (a first pull member 251), and the distal end of the rod body 260 has a C-shaped cross section due to the first wire groove 265.

In an embodiment, the distal end of the central core rod 26 protrudes out of the distal end of the first sleeve 242 and is located inside the angle knob 243, in this embodiment, the proximal end of the outer tube 31 is fixed to the distal end portion of the central core rod 26, that is, the proximal end of the outer tube 31 is combined with the portion of the central core rod 26 exposing out of the first sleeve 242, in a specific implementation manner, the outer tube 31 may be fixed to the distal end portion of the central core rod 26 by screw locking, or snapping, or heat fusing, and accordingly, the first limiting portion 262 is also located at the distal end portion of the central core rod 26 protruding out of the first sleeve 242, so as to limit the first sleeve 242 on the central core rod 26.

In one embodiment, a proximal portion of the shaft 260 of the middle core rod 26 is provided with a wire groove, in this embodiment, a proximal portion of the shaft 260 is provided with a second wire groove 266, and the second wire groove 266 extends from a proximal end of the shaft 260 to a distal end and terminates between the third position-limiting portion 264 and the engaging portion 261, so as to form an opening for passing the electrode lead 230 at a portion between the third position-limiting portion 264 and the engaging portion 261. Specifically, in a direction from the proximal end to the distal end, the distal end of the second wire groove 266 exceeds the third position-limiting portion 264, that is, the distal end of the second wire groove 266 is located at a position between the third position-limiting portion 264 and the engaging portion 261, in other words, when the traction block of the axial driving mechanism 250 is axially displaced, the distal end of the second wire groove 266 cannot reach the distal end of the third wire groove 266 due to the presence of the third position-limiting portion 264, so that a gap is left between the distal end of the second wire groove 266 and the third position-limiting portion 264, and the gap is used for allowing the electrode lead from the distal electrode assembly of the ablation catheter 30 to pass through to electrically connect to the electrode connector 23 disposed at the proximal end of the handle body 21.

In an embodiment, a distal end of the first sleeve 242 is exposed out of the first accommodating space 213 of the handle body 21 to combine with the angle knob 243, and in this embodiment, the first sleeve 242 and the angle knob 243 are coaxially disposed. A fastening hole 2420 is formed on a sidewall of the distal end of the sleeve, and correspondingly, a fastening hole 2430 is formed on a position of the angle knob 243 corresponding to the fastening hole 2430, in one embodiment, the fastening hole 2420 or 2430 is, for example, a screw hole, for allowing a screw or a combination of a screw and the screw hole to fasten the angle knob 243 on the distal end of the first sleeve 242. In this embodiment, the inner distal end of the angle knob 243 is formed with a counterbore structure for engaging the distal end of the center stem 26 protruding out of the distal end of the first sleeve 242.

In an embodiment, the port portion of the distal end of the handle body 21 is a structure for tightening the port, and the distal end of the first accommodating space 213 has a sleeve locking groove (not shown), and correspondingly, a locking strip 2421 corresponding to the sleeve locking groove is disposed on the outer peripheral wall of the first sleeve 242 to limit a portion of the first sleeve 242 in the first accommodating space 213, so as to prevent the first sleeve 242 from axially separating from the handle body 21.

The angle drive mechanism 240 is used to pull the bending pull wire 27 from the distal end of the ablation catheter 30 (distal end of the outer tube 31 and/or inner tube 32) by axial movement of the internal components to steer the distal end of the ablation catheter 30 so that the electrode assembly at the distal end of the ablation catheter 30 can be brought into better proximity with the target tissue.

In one embodiment, the angle driving mechanism 240 includes a first pulling member 241 and a first sleeve 242. In this embodiment, the first pulling element 241 is slidably sleeved between the second limiting portion 263 and the engaging portion 261 of the central rod 26, and can perform axial displacement between the second limiting portion 263 and the engaging portion 261 when being driven; the first sleeve 242 is sleeved between the first limiting portion 262 and the engaging portion 261 of the central core rod 26 to limit the sleeve to rotate only relative to the central core rod 26 and not to move axially.

The first pulling member 241 is slidably sleeved on the middle core rod 26, in this embodiment, the first pulling member 241 includes a first spiral part 2411 and a pulling part 2414, specifically, the first spiral part 2411 and the pulling part 2414 are integrally formed, the first spiral part 2411 is a spiral ring with an external thread, the pulling part 2414 is a sleeve integrated with the spiral ring, a protrusion 2416 is formed on an outer wall of the sleeve corresponding to an angle or a direction of the first thread groove 265, and a second thread hole 2415 is formed on the protrusion 2416 for fixing a pulling wire 27 for bending from a distal end of the ablation catheter 30 (a distal end of the outer tube 31 and/or the inner tube 32). Specifically, the overall cross-section of the first drawing member 241 is a T-shaped structure.

In an embodiment, in order to make the pulling wire 27 for bending from the distal end of the ablation catheter 30 finally reach the protrusion 2416, as described above, a first wire groove 265 is formed on the rod 260 between the distal end of the rod 260 and the second limiting portion 263, a first wire hole 2413 for the pulling wire 27 to pass through is further formed on the first spiral portion 2411 of the first pulling member 241, the pulling wire 27 passes through the lumen of the ablation catheter 30 from the distal end of the ablation catheter 30, passes through the first wire groove 265 and the first wire hole 2413, and finally reaches a second wire hole 2415 formed on the pulling portion 2414, and is fixed on the protrusion 2416 of the pulling portion 4; when the first pulling element 241 moves linearly in the axial direction on the central core rod 26, the pulling wire 27 is pulled or loosened, thereby achieving the purpose of bending or releasing the pulling of the distal end of the ablation catheter 30. When the angle driving mechanism 240 is assembled in this embodiment, the positions of the first line slot 265, the first line hole 2413 and the second line hole 2415 are located on the same straight line.

In this embodiment, a linear guide 267 is disposed on the rod 260 between the second limiting portion 263 on the middle core rod 26 and the engaging portion 261, the linear guide 267 is one or two linear ribs integrally formed on the sidewall of the rod 260 of the middle core rod 26, correspondingly, the inner wall of the first pulling member 241 has a guide groove corresponding to the linear guide 267, and through the combination of the guide groove and the linear guide 267, the first pulling member 241 does not rotate when axially moving on the rod 260 of the middle core rod 26, thereby ensuring the stability of the linear movement.

In this embodiment, the first sleeve 242 is sleeved between the first position-limiting portion 262 and the engaging portion 261 of the middle core rod 26, and a distal end of the first sleeve 242 is fixedly connected to the angle knob 243, so as to drive the first sleeve 242 to rotate when the angle knob 243 rotates. An inner thread corresponding to the outer thread of the first spiral portion 2411 is formed on the inner wall of the cylinder body of the first sleeve 242, and is used for driving the first traction member 241 screwed therein to displace between the second limiting portion 263 and the clamping portion 261 when the angle knob 243 drives the first sleeve 242 to rotate. In a specific implementation, the first pulling member 241 is screwed in the first sleeve 242 through the first screw 2411, and when the first sleeve 242 rotates, the first pulling member 241 can perform an axial linear motion in the first sleeve 242 due to the screwing action of the internal and external threads.

In an embodiment, the angle knob 243 is provided with a first operation portion 2431, and in a specific implementation, the first operation portion 2431 is an anti-slip structure integrally formed on the angle knob 243 or an anti-slip material wrapped on the angle knob 243. In an exemplary embodiment, the anti-slip structure on the first operation portion 2431 is a raised rib, the rib is uniformly spaced, and when the operator operates the angle knob 243, the operator can sense the traction degree of the traction wire 27, and thus the bending degree of the distal end of the ablation catheter 30, by sensing the rotation of the rib in a tactile manner.

Referring to fig. 12, which is an exploded view of an embodiment of the axial driving mechanism of the present application, in the embodiment, the axial driving mechanism 250 drives the inner tube 32 to move axially relative to the outer tube 31 by controlling the inner element of the axial driving mechanism to expand/expand and contract the electrode assembly fixed between the distal end of the outer tube 31 and the distal end of the inner tube 32. In one embodiment, the axial driving mechanism 250 includes a second pulling member 251 and a second sleeve 252.

The second pulling member 251 is slidably disposed between the third position-limiting portion 264 of the middle core rod 26 and the proximal end of the rod body 260, that is, the second pulling member 251 can axially move between the third position-limiting portion 264 of the middle core rod 26 and the proximal end of the rod body 260 when being driven, in this embodiment, the proximal end of the inner tube 32 is fixed on the second pulling member 251, and is used for pulling or pushing the inner tube 32 to axially move when the second pulling member 251 axially moves on the rod body 260.

In this embodiment, the second pulling member 251 includes a second spiral portion 2511 and a fixed tube 2512, wherein the second spiral portion 2511 is provided with an external thread, the fixed tube 2512 and the second spiral portion 2511 are integrally formed, and specifically, the fixed tube 2512 is a tubular structure. Specifically, the overall cross section of the second traction member 251 is a T-shaped structure.

In this embodiment, two symmetrical cylindrical structures are formed on the proximal section of the central core rod 26 from the third position-limiting portion 264, and a second line groove 266 is formed between the two symmetrical cylindrical structures; accordingly, the second pulling member 251 has two crescent holes (not shown) for passing through two symmetrical cylindrical structures on the rod body 260, so that the second pulling member 251 is in a linear motion state when moving axially on the central rod 26, in other words, the two symmetrical cylindrical structures of the rod body 260 are inserted into the two crescent holes of the second pulling member 251, and the second pulling member 251 is restricted from rotating relative to the rod body 260 and can only move linearly relative to the rod body 260. In this embodiment, the fixed tube 2512 of the second pulling member 251 is located in the space between the two symmetrical column structures, i.e. the fixed tube 2512 of the second pulling member 251 has a smaller tube diameter than the rod body 260.

In this embodiment, the second slot 266 extends from the proximal end of the rod 260 to the distal end and terminates between the third position-limiting portion 264 and the engaging portion 261, so as to form an opening for the electrode lead 230 to pass through at the portion between the third position-limiting portion 264 and the engaging portion 261. Specifically, in the direction from the proximal end to the distal end, the distal end of the second wire groove 266 exceeds the position of the third position-limiting portion 264, that is, the portion of the distal end of the second wire groove 266 between the third position-limiting portion 264 and the engaging portion 261, in other words, when the traction block of the axial driving mechanism 250 is axially displaced, the distal end of the second wire groove 266 cannot reach the distal end of the second wire groove 266 due to the presence of the third position-limiting portion 264, so that a gap g is left between the distal end of the second wire groove 266 and the third position-limiting portion 264, and the gap g is used for passing through the electrode lead 230 from the distal electrode assembly of the ablation catheter 30.

In this embodiment, the second spiral portion 2511 of the second pulling member 251 is provided with a through hole 2513 for passing the electrode lead 230 therethrough, so that the electrode lead 230 from the electrode assembly at the distal end of the ablation catheter 30 passes through the channel between the outer tube 31 and the inner tube 32, passes through the distal gap g of the second wire groove 266, and then passes through the through hole provided in the second spiral portion 2511 until reaching and electrically connected to the electrode connector 23 at the proximal end of the handle body 21. The second helical portion 2511 has a central hole for the inner tube 32 of the ablation catheter 30 to pass through to be fixed to the distal fixing tube 2512.

In this embodiment, the second sleeve 252 is sleeved between the third limiting portion 264 of the middle core rod 26 and the proximal end of the rod body 260, and an inner wall of the second sleeve 252 forms an inner thread corresponding to the outer thread of the second spiral portion 2511, so as to drive the second pulling member 251 screwed therein to axially move on the rod body 260 through the rotation of the second sleeve 252, and further drive the inner tube 32 fixed to the second pulling member 251 to axially move.

In this embodiment, the toggle button 253 is integrally formed at the proximal end of the second sleeve 252 to drive the second sleeve 252 to rotate when toggled. That is, when the angle knob 243 drives the first sleeve 242 to rotate, the second pulling member 251 screwed therein is driven to axially displace between the third limiting portion 264 and the proximal end of the rod 260. Specifically, the overall cross section of the second sleeve 252 is a T-shaped structure; when the second sleeve 252 and the second pulling member 251 are assembled in the handle body 21, the T-shaped direction of the second pulling member 251 with the T-shaped cross section is opposite to that of the second sleeve 252 with the T-shaped cross section.

In the present embodiment, the second receiving space 214 formed in the first housing 211 and the second housing 212 is an open space to expose a portion of the toggle button 253 disposed therein, that is, when the first housing 211 and the second housing 212 are assembled together, a portion of the toggle button 253 disposed in the second receiving space 214 exposes the handle body 21, specifically, in the present embodiment, for convenience of operation, a half of the toggle button 253 leaks out of the second receiving space 214 or the handle body 21, so that the user can operate the toggle button by toggling.

In one embodiment, the toggle button 253 disposed in the open space of the second accommodating space 214 is located at a position 1/3 of the proximal side of the handle body 21, i.e., the side of the compartment 216 closer to the proximal end of the handle body 21 as viewed from the whole of the handle body 21.

In an embodiment, the dial 253 knob is provided with a second operation portion 2531, and in a specific implementation, the second operation portion 2531 is an anti-slip structure integrally formed on the dial 253 or an anti-slip material wrapped on the dial 253. In an exemplary embodiment, the anti-slip structure on the second operation portion 2531 is a raised rib, the ribs are uniformly spaced, and when the operator dials the dial button 253, the operator can sense the degree of axial pulling or pushing of the inner tube 32, and thus the degree of expansion of the electrode assembly at the distal end of the ablation catheter 30, by sensing the rotation of the ribs through the sense of touch.

Referring to fig. 13, there is shown a schematic view of the operating handle of the present application equipped with an angle control assembly and an axial driving mechanism in an embodiment, as shown in the figure, and the present application configures the angle control assembly 240 and the axial moving assembly 250 in a single handle 20 through a central core rod by means of a unique mechanical assembly configuration and mechanism design, which not only optimizes the conventional operating handle design for ablation pulse, but also provides a smaller operation difficulty for the operator, especially for the doctor, during the operation, thereby facilitating the operation and the precision control.

As for the structure and installation manner disclosed in the above embodiment, the electrode connector 23 installed in the third accommodating space 215 of the proximal portion of the operating handle 20 is electrically connected to a control device or a delivery console through a cable, the operating handle 20 is connected to the ablation catheter 30, and the ablation catheter 30 is extended from the distal end of the handle body 21, during the use, when it is required to change the direction of the distal end of the ablation catheter 30, for example, when the ablation catheter 30 enters the human body, so that the electrode assembly at the distal end of the ablation catheter 30 can better approach the target tissue, the operator rotates the angle knob 243 disposed at the distal end of the handle body 21, the angle knob 243 drives the first pulling member 241 of the angle driving mechanism 240 to axially displace in the first sleeve 242, and since the proximal end of the pulling wire 27 is fixed on the first pulling member 241, the axial displacement of the first pulling member 241 will pull the pulling wire 27 or release the pulling force on the pulling wire 27, thereby achieving the direction adjustment of the distal end of the ablation catheter 30 at the distal end of the pulling wire.

In operation, when positioning of target tissue is completed or the electrode assembly at the distal end of the ablation catheter 30 reaches a target position, and it is necessary to release the electrode assembly in a contracted state from the ablation catheter 30 to expand the electrode assembly from the contracted state to an expanded state, at this time, an operator needs to toggle a toggle button 253 exposed at a portion of the handle body 21, the toggle button 253 rotates to drive the second traction member 251 of the axial driving mechanism 250 to axially displace in the second sleeve 252, and since the proximal end of the inner tube 32 is fixed on the second traction member 251, the inner tube 32 is also driven to axially displace in the second traction member 251, and since the plurality of electrode elements in the electrode assembly are fixed between the distal end of the outer tube 31 and the distal end of the inner tube 32, the inner tube 32 and the outer tube 31 move relatively to switch the plurality of electrode elements in the electrode assembly between the contracted state and the expanded state.

As described above, the pulse ablation device and the operation handle of the ablation catheter of the present application are configured on different operation handles, compared with the prior art in which the mechanism for driving the ablation electrode to bend and the mechanism for driving the ablation electrode to expand or contract are configured on different operation handles, the present application realizes both the bending function of the ablation catheter and the control of the expansion and contraction of the electrode ball on a single handle body, and the present application configures the angle control assembly and the axial movement assembly in the single handle through a center core rod through the configuration mode and the mechanism design of a unique mechanical assembly, thereby not only optimizing the design of the traditional operation handle of the ablation catheter, but also providing smaller operation difficulty for the application of professionals, particularly doctors, in the operation, and further facilitating the operation and the control of the precision.

The above embodiments are merely illustrative of the principles and utilities of the present application and are not intended to limit the present application. Any person skilled in the art can modify or change the above-described embodiments without departing from the spirit and scope of the present application. Accordingly, it is intended that all equivalent modifications or changes which can be made by those skilled in the art without departing from the spirit and technical concepts disclosed in the present application shall be covered by the claims of the present application.

Claims (32)

1. A pulse ablation device, comprising:

the ablation catheter comprises an outer tube extending from a proximal end to a distal end and an inner tube which is arranged in the outer tube in a penetrating way and can move axially relative to the outer tube;

an electrode assembly comprising a plurality of electrode elements disposed between an outer tube and an inner tube of the ablation catheter, each electrode element comprising a proximal structure secured to a distal end of the outer tube and a distal structure secured to a distal end of the inner tube;

the operation handle is used for being connected with the ablation catheter and comprises a handle body, an angle control assembly and an axial movement assembly, wherein the angle control assembly is arranged on the handle body and used for controlling the distal end of the ablation catheter to perform angle steering, and the axial movement assembly is used for driving the inner tube to move relative to the outer tube so as to enable the electrode elements to be converted between a contraction state and an expansion state.

2. The pulse ablation device according to claim 1, wherein the operating handle comprises a handle body formed with an external grip, a first accommodating space and a second accommodating space, the first accommodating space and the second accommodating space are respectively formed in the handle body and located at the distal end part and the proximal end part.

3. The pulse ablation device according to claim 2, wherein the angle control assembly comprises an angle driving mechanism disposed in the first accommodating space and an angle knob disposed at the distal end of the handle body and fixedly connected to the angle driving mechanism.

4. The pulse ablation device according to claim 3, wherein the axial movement assembly comprises an axial drive mechanism disposed in the second receiving space and fixedly coupled to the proximal end of the inner tube, and a toggle button partially disposed in the second receiving space for operating the axial movement of the axial drive mechanism.

5. The pulse ablation device according to claim 2, wherein a portion of the side wall of the handle body, which corresponds to the second accommodating space, is provided with a guide wire hole for a guide wire to pass through so that the guide wire enters the handle body from the guide wire hole.

6. The pulse ablation device according to claim 5, wherein the guidewire port is located in the handle body adjacent to the proximal end thereof.

7. The pulse ablation device according to claim 4, wherein the handle body comprises a first shell and a second shell connected with the first shell in a clamping manner, wherein a first accommodating space formed in the first shell and the second shell is a closed space; the second accommodating space formed in the first housing and the second housing is an open space to expose a part of the dial knob disposed therein.

8. The pulse ablation device of claim 7, wherein a proximal cap is sleeved over the proximal end of the handle body to secure the proximal ends of the first and second shells.

9. The pulse ablation device according to claim 4, wherein the toggle button disposed in the open space of the second housing space is located at 1/3 of the proximal side of the handle body.

10. The pulse ablation device according to claim 2, further comprising a third receiving space formed in the handle body at a proximal end thereof for receiving an electrode connector, the electrode connector being electrically connected to the electrode assembly through an electrode lead.

11. The pulse ablation device according to claim 4, further comprising a central core rod of a hollow structure for connecting the outer tube and the inner tube of the ablation catheter, wherein the central core rod is further used for arranging the angle driving mechanism in the first accommodating space and the axial movement mechanism in the second accommodating space.

12. The pulse ablation device according to claim 11, wherein the proximal end of the outer tube is fixed in the central core rod; the near end of the inner tube is fixedly connected to the axial movement mechanism.

13. The device of claim 11, wherein a compartment for engaging the mandrel is disposed between the first and second receiving spaces in the handle body, and an engaging structure is disposed in the compartment to retain the mandrel in the handle body.

14. The pulse ablation device of claim 13, wherein the compartment is located within the handle body adjacent 1/3 of a side of the distal end thereof.

15. The pulse ablation device of claim 11, wherein the central core rod comprises a hollow rod body and a clamping portion arranged in the middle of the rod body and clamped in the compartment to clamp the rod body in the handle body.

16. The pulse ablation device according to claim 15, wherein the shaft includes a first position-limiting portion disposed at a distal end of the shaft, a second position-limiting portion disposed between the first position-limiting portion and the engagement portion, and a third position-limiting portion disposed between the engagement portion and a proximal end of the shaft.

17. The pulse ablation device according to claim 16, wherein the first and/or second limiting portions are slots formed in the shaft body for engaging with a snap ring or a card; the third limiting part is a lug which is integrally formed on the rod body.

18. The pulse ablation device according to claim 16, wherein a first wire groove for passing a traction wire is formed on the rod body between the distal end of the rod body and the second limiting part.

19. The pulse ablation device according to claim 16, wherein the proximal portion of the shaft has a second wire groove extending from the proximal end of the shaft toward the distal end and terminating between the third stopper portion and the engagement portion to form an opening for passing an electrode wire at a portion between the third stopper portion and the engagement portion.

20. The impulse ablation device of claim 16, wherein said angular drive mechanism comprises:

the first traction piece is slidably sleeved between the second limiting part and the clamping part of the middle core rod; the traction part is integrally formed with the first spiral part;

the first sleeve is sleeved between the first limiting part and the clamping part of the middle core rod, the far end of the first sleeve is fixedly connected with the angle knob, and an internal thread corresponding to the external thread of the first spiral part is formed on the inner wall of the cylinder body of the first sleeve and used for driving the first traction piece screwed in the first sleeve to move between the second limiting part and the clamping part when the angle knob drives the first sleeve to rotate.

21. The impulse ablation device of claim 20, wherein a distal end of the central rod protrudes beyond a distal end of the first sleeve and is located within the angle knob.

22. The pulse ablation device according to claim 20, wherein a linear guide rail is disposed on the rod body between the second limiting portion and the engaging portion, and a guide groove corresponding to the linear guide rail is disposed on an inner wall of the first traction member.

23. The pulse ablation device according to claim 20, wherein the first spiral portion is provided with a first wire hole for passing a traction wire from the distal end of the outer tube and/or the inner tube.

24. The pulse ablation device according to claim 20, wherein the pulling portion is provided with a second wire hole for fixing a pulling wire from the distal end of the outer tube and/or the inner tube.

25. The impulse ablation device of claim 20, wherein a distal end of the first sleeve exposes the first receiving space of the handle body to engage the angle knob.

26. The pulse ablation device according to claim 20, wherein the distal end of the first accommodating space is provided with a sleeve clamping groove, and a clamping strip corresponding to the sleeve clamping groove is arranged on the peripheral wall of the outer side of the first sleeve so as to limit a part of the first sleeve in the first accommodating space.

27. The impulse ablation device of claim 16, wherein said axial drive mechanism comprises:

the second traction piece is arranged between the third limiting part of the middle core rod and the near end of the rod body in a sliding mode; the fixing device comprises a second spiral part provided with an external thread and a fixing pipe integrally formed with the second spiral part;

and the second sleeve is sleeved between the third limiting part of the middle core rod and the near end of the rod body, and an internal thread corresponding to the external thread of the second spiral part is formed on the inner wall of the cylinder body of the second sleeve and is used for driving the second traction piece screwed therein to displace between the third limiting part and the near end of the rod body when the angle knob drives the first sleeve to rotate.

28. The pulse ablation device according to claim 27, wherein the toggle button is integrally formed at a proximal end of the second sleeve to cause the second sleeve to rotate when toggled.

29. The pulse ablation device of claim 27, wherein a section of the central core rod from the third limiting portion towards the proximal end is two symmetrical cylindrical structures, and a second wire groove is formed between the two symmetrical cylindrical structures.

30. The pulse ablation device according to claim 29, wherein the second traction member has two crescent holes for passing two symmetrical cylindrical structures on the rod body respectively.

31. The impulse ablation device of claim 27, wherein the proximal end of the inner tube is secured to the fixed tube of the second traction element.

32. The pulse ablation device according to claim 27, wherein the second spiral part of the second traction member is provided with a through hole for passing an electrode lead.

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