CN115737109A

CN115737109A - Puncture ablation assembly, ablation device and ablation system

Info

Publication number: CN115737109A
Application number: CN202211510186.6A
Authority: CN
Inventors: 蒲朝霞; 张庭超; 丘信炯; 谢丽娟; 王柏栋
Original assignee: Hangzhou Nuoqin Medical Instrument Co ltd
Current assignee: Hangzhou Nuoqin Medical Instrument Co ltd
Priority date: 2022-11-29
Filing date: 2022-11-29
Publication date: 2023-03-07

Abstract

The application discloses subassembly, ablation device and system of ablating are ablated in puncture, and subassembly includes pipe and a plurality of syringe needle are ablated and located in the pipe movably to a plurality of syringe needles, and the distal end of pipe sets up at least one and goes out the needle mouth, and a plurality of syringe needles can stretch out and be between each other and be the form puncture entering target tissue of dispersing to melt target tissue. When the plurality of needles penetrate into the target tissue, the parts of the plurality of needles penetrating into the target tissue are all positioned on the first plane. When the ablation system using the puncture ablation assembly is used for ablation, the tissue form of target tissues can be better adapted, and the ablation accuracy is higher while full ablation is realized.

Description

Puncture ablation assembly, ablation device and ablation system

Technical Field

The application relates to the technical field of medical equipment, in particular to a puncture ablation assembly, an ablation device and an ablation system.

Background

Hypertrophic cardiomyopathy is a common autosomal dominant cardiovascular disease with an incidence rate of about 1:500, fatality rates of about 1.4% to 2.2%, are the most common cause of sudden death in young people and athletes. Hypertrophic cardiomyopathy is primarily characterized by one or more segments of the Left Ventricle (LV), with a typical diagnostic criterion being a thickness greater than or equal to 15mm. When the Anterior Mitral Valve (AMVL) systole moves forward against the Interventricular Septum (IVS) to cause stenosis or even obstruction of the Left Ventricular Outflow Tract (LVOT), i.e., when the Left Ventricular Outflow Tract pressure difference is too great, the patient is called obstructive hypertrophic cardiomyopathy.

At present, the treatment strategy for obstructive hypertrophic cardiomyopathy is to enlarge the left ventricular outflow tract to reduce the pressure difference and relieve the obstruction, and the commonly used treatment methods mainly comprise drug treatment, rotary ventricular septal ablation and ventricular septal alcohol ablation, but the methods have the defects of high surgical risk, poor treatment effect and the like.

In recent years, new techniques for treating obstructive hypertrophic cardiomyopathy have been disclosed, for example, using radiofrequency ablation with a radiofrequency ablation needle into the heart cavity. To increase the range of ablation, ablation devices employing multiple needles are disclosed in the prior art. However, the ablation range generated by the multiple needles of the existing ablation device is large, and non-target tissues are easily injured, so that the ablation accuracy of the target tissues is poor.

Disclosure of Invention

The utility model provides a subassembly, ablation device and system of melting puncture, the system of melting of using this subassembly of melting puncture is when melting, and the part that a plurality of syringe needles puncture got into the target tissue all is located the coplanar, and the tissue form of adaptation target tissue that can be better has still improved the accuracy nature of melting when realizing fully melting.

In a first aspect, the present application provides a ablation puncture assembly, which includes a catheter and a plurality of needles movably disposed in the catheter, wherein the distal end of the catheter is provided with at least one needle outlet, and the plurality of needles can extend out of the at least one needle outlet and penetrate into a target tissue in a divergent manner to ablate the target tissue. When the plurality of needles penetrate into the target tissue, the parts of the plurality of needles penetrating into the target tissue are all positioned on the first plane.

In a second aspect, the ablation device includes a sheath, a handle assembly and a puncture ablation assembly as described above, the puncture ablation assembly is movably disposed in the sheath, and both the puncture ablation assembly and the sheath are connected to the handle assembly.

In a third aspect, an ablation system is provided, which includes an energy generator and the ablation device, and the ablation device is electrically connected to the energy generator.

The utility model aims at providing a puncture melts subassembly, ablation device and ablation system, puncture melts subassembly and has a plurality of syringe needles, can form bigger ablation scope. When the ablation system using the puncture ablation assembly performs ablation, after the plurality of needle heads puncture into target tissues, the parts of the plurality of needle heads which puncture into the target tissues are all located on the same plane, so that the puncture ablation assembly can better adapt to the tissue form of the target tissues (such as compartment intervals), and the ablation accuracy is improved while the sufficient ablation is realized.

Drawings

FIG. 1 is a schematic view of a heart structure;

FIG. 2 is a schematic illustration of prior art RF ablation of a ventricular septum;

FIG. 3 is a schematic structural view of an ablation system provided herein;

FIG. 4 is a schematic view of a portion of a puncture ablation assembly provided herein in some embodiments;

FIG. 5 isbase:Sub>A schematic cross-sectional view taken along A-A of the ablation assembly of FIG. 4 in an extended state;

FIG. 6 isbase:Sub>A cross-sectional view of the catheter of FIG. 4 taken along line A-A;

FIG. 7 is a schematic cross-sectional view taken along line B-B of the heart after the plurality of needles of FIG. 3 have penetrated the heart;

FIG. 8 is a cross-sectional view of the catheter of FIG. 4 taken along line C-C;

FIG. 9 isbase:Sub>A schematic cross-sectional view taken along A-A of the needle ablation assembly of FIG. 4 inbase:Sub>A retracted state;

FIG. 10 is a schematic view of a portion of the puncture ablation assembly of FIG. 4 in some embodiments;

FIG. 11 is a schematic view of a portion of the internal structure of the ablation assembly of FIG. 10;

FIG. 12 is a schematic view of portions of further embodiments of a ablation assembly provided herein;

FIG. 13 is a cross-sectional view (one) of the needle ablation assembly of FIG. 4 in an extended state taken along line D-D;

FIG. 14 is a schematic cross-sectional view of the catheter of FIG. 4 taken along line C-C;

FIG. 15 is a cross-sectional view taken along D-D of the ablation assembly of FIG. 4 in an extended configuration;

FIG. 16 is a schematic structural view of the catheter shown in FIG. 3 in some embodiments;

FIG. 17 is a schematic view of a portion of the ablation device in the aorta;

fig. 18A-18D are schematic views illustrating a procedure of using the ablation system provided by the present invention.

Detailed Description

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

In the description of the present application, it is to be noted that, unless otherwise explicitly specified or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meaning of the above terms in the present application can be understood in a specific case by those of ordinary skill in the art. The term "and/or" is an associative relationship that describes an associated object, meaning that three relationships may exist, e.g., A and/or B, may mean: a exists alone, A and B exist simultaneously, and B exists alone.

In the description herein, references to embodiments of the terms "embodiment," "specific embodiment," "example," etc., the description to "specific embodiment," "example," etc., means that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the application. In this specification, the schematic representations of the terms used above do not necessarily refer to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.

In the field of interventional medical devices, proximal refers to the end closer to the operator, while distal refers to the end farther from the operator. "proximal" and "distal" are non-limiting positional descriptions. Axial refers to a direction parallel to a line connecting the center of the distal end and the center of the proximal end of the medical device, radial refers to a direction along a diameter or a radius, the radial direction is perpendicular to the axial direction, and circumferential refers to a circumferential direction around the central axis. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

Referring to fig. 1 and 2 in combination, fig. 1 is a schematic diagram of a heart structure, and fig. 2 is a schematic diagram of a prior art rf ablation of ventricular septum.

The heart may include the Left Ventricle (LV), right Ventricle (RV), left Ventricular Outflow Tract (LVOT), right Atrium (Right Atrium, RA), superior Vena Cava (SVC), aorta (aodic, AA), pulmonary Artery (PA), inferior Vena Cava (IVC), and the like. Myocardial tissue may include ventricular walls, atrial walls, ventricular Septum (VS) and atrial Septum. Wherein, the room interval can be divided into three parts again: a base portion, an intermediate portion, and an apex portion.

In the phenotype of Hypertrophic Cardiomyopathy (HCM), which is the most common and most influential for patients, hypertrophy and thickening of the base of the interventricular septum, which is located below the aortic valve, is often more pronounced, and is the most prominent cause of left ventricular outflow stenosis and even obstruction, with little or no hypertrophy of the medial and apical portions of the ventricular septum. The radio frequency ablation in the heart cavity is a new technology for treating obstructive hypertrophic cardiomyopathy, for example, the radio frequency ablation is carried out by adopting a radio frequency ablation needle to enter the heart muscle.

Referring to fig. 3, fig. 3 is a schematic structural diagram of an ablation system 1000 according to the present application.

In some embodiments, the ablation system 1000 can include an energy generator 200 and an ablation device 100, the energy generator 200 being configured to provide energy to the ablation device 100, the ablation device 100 being electrically connected to the energy generator 200. The ablation device 100 can include a sheath 30, a handle assembly 20 and a ablation puncture assembly 10, wherein the ablation puncture assembly 10 is movably disposed in the sheath 30, and the proximal ends of the ablation puncture assembly 10 and the sheath 30 are both connected to the handle assembly 20. Wherein ablation assembly 10 is electrically connected to energy generator 200 via handle assembly 20, and energy generator 200 is configured to provide ablation energy to ablation assembly 10. The ablation system 1000 of the present application is adapted for transvascular pathway ablation of myocardial tissue, and the penetrating ablation assembly 10 of the ablation system 1000 is capable of releasing energy to destroy myocardial activity of the myocardial tissue. The ablation system 1000 of the present application is particularly suitable for a scenario in which the ventricular septum is ablated via an aortic interventional path, and is mainly described below by taking ablation of the ventricular septum via the aortic interventional path as an example. It should be noted that the ablation system 1000 of the present application may also be applied to ablation of other tissues such as the ventricular wall, atrial wall, and atrial septum. In addition, the path of the ablation device 100 to the target tissue to ablate the target tissue may be: the inferior vena cava → the right atrium → the right ventricle → the target tissue, or the inferior vena cava → the right atrium → the interatrial septum → the left atrium → the left ventricle → the target tissue, etc., which is not specifically limited in the present invention.

Referring to fig. 3 and 4 in combination, fig. 4 is a schematic view of a portion of a needle ablation assembly 10 provided herein in some embodiments.

In some embodiments, ablation puncture assembly 10 can include a catheter 1 and a plurality of needles 2, with the plurality of needles 2 movably disposed through catheter 1. Multiple needles 2 can release ablation energy to the interventricular septum simultaneously or sequentially. A handle assembly 20 is attached to the proximal end of the ablation assembly 10 for controlling the extension or retraction of the plurality of needles 2 individually or simultaneously from the distal end of the catheter 1, or for controlling the extension or retraction of the plurality of needles 2 simultaneously or asynchronously from the distal end of the catheter 1. Wherein, the catheter 1 is sleeved in the inner cavity of the sheath 30, and the central axes of the sheath 30 and the catheter 1 are kept coincident under the ideal condition. In a scenario where the ventricular septum is ablated via the Aortic interventional path, the distal end of the sheath 30 is positioned on the Aortic Valve (AV) side near the Aortic arch (as shown in fig. 18B), the distal end of the catheter 1 extends out of the distal end of the sheath 30 and through the Aortic Valve into the left ventricle and then abuts the hypertrophied ventricular septum surface, and the needle 2 extends out of the distal end of the catheter 1 to insert into the ventricular septum and ablate the ventricular septum hypertrophied tissue.

Wherein the ablation energy may be, but is not limited to, radio frequency energy, microwave ablation, ultrasound energy, and the like. Illustratively, the energy generator 200 may output the ablation energy as rf ablation, and the energy generator 200 may further include an rf generating circuit electrically connected to the plurality of needles 2 for delivering the rf energy to the plurality of needles 2, and the plurality of needles 2 release the rf energy to surrounding tissue.

Referring to fig. 4 and 5 in combination, fig. 5 isbase:Sub>A cross-sectional view taken alongbase:Sub>A-base:Sub>A of ablation assembly 10 of fig. 4 in an extended state. It should be noted that fig. 4 only shows the specific structure of each of the ablation needles 3 of the puncture ablation assembly 10.

In some embodiments, the distal end of the catheter 1 is provided with at least one needle outlet 11, and a plurality of needles 2 can extend from the at least one needle outlet 11 and penetrate into the target tissue in a divergent manner to ablate the target tissue. Illustratively, the distal end of the catheter 1 is provided with a plurality of needle outlets 11, a plurality of needles 2 may protrude from the plurality of needle outlets 11 in a one-to-one correspondence, and the plurality of needles 2 penetrate into the target tissue in a divergent manner from each other. When the plurality of needles 2 extend from the plurality of needle outlets 11, the ablation assembly 10 is in an extended state, for example, the distal ends of the plurality of needles 2 are far away from each other, and the plurality of needles 2 may be substantially fan-shaped after being extended. After the plurality of needles 2 penetrate into the target tissue, the portions of the plurality of needles 2 penetrating into the target tissue are all located on the first plane E. Wherein the target tissue is a compartment divider and the first plane E is parallel or substantially parallel to the anterior to posterior compartment direction of the compartment divider (as shown in fig. 7). Wherein the first plane E is at an angle in the range of 0 ° to 8 ° to the direction of the front to back spacers of the cell gap, i.e. the first plane E can be considered to be substantially parallel to the direction of the front to back spacers of the cell gap.

In this embodiment, the puncture ablation assembly 10 has a plurality of needles 2, a plurality of needles 2 can be divergently inserted into the room interval, and a plurality of needles 2 can simultaneously form a plurality of ablation regions in the room interval respectively, so that a plurality of needles 2 can simultaneously destroy the cell activity of a plurality of regions of the room interval, so that the hypertrophic myocardial tissue of the room interval becomes thinner, the contractility is reduced, thereby rapidly reducing the phenomenon of left ventricular outflow tract obstruction, the ablation system 1000 (please refer to fig. 3) using the puncture ablation assembly 10 can effectively increase the ablation range of single ablation, thereby helping to reduce the number of ablation times, shorten the operation time, and improve the operation success rate. In addition, after the plurality of needles 2 penetrate into the target tissue, the portions of the plurality of needles 2 penetrating into the target tissue and the directions from the front space area to the rear space area of the chamber interval are located on the same plane (as shown in fig. 7), so that the ablation puncture assembly 10 of the present application can better adapt to the tissue form of the chamber interval, and the ablation accuracy is improved while the sufficient ablation is realized.

In some embodiments, the ablation assembly 10 can include a plurality of ablation needles 3, the plurality of ablation needles 3 being movably disposed through the catheter 1. For example, the number of the ablation needles 3 may be two, three, four, five, six, seven, etc. In this embodiment, the number of the ablation needles 3 is five, and the five ablation needles 3 can be uniformly arranged in the catheter 1. Wherein each ablation needle 3 may comprise a main body section 4 and one needle 2 at the distal end of each main body section 4, i.e. the penetrating ablation assembly 10 may comprise five needles 2. Illustratively, when the ablation assembly 10 is in the extended state, the main body section 4 of the ablation needle 3 is housed in the catheter 1, and the needle tip 2 of the ablation needle 3 is exposed relative to the catheter 1.

In some embodiments, the needle 2 may include a needle tip 21 and a flat ablation section 22 connected between the needle tip 21 and the body section 4. Wherein in a normal case, the needle tip 21 and the flat ablation section 22 can be used to form an energy release region, and the needle tip 21 and the flat ablation section 22 penetrate into the interventricular septum and release ablation energy to ablate the interventricular septum. Illustratively, the flat ablation segment 22 may be a solid rod or a hollow tube, and the flat ablation segment 22 may be made of a metal material with good electrical conductivity, so as to achieve the electrical conductivity function and achieve the purpose of releasing the rf energy. Illustratively, the flat ablation segment 22 may be made of a metallic material such as stainless steel, nitinol, or the like. The straight ablation segment 22 may be generally linear.

In some embodiments, the needle tip 21 and the straight ablation section 22 may be an integral structure, or the needle tip 21 and the straight ablation section 22 may be two separate structures. The distal end of the needle 2 has a sharp tip to facilitate smooth penetration of the needle 2 into the myocardial tissue. The needle tip 21 may be a conical needle tip, a triangular pyramid needle tip, a single bevel needle tip, etc., and the needle tip 21 in the present embodiment is a conical needle tip, for example. In order to enhance the visualization of the needle tip 21 under an external imaging device such as Computed Tomography (CT), the surface of the needle tip 21 may be coated with a gold coating or other radiopaque coating material. The needle tip 21 may be made of an electrically conductive material, and when the needle tip 21 is made of an electrically conductive material, the needle tip 21 may be used to release ablation energy. Furthermore, the needle tip 21 may also be made of an insulating material, in which case the needle tip 21 is not used for releasing ablation energy. Illustratively, the needle tip 21 in the embodiments of the present application is made of an electrically conductive material for releasing ablation energy. For example, the needle tip 21 may be made of a rigid conductive material, such as nickel titanium (NiTi) alloy (nitinol, etc.), nickel cobalt alloy, copper zinc aluminum (CuZnAl) alloy, etc. The needle tip 21 may also be made of biocompatible stainless steel or other materials, so that the needle tip 21 can smoothly penetrate myocardial tissue. Wherein the distal end of the needle tip 21 may be open or closed, and when the distal end of the needle tip 21 is open, the distal opening of the needle tip 21 may be used to release a drug or to release a cooling fluid.

In some embodiments, the body section 4 may be a solid rod-like structure or a hollow tubular structure. The body section 4 may be made of an insulating material or a conductive material covered with an insulating layer. Illustratively, the main body segment 4 in the embodiment of the present application is made of a metal material whose surface is covered with an insulating layer. The insulating layer of the main body section 4 may be formed by a layer of polymer material heat-shrinkable wrapping on the surface of the metal material, or formed by an insulating sleeve directly sleeved on the outer side of the metal material, or formed by a layer of polymer material attached to the surface of the metal material by a coating process. The insulating layer of the main body section 4 is made of a material with a low friction coefficient and a high insulation resistance, the low friction coefficient can endow the ablation needle 3 with good lubricity and pushing performance, and the high insulation resistance can enable the insulating layer of the main body section 4 to still keep good dielectric insulation performance under the action of high-frequency radio-frequency current without breakdown.

When the insulating layer of the main body section 4 is in the form of an insulating sleeve sleeved outside the metal material, the insulating sleeve can axially slide relative to the main body section 4 and the flat ablation section 22, so that the energy release area of the needle head 2 is adjustable, and the flexibility of the needle head 2 in energy release is improved. In this case, the insulating layer of the main body section 4 may be made of Polyetheretherketone (PEEK) or Polyimide (PI).

When the insulating layer of the main body section 4 is formed by coating the insulating layer on the surface of the metal material through thermal shrinkage of a polymer material, the insulating layer may be made of Polyethylene terephthalate (PET), polytetrafluoroethylene (PTFE), fluorinated ethylene propylene copolymer (FEP), or the like. When the insulating layer of the main body section 4 is formed by adhering a polymer material to the surface of the metal material through a coating process, the insulating layer may be Parylene (Parylene).

In some embodiments, the body section 4 may be made of a metallic material including, but not limited to, stainless steel, nitinol, and the like. In other embodiments, when the body segment 4 can also be made of an insulating material, for example, the body segment 4 can be made of a polymer material such as polyetheretherketone, polyimide, etc., which is not limited in this application. In this embodiment, the main body section 4 is made of a metal material such as stainless steel, nickel-titanium alloy, or a polymer material such as polyetheretherketone, polyimide, or the like, so that the main body section 4 has good bending resistance, pushing performance, and surface lubricity, and thus the needle head 2 can smoothly puncture myocardial tissue, and the main body section 4 does not deform greatly, which is helpful for improving the puncture accuracy of the needle head 2.

In some embodiments, the main body section 4 and the flat ablation section 22 of the needle 2 may be a unitary structure. In other embodiments, the distal end surface 14 of the main body segment 4 is connected to the proximal end surface of the flat ablation segment 22, or the distal end of the main body segment 4 is sleeved on the outer side surface or the inner side surface of the proximal end of the flat ablation segment 22, and the connection manner of the main body segment 4 and the flat ablation segment 22 may be bonding, welding, crimping, welding, etc.

In some embodiments, the ablation assembly 10 may further include an electrical lead (not shown in FIG. 5), the distal end of which is electrically connected to the proximal end of the body segment 4 and the proximal end of which is electrically connected to the energy generator 200 when the body segment 4 is made of an electrically conductive material with an insulating coating on the surface. Ablation energy is transferred to the needle 2 through the main body section 4, thereby achieving an electrical connection between the needle 2 and the energy generator 200 (see again fig. 3).

In other embodiments, when the main body segment 4 is made of an insulating material, the main body segment 4 may have an axially extending lumen, and the distal end of the electrical lead (not shown in fig. 5) may be electrically connected directly to the flat ablation segment 22 of the needle 2 through the lumen of the main body segment 4, thereby providing an electrical connection between the needle 2 and the energy generator 200.

Referring to fig. 5 to 7, fig. 6 isbase:Sub>A schematic cross-sectional view of the catheter 1 shown in fig. 4 taken alongbase:Sub>A-base:Sub>A, and fig. 7 isbase:Sub>A schematic cross-sectional view of the plurality of needles 2 shown in fig. 3 taken along B-B after puncturing the heart.

In some embodiments, the catheter 1 may include a guide section 12 and a body section 13, the guide section 12 being located at the distal end of the catheter 1, the guide section 12 being attached to the distal end of the body section 13. The body tube section 13 and the guide section 12 may be an integral structural member. In other embodiments, the main body pipe section 13 and the guide section 12 may also be formed by connecting two structural members, and the connection manner of the main body pipe section 13 and the guide section 12 may be welding, clamping, bonding, sleeving, and the like.

Wherein, direction section 12 is equipped with a plurality of direction chambeies 121, and a plurality of direction chambeies 121 are the setting of interval each other, and a plurality of direction chambeies 121 extend to the distal end of direction section 12 from the near-end of direction section 12, and a plurality of needle outlets 11 are communicated to the distal end one-to-one of a plurality of direction chambeies 121, and a plurality of syringe needles 2 one-to-one activity is worn to locate in a plurality of direction chambeies 121. Of the plurality of guide lumens 121, at least some of the distal ends of the guide lumens 121 extend divergently away from the axis of the catheter 1 with respect to the proximal ends thereof. After the needles 2 respectively extend from the distal ends of the guide cavities 121 (i.e. the needle outlets 11), the needles 2 can be inserted into the compartment in a divergent manner.

In this embodiment, through setting up a plurality of direction chambeies 121 at pipe 1 and leading to a plurality of syringe needles 2 respectively, a plurality of direction chambeies 121 can be spacing to a plurality of syringe needles 2 respectively in the footpath of pipe 1 to guarantee that a plurality of syringe needles 2 can not take place skew swing by a wide margin in the footpath of pipe 1 at the puncture in-process, and then help promoting stability and the accurate nature that the subassembly 10 punctures of puncture.

In some embodiments, the axes of the plurality of guide lumens 121 are spaced apart from each other in an axial cross-section of the catheter 1. Illustratively, the plurality of guide cavities 121 are arranged at intervals, and the axes of the plurality of guide cavities 121 may all be located on the same plane, which is an axial section of the catheter 1. Wherein the axial direction is the direction in which the axis of the catheter 1 is located. In this embodiment, at the position limited by the plurality of guide cavities 121, the plurality of needles 2 extend out from the guide section 12 along the extending direction of the guide cavities 121, and the plurality of needles 2 are spaced from each other, so as to avoid mutual interference among the plurality of needles 2, and further increase the stability of puncture of the ablation assembly 10.

Illustratively, the guide lumen 121 located at the most intermediate position among the plurality of guide lumens 121 is a central guide lumen 1211 (when the number of the guide lumens 121 is an odd number, the number of the central guide lumen 1211 is 1, when the number of the guide lumens 121 is an even number, the number of the central guide lumen 1211 is two, in the present embodiment, the number of the guide lumens 121 is 5, and the number of the central guide lumen 1211 is 1), the guide lumen 121 located at the radially outermost position among the plurality of guide lumens 121 is an edge guide lumen 1212, the central guide lumen 1211 extends in the axial direction of the catheter 1, the distal end of the edge guide lumen 1212 extends divergently away from the axial direction of the catheter 1 with respect to the proximal end thereof, and from the central guide lumen 1211 to the edge guide lumen 1212, the distal end of each guide lumen 121 extends divergently away from the axial direction of the catheter 1 with respect to the proximal end thereof. The number of the guide cavities 121 corresponds to the number of the needles 2, and exemplarily, the number of the guide cavities 121 is five, five guide cavities 121 can be uniformly arranged in the catheter 1, and five guide cavities 121 are movably arranged in the five guide cavities 121 in a one-to-one correspondence.

In some embodiments, a plurality of needle outlets 11 are provided on the distal end face 14 of the catheter 1. During the operation, the distal end of the guide section 12 is first placed against the thickened compartment space surface, and the handle assembly 20 (see fig. 3) controls the plurality of needles 2 to extend from the plurality of needle outlets 11 on the distal end surface 14 of the catheter 1 to penetrate into the compartment space. Illustratively, five needles 2 extend from five needle outlets 11 along five guide cavities 121, respectively, and then penetrate directly into the interventricular septum.

Compared with the ablation component with needle outlets arranged on the side wall of the distal end of the catheter, in the embodiment, the plurality of needle outlets 11 are arranged on the distal end surface 14 of the catheter 1, so that the plurality of needles 2 can directly penetrate into the ventricular septum after respectively extending out of the plurality of needle outlets 11, and the plurality of needles 2 can be ensured to penetrate into the ventricular septum in the expected direction. Meanwhile, under the limit of the guide cavities 121, the extending directions of the needle heads 2 are not easy to change during puncturing, and the needle heads 2 cannot interfere with each other, so that the puncturing stability of the puncture ablation assembly 10 is further improved.

In some embodiments, the unilateral gap between the outer surface of the straight ablation segment 22 and the inner wall of the corresponding guide cavity 121 is 0.05mm to 0.15mm, and the gap between the needle head 2 and the guide cavity 121 is small, so that it is ensured that the resistance of the needle head 2 moving in the guide cavity 121 is small, the needle head 2 can move smoothly in the guide cavity 121, and it is ensured that the plurality of needle heads 2 do not generate offset swing in the radial direction of the catheter 1 during the puncturing process, thereby improving the stability and accuracy of puncturing by the puncturing ablation assembly 10.

Illustratively, the outer diameter of the catheter 1 is in the range of 3.0mm to 5.0mm, the diameter of the guide lumen 121 is between 0.4mm to 1.0mm, the diameter of the straight ablation segment 22 is in the range of 0.3mm to 0.95mm, and the axial length of the guide lumen 121 is in the range of 5mm to 10 mm.

In some embodiments, the main body tube section 13 is provided with a hollow lumen 131, the hollow lumen 131 extends from the proximal end of the main body tube section 13 to the distal end of the main body tube section 13, the hollow lumen 131 is communicated with the guide cavity 121, and the main body sections 4 of the plurality of ablation needles 3 are movably arranged in the hollow lumen 131. Illustratively, the number of the hollow lumens 131 may be plural, and the plural hollow lumens 131 are arranged at intervals. The plurality of guide cavities 121 extend in the axial direction of the body tube section 13, and are arranged substantially parallel to each other with the plurality of guide cavities 121. The plurality of hollow lumens 131 are in one-to-one communication with the plurality of guide lumens 121, and the main body segments 4 of the plurality of ablation needles 3 are inserted into the plurality of hollow lumens 131 in one-to-one correspondence.

In other embodiments, the plurality of hollow lumens 131 of the main body tube section 13 may also be radially combined into one cavity, that is, the main body tube section 13 is provided with only one cavity, and the main body sections 4 of the plurality of ablation needles 3 are all accommodated in the one cavity, which is not strictly limited in this application.

In some embodiments, the distal face 14 of the catheter 1 is a curved face that is convex in the distal direction. Wherein the distal direction is a direction pointing from the proximal end of the catheter 1 to the distal side of the catheter 1. Illustratively, the radius of curvature of the distal end face 14 of the catheter 1 may be between 0.8mm and 2.5 mm.

In this embodiment, the distal end surface 14 of the catheter 1 is configured to be a cambered surface, so that the catheter 1 is more matched with the shape of the compartment wall, and the catheter 1 can be more stably attached to the compartment wall, thereby improving the stability of needle extraction of the puncture ablation assembly 10. Wherein, the needle withdrawing refers to the process that a plurality of needle heads 2 extend out of the catheter 1 to penetrate into target tissues. On the other hand, the distal end surface 14 of the catheter 1 is a cambered surface, which can increase the space between the needle outlets 11 without increasing the radial size of the catheter 1, thereby reducing the mutual interference between the needles 2. In addition, the distal end surface 14 of the catheter 1 is provided with a cambered surface, so that at least the guide cavity 121 (such as the edge guide cavity 1212) close to the outer side among the plurality of guide cavities 121 can divergently extend in a direction away from the axis of the catheter 1, the curvature of the distal end of the guide cavity 121 is smaller, and therefore the resistance of the ablation needle 3 to needle discharge is reduced, and the needle discharge smoothness is increased.

Referring to fig. 4, 7 and 8, fig. 8 is a sectional view of the catheter 1 shown in fig. 4 taken along the line C-C. In fig. 8, one needle outlet 11 of the plurality of needle outlets 11 of the catheter 1 is shown.

In some embodiments, the number of the needle outlets 11 of the catheter 1 is multiple, the multiple needle outlets 11 are spaced apart from each other and arranged on the distal end surface 14 of the catheter 1, the multiple needle outlets 11 correspond to the multiple needles 2 one by one, and projections of the multiple needle outlets 11 on a radial cross section of the catheter 1 are arranged along a straight line.

In this embodiment, a plurality of needles 2 one-to-one extend out of the catheter 1 from a plurality of needle outlets 11, the projections of the plurality of needle outlets 11 on the radial cross section of the catheter 1 are arranged along a straight line, so that after the plurality of needles 2 extend out of the catheter 1 and penetrate into target tissues, the portions of the plurality of needles 2 penetrating into the target tissues are all located on the first plane E, and the projections on the radial cross section of the catheter 1 are also arranged along a straight line, so that the arrangement directions of the penetrating points formed by the plurality of needles 2 on the ventricular septum are approximately the same as the extension direction of the basal part of the ventricular septum on the short-axis tangent plane of the left ventricle, so that the plurality of needles 2 can better match with tissue forms after extending out, and the accuracy of penetration of the ablation assembly 10 is improved.

It should be noted that the cross-section of the heart taken at B-B shows a short-axis slice of the left ventricle. The short axis slice of the left ventricle can be divided into six regions: anterior spacer a, anterior region b, anterolateral region c, posterolateral region d, posterior region e, posterospacer f. Wherein the cell compartments include anterior and posterior spacers a and f. In the long axis direction of the left ventricle, the ventricular septum is subdivided into three parts: a base portion, an intermediate portion, and an apex portion (see fig. 1). In the phenotype of hypertrophic cardiomyopathy, which is the most common and most influential to patients, it is generally manifested as an increase in the hypertrophy of the base portion located below the aortic valve in the ventricular septum, and therefore the target tissues for piercing the ablation assembly 10 are the anterior spacer region a of the base portion and the posterior spacer region f of the base portion (hereinafter simply referred to as the anterior septum base portion and the posterior septum base portion, respectively), and the longitudinal direction of the target tissues is parallel to the direction from the anterior septum base portion to the posterior septum base portion.

In the present embodiment, the number of the needles 2 is five, and the arrangement direction of the puncture points formed on the compartment interval by the five needles 2 is approximately the same as the length direction of the target tissue, so that the five needles 2 can be well adapted to the shape of the target tissue after being extended. While achieving adequate ablation, the number of needles 2 required to penetrate the ablation assembly 10 is minimized, thereby reducing the size of the required device (e.g., minimizing the radial dimension of the catheter 1), and increasing the flexibility of the catheter 1 as a whole, making it easier to push the catheter 1 through a tortuous vessel. In addition, the arrangement of the projections of the five needle outlets 11 on the radial section of the catheter 1 are arranged along a straight line, which helps to further define the puncture regions of the five needles 2, so that all or most of the puncture points formed by the five needles 2 on the ventricular septum are located in the target tissue, and ablation of heart tissue not to be ablated by the five needles 2 (for example, the middle part and the apex part of the ventricular septum) can be avoided, thereby reducing the damage of the ablation assembly 10 to the tissue not to be ablated, and improving the accuracy of puncturing by the ablation assembly 10.

In some embodiments, the spacing between any two adjacent needle outlets 11 in the plurality of needle outlets 11 is equal. Illustratively, five needle outlets 11 are evenly distributed on the distal end face 14 of the catheter 1 in the radial direction of the catheter 1, and the five needle outlets 11 are symmetrically arranged with respect to the axis of the catheter 1. The needle outlet 11 located at the most intermediate position is oriented substantially in the same direction as the axial direction of the catheter 1. In the present embodiment, five needle outlets 11 are uniformly distributed on the distal end surface 14 of the catheter 1 along the radial direction of the catheter 1, so that the stress on the whole of the plurality of needle heads 2 is uniform, and the needle outlet stability of the ablation assembly 10 can be ensured.

Referring to fig. 7 again, in some embodiments, the orientations of the needle outlets 11 on the same plane are different, after the needles 2 extend from the corresponding needle outlets 11, the needles 2 are divergent, and a first included angle θ between two needles 2 with the farthest interval satisfies: theta is more than or equal to 90 degrees and less than or equal to 130 degrees. Preferably, the first angle θ between the two most spaced needles 2 is between 95 ° and 115 °. It will be appreciated that, since the base portion is generally circular in shape around the short-axis tangential plane of the left ventricle (as shown in figure 7), the base portion corresponds to a central angle of between approximately 85 ° and 125 °. After a plurality of syringe needles 2 stretched out from the needle outlet 11 that corresponds, first contained angle theta between two syringe needles 2 that the interval was farthest was between 95 to 115, and a plurality of syringe needles 2 stretched out the back and whole or most can insert the basilar part just to insert non-target tissue when can avoiding a plurality of syringe needles 2 to stretch out, lead to irreversible damage to other cardiac muscle tissue that need not melt, thereby help improving the accurate nature of puncture ablation subassembly 10 puncture.

In some embodiments, after the plurality of needles 2 are extended, the included angle between any two adjacent needles 2 may be the same or different. Illustratively, after the plurality of needles 2 are extended, the included angle β between any two adjacent needles 2 may be 25 °, and the first included angle θ between the two needles 2 which are most spaced apart is 100 °. In other embodiments, the included angle β between two adjacent needles 2 may gradually increase or decrease from the middle to both sides, which is not strictly limited in this application.

Referring to fig. 5, 7 and 9 in combination, fig. 9 isbase:Sub>A cross-sectional view taken along linebase:Sub>A-base:Sub>A of ablation assembly 10 of fig. 4 inbase:Sub>A retracted state.

In some embodiments, the needle 2 located at the most middle position among the plurality of needles 2 is the central needle 23 (when the number of needles 2 is an odd number, the number of the central needles 23 is 1, and when the number of the central needles 23 is an even number, the number of the central needles 23 is two, in this embodiment, the number of needles 2 is 5, and the number of the central needles 23 is 1), and the needles 2 located at the most radially outer positions among the plurality of needles 2 are the edge needles (in this embodiment, the edge needles include the first edge needle 26 and the second edge needle 27). When the ablation assembly 10 is in the retracted state, the plurality of needles 2 are housed in the catheter 1, and the distal end of each needle 2 has a corresponding initial position. When the distal ends of the plurality of needles 2 have the same stroke and extend from the corresponding initial positions to the corresponding needle outlets 11, the extending lengths of the needles 2 from the central needle 23 to the edge needles relative to the corresponding needle outlets 11 gradually increase. Wherein the protruding length refers to the axial length of the portion of each needle 2 protruding from the catheter 1 with respect to the corresponding needle outlet 11.

Illustratively, when ablation assembly 10 is in the retracted state, the distal end of each needle 2 is in its respective initial position, and the distal end of each needle 2 is located within its respective guide lumen 121. The five needles 2 may include a center needle 23, a first middle needle 24, a second middle needle 25, a first edge needle 26, and a second edge needle 27, wherein the center needle 23, the first middle needle 24, and the first edge needle 26 are arranged in order from the most middle position to the most outer position, and the center needle 23, the second middle needle 25, and the second edge needle 27 are arranged in order from the most middle position to the most outer position. After the central needle 23, the first intermediate needle 24, the second intermediate needle 25, the first edge needle 26 and the second edge needle 27 extend from the corresponding needle outlet 11 by the same stroke from the corresponding initial positions, the lengths of the central needle 23, the first intermediate needle 24, the second intermediate needle 25, the first edge needle 26 and the second edge needle 27 extending from the corresponding needle outlet 11 are L1, L2, L3, L4 and L5, respectively, wherein L1 < L2= L3 < L4= L5, and the ratio of L4 (L5) to L1 may be 1.2 to 1.8.

In the present embodiment, the plurality of needles 2 are inserted into the chamber space together after being extended, and the needle 2 located at the outer position is deviated from the axis of the catheter 1 by a larger deviation angle in the thickness direction of the chamber space (i.e., the axial direction of the catheter 1). When the protruding lengths of the plurality of needles 2 are the same or the protruding lengths of the edge needles (first edge needle 26, second edge needle 27) are smaller than the protruding length of the central needle 23, the piercing depth of the central needle 23 is larger than the piercing depths of the edge first edge needle 26 and second edge needle 27, so that the central needle 23 is easy to approach or the piercing compartment space injures the conducting nerve on the right compartment face (i.e. the compartment space approaches the surface of the right ventricle) and the conducting nerve close to the right compartment face. In the plurality of needles 2, the extending length from the central needle 23 to the first edge needle 26 (or the second edge needle 27) relative to the corresponding needle outlet 11 is gradually increased, so that the central needle 23 is prevented from injuring the conducting nerve on the right ventricle and close to the right ventricle, and meanwhile, the penetration depth of the edge needles (the first edge needle 26 and the second edge needle 27) can be ensured to meet the ablation requirement, thereby improving the ablation effect of the ablation assembly 10.

In some embodiments, when the distal ends of the plurality of needles 2 are located at the corresponding initial positions, the distal end of each needle 2 can be displaced in the distal direction along the axial direction of the corresponding guide cavity 121 to the corresponding needle outlet 11, wherein the displacement corresponding to the central needle 23 to the edge needle in the plurality of needles 2 is gradually reduced. Illustratively, the axial distances of the central needle 23, the first intermediate needle 24, the second intermediate needle 25, the first edge needle 26 and the second edge needle 27 to the distal end face 14 of the catheter 1 are respectively: l6, L7, L8, wherein L6 > L7 > L8, the axial distance of the distal end of the plurality of needles 2 to the distal end face 14 of the catheter 1 should be at least greater than 1mm, illustratively, L6 may be between 3mm and 5mm, L7 may be between 2mm and 4mm, L8 may be between 1mm and 3mm.

In the present embodiment, in order to realize that the protruding lengths of the needles 2 from the central needle 23 to the edge needles (the first edge needle 26 and the second edge needle 27) gradually increase when the needles are simultaneously ejected, the corresponding displacement amount from the central needle 23 to the edge needles in the needles 2 is gradually reduced before the needles are ejected, so that the protruding lengths from the central needle 23 to the edge needles in the needles 2 gradually increase under the same pushing stroke. Furthermore, by providing an axial distance of the distal ends of the plurality of needles 2 to the distal end face 14 of the catheter 1 of at least more than 1mm, the influence of the plurality of needles 2 on the bending of the distal end of the catheter 1 can be reduced, such that the influence of the plurality of needles 2 on the bending of the distal end of the catheter 1 is minimized.

Referring to fig. 10 and 11 in combination, fig. 10 is a schematic illustration of a portion of ablation assembly 10 of fig. 4 in some embodiments, and fig. 11 is a schematic illustration of a portion of the internal structure of ablation assembly 10 of fig. 10. It should be noted that only one of the plurality of needle outlets 11 of the catheter 1 and only one of the plurality of guide lumens 121 are labeled in fig. 10 and 11.

In some embodiments, ablation assembly 10 may further include a first and a second developing member 51, 52, wherein first and second developing members 51, 52 are disposed on an outer sidewall of catheter 1, and first and second developing members 51, 52 are disposed in a direction parallel to first plane E. Illustratively, the first and second developing members 51 and 52 are disposed opposite to each other. The arrangement direction of the first and second developing members 51 and 52 may be a direction in which the first developing member 51 is directed toward the second developing member 52, or a direction in which the second developing member 52 is directed toward the first developing member 51. The axes of the plurality of guide cavities 121 of the catheter 1 are all located on a first plane E, and the arrangement direction of the plurality of needle outlets 11 is parallel to the first plane E. Wherein, the projections of the plurality of needle outlets 11 on the same radial plane of the catheter 1 can be arranged approximately in a straight line, and the first and second developing members 51 and 52 can be arranged approximately along the straight line.

In this embodiment, the first and second developing members 51 and 52 can be used to indicate the position of the distal end of the catheter 1 and the arrangement direction of the plurality of needle outlets 11 at the distal end of the catheter 1, so that the operator can adjust the direction of the catheter 1 to make the arrangement direction of the plurality of needle outlets 11 substantially the same as the length direction of the inter-chamber space, thereby helping to reduce the difficulty of using the ablation puncture assembly 10. In addition, the five needle outlets 11, the first development member 51, and the second development member 52 are arranged substantially along the same straight line, thereby enabling the operator to more intuitively acquire the arrangement direction of the plurality of needle outlets 11 at the distal end of the catheter 1 according to the positions of the first development member 51 and the second development member 52.

In some embodiments, the first and second developing members 51 and 52 may be attached to the outer sidewall of the distal end of the catheter 1 in a substantially block shape. Illustratively, the outer surfaces of the first and second visualization members 51, 52 may both be flush with the outer sidewall of the distal end of the catheter 1. For example, the outer side wall of the distal end of the catheter 1 may be provided with two grooves, the two grooves are oppositely arranged, and the arrangement direction of the two grooves is parallel to the first plane E. The first and second developing members 51 and 52 are formed by filling a developing material in the two grooves. The first and second developing members 51 and 52 may be made of a radiopaque metal material, such as platinum, tantalum, gold, and other metals and alloys thereof, which are not limited in this application.

Referring to fig. 12, fig. 12 is a schematic view of a portion of a puncture ablation assembly 10 in accordance with still further embodiments of the present disclosure. It should be noted that, this embodiment may include most technical features of the previous embodiment, the main difference between this embodiment and the previous embodiment is the difference of the structure of the ablation needle 3, and the difference between the two is mainly described below, and most of the same contents of the two are not described again.

In some embodiments, the ablation assembly 10 may include an ablation needle 3, the ablation needle 3 having a plurality of needles 2. Illustratively, the ablation needle 3 may include a plurality of needles 2 and a body section 4, the plurality of needles 2 being connected to a distal end of the body section 4. The specific structure and material of the needle 2 and the main body segment 4 can be referred to the above description, and the detailed description is omitted here. Wherein the catheter 1 may comprise a guiding section 12 and a main body section 13, the guiding section 12 being connected to the distal end of the main body section 13. The guiding section 12 is provided with a plurality of guiding cavities 121 arranged at intervals, the main body tube section 13 is provided with a hollow tube cavity 131, the hollow tube cavity 131 extends from the proximal end of the main body tube section 13 to the distal end of the main body tube section 13, the hollow tube cavity 131 is communicated with the plurality of guiding cavities 121, and the main body section 4 of the ablation needle 3 is accommodated in the hollow tube cavity 131 of the guiding section 12. In this embodiment, the main body section 4 is pushed to move in the distal direction, so as to control the multiple needles 2 of the ablation needle 3 to synchronously extend, and the main body section 4 is pushed to move in the proximal direction, so as to control the multiple needles 2 of the ablation needle 3 to synchronously retract.

Referring to fig. 13 and 14 in combination, fig. 13 is a schematic cross-sectional view (one) taken along line D-D of ablation assembly 10 of fig. 4 in an extended state, and fig. 14 is a schematic cross-sectional view (two) taken along line C-C of catheter 1 of fig. 4. It should be noted that the ablation assembly 10 shown in fig. 4 does not show the anchoring element 6.

In some embodiments, the ablation assembly 10 may further include an anchoring element 6, a distal end of the anchoring element 6 being sharpened, an anchoring lumen 15 being disposed in the catheter 1, the anchoring lumen 15 extending axially through the catheter 1, the anchoring element 6 being movably threaded in the anchoring lumen 15 and capable of extending beyond a distal end of the catheter 1 into the target tissue for anchoring to the target tissue. Illustratively, the anchoring cavities 15 extend through the proximal and distal ends of the catheter 1 in the axial direction of the catheter 1, and the diameter of the anchoring cavities 15 may be between 0.4mm and 3mm.

In this embodiment, the anchoring member 6 is adapted to anchor to the target tissue so that the distal surface 14 of the catheter 1 can be stably attached to the surface of the ventricular septum hypertrophic tissue, thereby facilitating the subsequent stable penetration of the plurality of needles 2 into the hypertrophic myocardial tissue. The distal end of anchor member 6 is sharpened to facilitate smooth penetration of anchor member 6 into the target tissue. It will be appreciated that due to the constant beating of the heart muscle, the distal end of the catheter 1 is difficult to rest stably against the hypertrophied septa of the chamber, which in turn affects the accuracy of the position and direction of the puncture site of the needle 2. Meanwhile, as the ablation needle 3 assembly is provided with the plurality of needles 2, when the puncture point position and the puncture direction are inaccurate, the plurality of needles 2 are difficult to retract into the catheter 1 and are easy to break. The puncture ablation assembly 10 enables the distal end of the catheter 1 to be stably attached to a thick compartment wall by arranging the anchoring piece 6, so that the stability of puncture of the plurality of needles 2 is increased, and the puncture point position and the puncture direction are more accurate. And the catheter 1 is stably attached to the chamber interval through the anchoring piece 6, the plurality of needles 2 can be more smoothly retracted into the catheter 1, the needles 2 are prevented from being broken, and the stability, accuracy and reliability of the puncture ablation assembly 10 are improved, so that the success rate of the operation is improved.

In some embodiments, the proximal end of anchor 6 has pusher 7 attached thereto, and the proximal end of pusher 7 is attached to handle assembly 20 (not shown in fig. 13), which handle assembly 20 is also used to drive anchor 6 out of or back out of the distal end of catheter 1. The distal end of anchor member 6 is sharpened to facilitate smooth penetration of anchor member 6 into the target tissue. The anchoring element 6 is radially constrained when received in the anchoring cavity 15, and the anchoring element 6 is restored from the radially constrained state to the radially expanded state after being extended from the distal end of the catheter 1.

In this embodiment, anchor member 6 is radially constrained when received in anchor lumen 15 so that anchor member 6 can be readily received in anchor lumen 15 of catheter 1 when anchor member 6 is not in use. Anchoring elements 6 are radially constrained and radially expanded after being extended from the distal end of catheter 1 to facilitate smooth penetration of the distal ends of anchoring elements 6 into the target tissue, and to provide secure fixation of anchoring elements 6 to the myocardial tissue, thereby facilitating a reduction in the difficulty of using ablation assembly 10.

Wherein the anchoring element 6 and the pushing element 7 may be an integrated structure. Alternatively, anchor 6 and pusher 7 may be two pieces, with the proximal end of anchor 6 being fixedly attached to the distal end of pusher 7, e.g., pusher 7 may be fixedly attached to anchor 6 by welding, adhesive bonding, etc.

In some embodiments, when anchor member 6 is in a radially expanded state, anchor member 6 includes at least one helical structure. Illustratively, the anchor 6 comprises at least one helical structure. In this embodiment, anchor member 6 can be screwed into myocardial tissue after being unscrewed from anchoring cavity 15, and the helical structure provides anchor member 6 with greater stability of anchoring tissue and is less likely to interfere with the penetration of multiple needles 2 into the ventricular septum. After the tip of the spiral structure of anchoring element 6 penetrates into the tissue, the surface area of anchoring element 6 in contact with the target tissue can be greatly increased, so that anchoring element 6 is firmly fixed in the tissue, anchoring element 6 can stably maintain a radial expansion state, and is not easy to deform and pull off, which is helpful for enhancing the stability of ablation puncture assembly 10.

In other embodiments, the anchoring element 6 may be a hook-shaped structure, a claw-shaped structure, an expandable spherical structure, an umbrella-shaped structure, etc., which is not strictly limited in this application.

Wherein the anchoring element 6 may have a continuously uniform and/or varying cross-section (i.e. the anchoring element 6 is helical). When anchor 6 is fully in the radially expanded condition, anchor 6 has a length in the range of 3mm to 10mm, an outer diameter in the range of 0.2mm to 3mm, and a penetration depth in the range of 2mm to 7 mm.

Wherein, the spiral structure of the anchoring element 6 can be made of rigid biocompatible metal material or material with shape memory function. The rigid biocompatible metal material can be one or more of iron, steel, copper, titanium, nickel and chromium. Illustratively, the anchoring elements 6 in this embodiment are made of stainless steel, and the rigid anchoring elements 6 are not easy to be separated from the myocardial tissue, and the anchoring stability is good.

Wherein the outer surface of the anchoring element 6 may also be coated or covered with a hydrophilic coating (not shown in fig. 13). The hydrophilic coating may be a hydrophilic material having a hydroxyl group, an amide group, an amino group, a carboxyl group, a carboxylate group, a sulfonic acid group, a sulfonate group, and/or a pyrrolidone group, etc. Since the hydrophilic coating contains a large number of hydrophilic groups, friction can be reduced and lubricity can be increased during the process of piercing the myocardial tissue by the anchor member 6.

In some embodiments, the anchoring cavities 15 are spaced apart from the plurality of guide cavities 121, with at least distal portions of the anchoring cavities 15 extending in a curved manner away from the first plane E. Illustratively, the axes of the plurality of guide cavities 121 of the catheter 1 are all located on the first plane E, the axis of the anchoring cavity 15 extends in a bending way in a direction away from the plurality of guide cavities 121, and the anchoring cavity 15 is arranged at a distance from the line connecting the plurality of needle outlets 11 at the opening of the distal end surface 14 of the catheter 1. In this embodiment, anchor chamber 15 guides anchor 6, can carry on spacingly to anchor 6 in the footpath of pipe 1, and the crooked extension of the direction of the first plane E of keeping away from a plurality of direction chambeies 121 place of at least distal portion of anchor chamber 15 can avoid anchor 6 to cause the interference to the play needle of a plurality of syringe needles 2 after stretching out anchor chamber 15, helps guaranteeing stability and the accuracy that a plurality of syringe needles 2 were gone out the needle.

In some embodiments, when anchor 6 and multiple needles 2 penetrate into the target tissue, projections of anchor 6 and multiple needles 2 on the same radial plane of catheter 1 do not overlap, so that the obstruction of needle exit by anchor 6 to multiple needles 2 can be avoided. Wherein the distal end of the anchoring cavity 15 extends curvedly away from the first plane E in which the plurality of needles 2 lie. The anchoring element 6 extends beyond the distal end of the anchoring cavity 15 and forms a second angle α with the first plane E, the second angle α satisfying: alpha is more than or equal to 30 degrees and less than or equal to 50 degrees.

In this application, anchor 6 forms the second contained angle alpha at 30 to 50 within ranges with the first plane E that a plurality of syringe needles 2 belonged to behind the distal end that stretches out anchor chamber 15 for anchor 6 can dodge a plurality of syringe needles 2 better, avoids anchor 6 to cause the interference to the play needle of a plurality of syringe needles 2, and the play needle of a plurality of syringe needles 2 is more smooth, the puncture is more accurate, helps strengthening the accuracy that melts subassembly 10.

In some embodiments, the surface of the distal end of anchor member 6 may be provided with a visualization layer, such as a gold coating or other radiopaque plating material, on the surface of the distal end of anchor member 6. The surface of the far end of the anchoring member 6 is provided with a developing layer, so that the developing performance of the far end of the anchoring member 6 under an external imaging device such as an electronic computed tomography device can be enhanced, and an operator can position and control the anchoring member 6 conveniently.

In some embodiments, the pusher 7 may be a solid thin rod or a hollow thin tube with a certain axial length, and the pusher 7 may be made of metal or polymer material. Wherein, the metal material can be one or more of iron, steel, copper, titanium, nickel or chromium. The polymer may be one or more of Acrylonitrile-Butadiene-Styrene (ABS), polyethylene (PE), polypropylene (PP), polyether block amide (PEBA), polycarbonate (PC), polyurethane resin (Polyurethane, PU), nylon (Nylon), polyvinyl chloride (PVC), polytetrafluoroethylene (ptfe), or Polybutylene (PB). The pusher 7 may be a single or single strand of rod or tube, or may be wound or braided from multiple or multiple strands of rod (or tube, wire, etc.). In the present embodiment, a single solid thin rod made of acrylonitrile butadiene styrene is used as the pushing member 7.

Referring to fig. 15, fig. 15 is a cross-sectional view taken along line D-D of ablation assembly 10 of fig. 4 in an extended state.

In some embodiments, pusher member 7 is removably received within anchor lumen 15, and pusher member 7 is at least partially threadably engaged with anchor lumen 15. Illustratively, the anchoring cavity 15 is provided with internal threads on the wall of the cavity and the pusher member 7 is provided with external threads on the outer surface thereof, the external threads of the anchoring cavity 15 engaging the internal threads of the pusher member 7. The pusher 7 is advanced distally or retracted proximally within the anchor lumen 15 by a rotating mechanism (not shown in FIG. 15) on the control handle assembly 20, which causes the anchor 6 to be released or withdrawn from the distal opening of the anchor lumen 15. Wherein, the proximal direction refers to the direction from the distal end to the proximal end.

In the present embodiment, the pusher 7 is at least partially threadedly engaged with the anchoring cavity 15, which can provide a certain anti-false-touch effect compared with a simple push-pull sliding, and the pushing distance of the anchoring element 6 is more controllable and precise, and meanwhile, it is avoided that the anchoring element 6 and the anchoring cavity 15 are undesirably displaced in the axial direction under the pulling force generated by the heart beat, and the displacement of the anchoring element 6 towards the distal end is more controllable, so that the anchoring element 6 anchors the target tissue more stably, which is helpful for improving the stability of the ablation assembly 10.

In other embodiments, pusher member 7 may also be threadably engaged with a handle in handle assembly 20, the handle having internal threads and pusher member 7 having external threads, which are not critical to the present disclosure.

In some embodiments, the cavity wall at the distal section of anchor lumen 15 is not internally threaded, and thus serves to provide a stop for anchor element 6 to control the penetration of anchor element 6 into the target tissue to a predetermined depth, preventing damage to the target tissue from excessive penetration by anchor element 6.

In some embodiments, the axial length L9 (i.e., pitch) of the internal thread section of the wall of the anchoring cavity 15 is greater than the axial length L8 (i.e., pitch) of the external thread section on the external surface of the pusher 7, and the pushing member 7 is controlled to advance or retract axially over the anchoring cavity 15 by screwing the external thread section on the external surface of the pusher 7 distally or proximally relative to the internal thread section of the wall of the anchoring cavity 15, thereby releasing or retracting the anchoring member 6 connected to the pushing member 7 from the opening at the distal end of the anchoring cavity 15. When the externally threaded section on the outer surface of pusher member 7 reaches the distal-most portion of the internally threaded section of the wall of anchoring lumen 15, anchoring element 6 is restricted from further distal movement, thereby limiting the protrusion of anchoring element 6. When the externally threaded section on the outer surface of the pusher 7 reaches the proximal most end of the internally threaded section of the wall of the anchoring lumen 15, the anchoring element 6 is restricted from further proximal movement, thereby limiting the retraction distance of the anchoring element 6.

Illustratively, the axial length L9 of the internally threaded section of the wall of the anchoring cavity 15 may be between 10mm and 20mm, and the axial length L8 of the externally threaded section on the outer surface of the pusher 7 may be between 7mm and 15mm.

In other embodiments, the anchoring element 6 can be limited in other ways, for example, the limiting of the extension and retraction of the anchoring element 6 can be achieved by providing the pusher 7 and the anchoring cavity 15 with mutually cooperating stop surfaces.

Referring to fig. 3 and 16 in combination, fig. 16 is a schematic view of the catheter 1 of fig. 3 in some embodiments.

In some embodiments, the catheter 1 may be a tubular structure having multiple lumens, comprising, in order from the proximal end to the distal end of the catheter 1: a first support section 16, a first shaping section 17 and a first bend-adjusting section 18. The first bending section 18 includes a first section 181 and a second section 182 from the distal end to the proximal end, and the first section 181 is the guide section 12 of the catheter 1. The second section 182, the first profiled section 17 and the first support section 16 together form the above-mentioned main body section 13 of the catheter 1. The handle assembly 20 is connected to the first bend adjustment section 18 by a pulling structure (not shown in fig. 16) to control the bending angle and bending direction of the first bend adjustment section 18, thereby facilitating the distal end of the catheter 1 to be able to abut against the surface of the target tissue. The bending curvature of the first plastic section 17 is basically consistent with that of the aortic arch part, so that the catheter 1 and the sheath 30 have better adaptability in the bending form.

The material hardness of the first bending adjusting section 18 may be less than that of the first molding section 17, so as to ensure that the angle of the first bending adjusting section 18 in the bending adjusting process is controllable, and prevent the first bending adjusting section 18 from driving the first molding section 17 to bend greatly in the bending adjusting process. The first supporting section 16 is mainly used for supporting the first bending adjusting section 18 and the first modeling section 17, and the material hardness of the first modeling section 17 can be smaller than that of the first supporting section 16, so that the first modeling section 17 cannot drive the first supporting section 16 to be bent greatly in the bending process. The catheter 1 may be made of a high molecular polymer material such as polyetheretherketone, polyimide, acrylonitrile butadiene styrene, polyethylene, polypropylene, polyether block polyamide, polycarbonate, polyurethane resin, nylon, polyvinyl chloride, polytetrafluoroethylene or polybutylene, or a copolymer or mixture of any of these.

In some embodiments, the first mold section 17 may be optional and the proximal end of the first turning section 18 may be directly connected to the distal end of the first support section 16.

Referring to fig. 17, fig. 17 is a schematic view of a portion of the ablation device 100 in the aorta. Note that the ablation needle of the ablation device 100 is not shown in fig. 17.

In some embodiments, the sheath 30 may be a tubular structure having a hollow lumen, and the sheath 30 includes, in order from the proximal end to the distal end, a second support section 301, a second shaping section 302, and a second bend-adjusting section 303. In operation, the proximal and distal ends of the second molding section 302 will be located at the beginning and end of the aortic arch curvature, respectively. The curvature of the second contoured section 302 substantially conforms to the curvature of the aortic arch to ensure that the second contoured section 302 can more smoothly pass the sheath 30 through the aortic arch and deliver it to a desired location. And after the sheath 30 reaches the designated position, the second plastic section 302 can be in good contact with the aortic arch part in the bending state, so that the second plastic section 302 can be fixed at the position of the aortic arch part, and the adverse effect on the operation caused by the movement of the sheath 30 is reduced as much as possible.

The hardness of the material of the second molding section 302 should not be too hard, and for example, the hardness of the material of the second molding section 302 may be in a range from 55D to 65D, so as to ensure that the second molding section 302 has good deformation performance and can maintain good shape memory after deformation. Where D (density) is a hardness index that indicates the density of the material from which the second mold section 302 is made, and the larger the data, the higher the hardness of the material. The second supporting section 301 mainly plays a role in supporting the second bending adjusting section 303 and the second molding section 302, and the material hardness of the second supporting section 301 may be greater than that of the second molding section 302, so as to ensure that the second molding section 302 does not drive the second supporting section 301 to bend greatly in the bending process. The material hardness of the second bend adjusting section 303 may be greater than that of the first bend adjusting section 18, so as to ensure that the first bend adjusting section 18 does not drive the second bend adjusting section 303 to bend greatly during the bend adjusting process. Illustratively, the sheath 30 may adopt a composite woven mesh tube structure, and the sheath 30 of such a structure can maintain high bending resistance while having good flexibility, pushing performance and twisting control performance.

Referring to fig. 3 and fig. 18A to 18D, fig. 18A to 18D are schematic views illustrating a process of using the transcatheter 1 myocardial ablation system 1000 according to the present invention.

The following will describe the operation of the myocardial ablation system 1000 via the catheter 1 by taking the working procedure of hypertrophic myocardial ablation as an example, which mainly comprises the following steps:

the first step is as follows: the sheath 30 is controlled by manipulating the handle assembly 20 to traverse the aortic valve into the left ventricle (see fig. 18A) under ultrasound and/or CT (Computed Tomography) guidance, transfemoral puncture, guidance over a guidewire (not shown in fig. 18A), and without damaging the aortic valve.

The second step is that: by operating the handle assembly 20, the control catheter 1 is advanced along the lumen of the sheath 30 across the aortic valve into the left ventricle, and the distal end of the catheter 1 protrudes beyond the distal end of the sheath 30, so that the catheter 1 crosses the aortic valve; then, the distal end of the sheath 30 is controlled to retreat from the left ventricle to the side of the aortic valve close to the aortic arch, and then the bending direction and the bending angle of the second bending adjusting section 303 at the distal end of the sheath 30 and the first bending adjusting section 18 at the distal end of the catheter 1 are controlled by the handle assembly 20, so that the distal end of the catheter 1 can be well attached to the expected puncture ablation site on the target tissue. Wherein the target tissue is located at the base of the interventricular hypertrophy (as shown in figures 17 and 18B). The catheter 1 is controlled to rotate integrally by operating the handle assembly 20, and the arrangement direction of the plurality of needles 2 in the catheter 1 is controlled to be substantially the same as the extension direction of the base portion on the short-axis tangential plane (as shown in fig. 7) of the left ventricle.

The third step: by operating handle assembly 20, control anchor 6 is extended from the distal opening of catheter 1, puncturing the interventricular septum, and reaching into the hypertrophic muscle tissue at the base of the interventricular septum. And the depth of penetration is controlled under the dual judgment of the ultrasonic image and the scale mark on the handle, so that the anchoring member 6 is stably anchored in the interventricular septum, as shown in fig. 18C.

The fourth step: by operating the handle assembly 20, the plurality of needles 2 are controlled to extend from the needle outlet 11 at the distal end of the catheter 1, to pierce the interventricular septum and into the hypertrophic musculature at the base of the interventricular septum. The puncture points formed by the plurality of needles 2 at the inter-ventricular intervals are arranged substantially in the same direction as the longitudinal direction of the target tissue. Under the dual judgment of the ultrasonic image and the scale marks on the handle, the penetration depth and the penetration angle of the multiple needles 2 are controlled (please refer to fig. 7 and 18D in combination, it should be noted that fig. 18D only illustrates one needle 2 of the ablation system 1000).

The fifth step: and starting the energy generator 200 to ablate the hypertrophic myocardial tissue at the target ablation site through the plurality of needles 2.

And a sixth step: by contrast, when the ablation volume reaches the desired size, the power output from the power generator 200 is stopped and the handle assembly 20 is operated to retract the plurality of needles 2 into the catheter 1. The second step to the sixth step in the above operation steps can be repeated once or for multiple times according to actual requirements until all target ablation point puncture and ablation are completed.

The foregoing shows and describes in detail the principles and features of the present application, with the advantages thereof. As will be understood by those skilled in the art after reviewing the principles thereof, the present application is not limited to the above-described embodiments, which are merely illustrative of the principles of the present application, and other variations and modifications which fall within the scope of the claimed application can be made without departing from the spirit and scope of the present application.

Claims

1. A puncture ablation assembly, comprising a catheter and a plurality of needles movably arranged in the catheter, wherein the distal end of the catheter is provided with at least one needle outlet, and the plurality of needles can extend out of the at least one needle outlet and are divergently punctured into target tissues to ablate the target tissues;

after the plurality of needles penetrate into the target tissue, the parts of the plurality of needles penetrating into the target tissue are all positioned on a first plane.

2. The needle ablation assembly of claim 1 wherein the target tissue is a cell compartment and the first plane is parallel or substantially parallel to a direction from an anterior compartment to a posterior compartment of the cell compartment.

3. The ablation puncture assembly of claim 1, wherein said ablation puncture assembly comprises a plurality of ablation needles movably disposed through said catheter, each of said ablation needles comprising a main body section and a needle at a distal end of each of said main body sections.

4. The ablation puncture assembly of claim 1, wherein the number of the needle outlets is plural, and the plural needle outlets are spaced apart from each other and arranged on the distal end surface of the catheter, the plural needle outlets correspond to the plural needles one by one, and projections of the plural needle outlets on a radial cross section of the catheter are arranged along a straight line;

the catheter comprises a guide section, the guide section is positioned at the far end of the catheter, the guide section is provided with a plurality of guide cavities, the guide cavities are arranged at intervals, the guide cavities extend from the near end of the guide section to the far end of the guide section, the far ends of the guide cavities are communicated with the needle outlets in a one-to-one correspondence manner, and the needle heads are movably arranged in the guide cavities in a one-to-one correspondence manner;

at least some of the guide cavities have distal ends that extend divergently away from the axis of the catheter relative to their proximal ends.

5. The needle ablation assembly of claim 1 wherein the distal surface of the catheter is curved in a distally convex manner.

6. The needle ablation assembly of claim 4 wherein the axes of a plurality of said guide lumens are spaced from one another in an axial cross-section of said catheter.

7. The needle assembly of claim 4 wherein the needle disposed at the most intermediate position of the plurality of needles is a center needle, the needle disposed at the most radially outward position of the plurality of needles is an edge needle, the distal end of each of the plurality of needles has a corresponding initial position, and the distal ends of the plurality of needles, after having traveled the same distance from the corresponding initial position to the corresponding outlet, extend from the center needle to the edge needle by a progressively increasing length relative to the corresponding outlet.

8. The assembly of claim 7, wherein when the distal ends of the plurality of needles are in the respective initial positions, the distal end of each needle is displaceable in a distal direction along the axis of the respective guide lumen to the respective needle outlet, wherein the displacement of the plurality of needles from the central needle to the peripheral needle is progressively reduced.

9. The assembly of any one of claims 1-8, wherein after a plurality of said needles extend from the corresponding needle outlets, a first included angle θ between two most spaced apart said needles satisfies: theta is more than or equal to 90 degrees and less than or equal to 130 degrees.

10. The ablation puncture assembly of any one of claims 1 to 8, further comprising a first and a second visualization member, wherein the first and second visualization members are distributed on an outer sidewall of the catheter, and wherein the first and second visualization members are arranged in a direction parallel to the first plane.

11. The ablation puncture assembly of any one of claims 1-8, further comprising an anchor, wherein the distal end of the anchor is sharpened, and wherein an anchor lumen is disposed within the catheter and extends axially through the catheter, wherein the anchor is movably threaded within the anchor lumen and is capable of extending beyond the distal end of the catheter into the target tissue for anchoring to the target tissue.

12. The ablation assembly of claim 11 wherein said anchor elements are radially constrained when received within said anchor lumen, said anchor elements returning from a radially constrained state to a radially expanded state after being extended from the distal end of said catheter.

13. The ablation assembly of claim 12 wherein said anchor includes at least one helical structure when said anchor is in a radially expanded state.

14. The needle ablation assembly of claim 13 wherein at least a distal portion of said anchor lumen extends curvedly away from said first plane.

15. The ablation assembly of claim 14 wherein said anchor extends distally of said anchor lumen at a second included angle α relative to said first plane, said second included angle α satisfying: alpha is more than or equal to 30 degrees and less than or equal to 50 degrees.

16. The ablation assembly of claim 11 wherein a pusher member is attached to a proximal end of the anchor, the pusher member being movably disposed through the anchoring lumen, the pusher member being at least partially threadably engaged with the anchoring lumen.

17. An ablation device comprising a sheath, a handle assembly and the ablation assembly of any one of claims 1-16, wherein the ablation assembly is movably disposed within the sheath, and wherein the ablation assembly and the sheath are both connected to the handle assembly.

18. An ablation system comprising an energy generator and the ablation device of claim 17, said ablation device electrically connected to said energy generator.